Technical Documentation IPM

Primus IE
Anaesthesia workstation

Warning

All servicing and/or test procedures on the

device require detailed knowledge of this
documentation. Use of the device requires
detailed knowledge and observance of the
relevant Instructions for Use.
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2 Primus IE Technical Documentation IPM

 Table of contents

Table of contents

General 5
1 General notes ........................................................................................................................... 6
Function descriptions 9
1 General..................................................................................................................................... 10
2 Neutral Point PCB .................................................................................................................... 15
3 GUI ........................................................................................................................................... 17
4 Patient gas module (PGM2 IE/PGM3 IE) ................................................................................. 23
5 Mixer......................................................................................................................................... 47
6 VGC.......................................................................................................................................... 64
7 Power supply unit ..................................................................................................................... 96
8 Operating modes ...................................................................................................................... 100
9 Anaesthetic vaporizer ............................................................................................................... 102
10 RFID unit M21 EAST ................................................................................................................ 103
11 Trolley brake............................................................................................................................. 106
12 Front lighting and vaporizer lighting.......................................................................................... 108
13 Bronchial suction device........................................................................................................... 110
14 Block diagrams and pneumatic assembly diagram .................................................................. 115
Maintenance instructions 127
1 General information on use of maintenance instructions ......................................................... 128
2 Safety instructions .................................................................................................................... 129
3 AGSS filter................................................................................................................................ 130
4 Replacing bronchial suction device bacterial filter .................................................................... 131
5 Replacing the top rolling seal (VGC) ........................................................................................ 132
6 O2 sensor on PGM3 IE ............................................................................................................. 133
7 Flow sensors ............................................................................................................................ 134
Parts catalog 135
1 Primus IE .................................................................................................................................. 136
Test instructions 245
1 Primus IE .................................................................................................................................. 246
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4 Primus IE Technical Documentation IPM

 General

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

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

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General
General notes

1 General notes

1.1 Notes on use

Read through the following notes thoroughly before applying this
documentation.

The warnings set out here apply to all parts of this documentation.

Dräger reserves the right to make changes to the device and/or to this
documentation without prior notice. This documentation is intended solely as
an information resource for maintenance personnel or technical specialists.

1.2 Copyright and other protected rights

The content of this documentation, in particular its design, text, software,
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,
distributed, reproduced, republished, displayed, transmitted or sold without
the prior written consent of Dräger.

1.3 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 patient or in damage to the
medical product or other assets if not prevented.

NOTE
A NOTE provides additional information intended to avoid inconvenience
during operation and/or servicing.

Term Definition
Maintenance Maintaining the operative condition of a medical product
by suitable means
Inspection Assessment of the actual condition of a medical product
Servicing Maintaining the operative condition of a medical product
by recurrent, specified measures
Repair Restoring the operative condition of a medical product
after failure of a device function
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6 Primus IE Technical Documentation IPM

 General
General notes

1.4 General safety precautions

Read through each section thoroughly before beginning servicing.

CAUTION
Incorrect use of tools
The device's function may be impaired, or the device may be damaged.
Always use the correct tools and the specified test equipment.

WARNING
The device must be regularly inspected and serviced by maintenance
personnel. Repairs and complex maintenance work on the medical
product must be carried out by qualified specialists.
If you require a service contract, or for any necessary repair work,
Dräger recommends DrägerService. Dräger recommends using
original Dräger parts for servicing.
If the aforementioned instructions and recommendations are ignored,
the correct functioning of the medical product may be put at risk. Pay
attention to the "Servicing" section of the Instructions for Use.

WARNING
Non-conforming test values
If test values do not conform to specifications, the safety of the patient
may be put at risk.
– Do not put the device into operation if test values do not conform to
specifications.
– Contact your local service organization.

WARNING
Impermissible modifications to the device
If impermissible modifications are made to the device, the safety of the
patient may be put at risk.
Do not modify the device without Dräger's permission.

WARNING
Risk of infection
The unit may transmit pathogens following use on the patient.
– Before carrying out any servicing, ensure that the device and its
components have been handed over by the user cleaned and
disinfected.
– Service only cleaned and disinfected units and unit components.

WARNING
Risk to patient.
Ensure that no patient is connected to the device before starting
maintenance or repair work.

NOTE
Where reference is made to legislation, regulations and standards, in
respect of devices used and serviced in Germany they are based on the
No.1208_0000007950

laws of Germany. Users and technicians in other countries must comply with
their national laws and/or international standards.

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8 Primus IE Technical Documentation IPM

 Function descriptions

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

1 General..................................................................................................................................... 10
2 Neutral Point PCB .................................................................................................................... 15
3 GUI ........................................................................................................................................... 17
4 Patient gas module (PGM2 IE/PGM3 IE) ................................................................................. 23
5 Mixer......................................................................................................................................... 47
6 VGC.......................................................................................................................................... 64
7 Power supply unit ..................................................................................................................... 96
8 Operating modes ...................................................................................................................... 100
9 Anaesthetic vaporizer ............................................................................................................... 102
10 RFID unit M21 EAST ................................................................................................................ 103
11 Trolley brake............................................................................................................................. 106
12 Front lighting and vaporizer lighting.......................................................................................... 108
13 Bronchial suction device........................................................................................................... 110
14 Block diagrams and pneumatic assembly diagram .................................................................. 115
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Function descriptions
General

1 General

In the following documentation "Primus Infinity Empowered" is referred to for

short as "Primus IE".

1.1 Intended use

The stipulations in the relevant instructions for use apply.

1.2 Short description of the Primus IE

The following sections provide an overview of the Primus IE components.

1.2.1 Ventilator
7385

Fig. 1 Ventilator with breathing system

The electronically controlled and driven ventilator has the following features:
– Ventilation modes such as volume mode, pressure mode, pressure
support (optional) and MAN/SPONT with switchable synchronization and
pressure support (optional).

1.2.2 Breathing system The breathing system comprises the following components:
– Integrated CO2 absorber, either reusable or disposable.
– Electronic interfaces for inspiratory and expiratory flow measurement.
– Direct patient section heating is integrated into the valve plate of the
breathing system.
– Pneumatic interface to ventilator.
– Fresh gas isolation and minimized compliance.
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 Function descriptions
General

1.2.3 Mixer (fresh gas dosage) The electronic fresh gas mixer offers the following features:
– Gas flow control for O2, N2O and AIR.
– Dosage range from 200 mL/min to 18 L/min.
– Alarm monitoring for the pressure values of the pipeline gas supply and
the cylinder supply. LEDs on the front panel indicate the pressure status.
– SORC function for low-flow and minimum-flow applications.
– O2 flush and mechanical safety O2 adjuster (see Fig. 2).

7386

Fig. 2 O2 flush (O2+), mechanical safety O2 adjuster

– Double vaporizer plug-in system with interlock.

– Auto Exclusion System (optional).
– Optional external A-cone as fresh gas outlet.

1.2.4 Monitor control panel

7387
No.1208_0000007950

Fig. 3 Monitor control panel

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Function descriptions
General

The following parameters are monitored:

– Airway pressure.
– Inspiratory and expiratory flow.
– Circle system leakage.
– Inspiratory and expiratory O2 concentration.
– CO2 measurement and anaesthetic gas measurement.
– Anaesthetic gas detection.
– Quantitative measurement of mixed gas values and MAC calculation
(age-relevant).
– A data view, a trend view (graphical) and a log view can be selected.
– Free configuration of three real-time curves and different numerical
values.
– Body-weight-relevant ventilator presettings (Vt and frequency) and age-
relevant calculation of minimum alveolar concentration (MAC ) according
to "Mapleson" as well as age-relevant scaling of volumeter and influence
on ventilation monitoring.

The safety concept incorporates the following tests:

– Automatic self-test with mixer test, ventilator test and test of the breathing
system.
– Test and automatic calibration of all sensors.

1.2.5 Options Primus IE is ready for the following options:

– Integrated SpO2 measurement.
– Consumption-free O2 measurement.
– PAW preview – display of expected airway pressure curve when
changing parameters.
– P/V and Flow/V loops.
– Econometer function.
– Additional ventilation modes (e.g. autoflow, CPAP).
– Additional languages available for display texts.

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 Function descriptions
General

1.3 Primus IE component structure

7388

Fig. 4 Primus IE component structure

1.3.1 Neutral Point PCB The Neutral Point PCB connects the components of the Primus IE to the
power supply, additional signal wires and the CAN bus.

1.3.2 Graphical User Interface The GUI has the following components:
(GUI) – On the Monitor Control Panel (MoBi) the ventilation mode is displayed.
Limit and target values are specified and the ventilation and anaesthesia
parameters are displayed.
– Interface Box (S-Box). PC ports and optional measuring functions such
as SpO2.
– Patient Gas Module (PGM) for measurement of O2, CO2 and anaesthetic
gas.

1.3.3 Mixer The mixer comprises the following function units:

– Electronically controlled and monitored mixer.
– Vaporizer plug-in system for one or two conventional vaporizer types.
– External fresh gas outlet, A-cone (optional).
– Pressure monitoring for pipeline supply and compressed gas cylinders.

1.3.4 RFID unit The RFID unit "M21 EAST" reads out the transponder data. The data is
transmitted to the CPU PCB of the mixer via an RS232 interface.

1.3.5 VGC (Ventilation and The VGC comprises the following function units:
Gas Controller) – Electronically controlled and driven ventilator.
– Integrated breathing system for "low flow" and "minimum flow"
applications.

1.3.6 Power supply unit The power supply unit comprises:

– Switched-mode power supply unit.
No.1208_0000007950

– Uninterruptible power supply (UPS) with one battery pack consisting of

two 12 V lead-gel batteries.
– Battery charging management.

Technical Documentation IPM Primus IE 13

Function descriptions
General

1.3.7 Cylinder pressure The cylinder pressure regulators reduce the pressure of the optional
regulator compressed gas cylinders.

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 Function descriptions
Neutral Point PCB

2 Neutral Point PCB

The Neutral Point PCB is the central signal and voltage distributor.

7390

Fig. 5 Position of Neutral Point PCB (rear panel of the device)

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Function descriptions
Neutral Point PCB

5022

Fig. 6 Neutral Point PCB component layout

Item Connector
1 Monitor control panel B (MoBi)
2 Monitor control panel A (MoBi)
3 Ventilation and Gas Controller (VGC)
4 Mixer B
5 Mixer A
6 Safety O2 flow valve (microswitch)
7 Power switch (main switch)
8 Halogen lamp
9 Jack plug (production tests)
10 PGM
11 Power supply unit A
12 Power supply unit B
13 Unassigned
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 Function descriptions
GUI

3 GUI

The following section describes the user interface ( "GUI = GUI").

8834

Fig. 7 GUI block diagram

The GUI has the following components:

– MoBi (monitor control panel).
– S-Box (Interface Box).
– Patient Gas Module = PGM.

3.1 MoBi (monitor control panel)

8835
No.1208_0000007950

Fig. 8 Position of monitor control panel

Technical Documentation IPM Primus IE 17

Function descriptions
GUI

The user and Primus IE communicate via the monitor control panel (MoBi).
The MoBi display presents system information and patient data. It is here that
the user sets the parameters and ventilation modes.

The Patient Gas Module (PGM) is connected to the GUI.

8836

Fig. 9 Exploded view of MoBi

Item Components
1 Front panel with keypad. Includes keypad membrane covering with
design imprint, keys, LEDs (e.g. for pipeline supply gases).
2 Carrier frame and the shielding, anti-glare glass screen
3 12 inch colour display (TFT, resolution: 800 x 600)
4 Carrier plate
5 MONITOR CONTROL PANEL PCB (motherboard)
6 Backlight Converter PCB (display backlighting)
7 Loudspeaker
8 Rotary encoder
9 Turn knob (central operator control element)
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 Function descriptions
GUI

3.1.1 MONITOR CONTROL PANE The following software is installed here:

L PCB – GUI software.
– Monitoring and evaluation software for the PGM.
– Software for Medibus ports and SpO2.

A 2-processor system is in operation on the PCB. It comprises a Display

Master (DiMa) and a Communication Master (CoMa).

The powerful DiMa processor incorporates the following components:

– Motorola processor (MPC823) with 48 MHz clock frequency and 32-bit
address and data buses.
– Flash-PROM (program memory).
– RAM (data memory).
– CAN controller.
– RS232 interface for in-house development purposes.
– Serial communication channel for Ethernet.

The LCD controller is a programmable logic device ("PLD"). A "DRAM"

serves as the video memory.

The CoMa processor system primarily controls communication with the

other Primus components.

The CoMa incorporates the following components:

– Motorola processor (M68332) with 16.7 MHz clock frequency, internal 32-
bit bus and external 16-bit data bus.
– Flash-PROM (program memory).
– RAM (data memory).
– RS232 interface for communication with the SPO2, PGM and Medibus 1-
2 modules.
– Real-time clock (RTC).
– Keyboard and turn knob scan, LED actuation and sound output.
– CAN interface.

Both processor systems communicate by way of a Dual-Port RAM (DPR).

This memory device is battery-buffered. The buffering is provided primarily by
the UPS batteries of the Primus. If they fail, the lithium battery on the
MONITOR CONTROL PANEL PCB ensures data is retained.

The operating voltage is provided by an unstabilized voltage of 20 V to 30 V

(Vcc). DC converters on the MONITOR CONTROL PANEL PCB generate all
other voltages on the PCB.

The MoBi is interconnected over the CAN bus with the other components of
the Primus IE (power supply unit, mixer and VGC).
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Function descriptions
GUI

3.2 S-Box (interface box)

8838

Fig. 10 Position of S-Box (rear panel of the device)

By default, the S-Box includes the externally accessible Medibus interfaces

(COM 1-2), IV-System (syringe pumps).

The S-Box is ready for retrofitting of the SpO2 measuring function (option)
(see 3.2.2 SpO2 sampling function (option)).

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 Function descriptions
GUI

5043

Fig. 11 S-Box layout

Item Components
1 Drawer unit components fully mounted
2 BACKPLANE PCB
3 SpO2 ADAPTER PCB (SpO2 PCB not shown)

The BACKPLANE PCB (see Fig. 12) is the base component for additional
modules and the insulated interfaces to external devices.
No.1208_0000007950

8839

Fig. 12 S-Box block diagram, detailed

Technical Documentation IPM Primus IE 21

Function descriptions
GUI

3.2.1 BACKPLANE PCB The BACKPLANE PCB has the following functions:
– Electrical isolation and level conversion of the two Medibus ports
(RS232).
– Interface to the IV system (Ethernet for TIVA).
– Connects the SpO2 sampling function (option) to the MoBi.

3.2.2 SpO2 sampling function The SpO2 sampling function has the following tasks:
(option) – Non-invasive measurement of functional oxygen saturation in the arterial
blood. The upper and lower alarm limits are monitored on the
MONITOR CONTROL PANEL PCB by the CoMa processor.
– Measurement of pulse rate.
– Monitoring of the pulse rate with upper and lower alarm limits.

The SpO2 sensor essentially comprises two LEDs (light-emitting diodes)

which alternatingly emit infrared light with typical wavelengths of 920 nm and
660 nm respectively. An opposing photodetector measures the radiant
intensity. The sensor is placed on a part of the body on which arterial blood
vessels can be X-rayed, such as the fingers, toes or bridge of the nose.

The module from Nellcor detects the "DS-100A" SpO2 sensor only. The
sensor is identifiable by the fact that all nine pins are present on the
connector.

The "DS-100A" SpO2 sensor is connected without a pre-amplifier to the

module. The module communicates through a serial port with the
MONITOR CONTROL PANEL PCB. On the BACKPLANE PCB the module is
electrically isolated with 1.5 kV.

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 Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)

4 Patient gas module (PGM2 IE/PGM3 IE)

The PGM (patient gas module) is an integral part of the GUI functional unit.

8834

Fig. 13 GUI block diagram

The two types of the "patient gas module" differ by the following
characteristics:

Component PGM2 IE PGM3 IE

Anaesthetic gas mea- ILCA2
surement.
O2 sampling. PATO sensor. Electrochemical O2 cell.
O2 measurement AMO MFM PCB. AMO O2 PUMP PCB
electronics.
Pump flow. 200 mL
Flush flow. 200 mL

The water trap is an integral part of the PGM2 IE/PGM3 IE (for position see
Fig. 14).
No.1208_0000007950

8840

Fig. 14 Water trap position (example: "WaterLock")

Technical Documentation IPM Primus IE 23

Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)

4.1 PGM2 IE

4.1.1 Übersicht PGM2 IE The following illustration shows the position of the PGM2 IE (rear panel
open).

8841

Fig. 15 Position of PGM2 IE (unit rear panel)

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 Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)

8842

Fig. 16 Exploded view of PGM2 IE

Item Component
1 PGM2 IE
2 ILCA2 sensor head
3 Fan
4 PGM IE Adapter PCB
5 Screws
6 PU tube, 1.6 mm, natural, to water trap
7 Water trap mount
8 Screws
9 Damper
10 Filter mat
11 PATO O2 sensor with PCB
12 ILCA2 (for detail see Fig. 17)
13 ILCA solenoid valves
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 Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)
8844

Fig. 17 Second exploded view of PGM2 IE (example with "WaterLock")

Item Component
2 ILCA2 sensor head
10 Pneumatic assembly, complete
11 OLC pump, 200 mL
12 O-rings
13 Insulating paperboard
14 MOPS PCB
15 AMO MFM PCB
16 ILCA2 sensor cable
17 AMO ILCA2 PCB
18 AMO Flow ILCA PCB
19 PATO cable
20 O-ring
21 Screw
No.1208_0000007950

22 ILCA solenoid valves

23, 24 WaterLock water trap
25 O-ring

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 Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)

Item Component
26 O-ring
27 Component carrier
28 Lock washer

The PGM2 automatically detects and measures the anaesthetic gas in use -
Halothane, Enflurane, Isoflurane, Desflurane or Sevoflurane. It also detects
and measures mixtures of two of the above anaesthetic gases. If it
encounters a mixture of more than two anaesthetic gases, the warning "AGas
mixture" is delivered.

CO2, O2 and the anaesthetic gas mixture are presented as a real-time curve.

Some of the parameters measured by the PGM2 (etCO2, inCO2 etN2O,

inN2O, etO2 and inO2) are presented on the GUI as digital values.

4.1.2 PATO O2 sensor

Measurement principle The PATO O2 sensor 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 in a magnetic field (see Fig. 18) changes
the thermal conductivity of the gas mixture. The change in the thermal
conductivity is used to determine the oxygen content.
606

Fig. 18 Oxygen molecules' orientation in a magnetic field

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Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)

Design The PATO O2 sensor consists of the PATO SA SH PCB and the sensor head.
The assemblies are contained in a housing.

5087

Fig. 19 PATO O2 sensor block diagram

PATO sensor head The PATO sensor head contains two electromagnets, one cuvette and one
sensor element. The cuvette itself contains the gas channel and the
measurement compartment.
607

Fig. 20 PATO system structure

Item Component
1 Electromagnets
2 Sensor element
3 Cuvette
4 Electromagnets
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 Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)

Sensor element On the sensor element there is a heating element and a thermocouple.

608

Fig. 21 PATO sensor system

Item Designation
1 Measurement compartment (part of the cuvette)
2 Heating element and thermocouple
3 Gas channel (part of the cuvette)
4 Sensor element

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

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

The electromagnets generate a continuously changing magnetic field. The

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

The measuring and control signals are amplified and then converted into
digital signals, and vice versa, by means of an AD/DA converter.

The EEPROM on the PATO SA SH PCB contains the sensor's calibration

data.
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 Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)

4.1.3 Pneumatics of the

PGM2 IE
8845

Fig. 22 PGM2 pneumatic assembly diagram with connection diagram

Item Meaning
1 Goretex membrane (flow 20 mL)
2 Goretex membrane (flow 180 mL)
3 Electrical connection between the ILCA2 solenoid valve and the
AMO Flow ILCA PCB
Pu OLC-Pump 200 mL (DC diaphragm pump)
R1/R2 Restrictors
P Pressure sensor in the ILCA2 cuvette
ΔP Differential pressure sensor
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 Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)

Water trap There are two different types of water trap.

If the "Infinity ID WaterLock 2" water trap is installed, see 4.1.4 "Infinity ID
WaterLock 2" water trap.

If the "WaterLock" water trap is installed, continue with the following

paragraphs.

The sampling gas flows into the water trap. In the water trap are two Goretex
membranes (Fig. 22/1, 2). The moisture in the sampling gas cannot pass
through the Goretex membranes. This prevents water from reaching the
ILCA2 (flow approx. 180 mL/min). Consequently no water can penetrate the
bypass branch (flow approx. 20 mL/min) either. An approximately 10 cm long
Teflon tube (Fig. 22/S2) serves as a resistor, and meters the flow in the
bypass branch.

If the water in the water tank reaches to the level of the membranes, they are
closed off by the water. An error message is displayed on-screen. A filling
level detector is therefore no longer necessary.

Gas distribution The sampling gas flows through the Nafion tube (Fig. 22/S1) and is
additionally dried. The sampling gas then passes on to the ILCA2 solenoid
valve (Fig. 22 /V1). Depending on the valve switching state, either the
sampling gas or, during calibration, the room air reaches the ILCA2. The
sampling gas is fed through the cuvette of the ILCA2 and passes on to the
"SERVOMEX" O2 sensor or to the "PATO" O2 sensor.

When the Primus IE is in Leak Test or Standby mode, the pump (Fig. 22/Pu)
of the PGM2 is shut off. Whenever the pump is off, the solenoid valve (Fig.
22/V2) interrupts the gas flow to the system. This does not increase the
leakage value.

The following low-pass filter comprises the restrictor (Fig. 22/R1) and the
volume (C1).

Dimensioning of R1 – R1 is small enough for the OLC pump not to be placed under
unnecessary strain.
– R1 is large enough so that the pump pressure surges occurring in the
ILCA2 cuvette do not impair the signal ratio and noise ratio in gas
sampling.
– The pressure drop at R1 is measured. The measured value is used for
pump control.

The pneumatic low-pass components are integrated into the module housing
of the electronics. The low pass minimizes the pressure surges generated by
the OLC pump. Downstream of the pneumatic low pass the sampling gas
passes to the OLC pump.

OLC pump The flow through the OLC pump (Pu) in measuring mode is approx.
200 mL/min (flush flow approx. 200 mL/min). The supply voltage of the OLC
pump is in the range from 2.5 VDC to 7.5 VDC at a current of up to 150 mA.

Dimensioning of R2 In a calibration, the switching of the ILCA2 solenoid valve (Fig. 22/V1) is
tested with the pressure sensor (Fig. 22/P, in the sensor head). In this case
No.1208_0000007950

the pressure drop via R2 and the filter (Fig. 22/A) must be significantly less
than the minimum pressure drop through the water trap and the sampling gas
tube. In the event of an error, an error log entry is generated.

Technical Documentation IPM Primus IE 31

Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)

Flow measurement Replacing a flow measurement, the pressure is measured with a differential
pressure sensor (Fig. 22 /ΔP) upstream and downstream of the low pass. The
AMO FLOW ILCA PCB controls the pump with the pressure signal as the
input variable.

Measurement accuracy In order to ensure an adequate measurement accuracy, an automatic zero

calibration is performed periodically. For this, room air is drawn in by the
diaphragm pump through the V2 solenoid valve (zero calibration valve) and
passed through the sensors. The zero calibration valve is controlled by the
AMO Flow ILCA PCB.

Further measures to safeguard measurement accuracy:

– Heating of the cuvette so the intensity of the light beam is not affected by
condensation. As the temperature also influences the measurement
result, the cuvette temperature is kept constant by means of a control
loop.
– The pressure in the cuvette likewise influences the result. So the
pressure is measured and entered as a correction variable into the
system.

4.1.4 "Infinity ID WaterLock 2"

water trap

Design
8846

Fig. 23 Components

Item Designation
1 Water trap
2 Transponder (stuck on)
3 Adapter with screw
4/5 O-rings
6 Water trap holder (housing for component carrier)
7 Antenna (with connecting cable to RFID unit)
No.1208_0000007950

8 Component carrier (for antenna and service tag)

9 Service tag (preprogrammed transponder)

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 Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)

Functional principle

8847

Fig. 24 Functional principle

Item Designation
1 PTFE membranes
2 Luer-Lock connection
3 Self-locking filters
4 Adapter and holder
5 Flow to sensors (70% of total flow)
6 Flow to pump (30% of total flow)
7 Blue connection (to drain water trap)
8 Connecting cable to RFID unit
9 Reservoir
10 Transponder (stuck on)
11 Antenna (with connecting cable to RFID unit)
12 Service tag (preprogrammed transponder)
13 Gas analyzer

The water trap is the inlet filter for suction-based patient gas measurement.
Bacteria, condensate and particles are filtered out.

The patient gas passes through the "Luer Lock" connection (Fig. 24/2) into
the water trap.

The condensate in the patient gas is filtered out by two water-repellant PTFE
No.1208_0000007950

diaphragms (Fig. 24/1).

Technical Documentation IPM Primus IE 33

Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)

Based on the size of the diaphragms and the downstream self-sealing filters
(Fig. 24/3) a 70/30 flow split is produced.

The filtered condensate is captured in the reservoir (Fig. 24/9).

If the water level in the reservoir rises and blocks a flow channel, the base
unit displays an error message.

The water trap is drained by the user by means of the "blue connection" (Fig.
24/7). When the water trap is in the mount, the "blue connection" is closed off
by a plug.
5057

Fig. 25 Sectional view of the water trap in the mount (seen from above)

If one of the PTFE diaphragms (Fig. 25/1) is permeable to condensate, the

following occurs:
– The downstream self-sealing filter (Fig. 25/2) expands and seals the gas
path to the gas analyzer module (Fig. 24/13).
– At the same time the corresponding self-sealing filter changes its colour
from "white" to "blue".
– The base unit displays an error message.

The antenna (Fig. 24/11) is used to read the data on the service tag (Fig.
24/12), regardless of whether the water trap is connected or not. In this way
the downstream RFID unit detects an operative antenna.

When a water trap is connected for the first time a data packet is transmitted
to the transponder (Fig. 24/10) by way of the antenna. When the water trap is
in place (or is reconnected after being removed) its remaining service life is
determined on the basis of the data readout.
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4.2 PGM3 IE

4.2.1 Overview Position of PGM3 IE with rear panel open (see Fig. 26).

8849

Fig. 26 Position of PGM3 IE (unit rear panel)

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Patient gas module (PGM2 IE/PGM3 IE)
8853

Fig. 27 First exploded view of PGM3 IE

Item Component Item Component

1-20 PGM3 IE 11 Pneumatic assembly, complete
1 Fan set 12 O-ring
2 Insulating paperboard 13 OLC pump, 200 mL
3 Screw 14 MOPS PCB
4 PGM IE Adapter PCB 15 AMO MFM PCB
5 Screws 16 ILCA2 sensor cable
6 Filter mat, PU tube, 1.6 mm 17 AMO ILCA2 PCB
7, 8 O2 button cell adapter 18 AMO Flow ILCA PCB
9 ILCA solenoid valve. 19 O-ring
10 ILCA2 sensor head 20 Screw 3x10
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8854

Fig. 28 Second exploded view of PGM3 IE (example with "WaterLock")

Item Component
21 Component carrier
22 Retaining ring
23,24 O-ring
25, 26 WaterLock water trap
27 PU tube, 1.6 mm

The PGM3 IE automatically detects and measures the anaesthetic gas in use
- Halothane, Enflurane, Isoflurane, Desflurane or Sevoflurane. It also detects
and measures mixtures of two of the above anaesthetic gases. If it
encounters a mixture of more than two anaesthetic gases, the warning "AGas
mixture" is delivered.

CO2, O2 and the anaesthetic gas mixture are presented as a real-time curve.

Some of the parameters measured by the PGM (etCO2, inCO2 etN2O, inN2O,
etO2 and inO2) are presented on the GUI as digital values.
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Patient gas module (PGM2 IE/PGM3 IE)

4.2.2 Electrochemical O2 The electrochemical O2 sensor (ELCH) works according to the galvanic cell
sensor principle. Oxygen molecules contained in the gas mixture to be measured
diffuse through a plastic diaphragm into the electrochemical cell and are
reduced at the noble metal electrodes. At the same time a base electrode is
being oxidized. The base electrode is spent by the oxidation process and
thus determines the life of a sensor. The current flowing through the cell is
proportional to the oxygen partial pressure in the gas mixture to be
measured.

Provided the pressure and temperature of the gas mixture to be measured

are kept constant, the measured value will be directly proportional to the
oxygen partial pressure. The O2 amplifier is located inside the ILCA2.

4.2.3 PGM3 IE pneumatics

5083

Fig. 29 PGM3 pneumatic assembly diagram with connection diagram

Item Meaning
1 Goretex membrane (flow 20 mL)
2 Goretex membrane (flow 180 mL)
3 Electrical connection between the ILCA2 solenoid valve and the
AMO Flow ILCA PCB
Pu OLC-Pump 200 mL (DC diaphragm pump)
No.1208_0000007950

R1/R2 Restrictors
P Pressure sensor in the ILCA2 cuvette
ΔP Differential pressure sensor

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Water trap There are two different types of water trap.

If the "Infinity ID WaterLock 2" water trap is installed, see 4.2.4 "Infinity ID
WaterLock 2" water trap.

If the "WaterLock" water trap is installed, continue with the following

paragraph.

The sampling gas (Fig. 29/1) enters the water trap (Fig. 29/4). In the water
trap are two Goretex membranes (Fig. 29/1, 2). The moisture in the sampling
gas cannot pass through the Goretex membranes. This prevents water from
reaching the ILCA2 (flow approx. 180 mL/min). Consequently no water can
penetrate the bypass branch (flow approx. 20 mL/min) either. An
approximately 9 cm long Teflon tube (Fig. 29/5) serves as a resistor, and
meters the flow in the bypass branch.

If the water in the water tank reaches to the level of the membranes, they are
closed off by the water. An error message is displayed on-screen. A filling
level detector is therefore no longer necessary.

Gas distribution The sampling gas flows through the Nafion tube and is additionally dried. The
sampling gas then passes on to the ILCA solenoid valve (Fig. 29/V1).
Depending on the valve switching state, either the sampling gas or, during
calibration, the room air reaches the ILCA2. The sampling gas is fed through
the ILCA2 cuvette and passes on to the electrochemical O2 sensor.

When the Primus is in Leak Test mode or the PGM3 in Standby, the OLC
pump is shut off. Whenever the OLC pump is off, the solenoid valve (Fig.
29/V2) interrupts the gas flow to the system. This does not increase the
leakage value.

The following low-pass filter comprises the restrictor (R1) and the
volume (C1).

Dimensioning of R1 – R1 is small enough for the pump not to be placed under unnecessary
strain.
– R1 is large enough so that the pump pressure surges occurring in the
IRIA cuvette do not impair the signal ratio and noise ratio in gas sampling.
– The pressure drop at R1 is measured. The measured value is used for
pump control.

The pneumatic low-pass components are integrated into the module housing
of the electronics. The low-pass minimizes the pressure surges generated by
the pump. Downstream of the pneumatic low pass the sampling gas passes
to the OLC pump.

OLC pump The flow through the OLC pump (Pu) in measuring mode is approx.
200 mL/min (flush flow approx. 200 mL/min). The supply voltage of the pump
is in the range from 2.5 VDC to 7.5 VDC at a current of up to 150 mA.

Dimensioning of R2 In a calibration, the switching of the valve is tested with the pressure sensor
in the IRIA. In this case the pressure drop via R2 and the filter (A) must be
significantly less than the minimum pressure drop through the water trap and
the sampling gas line. In the event of an error, an error log entry is generated.
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Patient gas module (PGM2 IE/PGM3 IE)

4.2.4 "Infinity ID WaterLock 2"

water trap

Design

8846

Fig. 30 Components

Item Designation
1 Water trap
2 Transponder (stuck on)
3 Adapter with screw
4/5 O-rings
6 Water trap holder (housing for component carrier)
7 Antenna (with connecting cable to RFID unit)
8 Component carrier (for antenna and service tag)
9 Service tag (preprogrammed transponder)

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Functional principle

8847

Fig. 31 Functional principle

Item Designation
1 PTFE membranes
2 Luer-Lock connection
3 Self-locking filters
4 Adapter and holder
5 Flow to sensors (70% of total flow)
6 Flow to pump (30% of total flow)
7 Blue connection (to drain water trap)
8 Connecting cable to RFID unit
9 Reservoir
10 Transponder (stuck on)
11 Antenna (with connecting cable to RFID unit)
12 Service tag (preprogrammed transponder)
13 Gas analyzer

The water trap is the inlet filter for suction-based patient gas measurement.
Bacteria, condensate and particles are filtered out.

The patient gas passes through the "Luer Lock" connection (Fig. 31/2) into
the water trap.

The condensate in the patient gas is filtered out by two water-repellant PTFE
No.1208_0000007950

diaphragms (Fig. 31/1).

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Patient gas module (PGM2 IE/PGM3 IE)

Based on the size of the diaphragms and the downstream self-sealing filters
(Fig. 31/3) a 70/30 flow split is produced.

The filtered condensate is captured in the reservoir (Fig. 31/9).

If the water level in the reservoir rises and blocks a flow channel, the base
unit displays an error message.

The water trap is drained by the user by means of the "blue connection" (Fig.
31/7). When the water trap is in the mount, the "blue connection" is closed off
by a plug.
5057

Fig. 32 Sectional view of the water trap in the mount (seen from above)

If one of the PTFE diaphragms (Fig. 32/1) is permeable to condensate, the

following occurs:
– The downstream self-sealing filter (Fig. 32/2) expands and seals the gas
path to the gas analyzer module (Fig. 31/13).
– At the same time the corresponding self-sealing filter changes its colour
from "white" to "blue".
– The base unit displays an error message.

The antenna (Fig. 31/11) is used to read the data on the service tag (Fig.
31/12), regardless of whether the water trap is connected or not. In this way
the downstream RFID unit detects an operative antenna.

When a water trap is connected for the first time a data packet is transmitted
to the transponder (Fig. 31/10) by way of the antenna. When the water trap is
in place (or is reconnected after being removed) its remaining service life is
determined on the basis of the data readout.
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4.3 ILCA2 function (PGM2 IE/PGM3 IE)

ILCA2 is a patient gas analyzer module for N2O, the anaesthetic gases
Halothane, Enflurane, Isoflurane, Desflurane and Sevoflurane, and for
measurement of mixtures.

The ILCA2 module is able to detect the aforementioned gases automatically.

Measurement principle The measurement principle of the ILCA2 module is based on the absorption
of infrared light by the various media (see Fig. 33). The sensor head consists
of a double measuring head with one emitter each which emits a broad
spectrum of infrared light. The light beam passes through a cuvette, through
which the gas being measured is also drawn by means of a diaphragm pump.
Downstream of the cuvette the light beam hits a multi-channel detector with
IR filters. The filters are dimensioned so that only the light in the absorption
wavelength of the measured gases is transmitted. If a gas is present light is
absorbed. The higher the partial pressure of the gas, the greater the
absorption of the light and the smaller the sensor signal.
5084

Fig. 33 Principle of multi-channel detector with IR filters

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Patient gas module (PGM2 IE/PGM3 IE)

4.3.1 ILCA2 module design The ILCA2 module essentially comprises the following components:
– Sensor head with double-optics, pressure sensor, and electronics.
– Diaphragm pump.
– Pneumatic low pass.
– Solenoid valves.
– Module rack with PCBs.

Sensor head The sensor head houses two PCBs with the following functions:
– Pre-amplifier PCB for the two multi-channel detectors.
– Base PCB with emitter activation, temperature regulation, absolute
pressure measurement and a serial EEPROM holding the serial number,
setting and calibration data for operation of the sensor head.

The module rack of the ILCA2 module contains four additional PCBs with the
following functions:
– AMO FLOW ILCA PCB - Control of the diaphragm pump and the zero
calibration solenoid. A serial EEPROM stores the necessary data such as
the serial number, hardware and software revision, control parameters
etc.
– AMO ILCA2 PCB - Here the necessary supply voltages are generated
and the data transfer from the sensor to the MOPS PCB is implemented.
– AMO MFM PCB - This circuit board amplifies the signal from the PATO
O2 sensor.
– Either the AMO MFM PCB, which amplifies the signal from the PATO O2
sensor, or the AMO O2 PUMP PCB, which amplifies the signal from the
electrochemical O2 sensor.
– MOPS PCB - Primarily delivers the data for further processing via an RS
232 interface.

4.3.2 MOPS PCB "MOPS" stands for "Modular Platform for Sensors". It is a modular concept
(PGM2 IE/PGM3 IE) by which suitable sensor components (pneumatic and mechanical
components) can be operated together by way of a processor board.

The resultant arrangements are supported by a software program with a

uniform communications interface. In this way, the user is provided with a
uniform view of the parameters on offer, irrespective of the components
deployed.

The software is automatically configured for the connected components when

the system starts up.

With this concept, different patient gas analyzers (for example "ILCA2" and
"IRIA") can be configured for specific user needs using standard components.

The MOPS PCB calculates the values of the patient parameters and checks
the sensor head signals.
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4.3.3 AMO ILCA2 PCB "AMO" stands for "Adapter MOPS". The PCB has the following tasks:
(PGM2 IE/PGM3 IE) – Convert digital target values from the MOPS PCB into analog voltages for
the ILCA2 emitter.
– Generate the ILCA2 supply voltage.
– Data transfer from the ILCA2 sensor to the MOPS PCB (data evaluation).

4.3.4 AMO O2-PUMP PCB The PCB has the following task:
(PGM3 IE) – Transfer the O2 sensor data to the MOPS PCB (data evaluation).

4.3.5 AMO MFM PCB The PCB has the following task:
(PGM2 IE) – Transfer the O2 sensor data (Servomex) to the MOPS PCB (data
evaluation).

4.3.6 AMO FLOW ILCA PCB The AMO FLOW ILCA PCB controls the pump and the valves. The PCB is
(PGM2 IE/PGM3 IE) controlled and powered by the MOPS PCB. The actual regulation of the
pump flow is handled by the software of the controller on the MOPS PCB.

The AMO FLOW ILCA PCB holds the following components:

– A DC/DC converter generates the pump voltage (2.5 - 7.5 V/DC). The
output voltage of the DC/DC converter is controlled with a digital
potentiometer on the PCB. The digital potentiometer is regulated by the
MOPS PCB.
– An output stage to operate the valve.
– Service LEDs for the pump voltage, the valves and the supply voltage
– A temperature-compensated differential pressure sensor for flow
measurement. The sensor offset is corrected with a digital potentiometer.
– Analog electronics for evaluation of the pump voltage, pump current,
valve current and differential pressure.

The flow is measured by way of the differential pressure of restrictor R1 plus

the upstream sintered-metal filter. The measuring range is 0 mbar to
350 mbar.

The AMO FLOW ILCA PCB is connected directly to a 60-pin connector on

the MOPS PCB and is detected automatically by the MOPS PCB.

4.4 Operating modes (PGM2 IE/PGM3 IE)

4.4.1 "ISO" mode Following "Reduced Accuracy" mode the ILCA2 has ISO accuracy. After a
maximum of 30 minutes the switch is made to "Full Accuracy" mode.

4.4.2 "Standby" behaviour After 90 minutes the ILCA2 emitter and the heater are shut off. This is done to
extend service life and reduce noise.

4.4.3 ILCA2 calibration ILCA2 is calibrated automatically. The user cannot initiate manual calibration.
Nor is calibration possible during the ventilator leak test. This prevents a
possible increase in volume resulting from intake of ambient air.
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Patient gas module (PGM2 IE/PGM3 IE)

4.4.4 Auto-Wake-up function When the Primus IE is switched to a ventilation mode after a cold start, alarm
monitoring is initially disabled. This applies to all the parameters of the CO2
gas analyzer except the alarm "CO2/AGENT INOP“. Alarm monitoring is
activated when a respiration phase is detected.

4.4.5 O2 sensor (PATO/ELCH) The electrochemical O2 sensor (ELCH) or the PATO sensor is calibrated
during the cold start. In operation, the electrochemical O2 sensor is calibrated
automatically every 8 hours. The PATO sensor is calibrated every 2 hours.
During this procedure, the V1 solenoid valve is switched to room air.

When the zero point of the ILCA2 is calibrated the plausibility of the
electrochemical O2 sensor signal is also checked. The PATO sensor is
calibrated to 21% oxygen.

If non-linearity occurs, the user is offered a 100% O2 calibration. In 100% O2

calibration the user is responsible for connecting 100% O2 to the sampling
line.

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5 Mixer

This section describes the mixer for the AIR, N2O and O2 gases. The newly
generated fresh gas is fed through the vaporizer to the VGC.

9295

Fig. 34 Position of mixer (rear panel open)

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Mixer

5102

Fig. 35 Mixer without hood

Item Components
1 PRIMUS CPU PCB
2 Gas inlet block
3 Mixer block
4 A-cone valve
5 Fresh gas tank
6 MIXER PCB
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5103

Fig. 36 Principle of fresh gas dosage

Item Component
1 Monitor Control Panel (MoBi)
2 CAN bus
3 Mixer electronics (PRIMUS CPU PCB/MIXER PCB)
4 Fresh gas outlet
5 Fresh gas flow valve
6 Fresh gas tank
7 Gas inlet valves
8 Pressure regulator

The item numbers and abbreviations occurring in this section relate to Fig.
36.

On the MoBi (1) the user selects the carrier gas AIR or N2O as well as the
fresh gas flow and the O2 concentration.

A CAN bus (2) transfers the setup parameters to the mixer electronics (3).
The mixer electronics generate the actuation signals for the gas inlet
valves (7).

At the inlet of the fresh gas tank (6) the flow (V) is measured. With the
measured flow value the switching times for the gas inlet valves (7) are
No.1208_0000007950

calculated. The selected gas concentration is set in the fresh gas tank. The
pressure in the tank (6) and at the fresh gas outlet (4) is measured and
monitored.

Technical Documentation IPM Primus IE 49

Function descriptions
Mixer

The fresh gas flow valve (5) delivers the selected fresh gas flow. The
flowmeter at the fresh gas outlet (4) regulates the fresh gas flow valve.

5.1 Operating modes

The operating mode is regardless of whether the Primus IE is powered from
the mains via its power plug or is powered up in battery mode.

5.1.1 "10 VA" operating mode Internal leakage may mean that the O2 concentration in the Primus IE is
above 21% when operation is begun. "10 VA" mode prevents dangerous
operating states from occurring.

When the power plug is connected to the mains power but the power switch
is not yet switched on, the following safety rule applies:
– A supply voltage of only 10 VA is fed into the interior of the mixer (10 VA
is the product of the no-load voltage and short-circuit current of the supply
voltage "24 V STECK“. Only the DC/DC converters (-15 V, +15 V) for the
pressure sensor amplifiers are supplied).
– The pressure sensors for the gases from the pipeline supply system and
the cylinder supply are read and the gas supply status is indicated by
LEDs on the front panel (see 5.3.2 Pressure status LEDs).

When the Primus IE is switched on at the power switch (mains or battery

powered) the following safety rule applies:
– Before other modules receive operating voltage, the fan in the mixer is
switched on for at least 10 seconds. Only then is "Normal" mode
activated.

5.1.2 Normal mode In this mode the mixer CPU PCB controls normal mixing. All DC/DC
converters (+5 V, +24 V, -15 V, +15 V) are supplied with the supply voltage
"24 V SCHALT".

5.2 Design

5.2.1 MIXER PCB The MIXER PCB comprises the following components:
– DC/DC converter (+5 V, +15 V, -15 V, +24 V) with voltage monitoring.
– Amplifiers of pressure sensors and temperature sensors.
– Valve power switch and monitoring circuits.
– Fan actuation and monitoring.
– Logic device for the safety O2 adjuster.

A cable harness connects the mixer with the Neutral Point PCB and with the
other device components. By way of the cable harness the mixer receives the
unstabilized 18 V to 30 V supply voltage and the 12 V fan power from the
power supply unit as well as the CAN bus.

The mixer fan is switched on 10 seconds before the other components and is
powered directly by the power supply unit (see 5.1.1 "10 VA" operating
mode).
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When the fan wheel rotates a proportional square signal is generated

(approx. 90 Hz). This square signal is monitored by the PRIMUS CPU PCB.

The valves on the mixer block are actuated by the

Master CPU (PRIMUS CPU PCB). Power drivers on the MIXER PCB switch
the valves. When one of the valves is actuated, the current flows through a
shunt. The voltage drop at the shunt is evaluated by a comparator circuit and
monitored by the supervisor processor on the PRIMUS CPU PCB. An
exception to this is the fresh gas flow valve "VMGS“. The proportional valve
cannot be monitored by this procedure.

For safety shut-off of all valves, the supply voltage can be cut to all valves.

5.2.2 PRIMUS CPU (Mixer) The PRIMUS CPU PCB is based on a 2-processor system with Master and
PCB Supervisor. Both 16-bit processor systems are identical in structure. The
peripherals are controlled by way of an interface.

Each processor has the following components:

– Quartz.
– Undervoltage detection.
– External watchdog.
– Flash PROM.
– RAM.
– EEPROM (system configuration).

A DUAL-PORT RAM is placed between the two processor systems for data
exchange. A logic circuit prevents both processors writing to a memory cell
simultaneously.

Each processor system has an isolated serial port and a CAN bus.

Configuration options for the serial port by jumper:

– Independent serial ports, RS232 level, isolation on jack plug.
– Independent serial ports, TTL level, no isolation, output to connector strip.

7-segment displays are provided for visual indication of operating states of

the Master and the Supervisor.
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5.3 Gas inlet block (AIR, O2 and N2O)

The following connections are located on the underside of the gas inlet block
(see Fig. 37).

9296

Fig. 37 Pipeline/cylinder connections

Item Components
1 Pipeline gases connections (e.g. NIST or DISS)
2 Compressed gas cylinder connections
3 Optional AIR outlet.
4 Optional O2 outlet

The following specifications apply to the pipeline supply and the compressed
gas cylinders:
– The pressure values of the pipeline supply gases must be between
270 kPa and 690 kPa (19 psi to 80 psi).
– If the pipeline supply pressure decreases below 270 kPa, the user must
open the O2 and N2O compressed gas cylinder. If the cylinder pressure is
too low, the user is warned on the MoBi display. The maximum cylinder
pressure is 19000 kPa.
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Mixer

5110

Fig. 38 Detail of gas inlet block

Item Component
1 Pressure regulators (N2O, AIR, O2) regulate the inlet pressure to
the mixer to 2.3 bar ± 0.1 bar
2 Sintered filter.
3 ISO port (e.g. NIST for O2 cylinder supply)
4 Optional gas outlet (plug-in connection for AIR)
5 Non-return valve
6 Non-return valve for N2O gas inlet
7 Pipeline supply sensor N2O
8 Pipeline supply sensor AIR
9 Pipeline supply sensor O2
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5.3.1 Gas inlet block

pneumatic assembly

5112

Fig. 39 Gas inlet block pneumatic assembly diagram

Abb./Item Component
PPO2 Relative pressure sensors with integrated amplifier for
pipeline supply pressure measurement
PPAIR
PPN2O
PCO2 O2 cylinder high pressure sensor
PCN2O N2O cylinder high pressure sensor
No.1208_0000007950

PRPO2 Pressure regulator, O2 line

PRPAIR Pressure regulator, AIR line
PRPN2O Pressure regulator, N2O line

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Mixer

Abb./Item Component
PRCO2 Pressure regulator, O2 compressed gas cylinder
PRCN2O Pressure regulator, N2O compressed gas cylinder
1 Gas inlet block (complete)
2 HP ISO port O2 (NIST or DISS).
3 Pipeline supply ISO port O2 (NIST or DISS).
4 Sintered-metal filter in the pipeline supply ISO port
5 Non-return valve, O2 pipeline inlet.
6 ISO O2 outlet (option).
7 ISO outlet AIR (option).
8 To flush button and safety O2 adjuster.
9 To the pipeline inlet valves of the flow control

The item numbers and abbreviations occurring in this section relate to Fig.
39.

For the following description the O2 gas path was chosen.

The pipeline supply gas (3) passes through the ISO port to the gas inlet
block.

By way of the sintered-metal filter (4) the gas passes to the pressure sensor
"PPO2". The relative pressure sensor delivers a signal proportional to the
pressure.

The sintered-metal filter (4) prevents the non-return valve (5) from being
contaminated by particles.

If the pipeline supply fails, no pipeline supply pressure is indicated. The non-
return valve (5) prevents O2 from escaping out of the compressed gas
cylinder (2) into the pipeline supply system.

The pressure regulator PRPO2 generates a constant inlet pressure for the
mixer (2.3 bar ± 0.1 bar). The O2 pressure regulator additionally supplies (8)
the flush button "VO2+" and the safety O2 adjuster "VSFC".

An optional compressed gas supply for an external endotracheal suction

device (7) or an external O2 flowmeter (6) is provided for.
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5.3.2 Pressure status LEDs The mixer measures and monitors the pressure of the pipeline supply and the
compressed gas cylinders. Depending on the measured values, LEDs on the
MoBi indicate the pressure status.

9297

Fig. 40 Position of LEDs (front panel)

The pipeline supply pressure and the cylinder pressure are indicated by five
LEDs on the front panel of the MoBi. The sixth LED is intended for an optional
AIR compressed gas cylinder.

The LEDs are lit either green or red or are unlit, depending on operating
status. The LEDs are made to change colour by reversing the polarity of the
supply voltage.

If the mixer is in "10 VA" operating mode, the LEDs are either green or unlit.

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The initial condition for table "LED status, Primus IE off" is:
– Primus IE is off, but mains power supply is connected.

LED status, Primus IE off

Gas supply Pressure value LED sta-

tus
p < 2.7 bar Off
O2 pipeline supply
p = 2.7 bar Green
p < 2.7 bar Off
AIR pipeline supply
p = 2.7 bar Green
p < 2.7 bar Off
N2O pipeline supply
p = 2.7 bar Green
p < 20 bar Off
O2 cylinder p = 20 bar Green
Pressure sensor not connected. Off
p < 20 bar Off
AIR cylinder p = 20 bar Green
Pressure sensor not connected. Off
p < 10 bar Off
N2O cylinder p = 10 bar Green
Pressure sensor not connected. Off
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Mixer

The initial condition for table "LED status, normal mode" is:
– Primus IE is on. The mixer is in normal mode.

LED status, normal mode

Gas supply Pressure value LED status

p < 2.7 bar Off
O2 pipeline supply p = 2.7 bar Green
Pressure sensor error Flashing green
p < 2.7 bar Off
AIR pipeline supply
p = 2.7 bar Green
Error Flashing
p < 2.7 bar Off
N2O pipeline supply
p = 2.7 bar Green
Pressure sensor error Flashing green
p < 20 bar and O2 pipeline Off
supply pressure = 2.7 bar.
p = 20 bar Green
O2 cylinder p < 20 bar and O2 pipeline Flashing red at 1.4
supply pressure is < 2.7 bar. to 2.8 Hz
Pressure sensor not con- Off
nected.
p < 10 bar and the N2O pipe- Flashing red at 1.4
line supply pressure is to 2.8 Hz
< 2.7 bar.
p = 10 bar Green
AIR cylinder
Pressure sensor not con- Off
nected.
p < 10 bar and N2O pipeline Off
supply pressure = 2.7 bar.
p < 10 bar and N2O pipeline Off
supply pressure = 2.7 bar.
p = 10 bar Green

N2O cylinder p < 10 bar and the N2O pipe- Flashing red at 1.4
line supply pressure is to 2.8 Hz
< 2.7 bar.
Pressure sensor not con- Off
nected.
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Mixer

5.4 Mixer block

5117

Fig. 41 Mixer block

Item Component Short name

1 Differential pressure sensors with piezo mea- PDMGSHI
suring bridge
2 PDMGSLO
3 Absolute pressure sensors with integrated PSYS
amplifier
4 PTANK
5 Tank vent valve VTANK
6 Temperature sensors TANKTEMP,
MGSTEMP
7 Connection for tank volume TANK
8 Gas inlet valves VMIXO2
9 VMIXAIR
10 VMIXN2O
11 Pressure inlets (N2O, AIR, O2) to the gas inlet
valves
12 O2 inlet to safety O2 adjuster and flush button
13 Differential pressure sensor with piezo measur- PDMIX
ing bridge
No.1208_0000007950

14 Fresh gas flow valve (proportional valve) VMGS

15 A-cone valve VSWAK

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5.5 Pneumatic assembly

9298

Fig. 42 Mixer pneumatic assembly diagram

Item Component/Meaning
1 Gas inlet block
2 A-cone valve (option)
3 Mixer, flow dosage
4 Vaporizer
I To breathing system
II To A-cone valve/breathing system switching valve (MV3) for airway
pressure measurement
III To A-cone outlet

The abbreviations occurring in the following sections relate to Fig. 42 and Fig.
41.
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5.5.1 VMIX valves The "VMIX" valves mix the desired gas concentration. By way of the "VMIX"
valves the pipeline supply gas (N2O, AIR, O2) passes to the differential
pressure sensor "PDMIX", to the pressure sensor "PTANK" and to the flow
measurement system "RM".

The "VMIX" valves fill the "TANK". The pressure range in the "TANK" is
between 1 bar and 1.5 bar. The pressure difference of 0.5 bar and the
"TANK" volume of 0.5 L produce a usable "TANK“ volume of 0.25 L (0.5 bar x
0.5 L = 0.25 L).

At a fresh gas flow setting of 18 L/min, the "VMIX" valves are opened
72 times a minute. The following equation illustrates the TANK filling process
(72 /min x 0.25 L = 18 L/min).

5.5.2 PDMIX and RM With the differential pressure sensor "PDMIX" and the flow measurement
system "RM" the gas flow and volume of the gas flowing into the "TANK" are
measured (flow x time = volume). At a constant, usable "TANK" volume of
0.25 L, any given gas concentration can be mixed.

The differential pressure sensor "PDMIX" and the absolute pressure sensor
"PTANK" form a single functional unit. The output signal of the pressure
sensor "PTANK" is used for the bridge supply voltage for "PDMIX". The
output voltage of "PDMIX" is evaluated on the PRIMUS CPU (Mixer) PCB.

5.5.3 PTANK (pressure The pressure sensor "PTANK" has the following tasks:
sensor) – Tank pressure monitoring.
– Compensation for effect of ambient pressure fluctuations on flow control
with "PDMIX".
– Monitoring of flow measurement system "RM" by means of the
proportional pressure rise in the "TANK".

The pressure sensor "PTANK" has a resolution of 2 mbar and a maximum

measuring range of 2.558 bar absolute. The pressure sensor "PTANK" also
has a second amplification branch to the AD converter of the PRIMUS CPU
(Mixer) PCB. To be able to measure higher pressures for service purposes,
the resolution is 4 mbar per digit. The maximum measured value is 4.092 bar
absolute.

5.5.4 VTANK valve The tank vent valve "VTANK" opens when:
– O2 and AIR are missing.

5.5.5 VMGS (fresh gas flow The fresh gas flow valve is a proportional valve. It delivers a fresh gas flow of
valve) 0.2 L/min to 18 L/min. The flow measurement at the fresh gas outlet
regulates the valve.

5.5.6 PDMGSHI / PDMGSLO The differential pressure sensors each have a press-dependent resistance
(differential pressure measuring bridge.
sensors)
The differential pressure sensors measure the flow through the flow
measurement system "RMGS". With the measured value the PRIMUS CPU
(Mixer) PCB regulates the fresh gas flow valve "VMGS".
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5.5.7 PSYS (pressure sensor) The pressure sensor "PSYS" compensates for the effect of ambient pressure
fluctuations on the flow measurement of "PDMGSHI" and "PDMGSLO".

The pressure sensor "PSYS" has a resolution of 1 mbar.

5.5.8 VSWAK (A-cone valve) The A-cone valve actuated by the MIXER PCB has a bistable switching
response.

The valve is switched with a time-limited voltage pulse. The polarity of the
voltage pulse determines the switching direction.

The valve position is detected by a proximity sensor in the valve and

monitored by the PRIMUS CPU (Mixer) PCB.

5.5.9 VBAK (safety valve) A mechanical safety valve for the A-cone valve. Opening pressure 80 mbar at
18 L/min +15%.

5.5.10 TEMPTANK / The volume of the gases "N2O, AIR, O2" is dependent on the temperature.
TEMPBLOCK Consequently, the measured values of the temperature sensors "NTC" are
(temperature sensors) incorporated into the mixing process. The temperature sensors
("TEMPTANK", "TEMPBLOCK") used for temperature compensation
generate voltages proportional to the temperature. The PRIMUS CPU (Mixer)
PCB compares and monitors the sensor voltages.

5.5.11 VSFC (safety O2 The safety O2 adjuster is located outside the mixer unit. With the manual
adjuster) safety O2 adjuster the user can set an additional O2 flow of 3 to 12 L/min
±30%.

When the overall system power-up test is running the flow adjuster must be
closed. The operating status is registered by a microswitch in the safety O2
adjuster. The microswitch is plugged into the Neutral Point PCB. The signal is
transmitted via the cable harness to the mixer.

5.5.12 VCAUXO2 (external O2 The pressure regulator "PRPO2" generates the constant inlet pressure
outlet) (2.3 bar ±0.1 bar) for the flow control and the external O2 outlet VCAUXO2
(see Fig. 43).

No.1208_0000007950
5119

Fig. 43 Position of VCAUXO2 (optional)

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5.5.13 VO2+ (flush button) Mechanical flush button. The flow rate is at least 35 L/minute.
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6 VGC

This section describes the VGC (Ventilation and Gas Controller). The VGC
consists of the ventilator and the breathing system.

8826

Fig. 44 VGC position

The patient is ventilated by the VGC according to the ventilation mode and
parameters set on the MoBi.

The VGC also measures the airway pressure and the inspiratory and
expiratory flow (two flow sensors).

A cable harness connects the VGC with the NEUTRAL POINT PCB. From
there, the VGC is connected to other Primus IE components.

By way of the cable harness the VGC receives the following voltages and
signals:
– The unstabilized supply voltage of 18 V to 30 V.
– The 12 V for the VGC fan (there immediately).
– The 12 V for the pneutronics valves (there after approx. 10 seconds).
– CAN bus.
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5141

Fig. 45 Exploded view of VGC

Item Component
1 MV4, Pneutronics
2 MV2, calibration and venting
3 Electrical connections for inspiratory and expiratory flow sensor
4 Piston cylinder unit (PCU)
5 VGC POWER PCB
6 BSE PCB
7 PRIMUS CPU PCB
8 Electronics fan
9 PRIMUS ANALOG PCB (VGC)
No.1208_0000007950

10 Bacterial filter
11 Non-return valve RV3

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Item Component
12 VGC pneumatic block
13 Interface plate
14 Interface plate fan
15 Light barrier
16 Breathing system heater contacts
17 Cover

6.1 VGC electronics

The supply voltages required for the VGC to function (5 V, 15 V, +24 V) are
generated by the VGC itself.

The interface plate holds the connecting pneumatic tubes and the plug-in flow
sensor connectors.

The interface plate is the carrier for all other VGC components, and includes
the breathing system lock. The complete interface unit is inserted from above
into the VGC housing.

6.1.1 VGC POWER PCB The following functional units are provided on the PCB:
– 5 V voltage regulator (Imax 2 A).
– Driver for the DC motor (M2) of the piston cylinder unit (PCU).
– Valve control.
– Breathing system heater control. Temperature monitoring with 2
independent NTCs in the heater mat.
– Control for the DC pump (M1). Output voltage 8 to 18 V.
– Monitoring of the PCB supply voltages.

6.1.2 PRIMUS ANALOG PCB The following functional units are provided on the PCB:
– +15 V voltage regulator (Imax 300 mA). 15 V is only connected if 5 V is
present.
– -15 V voltage regulator (Imax ca. 100 mA).
– PEEP valve control (0 to 430 mA).
– Pressure measurement with two airway pressure sensors and a vacuum
sensor.
– 12-bit A/D converter for the airway pressure sensors and the flow
sensors.
– Incremental encoder evaluation. Evaluation of direction of rotation,
rotation angle and velocity of the PCU motor (M2).
– Light barriers. One light barrier each for the end position of the PCU
piston and for detection of a fully inserted ventilator drawer unit.
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6.1.3 BSE PCB

5142

Fig. 46 Position of BSE module in the VGC

The BSE module is located on the right-hand side of the VGC housing and is
only visible when the VGC is pulled out. The BSE PCB and a separate
loudspeaker provide an audible signal of the inspiration and expiration.

The digitalized flow signal is generated by the VGC-CPU PCB (Fig. 45/7),
passes through the Analog PCB (Fig. 45/9) and reaches the BSE PCB (for
block diagram, see Fig. 47).

Two BSE module variants are available. The variants can be distinguished by
the following characteristics:
– BSE module (block diagram, see Fig. 47) without headphone output
socket.
– BSE module (block diagram, see Fig. 48) with one headphone output
socket.

The following individual components are also available on the PCB:

– +12 V voltage regulator (option).
– +5 V voltage regulator.
– +3.3 V voltage regulator.
– Level transformer 24 V/12 V (optional).
– RS 232 interface (optional).
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8827

Fig. 47 Block diagram of the BSE module (without headphone output socket)

No.1208_0000007950
8828

Fig. 48 Block diagram of the BSE module (with headphone output socket)

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Through the serial interface (Fig. 47/X5 or Fig. 48/Serial) the digitized flow
signal reaches the processor of the BSE PCB. The processor multiplies the
sound signal on the flow amplitude. The sound signal is stored in a FLASH
PROM.

The preprocessed signal is transmitted to an AF amplifier through the D/A

converter. The volume is selected in the Config menu of the Primus IE and
adjusted by the processor.

The BSE module comprises the BSE PCB and a separate loudspeaker. Four
LEDs on the BSE PCB indicate the operating conditions and the operating
voltages.

6.2 Piston cylinder unit (PCU)

5147

Fig. 49 Design of the piston cylinder unit

Item Component
1 Breathing volume dependent on piston position
2 Cylinder
3 Rolling seal (loose)
4 Piston
5 Diaphragm (fixed)
No.1208_0000007950

6 Piston motor
7 Perforated disk for incremental encoder

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Item Component
8 Incremental encoder
9 Rubber buffer
10 Light barrier
11 Spindle nut
12 Spindle

The ventilator unit consists of a piston cylinder unit and two diaphragms. The
vacuum for the rolling seal (Fig. 49 /3) comes from the pneumatic assembly
of the VGC and is generated in the space between the cylinder (Fig. 49/2)
and the rolling seal (Fig. 49/3).

The spindle (Fig. 49 /12) is permanently fixed to the piston. The spindle
nut (Fig. 49/11) is permanently fixed to the hollow shaft axle of the piston
motor. When the motor shaft, and thus the spindle nut, rotates the spindle is
moved vertically. This sends a corresponding volume through to the
breathing system and consequently to the patient. Also, the motor is
permanently fixed with rubber buffers (Fig. 49/9) to the drive housing.

When the spindle nut rotates once, a volume displacement of 38.5 mL is

produced. So to achieve a volume change of 1400 mL, around 37 revolutions
are required.

The piston motor (Fig. 49/6) is powered by direct voltage and operated by
way of the PCBs of the VGC. The actuator requires the signal from the
incremental encoder (Fig. 49/8). The incremental encoder has a resolution of
1024 pulses per motor revolution.

When the VGC is switched on, the counter of the incremental encoder must
be set. To do so, the piston is lowered until it reaches the light barrier (Fig.
49/10). This position is then recorded as the reference position.

Only when the vacuum is applied to the rolling seal is the piston motor
activated. An exception is possible, however. If the rolling seal is not inserted,
a vacuum may be created. The rolling seal can only be inserted without
difficulty when the piston is at its bottom end position, however. If the control
detects this state, it will slowly move the piston to the bottom end position in
"Standby" mode. With software version 2.n or higher, the piston motor (Fig.
49/6) is additionally switched on as an active brake when the light barrier
(Fig. 49/10) is broken. This is to avoid the spindle (Fig. 49 /12) getting stuck in
the bottom end position.
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6.3 VGC pneumatic block

5150

Fig. 50 Exploded view of VGC pneumatic assembly

Item Components
1 PEEP valve "MV1"
2 Restrictor "R2"
3 Pump motor "M2" with vacuum pump "VP"
4 Vacuum valve "Vu"
5 Bacterial filter "BF"
6 Volume "V" (2 containers)
7 Solenoid valve "MV3" "Pneutronics"

The components of the pneumatic block are detailed in the following section.
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6.4 VGC pneumatic assembly

8829

Fig. 51 VGC pneumatic assembly and breathing system

Item Component/Meaning
5 VGC ventilator unit
6 Breathing system
I Fresh gas inlet
II From A-cone valve (if fitted)
E Ejector
BF Bacterial filter
BPG Airway pressure manometer (option, only in connection with
VCAUXO2)
M2 Vacuum pump motor
MV1 PEEP/Pmax valve
MV2 Calibration and vent valve
MV3 Breathing system/A-cone outlet switching valve
No.1208_0000007950

MV4 PEEP valve/control valve

PAWe Expiratory airway pressure sensor
Pu Vacuum sensor

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Item Component/Meaning
R1 Restrictor to smooth pressure peaks
R2 Restrictor to reduce vacuum (when pump "VP" off)
RV3 PCU vacuum non-return valve
V Volume
V1 PEEP valve diaphragm
V2 Auto-man/spont ON/OFF valve
VP Vacuum pump
VU Vacuum valve -200 mbar

The item numbers occurring in this section relate to Fig. 51.

The vacuum sensor "Pu" is connected to the intake side of the vacuum pump
"VP". In operation, the vacuum sensor "Pu" measures the vacuum for the
rolling seal of the PCU. Another port is connected during operation to the
switching valve "V2", "AUTO-MAN/SPONT". When the vacuum pump is
running, the software checks the pressure value at the vacuum sensor "Pu".
The drive motor is only activated if the vacuum pump is able to build up a
vacuum of between 120 mbar and 250 mbar (hPa).

The vacuum pump "VP" draws the air in through the bacterial filter "BF". The
following valve "Vu" is preset to approx. 200 mbar. The air is pumped in two
consecutive volumes "V".

To smooth pressure peaks, the outlet of the volumes is designed as a fine

hole "R1". From there, the gas flows through the PEEP valve "MV1". If the
PEEP valve is not actuated, the integrated ejector "E" generates a low-level
vacuum in its control line. This smoothes the zero of the PEEP characteristic.

So that the vacuum is reduced when the vacuum pump is shut off, the
vacuum valve is bridged by a restrictor "R2".

When the user switches the ventilation mode from automatic ventilation to
MAN/SPONT, the vacuum pump is switched off. The vacuum is reduced with
R2. The non-return valve RV3 prevents the vacuum in the diaphragm volume
from being reduced too. This considerably reduces the switching time from
automatic ventilation to MAN/SPONT. At the same time, RV3 also prevents a
reduction of the vacuum in the diaphragm volume in MAN/SPONT mode. The
vacuum can then be built up faster when the user switches to an automatic
ventilation mode.

With valve "MV2" the system is calibrated and vented.

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6.5 Interface plate

5152

Fig. 52 Layout of interface plate measuring points

Item Connection/Meaning
1 Pressure sensor "Pz"
2 Fresh gas outlet
3 Anaesthetic gas scavenging system AGSS
4 ILCA2 suction device (optional)
5 PEEP valve "V1"
6 APL bypass valve "V2"
7 "PAWe" / "MV2" / BPG (option)
8 ILCA2 sampling gas return line (optional)
9 Expiratory flow sensor (electric)
10 ILCA2 sampling gas return line
11 Inspiratory flow sensor (electric)
12 A-cone airway pressure
13 ILCA2 sampling gas return line
14 Fresh gas
15 PCU piston
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The following diagram Fig. 53 permits assignment of the measuring

points/connections on the interface plate to the pneumatic assembly diagram.

8830

Fig. 53 Assignment of measuring points/connections

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6.6 Breathing system

8831

Fig. 54 Overview of the breathing system

Item Component
1 Breathing system cover with fixing screws
2 Valve "RV1"
3 Breathing system heater contacts
4 Valve "RV2" (new design)
5 Valve plate
6 Breathing system block
7 Fixing screws
8 Absorber canister
9 Absorber element
10 Expiratory flow sensor "Flowe"
11 Expiratory socket
No.1208_0000007950

12 Manual breathing bag connector "Bag"

13 Inspiratory socket with downstream inspiratory flow sensor "Flowi"

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Item Component
14 APL bypass valve "V2"
15 Valve "V1", PEEP diaphragm
16 Expiratory valve "Ve"
17 Inspiratory valve "Vi"
18 "APL" valve (adjustable pressuring limiting valve), new type

NOTE
– The breathing system is heated up. In normal operation a heating circuit
regulates the surface temperature to approximately 50°C.
– The Supervisor (SV) of the VGC CPU (see Fig. 45/7) monitors the
surface temperature with a second temperature sensor. If the surface
temperature exceeds 57°C, the Supervisor switches off the heating
circuit.
– At an ambient temperature of maximum 37°C, the respiratory gas
temperature (at the Y-piece) must not exceed 40°C.

The breathing system permits the following ventilation modes:

– Manual ventilation.
– Spontaneous breathing.
– Automatic, pressure-limited ventilation modes (IPPV, SIMV and PCV) or
Volume Mode and Pressure Mode with optional synchronization and
pressure support.
– (Optional) pressure-assisted ventilation Pressure Support for
spontaneously breathing patients.

The switch of the APL valve can be set to "MAN" or "SPONT".

In the "MAN" position, the breathing system is closed to atmosphere. The

APL valve opening pressure can be adjusted from 5 to 70 hPa (mbar). This
switch setting is the default for manual ventilation.

In the "SPONT" position the APL valve is open to atmosphere. This switch
setting is the default for spontaneous breathing.

The pressure limitation "Pmax" can also be adjusted between 20 hPa (mbar)
and 70 hPa (mbar) on the GUI during automatic ventilation.

The following section permits assignment of the components to the

pneumatic assembly diagram.
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6.6.1 Breathing system

pneumatic assembly

8829

Fig. 55 Pneumatic assembly breathing system and VGC

Item / Abbrevia- Component

tion
6 Breathing system pneumatic assembly
A CO2 absorbers
AGSS Anaesthetic gas scavenging system
APL APL valve
BAG Breathing bag
FLOWe Expiratory flow sensor
FLOWi Inspiratory flow sensor
PAWe Expiratory pressure sensor
PCU Piston cylinder unit
Pz Inspiratory pressure sensor
RV1 Fresh gas isolation valve
RV2 Non-return valve AGSS
No.1208_0000007950

V1 PEEP valve
V2 APL bypass valve
Ve Expiratory valve.

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Item / Abbrevia- Component

tion
Vi Inspiratory valve

6.6.2 External ventilation

pressure manometer
"BPG"

8833

Fig. 56 Position of external manometer for ventilation pressure

The external manometer for the ventilation pressure "BPG" has a measuring
range of between -20 cm/H2O and +80 cm/H2O.

6.7 Automatic ventilation

A sufficient supply of fresh gas to the patient is essential for automatic
ventilation.

The APL bypass valve "V2" is actuated by the VGC and is open. The setting
of the APL valve has no effect in automatic ventilation. The pressure limit
(Pmax) is adjustable on the GUI.
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6.7.1 Inspiration

5160

Fig. 57 Block diagram of mandatory inspiration

The abbreviations occurring in the following text relate to Fig. 57.

Mandatory inspiration process:

– The fresh gas isolation valve "RV1" is closed.
– The PEEP valve "V1" is closed during inspiration. Depending on the
preset maximum pressure "Pmax", an appropriate control pressure is
applied to the PEEP valve.
– The piston of the PCU rises according to the preset parameters (F, VT,
I:E...). The mixed gas (expiratory gas and fresh gas) flows through the
inspiratory valve "Vi", the flow sensor "Flowi", the inspiratory patient tube,
and through the Y-piece into the patient’s lung.
– The inspiratory pressure is measured.
– For inspiratory compliance only the volume between "RV1", "Vi" and "V1"
is active.
– The manual breathing bag serves as a mixed gas reservoir.

If the ventilation pressure exceeds the maximum pressure (Pmax) set on the
GUI, the PEEP "V1" opens. The gas from the patient's lung flows either into
the manual breathing bag or through the open APL bypass valve "V2".
Depending on the non-return valve opening pressure "RV2", the mixed gas
flows into the anaesthetic gas scavenging system AGSS.
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Advantage of this method:

– The fresh gas isolation valve "RV1" minimizes the inspiratory compliance
(without absorber and manual breathing bag).

6.7.2 Expiration

5161

Fig. 58 Block diagram of mandatory expiration

The abbreviations occurring in this section relate to Fig. 58.

Mandatory expiration process:

– The PEEP valve "V1" opens.
– The motor of the PCU is activated such that the piston follows the
physiological expiration curve. This means the patient is able to exhale at
an optimum flow rate.
– The downward movement of the piston opens "RV1".
– "Vi" is closed, and prevents breathing back into the inspiratory branch.
– The expiratory gas flows through the expiratory flow sensor "Flowe", the
PEEP control valve "V1", the expiratory valve "Ve" and the absorber and
back into the piston chamber of the piston cylinder unit.
– The patient gas is additionally enriched with fresh gas.
– Surplus mixed gas flows into the manual breathing bag or through the
APL bypass valve "V2" and the non-return valve "RV2" into the
anaesthetic gas scavenging system AGSS.
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Advantages of flow-optimized piston guidance:

– The gas loss through the AGSS valve is minimized, because no non-
physiological overpressure is created in the expiratory phase.
– The fresh gas consumption via the absorber is high as long as the fresh
gas flow is lower than the minute tidal volume "AMV".
– No non-physiological vacuum in the expiratory phase. Consequently
there is also no intake of the diaphragm by "V1" (PEEP valve in breathing
system).

6.8 Manual ventilation

During manual ventilation of the patient, the switch of the APL valve is set to
the MAN position.

Only the warnings/alarms for the lower O2 alarm, for the upper airway
pressure (Paw) and for CO2 are enabled.

The piston of the VGC is moved to the lower range, position 1100 mL.

The APL bypass valve "V2" is not actuated and is closed.

6.8.1 Inspiration
5162

No.1208_0000007950

Fig. 59 Block diagram of manual inspiration

The expiratory valve "Ve" is closed during the inspiratory phase.

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Manual inspiration process:

– When the manual breathing bag is compressed, the mixed gas
(expiratory gas and fresh gas) flows through the absorber, the fresh gas
isolation valve "RV1", the inspiratory valve "Vi" and the flow sensor
"Flowi" and then into the patient’s lung.
– The pressure sensor "PAWe" measures the airway pressure.
– The APL valve limits the ventilation pressure.
– The surplus mixed gas flows via the APL valve and the non-return valve
"RV2" into the anaesthetic gas scavenging system AGSS.

6.8.2 Expiration
5163

Fig. 60 Block diagram of manual expiration

The inspiratory valve "Vi" is closed, and prevents expiratory gas from flowing
back into the inspiratory branch.

Manual expiration process:

– When the pressure is relieved from the manual breathing bag, the
expiratory gas flows through the expiratory flow sensor "Flowe", the
PEEP control valve "V1" and the expiratory valve "Ve" and then into the
manual breathing bag.
No.1208_0000007950

– At the same time, fresh gas flows continuously during inspiration and
expiration into the manual breathing bag.

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6.9 Spontaneous breathing

During spontaneous breathing of the patient, the switch of the APL valve is
set to the SPONT position. No gas pressure builds up in the breathing
system. Only the warnings/alarms for the lower O2 alarm, for the upper
airway pressure (Paw) and for CO2 are enabled. The piston of the PCU is
moved to the upper end position in order to reduce the dead space volume of
the ventilator. The APL bypass valve "V2" is not actuated.

6.9.1 Inspiration
5164

Fig. 61 Block diagram of spontaneous inspiration

The expiratory valve "Ve" is closed during the inspiratory phase, and so
prevents inhalation of expiratory gas with CO2.

Inspiration process:
– The patient inhales independently. During inhalation, the gas flows out of
the manual breathing bag through the absorber and is additionally
enriched with fresh gas. The enriched mixed gas passes through the
fresh gas isolation valve "RV1", the inspiratory valve "Vi" and the
inspiratory flow sensor "Flowi" and then enters the patient’s lung.
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6.9.2 Expiration

5165

Fig. 62 Block diagram of spontaneous expiration

During expiration, the inspiratory valve "Vi" remains closed thus preventing
the expiratory gas from flowing back into the inspiratory branch.

Spontaneous expiration process:

– During exhalation, the expiratory gas flows out of the patient’s lung
through the expiratory flow sensor "Flowe", the PEEP control valve "V1"
and the expiratory valve "Ve" into the manual breathing bag and the
absorber.
– At the same time, fresh gas flows into the breathing bag.
– If the pressure in the manual breathing bag is greater than the opening
pressure of "RV2", the surplus gas mixture flows into the anaesthetic gas
scavenging system AGSS.
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6.10 Ventilation modes with software version 4.n

Software version 4.2 uses the following labels for the ventilation modes for
synchronization and pressure support in spontaneously breathing patients:
– "Volume Mode".
– "Pressure Mode".
– "Pressure Support Mode" (option).
– "Man./Spont Mode".
– "Auto Flow - Volume AF" (option).

6.10.1 "Volume Mode"

Ventilation mode
Volume-controlled ventilation mode with fixed mandatory tidal volume "VT"
and frequency Freq., including switchable synchronization and adjustable
pressure support for spontaneous breaths (optional Pressure Support).
5166

Fig. 63 Volume-controlled ventilation with constant inspiratory flow

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The following parameters determine the breathing cycle (see Fig. 63):
– Frequency 1/freq.
– Inspiratory time Tinsp.
– Inspiratory flow level.
– Inspiratory pause time TIP:Tinsp.
– Tidal volume "VT".
5167

Fig. 64 Synchronization of volume-controlled ventilation and spontaneous breathing

Synchronization is activated when a trigger sensitivity value is entered. The

message "sync" is displayed in the ventilation mode status field on the
screen.

The flow trigger sensitivity controls the synchronization. The maximum time
delay between the controlled ventilation breaths is adjusted by means of the
frequency. To keep the frequency constant in the event of a premature
triggering, the time is equalized in the next ventilation cycle.
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VGC

A ventilation breath triggered by the patient is indicated by a continuous line

(Fig. 64/1) in the pressure curve and in the flow curve (trigger indicator). The
active flow trigger window (Fig. 64/2) corresponds to the last 25% of the
relevant expiratory time.
5168

Fig. 65 Synchronization of volume-controlled ventilation and Pressure Support of spontaneous breathing

Pressure support is activated if, during volume-controlled ventilation, a value

is entered for the level of the pressure support ΔPps.

The message "Press Supp" is displayed in the ventilation mode status field
on the screen.

The flow trigger sensitivity and the ΔPps level control the synchronization and
the pressure support. The maximum time delay between the controlled
ventilation breaths is adjusted by means of the frequency. To keep the
frequency constant in the event of a premature triggering, the time is
equalized in the next cycle.

If, at the time of pressure support activation, the patient was being ventilated
without synchronization, automatic activation of the synchronization is
initiated with the last trigger setting used.
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If pressure support is deactivated with "OFF", the synchronization is

maintained with the set value.

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If the trigger is deactivated with "OFF", the pressure support is deactivated

automatically.

6.10.2 "Pressure Mode"

Ventilation mode
Pressure-controlled ventilation with decelerating flow (LP), with synchroni-
zation of mandatory breaths (SIMV-PC) and with pressure support of spon-
taneous breathing (Pressure Support).
5169

Fig. 66 Pressure-controlled ventilation with decelerating flow

Pressure-controlled ventilation with fixed pressure limit Pinsp and frequency

1/freq. Synchronization and adjustable pressure support of spontaneous
breaths (optional) are switchable.

A continuous flow is applied to the patient during the inspiratory time Tinsp.
The curve's rate of rise can be preset with the slope increase time TSlope.
The maximum time delay between the controlled ventilation breaths is
adjusted by means of the frequency. To keep the frequency constant in the
event of a premature triggering, the time is equalized in the next cycle.
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Changes to the lung compliance and the ventilation parameters affect the
tidal volume.

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VGC
5170

Fig. 67 Synchronization of pressure-controlled ventilation and spontaneous breathing

Synchronization is activated when a trigger value is entered.

The message sync is displayed in the ventilation mode status field on the
screen.

The flow trigger sensitivity controls the synchronization.

A breath triggered by the patient is indicated by a continuous line (Fig. 67/1)

in the pressure curve and in the flow curve (trigger indicator). The active flow
trigger window (Fig. 67/2) corresponds to the last 25% of the relevant
expiratory time.
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5171

Fig. 68 Synchronization of pressure-controlled ventilation and Pressure Support of spontaneous breathing

Activation of pressure support during pressure-controlled ventilation is

initiated by entering a value for the pressure support level Δpps. The
message "PressSupp" is displayed in the ventilation mode status field on the
screen.

The flow trigger sensitivity and the Δpps level control the synchronization and
the pressure support.

If, at the time of pressure support activation, the patient was being ventilated
without synchronization, automatic activation of the synchronization is
initiated with the last "trigger" setting used.

If pressure support is deactivated with "OFF", the synchronization is

maintained with the set value.

If the trigger is deactivated with "OFF", the pressure support is deactivated

automatically.
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VGC

6.10.3 "Pressure Support The ventilation mode "Pressure Support Mode" is an optional feature that
Mode" must be activated.

Ventilation mode
Pressure support for spontaneous breathing. This option can be used in all
mechanical ventilation modes. At the same time, this option is an indepen-
dent ventilation mode.

The patient's spontaneous breathing effort is supported by the following fac-

tors:
– The flow trigger sensitivity controls the synchronization.
– The adjusted pressure setting is a measure of the pressure support.

The curve's rate of rise can be preset with the slope increase time Tslope.

In addition, an apnoea ventilation can be set via the minimum frequency

Freqmin.

If the patient does not breathe spontaneously, the ventilator is activated

automatically dependent on the set minimum frequency Freqmin. The sub-
sequent ventilation breath is not a mandatory ventilation breath. The patient
can always stop the mandatory ventilation breath by his/her own breathing
activity.

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5172

Fig. 69 Spontaneous breathing support

The flow trigger sensitivity and the Δpps level control the synchronization and
the pressure support of the spontaneous breathing effort. The curve's rate of
rise can be preset with the slope increase time Tslope.

In addition, an apnoea ventilation can be set via the minimum frequency

1/freqmin. 1/freqmin controls the automatic triggering of the ventilator when
the patient is not breathing spontaneously. It is not a mandatory ventilation
breath from the ventilator. The patient can always stop the breath triggered by
the ventilator by his/her breathing activity. This breath is not provided with a
trigger indicator.

6.10.4 "Man./Spont Mode"

Ventilation mode
Manual ventilation or assisted ventilation and spontaneous breathing.
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VGC

6.10.5 "Auto Flow-Volume AF"

(optional)
5174

Fig. 70 Pressure-controlled ventilation mode with guaranteed tidal volume

Volume AF is a pressure-controlled ventilation mode with guaranteed tidal

volume VT and guaranteed respiratory rate "Freq." as well as switchable
synchronization and adjustable pressure support for spontaneous breaths.

Volume AF combines the benefits of pressure-controlled and volume-

controlled ventilation modes. The set tidal volume VT is applied in a pressure
controlled ventilation mode. The inspiratory pressure automatically adjusts to
the set tidal volume, limited by a maximum pressure PMAX. When ventilation
is started with Volume AF, the first mandatory breath is a pressure-controlled
one, this is to determine the required pressure level, unless it is already
known from a previous ventilation mode.

Primus IE automatically adjusts the inspiratory pressure to the changing lung

conditions; this is done in steps of max. ±3 mbar per respiratory cycle.
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The tidal volume applied during a respiratory cycle is limited to 130% of the
set tidal volume. If volume limit is active, the inspiratory pressure of the next
mandatory breath is reduced to 75% of the target pressure, but limited to a
maximum of 15 mbar above the PEEP.

Synchronization with Synchronization is activated by entering a trigger sensitivity value. This can
volume-guaranteed be determined via the "Additional Settings" softkey.
ventilation (also pressure
support activatable)

6.10.6 Switching ventilation When switching to another ventilation mode, the presettings of the previous
modes mode's parameters are transferred or usefully derived.

Identical parameters in both ventilation modes (Freq., TINSP, PEEP, Δpps,

trigger) are transferred directly.

Switching ventilation Transfer of settings

modes
Volume-controlled to The measured parameter Pplat is applied as new
pressure-controlled. parameter Pinsp.
Pressure-controlled to The new tidal volume VT is transferred from the
volume-controlled. measured minute volume MV and the set fre-
quency Freq.. Only the mechanically applied min-
ute volume is used in this case.

Pressure-supported breaths by the patients are not

taken into consideration.
Automatic ventilation The set PEEP, Δpps and trigger are transferred.
modes to Pressure
Support (optional). If Δpps and/or trigger were set to "OFF", the most
recently used values are transferred to pressure
support, otherwise the configured default settings.
Pressure support The set PEEP, Δpps and the trigger are trans-
(optional) to automatic ferred.
ventilation modes.
The other parameters correspond to the most
recently used settings, otherwise to the configured
default settings.

6.10.7 HLM mode The HLM mode (HLM = heart-lung machine) enables an alarm-free patient
monitoring during extracorporeal oxygenation of the patient by means of a
heart-lung machine.

The following conditions apply in the HLM mode:

– All gas concentrations are measured independent of the breathing phase.
– The CO2 apnea alarm, the pressure apnea alarm, and the SpO2
monitoring alarms are deactivated.

The HLM mode remains active when switching from one ventilation mode to
another. Switching to Standby mode will deactivate the HLM mode.
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Power supply unit

7 Power supply unit

This section describes the power supply unit. The power supply unit
comprises the electronics component and two UPS batteries (UPS =
Uninterruptible Power Supply).

8858

Fig. 71 Position of power supply unit (rear panel of the device)

7.1 Power supply unit input

The power supply unit generates the direct voltage for the Primus
components and the charging voltage for the UPS batteries.

The power supply unit input processes alternating voltages from 100 to 240 V
(45 to 65 Hz).

In the event of a mains failure or power supply unit failure, an automatic

switch is made to the UPS. The connection to the mains voltage is via a 16 A
inlet connector for non-heating apparatus.

The inlet connector for non-heating apparatus is protected by a mechanical

locking device (to EN 740) to prevent it being pulled out unintentionally.

The power supply unit has an earthing connection with a 6.3 mm contact.
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7.2 Power switch

8859

Fig. 72 Position of power switch

The power switch is connected to the power supply unit via the Neutral Point
PCB. The power switch switches an auxiliary voltage of 5 V.

7.3 Output voltages and currents

The power supply unit delivers the following output voltages:
– 3x 20 to approx. 30 V (battery voltage).
– 3x regulated output voltage of 12 V.

The voltages are battery-buffered.

Voltage Device on Device switched Applies to:

off
U1: 24 V, Always available. Battery buffered RAM
10 mA in the GUI.
U2: 24 V, Available as soon Pressure sensors of
10 VA as the power the pipeline supply
plug is plugged in and compressed gas
or the device is cylinders. Pipeline
switched on. LEDs, mixer LEDs
U3: 24 V, 1-23 Present 10 sec- - GUI - mixer - VGC
A onds after the
power switch is
U4: 12 V, 1-10 - IRIA - ILCA - VGC -
switched on Has an OFF-
A small pneutronic
(independent of delay of approx.
valves.
mains voltage). 10 s after opera-
tion of the power
U5: 12 V, Fan for VGC and
No.1208_0000007950

10 VA Available as soon switch. mixer.

as the device is
U6: 12 V, switched on. Fan for IRIA and opti-
10 VA cal Diva.

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Function descriptions
Power supply unit

A higher power demand than 600 W is supplied from the batteries.

The switched output voltages (U3 to U6) release with a delay after operation
of the switch. The delay is 10 seconds, but can be altered with the CAN
protocol to between 5 and 15 seconds.

The power supply unit is short-circuit-proof and shuts off if operating current =
Imax and U < Umin for t > 20 ms.

7.4 Secondary connector

The connector for the voltage outputs is a 24-pin plug. The connector
additionally carries the CAN signals, the switching contacts of the power
switch and the control wires for the power and battery LEDs on the front
panel.

7.5 UPS batteries

The two UPS batteries are fitted separately in the housing, behind the power
supply unit. The battery capacity is sufficient to run the Primus for at least
30 minutes.

The Primus power supply unit performs an automatic battery test every
30 days. The battery test has no effect on the operation of the Primus IE. In
testing, the batteries are discharged by 20% of the available capacity. The
battery condition is determined from the resultant battery curve.

The charging time for fully discharged batteries is a maximum of 10 hours.

The batteries' charging management system takes into account the battery
temperature. The battery temperature is measured with a temperature sensor
(NTC) directly at the batteries.

The battery charging management system prevents exhaustive discharge. If

the battery voltage falls below 20 V the power supply unit shuts down the
Primus IE. If the battery voltage is below 20 V the power supply unit cannot
be powered up.

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7.6 Power supply unit CAN communication

With the CAN (Controller Area Network) bus data can be exchanged between
the power supply unit and the other modules. The higher-level software
protocol is SABUS (Sensor and Actuator BUS).

The power supply unit has a CAN 2.0 B compatible interface. The interface
transfers data and status information in both directions.

The power supply unit sends its data periodically, every 500 ms, to the GUI.

The power supply unit CAN bus transfers the following data:
– Power supply unit version.
– Power supply unit hours. Total time in operation of power supply unit.
– Battery hours. Power supply unit operating time in battery mode. The
figure is given in Ah (Ampere hours).
– Time remaining: Indicates the time remaining in seconds until the power
supply unit will shut off.
– Battery type: Indication of battery type.
– Power supply unit details: e.g. self-test errors.
– Date: To determine how long the device was switched off.
– Switch off power supply unit. The power supply unit shuts when the
remaining time expires. The shut-off is aborted as soon as the value "0" (-
>switch off power supply unit = no) is received by the power supply unit.

7.7 Power failure warning

The power supply unit hooter sounds under the following conditions:
– About 1 second after power-up for about 1 second.
– If the "Hooter on" error is delivered over the CAN bus. For as long as the
CAN controller is in "Reset" mode.
– When the power switch is set to "On" and the batteries are flat or have
been removed.
– If no CAN messages are received for the power supply unit during
operation for more than 15 seconds after receipt of the first CAN
message.
– In case of mains power failure.

The hooter sounds for as long as the error condition persists, up to a

maximum of 30 seconds ±5 seconds.
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Operating modes

8 Operating modes

This section details the individual operating modes of the Primus IE.

8.1 Cold start

When the Primus IE is switched on, the device starts up with a so-called cold
start.

During the cold start the user checks and confirms the checklist on the
display. Then the user is prompted to connect the Y-piece to the patient unit
and set the APL valve to 30 mbar (MAN setting).

In the "self-test" which follows the device checks its system components. Any
errors detected are indicated on the display. If no errors occurred, the Primus
IE switches to Standby mode.

The "self-test" can be interrupted for an emergency start.

8.2 Standby mode

When the "self-test" is completed, Standby mode is automatically activated.
In this operating mode no pipeline supply gas is consumed. No fresh gas
supply is possible (except for fresh gas through the safety O2 adjuster
"VSFC"). The user can select all ventilation parameters, the fresh gas flow
setting and the ventilation mode.

Alarms and messages are indicated on the display.

8.3 Shutdown
All Primus IE components are switched off from the central power switch.
Only the charging circuit for the UPS batteries is permanently in operation.

When the Primus IE is off, the following alarms are inactive:

– Mains power failure.
– Pipeline supply pressure failure.

8.4 Safety mode

If the software detects a serious error in fresh gas supply or ventilation,
individual components (such as the mixer) or the entire Primus IE unit switch
to "Safety Mode".

In "Safety Mode" it is possible to provide the patient with manual ventilation or

spontaneous breathing. The fresh gas is then supplied by the adjustable
"safety O2 flow control" valve "VSFC".
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Operating modes

8.4.1 Safety O2 flow The "safety O2 flow" is usually set by the user with the safety O2 adjuster and
routed through the vaporizer.

The patient is supplied with O2 (4 L/min to 12 L/min) by the "VSFC". As a

result, anaesthetic gas dosage is possible. This operating mode is usually
activated by the user under the following conditions:
– In case of a total system failure. Primus IE switches to Safety mode.
– Mains power failure or UPS batteries flat.

In this case the control range of the O2 flow is 4 L/min to 12 L/min. If the
"safety O2 flow" is activated in normal mode, a warning appears on the
display. The mixer electronics additionally limit the fresh gas flow to 3 L/min.
The fresh gas settings are then grayed on the display (from software release
1.n).

8.5 Alarm system

The Primus IE has a common alarm system for visual and acoustic indication
of ventilator and monitoring alarms. Error messages are indicated on the
display.

There are three categories of alarm:

– Alarm (category I)
– Warning (category II)
– Advisory (category III)
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Anaesthetic vaporizer

9 Anaesthetic vaporizer

The interlock system prevents 2 vaporizers from operating simultaneously.

The active vaporizer enriches the mixed gas with anaesthetic.

For a detailed description refer to the relevant instructions for use of the
vaporizer being used.

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RFID unit M21 EAST

10 RFID unit M21 EAST

10.1 Introduction
The following describes the structure, the functional principle, and the
connections of the M21 EAST RFID unit. The M21 EAST RFID unit
comprises the M21 EAST PCB and up to eight connected antennas.

10.2 Design
9299

Fig. 73 M21 EAST PCB

10.3 Functional principle

The functional principle is based on RFID technology (RFID stands for Radio
FrequencyIdentification).

Data transmission between the RFID unit M21 EAST and the transponders
takes places via electromagnetic waves. The working frequency is
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 or
read by the RFID unit M21 EAST.

The data read by the RFID unit M21 EAST are transmitted to the medical
device via an RS232 interface.
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RFID unit M21 EAST
9300

Fig. 74 Block diagram of the M21 EAST PCB

Designation Function
X9 Connection for RS232 interface and power supply
ESD PROTECTION Overvoltage protection
TxD Transmit line of the RS 232 interface
RxD Receive line of the RS232 interface
SER-INTERFACE Serial port
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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RFID unit M21 EAST

10.4 Connections and interfaces

9301

Fig. 75 Connections and interfaces on the M21 EAST PCB

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

11 Trolley brake

11.1 Brake mechanism

The brake pedal (Fig. 76/1) locks two castors (Fig. 76/2/3).

8861

Fig. 76 Position of brake pedal

When the brake pedal (Fig. 76/1) is pushed down, it tightens a spring. In the
lower brake pedal position, the latch of the locking mechanism (Fig. 78/2)
engages in the cap (Fig. 77/5 and Fig. 78/3). The vertical movement of the
brake pedal is transferred to the brake lever (Fig. 77/2). Since the brake lever
is attached to the hex rod (Fig. 77/6), the vertical movement rotates the hex
rod one quarter turn. This activates the locking mechanism (Fig. 77/1/7) of
the castors (Fig. 77/4/8).

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Trolley brake

8862

Fig. 77 Brake mechanism

Pushing the brake pedal down again rotates the latch of the locking
mechanism (Fig. 78/1) one quarter turn disengaging it from the cap (Fig.
78/3). The brake pedal (Fig. 77/3) is pushed upwards by the spring force. The
vertical movement of the brake lever rotates the hex rod one quarter turn.
This deactivates the locking mechanism (Fig. 77/1/7).
8863

Fig. 78 Brake pedal unlocked (1) and locked (2)

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Front lighting and vaporizer lighting

12 Front lighting and vaporizer lighting

8864

Fig. 79 Position of control electronics and LEDs

The control electronics (Fig. 79/1) of the front lighting (3 white power LEDs)
and of the vaporizer lighting (1 white standard LED) are located underneath
the device's cover. The brightness of the four LEDs (e.g. Fig. 79/3-4) can be
adjusted using the potentiometer (Fig. 79/2). The final position stop switch of
the potentiometer (Fig. 79/2) is used to switch the control electronics on or
off.

The following components designations relate to Fig. 80.

A power supply unit switched 18 to 29 V DC is applied to X1. The voltage

(+24 Volt GESCHALTET) is applied to the LED Activation PCB through the
Neutral Point PCB (for details see "Block diagrams and pneumatic assembly
diagram").

When the supply voltage is present and the fuse F1 is intact, the green LED
D5 is lit. When the supply voltage is present and the fuse F1 (T1A5/125V)
has been tripped, the red LED D6 is lit.

The variable power source N1 generates an output voltage of 6 V to 24 V.

The output current is controlled in the range of 10 to 300 mA.

N1 is switched on or off with the final position stop switch of the potentiometer
R2. N1 controls the output voltage such that a voltage of approx. 1.23 V is
present at its feedback input.
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Front lighting and vaporizer lighting

Three front LEDs D1, D2, and D3 (300 mA LEDs) are connected in series to
X3. The voltage drop at the measuring resistor R1 corresponds to the current
across the LEDs. The operational amplifier N2 amplifies this voltage value by
a variable factor. The factor is adjusted with the potentiometer R2.

The Vaporizer LED D4 is connected alternatively to X4 (Fig. 80/D4b) or X2

(Fig. 80/D4a).

At X2 D4a changes its brightness in the same ways as the front LEDs. To do
so, nine series-connected diodes, V1 to V9, simulate the voltage drop of two
series-connected LEDs.

At X4, D4b is lit with a relatively constant brightness, regardless of the

position of potentiometer R2. D4b is connected to the forward voltage of the
three series-connected LEDs D1, D2, and D3 via a series resistor.
8865

Fig. 80 Block diagram of the LED Activation PCB

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Bronchial suction device

13 Bronchial suction device

13.1 Purpose
The bronchial suction device is intended for anaesthesia systems. The
driving gas is AIR, O2, or VAC (vacuum), depending on the type of bronchial
suction device.

13.2 Device types

The device types are designed as stand-alone devices.

The following device types are currently available:

– Bronchial suction device with ejector (AIR, O2).
– Bronchial suction device with vacuum (VAC).

13.2.1 Variants The following variants are available:

– NIST variant. Can be installed on rail system or on devices with
appropriate mounting option.
– Pipeline connector variant. The bronchial suction device is plugged
directly into the pipeline terminal unit.

13.3 Bronchial suction device with ejector

15741

Fig. 81 Front view of the bronchial suction device with ejector

The front panel has the following parts:

– Manometer (Fig. 81/1).
– Rotary knob for setting suction flow (Fig. 81/2).
– Rotary knob for fine adjustment of regulated suction flow (Fig. 81/3).
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The system vacuum is indicated on the control element (manometer).

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Bronchial suction device

13.3.1 Pneumatic assembly

(ejector)

7036

Fig. 82 Pneumatics of bronchial suction device with ejector

Item Meaning
1 Supply pressure connector (Nist "O2/AIR" or Nist "AIR" or
"O2/AIR" pipeline connector).
2 Mode switch.
3 Control valve.
4 Ejector.
5 Manometer.
6 Non-return valve (bacterial filter mount).
7 Bacterial filter.
8 Collector.

The item numbers and valve positions mentioned in this section refer to Fig.
82.

The driving gas (AIR or O2) enters into the bronchial suction device through
the supply pressure connector.

The operating mode selector (2) is used to select the following operating
modes:
– OFF (valve position "b"). The bronchial suction device is switched off.
– Regulated flow (valve position "a"). The driving gas passes through the
control valve (3). The control valve adjusts the ejector driving gas thus
generating the required vacuum.
– Maximum flow (valve position "c"). The supply pressure is fed directly to
the ejector. This generates a maximum vacuum in the suction system.

The non-return valve (6) is used as a mount for the bacterial filter. In the
event of malfunctions, the non-return valve makes sure no positive pressure
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is present in the vacuum system.

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Bronchial suction device

The bacterial filter (7) makes sure that no particles or bacteria from the
collector (8) enter the suction system. The filter material can block fluids up to
a vacuum pressure of 920 mbar.

The pneumatic circuit has the following advantages:

– In the "regulated flow" position only as much driving gas is used as
required to generate the vacuum.
– Fast toggling between regulated flow and maximum flow.
– Less noise by reduced gas consumption.
– No suction flow loss by bypass openings.

13.4 Bronchial suction device with vacuum

15742

Fig. 83 Front view of the bronchial suction device with vacuum

The front panel has the following parts:

– Manometer (Fig. 83/1).
– Vacuum regulator (Fig. 83/2).
– Mode switch (Fig. 83/3).

The system vacuum is indicated on the control element (manometer).

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Bronchial suction device

13.4.1 Pneumatics (vacuum)

7037

Fig. 84 Pneumatics of bronchial suction device with vacuum

Item Meaning
1 VAC connector (VAC-NIST or VAC pipeline connector).
2 Mode switch.
3 Vacuum regulator.
4 Manometer.
5 Non-return valve (bacterial filter mount).
6 Bacterial filter.
7 Collector.

The item numbers and valve positions mentioned in this section refer to Fig.
84.

The vacuum enters into the bronchial suction device through the VAC
connector (1).

The operating mode selector (2) is used to select the following operating
modes:
– OFF (valve position "b"). The bronchial suction device is switched off.
– Regulated flow (valve position "a"). The generated vacuum depends on
the position of the vacuum regulator (3). The vacuum is indicated by the
manometer (4).
– Maximum flow (valve position "c"). The vacuum is fed directly to the non-
return valve (5). This generates a maximum vacuum in the suction
system.

The non-return valve (5) is used as a mount for the bacterial filter.
No.1208_0000007950

The bacterial filter (6) makes sure that no particles or bacteria from the
collector (7) enter the suction system. The filter material can block fluids up to
a vacuum pressure of 920 mbar.

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Bronchial suction device

The pneumatic circuit has the following advantages:

– Fast toggling between regulated flow and maximum flow.
– High-quality vacuum control.
– No suction flow loss by bypass openings.

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Block diagrams and pneumatic assembly diagram

14 Block diagrams and pneumatic assembly diagram

Introduction The following block diagrams and the pneumatic assembly diagram form part
of the function description.
9302

Fig. 85 Primus IE block diagram, detailed

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Technical Documentation IPM Primus IE 115

 Function descriptions
Block diagrams and pneumatic assembly diagram
5238

Fig. 86 MoBi block diagram (with S-box)

8839

Fig. 87 S-Box block diagram, detailed

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116 Primus IE Technical Documentation IPM

 Function descriptions
Block diagrams and pneumatic assembly diagram
9304

Fig. 88 PGM2 IE pneumatic assembly diagram, detailed

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Technical Documentation IPM Primus IE 117

 Function descriptions
Block diagrams and pneumatic assembly diagram
9305

Fig. 89 PGM3 IE pneumatic assembly diagram, detailed

9308

Fig. 90 ILCA2 sensor head block diagram

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118 Primus IE Technical Documentation IPM

 Function descriptions
Block diagrams and pneumatic assembly diagram
9309

Fig. 91 MOPS PCB block diagram

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Technical Documentation IPM Primus IE 119

 Function descriptions
Block diagrams and pneumatic assembly diagram
9310

Fig. 92 VGC block diagram

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120 Primus IE Technical Documentation IPM

 Function descriptions
Block diagrams and pneumatic assembly diagram
5251

Fig. 93 PRIMUS CPU PCB block diagram, installed in mixer and VGC
No.1208_0000007950

Technical Documentation IPM Primus IE 121

 Function descriptions
Block diagrams and pneumatic assembly diagram
9311

Fig. 94 Mixer PCB block diagram

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 Function descriptions
Block diagrams and pneumatic assembly diagram
5255

Fig. 95 Power supply unit/UPS block diagram

9312

Fig. 96 Primus IE pneumatic assembly diagram

No.1208_0000007950

Short name Component name

A Gas inlet block.
B A-cone valve (option).

Technical Documentation IPM Primus IE 123

Function descriptions
Block diagrams and pneumatic assembly diagram

Short name Component name

C Mixer.
D Vaporizer plug-in system.
E Ventilator.
F Breathing system.
AB CO2 absorber.
AGSS Anaesthetic gas scavenging system.
APL APL valve.
BAG Breathing bag.
BPG Airway pressure manometer (option, only in connection with VCAUXO2).
CYLINDER N2O N2O compressed gas cylinder.
CYLINDER O2 O2 compressed gas cylinder.
E Ejector.
FG OUTLET Fresh gas outlet.
Flowe Expiratory flow sensor.
Flowi Inspiratory flow sensor.
ILCA2 ILCA2 (anaesthetic gas measurement).
PCU Piston cylinder unit.
M1 Piston cylinder unit motor.
M2 Motor PEEP pressure.
MV1 PEEP/Pmax valve.
MV2 Calibration valve.
MV3 Breathing system/fresh gas outlet switching valve.
MV4 PEEP valve/control valve.
P Patient.
PAWe Expiratory airway pressure sensor.
PCN2O N2O compressed gas cylinder pressure.
PCO2 O2 compressed gas cylinder pressure.
PDMGSHI Differential pressure (high range).
PDMGSLO Differential pressure (low range).
PDMIX Differential pressure mixer.
PDTANK Pressure in the "TANK".
PIPE AIR AIR pipeline supply.
PIPE N2O N2O pipeline.
PIPE O2 O2 pipeline.
PPAIR AIR pipeline supply pressure.
No.1208_0000007950

PPN2O N2O pipeline pressure.

PPO2 O2 pipeline pressure.

124 Primus IE Technical Documentation IPM

 Function descriptions
Block diagrams and pneumatic assembly diagram

Short name Component name

PRCN2O N2O compressed gas cylinder pressure regulator.
PRPAIR AIR pipeline supply pressure regulator.
PRPN2O N2O pipeline supply pressure regulator.
PRPO2 O2 pipeline supply pressure regulator.
PSYS System pressure.
Pu Vacuum pressure sensor, current vacuum.
Pz Inspiratory airway pressure sensor.
R1 Restrictor to smooth pressure peaks.
R2 Resistor to reduce vacuum (pump off).
RM Fresh gas measurement system (upstream of the TANK).
RMGS Fresh gas measurement system.
RV1 Non-return valve of fresh gas isolation.
RV2 AGSS non-return valve.
RV3 PCU vacuum non-return valve (from software 2.n).
SAMPLE O2 O2 connection for external O2 flowmeter (option).
SUCTION SYSTEM Connection of endotracheal suction device (option).
TANK Fresh gas tank.
V Volume.
V1 PEEP valve diaphragm.
V2 Auto-man/spont ON/OFF valve.
VBAK A-cone safety valve.
VCAUXO2 Flow control valve for additional O2 supply (option, only in connection with BPG).
Ve Expiratory valve.
Vi Inspiratory valve.
VMGS Fresh gas flow valve (proportional valve).
VMIXO2 O2 mixer valve.
VMIXAIR AIR mixer valve.
VMIXN2O N2O mixer valve.
VO2+ O2 Flush valve.
VP Vacuum pump.
VSFC Safety O2 control.
VSWAK A-cone valve.
VTANK TANK valve (safety valve).
VU Vacuum valve -200 mbar.
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 This page intentionally left blank.

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 Maintenance instructions

This chapter describes the measures required to maintain the specified

condition of the device.

1 General information on use of maintenance instructions ......................................................... 128

2 Safety instructions .................................................................................................................... 129
3 AGSS filter................................................................................................................................ 130
4 Replacing bronchial suction device bacterial filter .................................................................... 131
5 Replacing the top rolling seal (VGC) ........................................................................................ 132
6 O2 sensor on PGM3 IE ............................................................................................................. 133
7 Flow sensors ............................................................................................................................ 134
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Maintenance instructions
General information on use of maintenance instructions

1 General information on use of maintenance instructions

1.1 Introduction
The following sets out general requirements and information to be noted
when carrying out maintenance procedures.

1.2 Illustrations
The photos included in the following maintenance instructions indicate the
position of components, connectors and mounting elements.

The photos may differ in detail from the actual on-site hardware or options.

With regard to screenshots, only the entries cited in the text are relevant.
Information from other areas of the screen may differ in individual cases.

1.3 Brand

Brand Trademark holder

Dräger-Vapor ® Dräger
®
DrägerService
Drägersorb®
D-Vapor ®
Infinity®
Medibus.X®
WaterLock®

Brand Trademark holder

Barrierta® Klüber Lubrication München KG
®
Camapren KCL GmbH
Dismozon® BODE Chemie GmbH & Co. KG
Incidin® Ecolab GmbH & Co. OHG
Loctite® Henkel AG & Co. KGaA
Secutest® GMC-I Gossen-Metrawatt GmbH
Selectatec® Datex-Ohmeda
Snaploc® Böllhoff Produktion GmbH
Staburags® Klüber Lubrication München KG
Terralin® Schülke & Mayr GmbH
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 Maintenance instructions
Safety instructions

2 Safety instructions

Follow these safety instructions before or after carrying out any maintenance
procedure:

WARNING
Risk of explosion
Risk of explosion if oxygen or nitrous gas fittings are not free of oil and
grease inside and outside during operation.
– Keep oxygen or nitrous oxide fittings free of oil and grease inside
and outside.
– When performing procedures on oxygen or nitrous oxide fittings
wear gloves that are suitable for items exposed to oxygen, e.g.
"Camapren" or equivalent gloves.

WARNING
Hazardous voltage!
Touching live components can lead to serious injury or death.
– Before starting a repair, switch off the device at the power switch
(main switch).
– At the power supply unit, fold aside the mechanical safety of the
plug for non-heating apparatus. Disconnect the plug for non-
heating apparatus from the non-heating apparatus socket on the
power supply unit.

CAUTION
Electrostatic discharge!
Electrostatic discharge may damage electrostatic sensitive devices.
When handling electrostatic sensitive devices, use an anti-static mat and
wrist strap.

CAUTION
Malfunction and safety defects!
Malfunctions and safety defects may occur if no function test and electrical
safety test is carried out following the maintenance procedures.
When maintenance procedures are complete, perform a function test and an
electrical safety test.

CAUTION
Quality problems due to impermissible test equipment and spares!
Use of impermissible test equipment and replacement articles may lead to
quality problems.
Use only approved replacement articles and test equipment during
maintenance procedures.

NOTE
Dispose of the exchanged replacement articles in accordance with local
waste disposal regulations.
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Technical Documentation IPM Primus IE 129

Maintenance instructions
AGSS filter

3 AGSS filter

NOTE
For replacement interval of "AGSS filter" see instructions for use.

The AGSS filter (particle filter) is located at the flowmeter tube of the
anaesthetic gas scavenging system (AGSS).
1 Remove the AGS from its mount.
2 Remove the container for the buffer volume (Fig. 97/1).
3 Unscrew the union nut (Fig. 97/2) from the flowmeter tube.
5275

Fig. 97 Position of container (1), union nut (2), and particle filter (3)

4 Remove the spent particle filter (Fig. 97/3) from the union nut (Fig. 97/2),
and insert the new particle filter.

NOTE
The spent particle filter is classed as household waste. Dispose of it in
accordance with local waste disposal regulations.
5 Tighten the union nut (Fig. 97/2) on the flowmeter tube.
6 Fit the container for the buffer volume (Fig. 97/1) onto the AGS.
7 Place the AGSS into the mount.
8 Perform the function test according to the test instructions.
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 Maintenance instructions
Replacing bronchial suction device bacterial filter

4 Replacing bronchial suction device bacterial filter

NOTE
For replacement interval of "bronchial suction device bacterial filter" see
instructions for use.
1 Remove and replace the old bacterial filter on the bottom (see Fig. 98/1).

5277

Fig. 98 Position of bacterial filter

2 Perform the function test of the endotracheal suction device according to

the test instructions.
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Technical Documentation IPM Primus IE 131

Maintenance instructions
Replacing the top rolling seal (VGC)

5 Replacing the top rolling seal (VGC)

NOTE
For replacement interval of "top rolling seal (VGC)" see instructions for use.
1 Unlock the VGC and remove it from the Primus IE.
2 Loosen the three fixing screws for the breathing system and remove the
breathing system from the VGC.
3 Remove the old top rolling seal (see Fig. 99) from the VGC and replace it
with the new top rolling seal.
9332

Fig. 99 Position of top rolling seal

4 Fit the VGC in the reverse order of its removal.

5 Perform the function test according to the test instructions.
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132 Primus IE Technical Documentation IPM

 Maintenance instructions
O2 sensor on PGM3 IE

6 O2 sensor on PGM3 IE

NOTE
For replacement interval of "O2 sensor" see instructions for use.
Replacement of O2 sensors does not apply to consumption-free O2
measurement (option).

6.1 Replacing the O2 sensor

The O2 sensor is located on the rear of the device.
1 Observe the safety instructions ("Safety instructions").
2 Unscrew the screw (Fig. 100/1).
5271

Fig. 100 Position of screw (1) and O2 sensor (2)

3 Remove the spent O2 sensor (Fig. 100/2) from the screw and insert the
new O2 sensor into the screw.
4 Screw the screw in.

NOTE
– The spent O2 sensor is special waste.
– Dispose of the spent O2 sensor in accordance with local waste disposal
regulations. Spent O2 sensors can be returned to Dräger Medical.
5 After completion of the maintenance procedure, perform a function test
according to the test instructions.
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Technical Documentation IPM Primus IE 133

Maintenance instructions
Flow sensors

7 Flow sensors

NOTE
For replacement interval of "flow sensors" see instructions for use.

7.1 Replacing the flow sensors

The flow sensors are located in the breathing system of the device.
1 Observe the safety instructions ("Safety instructions").
2 Unscrew the inspiratory port and the expiratory port (Fig. 101/1).
5272

Fig. 101 Positions of ports (1) and flow sensors (2)

3 Remove the spent flow sensors (Fig. 101/2) from the breathing system
and insert the new flow sensors into the breathing system.

NOTE
– Spent flow sensors are special waste.
– Dispose of spent flow sensors in accordance with local waste disposal
regulations (treat as infectious special waste).
4 Tighten the inspiratory port and the expiratory port.
5 Perform the function test according to the test instructions.
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134 Primus IE Technical Documentation IPM

 Parts catalog

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

1 Primus IE .................................................................................................................................. 136

No.1208_0000007950

Technical Documentation IPM Primus IE 135

Parts catalog
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 Test instructions

This chapter contains the measures required to determine the actual

condition of the device.

1 Primus IE .................................................................................................................................. 246

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1 Primus IE

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Test Instructions / Service Card IPM

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3154

Warning
Revision 9.0
All servicing and/or test procedures on the 9500466
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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Table of contents

Table of contents

Important notes 5
1 Device configuration 6
1.1 Device configuration ................................................................................................................ 6
1.1.1 Serial numbers of base unit and breathing system ................................................... 6
1.1.2 Serial numbers – options ........................................................................................... 6
2 Maintenance parts 7
2.1 Maintenance parts, yearly ........................................................................................................ 7
2.1.1 Base unit.................................................................................................................... 7
2.1.2 Disposable absorber, Drägersorb CLIC (new) (if present)......................................... 8
2.2 Maintenance parts, 2-yearly..................................................................................................... 8
2.2.1 Base unit.................................................................................................................... 8
2.2.2 Disposable absorber, Drägersorb CLIC (new) (if present)......................................... 9
2.3 Maintenance parts, 3-yearly..................................................................................................... 9
2.3.1 Base unit.................................................................................................................... 10
2.3.2 Disposable absorber, Drägersorb CLIC (new) (if present)......................................... 10
2.4 Maintenance parts, 4-yearly..................................................................................................... 11
2.4.1 Base unit.................................................................................................................... 11
2.4.2 Disposable absorber, Drägersorb CLIC (new) (if present)......................................... 12
2.4.3 CLIC Adapter MX50090 (if present) .......................................................................... 12
2.5 Maintenance parts, 6-yearly..................................................................................................... 13
2.5.1 Base unit.................................................................................................................... 13
2.5.2 Disposable absorber, Drägersorb CLIC (new) (if present)......................................... 14
2.6 Maintenance parts as required ................................................................................................ 15
2.6.1 Maintenance parts as per instructions for use ........................................................... 15
3 Electrical safety 16
3.1 Electrical safety according to IEC 62353 ................................................................................. 16
3.1.1 Visual check............................................................................................................... 16
3.1.2 Protective earth resistance ........................................................................................ 17
3.1.3 Protective earth resistance measuring points............................................................ 18
3.1.4 Application component for device leakage current .................................................... 18
3.1.5 Equipment leakage current........................................................................................ 18
3.1.6 Applied part leakage current, mains on applied part, type BF ................................... 19
3.2 Electrical safety according to IEC 60601-1 .............................................................................. 20
3.2.1 Visual check............................................................................................................... 21
3.2.2 Protective earth resistance ........................................................................................ 22
3.2.3 Protective earth resistance measuring points............................................................ 22
3.2.4 Earth leakage current ................................................................................................ 23
3.2.5 Application component for patient leakage current.................................................... 24
3.2.6 Patient leakage current, optional "SpO2" .................................................................. 24
4 Function and condition test 26
4.1 Condition.................................................................................................................................. 26
No.2207_0000007705

4.1.1 Accompanying documents......................................................................................... 26

4.1.2 Base unit.................................................................................................................... 26
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Table of contents

4.2 Uninterruptible power supply "UPS" ........................................................................................ 26

4.2.1 UPS function ............................................................................................................. 27
4.3 Patient gas module "PGM" ...................................................................................................... 27
4.3.1 Leak test.................................................................................................................... 27
4.3.2 Plausibility test of PGM values .................................................................................. 28
4.3.3 PGM alarm response and measured value display................................................... 28
4.3.4 Accuracy of the gas measurement in room air and at 100% O2............................... 28
4.3.5 Accuracy of gas measurement with test gas............................................................. 29
4.3.6 Monitoring pumping power ........................................................................................ 31
4.4 Pneumatic device check .......................................................................................................... 31
4.4.1 Pipeline supply test ................................................................................................... 32
4.4.2 Pipeline supply leak test............................................................................................ 32
4.4.3 O2 Flush flow and button mechanism (yearly) .......................................................... 33
4.4.4 Leakage test on Drägersorb Clic (if fitted)................................................................. 33
4.4.5 APL valve linearity test (yearly) ................................................................................. 34
4.4.6 Fresh gas branch leak test ........................................................................................ 36
4.4.7 A-cone (if present) (yearly)........................................................................................ 37
4.4.8 Final test.................................................................................................................... 38
4.5 Ventilation, interlock function, alarms and monitor .................................................................. 38
4.5.1 Manual ventilation ..................................................................................................... 38
4.5.2 Spontaneous breathing ............................................................................................. 38
4.5.3 Pressure controlled ventilation (Pressure Mode) ...................................................... 38
4.5.4 Vaporizer interlock function ....................................................................................... 39
4.5.5 Audible and visual alarms ......................................................................................... 39
4.5.6 Screen brightness, alarm tone and ventilation tone volume...................................... 40
4.6 Options (if present) .................................................................................................................. 40
4.6.1 Tightening torque of the monitor arm fixing screws................................................... 40
4.6.2 External O2 flowmeter............................................................................................... 41
4.6.3 SpO2 measurement .................................................................................................. 42
4.6.4 Compressed gas cylinders ........................................................................................ 42
4.6.4.1 Serial number of O2 compressed gas cylinder ..................................................... 42
4.6.4.2 TÜV O2 compressed gas cylinder (applicable to Germany only) ......................... 42
4.6.4.3 O2 use-by date...................................................................................................... 42
4.6.4.4 Serial number of N2O compressed gas cylinder................................................... 43
4.6.4.5 TÜV N2O compressed gas cylinder (applicable to Germany only)....................... 43
4.6.4.6 N2O use-by date ................................................................................................... 43
4.6.4.7 Pendant head control (for Cicero ceiling version only).......................................... 43
4.6.4.8 O2 high-pressure leakage..................................................................................... 43
4.6.4.9 N2O high-pressure leakage (only in nitrous oxide mode) ..................................... 44
4.7 Gas type .................................................................................................................................. 44
4.7.1 Pipeline supply gas type test..................................................................................... 44
4.7.2 Cylinder inlets gas type test ...................................................................................... 45
4.8 Final action .............................................................................................................................. 46
No.2207_0000007705

4.8.1 Device handover ....................................................................................................... 46

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Table of contents

5 Test equipment 47
5.1 Test equipment list ................................................................................................................... 47
5.1.1 Test equipment subject to mandatory calibration ...................................................... 47
5.1.2 Test equipment not subject to mandatory calibration ................................................ 50
5.1.3 Additionally required items ........................................................................................ 53

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Important notes

NOTE
Prior to using these test instructions, check that they are the latest revision
(compare revision with latest service documentation).
All results and inputs must be documented.

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

General
These test instructions apply to software versions greater than/equal to 4.0.
For the devices listed below, use the test instructions specific to the relevant
device:
– Other breathing systems
– Vapor 19.n, Vapor 2000, Devapor
– Pressure Regulator Silverline etc.
Country-specific ventilation mode terms in software version 4.0:
International: Man./Spont = France: Man./Spont.
International: Vol.Mode = France: Mode Vol.
International: Press.Mode = France: Mode Press.
International: Press.Supp. = France: A.I. = (option)
International: Vol. AF = France: Mode Vol. AF = (option)
Conversion:
1 bar = 14.504 PSI; 1 mbar = 1.01973 cmH2O; 1 mbar = 1 hPa.
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Device configuration

1 Device configuration

This section records the device configuration.

1.1 Device configuration

Prerequisites None

1.1.1 Serial numbers of base unit and breathing system

Prerequisites None
Action • Read the serial number on the device. The serial number can be found on
the rear of the device (rating plate).
Result Device serial number (if not otherwise recorded)
[________txt]

Action • Read off the serial number on the breathing system cover. The serial num-
ber is located on the front right or on the rear right of the cover.
Result Breathing system cover (if present)
[________txt]

Action • Read the serial number of the valve plate. The serial number is located
underneath non-return valve 2.
Result Valve plate (8603857)
[________txt]

Action • Read the serial number of the respiratory gas block. The serial number is
located on the underside (cover to the rolling seal).
Result Respiratory gas block (8602804)
[________txt]

1.1.2 Serial numbers – options

Action • Read off the serial number of the endotracheal suction device. The serial
number is located on the rear.
Result Endotracheal suction device (if present)
[________txt]

Action • Read the serial number of the vacuum suction device.

Result Vacuum suction (if fitted)
[________txt]
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Maintenance parts

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

Prerequisites
NOTE
Prior to any maintenance procedure, check that the device has completed its
self-test without errors.
Repair any errors before carrying out maintenance.

The device has completed its self-test without errors.

The device has been switched off and the mains power has been cut.
Measures have been taken against electrostatic discharge.

2.1.1 Base unit

NOTE
The service set includes all standard maintenance parts.
The maintenance parts for the options need to be ordered separately.

NOTE
There are three of O-ring 6870522 in the service set. Water traps from third-
party vendors require three O-rings.

Replacement by specialist. The service set (quantity 1), part number

MX08241, includes the following maintenance parts:

Part number Maintenance part Quantity Location/Remark

8603662 Filter mat 80x80x10 1 Power supply unit
8601238 Nafion tube 1 PGM (internal)
6870910 Filter mat 1 PGM (rear panel)
6871057 Filter mat 1 PGM IE (only)
U04314 O-ring 4 Vaporizer plug-in system
8603301 Filter mat 1 VGC (large dust filter)
8603144 Filter mat 1 VGC (small dust filter)
2600650 Rolling seal, cover 1 VGC
6870522 O-ring 3 Water trap holder
6870529 O-ring 1 Water trap holder

Result Base unit

Next replacement: [________dat]
No.2207_0000007705
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Maintenance parts

2.1.2 Disposable absorber, Drägersorb CLIC (new) (if present)

Replacement by specialist. Replace the service set (quantity 1) with the num-
ber M36045.
Result Disposable absorber, Drägersorb CLIC (new) (if present)
Next replacement: [________dat]

2.2 Maintenance parts, 2-yearly

Prerequisites
NOTE
Prior to any maintenance procedure, check that the device has completed its
self-test without errors.
Repair any errors before carrying out maintenance.

The device has completed its self-test without errors.

The device has been switched off and the mains power has been cut.
ESD precautions have been taken

2.2.1 Base unit

NOTE
The service set includes all standard maintenance parts.
The maintenance parts for the options need to be ordered separately.

NOTE
There are three of O-ring 6870522 in the service set. Water traps from third-
party vendors require three O-rings.

Replacement by specialist. The service set (quantity 1), part number

MX08467, includes the following maintenance parts:
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Primus IE
Maintenance parts

Part number Maintenance part Quan- Location/Remark

tity
8410181 Diaphragm 1 Breathing system (MAN/SPONT
valve).
8603780 Diaphragm 1 Breathing system (PEEP valve).
9036904 Test Instructions 1 Test instructions for PEEP diaphragm.
8603781 Sealing washer 1 Breathing system (PEEP valve).
R52382 O-ring 2 Breathing system (between valve plate
and diaphragm cover).
M19238 Filter element 3 Gas supply block.
8603585 Filter mat 1 Device cover.
8607460 Primus IE filter 1 Device cover.
8603662 Filter mat 80x80x10 1 Power supply unit.
MX08834 Bacterial filter (37 mm) 2 PGM (internal) / VGC (pneumatic
assembly).
8601238 Nafion tube 1 PGM (internal)
6870910 Filter mat 1 PGM (rear panel).
6871057 Filter mat 1 PGM IE (only).
U04314 O-ring 4 Vaporizer plug-in system.
8603301 Filter mat 1 VGC (large dust filter).
8603144 Filter mat 1 VGC (small dust filter).
2600650 Rolling seal, cover 1 VGC.
6870522 O-ring 3 Water trap holder.
6870529 O-ring 1 Water trap holder.

Result Base unit

Next replacement: [________dat]

2.2.2 Disposable absorber, Drägersorb CLIC (new) (if present)

Replacement by specialist. Replace the service set (quantity 1) with the num-
ber M35381.
Result Disposable absorber, Drägersorb CLIC (new) (if present)
Next replacement: [________dat]

2.3 Maintenance parts, 3-yearly

Prerequisites
NOTE
Prior to any maintenance procedure, check that the device has completed its
self-test without errors.
Repair any errors before carrying out maintenance.

The device has completed its self-test without errors.

The device has been switched off and the mains power has been cut.
ESD precautions have been taken
No.2207_0000007705
No.1208_0000007950

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Maintenance parts

2.3.1 Base unit

NOTE
The service set includes all standard maintenance parts.
The maintenance parts for the options need to be ordered separately.

NOTE
After fitting the new UPS batteries, start Service mode.
In Service mode, open the "system info" screen.
For the batteries, on the "operation hours" menu set the "Ah" parameter to
zero.

NOTE
There are three of O-ring 6870522 in the service set. Water traps from third-
party vendors require three O-rings.

Replacement by specialist. The service set (quantity 1), part number

MX08468, includes the following maintenance parts:

Part number Maintenance part Quan- Location/Remark

tity
8603662 Filter mat 80 x 80 x 10 1 Power supply unit.
MX08901 Service set rechargeable 1 Power supply unit (UPS bat-
battery Primus teries). After replacing, the
following action is required:
Under "battery" set parame-
ter "Ah" to "0".
8601238 Nafion tube 1 PGM (internal)
6870910 Filter mat 1 PGM (rear panel).
6871057 Filter mat 1 PGM IE (only).
U04314 O-ring 4 Vaporizer plug-in system.
8603301 Filter mat 1 VGC (large dust filter).
2600651 Diaphragm, piston 1 VGC (internal).
8604831 O-ring 1 VGC (internal).
8603144 Filter mat 1 VGC (small dust filter).
2600650 Rolling seal, cover 1 VGC.
6870522 O-ring 3 Water trap holder.
6870529 O-ring 1 Water trap holder.

Result Base unit

Next replacement: [________dat]

2.3.2 Disposable absorber, Drägersorb CLIC (new) (if present)

Replacement by specialist. Replace the service set (quantity 1) with the num-
No.2207_0000007705

ber M36045.
Result Disposable absorber, Drägersorb CLIC (new) (if present)
Next replacement: [________dat]
No.1208_0000007950

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Maintenance parts

2.4 Maintenance parts, 4-yearly

Prerequisites
NOTE
Prior to any maintenance procedure, check that the device has completed its
self-test without errors.
Repair any errors before carrying out maintenance.

The device has completed its self-test without errors.

The device has been switched off and the mains power has been cut.
Measures have been taken against electrostatic discharge.

2.4.1 Base unit

NOTE
The service set includes all standard maintenance parts.
The maintenance parts for the options need to be ordered separately.

NOTE
There are three of O-ring 6870522 in the service set. Water traps from third-
party vendors require three O-rings.

Replacement by specialist. The service set (quantity 1), part number

MX08467, includes the following maintenance parts:
No.2207_0000007705
No.1208_0000007950

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Maintenance parts

Part number Maintenance part Quan- Location/Remark

tity
8410181 Diaphragm 1 Breathing system (MAN/SPONT
valve).
8603780 Diaphragm 1 Breathing system (PEEP valve).
9036904 Test Instructions 1 Test instructions for PEEP diaphragm.
8603781 Sealing washer 1 Breathing system (PEEP valve).
R52382 O-ring 2 Breathing system (between valve plate
and diaphragm cover).
M19238 Filter element 3 Gas supply block.
8603585 Filter mat 1 Device cover.
8607460 Primus IE filter 1 Device cover.
8603662 Filter mat 80x80x10 1 Power supply unit.
MX08834 Bacterial filter (37 mm) 2 PGM (internal) / VGC (pneumatic
assembly).
8601238 Nafion tube 1 PGM (internal)
6870910 Filter mat 1 PGM (rear panel).
6871057 Filter mat 1 PGM IE (only).
U04314 O-ring 4 Vaporizer plug-in system.
8603301 Filter mat 1 VGC (large dust filter).
8603144 Filter mat 1 VGC (small dust filter).
2600650 Rolling seal, cover 1 VGC.
6870522 O-ring 3 Water trap holder.
6870529 O-ring 1 Water trap holder.

Result Base unit

Next replacement: [________dat]

2.4.2 Disposable absorber, Drägersorb CLIC (new) (if present)

Replacement by specialist. Replace the service set (quantity 1) with the num-
ber M35381.
Result Disposable absorber, Drägersorb CLIC (new) (if present)
Next replacement: [________dat]

2.4.3 CLIC Adapter MX50090 (if present)

Replace the CLIC adapter (quantity 1) with the number MX50090.

Result CLIC Adapter MX50090 (if present)
Next replacement: [________dat]
No.2207_0000007705

No.1208_0000007950

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Maintenance parts

2.5 Maintenance parts, 6-yearly

Prerequisites
NOTE
Prior to any maintenance procedure, check that the device has completed its
self-test without errors.
Repair any errors before carrying out maintenance.

The device has completed its self-test without errors.

The device has been switched off and the mains power has been cut.
ESD precautions have been taken

2.5.1 Base unit

NOTE
The service set includes all standard maintenance parts.
The maintenance parts for the options need to be ordered separately.

NOTE
There are three of O-ring 6870522 in the service set. Water traps from third-
party vendors require three O-rings.

NOTE
After fitting the new UPS batteries, start Service mode.
In Service mode, open the "system info" screen.
For the batteries, on the "operation hours" menu set the "Ah" parameter to
zero.

Replacement by specialist. The service set (quantity 1), part number

MX08995, includes the following maintenance parts:
No.2207_0000007705
No.1208_0000007950

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Maintenance parts

Part number Maintenance part Quan- Location/Remark

tity
8410181 Diaphragm 1 Breathing system
(MAN/SPONT valve).
8603781 Sealing washer 1 Breathing system (PEEP
valve)
8603780 Diaphragm 1 Breathing system (PEEP
valve).
9036904 Test Instructions 1 Test instructions for PEEP dia-
phragm.
R52382 O-ring 2 Breathing system (between
valve plate and diaphragm
cover).
M19238 Filter element 3 Gas supply block.
8603585 Filter mat 1 Device cover.
8607460 Primus IE filter 1 Device cover.
MX08901 Service set recharge- 1 Power supply unit (UPS bat-
able battery Primus teries). After replacing, the fol-
lowing action is required:
Under "battery" set parameter
"Ah" to "0".
8603662 Filter mat 80x80x10 1 Power supply unit.
MX08834 Bacterial filter (37 mm) 2 PGM (internal) / VGC (pneu-
matic assembly).
8601238 Nafion tube 1 PGM (internal)
6870910 Filter mat 1 PGM (rear panel).
6871057 Filter mat 1 PGM IE (only).
U04314 O-ring 4 Vaporizer plug-in system.
8603301 Filter mat 1 VGC (large dust filter).
2600651 Diaphragm, piston 1 VGC (internal).
8604831 O-ring 105 x 4 1 VGC (internal).
8603144 Filter mat 1 VGC (small dust filter).
2600650 Rolling seal, cover 1 VGC.
6870522 O-ring 3 Water trap holder.
6870529 O-ring 1 Water trap holder.

Result Base unit

Next replacement: [________dat]

2.5.2 Disposable absorber, Drägersorb CLIC (new) (if present)

Replacement by specialist. Replace the service set (quantity 1) with the num-
ber M35381.
Result Disposable absorber, Drägersorb CLIC (new) (if present)
Next replacement: [________dat]
No.2207_0000007705

No.1208_0000007950

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Maintenance parts

2.6 Maintenance parts as required

2.6.1 Maintenance parts as per instructions for use

NOTE
The replacement of maintenance parts is described in the instructions for use
and is carried out by the user.

Quan- Designation Comments

tity
1 AGSS filter Replace if clogged.
1 Filter of the endotracheal Replace every 14 days.
suction system
1 Upper rolling seal of the Replace at the latest after 1 year.
ventilator unit
1 Water trap Replace if dirty or as from software 2.n in case of mes-
sage: "CHECK SAMPLING LINE" or as from software
4.n in case of message "WATER TRAP SAMPLING
LINE?" (if the sampling gas line is definitely open and
not bent); but no less than every 4 weeks.
1 O2 sensor – fuel cell Replace if no further calibration is possible or the mes-
sage: "O2 SENSOR FAILURE" is displayed.
- O2 sensor – consumption- Replacement of the O2 sensor does not apply to con-
free sumption-free O2 measurement (option).
2 Flow sensors Replace flow sensors if no further calibration is possi-
ble or in the event of an alarm. Follow the instructions
for use of the flow sensors.

Action • Check whether the above-named maintenance parts have been replaced.
Result Maintenance parts in the instructions for use
[________OK]
No.2207_0000007705
No.1208_0000007950

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3 Electrical safety

This section contains tests which have to be performed in order to determine

the operational readiness of the medical-electrical system.

3.1 Electrical safety according to IEC 62353

Introduction The following subsections provide descriptions of device checks, recurrent
testing and inspection of medical electrical (ME) devices.

NOTE
The device conforms to the conditions of protection class I, type BF.

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
In testing to IEC 62353, the medical electrical device (ME device) or the med-
ical 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 manu-
facturer, of which at least one must be an ME device, which are intercon-
nected by a functional connection or by means of a multiple socket outlet.

NOTE
In the case of devices connected to other devices by a data cable, this con-
nection must be disconnected prior to performing the electrical safety test, in
order to avoid false measurements.

3.1.1 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.
Ź Disconnect the power cable from the socket before testing the power fuse-
links.
No.2207_0000007705

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Test – The power fuse-links of the device under test match the specifications on
the rating plate.
– On auxiliary sockets with automatic circuit-breakers, check the circuit-
breakers are switched on.
– The power cable and plug are not dirty or damaged.
Result Condition checked.
[________OK]

3.1.2 Protective earth resistance

Test set-up

1936

Fig. 1 Protective earth resistance

Item Designation
1 Tester
2 Device under test
3 Tester probe cable
L Conductor
N Neutral conductor
PE Protective earth

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 probe cable, scan each of the points on the device
under test listed under Protective earth resistance measuring points 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 earth resistance of single devices (including the permanently
installed power supply cord, or power supply cord detachable only by use of
tools) must not exceed 0.3 Ohm in each case.
Result Maximum measured value.
[________ȍ]

or
No.2207_0000007705

Test The protective earth resistance of ME systems (including mains power cable)
must not exceed 0.5 ohms in each case.
Result Maximum measured value of ME system.
No.1208_0000007950

[________ȍ]

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3.1.3 Protective earth resistance measuring points

Action • Scan the following measuring points for protective earth resistance mea-
surement one after the other using the tip of the probe cable:
– Potential equalization pin on trolley
– Potential equalization pins on auxiliary sockets
– Protective conductor contacts on auxiliary socket-outlets.
Result Measuring points have been scanned.
[________OK]

3.1.4 Application component for device leakage current

Action • The following device-specific test adapter is required for the test:
Result 7901068, adapter for SPO2 connection
[________OK]

3.1.5 Equipment leakage current

NOTE
The equipment leakage current can be tested by the differential measure-
ment method or the direct measurement method.
In direct measurement, set up the device under test with insulation and scan
all accessible conductive components using the probe (the protective earth is
internally interrupted in the tester).

Prerequisites The tester is switched on.

Test set-up
1932

Fig. 2 Equipment leakage current

Item Designation
1 Tester
2 Device under test
3 (Applied part) Device-specific test adapter for tester
4 (Applied part) Configurable ports for applied part
L Conductor
No.2207_0000007705

N Neutral conductor
PE Protective earth
No.1208_0000007950

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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 port "A"
for applied parts (paying attention to the configuration!).
• Follow the instructions on the tester.

NOTE
Perform the test twice. In the second test attach the connector in the socket
rotated 180°. In many test devices the mains plug rotation is simulated by
means of a built-in selector switch.
Document the higher measured value.

NOTE
Always enter the reference value (initial value measured) in the "Test Report"
or "Result Sheet" document.

NOTE
If the measured values are between 90% and 100% of the permissible limit
value, apply the reference value and the previously measured values of the
recurrent test to assess electrical safety!

Test The reference value must not exceed 500 μA.

Result Reference value
[________μA]

Test The recurrent test value must not exceed 500 μA.
Result Recurrent test
[________μA]

3.1.6 Applied part leakage current, mains on applied part, type BF

Prerequisites The tester is switched on.
Test set-up
2267

Fig. 3 Leakage current on applied part

Item Designation
No.2207_0000007705

1 Tester
2 Device under test
No.1208_0000007950

3 Applied part, device-specific test adapters for tester

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Item Designation
4 Configurable connection sockets for applied parts (A - K)
L Conductor
N Neutral conductor
PE Protective earth

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 port "A"
for applied parts (paying attention to the configuration!).
• Follow the instructions on the tester.

NOTE
For symmetrical mains plugs that have no preferential position in the socket-
outlet, perform the test twice! Perform the second test 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. Document the higher measured value.

NOTE
Always enter the reference value (initial value measured) in the "Test Report"
or "Result Sheet" document.

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 5000 μA.

Result Reference value
[________μA]

Test The recurrent test value must not exceed 5000 μA.
Result Recurrent test
[________μA]

3.2 Electrical safety according to IEC 60601-1

Introduction
NOTE
The device conforms to the conditions of protection class I, type BF.

NOTE
All measures labelled in these test instructions with (applied part) must only
be performed if the device is fitted with applied parts.
No.2207_0000007705

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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
IEC 60601-1. Whether the standard is applicable or not depends on national
regulations and its use must be decided on site under consideration of appli-
cable national regulations.

NOTE
In testing to IEC 60601-1, 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 manu-
facturer, of which at least one must be an ME device, which are intercon-
nected by a functional connection or by means of a multiple socket outlet.

NOTE
In the case of devices connected to other devices by a data cable, this con-
nection must be disconnected prior to performing the electrical safety test, in
order to avoid false measurements.

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.
Ź Disconnect the power cable from the socket before testing the power fuse-
links.

Test – The power fuse-links of the device under test match the specifications on
the rating plate.
– On auxiliary sockets with automatic circuit-breakers, check the circuit-
breakers are switched on.
– The power cable and plug are not dirty or damaged.
Result Condition checked.
[________OK]
No.2207_0000007705
No.1208_0000007950

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3.2.2 Protective earth resistance

Test set-up

769

Fig. 4 Test setup for protective conductor resistance

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

Action • Prepare the test setup.

• Switch on the tester and the device under test.
• Configure the tester appropriately, and follow the instructions on the tester.
• Using the tip of the test probe, scan each of the measuring points on the
device under test listed under "Protective conductor resistance measuring
points" 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 earth resistance must not exceed 0.2 Ohm (including mains
power cable) in each case.
Result Enter the highest measured value of the protective earth resistance.
[________ȍ]

3.2.3 Protective earth resistance measuring points

Action • Scan the following measuring points for protective earth resistance mea-
surement one after the other using the tip of the probe cable:
– Potential equalization pin on trolley
– Potential equalization pins on auxiliary sockets
– Protective earth contacts on auxiliary sockets
Result Measurement points scanned.
[________OK]
No.2207_0000007705

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3.2.4 Earth leakage current

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

Test set-up

218
Fig. 5 Earth leakage current test setup

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.

• Switch on the tester and the device under test.
• 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
devices the mains plug rotation is simulated by means of a built-in selector
switch. The higher measured value must be documented.

Test Normal condition (N.C.): The value must not exceed 500 μA.
Result Normal condition (N.C.)
[________μA]

Test Single fault condition (S.F.C.): The value must not exceed 1000 μA.
Result Single fault condition (S.F.C.)
[________μA]
No.2207_0000007705
No.1208_0000007950

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3.2.5 Application component for patient leakage current

Action • The following device-specific test adapter is required for the test:
Result 7901068, adapter for SPO2 connection
[________OK]

3.2.6 Patient leakage current, optional "SpO2"

NOTE
This test is only required if the "SpO2" option is fitted. Install the device under
test insulated.

Test set-up

425

Fig. 6 Patient leakage current test setup

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

Action • Prepare the test setup.

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
devices the mains plug rotation is simulated by means of a built-in selector
switch. The higher measured value must be documented.

• Follow the instructions on the tester.

Test Normal condition (N.C.): The value must not exceed 100 μA.
Result Normal condition (N.C.)
No.2207_0000007705

[________μA]
No.1208_0000007950

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Test Single fault condition (S.F.C.): The value must not exceed 500 μA.
Result Single fault condition (S.F.C.)
[________μA]
No.2207_0000007705
No.1208_0000007950

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4 Function and condition test

This section contains tests to establish whether the device and the accesso-
ries used conform to the stipulations of the Instructions for Use in terms of
condition and function.

4.1 Condition
Introduction These instructions describe how to check the condition of the accompanying
documents and the base unit.

4.1.1 Accompanying documents

Prerequisites The device has been fully assembled according to the Instructions for Use.
Action • Check labels and Instructions for Use.
Test Labels are complete and legible.
The instruction for use is available as per the user.
The medical product book is available as per the user (only applies for the
Federal Republic of Germany).
Result Labels and accompanying documents are present.
[________OK]

4.1.2 Base unit

Action • Check base unit.
Test The device is clean and undamaged.
All labels are complete and legible.
On the device the retainer of the mains power cable, the inlet connector for
non-heating apparatus and the potential equalization pins are clean and
undamaged.
On the device the auxiliary sockets are clean and undamaged. For auxiliary
sockets with circuit breakers, the circuit breakers are switched on. In the case
of auxiliary sockets with fuses, the power fuse-links match the data specified
on the rating plate.
On the rear of the device, the fixing screws of the power supply unit, the mul-
tiple socket strip and the PGM are tight (secure loose fixing screws with Loc-
tite 221 (7901966)).
AGSS is clean and undamaged.
Result Base unit
[________OK]

4.2 Uninterruptible power supply "UPS"

No.2207_0000007705

Introduction These instructions describe the function test of the "UPS"

No.1208_0000007950

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4.2.1 UPS function

Prerequisites The device has been fully set up according to the instructions for use.
The self-test has been passed and the checklist has been acknowledged.
In screen mode, the battery capacity indicates 90 to 100%.
The "mains power supply" indicator on the monitor control panel is on.
Action • Disconnect the mains power plug (to switch the device to UPS).
• Start the stopwatch (7911336).
• During the following chapters of the test procedure, operate the device
without mains supply for at least 30 minutes.
Test The "battery supply" indicator on the monitor control panel is on.
The "mains power supply" indicator on the monitor control panel is off.
The device can be operated without mains supply for at least 30 minutes.
Action • After 30 minutes, reconnect the device to the mains supply (connect the
power plug).
• Confirm the checklist.
Test The "mains power supply" indicator on the monitor control panel is on.
The "battery supply" indicator on the monitor control panel is off.
Result UPS function
[________OK]

4.3 Patient gas module "PGM"

Introduction These instructions describe the function test of the "PGM".

4.3.1 Leak test

Test set-up 25482

Fig. 7 Test setup: "Leak test"

Item Designation
No.2207_0000007705

1 Syringe
2 Tube
3 Tube clamp
No.1208_0000007950

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Item Designation
4 Digital barometer (7900217)
5 T-piece
6 Water trap connection (if the Luer-Lock has a continuous thread, use the sam-
pling tube for the connection)

Action • Press the Standby key on the device (device switches to "Standby" mode.
The pump is set to "Pump OFF".).
• Measure the ambient pressure using the digital barometer.
• Push the syringe plunger all the way in. Prepare the test setup with no tube
clamp.
• Generate a negative pressure of -200 mbar with the syringe (readout on
digital barometer: ambient pressure minus 200 mbar).
• Clamp off the tube with the tube clamp before the syringe.
• Start the stopwatch.
Result The pressure on the digital barometer must not increase by more than
20 mbar within one minute.
[________OK]

4.3.2 Plausibility test of PGM values

Prerequisites The device was switched on for at least 20 minutes, uninterrupted.
The device is in "Vol. Mode".
The sampling gas line is connected to the water trap of the PGM but discon-
nected from the Y-piece.
Ambient air is drawn in through the sampling gas line (pump on).
Action • Breathe into the sampling gas line several times.
Result A CO2 curve is displayed. CO2 measured values for "insp." and "exp."
are displayed and are plausible.
[________OK]

4.3.3 PGM alarm response and measured value display

Action • Hold the sampling gas line to the ambient air.
Test The visual and acoustic "CO2 APNOEA" alarm signal is generated after max.
30 seconds.
After no more than 120 seconds the FiO2 and FeO2 readings show 18% to
24%.
Result PGM alarm response and measured value display
[________OK]

4.3.4 Accuracy of the gas measurement in room air and at 100% O2

Action • Switch the device to "Standby" mode and then to "Man Spont".
Test With ambient air, the values displayed under "real time state" are within toler-
No.2207_0000007705

ance:

Gas type Tolerance

No.1208_0000007950

AGas * 0.0 vol.% to 0.2 vol.%

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Gas type Tolerance

CO2 0.0 vol.% to 0.2 vol.%
N 2O 0.0 vol.% to 2.5 vol.%
O2 18% to 21%
* As from SV 2.03 no values are displayed.
* As from SV 4.00 the readout "No A-Gas" is displayed.

Action • Detach the tube from the socket of the breathing bag.
• Hold the sampling gas line into the socket of the breathing bag.
• Operate the O2 flush and draw in 100 % oxygen through the sampling gas
line.
Test The O2 value shown by the device is in the tolerance:

Gas type Tolerance

O2 97 % to 100 %

Result Accuracy of the gas measurement in room air and at 100% O2

[________OK]

4.3.5 Accuracy of gas measurement with test gas

Prerequisites The device is in "Man/Spont" mode.
The sampling gas line is connected to the water trap of the PGM but discon-
nected from the Y-piece.
The tolerance limits of the test gas in use have been calculated.

CAUTION
Possible miscalculation of test gas tolerance limits!
If the following information is ignored, there is a risk that the tolerance limits
may be miscalculated.
Ź Certified test gas is used to test the accuracy of Dräger gas analyzer mod-
ules. Each test gas cylinder is accompanied by a "CERTIFICATE OF
ANALYSIS" from the manufacturer. This certificate specifies the concen-
tration values (Actual Analyzed Concentration (AAC)) of the actual test
gases contained in the cylinders.
Ź For calculation of the tolerance limits (see following tables) use only the
concentration values (AAC) from the "CERTIFICATE OF ANALYSIS". Do
not use the concentration values indicated on the test gas cylinder itself.

Test gas Desflurane (7910345)

See following table for calculation of tolerance limits:

Desflurane Device with sensor module/mini-module:

test gas Tolerance limits for measured values
Desflurane AAC* +/-0.5 vol%
CO2 AAC* +/-0.83 vol%
N 2O AAC* +/-6.8 vol%
AAC* = Actual Analyzed Concentration. The AAC can be found in the
No.2207_0000007705

"CERTIFICATE OF ANALYSIS" accompanying the test gas cylinder.

Test gas mixed gas (7910349)

See following table for calculation of tolerance limits:
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Test gas Device with sensor module/mini-module:

mixed gas Tolerance limits for measured values
Isoflurane AAC* +/-0.35 vol%
Sevoflurane AAC* +/-0.35 vol%
CO2 AAC* +/-0.83 vol%
N 2O AAC* +/-7.60 vol%
AAC* = Actual Analyzed Concentration. The AAC can be found in the
"CERTIFICATE OF ANALYSIS" accompanying the test gas cylinder.

Test The status messages indicate readiness for operation and meet the following
specifications:

Designation Status
"module state" "OK"
"components" "OK"
"sample gas path" "OK"

Test The status message for anaesthetic gas measurement reads "full" or "iso" as
appropriate (under "accur.").
Test set-up

27070

Fig. 8 Test setup with test gas cylinder

Item Designation
1 Pressure regulator (test gas)
2 Test gas cylinder (Desflurane or mixed gas)
3 Silicone tube 4x1.5 (3 cm)
4 Bag
5 Silicone tube 7x2.5 (2 cm)
6 T-piece
7 Silicone tube 4x1.5 (3 cm)
8 Sampling tube
9 Water trap connection
10 Device under test

Action • Prepare the test setup.

• Set the handwheel of the test cylinder pressure regulator and open the
shut-off valve.
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CAUTION
Pressures above 1050 hPa (1050 mbar) will damage the analyzer!
At pressures above 1050 hPa (1050 mbar) the analyzer will be damaged.
Ź Fill the bag only lightly with test gas.
Ź For further measurements, briefly open the shut-off valve of the test cylin-
der pressure regulator until the bag has inflated a little and then close the
shut-off valve again.

• Using the test gas cylinder pressure regulator handwheel, slowly increase
the pressure until you can hear the calibration gas escaping from the cali-
bration adapter. Build up the pressure in the bag slowly until the bag has
inflated somewhat.
• Close the shut-off valve.
Test When test gas is drawn in for the first time, the CO2 measurement curve rises
steeply.
The values displayed match the specified values of the test gas cylinder. The
readouts are within the calculated tolerance limits.
Result The gas measurements with test gas are accurate.
[________OK]

Action • Close the shut-off valve and the handwheel of the test cylinder pressure
regulator.
• Remove the test setup.

4.3.6 Monitoring pumping power

Action • Seal off the sampling gas line.
Result After a few seconds the prompt "Check sampling gas line" appears on-
screen.
[________OK]

Action • Connect the sampling gas line to the Y-piece.

4.4 Pneumatic device check

Introduction These instructions describe the pneumatic device check.
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4.4.1 Pipeline supply test

Test set-up

3011
Fig. 9 "Pipeline supply" test setup

Item Designation
1 Test pressure regulator, DIN connector (7901482), PIN index connec-
tor (7910342).
2 High-pressure cylinder.
3 Gas manifold, DIN (7901495), international (7910341).

Prerequisites The device has been switched over from battery supply to mains power sup-
ply (if the device has been in battery mode for 30 minutes).
The device is in "Standby" mode.
Action • Prepare the test setup.
• Open the valve of the high-pressure cylinder. Adjust the test pressure reg-
ulator to the pipeline supply pressure that is available in the hospital
(2.5 bar to 5.5 bar).
• On the device start screen, click the "Test result" button and then under
"Gas metering" read off the "Pipeline supply pressure" value or, in cylinder
operation, the "Cylinder pressure" value.
Result The pressure value displayed on the device may deviate by a maximum
of 0.2 bar from the preset pressure value of the test pressure regulator.
[________OK]

4.4.2 Pipeline supply leak test

Action • Unscrew the HP upgrade kit connections, if present, from the gas supply
block.
• Close the high-pressure cylinder at the test pressure regulator.
Result The pressure indicated on the high-pressure manometer of the test
pressure regulator must not decrease by more than 10 bar within
No.2207_0000007705

2 minutes.
[________OK]
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NOTE
If the value is not within tolerance, select each pipeline supply connection
individually and perform a measurement for each gas type. Eliminate the
leakage and then repeat the test.

4.4.3 O2 Flush flow and button mechanism (yearly)

Action • Press the O2 flush button.
Result The breathing bag inflates. The O2 flush button runs smoothly and does
not snag.
[________OK]

4.4.4 Leakage test on Drägersorb Clic (if fitted)

Test set-up

18579

Fig. 10 "Leak test" setup (example with Drägersorb)

Item Designation
1 AIR supply pressure or O2 supply pressure, P = 3 to 5 bar.
2 Flowmeter 0 to 16 L/minute (2M86553) with connecting port (M06258) or
reducer (7900044 with stepped connector 7910054).
3 Tube length from flowmeter approx. 100 cm (1197851, 6x2.5 Si natural).
4 Retaining clamp (7900469).
5 T-piece (7910093).
6 Tube length approx. 100 cm (1197851, 6x2.5 Si natural)
7 Manometer, digital (7910722).
8 Tube length approx. 50 cm (1197851, 6x2.5 Si natural).
9 Expiratory connector on breathing system.
10 Manual breathing bag connector on breathing system with connecting sleeve
(M13506).
11 Inspiratory connector on breathing system.
- Stopwatch (7911336).

Prerequisites The device is switched on and connected to the pipeline supply.

No.2207_0000007705

The Drägersorb Clic adapter mount has been uncapped.

The APL valve is switched to the "MAN" position and set to maximum pres-
sure.
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Action • Prepare the test setup.

• Using the flowmeter, generate a pressure of 30 mbar at the manometer.
• Close the flowmeter (2) and the retaining clamp (4). Start the electronic
timer.
Result After 15 seconds the pressure drop is less than 15 mbar.
[________OK]

4.4.5 APL valve linearity test (yearly)

Test set-up

3017

Fig. 11 Test setup for "APL valve linearity test"

Item Designation
1 AIR supply pressure or O2 supply pressure, P = 3 to 5 bar
2 Flowmeter 0 to 16 L/minute (2M86553) with connecting port
(M06258) or reducer (7900044 with stepped connector 7910054).
3 Tube length from flowmeter approx. 100 cm (1197851, 6x2.5 Si nat-
ural).
4 T-piece (7910093).
5 Tube length approx. 100 cm (1197851, 6x2.5 Si natural)
6 Manometer, digital (7910722 or equivalent).
7 Tube length approx. 50 cm (1197851, 6x2.5 Si natural).
8 Expiratory connector on breathing system.
9 Manual breathing bag connector on breathing system with connect-
ing sleeve (M13506).
10 Inspiratory connector on breathing system.

Action • Prepare the test setup.

• Using the flowmeter (2), set a flow of 3 L/minute.

NOTE
There are two versions of the APL valve. Note the local version and apply the
corresponding procedure.
No.2207_0000007705

APL valve "1st version"

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25688
Fig. 12 APL valve, 1st version

Action • Adjust the APL valve to the settings in sequence (see following table) and
read off the measured value from the manometer (6).

APL valve settings APL valve target values

10 mbar 0 to 20 mbar
30 mbar 25 to 35 mbar
70 mbar 60 to 80 mbar

APL valve "2nd version"

25689
Fig. 13 APL valve, 2nd version

Action • Adjust the APL valve to the settings in sequence (see following table) and
read off the measured value from the manometer (6).

APL valve settings APL valve target values

10 mbar 0 to 20 mbar
30 mbar 25 to 35 mbar
40 mbar 30 to 50 mbar
70 mbar 60 to 80 mbar

Result The "APL valve setpoint" values are met.

[________OK]
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4.4.6 Fresh gas branch leak test

Test set-up

3014
Fig. 14 "Fresh gas branch leak test" setup

Item Designation
1 AIR supply pressure or O2 supply pressure, P = 3 to 5 bar
2 Flowmeter 0 to 16 L/minute (2M86553) with connecting port (M06258) or
reducer (7900044 with stepped connector 7910054).
3 Tube length from flowmeter block approx. 100 cm (1197851, 6x2.5 Si natu-
ral)
4 Retaining clamp (7900469).
5 T-piece (7910093).
6 Manometer, digital (7910722).
7 Tube length approx. 100 cm (1197851, 6x2.5 Si natural).
8 Port for fresh gas outlet (7911268).
- Stopwatch (7911336).

Action • Remove the breathing system from the "VGC".

• Prepare the test setup. The internal diameter of the tubes should be 6 mm.
• Using the flowmeter (2), generate a test pressure of 200 mbar at the
manometer (6).
• Close the flowmeter (2) and the retaining clamp (4). Start the electronic
timer.
Result After a measurement period of 30 seconds, the decrease in pressure at
the manometer (6) should be less than 50 mbar (100 mbar/minute).
[________OK]

Action • Set the breathing system to "VGC".

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4.4.7 A-cone (if present) (yearly)

Test set-up

2967
Fig. 15 "A-cone" test setup

Item Designation
1 AIR supply pressure or O2 supply pressure, P = 3 to 5 bar
2 Flowmeter 0 to 16 L/minute (2M86553) with connecting port (M06258) or
reducer (7900044 with stepped connector 7910054).
3 Tube length from flowmeter approx. 100 cm (1197851, 6x2.5 Si natural).
4 T-piece (7910093).
5 Tube length approx. 100 cm (1197851, 6x2.5 Si natural)
6 Manometer, digital (7910722).
7 "A-cone" connector with connecting sleeve (M13506).

Prerequisites The device is in "standby" mode.

Action • Disconnect the device from the pipeline supply.
• Press the "A-cone" button to switch the A-cone to "external" and confirm
with the rotary knob.
• Prepare the test setup.
• Using the flowmeter (2), set a flow of "0,2 L/min".
Test The pressure value displayed on the manometer (6) should be greater than
60 mbar.
Action • Using the flowmeter (2), set a flow of "18 L/min".
Test The pressure value displayed on the manometer (6) should be between
65 mbar and 80 mbar.
Result A-cone (if fitted)
[________OK]

Action • Press the "A-cone" button to switch the A-cone to "internal" and confirm
with the rotary knob.
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4.4.8 Final test

Action • Switch the device off and on again (a brief tone sounds on power-up after
approximately 10 seconds).
• Run the device self-test (leakage is less than 100 mL).
Result The device has successfully completed its self-test and is in Standby
mode again.
[________OK]

4.5 Ventilation, interlock function, alarms and monitor

Introduction These instructions describe the following function tests:
– Breathing
– Interlock function
– Acoustic and visual alarms
– Screen backlight, alarm tone and ventilation tone volume

4.5.1 Manual ventilation

Prerequisites The device has been fully assembled ready for use according to the instruc-
tions for use.
The device is supplied with pipeline compressed gases.
The device is fitted with two vaporizers.
The device has successfully completed the self-test and is in "Standby"
mode.
Action • Connect the test lung (7911140) to the Y-piece of the breathing system.
• Switch the device to "Man/Spont" mode.
• Switch the APL valve to "MAN".
• Set the fresh gas flow to 2 L/min.
• Press the O2 flush button until the breathing bag is full.
Result Manual ventilation can be simulated by squeezing the breathing bag.
[________OK]

4.5.2 Spontaneous breathing

Action • Switch the APL valve to "SPONT".
Result Manual spontaneous breathing can be simulated using the test lung
(7911140).
[________OK]

4.5.3 Pressure controlled ventilation (Pressure Mode)

Action • Switch the device to "PCV" mode (as from SW 2.0 "Press. Mode").
No.2207_0000007705

• Set the following parameters:

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Pinsp 20 hPa
Freq 12 /minute
Tinsp 1.7 seconds
TRamp 0.2 seconds
PEEP 0 hPa
O2 60% at 6 L/minute fresh gas setting

• Confirm the setting with the rotary knob.

Action • Press the "next page" key on the device (to select the data screen). The
following parameters are displayed:

PLAT = Plateau pressure

PEEP = Pmin
PEAK = Pmax
O2 = Oxygen

Test The readings are within tolerance (see following table):

Enter parameter Measured value

PLAT 17 to 23 hPa
PEEP -2 to +4 hPa
Pinsp 17 to 23 hPa
O2 60% ±2%
Time in/Time ex 1.6 to 1.8 : 3.2 to 3.4
I:E 1 : 1.8 to 2.1

Action • Detach the sampling line and hold it open to the ambient air for approx. 2
minutes.
Test FiO2 and FeO2 readings are 18% to 24%.
Result Pressure controlled ventilation (Pressure Mode)
[________OK]

4.5.4 Vaporizer interlock function

Prerequisites The device is connected to the AGSS.
The device is fitted with two vaporizers.
Action • Check the interlock function on the vaporizer plug-in system.
Result Only one vaporizer can be operated at a time.
[________OK]

Action • Make sure that both vaporizers are switched off.

4.5.5 Audible and visual alarms

Action • Release the VGC lock and withdraw the VGC plug-in unit from the hous-
ing.
No.2207_0000007705

Result The "Ventilator disconnect" alarm is displayed on the device screen. A

warning tone sounds and the red alarm LED flashes.
[________OK]
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4.5.6 Screen brightness, alarm tone and ventilation tone volume

Prerequisites The device is in "Standby" mode.
Screen brightness
Action • Click the "Monitor Mode" button, then the "Screen Layout" button.
• Use the rotary knob to select the "Brightness" menu and confirm your
selection.
• Use the rotary knob to change the brightness.
• Reset the brightness to the original value and confirm using the rotary
knob.
Test The brightness can be adjusted with the rotary knob.

Alarm tone volume

Action • Click the "Config" button. Use the rotary knob to select the "Alarm tone vol-
ume" window and confirm your selection.
• Use the rotary knob to adjust the alarm tone volume.
• Reset the alarm tone volume to the original value and confirm using the
rotary knob.
Test The alarm tone volume can be adjusted with the rotary knob.

Ventilation tone volume (if installed)

Action • Click the "Config" button. Use the rotary knob to select the "Vent. tone vol-
ume" window and confirm your selection.
• Use the rotary knob to adjust the ventilation tone volume.
• Reset the ventilation tone volume to the original value and confirm using
the rotary knob.
Test The ventilation tone volume can be adjusted with the rotary knob.
Result Screen brightness, alarm tone and ventilation tone volume are change-
able.
[________OK]

Action • Quit the "Standard config." menu with the "Close config." button.

4.6 Options (if present)

Introduction These instructions describe function testing of the options.

4.6.1 Tightening torque of the monitor arm fixing screws

Action • Tighten the two fixing screws (Fig. 16/1) on the monitor arm with a torque
of 12 +1 Nm (7911766).
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2934

Fig. 16 Position of screws

Result The fixing screws for the monitor arms have been tightened with a
torque of 12 Nm +1 Nm.
[________OK]

4.6.2 External O2 flowmeter

Test set-up

18523

Fig. 17 "External O2 Flowmeter" test setup

Item Designation
1 Flowmeter, block of 3 (7901161).
2 Flowmeter tube.
3 Outlet of the external O2 flowmeter.
4 Fine control valve.

Action • Prepare the test setup.

• Connect the device only to the O2 pipeline supply.
• Close the fine control valve of the external O2 flowmeter.
Test The flow readout must not exceed 10 mL/minute.
Action • Set the fine control valve of the external O2 flowmeter tube to 5 L per min-
No.2207_0000007705

ute.
Test The flow reading is 5 ±0.5 L per minute.
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Action • Set the fine control valve of the external O2 flowmeter tube to 10 L per min-
ute.
Test The flow reading is 10 ±1 L per minute.
Action • Slowly close the fine control valve of the O2 flowmeter tube and observe
the float at the same time.
Test The float in the flowmeter moves without catching.
Result External O2 flowmeter
[________OK]

Action • Close the fine control valve of the external O2 flowmeter.

4.6.3 SpO2 measurement

Prerequisites The device has been fully assembled ready for use according to the instruc-
tions for use.
The device is switched on.
The device has successfully completed the self-test and is in "PCV" mode.
Action • Press the "Next page" key on the device to select the data screen.
• On the device, connect the SpO2 sensor with finger clip.
Result The "SpO2" reading is greater than 95%.
[________OK]

Action • Switch the device to "Standby" mode and then switch it off at the main
switch.
• Disconnect the device from the pipeline supply.

4.6.4 Compressed gas cylinders

4.6.4.1 Serial number of O2 compressed gas cylinder

Action • Read off and enter the serial number of the O2 compressed gas cylinder.
Result O2 compressed gas cylinder
[________txt]

4.6.4.2 TÜV O2 compressed gas cylinder (applicable to Germany only)

Action • Read off and enter the date from the compressed gas cylinder label.
Result Date of compressed gas cylinder label
[________txt]

4.6.4.3 O2 use-by date

Action • Read off and enter the use-by date from the compressed gas cylinder
label.
No.2207_0000007705

Result Use-by date

[________txt]
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4.6.4.4 Serial number of N2O compressed gas cylinder

Action • Read off and enter the serial number of the N2O compressed gas cylinder.
Result N2O compressed gas cylinder
[________txt]

4.6.4.5 TÜV N2O compressed gas cylinder (applicable to Germany only)

Action • Read off and enter the date from the compressed gas cylinder label.
Result Date of compressed gas cylinder label
[________txt]

4.6.4.6 N2O use-by date

Action • Read off and enter the use-by date from the compressed gas cylinder
label.
Result Use-by date
[________txt]

4.6.4.7 Pendant head control (for Cicero ceiling version only)

Action • Check the following assemblies:

– Pressure regulators
– Lettering
– HP connecting tubes
– High-pressure measuring device
– Cylinder jackets
– Cylinder cap
– Cylinder holder
– Velcro strap.
Result The compressed gas cylinders are in perfect condition.
[________OK]

4.6.4.8 O2 high-pressure leakage

Prerequisites The device is switched off.

Action • Disconnect the pipeline supply tubing from the gas inlet block.
• Open the O2 compressed gas cylinder valve and allow the pressure to sta-
bilize.
• Close the O2 compressed gas cylinder valve.
• Observe the O2 compressed gas cylinder meter.
Result The pressure loss is maximum 10 bar per minute.
No.2207_0000007705

[________OK]
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4.6.4.9 N2O high-pressure leakage (only in nitrous oxide mode)

Prerequisites The device is switched on.

Action • Open the O2 compressed gas cylinder valve and the N2O compressed gas
cylinder valve.
• Set an O2 flow of 4 L/minute and allow the pressure to stabilize.
• Close the N2O compressed gas cylinder valve.
• Observe the N2O compressed gas cylinder meter.
Result The pressure loss is maximum 10 bar per minute.
[________OK]

Action • Connect the N2O compressed gas cylinder.

• Close the O2 flow control valve.
• Close the O2 compressed gas cylinder valve.

4.7 Gas type

Introduction The following instructions describe the "pipeline supply gas type test" and the
"cylinder inlets gas type test".

4.7.1 Pipeline supply gas type test

NOTE
The "pipeline supply gas type test" only has to be performed after replacing
the sintered-metal filter elements of the gas supply block.

Prerequisites Turn the device off and on again.

The device has passed the self-test and is in "Man/Spont" mode.
The device is only connected to the O2 pipeline supply.

O2 pipeline supply
Test On the device front panel only the O2 pipeline supply indicator is lit steadily
green.
Action • Disconnect the O2 from the pipeline supply and relieve the O2 pressure on
the gas supply block.
Test On the device front panel the O2 pipeline supply indicator goes out.
The pressure indicator shows 0 bar.
A visual and acoustic "No O2" alarm is triggered.

AIR pipeline supply

Action • Connect the device to the O2 pipeline supply and the AIR pipeline supply.
Test On the device front panel the O2 pipeline supply and AIR pipeline supply indi-
cators are lit steadily green.
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Action • Disconnect the AIR from the pipeline supply and relieve the AIR pressure
on the gas supply block.
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Function and condition test

Test On the device front panel the AIR pipeline supply indicator goes out.
The pressure indicator shows 0 bar.
A visual and acoustic "No AIR" alarm is triggered.

N2O pipeline supply (only in nitrous oxide mode)

Action • Connect the device to the AIR and N2O pipeline supply.
Test On the device front panel the O2, AIR and N2O pipeline supply indicators are
lit steadily green.
Action • Disconnect the N2O from the pipeline supply and relieve the N2O pressure
on the gas supply block.
Test On the device front panel the N2O pipeline supply indicator goes out.
The pressure indicator shows 0 bar.
A visual and acoustic "No N2O" alarm is triggered.
Result Gas type test (pipeline supply)
[________OK]

Action • Disconnect the device from the pipeline supply.

4.7.2 Cylinder inlets gas type test

NOTE
The "cylinder inlets gas type test" only has to be performed after one of the
following procedures:
Replacing the sintered-metal filter elements of the gas supply block.
General overhaul of the high pressure regulators.

Prerequisites The device is switched on.

The device has been disconnected from the pipeline supply.
The existing cylinders are connected to the device.
The cylinder valves are closed.
O2 cylinder inlet (if present)
Action • Open the "O2" cylinder.
Test On the device front panel only the O2 cylinder supply indicator is lit steadily
green.
Action • Close the "O2" cylinder.
• Disconnect the O2 cylinder supply from the gas supply block.
Test On the device front panel the O2 cylinder supply indicator goes out.
The pressure indicator shows 0 bar.

AIR cylinder inlet (if present)

Action • Open the "AIR" cylinder.
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Test On the device front panel only the AIR cylinder supply indicator is lit steadily
green.
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Function and condition test

Action • Close the "AIR" cylinder.

• Disconnect the AIR cylinder supply from the gas supply block.
Test On the device front panel the AIR cylinder supply indicator goes out.
The pressure indicator shows 0 bar.

N2O cylinder inlet (if present) (only in nitrous oxide mode)

Action • Open the "N2O" cylinder.
Test On the device front panel only the N2O cylinder supply indicator is lit steadily
green.
Action • Close the "N2O" cylinder.
• Disconnect the N2O cylinder supply from the gas supply block.
Test On the device front panel the N2O cylinder supply indicator goes out.
The pressure indicator shows 0 bar.
Result Gas type test of cylinder inlets
[________OK]

Action • Connect all cylinder supplies to the gas supply block.

• Make sure that all cylinders are closed.
• Switch the device to "Standby" mode and turn it off at the main switch.

4.8 Final action

Prerequisites – The test instructions have been performed as specified.
– All tests performed were passed successfully.
– The device has been switched off to "Standby" by the main switch.
– The device has been disconnected from the pipeline supply.

4.8.1 Device handover

Action • Attach a test label to the device.
Result A test label has been attached to the device.
[________OK]

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

Action • Supply the user/owner with a fully functioning device.

Result The fully functional device has been placed at the user's/owner's dis-
posal.
[________OK]

5 Test equipment

This section sets out the test equipment required for the tests in this test pro-
cedure.

5.1 Test equipment list

5.1.1 Test equipment subject to mandatory calibration

NOTE
Tests must be carried out with tests equipment that is calibrated in the appro-
priate way.

NOTE
Use the following test equipment or equivalent aids.

Designation Part number Remarks

Flowmeter 1, 10 to 120 L/min (O2, AIR) 7900718
(ISO port M25647 required.)

Torque wrench, 6 to 50 Nm 7900909

Barometer 7900217

Torque spanner set, complete; refer to 7900964

calibration instruction 7910934.

Flowmeter, block of 3, measuring range 7901161

0.02 to 15 L/min
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Test equipment

Designation Part number Remarks

Test pressure regulator, DIN connector 7901482
(or 7910342)

Test pressure regulator, PIN index con- 7910342

nector (or 7901482)

Gauge for electric safety "Secutest" 7910594

Manometer, digital, -1 bar to 1 bar 7910722

Manometer, digital, 0 to 20 bar 7910724

Stopwatch 7911336

MiniOx O2 analyzer with sensor. 7911610

Torque wrench, 0 to 5 Nm 7911766

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Test equipment

Designation Part number Remarks

Flowmeter, 0 to 16 L/minute 2M86553

Result Test equipment calibrated in a valid manner used.

[________OK]
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Test equipment

5.1.2 Test equipment not subject to mandatory calibration

NOTE
Use the following test equipment or equivalent aids.

Designation Part number Remarks

Wrench, 3/8 in - No image available.
Corrugated tube, 22 mm x 12 in long - No image available.
Tube 1180703 No image available.
Tube, 6.0 x 2.5 Si nat 1197851 No image available.
Wacker Elastosil E41, adhesive, 1202537
Omnivisc

Loctite 270 1213288

Barrierta I SL/OX, grease, 18 grams 1564706

Silicone tube 4x1.5 (1.2 m) (various sili- 1190520

cone tubes for test setups)

Silicone tube, 7x2.5 (2 cm) (to adapt 1198343

from T-piece 6800187 to bag 6726425)

Bag 6726425

T-piece (socket) 6800187

Reducer 7900044

Retaining clip 7900469

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Test equipment

Designation Part number Remarks

Socket wrench set, 1/4” 7900905

Shorting cable, Nellcor 7901068

Rubber plug 7901297

Fitting 6, G1/4 external 7901435

Gas distributor, DIN 7901495.

Syringe 7901541

Rubber plug 7901665

Loctite 221 7901966

Patient adapter 7910195

Plastic-jaw pliers 7910296

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Test equipment

Designation Part number Remarks

Wrench (two-hole wrench) 7910305

Test gas cylinder Desflurane 7910345

Test gas cylinder pressure regulator 7910346

Test gas cylinder mixed gas 7910349

Test lung 7911140

Calibration adapter 7911176

Probe cable 7911196

Pin-type face wrench set, adjustable 7911784

Test adapter for connecting cable 7911821

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Test equipment

Designation Part number Remarks

Valve crater key 7912205

O2 adapter 8405807

Connecting socket M06258

Connecting sleeve M13506

Tool for valve crater MX08817

5.1.3 Additionally required items

Designation Part number Comments

Test label - No image available.
"AIR" pipeline supply connecting tube As stated in instruc-
"O2" pipeline supply connecting tube tions for use.
"N2O" pipeline supply connecting tube
Breathing tube system
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Result Sheet Test Instructions / Service Card IPM

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Order number: 9500466

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 9.0 + = Spare part used
! = Error / Report
/ = Accessory not available
- = Not applicable

Test Result Test Result

1 Device configuration 3.1.6 Applied part leakage current, mains on applied
part, type BF
1.1 Device configuration
… 3.1.6.1 Reference value —A
1.1.1 Serial numbers of base unit and breathing system
… 3.1.6.2 Recurrent test —A
… 1.1.1.1 Device serial number (if not otherwise record- txt
ed) 3.2 Electrical safety according to IEC 60601-1
… 1.1.1.2 Breathing system cover (if present) txt … 3.2.1 Visual check OK
… 1.1.1.3 Valve plate (8603857) txt … 3.2.2 Protective earth resistance ȍ
… 1.1.1.4 Respiratory gas block (8602804) txt … 3.2.3 Protective earth resistance measuring points OK
1.1.2 Serial numbers – options 3.2.4 Earth leakage current
… 1.1.2.1 Endotracheal suction device (if present) txt … 3.2.4.1 Normal condition (N.C.) —A
… 1.1.2.2 Vacuum suction (if fitted) txt … 3.2.4.2 Single fault condition (S.F.C.) —A
2 Maintenance parts … 3.2.5 Application component for patient leakage cur- OK
rent
2.1 Maintenance parts, yearly
3.2.6 Patient leakage current, optional SpO2
… 2.1.1 Base unit dat
… 3.2.6.1 Normal condition (N.C.) —A
… 2.1.2 Disposable absorber, Drägersorb CLIC (new) (if dat
present) … 3.2.6.2 Single fault condition (S.F.C.) —A
2.2 Maintenance parts, 2-yearly 4 Function and condition test
… 2.2.1 Base unit dat 4.1 Condition
… 2.2.2 Disposable absorber, Drägersorb CLIC (new) (if dat … 4.1.1 Accompanying documents OK
present) … 4.1.2 Base unit OK
2.3 Maintenance parts, 3-yearly 4.2 Uninterruptible power supply UPS
… 2.3.1 Base unit dat … 4.2.1 UPS function OK
… 2.3.2 Disposable absorber, Drägersorb CLIC (new) (if dat 4.3 Patient gas module "PGM"
present)
… 4.3.1 Leak test OK
2.4 Maintenance parts, 4-yearly
… 4.3.2 Plausibility test of PGM values OK
… 2.4.1 Base unit dat
… 4.3.3 PGM alarm response and measured value dis- OK
… 2.4.2 Disposable absorber, Drägersorb CLIC (new) (if dat play
present)
… 4.3.4 Accuracy of the gas measurement in room air OK
… 2.4.3 CLIC Adapter MX50090 (if present) dat and at 100% O2
2.5 Maintenance parts, 6-yearly … 4.3.5 Accuracy of gas measurement with test gas OK
… 2.5.1 Base unit dat … 4.3.6 Monitoring pumping power OK
… 2.5.2 Disposable absorber, Drägersorb CLIC (new) (if dat 4.4 Pneumatic device check
present)
… 4.4.1 Pipeline supply test OK
2.6 Maintenance parts as required
… 4.4.2 Pipeline supply leak test OK
… 2.6.1 Maintenance parts as per instructions for use OK
… 4.4.3 O2 Flush flow and button mechanism (yearly) OK
3 Electrical safety
… 4.4.4 Leakage test on Drägersorb Clic (if fitted) OK
3.1 Electrical safety according to IEC 62353
… 4.4.5 APL valve linearity test (yearly) OK
… 3.1.1 Visual check OK
… 4.4.6 Fresh gas branch leak test OK
3.1.2 Protective earth resistance
… 4.4.7 A-cone (if present) (yearly) OK
… 3.1.2.1 Maximum measured value. ȍ
… 4.4.8 Final test OK
… 3.1.2.2 Maximum measured value of ME system. ȍ
4.5 Ventilation, interlock function, alarms and monitor
… 3.1.3 Protective earth resistance measuring points OK
… 4.5.1 Manual ventilation OK
… 3.1.4 Application component for device leakage cur- OK
… 4.5.2 Spontaneous breathing OK
rent
… 4.5.3 Pressure controlled ventilation (Pressure Mode) OK
3.1.5 Equipment leakage current
… 4.5.4 Vaporizer interlock function OK
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… 3.1.5.1 Reference value —A

… 4.5.5 Audible and visual alarms OK
… 3.1.5.2 Recurrent test —A

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Test Result
… 4.5.6 Screen brightness, alarm tone and ventilation OK
tone volume
4.6 Options (if present)
… 4.6.1 Tightening torque of the monitor arm fixing OK
screws
… 4.6.2 External O2 flowmeter OK
… 4.6.3 SpO2 measurement OK
4.6.4 Compressed gas cylinders
… 4.6.4.1 Serial number of O2 compressed gas cylinder txt
… 4.6.4.2 TÜV O2 compressed gas cylinder (applicable txt
to Germany only)
… 4.6.4.3 O2 use-by date txt
… 4.6.4.4 Serial number of N2O compressed gas cylin- txt
der
… 4.6.4.5 TÜV N2O compressed gas cylinder (applica- txt
ble to Germany only)
… 4.6.4.6 N2O use-by date txt
… 4.6.4.7 Pendant head control (for Cicero ceiling ver- OK
sion only)
… 4.6.4.8 O2 high-pressure leakage OK
… 4.6.4.9 N2O high-pressure leakage (only in nitrous ox- OK
ide mode)
4.7 Gas type
… 4.7.1 Pipeline supply gas type test OK
… 4.7.2 Cylinder inlets gas type test OK
4.8 Final action
4.8.1 Device handover
… 4.8.1.1 A test label has been attached to the device. OK
… 4.8.1.2 The fully functional device has been placed at OK
the user's/owner's disposal.
5 Test equipment
5.1 Test equipment list
… 5.1.1 Test equipment subject to mandatory calibration OK
5.1.2 Test equipment not subject to mandatory calibra-
tion
5.1.3 Additionally required items
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 Manufacturer:

Dräger Medical GmbH

Moislinger Allee 53 – 55
23542 Lübeck
Germany

+49 1805 3723437

FAX +49 451 882 - 3779

http://www.draeger.com

As of 2015-08:
Dräger Medical GmbH
changes to
Drägerwerk AG & Co. KGaA

Subject to change without notice

Will not be replaced in the event of modifications.

© Copyright 2015 by Dräger Medical GmbH, Lübeck, Germany.

Revision 5.0
9036375
5132.700
No.1208_0000007950