Professional Documents
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A616S Service Manual
A616S Service Manual
A616S InCare
A616S TCI
Service Manual
Version May 2018
en
Overview
Overview
Preface
History
This is the service manual for the CODAN A616S syringe pumps. It covers both product variants, the InCare and TCI.
Henceforth the A616S is referred to as the device.
The service manual is intended for use together with the user manual for the device and with the user manual for ARGUSservice.
The information in this document is relevant to the service personnel (as defined in IEC60601-1:2005+Amd1:2012) maintaining
the device.
Other users of the device (e.g. nurse, doctors, etc.) are not obliged to know the content of this service manual.
Every effort is made to ensure that the information in this service manual is complete and accurate at the time of publishing.
Please keep the service manual for future assistance. CODAN ARGUS AG products are continuously developed and we
reserve the right to make changes without prior notice.
Manuals, documents, up-to-date information
Download manuals, other documents and up-to-date information from www.codanargus.com\Login. If you do not have access
to the login area, please follow the link to the one-time registration.
Manufacturer
CODAN ARGUS AG
Oberneuhofstr. 10 www.codanargus.com
CH-6340 Baar Technical Services: Sales and delivery:
Switzerland support@codanargus.com codan@codanargus.com
General Remarks
Security
System Information
This information is important for service by your in-house service technician or our Technical Service Department. If you
contact our Technical Service Department by e-mail, please attach these information. To display version information choose:
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To help you find information quickly, there is a table of contents at the beginning of the book. The following lists are appended
at the end of the book:
• Lists of figures and instructions
• A glossary of keywords with short explanations
Elements of the user interface such as buttons, dialogue titles and keys on the keyboard are typed in capital letters. Additional
key names are in brackets:
• PUMP SETTINGS menu
• Select BOLUS MAX
• SAVE button
• [F7] key
The heading of the 3 safety note types contains a short summary. In the main text the following topics are mentioned:
• Description of kind and root of the hazardous situation
• Expectable harm if the recommendations are not observed
• Measures to avoid the hazardous situation
This is an advice
Information requiring special attention of the user are marked with a BULB symbol in the margin. There is no direct connection
to safety-relevant risks.
Visual cues help locate and interpret information in this manual quickly. Below are explained the used formatting conventions.
Symbols
Start of an instruction
End of an instruction
Cross-reference
List item
Item Definition
CODAN CODAN companies - the CODAN ARGUS AG is one of them
Device CODAN ARGUS product which is a medical device: volumetric infusion pumps, syringe
infusion pumps, docking stations.
Technical Services CODAN ARGUS Technical Services Department
A300P, A300M, A500P, ARGUS 300/ARGUS 500/ARGUS 600 P&M Docking Stations
A500M, A600P, A600M
A60P, A60M, A100P, A100M ARGUS 60/ARGUS 100 P&M – Docking Stations
A600S ARGUS 600 S – Syringe Pump
A606S ARGUS 606 S – Syringe Pump
A616S CODAN A616S – Syringe Pumps
Product variants: A616S InCare, A616S TCI
A707V, A708V ARGUS 707 V, ARGUS 708 V – Volumetric Infusion Pump
A717V, A718V ARGUS 717 V, ARGUS 718 V – Volumetric Infusion Pump
ARGUSservice Windows based service software for the configuration and maintenance of the CODAN
ARGUS devices.
FW Firmware: software installed on the medical device to control it.
SSC Safety Standard Check
PDMS Patient Data Management System
HIS Hospital Information System
MRI Magnetic Resonance Imaging
KVO Keep Vein Open
VTBI Volume To Be Infused
IV set Infusion set
IV stand Infusion stand
TCI Target Controlled Infusion
TIVA Total Intravenous Anesthesia
AFF clamp Anti-Free-Flow clamp
Table of Contents
Overview 2
Preface 3
General Remarks 3
1 Introduction 8
1.1 Intended Use.....................................................................................................................................8
1.2 Medical Purpose................................................................................................................................8
1.3 Intended User....................................................................................................................................8
1.4 Patient Population.............................................................................................................................8
1.5 Body Access......................................................................................................................................8
1.6 Application – Environment, Location, Frequency of Use..................................................................8
1.7 Contra-Indication...............................................................................................................................9
1.8 Expected Life-Time............................................................................................................................9
1.9 Operating Principle............................................................................................................................9
1.10 System Interfaces..............................................................................................................................9
1.11 Delivery Scope..................................................................................................................................9
2 Safety Notes 10
8 Wiring Diagram 36
9 Block Diagram 37
List of figures 46
List of instructions 47
Glossary 48
Intended Use
1 Introduction
The CODAN A616S – Syringe Pump is a continuously refined device, fitted with the latest technology.
There are 2 product variants of the device – A616S InCare and A616S TCI (with medication database on request).
The default display language is English. Your in-house service technician can load a second language on the device to
simplify operation.
The information required for maintenance and repair is in the service manual.
For further information please contact your local distributor, your in-house service technician or the CODAN ARGUS Customer
Service Department.
Contra-Indication
1.7 Contra-Indication
This device is not designed and approved for:
• Home use
• Emergency vehicles or helicopter use
• Use in a hyperbaric chamber
• Use in a MRI environment
• Use with non-qualified syringes
• Use by unqualified, untrained staff.
1.8 Expected Life-Time
The expected lifetime of this device is 10 years, under the assumptions that it is operated and serviced as specified in the
instructions for use.
2 Safety Notes
General
3.1 General
Henceforth configuration and maintenance mode is referred to as the configuration mode.
Only trained technicians are allowed to use ARGUSservice
Ensure that only professional service technicians, trained and approved by the CODAN ARGUS AG use the ARGUSservice.
Changes in device configuration, maintenance and repair work must be proceeded by these technicians. Failure to comply
could lead to an improper use or handling which may risk patient safety.
Disconnect the patient before device configuration
Ensure that the patient is disconnected from the device before you start the device configuration with ARGUSservice. Failure
to comply could lead to unexpected behavior or malfunctions which may risk patient safety.
Configuration only while the device is on mains supply
Ensure that the device is connected to the mains supply before you perform the device configuration. Failure to comply could
lead to an interrupted current supply and an inconsistent device configuration which may risk patient safety.
Device PIN code
It is strongly recommended that the device PIN code is changed periodically, and when taking delivery of the device.
After each change in the device configuration, a function check and a control measurement must be performed.
xx Configuration and maintenance mode – how to enter
1 Press simultaneously the 3rd numeric key and ON/OFF to start in configuration
mode.
The device always displays the splash screen during startup. The displayed
information is configurable.
The following 3 menus do not contain any submenu. They are just for information.
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3.2 Pump Settings
The main screen for the configuration mode is PUMP SETTINGS in which you can adjust the following:
1. Display Contrast 0 – 15 Factory setting: 7
2. Display Backlight 0 – 255 Factory setting: 240(a)
3. Define Buzzer Volume 0 – 10 Factory setting: 10(a)
4. Define Speaker volume 0 – 10 Factory setting: 10(a)
5. Language Change between English and a second language
(a) For a temporary change of these settings during normal infusion mode:
hh See user manual A616S InCare and A616S TCI, 5.8 Programmable options (technical), page 78
CODAN ARGUSservice
The other menus (SYRINGE CALIBRATION, PRESSURE CALIBRATION, KEYPAD&DISPLAY TEST) are described in:
hh See 5 Maintenance, page 19
For easy and quick configuration you need to use the PC software ARGUSservice. We describe the detailed instructions for
use for ARGUSservice in the ARGUSservice user manual.
hh The latest version is available on www.codanargus.com
In this service manual, we just mention where you find the required information in the ARGUSservice user manual.
You find the detailed description of the following main topics in the ARGUSservice user manual:
• Update
• Firmware
• Medication database
• Configuration
• Device general configuration
• Device syringe configuration and import
• Maintenance
• Diagnosis (device information, device history, device report, calibration state)
• Activities (SSC reminder, date/time synchronization, change main board, reset device after an technical error, manual
volume calibration)
ARGUSservice is an user friendly PC software. You can connect the device to your PC via the serial COM port. Use
ARGUSservice to:
• Change configurations
• Update the software
• Set the device clock
• Set or change the user PIN code
• Read and print out the device’s history
• Easily replicate pump configurations
• Set the service interval
• Download clear text in a language different from English
• Re-program the serial number
• Download medication libraries
The up-to-date and clearly structured design of this PC-tool allows an easy modification of all CODAN volumetric and syringe
infusion pumps as well as the CODAN ARGUS docking stations. ARGUSservice is available from your local distributor or
from CODAN ARGUS AG.
hh The latest version is available on www.codanargus.com
ARGUSservice is designed for the use with device firmware versions from 5.21.
Always disconnect the device from the patient before and while the serial interface cable is connected to the device. You can
connect the device over the serial interface RS232 to the serial interface outlet of the serial PC COM port by the interface
cable.
Before you start ARGUSservice ensure the following:
• The device is connected to mains
• The interface cable is connected to the device serial interface RS232 and your PC
• The device is in configuration mode
After each change of the configuration you should perform a functional check and control measurement. An active
communication between the device and the PC is not apparent on the device.
This section gives an overview of all relevant settings accessible with the PARAMETER tool of ARGUSservice
hh See user manual ARGUSservice
Parameter Value Range Unit Description
Alarms
Alarm Signal
CODAN ARGUSservice
CODAN ARGUSservice
Buzzer
Sound at True False/True Buzzer signal at keypress
keypress
Volume setting 10 1 - 10 Volume Buzzer loudness
General
Automatic bolus False False/True Option in addition to the manual bolus
function
Drug selection False False/True User is forced to select a drug before infusion start
required (drug library must be available)
Fallback time to 15 5 - 120 s Time to fall back within main screen
infusion rate
OFF key delayed 3 1-3 s Adjustments of the response time
Purge max 2000 1000 - 5000 µl Maximum volume of one single purge
volume
Rate modification False False/True User is forced to stop infusion before a rate change
in Stop Mode
Speaker
Volume setting 10 1 - 10 volume Speaker alarm loudness
Pre-Alarms
Infusion Near End
Enable False False/True Announcement that the VTBI will be reached soon
Reminder 120 1 - 120 s Time until pre-alarm is repeated after its last clearance
duration
Time before event 10 1 - 240 min Time of the pre-alarm release
Low Battery
Reminder 120 1 - 120 s Time until pre-alarm is repeated after its last clearance
duration
Syringe empty soon
Reminder 120 1 - 120 s Time until pre-alarm is repeated after its last clearance
duration
Time before event 3 1 - 120 min Time of the pre-alarm release before the syringe is
empty.
Pressure Control
Automatic True False/True Automatic activation of pressure reduction through
Pressure occlusion
Reduction
Default Occlusion 1000 50 - 1200 mBar Default Occlusion Alarm Limit in mbar
Alarm Limit in
mbar
Startup
Splash Screen
Text Department Text Department name to be displayed at the bottom of the
splash screen
Syringe
Auto-selection False False/True Enables syringe auto-selection, means syringe is
automatically selected based on detected syringe
dimensions.
Limits
10ml
Bolus rate 300000 100 - 300000 µl/h Bolus rate of the syringe with volume 10 ml in µl/h
Bolus volume 4000 100 - 10000 µl Bolus max volume of the syringe with volume 10 ml in
µl
Infusion rate 300000 100 - 300000 µl/h Infusion rate of the syringe with volume 10 ml in µl/h
Purge rate 300000 100 - 300000 µl/h Purge rate of the syringe with volume 10 ml in µl/h
20ml
Bolus rate 500000 100 - 500000 µl/h Bolus rate of the syringe with volume 20 ml in µl/h
Bolus volume 10000 100 - 20000 µl Bolus max volume of the syringe with volume 20 ml in
µl
Infusion rate 500000 100 - 500000 µl/h Infusion rate of the syringe with volume 20 ml in µl/h
Purge rate 500000 100 - 500000 µl/h Purge rate of the syringe with volume 20 ml in µl/h
30ml
Bolus rate 500000 100 - 500000 µl/h Bolus rate of the syringe with volume 30 ml in µl/h
Bolus volume 10000 100 - 30000 µl Bolus max volume of the syringe with volume 30 ml in
µl
Infusion rate 500000 100 - 500000 µl/h Infusion rate of the syringe with volume 30 ml in µl/h
Purge rate 500000 100 - 500000 µl/h Purge rate of the syringe with volume 30 ml in µl/h
50ml
Bolus rate 1500000 100 - 1500000 µl/h Bolus rate of the syringe with volume 50 ml in µl/h
Bolus volume 20000 100 - 50000 µl Bolus max volume of the syringe with volume 50 ml in
µl
Infusion rate 1500000 100 - 1500000 µl/h Infusion rate of the syringe with volume 50 ml in µl/h
Purge rate 1500000 100 - 1500000 µl/h Purge rate of the syringe with volume 50 ml in µl/h
60ml
Bolus rate 1500000 100 - 1500000 µl/h Bolus rate of the syringe with volume 60 ml in µl/h
Bolus volume 20000 100 - 60000 µl Bolus max volume of the syringe with volume 60 ml in
µl
Infusion rate 1500000 100 - 1500000 µl/h Infusion rate of the syringe with volume 60 ml in µl/h
Purge rate 1500000 100 - 1500000 µl/h Purge rate of the syringe with volume 60 ml in µl/h
Properties
Schema version 1 0 - 65535 Defines the schema version of the set of syringe
properties and meta-data
TCI
Drugs
Propofol
Decrement 1000 100 - 15000 ng/ml Decrement concentration for propofol
concentration
Maximum drug 20 10 - 20 mg/ml Maximum drug concentration for propofol
concentration
Minimum drug 10 10 - 20 mg/ml Minimum drug concentration for propofol
concentration
Remifentanil
Decrement 1000 100 - 20000 pg/ml Decrement concentration for remifentanil
concentration
Maximum drug 50 20 - 50 µg/ml Maximum drug concentration for remifentanil
concentration
Minimum drug 20 20 - 50 µg/ml Minimum drug concentration for remifentanil
concentration
Models
Minto
Effect mode True False/True Enable effect mode for the Minto model for
remifentanil
Plasma mode True False/True Enable plasma mode for the Minto model for
remifentanil
Schnider
Effect mode True False/True Enable effect mode for the Schnider model for
propofol
Plasma mode True False/True Enable plasma mode for the Schnider model for
propofol
User Permissions
Definition 1
Name Administrator The user name
Pin code 1220 0 - 9999 Pin code of the user
3.4.1 General
The device has a serial interface for connection to CODAN ARGUS docking stations.
The serial interface designed by CODAN ARGUS enables the communication with CODAN ARGUS docking stations. In such
a case, the separation device according to EN60601-1-1:2000 is given by the docking station itself. It is prohibited to connect
the interface cable to the serial interface of the device while it is connected to a patient.
Serial Communication
The following characteristics are valid for all ARGUS devices (volumetric pumps, syringe pumps, docking stations with V4.xx
and PCs) which are intended to communicate with the device mentioned in this service manual.
• Full-duplex RS232, currently 4 800 Baud for single pumps, 9 600 Baud for docking stations (also on master/slave-link).
• Simple master (host/PC) – slave (device) communication (host does polling).
• The host has to repeat the request if there is no valid response.
• Uses a checksum (CRC-8).
• Binary data transmission, thus no ASCII/text parsing.
• Fast & direct communication with pumps on ARGUS docking station.
• Basic framing technique used as in the Serial Infrared Link Access Protocol (IrLAP) version 1.1.
Please contact your local distributor or CODAN ARGUS AG for the complete serial communication protocol description.
Safety Aspects
4 Software Updates
Please inform your local distributor or CODAN ARGUS AG about every device update (serial number) to guarantee the
medical device traceability.
Never perform any software update
• While a patient is connected to the device
• While the device is in use.
The device does not indicate if it is connected to ARGUSservice. An active communication between the device and the PC
is not apparent on the device.
The latest firmware version is available under www.codanargus.com\Login ( Software A616S). If you do not have access
to the login area, please follow the link to the one-time registration.
Please verify the installed firmware version (step 1 of the SSC) in configuration mode.
hh See Configuration and maintenance mode – how to enter, page 11
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You can change the secondary language on the device during a firmware update, even
without any other update activities. For this you need ARGUSservice.
xx Language, secondary – how to change it
1 Connect the device to a PC (with ARGUSservice), start ARGUSservice and
connect the device.
hh See Firmware update – how to prepare, page 18
2 Enter the UPDATE control and start the firmware update.
hh See 4.3 Firmware Update, page 18
3 If you only want to change the secondary language activate the checkbox UPDATE
DEVICE LANGUAGE ONLY on the LANGUAGE SELECTION window in
ARGUSservice.
4 Select the desired secondary language and press OK. English is always the first language. You cannot change this.
5 Follow the instructions on the screen.
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Firmware Update
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During the firmware update the device configuration is retained. Save and restore configuration is automatically done if
required. This also includes the custom syringes.
xx Firmware update – how to proceed
1 Access www.codanargus.com\Login and download the latest firmware version to your PC.
If you do not have access to the login area, please follow the link to the one-time registration.
2 Proceed the steps in HOW TO PREPARE THE FIRMWARE UPDATE.
hh See 4.3 Firmware Update, page 18
3 Click on the UPDATE control to open it.
4 Click on OPEN FIRMWARE FILE and select the downloaded (latest) firmware file in the opened explorer window.
5 Click OPEN to open the firmware file.
6 Select your required language in the displayed SELECT LANGUAGE window. Click OK to confirm.
7 Wait until the message FLASH COMPLETED SUCCESSFULLY is displayed. Click OK to confirm.
8 Click on the EXIT control to return to the ARGUSservice start screen.
9 Perform a Safety Standard Check (SSC) after every software update.
hh See 10 Safety Standard Check, page 39
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4.4 Upgrade the Device with Medication Database
5 Maintenance
Only authorized persons trained by CODAN ARGUS are allowed to service the CODAN A616S – Syringe Pump. In case of
a request for repair, send the device together with the filled out REPAIR ORDER FORM to your local distributor.
hh See 14 Repair Order Form, page 45
You can get further information from: CODAN ARGUS AG
CH – 6340 Baar
Switzerland
E-mail: support@codanargus.com
Perform the Safety Standard Check (SSC) at least every 24 month or after 10 000 operational hours. No special maintenance
of the device is necessary. There are no wear and tear parts.
hh See 10 Safety Standard Check, page 39
Define a service PIN to prevent unauthorized use by accessing the configuration mode.
hh See Configuration and maintenance mode – how to enter, page 11
Start the device in configuration mode. Press the MENU key to enter the several menus which are described in the following.
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xx Keypad test – how to execute
With this test you can check the correct function of all keys except the ON/OFF key. Every time you switch on or off the device
the ON/OFF key is automatically checked.
1 Select the KEYPAD & DISPLAY TEST menu.
2 Press SELECTION to select KEYPAD TEST.
3 Press ENTER to execute the keypad test.
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The factory base calibration is part of the manufacturing process by CODAN ARGUS AG. You must repeat the process after
the replacement of parts (e.g. main board, the complete syringe drive or parts of it, syringe barrel holder, potentiometer etc.)
as well as after a downfall or a heavy impact. We recommend to check the factory base calibration values during the SSC.
Please remove any syringe before you start the calibration process. Spare parts, accessories and consumables for the device
are listed in a separate catalogue.
hh See catalogue Spare parts, Accessories, Consumables
The latest version is available on www.codanargus.com/Downloads.
1 Open the device but leave all cables connected.
2 Enter the CONFIGURATION mode.
hh See Configuration and maintenance mode – how to enter, page 11
3 Press MENU to enter the CALIBRATION menu.
4 Press SELECTION to select LONG CALIB. PART.
5 Press ENTER to get access to the different signal voltages.
Do not press this key again as this will only be done during the final calibration with a closed device.
6 Ensure that the red syringe barrel holder is in completely closed position. Adjust the white potentiometer to 360 mV ± 40 mV
(BARREL DIAM.). Tighten the set screw on the white cog wheel and verify the declared value again.
7 Completely pull out the syringe barrel holder. The signal of the barrel diameter must be 2 600 mV – 3 180 mV. Repeat
step 3 if this range is exceeded.
8 Push the syringe drive to the left. Adjust the black potentiometer on the drive unit to 300 mV ± 10 mV (PLUNGER POS.).
Tighten the set screw and verify the declared value again.
9 Push the syringe drive to the right. The signal of the plunger position must be 2 900 mV – 3 000 mV. Repeat step 5 if this
range is exceeded.
10 Remove the red cover of the driving head according to instruction:
hh Red cover of the driving head – how to remove, page 32
11 Check if the piston clamps are fully closed. Adjust the signal of the potentiometer to 460 mV ± 50 mV (CLAMP DIAM.).
Tighten the set screw and verify the declared value again.
12 Assemble the red driving unit again.
Syringe Calibration
13 Ensure that the piston clamps are fully closed. Check if the clamp lever does not abut against the table. The signal of the
CLAMP DIAM. must be 460 mV ± 50 mV. Repeat steps 7 to 8 if this value is not reached.
14 Fully open the piston clamps. The signal of the CLAMP DIAM. must be 2 400 mV – 3 000 mV. Repeat steps 7 – 9 if this
value is not reached.
15 Press EXIT to exit the CALIBRATION menu. Do not press the ENTER key.
16 Close the device and proceed the final calibration.
Failure to observe the above given value ranges may lead to an technical alarm when you start the device.
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5.3 Syringe Calibration
Only use syringe calibration parts specified for the A616S
Ensure that only the specified calibration parts for syringe calibration are used. Failure to comply could lead to unexpected
behavior or malfunctions which may risk patient safety.
The SYRINGE CALIBRATION menu has two submenus, LONG CALIB. TOOL and SHORT CALIB. TOOL. Use the submenus
and the calibration tools to calibrate the barrel, the clamp diameter and plunger position.
xx Calibration tool, short – how to use
1 Press SELECTION to select SHORT CALIB. TOOL.
2 Press ENTER to confirm.
4 Check whether the measured values are within the specified range. If not, repeat
the factory base calibration.
hh See 5.2 Factory Base Syringe Calibration, page 20
5 Press ENTER to select and confirm calibration.
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xx Calibration tool, long – how to use
1 Press SELECTION to select LONG CALIB. TOOL.
2 Press ENTER to confirm.
4 Ensure that the piston clamps capture firmly without any gap between drive unit and
calibration part.
5 Slightly press the calibration part against the drive unit.
6 Check whether the measured values are within the specified range. If not, repeat
the factory base calibration.
hh See 5.2 Factory Base Syringe Calibration, page 20
7 Press ENTER to select and confirm calibration.
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Pressure Calibration
5.3.1 Workflow
Pressure Calibration
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xx Sensitivity – how to calibrate
1 Press SELECTION to select CALIB. SENSITIVITY.
2 Insert the spring gauge for syringe pumps.
3 Press ENTER.
4 Press the 4th or the 1st numeric key to increase or decreased the delivery speed.
5 When 0.2 bar are reached, press the ENTER key.
6 When 1.2 bar are reached, press the ENTER key.
7 Press ENTER again.
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xx Control measurement – how to execute
1 Switch the device off and on again.
2 Control the pressure survey by means of a manometer:
• Adjust the occlusion alarm limit to 1 000 mbar
• Initiate the pressure build-up with 200 ml/h
• Release an occlusion alarm at 1 000 mbar ± 200 mbar.
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5.4.1 Workflow
Battery Maintenance
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5.6.1 Correction Factor for the Remaining Battery Capacity
The capacity of the battery will decrease over time like all batteries do.
Therefore the capacity status (percentage and remaining time) displayed in the menu
BATTERY INFO may differ from the real battery capacity.
The battery capacity can be reduced to a minimum of 50%. For you there is no
opportunity to adjust the battery capacity on the device to its real value. But you can
calculate an estimated value of the remaining battery capacity.
66
The battery charging system included in the device requires additional electronics (temperature and current sensors) to
provide a high current to accelerate charging time. Therefore the battery must be obtained from CODAN ARGUS AG. The
charging time depends also on the current pump status (infusing rate, standby).
When you switch OFF the device after a detected technical error, the error code is stored in the device history and also in
the device configuration file.
8000 – 8081
8004 – 8081
8085
8088 – 8105
8118
8124, 8125
8147 – 8152
8156 – 8163
8166 – 8168
8171
8176 – 8180
8187
8192 – 8208
8215 – 8220 Firmware error: Contact CODAN ARGUS Technical Service
8222 – 8243
8253, 8254
8257, 8261
8264 – 8279
8281 – 8322
8324 – 8326
8328 – 8334
8338 – 8347
8349 – 8378
48000
48004 – 48012
48024 – 48027
48038, 48064
8174 Key pressed for too long or Keypad error
8184 MedDB error: Invalid medication flashed to the pump.
8185 Wrong Device Type
If the error is located in the firmware, check if a new firmware version is available. Some technical errors give a hint in the
history which hardware component is defective. In the table above, the possible components are in the order of probability
as error source. If you have found the defective component, first check the connections of the component. If the error occurs
again, replace the components after order of the probability and check if the error occurs again. If no action has success,
inform CODAN ARGUS Technical Services.
You can find the exact reason for the reminder PERFORM SAFETY CHECK in the history. Look for Safety Standard Check
(SSC) in the history. The same message is displayed under the following conditions:
Faulty pressure or mechanic calibration
To check the current calibration status (here:
volume and pressure calibration for IV set 1 are
okay), enter the control CALIBRATION and select
the respective device (COM port).
6 Replacement of Parts
Never modify spare parts without prior authorization from the manufacturer.
Spare parts and their reference numbers are listed in a separate catalogue (Spare parts, Accessories, Consumables).
hh The latest version is available on www.codanargus.com/Downloads
After a device repair SSC is mandatory
Ensure that after each device repair a Safety Standard Check (SSC) is performed. Failure to comply could lead to unexpected
behavior or malfunctions which may risk patient safety.
Never use a device with defects
Ensure that the device must not be used after an unsuccessful repair. Failure to comply could lead to malfunction which may
risk patient safety.
Repair and maintenance work must only be performed by service technicians, which are trained and authorized by the
CODAN ARGUS AG.
The internal mains connectors under the transformer are not insulated.
Before you replace any part always disconnect the device from mains supply and remove the battery connector (X15).
A complete Safety Standard Check (SSC) is mandatory after
• The configuration of new syringe
• Any repair which require to open the housing
hh See 13 Safety Standard Check Form, page 43
Also a factory base calibration might be required.
xx Housing – how to disassemble
1 Remove combination clamp at the rear side.
2 Remove the screws on the casing base (5xM4) and the screw at the gray syringe guide (1xM3).
3 Place the casing cover behind the casing base.
4 Continue with the required repair work.
5 Afterwards perform the Safety Standard Check (SSC).
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xx Casing cover (including display, keypad, display board) – how to replace
1 Remove pole clamp at the rear side.
2 Remove the screws on the casing base (5xM4) and the screw at the gray syringe guide (1xM3).
3 Place the casing cover behind the casing base.
4 Afterwards disconnect the flat cable of the casing cover
5 Replace the casing cover
6 For assembling repeat steps 4 to 1 (reverse order).
7 Afterwards perform the Safety Standard Check (SSC).
66
66
xx Battery – how to replace
1 Switch off the device and disconnect the mains power cable.
2 Remove the screws (2xM3) and open the battery cover.
3 Replace the battery.
4 Check all cable connections carefully.
The shrink-wrapped PCB (Printed Circuit Board) includes a temperature sensor.
5 Position it in direction of the connector (avoid a positioning towards the transformer) an fix it with the screws (2xM3).
6 Close the battery cover and fix the screws (2xM3).
7 Afterwards perform the Safety Standard Check (SSC).
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xx Red cover of the driving head – how to remove
1 Remove the 3 screws (3xM3) on the cover.
2 Important: manually open the beaks one third (or put a coin between the beaks) to disassemble the unit.
3 Then pull the cover with the levers out of the housing.
4 Continue with the required repair work.
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xx Main board – how to replace
1 Remove the battery connector first and then all other cables of the main board.
Remove the drive completely prior to the replacement of the main board.
2 Remove the screw on the fixing plate (1xM3). Remove the drive.
3 Remove the screws on the main board (6xM2.5). Remove the main board.
4 Insert the new main board. Fix it with the screws (6xM2.5).
5 Insert the drive. Fit it with the fixing plate and the screw (1xM3).
6 Ensure that the cog wheel on the potentiometer and the screw on the top side are unlocked.
7 Afterwards perform the Safety Standard Check (SSC).
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xx Syringe drive, complete – how to replace
First remove the syringe drive:
1 Move the drive unit fully to the right. Remove the screw (1xM3) on the fixing plate down at side wall (kit: side wall with
DMS) of the drive. Remove the fixing plate.
2 Unplug the motor cable, the flex cable and the cable to the sidewall.
3 Remove the syringe drive.
4 Insert the syringe drive in the casing base.
5 Fix the syringe drive with the fixing plate and the screw (1xM3).
6 Plug the motor cable, the flex cable and the cable to the sidewall
7 Afterwards perform the Safety Standard Check (SSC).
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xx Syringe clamp – how to replace
1 Remove the battery connector first and unplug all cables of the main board.
2 Remove the drive completely
3 Remove the main board.
4 Change the syringe barrel holder by loosening the snap ring at the end of the gear.
5 Replace the syringe clamp.
6 Fix the syringe barrel holder with the snap ring.
7 Insert the main board and fix it with the screws (6xM2.5).
8 Afterwards perform the Safety Standard Check (SSC).
9 Perform a factory base calibration.
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xx Motor and gear – how to replace
1 Move the drive unit fully to the right and remove the fixing plate down at side wall (kit: side wall with DMS) of the drive.
2 Unplug the motor cable, the flex cable and the cable to the sidewall.
3 Remove the screws from the side wall (2xM4).
4 Remove the syringe drive out of the housing.
5 Insert the new motor and fix it on the side wall with the screws (2xM4).
6 Insert the syringe drive and fix it.
7 Fix the screws on the side wall (2xM4).
8 Plug the motor cable, the flex cable and the cable to the sidewall.
9 Afterwards perform the Safety Standard Check (SSC).
10 Perform a factory base calibration.
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xx Coin cell (main board) – how to replace
1 Remove the coin cell by pushing it out with an insulated object.
Be aware of local short circuits to the electronics.
2 Use a new coin cell qualified by the CODAN ARGUS AG.
hh See catalogue Spare parts, Accessories, Consumables
3 After replacement switch the device on in normal mode.
The internal real time clock is re-initialized.
4 Switch off the device.
5 Switch on the device in configuration mode and use ARGUSservice to set the clock.
hh See user manual ARGUSservice
6 Afterwards perform the Safety Standard Check (SSC).
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Repair Instructions
7 Insulation
Repair Instructions
Repair Instructions
8 Wiring Diagram
9 Block Diagram
The numbers circled in the block diagram have the following meanings:
Digital part
Acoustic signals (buzzer, speaker) and power supply fail supervisor (super-capacitor)
Sensor module
Drive
Communication
10.2 Calibration
Check the calibration status using ARGUSservice. Enter the CALIBRATION control and select the required Com-port for your
device. Then the calibration status for the syringe and the pressure calibration is displayed.
The pressure calibration procedure always includes all of the following steps and is complete when the control measurement
was successful. The previous values remain stored in a premature termination of the calibration.
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10.3.1 Check the Battery with ARGUSservice
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10.3.2 Check the Battery without ARGUSservice
3 Fully discharge the battery by running at a rate of 5 ml/h for at least 6 hours.
4 Wait until the battery alarm is displayed and stop the stopwatch.
5 Read out the elapsed time.
6 Replace the battery if it does not reach the required capacity.
hh See POWER SUPPLY in 12 Product Specification - Fact Sheet, page 42
hh See Battery – how to charge, page 39
7 Connect the device to mains for 7 hours to charge the battery.
hh See Battery – how to charge, page 39
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10.4 Nurse Call Test
Check the nurse call signaling in the hospital
Ensure that the device is configured according to your nurse call system (signaling). Check that the same type of nurse call
signaling is used in the whole hospital. Failure to comply could lead to not recognized alarms which may risk patient safety.
Check the nurse call function after signal configuration
Ensure that the device is configured according to your nurse call system (signaling). Check that the combination of your
nurse call system and the device is working correctly. Failure to comply could lead to not correctly raised alarms which may
risk patient safety.
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Keep the device and the accessories clean and dry. In order to maintain the full functionality, we recommend to clean the
device regularly according to the product specifications. Do not use any abrasive cleaning agents. The device shall not
experience any visible abrasions when regularly cleaned with one of the following cleaning agents:
• 60% 1-Propanol/40% water • B Braun Softasept N (Ethanolum 96%)
• 70% Isopropanol (IPA)/30% water • Glycerin
• Industrial alcohol • Deconex 50 FF surface (0.5%)
• Kodan Tincture forte antiseptic • Septo Clean - pantasept
• Industrial alcohol 70% • Johnson Sani Cid
• B Braun Meliseptol Foam pure • Bode Sterillium Gel
• B Braun Meliseptol Rapid • 80% Glycerin/20% Isopropanol (IPA)
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11.2 Storage and Transportation
Devices may only be stored in clean conditions at a cool and dry place according to:
hh See 12 Product Specification - Fact Sheet, page 42
Never use the device during patient transportation
The device is not designed or approved for use during patient transportation in the hospital, in a vehicle (e.g. an ambulance),
in a helicopter or in an airplane. Vibration or low barometric pressure at high altitude may cause device malfunctions. Alarms
may be missed due to noisy environments. The battery may become empty during transportation. Any of these may risk
patient safety.
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Device identification
CODAN A616S InCare CODAN A616S TCI
Serial no.: Hospital:
The SSC has to be performed at least every 24 months or after 10 000 hours of operation.
The check has to be done in accordance to the user and service manuals.
Test steps for CODAN A616S InCare and CODAN A616S TCI
1 Wear gloves to unpack and immediate disinfect the device hh See user manual A616S, 7.3.1 Cleaning and
with one of the recommended disinfectants. Disinfection, page 89
2 Check time and date hh See ARGUSservice: DATE & TIME
3 Check the history file whether a technical error happened. hh See ARGUSservice: HISTORY
No technical error happened
4 Visual check for damage, Housing, labels, accessories, connectors, power cable, etc.
cleanness and completeness
Pull out syringe holder completely (without syringe)
Turn syringe holder to left/right position; verify the proper
function of the mechanical stop; the distance from handhold
0 stop to duct stop must measure > 18 mm (otherwise the
guidance duct is worn out)
Piston clamp closes completely (without syringe)
5 Switch on the device in configuration mode and note the Firmware version:
firmware version on the splash screen and compare the
right device type. Is the device type identical to the pump?
6 Check if a firmware update is required Latest firmware is available on CODAN ARGUS AG website
(www.codanargus.com)
7 Perform display, keypad, LED and backlight tests Were all 3 tests successful?
hh See 5.1 Keypad and Display Test, page 19
8 Switch pump off and start the pump in normal mode. Check Acoustic signal is audible?
the acoustic signal and indication of red status LED during
The red status LED lights up?
start-up procedure.
9 Connect/disconnect the pump to/from the mains The mains LED lights up only when connected to mains?
10 Check switches and potentiometers Start to infuse and test general activity status by verifying
alarm and buzzer functions plus red blinking status lamp.
Repeat this procedure until all the tests are done.
Press clutch Iever down: verify alarm indicators, display
picture and text information
Lift the syringe a little from the pushbutton switch: verify
alarm indicators, display picture and text information
Press the clamp Iever up: verify alarm indicators, display
picture and text information
Pull the syringe holder: verify alarm indicators, display
picture and text information
11 Interfaces tests
When the nurse call is enabled, check the NURSE CALL Relay contact switches
connector
hh See 10.4 Nurse Call Test, page 40
Check the interface to docking station (connect pump to The indicator for mains operation must light green
docking station). The green status LED on the pump lights up.
12 Insert a 50 ml syringe Verify whether the device runs smooth at its maximum rate
13 Check the factory base calibration values. hh See page 5.2 Factory Base Syringe Calibration, page 20
The pump has passed the Safety Standard Check and is safe for use.
Date: Name: Signature:
Purchase Order
Pro forma Invoice
Number:
Customer Name:
Address:
Contact Person:
Phone No.:
Device Identification :
A717V A718V ARGUS 707 V ARGUS 708 V ARGUS 717 V ARGUS 718 V
A616S InCare A616S TCI ARGUS 606 S ARGUS 600 S
ARGUS 300 P ARGUS 500 P ARGUS 600 P ARGUS 300 M ARGUS 500 M ARGUS 600 M
ARGUS 60 P ARGUS 100 P ARGUS 60 M ARGUS 100 M
Accessory:
List of figures
List of instructions
Glossary
3-way valve Device to administer 2 infusions simultaneously, one after the other or alternating by a
permanent venous catheter to the patient.
A
Air bubble detection Electronic technique to detect size and number of air bubbles in the infusion system.
A600S ARGUS 600 S – Syringe infusion pump (with 7-segment display).
A606S ARGUS 606 S – Syringe infusion pump (with monochrome display).
A616S CODAN A616S – Syringe infusion pump (with monochrome display).
A707V, A708V ARGUS 707 V, ARGUS 708 V – Volumetric infusion pump (with 7-segment display).
A717V, A718V ARGUS 717 V, ARGUS 718 V – Volumetric infusion pump (with monochrome display).
Accumulated volume Total infused volume over several therapies administered to one patient (feature of infusion
pumps).
Administration set Infusion set
Anti-free-flow clamp AFF clamp: equipment to avoid uncontrolled flow of medication.
Applied part Part of ME (medical electrical) equipment, including the infusion liquid pathway, that in
normal use necessarily comes into physical contact with the patient for ME equipment to
perform its function (for CODAN ARGUS these are the infusion sets and infusion pumps).
ARGUSservice Windows based service software for the configuration and maintenance of the CODAN
infusion pumps.
ASA High performance plastics: better chemical resistance and better mechanical characteristics
than normal plastics.
Audible signal Warning signal to bring attention to pre-alarms and alarms.
Autoclave Sealable pressure vessel for thermal treatment in overpressure range of substances.
B
Balancing Feature of infusion pumps to reset the previously infused volume to zero without effect to the
accumulated volume.
Barcode An optoelectronic readable scripture. Data are represented in binary code. They can be read
by optical reading devices, e.g. scanners or cameras.
Bolus The administration of a discrete amount of medication or other compound to raise its
concentration in blood to an effective level.
Bolus – automatic Administration of a bolus with a defined infusion volume. An automatic bolus is started by
pressing the bolus button (A616S) or start button (A717V, A718V) once.
Bolus – manual Administration of a bolus by pressing the BOLUS button (A616S) or START button (A717V,
A718V) until the bolus volume is reached.
Bolus – physical Administration of a bolus on a syringe pump (A616S) by pressing the syringe clutch and
clamp lever and manually pushing the syringe plunger. In contrast a manual bolus is
administered by pressing the BOLUS (A616S) or START (A717V, A718V) button.
Basic infusion A simple infusion with rate, rate/volume, rate/time and volume/time. ARGUSmedDB related
infusions are not part of basic therapies, e.g. TIVA, dose calculation etc.
C
Clamp lever Lever to fix/loosen the device (pump) piston.
Clutch lever Lever to fix/loosen the device (pump) clutch.
Collective alarm Alarm with several causes/triggers.
Commissioning First-time operation of a CODAN infusion pump.
Customer configuration Customer specific settings on the device.
Cyto-set Closed infusion system for safe and needle-free preparation and administration of
cytostatics. Used particularly in chemotherapeutics.
D
Delivery package Accessories and documents supplied with the device.
Docking station The ARGUS 300/ARGUS 500/ARGUS 600 P&M Docking Stations enable compact stacking
of CODAN infusion pumps, make them easier and more space-saving to operate. The
communication interface of the M versions additionally enables permanent remote
monitoring of the inserted devices by a PDMS or HIS.
M docking station M for monitoring: docking station can communicate with device (pump) and provides power.
Pump – volumetric Volumetric pump: dosing device for intravenous administration of infusions (medication). The
volumetric pump generates an even flow with low pulsation and variable volume. By
compressing a defined tube volume a certain volume of infusion fluid is supplied to the
infusion system.
Purge Automatic filling of the infusion set purges the air from the infusion set, also called PRIME or
FILL.
R
Rails Hard rails/soft rails
Rail fixation Mechanism to fix the device on the wall.
Rest capacity Remaining capacity of the battery until it is empty.
Repository Storage for data, the device has 5 repositories: customer configuration, factory configuration,
current configuration, states, immutables.
Responsible Organization Standard term used in IEC-60601-1-8 for an organization that owns and operates pumps
(e.g. hospital). A user role corresponding to responsible organization would be an
administrator.
S
Safety notes Product identification to protect people, objects or the environment from harm and damages.
Safety notes are on the device casing or in the user and service manual. They are pictured
with standardized hazard symbols.
Safety Standard Check SSC: At least every 24 months or 10 000 operating hours some basic safety checks have to
be performed on every device. Under specific technical conditions a SSC may also be
necessary, e.g. technical errors.
Self-test Automatically running test while switching on the device and during operation.
Serial number SN: Number for the unambiguous identification of a device, located on the type plate.
Soft rails If either the volume or rate exceeds their values defined in ARGUSmedDB, a warning
message is displayed to inform the user about a possible risk.
Software Program to be used on a laptop or desktop computer, e.g. ARGUSservice
Standard care Basic procedures and mobilization in a hospital ward without special therapies.
Stopcock Device to administer two infusions simultaneously, one after the other or alternating by a
permanent venous catheter to the patient.
Storage temperature Recommended temperature range for objects, medication etc.; if not observed damages are
possible.
T
Target Controlled Infusion TCI: Target-oriented infusion of medication using infusion pumps. The purpose is to reach
and maintain a specific effect (e.g. absence of pain) by a defined plasma level.
Total Intravenous Anesthesia TIVA: A special kind of anesthesia whose the loss of the consciousness and the absence
of pain is only brought about by intravenous injection or permanent infusion of a sleep-
inducing medication or an analgesic. With a specific plasma level is to be expected a
sufficient analgesia and anesthesia. Under a specific plasma level is to be expected the
awakening of the patient.
Total volume Total volume to be infused
Transport mode In activated transport mode (ON) the drop alarm is inactive to avoid that too many drops are
detected due to vibrations.
U
User Manual Instruction for use
V
Volume calibration Measurement for detection and documentation the deviation of the infusion pump from the
normal value. On further operation of the infusion pump the detected deviation must be
taken into account.
Volume To Be Infused VTBI: Total volume
CODAN Companies
• Single use syringes
• Invasive blood pressure monitoring systems
• Infusion pumps
• Continence care products
CODAN Medizinische Geräte GmbH & Co KG · Deutschland • Other CODAN Products
CODAN pvb Critical Care GmbH · Deutschland
CODAN pvb Medical GmbH · Deutschland
Compliance of the established quality management systems with
CODAN PORTUGAL, S.A. · Portugal the provisions of EN ISO 13485 and the Council Directive 93/42/
CODAN 11, S.A. · Portugal EEC has been certified by the relevant, competent notified bodies.
CODAN US Corporation · California · USA Our products are thus entitled to bear the following marks:
CODAN Inc. · California · USA
CODAN NORGE AS · Norge
CODAN TRIPLUS AB · Sverige
CODAN Limited · Great Britain
CODAN FRANCE Sarl · France
CODAN Medical AG · Schweiz
CODAN ARGUS AG · Schweiz
CODAN BV · Nederland
CODAN s.r.l. · Italia
CODAN Medical GmbH · Österreich
CODAN Steritex ApS · Danmark
CODAN Medical ApS · Danmark
CODAN DEHA ApS · Danmark
14.600_C_SM_en_A616S
Manufacturer
CODAN ARGUS AG
Oberneuhofstrasse 10 · 6340 Baar, Switzerland
Tel. +41 (0) 41 785 09 44 · Fax +41 (0) 41 785 09 40
www.codanargus.com