Evita V500 Service Manual en

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Technical Documentation IPM

Workstation Critical Care


C500, V500, GS500, Trolley

Warning

All servicing and/or test procedures on the


device require detailed knowledge of this docu-
mentation. Use of the device requires detailed
knowledge and observance of the relevant
Instructions for Use.
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2 Workstation Critical Care


Table of contents

Table of contents

General 5
General notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Abbreviations 9
List of abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Function descriptions 13
General points about the workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Function descriptions pneumatic assembly 17
Pneumatic assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Gas metering module M1.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Basics of flow measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Explanation of the terms NTPD, BTPS and NTPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Inspiratory unit/safety valve unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Expiratory valve/expiratory flow sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Neonatal expiratory valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Calibration unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
PATO O2 sensor M12.4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Nebulizer/ejector option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Blower adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Function descriptions electronics 55
Electronic assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Battery NiMH M7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Power supply unit M7.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Fan unit fan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Power PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Therapy Control Unit PCB M16 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
SysCon PCB. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Main PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
„Connector” PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
OLED-Contact PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
OLED Controller PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
PVT Monitoring PCB M4.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
RFID PCB M21 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Valve drive M15.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Lift magnet M15.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
MCable-Mainstream CO2 sensor M11.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Heating fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Nurse call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Neo Flow PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
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Function description Infinity C500 113


Infinity C500 function description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Function description GS500 121
Gas supply unit GS500. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Annex 131

Workstation Critical Care 3


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4 Workstation Critical Care


General

This chapter contains general notes and definitions that are important for the
use of this documentation.

General notes .................................................................................................................................... 6


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Workstation Critical Care 5


General
General notes

General notes

Notes on use Read through the following notes thoroughly before applying this documenta-
tion.

Dräger reserves the right to make changes to the device and/or to this docu-
mentation without prior notice. This documentation is intended solely as an
information resource for experts, and will be updated only at their request.

Copyright and other pro- The content of this documentation, in particular its design, text, software,
tected rights technical drawings, configurations, graphics, images, data and their selection
and its composition and any amendments to it ("content") are protected by
copyright. The content must not (in whole or in part) be modified, copied, dis-
tributed, reproduced, republished, displayed, transmitted or sold without the
prior written consent of Dräger.

Definitions
WARNING!
An important advisory indicating a potentially hazardous situation which
may result in death or serious injury if not prevented.

CAUTION
An important advisory indicating a potentially hazardous situation which
may result in minor or moderate injury to the user or to patients or in dam-
age to the device or to other assets if not prevented.

NOTE
An additional advisory intended to avoid problems in using or servicing the
device.

Inspection = Identification of actual condition


Maintenance = Measures to maintain the speci-
fied condition
Repair = Measures to restore specified
condition
Servicing = Inspection, maintenance, repair
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6 Workstation Critical Care


General
General notes

Notes Read through each section thoroughly before beginning servicing. Always
use the correct tools and the specified test equipment. Otherwise the device
may not work correctly or may be damaged.

WARNING!
– Dräger recommends using original Dräger parts for servicing. Other-
wise the device's correct functioning could be compromised.
– Pay attention to the „Servicing“ section of the Instructions for Use.

CAUTION
Improper servicing.
Device not working or working incorrectly.
– Servicing may only be carried out by experts.

NOTE
Where reference is made to legislation, regulations and standards, in
respect of devices used and serviced in Germany they are based on the
laws of Germany. Users and technicians in other countries must comply
with their national laws and/or international standards.

CAUTION
Non-conforming test values.
Device not working or working incorrectly.
– Do not put the device into operation.
– Contact your local service organization.

CAUTION
Before carrying out any servicing, check that the device and its compo-
nents have been handed over by the user cleaned and disinfected.
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Workstation Critical Care 7


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8 Workstation Critical Care


Abbreviations

This section contains a list of the abbreviations used in this document.

List of abbreviations ........................................................................................................................... 10


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Workstation Critical Care 9


Abbreviations
List of abbreviations

List of abbreviations

Abbreviations
Abbreviation Explanation
ADC Analog/Digital Converter
APRV Airway Pressure Release Ventilation
ATC Automatic Tube Compensation
autoPPS automatic Proportional Pressure Support
bpm breaths per minute
BSP Board Support Package
BTPS Body Temperatur Pressure Saturated, measurements
referred to conditions of the patient's lung, body temper-
ature 37 °C, ambient pressure, water vapor saturated
gas
C Compliance
CDPOC Cross Domain Point of Care Application
' Psupp Pressure support Psupp setting relative to PEEP
DAC Digital/Analog Converter
dynamic PEEPi Positive end-expiratory pressure
EAST Electronic Accessory Signature Technology
EEPROM Electrically Erasable Programmable Read Only Memory
EMC Electro Magnetic Compatibility
f Respiratory rate
fEIT functional Electrical Impedance Tomography
FiO2 Inspiratory O2 concentration
FPGA Field Programmable Gate Array
FRC Free Residual Capacity
Heliox Gas mixture, mostly 79% helium, 21% oxygen
I: E Inspiratory-to-expiratory time ratio
ILV Independent Lung Ventilation
LVDS Low Voltage Differential Signaling
MEDIBUS Dräger communications protocol for medical devices
MMV Mandatory Minute Volume Ventilation
MV Minute Volume = product of the VT and f settings (VT x
f)
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MVi Inspiratory minute volume


NIF Measurement of Negative Inspiration Force
NIV Non-Invasive Ventilation (mask ventilation)
NTPD Normal Temperature Pressure Dry

10 Workstation Critical Care


Abbreviations
List of abbreviations

Abbreviation Explanation
OP Operational amplifier
Pa Pascal, unit of pressure; 1 mbar = 100 Pa = 1 hPa; 1 bar
= 100 kPa = 1000 hPa
PAN Patient Area Network
Paw Airway pressure
PI Product Integration
Pinsp Setting of the upper pressure level in Pressure Control
mode
PIP Measured inspiratory peak pressure
Pmax Setting of the maximum permitted airway pressure
Pmean Mean airway pressure
PPS Proportional Pressure Support
R Resistance
RFID Radio Frequency Identification
SC System Cable
SPI Serial Peripheral Interface
VG Volume Guarantee
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12 Workstation Critical Care


Function descriptions

This chapter contains descriptions of the device's technical functions.

General points about the workstation ................................................................................................ 14


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Workstation Critical Care 13


Function descriptions
General points about the workstation

General points about the workstation

Introduction The following provides a brief introduction to the workstation. The detailed
functionality of the electronic and pneumatic components is set out in the
function description “Elektronik“ and “Pneumatik“.

Design

Fig. 1 Front view of workstation

Item Designation
1 Display unit
2 Ventilation unit
3 Trolley option
4 Gas supply unit option
5 Power supply unit option
6 Nebulizer option
7 Humidifier option
8 Other devices and accessories from Dräger or third par-
ties (see accessories list)
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14 Workstation Critical Care


Function descriptions
General points about the workstation

Functional principle The modular workstations permit implementation of standardized treatment


processes and procedures in all areas of care. All functional units of a work-
station can be deployed in different care environments. The workstations are
configured according to customer requirements. They comprise monitoring
and control displays as well as additional units, devices or accessories.
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Workstation Critical Care 15


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16 Workstation Critical Care


Function descriptions pneumatic assembly

This chapter contains descriptions of the pneumatic components and of the


device's technical functions.

Pneumatic assembly .......................................................................................................................... 18


Gas metering module M1.3................................................................................................................ 23
Basics of flow measurement .............................................................................................................. 30
Explanation of the terms NTPD, BTPS and NTPS ............................................................................ 32
Inspiratory unit/safety valve unit......................................................................................................... 34
Expiratory valve/expiratory flow sensor ............................................................................................. 37
Neonatal expiratory valve .................................................................................................................. 40
Calibration unit ................................................................................................................................... 43
PATO O2 sensor M12.4..................................................................................................................... 46
Nebulizer/ejector option ..................................................................................................................... 49
Blower adapter................................................................................................................................... 52
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Workstation Critical Care 17


Function descriptions pneumatic assembly
Pneumatic assembly

Pneumatic assembly

Introduction The pneumatic components are actuated by the electronics and regulate the
ventilation pressure and ventilation flow to the patient. The following details
the design and function of the pneumatic assembly.

Design The pneumatic assembly consists of the following main components:

Fig. 2 Main pneumatic components

Item Designation Design


A Gas metering module M1.3 For a detailed description see Gas
metering module M1.3
B Inspiratory unit/safety valve For a detailed description see Inspi-
unit module ratory unit/safety valve unit
C Expiratory valve module For a detailed description see Expi-
ratory valve/expiratory flow sensor
D Expiratory flow sensor For a detailed description see Expi-
ratory valve/expiratory flow sensor
E Barometric pressure sensor The barometric pressure sensor is
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located on the PI Main PCB. For a


detailed description see Main PCB
F Pressure measurement mod- For a detailed description see PVT
ule, PVT Monitoring PCB Monitoring PCB M4.1
M4.1

18 Workstation Critical Care


Function descriptions pneumatic assembly
Pneumatic assembly

Item Designation Design


G Calibration unit module For a detailed description see Calib-
ration unit
H PATO-O2 sensor module The PATO O2 sensor M12.4 is pneu-
M12.4 matically connected via an attenuator
(1) to the calibration unit (G). For a
detailed description see PATO O2
sensor M12.4
I Nebulizer/ejector option For a detailed description see Nebu-
lizer/ejector option
J Attenuator The attenuator provides a laminar
flow of the mixed gas to the PATO O2
sensor M12.4.
K Blower adapter This blower adapter is only installed if
the gas supply unit option is fitted.

Functional principle

Fig. 3 Functional principle of the pneumatics

Item Designation Item Designation


1 Gas inlet - Air 15 Expiratory flow sensor (S4)
2 Gas inlet - O2 16 Barometric pressure sensor (S8)
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3 Air non-return valve (M1_3_CV1) 17 Calibration valve (V8) for inspiratory pres-
sure sensor (S9)
4 O2 non-return valve (M1_3_CV2) 18 Inspiratory pressure sensor (S9)
5 Air metering valve (M1_3_V1) 19 Calibration valve (V6) for expiratory pres-
sure sensor (S6)

Workstation Critical Care 19


Function descriptions pneumatic assembly
Pneumatic assembly

Item Designation Item Designation


6 O2 metering valve (M1_3_V2) 20 Expiratory pressure sensor (S6)
7 Gas mixing tank 21 PATO O2 sensor (S1)
8 Mixed gas metering valve (M1_3_V3) 22 Nebulizer outlet
9 Safety valve (V5) 23 Air pressure regulator (PR1)
10 Emergency expiratory valve (SV2) 24 O2 pressure regulator (PR2)
11 Emergency respiratory valve (SV3) 25 Nebulizer mixing valve (V10)
12 Patient's lung 26 Nebulizer switching valve (V9)
13 Expiratory valve (V16) 27 CO2 sensor (optional) (S5)
14 Non-return valve (CV5)

The gas metering module M1.3 (A) delivers the timed variable flow of a gas
mixture with adjustable O2 and air content. Gas from the (central) supply sys-
tem enters the device via the gas inlet ports for O2 and air (1, 2). Two non-
return valves (3, 4) prevent each gas from flowing back into the supply line of
the other. The gases are mixed in the tank (7), and the mixing process is con-
trolled by way of two regulated valves (5, 6). The delivered inspiratory flow is
controlled by way of a third regulated valve (8).

The blower adapter (K) connects the optionally fitted gas supply unit to the
gas metering module.

The inspiratory unit/safety valve unit module (B) comprises the safety
valve (9) and two non-return valves (10, 11). In normal operation the safety
valve is closed, so that the inspiratory flow passes from the gas mixing and
metering module to the patient (12). In the other operating states, such as
when the Infinity V500 is in Standby mode, the safety valve is open and per-
mits spontaneous inspiration through the emergency respiratory valve (11).
The emergency expiratory valve (10) provides a second channel for sponta-
neous expiration if the expiratory branch is blocked.

The expiratory valve module (C) consists of the expiratory valve (13) and a
non-return valve (14). The expiratory valve is a proportional valve, and its
purpose is to adjust the pressure in the respiratory system. The non-return
valve (14), in conjunction with the emergency air outlet valve (10), prevents
rebreathing during spontaneous breathing. The expiratory flow sensor (D,
15) measures the expiratory flow based on the hot-wire anemometry measur-
ing principle.

Conversion of the mass flow into a volumetric flow (BTPS) requires knowl-
edge of the ambient pressure. The ambient pressure is measured with the
barometric pressure sensor (E, 16).

The pressure in the respiratory system is measured by two independent pres-


sure sensors (18, 20). They together make up the pressure measurement
No.1012_0000000469_Publication

module (F). The pressure sensors are balanced cyclically. For that purpose,
the pressure sensors are vented to atmosphere via the two calibration valves
(17, 19). Together with an additional calibration valve for the O2 sensor (21),
the calibration valves make up the calibration unit (G).

20 Workstation Critical Care


Function descriptions pneumatic assembly
Pneumatic assembly

The PATO O2 sensor (H, 21) measures the inspiratory O2 concentration


based on a sidestream measuring principle. For calibration by the user in the
device check, the O2 sensor can be flushed with pure O2 from the tank (7).

For drug nebulizing, a pneumatic drug nebulizer can be connected to the


nebulizer gas outlet (22). To drive the drug nebulizer the Infinity V500 delivers
an intermittent gas flow comprising O2 and air. Cycling of the two gases
ensures that the variation from the preset O2 concentration remains within
the specified limits. The gas from the two gas inlet ports (1, 2) is throttled by
the pressure regulators (23, 24) for the purpose. The gases are cycled by
means of the nebulizer mixing valve (25). The nebulizer switching valve (26)
closes the nebulizer gas outlet when the nebulizer function is not active.

The nebulizer mixing valve, the nebulizer switching valve and the two pres-
sure regulators make up the optional nebulizer/ejector module (I).

The CO2 concentration of the respiratory gas can be measured with the
optional MCable-Mainstream CO2 sensor (27). The CO2 is measured in the
main stream based on an optical measuring principle.

The internal gas consumption figures of the V500 in standby mode are < 1
L/min AIR and < 2 L/min O2; in operating mode 2 L/min basic consumption
(gas mixture as per FiO2 setting) + ventilation dependent on minute volume
(gas mixture as per FiO2 setting).

The gas return flow of the device meets the requirements laid down in section
6 of the ISO 11195:1995 standard: "Gas mixers for medical use - single
devices".

Connections and inter- The following illustration show an overview of the existing pneumatic connec-
faces tions mentioned in the function description. For tubing and pneumatic dia-
grams see „Schematics and diagrams“.
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Fig. 4 Pneumatic connections of the Infinity V500

Item Designation Item Designation


1 Expiratory valve 4 Nebulizer port

Workstation Critical Care 21


Function descriptions pneumatic assembly
Pneumatic assembly

Item Designation Item Designation


2 Inspiratory unit with safety valve 5 Expiratory flow sensor
3 Safety valve gas inlet 6 Connection for AIR compressed gas tube
7 Connection for O2 compressed gas tube

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22 Workstation Critical Care


Function descriptions pneumatic assembly
Gas metering module M1.3

Gas metering module M1.3

Introduction The gas metering module M1.3 delivers the timed variable flow of a gas mix-
ture with adjustable O2 and air. The following details the design and function
of the gas metering module M1.3.

Design The gas metering module M1.3 forms a complete function unit and comprises
the following main components:

Fig. 5 Main components

Item Designation Design


1 Valve drive The valve drive controls the propor-
tional valve M1_3_V3 and is attached
to the housing of the gas outlet. The
upper diaphragm of the proportional
valve M1_3_V3 is also housed in the
valve drive.
2 M1.3 PCB The PCB includes the electronics for
the gas metering module.
3 Gas inlet housing The housing of the gas inlet incorpo-
rates the gas connections for O2 and
AIR/Heliox, the filters M1_3_F1/F2,
the metering unit M1_3_R1 and the
non-return valves M1_3_CV1 / CV2.
4 AIR/Heliox proportional valve The AIR/Heliox proportional valve is
located on the housing of the gas
inlet.
5 O2 proportional valve The O2 proportional valve is located
on the housing of the gas inlet.
6 AIR/Heliox flow sensor The flow sensor is located behind the
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cap.
7 O2 flow sensor The flow sensor is located behind the
cap.

Workstation Critical Care 23


Function descriptions pneumatic assembly
Gas metering module M1.3

Item Designation Design


8 Mixing tank The mixing tank is located between
the housings of the gas inlet and gas
outlet.
9 Cover Behind the cap are the gas inlets from
the O2, AIR/Heliox flow sensors, the
optional blower, and the gas feed to
the mixing tank.
10 Gas outlet housing In the housing of the gas outlet are
the lower diaphragm of the propor-
tional valve M_1_3_V3 and the flow
sensor M1_3_S3.

Functional principle

Fig. 6 Principle

Two proportional valves mix oxygen and air or Heliox (a mixture of helium
and oxygen) from a central compressed gas supply into a mixing tank based
on preset parameters. A proportional valve downstream of the mixing tank
meters the inspiratory flow from the tank to the patient.

Sensors measure the flow, pressure and temperature of the gases. Together
with the actuators of the valves, they form a control circuit for precise meter-
ing of the patient flow.

A blower can also be connected in place of the compressed gas supply.


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A printed circuit board (PCB) amplifies the measured values of the sensors,
converts them into digital signals (A/D converter) and delivers them to a
microprocessor system by way of the interface. A D/A converter and amplifier
are used to operate the valves and calibrate the flow sensors.

24 Workstation Critical Care


Function descriptions pneumatic assembly
Gas metering module M1.3

Pneumatics function The pneumatic system is supplied with gas via central supply ports or by an
optional blower. Proportional valves control the gas flow at the gas outlet.

Fig. 7 Pneumatic diagram

Item Designation Pneumatics function


M1_3_C1/C2 AIR/Heliox, O2 supply inlet Compressed air/Heliox and oxygen from a central
gas supply is connected to the ports M1_3_C1
and M1_3_C2.
M1_3_F1/F2 Filter The gas flows through the filters M1_3_F1/F2 to
the non-return valves.
M1_3_R1 Metering unit 0.7 L/min/6 bar The mechanical design of filters M1_3_F1 and
M1_3_R1 together forms a water trap for the
AIR/Heliox connection. A continuous flow of 0.7
L/min discharges any moistures by way of the
metering unit.
M1_3_CV1/CV2 Non-return valve From the non-return valves M1_3_CV1/ CV2 the
gas flows to the proportional valves M1_3_V1/V2.
M1_3_C4/C5 Additional AIR/Heliox and O2 outlet Options such as a nebulizer or ejector can be con-
nected to the auxiliary outlet C4. The port C5 is
used to calibrate the O2 sensor.
M1_3_V1/V2 Proportional valve The proportional valves meter air/Heliox and oxy-
gen into the tank according to the preset O2 con-
centration and the pressure in the mixing tank
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(200 to 400 mbar) (closed pressure control loop).


The flow of the proportional valves is measured by
the downstream flow sensors M1_3_S1/S2.
M1_3_F4/F5 Filter (component of flow sensor) The function of the two filters M1_3_F4/F5
upstream of the flow sensors is to keep the flow
steady.

Workstation Critical Care 25


Function descriptions pneumatic assembly
Gas metering module M1.3

Item Designation Pneumatics function


M1_3_S1/S2 AIR/Heliox and O2 flow sensor The flow sensors transmit the measured values to
the electronics unit, which then actuates the pro-
portional valves.
M1_3_F6/F7 Filter (wire mesh) The filters M1_3_F6/F7 downstream of the flow
sensors prevent crosstalk from the oxygen to the
air/Heliox flow sensor and vice versa.
M1_3_C3 Blower connection A blower can be connected to the inlet M1_3_C3.
In operation with a blower the pressure in the tank
is around 100 mbar.
M1_3_S4 Temperature sensor upstream of mixing To improve the accuracy of the flow measurement
tank at the flow sensor M1_3_S3, the temperature at
the inlet of the mixing tank (M1_3_S4) and at the
outlet of the proportional valve (M1_3_S6) is mea-
sured.
MC Mixing tank 0.5 L In the mixing tank the gases are intermingled to
form a homogeneous gas mixture.
M1_3_C7 Mixed gas outlet The outlet of the mixed gas is used to monitor and
regulate the O2 concentration.
M1_3_S7 Mixing tank pressure sensor The pressure sensor on the mixing tank transmits
the pressure to the electronics of the gas metering
module. If the pressure falls below the pressure
value preset by the electronics, the proportional
valves are opened according to the preset O2
concentration.
M1_3_F3 Filter (component of flow sensor) The filter M1_3_F3 ensures a uniform flow to the
flow sensor.
M1_3_S3 LPSV flow sensor With the flow sensor M1_3_S3 the flow to the
downstream proportional valve is measured and
the proportional valve M1_3_V3 is regulated
accordingly.
M1_3_V3 Proportional valve (LPSV = Low Presssure The (LPSV = Low Pressure Servo Valve) propor-
Servo Valve) tional valve M1_3_V3 actuated by the valve drive
M15.1 meters an inspiratory flow to the patient
according to the preset values.
M1_3_S6 Temperature sensor directly behind LPSV The temperature sensor S6 measures the temper-
ature behind the proportional valve and so the
temperature of the gas flow to the patient.
M1_3_S8 Temperature sensor behind LPSV The measured values from the temperature sen-
sor M1_3_S8 can be used to determine the
inspiratory gas temperature of other components.
The pressure sensor is also used to monitor
M1_3_S6.
M1_3_C6 Respiratory gas outlet The gas flows via the respiratory gas outlet to the
No.1012_0000000469_Publication

patient.
M1_3_C8 Inspiratory pressure sensor connection The optional inspiratory pressure sensor routes
the pressure signal outwards and can be used
there by other components.

26 Workstation Critical Care


Function descriptions pneumatic assembly
Gas metering module M1.3

Electronics function The electronics of the gas metering module comprises a printed circuit board
(M1.3 PCB). All sensors and valves apart from M1_3_S8 are operated by the
PCB.

Fig. 8 Block diagram, M1.3 PCB

Item Designation Electronics function


M1_3_S1 AIR/Heliox flow sensor Driver modules amplify the sensor signals and
forward them to A/D converters. The A/D con-
M1_3_S2 O2 flow sensor
verters convert the analog measured value
M1_3_S3 LPSV flow sensor into a digital value and make it available on a
bus system (LVDS=Low Voltage Differential
S5 Temperature sensor directly on PCB
Signaling). The signal of the pressure sensor
M1_3_S4 Temperature sensor upstream of mixing tank (M1_3_S7) is also available for external pres-
sure monitoring.
M1_3_S6 Temperature sensor directly behind LPSV
To calibrate the flow sensors (M1_3_S1,
M1_3_S7 Mixing tank pressure sensor M1_3_S2, M1_3_S3) the driver modules are
actuated by D/A converters.
M1_3_S8 Temperature sensor behind LPSV
M1_3_V1 Proportional valve The proportional valves (M1_3_V1, M1_3_V2,
M1_3_V3) are also actuated by D/A convert-
M1_3_V2 Proportional valve
ers which convert the digital signal into an
M1_3_V3 Proportional valve analog signal, and driver modules. The driver
modules can generally be enabled and dis-
abled, such as to switch all valves to a safe
state in the event of a fault.
EEPROM The EEPROM holds data such as the serial
number of the gas inlet, the flow sensors and
the valve drive M15.1. The EEPROM also
No.1012_0000000469_Publication

stores the correction factors and measured


values of the flow sensors.
Power supply The voltage supply to the PCB is 24 V DC. A
DC/DC converter generates from that the
operating voltages for the modules, such as
A/D converters etc.

Workstation Critical Care 27


Function descriptions pneumatic assembly
Gas metering module M1.3

Item Designation Electronics function


LVDS LVDS is an abbreviation for Low Voltage Dif-
ferential Signaling. LVDS uses a differential
data transfer and reduces the number of
cables. Instead of a defined voltage for Low or
High, LVDS specifies a voltage difference.
This protects the transfer against external
interference. Any interference voltage is
detected as a DC voltage offset and sup-
pressed by the receiver. To attain a high data
rate and keep down the demands made on the
voltage supply, LVDS applies a voltage excur-
sion of 345 mV (typical).

Connections and inter- The following illustration show an overview of the existing pneumatic and
faces electronic interfaces mentioned in the function description.

Fig. 9 Pneumatic and electrical interfaces


No.1012_0000000469_Publication

Item Pneumatic interfaces Item Electrical interfaces


5 M1_3_C3 Blower connection 1 M1_3_V3 Proportional valve
8 M1_3_C4 Auxiliary AIR/Heliox connection 2 M1_3_V2 O2 proportional valve
10 M1_3_C1 Central supply AIR/Heliox connection 3 M1_3_V1 AIR/Heliox proportional valve

28 Workstation Critical Care


Function descriptions pneumatic assembly
Gas metering module M1.3

14 M1_3_C2 Central supply O2 connection 4 Electrical interface to the product


15 M1_3_C5 Auxiliary O2 connection 6 M1_3_S6 Temperature sensor at respiratory gas
outlet
16 M1_3_S7 Mixing tank pressure sensor connec- 7 M1_3_S4 Mixing tank temperature sensor
tion
17 M1_3_C7 Test gas measurement connection 9 M1_3_S7 Pressure sensor for pressure in mixing
tank
19 M1_3_C6 Respiratory gas outlet 11 M1_3_S1 AIR/Heliox flow sensor
20 M1_3_C8 Pressure sensor connection 12 M1_3_S2 O2 flow sensor
13 M1_3_S3 Proportional valve flow sensor
(M_1_3_V3)
18 M1_3_S8 Temperature sensor
No.1012_0000000469_Publication

Workstation Critical Care 29


Function descriptions pneumatic assembly
Basics of flow measurement

Basics of flow measurement

Introduction Flow measurement in Dräger devices works on the principle of hot-wire ane-
mometry. Heat is extracted from a hot-wire sensor by a gas flow. The
extracted heat is a measure for the intensity of the gas flow. The following text
describes the design and the functional principle.

Design

Fig. 10 Flow sensor for flow measurement

Functional principle

Fig. 11 Simplified block diagram of flow measurement


No.1012_0000000469_Publication

The hot-wire sensor contains two thermistors (platinum wires) which are
exposed to the gas flow being measured. Both wires have virtually the same
cold resistance. Appropriate wiring configuration produces a measuring
bridge.

30 Workstation Critical Care


Function descriptions pneumatic assembly
Basics of flow measurement

At a flow of 0 L/min, a high flow courses through the one bridge branch and
heats the platinum wire in the „hot“ branch to around 180°C. Only a low flow
courses through the other platinum wire in the „cold“ branch, so that the plati-
num wire is barely heated and is used for temperature compensation.

The measuring bridge is balanced when the resistor ratios in both branches
of the bridge are identical. This is the case when the temperature of the hot
platinum wire is constant. If heat is extracted from the „hot“ platinum wire by
gas flow, the measuring bridge feed control increases the heat flow in order to
keep the temperature constant.

The voltage drop caused by the heat flow of the „hot“ platinum wire at the
15 : resistor is a measure for the gas flow. When the bridge is balanced, and
at a flow of 0 L/min, the voltage at the 15 : resistor is 1.01 V. The higher the
gas flow, the more heat is extracted from the hot platinum wire. This causes
the heat flow to rise and the voltage drop at the 15 : resistor.

Since the hot-wire sensors have resistance tolerances due to the manufactur-
ing process and ageing, they must be balanced individually. For this, in the
„cold“ branch of the bridge the resistance Rcal. is fed with a voltage propor-
tional to the measured voltage. The proportionality factor is set with a D/A
converter. This means the total resistance in the cold branch of the bridge is
variable, and resistance tolerances of the platinum wires can be compen-
sated.
No.1012_0000000469_Publication

Workstation Critical Care 31


Function descriptions pneumatic assembly
Explanation of the terms NTPD, BTPS and NTPS

Explanation of the terms NTPD, BTPS and NTPS

Introduction NTPD, BTPS and NTPS are terms in ventilation which define the ambient
conditions for the breathing volume.

NTPD = Normal Temperature, Pressure, Dry


BTPS = Body Temperature, Pressure, Saturated
NTPS = Normal Temperature, Pressure, Saturated

The volume absorbed by a gas depends on the ambient temperature, pres-


sure and relative humidity. In ventilation this is indicated by the terms NTPD,
BTPS and NTPS. The terms, and how they inter-relate, are explained in the
following.

NTPD In ventilator technology, medical gases are metered from cylinders or from a
central supply system under normal pressure, meaning the inspiratory gas
emerges at the inspirator port under the following conditions:
– 20 °C ambient temperature
– Normal air pressure
– 0% rel. humidity

Volume measurements under these conditions are indicated as NTPD.

BTPS In lung physiology, breath volumes and minute volumes are referred to the
ambient temperatures in the lung, i.e.
– 37 °C body temperature
– Normal air pressure
– 100% rel. humidity

Volume measurements under these conditions are indicated as BTPS.

NTPS With regard to expiratory gas, passing through a flow sensor for example, the
following basic characteristics are applied:
– 20 °C ambient temperature
– Normal air pressure
– 100% rel. humidity

Volume measurements under these conditions are indicated as NTPS.


No.1012_0000000469_Publication

Sensitivities The difference in measured values between NTPD and BTPS is about 12%.
If a ventilator delivers 500 mL breath volume under NTPD-Bedingungen for
example, the resultant supply under BTPS conditions (heating to 37°C and
humidification to a relative humidity of 100%) in the lung is approximately 564

32 Workstation Critical Care


Function descriptions pneumatic assembly
Explanation of the terms NTPD, BTPS and NTPS

mL. This difference must be taken into account in application of the breath
volume. Ventilators meters the breath volume generally so that the preset
breath volume is active in the lung under BTPS-Bedingungen.

Apart from the 100% relative humidity, the expiratory volume measurement
relates to gas measured under normal conditions (NTPS). Since different
conditions to those in the lung prevail here (BTPS), the measured volume
must be assigned a correction factor. As a result, the volume displayed is that
which was actually present in the lung.
No.1012_0000000469_Publication

Workstation Critical Care 33


Function descriptions pneumatic assembly
Inspiratory unit/safety valve unit

Inspiratory unit/safety valve unit

Introduction The inspiratory unit/safety valve unit houses the valves (SV2, SV3) and the
safety valve (V5). The inspiratory tube to the patient is connected to this unit.

The following details the design and function of the inspiratory unit/safety
valve unit.

Design The inspiratory unit/safety valve unit comprises the following main compo-
nents:

Fig. 12 Main components of the inspiratory unit/safety valve unit

Item Designation Design


1 Inspiratory unit/safety valve The inspiratory unit/safety valve unit
unit is a complete unit locked into the con-
nector plate on the front of the Evita
Infinity V500.
2 Neonatal inspiratory The neonatal inspiratory unit/safety
unit/safety valve unit valve unit is fitted with a smaller-
diameter socket, though its function is
identical to the standard inspiratory
unit/safety valve unit.
SV2 Emergency expiratory The emergency expiratory valve
valve (SV2) is housed in the inspiratory
No.1012_0000000469_Publication

unit/safety valve unit.


SV3 Emergency respiratory The emergency respiratory valve
valve (SV3) is housed in the inspiratory
unit/safety valve unit.

34 Workstation Critical Care


Function descriptions pneumatic assembly
Inspiratory unit/safety valve unit

Item Designation Design


V5 Safety valve The safety valve (V5) is housed in the
inspiratory unit/safety valve unit and
is mechanically connected to the lift
magnet (M15.2).
M15.2 Lift magnet The lift magnet (M15.2) opens or
closes the safety valve (V5). The lift
magnet is attached to the connector
plate.

Pneumatics function

Fig. 13 Pneumatic diagram of the inspiratory unit/safety valve unit

Designation Pneumatics function


Inspiratory In normal operation the safety valve (V5) is closed by the
unit/safety valve lift magnet (M15.2). In the following operating states the
unit safety valve (V5) is opened:
– Overpressure in gas mixing tank of gas mixing mod-
ule M1.3
– Reboot of Therapy Control Unit PCB M16
– In Standby mode
– Partially in the device check
– During therapy “Paw High” + 2 to 5 mbar
– If M1.3 is not able to deliver any flow (no gas supply
connected)
– At a negative pressure of -4 mbar
– At a positive pressure of 115 mbar
Spontaneous When the safety valve (V5) is open, spontaneous inspi-
No.1012_0000000469_Publication

inspiration ration via the ports (C8), (SU1), the safety valve (V5),
the emergency respiratory valve (SV3) and the opening
(SU2) is possible. This circuit is the classic emergency
inspiratory valve configuration.

Workstation Critical Care 35


Function descriptions pneumatic assembly
Inspiratory unit/safety valve unit

Designation Pneumatics function


Spontaneous When the safety valve (V5) is open, spontaneous expira-
expiration tion via the ports (C8), (SU1), the safety valve (V5), the
emergency expiratory valve (SV2) and the opening
(SU3) is possible. This circuit is the classic emergency
expiratory valve configuration.

Connections and inter- The following illustration show an overview of the existing pneumatic and
faces electrical interfaces mentioned in the function description.

Fig. 14 Pneumatic and electrical interfaces

Pneumatic interfaces Electrical interfaces


C8 Connection for inspiratory M15.2 Lift magnet (M15.2) to Con-
ventilation tube nector PCB
M1.3- Inspiratory unit/safety valve
C6 unit connection to gas mixing
module M1.3
SU1 Transition to valve (V5)
SU2 Opening for safety valve
(SV3) against atmosphere
SU3 Opening for safety valve
(SV2) against atmosphere
No.1012_0000000469_Publication

36 Workstation Critical Care


Function descriptions pneumatic assembly
Expiratory valve/expiratory flow sensor

Expiratory valve/expiratory flow sensor

Introduction The expiratory valve (1) houses the expiratory flow sensor (S4), the valve
(V16), the non-return valve (CV5), the filter (F8) and the water trap (W2). The
expiratory tube from the patient is connected to this unit.

The following details the design and function of the expiratory valve.

Design The expiratory valve consists of the following main components:

Fig. 15 Main components of the expiratory valve

Item Designation Design


1 Expiratory valve/expiratory The expiratory valve with the expira-
flow sensor tory flow sensor forms a complete
pneumatic unit, and locked onto the
connector plate on the front of the
Evita Infinity V500.
CV5 Non-return valve The non-return valve is located in the
expiratory branch of the expiratory
valve to the flow sensor.
F8 Filter The filter is installed in the expiratory
valve.
M15.1 Valve drive The valve drive (M15.1) is mechani-
cally connected to the valve (V16).
The valve (V16) controls the expira-
tory flow/pressure.
S4 Expiratory flow sensor The expiratory flow sensor is located
in the expiratory branch of the expira-
tory valve.
No.1012_0000000469_Publication

S23 Flow switch (not shown) The flow switch is located on the con-
nector plate behind the flow sensor,
and is used to detect the position of
the flow sensor.

Workstation Critical Care 37


Function descriptions pneumatic assembly
Expiratory valve/expiratory flow sensor

Item Designation Design


V16 Valve (crater/diaphragm) The valve (V16) is mounted on the
expiratory valve.
W2 Water trap The water trap (W2) is mounted
beneath the expiratory valve.

Pneumatics function

Fig. 16 Pneumatic diagram, expiratory valve/expiratory flow sensor

Designation Pneumatics function


Expiratory valve The valve (V16) in the expiratory valve regulates the
expiratory flow/pressure. The valve is mechanically con-
nected to the valve drive (M15.1), which is electrically
operated via the Connector PCB.
Expiration During expiration, die breathed-out air flows via the port
(C11), the valve (V16), the non-return valve (CV5), the
filter (F8) and the expiratory flow sensor (S4) into the
atmosphere.
Expiratory flow The expiratory flow sensor measures the flow during the
measurement expiration phase. The flow sensor (S4) is electrically
connected to the M4.1 PV-Monitoring PCB, which trans-
mits the measurement results to the ventilation controller
of the Evita Infinity V500.

The microswitch (S23), which is connected to the PI


Main PCB, transmits the correct horizontal position of
the flow sensor.
Water trap The water trap (W2) captures the condensation water
No.1012_0000000469_Publication

which occurs during expiration in the expiratory valve.


Expiratory pres- For the expiratory pressure measurement the pressure
sure measure- is transmitted via the port (C6) and (EV1) and the cali-
ment bration unit to the PV-Monitoring PCB M4.1. The mea-
surement results are transmitted to the ventilation
controller of the Evita Infinity V500.

38 Workstation Critical Care


Function descriptions pneumatic assembly
Expiratory valve/expiratory flow sensor

Connections and inter- The following illustration show an overview of the existing pneumatic and
faces electrical interfaces mentioned in the function description.

Fig. 17 Pneumatic and electrical interfaces

Item Pneumatic interfaces Item Electrical interfaces


C6- Connection for pressure mea- M15.1 Valve drive (M15.1) to
EV1 surement Connector PCB
C5- Optional ejector connection S4 Flow sensor (S4) to PV-
EV2 for expiratory valve (HFV) Monitoring PCB M4.1
C11 Ventilation tube connection S23 Flow sensor switch to Con-
port nector PCB (not shown)
No.1012_0000000469_Publication

Workstation Critical Care 39


Function descriptions pneumatic assembly
Neonatal expiratory valve

Neonatal expiratory valve

Introduction The neonatal expiratory valve (1) with the ejector (E) houses the sound
absorber (SA), the valve (V17), the check valves/non-return valves (CV6) and
(CV9), and the water trap (W3). The expiratory tube from the patient is con-
nected to the neonatal expiratory valve.

The following details the design and function of the neonatal expiratory valve.

Design The neonatal expiratory valve consists of the following main components:

Fig. 18 Main components of the neonatal expiratory valve

Item Designation Design


1 Neonatal expiratory valve The neonatal expiratory valve with
the sound absorber is locked on the
front of the ventilation unit connector
plate.
CV6 Non-return valve The non-return valve is located in the
expiratory branch of the neonatal
expiratory valve to the sound
absorber.
CV9 Non-return valve The non-return valve is housed in the
supply line to the ejector.
E Ejector The ejector is located in the neonatal
expiratory valve.
M15.1 Valve drive The valve drive (M15.1) is mechani-
cally connected to the valve (V17).
The valve (V17) controls the expira-
No.1012_0000000469_Publication

tory flow/pressure.
SA Silencer The sound absorber is positioned
downstream of the neonatal expira-
tory valve.
V17 Valve (crater/diaphragm) The valve (V17) is positioned in the
neonatal expiratory valve.

40 Workstation Critical Care


Function descriptions pneumatic assembly
Neonatal expiratory valve

Item Designation Design


W3 Water trap The water trap (W3) is mounted
beneath the neonatal expiratory
valve.

Pneumatics function

Fig. 19 Pneumatic diagram of neonatal expiratory valve

Designation Pneumatics function


Expiratory valve The valve (V17) in the expiratory valve regulates the
expiratory flow/pressure. The valve is mechanically con-
nected to the valve drive (M15.1), which is electrically
operated via the Connector PCB.
Expiration During expiration, die breathed-out air flows via the port
(C11), the ejector (E), the valve (V17), the non-return
valve (CV6) and the sound absorber (SA) to the atmo-
sphere.

The ejector (E) generates the necessary vacuum for


HFO mode. The ejector is supplied with propellant gas
via the connection (EV2), the connection (C5) and the
non-return valve (CV9).

The sound absorber (SA) reduces disturbing noise dur-


ing expiration.
Inspiratory and The inspiratory and expiratory flow is measured via the
expiratory flow neonatal flow sensor on the Y-piece.
measurement
Water trap The water trap (W3) captures the condensation water
which occurs during expiration in the expiratory valve.
Expiratory pres- For the expiratory pressure measurement the pressure
No.1012_0000000469_Publication

sure measure- is transmitted via the port (C6) and (EV1) and the cali-
ment bration unit to the PV-Monitoring PCB M4.1. The mea-
surement results are transmitted to the ventilation
control.

Workstation Critical Care 41


Function descriptions pneumatic assembly
Neonatal expiratory valve

Connections and inter- The following illustration show an overview of the existing pneumatic and
faces electrical interfaces mentioned in the function description.

Fig. 20 Pneumatic and electrical interfaces

Item Pneumatic interfaces Item Electrical interfaces


C6- Connection for pressure mea- M15.1 Valve drive (M15.1) to
EV1 surement Connector PCB
C5- Ejector connection for expira-
EV2 tory valve (HFO)
C11 Ventilation tube connection
port

No.1012_0000000469_Publication

42 Workstation Critical Care


Function descriptions pneumatic assembly
Calibration unit

Calibration unit

Introduction The calibration unit houses the valves (V6, V8, V15) for calibration of the
pressure sensor Pinsp and the pressure sensor Pexsp and the pressure sen-
sor (S2). The calibration unit is connected by tubes to the sensors. Mixed gas
is passed on to the TGI (Tracheal Gas Insufflation) option.

The following details the design and function of the calibration unit.

Design The calibration unit consists of the following main components:

Fig. 21 Main components of the calibration unit

Item Designation Design


1 Calibration unit The calibration unit comprises a
housing in which the valves V6, V8
and V15 and the pressure sensor S2
are installed.
S2 Pressure sensor The pressure sensor is mounted on
the calibration unit and connected
electrically with the Connector PCB.
V6 Valve The valves are mounted on the cali-
bration unit and connected electrically
V8 Valve
with the Connector PCB.
V15 Valve
No.1012_0000000469_Publication

Workstation Critical Care 43


Function descriptions pneumatic assembly
Calibration unit

Pneumatics function

Fig. 22 Schematic diagram of the calibration unit pneumatic components

Designation Pneumatics function


O2 sensor circuit Mixed gas flows from the gas mixing module M1.3 via
the port (CU8), the filter (F14), the metering unit (R14),
the valve (V15) and the port (CU3) to the O2 sensor.

To calibrate the O2 sensor with pure oxygen, during the


Device Check pure oxygen is connected to the port
(CU8) from the gas mixing module M1.3.
Without nebu- If no nebulizer/ejector option is installed, O2 central sup-
lizer/ejector ply pressure from gas mixing module M1.3 is connected
option via the port (CU2), the filter (F11) on the pressure sensor
(S2).
With nebu- If the nebulizer/ejector option is installed, the tubing
lizer/ejector between the gas mixing module M1.3 and the nebu-
option lizer/ejector option can be checked using the calibration
unit.

Depending on the setting of the valve (V10) on the nebu-


lizer/ejector option, O2/air flows via the port (CU2), the
valve (V15) and port (CU3) to the O2 sensor. The pres-
sure sensor (S2) measures the pressure at the port
(CU2).
Pinsp circuit The inspiratory pressure Pinsp from the gas mixing mod-
ule M1.3 passes via the port (CU6), the valve (V8) and
the port (CU7) to the pressure sensor (S9). For the cali-
bration the valve (V8) switches and atmospheric pres-
No.1012_0000000469_Publication

sure is connected to the pressure sensor via the port


(CU7).
Pexsp circuit The expiratory pressure Pexsp from the expiration valve
passes via the port (CU4), the valve (V6) and the port
(CU5) to the pressure sensor (S6). For the calibration
the valve (V6) switches and atmospheric pressure is
connected to the pressure sensor via the port (CU5).

44 Workstation Critical Care


Function descriptions pneumatic assembly
Calibration unit

Designation Pneumatics function


Flush flow The metering unit (R7) provides a continuous flow to
prevent the calibration unit from being contaminated with
breathing gas via the port (CU4).

Connections and inter- The following illustration show an overview of the existing pneumatic and
faces electrical interfaces mentioned in the function description.

Fig. 23 Pneumatic and electrical interfaces

Pneumatic interfaces Electrical interfaces


CU1 Option not used 1 Valve V8 to Connector PCB
CU2 O2 in from nebulizer/ejector 2 Valve V15 to Connector PCB
option or gas mixing module
M1.3
CU3 To O2 sensor 3 Valve V6 to Connector PCB
CU4 Pexsp. in from expiratory 4 Pressure sensor S2 to Con-
valve nector PCB
CU5 Pexsp out to Monitoring PCB
M4.1
CU6 Pinsp. in from gas mixing
module M1.3
CU7 Pinsp out to Monitoring PCB
M4.1
CU8 Mix from gas mixing module
No.1012_0000000469_Publication

M1.3

Workstation Critical Care 45


Function descriptions pneumatic assembly
PATO O2 sensor M12.4

PATO O2 sensor M12.4

Introduction The PATO O2 sensor M12.4 measures the oxygen concentration of a flowing
mixed gas.

The following details the design and function of the PATO O2 sensor M12.4.

Design The PATO O2 sensor M12.4 consists of the PATO SA MC PCB, PATO SA SH
PCB, and the PATO sensor head. These assemblies are contained in a hous-
ing.

Fig. 24 PATO O2 sensor M12.4

Item Designation
1 PATO sensor head
2 Housing with PCBs

PATO sensor head The PATO sensor head contains two electromagnets, one cuvette, and one
sensor element. The cuvette itself contains a gas channel and a measure-
ment compartment. No.1012_0000000469_Publication

Fig. 25 PATO sensor head design

Item Designation
1 Electromagnets
2 Sensor element

46 Workstation Critical Care


Function descriptions pneumatic assembly
PATO O2 sensor M12.4

Item Designation
3 Cuvette
4 Electromagnets

Sensor element The sensor element has a heating element and a thermoelement.

Fig. 26 Sensor element

Item Designation
1 Measurement compartment (part of the cuvette)
2 Heating element and thermoelement assembly
3 Gas channel (part of the cuvette)

Functional principle
Principle The PATO O2 sensor M12.4 uses the fact that oxygen molecules have a
stronger paramagnetic characteristic (attracted to a magnetic field) than the
molecules of other gases. The oxygen molecules' orientation changes the
thermal conductivity of the gas mixture The change in the thermal conductiv-
ity is used to determine the oxygen content.
No.1012_0000000469_Publication

Fig. 27 Oxygen molecules' orientation in a magnetic field

Function The gas mixture to be measured continuously flows through the gas channel.
In the measurement compartment the gas mixture is only exchanged by diffu-
sion, that is, there is no active flow.

Workstation Critical Care 47


Function descriptions pneumatic assembly
PATO O2 sensor M12.4

The heating element in the PATO sensor element heats the gas mixture and
the thermoelement measures the temperature.

The electromagnets generate a magnetic field which changes constantly. The


oxygen molecules align with this magnetic field thus reducing the thermal
conductivity of the gas mixture. This also changes the temperature at the
thermoelement. This change in temperature is proportional to the oxygen
content of the gas mixture.

The measuring and control signals are amplified and then converted into dig-
ital signals, or vice versa, by means of an AD/DA converter. A microcontroller
system on the PATO SA MC PCB corrects these measured values and deliv-
ers them to the medical product via an RS232 interface.

The EEPROM on the PAT SA SH PCB contains the sensor's calibration data.

The voltage supply to the PATO O2 sensor M12.4 is 10 V to 36 V.

Fig. 28 Block diagram

Connections and inter-


faces

Fig. 29 Connections
No.1012_0000000469_Publication

Item Designation
1 Socket connector (RS232 and operating voltage)
2 Pneumatic outlet (inlet is on the opposite side of the sen-
sor head)

48 Workstation Critical Care


Function descriptions pneumatic assembly
Nebulizer/ejector option

Nebulizer/ejector option

Introduction The nebulizer/ejector option houses the valves (V9, V10, V12) and the pres-
sure regulators (PR1, PR2) and pneumatically supplies the drug nebulizer
and the ejector of the expiratory valve HFV (High Frequency Ventilation) with
driving gas. The nebulizer/ejector option is connected via tubing to the ports
for the drug nebulizer and the ejector.

The following details the design and function of the nebulizer/ejector option.

Design The nebulizer/ejector option comprises the following main components:

Fig. 30 Main components of the nebulizer/ejector option

Item Designation Design


1 Nebulizer/ejector option The nebulizer/ejector option consists
of a housing on which the valves V9,
V10 and V12 and the pressure regu-
lators (PR1, PR2) are installed.
PR1 Air pressure regulator The Air pressure regulator is mounted
on the nebulizer/ejector option.
PR2 O2 pressure regulator The O2 pressure regulator is
mounted on the nebulizer/ejector
option.
V9 Valve The valves are installed in the hous-
ing of the nebulizer/ejector option and
V10 Valve
electrically connected to the Connec-
V12 Valve tor PCB.
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Workstation Critical Care 49


Function descriptions pneumatic assembly
Nebulizer/ejector option

Pneumatics function

Fig. 31 Pneumatic diagram of the nebulizer/ejector option

Designation Pneumatics function


Driving gas O2, Oxygen flows from the gas mixing module M1.3 via the
Air port (NE4) and the pressure regulator (PR2) to the nebu-
lizer mixing valve (V10). The pressure regulator regu-
lates the downstream pressure to 2 bar.

Air flows from the gas mixing module M1.3 via the port
(NE5) and the pressure regulator (PR1) to the nebulizer
mixing valve (V10). The pressure regulator regulates the
downstream pressure to 2 bar.

The nebulizer mixing valve (V10) delivers an intermittent


gas flow comprising O2 and AIR. By cycling the two
gases, the variation from the preset O2 concentration is
minimized.

The 40 mL/min metering unit ensures that pipeline sup-


ply pressure can be built up when valves (V9, V12) are
closed and valve (V10) is leaking.
Nebulizer The mixed gas flows via the valve (V9) and the metering
unit (R10) at a continuous flow rate of 10 L/min at 2 bar
via the port (NE2) to the nebulizer outlet C4 on the Evita
Infinity V500.
Ejector The mixed gas flows via the valve (V12) and the port
(NE1) to the ejector of the expiratory valve HFV (High
Frequency Ventilation) option.
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50 Workstation Critical Care


Function descriptions pneumatic assembly
Nebulizer/ejector option

Connections and inter- The following illustration show an overview of the existing pneumatic and
faces electrical interfaces mentioned in the function description.

Fig. 32 Pneumatic and electrical interfaces

Pneumatic interfaces Electrical interfaces


NE1 Ejec. to Evita Infinity V500 ejector port 1 Valve V10 to Connector PCB
NE2 Neb. to Evita Infinity V500 nebulizer port 2 Valve V9 to Connector PCB
NE3 Cal. to calibration unit 3 Valve V12 to Connector PCB
NE4 O2 in from gas metering module M1.3
NE5 Air in from gas metering module M1.3
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Function descriptions pneumatic assembly
Blower adapter

Blower adapter

Introduction The blower adapter connects the gas supply unit to the ventilation unit and
prevents the O2 enriched respiratory gas from flowing out of the mixing tank
of the ventilation unit gas metering module into the gas supply unit.

Design The blower adapter consists of the following main components:

Fig. 33 Main components of the blower adapter

Item Designation Design


1 Blower adapter The blower adapter consists of a
housing containing the non-return
valves CV4 and CV8.

Pneumatics function

Fig. 34 Pneumatic diagram of blower adapter

Designation Pneumatics function


Gas supply Air flows from the gas supply unit via the port C3, the
non-return valves CV8 and CV4 and the port BA1 to the
gas metering module of the ventilation unit.
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Vent hole The vent hole prevents pressure build-up in the blower
adapter if non-return valve CV4 is leaking, as this would
impair the functioning of non-return valve CV8.

52 Workstation Critical Care


Function descriptions pneumatic assembly
Blower adapter

Connections and inter- The following illustration show an overview of the existing pneumatic inter-
faces faces mentioned in the function description.

Fig. 35 Pneumatic interfaces

Pneumatic interfaces
C3 Connection to gas supply unit 1 Vent hole
BA2
BA1 Connection to gas metering
unit M1.3
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Function descriptions pneumatic assembly
Blower adapter

– This page has been intentionally left blank –

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54 Workstation Critical Care


Function descriptions electronics

This section contains descriptions of the device's electronic components.

Electronic assembly ........................................................................................................................... 56


Battery NiMH M7................................................................................................................................ 60
Power supply unit M7.3...................................................................................................................... 63
Fan unit fan ........................................................................................................................................ 66
Power PCB ........................................................................................................................................ 68
Therapy Control Unit PCB M16 ......................................................................................................... 72
SysCon PCB ...................................................................................................................................... 75
Main PCB ........................................................................................................................................... 77
„Connector” PCB................................................................................................................................ 83
OLED-Contact PCB ........................................................................................................................... 86
OLED Controller PCB ........................................................................................................................ 88
PVT Monitoring PCB M4.1................................................................................................................. 91
RFID PCB M21 .................................................................................................................................. 94
Valve drive M15.1 .............................................................................................................................. 97
Lift magnet M15.2 .............................................................................................................................. 101
MCable-Mainstream CO2 sensor M11.1 ........................................................................................... 103
Heating fan......................................................................................................................................... 106
Nurse call ........................................................................................................................................... 108
Neo Flow PCB ................................................................................................................................... 109
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Workstation Critical Care 55


Function descriptions electronics
Electronic assembly

Electronic assembly

Introduction The electronics actuate the pneumatic components and regulate and monitor
the ventilation pressure and flow to the patient. The following details the
design and function of the electronic assembly.

Design The electronic assembly consists of the following main components:

Fig. 36 Main electronic components

Item Designation Design


1 Battery NiMH M7 For a detailed function description
see Battery NiMH M7
2 Power supply module M7.3 For a detailed function description
see Power supply unit M7.3
3 Power PCB For a detailed function description
see Power PCB
4 Therapy Control Unit PCB For a detailed function description
M16 see Therapy Control Unit PCB M16
5 SysCon PCB For a detailed function description
see SysCon PCB
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6 Main PCB For a detailed function description


see Main PCB
7 Connector PCB For a detailed function description
see „Connector” PCB

56 Workstation Critical Care


Function descriptions electronics
Electronic assembly

Item Designation Design


8 OLED-Contact PCB For a detailed function description
see OLED-Contact PCB
9 RFID PCB M21 For a detailed function description
see RFID PCB M21
10 PVT Monitoring PCB M4.1 For a detailed function description
see PVT Monitoring PCB M4.1
11 Neo Flow PCB The Neo Flow PCB is only installed
when the ventilation unit has been
converted to the Babylog VN500. For
a detailed function description see
“LP Neo Flow“
12 Interface box This interface box is only installed if
the gas supply unit option is fitted.

Functional principle
Connector PCB The electronic assembly is isolated by seals from the pneumatic assembly.
This prevents leaking oxygen from penetrating the electronics in the event of
a fault and causing the device to burn out due to sparking. The connecting
link between the pneumatics and the electronics is the Connector PCB, on
which the wiring of the actuators and pneumatic modules is connected and
looped-through.

Main PCB The core of the electronic assembly is the Main PCB. The Main PCB delivers
all the required electrical functions not covered by peripheral modules, e.g.:
– On/Off logic
– Control/monitoring of the piezo alarm
– Evaluation/processing of sensor signals
– Valve drivers
– Interfaces for modules and for product integration components
– Voltage monitoring for the individual modules

The EEPROM of the Main PCB contains the serial numbers of the device, the
valve drive M15.1 and the lift magnet M15.2 as well as data from the device
check. For security reasons, this data is mirrored in the EEPROM of the
Power PCB. The EEPROM of the Main PCB is the master, meaning that
when the Power PCB is replaced the data from the Main PCB is automatically
imported into it.

All software options belonging to the device are stored on the Main PCB on a
Smart Card.

The function of the piezo alarm is checked by way of the „GC Test“ signal to
the piezo circuit. A short pulse from the Gold Cap controls the piezo buzzer.
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The current through the piezo buzzer is measured via the „IPZ Flag“ wire.
The current level provides an indication of function capability. By way of the
„PzSync“ wire the interval frequency of the piezo alarm is measured.

Workstation Critical Care 57


Function descriptions electronics
Electronic assembly

If the pressure in the tank of the gas metering module M1.3 rises to a value
>600 mbar due to a fault, the „over pressure“ signal is generated and triggers
a shut-off of all valves via the „PI Release Logic“. In this process, the safety
valve and the expiratory valve are opened so that the patient's lung is venti-
lated.

Power PCB To make room on the Main PCB for additional circuitry components, a portion
of the voltage supply is relocated from the Main PCB to the Power PCB. The
following voltages are generated on the Power PCB, with readiness indicated
by green LEDs:

– exter- +5 V
nal
– +7 V
– +12 V
– +15 V
– -15 V

SysCon PCB The SysCon PCB provides the connection between the system cable and the
„IFLAN“ and „RS232 User“ ports on the rear of the device. In addition, the
„Nurse Call“ connection on the Main PCB and the „Nurse Call“ port on the
rear of the device are also interconnected.

OLED Controller PCB with The OLED Controller receives its data from the Therapy Control Unit PCB
display M16. During operation, the MV and the O2 concentration are displayed
together with a bar graph for the breaths. This provides a function monitor if
the display unit is replaced while in operation.

OLED-Contact PCB The OLED-Contact PCB provides the connection between the electronics
unit and the OLED Controller PCB in the hood of the device by way of a
spring contact strip. This saves on a cable connection between the hood and
the electronics unit, and so makes installation and removal easier.

Battery NiMH M7 When the patient is relocated, or if the mains power supply fails, the inte-
grated rechargeable battery maintains operation, including the display unit,
for at least 30 minutes. The heater and fan in the expiration branch are shut
down during that time however.

The rechargeable battery comprises 20 2500 mAh series-connected cells.


After 10 cells a central tap is installed to detect defective cells. An NTC
records the temperature of the rechargeable battery during charging.

Power supply unit M7.3 The power supply unit is a module which can also be used in other products.
It delivers a direct voltage of 24 V at a maximum of 250 Watts. The output is
short-circuit proof and stable at no-load.

Therapy Control Unit PCB The Therapy Control Unit PCB M16 is the actual controller of the device. Two
M16 microprocessors monitor each other as a safety precaution. Microprocessor 1
(„slow“ tasks) is primarily responsible for communication. Microprocessor 2
(„fast“ tasks) records the data and controls the valves.
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The communication between the microprocessors is handled via a DPRAM


(Dual Port Random Access Memory) which is a component element of the
FPGA (Field Programmable Gate Array). The FPGA is a programmable logic
module which permits different hardware configurations without have to
change the physical hardware, making the Therapy Control Unit PCB M16
universally usable. The FPGA provides external communications for the
microprocessors via various interfaces.

58 Workstation Critical Care


Function descriptions electronics
Electronic assembly

The two microprocessors load their program from a flash memory. The actual
device software is located on a Compact Flash (CF) card. The CF card also
holds the device's Info Log and User Log.

RFID PCB M21 The RFID (Radio Frequency Identification) PCB M21 enables RFID tags in
the tubing system, the expiratory valve, the flow sensor and the device (ser-
vice tags) to be read and written to. This allows the device settings to be
transferred to another device by connecting the tubing system to it, for exam-
ple.

A maximum of 8 tags can be read or written.

PVT Monitoring PCB M4.1 The PVT Monitoring PCB monitors pressure, volume and temperature. The
sensor data is read-in via an A/D converter and passed over the LVDS (Low
Voltage Differential Signaling) bus on the Main PCB to microprocessors 1
and 2.

The PVT Monitoring PCB consists of two identically constructed channels


(LVDS fast and slow). For safety reasons, the measured values are recorded
by both channels.

Neo Flow PCB The Neo Flow PCB with the connected Neo Flow sensor transmits den
inspiratory and expiratory flow to the control electronics of the ventilation unit.

Interface box The interface box connects the control electronics of the ventilation unit to the
electronics of the gas supply unit.

Connections and inter- The following illustration show an overview of the existing electrical connec-
faces tions and components mentioned in the function description. For cable dia-
gram see „Schematics and diagrams“.

Fig. 37 Electrical connections

Item Designation Item Designation


No.1012_0000000469_Publication

1 CO2 sensor connection 5 IFLAN/FRC


2 Potential equalization pin 6 RS232 (option)
3 Mains voltage supply connection 7 Nurse Call connection
4 System cable connection

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Function descriptions electronics
Battery NiMH M7

Battery NiMH M7

Introduction The battery provides short-time power supply to the device in the event of a
mains power failure. The following details the design and function of the
NiMH battery M7.

Design The NiMH battery M7 (Fig. 38/1) consists of 20 battery cells which are located
inside a compact housing.

Fig. 38 Battery NiMH M7

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Function descriptions electronics
Battery NiMH M7

Functional principle

Fig. 39 Block diagram

Features Explanation
Capacity In a fully charged state, the battery supplies a nominal voltage of 24 V and a nominal
capacity of 2500 mAh.
Number of cells The battery consists of 20 individual cells at 1.2 V each.
Resistor 4k7 Protective resistor -> The pick-up is used to measure the medium voltage. Thus, e.g., a
single cell short-circuit can be detected. The resistor is used to protect against an
unwanted short-circuit, however it slightly distorts the measurement result.
NTC 10k The temperature can be determined by using the values of the NTCs.
Thermal fuse In case of overheating, the thermal fuse melts thus interrupting the series connection of
the cells.
Fuse A fuse in the positive line to the battery provides protection against short-circuits.
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Function descriptions electronics
Battery NiMH M7

Connections and inter- The battery connection consists of a 6-pin connector (Fig. 40/1).
faces

Fig. 40 Battery connector

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Function descriptions electronics
Power supply unit M7.3

Power supply unit M7.3

Introduction The power supply unit supplies the necessary voltages. The following details
the design and function of the power supply unit M7.3.

Design The power supply unit M7.3 is a compact unit which must not be opened.
There is one AC voltage input protected by two fuses, one DC voltage input,
and one output for connection of a battery.

Fig. 41 Power supply unit M7.3

Item Designation
1 Power supply unit M7.3
2 Ground pin
3 Connection to mains power supply with fuse insert

Functional principle The power supply unit uses an AC/DC converter to convert the present AC
voltage into a DC voltage. The AC voltage range is 100 to 240 V at a fre-
quency ranging from 47 to 63 Hz. The generated DC voltage is in the range
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Workstation Critical Care 63


Function descriptions electronics
Power supply unit M7.3

from 18 to 30 Volts (mains operation 24.5 to 27 Volts, battery operation 18 to


30 Volts). The power output is 250 W. The control electronics has the follow-
ing functions:
– Switches the output voltage to battery voltage in the event of an AC volt-
age failure
– Charges the connected battery
– Controls a fan
– Provides an RS232 port

Fig. 42 Block diagram

Designation Function
+24 V 24 Volts output voltage (mains operation 24.5 to 27
Volts, battery operation 18 to 30 Volts).
RS232 RS232 port for communication with the medical product,
e.g. for transmission of the serial number, software ver-
sion, etc.
fan Connection for a fan. The fan is controlled in relation to
the internal temperature present in the power supply
unit.
ac-av AC voltage supply status signal (ac-av) available (status
signal whether the AC voltage is present (+24 V) or not
(0 V)).
bat-off Battery status signal (bat-off, input). Used to switch off
the battery when the AC voltage supply is not present,
e.g in order to avoid power consumption when the medi-
cal product is not used for a longer period of time.
Battery connec- A rechargeable battery (NiMH or Pb) can be connected
tion here in order to ensure a DC supply in the event of a
power failure. The battery is charged by the power sup-
ply unit as soon as the AC voltage is applied to the
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power supply unit.

64 Workstation Critical Care


Function descriptions electronics
Power supply unit M7.3

Connections and inter-


faces

Fig. 43 View of the power supply unit

Number Designation
1 AC voltage receptacle (100 to 240 V, mains supply)
2 Connection for a rechargeable battery
3 Connection to the medical product
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Function descriptions electronics
Fan unit fan

Fan unit fan

Introduction The function of the fan is to discharge the heat loss, especially in the area of
the power supply unit. The following details the design and function of the fan.

Design

Fig. 44 Fan

The power supply unit fan is a DC axial fan mounted on the rear of the power
supply unit.

Functional principle Filtered room air is drawn in on the rear of the device and on the side of the
fan unit and flows through the power supply unit. The air emerges at the front
of the power supply unit and is distributed above it, and then exits from the
device again beneath the housing grip recess. The fan is temperature-con-
trolled.

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66 Workstation Critical Care


Function descriptions electronics
Fan unit fan

Connections and inter-


faces

Fig. 45 Fan connector

Con- Connected where?


nector
1 Main PCB, X65
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Function descriptions electronics
Power PCB

Power PCB

Introduction The Power PCB provides the supply voltages for the electronics. The follow-
ing details the design and function of the Power PCB.

Design By way of connector X4 (see Fig. 47) the power supply unit M7.3 is con-
nected to the Power PCB and forwarded to the inputs of various DC/DC con-
verters. The output voltages of the DC/DC converters are available at
connector X1 (see Fig. 47) and are distributed from there to the individual
electronic components.

Fig. 46 Power PCB

Functional principle The following voltages are generated on the Power PCB, with readiness indi-
cated by LEDs:

– exter- +5 V
nal
– +7 V
– +12 V
– +15 V
– -15 V

The following voltages can also be measured on the Connector PCB (X21)
(pin assignment to be found directly on the PCB):

– +3.3 V
– +5 V
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– +15 V
– -15 V
– +24 V switched

68 Workstation Critical Care


Function descriptions electronics
Power PCB

Fig. 47 Block diagram of Power PCB

Designation Function
X1 This connector connects to the Main PCB. As well as the
operating voltages, data and control signals are also
passed via the connector.
X3 A MCable-Mainstream CO2 sensor M11.1 can be con-
nected to connector X3. The sensor data is routed via an
RS232 link from this connector to connector X1.
X4 By way of this connector the supply voltage from the power
supply unit (24 V-Rail), the data link (RS232) and the con-
trol line for the power supply unit fan are routed to the
Power PCB. These signals also go directly to connector X1.
X6 The heating resistor of the patient system heater is con-
nected to this connector.
X7 The fan of the patient system heater is connected to this
connector.
X8 Dieser connector carries two logic voltages and an I2C bus.
Here display or LED driver for visualization of the ventilation
activity can be connected.
Main Power The Main Power Switch switches the supply for the com-
Switch plete device and reflects the status of the rocker switch (see
function description, Main PCB).
Vent Power The output voltage of the power supply unit is transmitted to
No.1012_0000000469_Publication

Switch the inputs of the various DC/DC converters depending on


the signals at the input of the Vent Power Switch.
M15.2 Driver Circuit to operate the safety valve. The circuit is switched on
and off by control signals from connector X1.

Workstation Critical Care 69


Function descriptions electronics
Power PCB

Designation Function
Heater supply Circuit to operate the patient system heater. The circuit is
switched on and off by control signals from connector X1.
Sync. Oscilla- The sync. oscillator synchronizes the DC/DC converters
tor 5 V ext., 7 V supply, 12 V supply, M15.2 Driver and Heater
supply.
X V supply Various DC/DC converters delivering the individual supply
voltages.
24 V rails The 24 V rails are connected constantly. The voltage can be
measured at the power supply unit connector. The following
voltage is also generated from it:
– 3.3 V standby for the M 10 „Connectivity Board“ module
3.3 V standby This voltage is needed for power-up via the Connectivity
Board. Because this voltage is connected constantly to the
Connectivity Board, and the current consumption should be
as low as possible, there is no LED voltage indicator.
24 V switched The switched 24 V directly supplies the heater of the expira-
tory valve. The voltage can be measured on the Connector
PCB at X21.
The following voltages are also generated from the
switched 24 V:
– ±15 V
– 12 V
– 7V
– 5 V external
±15 V Supply voltage for the expiratory valve (display of voltage
by LED on PCB or measurable on Connector PCB at X21).
12 V Sweep voltage for the valves (display of voltage by LED on
PCB).
7V Holding voltage for the valves and supply voltage for the fan
of the expiratory valve heater (display of voltage by LED on
PCB). The following voltages are also generated from it:
– 5V
– 3.3 V
5V Powers analog and digital circuit components. Measurable
on the Connector PCB at X21.
3.3 V Powers analog and digital circuit components. Measurable
on the Connector PCB at X21.
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Function descriptions electronics
Power PCB

Connections and inter- The following illustration shows the connector assignments.
faces

Fig. 48 Power PCB connector assignments

Con- Connected modules


nector
X1 Connector to Main PCB
X3 MCable-Mainstream CO2 sensor M11.1
X4 Power supply unit M7.3
X6 Heizwiderstand der Patiententeilheizung
X7 Patient system heater fan
X8 Display or LED driver
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Function descriptions electronics
Therapy Control Unit PCB M16

Therapy Control Unit PCB M16

Introduction The Therapy Control Unit PCB M16 is a printed circuit board with a micropro-
cessor system for control of ventilators and anaesthetic units.

The following details the design and function of the Therapy Control Unit PCB
M16.

Design The PCB has SMD components mounted on both sides. On the rear is a slot
for a Compact Flash (CF) card.

Fig. 49 Therapy Control Unit PCB M16

Function The PCB includes two microprocessors which monitor each other to ensure
that the computed data and the resultant measures are safe (see also Fig.
49).

Microprocessor 1 (μP1) is mainly responsible for communication, and micro-


processor 2 (μP2) for data recording and control of the actuators. Communi-
cation between the two microprocessors is handled by a DPRAM provided by
the FPGA.

The two microprocessors load their program from a flash memory. The Info
and User logs, and a backup of the Evita Infinity V500 firmware, are stored on
a CF card.

The FPGA used permits various hardware configurations. This makes the
Therapy Control Unit PCB M16 variable in use. The program information for
the FPGA can be saved on the CF card, and so is easily interchangeable.
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Function descriptions electronics
Therapy Control Unit PCB M16

For internal and external communications, the Therapy Control Unit PCB
M16 features various bus systems and interfaces.
– Five asynchronous serial ports (COM 1 to 5) (each microprocessor has
its own interface for Debug mode).
– Compact Flash card.
– Two Ethernet ports.
– General parallel inputs/outputs (GPIO).
– SPI (LVDS) interfaces.

The voltage supply for the Therapy Control Unit PCB M16 is 24 Volts (18 to
30 Volts). An internal DC/DC converter generates from it the various operat-
ing voltages.

The Therapy Control Unit PCB M16 also delivers the „POWER_PNEU_OFF“
signal with which, for example, a pneumatic system can be completely shut
down.

Fig. 50 Block diagram

Abbreviations
No.1012_0000000469_Publication

Abbreviation Explanation
COM Communication (Communication)
DPRAM Dual Port Random Access Memory -> RAM module
which can be accessed from two side simultaneously.

Workstation Critical Care 73


Function descriptions electronics
Therapy Control Unit PCB M16

Abbreviation Explanation
ETH Ethernet -> General interface in a computer system.
FPGA Field Programmable Gate Array -> Freely programma-
ble logic circuit.
GPIO General Purpose Input Output -> General parallel
inputs/outputs.
JTAG Joint Test Action Group -> Standard interface for circuit
testing.
RTC Real Time Clock -> Real-time clock
SMD Surface-Mounted-Device -> Surface-mounted device
SPI/LVDS Serial Periphal Interface/Low Voltage Differential Signal-
ing -> Serial interface operating at a low voltage.

Connections and inter- Communication with the „outside world“ runs by way of various interfaces
faces routed to a port array. The voltage supply is also transmitted by this route
(see also Fig. 49 and Fig. 50).

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Function descriptions electronics
SysCon PCB

SysCon PCB

Introduction The SysCon PCB makes the connections from the Main PCB to the user
interfaces. The following details the design and function of the SysCon PCB.

Design The SysCon PCB contains only electro-mechanical components in the form
of connectors.

Fig. 51 SysCon PCB

Functional principle
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Fig. 52 Block diagram, SysCon PCB

Workstation Critical Care 75


Function descriptions electronics
SysCon PCB

The signals are received inside the device on the Main PCB via the two con-
nectors X5 and X6 and forwarded to the externally accessible connectors X1
to X4, as shown in the block diagram above.

Connector Function
X1 Dräger connector to which additional system components
can be connected.
X2 RJ45 port. By way of this connector an Ethernet connection
is routed from the operating unit (IFLAN) to the rear of the
device.
X3 Modular jack 4/4. By way of this connector an RS232 inter-
face is routed from the operating unit to the rear of the
device.
X4 Modified modular jack 6/6. By way of this connector the
user can connect a Nurse Call box.

Connections and inter- The following illustration shows the slot and connector assignments.
faces

Fig. 53 SysCon PCB connector assignments

Con- Connected modules


nector
X1 Connector system for connection of additional system compo-
nents, e.g the operating unit.
X2 IFLAN/FRC
X3 RS232 User
X4 Nurse call
X5 Main PCB
X6 Main PCB
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Function descriptions electronics
Main PCB

Main PCB

Introduction The Main PCB holds additional PCBs, modules and components. The fol-
lowing details the design and function of the Main PCB.

Design The Main PCB is fitted with connector strips to connect additional PCBs and
with connectors to connect modules and components. The Main PCB also
includes various circuitry components for product-specific peripheral ele-
ments.

Fig. 54 Main PCB


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Function descriptions electronics
Main PCB

Functional principle

Fig. 55 Block diagram of Main PCB

Designation Function
X1 Slot for Connector PCB
This connector makes data connections to the gas metering
module M1.3, the PVT monitoring module M4.1 and the O2
monitoring module M12.4.
X2 As X1
X3 Connector for piezo alarm generator
The piezo alarm generator is connected directly to connec-
tor X3.
Safety Power This circuitry component on the Main PCB generates from
the output voltage of the power supply unit (24 V-Rail) the
supply voltage to charge the capacitor (GoldCap) which is
required for the auxiliary alarm in case of a power failure.
In normal operation the voltage is used to supply the piezo
alarm circuit.
Standby Since the piezo alarm generator is not intended to be active
Silence/Watc under normal circumstances, the muting of the piezo alarm
hdog generator from normal operation to Standby mode is trans-
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mitted to the NodeController M10.1.


The Standby Silence circuit on the Main PCB generates a
signal with which the alarm generator mute is activated.
If the microcontroller of the NodeController hangs up, the
watchdog on the Main PCB permits the microcontroller to
be reset.

78 Workstation Critical Care


Function descriptions electronics
Main PCB

Designation Function
X9 Smart Card-Adapter
The Smart Card-Adapter holds a Smart Card for secure
storage of device options.
X11 Connector for Flow Switch
A switch to detect a flow sensor can be connected to this
connector.
X14 Slot for Power PCB
By way of this connector all supply voltages are routed from
the Power PCB to the Main PCB. The data links to the
power supply unit M7.3, to the MCable-Mainstream CO2
module M11.1 and to the EEPROM of the Power PCB are
also connected. There are also control wires for the fan unit
and to the lift magnet M15.2.
X15 Slot for NeoFlow PCB
The NeoFlow PCB is an option.
X16 Slot for Extension PCB
Connector for an optional PCB. The PCB is connected via
RS232.
X31 Slot for Therapy Control Unit PCB M16
The connector provides all data links via Ethernet, RS232,
SPI, GPIO and SPI/LVDS from other modules to the two
processors of the Therapy Control Unit PCB M16.
X32 As X31
X33 As X31
X34 As X31
X65 Connector for fan unit
The fan is controlled by the power supply unit M7.3.
X66 Connector for Rocker Switch
With the Rocker Switch the device can be switched off in
an emergency. The voltage supply to the device is cut and
the auxiliary alarm is interrupted.
X67 Slot for Syscon PCB
By way of the connector of the Syscon PCB data links are
connected to the LP SysCon and to user interfaces. The
supply voltage for the operating unit is likewise routed via
the connector.
X68 As X67
X69 Voltage selection jumper for optional ambient pressure sen-
sor
X70 In operation mode the jumpers are connected to pins 1-3, 2-
4, 5-7, and 6-8.
To download the NodeController M10.1 module replug the
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jumpers to pins 3-5, 4-6, 7-9, 8-10.


X71 Connector for RFID M21 PCB.
X113 Connector for optional ambient pressure sensor
X114 Connector for optional ambient pressure sensor

Workstation Critical Care 79


Function descriptions electronics
Main PCB

Designation Function
X115 Connector for Test-ON
Connection of the connector contacts switches on the 24V
supply voltage on the connected Power PCB. This enables
a system to be switched on without an operating unit.
Safety Pneu- This circuitry component on the Main PCB generates from
matic/Shut- the Pneu_off and Over_pressure signals the
down Gas_Dosage_off signal. With this signal the power to the
pneumatic components is cut in the event of a fault.
ADC supply An A/D converter on the Main PCB monitors the operating
voltages.
ADC1 By way of the A/D converter ADC1 on the Main PCB prod-
uct-specific sensor data is read-in.
Some channels are used for monitoring of the piezo alarm
circuit.
ADC2 The A/D converter ADC2 on the Main PCB reads a second
channel from some sensors as a safety measure.
EEPROM The EEPROM on the Main PCB stores the following data:
– Mirrored data from the EEPROM of the Power PCB
– V500 serial number/operating hours
– Material Revision Index/serial number of Driver M15.1
module
– Material Revision Index/serial number of Driver module
M15.2
Valve drive With this circuitry component on the Main PCB the drive of
M15.1 the expiratory valve is operated. A setting value is transmit-
ted via an SPI interface to a D/A converter and amplified
with a power OP.
Valve Drivers The Valve Drivers component on the PI Main
PCB actuates discrete switching valves. To reduce the
power consumption of the switching valves, they are initially
actuated at rated voltage and then at a lower holding volt-
age.
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80 Workstation Critical Care


Function descriptions electronics
Main PCB

Connections and inter- The following illustration shows the slot and connector assignments.
faces

Fig. 56 Main PCB connector assignments

Con- Connected modules


nector
B1 Barometric pressure sensor (S8)
X1 Connector PCB
X2 Connector PCB
X3 Piezo alarm generator
X9 Smart Card-Adapter
X11 Flow Switch connected only with Evita Infinity V500
X14 Power PCB
X15 NeoFlow PCB
X16 Extension PCB
X31 Therapy Control Unit PCB M16
X32 Therapy Control Unit PCB M16
X33 Therapy Control Unit PCB M16
X34 Therapy Control Unit PCB M16
X64 NodeController M10.1
X65 Fan unit
X66 Rocker Switch
X67 Syscon PCB
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X68 Syscon PCB


X69 Voltage selection jumper for optional ambient pressure sensor
X70 Jumper for download
X71 RFID PCB M21

Workstation Critical Care 81


Function descriptions electronics
Main PCB

Con- Connected modules


nector
X113 Connector for optional ambient pressure sensor
X114 Connector for optional ambient pressure sensor
X115 Test-ON

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82 Workstation Critical Care


Function descriptions electronics
„Connector” PCB

„Connector” PCB

Introduction The Connector PCB is a component of the oxygen separation system, and
provides the connection between the electronic and pneumatic assemblies.
The following details the design and function of the Connector PCB.

Design The Connector PCB contains only electro-mechanical components in the


form of connectors.

Fig. 57 Connector PCB


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Workstation Critical Care 83


Function descriptions electronics
„Connector” PCB

Functional principle

Fig. 58 Block diagram, Connector PCB

The Connector PCB is the interface between the electronic and pneumatic
assemblies. It provides the connecting elements between the electronics and
the pneumatic modules and components; the signals are merely looped-
through the Connector PCB. The operating voltages can be checked at a ser-
vice connector.

Connections and inter- The following illustration shows the connector assignments.
faces
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Fig. 59 Connector PCB connector assignments

84 Workstation Critical Care


Function descriptions electronics
„Connector” PCB

Connector Connected modules


X1 PI Main PCB
X2 PI Main PCB
X3 Pato-O2-Sensor M12.4 module
X7 PV Monitoring M4.1, Power module
X8 PV Monitoring M4.1, SPI-1 module
X9 PV Monitoring M4.1, SPI-2 module
X10 V5 (Safety Valve)
X11 V16 (Exp. Valve)
X12 V6 (Pexp Calibration)
X13 V15 (O2 Calibration)
X14 V8 (Pinsp Calibration)
X15 V9 (Nebulizer)
X16 V12 (Ejector)
X17 V10 (Switch Over)
X18 P_O2 (O2 Pressure)
X19 Exp. Valve Switch
X20 P_AT (Abdominal Pressure)
X21 Service (Betriebsspannungen)
X22 Blower
X24 V14 (TGI Valve)
X25 TGI_Flow
X26 P_Ext
X27 Spare3
X28 Gas Dosage M1.3 module
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Workstation Critical Care 85


Function descriptions electronics
OLED-Contact PCB

OLED-Contact PCB

Introduction The OLED-Contact PCB provides a wireless connection of the OLED-Con-


troller PCB in the housing hood. The following details the design and func-
tion of the OLED-Contact PCB.

Design The OLED-Contact PCB contains only electro-mechanical components in


the form of a connector and double spring contacts.

Fig. 60 OLED-Contact PCB

Functional principle

Fig. 61 Block diagram of OLED-Contact PCB

The OLED-Contact PCB is located in the upper area on the electronics side
of the Infinity V500. The OLED-Contact PCB receives the signals via con-
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nector X1 on the Power PCB and distributes them to the double spring con-
tacts X2 to X4. The OLED-Controller PCB is installed in the housing hood of
the Infinity V500. The electrical connection to the OLED-Contact PCB is
made automatically when the housing hood is fitted, as the double spring
contacts of the OLED-Contact PCB contact on the gold-plated pads of the
OLED-Controller PCB.

86 Workstation Critical Care


Function descriptions electronics
OLED-Contact PCB

Connections and inter- The following illustration shows the assignments of the connector and the
faces double spring contacts.

Fig. 62 Assignment of connectors on the OLED-Contact PCB

Con- Connected modules


nector
X1 Power PCB
X2 OLED-Controller PCB
X3 OLED-Controller PCB
X4 OLED-Controller PCB
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Function descriptions electronics
OLED Controller PCB

OLED Controller PCB

Introduction The OLED-Controller PCB controls a small display showing ventilator oper-
ation messages.
The description of the OLED-Controller PCB of the Infinity V500 is divided
into the following sections:

Design The OLED-Controller PCB is equipped with a microcontroller which pre-pro-


cesses data to activate an OLED display.

Fig. 63 OLED Controller PCB

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88 Workstation Critical Care


Function descriptions electronics
OLED Controller PCB

Functional principle

Fig. 64 Block diagram, OLED-Controller PCB

Designation Function
X1 Activation of the display via an 8-bit parallel interface.
X2 By way of this interface the OLED-Controller PCB is sup-
plied with the necessary voltages (3.3 V and 5 V). Over
another line the voltage supply for the display (15 V) is
enabled or disabled.
The data signals from the Therapy Control Unit PCB M16
are forwarded via this interface to the microcontroller.
X3 The flash download of the microcontroller runs via this inter-
face.
μC Microcontroller which receives data from the Therapy Con-
trol Unit M16 and converts it to activate the OLED display.
DC/DC DC/DC converter controlled by the microcontroller (on/off)
which generates the operating voltage for the OLED dis-
play.
FET FET switching stage which is supply with 15 V via the
DC/DC converter and thereby switches on the OLED dis-
play.
PneuDisable Hardware line which disables the OLED display in the event
of a system error.
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Workstation Critical Care 89


Function descriptions electronics
OLED Controller PCB

Connections and inter- The following illustration shows the connector assignments.
faces

Fig. 65 Connector assignments of the OLED-Controller PCB

Con- Connected modules


nector
X1 OLED display
X2 Therapy Control Unit PCB M16
X3 Connection for flash download
X4 - X9 Instead of X2, the OLED-Display PCB can be connected via these
contact surfaces, in conjunction with gold spring contacts, to the
Therapy Control Unit PCB M16.

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90 Workstation Critical Care


Function descriptions electronics
PVT Monitoring PCB M4.1

PVT Monitoring PCB M4.1

Introduction The PVT Monitoring PCB M4.1 transmits pressure, flow and temperature val-
ues to the device controller. The following details the design and function of
the PVT Monitoring PCB M4.1.

Design The PVT Monitoring PCB M4.1 comprises a printed circuit board with a shield
housing. Two flow sensors and two temperature sensors can be connected to
the PCB. On the PCB itself, alongside the electronic components there are
also two pressure sensors.

Fig. 66 PVT Monitoring PCB M4.1

Item Designation
1 Printed circuit board
2 Pressure sensors
3 Shield housing

Functional principle
Operating voltages The operating voltage is +24 V, from which the internal voltage supply gener-
ates +3.3 V for the interface and +5 V for internal supply. The +5 V and the
interface are electrically isolated from the rest of the medical product.

Sensors The analog sensor data is routed to an A/D converter which converts it into
digital signals. The signals are passed via the interface to the microprocessor
system of the medical product. The D/A converter balances the flow sensors.

The control unit controls the operation of the A/D and D/A converters. The
EEPROM holds the serial number of the PCB and sensor data, such as cali-
bration data for temperature measurement.
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Workstation Critical Care 91


Function descriptions electronics
PVT Monitoring PCB M4.1

The PVT Monitoring PCB 4.1 comprises two channels of identical construc-
tion. Fig. 67 shows one channel. The analog measured values of the sensors
are recorded by each channel (as a safety system). The EEPROM and the
voltage supply exist just once for both channels.

Fig. 67 Block diagram

Connections and inter-


faces

Fig. 68 Connector layout


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Designation Connections
B3 Pressure sensor (2)
B4 Pressure sensor (1)

92 Workstation Critical Care


Function descriptions electronics
PVT Monitoring PCB M4.1

Designation Connections
X3 Expiratory flow sensor (2) only connected with Evita Infi-
nity V500
X4 Flow sensor (1)
X5 Temperature sensor (2)
X6 Temperature sensor (1)
X7 SPI_1 (serial interface)
X8 SPI_2 (serial interface)
X9 Voltage supply +24 V

Pin layout Flow sensors, connectors X3, X4

Pin Assignment
1 AGND
2, 3, 4, 5 Inputs 0 to 5 V respectively
6,7 Outputs 0 to 5 V respectively

Temperature sensors, connectors X5, X6

Pin Assignment
1 Temperature sensor connection
2 Temperature sensor connection
3 Shield

Power supply, connector X9

Pin Assignment
1, 4 + 24 V (18 to 30 V)
2, 3 GND
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Workstation Critical Care 93


Function descriptions electronics
RFID PCB M21

RFID PCB M21

Introduction The RFID PCB M21 is the interface between the RFID antennas and the
electronic control of the device. The following details the design and function
of the RFID PCB M21. The RFID PCB M21 comprises the LP PCB M21 and
up to 8 connected antennas.

Design

Fig. 69 RFID PCB M21

Functional principle The functional principle is based on the RFID technology (RFID stands for
Radio Frequency Identification).

Data transfer between the RFID PCB M21 and the transponders takes places
via electromagnetic waves. The working frequency 13.56 MHz.

Transponders are memory units with no internal power supply. Transponders


are attached to accessories or device components, for example, and allow
them to be scanned in an efficient way. The transponders can be written to or
read by the RFID PCB M21.

The data read by the RFID PCB M21 is transmitted to the medical device via
an RS232 interface.
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94 Workstation Critical Care


Function descriptions electronics
RFID PCB M21

Fig. 70 Block diagram, RFID PCB M21

Designation Function
X9 Connection for RS232 interface and power supply.
ESD PROTECTION Overvoltage protection.
TxD Send line of RS232 interface.
RxD Receive line of RS232 interface.
SER-INTERFACE Serial interface.
CPU Processing of data from the RF FRONT-END.
DIG-INTERFACE Digital interface.
OSZILATOR Oscillator.
RF-FRONT-END Send-and-receive circuit.
ANTENNA MATCH Antenna match.
Channal Switch Electronic switch for antenna selection.
X1 to X8 Connection for antenna 1 to antenna 8.
FUSE Fuse.
LC-LP Low pass.
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Power Supply DC/DC voltage converter.

Workstation Critical Care 95


Function descriptions electronics
RFID PCB M21

Connections and inter-


faces

Fig. 71 Connections and interfaces, RFID PCB M21

Item Designation
1 Connection for RS232 interface and power supply.
2 Connection for antenna 1 to antenna 8 (A1 - A8).

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96 Workstation Critical Care


Function descriptions electronics
Valve drive M15.1

Valve drive M15.1

Introduction The valve drive M15.1 provides the hardware, the software and the electronic
circuit to operate a drive. The software runs on the microprocessor system of
the medical product and the hardware of the electronic circuit is located on a
PCB in the medical product. The following details the design and function of
the valve drive M15.1.

Design The following illustration shows the mechanical construction of the valve drive
M15.1.

Fig. 72 Design

Item Designation Item Designation


1 Cover 6 Magnet
2 Housing 7 Measuring coil
3 Drive coil with coil carrier 8 Base plate
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4 Plunger 9 Screen
5 Socket

Workstation Critical Care 97


Function descriptions electronics
Valve drive M15.1

Functional principle
Principle The valve drive M15.1 operates on the plunger coil principle. In a magnet
(Fig. 73/1) is a coil (Fig. 73/4) which is diverted according to the direction of
flow of the current through the coil in the magnetic field, thereby moving a
plunger (Fig. 73/3). The electrical connection (Fig. 74/5) of the coil (Fig. 74/4)
is made by a flexible PCB (Fig. 73/2). The Fig. 73 illustrates the principle, and
Fig. 74 shows the mechanical construction.

Fig. 73 Principle

Fig. 74 Mechanical construction

Operating voltages A DC/DC converter generates from the +24 Volt supply voltage +/-16 Volts for
the amplification and +6 Volts for the reference voltage generation of the D/A
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converter. In the event of a +6 Volt (Powerfail) outage, a D/A converter Reset


is generated.

Enable The „enable“ signal causes a general shutdown or enable (Low aktiv) of the
valve drive M15.1.

98 Workstation Critical Care


Function descriptions electronics
Valve drive M15.1

Control The microprocessor system of the medical product presets a value to operate
the valve drive M15.1. This preset passes via the serial port to the D/A con-
verter, which generates an analog actuation signal from the digital signal. The
actuation signal is amplified and routed to the drive coil. A current flows
through the drive coil. The coil is diverted and moves the plunger which -
depending on the application - moves a diaphragm for example.
Beneath the magnet is a measuring coil. The movement of the plunger (which
has a magnet in the bottom) generates a voltage in the measuring coil (induc-
tion). The amplification circuit is designed to enable attenuation of the drive
by means of this voltage and the actual actuation voltage.

Protective circuit A protective circuit and a fuse in the actuation branch of the drive coil limit the
maximum current.

Fig. 75 Block diagram


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Function descriptions electronics
Valve drive M15.1

Connections and inter-


faces

Fig. 76 Pin assignment

Item Designation
1 Connections of the drive coil (pins 2 + 3)
2 Connections of the measuring coil (pins 4 + 5)

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100 Workstation Critical Care


Function descriptions electronics
Lift magnet M15.2

Lift magnet M15.2

Introduction The lift magnet M15.2 provides the hardware, the software and the electronic
circuit to operate a drive. The software runs on the microprocessor system of
the medical product and the hardware of the electronic circuit is located on a
PCB in the medical product. The following details the design and function of
the lift magnet M15.2.

Design The following illustration shows the mechanical construction of the lift magnet
M15.2.

Fig. 77 Sectional view

Item Designation Item Designation


1 Shaft 5 Coil body
2 Lock washer 6 Armature
3 Washer 7 Inventory
4 Cover 8 Housing

Functional principle
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Operating voltages The actuation circuit generates from the +24 V supply voltage the +16 V start-
up voltage and the +5.1 V holding voltage to operate the lift magnet M15.2.

Workstation Critical Care 101


Function descriptions electronics
Lift magnet M15.2

Enable The lift magnet M15.2 is enabled and actuated with the two enable signals
POWER_PNEU_OFF and Safety Valve on/off. The POWER_PNEU_OFF
signal is a global enable, while the Safety Valve on/off signal actually
switches the lift magnet M15.2.

Control If the microprocessor system of the medical product switches the Safety
Valve on/off signal to High, the lift magnet M15.2 is actuated with +16 V DC.
A current flows through the coil and the shaft is diverted. Depending on the
application, the shaft presses onto a diaphragm, for example, which in turn
closes a crater. Because of the mechanical construction of the lift magnet
M15.2, the lift magnet M15.2 then only needs a holding voltage to maintain its
position. The actuation voltage is reduced to +5.1 V DC. The maximum dis-
placement of the shaft is approximately 4.5 mm.

Fig. 78 Block diagram

Connections and inter-


faces

Fig. 79 Connector
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Item Designation
1 Connector to operate the valve

102 Workstation Critical Care


Function descriptions electronics
MCable-Mainstream CO2 sensor M11.1

MCable-Mainstream CO2 sensor M11.1

Introduction The MCable-Mainstream CO2 sensor M11.1 measures the CO2 content in
the respiratory gas. The following section describes the design and function
of the MCable-Mainstream CO2 sensor.

Design

Fig. 80 MCable-Mainstream CO2 sensor

Item Designation
1 Connector
2 Test filter
3 CO2 sensor

Principle The CO2 measurement is based on the principle that CO2 molecules absorb
light at a specific wavelength. Light at a wavelength of around 4.26 μm is
strongly absorbed by the CO2 molecule. Light at a wavelength of around
4.13 μm is virtually not absorbed.

Function
Beam path The beams emitted from the light source (9) are reflected by a parabolic
reflector (8), travel through the cuvette (7), and reach a filter/reflector (5). The
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filter/reflector allows light at a wavelength of 4.13 μm to pass through, but


reflects the other wavelengths. The light at a wavelength of 4.13 μm is bun-
dled by a parabolic reflector (3) and sent to a detector (2).

Workstation Critical Care 103


Function descriptions electronics
MCable-Mainstream CO2 sensor M11.1

The light reflected by the filter/reflector travels to a filter (10) which allows the
light at a wavelength of 4.26 μm to pass through. This light is bundled by a
parabolic reflector (11) and sent to a detector (12). The values measured by
the detectors are evaluated and used to calculate the CO2 value. The elec-
tronics required to do so is located on two printed circuit boards (1 and 13).

The optical assembly, including filters and detectors, is mounted on a metal


block which is kept at a constant temperature of approx. 42 °C. The discs that
face the cuvette have small heaters (6) which prevent the discs from misting
up.

Fig. 81 Mode of operation of the MCable-Mainstream CO2 sensor

Electronic assembly A preamplifier and filter assembly amplifies the values measured by the
detectors. The A/D converter converts these measured values into digital sig-
nals. The microcontroller then calculates the CO2 measured values, and
makes them available at the RS232 port.

The A/D converters also converts the measured values from the temperature
sensors as well as the supply voltages into digital signals. With the help of the
control circuit, the microcontroller uses these signals to control the heaters
and to monitor the system.

The calibration data of the detectors are stored in the EEPROM.

The value of the test filter is stored in the MCable-Mainstream CO2 sensor.
Depending on the cuvette used (disposable or reusable), a correction value is
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applied to the CO2 measurement.

The supply voltage to the electronics is +5 V. The various internal voltages


required for operation are generated on the Mainboard PCB.

104 Workstation Critical Care


Function descriptions electronics
MCable-Mainstream CO2 sensor M11.1

Fig. 82 Block diagram

General information Each CO2 sensor is fitted with a test filter. The value of the test filter is stored
in the CO2 sensor.

As from Revision 05 Defibrillator the CO2 sensor is fixed. This is indicated on


the sensor.

Connections and inter- The MCable-Mainstream CO2 sensor is attached by a connector to the medi-
faces cal product (see also Fig. 80). This connector carries the voltage supply and
the communication (RS232).

Pin assignment

Fig. 83 Connector (1 = rear view, solder terminals, 2 = front view, pins)

Pin Assignment
1 TXD
2 Unassigned
3 Unassigned
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4 +5 V
5 GND
6 RXD
7 Cable shield

Workstation Critical Care 105


Function descriptions electronics
Heating fan

Heating fan

Introduction The function of the heating fan is to heat up the area around the expiratory
valve to minimize the condensation there. The following details the design
and function of the heating fan.Fig. 84

Design

Fig. 84 Heating fan

An axial fan sitting at the end of a square tube flushes air heated by a PTC
through the tube. A PTC (Positive Temperature Coefficient) is a so-called
thermistor in which the resistance increases as the temperature rises. Owing
to their physical properties, thermistor applications include use as self-regu-
lating heating elements.

Functional principle

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Fig. 85 Modelled view of the air flow

106 Workstation Critical Care


Function descriptions electronics
Heating fan

Heated air emerges from the air vents (see arrows in Fig. 85) and flushes
around the flow sensor (Fig. 85/1) and the expiratory valve (Fig. 85/3). The
air-guide plate (Fig. 85/2) prevents the warm air from being routed directly to
the flow sensor and causing measurement inaccuracies. The area marked by
the box in Fig. 85 is covered by a flap during operation.

Connections and inter-


faces

Fig. 86 Heating fan connector

Con- Connected where?


nector
X6 The larger connector, labelled X6, belongs to the PTC (heating
resistor) and is connected to X6 of the PI Power PCB.
X7 The smaller connector, labelled X7, belongs to the axial fan and is
connected to X7 of the PI Power PCB.
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Function descriptions electronics
Nurse call

Nurse call

Introduction This section details the design and function of the nurse call.

Design The nurse call is part of the alarm system, and connects the device to the
hospital alarm system.

Fig. 87 Nurse call

Functional principle The nurse call operates according to the watchdog principle for microproces-
sors. If the device does not regularly reset the watchdog, an alarm is trig-
gered. The alarm causes a relay to switch. Contacts X4 and X5 are closed
and the nurse call of the hospital's alarm system is activated.

Fig. 88 Nurse call relay

Connections and inter- The PCB in the nurse call unit has three input and output signals. The 24 V
faces voltage, the square signal and the earth are connected to the device-side
inputs (X1,X2,X3). The outputs (X4,X5,X6) are connected to internal relays.

Fig. 89 Nurse Call PCB

Item Designation Item Designation


X1 Green, device X4 Brown, central alarm system
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X2 Brown, device X5 White, central alarm system


X3 White, device X6 Green, central alarm system

108 Workstation Critical Care


Function descriptions electronics
Neo Flow PCB

Neo Flow PCB

Introduction The Neo Flow PCB, in conjunction with the external Neo-Flow sensor on the
Y-piece, transmits the expiratory and inspiratory flow to the control of the ven-
tilation unit. The following details the design and function of the Neo Flow
PCB.

Design The Neo Flow PCB comprises a printed circuit board with a shield housing.
The Neo-Flow sensor is connected to the PCB.

Fig. 90 Neo Flow PCB

Item Designation
1 Shield housing
2 Printed circuit board

Functional principle The Neo Flow PCB includes two measurement channels of identical con-
struction. One measurement channel is connected to the measurement wire
and the second to the shadow wire of the flow sensor, in order to identify the
direction and the flow at the Y-piece.

A continuous current is applied to the measurement wire and the shadow


wire and they are heated. The wires of the flow sensors in the Y-piece are
cooled depending on the flow, resulting in a lower resistance of the platinum
wire and a higher current flow. The current is measured by way of analog
measuring bridges.

The measured current of the analog measuring bridge flows to the AD con-
verter which converts the data into digital signals. The signals are passed via
the interfaces to the microprocessor system of the medical product.
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The Neo Flow PCB is supplied with an operating voltage of +24 V. The inter-
nal voltage supply, which exists only once on the Neo Flow PCB, supplies the
electronics with +3.3 V, +5 V and +12V.

A “Gas dosage off” control signal is used to reset the Neo Flow PCB.

Workstation Critical Care 109


Function descriptions electronics
Neo Flow PCB

The complete Neo Flow PCB is electrically isolated from the rest of the medi-
cal product.

The EEPROM contains the name of the PCB “Neo Flow”, the part number
“8415051”, the version, e.g. “03”, the serial number of the PCB and flow sen-
sor data, such as calibration data.

Fig. 91 Block diagram

Connections and inter-


faces

Fig. 92 Connector layout

Designation Connections
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X4 Connection to Main PCB (includes operating voltage


+24 V, GND, „Gas dosage off“ signal line and two serial
interfaces)
X5 Neo-Flow sensor connection

110 Workstation Critical Care


Function descriptions electronics
Neo Flow PCB

Pin layout Neo Flow sensor, connector X5

Pin Assignment
1 S1 Shadow wire
2 Vacant
3 Vacant
4 M4 Measurement wire
5 S2 Shadow wire
6 free slot
7 M3 Measurement wire
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Function descriptions electronics
Neo Flow PCB

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112 Workstation Critical Care


Function description Infinity C500

This chapter contains descriptions of the device's technical functions.

Infinity C500 function description ....................................................................................................... 114


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Workstation Critical Care 113


Function description Infinity C500
Infinity C500 function description

Infinity C500 function description

Introduction The display unit Infinity C500 is used to enter, monitor, and control the venti-
lation parameters of the Workstation Critical Care. The following details the
design and function of the device.

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114 Workstation Critical Care


Function description Infinity C500
Infinity C500 function description

Design The unit comprises the following main components:

Fig. 93 Main components

Item Designation
1 Backlight Converter PCB
2 Main Board PCB
3 RAM chips (concealed by heat sink)
4 Touch Controller PCB
5 Connectivity Board PCB
6 SIM PCB option
7 Display with touchscreen (concealed by chassis plate and Main
Board PCB)
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Workstation Critical Care 115


Function description Infinity C500
Infinity C500 function description

Fig. 94 Main components

Item Designation
1 Hard disk (concealed by cover)
2 Internal battery (concealed by cover)
3 Alarm luminaire
4 Turn knob (rear)

Functional principle

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Fig. 95 Block diagram

Screen with touch-sensi- The screen is a demirrored 17” TFT LC color display with a resolution of 1440
tive surface x 900 pixels.

116 Workstation Critical Care


Function description Infinity C500
Infinity C500 function description

The 17” TFT LC colour display is behind a touch-sensitive covering, compris-


ing two screens positioned a defined space apart. The screens are coated in
a conductive material on the sides facing each other. When any point on the
touchscreen is touched, the resistance between the outer and inner screens
at that point changes. The change in resistance is used to determine x and y
coordinates. The accuracy is to within 2 mm. Communication between the
touch-sensitive covering and the processor unit is controlled by an internal
RS232 interface.

Processor unit The processor unit consists of the Main Board PCB and a hard disk. The
operating system is Windows XP.
The Main Board PCB is fitted with an INTEL processor running at a speed of
1.4 GHz. The system bus runs at a speed of 400 MHz. The Main Board PCB
features two DDR2 SO-DIMM slots, and can be upgraded to a maximum 2
GB of RAM.
The Main Board PCB provides the following interfaces:
– RS232 (3x)
– DVI (3x)
– LAN (2x)
– USB 2.0 (6x)
– System connector (supply voltage and data transfer)

During the boot phase software is searched for on the following media, in the
order specified (default):
No.1012_0000000469_Publication

Workstation Critical Care 117


Function description Infinity C500
Infinity C500 function description

1. via the USB port, e.g. on a floppy disk, a memory stick, CD-ROM or DVD-
ROM
2. over the network
3. on the hard disk

Connectivity Board PCB

Fig. 96 Block diagram

The Connectivity Board PCB is powered even when the unit is switched off. It
is equipped with a 16-bit RISC microcontroller.
Other key functional units on the Connectivity Board PCB are:
– the power-up logic and power-up current limiter
– the ports
– the drivers for the LEDs
– the node controller
No.1012_0000000469_Publication

The 24 V DC supply voltage is tapped from the system connector and routed
to power-up logic and power-up current limiter circuits. The voltage is for-
warded to the Mainboard PCB.

118 Workstation Critical Care


Function description Infinity C500
Infinity C500 function description

The following ports are available on the system connector and are only
looped through the Connectivity Board PCB:
– User RS232
– Infinity Ethernet
– PAN Ethernet

The LEDs are controlled by way of the microcontroller and downstream FET
switching stages.

The function of the node controller is to compile data packets from the sta-
tus information and bundle them onto an RS232 channel for communication
purposes.

The „DockA & DockB“ signal line gives feedback indicating the Infinity
PS250 communication hub to which the system cable of the Infinity C500 is
connected.

Connections and inter-


faces
Rear

Fig. 97 Ports and connectors on the rear

Item Designation
1 COM1
2 COM2
3 DVI1
4 Ethernet1
5 Ethernet2
6 USB5
No.1012_0000000469_Publication

7 USB6
8 USB4
9 USB3
10 DVI3

Workstation Critical Care 119


Function description Infinity C500
Infinity C500 function description

Item Designation
11 DVI2
12 COM3

Right side

Fig. 98 USB1 port on right side

Item Designation
1 USB1

Left side

Fig. 99 System connector and USB2 port on left side

Item Designation
1 System connector
2 USB2
No.1012_0000000469_Publication

120 Workstation Critical Care


Function description GS500

This chapter contains descriptions of the device's technical functions.

Gas supply unit GS500 ...................................................................................................................... 122


No.1012_0000000469_Publication

Workstation Critical Care 121


Function description GS500
Gas supply unit GS500

Gas supply unit GS500

Introduction The optional gas supply unit GS500 (Fig. 100/2 and Fig. 101), here referred
to merely as GS500, for the Evita Infinity V500 and Babylog VN500 ventila-
tion units (Fig. 100/1) supplies the ventilation unit with compressed air in the
event if the central compressed air supply is missing or fails. Use of the
GS500 means no compressed air cylinders are required when transporting
patients. The following describes the function of the GS500.

Design

Fig. 100 Babylog VN500 (example of execution) with GS500

No.1012_0000000469_Publication

Fig. 101 GS500

122 Workstation Critical Care


Function description GS500
Gas supply unit GS500

The GS500 comprises the following main components:

Fig. 102 GS500 (left and right side panel, cover and front removed)

Item Designation
1 Non-heating apparatus socket
2 Respiratory gas filter
3 Bypass valve (solenoid valve)
4 Pneumatic port for tube connecting to ventilation unit
5 Communication PCB
6 Controller PCB
7 Power PCB
8 Power supply unit (below Power PCB)
9 Fan for device and respiratory gas cooling (outlet air)
10 Sound box (containing blower unit)
No.1012_0000000469_Publication

11 Fan for device and respiratory gas cooling (inlet air)

Workstation Critical Care 123


Function description GS500
Gas supply unit GS500

Fig. 103 GS500 (left and right side panel, cover, front, sound box, Controller
PCB, Power PCB and power supply unit removed)

Item Designation
1 Intake side (from respiratory gas filter to blower unit)
2 Heat exchanger
3 Blower unit (with three radial fans)
4 Delivery side (from blower unit to pneumatic port)
No.1012_0000000469_Publication

124 Workstation Critical Care


Function description GS500
Gas supply unit GS500

Functional principle

Fig. 104 Block diagram

Ambient air is drawn in via the respiratory gas filter from the blower unit and
compressed. The speed of the radial fans in the blower unit is regulated by
the controller. To cool the device and the respiratory gas, the ambient air is
drawn into the housing by a fan. Sensors continuously measure the ambient
temperature and humidity. The respiratory gas is cooled by way of a heat
exchanger. The waste heat from the device and respiratory gas cooling is
routed out of the housing by a fan.

The respiratory gas is fed to the Evita Infinity V500 or Babylog VN500 ventila-
tion unit.

Data transfer and communication is routed via the serial port.

Pneumatics function The pneumatic function of the GS500 essentially comprises the blower unit.
No.1012_0000000469_Publication

Workstation Critical Care 125


Function description GS500
Gas supply unit GS500

Fig. 105 Blower unit

Item Designation
A Top section air duct
B Middle section air duct
C Bottom section air duct
D Radial fan, 1st stage
E Radial fan, 2nd stage
F Radial fan, 3rd stage

Item Function
No.1012_0000000469_Publication

1 Ambient air is drawn in via the inlet of the blower unit.


2 The intake air enters the 1st stage radial fan via the air
ducts and is compressed.

126 Workstation Critical Care


Function description GS500
Gas supply unit GS500

Item Function
3 The compressed air is passed on by way of the outlet of
the 1st stage radial fan through the air ducts to the inlet
of the 2nd stage.
4 The compressed air enters the 2nd stage radial fan and
is compressed further.
5 The compressed air is passed on by way of the outlet of
the 2nd stage radial fan through the air ducts to the inlet
of the 3rd stage.
6 The compressed air enters the 3rd stage radial fan and
is compressed further.
7 The compressed air is passed on by way of the outlet of
the 3rd stage radial fan through the air ducts to the outlet
of the blower unit.
8 The compressed air is routed from the outlet of the
blower unit via a connected heat exchanger to the pneu-
matic port of the GS500.

Electronics function The electronics function of the GS500 essentially comprises the following
components:
– Sensors (Fig. 106/1, 2 and 13 to 16)
– Controller PCB (Fig. 106/3)
– Communications interfaces (Fig. 106/4 and 5)
– Memory (Fig. 106/6)
– Power supply unit and Power PCB (Fig. 106/7)
– Service interface (Fig. 106/8 and 9)
– User interface (Fig. 106/10)
– Actuators (Fig. 106/11 and 12)
No.1012_0000000469_Publication

Workstation Critical Care 127


Function description GS500
Gas supply unit GS500

Fig. 106 Electronics block diagram

Item Designation Function


1 Moisture sensor Measures the relative humidity of the intake
air.
2 Temperature sensor Measures the temperature of the humidity
sensor.
3 Controller PCB Evaluates the sensor signals, controls the
motors and fans and the communication
with the ventilation unit.
No.1012_0000000469_Publication

4 Communications inter- Used only in servicing by a trained service


face (Service) technician to download firmware updates.
5 Communications inter- For communication between the ventilation
face (ventilation unit) unit and the GS500.

128 Workstation Critical Care


Function description GS500
Gas supply unit GS500

Item Designation Function


6 Memory For firmware, program data and events
(status and error messages).
7 Power supply unit and Power supply unit 230 VAC/50 Hz with
Power PCB On/Off switch and additional transformer for
voltage supply to the controller (including
communication) when the power supply
unit is switched off. The power supply unit
is temperature-monitored, and supplies an
output voltage of max. 24 V. The Power
PCB converts the output voltage of the
power supply unit into 3.3 V, 5 V, -5 V and
12 V.
8 Service interface (volt- The voltage LEDs are located on the Power
age LEDs) PCB, and are only available to the service
technician. Each voltage generated by the
power supply unit and the Power PCB (3.3
V, 5 V, -5 V, 12 V and 24 V) is indicated by a
dedicated LED.
9 Service interface (status The status LEDs are located on the Con-
LEDs) troller PCB, and are only available to the
service technician. The displayed status
are: Reset, voltage, temperature, sensor
and actuator.
10 User interface When the GS500 is switched on an LED is
lit steadily green.
11 Actuators (motors) Three radial fans with motorized drivers
and Hall sensors (to regulate the speed of
the radial fans) are used to draw in and
compress the ambient air. Two fans with
motorized drivers and pulse sensors (to
detect a fan failure) cool the GS500.
12 Actuator (bypass valve) A solenoid valve serves as a bypass valve
to the respiratory gas flow, and is actuated
via temperature and flow sensors. The
solenoid valve opens when the temperature
exceeds a maximum limit value and at the
same time the flow falls below a minimum
limit value.
13 Microswitch The microswitch indicates whether the
respiratory gas filter is inserted.
14 Sensors (voltage) Monitor the voltages (3,3 V, 5 V, -5 V, 12 V
and 24 V).
15 Sensors (motor current To control the radial fans, the motor current
and temperature) and temperature are measured. The device
No.1012_0000000469_Publication

interior temperature is measured by two


redundant temperature sensors.
16 Sensors (bypass valve) To actuate the bypass valve (solenoid
valve) the temperature and flow of the
respiratory gas are measured.

Workstation Critical Care 129


Function description GS500
Gas supply unit GS500

Connections and inter-


faces

Fig. 107 Rear of the GS500 (right and left side panel removed)

Item Description
1 Mains connection
2 Left side panel
3 Right side panel
4 Pneumatic port for tube connecting to ventilation unit.
5 Service port (RS232). Used in servicing by a trained ser-
vice technician to download firmware updates.
6 A port (RJ45) for data exchange with the ventilation unit.
A second port (RJ45) is provided for future upgrades.
No.1012_0000000469_Publication

130 Workstation Critical Care


Annex

Parts catalog

This chapter contains a list of the device's orderable parts.

Test Instructions

This chapter contains the measures required to determine the actual condi-
tion of the device.
No.1012_0000000469_Publication

Workstation Critical Care 131


Parts catalog

Infinity C500

Revision: 0
2009
6500.051
Parts catalog
Products concerned

Item Order No. Description Qty. Qty.unit Remark


No.
without Rotary Knob
MS18746 SHP OEM DISPLAY INFINITY C500 1.000 St and Holder/adaptor
cockpit available

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 01 Infinity C500

2/6
Parts catalog
Basic unit

Item Order No. Description Qty. Qty.unit Remark


No.
Fastening clamps 1.000 St
1 MK30311 Alarm Light PCB C500 1.000 St
2 MK30301 Hard Disk Drive Assembly C500 1.000 St
3 MK30312 Side Covers C500 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Infinity C500 Revision: 01

3/6
Parts catalog
Fastening clamps

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416140 Cockpit holder 1.000 St
2 8416635 Clamp system cable 38mm pole 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 01 Infinity C500

4/6
Parts catalog
Modification kits/Options

Item Order No. Description Qty. Qty.unit Remark


No.
0 MK30320 DVD Cockpit Base Download Imag 1.000 St
1 MK30300 Rotary Knob C500 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Infinity C500 Revision: 01

5/6
Parts catalog
Accessoies/Consumables

Item Order No. Description Qty. Qty.unit Remark


No.
1 1868039 SIM-CARD-STICK USB 1.000 St
2 8416347 USB Stick 1GB PDM20-1 Dräger 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Infinity C500 Revision: 01

6/6
Parts catalog

Evita Infinity V500

Revision: 0
2009
6500.310
Parts catalog
Products concerned

Item Order No. Description Qty. Qty.unit Remark


No.
8416000 Ventilation Unit 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

2/46
Parts catalog
Chassis complete

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416651 O2-Sealing 1.000 St
2 8415489 EMC-Gasket 1.166 m
3 8416618 PCB-holder 2.000 St
4 8416615 Bottom bar 2.000 St
5 8416617 Device pad 4.000 St
6 1328956 HEXAGON NUT M4 DIN 934-A4/051 1.000 St
7 8416246 Housing foot 2.000 St
8 8416625 Interlink lever bearing 2.000 St
9 8416622 Connector housing holder 2.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

3/46
Parts catalog
PCB rack

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416240 Piezo 1.000 St
2 8416799 spacer 1.000 St
3 8416752 Cable holder 1.000 St
4 8415436 Clamp 1.000 St
5 8416248 cable support 1.000 St
6 8416247 M4x6 Allen screw WAF3 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

4/46
Parts catalog
Expiration Valve

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416750 ID Expiration valve, reusable, V500 1.000 St
2 8416201 Lip seal (gray) 1.000 St
3 8413661 Membrane, complete 1.000 St
4 8416204 Pot (grey) 1.000 St
5 8416203 Flow sensor sleeve, compl. (gray) 1.000 St
6 8415864 Expiration valve, flutter seal 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

5/46
Parts catalog
Infinity Trolley 2

Item Order No. Description Qty. Qty.unit Remark


No.
1 G93127 Color design bottom part left 1.000 St
2 G93128 Color design bottom part right 1.000 St
3 G93104 Cover basic open complete 1.000 St
4 G93129 Design band processed 2.000 St
5 G93118 Bumper basic complete 4.000 St
6 G93107 Castor 551-125 Steinco 4.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

6/46
Parts catalog
Infinity Trolley 2

Item Order No. Description Qty. Qty.unit Remark


No.
7 G93169 Set Hook 1.000 St 1 piece of hook and
cap
8 G93062 Cap M8 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

7/46
Parts catalog
Fastening clamps

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416140 Cockpit holder 1.000 St
2 8416635 Clamp system cable 38mm pole 1.000 St
3 8418722 Assembly plate 38mm tube 1.000 St
4 8415480 Claw 40 1.000 St
5 8416190 Claw 80 1.000 St
6 8416191 Claw 160 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

8/46
Parts catalog
Cylinder support

Item Order No. Description Qty. Qty.unit Remark


No.
1 G93110 Cylinder Support compl 1.000 St Accessory only from
DE10
2 G93153 Lug 1.000 St
3 G93144 Cover Cylinder Support compl 1.000 St
4 8416196 End section 1.000 St
5 G93142 Velcro Tape 570 1.000 St
6 G93141 Velcro Tape 450 1.000 St
7 G93062 Cap M8 1.000 St
8 G93168 Cap 7 1.000 St
10 G93091 Cover cap SW5 D18 1.000 St
11 G93206 Schild "Gasflaschenstellung" 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

9/46
Parts catalog
Cylinder support

Item Order No. Description Qty. Qty.unit Remark


No.
7 G93062 Cap M8 1.000 St
9 G93169 Set Hook 1.000 St 1 piece of hook and
cap M8

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

10/46
Parts catalog
Connector housing

Item Order No. Description Qty. Qty.unit Remark


No.
1 8415190 Connector housing flap, compl. 1.000 St
2 8416227 Set Connectorhousing FS 1.000 St
3 MP02011 pba antenna Spirolog 1.000 St
4 8416012 Cable harness spirologsensor 1.000 St
5 MP02021 pba antenna insp/exp 1.000 St
6 8415489 EMC-Gasket 0.867 m
7 1343289 Screw for plastic, 4X25 DWN562 6.000 St
8 8415181 Nebulizer connection adult 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

11/46
Parts catalog
Connector housing

Item Order No. Description Qty. Qty.unit Remark


No.
7 1343289 Screw for plastic, 4X25 DWN562 6.000 St
9 8416663 Snap-fit 1.000 St
10 M30953 ANGLE CONNECTION 1.000 St
11 8414950 Valve drive 1.000 St
12 8416370 Cable harness flow switch 2.000 St
13 8415186 Heating fan 1.000 St
14 8416652 O2-Sealing 1.000 St
15 1328786 Screw M4x35 DIN912 2.000 St
16 8415117 Solenoid M15.2 1.000 St
17 MP02040 Service Tag 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

12/46
Parts catalog
Conclusion elements

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416290 Conclusion element white, down 1.000 St
2 8416295 Conclusion element white, abov 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

13/46
Parts catalog
Housing cover

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416698 Housing cover, left door compl 1.000 St without 8416684 or
8418718
2 8416684 Option label 1.000 St only for V500
2 8418718 Option label VN500 1.000 St only for VN500
3 8416364 Spare parts housing cover whit 1.000 St
4 8416196 End section 1.000 St
5 8416366 Spare parts right side part 1.000 St
6 8416699 Housing cover, right door comp 1.000 St
7 8416365 Spare parts left side part 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

14/46
Parts catalog
Connector metal sheets

Item Order No. Description Qty. Qty.unit Remark


No.
1 8415489 EMC-Gasket 0.270 m 3 pieces with 90mm
2 8416358 Hinged cover, compl. 1.000 St
3 8415435 Cable conduit 1.000 St
4 8416247 M4x6 Allen screw WAF3 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

15/46
Parts catalog
Inspiration Unit

Item Order No. Description Qty. Qty.unit Remark


No.
1 8415195 Safety valve 1.000 St
2 8415171 Seal 1.000 St
3 8415177 Diaphragm, compl. 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

16/46
Parts catalog
Cable Harnesses V500/VN500

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416012 Cable harness spirologsensor 1.000 St only V500
2 8416217 M4.1 Data Cable 2.000 St
3 8416241 Flex connector 1.000 St
4 8416218 M12.4 Data Cable 1.000 St
5 8416370 Cable harness flow switch 2.000 St
6 8415366 V16 Cable (Exp. Valve) 1.000 St
7 MP02021 pba antenna insp/exp 1.000 St
8 MP02011 pba antenna Spirolog 1.000 St
9 8416265 M21 data cable 1.000 St
10 8416216 O2 Pressure Cable 1.000 St
11 8416268 OLED cable 1.000 St
12 8415368 M7.3 Power Cable 1.000 St
13 1859099 Flat fuse 15A/80V 1.000 St
14 8415367 NiMH Battery Cable 1.000 St
15 8416219 Rocker Switch 1.000 St
16 8415365 M4.1 Power Cable 1.000 St
17 MS18781 SHP ACC CABLE SYS UP DN 2.8M 1.000 St
17 MS18782 SHP ACC CABLE SYS UP DN .7M 1.000 St
18 8416240 Piezo 1.000 St
25 8416600 Flow sensor connector cable 1.000 St for Neo-Flow Sensor

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

17/46
Parts catalog
Cable Harnesses V500/VN500

Item Order No. Description Qty. Qty.unit Remark


No.
19 8416248 cable support 1.000 St
20 8416752 Cable holder 1.000 St
21 8416308 Fastener system cable 1.000 St
22 8415435 Cable conduit 1.000 St
2 ferrite on system
23 1843516 Ferrite sleeve DM7-8.5 1.000 St cable MS18782 or
MS18781
24 8416635 Clamp system cable 38mm pole 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

18/46
Parts catalog
Calibration Unit

Item Order No. Description Qty. Qty.unit Remark


No.
1 8415213 Calibration Unit 1.000 St
2 8415223 Solenoid valve 12V 3.000 St
3 8415209 Pressure sensor 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

19/46
Parts catalog
PCBs PI V500/VN500

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416240 Piezo 1.000 St
2 8415061 pba Connector 1.000 St
3 8416673 SIM card (Ventilation Unit) 1.000 St
4 8415436 Clamp 1.000 St
5 8415051 pba NeoFlow 1.000 St Option for V500
6 8416316 Clip contact PCB 1.000 St
7 8419371 pba OLED controller 1.000 St
8 8416328 Spare parts OLED Display 1.000 St inclusive display foil
9 8419311 OLED Contact PCB assy 1.000 St
10 8415041 pba PI-Power 1.000 St
11 8415011 pba PI Main 1.000 St
12 8416761 pba syscon 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

20/46
Parts catalog
Fan unit

Item Order No. Description Qty. Qty.unit Remark


No.
1 8415329 Fan unit, complete 1.000 St
2 8416753 Filter 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

21/46
Parts catalog
M1.3 Gas Dosage Module

Item Order No. Description Qty. Qty.unit Remark


No.
Gas Inlet M1.3 1.000 St
Dosage M1.3 1.000 St
PCBs/Cable Harnesses 1.000 St
1 8415249 M1.3 Gas Mixture and Dosage 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

22/46
Parts catalog
Gas Inlet M1.3

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416067 O-ring 57 x 2 1.000 St
2 M31982 O-Ring 1.000 St
3 8416956 Restrictor element upgrade kit 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

23/46
Parts catalog
Gas Inlet M1.3

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416067 O-ring 57 x 2 1.000 St
2 M31982 O-Ring 1.000 St
3 8416956 Restrictor element upgrade kit 1.000 St
4 8416044 Non return valve 2.000 St
5 8416069 O-ring 12.42 x 1.78 2.000 St
6 M31348 PLUG 04 1.000 St
7 M30963 THRUST COLLAR 4, BLACK 1.000 St
8 M30953 ANGLE CONNECTION 2.000 St
9 8414731 proportional valve 2.000 St
10 8418112 AIR FILTER 1.000 St
11 1329294 Pan-head screw M4x16 DIN912 9.000 St
12 8415127 PARTICLE FILTER 1.000 St
13 M31602 THRUST COLLAR 4, WHITE 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

24/46
Parts catalog
Gas Inlet M1.3

Item Order No. Description Qty. Qty.unit Remark


No.
11 1329294 Pan-head screw M4x16 DIN912 9.000 St
14 1210157 HOSE 2,7X0,65 PAE WHITE 1.000 m
15 8415357 Gasket 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

25/46
Parts catalog
Dosage M1.3

Item Order No. Description Qty. Qty.unit Remark


No.
1 1293664 Cheese head screw M4x12 DIN912 17.000 St
2 1335308 Lock washer B4 DIN137 20.000 St
3 1329308 SCREW M4X20 DIN 912-A4/051 4.000 St
4 8415256 Temperature sensor 2.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

26/46
Parts catalog
Dosage M1.3

Item Order No. Description Qty. Qty.unit Remark


No.
2 1335308 Lock washer B4 DIN137 20.000 St
3 1329308 SCREW M4X20 DIN 912-A4/051 4.000 St
5 1335073 0EXAGON NUT M2 DIN 934-M A4 4.000 St
6 8415156 Compensating diaphragm 1.000 St
7 1345982 Pan-head screw M2x6 DIN912 4.000 St
8 M30430 O-ring 1.000 St
9 8414950 Valve drive 1.000 St
10 8415111 DIAPHRAGM 1.000 St
11 8416002 O Ring 18.77x1.78 1.000 St
12 8415377 O-ring seal 1.000 St
13 8415254 Crater 1.000 St
14 4301949 O-RING SEAL 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

27/46
Parts catalog
Dosage M1.3

Item Order No. Description Qty. Qty.unit Remark


No.
1 1293664 Cheese head screw M4x12 DIN912 17.000 St
2 1335308 Lock washer B4 DIN137 20.000 St
15 1331930 Cylinder screw M3X6 DIN912 5.000 St
16 1204831 HOSE 2X1-SIGN YELLOW 0.300 m
17 8416808 Temperatur Sensor 1.000 St
18 M20622 O-RING SEAL 1.000 St
19 8415905 flowsensor M1.3 3.000 St
20 8415903 wire mash 2 2.000 St
21 4302374 O-RING SEAL 1.000 St
22 8416788 tank seal 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

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Parts catalog
PCBs/Cable Harnesses

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416779 cable harness LPSV 1.000 St
2 8416241 Flex connector 1.000 St
3 8415081 pba M1.3 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

29/46
Parts catalog
M4.1 PV Monitoring

Item Order No. Description Qty. Qty.unit Remark


No.
ohne
1 MK03411 pba M4.1 1.000 St 8416695/without
8416695
2 8416695 Angled connector 2.000 St nur für/only for V500
and VN500
3 6871785 pressure sensor MO4 2.000 St Inhalt von/content of
MK03411;

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

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Parts catalog
M12.4 Pato SA

Item Order No. Description Qty. Qty.unit Remark


No.
1 6871530 M12.4_PATO_SA 1.000 St
2 6871521 PCB Pato SA MC 1.000 St Inhalt von/content of
6871530;
3 1342630 Screw for plastic .3X16 DWN562 4.000 St Inhalt von/content of
6871530;

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

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Parts catalog
M12.4 Pato SA

Item Order No. Description Qty. Qty.unit Remark


No.
4 8416850 Damper, compl. 1.000 St nur für/only for V500
und/and VN500;

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

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Parts catalog
M16 Therapy Control Unit

Item Order No. Description Qty. Qty.unit Remark


No.
1 8415900 Therapy Control Unit (M16) 1.000 St
2 1869604 CF-Card 128MB RoHS 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

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Parts catalog
M21 RFID Module (EAST)

Item Order No. Description Qty. Qty.unit Remark


No.
1 MP02001 Modul M21 1.000 St
2 8416799 spacer 4.000 St
3 MP02021 pba antenna insp/exp 1.000 St nur für/only for
V500/VN500;
4 MP02011 pba antenna Spirolog 1.000 St nur für/only for
V500/VN500;
5 MP02040 Service Tag 3.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

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Parts catalog
Labels

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416684 Option label 1.000 St only for V500
2 8418718 Option label VN500 1.000 St only for VN500
3 8417492 Safety sign 1.000 St
4 8416324 Safety sign 1.000 St
5 8416659 Nebulizer Label 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

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Parts catalog
Hoses (internal) V500/VN500

Item Order No. Description Qty. Qty.unit Remark


No.
1 1204807 HOSE 2X1-SIGN GREEN 0.300 m
nur bei "Option
2 1210181 HOSE 2,7X0,65 PAE SW/WS 0.570 m Vernebler/Ejektor"/onl
y for "Option
Nebulizer/Ejector";
nur bei "Option
3 1204785 HOSE 2X1-SIGN BL 0.560 m Vernebler/Ejektor"/onl
y for "Option
Nebulizer/Ejector";
4 1210157 HOSE 2,7X0,65 PAE WHITE 0.440 m
5 1204831 HOSE 2X1-SIGN YELLOW 0.300 m
6 8600513 PU-HOSE 1,5 0.290 m
7 1204823 HOSE 2X1-SIGN ORANGE 0.230 m
8 1204793 HOSE 2X1-SIGN RED 0.180 m

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

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Parts catalog
Power cable

Item Order No. Description Qty. Qty.unit Remark


No.
1851683 SUPPLY MAIN, 3m, 10A 1.000 St
1859714 Power cable 10A,3m,black,China 1.000 St
1851713 Cable Great Britian,3m,10A 1.000 St
1868950 PWR Cord DK,3m,10A,C13,HG RoHS 1.000 St
1851705 Cable Australia,3m,10A,C13 1.000 St
1841793 PWR Cord 10A,3m,gr,USA/J RoHS 1.000 St
1868152 PWE Cord 10A,3m,NEMA6-15 RoHS 1.000 St
1868160 Cable TH/BR,3m,C13,black RoHS 1.000 St
1851691 Mains cable Swiss ,3m,10A 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

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Parts catalog
M7.3 Power Pack Module

Item Order No. Description Qty. Qty.unit Remark


No.
1 8416270 Assembly kit M7.3 (Vent Box) 1.000 St nur für/only for
V500/VN500;
ohne 8416270 und
2 8415328 Electrical Energy Unit (M7.3) 1.000 St 8416627/ without
8416270 and 8416627
3 1865811 Fuse cartridge F 6.3A RoHS 2.000 St
4 8416627 Cable clip 2.000 St nur für/only for
V500/VN500;

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

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Parts catalog
Power Failure Battery NiMH

Item Order No. Description Qty. Qty.unit Remark


No.
1 8415290 baterypar m7 NM2.5 1.000 St
2 8416755 Bracket 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

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Parts catalog
etCO2

Item Order No. Description Qty. Qty.unit Remark


No.
1 6871950 MCable-Mainstream CO2 1.000 St complete
2 6870281 TEST FILTER 1.000 St
3 8416352 Standby holder w/o calibration 1.000 St Not for "Oxylog 3000
plus"
4 6872159 Extension cable MCable CO2 1.000 St for "Oxylog 3000
plus" only

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

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Parts catalog
Expiratory valve, neonate

Item Order No. Description Qty. Qty.unit Remark


No.
1 8415270 ID_Expiration valve, reuse.,VN 1.000 St
2 8416201 Lip seal (gray) 1.000 St
3 M20622 O-RING SEAL 1.000 St
4 8415864 Expiration valve, flutter seal 1.000 St
5 8415230 Silencer W 1.000 St
6 8413661 Membrane, complete 1.000 St
7 8415261 Lip sealing 1.000 St
8 8416204 Pot (grey) 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

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Parts catalog
Nursecall

Item Order No. Description Qty. Qty.unit Remark


No.
8417370 MCable - Nurse Call 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

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Parts catalog
Software

Item Order No. Description Qty. Qty.unit Remark


No.
8417355 DVD Software IACS WSCC 1.20 1.000 St
8417548 DVD Software IACS WSCC 1.21 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

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Parts catalog
Nebulizer/Ejector

Item Order No. Description Qty. Qty.unit Remark


No.
1 8414681 Option nebulizer/ejector 1.000 St
2 M31601 THRUST COLLAR 6 BLACK 1.000 St
3 M31603 THRUST COLLAR 6, WHITE 1.000 St
4 M30952 PLUG-TYPE CONNECTION 1.000 St
5 8415403 nozzle 1.000 St
6 8415411 2/2 way valve 1.000 St
7 8415412 3/2 way valve 1.000 St
8 8415413 shock-mount M4 1.000 St
9 8415407 o-ring 1.000 St
10 8413666 Pressure regulator 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

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Parts catalog
Maintenance parts/Service kits

Item Order No. Description Qty. Qty.unit Remark


No.
2-jährliches
1 8415290 baterypar m7 NM2.5 1.000 St Intervall/2-year
interval;
2-jährliches
2 8418112 AIR FILTER 1.000 St Intervall/2-year
interval;
6-jährliches
3 8415127 PARTICLE FILTER 1.000 St Intervall/6-year
interval;

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Evita Infinity V500 Revision: 03

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Parts catalog
Accessories/Consumables

Item Order No. Description Qty. Qty.unit Remark


No.
CP-Catalog Accesso./Consumabl. 1.000 St
1 8416600 Flow sensor connector cable 1.000 St for Neo-Flow-Sensor
2 8416349 Filter for fan (10pcs.) 1.000 St
3 8416347 USB Stick 1GB PDM20-1 Dräger 1.000 St
4 1868039 SIM-CARD-STICK USB 1.000 St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 03 Evita Infinity V500

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Test instructions / Service Card IPM
Workstation Critical Care

Configuration of the Workstation Critical Care (Workstation):


- Control and display unit Infinity C500 (C500)
- Ventilation unit Evita Infinity V500 (V-unit) with expiratory valves

Options:
- Nebulizer-ejector
- MCable-Mainstream CO2 module M11.1 (CO2 sensor)
- Drug nebulizer
- Neonate flow measurement
- Neonate expiratory valve
- Gas supply unit (GS500)
- Power supply unit (PS500)
- Trolley 2 (trolley)

NOTE
– Prior to using these test instructions, check that they are the latest revi-
sion (compare revision with current service documentation).
– All results and inputs must be documented in the „Test Report“ or „Result
Sheet“, as applicable.

NOTE
Do not use these test instructions for testing after a repair procedure.

These test instructions apply to software versions 2.0 or higher.


Conversion table: 1 bar = 14.504 PSI / 1 mbar = 1.01973 cm H2O.
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Table of contents

Table of contents

1 Device configuration 7
1.1 Device configuration ................................................................................................................. 8
1.1.1 Serial numbers (if not otherwise recorded) ................................................................ 8
1.1.2 Software versions....................................................................................................... 9
2 Maintenance parts 11
2.1 Maintenance parts, yearly ........................................................................................................ 12
2.1.1 GS500 option ............................................................................................................. 12
2.2 Maintenance parts, 2-yearly ..................................................................................................... 12
2.2.1 V-unit .......................................................................................................................... 12
2.2.2 GS500 option ............................................................................................................. 13
2.3 Maintenance parts, 6-yearly ..................................................................................................... 13
2.3.1 V-unit .......................................................................................................................... 13
2.3.2 GS500 option ............................................................................................................. 14
2.4 Maintenance parts as required ................................................................................................. 14
2.4.1 V-unit .......................................................................................................................... 14
3 Electrical safety 17
3.1 Electrical safety of V-unit or ME system according to DIN EN 62353 (IEC 62353) .................. 18
3.1.1 Notes on the „Electrical safety to DIN EN 62353“ section.......................................... 18
3.1.2 Visual check ............................................................................................................... 19
3.1.3 Protective conductor resistance ................................................................................. 19
3.1.4 Protective conductor resistance measuring points..................................................... 20
3.1.5 Device leakage current............................................................................................... 20
3.1.6 Applied parts for device leakage current .................................................................... 22
3.1.7 Leakage current from applied part, Mains at applied part, type BF............................ 22
3.1.8 Applied parts for leakage current from applied part test............................................. 23
3.2 Option, Electrical safety of GS500 as single device (not ME system) according to 23
DIN EN 62353 (IEC 62353)
3.2.1 Visual check ............................................................................................................... 23
3.2.2 Protective conductor resistance ................................................................................. 24
3.2.3 Protective conductor resistance measuring points..................................................... 25
3.2.4 Device leakage current............................................................................................... 25
3.3 Electrical safety according to IEC 60601-1............................................................................... 26
3.3.1 Visual check ............................................................................................................... 26
3.3.2 Protective conductor resistance ................................................................................. 27
3.3.3 Earth leakage current of Workstation without GS500 and PS500 options ................. 29
3.3.4 Earth leakage current of Workstation with GS500 option only ................................... 30
3.3.5 Earth leakage current of Workstation with PS500 option ........................................... 32
3.3.6 Patient leakage current .............................................................................................. 33
4 Function and condition test 35
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4.1 General condition check ........................................................................................................... 36


4.1.1 Workstation ................................................................................................................ 36
4.1.2 Accompanying documents ......................................................................................... 36
4.1.3 Rating plates, labels, and inscriptions on the Workstation ......................................... 36
4.1.4 Rating plates, labels, and inscriptions on available options ....................................... 38

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Table of contents

4.2 C500 and V-unit condition test.................................................................................................. 39


4.2.1 C500 ........................................................................................................................... 39
4.2.2 V-unit .......................................................................................................................... 40
4.3 Options condition test ............................................................................................................... 40
4.3.1 MCable-Mainstream CO2 module M11.1 (CO2 sensor) option.................................. 40
4.3.2 Neonatal flow measurement option ............................................................................ 40
4.3.3 Drug nebulizer option ................................................................................................. 41
4.3.4 Trolley option .............................................................................................................. 42
4.3.5 Trolley option, optional gas cylinder mounts .............................................................. 42
4.3.6 Trolley option, optional hose mounts.......................................................................... 43
4.3.7 GS500 option.............................................................................................................. 43
4.3.8 PS500 option .............................................................................................................. 43
4.4 C500, function tests .................................................................................................................. 44
4.4.1 Preparation for the function tests................................................................................ 44
4.4.2 Workstation software version ..................................................................................... 44
4.4.3 C500, „Red“ and „yellow “ visual alarms..................................................................... 44
4.4.4 C500, Audible alarm ................................................................................................... 44
4.4.5 Rotary encoder ........................................................................................................... 45
4.4.6 Silence key ................................................................................................................. 45
4.5 Reading out operating data....................................................................................................... 45
4.5.1 Workstation operating data......................................................................................... 45
4.6 Safety device function tests ...................................................................................................... 46
4.6.1 Emergency expiratory valve SV2 ............................................................................... 46
4.6.2 Emergency respiratory valve SV3 .............................................................................. 47
4.6.3 Non-return valve in expiratory valve ........................................................................... 48
4.7 Function test of power failure battery, part 1............................................................................. 49
4.7.1 Function test ............................................................................................................... 49
4.8 Workstation, Device checks according to Instructions for Use ................................................. 49
4.8.1 Device checks ............................................................................................................ 49
4.9 Function test of power failure battery, part 2............................................................................. 49
4.9.1 Function test ............................................................................................................... 50
4.10 Option, V-unit, Function test of PS500, part 1 .......................................................................... 50
4.10.1 Function test ............................................................................................................... 50
4.11 Breathing circuit check according to Instructions for Use ......................................................... 50
4.11.1 Breathing circuit check ............................................................................................... 51
4.12 Function tests in ventilation mode............................................................................................. 51
4.12.1 Flowmeter function test .............................................................................................. 52
4.12.2 Airway pressure gauge function test .......................................................................... 52
4.12.3 O2 measurement function test ................................................................................... 52
4.13 Option, Function test of PS500, part 2...................................................................................... 52
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4.13.1 Function test ............................................................................................................... 53


4.14 Function test of the V-unit display............................................................................................. 53
4.14.1 Function test ............................................................................................................... 53
4.15 Function test of non-return valves in gas inlet .......................................................................... 53
4.15.1 Function test ............................................................................................................... 53
Workstation Critical Care
4.16 Nurse call function test.............................................................................................................. 54

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Table of contents

4.16.1 Nurse call with nurse call box (8417370) ................................................................... 54


4.16.2 Nurse call with test adapter (7911671)....................................................................... 55
4.17 Option, Function test of the MCable-Mainstream CO2 (CO2 sensor) ...................................... 55
4.17.1 Function test............................................................................................................... 55
4.18 Option, Resetting the GS500 configuration to user setting ...................................................... 56
4.18.1 User setting ................................................................................................................ 56
4.19 Workstation, Final procedure.................................................................................................... 56
4.19.1 Device handover with test label.................................................................................. 56
5 Test equipment 57
5.1 Test equipment ......................................................................................................................... 58
5.1.1 Test equipment subject to mandatory calibration....................................................... 58
5.1.2 Test equipment not subject to mandatory calibration................................................. 59
5.1.3 Required spares (if applicable)................................................................................... 60
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Table of contents

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1 Device configuration
This chapter is used to record the device configuration.

1.1 Device configuration ................................................................................................................. 8


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Device configuration
Device configuration

1.1 Device configuration


Introduction The testing covers the following components:
– C500
– V-unit with expiratory valves
– All options listed on the cover page

1.1.1 Serial numbers (if not otherwise recorded)


Prerequisites The Workstation is switched off.
Action • Read off the serial number of the C500. Note: The serial number is located
on the back of the C500.
Entry C500 serial number
[________txt]

Action • Read off the serial number of the V-unit. Note: The serial number is
located above the power supply unit filter.
Entry V-unit serial number
[________txt]

Action • Remove the inspiratory safety valve (inspiratory unit) from the V-unit and
read off its serial number. Note: The serial number is located on the side of
the inspiratory safety valve.
Entry Inspiratory safety valve (inspiratory unit) serial number
[________txt]

Action • Remove the expiratory safety valve for adults from the V-unit and read off
its serial number. Note: The serial number is located on the side of the
expiratory valve.
Entry Expiratory valve for adults serial number
[________txt]

Action • If available, read off the serial number of the additional expiratory valve for
adults.
Entry Additional expiratory valve for adults serial number
[________txt]

Action • If available, read off the serial number of the MCable-Mainstream CO2
option (CO2 sensor). Note: The serial number is located on the sensor
housing.
Entry Serial number of the MCable-Mainstream CO2 (CO2 sensor) option
[________txt]

Action • If fitted, read off the serial number of the neonate expiratory valve option.
Note: The serial number is located on the neonate expiratory valve.
Entry Serial number of Neonate expiratory valve option
[________txt]
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Action • If an additional neonate expiratory valve is available, read off the serial
number of the additional neonate expiratory valve. Note: The serial num-
ber is located on the neonate expiratory valve.
Entry Serial number of Additional neonate expiratory valve option
Workstation Critical Care [________txt]

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Device configuration
Device configuration

Action • If fitted, read off the serial number of the GS500 option. Note: The serial
number is located on the rating plate, above the power supply socket
(remove left-hand side cover).
Entry Serial number of the GS500 option
[________txt]

Action • If fitted, read off the serial number of the PS500 option. Note: The serial
number is located on the rating plate on the back of the PS500 option.
Entry Serial number of the PS500 option
[________txt]

Action • If fitted, read off the serial number of the trolley option. Note: The serial
number is indicated on the rating plate on the back of the trolley.
Entry Serial number of Trolley option
[________txt]

Action • On the inside of the housing flap, read whether the additional hardware
option nebulizer-ejector (without serial number) is fitted and enter „Yes“ (fit-
ted) or „No“ (not fitted) in the text box.
Entry Additional hardware option nebulizer-ejector (without serial number)
(yes or no)
[________txt]

Action • On the inside of the housing flap, read whether the additional hardware
option neonate flow measurement (without serial number) is fitted and
enter „Yes“ (fitted) or „No“ (not fitted) in the text box.
Entry Additional hardware option neonate flow measurement (without serial
number) (yes or no)
[________txt]

1.1.2 Software versions


NOTE
Software versions will be read out under „Readout of software version and
operating data“.
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Device configuration
Device configuration

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2 Maintenance parts
This chapter contains interval-related maintenance parts, measures, and tests that can only
be performed on an open device.

2.1 Maintenance parts, yearly ........................................................................................................ 12


2.2 Maintenance parts, 2-yearly ..................................................................................................... 12
2.3 Maintenance parts, 6-yearly ..................................................................................................... 13
2.4 Maintenance parts as required ................................................................................................. 14
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Maintenance parts
Maintenance parts, yearly

2.1 Maintenance parts, yearly

2.1.1 GS500 option

Quan- Designation Number Location/Remark


tity
1 Ambient air filter 8419758
(filter mat)

Entry Next replacement: [________dat]

Quan- Designation Number Location/Remark


tity
1 Blower unit AIR fil- 6737545
ter (microfilter)

Entry Next replacement: [________dat]

2.2 Maintenance parts, 2-yearly

NOTE
After replacing the battery, the battery wear data must be reset in the „Op-
erating Data“ service menu.

NOTE
Batteries are special waste. Dispose of batteries according to local waste
disposal regulations.

2.2.1 V-unit

Quan- Designation Number Location/Remark


tity
1 Air filter 8418112 In Air gas inlet/Replacement
by qualified service person-
nel.

Entry Next replacement: [________dat]

Quan- Designation Number Location/Remark


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tity
1 Battery M7 NM2.5 8415290 Replacement by qualified ser-
vice personnel.

Entry Next replacement: [________dat]


Workstation Critical Care

12 / 61 9500693 Workstation Critical Care Revision 3.0


Maintenance parts
Maintenance parts, 6-yearly

2.2.2 GS500 option

Quan- Designation Number Location/Remark


tity
1 Ambient air filter 8419758
(filter mat)

Entry Next replacement: [________dat]

Quan- Designation Number Location/Remark


tity
1 Blower unit AIR fil- 6737545
ter (microfilter)

Entry Next replacement: [________dat]

2.3 Maintenance parts, 6-yearly

NOTE
After replacing the battery, the battery wear data must be reset in the „Op-
erating Data“ service menu.

NOTE
Batteries are special waste. Dispose of batteries according to local waste
disposal regulations.

2.3.1 V-unit

Quan- Designation Number Location/Remark


tity
1 Air filter 8418112 In Air gas inlet/Replacement
by qualified service person-
nel.

Entry Next replacement: [________dat]

Quan- Designation Number Location/Remark


tity
1 Battery M7 NM2.5 8415290 Replacement by qualified ser-
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vice personnel.

Entry Next replacement: [________dat]

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Maintenance parts
Maintenance parts as required

Quan- Designation Number Location/Remark


tity
1 Particle filter(O2 fil- 8415127 In O2 gas inlet/Replacement
ter) by qualified service person-
nel.

Entry Next replacement: [________dat]

2.3.2 GS500 option

Quan- Designation Number Location/Remark


tity
1 Ambient air filter 8419758
(filter mat)

Entry Next replacement: [________dat]

Quan- Designation Number Location/Remark


tity
1 Blower unit AIR fil- 6737545
ter (microfilter)

Entry Next replacement: [________dat]

2.4 Maintenance parts as required

2.4.1 V-unit
NOTE
Replacement of the following maintenance parts is detailed in the Instruc-
tions for Use, and must be carried out by the user.

Quan- Designation Number Location/Remark


tity
1 Expiratory valve 8413661 Expiratory valve dia-
diaphragm phragm./Check condition.

Entry Replaced on: [________dat]


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Maintenance parts
Maintenance parts as required

Quan- Designation Number Location/Remark


tity
1 Room air filter 8416753 Filter inside housing
fan./Check condition.

Entry Replaced on: [________dat]


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Maintenance parts
Maintenance parts as required

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Workstation Critical Care

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3 Electrical safety
This chapter contains tests that need to be performed in order to verify that the medical elec-
trical system is operational.

3.1 Electrical safety of V-unit or ME system according to DIN EN 62353 (IEC 62353) .................. 18
3.2 Option, Electrical safety of GS500 as single device (not ME system) according to 23
DIN EN 62353 (IEC 62353)
3.3 Electrical safety according to IEC 60601-1............................................................................... 26
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Electrical safety
Electrical safety of V-unit or ME system according to DIN EN 62353 (IEC 62353)

3.1 Electrical safety of V-unit or ME system according to


DIN EN 62353 (IEC 62353)

NOTE
The Workstation under test conforms to the conditions of protection class I.
With the MCable-Mainstream CO2 module M11.1 (CO2 sensor) (sensor
connected) or the neonatal flow sensor the Workstation conforms to
type BF.

3.1.1 Notes on the „Electrical safety to DIN EN 62353“ section


Introduction The test of electrical safety following maintenance procedures as per
DIN EN 62353 also fulfills the requirements of VDE 0751-1 and IEC 60601-1.
NOTE
All measures labelled in these test instructions with (applied parts) must only
be performed if the device is fitted with applied parts.

NOTE
The tester, e.g. SECUTEST, must be correctly configured for all measure-
ments. If implausible measurement results are obtained, such as a leakage
current of 0.0 μA, check the tester configuration in addition to the test setup!

NOTE
The following presents a description of the electrical safety tests according
to DIN EN 62353 (IEC 62353). Whether the standard is applicable or not de-
pends on national regulations and its use must be decided on site under
consideration of applicable national regulations.

NOTE
– In testing to DIN EN 62353, not only the medical electrical device (ME
device) but also the medical electrical system (ME system) must be
tested.
– ME systems must be treated like ME devices.
– An ME system is a combination of several devices, as specified by the
manufacturer, of which at least one must be an ME device, which are
interconnected by a functional connection or by means of a multiple
socket outlet.

NOTE
With devices that are connected to other devices by means of a data cable,
this connection must be disconnected prior to performing the electrical safe-
ty check, in order to avoid incorrect measurements.
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3.1.2 Visual check


Prerequisites The tester and the device under test are switched off.
Action • Disconnect the power plug from the mains socket.
WARNING!
Hazardous voltage.
Touching live components can lead to serious injury or death.
– Disconnect the power cord from the AC outlet before checking the power
fuse-links.

Test – The power fuse-links of the device under test match the specifications on
the rating plate.
– The power cable and plug are not dirty or damaged.
Result Condition checked.
[________OK]

3.1.3 Protective conductor resistance


Test set-up

Fig. 1 Protective conductor resistance

Item Designation
1 Tester, e.g. SECUTEST
2 Device under test
3 Tester probe cable
L Conductor
N Neutral conductor
PE (Protective earth) conductor

Action • Prepare the test setup.


• Switch the tester on.
NOTE
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The test can be performed optionally with 200 mA DC or 10 A AC (tester


configuration!). When measuring with 200 mA, the measurement is per-
formed a second time with reversed polarity (see instructions on tester dis-
play!). The higher measured value must be documented.

• Configure the tester appropriately, and follow the instructions on the tester.

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• Using the tip of the probe cable, scan each measurement point listed
under chapter "" on the device under test one after the other, moving the
mains power cable along the entire length during the measurement. The
resistance must not change when you do so.
Test The protective conductor resistance of single devices (including permanently
connected mains power cable or mains power cable that can only be discon-
nected using tools) must not exceed 0.3 Ohm in each case.
Entry Maximum measured value.
[________Ohm]

or
Test The protective conductor resistance of ME systems (including mains power
cable) must not exceed 0.5 Ohm in each case.
Entry Maximum measured value of the ME system.
[________Ohm]

3.1.4 Protective conductor resistance measuring points


Action • Scan the following measurement points for protective earth conductor
resistance measurement one after the other using the tip of the probe
cable:
– Potential equalization pin on power supply unit of the V-unit
Action • If the PS500 option is fitted: Scan the following measurement points for
protective earth conductor resistance measurement one after the other
using the tip of the probe cable:
– Potential equalization pin on the PS500
Action • If the GS500 option is fitted in addition to the PS500 option: Scan the fol-
lowing measurement points for protective earth conductor resistance mea-
surement one after the other using the tip of the probe cable:
– Trolley/GS500 fixing claw
Entry Measurement points scanned.
[________OK]

3.1.5 Device leakage current


NOTE
– The device leakage current can be tested by the differential measure-
ment method or the direct measurement method.
– For direct measurement, set up the device under test so that it is insu-
lated!

Prerequisites The tester is switched on.


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Test set-up

Fig. 2 Device leakage current

Item Designation
1 Tester, e.g., SECUTEST
2 Device under test
3 (applied part) Device-specific test adapter for tester
4 (applied part) Configurable sockets for applied parts
L Conductor
N Neutral conductor
PE (Protective earth) conductor

Action • Prepare the test setup.


• (applied part) Connect the device-specific test adapter on one end to the
device under test and on the other end to the tester's configurable socket
„A“ for applied parts (paying attention to the configuration!).
• Follow the instructions on the tester.

NOTE
The test must be performed twice! The second test is performed with the
plug reversed 180° in the socket. In many test devices the mains plug rota-
tion is simulated by means of a built-in selector switch. The higher measured
value must be documented.

NOTE
The reference value (initial measured value) must always be transmitted!

NOTE
If the measured values are between 90% and 100% of the permissible limit
value, the reference value and the previously measured values of the recur-
rent test should be applied to assess electrical safety!

Test The reference value must not exceed 500 μA.


Entry Reference value
[________μA]
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Test The recurrent measurement value must not exceed 500 μA.
Entry Recurrent measurement
[________μA]

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3.1.6 Applied parts for device leakage current


Action • Use the following device-specific test adapters for the device under test:
Result 7901772, VDE Babylog test plug (if Neo-Flow option installed)
[________OK]

3.1.7 Leakage current from applied part, Mains at applied part, type BF
Prerequisites The tester is switched on.
Test set-up

Fig. 3 Leakage current at the applied part

Item Designation
1 Tester, e.g. SECUTEST
2 Device under test
3 Applied part, device-specific test adapter for tester
4 Configurable sockets for applied parts
L Conductor
N Neutral conductor
PE (Protective earth) conductor

Action • Prepare the test setup.


• (applied part) Connect the device-specific test adapter on one end to the
device under test and on the other end to the tester's configurable socket
„A“ for applied parts (paying attention to the configuration!).
• Follow the instructions on the tester.

NOTE
The test must be performed twice! The second test is performed with the
plug rotated 180° in the socket. In many test devices the mains plug rotation
is simulated by means of a built-in selector switch. The higher measured val-
ue must be documented.
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NOTE
The reference value (initial measured value) must always be transmitted!

NOTE
If the measured values are between 90% and 100% of the permissible limit
value, the reference value and the previously measured values of the recur-
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rent test should be applied to assess electrical safety!

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Option, Electrical safety of GS500 as single device (not ME system) according to DIN EN 62353 (IEC 62353)

Test The reference value must not exceed 5000 μA.


Entry Reference value
[________μA]

Test The recurrent measurement value must not exceed 5000 μA.
Entry Recurrent measurement
[________μA]

3.1.8 Applied parts for leakage current from applied part test
Action • Use the following device-specific test adapters for the device under test:
Result 7901772, VDE Babylog test plug (if Neo-Flow option installed)
[________OK]

3.2 Option, Electrical safety of GS500 as single device (not ME sys-


tem) according to DIN EN 62353 (IEC 62353)

NOTE
The device conforms to the requirements of protection class I.

3.2.1 Visual check


Prerequisites The tester and the device under test are switched off.
Action • Disconnect the power plug from the mains socket.
WARNING!
Hazardous voltage.
Touching live components can lead to serious injury or death.
– Disconnect the power cord from the AC outlet before checking the power
fuse-links.

Test – The power fuse-links of the device under test match the specifications on
the rating plate.
– The power cable and plug are not dirty or damaged.
Result Condition checked.
[________OK]
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3.2.2 Protective conductor resistance


Test set-up

Fig. 4 Protective conductor resistance

Item Designation
1 Tester, e.g. SECUTEST
2 Device under test
3 Tester probe cable
L Conductor
N Neutral conductor
PE (Protective earth) conductor

Action • Prepare the test setup.


• Switch the tester on.
NOTE
The test can be performed optionally with 200 mA DC or 10 A AC (tester
configuration!). When measuring with 200 mA, the measurement is per-
formed a second time with reversed polarity (see instructions on tester dis-
play!). The higher measured value must be documented.

• Configure the tester appropriately, and follow the instructions on the tester.
• Using the tip of the probe cable, scan each measurement point listed
under chapter "Protective conductor resistance measuring points" on the
device under test one after the other, moving the mains power cable along
the entire length during the measurement. The resistance must not change
when you do so.
Test The protective conductor resistance of single devices (including permanently
connected mains power cable or mains power cable that can only be discon-
nected using tools) must not exceed 0.3 Ohm in each case.
Entry Maximum measured value.
[________Ohm]
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or
Test The protective conductor resistance of ME systems (including mains power
cable) must not exceed 0.5 Ohm in each case.

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Entry Maximum measured value of the ME system.


[________Ohm]

3.2.3 Protective conductor resistance measuring points


Action • Scan the following measurement points for protective earth conductor
resistance measurement one after the other using the tip of the probe
cable:
– Fixing claw on trolley
Entry Measurement points scanned.
[________OK]

3.2.4 Device leakage current


NOTE
– The device leakage current can be tested by the differential measure-
ment method or the direct measurement method.
– For direct measurement, set up the device under test so that it is insu-
lated!

Prerequisites The tester is switched on.


Test set-up

Fig. 5 Device leakage current

Item Designation
1 Tester, e.g. SECUTEST
2 Device under test
L Conductor
N Neutral conductor
PE (Protective earth) conductor

Action • Prepare the test setup.


• Follow the instructions on the tester.
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NOTE
The test must be performed twice! The second test is performed with the
plug rotated 180° in the socket. In many test devices the mains plug rotation
is simulated by means of a built-in selector switch. The higher measured val-
ue must be documented.

NOTE
The reference value (initial measured value) must always be transmitted!

NOTE
If the measured values are between 90% and 100% of the permissible limit
value, the reference value and the previously measured values of the recur-
rent test should be applied to assess electrical safety!

Test The reference value must not exceed 500 μA.


Entry Reference value
[________μA]

Test The recurrent measurement value must not exceed 500 μA.
Entry Recurrent measurement
[________μA]

3.3 Electrical safety according to IEC 60601-1

NOTE
The Workstation under test conforms to the conditions of protection class I.
With the MCable-Mainstream CO2 module M11.1 (CO2 sensor) (sensor
connected) or the neonatal flow sensor the Workstation conforms to
type BF.

NOTE
An optional multiple socket-outlet, if any, must be included in the individual
tests (medical electrical system).

NOTE
With devices that are connected to other devices by means of a data cable,
this connection must be disconnected prior to performing the electrical safe-
ty check, in order to avoid incorrect measurements.

3.3.1 Visual check


Prerequisites The following preconditions must be met for the visual check:
– The Workstation is switched off.
– The power plug is unplugged.
– The pipeline supply lines have been removed.
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Test – The ratings of the V-unit's power fuse links conform to the specifications on
the power supply unit label.
– The mains power cable and cable retainer of the V-unit are not dirty or
damaged.
– If present: The mains power cable of the GS500 option is not dirty or dam-
aged.
– If present: The mains power cable of the PS500 option is not dirty or dam-
aged.
Result Condition checked.
[________OK]

3.3.2 Protective conductor resistance


Test set-up

Fig. 6 Test setup for protective conductor resistance

Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Device under test
3 Test probe with tip (e.g. SECUTEST accessories)
L Conductor
N Neutral conductor
PE (Protective Earth) conductor

Action • Prepare the test setup.


• Switch the tester on.
• Configure the tester appropriately, and follow the instructions on the tester.
• Using the tip of the test probe, scan the following points on the V-unit, mov-
ing the mains power cable section-by-section while doing so:
– Power supply unit potential equalization pin
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Test The protective earth conductor resistance must not exceed 0.2 Ohm (includ-
ing mains power cable) in each case.
Entry V-unit protective earth conductor resistance
[________Ohm]

Action • If the GS500 option is present, proceed as follows:

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Electrical safety according to IEC 60601-1

• Prepare the test setup.


• Switch the tester on.
• Configure the tester appropriately, and follow the instructions on the tester.
• Using the tip of the test probe, scan the following points on the GS500
option, moving the mains power cable section-by-section while doing so:
– Potential equalization pin
Test The protective earth conductor resistance must not exceed 0.2 Ohm (includ-
ing mains power cable) in each case.
Entry Protective earth conductor resistance of the GS500 option
[________Ohm]

Action • If the PS500 option is present, proceed as follows:


• Prepare the test setup.
• Switch the tester on.
• Configure the tester appropriately, and follow the instructions on the tester.
• Using the tip of the test probe, scan the following points on the PS500
option, moving the mains power cable section-by-section while doing so:
– Potential equalization pin
Test The protective earth conductor resistance must not exceed 0.2 Ohm (includ-
ing mains power cable) in each case.
Entry Protective earth conductor resistance of the PS500 option
[________Ohm]

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3.3.3 Earth leakage current of Workstation without GS500 and PS500


options
NOTE
In order to avoid incorrect measurement, set up the V-unit under test so that
it is insulated.

Test set-up

Fig. 7 Earth leakage current test setup

Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Device under test
L Conductor
N Neutral conductor
PE (Protective earth) conductor

Action • Prepare the test setup.


• Switch on the Workstation.
• Follow the instructions on the tester.

NOTE
For symmetrical mains plugs that have no preferential position in the socket-
outlet, the earth leakage current test must be performed twice! The second
test is performed with the plug rotated 180° in the socket. In many test de-
vices the mains plug rotation is simulated by means of a built-in selector
switch. The higher measured value must be documented.

IEC 60-601-1
Test Normal condition (N.C.): The value must not exceed 500 μA.
Entry Normal condition (N.C.) according to IEC 60-601-1
[________μA]

Test Single fault condition (S.F.C.): The value must not exceed 1000 μA.
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Entry Single fault condition (S.F.C.) according to IEC 60-601-1


[________μA]

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UL 60-601-1
Test Normal condition (N.C.): The value must not exceed 300 μA.
Entry Normal condition (N.C.) according to UL 60-601-1
[________μA]

Test Single fault condition (S.F.C.): The value must not exceed 500 μA.
Entry Single fault condition (S.F.C.) according to UL 60-601-1
[________μA]

3.3.4 Earth leakage current of Workstation with GS500 option only


NOTE
In order to avoid incorrect measurement, set up the V-unit under test so that
it is insulated.

NOTE
If the Workstation is equipped with the GS500 option, but not with the PS500
option, then the earth leakage current must be determined for the V-unit and
for the GS500 in each case.

Test set-up

Fig. 8 Earth leakage current test setup

Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Device under test
L Conductor
N Neutral conductor
PE (Protective earth) conductor

Action • Prepare the test setup.


• Switch on the Workstation.
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• Follow the instructions on the tester.


NOTE
For symmetrical mains plugs that have no preferential position in the socket-
outlet, the earth leakage current test must be performed twice! The second
test is performed with the plug rotated 180° in the socket. In many test de-
vices the Critical
Workstation mainsCare
plug rotation is simulated by means of a built-in selector
switch. The higher measured value must be documented.

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IEC 60-601-1
Test Normal condition (N.C.): The value must not exceed 500 μA.
Entry V-unit: Normal condition (N.C.) IEC 60-601-1
[________μA]

Test Single fault condition (S.F.C.): The value must not exceed 1000 μA.
Entry V-unit: Single fault condition (S.F.C.) IEC 60-601-1
[________μA]

UL 60-601-1
Test Normal condition (N.C.): The value must not exceed 300 μA.
Entry V-unit: Normal condition (N.C.) according to UL 60-601-1
[________μA]

Test Single fault condition (S.F.C.): The value must not exceed 500 μA.
Entry V-unit: Single fault condition (S.F.C.) UL 60-601-1
[________μA]

IEC 60-601-1
Test Normal condition (N.C.): The value must not exceed 500 μA.
Entry GS500 option: Normal condition (N.C.) IEC 60-601-1
[________μA]

Test Single fault condition (S.F.C.): The value must not exceed 1000 μA.
Entry GS500 option: Single fault condition (S.F.C.) IEC 60-601-1
[________μA]

UL 60-601-1
Test Normal condition (N.C.): The value must not exceed 300 μA.
Entry GS500 option: Normal condition (N.C.) according to UL 60-601-1
[________μA]

Test Single fault condition (S.F.C.): The value must not exceed 500 μA.
Entry GS500 option: Single fault condition (S.F.C.) UL 60-601-1
[________μA]
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3.3.5 Earth leakage current of Workstation with PS500 option


NOTE
In order to avoid incorrect measurement, set up the V-unit under test so that
it is insulated.

NOTE
If the Workstation is equipped with the PS500 option, then the earth leakage
current for the entire Workstation must be measured via the PS500 option.

Test set-up

Fig. 9 Earth leakage current test setup

Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Device under test
L Conductor
N Neutral conductor
PE (Protective earth) conductor

Action • Prepare the test setup.


• Switch on the Workstation.
• Follow the instructions on the tester.
NOTE
For symmetrical mains plugs that have no preferential position in the socket-
outlet, the earth leakage current test must be performed twice! The second
test is performed with the plug rotated 180° in the socket. In many test de-
vices the mains plug rotation is simulated by means of a built-in selector
switch. The higher measured value must be documented.

IEC 60-601-1
Test Normal condition (N.C.): The value must not exceed 500 μA.
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Entry PS500 option: Normal condition (N.C.) IEC 60-601-1


[________μA]

Test Single fault condition (S.F.C.): The value must not exceed 1000 μA.
Entry PS500 option: Single fault condition (S.F.C.) IEC 60-601-1
Workstation Critical Care [________μA]

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UL 60-601-1
Test Normal condition (N.C.): The value must not exceed 300 μA.
Entry PS500 option: Normal condition (N.C.) according to UL 60-601-1
[________μA]

Test Single fault condition (S.F.C.): The value must not exceed 500 μA.
Entry PS500 option: Single fault condition (S.F.C.) UL 60-601-1
[________μA]

3.3.6 Patient leakage current


NOTE
Perform the patient leakage current test only if the Neo-Flow measurement
option is fitted.

Test set-up

Fig. 10 Patient leakage current test setup

Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Device under test
3 Test plug, 7901772
4 Sockets for applied parts
L Conductor
N Neutral conductor
PE (Protective Earth) conductor

Action • Prepare the test setup.


• Connect the Neo-Flow sensor cable to the V-unit.
• Remove the Neo-Flow sensor.
• Connect the test plug (7901772) to the Neo-Flow sensor socket and to the
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tester.
• Start up the test specimen and perform patient leakage current measure-
ments.
• Follow the instructions on the tester.

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Electrical safety according to IEC 60601-1

NOTE
For symmetrical mains plugs that have no preferential position in the socket-
outlet, the patient leakage current test must be performed twice! The second
test is performed with the plug rotated 180° in the socket. In many test de-
vices the mains plug rotation is simulated by means of a built-in selector
switch. The higher measured value must be documented.

IEC 60-601-1
Test Normal condition (N.C.) DC: The value must not exceed 10 μA.
Entry Normal condition (N.C.) according to DC IEC 60-601-1
[________μA]

Test Normal condition (N.C.) AC: The value must not exceed 100 μA.
Entry Normal condition (N.C.) according to AC IEC 60-601-1
[________μA]

Test Single fault condition (S.F.C.) DC: The initial value must not exceed 50 μA.
Entry Single fault condition (S.F.C.) according to DC IEC 60-601-1
[________μA]

Test Single fault condition (S.F.C.) AC: The value must not exceed 500 μA.
Entry Single fault condition (S.F.C.) according to AC 60-601-1
[________μA]

UL 60-601-1
Test Normal condition (N.C.) DC: The value must not exceed 10 μA.
Entry Normal condition (N.C.) according to DC UL 60-601-1
[________μA]

Test Normal condition (N.C.) AC: The value must not exceed 100 μA.
Entry Normal condition (N.C.) according to AC UL 60-601-1
[________μA]

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4 Function and condition test
This chapter contains tests that need to be performed in order to verify that the function and
condition of the device and the accessories used meet the specifications according to the
Instructions for Use.

4.1 General condition check ........................................................................................................... 36


4.2 C500 and V-unit condition test ................................................................................................. 39
4.3 Options condition test ............................................................................................................... 40
4.4 C500, function tests .................................................................................................................. 44
4.5 Reading out operating data ...................................................................................................... 45
4.6 Safety device function tests ...................................................................................................... 46
4.7 Function test of power failure battery, part 1 ............................................................................ 49
4.8 Workstation, Device checks according to Instructions for Use ................................................. 49
4.9 Function test of power failure battery, part 2 ............................................................................ 49
4.10 Option, V-unit, Function test of PS500, part 1 .......................................................................... 50
4.11 Breathing circuit check according to Instructions for Use ......................................................... 50
4.12 Function tests in ventilation mode ............................................................................................ 51
4.13 Option, Function test of PS500, part 2 ..................................................................................... 52
4.14 Function test of the V-unit display ............................................................................................ 53
4.15 Function test of non-return valves in gas inlet .......................................................................... 53
4.16 Nurse call function test ............................................................................................................. 54
4.17 Option, Function test of the MCable-Mainstream CO2 (CO2 sensor) ...................................... 55
4.18 Option, Resetting the GS500 configuration to user setting ...................................................... 56
4.19 Workstation, Final procedure.................................................................................................... 56
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Function and condition test
General condition check

4.1 General condition check


Prerequisites The Workstation has been fully assembled according to the Instructions for
Use manuals.

4.1.1 Workstation
Test Check that the Workstation is clean and undamaged.
Result
[________OK]

4.1.2 Accompanying documents


Test Check that all accompanying documents are available (according to
user/owner).
Only applicable in Germany: Check that the medical product logbooks are
available (according to user/owner).
Result
[________OK]

4.1.3 Rating plates, labels, and inscriptions on the Workstation


Test Check that the following rating plates, labels, and inscriptions are complete
and legible:

Fig. 11 Rating plate on the C500


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Fig. 12 Rating plate (left) and options label (right) on the V-unit

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General condition check

Fig. 13 RFID label (left) and gas supply connections label (right) on the V-
unit

Fig. 14 Country-specific label (e.g. USA/Canada, Japan, China) on the V-


unit

– Inscriptions on all interfaces


– Inscription on connection housing
Result [________OK]
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Function and condition test
General condition check

4.1.4 Rating plates, labels, and inscriptions on available options


Test Check that the following rating plates, labels, and inscriptions are complete
and legible:

Fig. 15 Label on front of trolley option

Fig. 16 Rating plate (example) on back of trolley option

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Fig. 17 Rating plate on back of GS500 option

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Function and condition test
C500 and V-unit condition test

Fig. 18 Rating plate on back of PS500 option

Result [________OK]

4.2 C500 and V-unit condition test

4.2.1 C500
Test Check that the following items are fully present, undamaged, clean and oper-
able:
– Mount (including pivot and lock function) and fitting on C500
– Housing
– Rotary knob cap
– Touch-screen
– Silence key
– ON/OFF switch
– System cable to the V-unit including C500 connector cover
– Vent slots
– Silicone cover for gas LEDs fitted
Result
[________OK]
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Function and condition test
Options condition test

4.2.2 V-unit
Test Check that the following items are fully present, undamaged, clean and oper-
able:
– Housing
– Retainer of mains power cable
– Pipeline supply connections
– ON/OFF switch
– Column attachment fixture
– Expiratory valves with lip seals, crater and water trap
– Inspiratory unit (safety valve) with diaphragm and silicone seal
– Flap of connection housing (flow sensor and expiratory valve cover),
including function
– Device rails
– Flow sensor, including function of slide mechanisms (Slide mechanism to
left and right. Flow sensor must remain at the respective position.)
– Patient tubes
Result
[________OK]

4.3 Options condition test


Action • Check whether options are fitted and, if fitted, check their condition.

4.3.1 MCable-Mainstream CO2 module M11.1 (CO2 sensor) option


Test Check that the following items are undamaged and clean:
– Housing
– Connecting cable
– Connector
Result
[________OK]

4.3.2 Neonatal flow measurement option


Test Check that the following items (if fitted) are undamaged and clean:
– Neo-Flow sensor
– Neo-Flow sensor cable with plug
Result
[________OK]
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Function and condition test
Options condition test

4.3.3 Drug nebulizer option


CAUTION
Variation in breathing volume and inspiratory oxygen concentration!
If other pneumatic drug nebulizers are used, significant variances in the
breathing volume and the inspiratory oxygen concentration may result.
– Use only drug nebulizers that have been approved for the Workstation.

NOTE
Do not connect the drug nebulizer with the black housing to the unit!

Test Check that the following items are undamaged and clean:

Fig. 19 Drug nebulizer

Item Description
1 Patient connection
2 Drug nebulizer housing, white
3 Flat seal
4 O-ring
5 Nozzle
6 O-ring
7 Atomizer
8 Container
9 Drug nebulizer tube

Result
[________OK]
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Function and condition test
Options condition test

4.3.4 Trolley option


Test Check that the following items are installed securely, undamaged and clean:
– Castors and brakes: Check castors and function of brakes on level ground.
Check each castor individually. Operate brake and move trolley in each
direction. Check function of brakes when doing so. The castor must not
rotate when then brake is applied. This might be a sign of a loose screw.
Slight axial play is permissible.
– Impact guard
– Handle
Result
[________OK]

4.3.5 Trolley option, optional gas cylinder mounts

Fig. 20 Optional gas cylinder mounts

Test Check that the following items are in perfect condition:


– Both gas cylinder mounts (bottom and top) are securely installed.
– Velcro strips have the correct length for the installed gas cylinders and are
undamaged.
– Tabs for mounting of Velcro strips are undamaged.
Result
[________OK]
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Function and condition test
Options condition test

4.3.6 Trolley option, optional hose mounts

Fig. 21 Optional hose mounts

Test Check that both hose mounts (bottom and top) are securely installed and
undamaged.
Result
[________OK]

4.3.7 GS500 option


Test Check that the following items are in perfect condition:
– Housing
– Side cover with integrated retainer for mains power cable
– Data cable
– Connecting hoses
– Gas channel from GS500 to V-unit
Result
[________OK]

4.3.8 PS500 option


Test Check that the following items are in perfect condition:
– Housing
– Side cover with integrated retainer for mains power cable
– Toggle switch on rear panel
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– Standby button
Result
[________OK]

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Function and condition test
C500, function tests

4.4 C500, function tests

NOTE
If the PS500 option is fitted, then the V-unit and, if applicable, also the
GS500 option must be supplied with mains voltage via the PS500.

4.4.1 Preparation for the function tests


Action • Plug the power plug of the Workstation into the mains socket-outlet.
• If the PS500 option is fitted, switch the toggle switch on the rear panel to the „I“ position.
• Connect the gas supply.
• If available, connect the CO2 sensor to the V-unit.
• If available, connect the neonate flow sensor to the V-unit.
NOTE
Read this Note thoroughly before starting the Workstation:
When the Workstation is started, different functions are checked and the
software version is displayed. In order to avoid having to restart the Work-
station several times, perform the following tests first before entering the val-
ues in the Test Report or Result Sheet, whichever is applicable.
– After pressing the power-on button of the C500, the rotary knob lighting
lights up blue briefly. Check function.
– During the self-test, the yellow and the red alarm LED bar of the C500
are activated once. Check function.
– After power-on (when the „Please wait for system start” screen
appears), the software version is displayed at the bottom of the screen.
Make a mental note of the software version.
– Shortly before the end of the self-test, both loudspeakers of the C500
are activated (the primary loudspeaker is louder than the secondary
loudspeaker). Check function.

Action • Power up the Workstation and perform the tests listed in the Note.

4.4.2 Workstation software version


Test Software version was displayed during power-up.
Entry Enter the software version.
[________txt]

4.4.3 C500, „Red“ and „yellow “ visual alarms


Test – The yellow and red alarm LED bars of the C500 were activated during
power-up.
Result
[________OK]

4.4.4 C500, Audible alarm


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Test – The primary loudspeaker and the secondary loudspeaker were activated
during power-up.
Result
[________OK]
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Function and condition test
Reading out operating data

4.4.5 Rotary encoder


Test – The blue rotary knob lighting came on when the power-on button of the
C500 was pressed.
Action • In standby menu, under „New patient“, select „New adult“.
Test – The yellow rotary knob lighting comes on.
Action • Confirm „New adult“ with the rotary knob.
Test – The „Start/Standby“ menu opens.
Result
[________OK]

4.4.6 Silence key


Action • In standby mode, press the silence key.
Test – At the top right of the screen a box is displayed showing the Silence count-
down.
Result
[________OK]

4.5 Reading out operating data

4.5.1 Workstation operating data


Prerequisites The following preconditions must be met in order to read the operating data:
– The Workstation is switched on.
– The Workstation is in Standby mode.
NOTE
If the GS500 option is fitted, in standby mode, under „System setup / Sys-
tem/ Supply units“, switch on the GS500 using the „On“ button. Make a note
of the user settings for later re-entry!

NOTE
If the Service menu is called up immediately after power-on, it may take up
to 1 minute for access to be enabled.

Action • In Standby mode, call up service menu „System setup/System/Service“.


• Enter code „8270” and press „Enter“.
• Open the Service menu by pressing the „Enter“ key again.
• Open the „Operating Data” service page.
• Open the „V(N)500 Battery“ service page.
• Read out the „Battery Charge Delivered” parameter.
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NOTE
Above 500 Ah a battery running time of 30 minutes may possibly no longer
be attainable. If 250 Ah has already been exceeded since the last battery
replacement, advise the user that the 500 Ah limit is likely to be reached pri-
or to the next scheduled inspection. It is advisable to replace the battery as
a precaution.

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Function and condition test
Safety device function tests

Entry Enter the „Battery Charge Delivered” parameter.


[________Ah]

Action • Exit the service menu.

4.6 Safety device function tests


Prerequisites – The AIR pipeline supply (or the GS500 option) and the O2 pipeline supply
are connected.
– The Workstation is in Standby mode.

4.6.1 Emergency expiratory valve SV2


Action • Prepare the following test set-up:

Fig. 22 Test set-up for function testing of the emergency expiratory valve
SV2

Item Test equipment Part number


1 Test pressure regulator DIN or 7901482or
1 Pin index test pressure regulator 7910342
2 Connecting port M06258
3 Silicone tube
4 Flowmeter, block of 3 7901161
5 Connecting sleeve M13506
6 ISO Y-piece M25650
7 Connecting sleeve M13506
8 Pressure measuring device 7910722
9 Patient tube, e.g. breathing tube K 22/10 0.6 2165821
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Action • Do not yet connect the patient tube to the inspiratory port.
• Set a flow of 5 +/- 0.5 L/min with the test pressure regulator.
• Perform a zero calibration on the pressure gauge.
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• Connect the patient tube to the inspiratory outlet.

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Function and condition test
Safety device function tests

• Read the pressure from the pressure gauge.


Test The pressure rise indicated on the gauge is 1.9 to 4.4 mbar.
Result [________OK]

4.6.2 Emergency respiratory valve SV3


Action • Prepare the following test set-up:

Fig. 23 Test set-up for function testing of the emergency respiratory valve
SV3

Item Test equipment Part number


1 Test pressure regulator DIN or 7901482or
1 Pin index test pressure regulator 7910342
2 Injector 7900930
3 Silicone tube
4 Connecting sleeve M13506
5 ISO connector M25647
6 Flowmeter, 10 to 120 L/min 7900718
7 ISO Y-piece M25650
8 Connecting sleeve M13506
9 Pressure measuring device 7910722
10 Patient tube, e.g. breathing tube K 22/10 0.6 m 2165821

NOTE
The silicon tube must not be too long, otherwise the required extraction flow
will not be attained.
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Action • Do not yet connect the patient tube to the inspiratory port.
• Set an extraction flow of 60 to 65 L/min with the test pressure regulator.
• Perform a zero calibration on the pressure gauge.
• Connect the patient tube to the inspiratory outlet.
• Read the pressure from the pressure gauge.

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Function and condition test
Safety device function tests

Test The pressure drop indicated on the gauge is 0 to -6.5 mbar.


Result [________OK]

4.6.3 Non-return valve in expiratory valve


NOTE
Check all neonate expiratory valves belonging to the Workstation.

Action • Prepare the following test set-up:

Fig. 24 Test set-up for function test of non-return valve in expiratory valve

Item Test equipment Part number


1 Test pressure regulator DIN or 7901482or
1 Pin index test pressure regulator 7910342
2 Injector 7900930
3 Silicone tube
4 Flowmeter, block of 3 7901161
5 Connecting sleeve M13506
6 ISO Y-piece M25650
7 Connecting sleeve M13506
8 Pressure measuring device 7910722
9 Breathing tube K 22/10 0.6 m (for neonate expiratory valve 2165821
only

Action • Connect the breathing tube to the expiratory valve.


• Using the test pressure regulator, slowly set a negative pressure of -2.5
mbar.
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• As soon as the negative pressure has been reached, read off the flow from
the flowmeter tube, measuring range 0 to 0.22 L/min.
Test The measured leakage flow of the flowmeter must not exceed 110 mL/min.
Result [________OK]
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Function and condition test
Function test of power failure battery, part 1

4.7 Function test of power failure battery, part 1


Prerequisites – The Workstation is in Standby mode.

4.7.1 Function test


Test The external power LED lights up. Remark: The LED is to the left of the
ON/OFF switch of the C500.
The battery LED to the right of the C500 On/Off switch is lit green or yellow.
A battery icon in the top left corner of the screen indicates the battery state of
charge. Each charge bar corresponds to about 20% of a full battery charge.
The battery icon should show at least 2 bars’ charge.
Action • Unplug the power plug of the device from the mains supply.
Test The external power LED goes out.
Result [________OK]

Action • Run the Workstation for about 5 minutes on the battery.


• Continue with the following tests.
• After approximately 5 minutes, connect the power plug for "4.9 Function
test of power failure battery, part 2".

4.8 Workstation, Device checks according to Instructions for Use


Prerequisites – The Workstation is in Standby mode.
Action • If fitted, switch on the GS500 via the „System setup / System / Supply
units“ menu.
• Make a (mental) note of the user settings for later re-entry.

4.8.1 Device checks


Action • Connect the patient tubes to the Y-piece.
• If available, connect the MCable-Mainstream CO2 module M11.1 (CO2
sensor).
• If available, connect the Neo-Flow sensor to the breathing circuit.
• Connect the Dräger test lung (thorax), 7911140.
• From the menu select „Start/Standby -> System check -> Device check“.
• Press the „Start“ softkey and acknowledge.
• Follow the instructions on the C500.
• Perform each device check.
Test – Device checks completed without errors.
Result [________OK]
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4.9 Function test of power failure battery, part 2


Prerequisites – The Workstation is in Standby mode.
– The Workstation has been running on battery power for about 5 minutes.

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Function and condition test
Option, V-unit, Function test of PS500, part 1

4.9.1 Function test


Action • Connect the power plug of the V-unit.
Test The housing fan of the V-unit runs temporarily at high speed.
The power LED on the C500 is on.
Result [________OK]

4.10 Option, V-unit, Function test of PS500, part 1

NOTE
During the test, at least the power cable of the V-unit must be connected as
load to the PS500.

NOTE
This function test is in two parts. In this part 1, power failure mode is tested.
For this purpose, the power plug of the PS500 is disconnected and the
Workstation is powered by the PS500 for approximately 5 minutes. In part 2
(after 5 minutes), a test is performed to verify that the devices connected to
the PS500 are still supplied with voltage.

4.10.1 Function test


Test – The mains power indicator LED on the PS500 is on.
– The fault indicator LED on the PS500 is off.
– The battery charge indicator on the PS500 shows at least 3 bars.
Action • Interrupt the mains power supply to the PS500 and make a note of the cur-
rent time.
Test – The mains power indicator LED on the PS500 goes off.
– The Workstation continues to run without interruption.
– The green power LED on the C500 is on.
Result [________OK]

Action • Power the Workstation from the PS500 battery for approximately 5 min-
utes.
• Continue with the other function tests.

4.11 Breathing circuit check according to Instructions for Use


Prerequisites – The Workstation is in Standby mode.
– Device checks according to Instructions for Use completed.
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Function and condition test
Function tests in ventilation mode

4.11.1 Breathing circuit check


NOTE
All adult expiratory valves and, if available, neonate expiratory valves be-
longing to the Workstation must be checked.

Action • Select menu „Start/Standby -> System check -> Breathing circuit check“.
• Press the „Start“ softkey and acknowledge.
• Connect tube system and seal Y-piece.
• Press the „OK“ key.
• Follow the on-screen instructions.
Test The leakage is < 200 mL/min.
Result [________OK]

4.12 Function tests in ventilation mode


Prerequisites – The Workstation is fully fitted out and in Standby mode.
– An expiratory valve for adults and an expiratory flow sensor are fitted.
– An adult tubing system is connected.
– The Dräger test lung (thorax), 7911140, is connected.
– The device check and the breathing circuit check were performed accord-
ing to Instructions for Use.
– The „Start/Standby“ menu is open.
Action • Use the tapered socket, 8400904, to connect the DPI between the patient
tube and the Dräger test lung.
• Open the „Br. circuit / Humidifier“ menu and select „HME/Filter“ humidifica-
tion.
• On the screen, press the „Ventilation settings“ key.
• Select „VC-CMV“ ventilation mode.
• Set the following parameters:

FiO2: 50%
VT: 500
TI: 1,7
f: 12
Flow: 30
PEEP: 5

Action • Select the „Start/Standby“ menu.


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• Start „VC-CMV“ ventilation mode.


• Disable any triggered alarms by adjusting the alarm limits.

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Function and condition test
Option, Function test of PS500, part 2

4.12.1 Flowmeter function test


Action • Select the „System setup -> Ventilation -> Password 8270 (Enter) -> Gen-
eral settings“ menu and set the leakage compensation to „Off“. After the
test reset the leakage compensation to the user settings.

NOTE
Any missing measurement parameters must be configured on-screen. The
„VTemand” parameter differs from the preset value by about -3% when op-
erating with a test lung because of the lack of moisture and CO2. For this
reason the test value is 485 mL.

Action • Check the following parameter:

VTemand = 485 +/-50 mL

Result [________OK]

Action • Reset leakage compensation to user setting.

4.12.2 Airway pressure gauge function test


Action • Configure the „Pplat“ parameter on the C500.
• Open the menu „Special maneuvers -> Functions“.
• Press and hold the „Manual Inspiration/Hold” key.
• Read the measured value off the DPI shortly before releasing the „Manual
Inspiration/Hold” key.
• Release the „Manual Inspiration/Hold” key. Remark: The parameter
„Pplat“ is updated on the C500 with the following breath.
• Read off the „Pplat“ value. Remark: If no „Pplat“ value is displayed, then
there is probably a leak.
Test The deviation between the DPI reading and the „Pplat“ reading does not
exceed 6%.
Result [________OK]

4.12.3 O2 measurement function test


Test FiO2 = 50 +/-2% by vol.

Result [________OK]

4.13 Option, Function test of PS500, part 2

NOTE
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In this part 2, a test is performed to verify that the devices connected to the
PS500 are still supplied with voltage.

Prerequisites – The test step "4.10 Option, V-unit, Function test of PS500, part 1" has been
completed.
– The Workstation
Workstation Critical Carehas been running on PS500 battery power for approxi-
mately 5 minutes.

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Function and condition test
Function test of the V-unit display

4.13.1 Function test


Test – The green power LED on the C500 is on.
Result [________OK]

Action • Connect the power plug of the PS500.

4.14 Function test of the V-unit display


Prerequisites The device is in operation mode with the parameter settings from the test
"4.12 Function tests in ventilation mode".

NOTE
Changes to measurements are applied after a delay. This may result in vari-
ations between the readout on the C500 and the V-unit display readout.

4.14.1 Function test


Test – The bar graph indicates the breath.
– The „FiO2“ readout corresponds to the „FiO2“ value on the C500.
– The „MV“ readout corresponds to the „MV“ value on the C500.

Result [________OK]

4.15 Function test of non-return valves in gas inlet


Prerequisites – The device is in ventilation mode with the parameter settings from the previous test.

NOTE
If the device is not fitted with NIST pipeline supply ports, the connection be-
tween the flowmeter and the device pipeline supply inlet can be made by
other means for the purposes of this test, such as by detaching the connec-
tor from a country-specific pipeline supply tube and using it as an adapter.

4.15.1 Function test


Action • If the GS500 option is fitted, open the „System setup / System / Supply
units“ menu, and then switch the GS500 off using the „Off“ key.
• Disconnect the AIR pipeline supply.
• Unscrew AIR pipeline supply tube from device.
• Silence any alarms using the silence key.
• Connect NIST AIR M32301 set to AIR inlet.
• Connect triple flowmeter, 7901161, to set.
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Test – The flowmeter float may rise a maximum of 50 mL/min.


Action • Unscrew set and connect AIR pipeline supply.
• Disconnect the O2 pipeline supply.
• Unscrew O2 pipeline supply tube from device.
• Connect NIST O2 M32048 set to O2 inlet.

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Function and condition test
Nurse call function test

• Connect triple flowmeter, 7901161, to set.


Test – The flowmeter float may rise a maximum of 50 mL/min.
Result [________OK]

Action • Unscrew set and connect O2 pipeline supply.

4.16 Nurse call function test


Prerequisites – The device is in Ventilation mode with the parameter settings from the pre-
vious test.

NOTE
– If the external nurse call box (8417370) is installed, and if the open cable
ends of the external nurse call box are freely accessible, connect the
nurse call box to the nurse call socket on the V-unit. Proceed to function
test „Nurse call with nurse call box (8417370)“.
– If the nurse call box 8417370 is permanently wired to the control center,
the Ohm tests cannot be performed. In this case the control center alarm
check with the device alarm active is sufficient.

NOTE
If the external nurse call box (8417370) is not available, connect the nurse
call test adapter (7911671) to the nurse call socket on the V-unit. Proceed
to function test „Nurse call with test adapter (7911671)“.

4.16.1 Nurse call with nurse call box (8417370)


Prerequisites No device alarm must be active (if necessary, adjust the relevant alarm limit
values accordingly).
Action • Connect an ohmmeter to the output of the nurse call box (brown and green
cables).
Test The resistance is < 3 Ohms.
Action • Press the „Alarms“ key on the C500.
• Set an alarm limit (for example, „Paw high“) within the active range and
confirm with the rotary knob.
Test An open circuit is measured between the brown and green cables.
Action • Connect an ohmmeter to the output of the nurse call box (brown and white
cables).
Test The resistance is < 3 Ohms.
Action • Reset alarm limit.
Test An open circuit is measured between the brown and white cables.
Result [________OK]
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Action • Skip the test "4.16.2 Nurse call with test adapter (7911671)".

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Function and condition test
Option, Function test of the MCable-Mainstream CO2 (CO2 sensor)

4.16.2 Nurse call with test adapter (7911671)


NOTE
The nurse call with test adapter (7911671) test is only necessary, if no nurse
call box (8417370) is available.

Prerequisites No device alarm must be active (if necessary, adjust the relevant alarm limit
values accordingly).
Action • Connect the nurse call test adapter (7911671) to the nurse call socket on
the V-unit.
Test – The 24-Volt LED of the test adapter is lit green.
– The nurse call LED is lit green.
Action • Press the „Alarms“ key on the C500.
• Set an alarm limit (for example, „Paw high“) within the active range and
confirm with the rotary knob.
Test The nurse call LED is lit red.
Result [________OK]

Action • Reset alarm limit.

4.17 Option, Function test of the MCable-Mainstream CO2 (CO2 sen-


sor)
Prerequisites – The CO2 sensor is connected and the warm-up phase is completed.

NOTE
During the following tests, do not breathe in the direction of the CO2 sensor.

4.17.1 Function test


Action • Call up the Standby mode.
• Open the „Sensors / Parameters -> CO2“ menu.
• Switch monitoring to „On“.
• Do not insert a cuvette.
• Press the „Start zero calibration“ key and confirm.
Test – The message „Zero calibration successful“ is displayed on the C500.
Action • Open the „Check sensor“ menu.
• Insert the test filter.
• Press the „Filter test“ key.
Test – The message „Filter test successful“ is displayed on the C500.
Result [________OK]
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Action • Remove the test filter.

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Function and condition test
Option, Resetting the GS500 configuration to user setting

4.18 Option, Resetting the GS500 configuration to user setting

NOTE
If the GS500 is fitted, it must be reset to the original user setting in operating
mode.

4.18.1 User setting


Action • In standby mode, under „System setup / System / Supply units“ reset the
GS500 to the original user setting by clicking „On“ or „Off“, whichever is
applicable.
Result [________OK]

4.19 Workstation, Final procedure


Prerequisites – The test instructions have been performed as specified.
– All tests performed were passed.

4.19.1 Device handover with test label


CAUTION
Batteries not fully charged!
If the batteries are not fully charged, the operating time of the Workstation
in the event of a mains power failure could be reduced considerably.
– If applicable, inform the user that the batteries still need to be recharged.

Action • Shut down the Workstation.


• Attach a test label to the Workstation.
• Place ready-for-use Workstation at the owner's/user's disposal.
Result
[________OK]

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5 Test equipment
This chapter lists the service equipment required to perform the tests specified in these test
instructions.

5.1 Test equipment ......................................................................................................................... 58


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Test equipment
Test equipment

5.1 Test equipment

5.1.1 Test equipment subject to mandatory calibration

Designation Part number


Digital multimeter, 4 3/4-digit 7901021 or equivalent

Measuring equipment for electrical 7910594 or equivalent


safety

DIN test pressure regulator (matching 7901482 or equivalent


high-pressure cylinder)

Pin index test pressure regulator 7910342 or equivalent No picture available.


(matching high-pressure cylinder)
Flowmeter, block of 3 7901161 or equivalent

Flowmeter (10 to 120 L/min) 7900718 or equivalent


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Test equipment
Test equipment

Designation Part number


Pressure gauge, digital, 1 bar 7910722 or equivalent

Result Valid calibrated test equipment used.


[________OK]

5.1.2 Test equipment not subject to mandatory calibration

Designation Part number


Service laptop running latest Service No picture available.
software
VDE Babylog test plug (if Neo-Flow 7901772 or equivalent
option installed)

High-pressure cylinder O2 No picture available.


Connecting port, subassembly M06258 or equivalent

Silicone tube No picture available.


Connecting sleeve M13506 or equivalent

Y-piece, adult, straight M25650 or equivalent No picture available.


Injector 7900930 or equivalent
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Test equipment
Test equipment

Designation Part number


Dual connector 22/22 M25647 or equivalent

Test lung 7911140 or equivalent

Nurse call test adapter 7911671 or equivalent No picture available.


Altitude correction table 7910698 No picture available.
Patient tube for adults No picture available.
Breathing tube K22/10 0.6 (if optional 2165821 or equivalent No picture available.
neonate expiratory valve is present)
Tapered socket 8400904 or equivalent

NIST O2 spare parts set M32048 No picture available.


NIST AIR spare parts set M32301 No picture available.
Change grip + blade (hexagon socket, 3 7910520 + 7910518 or equiv-
mm) alent

Change grip + blade (hexagon socket, 4 7910520 + 7910554 or equiv-


mm) alent
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5.1.3 Required spares (if applicable)


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Test equipment
Test equipment

Designation Part number


Filter (power supply unit fan) 8416753 No picture available.
Diaphragm, complete (expiratory valve) 8413661 No picture available.
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Result Sheet Test instructions / Service Card IPM

Workstation Critical Care


Order number: 9500693

Location: Serial no. (basic unit):

Department: Cust. invent. no.:

Maintenance interval: Other / Delivery date:

Key

9 / OK = OK
Applies to Test instructions / Service Card IPM Revision 3.n + = Spare part used
! = Error / Report
/ = Accessory not available
- = Not applicable

OK Result OK Result
1 Device configuration 3 Electrical safety
1.1 Device configuration 3.1 Electrical safety of V-unit or ME system according to
DIN EN 62353 (IEC 62353)
1.1.1 Serial numbers (if not otherwise recorded)
3.1.1 Notes on the Electrical safety to DIN EN 62353
1.1.1.1 C500 txt
section
1.1.1.2 V-unit txt OK
3.1.2 Visual check
1.1.1.3 Inspiratory safety valve (inspiratory unit) txt 3.1.3 Protective conductor resistance
1.1.1.4 Expiratory valve for adults txt 3.1.3.1 Maximum measured value. Ohm
1.1.1.5 Additional expiratory valve for adults txt 3.1.3.2 Maximum measured value of the ME system. Ohm
1.1.1.6 MCable-Mainstream CO2 (CO2 sensor) op- txt 3.1.4 Protective conductor resistance measuring OK
tion points
1.1.1.7 Neonate expiratory valve option txt 3.1.5 Device leakage current
1.1.1.8 Additional neonate expiratory valve option txt 3.1.5.1 Reference value μA
1.1.1.9 GS500 option txt 3.1.5.2 Recurrent measurement μA
1.1.1.10 PS500 option txt 3.1.6 Applied parts for device leakage current
1.1.1.11 Trolley option txt 3.1.6.1 VDE Babylog test plug (if Neo-Flow option in- OK
txt stalled)
1.1.1.12 Additional hardware option nebulizer-ejector
(without serial number) (yes or no) 3.1.7 Leakage current from applied part, Mains at ap-
plied part, type BF
1.1.1.13 Additional hardware option neonate flow mea- txt
surement (without serial number) (yes or no) 3.1.7.1 Reference value μA
2 Maintenance parts 3.1.7.2 Recurrent measurement μA
2.1 Maintenance parts, yearly 3.1.8 Applied parts for leakage current from applied
2.1.1 GS500 option part test

dat 3.1.8.1 VDE Babylog test plug (if Neo-Flow option in- OK
2.1.1.1 Ambient air filter (filter mat)
stalled)
2.1.1.2 Blower unit AIR filter (microfilter) dat
3.2 Option, Electrical safety of GS500 as single device
2.2 Maintenance parts, 2-yearly (not ME system) according to DIN EN 62353
2.2.1 V-unit (IEC 62353)

2.2.1.1 Air filter dat 3.2.1 Visual check OK

2.2.1.2 Battery M7 NM2.5 dat 3.2.2 Protective conductor resistance

2.2.2 GS500 option 3.2.2.1 Maximum measured value. Ohm

2.2.2.1 Ambient air filter (filter mat) dat 3.2.2.2 Maximum measured value of the ME system. Ohm

2.2.2.2 Blower unit AIR filter (microfilter) dat 3.2.3 Protective conductor resistance measuring OK
points
2.3 Maintenance parts, 6-yearly
3.2.4 Device leakage current
2.3.1 V-unit
3.2.4.1 Reference value μA
2.3.1.1 Air filter dat
3.2.4.2 Recurrent measurement μA
2.3.1.2 Battery M7 NM2.5 dat
3.3 Electrical safety according to IEC 60601-1
2.3.1.3 Particle filter(O2 filter) dat
3.3.1 Visual check OK
2.3.2 GS500 option
3.3.2 Protective conductor resistance
2.3.2.1 Ambient air filter (filter mat) dat
3.3.2.1 V-unit protective earth conductor resistance Ohm
2.3.2.2 Blower unit AIR filter (microfilter) dat
3.3.2.2 Protective earth conductor resistance of the Ohm
2.4 Maintenance parts as required GS500 option
2.4.1 V-unit Ohm
3.3.2.3 Protective earth conductor resistance of the
2.4.1.1 Expiratory valve diaphragm dat PS500 option
2.4.1.2 Room air filter dat

Revision 3.0 Workstation Critical Care 1/3


OK Result OK Result
3.3.3 Earth leakage current of Workstation without 4.3.5 Trolley option, optional gas cylinder mounts OK
GS500 and PS500 options
4.3.6 Trolley option, optional hose mounts OK
3.3.3.1 Normal condition (N.C.) according to IEC 60- μA
4.3.7 GS500 option OK
601-1
μA 4.3.8 PS500 option OK
3.3.3.2 Single fault condition (S.F.C.) according to
IEC 60-601-1 4.4 C500, function tests
3.3.3.3 Normal condition (N.C.) according to UL 60- μA 4.4.1 Preparation for the function tests
601-1 txt
4.4.2 Workstation software version
3.3.3.4 Single fault condition (S.F.C.) according to μA
4.4.3 C500, Red and yellow visual alarms OK
UL 60-601-1
4.4.4 C500, Audible alarm OK
3.3.4 Earth leakage current of Workstation with GS500
option only 4.4.5 Rotary encoder OK
3.3.4.1 V-unit: Normal condition (N.C.) IEC 60-601-1 μA 4.4.6 Silence key OK
3.3.4.2 V-unit: Single fault condition (S.F.C.) IEC 60- μA 4.5 Reading out operating data
601-1 Ah
4.5.1 Workstation operating data
3.3.4.3 V-unit: Normal condition (N.C.) according to μA
4.6 Safety device function tests
UL 60-601-1
4.6.1 Emergency expiratory valve SV2 OK
3.3.4.4 V-unit: Single fault condition (S.F.C.) UL 60- μA
601-1 4.6.2 Emergency respiratory valve SV3 OK

3.3.4.5 GS500 option: Normal condition (N.C.) IEC μA 4.6.3 Non-return valve in expiratory valve OK
60-601-1 4.7 Function test of power failure battery, part 1
3.3.4.6 GS500 option: Single fault condition (S.F.C.) μA 4.7.1 Function test OK
IEC 60-601-1
4.8 Workstation, Device checks according to Instruc-
3.3.4.7 GS500 option: Normal condition (N.C.) ac- μA tions for Use
cording to UL 60-601-1
4.8.1 Device checks OK
3.3.4.8 GS500 option: Single fault condition (S.F.C.) μA
4.9 Function test of power failure battery, part 2
UL 60-601-1
4.9.1 Function test OK
3.3.5 Earth leakage current of Workstation with PS500
option 4.10 Option, V-unit, Function test of PS500, part 1
3.3.5.1 PS500 option: Normal condition (N.C.) IEC 60- μA 4.10.1 Function test OK
601-1 4.11 Breathing circuit check according to Instructions for
3.3.5.2 PS500 option: Single fault condition (S.F.C.) μA Use
IEC 60-601-1 4.11.1 Breathing circuit check OK
3.3.5.3 PS500 option: Normal condition (N.C.) accord- μA 4.12 Function tests in ventilation mode
ing to UL 60-601-1
4.12.1 Flowmeter function test OK
3.3.5.4 PS500 option: Single fault condition (S.F.C.) μA
UL 60-601-1 4.12.2 Airway pressure gauge function test OK

3.3.6 Patient leakage current 4.12.3 O2 measurement function test OK

3.3.6.1 Normal condition (N.C.) according to DC μA 4.13 Option, Function test of PS500, part 2
IEC 60-601-1 4.13.1 Function test OK
3.3.6.2 Normal condition (N.C.) according to AC μA 4.14 Function test of the V-unit display
IEC 60-601-1
4.14.1 Function test OK
3.3.6.3 Single fault condition (S.F.C.) according to DC μA
4.15 Function test of non-return valves in gas inlet
IEC 60-601-1
4.15.1 Function test OK
3.3.6.4 Single fault condition (S.F.C.) according to μA
AC 60-601-1 4.16 Nurse call function test
3.3.6.5 Normal condition (N.C.) according to DC UL μA 4.16.1 Nurse call with nurse call box (8417370) OK
60-601-1 4.16.2 Nurse call with test adapter (7911671) OK
3.3.6.6 Normal condition (N.C.) according to AC UL μA 4.17 Option, Function test of the MCable-Mainstream CO2
60-601-1 (CO2 sensor)
4 Function and condition test 4.17.1 Function test OK
4.1 General condition check 4.18 Option, Resetting the GS500 configuration to user
4.1.1 Workstation OK setting
4.1.2 Accompanying documents OK 4.18.1 User setting OK

4.1.3 Rating plates, labels, and inscriptions on the OK 4.19 Workstation, Final procedure
Workstation 4.19.1 Device handover with test label OK
4.1.4 Rating plates, labels, and inscriptions on avail- OK 5 Test equipment
able options
5.1 Test equipment
4.2 C500 and V-unit condition test
5.1.1 Test equipment subject to mandatory calibration
4.2.1 C500 OK
5.1.1.1 Valid calibrated test equipment used OK
4.2.2 V-unit OK
4.3 Options condition test
4.3.1 MCable-Mainstream CO2 module M11.1 (CO2 OK
sensor) option
4.3.2 Neonatal flow measurement option OK
4.3.3 Drug nebulizer option OK
4.3.4 Trolley option OK

Revision 3.0 Workstation Critical Care 2/3


Report:

Test has been performed according to the test instructions.

Name: ............................. __________________________________________________________


Date/Signature:............... __________________________________________________________

Revision 3.0 Workstation Critical Care 3/3


Manufacturer:

Dräger Medical GmbH


Moislinger Allee 53 – 55
23542 Lübeck
Germany

Tel: (+49) (0) 1805-3723437

FAX Fax: (+49) (0) 451/882 - 3779

Web: http://www.draeger.com

Subject to change without notice


Will not be replaced in the event of modifications.

© Copyright 2009 by Dräger Medical GmbH , Lübeck, Germany.

Revision 3.0
9036402
6500.000
No.1012_0000000469_Publication

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