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Agilia VP

Agilia VP MC
Agilia VP MC WiFi
Volumetric Infusion Pumps

Applicable to software version 2.2

Technical Manual
Symbol Descriptions

Symbols Used in this Document

Warning of a potential hazard that could result in serious personal injury and/or product damage if the written
instructions are not followed.

Recommendations to be followed.

__________________________________________________________________________________________________________________

Labeling symbols

Warning
Name and address of the manufacturing facility
(Refer to the Instructions for Use)

Name and address of the manufacturer / Date of


Refer to the Instructions for Use
manufacture

Product reference / part number Protection against electric shock: class II

Product serial number Non-ionizing electromagnetic radiation

Input terminal - connector 0123


CE mark

Output terminal - connector Fragile, handle with care

Electrical fuses This way up

Alternating Current (AC) Keep away from rain

Direct Current (DC) Temperature limitation

Index of protection against solid foreign objects


IP22 Humidity limitation
(> 12.5 mm) and driping liquids

Not for use in residential areas Atmospheric pressure limitation

Part included in a recycling process General symbol for recyclable material

Protection against leakage current; defibrillation-


Eco packaging symbol
proof type CF applied part

2 11396-4_TM_Agilia_VP_range_ASU_Eng
Table of Contents

1 INTRODUCTION 6

1.1 SCOPE ................................................................................................................................................... 6


1.2 INTENDED USE ....................................................................................................................................... 6
1.3 PRINCIPLES OF OPERATION ..................................................................................................................... 6
1.4 INTENDED USERS.................................................................................................................................... 7
1.5 CONTRAINDICATIONS ............................................................................................................................... 7
1.6 USE ENVIRONMENT ................................................................................................................................. 7
1.7 SPECIFICITIES FOR HOMECARE ENVIRONMENTS ....................................................................................... 7

2 DESCRIPTION 8

2.1 PHYSICAL DESCRIPTION .......................................................................................................................... 8


2.1.1 Housing ...................................................................................................................................................... 8
2.1.2 Keypad ....................................................................................................................................................... 9
2.1.3 Display Board ........................................................................................................................................... 11
2.1.4 CPU Board ............................................................................................................................................... 14
2.1.5 Power Supply Board................................................................................................................................. 19
2.1.6 AC Power Board....................................................................................................................................... 22
2.1.7 Air Detector Board.................................................................................................................................... 23
2.1.8 Wi-Fi Board .............................................................................................................................................. 24
2.1.9 Back View................................................................................................................................................. 25
2.2 PRINCIPLES OF OPERATION ................................................................................................................... 25
2.3 OPERATION DIAGRAM ........................................................................................................................... 26

3 FUNDAMENTALS 27

3.1 TRAINING .............................................................................................................................................. 27


3.2 MAINTENANCE SCHEDULE ..................................................................................................................... 27
3.3 ACCESSING / EXITING THE OPERATING FUNCTIONS ................................................................................ 28

4 PROFILE MENU 29

4.1 ACCESSING THE PROFILE MENU ............................................................................................................ 29


4.2 PROFILE MENU FUNCTIONS ................................................................................................................... 29

5 BASIC PROFILE CONFIGURATION 30

5.1 ACCESSING THE BASIC PROFILE CONFIGURATION .................................................................................. 30


5.2 BASIC PROFILE CONFIGURATION FUNCTIONS ......................................................................................... 30

6 MAINTENANCE OPERATIONS 35

6.1 MAINTENANCE OPTIONS ........................................................................................................................ 35


6.2 RUNNING TESTS ................................................................................................................................... 37
6.2.1 Accessing the Tests Menu ....................................................................................................................... 37
6.2.2 Test 1: Identification ................................................................................................................................. 38
6.2.3 Test 2: Maintenance................................................................................................................................. 39
6.2.4 Test 3: Maintenance Messages ............................................................................................................... 39
6.2.5 Test 4: Events .......................................................................................................................................... 39
6.2.6 Test 5: Upstream Pressure ...................................................................................................................... 40
6.2.7 Test 6: Downstream Pressure.................................................................................................................. 41
6.2.8 Test 7: Door.............................................................................................................................................. 42
6.2.9 Test 8: Battery Info ................................................................................................................................... 44
6.2.10 Test 9: Indication ...................................................................................................................................... 45

3
6.2.11 Test 10: Keypad ....................................................................................................................................... 45
6.2.12 Test 11: Ageing Test ................................................................................................................................ 46
6.2.13 Test 12: Battery Life ................................................................................................................................. 48
6.2.14 Test 13: Battery Test ................................................................................................................................ 48
6.2.15 Test 14: Air Detector ................................................................................................................................ 50
6.2.16 Test 15: Anti-Free Flow Clamp Motor ...................................................................................................... 51
6.2.17 Test 16: Flow Rate ................................................................................................................................... 53
6.2.18 Test 17: Flow Rate Correction.................................................................................................................. 54
6.2.19 Test 19: Clamp ......................................................................................................................................... 55
6.2.20 Test 20: Pump Code ................................................................................................................................ 56
6.2.21 Test 21: Power Info .................................................................................................................................. 57
6.2.22 Test 22: LCD Voltage ............................................................................................................................... 58
6.2.23 Test 23: Temperature............................................................................................................................... 59
6.2.24 Test 24: Watchdog ................................................................................................................................... 60
6.2.25 Test 25: Wi-Fi Module Information ........................................................................................................... 61
6.2.26 Checking the Pressure Limit Alarm .......................................................................................................... 62
6.2.27 Checking the AC power supply / Battery Operation ................................................................................. 64
6.2.28 Electrical Test........................................................................................................................................... 64
6.2.29 Testing the Flow Rate .............................................................................................................................. 65
6.3 QUALITY CONTROL PROCEDURE............................................................................................................ 67
6.3.1 Running a Quality Control ........................................................................................................................ 67
6.3.2 Quality Control Certificate ........................................................................................................................ 71

7 TROUBLESHOOTING AND MESSAGES 72

7.1 ALARM MESSAGES AND INFORMATION SIGNALS ..................................................................................... 72


7.2 TROUBLESHOOTING GUIDE .................................................................................................................... 79
7.3 ERROR CODES ..................................................................................................................................... 80

8 INTERVENTION PROCEDURES 84

8.1 PROCEDURE #1: BATTERY AND BATTERY DOOR - BOOST CAPACITOR DISCHARGE.................................. 85
8.2 PROCEDURE #2: UPPER CASE .............................................................................................................. 87
8.3 PROCEDURE #3: DISPLAY BOARD/LCD DISPLAY .................................................................................... 89
8.4 PROCEDURE #4: CPU BOARD ............................................................................................................... 91
8.5 PROCEDURE #5: POWER SUPPLY BOARD AND AC POWER BOARD ......................................................... 94
8.6 PROCEDURE #6: WI-FI BOARD .............................................................................................................. 96
8.7 PROCEDURE #7: BASE KIT .................................................................................................................... 99
8.8 PROCEDURE #8: AIR DETECTOR BOARD .............................................................................................. 104
8.9 PROCEDURE #9: PUMPING SYSTEM ..................................................................................................... 107
8.10 PROCEDURE #10: PUMPING SYSTEM MOTOR ...................................................................................... 112
8.11 PROCEDURE #11: PRESSURE SENSORS .............................................................................................. 117
8.12 PROCEDURE #12: ANTI-FREE FLOW CLAMP MOTOR ............................................................................ 122
8.13 PROCEDURE #13: DOOR ..................................................................................................................... 125
8.14 PROCEDURE #14: MEMBRANE ............................................................................................................. 126
8.15 PROCEDURE #15: OCS FLEXIBLE IC................................................................................................... 128

9 CLEANING AND DISINFECTING 133

10 DEVICE STORAGE 134

11 POWER MANAGEMENT 135

4
12 TECHNICAL CHARACTERISTICS 136

12.1 POWER SUPPLY .................................................................................................................................. 136


12.2 BATTERY ............................................................................................................................................ 136
12.3 POWER CONSUMPTION ....................................................................................................................... 136
12.4 COMMUNICATION PORT ....................................................................................................................... 137
12.5 INFRARED COMMUNICATION ................................................................................................................ 137
12.6 AGILIA USB CABLE ............................................................................................................................. 137
12.7 DROP SENSOR CONNECTOR ............................................................................................................... 137
12.8 COMPLIANCE ...................................................................................................................................... 138
12.9 DIMENSIONS - WEIGHT ........................................................................................................................ 138
12.10 ELECTRONIC BOARDS ......................................................................................................................... 138
12.11 MATERIAL CHARACTERISTICS ............................................................................................................. 139

13 SPECIFICATIONS 140

14 RECYCLING 141

15 WARRANTY 142

16 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 143

17 SPARE PARTS CATALOG 144

18 ORDERING INFORMATION 145

18.1 DATA MANAGEMENT CABLES............................................................................................................... 145


18.2 ASSOCIATED SOFTWARE ..................................................................................................................... 145
18.3 DISPOSABLES ..................................................................................................................................... 145

19 GLOSSARY OF TERMS 146

INDEX 149

5
1 Introduction

1.1 Scope
This Technical Manual is applicable to the following Agilia VP range:
 Agilia VP
 Agilia VP MC
 Agilia VP MC WiFi
The user must adhere to the instructions specified in this Technical Manual. Failure to adhere to these
instructions may result in damage to the equipment, injury to patients or injury to users.
Certain functions and options described in this technical manual differ from one infusion pump version to
another (Agilia VP, Agilia VP MC, Agilia VP MC WiFi), and according to the destination country.

WARNING
Check that this Technical Manual is applicable to the current software version of the device.
 The software version of the device is displayed on the startup screen.
 The software version described in this Technical Manual is displayed in the Release Notes at the
end of this document.

1.2 Intended Use


The Agilia Connect Infusion System is dedicated to the intermittent or continuous delivery of parenteral
fluids (such as solutions, colloids, parenteral nutrition) and medications (such as diluted drugs,
chemotherapy, anesthesia drugs) and transfusion of blood and blood derivative products. Infusions can
be performed on adult, pediatric and neonatal patients through clinically accepted routes of administration
(such as intravenous, intra-arterial, or subcutaneous routes) in healthcare facilities, by trained healthcare
professionals, and according to healthcare facility protocols.
The Agilia VP and the Agilia VP MC Large Volume Infusion Pumps are peristaltic pumps intended for use
on adults, pediatrics, and neonatal patients for the intermittent or continuous delivery of parenteral fluids
(such as solutions, colloids, parenteral nutrition), medications (such as diluted drugs, chemotherapy,
anesthesia drugs), blood and blood derivatives, and medications through clinically accepted routes of
administration. They are intended for use by both trained healthcare professionals in clinical healthcare
facilities and in pre-hospital medical ground transportation and home users in home care.

1.3 Principles of operation


The Agilia VP is a programmable electronic medical system dedicated to administering a pre-determined
volume of infusion product at a programmed rate. This peristaltic pump ensures fluid delivery using
pumping and clamping fingers to advance the liquid to the patient through an administration set.
The Agilia VP range is a transportable and reusable device that can be used everyday.
The Agilia VP range can be used standalone or mounted on the Link Agilia rack.
The Agilia VP range can be used for intermittent or continuous infusions.
The Agilia VP range is intended for use on only one patient at a time. It can be reused indefinitely on
multiple patients throughout its lifetime.
For more information, refer to the Instructions for Use of the relevant pump.

6
1.4 Intended Users
In healthcare facilities, the Agilia VP range must only be used by qualified and trained healthcare
professionals, including but not limited to: nurses (primary users), physicians, nurse practitioners and
physician assistants.
In homecare environments, the pump must only be used by appropriately trained users including
homecare professionals, patients or their relatives (in case of inability to correctly react to pump alarms).
In homecare environments, the IFU must be provided to the homecare nurse.
Service and maintenance must only be performed by biomedical engineers or technicians, or by IT
specialists.
Technical maintenance tasks (including inspections and checks) are performed by trained biomedical
engineers, or by dedicated medical rental and/or service organizations who have been trained and
approved by the manufacturer.
For training, contact your Fresenius Kabi sales representative.

1.5 Contraindications
 While being serviced, the device must not be connected to a patient.
 Do not modify the pump unless recommended to do so by Fresenius Kabi.
For more information, refer to the Instructions for Use of the relevant pump.

1.6 Use Environment


Pumps must be used in the operating conditions (temperature, pressure, humidity and altitude) specified
in their Instructions for Use. Refer to the Instructions for Use of the relevant pump.

1.7 Specificities for Homecare Environments


Refer to the Instructions For Use of the relevant pump.

7
2 Description

2.1 Physical Description


2.1.1 Housing

1
6
6

3 8
7

1
5

Figure 2.1: Housing

Legend
1 Angle Bracket 5 Door Lever

2 Keypad 6 Cover

3 Air Detector 7 Membrane

4 Pump Door 8 Base

The Agilia VP range of pumps is made up of 3 main parts: a cover, a base and an angle bracket.
 The cover contains the following:
- Display board
- Keypad
 The base supports the following:
- CPU board
- Air detector board
- Air detector
- Pump motor mechanism
- Anti-free flow clamp opto motor and switch board (OCS system)
- Wi-Fi board (for Wi-Fi infusion pumps)
 The angle bracket supports the following:
- Power supply board
- AC power board
- Battery

8
2.1.2 Keypad
There are different keypads for the Agilia VP range depending on the pump's country of destination

1
2 14
3
4

13

4 5 6 7 8 9 10 11 12
Figure 2.2: Keypad for Agilia VP

Legend
1 Screen 93
7 Decrement
21 Battery Charge Status Indicator 10
73 Fast Decrement
3 Power Supply Indicator 11
3 Confirm Value / Move to Next Field / Start Infusion
4 On / Off 12
3 Stop / Pause
5 Bolus / Prime / Advance Air 13
3 Menu / Cancel Value / Move Back to Previous Field
63 Fast Increment 14
3 Alarm Silence
73 Increment
83 Infusion Indicator Lights

9
1
2 17
3
16
4
15

14

5 6 7 8 9 10 11 12 13
Figure 2.3: Keypad for Agilia VP MC

Legend
1 Screen 10 Decrement

2 Battery Charge Status Indicator 11 Fast Decrement

3 Power Supply Indicator 12 Confirm Value / Move to Next Field / Start Infusion

4 Wi-Fi Symbol (For Wi-Fi pumps only) 13 Stop / Pause

5 On / Off 14
3 Cancel Value / Move Back to Previous Field

6 Bolus / Prime / Advance Air 15


3 Menu

7 Fast Increment 16
3 Primary / Secondary, or Pressure Menu

8 Increment 17
3 Alarm Silence

9 Infusion Indicator Lights

10
2.1.3 Display Board
The display board is located under the front of the command panel, and contains all essential parts for
human-machine interaction:
 Keypad
 Synoptics and control indicators
 LCD screen
 Door sensor
This board is connected to other parts with the connectors shown below.

J2

J1

J3
Figure 2.4: Display Board

Legend
J1 J1 Connector to Keypad

J2 J2 Connector to CPU Board

J3 J3 Connector to LCD Display

11
J1 Connector to Keypad
Pin n° Signal Description
1 GND Ground
2 KBD_COL_0 Column 0
3 KBD_COL_1 Column 1
4 KBD_COL_2 Column 2
5 KBD_LINE_0 Line 0
6 KBD_LINE_1 Line 1
7 KBD_LINE_2 Line 2
8 TON/OFF On/Off key
9 KBD_LINE_3 Line 3
10 GND Ground
11 GND Ground
12 GND Ground

J2 Connector to CPU Board


Pin n° Signal Description
1 GND Ground
2 PRES_BOARD/ HMI board presence detection
3 +3V3 +3.3V power supply
4 +3V3 +3.3V power supply
5 ANA_VLCD LCD charge pump voltage
6 GND Ground
7 S_ANA_DOOR Door close detection
8 RESET/ Global reset
9 GND Ground
10 CS_LED-KBD/ LED or keypad selection
11 CS_LCD/ LCD selection
12 GND Ground
LCD type of the interface cycle:
13 LCD_CD
Control/Data (0:control, 1:data)
14 LCD_MS LCD mode selection
15 GND Ground
16 HMI_MOSI_SDA SPI data written / I²C data for HMI board
17 GND Ground
18 HMI_MISO SPI data read for HMI board
19 GND Ground
20 HMI_SCK_SCL SPI/I²C clock for HMI board
21 GND Ground
22 KON-OFF On/Off key
23 +5V +5V power supply
24 +5V +5V power supply
25 CMD_FAIL LED command failure
26 GND Ground

12
J3 Connector to Display
Pin n° Signal Description
1 GND Ground
2 A Anode of the backlight (+5V)
3 K Cathode of the backlight
4 GND Ground
5 SCK SPI clock (HMI_SCK_SCL signal)
6 GND Ground
7 SDA SPI data (MOSI) (HMI_MOSI_SDA signal)
8 GND Ground
9 CD Control/Data (0:control, 1:data) (LCD_CD signal)
10 GND Ground
11 /RST Reset (RESET/ signal)
12 GND Ground
13 CS0 Chip select (CSLCD/ signal)
14 GND Ground
15 BM0/DB13 Mode select (LCD_MS signal)
16 GND Ground
17 VLCD Charge pump voltage (ANA_VLCD signal)
18 GND Ground
19 +3V3 +3V3 power supply
20 GND Ground
21 GND Ground
22 GND Ground

13
2.1.4 CPU Board
The CPU board consists of a main microcontroller, FLASH and RAM memories, and various analog or
power functions, such as:
 Two single-step bipolar motor commands
 Adjustment of and acquisition from different detectors
 Different lines of communication (synchronous and asynchronous serial links).
The CPU Board is connected to the Display Board with the J5 connector.
A ribbon cable connects it to the Power Supply Board with the J10 connector.

J1 J2 J3 J4 J5

J6 J7

J8 J9 J10
Figure 2.5: CPU Board (Front View)

J11 J12

Figure 2.6: CPU Board (Back View)

Legend
J1 J1 Connector - Connection to Opto Switch Board J7 J7 Connector - Connection to Drop Sensor RJ11
for Anti-Free Flow Clamp Socket. Unavailable in some countries.
J2 J2 Connector - Connection to Downstream J8
J1 J8 Connector - Connection to Motor Connector for
Pressure Sensor Anti-free flow clamp
J3 J3 Connector - Connection to Opto Motor J9 J9 Connector - Connection to Pumping Motor

J4 J4 Connector - Connection to JTAG connector J10 J10 Connector - Connection to Power Supply
(micro programming) Board
J5 J5 Connector - Connection to Display Board J11 J11 Connector - Connection to Upstream Pressure
Sensor
J6 J6 Connector - Connection to Air Detector Board J12 J12 Connector - Connection to Wi-Fi Board if one is
present

14
J1 Connector to Opto Switch Board for Anti-free flow Clamp
Pin n° Signal Description
1 GND Ground
Analog output signal of the photomicrosensor 2 (anti-free flow clamp position:
2 MC_OPTO2
open/closed)
Power supply signal for the photomicrosensor 2 (anti-free flow clamp position:
3 MC_CD_OPTO2
opened/closed)
4 GND Ground
Analog output signal of the photomicrosensor 1 (anti-free flow clamp position:
5 MC_OPTO1
opened/closed)
Power supply signal for the photomicrosensor 1 (anti-free flow clamp position:
6 MC_CD_OPTO1
opened/closed)
7 GND Ground
Analog output signal of the photomicrosensor (anti-free flow clamp presence:
8 S_CLAMP_OPTO
absent/present)
Power supply signal for the photomicrosensor (anti-free flow clamp presence:
9 S_CD_OPTO
absent/present)
10 GND Ground

J2 Connector to Downstream Pressure Sensor


Pin n° Signal Description
1 GND Ground
2 +3V3 +3.3V power supply
3 V+ Negative output of the wheatstone bridge
4 GND Ground
5 V- Positive output of the wheatstone bridge
6 GND Ground

J3 Connector to Opto Motor


Pin n° Signal Description
1 GND Emitter of the photo-transistor of the photomicrosensor connected to ground
Collector of the photo-transistor of the photomicrosensor / Analog output signal of
2 OP_OPTO
the photomicrosensor
Anode of the photo-diode of the photomicrosensor / Power supply signal of the
3 OP_CD_OPTO
photomicrosensor
6 GND Cathode of the photo-diode of the photomicrosensor connected to ground

J4 to JTAG Connector (micro programming)


Pin n° Signal Description
1 GND Ground
2 +3V3 +3.3V power supply
3 TRST/ Test reset
4 TDO Test data output
5 GND Ground
6 TDI Test data input
7 MR/ Manual reset
8 TMS Test mode select
9 TCK Test clock
10 GND Ground

15
J5 Connector to Display Board
Pin n° Signal Description
1 GND Ground
2 PRES_BOARD/ HMI board presence detection
3 +3V3 +3.3V power supply
4 +3V3 +3.3V power supply
5 ANA_VLCD LCD charge pump voltage
6 GND Ground
7 S_ANA_DOOR Door close detection
8 RESET/ Global reset
9 GND Ground
10 CS_LED-KBD/ LED or keypad selection
11 CS_LCD/ LCD selection
12 GND Ground
13 LCD_CD LCD type of the interface cycle: Control/data (0:control, 1:data)
14 LCD_MS LCD mode select
15 GND Ground
16 HMI_MOSI_SDA SPI data written / I²C data for HMI board
17 GND Ground
18 HMI_MISO SPI data read for HMI board
19 GND Ground
20 HMI_SCK_SCL SPI/I²C clock for HMI board
21 GND Ground
22 ON-OFF On/Off key on keypad
23 +5V +5V power supply
24 +5V +5V power supply
25 CMD_FAIL LED command failure
26 GND Ground

J6 Connector to Air Detector Board


Pin n° Signal Description
1 GND Ground
2 DA_ANA_AIR Analog voltage delivered by the air sensor
3 GND Ground
4 DA_DISCHARGE Digital signal generated by the MMP to reset the peak detector
5 +3V3 +3.3V power supply
6 DA_TEST Signal generated by the MMP to test the receiver chain
7 +3V3 +3.3V power supply
8 DA_SCL I²C clock
9 DA_SDA I²C data
10 GND Ground

J8 to Anti-free flow Clamp Motor Connector


Pin n° Signal Description
1 MOTC_OUT1A A+ winding
2 MOTC_OUT1B A- winding
3 MOTC_OUT2A B+ winding
4 MOTC_OUT2B B- winding
5 GND Ground
6 GND Ground

16
J9 Connector to Pumping Motor
Pin n° Signal Description
1 MOTP_OUT1A A+ winding
2 MOTP_OUT1B A- winding
3 MOTP_OUT2A B+ winding
4 MOTP_OUT2B B- winding
5 GND Ground
6 GND Ground

J10 Connector to Power Supply Board


Pin n° Signal Description
1 GND Ground
2 +5V +5V power supply
3 +5V +5V power supply
4 GND Ground
5 +VCOMM Common power supply (Main or External +10V)
6 +VCOMM Common power supply (Main or External +10V)
7 GND Ground
8 SO_ANA_SPEAK Speaker analog output
9 +3V3-PERM Permanent +3.3 V power supply (Battery Backup)
10 GND Ground
11 PWR_SCL I²C clock for POWER Board
12 GND Ground
13 PWR_SDA I²C data for POWER Board
14 GND Ground
15 IRDA_TX Infrared data transmission
16 PWR_CD_PRI_VCOMM Primary microcontroller common power supply switch
17 IRDA_RX Infrared data received
18 SO_CD_SHDN/ Speaker shutdown command
19 SO_ANA_MIC Microphone analog input
20 GND Ground
21 EXT_TX External transmit data
22 PRES_BOARD/ HMI and UC board presence detection
23 EXT_RX External receive data
24 CMD_FAIL LED command failure
25 ON-OFF Keypad On/Off key
26 GND Ground

J11 Connector to Upstream Pressure Sensor


Pin n° Signal Description
1 GND Ground
2 +3V3 +3.3V power supply
3 V+ Negative output of the wheatstone bridge
4 GND Ground
5 V- Positive output of the wheatstone bridge
6 GND Ground
7 GND Ground
8 GND Ground

17
J12 Connector to Wi-Fi Board (for Agilia Wi-Fi pumps only)
Pin n° Signal Description
1 Floating Not used on Agilia VP range. Leave floating
2 Floating Not used on Agilia VP range. Leave floating
3 GND Ground
4 Floating Not used on Agilia VP range. Leave floating
5 Floating Not used on Agilia VP range. Leave floating
6 GND Ground
7 WIFI_VCC +3V3 Wi-Fi power supply
8 WIFI_VCC +3V3 Wi-Fi power supply
9 UART-RxD Receive data
10 UART-TxD Transmit data
11 UART-RTS Hardware flow control (request to send)
12 UART-CTS Hardware flow control (clear to send)
13 GND Ground
14 GND Ground

18
2.1.5 Power Supply Board
The power supply board consists of the following:
 A Tmega48 secondary microcontroller associated with the one on the CPU board.
 Different analog or power functions, including:
- Power supply management for all boards
- Battery charger
- Infrared interface
- Separate lines of communication (internal and external) to the boards
- Speaker
- Buzzer
- Super-capacitor
The power supply board is located on the angle bracket. See figure 2.1, page 8. It supplies power to the
electronic unit from the 100 V - 240 V AC network, or from 9 V DC. It also charges a 2.2 Ah battery. This
board is connected to other parts with the connectors shown below.

J1

J2

Figure 2.7: Power Supply Board (Front View)

J5
J3

J4

Figure 2.8: Power Supply Board (Back View)

Legend
J1 Connector - Connection to CPU Board J4 Connector - Connection to Secondary
J1 J4
Microcontroller
J2 Connector - Connection to microphone, J5 Connector - Connection to AC Power Board
J2 speaker and external plug (RS232 Communication J5
Port and DC Power Input/Output)
J3 J3 Connector - Connection to Internal Battery

19
J1 Connector to CPU Board
Pin n° Signal Description
1 GND Ground
2 +5V +5V power supply
3 +5V +5V power supply
4 GND Ground
5 +VCOMM Common power supply (main or external +10V)
6 +VCOMM Common power supply (main or external +10V)
7 GND Ground
8 SO_ANA_SPEAK Speaker analog output
9 +3V3-PERM Permanent +3.3V power supply (battery backup)
10 GND Ground
11 PWR_SCL I²C clock for POWER board
12 GND Ground
13 PWR_SDA I²C data for POWER board
14 GND Ground
15 IRDA_TX Infrared data transmission
16 PWR_CD_PRI_VCOMM Primary microcontroller common power supply switch
17 IRDA_RX Infrared data received
18 SO_CD_SHDN/ Speaker shutdown command
19 SO_ANA_MIC Analog microphone input
20 GND Ground
21 EXT_TX External transmit data
22 PRES_BOARD/ HMI and UC board presence detection
23 EXT_RX External receive data
24 CMD_FAIL LED command failure
25 KON-OFF On/Off key
26 GND Ground

J2 Connector to External plug


Pin n° Signal Description
1 SP- Negative connection to the speaker
2 SP+ Positive connection to the speaker
3 GND Ground - Terminal 2 of the microphone
4 MIC_TERM1 Microphone terminal 1 signal
5 GND Ground
6 VEXT_IN 10 VDC input
7 GND Ground
8 RELAY Nurse call output
9 GND Ground
10 5V0_OUT 5 VDC output
11 RXD RxD communication line
12 TXD TxD communication line
13 GND Ground
14 GND Ground

20
J3 Connector to Internal Battery
Pin n° Signal Description
1 VBAT Positive output of the smart battery
2 BAT_DATA One-wire communication link between the SMP and the battery
3 GND Ground (negative output of the smart battery)
4 GND Ground
5 GND Ground

J4 Connector to Secondary Microcontroller


Pin n° Signal Description
1 MISO Secondary microcontroller SPI data input
2 +3V3-PERM Secondary microcontroller power supply
3 SCK Secondary microcontroller SPI clock
4 MOSI Secondary microcontroller SPI data output
5 RST/ Secondary microcontroller reset
6 GND Ground

J5 Connector to AC Power Board


Pin n° Signal Description
1 Neutral Neutral wire
2 Line Hot wire
3 GND Ground

21
2.1.6 AC Power Board
The AC power board contains the power cord inlet, the ECM filter, and the F1 line fuse.
It is the interface of the power supply. The AC power board is located on the angle bracket.
See figure 2.1, page 8. This allows the power supply board to be changed without the need for soldering.
This board is connected to other parts with the connectors shown below.

J1

Figure 2.9: AC Power Board (Front View)

J2

F1 1

Figure 2.10: AC Power Board (Back View)

Legend
J1 J1 Connector - Connection to Power Supply F1
J1 Line Fuse F1
Board
J2 J2 Connector - Power Cord Inlet 1
J1 Fuse Identification Label

J1 Connector to Power Supply Board


Pin n° Signal Description
1 Neutral Neutral wire
2 Line Hot wire
3 GND Ground

J2 Connector to AC Power
Pin n° Signal Description
1 Neutral Neutral wire
2 Line Hot wire
3 GND Ground

22
2.1.7 Air Detector Board
The air detector board consists of input and output amplifiers, which are both linked to the ceramic
elements for reception and transmission.
The air detector board is fixed to the base. See figure 2.1, page 8. It transmits the air bubble volumes
present in the administration set in the form of analog data to the CPU board.
This board is connected to other parts with the connectors shown below.

J1

J3
J2

Figure 2.11: Air Detector Board

Legend
J1 J1 Connector - Connection to CPU Board J3 J3 Connector - Connection to Emitter

J2 J2 Connector - Connection to Receiver

J1 Connector to CPU Board


Pin n° Signal Description
1 GND Ground
2 DA_ANA_AIR Analog signal sent by the air detector
3 GND Ground
4 DA_DISCHARGE Digital signal generated by the MMP to reset the peak detector
5 +3V3 +3.3 V power supply
6 DA_TEST Signal generated by the MMP to test the receiver chain
7 +3V3 +3.3 V power supply
8 DA_SCL I²C clock
9 DA_SDA I²C data
10 GND Ground

23
2.1.8 Wi-Fi Board
For Agilia Wi-Fi pumps only.
The Wi-Fi board is securely fixed to the left flange of the pump.
A ribbon cable connects it to the CPU Board with the J1 connector.

Figure 2.12: Wi-Fi Board (Front View)

J1

Figure 2.13: Wi-Fi Board (Back View)

Legend
J1 J1 Connector - Connection to CPU Board

J1 Connector to CPU Board


Pin n° Signal Description
1 Floating Not used on Agilia VP range. Leave floating
2 Floating Not used on Agilia VP range. Leave floating
3 GND Ground
4 Floating Not used on Agilia VP range. Leave floating
5 Floating Not used on Agilia VP range. Leave floating
6 GND Ground
7 WIFI_VCC +3V3 Wi-Fi power supply
8 WIFI_VCC +3V3 Wi-Fi power supply
9 UART-RxD Receive data
10 UART-TxD Transmit data
11 UART-RTS Hardware Flow Control (Request to send)
12 UART-CTS Hardware Flow control (Clear to send)
13 GND Ground
14 GND Ground

24
2.1.9 Back View

5
1
4
2
3
Figure 2.14: Back View

Legend
1 Release Button 53 Power Cord Inlet
Drop Sensor Connection Socket (not available in
21 63 Infrared Cell
some countries)
3 Rotating Pole Clamp 73 Attachment Lock Knob

4 RS232 Communication Port

2.2 Principles of Operation


From an operational point of view, the Agilia VP range of pumps is made up of 3 sub-assemblies:
 Administration set test and maintenance
 Motor
 External connection

2.2.1 Administration Set Test and Maintenance Sub-assembly


The administration set is positioned along the front part panel and held in place by the door.
The front part is equipped with four detection systems:
 Detector to check the position of the door (open/closed)
 Photoelectric cell to detect the presence of the anti-free flow clamp
 Ultrasonic sensor to detect the presence of air bubbles in the administration set
 Two piezo-resistant pressure sensors

2.2.2 Motor Sub-assembly


The motor sub-assembly contains the peristaltic pumping mechanism.
The mechanism is made up of a camshaft that creates a wave-like movement in a bank of 12 fingers. The
displacement of these fingers is controlled by the CPU board, while turning it displaces the liquid at the
programmed flow rate.
The camshaft is driven by a stepper-motor and a reduction gearbox assembly through a toothed belt.
A light sensor and a rotation palette are located on the end of the camshaft.

25
2.2.3 External Connection Sub-assembly
The Agilia VP range of pumps has two plugs located at the back of the angle bracket. See figure 2.14,
page 25.
 AC power supply plug
 8-pin binder plug which, together with various specific Fresenius Kabi accessories, enables the
following:
- Continuous external power supply
- Serial link

2.3 Operation Diagram


3 optical
sensors Drop sensor
Air (opto Linear Mobile Pressure Optical Optical Peristaltic Membrane Silicon Pressure Magnet Hall effect
Plastic insert
detector switches) actuator clamp sensor disk sensor system part sensor sensor

PVC part PVC part


DOOR
Flow direction
Flow direction

DISPLAY BOARD
Stepper
Motor LEDs Display
Air detector

Interface Keypad
AIR BOARD

Anti-free flow Downstream Pumping mechanism Drop sensor


clamp, pressure and door unavailable
Upstream pressure
and sensor in some
sensor
clamp motor countries

Internal
watchdog
Main microprocessor Flash memory
Supervisory circuit RAM memory
Sound Communication Temperature sensor
Watchdog management interface
CPU BOARD

Communication Wi-Fi BOARD


Microphone (if present)
Secondary Battery/Battery
HP

Speaker microprocessor charger Communication


IrDa Battery
communication Internal watchdog Interface

RS232 to USB cable (USB)

External connector
DC supplies AC/DC EMC filter AC
Different converter
power supply
voltages Power supply

Safety management
AC POWER BOARD
POWER SUPPLY BOARD

26
3 Fundamentals

3.1 Training
The following three training levels outline the specifics needed to maintain and preserve the equipment.

Training level Description / Prerequisites


Training intended for users for on-site maintenance, using the technical documentation of the pump and
specific tools.
1 This degree of maintenance does not need an important inventory.
 Mechanical and electrical knowledge.
 Biomedical structures knowledge.
Training intended for technicians specialized in maintenance performed with specific tools and
procedures.
2
 Good mechanical and electronics knowledge.
 Two years experience minimum in a biomedical department.
Training intended for technicians specialized in repair performed in the maintenance department using
specific procedures and tools, including instruments for measurement and adjustment.
Complete check-up using this document.
3
 Good mechanical and electrical knowledge.
 Good computer knowledge.
 Two years experience minimum in a biomedical department.

INFORMATION
For training, contact your Fresenius Kabi sales representative.

3.2 Maintenance Schedule


3.2.1 Preventive Maintenance
Any abnormal functioning or failures must be reported to the qualified technical staff in your organization,
or to your Fresenius Kabi representative. In these instances, the pump should not be used.

Homecare providers are responsible for periodic maintenance and calibration of pumps used in homecare
environments.
Homecare providers must be informed if the device is dropped or if any malfunctions occur. In this case,
do not use the device and contact your homecare providers.

WARNING
In order to maintain the pump’s performance, a preventive maintenance inspection must be carried out at
least once every 3 years. This procedure, which includes changing the battery and the membrane, should
be carried out by trained and qualified technical personnel in compliance with this document and
procedures. Only authorized personnel should attempt to repair the device.
If these maintenance procedures are not observed, the pump’s correct operation will be impaired.

3.2.2 Quality Control


Upon request by the healthcare facility, a quality control check can be performed on the device every
12 months.
A regular quality check (not included in the guarantee) consists of various inspection operations listed in
this document. See section 6.2, page 37.

INFORMATION
These control checks must be performed by trained technical personnel, and are not covered by any
contracts or agreements provided by Fresenius Kabi.
For more information, contact your Fresenius Kabi sales representative.

27
3.3 Accessing / Exiting the Operating Functions
The Options menu gives access to the pump operating functions. The Options menu allows the operator
to customize the pump, edit infusion and maintenance parameters, and run tests.
The Options menu comprises the following:
 Pump Settings
 Basic Profile Configuration
 Profile Menu
 Maintenance

3.3.1 Accessing the Options Menu


When the pump is powered off, simultaneously press both and to access the Options menu.

Options Menu Access code? Description


Pump Settings No (unless modified by Test 20) Please refer to the IFU.
Profile Yes Section 4, page 29.
Basic Profile Configuration Yes Section 5, page 30.
Maintenance Yes Section 6, page 35.

INFORMATION
If the wrong access code is entered, Error is displayed.
As long as the pump remains powered on, the code does not need to be entered again.

Commands
Operation Key
Scroll options and change selected value (increasing/decreasing) Arrow keys

Confirm Value / Move to Next Field Confirmation key

Select -Deselect  Fast Increment key

Go to parent menu (if any) and cancel option Menu key

3.3.2 Exiting the Options Menu


Power the pump off and on again to exit the Options menu and return to standard operation.
All data, including newly selected and entered option, is saved to memory when the pump is powered off.

28
4 Profile Menu

4.1 Accessing the Profile Menu


1. Access the Options menu. See section 3.3, page 28.
2. Press the arrow keys to select Profile menu.
3. Press enter.
4. Enter the Profile menu access code "0080".
5. Press OK.

4.2 Profile Menu Functions


Function Choice Action
Pro 1: Default profile Basic Profile Displays the active profile name, and gives access
Profile 1 to the profile menu by the confirmation key.
Selects and loads a profile. See procedure below.
Profile 2
...
Pro 2: Select profile at power on Select  - Deselect  Activates or deactivates profile selection at startup.
- Restores the Basic Profile factory settings to the
Pro 3: Restore Basic Profile (Factory settings)
pump.
Select  - Deselect  Activates or deactivates data set information at
Pro 4: Data set info. at power on
startup.
Pro 5: Data set Select  - Deselect  Activates or deactivates the data set.

Selecting and loading a profile


1. Access the Profile menu.
2. Press the arrow keys to select Pro1: Default profile.
3. Press enter.
4. Press the arrow keys to select the profile name in the list provided.

5. Press OK.
The relevant profile information is displayed:
 Profile name
 Author
 Creation date
 Modification date
 Version

INFORMATION
In addition to Basic Profile, the default profile names are available if specified with Agilia Vigilant Drug'Lib.

6. Press OK to confirm the loading operation, or C to change the profile.


The drug library associated with the selected profile is loaded.

29
5 Basic Profile Configuration

The Basic Profile Configuration menu is available only if Basic Profile has previously been selected as the
default profile. See section 4, page 29.

5.1 Accessing the Basic Profile Configuration


1. Access the Options menu. See section 3.3, page 28.
2. Press the arrow keys to select Basic Profile configuration.
3. Press enter.

4. Enter the Basic Profile configuration access code "0200".


5. Press OK.

6. Press the arrow keys to select the setting category (User or Ward).
7. Press enter.

5.2 Basic Profile Configuration Functions


Function Setting Description Range of Settings
User 2: Profile Pro Displays or hides menu items Enabled / Disabled
Menu items available for Basic Profile.
Pause

Drug

Patient

Primary / Secondary P/S


Programmed bolus
Infusion mode
mL/h
(with Basic Profile, dose is
not available in certain
countries). Dose
Alarm volume

Call-back alert

View event log

Library information

Data Set DS

30
Function Setting Description Range of Settings
User 4: Pressure Mode Selects the mode. Variable / 3 levels
 Variable: One initial pressure
value that can be adjusted during
infusion
 3 levels: 3 fixed pressure limits
that can be selected during
infusion.
DPS Activates or deactivates the DPS Yes / No
(Dynamic Pressure System) mode
while an infusion is in progress.
Unit Selects the pressure unit. mmHg / kPa / PSI
Maximum pressure value If Mode = Variable, defines the 500  750 mmHg
maximum pressure allowed during
an infusion.
High pressure value If Mode = 3 levels, defines the 300  750 mmHg
maximum pressure allowed during
an infusion.
Medium pressure value If Mode = 3 levels, defines the 150  600 mmHg
medium pressure allowed during an
infusion.
Low pressure value If Mode = 3 levels, defines the low 50  300 mmHg
pressure allowed during an infusion.
Limit stored If enabled, the last pressure limit Enabled / Disabled
adjustment is automatically stored in
memory for the next startup.
If disabled, the user has to enter
pressure limit for the next startup.
Limit If Limit stored is disabled, sets the 50 mmHg  "Maximum
maximum pressure allowed during pressure value"
an infusion.
If Limit stored is enabled, the limit is
set to ’---’ and cannot be changed.
Drop threshold If DPS = Yes, sets a pressure drop ’----’ (No drop pressure
threshold. A message is generated if monitoring) or:
the pressure drops below this 100  400 mmHg
threshold.
Raise threshold If DPS = Yes, defines a pressure rise 50  600 mmHg
threshold. A message is generated if
the pressure rises above this
threshold.
DPS stored If DPS = Yes and DPS stored is Enabled / Disabled
enabled, the latest DPS adjustments
during infusion are saved
automatically at power off for the
next startup.
If DPS stored is disabled, the DPS
adjustments must be entered at the
next startup.
User 5: KVO KVO Sets the KVO flow rate. 0  20 mL/h
Silence duration Sets the silence duration alarm in 1 min  12 hours
KVO.
User 10: Volume / Rate, Displays the available infusion mode. -
Infusion mode Volume / Time / Rate,
Ramp or Sequential
(depending on the pump's
country of destination)

31
Function Setting Description Range of Settings
User 12: View flow rate history Displays or hides menu item: View Enabled / Disabled
Graph items flow rate history.
View pressure history Displays or hides menu item: View Enabled / Disabled
pressure history.
Par 1: Key press sound Turns the key press sound on or off. Enabled / Disabled
Key press sound
Par 2: Alarm Volume Sets the volume for alarms. 7 volume levels
Alarm Volume
Par 3: Drug and parameters: Saves the drug name only, or all Enabled / Disabled
Store infusion  Store drug name only infusion parameters, or nothing.
parameters  Store param. infusion
Same infusion screen: If Displayed is enabled, enables the Enabled / Disabled
Displayed display of the same infusion screen.
Same infusion screen:Time Duration of context backup. 1  24 hours
Volume infused: Cleared If Cleared is enabled, the infused Enabled / Disabled
volume is reset to 0 at each infusion
start.
Volume infused: Stored If Stored is enabled, the infused Enabled / Disabled
volume is saved in memory.
Par 4: Maximum rate: Primary Sets the maximum flow rate of 50.0  1500 mL/h
Maximum rate primary infusions.
Maximum rate:Secondary Sets the maximum flow rate of 50.0  1000 mL/h
secondary infusions.
Par 9: Direct bolus: Sets the direct bolus rate. 50.0  1500 mL/h
Bolus and loading Flow rate
dose rates Programmed bolus and Sets the upper limit of both 0.1 1500 mL/h
loading dose: Maximum: programmed bolus rate and loading
dose.
Par 18: Screen brightness low Brightens or darkens the screen at Enabled / Disabled
Day/Night mode next night mode startup.
Infusion indicators low Brightens or darkens the infusion Enabled / Disabled
indicators at next night mode startup.
Key press sound off Turns on or off the key press sound Enabled / Disabled
at next night mode startup.
Manual mode Displays or hides menu item: Enabled / Disabled
Day/Night mode.
Auto mode Enables/disables the ability to Enabled / Disabled
automatically activate night mode.
Day/Night mode If Auto mode is enabled, press OK 00h00  23h59
to set a daily period of the night 00:00  23:59
mode automatic activation.
Par 19: Direct bolus Activates or deactivates the Direct Enabled / Disabled
Other functions bolus function.
Advance air bubble Activates or deactivates the Enabled / Disabled
Advance air bubble function.
Prime set Activates or deactivates the Prime Enabled / Disabled
set function.
Loading dose Activates or deactivates the Loading Enabled / Disabled
dose function.
Programmed bolus Activates or deactivates the Enabled / Disabled
Programmed bolus function.

32
Function Setting Description Range of Settings
Par 20: Concentration units Sets the available concentration Enabled / Disabled
Authorized units units:
nanog, µg, mg, g, mmol, munit, unit,
cal, kcal, mEq, /mL, /XmL
Dose rate unit Sets the available dose units: Enabled / Disabled
mL/kg/min, mL/kg/h, mL/kg/24h,
nanog/h, nanog/kg/min, nanog/kg/h,
µg/h, µg/min, µg/kg/min, µg/kg/h,
mg/min, mg/h, mg/24h, mg/kg/min,
mg/kg/h, mg/kg/24h, mg/m2/h,
mg/m2/24h, g/h, g/kg/min, g/kg/h,
g/kg/24h, mmol/h, mmol/kg/h,
mmol/kg/24h, munit/min,
munit/kg/min, munit/kg/h, unit/min,
unit/h, unit/kg/min, unit/kg/h, kcal/h,
kcal/24h, kcal/kg/h, mEq/min,
mEq/h, mEq/kg/min, mEq/kg/h
Par 22: Dose Sets the available modes for the Enabled / Disabled
Programming modes profile.
Par 23: Min weight (kg) Sets the lower programmable limit of 0.25 kg  "Max
Patient default patient weight. weight (kg)"
parameters Max weight (kg) Sets the upper programmable limit of "Min weight (kg)" 
patient weight. 350 kg
Default weight (kg) Sets the patient default weight. "Min weight (kg)"  "Max
weight (kg)"
Min surface (m²) Sets the lower programmable limit of 0.05 m² 
patient BSA. "Max surface (m²)"
Max surface (m²) Sets the upper programmable limit of "Min surface (m²)"
patient BSA.  4.5 m²

Default surface (m²) Sets the default patient BSA. "Min surface (m²)"

"Max surface (m²)"
Par 25: Same therapy screen Displays or not the same therapy Yes / No
Same therapy screen, when changing current drug.
screen
Par 27: Total air volume/15 min Sets the accumulated volume of air 10  2000 µL
Air parameter to be detected over 15 minutes for
the pump to trigger an air bubble
alarm.
Bubble filter Sets the air bubble maximum volume 0 and 10  250 µL
that can pass through the air
detector without triggering an alarm.
Par 29:  Volume/time/rate Sets the available infusion modes for Enabled / Disabled
Infusion setting fields  Volume/rate the infusion mode selected.
 Volume/time
 Time/rate
 Ramp
 Sequential

33
Function Setting Description Range of Settings
Par 30: Required Allows making the drop sensor Enabled / Disabled
Drop sensor mandatory.
Drop sensor on primary Allows making the drop sensor Enabled / Disabled
required on the primary set during a
primary infusion.
Drop sensor on secondary This option allows making drop Enabled / Disabled
sensor required on the secondary
set during secondary infusion.
When drop sensor on secondary
infusion is needed, the user has to
switch the drop sensor from the
primary to the secondary infusion
during the secondary infusion. The
drop sensor returns to the primary
infusion when the secondary is
ended.
Par 31: Time Sets the remaining time that triggers 0  30 min
Near end of infusion the Near end of infusion alert.
alert % volume Sets the volume of initial VTBI that 0  15 %
triggers the alarm.
Volume Sets the volume of remaining VTBI 0  50 mL
that triggers the alarm.
Par 34: While stopped only If While stopped only is enabled, Enabled / Disabled
Rate titration allows rate modification after an
infusion stop only.
Par 36: Secondary Manual return to primary If Manual return to primary is Enabled / Disabled
enabled, the user must confirm the
completion of the secondary infusion
before resuming the primary
infusion.
Automatic return to primary If Automatic return to primary is Enabled / Disabled
enabled, the primary infusion
automatically resumes after the
completion of the secondary
infusion.
Alert when switching back If Alert when switching back Enabled / Disabled
to primary primary is enabled, an alert is
triggered at the end of the secondary
infusion before resuming the primary
infusion.
Par 39: Automatic Locking modes Automatic lock of the keyboard can Enabled / Disabled
keypad lock management be programmed.
To unlock keypad, a code is
necessary.

Note:
 The displayed menu may change depending on the pump configuration and destination country.
 µ = mc or micro.

34
6 Maintenance Operations

6.1 Maintenance Options


6.1.1 Accessing the Maintenance Options Menu
1. Access the Options menu. See section 3.3, page 28.
2. Press the arrow keys to select Maintenance.
3. Press enter.

4. Enter the Maintenance access code.


5. Press OK.

6. Press the arrow keys to select Maintenance options.


7. Press enter.

6.1.2 Maintenance Date


1. Access the Maintenance options menu. See section 6.1.1, page 35.
2. Press the arrow keys to select Svc 1: Maintenance date.
3. Press enter.
The next scheduled maintenance date is displayed.
4. Press exit to return to the Maintenance options menu.

INFORMATION
This date corresponds to the next preventive maintenance date to be carried out.
See section 3.2.1, page 27.
The date is displayed for consultation only, and cannot be changed here.

6.1.3 Initial Setup


1. Access the Maintenance options menu. See section 6.1.1, page 35.
2. Press the arrow keys to select Svc 2: Initial setup.
3. Press enter.
4. Select Yes using the arrow keys to ask for the initial configuration to be
loaded at the next pump startup. Otherwise, select No.
5. Press OK to confirm the selection.

35
6.1.4 Data Log Event
1. Access the Maintenance options menu. See section 6.1.1, page 35.
2. Press the arrow keys to select Svc 3: Data log event.
3. Press enter.
4. Use the arrow keys to select the desired clinical or technical event.

5. Press enter.
The details of the event are displayed.
6. Press exit to return to the Maintenance options menu.

6.1.5 Maintenance Information


1. Access the Maintenance options menu. See section 6.1.1, page 35.
2. Press the arrow keys to select Svc 4: Maintenance information.
3. Press enter.

4. Press to allow or disallow the display of a Maintenance info. screen at the


next pump startup.
5. Press OK to confirm the selection.

36
6.2 Running Tests
You must systematically run tests after calibrating sensors.
At the end of a full test cycle, you can obtain certificates. See section 6.3.2, page 71.

INFORMATION
Before running Tests/Controls from the pump or with Agilia Partner, it is recommended to work with a pump
configured with the Basic Profile and with Factory (default) settings. Load the Basic Profile from the pump’s
maintenance Profile menu: "Pro3:Restore Basic Profile". See section 4.2, page 29.

Calibration Associated Tests


 Upstream pressure sensor
Pressure sensors
 Downstream pressure sensor
Door sensor  Door position
Air detector  Air detector
Flow rate  Flow rate

6.2.1 Accessing the Tests Menu


1. Access the Options menu. See section 3.3, page 28.
2. Press the arrow keys to select Maintenance.
3. Press enter.

4. Enter the Maintenance access code.


5. Press OK.

6. Press the arrow keys to select Tests.


7. Press enter.

The Tests screen is displayed.

List of Tests
Tests Tests
Test 1 Identification. See section 6.2.2, page 38. Test 13 Battery test. See section 6.2.14, page 48.
Test 2 Maintenance options. See section 6.2.3, page 39. Test 14 Air detector. See section 6.2.15, page 50.
Maintenance messages.
Test 3 Test 15 Clamp motor. See section 6.2.16, page 51.
See section 6.2.4, page 39.
Test 4 Events. See section 6.2.5, page 39. Test 16 Flow rate. See section 6.2.17, page 53.
Test 5 Upstream pressure. See section 6.2.6, page 40. Test 17 Flow rate correction. See section 6.2.18, page 54.
Test 6 Downstream pressure. See section 6.2.7, page 41. Test 19 Clamp. See section 6.2.19, page 55.
Test 7 Door. See section 6.2.8, page 42. Test 20 Pump code. See section 6.2.20, page 56.
Test 8 Battery information. See section 6.2.9, page 44. Test 21 Power information. See section 6.2.21, page 57.
Test 9 Indication. See section 6.2.10, page 45. Test 22 LCD voltage. See section 6.2.22, page 58.
Test 10 Keypad. See section 6.2.11, page 45. Test 23 Temperature. See section 6.2.23, page 59.
Test 11 Ageing test. See section 6.2.12, page 46. Test 24 Watchdog. See section 6.2.24, page 60.
Wi-Fi module information
Test 12 Battery life. See section 6.2.13, page 48. Test 25
See section 6.2.25, page 61.

37
6.2.2 Test 1: Identification
Test Description
This test checks that the Identification parameters of the pump are correct. The Identification
parameters are displayed for information only. They cannot be modified here.

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 1: Identification.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Pump name
 Pump version or revision with software generation date
 Pump serial number
 CPU board serial number
 Power supply board serial number
 Power supply board software version or software revision with the
generation date
 Battery serial number

 For each language available:


- Language name
- Language file version or revision
- Language file creation date
 For each parameter zone:
- Parameter zone number + version or revision
- Parameter zone creation date
- Last manual modification date
 Boot version or revision
 Boot creation date

 Embedded software version or software revision with the generation date

5. Press exit to return to the Tests menu.

38
6.2.3 Test 2: Maintenance
Test Description
Run this test to check that the pump maintenance data is correct.

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 2: Maintenance.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Duration: Running time since last preventive maintenance in hours (if less
than 72 hours), in days (if less than 120 days) or in months
 Date: Last preventive maintenance date
 Total duration: Total running time in hours (if less than 72 hours), in days
(if less than 120 days) or in months.
 Total turn number: Total number of cycles performed by pumping motor.

5. Press exit to return to the Tests menu.

6.2.4 Test 3: Maintenance Messages


Test Description
Run this test to check the maintenance messages entered. The maintenance message is
displayed for information only. It cannot be modified here.

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 3: Maintenance messages.
3. Press enter.
Informational messages stored by After Sales Service are displayed.

4. Press exit to return to the Tests menu.

6.2.5 Test 4: Events


Test Description
Run this test to consult the list of pump events, and the details of each recorded technical event.
The clinical events are not displayed here.

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 4: Events.
3. Press enter.
The technical events are listed.
4. Press the arrow keys to select an event.

5. Press enter.
The selected event is displayed in detail.
6. Press the arrow keys to scroll through the event detail screen.

7. Press exit to return to the list of events.

39
6.2.6 Test 5: Upstream Pressure
Test Description
The upstream pressure sensor detects any occlusion that may occur upstream the pump.
Run this test to check if the pump correctly detects the occlusion and generates the appropriate
high-priority alarm.

Upstream
pressure sensor Pressure sensor
Main
microprocessor
Interface

CPU BOARD

The pump triggers a high-priority alarm and stops an infusion as soon as an upstream
occlusion is detected.
This test failed if one of these two conditions is encountered:
 Upstream pressure sensor is not calibrated. Calibrate the upstream pressure
sensor using Agilia Partner maintenance software.
 Upstream pressure sensor is defective or not correctly connected to the CPU board.
This problem leads to an error code 41:
- Check the cable connection to CPU board (J11) connector.
See figure 2.5, page 14.
- Replace the upstream pressure sensor. See section 8.11, page 117.

Required Tools and Equipment


 1 Administration set (VL infusion set range)

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 5: Upstream pressure.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Conversion: Sensor value in mV. The displayed voltage value depends on
the pressure applied on the sensor.
 Door opened: Door opened calibration value in mV. Value saved during
last calibration (door opened without administration set),
 0 mmHg: Calibration at 0 mmHg (0 PSI) in mV. Value saved during last
calibration (door closed with no pressure applied),
 Offset: Adjustment offset of the sensor zero in LSB. Value saved during
last calibration,
 Date: Date of last calibration,
 Number: Last calibration number.
5. Check that the Conversion value displayed in mV is within the limits shown in
the table below.
6. Press exit to return to the Tests menu.

’Conversion’ value Limit


Door opened with no administration set installed 2978 LSB to 3226 LSB (2400 mV to 2600 mV)
Door closed with an administration set and no pressure applied 870 LSB to 2730 LSB (700 mV to 2200 mV)

40
6.2.7 Test 6: Downstream Pressure
Test Description
The downstream pressure sensor detects any occlusion that may occur downstream the pump.
Run this test to check if the pump correctly detects the occlusion and generates the appropriate
high-priority alarm.

Downstream
pressure sensor Pressure sensor
Main
microprocessor
Interface

CPU BOARD

The pump triggers a high-priority alarm and stops an infusion as soon as a downstream
occlusion is detected.
This test failed if one of these two conditions is encountered:
 The downstream pressure sensor is not calibrated. Calibrate the downstream
pressure sensor using Agilia Partner maintenance software.
 The downstream pressure sensor is defective or not correctly connected to the CPU
board. This problem leads to an error code 42:
- Check the cable connection to CPU board (J2) connector.
See figure 2.5, page 14.
Replace the downstream pressure sensor. See section 8.11, page 117.

Required Tools and Equipment


 1 Administration set (VL infusion set range)

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 6: Downstream pressure.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Conversion: Sensor value in mV. The displayed voltage value depends on
the pressure applied on the sensor.
 Door opened: Door opened calibration value in mV. Value saved during
last calibration (door opened without administration set).
 0 mmHg: Calibration value at 0 mmHg (0 PSI) in mV. Value saved during
last calibration (door closed with no pressure applied).
 760 mmHg: Calibration value at 760 mmHg (14.7 PSI) in mV. Value saved
during last calibration (door closed with 14.7 PSI pressure applied).
 Offset: Adjustment offset of the sensor zero in LSB. Value saved during
last calibration.
 Date: Date of last calibration.
 Number: Last calibration number.
5. Check that the Conversion value displayed in mV is within the limits shown in
the table below. If not, run a calibration of the downstream sensor using Agilia Partner maintenance
software.
6. Press exit to return to the Tests menu.

’Conversion’ value Limit


Door opened with no administration set installed 2978 LSB to 3226 LSB (2400 mV to 2600 mV)
Door closed with an administration set and no pressure applied 1738 LSB to 2854 LSB (1400 mV to 2300 mV)

41
6.2.8 Test 7: Door
Test Description
Run this test to check the Hall effect door sensor and the correct functioning of the door
fastening system.

Door Magnet

Membrane

Optical sensor
Hall effect sensor

Stepper motor

Optical disk

Pump mechanism and door


Optical sensor
Motor driver
interface

Main DISPLAY
microprocessor BOARD

CPU BOARD

The door sensor works properly and is correctly calibrated.


If this test fails:
 Calibrate the door sensor using Agilia Partner maintenance software.
 Run the test again. If the test fails, replace the door.
See section 8.13, page 125.

Required Tools and Equipment


 No specific tools or equipment are required

42
1. Access the Tests menu. See section 6.2.1, page 37.
2. Press the arrow keys to select Test 7: Door.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Conversion: Hall effect sensor value in mV. The displayed voltage value
is updated according to the Hall effect sensor
 State: Door state (open or closed) according to the Hall effect sensor
 Opened: Opened door calibration value in mV (value saved during last
calibration)
 Intermediate: Closed door using calibration tool calibration value in mV
(value saved during last calibration)
 Closed: Closed door calibration value in mV (value saved during last
calibration)
 Date: Date of last calibration
 Number: Last calibration number
5. Check that the Conversion value displayed in mV is within the limits shown in the table below. If not,
run a calibration of the door sensor using Agilia Partner maintenance software.
6. Press exit to return to the Tests menu.

Values Limit
Door opened 1737 LSB to 2234 LSB (1400 mV to 1800 mV)
Door closed 744 LSB to 3351 LSB (600 mV to 2700 mV)

43
6.2.9 Test 8: Battery Info
Test Description
This test provides information about battery usage time, voltage output, current output, and
temperature.
Run this test to check that the battery data is correct.

The battery capacity is acceptable.


If this test fails:
 Connect the pump to an AC power supply to charge the battery.
 Run the test again. If the test fails, replace the battery.
See section 8.1, page 85.

Required Tools and Equipment


 No specific tools or equipment are required

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 8: Battery info.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Duration: Battery operating time in hours, days and months
 Cycles: Number of charge/discharge cycles, equivalent to Duration (in
hours) divided by 7
 Since: Date of the first use on battery
 Conversion and Voltage: Voltage value at the battery terminals in V, and
conversion into mV
 Conversion and Temperature: Battery temperature in °C, and conversion
into LSB
 Conversion and Current: Battery charge/discharge current in mA, and
conversion into LSB

5. Check that the displayed values are within the limits shown in the table below.

Value Limits
Voltage 5.0 V to 8.7 V
Current - Connected to an AC power supply, battery being charged -135 mA to -165 mA
(battery charge status indicator is flashing)
Current - Connected to an AC power supply, battery fully charged -50 mA to +50 mA
(battery charge status indicator is lit permanently)
Current - Pump running on battery -50 mA to -300 mA
(battery charge status indicator is off)
Temperature +2 °C to +48 °C (+35.6 °F to +118.4 °F) for normal
room temperatures

6. Press exit to return to the Tests menu.

44
6.2.10 Test 9: Indication
Test Description
Run this test to check the correct functioning of display, battery charge status indicator, power
supply indicator, infusion indicator lights, microphone and buzzer.

The pump screen, indicators, microphone and buzzer work properly.


If this test fails, replace the display board and LCD display. See section 8.3, page 89.

Required Tools and Equipment


 No specific tools or equipment are required

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 9: Indication.
3. Press enter.
4. Check that:
 A white screen is displayed.
 The battery charge status indicator, power supply indicator, infusion
indicator lights are lit.
 OK is blinking in the bottom-right corner of the screen.
5. Press OK.
6. Check that:
 A blue Indication screen is displayed.
 The battery charge status indicator, power supply indicator, infusion
indicator lights are flashing.
 Exit is displayed in the bottom-right corner.
 The microphone and buzzer sound.
7. Press exit to return to the Tests menu.
If you do not press exit in the next 10 seconds, the pump returns automatically to the Tests menu.

6.2.11 Test 10: Keypad


Test Description
Run this test to check the correct functioning of all pump keys.

The keypad works properly.


If this test fails, replace the upper case that supports the keypad.
See section 8.2, page 87.

Required Tools and Equipment


 No specific tools or equipment are required

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 10: Keypad.
3. Press enter.
4. Press all keys one by one, and check that the corresponding circle on the
screen is highlighted.

5. Press for at least 5 seconds to exit and return to the Tests menu.

45
6.2.12 Test 11: Ageing Test
Test Description
The Ageing test, equivalent to an OCS, checks the protection of the system against free flow.
The test verifies the pump occlusivity regarding the administration set and its anti-free flow
clamp installed.
This test also verifies that the motor unit is functioning correctly by carrying out forward or
backward running cycles.

The peristaltic system works properly.


If the test fails:
 Replace the membrane.
See section 8.14, page 126.
 If the test fails again, replace the anti-free flow clamp motor.
See section 8.12, page 122.
 If the test fails again, replace the pumping system motor.
See section 8.10, page 112.

Required Tools and Equipment


 No specific tools or equipment are required

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 11: Ageing test.
3. Press enter.
4. Press the arrow keys to enter the flow rate to be applied in mL/h.
Available range: 0.1 to 1500 mL/h.
5. Press OK.

6. Press the arrow keys to select the displacement mode.


Available modes: forward, backward, forw./backw. or synchro.
7. Press OK.
If Mode = synchro, go to step 12.
8. Press the arrow keys to select the displacement type Step number or Turns
number .
9. Press OK.

10.Press the arrow keys to select the total number of turns or cycles to be
performed by the pump.
Available range:
- 1 to 9999 or
- Continuous (available in forward or backward mode only).
11.Press OK.
12.Press the arrow keys to select the motor command mode (Current).
Available options:
- standard or maximum
13.Press OK to start the test.

INFORMATION
If a battery alarm is present, the test cannot be launched (the OK button is not available).

46
While an ageing test is in progress, the pump displays the following information:
 Flow rate in mL/h
 Motor command mode (Current = standard or maximum)
 Mode (forward, backward, forw./back., synchro)
 Number of remaining steps/turns to perform
 Total number of steps/turns to perform
 Displacement type (step or turns)
The test ends if:
 The programmed number of steps/turns is reached (Mode = forward, backward or forw./back.).
 The required position is reached (Mode = synchro.).
 The user presses the exit key. The exit key is the only way to stop a test with a "Number of
steps/turns" = Continuous.

INFORMATION
During the test, the motor rotation is tested and the pump triggers an error if a problem is detected.

At end of test, the pump displays the following information:


 Flow rate in mL/h
 Motor command mode (standard or maximum)
 Displacement mode (forward, backward, forw./back., synchro)
 Number of remaining steps/turns to perform
 Total number of steps/turns to perform
 Displacement type (step or turns)
 The test status (Finish)
14.Press OK at end of test to return to the Ageing test screen.
The test can be repeated under the same operating conditions.

47
6.2.13 Test 12: Battery Life
Test Description
This test provides information on the current battery charge percentage and displays results of
the last battery discharge test (last run of "Test 13: Battery test").

The battery capacity is acceptable.


If the charge is low, connect the pump to an AC power supply to charge the battery.
If the displayed "Alarm" is less than 06h30 (6:30), replace the battery.
See section 8.1, page 85.

Required Tools and Equipment


 No specific tools or equipment are required

Prerequisites
 Run test 13: "Battery test" on the pump before launching this test.
See section 6.2.14, page 48.

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 12: Battery life.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Charge: Battery charge current rate (in %)
 Auto Off: Date of last automatic cut off (value saved during last battery
test)
 Pre alarm: Duration between transition to battery and pre alarm (value
saved during last battery test)
 Alarm: Duration between transition to battery and alarm (value saved
during last battery test)
 Cut off: Duration from alarm to automatic pump power off (value saved
during last battery test)
5. Press exit to return to the Tests menu.

6.2.14 Test 13: Battery Test


Test Description
During this test, a battery discharge is performed. Pre alarm, alarm and cut off times are
determined and registered so that it is possible to evaluate if the battery works correctly.
At the end of a battery test, the results are recorded and can be checked by running
"Test 12: Battery life". Then the pump powers off.

The battery capacity is acceptable.


Replace the battery.
See section 8.1, page 85.

Required Tools and Equipment


 No specific tools or equipment are required

Prerequisites
 The pump is disconnected from the AC power supply.

48
1. Access the Tests menu. See section 6.2.1, page 37.
2. Press the arrow keys to select Test 13: Battery test.
3. Press enter.

INFORMATION
If the pump is connected to an AC power supply, the test does not start and the
following screen is displayed.
Disconnect the pump from the AC power supply. The test is automatically initiated.

While a battery test is in progress, the pump displays the following information:
 Pre alarm: Duration from transition to battery until pre alarm in hours and
minutes (hh:mm).
This duration increases up to the pre alarm triggering time, then stops.

 Alarm: Duration from transition to battery until alarm in hours and minutes
(hh:mm).
This duration:
- is equal to ’--:--’ as long as the pre alarm is not triggered,
- starts from the pre alarm triggering time, then increases up to the alarm
triggering time, and finally stops.
 Cut off: Duration from alarm to automatic pump power off.
This duration:
- is equal to ’--:--’ as long as the alarm is not triggered,
- is reset to ’00:00’ when the alarm is triggered,
- increases up to the pump cut off.

INFORMATION
If the pump is connected to an AC power supply while a battery test is running,
the test stops and the following screen is displayed.
Press exit to return to the Tests menu.

4. At end of test, display the "Pre alarm", "Alarm" and "Cut off" stored in memory:
 Connect the pump to an AC power supply
 Power on the pump
 Run test 12 (Battery life)
 Check that the displayed "Alarm" is equal to or greater than 06h30 (6:30).
If not, replace the battery. See section 8.1, page 85.
5. Press exit to return to the Tests menu.

49
6.2.15 Test 14: Air Detector
Test Description
Run this test to check the correct functioning of the air detector. The air detector allows the
pump to detect air bubbles before an infusion. This test only checks that the detector can
differentiate between air and infused medicine.

Ceramic
Reception
Main Air
microprocessor detector
Emission
AIR DETECTOR
BOARD
Ceramic
CPU BOARD

Communication

The pump triggers a high-priority alarm and stops an infusion as soon as an air bubble with
a width of at least 5 cm (2 in) passes through the pump.
If this test fails:
 Calibrate the air detector using Agilia Partner maintenance software.
 The air detector board is defective, or not correctly connected to the CPU board.
This problem leads to an error code 33:
- Check the cable connection to CPU board, (J6) connector.
See figure 2.5, page 14.
- Replace the air detector board.
See section 8.8, page 104.

Required Tools and Equipment


 1 Administration set (VL infusion set range)

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 14: Air detector.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Conversion: Air detector voltage live measurement value. The displayed
value (in mV) is updated according to the value measured by the air
detector board,
 State: Air detector measuring state (air or water) according to the
Conversion measurement displayed above
 No set: No set calibration value in mV (value saved during last calibration)
 Set/air: Administration set filled with air calibration value in mV (value
saved during last calibration)
 Set/water: Administration set filled with water calibration value in mV
(value saved during last calibration)
 Frequency: Measurement frequency in kHz used during calibration (value
saved during last calibration)
 Frequency shift: Measurement frequency deviation value calculated as a
percentage (value saved during last calibration)
 Date: Date of last calibration
 Number: Last calibration number
5. Check that the State (air or water) value displayed is coherent.
6. Press exit to return to the Tests menu.

50
6.2.16 Test 15: Anti-Free Flow Clamp Motor
Test Description
Run this test to check the correct functioning of the anti-free flow clamp motor. The anti-free
flow clamp motor drives an endless screw which may deviate from its original position.

Opto switch board:


Opto switch (presence of Anti-free flow clamp) Anti-free flow clamp

Opto switch board:


2 opto switches (status of Anti-free flow clamp) Anti-free flow clamp
motor

Main
microprocessor Interface
Motor driver
CPU BOARD

The anti-free flow clamp motor works properly.


If this test fails, the clamp deviates from its original position. This can lead to failures
related to clamping or unclamping movements. Replace the anti-free flow clamp motor.
See section 8.12, page 122.

Required Tools and Equipment


 1 Administration set (VL infusion set range)

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 15: Clamp motor.
3. Press enter.
4. Press the arrow keys to select the displacement mode.
Available modes: unclamping, initialization, forward, backward, or continuous.
5. Press OK.

6. Press the arrow keys to enter the number of displacement steps to be


performed.
Available range:
"Auto" or a value from 1 to 1000 (available in unclamping, forward, backward,
or continuous displacement mode).
7. Press OK.
8. Press the arrow keys to enter the clamp motor operating frequency.
Available range:
"Auto" or a value from 10 to 500 Hz (available in unclamping, forward,
backward, or continuous displacement mode).
9. Press OK to start the test.

INFORMATION
If a battery alarm is present, the test cannot be launched (the OK button is not available).

51
While a clamp motor test is in progress, the pump displays the following
information:
 Displacement mode (forward or backward)
 Anti-free flow clamp motor position
 Number of remaining steps to perform
 Total number of steps to perform
The test ends if:
 The programmed number of steps is reached (forward or backward displacement mode).
 or the required position is reached (initialization or unclamping displacement mode).
 or the user presses the exit key. The exit key is the only way to stop a test in continuous
displacement mode.

INFORMATION
During the test, the rotation control is activated and the pump triggers an error if a problem is detected.

At end of test, the pump displays the following information:


 Displacement mode (forward or backward)
 Anti-free flow clamp motor position
 Number of remaining steps to perform
 Total number of steps to perform
 The test status (Finish)
10.Press OK at end of test to return to the Clamp motor test screen.
The test can be repeated under the same operating conditions.

52
6.2.17 Test 16: Flow Rate
Test Description
Run this test to check the flow rate correction coefficient stored in memory. This coefficient
comes from the last flow rate calibration performed with Agilia Partner maintenance software.
The flow rate correction coefficient cannot be modified here

The flow rate is correctly calibrated.

If this test fails, calibrate the flow rate using Agilia Partner maintenance software.

Required Tools and Equipment


 See section 6.2.29, page 65.

1. Setup a flow rate test that conforms to the EN-60601-2-24 standard. See section 6.2.29, page 65.
2. Access the Tests menu. See section 6.2.1, page 37.
3. Press the arrow keys to select Test 16: Flow rate.
4. Press enter.
5. Press the arrow keys to enter the flow rate.
Available range: 1 mL/h to 1500 mL/h. Default value: 100 mL/h.
6. Press OK.

7. Press the arrow keys to enter the volume to be infused.


Available range: 1 mL to 9999 mL. Default value: 25.0 mL.
8. Press OK.
The duration of infusion "Time" is calculated from the newly entered "Flow
rate" and "Volume".

INFORMATION
We recommend setting the "Flow rate" and "Volume" to default values. The resulting 25 mL infusion
performed at 100 mL/h best fits the EN-60601-2-24 standard and the equipment requirements
(administration set and scale accuracies).
The flow rate calibration is also based on the same infusion parameters.

The test starts. The pump:


 unclamps the anti-free flow clamp.

 starts the programmed infusion. While the infusion is in progress, the


following information are displayed:
- Flow rate (in mL/h)
- Remaining volume to be infused and total volume to be infused (in mL)
- Remaining duration of infusion, and total duration of infusion (in min)
The pump motor rotation speed depends on both flow rate entered and flow rate coefficient stored in
memory.

INFORMATION
During the test, the rotation control is activated and the pump triggers an error if a problem is detected.

53
9. At end of test, check that the infused volume displayed on the scale or read on the graduated tube is
between:
 Maximum volume: infused volume - 5 % rounded up to 1/10 (23.8 mL for a
25 mL infusion)
 Minimum volume: infused volume +5 % rounded down to 1/10 (26.2 mL for
a 25 mL infusion)
10.Press exit to end the test and return to the Tests menu.

INFORMATION
The test fails if:
 the volume read on the scale or the graduated is outside the limits
displayed,
 the test ends by a ’Finish’ message.
In both cases, press exit and start a flow rate calibration using Agilia Partner maintenance software.

6.2.18 Test 17: Flow Rate Correction


Test Description
Run this test to display the flow rate correction coefficient. This coefficient is for information
only, and cannot be modified here. The only way to modify a flow rate correction coefficient is
to run a flow rate calibration using Agilia Partner maintenance software.

Required Tools and Equipment


 No specific tools or equipment are required

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 17: Flow rate correction.
3. Press enter.
The flow rate coefficient is displayed.

4. Press the down arrow key to display the last calibration date and number.
This calibration is the one that leads to the flow rate correction coefficient
displayed.

5. Press exit to end the test and return to the Tests menu.

54
6.2.19 Test 19: Clamp
Test Description
Run this test to check the sensors that verify whether the clamp is present or absent, and
clamped or unclamped.

Opto switch board:


Opto switch (presence of Anti-free flow clamp) Anti-free flow clamp

Opto switch board:


Anti-free flow clamp
2 opto switches (status of Anti-free flow clamp)
motor

Main
microprocessor Interface
Motor driver
CPU BOARD

The sensors work properly.


If this test fails:
 The anti-free flow clamp motor is defective. Replace the anti-free flow clamp motor.
See section 8.12, page 122.
 The anti-free flow clamp opto switch board is defective or not correctly connected to
the CPU board. This problem leads to an error code 22 or 23:
- Check the cable connection to CPU board, (J1 connector).
See figure 2.5, page 14.
- Replace the OCS flexible IC.
See section 8.15, page 128.

Required Tools and Equipment


 1 Administration set (VL infusion set range)

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 19: Clamp.
3. Press enter.
The following data is displayed:
 Clamp: if the clamp detector latch [1] detects the presence of the anti-free
flow clamp, "present" is displayed. Otherwise "absent" is displayed.

 Position: "opened" or "closed" according to the


position of the clamping finger [2] which opens or 1
closes the anti-free flow clamp. When the anti-
free flow clamp is opened, the administration set
is unclamped. When the anti-free flow clamp is
closed, the administration set is clamped. 2

55
4. Test the presence and position of the anti-free flow clamp as follows:
 Door opened without administration set installed, check:
- Clamp: "absent"
- Position: "opened"

 Install an administration with open


clamp position, check:
- Clamp: "present"
- Position: "opened"
 Close the door with administration set
installed, check:
- Clamp: "present"
- Position: "closed"

 Press and check:


- Clamp: "present"
- Position: "opened"
 Open and close the door with administration set installed, check:
- Clamp: "present"
- Position: "closed"

5. Remove the administration set and check


the anti-free flow clamp is closed and that
the pump displays:
 Clamp: "absent"
 Position: "opened"
6. Press exit to return to the Tests menu.

6.2.20 Test 20: Pump Code


Test Description
Run this test to display and modify the code which gives access to the Pump Settings from the
Options menu. See section 3.3, page 28.

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 20: Pump code.
3. Press enter.
The current Pump Settings access code is displayed.
4. Enter the code.
5. Press OK to confirm.
6. Press exit to return to the Tests menu.

INFORMATION
If you do not want to protect access to the Pump settings by a code, enter "0000".

56
6.2.21 Test 21: Power Info
Test Description
Run this test to display power source information on the following parts:
 DC voltage
 Battery DC voltage charging value
 Backup capacitor voltage and temperature
 5 V booster voltage.

INFORMATION
The backup capacitor voltage and temperature must be systematically checked during the maintenance
protocol.

The AC power board and power supply boards work properly.


DC voltage out of limits:
 Check the connections between power supply board (J5 connector) and AC power
board.
 Check the fuse on AC power board.
 Replace the power supply board.
See section 8.5, page 94.
 Replace the angle bracket supporting the AC power board.
See section 8.5, page 94.
Backup capacitor voltage and/or 5 V booster voltage out of limits:
 Connect the pump to an AC power supply and wait for 30 minutes.
 Check the backup capacitor voltage.
 Replace the power supply board if the voltage is outside the limits.
See section 8.5, page 94.
A too high voltage may result in damage to the equipment.

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 21: Power info.
3. Press enter.
The DC voltage is displayed:
 Conversion: DC voltage conversion value (in mV)
 DC voltage: DC voltage charging value (in V)
4. Connect and disconnect the pump from the power source, and check that the DC voltage value
changes:
 With a pump connected to an AC power supply:

 With a pump running on battery:

57
5. Press the arrow keys to scroll through the other information screens:
 Conversion: Backup capacitor conversion value in mV
 Backup capacitor: Backup capacitor voltage in V

 Conversion: Backup capacitor temperature conversion value in mV


 Backup temperature: Backup capacitor temperature in °C

 Conversion: 5 V booster conversion value in mV


 5 V booster: 5 V booster voltage in V

6. Check that the displayed values are within the limits shown in the table below.

Value Limits
DC Voltage - Pump connected to an AC power supply 9.5 V to 10.5 V
DC Voltage - Pump running on battery -0.5 V to 0.5 V
Backup capacitor 2.3 V to 2.7 V
Backup temperature -20 °C to +110 °C (-4 °F to +230 °F)
5 V booster 4600 mV to 5920 mV

7. Press exit to return to the Tests menu.

6.2.22 Test 22: LCD Voltage


Test Description
Run this test to display the charge voltage of the pump’s LCD screen. This value is displayed
for information only.

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 22: Lcd Voltage.
3. Press enter.
The following data is displayed:
 Conversion: This conversion voltage value is the LCD charge pump
voltage measured at the CPU board input terminals.
 Voltage: This voltage value is the measured LCD charge pump voltage.
4. Press exit to return to the Tests menu.

58
6.2.23 Test 23: Temperature
Test Description
Run this test to display the temperature measured by the NTC thermistor (for information only).

The CPU board works properly.


If this test fails, replace the CPU board. See section 8.4, page 91.
If the problem persists, contact the Fresenius Kabi Technical Service.

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 23: Temperature.
3. Press enter.
The following data is displayed:
 Conversion: The temperature conversion value measured in mV by the
NTC thermistor on the CPU board.
 Temperature: The temperature measured in °C by the NTC thermistor on
the CPU board.
4. Check that the displayed value is within the limits shown in the table below.

Values Limit
Temperature -20 °C to +80 °C (-4 °F to +176 °F)

59
6.2.24 Test 24: Watchdog
Test Description
This test checks the status of the pump’s microprocessor (free or busy) every 2 seconds.

The pump’s microprocessor is not too busy to carry out infusions correctly.
If the test fails, it means that the pump’s microprocessor is too busy.
An infusion is likely not to be carried out correctly.

Required Tools and Equipment


 No specific tools or equipment are required

Prerequisites
 The pump must be used on battery with the AC power cord disconnected.

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 24: Watchdog.
3. Press enter.
If the pump is connected to the AC power supply:

 Disconnect the AC power cable.


The OK button becomes available.
 Press OK.

4. Press OK to confirm.

The pump starts checking the fault mode.

5. Check that all red LEDs light up and that the buzzer sounds between 1.0 seconds and 2.25 seconds.
If the test fails, a message "Watchdog not functional return to After Sales Service" is displayed.
6. Press key for 5 seconds to stop the alarm and return to Tests screen.

INFORMATION
The Watchdog test must be systematically carried out after each maintenance procedure.

60
6.2.25 Test 25: Wi-Fi Module Information
Test Description
This test displays for information the Wi-Fi parameters saved on the pump. Run this test to
check that all parameters are correct.
If they are not, upload the Wi-Fi configuration to the pump using Agilia Partner maintenance
software.

Prerequisites
 The pump must be equipped with Wi-Fi.

INFORMATION
When powering on a pump, it may take a few minutes for the Wi-Fi module information to refresh.
If some data are not displayed when performing this test, wait a few minutes for the pump to refresh Wi-Fi
module information (without powering off the pump), then run the test again.
If after a prolonged period where no information is displayed, contact your Biomed or IT service
department.

1. Access the Tests menu. See section 6.2.1, page 37.


2. Press the arrow keys to select Test 25: Wi-Fi module information.
3. Press enter.
The following data is displayed for information:
 Network SSID (Service Set IDentifier)
 MAC address
 IP address
 Subnet mask address
 Gateway address
 RSSI: value in dBm
 SNR: value in dBm

 Data rate: value in Mbps.


 Date and time of last connection to server

 Version of Wi-Fi module application firmware

 Version of Wi-Fi module Bootloader firmware

 Version of Wi-Fi module Radio firmware

4. Press exit to return to the Tests screen.

61
6.2.26 Checking the Pressure Limit Alarm
Test Description
Run this test to check the triggering of an occlusion alarm when the pressure downstream the
pump exceeds the pressure limit stated in the Pressure management menu.

Required Tools and Equipment


 1 Administration set (VL infusion set range)
 1 Manometer
 1 ‘3-way stopcock with Luer lock connector’
 1 container
 1 Bag

Prerequisites
 The manometer’s calibration certificate is valid.

1. Power off then on the pump.


2. Install an administration set filled with water into the pump.
3. Close the door.
4. Setup the equipment as follows:

40 in (100 cm)

20 in (50 cm)
Manometer

T 3-way stopcock
Pump

Container

5. Power on the manometer.


6. Connect the outlet end of administration set to one part of the 3-way stopcock.
7. Connect the manometer to the second part of the 3-way stopcock.
8. Connect a tubing to the third part of the 3-way stopcock.
9. Open the tap over the container.
10.Select a flow rate of 125 mL/h.
11.Press .
12.Press the arrow keys to select Pressure management .
13.Press the arrow keys to select 750 mmHg for Limit.

14.Start the infusion at 125 mL/h.


15.Wait for 30 seconds.
16.Turn the tap of the 3-way stopcock, allowing the pressure in the tube to be measured by the
manometer.

62
17.Check that the alarm is triggered when:
 P > 14.5 ± 2.2 PSI
 P > 1.00 ± 0.15 bar
 P > 750 mmHg ± 115 mmHg
18.Stop the infusion.
Adjusting the pressure limit to 750 mmHg
If the Limit cannot be adjusted directly to 750 mmHg carry out the following procedure:
1. Power off the pump.
2. Access the Options menu. See section 3.3, page 28.
3. Press the arrow keys to select Basic Profile configuration.
4. Press enter.
5. Enter the Basic Profile configuration access code "0200".
6. Press OK.
7. Press the arrow keys to select the User setting category.
8. Press the arrow keys to select the User 4: Pressure.
9. Scroll through and write down the Pressure parameters:
 Mode, DPS, Unit
 High, Medium and Low pressures
 Limit stored, Limit, Drop threshold, Raise threshold, DPS stored/DPS state
(enabled/disabled)
10.Press enter.
11.Edit the Mode and High pressure parameters as follows:
 Mode = 3 levels
 High = 750 mmHg

If a Profile other than a Basic Profile is loaded:


 Press several times to return to the Options menu.
 Press the arrow keys to select Profile menu.
 Press enter.
 Enter the Profile menu access code "0080".
 Press OK.
 Press the arrow keys to select Select profile at power on.
 Tick the option Select profile at power on.
 Press OK.
 Press several times to return to the Options menu.
 Power off the pump.
 Power on the pump.
 When prompted, select Basic Profile in the list provided.
 Press OK twice to start loading the Basic Profile.

12.Power off then on the pump.


13.Press .
14.Press the arrow keys to select Pressure management .

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15.Press the arrow keys to select 750 mmHg for Limit.

16.Start an infusion at 100 mL/h.


17.Wait for 30 seconds.
18.Turn the end part tap of the 3-way stopcock allowing the pressure in the tube to be measured by the
manometer.
19.Check that the alarm is triggered when:
 12.3 PSI < P < 16,7 PSI or
 0.85 bar < P < 1.15 bar or
 625 mmHg < P < 875 mmHg.
20.Press to stop the infusion.
21.Turn the end part tap of the 3-way stopcock to release the pressure.
22.Reload the Profile and/or restore the previous Basic Profile configuration.

6.2.27 Checking the AC power supply / Battery Operation


Test Description
Run this test to check the power supply indicator state while switching from AC power supply
to battery.

The power supply indicator works properly.


If this test fails, replace the upper case that supports the keypad.
See section 8.2, page 87.

1. Disconnect the pump’s AC power cord.


2. Check that the plug-shaped power supply indicator is off.
3. Connect the pump to an AC power supply.
4. Check that the plug-shaped power supply indicator lights up green.

6.2.28 Electrical Test


Test Description
This test checks the electrical safety of the pump according to the IEC 60601-1 medical
electrical equipment standard.

The pump is compliant with the IEC 60601-1 medical electrical equipment standard.
Contact your biomedical department or your Fresenius Kabi sales representative.

Required Tools and Equipment


 No specific tools or equipment are required

Run the electrical safety test according to the IEC 60601-1 medical electrical equipment standard.

64
6.2.29 Testing the Flow Rate
Test Description
During this flow rate test (compliant with the EN-60601-2-24 standard), a 25 mL infusion at
100 mL/h is carried out, and the delivered volume is reported.
The volume reported is compared to the theoretical volume (25 mL), and the flow rate test is
stated as passed if the calculated flow rate error is between -5 % and +5 %.

The flow rate is correctly calibrated.

If the test fails, calibrate the flow rate using Agilia Partner maintenance software.

Required Tools and Equipment


 1 Scale with a sensitivity of 0.01 g and a beaker
 1 Catheter extension with a Luer lock end: length 40 in (100 cm), interior diameter 0.1 in (2.5 mm)
 1 Needle: type G18 or G21
 1 Administration set (VL infusion set range)
 1 Bag
 Distilled water, oil.

Recommended temperatures for flow rate accuracy:


 Administration set temperature: 10 °C to 40 °C (50 °F to 104 °F)
 Temperatures of the water in the administration set: 10 °C to 40 °C (50 °F to 104 °F)

Prerequisites
 The scale’s calibration certificate is valid.

1. Setup the equipment:


 Fill the container with 600 mL or more of distilled water.
 Connect an administration set to the container.
 Connect the cannula to the other end of the administration set.
 Open the pump door.
 Install a water-filled administration set into the pump.
Make sure that no air is present in the administration set before measurement starts.
 Place the beaker at the center of the scale platform.
 Place the cannula inside the beaker.
 Fill the beaker with some water, making sure the cannula is dipped in the water (> 1 cm (0.4 in)).
 Add several drops of oil to create a greasy film on the surface of the water. This way the user will
avoid any measurement error due to evaporation of the water.
 Close the pump door.
 Power on the pump.

65
20 in (50 cm)

0.4 in
(1 cm)
2
3
Figure 6.1: Flow rate test using a scale

Legend
1 Catheter extension bracket support 3 Anti-vibration measuring table

2 Scale

INFORMATION
Check that the installation surface is level.

2. Prime the administration set using the key.


Refer to the Instructions for Use of the relevant pump.
3. Check for the absence of air bubbles.
4. Program the following infusion:
 Basic Profile.
 Volume to be infused (VTBI) = 25 mL.
 Flow rate = 100 mL/h.
5. On the pump, start a first 25 mL infusion at 100 mL/h (duration: 15 minutes) to warm up the
administration set.
6. Empty the beaker.
7. Zero the scale, or write down the weight of the empty beaker.
8. Start a second 25 mL infusion at 100 mL/h (duration: 15 minutes).
9. Read the "VI" volume infused in mL on the scale, and write it down.
10.Calculate the "F" flow rate of the second infusion as:
F (in mL/h) = 4 x VI (in mL with 1 mL = 1 g)
11.Check that the "F" Flow rate is between 95 mL/h and 105 mL/h.
If not, calibrate the flow rate using Agilia Partner maintenance software.

66
6.3 Quality Control Procedure
6.3.1 Running a Quality Control
Print the form provided. See section 6.3.2, page 71.
Run Test 2: Maintenance. See section 6.2.3, page 39.
 Enter the following maintenance data in the form:
- Running time in hours since last preventive maintenance date
- Last preventive maintenance date
 Fix the next preventive maintenance date. Add a maximum of 3 years to the date of last preventive
maintenance.
 Fill the Next maintenance date in the form.
1. Run Test 1: Identification. Identification and general appearance check. See section 6.2.2, page 38.
 Check housing.
 Check AC power cord.
 Check the product code REF and serial number SN on the pump
identification label.
 Fill the pump identification data in the form:
- Pump type
- Product code
- Serial number

2. Check the attachment lock knob and rotating pole clamp (locking system test).

67
3. Check the LCD contrast and adjust if necessary:
 Access the Pump Settings menu in the Options menu.
 Select User 3: Contrast.
4. Run Test 9: Indication. See section 6.2.10, page 45.
Check backlight, all pump LEDs, power supply indicator, battery charge indicator. Check that the
speaker and buzzer are functioning correctly.
5. Run Test 10: Keypad. See section 6.2.11, page 45.
Check the keypad.
6. Run Test 24: Watchdog. See section 6.2.24, page 60.
 Check that all red LEDs light up and that the buzzer sounds between 1.0 seconds and
2.25 seconds.
 Press for 5 seconds to stop the alarm and power off the pump.
7. Run Test 15: Clamp motor. See section 6.2.16, page 51.
Check the anti-free flow clamp motor correct functioning.
8. Run Test 19: Clamp. See section 6.2.19, page 55.
Check the presence and state (open/closed) of the administration set’s anti-free flow clamp.
9. Run Test 7: Door. See section 6.2.8, page 42.
Check the correct functioning of the door fastening system:
 Open the door.
 Check that "State" = "opened".
 Close the door.
 Check the message "State" = "closed".
 If the state displayed is not coherent:
- Calibrate the door sensor using Agilia Partner maintenance software.
- Repeat Test 7: Door.
10. Run Test 11: Ageing test (occlusivity test). See section 6.2.12, page 46.
 Install a manometer at the administration set outlet.
 Install a water-filled administration set into the pump.
 Run Test 11: Ageing test with the following settings:
- Flow rate: 500 mL/h
- Mode: Forward
- Current: Standard
- Step number: Continuous
 Check that:
- No motor errors are triggered
- Maximum pressure is between 24.6 PSI (1.7 bar) and 36.3 PSI (2.5 bar)
- Pressure rises to maximum in less than 45 seconds

68
11. Check the upstream pressure limit alarm:
 Install a water-filled administration set into the pump.
 Install the roller clamp as close as possible to the drip
chamber.
 Close the pump door.
 Close the roller clamp upstream the pump.
 Start an infusion at 100 mL/h.

 Check that the upstream occlusion alarm is triggered


within a maximum of 30 seconds.
If the upstream occlusion alarm is triggered after 30 seconds,
calibrate the upstream pressure sensor using Agilia Partner
maintenance software.
 Press to silence the alarm.
 Open the roller clamp.
 Press start.
Infusion is resumed.
12. Check the downstream pressure limit alarm.
 Install a manometer at the administration set outlet.
 Load a water-filled administration set into the pump.
 Close the pump door
 Wait for the end of OCS test
 Press .
 Press the arrow keys to select Pressure management .
 Press the arrow keys to select 750 mmHg for Limit.
If this pressure cannot be adjusted here, go to Adjusting the pressure limit to 750 mmHg, page 63.
 Start an infusion at 100 mL/h.
An occlusion alarm is triggered when 12.3 PSI (0.85 bar) <
Pressure < 16.7 PSI (1.15 bar).
If it is not, calibrate the downstream pressure sensor using
Agilia Partner maintenance software.
 Press to silence the alarm.
 Press to stop the infusion.
13. Check the air detector alarm:
 Load a water-filled administration set into the pump.
 Start an infusion at 500 mL/h.
 Turn the drip chamber upside down to create an air bubble with a length between 5 cm (2 in) and
11.5 cm (4.5 in).
 Wait for the pump to detect the bubble.
 Check that the Air alarm is triggered when the air bubble passes
through the air detector. All red LEDs are lit.
If the air alarm is not triggered, calibrate the air detector using
Agilia Partner maintenance software.
 Press to silence the alarm.

69
14. Check the flow rate:
 Load a water-filled administration set into the pump.
 Carry out an infusion of 25 mL at 100 mL/h to warm up the administration set.
 Carry out a flow rate test according to EN/IEC 60601-2-24 standard using a scale or graduated
tube.
Section 6.2.29, page 65.
 Check that the flow rate error is between -5 % and +5 %. The volume measured is between
23.75 mL and 26.25 mL.
If the flow rate is out of range, calibrate the flow rate using Agilia Partner maintenance software.
15. Check the AC power disconnection:
 Disconnect the pump’s AC power cord.
 Check that the plug-shaped power supply indicator is off.
 Connect the pump to an AC power supply.
 Check that the plug-shaped power supply indicator lights up green.
16. Check the battery life:
 Connect the pump to an AC power supply.
 Recharge the battery for 8 hours (pump switched off).
 Run Test 13: Battery test. See section 6.2.14, page 48.
 At end of test:
-Connect the pump to an AC power supply
-Power on the pump
-Run Test 12: Battery life. See section 6.2.13, page 48.
-Check that the displayed "Alarm" is equal to or greater than 06h30. (06:30)
If not, replace the battery. See section 8.1, page 85.
17. Run the electrical test according to EN/IEC 60601-1 standard. See section 6.2.28, page 64.
18. Enter the following identification data in the form:
 Result (Pass/Fail) for each test
 Global result for Quality control (Pass/Fail)
 Biomedical name
 Ward name
 Name
 Technical department
 Date and signature

70
6.3.2 Quality Control Certificate
Pump type: Product code: Serial number:
Hospital name: Running time since last Date of last preventive maintenance:
preventive maintenance date:
Ward name: Date of next preventive maintenance:

No. Procedure Pass Fail


1 Test 1: Identification and general appearance check.
Pump housing, AC power cord, product code, serial number.
2 Locking system test. Check the attachment lock knob and rotating pole clamp.
3 LCD display test. Check/adjust the LCD contrast (Pump settings > User 3).
4 Test 9: Indication. Backlight, LEDs, indicators and buzzer test.
5 Test 10: Keypad test.
6 Test 24: Watchdog.
Default mode triggered in seconds (between 1.0 second and 2.25 seconds).
7 Test 15: Clamp motor. Anti-free flow clamp motor.
8 Test 19: Clamp. Administration set anti-free flow clamp.
9 Test 7: Door. Pump door position.
10 Test 11: Ageing test. Occlusivity.
Pressure rises up to maximum level in seconds (less than 45 seconds)
11 Upstream pressure sensor.
Triggering of a "Upstream occlusion" alarm in seconds (less than 30 seconds).
12 Downstream pressure sensor.
Triggering of a "Downstream occlusion" alarm at PSI (between 12.3 PSI (0.85 bar) and
16.7 PSI (1.15 bar)).
13 Air detector. Triggering of an "Air alarm".
14 Flow rate test.
Volume infused mL (between 23.75 mL and 26.25 mL).
15 Power indicator test. AC power disconnection.

Not executed
16 Battery life. Test 13: Battery test and Test 12: Battery life.
Displayed "Alarm": : (greater than 6h30 (06:30))

17 Electrical test.

Pass
Fail
Name: Date: Signature:

Technical department:

Observations:

71
7 Troubleshooting and Messages

7.1 Alarm Messages and Information Signals


Alarm Priority Required Operator Response Description
 The infusion stops.
 The infusion indicator lights flash red.
 The pump emits audible alarm signals.
 An alarm description is displayed on the pump
High (!!!) Immediate response screen.

 Depending on the alarm, the key silences


the alarm for no time limit or for a defined duration.
For detailed description of each alarm, see below.
Medium (!!) Prompt response  The infusion continues.
 The infusion indicator lights flash yellow.
 The pump emits audible alarm signals.

Low (!) Awareness  Depending on the alarm, the key silences


the alarm for no time limit or for a defined duration.
For detailed description of each alarm, see below.
 The infusion continues.
Information
Awareness  An information message is displayed on the pump
Signals screen.

Displayed Message Priority Problem / Resolution


Technical alarm.
 See section 7.3, page 80.
 Contact your qualified technician or your Fresenius Kabi
ERxx(yyyy) !!! High (!!!)
sales representative.

Note: the key silences the alarm for 30 seconds.


The battery is discharged.
The pump will power OFF automatically within 5 minutes.
Battery alarm !!! High (!!!)  Connect the pump to a power supply immediately.

Note: the key silences the alarm for 2 minutes.


Very low battery.
 Connect the pump to a power supply and allow time to
Very low battery !!! High (!!!) charge.

Note: the key silences the alarm for 2 minutes.


The Hall effect door sensor detects that the door is open.
 Check the administration set installation and close the door.
 Check that the magnet is present on the door.
 Calibrate, then test the door sensor using Agilia Partner
maintenance software.
Door opened !!! High (!!!)
 Replace the upper case supporting the HMI board, with the
Hall effect door sensor. See section 8.2, page 87.
 Replace the door. See section 8.13, page 125.

Note: the key silences the alarm for 2 minutes.


At startup, the administration set is not loaded or the door is
open.
Install set !!! High (!!!)  Install the administration set and close the door.

Note: the key silences the alarm for 2 minutes.

72
Displayed Message Priority Problem / Resolution
The pump does not detect the presence of the anti-free flow
clamp.
 Install the administration set and close the door.
 Check the position of the administration set and the anti-free
flow clamp.
 Check the OCS flexible IC (switch board and opto sensors)
and replace if necessary. See section 8.15, page 128.
There is no administration set in front of the upstream or
Check set installation !!! High (!!!) downstream sensor.
 Check the administration set installation.
 Check that the magnet is present on the door.
 Calibrate then test the door sensor using Agilia Partner
maintenance software.
 Replace the upper case supporting the HMI board with the
door sensor. See section 8.2, page 87.

Note: the key silences the alarm for 2 minutes.


The administration set is incorrectly positioned in front of the
air sensor.
 Check the position of the administration set and the anti-free
flow clamp.
Set / air installation !!! High (!!!)  Prime the administration set to remove air bubbles.
 Check the administration set installation in front of the air
sensor, and close the door.

Note: the key silences the alarm for 2 minutes.


An air bubble has been detected (at startup, during the
infusion, or while the infusion is stopped).
 Remove the air bubble by priming the administration set.
The volume of air detected in the line exceeds the limit.
 Remove the air bubbles by repositioning the administration
set.
Air bubble !!! High (!!!)
 Check the air bubble size setting.
 Calibrate the air detector using Agilia Partner maintenance
software.
 Replace the air detector board. See section 8.8, page 104.

Note: the key silences the alarm for 2 minutes.


An air bubble has been detected during the infusion.
 Remove the air bubble by priming the administration set.
Air alarm !!! High (!!!)
Note: the key silences the alarm for no time limit.
The VTBI is completed.
 Press to select new infusion settings (if required).
End of infusion !!! High (!!!)
Note: the key acknowledges the alarm.

73
Displayed Message Priority Problem / Resolution
The OCS control system has detected a failure.
The pumping mechanism has not managed to raise the
pressure in the line during the OCS test.
 Close the roller clamp, check the administration set
installation, check the door integrity, check the
administration set integrity.
 Calibrate then test the pressure sensors using
Agilia Partner maintenance software.
OCS Failure !!! High (!!!)  Check the membrane and replace it if necessary.
See section 8.14, page 126.
 Check the installation and the integrity of the administration
set.
 Check the door integrity.
 If the problem cannot be resolved, contact the
Fresenius Kabi Technical Service.

Note: the key silences the alarm for 2 minutes.


The pressure level in the upstream line is too low.
 Check the roller clamp. Check the container and line. Check
the container height. Check air vent (if a bottle is used).
Check for kinked line.
 Calibrate then test the pressure sensors using
Upstream occlusion !!! High (!!!)
Agilia Partner maintenance software.
 Replace the upstream pressure sensor.
See section 8.11, page 117.

Note: the key silences the alarm for 2 minutes.


The pressure in the infusion line has reached the threshold
level.
 Check whether the infusion line is occluded. If necessary,
readjust the pressure threshold.
 Calibrate then test the pressure sensors using
Agilia Partner maintenance software.
Downstream occlusion !!! High (!!!)
 Replace the downstream pressure sensor.
See section 8.11, page 117.

Note: the key silences the alarm for 2 minutes if the


pressure condition is still present. Otherwise, alarm is
acknowledged.
The secondary infusion is completed (only with manual return
to primary).
Not available in certain countries.
End secondary alarm !!! High (!!!)
 Restart the primary infusion.

Note: the key acknowledges the alarm.


A downstream occlusion has been detected by the device.
Wait during pressure  Check the line.
measurement High (!!!)  If the occlusion is released before the end of
checking !!! temporization, the infusion will restart automatically.
 Otherwise, a downstream occlusion alarm is triggered.
This message displays only if the drop sensor is mandatory.
At start-up, the drop sensor is not connected to the pump.
 Connect the drop sensor to the pump and the drip
Connect drop chamber.
High (!!!)
sensor !!!
Not available in certain countries.

Note: the key silences the alarm for 2 minutes.

74
Displayed Message Priority Problem / Resolution
During the infusion or when the infusion is stopped, the drop
sensor is connected to the pump.
 Disconnect the drop sensor from the pump.
No drop sensor !!! High (!!!)
Not available in certain countries.

Note: the key silences the alarm for no time limit.


The flow rate detected by the drop sensor is inferior to the
programmed flow rate.
 Check the container.
 Check the roller clamp.
 Check that the fluid drip forms ~20 drops/mL.
Underflow !!! High (!!!)  Check that the drip chamber is in a vertical position.
 Check that the drop sensor is installed as recommended.

Not available in certain countries.

Note: the key acknowledges the alarm.


The flow rate detected by the drop sensor is superior to the
programmed flow rate.
 Open the pump door and check the administration set
positioning.
 Check the fluid temperature.
Overflow !!! High (!!!)  Check that the fluid drip forms ~20 drops/mL.
 Check that the drop sensor is installed as recommended.

Not available in certain countries.

Note: the key acknowledges the alarm.


At start-up or when the infusion is stopped, a free flow is
detected by the drop sensor.
 Clsoe the roller clamp.
 Check the drop sensor and the administration set
installation.
Uncontrolled flow !!! High (!!!)
Not available in certain countries.

Note: the key acknowledges the alarm. If free flow


continues, alarm will raise again.
One of the near end of infusion alert criteria is reached (time
before the end of infusion, % of VTBI remaining, remaining
VTBI).
 Check whether the remaining volume in the container
Near end of infusion !! Medium (!!)
corresponds to the remaining VTBI.
 If needed, prepare a container for a new infusion sequence.

Note: the key silences the alarm for no time limit.


A value must be entered.
 Enter a value and press OK to confirm.
Waiting settings !! Medium (!!)
Note: the key silences the alarm for 2 minutes.
The flow rate (or dose) has been modified using the keys but
has not been confirmed.
Check settings !! Medium (!!)  Check the flow rate (or dose) and press OK to confirm.

Note: the key silences the alarm for 2 minutes.


The infusion settings have been entered but have not been
confirmed with Start.
 Check infusion parameters and press Start to start the
Waiting start !! Medium (!!)
infusion.

Note: the key silences the alarm for 2 minutes.

75
Displayed Message Priority Problem / Resolution
In-line pressure has reached 50 mmHg / 5 kPa / 1 PSI below
the programmed threshold.
 Check the infusion line.
Occlusion pre alarm !! Medium (!!)  Define the pressure threshold parameter (User 4).
See section 5.2, page 30.

Note: the key silences the alarm for no time limit.


Low battery.
 Connect the pump to a power supply.
Battery pre alarm !! Medium (!!)
Note: the key silences the alarm for 2 minutes.
End of infusion ! End of infusion - with KVO
The VTBI is completed and the KVO is activated according to
its configuration in Agilia Vigilant Drug’Lib software or in the
pump options.
Low (!)
Stop for new infusion !  Press to select new infusion settings (if required).

Note: the key silences the alarm for a time duration from
1 minute to 12 hours.
The pressure is increasing in the infusion line. This warning
can be selected as an option.
 Check for occlusions in the infusion line (roller clamp or tap
Pressure increase ! Low (!) closed, administration set blocked, line kinked or twisted,
etc.).

Note: the key acknowledges the alarm.


The pressure is decreasing in the infusion line. This warning
can be selected as an option.
 Check the downstream Luer lock connection and the
Drop in pressure ! Low (!)
integrity of the entire line.

Note: the key acknowledges the alarm.


The power supply is inconsistent.
 Contact your Technical Service.
AC power failure ! Low (!)
Note: the key acknowledges the alarm.
Check bags position and line End of secondary infusion.
installation for primary Low (!) Not available in certain countries.
infusion !  Press to acknowledge.
Re-open primary line ! End of secondary infusion.
Low (!) Not available in certain countries.
Close secondary line !  Press to acknowledge.
Temperature increase.
 Check device environment.
High internal temperature ! Low (!)  Send the pump for maintenance.

Note: the key silences the alarm for 2 minutes.


If the pump is not used during an extended period, connect to a
Low (!)
power supply and wait until the battery is charged.
The pump is mounted on a Link+ Agilia rack that has not been
upgraded.
Alarm reporting not available  Contact your qualified technician or your Fresenius Kabi
Low (!)
on the Link ! Technical Service.

Note: the key acknowledges the alarm.

76
Displayed Message Priority Problem / Resolution
At start-up or when the infusion is stopped, the drop sensor is
connected to the pump.
 Disconnect the drop sensor from the pump.
No drop sensor ! Low (!)
Not available in certain countries.

Note: the key silences the alarm for no time limit.


The upper soft limit is exceeded, according to the drug settings
Upper soft max Information signal
defined in the drug library.
The lower soft limit is exceeded, according to the drug settings
Lower soft min Information signal
defined in the drug library.
Reached hard limit Information signal The upper or lower hard limit is reached.
The pump is disconnected from the AC power. A single beep is
emitted.
 Press to acknowledge.
Power disconnection Information signal  Check that the battery life is sufficient for the expected
infusion duration.
 If the disconnection was unintentional, check the power
connection.
Under specific conditions, the pump asks you to open and
Open and close door for OCS
Information signal close the door to perform the OCS test.
test
 Open and close the door.
The keypad is locked.
Keypad lock status Information signal
 Unlock the keypad.
Keypad locked The keypad is locked and the door was opened and closed.
Information signal
Unlock keypad to continue  Unlock the keypad.

In the case of a system malfunction, the alarm sounds and an error message Erxx(yyyy) !!! is
displayed.
1. Record the error message Erxx(yyyy) !!!.
2. Close the roller clamp.
3. Disconnect the pump from the power supply.

4. Switch the device off by pressing the key.

WARNING
If the alarms persist when the pump is powered on again, do not use the device on a patient, and contact
qualified biomedical engineering staff in your healthcare facility, or your Fresenius Kabi sales
representative.

77
78
7.2 Troubleshooting Guide
Description Cause Recommended Action
 Check the display board.
 Check the connectIons between CPU board
Control transistors, LEDs and/or
Display defect: LED, LCD display. and display board.
connections are defective.
 Replace the display board/LCD display.
See section 8.3, page 89.
Detection of a open door while the door is  Calibrate the door sensor using Agilia Partner
closed. maintenance software.
The door sensor is not calibrated.
Detection of an closed door while the
door is open.
Wrong calibration of the  Recalibrate the downstream or upstream
downstream or upstream sensor using Agilia Partner maintenance
Occlusion alarm after the pump has been
pressure sensor. software.
turned on.
The downstream or upstream  Replace the downstream or upstream sensor.
pressure sensor is damaged. See section 8.11, page 117.
 Select a higher pressure limit (Pressure
The pressure limit selected is too
management menu ).
low.
 Recalibrate the downstream or upstream
Wrong calibration of the
Occlusion alarm during the infusion. sensor using Agilia Partner maintenance
downstream or upstream
software.
pressure sensor.
 Replace the downstream or upstream sensor.
Flexible circuit is cut.
See section 8.11, page 117.
 Connect the pump to the AC power supply.
 Replace the battery.
The power supply indicator doesn't light Battery is totally discharged. See section 8.1, page 85.
up. Power supply board is defective.  Check the power cord and AC power supply.
 Replace the power supply board.
See section 8.5, page 94.
Battery alarm even though it has been The power supply board is  Replace the power supply board.
completely charged. damaged. See section 8.5, page 94.
 Replace the upper case. See section 8.2,
page 87.
Defective keypad.  Check the keypad by running test 10.
The pump turns ON or OFF itself.
Power supply board is damaged. See section 6.2.11, page 45.
 Replace the power supply board if necessary.
See section 8.5, page 94.
 Replace the upper case.
See section 8.2, page 87.
Some keys of the keypad do not work. Defective keypad.
 Check the keypad by running test 10.
See section 6.2.11, page 45.
 Connect the pump to the AC power supply.
Then, wait few minutes without touching the
At start-up, the pump displays: "Software keypad until the message disappears and the
Pump upgrade from V1.x to V2.x
is upgrading...". pump starts as usual.
 Contact your biomedical department or your
Fresenius Kabi sales representative.
 Check the status of the casings and the
Mechanical elements are damaged. After a fall.
mechanical system.

79
7.3 Error Codes
Error Code Description Recommended Actions
 Check correct functioning of the motor.
 Check the ribbon cable connection between the optical switch
and CPU board (J3 connector). See figure 2.5, page 14.
01 Motor rotation  Check the correct functioning of the motor rotation optical switch.
 Replace the CPU board. See section 8.4, page 91.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
 Replace the CPU board. See section 8.4, page 91.
10 RAM  Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
 Replace the CPU board. See section 8.4, page 91.
Flash memory (deleting or
11  Carry out a complete configuration/calibration/control cycle using
programming problem)
Agilia Partner maintenance software.
 Carry out a complete configuration for the pump using the
Agilia Partner maintenance software.
If the problem cannot be resolved:
12 Resources
 Replace the CPU board.See section 8.4, page 91.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
Secondary Crc16  Carry out a complete configuration/calibration/control cycle using
13 microcontroller - version is Agilia Partner maintenance software.
incorrect
Secondary microcontroller  Replace the Power supply board. See section 8.5, page 94.
14 restarting - Watchdog
problem
 Check the ribbon cable connection between Power supply board
(J1 connector) and CPU board (J10 connector).
Secondary microcontroller
15 See figure 2.5, page 14.
communication
See figure 2.7, page 19.
 Replace the Power supply board. See section 8.5, page 94.
 Check the battery connection to Power supply board
(J3 connector). See section 2.1.5, page 19.
16 Disconnected battery  Check the battery charging voltage. Run test 12.
See section 6.2.13, page 48.
 Replace the battery. See section 8.1, page 85.
 Check the battery charging voltage. Run test 12.
17 Battery charge See section 6.2.13, page 48.
 Replace the battery. See section 8.1, page 85.
 Remove the battery door. See section 8.1, page 85.
18 AC power presence  Check the status of the AC power fuse.
 Replace the Power supply board. See section 8.5, page 94.
 Check the battery status. Run test 8. See section 6.2.9, page 44.
19 Battery temperature
 Replace the battery. See section 8.1, page 85.
 Check that the opto switch is functioning correctly by running
test 19, (line Clamp). See section 6.2.19, page 55.
Anti-free flow clamp
22  Check the cable connection to CPU board (J1 connector).
presence opto switch
See figure 2.5, page 14.
 Replace the OCS flexible IC.See section 8.15, page 128.
 Check that the 2 opto switches are functioning correctly by
running test 19, (line Position). See section 6.2.19, page 55.
Anti-free flow clamp motor
23  Check the cable connection to CPU board (J1 connector).
position opto switches
See figure 2.5, page 14.
 Replace the OCS flexible IC. See section 8.15, page 128.

80
Error Code Description Recommended Actions
 Run test 15. See section 6.2.16, page 51.
 Check the status of the Anti-free flow clamp motor.
 Check the connection of the Anti-free flow clamp motor to the
24 Unclamping
CPU board (J8 connector). See figure 2.5, page 14.
 Replace the Anti-free flow clamp motor.
See section 8.12, page 122.
 Run test 7 to check the "open or closed" door detection.
See section 6.2.8, page 42.
 Check that the magnet is present on the door.
25 Door Hall effect sensor
 Replace the door. See section 8.13, page 125.
 Calibrate then test the door sensor using Agilia Partner
maintenance software.
 Check the connection between Display board and CPU board.
See section 2.1.3, page 11.
See section 2.1.4, page 14.
 Check the connection between Power supply board and CPU
26 Board missing
board.
See section 2.1.4, page 14.
See section 2.1.5, page 19.
 Replace the faulty part(s).
 Check the connection between Display board (J3 connector) and
LCD display. See section 2.1.3, page 11.
27 LCD blacklight missing
 Replace the LCD display. See section 8.3, page 89.
 If the problem cannot be resolved, replace the Display board.
 Run test 10 to check the keypad. See section 6.2.11, page 45.
 Replace the upper case. See section 8.2, page 87.
28 Keypad  Run test 10 to check the keypad.
 If the problem cannot be resolved, replace the Display board.
See section 8.3, page 89.
 Replace the CPU board. See section 8.4, page 91.
29 Analog/digital converter  Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
 Replace the Power supply board supporting the secondary
microcontroller. See section 8.5, page 94.
30 Time keeper  Replace the CPU board. See section 8.4, page 91.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
 Run test 14. See section 6.2.15, page 50.
 Check the status of the air detector using an administration set
33 Air detector filled with water and air.
 Calibrate the air detector using Agilia Partner maintenance
software.
 Carry out a complete configuration using Agilia Partner
34 Infusion flow rate
maintenance software.
 Carry out a complete configuration using Agilia Partner
35 Motor period
maintenance software.
 Carry out a complete configuration using Agilia Partner
36 Motor rotation direction
maintenance software.
 Check that you have not pressed the OFF key too repeatedly.
 Replace the Power supply board to check the functionality of the
secondary microcontroller. See section 8.5, page 94.
OFF key.
 Replace the Display board. See section 8.3, page 89.
37 Reading status problem or
 Replace the CPU board to check the functionality of the main
key pressed too repeatedly
microcontroller.See section 8.4, page 91.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
 Run test 10 to check the functionality of the keypad, and
especially the OFF key. See section 6.2.11, page 45.
38 OFF key locked  Replace the upper case. See section 8.2, page 87.
 Replace the Power supply board to check the secondary
microcontroller functionality. See section 8.5, page 94.

81
Error Code Description Recommended Actions
39 Impossible to power off  Replace the Power supply board. See section 8.5, page 94.
 Run test 5. See section 6.2.6, page 40.
 Check the sensor state change by applying pressure on the
upstream sensor.
Upstream pressure sensor
41  Check the connections to CPU board (J11 connector).
out of range
See figure 2.5, page 14.
 Calibrate the upstream sensor using Agilia Partner maintenance
software.
 Run test 6. See section 6.2.7, page 41.
 Check the sensor state change by applying pressure on the
downstream sensor.
Downstream pressure
42  Check the connections to CPU board (J2 connector).
sensor out of range
See figure 2.5, page 14.
 Calibrate the downstream sensor using Agilia Partner
maintenance software.
43 LCD communication failure  Replace the Display board.See section 8.3, page 89.

44 LCD driver failure  Replace the Display board.See section 8.3, page 89.

45 Defective LCD voltage  Replace the Display board.See section 8.3, page 89.
Backup capacitor  Contact the Fresenius Kabi Technical Service.
46
temperature too high
Backup capacitor  Contact the Fresenius Kabi Technical Service.
47
temperature out of range
Pump temperature out of  Place the pump in normal operating temperature.
48
range Please refer to the Instructions for Use of the relevant pump.
Backup capacitor and safety  Replace the Power supply board. See section 8.5, page 94.
49 5 V booster charging circuit
defective
Power supply board voltage  Replace the Power supply board. See section 8.5, page 94.
50
out of range
 Check the connection to Power supply board (J2 connector).
51 Defective speaker See section 2.1.5, page 19.
 Replace the speaker and flexible circuit.
Buzzer sound level too low or defective speaker (see error code 51).
52 Defective buzzer  Replace the Power supply board supporting the buzzer.
See section 8.5, page 94.
Battery parameter in  Contact the Fresenius Kabi Technical Service.
53
coulometer EPROM
Secondary microcontroller /  Contact the Fresenius Kabi Technical Service.
54 coulometer power supply
board communication
 Carry out a complete configuration check using Agilia Partner
55 Defective profile
maintenance software.
 Replace the Power supply board. See section 8.5, page 94.
CMDFAIL  Replace the Display board. See section 8.3, page 89.
56 Autotest failure on starting  Replace the CPU board.See section 8.4, page 91.
up the pump.  Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
 Replace the CPU board. See section 8.4, page 91.
97 Defective oscillator  Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
 Replace the CPU board. See section 8.4, page 91.
98 Defective reset circuit  Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.

82
Error Code Description Recommended Actions
 Replace the Power supply board to check the functionality of the
secondary microcontroller. See section 8.5, page 94.
 Replace the CPU board to check the functionality of the main
99 Activation of the watchdog
microcontroller. See section 8.4, page 91.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.

83
8 Intervention Procedures

This section details all dismantling and re-assembling procedures.

WARNING
 ONLY use the recommended accessories and spare parts delivered with the pump. NO PART IS
REPAIRABLE. When replacing components, only use Fresenius Kabi spare parts. Refer to the
"Spare Parts Catalog" for ordering information.
 Any instruments or devices used for maintenance must be regularly checked or re-calibrated
according to their specifications and local regulations.
 Disconnect the battery, and discharge the boost capacitor before opening the pump (see
procedure no.1). A risk of electric shock exists when touching a charged boost capacitor.
 For safety reasons, the technician should not intervene when the pump is connected to an AC power
supply:
- Unplug the power supply cord from the AC power supply.
- Power off the pump.
 When working with electronic components, we recommend wearing an anti-static bracelet
connected to earth and working on an anti-static mat.
 Do not touch the electronic boards with your hands.

84
8.1 Procedure #1: Battery and Battery Door - Boost Capacitor Discharge
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
The battery must be only replaced by a qualified person.
See section 3.1, page 27.

Dismantling
1. Unscrew the 2 screws [1] that hold the battery door in place.
2. Remove the battery door [2].
3. Power on the pump.

1 1

85
4. Disconnect the [J3] connector and remove the battery [3].
The boost capacitor starts to discharge.
The buzzer sounds and red LEDs light during this discharge (approximately 20 minutes).

J3
5

INFORMATION
If the identification labels of the fuse [5] and the battery [4] are damaged, they must be replaced.
Contact Fresenius Kabi to get new labels.

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Insert the battery in the correct direction.
3. Perform a charge/discharge cycle.
4. Perform the regular servicing tests. See Quality Control Procedure, page 67.

86
8.2 Procedure #2: Upper Case
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].

1 1

3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.

6
J1
5
3
3
4

87
8. Disconnect the display board flat cable at [J2].
9. Disconnect the display board / keypad cable (connection at [J1]).
10.Remove the 4 screws [7] that fasten the board unit to the upper case.

7 7

J1

7 J2 7

11.Remove the display board unit from the upper case [8].

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibration using Agilia Partner maintenance software:
 Door
3. Perform the regular servicing tests. See Quality Control Procedure, page 67.

88
8.3 Procedure #3: Display Board/LCD Display
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].

1 1

3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.

6
J1
5
3
3
4

89
8. Disconnect the display board flat cable at [J2].
9. Disconnect the keypad/display board connection at [J1].
10.Unscrew the 4 screws [7] that fasten the board to the upper case.
11.Remove the display board / LCD display from the upper case.

7 7

J1

7 J2 J3 7

12.Disconnect the display board /LCD display connection at [J3].


13.Unclip and separate the LCD display [9] from the display board [8].

J3

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Door
 LCD contrast
3. Perform the regular servicing tests. See Quality Control Procedure, page 67.

90
8.4 Procedure #4: CPU Board
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The battery is disconnected and the boost capacitor discharged. See section 8.1, page 85.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].

1 1

3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.

6
J1
5
3
3
4

91
8. Disconnect the display board flat cable at [J2].

J1

J2

9. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
10.If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12]. To remove the Wi-Fi board: See section 8.6, page 96.
11.Unscrew the screw [7] that holds the CPU board to the flange.

J2

J1 J3

8 J6

J12

J7

J8

J11

J8 J9

92
12.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
13.Disconnect the flat cables [J10] and [J5].

J5

J7

J10

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Pressure sensors
 Door
 Air detector
 Flow rate
 Date
 LCD contrast
3. Perform the regular servicing tests. See Quality Control Procedure, page 67.

INFORMATION
When replacing the CPU board, carry out a complete configuration of the pump (calibrations and tests).
Each pump has its own CPU board model. Be careful not to mix up the different pump references.

93
8.5 Procedure #5: Power Supply Board and AC Power Board
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].

1 1

3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [3].
4. Disconnect the CPU board flat cable [3] at [J1].

3
J1

94
5. Disconnect flat cable [J2].
6. Unscrew and remove screw [4].
7. Remove the power supply board:
 Pull the board out by its corner edge to dislodge it from securing clip [5].
 Dislodge the board from slot [6].

J2
5 6

Re-assembling
1. Place the black insulator part [7] on the AC supply board.
2. Insert the power supply board in slot [6].
3. Locate securing clip [5] then press the power supply board down, locking the board into
position with the securing clip.
4. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.

6
5

5. Perform the regular servicing tests. See Quality Control Procedure, page 67.

95
8.6 Procedure #6: Wi-Fi Board
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 This procedure is only applicable to pumps equipped with a Wi-Fi module.
 The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].

1 1

3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.

6
J1
5
3
3
4

96
8. Disconnect the display board flat cable at [J2].

J1

J2

9. Disconnect flat cable that connects the Wi-Fi board to the CPU board at [J12].
10.Unscrew and remove the screw [6] that holds the Wi-Fi board [7] to the flange.
11.Remove the Wi-Fi board holder.

J12

97
12.Dislodge the Wi-Fi board [7] from the flange.

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibration using Agilia Partner maintenance software:
 Door
3. Perform the regular servicing tests. See Quality Control Procedure, page 67.

98
8.7 Procedure #7: Base Kit
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The battery is disconnected and the boost capacitor discharged. See section 8.1, page 85.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].

1 1

3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.

6
J1
5
3
3
4

99
8. Disconnect the display board flat cable at [J2].

J1

J2

9. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
10.If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12]. To remove the Wi-Fi board: See section 8.6, page 96.
11.Unscrew the screw [7] that holds the CPU board to the flange.

J2

J1 J3

8 J6

J12

J7

J8

J11

J8 J9

100
12.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
13.Disconnect the flat cables [J10] and [J5].

J5

J7

J10

14.Unscrew the 2 screws [9] on either side of the right and left flanges, being careful not to
damage the air detector board [10].

9 9
10

15.Place the pump with the door facing down.


16.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
17.Unscrew the screw [12] positioned under the base.
18.Remove the pumping plate [13].
19.Unscrew the 2 screws [14] positioned under the base.

101
12 13

15 16

14 11 14

20.Remove the left flange [15].


21.Remove the right flange [16].

16

15

13

102
22.Separate the base kit [17] from the motor kit [18] pulling the motor out of its axis [19].

17 18

19

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Pressure sensors
 Door
 Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 67.

103
8.8 Procedure #8: Air Detector Board
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].

1 1

3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.

6
J1
5
3
3
4

104
8. Disconnect the display board flat cable at [J2].

J1

J2

9. Unscrew the 2 screws [7] from the air detector board [8].

105
10.Remove the air detector board, being careful not to pull out the flat cable [9].
11.Disconnect the flat cable [9] connected to the air detector board at [J1].

J1
8

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Pressure sensors
 Door
 Air detector
3. Perform the regular servicing tests. See Quality Control Procedure, page 67.

106
8.9 Procedure #9: Pumping System
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The battery is disconnected and the boost capacitor discharged. See section 8.1, page 85.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].

1 1

3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.

6
J1
5
3
3
4

107
8. Disconnect the display board flat cable at [J2].

J1

J2

9. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
10.If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12]. To remove the Wi-Fi board: See section 8.6, page 96.
11.Unscrew the screw [7] that holds the CPU board to the flange.

J2

J1 J3

8 J6

J12

J7

J8

J11

J8 J9

108
12.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
13.Disconnect the flat cables [J10] and [J5].

J5

J7

J10

14.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].

9
10

109
15.Place the pump with the door facing down..
16.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
17.Unscrew the screw [12] positioned under the base.
18.Remove the pumping plate [13].
19.Unscrew the screw [14] positioned under the base.

12 13

15

11 14

20.Remove the left flange [15].

16

15

13

110
21.Pull out the pumping system [16].

16

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Pressure sensors
 Door
 Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 67.

111
8.10 Procedure #10: Pumping System Motor
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet
 Weak loctite ref. 248

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The battery is disconnected and the boost capacitor discharged. See section 8.1, page 85.

Dismantling
1. If a Wi-Fi pump is used, remove the Wi-Fi board then dislodge the CPU board as explained
later in this procedure. To remove the Wi-Fi board: See section 8.6, page 96.
2. Turn the pump upside down.
3. Unscrew and remove the 3 screws [1].

1 1

4. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
5. Disconnect CPU board flat cable [6] at [J1].
6. Pull out the RJ11 cap [4] .
7. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
8. Remove the upper case [5], being careful not to pull out the display board flat cable.

6
J1
5
3
3
4

9. Disconnect the display board flat cable at [J2].

112
6

J1

J2

10.Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
11.If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12]. To remove the Wi-Fi board: See section 8.6, page 96.
12.Unscrew the screw [7] that holds the CPU board to the flange.

J2

J1 J3

8 J6

J12

J7

J8

J11

J8 J9

113
13.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
14.Disconnect the flat cables [J10] and [J5].

J5

J7

J10

15.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].

9
10

114
16.Place the pump with the door facing down..
17.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
18.Unscrew the screw [12] positioned under the base.
19.Remove the pumping plate [13].
20.Unscrew the screw [14] positioned under the base.

12 13

15

11 14

21.Remove the left flange [15].


22.Pull out the pumping system [16].

16

15

13

115
23.Unscrew the 4 motor holding nuts [17].
24.Pull out the 4 screws, and remove the motor with its silent blocks.

16

17 17

17 17

Re-assembling
1. Put the motor in position, motor wires on the left side of the mechanical block using a weak
loctite ref. 248 to hold the motor with its nuts.
2. Moderately tighten the motor holding nuts [17].
3. Tighten the 4 motor screws, following the order [A], [B], [C], [D] as shown below.

D B

A C

4. Perform the dismantling procedure in reverse order to re-assemble the unit.


Pay attention to the direction of the flat cable connections when assembling.
5. Perform the following calibrations using Agilia Partner maintenance software:
 Pressure sensors
 Door
 Flow rate
6. Perform the regular servicing tests. See Quality Control Procedure, page 67.

116
8.11 Procedure #11: Pressure Sensors
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].

1 1

3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.

6
J1
5
3
3
4

117
8. Disconnect the display board flat cable at [J2].

J1

J2

9. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
10.If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12]. To remove the Wi-Fi board: See section 8.6, page 96.
11.Unscrew the screw [7] that holds the CPU board to the flange.

J2

J1 J3

8 J6

J12

J7

J8

J11

J8 J9

118
12.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
13.Disconnect the flat cables [J10] and [J5].

J5

J7

J10

14.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].

9
10

119
15.Place the pump with the door facing down..
16.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
17.Unscrew the screw [12] positioned under the base.
18.Remove the pumping plate [13].
19.Unscrew the screw [14] positioned under the base.

12 13

15

11 14

20.Remove the left flange [15].

16

15

13

120
21.Pull out the pumping system [16] out of its axis [17].
22.Unscrew the 2 upstream sensor and downstream sensor screws [18] and [19].

19
18

17

23.Pull out the sensors.

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Pressure sensors
 Door
 Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 67.

121
8.12 Procedure #12: Anti-Free Flow Clamp Motor
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 flat screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].

1 1

3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.

6
J1
5
3
3
4

122
8. Disconnect the display board flat cable at [J2].

J1

J2

9. Unscrew the 2 screws [7] that hold the motor to the flange.
10.Unscrew the 2 screws [8] that hold the air detector board [9] to the flange.
11.Dislodge the air detector board [9].
12.Using a small flat screwdriver, apply a light pressure in order to disengage the motor
positioning spigot .
This operation should be handled with care in order to avoid any damage to the air detector
board flat cable when using a screwdriver.

9
8

7
7

123
13.Disconnect the cable connected to the CPU board at [J8].
14.Remove the anti-free flow clamp motor [10].

J8

10
9

Re-assembling
1. Position the anti-free flow clamp motor into the flask.
2. Position the wires in the guides as shown below at [11].
3. Screw the 2 screws [7] that hold the motor to the flange.
4. Check that the motor is clipped correctly [12].
Check the correct position of the anti-free flow clamp motor fins when assembling the
motor kit. The fins should be on the left side of the OCS optical sensor board.

J8

11

7 12

5. Perform the dismantling procedure in reverse order to re-assemble the unit.


Pay attention to the direction of the flat cable connections when assembling.
6. Perform the following calibrations using Agilia Partner maintenance software:
 Pressure sensors
 Door
 Flow rate
7. Perform the regular servicing tests. See Quality Control Procedure, page 67.

124
8.13 Procedure #13: Door
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 2 screws [1].

1
1

3. Remove the door [2].

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Door
 Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 67.

125
8.14 Procedure #14: Membrane
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 flat screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 2 screws [1].

1
1

3. Remove the door [2].

126
4. Release the 2 pins [3] using a flat screwdriver.

3 3

5. Dislodge the membrane using the flat screwdriver.

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the position of the membrane before clipping it back in place.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Pressure sensors
 Door
 Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 67.

127
8.15 Procedure #15: OCS Flexible IC
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.

Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].

1 1

3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.

6
J1
5
3
3
4

128
8. Disconnect the display board flat cable at [J2].

J1

J2

9. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
10.If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12]. To remove the Wi-Fi board: See section 8.6, page 96.
11.Unscrew the screw [7] that holds the CPU board to the flange.

J2

J1 J3

8 J6

J12

J7

J8

J11

J8 J9

129
12.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
13.Disconnect the flat cables [J10] and [J5].

J5

J7

J10

14.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].

9
10

130
15.Place the pump with the door facing down.
16.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
17.Unscrew the screw [12] positioned under the base.
18.Remove the pumping plate [13].
19.Unscrew the screw [14] positioned under the base.

12 13

15

11 14

20.Remove the left flange [15].

16

15

13

131
21.Unscrew and remove screw [16].
22.Remove the OCS flexible IC [17].

17

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Pressure sensors
 Door
 Air detector
 Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 67.

132
9 Cleaning and Disinfecting

Refer to the Instructions for Use of the relevant pump for the following information:
 When to clean and disinfect the pump
 Recommended and prohibited agents
 Instructions for cleaning and disinfecting

WARNING
 The disinfecting procedure must be done immediately after cleaning. Disinfecting the pump without
prior cleaning is not effective.
 The pump is not intended to be sterilized; sterilization may result in damage to the pump.

133
10 Device Storage

Refer to the Instructions for Use of the relevant pump for the following information:
 Precautions for storage
 Storage and transport conditions
 Preparing the device for storage
 Using the device after storage

134
11 Power Management

Refer to the Instructions for Use of the relevant pump for the following information:
 AC power supply precautions
 Battery precautions
 Battery operating mode

135
12 Technical Characteristics

12.1 Power Supply


Use the power supply cord supplied with the pump.
For use in the US, it is mandatory to use an Agilia power cord compliant with USA standards and with the
IEC 60227 standard.
Maximum admissible apparent electrical cable network impedance: 50 Ω.
The power cord conductor must have a cross section of at least 0.75 mm2.

Power supply
100 V - 240 V ~ / 50 / 60 Hz with functional earth

AC Power Maximum consumption 10-15 VA


1 X T1.6AH 250V accessible in the battery
Protective fuse
compartment
External
Power Supply
9 VDC / Power > 15 W
(Available in a
Future Release)
Length: 3.00 m
Maximum length: 3.00 m
Cord Type: SJT3x18AWG
Technical data: 3x18AWG (green, black, white), dielectric strength: 2 kVac, 1 min
Standard: UL62 CSA 22.2 No. 49
Type: HG/TR
Plug Technical data: 15A - 12.5V AC.
Standard: NEMA 5-15 Hospital Grade
Type: C13
Connector Technical data: 10A - 250V UL CSA
Standard: EN 60320-1 C22.2 N°21 UL 817

12.2 Battery
Disconnect the battery before opening the device. Avoid short circuits and extreme temperatures.
If the device is not used for more than 3 months, the date is erased (all other settings are stored
permanently). When you power on the pump, you must set the date again.

Characteristics 7.2 V 2.2 Ah - Li-ion Smart battery

Weight Approximately 100 g


Flow Rate Wi-Fi Battery Life
25 mL/h  >5h
Battery Life 25 mL/h  >8h
1500 mL/h  >4h
1500 mL/h  >5h
Battery Recharge Pump OFF: < 6 h / Pump ON: < 20 h
 = Wi-Fi enabled
 = Wi-Fi disabled or not used

12.3 Power Consumption


The pump typically consumes about 4.3 W in standard operating conditions.

136
12.4 Communication Port
The connector located at the back of the device allows data communication with a PC.

Serial Cable TTL output

Power Input 10 V / 15 W to power supply the product

Power Output 5 VDC / 150 mA to power Agilia USB cable

12.5 Infrared Communication


The pump is equipped with an infrared cell located at the back of the device.

Mode Wireless optical communication using infrared light

Compatibility Asynchronous Serial Infrared (SIR) physical layer irPHY 1.0, baseband no carrier

Transport
Proprietary
Protocol
Speed 115.2 kb/s max

Wavelength 880 nm to 900 nm infrared band with 45 nm spectral bandwidth

Eye Safety Class 0 of IEC 62471

12.6 Agilia USB Cable


Function Allows communication between a pump and a computer on the USB port

Connector 8-pin proprietary connector / Male A USB connector

Input / Output
250 mW
power (pump)
Input / Output
100 mW
Power (PC)
Compatibility USB 2.0 compliant.

Insulation 1500 V, compliant with UL standard

Speed 19.2 kb/s max

Length 85 in (2.15 m)

Maximum Length 110 in (2.8 m)

12.7 Drop Sensor Connector


Power Output 3.3 V / 45 mA to power drop sensor

137
12.8 Compliance
Compliant with the following standards:
ElectroMedical Index of protection against solid foreign objects
 IEC 60601-1 IP22
Equipment Safety (> 12.5 mm) and driping liquids
 IEC 60601-1-8
EMC
Compliant with the following standards: Protection against leakage current: Defibrillation-proof
(ElectroMagnetic
 IEC 60601-1-2 type CF applied part*
Compatibility)

Particular  IEC 60601-2-24 Protection against electric shocks: class II


Standards  ANSI/AAMI ID26 Functional earth**

* After a defibrillation, the pump recovery time is around 2 seconds.


** The functional earth is directly connected to the power supply cord. It reduces residual current that may disturb ECG or EEG devices.

12.9 Dimensions - Weight


H/W/D 135 x 190 x 170 mm (5.3 x 7.5 x 6.7 in)

Weight Approximately 2 kg (4.4 lbs)

Screen Size 70 x 35 mm (2.7 x 1.4 in)

12.10Electronic Boards
The Agilia VP MC and Agilia VP pumps are equipped with 5 electronic boards:
 Power supply board
 AC Power board
 CPU board
 Display board
 Air detection board
The Agilia VP MC WiFi pumps are equipped with 6 electronic boards:
 Power supply board
 AC Power board
 CPU board
 Display board
 Air detection board
 Wi-Fi board

138
12.11 Material Characteristics
Component Material
1 Screw cap (2) Polyamide
2 Nut bolt button Polyamide
3 M8 molded screws Polyamide
4 Angle bracket ABS
5 Battery door ABS
6 Left and right flanges Polycarbonate
7 Pumping block plate Polyamide
8 Light guide Polycarbonate
9 Window Polycarbonate
10 Molded base ABS
11 Central hook on the cover Polyamide 6
12 Right and left hook on the cover Polyamide 6
13 Infrared window Polycarbonate
14 Eccentric bolt POM
15 Bolt front case POM
16 Bolt rear case POM
17 Bolt button POM
18 Bolt button pen POM
19 Air detector support ABS
20 Door ABS
21 Door plate Polyarylamide
22 Molded lever + hooks Polyarylamide
23 Left and right door hinge Polyamide 6
24 OCS fuse Polyacetal
25 OCS unclamping finger Polyamide
26 Mechanical spring cap Polyamide
27 OCS detector cradle Polyarylamide
28 Pumping block Polyamide
29 Star motor ring Polyacetal
30 Motor pulley Polyamide
31 Cam shaft pulley Polyamide
32 Belt idler pulley Polyamide
33 Belt idler lever Polyacetal
34 Rotation control disk Polyamide
35 Pumping finger PA6-12
36 Molded cam shaft PA66
37 Bearing motor support Polyarylamide
38 Magnet support ABS
39 Membrane TF3 STE
40 Membrane frame Polypropylene
41 Back foot LSR
42 Front foot LSR
43 RJ11 stopper TPE EPTR
44 Connector stopper TPE EPTR
45 Star motor shock absorber Elastomere

139
13 Specifications

Refer to the Instructions for Use of the relevant pump for the following information:
 Infusion Rate
 Volume To Be Infused (VTBI)
 Infusion Time
 Air Detection
 Flow Rate Accuracy
 Occlusion Alarm Response Time
 Bolus Volume at Occlusion Release
 Pressure Management
 Trumpet and Start-up Curves
Essential Features
Feature Refer to
Flow rate accuracy IFU
Time to Detect Occlusion IFU
Bolus Volume After Occlusion Release IFU
Management of High-priority Alarms IFU

140
14 Recycling

Before disposal, remove the battery from the device. Batteries and devices with this label must
not be disposed of with the general waste. They must be collected separately and disposed of
according to local regulations.

INFORMATION
 For more information on waste processing regulations, contact your local Fresenius Kabi
organization or the local distributor.
 For more information on dismantling the device, refer to the chapter "Intervention Procedures" in this
document.
 Follow healthcare facility policy regarding proper disposal after use.

141
15 Warranty

Refer to the Instructions for Use of the relevant pump for the following information:
 General conditions of warranty
 Limited warranty
 Warranty conditions for accessories

142
16 Guidance and Manufacturer's Declaration on EMC

Refer to the Instructions for Use of the relevant pump for the following information:
 Electromagnetic compatibility
 Electrostatic discharge (ESD) information
 ESD precautions to be taken
 Electromagnetic compatibility and interference guidance
 Table 1 - Guidance and manufacturer's declaration - Electromagnetic Emissions
 Table 2 - Guidance and manufacturer's declaration - Electromagnetic Immunity
 Table 4 - Guidance and manufacturer's declaration - Electromagnetic Immunity
 Table 6 - Recommended separation distances between portable and mobile RF communication
equipment and Agilia infusion pumps.

Wi-Fi compatibility
The Agilia infusion pumps include RF transmitters whose effective radiated power (EIRP power) is defined
below:
 Frequency band 2.4 GHz: 20 dBm.
 Frequency band 5 GHz: 17 dBm.

143
17 Spare Parts Catalog

Refer to the spare parts catalog of the relevant pump.

144
18 Ordering Information

For more information, contact your Fresenius Kabi sales representative.

18.1 Data Management Cables


Refer to the Instructions for Use of the relevant pump

18.2 Associated Software


Refer to the Instructions for Use of the relevant pump

18.3 Disposables
Refer to the Instructions for Use of the relevant pump

145
19 Glossary of Terms

Term Description

A Amperes

AC Alternating Current

Ah Ampere-hours

AM Amplitude Modulation

BSA Body Surface Area

CCU Critical Care Unit

CDC Centers for Disease Control

CIS Clinical Information System

CISPR Special International Committee on Radio Interference

CT Scan Computed Tomography

dBA Decibels

DC Direct Current

DECT Digital Enhanced Cordless Telecommunications

DEHP Di(2-ethylhexyl) phthalate

DERS Dose Error Reduction Software

DI Dose Infused

DPS Dynamic Pressure System

DUR Duration

ECG Electrocardiogram

ECMO ExtraCorporeal Membrane Oxygenation

ED Emergency Department

EEG Electroencephalogram

EMC ElectroMagnetic compatibility

ErXX Error message

ESD ElectroStatic Discharge

FM Frequency Modulation

ft Feet

GPL General Public License

H/W/D Height / Width / Depth

HF High Frequency

hPa Hectopascals

Hz Hertz

IEC International Electrotechnical Commission

IFU Instructions for Use

in Inches

IT Information Technology

146
Term Description

IV Intravenous

kg Kilograms

KVO Keep Vein Open

lb Pounds

LED Light Emitting Diode

LSB Least Significant Bit

mA Milliamperes

mEq Milliequivalents

mL/h Milliliters per hour

mmHg Millimeters of Mercury

MOS Metal Oxyde Semiconductor

MRI Magnetic Resonance Imaging

mW/sr Milliwatts per steradian

NAM North America

NICU, PICU Neonatal and Pediatric Intensive Care Units

NMR Nuclear Magnetic Resonance

OCS Occlusivity Check System

OR Operating Room

PACU Post-Anesthesia Care Unit

PC Personal Computer

PE Protective Earth

PSI Pounds per Square Inch

RAM Random Access Memory

REF Product reference / part number

RF Radio Frequency

RFID Radio Frequency IDentification

ROW Rest Of the World (Other countries than US and Canada)

RS232 Serial interface connector

S/N Serial Number

SELV Safety Extra Low Voltage

SIR Asynchronous Serial Infrared

UPS Uninterruptable Power Supply

USB Universal Serial Bus

USB 2.0 OTG USB On-The-Go

Ut Test specification level

V Volt

VA Volt-Amperes

VDC Volts Direct Current

VI Volume Infused

147
Term Description

VTBI Volume to Be Infused

W Watts

148
Index

A L
AC Power Board LCD Display
Description 22 Dismantle/Re-assemble 89
Dismantle/Re-assemble 94 Voltage 58
Ageing Test 46
Air Detector M
Test 50 Maintenance
Air Detector Board Date 35
Description 23 Display Startup Screen 36
Dismantle/Re-assemble 104 Schedule 27
Alarms 72 Test 39
Anti-Free Flow Clamp Motor Maintenance Options Menu 35
Dismantle/Re-assemble 122 Material Characteristics 139
Test 51 Membrane 126
B O
Base Kit 99 OCS Flexible IC 128
Basic Profile Configuration 30 Operation Diagram 26
Battery Options Menu 28
Dismantle/Re-assemble 85
Test 44, 48
P
C Power Information 57
Power Supply Board
Clamp 55
Description 19
CPU Board Dismantle/Re-assemble 94
Description 14 Pressure
Dismantle/Re-assemble 91
Downstream Sensor 41
Upstream Sensor 40
D Pressure Limit Alarm Test 62
Display Board Pressure Sensors 117
Description 11 Profile Menu 29
Dismantle/Re-assemble 89 Pump Code 56
Door Pump Identification 38
Dismantle/Re-assemble 125 Pumping System
Test 42 Dismantle/Re-assemble 107
Dismantle/Re-assemble Motor 112
E
Electrical Test 64 Q
Error Codes 80 Quality Control
Events Certificate 71
Data Log 36 Maintenance 27
Test 39
R
F Release Notes 151
Flow Rate Test 65
S
I Symbol Descriptions 2
Indication Test 45

K
Keypad
Description 9
Test 45

149
T
Table of Contents 3
Technical Characteristics 136
Temperature Test 59
Tests
Access Menu 37
List 37
Training 27
Troubleshooting 79

U
Upper Case 87

W
Watchdog 60
Wi-Fi Board
Description 24
Dismantle/Re-assemble 96
Wi-Fi Module Information 61

150
Release Notes

Date Software Version Revision Description


November 2016 0 Creation
- Intended use modification in this document.
- Removal of the "Not for use in residential areas"
symbol in the Symbols description section.
January 2017 1 - § 3.2.1 2: sentences are added to have information
about the role of homecare providers regarding
2.2 maintenance.
- New IFU revision.
January 2017 2 - New IFU revision (EMC tables update).
- New IFU revision.
March 2020 3 - Improvement of alarms descriptions in section 7
(documentary only - no impact on the device itself).
May 2020 4 - New IFU revision.

This document may contain inaccuracies or typographical errors.


Modifications may thus be made, and included in later editions.
Due to the evolution of standards, and of legal texts and materials, the characteristics indicated in the text and images of this document are
applicable only to the device with which it is included.

The screenshots and illustrations in this document are for illustrative purposes only. Screen contents may vary based on individual configurations
and minor software modifications; therefore, some screenshots may appear slightly different from what you see on the product.

This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi.
Vigilant® and Agilia® are registered trademarks in the name of Fresenius Kabi in selected countries.

Made in France
Revision date: May 2020

Fresenius Vial S.A.S


Fresenius Kabi AG
Le Grand Chemin
61346 Bad Homburg
38590 Brézins
Germany
France

0123
www.fresenius-kabi.com
First CE Mark: Agilia VP MC WiFi: December 2015
Agilia VP MC: November 2016

151
Local Contacts for Servicing

11396-4_TM_Agilia_VP_range_ASU_Eng

Fresenius Kabi AG Fresenius Vial S.A.S


61346 Bad Homburg Le Grand Chemin
Germany 38590 Brézins - France
Agilia VP MC
Agilia VP MC WiFi
Volumetric Infusion Pumps

Applicable to software version 2.2


Instructions For Use
For Use in Healthcare Facilities and
Homecare Environments
Symbol Descriptions

Warning Name and address of the


(Refer to the Instructions for Use) manufacturer / Date of manufacture

Name and address of the


Refer to the Instructions for Use
manufacturing facility

Protection against electric shock:


Product reference / part number
class II

Non-ionizing electromagnetic
Product serial number
radiation

Input terminal - connector Fragile, handle with care

Output terminal - connector This way up

Electrical fuses Keep away from rain

Alternating Current (AC) Temperature limitation

Direct Current (DC) Humidity limitation

Index of protection against solid


IP22 foreign objects (> 12.5 mm) and Atmospheric pressure limitation
dripping liquids

General symbol for recyclable


Part included in a recycling process
material

Protection against leakage current;


defibrillation-proof type CF applied Eco packaging symbol
part

0123
CE mark

Warning of a potential hazard that


could result in serious personal
Recommendations to be followed.
injury and/or product damage if the
written instructions are not followed.

2 11106-6_Master_IFU_Agilia_VP_MC_Eng
Table of Contents
1 INTRODUCTION 9
1.1 SCOPE ..................................................................................................9
1.2 INTENDED USE ........................................................................................9
1.3 PRINCIPLES OF OPERATION ....................................................................9
1.4 INTENDED PRODUCTS TO BE INFUSED ....................................................10
1.5 INTENDED USERS ..................................................................................11
1.6 INTENDED PATIENTS .............................................................................11
1.7 CONTRAINDICATIONS .............................................................................12
1.8 USE ENVIRONMENT .............................................................................12
1.9 SPECIFICITIES FOR HOMECARE ENVIRONMENTS ....................................13
2 AGILIA CONNECT INFUSION SYSTEM 14

3 DESCRIPTION 16
3.1 FRONT VIEW .........................................................................................16
3.2 BOTTOM VIEW (DEVICE IDENTIFICATION LABEL) .....................................16
3.3 BACK VIEW ...........................................................................................17
3.4 KEYPAD ................................................................................................18
3.5 DISPLAY AND SYMBOLS .........................................................................20
3.5.1 Infusion Status.................................................................................... 20
3.5.2 Screen Options................................................................................... 20
3.5.3 Navigation Buttons ............................................................................. 21
3.5.4 Alarms and Safety Features............................................................... 21
3.5.5 Infusion Features................................................................................ 21
3.5.6 Data Communication .......................................................................... 22
3.6 PACKAGING ..........................................................................................22
4 FUNDAMENTALS 23
4.1 PROFILES ............................................................................................23
4.2 DRUG LIBRARIES...................................................................................24
4.3 DRUG LISTS..........................................................................................24
4.4 DRUGS .................................................................................................24
4.4.1 Infusion Rates .................................................................................... 24
4.4.2 Drug X (mL/h)..................................................................................... 25
4.4.3 Hard Limits and Soft Limits ................................................................ 25
4.4.4 Infusion Modes ................................................................................... 25
4.5 DATA SET .............................................................................................26
3
5 INSTALLATION 27
5.1 TYPES OF INSTALLATIONS .....................................................................27
5.2 USING THE ROTATING POLE CLAMP.......................................................28
5.3 ATTACHING THE PUMP(S) ......................................................................29
5.3.1 Attaching to a Pole ............................................................................. 29
5.3.2 Attaching to a Rail .............................................................................. 30
5.3.3 Using on a Flat Table ......................................................................... 30
5.3.4 Attaching Two Pumps Together ......................................................... 31

6 GETTING STARTED 32
6.1 FLOWCHART .........................................................................................32
6.2 USING THE PUMP FOR THE FIRST TIME ..................................................33
6.3 POWERING ON ......................................................................................33
6.4 INSTALLING THE ADMINISTRATION SET IN THE PUMP ..............................35
6.5 CONNECTING A DROP SENSOR .............................................................36
6.6 PUMP HEIGHT ......................................................................................37
7 OPERATION 38
7.1 FLOWCHART .........................................................................................38
7.2 SELECTING A PROFILE ..........................................................................39
7.3 SELECTING THE INFUSION RATE (FLOW RATE OR DOSE) ........................40
7.4 SELECTING A DRUG .............................................................................41
7.5 PROGRAMMING AN INFUSION .................................................................41
7.5.1 Programming an Infusion by Flow Rate ............................................. 42
7.5.2 Programming an Infusion by Dose ..................................................... 43
7.5.3 Programming Beyond Soft Limits ....................................................... 48
7.6 STARTING AN INFUSION .........................................................................49
7.7 MONITORING AN INFUSION .....................................................................50
7.8 FUNCTIONS DURING INFUSION ...............................................................52
7.8.1 Stop .................................................................................................... 52
7.8.2 Rate Titration...................................................................................... 52
7.8.3 Secondary (Piggyback) Infusions ...................................................... 52
7.8.4 Administering a Bolus ........................................................................ 58
7.9 COMPLETING AN INFUSION ....................................................................60
7.9.1 Near End of Infusion Alert ................................................................ 60
7.9.2 End of Infusion ................................................................................... 61
7.9.3 Powering off ....................................................................................... 62
7.10 INFUSION MODES ..................................................................................62

4
7.10.1 Volume / Time / Rate (V/T/R) ............................................................. 62
7.10.2 Volume / Rate (V/R) ........................................................................... 62
7.10.3 Volume / Time (V/T) ........................................................................... 62
7.10.4 Time / Rate (T/R)................................................................................ 62
7.10.5 Simple Rate (only with Drop Sensor) ................................................. 63
7.10.6 Ramp-up / Ramp-down ...................................................................... 63
7.10.7 Sequential Infusion............................................................................. 65
7.10.8 Drops/min ........................................................................................... 67
7.11 OTHER FUNCTIONS ...............................................................................68
7.11.1 Priming the Administration Set ........................................................... 68
7.11.2 Advancing an Air Bubble ................................................................... 69
7.11.3 Auto-restart......................................................................................... 70
7.11.4 Pre-programming the Pump ............................................................... 71

8 MENUS 72
8.1 OVERVIEW ............................................................................................72
8.2 PROFILE ...............................................................................................74
8.3 PRESSURE ............................................................................................75
8.4 VOLUME TO BE INFUSED (VTBI) ...........................................................77
8.5 KEYPAD LOCK STATUS ..........................................................................78
8.6 BATTERY LIFE .......................................................................................80
8.7 VOLUME INFUSED / DOSE INFUSED ........................................................81
8.8 PAUSE ..................................................................................................82
8.9 DRUG ...................................................................................................83
8.10 PATIENT ...............................................................................................84
8.11 DAY/NIGHT MODE .................................................................................85
8.12 PRIMARY / SECONDARY .........................................................................87
8.13 PROGRAMMED BOLUS ...........................................................................87
8.14 FLOW RATE (ML/H) / DOSE ...................................................................88
8.15 RAMP-UP / RAMP-DOWN ........................................................................89
8.16 SEQUENTIAL INFUSION ..........................................................................89
8.17 ALARM VOLUME ....................................................................................90
8.18 CALL-BACK ALERT ................................................................................91
8.19 VIEW FLOW RATE HISTORY ...................................................................93
8.20 VIEW PRESSURE HISTORY ....................................................................94
8.21 VIEW EVENT LOG ................................................................................95
8.22 DATE / TIME .........................................................................................96
8.23 MAINTENANCE ......................................................................................97

5
8.24 LIBRARY INFORMATION ..........................................................................98
8.25 CLINICAL INFORMATION .........................................................................99
8.26 DATA SET ...........................................................................................100
9 OPTIONS 101
9.1 COMMANDS ........................................................................................101
9.2 OPTION DESCRIPTIONS .......................................................................101
9.3 PUMP SETTINGS .................................................................................102
10 DATA COMMUNICATION 103
10.1 OVERVIEW .........................................................................................103
10.2 COMMUNICATION VIA AGILIA CABLES ...................................................103
10.3 COMMUNICATION VIA WI-FI ................................................................104
10.4 DATA SET UPLOAD ...........................................................................104
11 USER TEST 105

12 ALARMS AND SAFETY FEATURES 106


12.1 INTRODUCTION ....................................................................................106
12.2 ALARM DESCRIPTIONS ........................................................................106
12.3 GENERAL REMARKS ............................................................................107
12.4 LIST OF ALARMS .................................................................................107
12.5 AUDIO ONLY INFORMATION SIGNALS ....................................................115
13 VOLUMAT LINES 116
13.1 PREPARING THE ADMINISTRATION SET AND THE FLUID CONTAINER ..116
13.2 PRIMING THE ADMINISTRATION SET BEFORE USE ................................117
13.3 OTHER USES OF ADMINISTRATION SETS ..............................................119
13.4 REMOVAL AND REPLACEMENT OF ADMINISTRATION SETS .....................121
14 DEVICE STORAGE 122
14.1 PRECAUTIONS FOR STORAGE ..............................................................122
14.2 STORAGE AND TRANSPORT CONDITIONS..............................................122
14.3 PREPARING THE DEVICE FOR STORAGE ...............................................122
14.4 USING THE DEVICE AFTER STORAGE ...................................................123
15 SPECIFICATIONS 124
15.1 ESSENTIAL FEATURES ........................................................................124

6
15.2 FLOW RATE ........................................................................................124
15.3 VOLUME TO BE INFUSED (VTBI) .........................................................125
15.4 DOSE TO BE INFUSED (DTBI) .............................................................125
15.5 INFUSION TIME ....................................................................................125
15.6 CONCENTRATION ................................................................................126
15.7 PATIENT DATA ....................................................................................126
15.8 AIR DETECTION...................................................................................126
15.9 PRESSURE MANAGEMENT ...................................................................127
15.10 ACCURACY .........................................................................................128
15.11 CALCULATION RULES ..........................................................................130
15.12 UNITS AND CONVERSION RULES ..........................................................131
16 CLEANING AND DISINFECTING 133
16.1 WHEN TO CLEAN AND DISINFECT THE PUMP ........................................133
16.2 RECOMMENDED AND PROHIBITED AGENTS ...........................................134
16.3 INSTRUCTIONS FOR CLEANING AND DISINFECTING ................................134
17 POWER MANAGEMENT 137
17.1 AC POWER SUPPLY PRECAUTIONS......................................................137
17.2 BATTERY PRECAUTIONS ......................................................................137
17.3 BATTERY OPERATING MODE ...............................................................138
18 TECHNICAL CHARACTERISTICS 140
18.1 POWER SUPPLY ..................................................................................140
18.2 BATTERY ............................................................................................140
18.3 POWER CONSUMPTION........................................................................140
18.4 COMMUNICATION PORT ......................................................................141
18.5 INFRARED COMMUNICATION ................................................................141
18.6 DROP SENSOR CONNECTOR ...............................................................141
18.7 SOUND LEVELS ...................................................................................141
18.8 COMPLIANCE ......................................................................................142
18.9 DIMENSIONS AND WEIGHT ...................................................................142
18.10 TRUMPET AND START-UP CURVES .......................................................143
19 WI-FI 146
19.1 GENERAL INFORMATION ......................................................................146
19.2 SPECIFICATIONS .................................................................................147

7
20 TROUBLESHOOTING 149

21 RECYCLING 151

22 WARRANTY 152
22.1 GENERAL WARRANTY CONDITIONS ......................................................152
22.2 LIMITED WARRANTY ............................................................................152
22.3 WARRANTY CONDITIONS FOR ACCESSORIES ........................................152
23 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 153
23.1 ELECTROMAGNETIC COMPATIBILITY ..................................................153
23.2 ELECTROSTATIC DISCHARGE (ESD) ....................................................153
23.3 ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE .154
23.4 EMC AND ESSENTIAL PERFORMANCES ................................................156
24 SERVICING 162
24.1 INFORMATION ON DEVICE SERVICING ...................................................162
24.2 MAINTENANCE REQUIREMENTS ............................................................162
24.3 QUALITY CONTROL .............................................................................163
25 GLOSSARY OF TERMS 164

APPENDIX: FACTORY CONFIGURATION 168

INDEX 169

8
1 Introduction

1.1 Scope
These Instructions for Use (IFU) are applicable to the Agilia VP MC and
Agilia VP MC WiFi large volume pumps. These devices are referred to
throughout this manual as the "Agilia VP MC".
The user must adhere to the instructions specified in this IFU. Failure to
adhere to these instructions may result in damage to the equipment,
injury to patients or injury to users.
Warning
Check that this IFU is applicable to the current software version of the
device.
 The software version of the device is displayed on the start-up
screen.
 The software version described in this IFU is displayed in the
Release Notes, page 173.

1.2 Intended Use


The Agilia VP MC Large Volume Infusion Pump is a peristaltic pump
intended for use on adults, pediatrics, and neonatal patients for the
intermittent or continuous delivery of parenteral fluids (such as solutions,
colloids, parenteral nutrition), medications (such as diluted drugs,
chemotherapy, anesthesia drugs), blood and blood derivatives, and
medications through clinically accepted routes of administration. It is
intended for use by both trained healthcare professionals in clinical
healthcare facilities and in pre-hospital medical ground transportation
and home users in homecare.
1.3 Principles of Operation
Agilia VP MC is a programmable electronic medical system dedicated to
administering a pre-determined volume of infusion product at a
programmed rate. This peristaltic pump ensures fluid delivery using
pumping and clamping fingers to advance the liquid to the patient
through an administration set.
Agilia VP MC is a transportable and reusable device that can be used
everyday.
Agilia VP MC can be used standalone or mounted on the Link Agilia
rack.
Agilia VP MC can be used for intermittent or continuous infusions.
Agilia VP MC is intended for use on only one patient at a time. It can be
reused indefinitely on multiple patients throughout its lifetime.

9
1.4 Intended Products to be Infused
Warning
In homecare environment, the pump must only be used to infuse
noncritical drugs. Otherwise, there is a risk of interruptions in the therapy
which could have critical consequences for the patient. The following
fluids can only be infused under the permanent supervision of a trained
healthcare professional:
 Catecholamines
 Morphine
 Chemotherapy
 Other critical drugs
The pump administers products through clinically accepted routes.
These products include but are not limited to the following:

Intended Products
 Standard solutions
Parenteral Fluids  Colloids
 Parenteral nutrition
 Diluted drugs
 Antibiotics
 Chemotherapy
Medication
 Catecholamines
 Short acting drugs
 Anaesthesia drugs
 Blood
 Red blood cells
Transfusion  Platelets
 Plasma
 Albumin

When using Agilia VP MC to infuse critical medications in healthcare


facilities, ensure that adequate monitoring is provided, and that backup
pumps and administration sets are available for immediate use.
Only use Agilia VP MC for the infusion of fluids that are intended for
infusion pumps.
Administration Routes
The system allows infusion via the following access routes:
 IV access with any device that administers a medical fluid to a vein
and is equipped with a female Luer lock,
 Subcutaneous access.

10
1.5 Intended Users
In healthcare facilities, the pump must only be used by qualified and
trained healthcare professionals including but not limited to: nurses
(primary users), physicians, nurse practitioners and physician
assistants.
In homecare environments, the pump must only be used by
appropriately trained users including homecare professionals, patients
or their relatives (in case of patient's inability to correctly react to pump
alarms). In homecare environments, the IFU must be provided to the
homecare nurse.
Two Quick Reference Guides are available (one for homecare
professionals, one for the patient) in order to describe the typical
operations performed at home. We recommend using them and keeping
the Quick Reference Guide for the patient near the pump.
Typical initial training duration: 1 hour.
It is recommended that users attend a refresher training session of about
20 minutes every year.
For training, contact your Fresenius Kabi sales representative.

1.6 Intended Patients


Agilia VP MC is intended to be used according to healthcare facilities
protocols on patients with the following characteristics:

Patient Characteristics
Male
Sex
Female
Neonates (except in homecare environment)
Pediatrics
Age
Adults
Elderly
Weight 0.25 kg to 350 kg

Body Surface Area 0.05 m² to 4.5 m²

When using the pump with a very sensitive population such as the
neonates, make sure to:
 Switch to night mode
 Set the alarm volume to the minimum level

11
1.7 Contraindications
 Do not modify the pump (except in the case of operations
recommended by Fresenius Kabi).
 Do not use the pump with the following fluids:
- Flammable liquids
- Fluids not suitable for infusion
 Do not use the pump in the following environments:
- Explosive or flammable environments
- High humidity environments (shower, bath, etc.)
- Ultrasonic environments
- Magnetic Resonance Imaging (MRI)
- Hyperbaric chamber
 Do not use the pump for the following purposes:
- Infusion in association with a dialyser or ECMO
- Enteral nutrition
- Epidural use
 Do not allow the pump to come in direct contact with the patient's
body.
 While the pump is infusing a patient, do not connect a computer
installed with Agilia Partner software to perform technical operations.

1.8 Use Environment


Agilia VP MC is intended for use in the following environments:
 Healthcare facilities, under the supervision of trained healthcare
personnel.
 Homecare environment, by following specific precautions:
See section 1.9, page 13.
The pump must be used in the following operational conditions to ensure
proper performance:
 Operating temperature range: 5 °C to 40 °C
 Operating pressure range: 700 hPa (525 mmHg / 10.15 PSI) to
1060 hPa (795 mmHg / 15.37 PSI)
 Operating humidity range: 20 % to 90 % with no condensation
 Altitude: Up to 3000 m above sea-level
Warning
The functionality of the pump can be affected by pressure variations,
mechanical shocks, heat ignition sources, and so on.
Information
 The pump can be used in ambulances exclusively with the Agilia
Holder Ambulance accessory. Due to use in road ambulances,
performances of the device can be modified. For more information,
refer to Agilia Holder Ambulance IFU.
 For more information on using the device in specific conditions,
contact your Fresenius Kabi representative.

12
1.9 Specificities for Homecare Environments
Warning: Product version
Only pumps with software version 2.2 or above can be used in
homecare environments. In early versions, all homecare functionalities
are unavailable.
If your software version is not compatible with homecare environments,
contact your Fresenius Kabi representative.
Environment Considerations
 Consider the following operational conditions to ensure proper
device performance:
- Do not expose to sun light, keep in dry place, at room
temperature, normal pressure.
- Keep in clean environment.
- Keep away from objects which can potentially damage the
device.
- Keep away from any noise disturbance which could prevent
patient or relatives from hearing the pump alarms.
- Keep away from heat source, dust, fluff, direct and prolonged
light exposure.
- Keep away from animals, pests or children.
 Do not share an outlet with another electrical device.
General Considerations
 Healthcare professionals should not divulge to the patient or
relatives the pump's lock system or any information that may allow
an access to all programming and operating functions.
 The responsibility of using the pump is shared between the
healthcare professional and the patient.
 Homecare providers or healthcare facilities are responsible for
disposal of administration sets and bags used at home according to
current standards in order to limit the risk of harm and infection.
Warning
 It is the healthcare professional’s responsibility to ensure that the
patient or his/her relatives have the required capacity (physical,
cognitive or perceptive) to use the pump in homecare environments.
Otherwise, there is a risk of usage errors and incorrect therapy which
could have critical consequences for the patient.
 Homecare providers must ensure that they can provide backup sets
and a backup pump within a short time period to avoid interruptions
of administration which could have critical consequences in case of
pump failure in the patient’s home.
 Give particular attention to the risk of strangulation with cables and
sets, and with the small parts that could be swallowed or inhaled.
Maintenance Requirements
Homecare providers are responsible for periodic maintenance and
calibration of pumps used in homecare environments.
Homecare providers must be informed if the device is dropped or if any
malfunctions occur. In this case, do not use the device and contact your
homecare providers.

13
2 Agilia Connect Infusion System

Agilia Range Description


Volumetric Infusion Pump
Pumps designed to deliver the contents of parenteral
Agilia VP range
infusion container (bag or bottle) through a line connected
to a patient.
Syringe Infusion Pump
Agilia SP range Pumps designed to deliver the contents of a syringe through
a line connected to a patient.
Pump Patient Controlled Analgesia (PCA) syringe pump
Pumps intended for PCA therapy and for the administration
Agilia SP PCA
of analgesic drugs under the patient’s or the clinician’s
control.
Enteral Nutrition Syringe Pump for Neonates
Pumps designed to deliver enteral nutrition to neonates,
Agilia ProNeo
preterm babies and children via clinically accepted routes of
administration.
Medication Safety Solution
DERS (Dose Error Reduction Software) designed to create,
Vigilant Master Med
customize and manage data sets to be uploaded to the
Agilia VP and SP infusion pumps.
Medication Safety Software
Agilia
Software designed to create, customize and manage data
Vigilant Drug’Lib
sets to be uploaded to the Agilia VP and SP infusion pumps.
Maintenance Software
Agilia Partner Software designed to maintain, configure, test and calibrate
Software
the Agilia VP and SP infusion pumps.
Distribution Server
Software intended to distribute data sets to Agilia infusion
Centerium
pumps and centralize information coming from infusion
pumps for post analysis and reporting.
Infusion Data Reporting Software
Software designed to improve the accuracy of clinical
Vigilant Insight
settings included into a data set. It provides reports about
the use of infusion pumps.
Stacking Rack Systems
Rack systems designed to stack 4, 6 or 8 Agilia infusion
Link Agilia
Rack pumps. Link Agilia is designed to centralize the power
Link+ Agilia
supply. Link+ Agilia is designed to centralize the power
supply and to centrally replicate infusion pump signalling.
Medical device intended to be used in road ambulances
Agilia Holder
Accessories equipped with AC power source and a horizontal rail in
Ambulance
order to fix an infusion pump.

14
Agilia Range Description
Administration Sets
Disposables Volumat Lines Administration sets can be in contact with the patient
(applied part).

Information
For a list of compatible accessories, disposables and software, and for
ordering information, refer to the System Components booklet.

15
3 Description

3.1 Front View


1

3
2
Figure 3.1: Front View
Legend
1 Handle 3 Door Lever

21 Pump Door

3.2 Bottom View (Device Identification Label)

For more information on device identification label symbols, see Symbol


Descriptions, page 2.

16
3.3 Back View
7

5
1
4
2
3
Figure 3.2: Back View
Legend
1 Release Button 53 Power Cord Inlet

21 Drop Sensor Connection Socket 63 Infrared Cell

3 Rotating Pole Clamp 73 Attachment Lock Knob

4 RS232 Communication Port

Symbol Location Description


Warning
See section 18, page 110.
Near Power Cord Inlet

Warning
Near RS232 See section 10, page 103.
Communication Port

17
3.4 Keypad
3.4.1 Keypad Description

1
2 17
3
16
4
15

14

5 6 7 8 9 10 11 12 13
Figure 3.3: Keypad
Legend
1 Screen 10
73 Decrement

21 Battery Charge Status Indicator 11


3 Fast Decrement

3 Power Supply Indicator 12


3 Confirm Value / Move to Next Field

4 Wi-Fi Symbol 13
3 Stop

5 On / Off
Cancel Value / Move Back to Previous
14
3 Field
63 Bolus / Prime / Advance Air

73 Fast Increment 15
3 Menu

83 Increment 16
3 Pressure Menu

93
7 Infusion Indicator Lights 17
3 Alarm Silence

18
3.4.2 Keypad Details

3.4.2.1 Selection Keys


Key Description
Arrow Keys
Keys for selecting volume, time, flow rate and other values.

+ Fast Access to Maximum Value or Top of a List

+ Fast Access to Minimum Value or Bottom of a List

Note:
 Fast increment and decrement keys have been programmed with different levels corresponding to
standardized volumes of bags and bottles.
 Pressing and holding any of the arrow keys results in faster increment or decrement.

3.4.2.2 Infusion Indicator Lights


Indicator Description

Infusion in Progress (flashing green)

Low-Priority Alarm (constant yellow)

Medium-Priority Alarm (flashing yellow)

High-Priority Alarm (flashing red)

Note:
 Infusion indicator lights provide information about the infusion: in progress, or with a low, medium
or high-priority alarm.
 Green indicator lights will continuously flash from right to left while the infusion is running.
 The frequency of flashing varies according to flow rate.

3.4.2.3 Status Indicators


Indicator Description
Power Supply Indicator
When the device is attached to an active power supply, the indicator light is
a constant green. If the pump is not connected to the AC power, it does not
light up.
Battery Charge Status Indicator
When the device is attached to an active power supply, the indicator light
provides information about battery charge status:
 If the indicator is blinking, the battery is being charged.
 If the indicator is lit permanently, the battery is fully charged.
If the pump is not connected to the AC power, it does not light up.

19
3.5 Display and Symbols
3.5.1 Infusion Status
Symbol Description
Infusion in Progress (All Profiles)
This symbol shows a drop falling into the drip chamber.
The drop appears in the drip chamber when an infusion is in progress.

Infusion in Progress (Drop sensor connected)

Infusion in Progress (Custom Profiles)


This symbol is displayed when the pump is infusing a drug customized with
Agilia Vigilant Drug’Lib software.
Infusion Stopped
STOP remains in the center of the screen until the user starts the infusion
again.

3.5.2 Screen Options


Symbol Description
Battery Logo
 This symbol shows three different charge levels.
< 30 % battery charge
30 % - 70 % battery charge
> 70 % battery charge
 If the ‘Battery logo’ option is enabled, this symbol is displayed constantly.
 If the ‘Battery logo’ option is disabled, this symbol is only displayed when
the pump is operating on battery.
Pressure Logo
This symbol gives information about pump pressure settings and measured
pressure levels.
Keypad locked symbol
This symbol informs the user that the keypad is locked.
Wi-Fi module status
 The Wi-Fi signal strength is high.
 The Wi-Fi signal strength is medium.
 The Wi-Fi signal strength is low.
 No Wi-Fi signal (the Wi-Fi module is activated).
 The Wi-Fi module is not activated.

20
3.5.3 Navigation Buttons
Symbol Description
start Start

OK Confirm

enter Access Function

New ? Access Function and Clear Settings

exit Exit Function

C Change Selection

prog Program Function

Select / Unselect

See More Information

/ Zoom in / Zoom out

/ Move the Event Marker to the Left / Right

3.5.4 Alarms and Safety Features


Symbol Description
Power Disconnection

Alarm Silenced

Pressure Increase

Drop in Pressure
Note: For more information on alarms, see section 12, page 106.

3.5.5 Infusion Features


Symbol Description
Loading Dose
This symbol is displayed when programming a loading dose.
Secondary Infusion
SEC This symbol is displayed when programming and infusing a secondary
infusion.
Ramp-up / Ramp-down Infusion
This symbol is displayed when programming and infusing a ramp-up /
ramp-down infusion.
Sequential Infusion
seq This symbol is displayed when programming and infusing a sequential
infusion.
Drops/min
This symbol is displayed when programming and infusing a drops/min
infusion.

21
3.5.6 Data Communication
Symbol Description
Data Set Loaded
A new data set has been loaded to the pump.

3.6 Packaging
The Agilia VP MC packaging contains the following:
 1 Agilia VP MC pump
 1 Instructions for Use manual
(this document + System Components booklet)
 1 Power cord
Packaging weight: Approximately 530 g.
Packaging consists of: Recycled cardboard.

Information
 It is the healthcare facility’s responsibility to check the pump integrity
upon reception.
 If the packaging contents are incomplete or damaged, contact your
Fresenius Kabi sales representative.

22
4 Fundamentals

4.1 Profiles
A profile defines the device configuration and drug library used for a
group of patients in a given health care environment.
By default, factory settings include only 1 profile (Basic Profile).
Custom profiles can be created and loaded to the pump with Agilia
Vigilant Drug’Lib software. Custom profiles feature a specific pump
configuration and a drug library.
A pump can manage up to 20 profiles:
 1 Basic Profile
 Up to 19 custom profiles
Information
For pumps used on only one group of patients, we recommend disabling
the ability to select the profile, thus locking the pumps to the selected
profile.

4.1.1 Basic Profile


Basic Profile allows programming of an infusion whose settings have not
been pre-defined with Agilia Vigilant Drug’Lib software. To program an
infusion with Basic Profile, choose "Basic Profile" when selecting a
profile.
Basic Profile has the following characteristics:
 All infusion settings are to be defined.
 The Agilia Vigilant Drug’Lib software's safeguards are unavailable:
- The infusion is programmed without drug names.
- Limits on drug infusion rates are not included.
Configurations and settings accessible in Basic Profile may not be
suitable for all patient groups and protocols.

4.1.2 Custom Profiles


Custom profiles can be configured and loaded to the pump with Agilia
Vigilant Drug’Lib software. A custom profile contains the following:
 a specific device configuration (pump settings that control the
mechanical functions of the pump such as alarm volume, air-in-line
detection, and so on)
 a comprehensive list of medications and fluids to be infused
(optional):
- a drug library: a list with limits on drug infusion rates,
see section 4.2, page 24.
- a drug list: a list without limits on drug infusion rates.
23
Depending on the way it is pre-configured with Agilia Vigilant Drug’Lib
software, a custom profile may or may not include all of the
functionalities described in this IFU.
Information
 We recommend using a custom profile when infusing critical drugs.
 We recommend that you create and upload profiles in order to limit
usage errors, and to better adapt the use of the pump to the local
practices of the different care units. For example, make sure to limit
flow rates for sensitive populations.
 We recommend creating a specific profile per patient population
and/or care unit, therapy, protocol, and so on.

4.2 Drug Libraries


A drug library is a comprehensive list of drugs that includes limits on drug
infusion rates.

Information
 Each drug library can support up to 150 drug entries that are defined
and validated by healthcare professionals according to the drug
protocols used at the healthcare facility and/or ward level.
 Drug settings may be adjusted on the pump according to pre-defined
programming limits, such as dose limits.
 Infusion modes are not adjustable on the pump for drugs pre-
configured with Agilia Vigilant Drug’Lib software.

4.3 Drug Lists


A drug list is a list of drugs that does not include limits on drug infusion
rates.

4.4 Drugs
4.4.1 Infusion Rates
A drug can be pre-configured with Agilia Vigilant Drug’Lib software
according to one of the following rates:
 Flow rate: Infusion of a volume over a period of time
 Dose: Infusion of a specific amount of a drug corresponding to a
dose rate

24
4.4.2 Drug X (mL/h)
Drug X (mL/h) is an open entry that can be selected if the intended drug
is not found in the drug library. It has the following characteristics:
 Fewer limits than the other drugs in the library.
 A full compliment of the Agilia Vigilant Drug’Lib software’s
safeguards are unavailable.
It is strongly recommended to use Drug X (mL/h) in a limited number of
clinical cases and under close patient monitoring by the clinical staff.
For each custom profile, the healthcare facility can enable or disable
Drug X (mL/h) using the Agilia Vigilant Drug’Lib software.

4.4.3 Hard Limits and Soft Limits


Programming limits can be set for each drug with Agilia Vigilant Drug’Lib
software. Two types of limits can be set:
 Hard limits: limits that cannot be overridden when programming an
infusion.
 Soft limits: limits that can be overridden within an authorized range
when programming an infusion. An additional confirmation will be
required.

4.4.4 Infusion Modes


An infusion can be started according to the following modes:

Infusion Rate
Infusion Mode Description
Flow Rate Dose
Volume / Time / Rate This infusion mode gives access to the 3 infusion
 
(V/T/R) parameters (V, T, R)
Volume / Rate Infusion of a programmed volume of fluid at a
 
(V/R) programmed rate
Volume / Time Infusion of a programmed volume of fluid over a
 
(V/T) programmed period of time
Time / Rate Infusion over a programmed period of time, at a
 
(T/R) programmed rate
Infusion defined by a flow rate. Only available with
Simple Rate the optional drop sensor fixed to the drip chamber  
and connected to the pump.
Infusion defined by a total volume, a total infusion
time, a ramp-up and ramp-down time and a plateau
Ramp-up / Ramp-
flow rate. This mode allows the flow rate to be  
down increased gradually by intermediate stages in order
to reach the plateau flow rate.
Infusion by sequences (up to a maximum of 20)
Sequential defined by volume to be infused and the infusion  
flow rate for each sequence.
Infusion defined by a flow rate expressed in drops
Drops/min  
per minute

25
4.5 Data Set
A data set is a combination of custom profiles (up to a maximum of 19)
that can be uploaded to Agilia pumps with Agilia Vigilant Drug’Lib
software.

Device Device Device Device Device


Configuration Configuration Configuration Configuration Configuration
(factory) 2 3 4 20

Drug Library Drug List Drug Library Drug Library


A B C S

Profile 1
(Basic Profile)
Profile 2
(Custom)
Profile 3
(Custom)
Profile 4
(Custom) ... Profile 20
(Custom)

Data Set configured with Agilia Vigilant Drug’Lib software

If there is no data set uploaded to the pump, the pump can be used with
the Basic Profile, without the protections of the Agilia Vigilant Drug’Lib
software.

26
5 Installation

5.1 Types of Installations


A pump can be installed on any of the following:

Location Comments
 See section 5.3.1, page 29.
On a Pole Pole specifications:
 Diameter: from 15 to 40 mm

 See section 5.3.2, page 30.

Rail specifications:
On a Rail
 Height: from 25 to 35 mm
 Depth: from 8 to 10 mm

 Refer to the Agilia Link accompanying


documents.

On the
Agilia Link
Rack

 See section 5.3.3, page 30.

On a Table Only install a pump on a table if it is not


possible to attach it to a pole, a rail or
recommended Agilia accessory.
 See section 5.3.4, page 31.

On Another
Pump

 Refer to the Agilia Duo accompanying


documents.
On an Agilia
Duo

27
Location Comments
 Refer to the Agilia Holder Ambulance
In an Agilia accompanying documents.
Holder
Ambulance

Do not use accessories that appear to be damaged. For more


information on accessories, refer to their respective accompanying
documents.
Warning
 The pump must be used in a horizontal and stable position to function
properly.
 Use recommended Agilia accessories to ensure stability and prevent
the pump from falling. Do not stack the pump with equipment other
than those recommended.

5.2 Using the Rotating Pole Clamp


The rotating pole clamp is located at the back of the pump.
When installing the pump on a pole or a rail, fasten the rotating pole
clamp firmly to avoid any movement of the pump.

5.2.1 Rotating Pole Clamp Description

1 3

2
Figure 5.1: Rotating Pole Clamp System
Legend
1 Screw Clamp

21 Release Button

3 Rotating Pole Clamp

5.2.2 Using the Rotating Pole Clamp


You can secure the rotating pole clamp vertically or horizontally by
folding it outward until the release button clicks into the locked position.

28
5.2.2.1 Folding the Clamp Down (outward)
You can fold the clamp down as follows:
1. Push the release button.
2. Fold the clamp outward.

5.2.2.2 Folding the Clamp Up (inward toward the pump)


You can fold the clamp up as follows:
1. Push the release button.
2. Fold the pole clamp inward toward the
pump.

5.2.2.3 Rotating the Clamp


You can rotate the clamp as follows:
1. Fold the clamp up (see above).
2. Rotate the clamp to a vertical position.
3. If necessary, fold the clamp outward
(see above).

5.3 Attaching the pump(s)


5.3.1 Attaching to a Pole
1. Fold the pole clamp down to the horizontal position:
see section 5.2.2.1, page 29.
2. Unscrew the clamp, attach to the
pole, and screw the clamp until the
pump is fully secured to the pole.
3. Make sure that the pump is securely
attached.
For more information on installing the
pump on a pole, consult the pole’s
Instructions for Use.
Information
When installed on a rolling stand, do not tip over the system more than
5°: it may fall.

29
5.3.2 Attaching to a Rail
Only single pumps can be attached to a bed rail or gurney rail.
1. Rotate the pole clamp to the vertical
position: see section 5.2.2.3, page 29.

2. Unscrew the clamp, attach to the rail,


and screw the clamp until pump is
fully secured to the rail.

3. Make sure that the pump is securely


attached.

5.3.3 Using on a Flat Table


1. Fold the pole clamp up: see section 5.2.2.2, page 29.
2. Place the pump far enough from the
table's edges to prevent it from
accidentally being pushed off.

30
5.3.4 Attaching Two Pumps Together
You can attach two pumps together either for transport, or before fixing
them to a pole.

1. Fold both pumps’ pole clamps up: see


section 5.2.2.2, page 29.
2. Slide the slot on the bottom of the
upper pump onto the handle of the
lower pump.

3. Turn the attachment lock knob on the


lower pump handle clockwise until the
locked symbol lines up with the
marker.
4. Make sure the two pumps are
securely attached together.
5. If needed, fold the two pole clamps
down and secure them tightly to the
pole.

Symbol Location Description

Attachment Lock Knob Locked Position

Attachment Lock Knob Unlocked Position

31
6 Getting Started

6.1 Flowchart
Once the pump is installed at the bedside, you must follow the steps
below in order to install an administration set and power on the pump.

Preparing the administration set and the fluid container


Section 13.1, page 116.

Priming the administration set


Section 13.2, page 117. (Manual)
Section 7.11.1, page 68. (Pump Feature)

Powering on
Section 6.3, page 33.

Installing the administration set in the pump


Section 6.4, page 35.

Programming an infusion
Section 7, page 38.

Information
In order to ensure that all the safety features of the device are activated,
make sure that the following instructions are applied:
 The pump is powered on prior to being connected to the patient.
 The pump is not connected to the patient during the set-up.

32
6.2 Using the Pump for the First Time
1. Make sure the pump is correctly installed at the bedside.
See section 5, page 27.
2. Plug the pump into the AC power supply.
See section 17.1, page 137.
3. Before starting the pump for the first time, you must charge the
battery for approximately 6 hours.
Wait until the pump is fully charged.
Do not use the pump during the first charge.
4. Prepare the administration set.
See section 13.1, page 116.
5. Power on the pump.
See section 6.3, page 33.

6.3 Powering on
Information
 The pump can operate using the battery; however, we recommend
that the pump be connected to a power supply as often as possible
during use in order to ensure that the battery remains charged.
 When the pump is connected to the power supply, check that the
power supply indicator lights up green, and that the power cord
and the wall plug are accessible.
 When plugged into a power supply, the pump automatically powers
on when the pump door is opened. You can deactivate this option in
the pump options. For more information, refer to the technical
manual.

1. Press or open the pump door by lifting the door lever.


An auto-test checks the functionality of the pump.
2. Immediately after powering on the pump, make sure that all LED
lights blink.
3. Acknowledge the different screens listed in the table below.

Screen After Powering on Description


Startup screen: the following information is
displayed:
 Product name / Ward name
 Wi-Fi module status (if applicable)
 Date & time

33
Screen After Powering on Description
 The pump is operating on battery.
 The symbol shows three different charge
levels:
< 30 % battery charge
30 % - 70 % battery charge
> 70 % battery charge

 No administration set is installed on the pump.


 Install set !!! is displayed on top of the
screen.
 Install an administration set.
See section 6.4, page 35.

 The administration set is loaded into pump.


 OCS test is successfully completed.
 The OCS test verifies the circuit and pump
occlusivity at start-up, thus reducing the
occurrence of unintentional gravity flow.

 Maintenance reminder message (optional).

 Same infusion screen (optional).


Press Yes to keep previous infusion settings.

 Profile confirmation screen (optional).


Press Ok to confirm the profile.

Note: This screen is linked to the "same infusion"


function above.

34
Screen After Powering on Description
 Data Set information (optional)

6.4 Installing the Administration Set in the Pump


Warning
 Do not open the roller clamp until the OCS test has successfully
completed.
 During all manipulations of the pump with administration set
(administration set installation, door opening, administration set
removal), close the roller clamp and make sure the line is closed.
1. Power on the pump, see section 6.3, page 33.
2. Open the pump door.
3. Align the fully primed administration set horizontally along the tube
guides so that the green connector is on the right (green), and the
SafeClip (blue anti-free-flow clamp) is in front of the clamp guide
(blue).
4. Insert the green connector into the
green slot [A]. A
5. Guide the SafeClip (blue clamp)
into the blue slot, with the spherical
hinge on top [B]. B
6. Push the SafeClip to move the
spherical hinge into place.
7. Check that the tube is inserted in
the left tube guide.
8. Push the door lever down to close
the pump door.
 SafeClip engages automatically
when it is inserted into the clamp
guide and the pump door is closed.
 The Occlusivity Check System
(OCS) automatically clamps the
line, activates pumping and checks
for a rise in pressure.
9. When the OCS test is successful,
the infusion mode defined in the
options is displayed.

35
6.5 Connecting a Drop Sensor
Using a drop sensor is recommended if the actual volume of the fluid
container is not known accurately.
The pump automatically detects the presence of a drop sensor. The
presence of the drop sensor can be set as mandatory in the pump
options. For more information on drop sensor options, refer to the
technical manual.
Always connect a drop sensor when the pump is off.
1. Before powering on the pump, connect
the drop sensor plug to the connection
socket on the back of the pump.
2. Press the drop sensor clip and align the
vertical part of the drop sensor with the
drip chamber’s air vent.
3. Release the clip.
4. Check the following:
 The drop sensor and the drip chamber
are in a vertical position.
 The drop sensor is correctly aligned
with the drip chamber’s air vent.

 There are no drops on the drip chamber


walls.
 The drip chamber is filled approximately
1/2 full and the level of liquid is below
the drop sensor.
 The pump and the drop sensor are
correctly installed. Do not use the drop
sensor if it appears to be damaged.
Standard Drip Chamber Drip Chamber with Central Ring
(example: VL ST00) (example: VL ON42)

Note: The drop sensor is equipped with two circular magnets. You can use
these magnets to fix the drop sensor and the drip chamber on the right
side of the pump.

36
Information
When a drop sensor is detected on a pump, the following happens
 Simple Rate infusion mode is available and recommended,
 Programmable infusion ranges are different.
Warning
For transport during infusion, the pump with a drop sensor connected on
it must be installed on a rolling stand.

6.6 Pump Height


Warning
Ideally, the volumetric pump should be level with the distal tip of the
catheter (e.g., the site of fluid delivery; if accessing a central line the
volumetric pump should be at the level of the patient’s heart). If the pump
height is raised relative to the distal tip of the catheter (e.g., during
patient transport), the increase in height of the volumetric pump can
result in a temporary increase in fluid delivery or bolus until the flow rate
stabilizes. Alternatively, if the pump is lowered relative to the distal tip of
the catheter, the decrease in height of the volumetric pump may result
in a decrease in delivery or under-infusion until the flow rate stabilizes.
Hang the container between 20 to 80 cm above the pump.
We recommend that the container is positioned on the right side of the
pump, to protect the pump from dripping fluids.

20 to 80 cm

Figure 6.1: Global Installation


Precautions for pump position
 If using multiple volumetric pumps and it is not clinically feasible to
have all pumps level with the distal tip of the catheter (or the site of
fluid delivery), place the high risk or life-sustaining medications as
close to level with the distal tip of the catheter as possible. When
infusing multiple high risk or life-sustaining medications, consider
placing the ones infusing at the lowest rates as close to the level with
the distal tip of the catheter as possible.
 Minimize the height difference between the pump and the patient and
avoid changes in the height of the pump (e.g., during transport of
critically ill patients) to prevent unintended fluctuations in the flow rate.
37
7 Operation

7.1 Flowchart

Selecting a Profile
Section 7.2, page 39.

Basic Profile Custom Profile Custom Profile


Section 4.1.1, page 23. (with a Drug List) (with a Drug Library)
Section 4.1.2, page 23. Section 4.1.2, page 23.

Selecting the Selecting the


Infusion Rate Infusion Rate
Section 7.3, page 40. Section 7.3, page 40.

Selecting a Drug
Section 7.4, page 41.

Flow Rate Programming Dose Programming


Section 7.5.1, page 42. Section 7.5.2, page 43.

Starting an Infusion
Section 7.6, page 49.

Monitoring an Infusion
Section 7.7, page 50.

Functions during Infusion


Section 7.8, page 52.

Completing an Infusion
Section 7.9, page 60.

38
7.2 Selecting a Profile
You can only select a profile if more than one profile is loaded in the
pump.
1. Press to power on the pump.

2. Press the arrow keys to select a profile that corresponds to the


target group of patients.
The (lighthouse) symbol refers to custom profiles that contain
drug libraries and have been configured with Agilia Vigilant Drug’Lib
software.
3. Press OK to confirm.
The selected profile information is displayed.

4. Press OK to confirm the drug library version, or C to change the


profile.
 The drug library is loaded for the profile selected.
 The OCS test is performed.

39
7.3 Selecting the Infusion Rate (Flow rate or Dose)
The programming mode step allows you to select the infusion rate. This
step occurs just after selecting Basic Profile, or a custom profile with a
drug list.
Note: The infusion rates for each drug of a drug library are pre-defined
with Agilia Vigilant Drug’Lib software.

Flow rate Dose


The infusion rate that was last used is displayed.
1. Press OK to confirm the infusion rate or press C to change it.

Flow rate Dose


2. Press the arrow keys to select a new infusion rate.
3. Press OK to confirm.

40
7.4 Selecting a Drug
Note: The drug selection step is not applicable with Basic Profile.
Drugs are sorted alphabetically by the first letter of their names:
 A  C  J  L  S  U
 D  F  M  O  V  Z
 G  I  P  R  Drug X (mL/h)

1. Press the arrow keys to scroll to the drug's first letter, and press OK.

2. Press the arrow keys to scroll to the drug's name, and press OK.
A clinical advisory message may appear, if one is configured for the
selected drug.
3. Press OK to acknowledge the clinical advisory message and
continue programming, or C to change the drug.

7.5 Programming an Infusion


 This section describes the programming of an infusion with the
V/T/R infusion mode.
 To change the infusion mode, see section 8.14, page 88.

41
7.5.1 Programming an Infusion by Flow Rate

1. Press the arrow keys to program the Volume to be Infused (VTBI)


and press OK.
(Press to select the VTBI from pre-defined values:
0.1 mL, 10 mL, 20 mL, 50 mL, 100 mL, 250 mL, 500 mL, etc.)

Information
 Ensure VTBI is not greater than actual volume in the container to
avoid air-in-line at the end of infusion.
 All volumes added or removed must be taken into consideration,
including the volume of fluid contained in the administration set and
lost during priming (priming volume varies by administration set; see
the administration set IFU for priming volumes).

2. Press the arrow keys to program the infusion duration (__ h __), and
press OK.

3. Press the arrow keys to program the flow rate, and press OK.

42
7.5.2 Programming an Infusion by Dose
7.5.2.1 Selecting the Drug Concentration
Profile Drug Concentration Selection Procedure
Basic Profile
Custom Profile A- Basic Profile and Custom Profile (with a Drug List), page 43.
(with a drug list)
Custom Profile
B- Custom Profiles, page 43.
(with a drug library)

A- Basic Profile and Custom Profile (with a Drug List)

1. Press the arrow keys to select the drug concentration unit, and
press OK.

2. Press the arrow keys to select a mass value, and press OK.
3. Press the arrow keys to select a volume value, and press OK.
The concentration is automatically calculated and displayed in the
unit selected above.
4. Press OK to confirm.

B- Custom Profiles
The selected drug is configured in Agilia Vigilant Drug’Lib software to
allow adjustments to its concentration in one of the following ways:
 Within an authorized range
 At authorized finite values (up to 5)
If no adjustment on the concentration is allowed, see section 7.5.2.2,
page 44.

43
Authorized Concentration Range Authorized Finite Concentrations

Legend
Unauthorized Range Hard Limits

Authorized Range Default Value

Finite Values

Selecting the Drug Concentration

Range Finite values


1. Press the arrow keys to select the concentration.
2. Press OK to confirm.

7.5.2.2 Selecting the Patient’s Characteristics


Note: This step is only applicable with custom profiles that contain a drug
library.

Weight Body Surface Area


1. Press the arrow keys to enter the patient's weight or body surface
area.
2. Press OK to confirm.
Information
 The weight entry screen only appears if the selected drug uses
weight for dose rate calculations.
 The body surface area entry screen only appears if the selected drug
uses body surface area for dose rate calculations.
 A pre-populated default weight or body surface area will be
configured with the Agilia Vigilant Drug’Lib software.
44
7.5.2.3 Selecting the Infusion Unit
Note: This step is only applicable with Basic Profile and custom profiles
that contain a drug list. The infusion units for each drug of a drug library
are pre-defined with Agilia Vigilant Drug’Lib software.

1. Press the arrow keys to select the infusion unit.


2. Press OK to confirm.

7.5.2.4 Programming the Infusion

1. Press the arrow keys to program the Volume to be Infused (VTBI),


and press OK.
(Press to select the VTBI from pre-defined values:
1 mL, 10 mL, 20 mL, 50 mL, 100 mL, 250 mL, 500 mL, etc.)
Information
 Ensure VTBI is not greater than actual volume in the container to
avoid air-in-line at the end of infusion.
 All volumes added or removed must be taken into consideration,
including the volume of fluid contained in the administration set and
lost during priming (priming volume varies by administration set; see
the administration set IFU for priming volumes).

2. Press the arrow keys to program the infusion duration (__ h __), and
press OK.

45
3. Press the arrow keys to program the dose, and press OK.

4. Press OK to confirm the infusion settings, or C to cancel.

7.5.2.5 Programming a Loading Dose


Note: This feature can be activated or deactivated in Agilia
Vigilant Drug’Lib software (custom profiles).

Information
The loading dose is only available with the first start of an infusion. If no
is pressed inadvertently, power the pump off and then on to access the
loading dose again.
If enabled for the selected drug, you can program a loading dose after
programming an infusion defined by dose.
The screens below will appear prior to starting the infusion.
Selecting a Loading Dose

On the loading dose screen:


 Press no to return to the programming screen.
 Press Yes to program a loading dose prior to starting the primary
infusion.

46
Programming a Loading Dose

1. Press the arrow keys to enter a value for the dose, and press OK to
confirm.
2. Press the arrow keys to program the loading dose duration
(__ h __ min __), and press OK to confirm each time segment.
The VTBI and the flow rate are automatically calculated based on
dose and duration settings.
3. Press OK to confirm the loading dose settings.
If needed, press C or to change the loading dose settings before
starting.

4. Press start to initiate the loading dose.


Once the loading dose is finished, the pump automatically starts the
programmed primary infusion.

Interrupting a Loading Dose

1. To pause the loading dose, press .


The screen displays Continue?
2. Choose one of the following options:
 Press no or to stop the loading dose and proceed to the
programmed primary infusion.
 Press start to continue with the loading dose.

47
7.5.3 Programming Beyond Soft Limits
Note: This step is only available with custom profiles that contain a drug
library.
You can override soft limits, and adjust flow rate and dose within the
authorized ranges. You cannot override a hard limit.

Legend
Unauthorized Range Hard Limits
Programmable Range
Soft Limits
(warning and confirmation)
Authorized Range Default Value

Overriding a Soft Limit


1. If you reach a soft limit when programming an infusion, the pump
displays a message at the top of the screen:
 Upper soft max = the upper soft limit is exceeded
 Lower soft min = the lower soft limit is exceeded

Flow rate Dose


2. If the displayed settings correspond to the intended flow rate or
dose, press OK.

Flow rate Dose


3. Carefully review the program settings.
The original infusion settings continue until you confirm the new
settings.
4. Press OK or start to confirm the soft limit override.

48
Flow rate Dose
During infusion, the upper or lower soft limit message will alternate with
the drug name and concentration at the top of the screen.

7.6 Starting an Infusion

Flow rate Dose

1. Check the administration set integrity.


2. Check that no air remains in the administration set.
3. Confirm that the administration set is correctly installed in the pump.
4. Open the roller clamp.
5. Connect the administration set to the patient's access device.
6. Check the infusion settings prior to starting the infusion.
7. Press start to start the infusion, or C to modify the infusion settings.

Warning
When connecting the administration set to the patient's access device,
always use aseptic technique according to your healthcare facility policy.

49
7.7 Monitoring an Infusion
7.7.1 Monitoring an Infusion when Programmed by Flow Rate

7 6 5

2 3

Legend
Custom Profile Sign
1
When infusing a drug selected from the Agilia Vigilant Drug’Lib software library,
this lighthouse sign is displayed on the screen continuously.
VI (Volume Infused).
21
Will increase during the infusion. To clear VI, see section 8.7, page 81.
Infusion Flow Rate (mL/h)
3
To change the flow rate during an infusion, see section 7.8.2, page 52.
The flow rate is displayed with the largest font size.
Infusion in Progress
4
The infusion in progress indicator displays falling drops.
Infusion Duration
5
At the current rate, the remaining infusion time in hours and minutes.
Infusion duration may or may not be displayed depending on the configuration preset with
Agilia Vigilant Drug’Lib software for this drug.
VTBI (Volume To Be Infused) remaining.
6
Will decrease during the infusion.
To change VTBI during an infusion, see section 8.4, page 77.

7 Drug Name (Custom Profiles only)

50
7.7.2 Monitoring an Infusion when Programmed by Dose

9 8 7 6
1

2 3 4

Legend
Custom Profile Sign
1
When infusing a drug selected from the Agilia Vigilant Drug’Lib software library,
this lighthouse sign is displayed on the screen continuously.
VI (Volume Infused).
21
Will increase during the infusion. To clear VI, see section 8.7, page 81.
Dose
3
To change the dose during an infusion, see section 7.8.2, page 52.
Dose is displayed with the largest font size.

4 Infusion Flow Rate

Infusion in Progress
5
The infusion in progress indicator displays falling drops.
Infusion Duration
6
At the current rate, the remaining infusion time in hours and minutes.
Infusion duration may or may not be displayed depending on the configuration preset with
Agilia Vigilant Drug’Lib software for this drug.

7 Drug Concentration

VTBI (Volume To Be Infused) remaining.


8
Will decrease during the infusion.
To change VTBI during an infusion, see section 8.4, page 77.

9 Drug Name (Custom Profiles only)

51
7.8 Functions During Infusion
7.8.1 Stop

Flow rate Dose


To stop the infusion, press .
After 2 minutes, an alarm is generated as a reminder that the infusion is
stopped.

To restart the infusion, first confirm or modify the programming settings,


then start the infusion. See section 7.5, page 41.

7.8.2 Rate Titration


You can adjust the infusion rate (flow rate or dose) during the infusion.
Depending on your pump configuration, stopping the infusion may be
required before modifying the infusion rate.
1. If required, stop the infusion, see section 7.8.1, page 52.
2. Press the arrow keys to modify the flow rate or dose.
3. Press OK to confirm.

Flow rate Dose

7.8.3 Secondary (Piggyback) Infusions


Note: This feature can be activated or deactivated in Agilia
Vigilant Drug’Lib software (custom profiles) or in the pump options
(Basic profile).
A secondary infusion delivers the contents of a secondary bag or
bottle, by connecting a secondary line to the upstream access port of the
primary line. When the secondary infusion is complete, the return to
primary infusion can be done manually or automatically, depending on
the drug's settings.

52
Information
 You can only add a secondary infusion when the primary infusion is
programmed by flow rate.
 The secondary infusion drug must be programmed by flow rate.
 You can configure the end of secondary infusion settings in the pump
options.
 An end of secondary alert may be activated or deactivated in the
pump options.

7.8.3.1 Connecting the Secondary Line


1. Prime the secondary administration set.
2. Lower the primary container and hang the secondary approximately
30 cm higher than the primary container.
3. Press to pause the primary infusion.
4. Using aseptic technique, connect the secondary line to the upper
access port on the primary line.

1 2

Figure 7.1: Primary and Secondary Infusion


Legend
1 Primary Line

21 Secondary Line

Information
 Specific administration sets are available for secondary infusions.
For more information, refer to the instructions on the administration
set packaging.
 It is recommended to use a primary administration set with a back
check valve above the upper access port.

53
7.8.3.2 Accessing Secondary Infusion

1. Open the Primary / Secondary menu:


 Press .
 Press the arrow keys to select P/S .
2. Press enter.

3. Press OK to confirm access to the secondary infusion.

7.8.3.3 Programming Secondary Infusion

1. Select a secondary drug (only when using a custom profile) and


press OK.

2. Press the arrow keys to program the secondary VTBI, and


press OK.
3. Press the arrow keys to program the infusion duration, and
press OK.

54
4. Press the arrow keys to program the secondary flow rate and
press OK.
5. Press OK to proceed.
Information
 The current volume infused displayed becomes the secondary
volume infused while infusing the secondary.
 Pri VI indicates the total primary volume infused since it was last
cleared.
 Sec VI indicates the volume infused since the start of the current
secondary infusion.

7.8.3.4 Secondary Infusion Start

Manual Return Automatic Return

1. Confirm the following:


 The secondary line is connected to the primary upper port.
 The roller clamp is open.
 The secondary container is hung approximately 30 cm above the
primary container.
2. Press start to start the secondary infusion.

55
7.8.3.5 End of Secondary Infusion
Information
The near end of infusion alert is not activated in secondary infusion.

Manual Return to Primary Infusion

1. Press to silence the alarm.

2. Answer the question Continue sec ?


 Press Yes to program another secondary infusion.
 Press no to return to primary infusion.
An alert message is displayed (optional).

3. Ensure that the primary line is open.


4. Press to acknowledge the message.

5. Press start to resume primary infusion.

56
Automatic Return to Primary Infusion
At the end of secondary infusion, a short beep is emitted.
An alert message is displayed (optional).

1. Ensure that the primary line is open.


2. Press to acknowledge the message.

The infusion automatically returns to the programmed primary infusion.

57
7.8.4 Administering a Bolus
A bolus is an extra dose that a pump can deliver during an infusion.
There are two ways to deliver a bolus dose during an infusion:
 Direct bolus
 Programmed bolus
Direct Bolus Programmed Bolus

Access Key or

Occlusion Pressure Level Set to its maximum value: 750 mmHg / 100 kPa / 14.5 PSI

Information
 The bolus volume is added to the Volume Infused (VI).
 In Basic Profile, programmed bolus is only available for primary
infusion, not secondary infusion.
 The key is not active when the menu screen is displayed.
 The key is not active when the following infusion modes are
selected:
- Ramp-up / ramp-down
- Sequential

7.8.4.1 Direct Bolus


Note: This feature can be activated or deactivated in Agilia
Vigilant Drug’Lib software (custom profiles) or in the pump options
(Basic profile).

1. During the infusion, press .


2. Press bolus to confirm access to bolus function.

58
3. To administer a direct bolus, press and hold .
4. Monitor the volume infused on the main display until the desired
bolus is reached.
5. To stop the bolus, release the key.
The infusion resumes its previous rate after the bolus is delivered.

7.8.4.2 Programmed Bolus


Note: This feature can be activated or deactivated in Agilia
Vigilant Drug’Lib software (custom profiles) or in the pump options
(Basic profile).

During the infusion, you can program a bolus in one of the following two
ways:
 Press , then prog.
 Press , and select in the menu. Press enter to confirm.

Programming a Bolus
1. Press the arrow keys to program the bolus volume or dose, and
press OK.
2. Press the arrow keys to program the bolus duration
(__ h __ min __), and press OK.
The flow rate is calculated automatically.

Flow rate Dose

3. Press start to start the bolus.

Flow rate Dose

59
The infusion resumes its previous rate after the bolus is delivered.
Press exit or to exit the bolus function and save the programmed
bolus settings.
If you press again, this screen appears immediately and displays the
settings of the last bolus.
Interrupting a Programmed Bolus
1. Press to interrupt the bolus.

Flow rate Dose

2. Answer the question: Continue?


 Press no to return to the infusion.
 Press start to continue the bolus.

7.9 Completing an Infusion


7.9.1 Near End of Infusion Alert
Prior to the end of an infusion, a near end of infusion alert is
automatically triggered. The following happens:
 An audible alarm is triggered.
 An alarm message appears on the pump screen.
 The infusion indicator lights flash yellow.
Near end of infusion alert is triggered when the first of the three criteria
below is reached.
Default Pump
Setting Range of Values
Setting
Time Before the End of the Infusion From 0 to 30 minutes 5 minutes

% of VTBI Remaining From 0 to 15 % 5%

Remaining VTBI From 0 to 50 mL 5 mL

Near end of infusion alert settings are configurable with Agilia


Vigilant Drug’Lib software (custom profiles), or in the pump options
(Basic Profile). For more information, refer to the technical manual.

60
Silencing Near End of Infusion Alert

Flow rate Dose

1. Press to silence the alarm.


The infusion will continue until the VTBI reaches zero.

7.9.2 End of Infusion


When the VTBI reaches zero, the infusion is complete. The following
happens:
 An audible alarm is triggered.
 An alarm message appears on the pump screen.
 The infusion indicator lights flash yellow.
 KVO (Keep Vein Open) rate is maintained.

End of infusion settings (KVO rate, Silence duration) are configurable


with Agilia Vigilant Drug’Lib software (custom profiles), or in the pump
options (Basic Profile). For more information, refer to the technical
manual.
Information
 If KVO is disabled, the infusion indicator lights flash red, and pump
stops infusing.
 If the programmed infusion rate is lower than the configured KVO
rate, the pump continues infusing at the programmed rate.
Silencing the Alarm

1. Press to silence the alarm.


2. Prepare the new container, and adjust the settings for a new
infusion.

61
7.9.3 Powering off

You can power off the pump as follows:


1. Press to stop the infusion.
2. Close the roller clamp.
3. Press and hold until the pump powers off.

7.10 Infusion Modes


You can program an infusion with the different infusion modes available,
depending on the pump configuration, and on the selected drug.
To select an infusion mode, see section 8.14, page 88.
For more information on calculation rules, see section 15.11, page 130.

7.10.1 Volume / Time / Rate (V/T/R)


1. Press the arrow keys to select the VTBI and press OK.
2. Press the arrow keys to adjust the infusion duration and press OK.
The flow rate is automatically readjusted.
3. Press the arrow keys to select the flow rate and press OK.
The infusion duration is automatically readjusted.
For more information, see section 7.5, page 41.

7.10.2 Volume / Rate (V/R)


1. Press the arrow keys to select the VTBI and press OK.
2. Press the arrow keys to adjust the flow rate and press OK.
The infusion duration is automatically readjusted.

7.10.3 Volume / Time (V/T)


1. Press the arrow keys to select the VTBI and press OK.
2. Press the arrow keys to adjust the infusion duration and press OK.
The flow rate is automatically readjusted.

7.10.4 Time / Rate (T/R)


1. Press the arrow keys to select the infusion duration and press OK.
2. Press the arrow keys to select the flow rate and press OK.
The VTBI is automatically readjusted.
62
7.10.5 Simple Rate (only with Drop Sensor)
When a Drop Sensor is connected to the pump, Simple Rate infusion
mode is available.

1. Press the arrow keys to select the flow rate.


2. Press OK.
When no more drops are detected, the infusion is stopped and an alarm
is generated.

7.10.6 Ramp-up / Ramp-down


In ramp mode, you can divide an infusion into three different phases:
 Ramp-up: the flow rate increases by 10 intermediate steps up to a
programmed value
 Plateau: the flow rate remains constant
 Ramp-down: the flow rate gradually falls to zero by 10 intermediate
steps

7.10.6.1 Programming the Ramp-up / Ramp-down Infusion


You can program an infusion with the ramp-up / ramp-down infusion
mode as follows:
1. In the "flow rate (mL/h)" menu, select the ramp-up / ramp-down
infusion mode, see section 8.14, page 88.
2. Press OK to confirm the new infusion mode.
3. Press OK to confirm the drug.

4. Press the arrow keys to program the VTBI, and press OK.
5. Press the arrow keys to program the total infusion duration
(__ h __), and press OK.
6. Press the arrow keys to program the ramp-up duration (__ h __),
and press OK.
63
7. Press the arrow keys to program the ramp-down duration (__ h __),
and press OK.
8. Press the arrow keys to program the plateau flow rate, and
press OK.

9. Press OK to confirm, or C to cancel the settings.

10.Press start to start the infusion.


Information
During the infusion, a part of the ramp symbol blinks. This part
corresponds to the current infusion phase ( : Ramp-up, : Plateau,
: Ramp-down).

7.10.6.2 Stopping the Ramp-up / Ramp-down infusion

1. During the infusion plateau, press and choose one of the


following actions:
 Press to start the ramp-down.
 Press C to cancel the previous action (pressing ), and return to
the infusion screen.
 Press to stop the infusion.

64
2. If ramp-down is selected, check the ramp-down values and
press OK.

7.10.7 Sequential Infusion


You can program up to 20 infusion sequences with the sequential
infusion mode, each with their own VTBI and flow rate.
You can also program the following sequences:
 Stop: programming of a pause between two sequences
 KVO: programming of a KVO sequence
 Repeat: Up to 20 repetitions of the already programmed sequences
(limited by the total VTBI)
 End: end of the programming sequences
To program a sequential infusion, proceed as follows:
1. In the "flow rate (mL/h)" menu, select the sequential infusion mode,
see section 8.14, page 88.
2. Press OK to confirm the new infusion mode.
3. Press OK to confirm the drug.

4. Press OK to program sequence 1, or the down arrow key to move to


sequence 2.
5. Follow the instructions in the table below to program the desired
sequence.
Note: When the sequence number is selected, press the down
arrow key to move to the next sequence.

65
Sequence Programming
 Press the arrow keys to program the VTBI, and press OK.
The infusion duration is automatically calculated.
 Press the arrow keys to program the flow rate, and press OK.
VTBI
The infusion duration is automatically readjusted.
 Press the arrow keys to activate or mute the end of sequence beep, and
press OK.
 Press the arrow keys to select Stop, and press OK.
 Press the arrow keys to select the pause duration, and press OK.
Stop  Press the arrow keys to activate or mute the end of sequence beep, and
press OK.
 Other sequences can be programmed after a "Stop" sequence.
 Press the arrow keys to select KVO, and press OK.
 Press the arrow keys to select the KVO duration, and press OK.
KVO  Press the arrow keys to activate or mute the end of sequence beep, and
press OK.
 Other sequences can be programmed after a "KVO" sequence.
 Press the arrow keys to select Repeat, and press OK.
Repeat  Press the arrow keys to select the number of repetitions, and press OK.
 No other sequence can be programmed after a "Repeat" sequence.
 Press the arrow keys to select End.
End  Press OK.
 No other sequence can be programmed after a "End" sequence.

6. Press start to start the infusion.

Warning
When editing a stopped infusion with repetition (on infusion screen by
pressing Cancel/C), you can change a step with a repetition.
There is no change on all other repetitions and steps.
Information
To modify a sequential infusion, in the sequential menu, see section
8.16, page 89.
In this case, you can only modify a sequence that has not started yet.

66
7.10.8 Drops/min
You can program an infusion with the drops/min infusion mode as
follows:
1. Select the drops/min infusion mode, see section 8.14, page 88.
2. Press OK to confirm the new infusion mode.
3. Press OK to confirm the drug.

4. Check the equivalent quantity of drops per mL and press OK.


Note: The conversion in drops/min can differ according to the choice
of the drug.

5. Press the arrow keys to program the VTBI and press OK.
6. Press the arrow keys to program the flow rate or the number of
drops per minute and press OK.
The setting to program depends on the pump configuration.

7. Press start to start the infusion.

67
7.11 Other Functions
7.11.1 Priming the Administration Set
Note: This feature can be activated or deactivated in Agilia
Vigilant Drug’Lib software (custom profiles) or in the pump options
(Basic profile).

1. Press to power on the pump.


2. Press .
3. Make sure the administration set is not connected to the patient, as
indicated on screen.
4. Press OK to proceed.

5. Press and hold the key to prime, or press C to cancel.


6. To end priming, release the key.
7. Make sure there is no air in the infusion line.
Information
 Priming is only accessible prior to starting the infusion.
 The key is not active when the menu screen is displayed.
 During priming, the occlusion pressure level is set to its maximum
value 750 mmHg / 100 kPa / 14.5 PSI, and the air-in-line alarm is
disabled.
 Priming is limited to 30 mL maximum. Above 30 mL, you must
release and press the key again to restart priming.
 The pump does not detect air bubbles or occlusions when priming.

68
7.11.2 Advancing an Air Bubble
Note: This feature can be activated or deactivated in Agilia
Vigilant Drug’Lib software (custom profiles) or in the pump options
(Basic profile).
When an air bubble is detected by the air detector (behind the pump
door), an alarm is triggered.
You can use the advance air bubble function to advance the air bubble
beyond the air detector, avoiding the need to remove the administration
set.

1. Press to silence the audible signal for 2 minutes.

2. Press .
3. Press OK to advance the air bubble.

4. Press and hold to advance the air past the air detector.
5. Restart the infusion, or press C to cancel the advance air bubble
function.

Information
 Air that has advanced past the air detector is still in the administration
set.
 Ask for medical advice on whether or not the infusion can be restarted
due to air in the set. If you decide to remove the air bubble, follow facility
procedures for priming or changing the administration set.
 The air bubble advances at the programmed rate. The maximum
volume advanced equals the configured air bubble detection setting.

69
7.11.3 Auto-restart
Auto-restart is an optional feature that alters the pump’s response when
a downstream occlusion is detected.
When this feature is activated, and when a downstream occlusion is
detected, the following occurs:
 An alert is generated to inform the user that the pressure limit is
reached.
 The infusion is stopped.
 The pressure sensor measures the pressure evolution during a
configurable period of time:
- If the pressure decrease is significant, the infusion automatically
restarts.
- If the pressure does not decrease, the downstream occlusion
alarm is generated.

Information
 When the alert is generated, we recommend checking that the
infusion line is not kinked.
 When this feature is deactivated, an alarm is immediately generated
when a downstream occlusion is detected.
 For more information on how to activate or deactivate this feature,
see section 8.3, page 75.

70
7.11.4 Pre-programming the Pump

You can program the pump before installing the administration set.
1. Press to power on the pump.
Install set !!! is displayed on top of the pump screen.
2. Make sure the pump door is closed.
The prog symbol is displayed.
3. Press prog.
4. Program the infusion.
See section 7.5, page 41.

5. Press exit to confirm or C to reprogram.


6. When ready, install the administration set.
7. Press start to start the infusion, or C to change the settings.

71
8 Menus

8.1 Overview
8.1.1 Commands
Operation Key

Access menu or exit menu

Select

Confirm (corresponds to enter on the screen)

Select  / Deselect 

8.1.2 Menu Description


Stop
Menu Symbol Infusion Associated Procedure
Required

Profile Pro NO  Displaying active profile information, page 74.

Pressure NO  Modifying the pressure limit, page 75.

Volume to be infused VTBI NO  Changing VTBI, page 77.

Keypad lock status NO  Locking / Unlocking the keypad, page 78.

Battery life NO  Viewing the battery life, page 80.

Volume Infused  Viewing and clearing the volume or dose infused,


Dose Infused
mL? NO
page 81.

Pause YES  Programming a pause, page 82.

Drug YES  Changing the drug selection, page 83.

Patient NO
 Changing a patient’s weight or body surface area,
page 84.

Day/Night mode NO
 Switching between day mode and night mode,
page 85.

Primary / Secondary P/S YES  Programming a secondary infusion, page 87.

Programmed bolus NO  Programming a bolus, page 87.

Flow Rate
(mL/h) mL/h YES
 Changing the infusion mode, page 88.
Dose Dose YES

72
Stop
Menu Symbol Infusion Associated Procedure
Required

Ramp-up / Ramp-down YES  Modifying a ramp-up /ramp-down infusion, page 89.

Sequential seq YES  Modifying a sequential infusion, page 89.

Alarm volume NO  Adjusting the alarm volume, page 90.

Call-back NO  Activating / Deactivating the call-back alert, page 91.

View flow rate history NO  Viewing flow rate history, page 93.

View pressure history NO  Viewing pressure history, page 94.

View event log NO  Viewing the event log, page 95.

Date / Time NO  Setting up the date and time, page 96.

Maintenance NO  Displaying maintenance information, page 97.

Library information NO  Displaying drug library information, page 98.

Clinical information NO
 Viewing remaining time before clinical information
display, page 99.

Data Set DS NO  Displaying active data set information, page 100.

Note: The displayed menu may change depending on the pump configuration.
For more information on factory configuration, refer to Appendix: Factory Configuration, page 168.

73
8.2 Profile
Symbol Pro
Procedure Displaying active profile information

You can display the active profile name as follows:


1. Press .

2. Press the arrow keys to select Pro .


3. Press enter.
The active profile information is displayed.

74
8.3 Pressure
Symbol

Procedure Modifying the pressure limit

The pump pressure limit is pre-defined in the pump options in one of the
following modes:

 3 levels (low , medium , high ).


The pressure limit is adjustable according to 3 pre-set values.
 Variable
The pressure limit is adjustable within a pre-defined range.
When the pressure limit is reached, an occlusion alarm is triggered.
You must silence the alarm, resolve the occlusion and start the infusion
again.
To consult the pressure settings, see section 15.9, page 127.
Warning
When addressing or clearing an occlusion, ensure the fluid flow to the
patient is OFF to prevent administering an unintended bolus. An
occlusion may pressurize the administration set, which can result in an
unintended bolus of drug when the occlusion is cleared. In order to
prevent this additional bolus, disconnect the administration set or relieve
the excess pressure through a stopcock, if present. The health care
professional should weigh the relative risks of disconnection with the
risks of an unintended bolus of drug.

You can modify the pressure limit as follows:


1. Open the pressure menu in one of the two following ways:
 Press .
 Through the Menu:
- Press .
- Press the arrow keys to select .
2. Press enter to access the pressure limit screen.

75
3. Press the arrow keys to increase or decrease the pressure limit.
4. Press OK to validate.

5. Press to enable or disable the Auto-restart function (optional).


6. Press OK to confirm.
7. Press to enable or disable the DPS function (optional).
8. Press OK to confirm.
Warning
To avoid the presence of air and to minimize the amount of time it takes
the pump to recognize an occlusion and generate an alarm while
infusing at low rates (e.g., less than 5 mL per hour, and especially flow
rates less than 0.5 mL per hour): consider occlusion pressure threshold
setting and adjust it, as necessary. The lower the occlusion pressure
threshold setting, the shorter the occlusion detection time. However,
when infusing viscous or thick fluids (e.g., lipids), the occlusion pressure
threshold setting may need to be adjusted to reduce false alarms.

Information
 For more information on the Auto-restart function, see section 7.11.3,
page 70.
 The Dynamic Pressure System (DPS) informs the user of any
sudden rise or drop in pressure before the pressure limit is reached.
 If variable pressure mode is enabled, a pre alarm is triggered when
the pressure reaches 50 mmHg below maximum pressure
(25 mmHg when maximum pressure is 50 mmHg).
 If other pumps are used in parallel, it is recommended that their
pressure limits be adjusted to the same level.

76
8.4 Volume To Be Infused (VTBI)
Symbol VTBI
Procedure Changing VTBI

You can change the VTBI as follows:


1. Press .

2. Press the arrow keys to select VTBI .


The active VTBI is displayed.
3. Press enter.
4. Press the arrow keys to modify the VTBI.
5. Press OK to confirm.

77
8.5 Keypad Lock Status
Symbol

Procedure Locking / Unlocking the keypad

You can use this feature to avoid inadvertent key presses.


Note: The following features can be activated or deactivated in the pump
options:
 Automatic lock: The keypad will lock automatically at infusion start,
or after a time-out.
 Unlock code: The user must enter a code to unlock the keypad.
Locking the Keypad

You can lock the keypad as follows:


1. Press .

2. Press the arrow keys to select .


3. Press enter.

4. Lock the keypad as follows:


 Press to lock the keypad.
The keypad is locked and the screen displays .
 Press to activate the automatic lock.
The keypad will lock automatically at infusion start. If the keypad is
unlocked during the infusion, it will lock again automatically after a
time-out.
5. Press OK to confirm.

78
Unlocking the Keypad

You can unlock the keypad as follows:


1. Press .

2. Press the arrow keys to select .


3. Press enter.

Unlock code enabled Unlock code disabled

4. Unlock the keypad as follows:


 If a code is required, press the keys to enter the unlock code.
The keypad is unlocked.
 If no code is required, press , and press OK to confirm.
The keypad is unlocked and the screen displays .
Information
 The and keys remain functional when the keypad is locked.
 During keypad lock, the key is functional when the infusion is
stopped.
 During keypad lock, the key is functional when an alarm occurs,
or at the end of infusion.
 The keypad locked status is memorized when the pump is powered
off.
 In case of forgotten unlock code, contact your biomedical
department.

79
8.6 Battery Life
Symbol

Procedure Viewing the battery life

You can view the battery life as follows:


1. Press .
2. Press the arrow keys to select .
The time remaining under current flow rate conditions is displayed.
The bar graph shows a visual representation of battery life.
The symbol displayed shows the following:
 : The pump is plugged into the AC power supply.
 : The pump is operating on battery.

80
8.7 Volume Infused / Dose Infused
Symbol mL?
Procedure Viewing and clearing the volume or dose infused

Flow rate Dose

You can view and clear the volume or dose infused as follows:
1. Press .

2. Press the arrow keys to select mL? .


The total volume, or total dose, infused includes primary and
secondary infusions, loading doses and boluses. The length of time
over which they were infused is also displayed.
3. To clear the volume or dose infused, press enter.
4. Press OK to confirm.

Information
When the pump is powered off or a new drug is selected, the volume or
dose infused is cleared.

81
8.8 Pause
Symbol

Procedure Programming a pause

You can program a pause as follows:


1. Press to stop the infusion.
2. Press .

3. Press the arrow keys to select .


4. Press enter.
5. Press the arrow keys to program the pause duration in hours and
minutes, and press OK.
6. Press the button to activate the "Start infusion at pause end"
feature (optional).
7. Press OK to begin the programmed pause.
8. To restart the infusion before the end of the pause period, press ,
and start.

Information
If you do not activate the "Start infusion at pause end" option, an audible
alarm is generated at the end of the pause. The infusion must be started
manually to continue the infusion.

82
8.9 Drug
Symbol

Procedure Changing the drug selection

You can change the drug selection as follows:


1. Press to stop the infusion.
2. Press .

3. Press the arrow keys to select .


4. Press enter.
5. Press OK to confirm.

6. Press the arrow keys to select the new drug.


7. Press OK to confirm selection.
8. Press OK to validate new drug’s settings.
9. Press OK to acknowledge the drug modification and continue
programming infusion, or C to select another drug.
10.Program the infusion for the new drug.
Information
 Changing a drug resets the infusion settings.
 If the previous infusion was programmed by flow rate, the new drug’s
confirmation screen will display VI (Volume Infused).
 If the previous infusion was programmed by dose, the new drug’s
confirmation screen will display DI (Dose Infused).

83
8.10 Patient
Symbol

Procedure Changing a patient’s weight or body surface area

Information
 If the selected dose rate unit is weight-based (kg), the screen
displays the patient’s weight.
 If the selected dose rate unit is body surface area-based (m²), the
screen displays the patient’s body surface area.

Weight Body Surface Area

You can change the patient’s weight or body surface area as follows:
1. Press .

2. Press the arrow keys to select .


3. Press enter.
4. Press OK to change the patient’s weight or body surface area.
5. Press OK to confirm the infusion settings.

84
8.11 Day/Night Mode
Symbol

Procedure Switching between day mode and night mode

This function switches between day mode and night mode .


The default night mode settings are as follows:
 The key-press beep is silenced.
 Infusion indicators and screen brightness are dimmed.
Depending on your pump configuration, the switch between day and
night mode may be managed either through this menu (manual mode),
or according to pre-defined settings (auto mode). For more information,
refer to the technical manual.

Switching from Day Mode to Night Mode

You can switch to night mode as follows:


1. Press .
2. Press the arrow keys to select .
3. Press enter.

4. Press to activate night mode.


The screen displays .
5. Press OK to confirm.

85
Switching from Night Mode to Day Mode

You can switch to day mode as follows:


1. Press .
2. Press the arrow keys to select .
3. Press enter.

4. Press to activate day mode.


The screen displays .
5. Press OK to confirm.

86
8.12 Primary / Secondary
Symbol P/S
Procedure Programming a secondary infusion

To program a secondary infusion, see section 7.8.3, page 52.

8.13 Programmed Bolus


Symbol

Procedure Programming a bolus

To program a bolus, see section 7.8.4.2, page 59.

87
8.14 Flow Rate (mL/h) / Dose
mL/h
Symbols
Dose
Procedure Changing the infusion mode

Flow rate Dose

You can change the infusion mode as follows:


1. Press .

2. Press the arrow keys to select mL/h or Dose .


3. Press enter.
The available infusion modes are displayed.

Flow rate Dose

4. Press the arrow keys to select a new infusion mode.


5. Press OK to apply the selected infusion mode to the current infusion
settings, or New ? to apply the selected infusion mode and clear the
infusion settings.

88
8.15 Ramp-up / Ramp-down
Symbol

Procedure Modifying a ramp-up /ramp-down infusion

Ramp-up/ramp-down infusion mode must be selected, see Section 8.14,


Prerequisite
page 88.

To program an infusion in the ramp-up /ramp-down infusion mode, see


section 7.10.6, page 63.

8.16 Sequential Infusion


Symbol seq
Procedure Modifying a sequential infusion

Prerequisite Sequential infusion mode must be selected, see Section 8.14, page 88.

To program an infusion in the sequential infusion mode, see section


7.10.7, page 65.

89
8.17 Alarm Volume
Symbol

Procedure Adjusting the alarm volume

You can adjust the alarm volume as follows:


1. Press .

2. Press the arrow keys to select .


3. Press enter.
4. Press the arrow keys to select the alarm volume.
The pump emits an alarm at the selected volume level.
5. Press OK.

90
8.18 Call-back Alert
Symbol

Procedure Activating / Deactivating the call-back alert

The call-back alert notifies the user when the set time interval has
elapsed.

Activating the Call-back Alert

You can activate the call-back alert as follows:


1. Press .

2. Press the arrow keys to select .


3. Press enter.

4. Press the arrow keys to set the interval in hours and minutes
(__h__) before the alert.
5. Press OK.

Information
 The activation time is calculated according to the device time, which
is indicated at the bottom of the screen.
 If the device is powered off during the call-back period, a warning
message is displayed when the device is powered on.

91
Deactivating the Call-back Alert

You can deactivate the call-back alert as follows:


1. Press .

2. Press the arrow keys to select .


3. Press enter.

4. To deactivate the programmed call-back alert, press the down arrow


keys to set the duration period to "Off".
5. Press OK.

92
8.19 View Flow Rate History
Symbol

Procedure Viewing flow rate history

This function allows the user to check the current infusion’s history
information in order to verify the dose administered.

You can view flow rate history as follows:


1. Press .

2. Press the arrow keys to select .


3. Press enter.
The following information is displayed:
- An event marker (cursor)
- The event details (time and flow rate)
- The measured flow rate (solid line)

4. Press the and buttons to browse the events.


5. Press to view information about the selected event.

Information
 The history is not refreshed while the history screen is displayed. To
refresh the history data, exit and select the history again.
 Flow rate history is not stored after powering off.

93
8.20 View Pressure History
Symbol

Procedure Viewing pressure history

This function allows the user to check the current infusion’s history
information in order to verify changes in pressure.

You can view pressure history as follows:


1. Press .

2. Press the arrow keys to select .


3. Press enter.
The following information is displayed:
- An event marker (cursor)
- The event details (time and pressure limit)
- The pressure limit (dotted line)
- The measured pressure (solid line)

4. Press the and buttons to browse the events.


5. Press to view information about the selected event.

Information
 The history is not refreshed while the history screen is displayed. To
refresh the history data, exit and select the history again.
 Pressure history is not stored after powering off.

94
8.21 View Event Log
Symbol

Procedure Viewing the event log

The event log displays details of the last events that occurred on the
pump. Events are stored in the log even after the pump is powered off
and on again. The log can store up to 1500 events. Older events are
overwritten.
Note: When the AC Power is disconnected for a period of time, or when
the batteries are not operating, the log file is kept in a non-volatile
memory for approximately 10 years.

You can view the event log as follows:


1. Press .

2. Press the arrow keys to select .


3. Press enter.

4. Press the arrow keys to select the desired event.


5. Press enter.
The details of the event are displayed.

6. Press exit to return to the previous screen.

95
8.22 Date / Time
Symbol

Procedure Setting up the date and time

You can set the date and time as follows:


1. Press .

2. Press the arrow keys to select .


3. Press enter.
4. Press the arrow keys to set the following:
 Day
 Month
 Year
 Hours
 Minutes
5. Press OK to confirm.

96
8.23 Maintenance
Symbol

Procedure Displaying maintenance information

You can display maintenance information as follows:


1. Press .

2. Press the arrow keys to select .


3. Press enter.
4. Press the arrow keys to scroll through the maintenance information.
The following information is displayed:
 Pump serial number
 Next maintenance date (dd/mm/yyyy)
 Pump model
 Software version
 Total operating time since last maintenance

97
8.24 Library Information
Symbol

Procedure Displaying drug library information

You can display drug library information as follows:


1. Press .

2. Press the arrow keys to select .


The number of drugs contained in the drug library is displayed.
3. Press enter.
All the drugs contained in the drug library are displayed.

4. Press the arrow keys to select a drug.


5. Press to view information on the selected drug.

98
8.25 Clinical Information
Symbol

Procedure Viewing remaining time before clinical information display

If configured for the selected drug with Agilia Vigilant Drug’Lib, a


protocol message will be displayed on the pump screen after a pre-
defined period of time.

You can view the remaining time before clinical information display as
follows:
1. Press .

2. Press the arrow keys to select .


The remaining time before clinical information is displayed.
3. Press enter.
The clinical information message is displayed.

99
8.26 Data Set
Symbol DS
Procedure Displaying active data set information

You can display active data set information as follows:


1. Press .

2. Press the arrow keys to select DS .


3. Press enter.
The active data set information is displayed.

100
9 Options

9.1 Commands
Operation Key

Options access +

Option selection

Confirm (corresponds to enter on the screen)

Select  / Deselect 

Selected current values are stored when the device is powered off after programming.
To return to the normal menus, power off then power on again.

9.2 Option Descriptions


Four different option groups are available on the pump. This IFU only
describes the "Pump Settings" options.

Option Access Code? Description

Pump Settings No Section 9.3, page 102.

Basic Profile Configuration Yes Technical Manual

Profile Yes Technical Manual

Maintenance Yes Technical Manual

Information
If the wrong access code is entered, error is displayed.

101
9.3 Pump Settings
The following options have different functions that you can select or
deselect to customize your Agilia VP MC.

Default
Function Choice
Pump Setting
 Selection assistance: display or hide selection
[User 1]:
assistance banner at the bottom of the screen Enabled
Screen option
to help the user program an infusion
 Maintenance: display or hide maintenance
[User 2]: Disabled
menu
Menu items
 Date / Time: display or hide date/time menu Disabled
[User 3]:  Adjustment of screen contrast using the fast
Medium level
Contrast increment and decrement keys

[User 7]:  Date selection: dd/mm/yyyy Production plant date


Date/Time  Time selection: __ h __ and time

[User 8]: Official language of the


Language
 A scrolling list with all available languages
target country
[User 14]:
 Enable/Disable the Wi-Fi module Enabled
Wi-Fi module
[Par 13]:  Enable/Disable "AC power disconnection"
AC power message and "Device operating on battery" Enabled
disconnection message at power on
[Par 28]:
 Enable/Disable automatic device powering on
Auto power on at door Enabled
at door opening
opening
[Par 33]:  Enable/Disable "volumic flow rate (mL/h)" and
Enabled
Drops/min "Drops/min flow rate"
Remove trailing 0 /
[Par 35]:  Enable/Disable display of the decimal "0" after
Remove trailing 0
Dose display format a dose value
during programming
[Par 37]:  Enable/Disable preventive silence for alarm
Enabled
Alarm system system
[Par 38]:  Set or disable keypad unlock code (4-digit).
1234
Keypad unlock code Disable value: 0000

102
10 Data Communication

10.1 Overview
Cable Communication Wi-Fi Communication
Connection of 1 pump to a PC for the following Communication between a hospital information
purposes: system server and a number of identified pumps
 Data set upload (via Agilia Vigilant Drug’Lib for the following purposes:
software)  Data set upload
 Maintenance (via Agilia Partner software)  Pump history retrieval
Information
 Ensure that all hospital information systems have been approved by
Fresenius Kabi. For more information, contact your technical
services representative.
 Before connecting the pump to a hospital information system, ask
your IT or biomedical department to configure the device.

10.2 Communication via Agilia Cables


10.2.1 Data Communication Cables
Information
 Only use recommended Agilia cables.
 All connections and disconnections must be performed by qualified
and appropriately trained staff.
 All IT devices (including computers, hubs and switches) inside the
patient area (< 1.5 m) must comply with IEC/EN 60601-1 (leakage
current).
 IT devices connected outside the patient area (> 1.5 m) must be at
least IEC/EN 60950 compliant.

10.2.2 Using the Communication Port


1. Remove the protective cap from the
pump’s RS232 communication port.

2. Connect the cable to the RS232


communication port by turning the
cable wheel.

Information
Do not disconnect communication cables while data is being transferred.

103
10.3 Communication via Wi-Fi
The Wi-Fi option allows the pump to connect to a hospital information
system without cables.
To know if your pump is equipped with a Wi-Fi module, check for the
presence of the Wi-Fi logo on the pump’s keypad.
See section 3.4.1, page 18.

Wi-Fi pump Non Wi-Fi pump


To activate or deactivate the Wi-Fi module, see section 9.3, page 102.
For more information on the Wi-Fi module, refer to the technical manual.
Information
Wi-Fi pumps can be configured with Wi-Fi module enabled or disabled.

10.4 Data Set Upload


A new data set may be uploaded to the pump while it is infusing. The
new data set will be installed at the next pump start-up.
When a new data set has been uploaded since the last start-up of the
pump, the symbol is displayed on the screen.
1. Power on the pump.

2. Press OK to acknowledge.
The data set information is displayed.

3. Press OK to acknowledge this information, or C to return to the


previous screen.
The data set is installed in the pump.
Information
It is the hospital's responsibility to define a data set and upload it to the
Centerium Server for distribution to the device.
104
11 User Test

The following protocol provides the user with a quick integrity check
guide to ensure that the pump system is functional. Perform this user
test before each use of the pump.

1. Check the external appearance of the pump for the absence of


cracks or other visible damage.
2. Check for the absence of visible damage on the power cord inlet
and the power cord.
3. When used on a pole or a rail, check that the pump is securely
attached.
4. Connect the pump to the AC power supply, and check that the
power indicator lights up and a beep is emitted.
5. Power on the pump, and wait for the auto-test to complete. Check
the display and light indicators.
6. Press any key and listen for a key beep (if key beep is activated).

105
12 Alarms and Safety Features

12.1 Introduction
Agilia VP MC has a continuous monitoring system that begins when the
pump is started.
When an alarm is triggered, a message is displayed on the pump
screen. We recommend that the user stand in front of the pump to read
the message before acknowledgment.

Warning
Audible alarm signals from medical devices may be masked by
environmental noise. Make sure to set the alarm volume high enough so
that you can hear the alarm signal above environmental noise.

12.2 Alarm Descriptions


There are several different levels of alarm priorities:
 High-priority alarms
 Medium-priority alarms
 Low-priority alarms
 Information signals

Required
Alarm Priority Operator Description
Response
 The infusion stops.
 The infusion indicator lights flash red.
 The pump emits audible alarm signals.
Immediate
High (!!!)  An alarm description is displayed on the pump screen.
response
 The key silences the alarm for no time limit or for a
defined duration. For detailed description of each alarm,
please refer to List of Alarms, page 107.
Prompt  The infusion continues.
Medium (!!)
response  The infusion indicator lights flash yellow.
 The pump emits audible alarm signals.
 Depending on the alarm, the key silences the
Low (!) Awareness alarm for no time limit or for a defined duration. For
detailed description of each alarm, please refer to List of
Alarms, page 107.
 The infusion continues.
Information Signals Awareness  An information message is displayed on the pump
screen.

106
12.3 General Remarks
 Alarms are not configurable.
 When two alarms occur at the same time, the higher priority alarm is
displayed.
 When two alarms with the same priority level are triggered at the
same time, the pump software assigns them a priority.
 When the cause of a high-priority alarm has been fixed, the red
indicators switch off. However, the message remains displayed at
the top of the screen as a reminder of the cause of the alarm.
 The device guarantees the triggering of high-level priority alarms in
every use condition.
 A maximum of 1 mL may be infused due to a single fault condition.
 For all alarms (except occlusion alarms), the amount of time
between the alarm condition and the alarm generation is less than
5 seconds.
 If the AC power is disconnected and if the battery is discharged, the
alarms settings are not modified and are stored indefinitely.

12.4 List of Alarms


12.4.1 Installed Set Alarms
Stops
Message Priority Problem / Resolution
Infusion?
At start-up, the administration set is not loaded
or the door is open.
 Install the administration set and close the
Install set !!! High (!!!) Yes door.

Note: the key silences the alarm for 2


minutes.
There is no administration set in front of the
upstream or downstream sensor.
Check set
High (!!!) Yes  Check the administration set installation.
installation !!!
Note: the key silences the alarm for 2
minutes.
The door is open (during the infusion, or while
the infusion is stopped).
 Check the administration set installation
Door opened !!! High (!!!) Yes and close the door.

Note: the key silences the alarm for 2


minutes.

107
Stops
Message Priority Problem / Resolution
Infusion?
The administration set is incorrectly positioned
in front of the air sensor.

Set / air
 Check the administration set installation in
installation !!!
High (!!!) Yes front of the air sensor and close the door.

Note: the key silences the alarm for 2


minutes.
An air bubble has been detected (at start-up,
during the infusion, or while the infusion is
stopped).
Air bubble !!! High (!!!) Yes  Remove the air from the administration set.

Note: the key silences the alarm for 2


minutes.
An air bubble has been detected during the
infusion).

Air alarm !!! High (!!!) Yes  Remove the air from the administration set.

Note: the key silences the alarm for no


time limit.

12.4.2 OCS Alarms


Stops
Message Priority Problem / Resolution
Infusion?
The OCS control system has detected a
failure.
 Close the roller clamp, check the
administration set installation, check the
door integrity, check the administration set
OCS failure !!! High (!!!) Yes integrity.
 If the problem cannot be resolved, contact
your Fresenius Kabi sales representative.

Note: the key silences the alarm for 2


minutes.
Under specific conditions, the pump asks you
Open and close door Information to open and close the door to perform the
for OCS test
No OCS test.
Signal
 Open and close the door.

108
12.4.3 Infusion Alarms
Stops
Message Priority Problem / Resolution
Infusion?
The VTBI is completed.
 Press to select new infusion settings
End of infusion !!! High (!!!) Yes (if required).

Note: the key acknowledges the alarm.


The secondary infusion is completed (only
with manual return to primary).
End secondary
alarm !!!
High (!!!) Yes  Restart the primary infusion.

Note: the key acknowledges the alarm.


One of the near end of infusion alert criteria is
reached (time before the end of infusion, % of
VTBI remaining, remaining VTBI)
 Check whether the remaining volume in the
container corresponds to the remaining
Near end of
infusion !!
Medium (!!) No VTBI.
 If needed, prepare a container for a new
infusion sequence.

Note: the key silences the alarm for no


time limit.
The flow rate (or dose) has been modified
using the keys but has not been confirmed.
 Check the flow rate (or dose) and press OK
Check settings !! Medium (!!) No to confirm.

Note: the key silences the alarm for 2


minutes.
A value must be entered.
 Enter a value and press OK to confirm.
Waiting settings !! Medium (!!) No
Note: the key silences the alarm for 2
minutes.
The infusion settings have been entered but
have not been confirmed with start.
 Check the infusion settings, and
Waiting start !! Medium (!!) No press start to start the infusion.

Note: the key silences the alarm for 2


minutes.

109
Stops
Message Priority Problem / Resolution
Infusion?
End of infusion ! End of infusion - with KVO
The VTBI is completed and the KVO is
activated according to its configuration in
Agilia Vigilant Drug’Lib software or in the
pump options.
Stop for new Low (!) No
infusion !  Press to select new infusion settings
(if required).

Note: the key silences the alarm for a


time duration from 1 minute to 12 hours.
Re-open primary
line ! End of secondary infusion.
Low (!) No
Close secondary  Press to acknowledge.
line !
Information The upper soft limit is exceeded according to
Upper soft max No
signal the drug settings defined in the drug library.
Information The lower soft limit is exceeded according to
Lower soft min No
signal the drug settings defined in the drug library.
Information
Reached hard limit No The upper or lower hard limit is reached.
signal

12.4.4 Pressure Alarms


Stops
Message Priority Problem / Resolution
Infusion?
The pressure in the infusion line has reached
the threshold level.
 Check whether the infusion line is
occluded.
Downstream  If necessary, readjust the pressure
occlusion !!!
High (!!!) Yes
threshold in relation to the flow rate.

Note: the key silences the alarm for 2


minutes if the pressure condition is still
present. Otherwise, alarm is acknowledged.
The pressure in the upstream line is too low.
 Check the roller clamp.
 Check the container and line.
Upstream
 Check the container height.
High (!!!) Yes
occlusion !!!  Check air vent (if a bottle is used).
 Check for kinked line.
Note: the key silences the alarm for 2
minutes.

110
Stops
Message Priority Problem / Resolution
Infusion?
A downstream occlusion has been detected by
the device.
 Check the line.
Wait during pressure
measurement High (!!!) Yes  If the occlusion is released before the end
checking !!! of temporization, the infusion will restart
automatically.
 Otherwise, a downstream occlusion alarm
is triggered.
In-line pressure has reached 50 mmHg / 5 kPa
/ 1 PSI below the programmed threshold.
 Check the infusion line.
Occlusion
pre alarm !!
Medium (!!) No  Set the correct pressure threshold.

Note: the key silences the alarm for no


time limit.
The pressure is increasing in the infusion line.
This warning can be selected as an option.
Pressure increase ! Low (!) No  Check for occlusions in the infusion line.

Note: the key acknowledges the alarm.


The pressure is decreasing in the infusion line.
This warning can be selected as an option.
 Check the downstream Luer lock
Drop in pressure ! Low (!) No connection and the integrity of the entire
line.

Note: the key acknowledges the alarm.

12.4.5 Battery Alarms


Stops
Message Priority Problem / Resolution
Infusion?
The battery is discharged.
 The pump will power OFF automatically
within 5 minutes.
Battery alarm !!! High (!!!) Yes  Connect the pump to a power supply
immediately.

Note: the key silences the alarm for 2


minutes.
Very low battery.
 Connect the pump to a power supply and
Very low battery !!! High (!!!) Yes allow time to charge.

Note: the key silences the alarm for 2


minutes.

111
Stops
Message Priority Problem / Resolution
Infusion?
Low battery.
 Connect the pump to a power supply.
Battery pre alarm !! Medium (!!) No
Note: the key silences the alarm for 2
minutes.
If the pump is not used during an extended
Low (!) No period, connect to a power supply and wait
until the battery is charged.

12.4.6 Power Alarms


Stops
Message Priority Problem / Resolution
Infusion?
The power supply is inconsistent.

AC power failure ! Low (!) No  Contact your technical support.

Note: the key acknowledges the alarm.


The pump is disconnected from the AC power.
A single beep is emitted.
 Press to acknowledge.
Information
Power disconnection No  Check that the battery life is sufficient for
signal
the expected infusion duration.
 If the disconnection was unintentional,
check the power connection.

12.4.7 Keypad Alarms


Stops
Message Priority Problem / Resolution
Infusion?
Information The keypad is locked.
Keypad lock status No
signal  Unlock the keypad.
Keypad locked The keypad is locked and the door was
Information opened and closed.
Unlock keypad to No
continue
signal
 Unlock the keypad.

112
12.4.8 Drop sensor
Stops
Message Priority Problem / Resolution
Infusion?
This message displays only if the drop sensor
is mandatory.

At start-up, the drop sensor is not connected


Connect drop to the pump.
sensor !!!
High (!!!) Yes
 Connect the drop sensor to the pump and
the drip chamber.

Note: the key silences the alarm for 2


minutes.
During the infusion or when the infusion is
stopped, the drop sensor is connected to the
pump.
No drop sensor !!! High (!!!) Yes  Disconnect the drop sensor from the pump.

Note: the key silences the alarm for 2


minutes.
The flow rate detected by the drop sensor is
inferior to the programmed flow rate.
 Check the container.
 Check the roller clamp.
 Check that the fluid drip forms
Underflow !!! High (!!!) Yes ~20 drops/mL.
 Check that the drip chamber is in a vertical
position.
 Check that the drop sensor is installed as
recommended.

Note: the key acknowledges the alarm.


The flow rate detected by the drop sensor is
superior to the programmed flow rate.
 Open the pump door and check the
administration set positioning.
 Check the fluid temperature.
Overflow !!! High (!!!) Yes  Check that the fluid drip forms ~20 drops/
mL.
 Check that the drop sensor is installed as
recommended.

Note: the key acknowledges the alarm.

113
Stops
Message Priority Problem / Resolution
Infusion?
At start-up or when the infusion is stopped, a
free flow is detected by the drop sensor.
 Close roller clamp.
Uncontrolled  Check the drop sensor and the
flow !!!
High (!!!) Yes
administration set installation.

Note: the key acknowledges the alarm. If


free flow continues, alarm will raise again.
During the infusion or when the infusion is
stopped, the drop sensor is connected to the
pump.
No drop sensor ! Low (!) No  Disconnect the drop sensor from the pump.

Note: the key silences the alarm for no


time limit.

12.4.9 Technical Error Alarms


Stops
Message Priority Problem / Resolution
Infusion?
Technical alarm.
 Contact your qualified technician or your
Erxx(yyyy) !!! High (!!!) Yes Fresenius Kabi sales representative.

Note: the key silences the alarm for 30


seconds.
Temperature increase.

High internal
 Check device environment.
temperature !
Low (!) No
Note: the key silences the alarm for 2
minutes.
The pump is mounted on a Link+ Agilia rack
that has not been upgraded.
Alarm reporting not
available on the Low (!) No  Contact your qualified technician or your
Link ! Fresenius Kabi sales representative.

Note: the key acknowledges the alarm.

In the case of a system malfunction, the alarm sounds and an error


message Erxx(yyyy) !!! is displayed.
1. Record the error message Erxx(yyyy) !!!.
2. Close the roller clamp.
3. Disconnect the pump from the power supply.
4. Switch the device off by pressing the key.

114
Warning
If the alarms persist when the pump is powered on again, do not use the
device on a patient, and contact qualified biomedical engineering staff in
your healthcare facility or your Fresenius Kabi sales representative.

12.5 Audio Only Information Signals


Stops
Type Comment Activation
Infusion?
Beep until key is
Switch mode No Beep starts when action is not allowed
released
Depends on
Return to primary mode No At the end of secondary mode
configuration
Pressure measurement When auto-restart is activated and a
4 beeps Yes
checking downstream occlusion is detected
At the end of secondary when automatic
End of secondary 3 beeps No
mode is activated
End of loading dose 3 beeps No At the end of the loading dose
End of programmed
3 beeps No At the end of programmed bolus
bolus
At the end of each sequence (sequential
End of sequence 3 beeps No
mode)
Start infusion at the end At the end of a pause, when the infusion
3 beeps N/A
of pause automatically starts
AC power connection 1 beep No When power is connected
Forbidden key 1 beep No Repeated until key is released
Key beep 1 beep No For each key pressed
Other non validation
1 beep No For each key pressed
beep
Call-back 1 beep No At the end of call-back
Direct bolus 1 beep No Repeated for each mL infused
Air advance 1 beep N/A Repeated every 5 seconds
Administration set
1 beep N/A Repeated every 5 seconds
prime
End of pause 4 beeps N/A At the end of pause - repeated

115
13 Volumat Lines

13.1 Preparing the Administration Set and the Fluid Container


Agilia Volumat Lines are supplied sterile and are indicated for single use.
1. Prepare the fluid container according to your
healthcare facility’s protocol.
2. Select a Volumat Line.
3. Check the container, the line and access
device integrity.
Refer to the Instructions for Use of the
Volumat Lines for more information on the
following elements: name, description, expiration date, intended use,
contraindications, compatibility between the administration set and the
administered fluid (for example, photosensitive fluids, degassing fluids,
etc.)
To use the SafeClip with gravity infusions, see section 13.3.2, page 120.
Warning
 Only use recommended Agilia Volumat Lines. Use of any other
administration sets may affect the accuracy of the infusion, and result
in injury to the patient and damage to the pump.
 Do not use an administration set if its packaging appears to be
damaged or opened.
Information
 The fluid in the administration set, the administration set and the bag
or bottle must be within normal operating temperature conditions:
18 °C to 30 °C.
 Do not use in conjunction with positive pressure infusion devices that
could generate back pressure higher than 2000 hPa (1500 mmHg):
doing so will damage the administration set and the pump.
 Some administration sets may have components such as a burette
or filter that require special instructions.
 For administration sets with two spikes, only open one line at a time.
 When administering a manual bolus using Luer lock syringe via the
needle-free downstream port, it is recommended to stop the infusion
and close the Roberts clamp (pinch clamp).
 Certain drugs may require specific administration sets for infusion or
transfusion.
 When using an administration set with a filter, verify that the fluid to
be infused is compatible with the size of the filter.
 Follow your healthcare facility’s protocol for installing and replacing
the fluid container.

116
Precautions for the use of administration sets
 Use administration sets which have the smallest internal volume or
“deadspace” to minimize residual volumes when administering
medications or fluids at low infusion rates (e.g., less than 5mL per
hour, and especially flow rates less than 0.5 mL per hour). This
reduces the amount of time it takes for fluid to reach the patient,
maintains delivery accuracy, and reduces occlusion detection times.
For example:
- Administration set internal diameter: Small bore or microbore
tubing is recommended when infusing at low rates
- Administration set length: Administration set length should be
minimized, when possible
- Filters: Internal volume (deadspace) of in-line filters should be
minimized
- Connection sites: The number of connection sites such as
stopcocks and Y-sites should be limited, and high risk or life
sustaining solutions should be connected as close to the
intravenous access site as possible.
 Avoid use of manifolds with ports containing high pressure valves.
High pressure valves require additional pressure (e.g., 50-200
mmHg) to open and allow fluid flow. These high pressure valves may
cause a significant delay in therapy followed by a sudden bolus once
the valve is opened, particularly at low infusion rates (e.g., less than
5 mL per hour, and especially flow rates less than 0.5 mL per hour).

13.2 Priming the Administration Set Before Use


The administration set is primed with fluid to displace air from the set.
It is recommended to prime the administration set immediately before
starting the infusion.
Certain administration sets may require specific priming procedures.
Refer to the specific IFU provided with the administration sets.

Warning
During priming, make sure that the administration set is not connected
to the patient.

117
13.2.1 With a Bag
The following diagram shows how to prime the administration set with a
bag:

1. Remove the cap from the spike and insert the spike into the bag.
2. After hanging the bag, close the roller clamp.
3. Fill the drip chamber approximately 1/2 full.
4. Slowly open the roller clamp for priming.
Invert the needle-free port while priming, and gently tap the valve to
remove all air.
5. When the administration set is fully primed, close the roller clamp
and check carefully for the absence of air bubbles.
For gravity infusions, the flow rate is regulated by the roller clamp.

13.2.2 With a Bottle


The following diagram shows how to prime the administration set with a
bottle:

5
1 3
2
4

1. Open the roller clamp, close the air vent, and push the spike down
into the bottle.
2. Close the roller clamp.
3. Hang the bottle upside down, then squeeze and release the drip
chamber in order to fill it approximately 1/2 full.
4. Slowly open the roller clamp for priming.
5. Open the air vent, and allow the liquid to flow into the
administration set.
Invert the needle-free port while priming, and gently tap the valve to
remove all air.
6. When the administration set is fully primed, close the roller clamp
and check carefully for the absence of air bubbles.
For gravity infusions, the flow rate is regulated by the roller clamp.

118
13.3 Other Uses of Administration Sets
13.3.1 Access Ports
The administration set may be equipped with access ports, that can be
used to connect a gravity line, a secondary line, or administer a manual
bolus (needle-free port).
Legend
Upstream port (before
1
the pump)
Downstream port (after
2
the pump)
2

Figure 13.1: Needle-Free Ports

Information
 Use aseptic technique when accessing the ports.
 Stop the infusion before accessing the ports.
 Do not use the upstream access ports to deliver a manual bolus into
the line. They should only be used to connect a secondary infusion
line.
 Do not use the downstream ports to connect a secondary line.
 For multi-line infusions, connect administration sets as close as
possible to the patient.

119
13.3.2 Use of Administration Sets for Gravity Infusion
13.3.2.1 Gravity Infusion (without pump)
In order to use the administration set to infuse the contents of the fluid
container via gravity, without the pump, release the SafeClip as follows:
1. Close the roller clamp.
2. Slide the blue part of the SafeClip to the open position.
3. Adjust the roller clamp on the administration set to regulate gravity
flow.
Closed position after removing Open position
from the pump (stops flow) (allows flow from gravity)

Figure 13.2: Operation of the SafeClip (blue anti-free flow clamp)


13.3.2.2 Gravity Infusion in Parallel with a Pump

Figure 13.3: Gravity Infusion (in parallel with a pump)

120
Information
 Fresenius Kabi recommends the use of a back check valve or
positive pressure infusion devices when an infusion on the pump is
connected to a gravity line. This will prevent the back-up of IV fluid or
medication into the gravity line.
 If there is no back check valve on a gravity infusion line during a
multi-line infusion, it may be impossible to detect patient-side
occlusions. Such an occlusion could cause the pumped drug to back
up into the gravity line, and later be infused in an uncontrolled
manner when the occlusion is released.
 When connecting a pump-based infusion to a gravity line, connect
the pump administration set as close as possible to the patient, to
minimize dead space and the impact of the gravity line flow rate
changes.

13.4 Removal and Replacement of Administration Sets


13.4.1 Removing an Administration Set
1. Press to stop the infusion.
2. Close the roller clamp.
3. Open the pump door.
4. Press to silence the audible signal for 2 minutes.
5. Remove the administration set from the pump.
6. Disconnect the administration set from the access device in
accordance with healthcare facility protocol.

13.4.2 Changing an Administration Set


1. Remove the administration set.
See section 13.4.1, page 121.
2. Install another administration set, and follow the steps described in
the flowchart.
See section 6.1, page 32.

Information
Properly dispose of used administration sets as per the healthcare
facility’s guidelines.

13.4.3 Administration Set Replacement Interval


The mechanical properties of the administration set in association with
the pump are designed to maintain pumping performance for a
maximum of 10 liters or a 96-hour period.
Replace the administration set according to your healthcare facility’s
protocol or CDC guidelines.

121
14 Device Storage

14.1 Precautions for Storage


 Handle the device with care during storage.
 Store the device in a cool, dry place. The storage area must be
clean and organized.
 Clean and disinfect the device prior to storage.
Warning
If the device is not used for an extended period (longer than 2 months),
it is recommended that the battery be removed from the device and put
in storage by authorized personnel. If the battery cannot be removed, or
the device will be used in less than 2 months, charge the battery at least
once a month by connecting the device to the AC power supply for at
least 6 hours.

14.2 Storage and Transport Conditions


Observe the following conditions for storage and transport:
 Temperature: -10 °C to +60 °C
 Pressure: 500 hPa (375 mmHg / 7.25 PSI) to 1060 hPa (795 mmHg
/ 15.37 PSI)
 Relative humidity: 10 % to 90 % without condensation
 Altitude: Up to 3000 m

14.3 Preparing the Device for Storage


Prepare the device for storage as follows:
1. Power the pump OFF and remove the disposable.
2. If necessary (long-term storage), disconnect the pump’s power cord
and all data communication cables.
3. Remove the pump from its mounting point.
4. Clean the pump.
5. Handle the pump with care, and store it in a compliant area.
For detailed instructions, refer to the related chapters in this document.

122
14.4 Using the Device After Storage
The device can be used immediately after storage without any cooling
or warm up period.
If the battery has been removed for long-term storage, contact your
biomedical department in order to reinstall the battery prior to use.
We recommend charging the battery for at least 6 hours.
We recommend that the "User test" is performed when the device is
installed after storage, and before being used on a patient, see section
11, page 105.

123
15 Specifications

Information
The range of settings and default values described in this section
correspond to the factory configuration. Range of settings and default
values may be adjusted in the pump options (Basic Profile) or in Agilia
Vigilant Drug’Lib software (custom profiles). Increment rules may be
modified by Agilia Vigilant Drug’Lib software (custom profiles).

15.1 Essential Features


The pump’s essential features are defined in standard operating
conditions:

Feature Refer to
Section 15.10.1, page 128.
Flow Rate Accuracy
Section 18.10, page 113.
Time to Detect Occlusion Section 15.10.3, page 128.

Bolus Volume After Occlusion Release Section 15.10.4, page 129.

Management of High-priority Alarms Section 12, page 106.

15.2 Flow Rate


Default Minimum
Format Range of Settings
Value Increment
0.01 (0.10  9.99)
Primary Infusion mL/h 0.1  1500* N/A 0.1 (10.0  99.9)
1 (100  1500)
Direct Bolus mL/h 50  1500 1500 50
0.01 (0.10  9.99)
Programmed Bolus mL/h 0.1  1500 N/A 0.1 (10.0  99.9)
1 (100  1500)
0.01 (0.10  9.99)
Secondary Infusion mL/h 0.1  1500** N/A 0.1 (10.0  99.9)
1 (100  1500)
KVO mL/h 0  20 1 1
0.01 (0.10  9.99)
Loading Dose mL/h 0.1  1500 N/A 0.1 (10.0  99.9)
1 (100  1500)
0.1 (2.0  99.9)
Ramp (plateau) mL/h 2  1500 N/A 1 (100  1500)
0.1 (0.1  99.9)
Sequential mL/h 0.1  1500 N/A 1 (100  1500)
Priming mL/h 1500 N/A N/A
* The maximum value can be adjusted between 50 and 1500 in the pump options (Basic Profile).
** The maximum value can be adjusted between 50 and 1000 in the pump options (Basic Profile).
For more information, refer to the technical manual.

124
15.3 Volume To Be Infused (VTBI)
Default Minimum
Format Range of Settings
Value Increment
0.1 (0.1  99.9)
VTBI (Primary) mL 0.1  9999 N/A 1 (100  9999)
0.1 (0.1  99.9)
VTBI (Secondary) mL 0.1  9999* N/A 1 (100  9999)

Direct Bolus mL 0.1  50 N/A 0.1

0.1 (0.1  99.9)


Programmed Bolus mL 0.1  1000 0.1 1 (100  1000)
0.1 (0.1  99.9)
Ramp mL 0.1  9999 N/A 1 (100  9999)
0.1 (0.1  99.9)
Sequential mL 0.1  9999 N/A 1 (100  9999)
* Basic Profile: 2000 mL

15.4 Dose To Be Infused (DTBI)


Default Minimum
Format Range of Settings
Value Increment
0.001 (0.010  4.999)
0.01 (5.00  9.99)
Dose Unit 0.010  9999 N/A 0.1 (10.0  99.9)
1 (100  9999)
0.01 (0.01  9.99)
Programmed Bolus Unit 0.01  9999 N/A 0.1 (10.0  99.9)
1 (100  9999)
0.01 (0.01  9.99)
Loading Dose Unit 0.01  9999 N/A 0.1 (10.0  99.9)
1 (100  9999)

15.5 Infusion Time


Default Minimum
Format Range of Settings
Value Increment

Primary/Secondary __ h __ 00h01  168h00* N/A 00h01

00h00min01
__ h __
Programmed Bolus  00h02min00 00h00min01
min __
24h00min00
00h00min01
__ h __
Loading Dose  00h02min00 00h00min01
min __
24h00min00
KVO Silence Alarm
__ h __ 00h01  12h00 01h00 00h01
Duration

Pause __ h __ 00h01  24h00 00h01 00h01

125
Default Minimum
Format Range of Settings
Value Increment

Ramp (Total
__ h __ 00h01  48h00** 12h00 00h01
Duration)

Ramp (Ramp-up /
__ h __ 00h00  06h00 00h01 00h01
Ramp-down)
* If the calculated infusion time exceeds this value, ↑ 168h00 will be displayed on the pump.
** If the calculated infusion time exceeds this value, ↑ 48h00 will be displayed on the pump.

15.6 Concentration
Default Minimum
Format Range of Settings
Value Increment
0.01 (0.01  9.99)
Concentration Unit 0.01  70000 0.01 0.1 (10.0  99.9)
1 (100  70000)

Volume of Diluent mL 1  2000 1 1

15.7 Patient Data


Default Minimum
Format Range of Settings
Value Increment
0.01 (0.25  9.99)
Patient Weight kg 0.25  350 70 0.1 (10.0  19.9)
1 (20  350)

Patient Body
m² 0.05  4.5 2 0.01
Surface Area

15.8 Air Detection


Default Minimum
Format Range of Settings
Value Increment

Total Air Volume


microL 10  2000 250 10
Over 15 minutes

Air Bubble Filter microL 0  250 50 10

126
15.9 Pressure Management
Information
 You can change the Basic Profile’s infusion pressure settings in the
pump options. See section 9, page 101.
 You can pre-configure custom profiles’ infusion pressure settings
with Agilia Vigilant Drug’Lib software.

Setting Description Setting Format Default Value

Mode Infusion pressure mode. 3 levels / Variable Variable


Allows DPS option activation
DPS Yes / No Yes
on the pump pressure menu.
Unit Pressure unit selection. mmHg / kPa / PSI mmHg
The last pressure limit
adjustment is automatically
Limit Stored Enabled / Disabled Disabled
stored in memory for the next
startup.
The last DPS adjustment is
DPS Stored automatically stored in Enabled / Disabled Disabled
memory for the next startup.

Default Minimum
Format Range of Settings
Value Increment

Low mmHg 50  300 100 50


3 Levels

Medium mmHg 150  600 250 50

High mmHg 250  750 500 50

25 (50  250)
Full Range mmHg 50  750 500
Variable

50 (250  750)

Maximum
mmHg 300  750 750 50
Limit

Raise
mmHg 50  400 300 50
Threshold
DPS

Drop
mmHg 100  400 200 50
Threshold
Note: 1 bar = 750 mmHg = 100 kPa = 14.5 PSI.

127
15.10Accuracy
Warning
Accuracy (flow rate, time, volume infused, pressure) can be influenced
by administration set model, administration set configuration, fluid
viscosity, and fluid temperature.

Note: All tests below are in accordance with the IEC 60601-2-24
standard and ANSI/AAMI ID26.

15.10.1Flow Rate Accuracy


Accuracy

Cumulative Flow Rate


± 5 % for 96 hours with an infusion of 10 liters maximum
(Primary/Secondary)*
* Test condition: Back pressure: 0 mmHg, Container height: 50 cm

15.10.2Effects of Pressure Variations on Accuracy


Accuracy
Accuracy
Effects of Pressure Back pressure
(from mean values)
Variations on Flow Rate + 39.9 kPa ~-3%
Accuracy* + 13.33 kPa ~ - 1.5 %
- 13.33 kPa ~ + 1.5 %
Effects of Negative Solution Accuracy
Container Height
(from mean values)
Container Heights on Flow
-0.5 m - 10 %
Rate Accuracy** + 0.2  0.8 m ±3%
* Test condition: Container height: 50 cm
** Test condition: Back pressure: 0 mmHg

15.10.3Occlusion Alarm Accuracy


Accuracy

Occlusion Alarm Threshold

Occlusion Alarm Response Rate 50 mmHg 750 mmHg


Time*
0.1 mL/h < 3 hours < 24 hours
1 mL/h < 15 minutes < 2 hours
25 mL/h < 30 seconds < 4 minutes
* Test condition: Temperature: 20 °C, Administration set: VLST00, Administration set length: 270 cm
Note: The maximum values of the occlusion alarm response time specified above don't take into account the auto-
restart feature when it is activated. When auto-restart is triggered, a period of 30 seconds maximum is added
depending on the configurable period of pressure measurement. See Section 7.11.3, page 70. It is the healthcare
professional’s responsibility to define whether the auto-restart feature must be activated or not depending on the
clinical practices.

128
15.10.4Volume Accuracy
Accuracy
< 10 mL: ± 0.5 mL
Direct Bolus*
> 10 mL: ± 5 %
< 8 mL: ± 0.4 mL
Programmed Bolus*
> 8 mL: ± 5 %
Limit to Detect Upstream
≤ 1.0 mL
Occlusion*

Bolus Volume at Occlusion Release

Bolus Volume at Occlusion


Rate 50 mmHg 750 mmHg
Release*
25 mL/h -0.05 ≤ X ≤ 0.35 mL -0.05 ≤ X ≤ 0.35 mL

Limit to Detect Flow Rate


-70% ≤ X ≤ +250%
Deviation with Drop Sensor
* Test condition: Back pressure: 0 mmHg, Container height: 50 cm
Note:
 A back flow pumping is provided to reduce the bolus volume at occlusion release.
 During pump movement from 0 to 1 m above the patient, a bolus (-0.05 ≤ X ≤ 0.35 mL) may occur.

15.10.5Pressure Accuracy
Accuracy
< 500 mmHg: ± 75 mmHg
Pressure*
> 500 mmHg: ± 15 %
* Test condition: Back pressure: 0 mmHg, Container height: 50 cm

129
15.11Calculation Rules
Infusion Stopped During Infusion
Modify V,
 T is calculated according to T = V/R Modify R,
V/T
Modify T,  T is calculated according to T = V/R
 R is calculated according to R = V/T
Modify V,
 T is calculated according to T = V/R Modify R,
V/R
Modify R,  T is calculated according to T = V/R
 T is calculated according to T = V/R
Modify T,
 V is calculated according to V = R x T Modify R,
T/R
Modify R,  T is calculated according to T = V/R
 V is calculated according to V = R x T
Modify V,
 T is calculated according to T = V/R
Modify T, Modify R,
V/T/R
 R is calculated according to R = V/T  T is calculated according to T = V/R
Modify R,
 T is calculated according to T = V/R
V = Volume To Be Infused, T = Infusion Time, R = Rate

Calculated value Examples


 Calculated V = 1.8 mL
V Rounded up to the nearest mL
 Displayed V = 2 mL
 Calculated T = 1 hour 12 min 32 sec
T Rounded up to the nearest minute
 Displayed T = 01h13
 Calculated R = 42.57 mL/h
 Displayed R = 42.6 mL/h
R Rounded at  0.05 mL/h
 Calculated R = 42.32 mL/h
 Displayed R = 42.3 mL/h
Actual infusion rate = calculated rate

130
15.12Units and Conversion Rules
15.12.1Concentration Units
Units Suffix

nanog, microg, mg, g

mmol
Concentration
mUnit, Unit /mL, /--mL
Units
cal, kcal

mEq

15.12.2Dose Units
Units
nanog/h,
nanog/kg/min, nanog/kg/h
microg/min, microg/h,
microg/kg/min, microg/kg/h
mg/min, mg/h, mg/24h,
mg/kg/min, mg/kg/h, mg/kg/24h,
mg/m²/h, mg/m²/24h

g/h, g/kg/min, g/kg/h, g/kg/24h

Dose Units mmol/h, mmol/kg/h, mmol/kg/24h

mUnit/min, mUnit/kg/min, mUnit/kg/h

Unit/min, Unit/h, Unit/kg/min, Unit/kg/h

kcal/h, kcal/24h, kcal/kg/h

mEq/min, mEq/h, mEq/kg/min, mEq/kg/h

mL/kg/min, mL/kg/h, mL/kg/24h

131
15.12.3Conversion Rules
1 micro unit = 1000 nano unit

1 m unit = 1000 micro unit

1 k unit = 1000 unit

1 unit/h = 24 unit/24 h

1 unit/min = 60 unit/h

unit/kg/h (dose) × kg (weight) Conversion of a dose


mL/h = including the unit/kg into
unit/mL (concentration) volume flow rate (mL/h)

unit/m2/h (dose) × m2 (body surface area) Conversion of a dose


mL/h = including the unit/m2 into
unit/mL (concentration) volume flow rate (mL/h)
Conversion Rules

unit/h (dose) Expression of a


mL/h =
unit/mL (concentration) volumetric flow rate

unit/kg (dose) × kg (weight) Conversion of a dose


mL = including the unit/kg into
unit/mL (concentration) volume (mL)

unit/m2 (dose) × m2 (body surface area) Conversion of a dose


mL = including the unit/m2 into
unit/mL (concentration) volume (mL)

unit (dose) Expression of a volume


mL =
unit/mL (concentration) (mL)

132
16 Cleaning and Disinfecting

To avoid the risks of infection and microbial transmission, make sure to


adequately clean and disinfect the equipment.

Warning
 The disinfecting procedure must be done immediately after cleaning.
Disinfecting the pump without prior cleaning is not effective.
 The pump is not intended to be sterilized; sterilization may result in
damage to the pump.
 In case of contamination by blood or bodily fluids when the pump is
in use, and if allowed by your local practices and healthcare facility
policies, immediately perform the quick cleaning described below.
Always follow your local protection rules.

Quick Cleaning Only


Note:
 This quick cleaning does not replace the need for a complete
cleaning.
 In homecare environments, this quick cleaning protocol is suitable to
be applied by the nurse.
1. Check that the keypad is locked in order to avoid unintended
modification of the infusion parameters. Do not move the pump.
2. Use ready-to-use wipes to wipe down all exposed surfaces of the
pump.
3. At the end of the infusion, perform the complete cleaning protocol,
see section 16.3.1, page 135.

16.1 When to Clean and Disinfect the Pump


Thoroughly clean and disinfect the pump in the following cases:
 After each patient use
 Before any maintenance
 On a routine basis when the pump is not in use
 Before storage

133
16.2 Recommended and Prohibited Agents
We recommend the following cleaning and disinfecting agents:

16.2.1 Recommended Agents


Recommended Agent
Didecyldimethylammonium chloride
Cleaning
(example: Wip’Anios Excel by Anios)
Didecyldimethylammonium chloride
Disinfecting
(example: Wip’Anios Excel by Anios)

16.2.2 Prohibited Agents


The following cleaning and disinfecting agents are prohibited:
 Trichloroethylene
 Abrasive detergents
 Undiluted alcohol
These aggressive agents may damage the plastic parts of the pump and
cause it to malfunction.

16.3 Instructions for Cleaning and Disinfecting


Follow the instructions provided to ensure effective cleaning and
disinfecting of the equipment.
 Use the agents according to the manufacturer's instructions. This
may include wearing personal protective equipment (gloves, lab
coat, glasses, and so on), or diluting the agent according to the
manufacturer's guidelines.
 For disinfectants, respect the contact time required for the
antimicrobial agents to act (the time the agent must be left on the
pump for disinfection to be effective).

The following warning is provided to protect staff against electric shock,


and to protect the pump from damage that can cause it to malfunction.

Warning
 Only trained staff can clean and disinfect the pump.
 Do not place the pump in an autoclave or immerse it in liquid.
 Do not spray liquids directly on connectors. Instead, use a cleaning
cloth or disposable wipes.

134
16.3.1 Cleaning Instructions
Prerequisites
 The pump is powered off.
 The power cord and all other cables are unplugged.
 The air is at room temperature (20 to 25 °C).
 The operator is wearing suitable protective equipment.
Protocol
1. Place the pump on a clean surface or disposable underlay.
2. Use a ready-to-use wipe to remove any major grime.
3. Thoroughly wipe down all exposed surfaces (housing, keyboard,
pump door, door lever, etc.) of the pump, from top to bottom. You
can use the silver handle to lift and move the pump.
 When wiping down the sides, avoid wetting the connector sockets.
 Do not allow liquids to run, leak, or drip into the pump housing.
4. Make sure the pump remains damp for at least 1 minute.
5. Set down the pump, and wipe down the silver handle, the
attachment lock knob, the screw clamp and the release button.
6. Open the pump door, and gently wipe down the exposed surfaces
(tube guides, blue clamp).
7. Using a fresh ready-to-use wipe, thoroughly wipe down all exposed
surfaces, including the tube guides and the back of the door lever.
8. Make sure the pump remains damp for at least 1 minute to dissolve
all organic matter.
9. Use a swab to gently scrub the exposed surfaces of the pump. Be
sure to scrub along the seams and edges of the control panel, and
the narrow or hard-to-reach areas.
10.Wipe down the power cord and any pump accessories.
11.Allow the pump to dry completely at room temperature.

Warning
To avoid short circuits, make sure that the air sensor is completely dry
after cleaning.

135
16.3.2 Disinfecting Instructions
Prerequisites
 The cleaning protocol has been performed.
 The pump is powered off.
 The power cord and all other cables are unplugged.
 The air is at room temperature (20 to 25 °C).
 The operator is wearing suitable protective equipment.
Protocol
1. Place the previously cleaned pump on a clean surface or disposable
underlay.
2. Use a ready-to-use wipe to wipe down all exposed surfaces of the
pump, making sure to cover all cracks, crevices, and hard-to-reach
areas. You can use the silver handle to lift and move the pump.
 When wiping down the sides, avoid wetting the connector sockets.
 Do not allow liquids to run, leak, or drip into the pump housing.
3. Set down the pump, and wipe down the silver handle, the
attachment lock knob, the screw clamp and the release button.
4. Open the pump door, and gently wipe down the exposed surfaces
(tube guides, blue clamp).
5. Using a fresh ready-to-use wipe, repeat steps 2 to 4.
6. Leave the disinfecting agent on the pump for at least 3 minutes.
7. Wipe down the power cord and any pump accessories.
8. Allow the pump to dry completely at room temperature.

136
17 Power Management

17.1 AC Power Supply Precautions


Check that the AC power supply voltage corresponds to the value
indicated on the label on the bottom of the device. Do not exceed the
permitted voltage.
The power outlet must remain accessible at all times to allow emergency
power supply disconnection.

Warning
 The pump and its accessories can only be connected to the AC
power supply with the power cord supplied by Fresenius Kabi, or
with a power supply accessory from the Agilia product range.
 Do not use an extension cord when connecting the pump to the AC
power supply.
 Pumps must be plugged into a medical grade power strip if one is
used.

17.2 Battery Precautions


The device uses a Lithium-ion rechargeable battery.
The following actions may cause leakage, overheating, smoke,
explosion or fire; which could result in deterioration of performance,
failure, damage to the equipment or injury to the user:
 Incorrect handling of a Lithium-ion battery.
 Replacement of the battery by inadequately trained personnel.

137
Information
 Do not replace with a battery other than the one provided by
Fresenius Kabi.
 Do not use the pump without the battery connected.
 Do not disconnect the battery when the device is operating on AC or
battery power. Disconnect the power cord and power off the device
before disconnecting the battery.
 Do not incinerate or place near a flame.
 Do not drop, crush, puncture, modify or disassemble the battery.
 Do not use a battery that is severely scratched or damaged.
 Do not short the terminals.
 Do not expose to high temperatures or very low temperatures: refer
to the operating conditions for use, and the storage instructions.
 Do not try to charge or discharge the battery outside of the device.
 For more information on replacing the battery, refer to the technical
manual.

17.3 Battery Operating Mode


The device is provided with an internal battery that automatically
provides power to the device in case of power failure or disconnection
from the AC power supply. The battery charges when the pump is
connected to AC power supply.
Before starting for the first time, charge the battery for approximately
6 hours by plugging in the power supply cord with the pump powered off.

Information
During operation, leave the device connected to the power supply in
order to maintain the battery's charge and maximum capacity, and to
maximize battery lifetime and performance.

138
139
18 Technical Characteristics

18.1 Power Supply


It is mandatory to use an Agilia power cord compliant with the IEC 60227
standard.
The power cord conductor must have a cross section of at least
0.75 mm2.

100 V - 240 V ~ / 50 / 60 Hz with functional


Power supply
earth
AC Power Maximum consumption 10-15 VA
1 X T1.6AH 250V accessible in the battery
Protective fuse
compartment

18.2 Battery
Disconnect the battery before opening the device. Avoid short circuits
and extreme temperatures.
If the device is not used for more than 3 months, the date is erased (all
other settings are stored permanently). When you power on the pump,
you must set the date again.

Characteristics 7.2 V 2.2 Ah - Li-ion Smart battery

Weight Approximately 100 g

Flow Rate Wi-Fi Battery Life


25 mL/h  >5h
Battery Life 25 mL/h  >8h
1500 mL/h  >4h
1500 mL/h  >5h
Battery Recharge Pump OFF: < 6 h / Pump ON: < 20 h
 = Wi-Fi enabled
 = Wi-Fi disabled or not used

18.3 Power Consumption


The pump typically consumes about 4.3 W in standard operating
conditions.

140
18.4 Communication Port
The connector located at the back of the device allows data
communication with a PC.

Serial Cable TTL output

Power Input 10 V / 15 W to power supply the product

Power Output 5 VDC / 150 mA to power Agilia USB cable

18.5 Infrared Communication


The pump is equipped with an infrared cell located at the back of the
device.

Mode Wireless optical communication using infrared light

Asynchronous Serial Infrared (SIR) physical layer irPHY 1.0, baseband no


Compatibility
carrier

Transport Protocol Proprietary

Speed 115.2 kb/s max

Wavelength 880 nm to 900 nm infrared band with 45 nm spectral bandwidth

Eye Safety Class 0 of IEC 62471

18.6 Drop Sensor Connector


Power Output 3.3 V / 45 mA to power drop sensor

18.7 Sound Levels


18.7.1 Operating Pump Sound Levels (without alarms)
Flow Rate (mL/h) Sound Level (dBA)

0 21

1 30

100 37

400 33

1500 46
Note: These values are provided for information purposes only.

141
18.7.2 Alarms Sound Levels
Sound Level (dBA)
Alarm Priority
min Max

High-priority 55 63

Medium-priority 50 57

Low-priority 49 53

18.8 Compliance
Compliant with the following
Index of protection against
ElectroMedical standards:
IP22 ingress of water or particulate
Equipment Safety  IEC 60601-1 matter
 IEC 60601-1-8
EMC Compliant with the following Protection against leakage
(ElectroMagnetic standard: current: Defibrillation-proof
Compatibility)  IEC 60601-1-2 type CF applied part*

Protection against electric


Particular  IEC 60601-2-24 shocks: class II
Standards  ANSI/AAMI ID26
Functional earth**

* After a defibrillation, the pump recovery time is around 2 seconds.


** The functional earth is directly connected to the power supply cord. It reduces residual current that
may disturb ECG or EEG devices.

18.9 Dimensions and Weight


H/W/D 135 x 190 x 170 mm

Weight Approximately 2 kg

Screen Size 70 x 35 mm

142
18.10Trumpet and Start-up Curves
The trumpet curve shows the variation of the mean flow rate accuracy
over specific observation periods. The variations are presented only as
maximum and minimum deviations from the overall mean flow within the
observation window.
Trumpet curves are presented below for a number of representative flow
rates.
The test protocol used to obtain these results is described in ANSI/AAMI
ID26.
The curves can be helpful in determining the suitability of infusion
parameters for specific drugs and concentrations.
Administration set used: VLST00
Fluid used: distilled water
Recommendations to improve performances and safety when the pump
is commonly used at low flow rates (≤ 20 mL/h):
 Limit the range of available flow rates in accordance with the
maximum flow rate to be used.
 Lower the pressure limit in order to gain in time to detect occlusion.
 For the infusion of very short half-life at flow rate below 5 mL/h, we
recommend using syringe pumps that usually offer better
performances of instant flow rates.

143
18.10.1Flow Rate: 1 mL/h
Legend
4
Instantaneous
flow rate
Set flow rate
3

Sampling time: 10 s
Flow rate (mL/h)

0
0 10 20 30 40 50 60 70 80 90 100 110 120

-1

Time (minutes)

Figure 18.1: Start-up and instantaneous flow rate


(1 mL/h over first 2 hours on 96 hours)
Legend
60
Measured
variance from
flow rate
40
25,1 Error
Flow rate
20
12,9
Flow rate (mL/h)

4,3 0,6
1,7

0 Sampling time: 10 s

-3,7 -4,2
-7,7
-20 -11,7

-40
-43,2

-60
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

Time (minutes)

Figure 18.2: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows
(1 mL/h over first 2 hours on 96 hours)
Legend
60
Measured
variance from
flow rate
40 31,7
Error
Flow rate
20 15,2 9,0 3,6
Flow rate (mL/h)

5,2

0 Sampling time: 10 s
-2,0 -1,2
-4,7
-20 -10,2

-40

-47,4
-60
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

Time (minutes)

Figure 18.3: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows
(1 mL/h over last 2 hours on 96 hours)

144
18.10.2Flow Rate: 25 mL/h
Legend
50
Instantaneous
45
flow rate
Set flow rate
40

35
Sampling time: 10 s
Flow rate (mL/h)

30

25

20

15

10

0
0 10 20 30 40 50 60 70 80 90 100 110 120
Time (minutes)

Figure 18.4: Start-up and instantaneous flow rate


(25 mL/h over first 2 hours on 96 hours)
Legend
10
Measured
variance from
flow rate
Error
5
Flow rate
Flow rate (mL/h)

0 Sampling time: 10 s
-2,5
-4,3
-3,5 -4,1 -4,2

-5
-4,7 -4,7 -4,5
-5,3
-6,3

-10
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

Time (minutes)

Figure 18.5: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows
(25 mL/h over first 2 hours on 96 hours)
Legend
10
Measured
variance from
flow rate
Error
5
Flow rate
Flow rate (mL/h)

1,1
-0,8
0,0 -0,5 -0,7
0 Sampling time: 10 s

-1,3 -1,3 -1,2


-1,9
-3,0
-5

-10
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

Time (minutes)

Figure 18.6: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows
(25 mL/h over last 2 hours on 96 hours)

145
19 Wi-Fi

19.1 General Information


The Agilia Connect Infusion System includes an IEEE 802.11 radio-
frequency transmitter incorporated in the Agilia Wi-Fi pumps. It operates
using the following standards and frequencies:
 IEEE 802.11a: 5 GHz Frequency Band
 IEEE 802.11b: 2.4 GHz Frequency Band
 IEEE 802.11g: 2.4 GHz Frequency Band
 IEEE 802.11n: 2.4 and 5 GHz Frequency Band

Information
For more information on differentiation between Wi-Fi and non Wi-Fi
pumps, see section 10.3, page 104.

The Wi-Fi module incorporated in the Agilia Wi-Fi pumps is intended to


perform the following, via periodic communication cycles:
 Transfer data sets (from Centerium server to pump)
 Transfer pump history (from pump to a server)
 Communicate general information on the operating status of the
pump
Agilia infusion pumps contain transmitter with the following IDs:
 FCC ID: XF6-RSWC301
 IC ID: 8407A-RSWC301.
Agilia Wi-Fi pumps must be installed to provide a separation distance of
at least 8 in (20 cm) from all persons and must not be co-located or
operating in conjunction with any other antenna or transmitter.

Warning
Agilia Wi-Fi pumps must be configured by qualified and appropriately
trained staff.

Information
If communication with the wireless network is interrupted, the pump can
be used as intended. For more information, contact your
Fresenius Kabi sales representative

146
19.2 Specifications
19.2.1 Technical Specifications
Description

Technology IEEE 802.11 a/b/g/n

 2.400  2.500 GHz (2.4 GHz is ISM band)


Frequency Band
 4.900  5.850 GHz (High Band)
OFDM with BPSK, QPSK, 16-QAM, and 64-QAM 802.11b with CCK and
Modulation
DSSS

Wireless Security WPA/WPA2-Entreprise, WPA/WPA2-PSK

Network Protocols TCP, IPv4, DHCP, HTTP

 17 dBm for 802.11b DSSS


Typical Transmit  17 dBm for 802.11b CCK
Power (± 2 dBm)  15 dBm for 802.11g/n OFDM
 12 dBm in 802.11a mode

19.2.2 Electromagnetic Compatibility


For information on electromagnetic compatibilty, see section 23,
page 153.

19.2.2.1 USA - FCC Notice


The users manual or instruction manual for an intentional or
unintentional radiator shall caution the user that changes or
modifications not expressely approved by the party responsible for
compliance could void the user's authority to operate the equipment.

19.2.2.2 Europe - RED


This product is designated as a radio device that utilizes harmonized
frequencies and power levels for Europe.

147
19.2.3 Protocols and Standards
This wireless functionality references and uses the following protocols
and standards:
 IEEE 802.11a/b/g/n standard
 WPA/WPA2-Entreprise, WPA/WPA2-PSK (Wi-Fi protected access)
is a long-term security solution for wireless networks. For more
information, refer to the IEEE 802.11.
 TCP (Transmission Control Protocol / Internet Protocol), IPv4
(Internet Protocol Version 4), DHCP (Dynamic Host Configuration
Protocol) and HTTP (Hypertext Transfer Protocol) are standard data
transport protocol used for the internet and other similar networks.
Agilia infusion pumps do not require an active wireless communication
to function as intended (infuse). All wireless transactions are initiated by
the device and are periodic in nature. The absence of connection (for
example, out of range) does not affect the device ability to infuse. Data
that is pending is stored and re-transmitted when the connection
becomes available. Data integrity and quality of service are inherent in
the design. The system should be ensured and maintained by a qualified
and trained technical user, or a Fresenius Kabi representative.

148
20 Troubleshooting

Issue Recommended Actions


The pump is unstable when mounted.  Check that the rotating pole clamp is fastened.
The pump is damaged, or you notice  Remove the power cord.
something abnormal (unusual noise,  Contact your biomedical department or your
abnormal heat or smoke). Fresenius Kabi sales representative immediately.
The pump has been dropped or was  Do not use the pump.
subjected to a force that may have  Contact your biomedical department or your
produced internal damage. Fresenius Kabi sales representative.
 Check the rotating pole clamp position.
The pump cannot be installed or
 Contact your biomedical department or your
removed from the Link Agilia.
Fresenius Kabi sales representative.
 Connect the pump to the AC power supply to see if the
The pump does not start after battery is fully discharged.
pressing .  Contact your biomedical department or your
Fresenius Kabi sales representative.
 Check the cable connector.
Data communication cables cannot be  Check the pump connector.
connected or removed from the pump.  Contact your biomedical department or your
Fresenius Kabi sales representative.
 Check the infusion line configuration.
 Check the fluid viscosity.
Flow rate variance is higher than flow  Check that the fluid temperature is within the
rate accuracy. recommended range.
 Contact your biomedical department or your
Fresenius Kabi sales representative.
 Check the general condition of the keypad.
 Check the contrast.
Keypad problem (keys, LEDs).
 Contact your biomedical department or your
Fresenius Kabi sales representative.
 Connect the pump to the AC power supply.
The power supply indicator does not
 Contact your biomedical department or your
light up.
Fresenius Kabi sales representative.
 Connect the pump to the AC power supply.
The pump powers off on its own.  Contact your biomedical department or your
Fresenius Kabi sales representative.
 Check the AC power voltage.
The battery alarm is ON even though
 Contact your biomedical department or your
the pump has been correctly charged.
Fresenius Kabi sales representative.
The pump powers off when it is  The battery is completely discharged: charge the battery.
disconnected from the AC power  Contact your biomedical department or your
supply. Fresenius Kabi sales representative.
 Contact your IT or biomedical department, or your
Wi-Fi communication error.
Fresenius Kabi sales representative.

149
Issue Recommended Actions
 Connect the pump to the AC power supply. Then, wait few
minutes without touching the keypad until the message
At start-up, the pump displays:
disappears and the pump starts as usual.
"Software is upgrading...".
 Contact your biomedical department, or your
Fresenius Kabi sales representative.

150
21 Recycling

Before disposal, remove the battery from the device. Batteries and
devices with this label must not be disposed of with the general waste.
They must be collected separately and disposed of according to local
regulations.

Information
 For more information on waste processing regulations, contact your
Fresenius Kabi sales representative or the local distributor.
 For more information on dismantling the device, refer to the technical
manual.
 Follow healthcare facility policy regarding proper disposal after use.

151
22 Warranty

22.1 General Warranty Conditions


Fresenius Kabi guarantees that this product is free from defects in
material and workmanship during the period defined by the accepted
sales conditions, except for the batteries and the accessories.

22.2 Limited Warranty


To benefit from the materials and workmanship guarantee from our
Fresenius Kabi sales representative or authorized agent, make sure to
observe the following conditions:
 The device must have been used according to the instructions
described in this document and in other accompanying documents.
 The device must not have been damaged while being stored or
repaired, and must not show signs of improper handling.
 The device must not have been altered or repaired by unqualified
personnel.
 The internal battery of the device must not have been replaced by a
battery other than that specified by the manufacturer.
 The serial number (SN) must not have been altered, changed or
erased.

Information
 If one or more of these conditions have been violated,
Fresenius Kabi will prepare a repair estimate covering all required
parts and labor.
 To repair or return a device, contact your Fresenius Kabi sales
representative.

22.3 Warranty Conditions for Accessories


Batteries and accessories may have specific warranty conditions.
Contact your Fresenius Kabi sales representative for more information.

152
23 Guidance and Manufacturer's Declaration on
EMC

23.1 Electromagnetic Compatibility


Warning
 The Agilia pump and its accessories are intended to be used in the
electromagnetic environments specified below.
 The customer or the user of the Agilia pump should ensure that it is
used in such environments.
 The Agilia pump must not be used in the presence of intense
electromagnetic fields, such as those generated by certain
electrically powered medical devices. Do not use the pump in MRI.
 Prolonged exposure to X-ray environments can damage the
electronic components of the device and influence the flow rate
accuracy. For a safe usage, we recommend to:
- always put the device at the maximum distance from the patient
and the source
- limit the presence of the device in such environments.
When mounted on the Link+ Agilia, the pump is intended to be used in
the electromagnetic environment specified in the Link+ Agilia IFU.
Excluding the cases described in this manual, pump operation must be
systematically checked by a qualified operator, if the pump is installed in
the vicinity of other electrical devices.
Points (e.g. screws) and surfaces that are only accessible for
maintenance also require precautions. Points (e.g. battery contacts for
battery replacement) and surfaces that are accessible only by
maintenance staff also require precautions.

23.2 Electrostatic Discharge (ESD)


Information
 Electronic components and semiconductors can be destroyed by
electrostatic discharge (ESD). In particular, components made with
metal oxide semiconductor (MOS) can be damaged from direct or
indirect discharges. Damage caused by ESD may not be
immediately identifiable, and malfunctions can even occur after a
longer period of operation.
 Exceeding and / or repeating the test level attained in guidance &
manufacturer's declaration on EMC may permanently damage the
device and / or cause serious malfunctions (for example, loss of
communication and system failures).

153
The following environmental conditions related to electrostatic sensitive
components (ESD standards) must be observed:
 Floors coated with wood, tiles or concrete
 Relative humidity of at least 30%
If it is not possible to guarantee this environment, the following additional
precautions must be taken:
 Use of anti-static equipment
 Preliminary user discharge (explained below)
 Anti-static clothing
The best precaution is preliminary user discharge on a grounded metal
object such as a rail, a pole or a metal part located at the rear of the
Agilia pump.
For maintenance operations performed on the Agilia pump, place the
device on a conductive working surface, and wear a special ESD
conductive wristband.

23.3 Electromagnetic Compatibility and Interference Guidance


The Agilia pump has been tested in accordance with the
electromagnetic compatibility standards applicable to medical devices.
Its immunity is designed to ensure correct operation. Limitation of the
emitted radiation avoids undesirable interference with other equipment.
The Agilia pump is classified as a Class B device according to CISPR 11
emitted radiation. The user might be required to take mitigation
measures, such as relocating or reorienting the equipment.

154
Warning
 Use of the Agilia pump adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If
such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
 Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of the Agilia pump could
result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.
 Portable RF communications equipment (including peripherals such
as antenna cables, internal and external antennas) should be used
no closer than 10 cm for cell phones and 30 cm for other equipments,
to any part of the Agilia pump, including cables specified by the
manufacturer. Otherwise, degradation of the essential performances
of Agilia pump could result.
 Electrosurgical equipment (including base unit, cables, electrodes)
should be used no closer than 30 cm, to any part of the Agilia pump,
including cables specified by the manufacturer. Otherwise,
degradation of the essential performances of Agilia pump could
result.
The user might be required to take mitigation measures, such as
relocating or re-orienting the equipment.
If the Agilia pump is placed near RF communication equipment such as
cell phones, DECT phones or wireless access points, RFID reader &
tags,... It is essential to observe a minimum distance between the Agilia
pump and this equipment specified above. If the Agilia pump causes
harmful interference or if it is itself disrupted, the user is encouraged to
try to correct the interference by one of the following actions:
- Reorient or relocate the Agilia pump, the patient or disruptive
equipment.
- Change the routing of cables.
- Connect the Agilia pump power plug to a protected / backed-up /
filtered supply or directly to the UPS circuit (uninterruptible power
supply).
- Increase the separation between the Agilia pump and disruptive
equipment.
- Plug the Agilia pump into an outlet on a different circuit from the
one to which the patient or disruptive equipment is connected.
- In any case, whatever the context, the user should conduct
interoperability testing in a real situation to find the correct setup
and location.

155
23.4 EMC and essential performances
In the case of electromagnetic disturbances, if the essential
performance, Section 15.1, page 124, is lost or degraded, the
consequences for the patient are as follows: overdose, underdose,
delay of therapy, air embolism, trauma, exsanguination.

23.4.1 Table 1 - Guidance and Manufacturer's Declaration -


Electromagnetic Emissions
Warning
 The Agilia pump and its accessories are intended to be used in the
electromagnetic environments specified below.
 The customer or the user of the Agilia pump should ensure that it is
used in such environments.

Compliance
Emission Test Obtained by Electromagnetic Environment - Guidance
the Device
The Agilia pump only uses RF energy for its internal
RF emissions operation. Its RF emissions are therefore very low and are
Group 1
CISPR 11 not likely to cause any interference in nearby electronic
equipment.
RF emissions
Class B
CISPR 11
The Agilia pump is suitable for use in all establishments
Harmonic emissions
Class A other than domestic and those directly connected to the
IEC61000-3-2
public low-voltage power supply network that supplies
Voltage fluctuations buildings used for domestic purposes.
Flicker emissions Compliant
IEC 61000-3-3
Conducted
emissions 150 kHz - Class 5
108 Mhz CISPR25 The Agilia pump is suitable for use in automotive
Radiated emissions environments.
150 kHz - 2.5 Ghz Class 3
CISPR25

23.4.2 Table 2 - Guidance and Manufacturer's Declaration -


Electromagnetic Immunity
Warning
 The Agilia pump and its accessories are intended to be used in the
electromagnetic environments specified below.
 The customer or the user of the Agilia pump should ensure that it is
used in such environments.

156
IEC 60601-1-2
--------------
Compliance
IEC 60601-2-24 Level Electromagnetic Environment -
Immunity Test
and ANSI/AAMI Obtained by Guidance
ID26 the Device
Test Level
Electrostatic ± 6 kV contact ± 8 kV contact Floor coverings made from wood, tiles and
Discharge (ESD) ± 8 kV air ± 15 kV air concrete, with relative humidity level at
IEC 61000-4-2 -------------- least 30 %, make it possible to guarantee
± 8 kV contact the necessary level of conformity. If it is not
± 15 kV air possible to guarantee this environment,
additional precautions must be taken, such
as: use of anti-static equipment,
preliminary user discharge and the
wearing of antistatic clothing.
± 2 kV for power ± 2 kV for power
Electrical fast AC power quality should be that of a
supply lines supply lines
Transient / burst typical commercial or healthcare facility
± 1 kV for input ± 1 kV for input
IEC 61000-4-4 environment.
output lines output lines
± 1 kV ± 1 kV
AC power quality should be that of a
Surge differential mode differential mode
typical commercial or healthcare facility
IEC 61000-4-5 ± 2 kV ± 2 kV
environment.
common mode common mode
< 5% Ut < 5% Ut
(> 95% dip in Ut) (> 95% dip in Ut)
for 0.5 cycles for 0.5 cycles
Voltage dips,
40% Ut 40% Ut AC power quality should be that of a
short
(60% dip in Ut) (60% dip in Ut) typical commercial or healthcare facility
interruptions and
for 5 cycles for 5 cycles environment.
voltage
variations on 70% Ut 70% Ut For short and long interruptions (< than
power supply (30% dip in Ut) (30% dip in Ut) battery life) of AC power, the internal
input lines for 25 cycles for 25 cycles battery provides continuity of service.
IEC 61000-4-11
< 5% Ut < 5% Ut
(> 95% dip in Ut) (> 95% dip in Ut)
for 5 s for 5 s
Power frequency 3 A/m 400 A/m If necessary, the power of the magnetic
(50/60 Hz) -------------- field should be measured in the intended
magnetic field 400 A/m installation location to ensure that it is
IEC 61000-4-8 lower than compliance level.
If the measured field in the location where
the Agilia pump is used exceeds the
applicable magnetic field compliance level
above, observe the Agilia pump to verify
that it is operating normally. If you notice
abnormal performance, additional
measures may be necessary, such as
reorienting or relocating the Agilia pump,
or installing magnetic shielding.
Note: "Ut" is the AC Power voltage prior to applying the test level.

157
23.4.3 Table 4 - Guidance and Manufacturer's Declaration -
Electromagnetic Immunity
Warning
 The Agilia pump and its accessories are intended to be used in the
electromagnetic environments specified below.
 The customer or the user of the Agilia pump should ensure that it is
used in such environments.
IEC 60601-1-2
-------------- Compliance
IEC 60601-2-24 Level Electromagnetic Environment -
Immunity Test
and ANSI/AAMI Obtained by Guidance
ID26 the Device
Test Level
Portable and mobile RF communication
equipment should be used no closer to
any part of the Agilia pump (including
cables), than the recommended
separation distance calculated from the
transmitter frequency equation.
3 Vrms
150 kHz to Recommended separation distance:
Conducted RF
80 MHz 3 Vrms D = 0.35  P,
IEC 61000-4-6
-------------- for a frequency of 150 kHz to 80 MHz
Not applicable
Radiated RF 3 V/m 10 V/m D = 0.35  P,
IEC 61000-4-3 80 MHz to for a frequency of 80 MHz to 800 MHz
2.5 GHz D = 0.7  P,
-------------- for a frequency of 800 MHz to 2.5 GHz
10 V/m P is the maximum output power rating of
80 MHz to the transmitter in Watts (W) according to
2.5 GHz the transmitter manufacturer, and D is the
recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey (a), should be less than compliance
level (b).
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Notes:
 At 80 MHz and 800 MHz, the highest frequency range applies.
 These guidelines may not apply to all situations. Absorption and reflection from structures, objects and people may
affect the electromagnetic propagation.
 (a) Field strengths from fixed transmitters, such as base stations for radio (cell / cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically
with accuracy. To access the electromagnetic environment due to the fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location where the Agilia pump is used
exceeds the applicable RF compliance level above, the Agilia SP pump should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the Agilia pump, or installing magnetic shielding.
 (b) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
158
23.4.4 Table 6 - Recommended Separation Distances Between Portable
and Mobile RF Communication Equipment and the Agilia Pump
Information
 The Agilia pump and its accessories are intended for use in
electromagnetic environments in which radiated RF disturbances are
controlled.
 Users of the Agilia pump may prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF
communication equipment (transmitters) and the Agilia pump as
recommended below, and according to the maximum output power
of the communication equipment (transmitters).
 The device should not be used next to other equipment. If adjacent
use is necessary, observe the device to verify that it operates
normally in the configuration in which it will be used (pump with a AC
power cord, an RS232 cable).

Separation Distance According


Rated Maximum to Transmitter Frequency in Meters (m)
Output Power of
Transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
D = 0.35  P D = 0.35  P D = 0.7  P
0.01 0.04 0.04 0.07
0.1 0.11 0.11 0.22
1 0.3 0.3 0.7
10 1.1 1.1 2.2
100 3.5 3.5 7

For transmitters rated at a maximum output power not listed above, the
recommended separation distance D in meters (m) can be estimated
using the equation applicable to the transmitter frequency, where P is
the maximum output power rating of the transmitter in watts (W) as
designated by the transmitter manufacturer.
Information
 At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.

159
23.4.5 EMC test deviations and suplementary tests
To ensure compatibility with the new EMC standard IEC / EN 60601-1-2 Ed4 and special
environments, specific, additional or deviating tests are listed below with respect to the
basic tests, in accordance to manufacturer risk analysis.
IEC 60601-1-2 Compliance level
Electromagnetic
Immunity test IEC 60601-2-24 obtained
environment – guidance
Test level by the device
Discharge (ESD) ± 8 kV contact ± 8 kV contact Wooden, tiled or concrete flooring, with a
IEC 61000-4-2 relative humidity level at least 30%, makes it
possible to guarantee the level of necessary
conformity. If it is not possible to guarantee this
environment, the additional precautions must
± 15 kV air ± 15 kV air be taken, such as: use of anti-static material,
preliminary user discharge and wearing anti-
static clothing.

Portable and mobile RF


communications equipment should be
used no closer to any part of the Agilia
pump, including cables, than the
recommended separation distance
calculated from the equation
Radiated RF - IEC
10 V/m, 80 MHz à 2,7 GHz 10 V/m, 80 MHz à 2,7 GHz applicable to the frequency and power
61000-4-3
of transmitter
For standard communication services
and equipment, the specific
frequencies were tested for a minimum
approach distance of 30 cm and 10 cm
(see below)
385 MHz, PM 18Hz, 27 V/m Not tested For minimal distance approach 30 cm
(12 inches)
450 Mhz, 1 KHz, 28 V/m Not tested
710 MHz, PM 217 Hz, 9 V/m Not tested "Not tested" frequencies are replaced
by IEC 61000-4-39 test method and
745 MHz, PM 217 Hz, 9 V/m Not tested
reduced minimal distance approach
780 MHz, PM 217 Hz, 9 V/m Not tested (see below)
810 MHz, PM 18 Hz, 28 V/m Not tested
Portable and mobile RF
Near field radiated 870 MHz, PM 18 Hz, 28 V/m Not tested communications equipment should be
RF used no closer to any part of the Agilia
930 MHz, PM217 18 Hz, 28V/m Not tested
IEC 61000-4-3 pump, including cables, than the
test method 1720 MHz, PM 217 Hz, 28 V/m Not tested recommended minimal separation
distance (30 cm) for these frequencies
1845 MHz, PM 217 Hz, 28 V/m Not tested
1970 MHz, PM 217 Hz, 28 V/m Not tested
2450 MHz, PM 217 Hz, 28 V/m 2450 MHz, PM 217 Hz, 28 V/m
5240 MHz, PM 217 Hz, 9 V/m 5240 MHz, PM 217 Hz, 9 V/m
5500 MHz, PM 217 Hz, 9 V/m 5500 MHz, PM 217 Hz, 9 V/m
5785 MHz, PM 217 Hz, 9 V/m 5785 MHz, PM 217 Hz, 9 V/m
450 MHz, PM 217 Hz, 28 V/m 450 MHz, PM 217 Hz, 28 V/m For minimal distance approach 10 cm

710 MHz, PM 217 Hz, 28 V/m 710 MHz, PM 217 Hz, 28 V/m

787 MHz, PM 217 Hz, 28 V/m 787 MHz, PM 217 Hz, 28 V/m 250 mW average power for 28 V/m
test level
810 MHz, PM 217 Hz, 44 V/m 810 MHz, PM 217 Hz, 44 V/m

830 MHz, PM 217 Hz, 44 V/m 830 MHz, PM 217 Hz, 44 V/m 600 mW average power for 44 V/m
Near field radiated
test level
RF - special test
870 MHz, PM 217 Hz, 44 V/m 870 MHz, PM 217 Hz, 44 V/m
IEC 61000-4-39
Portable and mobile RF
test method
1750 MHz, PM 217 Hz, 28 V/m 1750 MHz, PM 217 Hz, 28 V/m communications equipment should be
used no closer to any part of the Agilia
1875 MHz, PM 217 Hz, 28 V/m 1875 MHz, PM 217 Hz, 28 V/m pump, including cables, than the
recommended minimal separation
1970 MHz, PM 217 Hz, 28 V/m 1970 MHz, PM 217 Hz, 28 V/m distance (10 cm) for these frequencies

2560 MHz, PM 217 Hz, 28 V/m 2560 MHz, PM 217 Hz, 28 V/m

2655 MHz, PM 217 Hz, 28 V/m 2655 MHz, PM 217 Hz, 28 V/m

160
IEC 60601-1-2 Compliance level
Electromagnetic
Immunity test IEC 60601-2-24 obtained
environment – guidance
Test level by the device
Electrical Fast ± 2 kV for power ± 2 kV for power Electricity power quality should be that
transient / Burst supply lines supply lines of a typical domestic, commercial or
IEC 61000-4-4 ± 1 kV for input ± 1 kV for input hospital environment
output lines output lines
100 KHz repetition 100 KHz repetition
Electricity power quality should be that
of a typical domestic, commercial or
± 1 kV ± 1 kV hospital environment. For very
Surge differential mode differential mode exposed establishments or buildings
IEC 61000-4-5 ± 2 kV ± 2 kV with the lightning, a protection must be
common mode common mode installed on electricity power. Class II
product and no earth connexion.

Portable and mobile RF


communications equipment should be
3 Vrms 3 Vrms used no closer to any part of the Agilia
Conducted RF 150 KHz to 80 MHz 150 KHz to 80 MHz pump including cables, than the
IEC 61000-4-6 And 6 Vrms in the ISM and And 6 Vrms in the ISM and recommended separation distance
amateur radio bands amateur radio bands calculated from the equation
applicable to the frequency and power
of transmitter (see table 6)

If necessary, the power magnetic field


should be measured in the intended
installation location to make sure it is
lower than the compliance level.

If the measured field in the location


Power frequency where the Agilia pump is used exceeds
(50 / 60 Hz) 400 A / m 400 A / m the applicable magnetic field
magnetic field compliance level above, the Agilia
IEC 61000-4-8 pump should be observed to verify
normal operation. If abnormal
performance is observed, additional
measures may be necessary, such as
reorienting or relocating the Agilia
pump, or installing magnetic shielding.

0 % Ut 0 % Ut Electricity power quality should be that


(100% dip in Ut) (100% dip in Ut) of a typical domestic, commercial or
for 0,5 cycle for 0,5 cycle hospital environment.
at 0°, 45°, 90°, 135°,180°, 225°, at 0°, 45°, 90°, 135°,180°, 225°,
Voltage dips,
270°,and 315° 270°,and 315° For short and long interruptions (< than
short
battery autonomy) of electricity power
interruptions
0% Ut 0% Ut supply, the internal battery provides
and voltage
(100% dip in Ut) (100% dip in Ut) the continuity of service.
variations on
for 1 cycle for 1 cycle
power supply
For very long (> than battery
input lines
70% Ut 70% Ut autonomy) interruptions of electricity
IEC 61000-4-11
(30% dip in Ut) (30% dip in Ut) power supply, the Agilia pump must be
for 25 cycles at 50 Hz for 25 cycles at 50 Hz powered from an external
for 30 cycles at 60 Hz for 30 cycles at 60 Hz Uninterruptible Power Supply (UPS).
at 0° at 0° Note: Ut is the a/c mains voltage prior
to application of the test level.

161
24 Servicing

24.1 Information on Device Servicing


If the device must be sent for servicing, proceed as follows:
1. Contact Fresenius Kabi to have packaging shipped to your facility.
2. Clean and disinfect the device.
3. Pack the device in the provided packaging.
4. Ship the device to Fresenius Kabi.

Information
 Fresenius Kabi is not liable for loss or damage to the device during
transport.
 For more information on servicing, contact your Fresenius Kabi
sales representative.

24.2 Maintenance Requirements


Warning
Perform preventive maintenance at least once every 3 years. This
includes replacing the battery and the pumping membrane.
To ensure the device continues to operate normally, follow the
instructions below:
 Preventive maintenance should be performed by trained and
qualified technical personnel in compliance with the technical
manual and procedures. Only authorized service personnel should
attempt to repair the device.
 The qualified personnel must be informed if the device is dropped or
if any malfunctions occur. In this case, do not use the device and
contact your biomedical department or Fresenius Kabi.
 Failure to comply with these maintenance procedures could damage
the device and lead to a functional failure. Internal inspection of the
device requires compliance with special procedures to avoid
damage to the device.
 When replacing components, only use spare parts from
Fresenius Kabi.

The life cycle of the pump is 10 years provided that the maintenance is
properly performed as described above.
Information
If the device needs upgrading, Fresenius Kabi or its representative will
provide relevant instructions. It is the healthcare facility's responsibility
to follow Fresenius Kabi’s instructions.

162
24.3 Quality Control
Upon request by the healthcare facility, a quality control check can be
performed on the device every 12 months.
A regular quality control check (not included in the guarantee) consists
of various inspection operations listed in the technical manual.

Information
 These control checks must be performed by trained technical
personnel, and are not covered by any contract or agreement
provided by Fresenius Kabi.
 For more information, refer to the technical manual, or contact your
Fresenius Kabi sales representative.

163
25 Glossary of Terms

Term Description
A Amperes

AC Alternating Current

Ah Ampere-hours

AIDC Automatic Identification and Data Capture

AM Amplitude Modulation

A/m Amperes per meter

BPSK Binary Phase Shift Keying

BSA Body Surface Area

cal Calorie

CCK Complementary Code Keying

CDC Centers for Disease Control

CISPR Special International Committee on Radio Interference

CT Scan Computed Tomography

dBA Decibels

dBm Decibels-Milliwatts

DC Direct Current

DECT Digital Enhanced Cordless Telecommunications

DEHP Di(2-ethylhexyl) phthalate

DERS Dose Error Reduction Software

DHCP Dynamic Host Configuration Protocol

DTBI Dose to Be Infused

DI Dose Infused

DPS Dynamic Pressure System

DSSS Direct Sequence Spread Spectrum

DUR Duration

164
Term Description
ECG Electrocardiogram

ECMO ExtraCorporeal Membrane Oxygenation

EEG Electroencephalogram

EMC Electromagnetic compatibility

ErXX Error message

ESD Electrostatic Discharge

FCC Federal Communications Commission

FM Frequency Modulation

ft Feet

GPL General Public License

GTIN Global Trade Item Number

H/W/D Height / Width / Depth

HF High Frequency

hPa Hectopascals

HTTP HyperText Transfer Protocol

Hz Hertz

IC Industry Canada

IEC International Electrotechnical Commission

IEEE Institute of Electrical and Electronics Engineers

IFU Instructions for Use

in Inches

IT Information Technology

IV Intravenous

kg Kilograms

KVO Keep Vein Open

lb(s) Pound(s)

LED Light Emitting Diode

165
Term Description
mA Milliamperes

mEq Milliequivalents

mL/h Milliliters per hour

mmHg Millimeters of Mercury

mmol Millimole

MOS Metal Oxyde Semiconductor

MRI Magnetic Resonance Imaging

mW/sr Milliwatts per steradian

N/A Not Applicable

NMR Nuclear Magnetic Resonance

OCS Occlusivity Check System

OFDM Orthogonal Frequency Division Multiplexing

OR Operating Room

PC Personal Computer

PSI Pounds per Square Inch

PSK Phase Shift Keying

QAM Quadrature Amplitude Modulation

QPSK Quadrature Phase Shift Keying

REF Product reference / part number

RF Radio Frequency

RFID Radio Frequency IDentification

RS232 Serial interface connector

SN Serial Number

SELV Safety Extra Low Voltage

SIR Asynchronous Serial Infrared

TCP Transmission Control Protocol

UDI Unique Device Identifier

166
Term Description
USB Universal Serial Bus

Ut Test specification level

V Volts

VA Volt-Amperes

VDC Volts Direct Current

VI Volume Infused

Vrms Root Mean Square Voltage

VTBI Volume to Be Infused

V/m Volts per meter

W Watts

WPA Wi-Fi Protected Access

167
Appendix: Factory Configuration

Feature Availability Feature Availability


Profile  V/T/R 
Pressure
 V/R 
management
Volume to be
 V/T 
infused
Keypad lock Infusion
 T/R 
status Modes
Ramp-up /
Battery life  
Ramp-down
Volume Infused
 Sequential 
/ Dose infused
Pause  Drops/min 
Drug  Direct Bolus 
Programmed
Patient  
Bolus
Day/Night
 Loading Dose 
mode
Primary / Secondary
Secondary
 Infusion

Infusion
Programmed Features
 KVO 
bolus
Menus Infusion mode  Prime Set 
Ramp-up / Advance Air
Ramp-down
 Bubble

Dynamic
Sequential  Pressure 
System (DPS)
Alarm volume 
Call-back 
View flow rate
history

View pressure
history

View event log 


Date / Time 
Maintenance 
Library
information

Clinical
information

Data Set 

 = Activated with factory configuration (Basic Profile).


 = Not activated with factory configuration. Can be activated in the pump options or with Agilia Vigilant
Drug’Lib software. Otherwise can be activated on request.

168
Index
A Drop Sensor 36, 63
Drops/min 25, 67
Administration Set
Drug 24
Change 121
Change 83
Install 35
Concentration Selection 43
Other Uses 119
Select 41
Prepare 116
Drug Library 24
Prime 68, 117
Display Information 98
Remove 121
Drug X (mL/h) 25
Replacement Interval 121
Agilia Connect Infusion System 14
Agilia USB Cable 104
E
Air Bubble Electromagnetic Guidance 153
Advance 69 Environment 12
Specifications 126 Essential Features 124
Alarm Event Log 95
Adjust Volume 90
List 107 F
Priority 106 Factory Configuration 168
Sound Level 142 First Use 33
Arrow Keys 19 Flow Rate 24, 42, 50
Auto-restart 76
G
B Glossary 164
Battery Graphics
Characteristics 140 Flow Rate History 93
Charge Level 34, 80 Pressure History 94
Full Charge Time 33 Gravity Infusion 120
Operating Mode 138
Bolus 58 H
Direct 58 Hard Limit 25
Programmed 59, 87 Homecare
Intended Products 10
C Intended Users 9
Cables 103 Warnings 13
Call-back Alert 91
Cleaning 133 I
Clinical Information Message 99 Infusion
Contraindications 12 Change Infusion Rate 52
End 61
D Monitor 50
Data Communication 103 Pause 82
Data Set 26 Program 41
Display Information 100 Start 49
Upload 22, 104 Status 20
Date / Time 96, 102 Stop 52
Day Mode 85 Infusion Modes 25, 88
Dimensions and Weight 142 Installation 27
Disinfecting 133 Intended Products 10
Dose 24, 43, 51 Intended Use 9

169
K Pressure
DPS 76
Keypad
Management 127
Description 18
Modify Limit 75
Lock / Unlock 78
Operating Range 12
Unlock Code 102
Priming
KVO 61, 65
Manual Prime 117
L Prime With Pump 68
Profile 23
Language Selection 102
Basic Profile 23
Loading Dose
Custom Profile 23
Pause 47
Display Information 74
Program 47
Select 39
Select 46
Stop 47
R
M Ramp-up / Ramp-down 25
Modify 89
Maintenance 162
Program 63
Display Information 97
Recycling 151
Reminder Message 34
Rotating Pole Clamp 28
Requirements 162
Menu
Customization 102
S
SafeClip 35, 120
List 72
Screen
Monitoring
Contrast 102
Dose 51
Display and Symbols 20, 22
Flow Rate (ml/h) 50
Logo Display 102
N Secondary Infusion 52, 87
Automatic Return 57
Navigation Buttons 21
Manual Return 56
Near End of Infusion Alert 60
Selection Keys 19
Night Mode 85
Sequential Infusion 25
Modify 89
O Program 65
OCS 34, 35
Servicing 162
Options 101
Simple Rate 25, 63
Soft Limit 25
P Override 48
Packaging 22 Software Version 173
Patient Characteristics 11, 126 Sound Levels 141
Change 84 Stop function 52
Select 44 Storage 122
Power Cord 140 Symbol Descriptions 2
Power Supply 19, 140
Powering Off 62 T
Powering On 33 T/R 25, 62
Pre-programming 71 Table of Contents 3
Temperature
Operating Range 12
Titration 52

170
Training 11
Troubleshooting 149
Trumpet Curves 143

U
Units 131
User Test 105
Users 11

V
V/R 25, 62
V/T 25, 62
V/T/R 25, 41, 62
Volume Infused 81
VTBI 77, 125

W
Warranty 152
Wi-Fi 20, 102, 104
Communication 146
Specifications 147

171
172
Release Notes

Date Software Version Description


January 2017 Creation
Improvement of alarms description (documentary only
March 2020
- no impact on the device itself)
2.2
Update of the compliance to IEC 61000-3-3 and IEC
May 2020 61000-4-5 standards in Section "Guidance and
Manufacturer's Declaration on EMC".

This document may contain inaccuracies or typographical errors.


Modifications may thus be made, and included in later editions.
Due to the evolution of standards, and of legal texts and materials, the characteristics indicated in the
text and images of this document are applicable only to the device with which it is included.

The screenshots and illustrations in this document are for illustrative purposes only. Screen contents
may vary based on individual configurations and minor software modifications; therefore, some
screenshots may appear slightly different from what you see on the product.

This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi.
Vigilant® and Agilia® are registered trademarks in the name of Fresenius Kabi in selected countries.

Made in France
Revision date: May 2020

Fresenius Kabi AG Fresenius Vial S.A.S


61346 Bad Homburg Le Grand Chemin
Germany 38590 Brézins
France

www.fresenius-kabi.com 0123

First CE Mark: Agilia VP MC WiFi: December 2015


Agilia VP MC: November 2016

173
Local Contacts for Servicing

11106-6_Master_IFU_Agilia_VP_MC_Eng

Fresenius Kabi AG Fresenius Vial S.A.S


61346 Bad Homburg Le Grand Chemin
Germany 38590 Brézins - France

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