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Technical Documentation IPM

Primus
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 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................................................................................................................... 24
5 Mixer......................................................................................................................................... 50
6 VGC.......................................................................................................................................... 64
7 Power supply unit ..................................................................................................................... 96
8 Operating modes ...................................................................................................................... 100
9 Anaesthetic vaporizer (Vapor) .................................................................................................. 102
10 Bronchial suction device........................................................................................................... 103
11 Block diagrams ......................................................................................................................... 108
Maintenance instructions 121
1 General information on use of maintenance instructions ......................................................... 122
2 Safety instructions .................................................................................................................... 123
3 AGSS filter................................................................................................................................ 125
4 Filter of the endotracheal suction system ................................................................................. 127
5 Top rolling seal (VGC) .............................................................................................................. 129
6 Water trap................................................................................................................................. 131
7 O2 sensor (fuel cell) .................................................................................................................. 133
8 Flow sensors ............................................................................................................................ 135
9 Filter mat of patient gas module (PGM).................................................................................... 136
10 Filter mat of power supply unit.................................................................................................. 137
11 Large and small dust filter (VGC) ............................................................................................. 138
12 O-rings in vaporizer plug-in system .......................................................................................... 141
13 Replacing the O-rings for the water trap................................................................................... 142
14 Removing and fitting the rear panel.......................................................................................... 146
15 Nafion tube and bacterial filter (PGM) ...................................................................................... 147
16 Filter mat in the housing cover ................................................................................................. 153
17 Gas inlet sintered-metal filter .................................................................................................... 155
18 PEEP diaphragm, switching diaphragm and O-rings (breathing system)................................. 158
19 Bottom rolling seal with O-ring (VGC) ...................................................................................... 164
20 UPS lead-gel batteries.............................................................................................................. 180
Parts catalog and test instructions 185
1 Parts catalog............................................................................................................................. 186
2 Test Instructions / Service Card IPM ........................................................................................ 342
3 Result Sheet Test instructions / Service Card IPM................................................................... 392
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4 Primus 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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Technical Documentation IPM Primus 5


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

1.4 General safety precautions


No.2310_0000005920

Read through each section thoroughly before beginning servicing. Always


use the correct tools and the specified test equipment. Otherwise the device
may not work correctly or may be damaged.

6 Primus Technical Documentation IPM


General
General notes

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
laws of Germany. Users and technicians in other countries must comply with
their national laws and/or international standards.
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Technical Documentation IPM Primus 7


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8 Primus 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................................................................................................................... 24
5 Mixer......................................................................................................................................... 50
6 VGC.......................................................................................................................................... 64
7 Power supply unit ..................................................................................................................... 96
8 Operating modes ...................................................................................................................... 100
9 Anaesthetic vaporizer (Vapor) .................................................................................................. 102
10 Bronchial suction device........................................................................................................... 103
11 Block diagrams ......................................................................................................................... 108
No.2310_0000005920

Technical Documentation IPM Primus 9


Function descriptions
General

1 General

1.1 Medical purpose


Primus is an anaesthetic workstation for automatic and manual ventilation
and spontaneous breathing, usable for adults, children and infants. For
details see relevant instructions for use.

1.2 Short description of Primus


The following sections provide an overview of the Primus components.

1.2.1 Ventilator
4906

Fig. 1 Ventilator with breathing system

The electronically controlled and driven ventilator features the following


functions:
– Tidal volume from 20 mL (5 mL from software version 4.n) (10 mL from
software version 2.n) to 1400 mL at frequencies from 3/min to 80/min
(100/min from software version 4.n).
– Peak flow up to 150 L/min
– Ventilation modes such as IPPV, PCV, SIMV (plus adjustable trigger, plus
adjustable PEEP) and MAN/SPONT (up to software 1.n).
– 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 absorber, either reusable or disposable.
No.2310_0000005920

– Electronic interfaces for inspiratory and expiratory flow measurement.


– Direct patient section heating is integrated into the valve plate of the
breathing system.

10 Primus Technical Documentation IPM


Function descriptions
General

– Pneumatic interface to ventilator


– Fresh gas isolation and minimized compliance

1.2.3 Mixer (fresh gas dosage) The electronic mixer offers the following features:
– Gas dosage 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
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).
4905

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

– Double vaporizer plug-in system with lock


– Auto Exclusion system
– Optional external A-cone as fresh gas outlet
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Technical Documentation IPM Primus 11


Function descriptions
General

1.2.4 Monitor control panel

4901

Fig. 3 Monitor control panel

The parameters for fresh gas flow control, ventilation, and gas monitoring are
displayed on a 12-inch colour screen.

The following parameters are monitored:


– Airway pressure
– Inspiratory and expiratory flow
– Circle system leakage
– Inspiratory and expiratory O2 concentration
– CO2 and anaesthetic gas measurement
– Anaesthetic gas recognition
– 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.

As from software release 2.n the following settings are possible:


– Free configuration of 3 real-time curves and different numerical values.
– Ventilator presets dependent on body weight (Vt and frequency) and age-
dependent calculation of the minimum alveolar concentration (MAC)
according to "Mapleson" as well as age-dependent scaling of the
volumeter and influence on ventilation monitoring.
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12 Primus Technical Documentation IPM


Function descriptions
General

The safety concept incorporates the following tests:


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

1.2.5 Options Primus is prepared for future upgrading with the following options:
– Integrated SpO2 measurement
– Consumption-free O2 measurement (with software 2.n or higher)
– PAW preview: Display of expected airway pressure curve when changing
parameters.
– Airway and V loops (from software version 2.n)
– Econometer function (from software version 2.n)
– Additional ventilation modes (e.g. Autoflow, CPAP)
– Additional display text languages available

1.3 Primus component structure


4907

Fig. 4 Primus component structure

The "Block diagrams" section includes a "Block diagrams".

1.3.1 NEUTRAL POINT PCB The NEUTRAL POINT PCB connects the components of the Primus to the
power supply, additional signal wires and the CAN bus.

For more information see the following section on "NEUTRAL POINT PCB".

1.3.2 Graphical user interface The GUI comprises the following components:
(GUI) – The monitor/control panel (MoBi) displays the ventilation mode. Limit and
target values are specified and the ventilation and anaesthesia
parameters are displayed.
– S-Box (interface box). PC port and optional measuring functions such as
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SpO2.
– Patient Gas Module (PGM) for measurement of O2, CO2 and anaesthetic
gas.

Technical Documentation IPM Primus 13


Function descriptions
General

For more information see "GUI".

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

For more information see the following section on "Mixer".

1.3.4 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
– The BSE module (option) delivers an acoustic signal for inspiration and
expiration.

For more information see "VGC".

1.3.5 Power supply unit The power supply unit comprises:


– Switched-mode power supply unit
– Uninterruptible power supply (UPS) consisting of two 12 V lead-gel
batteries.
– Battery charge management

For more information see "Power supply unit".

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

No.2310_0000005920

14 Primus Technical Documentation IPM


Function descriptions
NEUTRAL POINT PCB

2 NEUTRAL POINT PCB

The NEUTRAL POINT PCB is the central signal and voltage distributor.

5021

Fig. 5 Position of Neutral Point PCB


5022

Fig. 6 NEUTRAL POINT PCB component layout

Item Connector (to Fig. 6)


1 Monitor Control Panel B (MoBi).
2 Monitor Control Panel A (MoBi).
3 Ventilation and Gas Controller (VGC).
4 Mixer B.
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5 Mixer A.
6 Safety O2 flow valve (microswitch).
7 Power switch (main switch).

Technical Documentation IPM Primus 15


Function descriptions
NEUTRAL POINT PCB

Item Connector (to Fig. 6)


8 Halogen lamp
9 Jack plug (production tests).
10 PGM.
11 Power supply unit A.
12 Power supply unit B.
13 Not assigned.

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16 Primus Technical Documentation IPM


Function descriptions
GUI

3 GUI

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

5028

Fig. 7 GUI block diagram

The "Block diagrams" section includes a "Block diagrams".

The GUI comprises the following components:


– MoBi (monitor/control panel)
– S-Box (interface box)
– Patient Gas Module (PGM), see "Patient gas module".

3.1 Monitor/control panel (MoBi)


5029

Fig. 8 Position of monitor/control panel (MoBi)

The "Block diagrams" section includes a "Block diagrams".

The user and Primus communicate via the MoBi. The MoBi display presents
system information and patient data. It is here that the user sets the
parameters and ventilation modes.
No.2310_0000005920

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

Technical Documentation IPM Primus 17


Function descriptions
GUI

5031

Fig. 9 Exploded view of MoBi

Item Components (to Fig. 9)


1 Front panel with keypad. Includes keypad membrane covering with
design imprint, keys LEDs (e.g. for pipeline supply gases), the car-
rier plate and the shielding, anti-glare glass screen.
2 12-inch colour display (TFT, resolution: 800 x 600).
3 MONITOR/CONTROL PANEL PCB (motherboard).
4 Backlight converter (display backlight).
5 LCD800 PCB (Adapter PCB for connection of different makes of
display).
6 Loudspeaker.
7 Rotary knob.
8 Adjuster (central operator control element).

3.1.1 MONITOR/CONTROL The following software is installed on the PCB:


PANEL 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. The system 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
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– RS232 interface for in-house development purposes


– Serial communication channel for Ethernet

18 Primus Technical Documentation IPM


Function descriptions
GUI

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-
3 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 block is battery-buffered. The buffering is provided primarily by
the UPS batteries of the Primus. If the UPS batteries 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 (power supply unit, mixer and VGC).

3.2 S-Box (new version)


No.2310_0000005920

5033

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

Technical Documentation IPM Primus 19


Function descriptions
GUI

As standard the S-Box includes the externally accessible Medibus ports


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

The S-Box is prepared for conversion to the SpO2 measurement function


(option) – see 3.3.2 SpO2 sampling function (option)).

5043

Fig. 11 S-Box layout

Item Components (to Fig. 11)


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.
5035

Fig. 12 S-Box, block diagram, detailed

3.2.1 BACKPLANE PCB The "Block diagrams" section includes a "Block diagrams".
No.2310_0000005920

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)

20 Primus Technical Documentation IPM


Function descriptions
GUI

– Connection of SpO2 measurement function (option) to 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 or
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.

3.3 S-Box (old version)


5042

Fig. 13 Position of S-Box (device rear panel)


No.2310_0000005920

The "Block diagrams" section includes a "Block diagrams".

Technical Documentation IPM Primus 21


Function descriptions
GUI

5040

Fig. 14 S-Box layout

Item Components (to Fig. 11)


1 Drawer unit components fully mounted
2 BACKPLANE PCB
3 SpO2 ADAPTER PCB (SpO2 PCB not shown)
5039

Fig. 15 S-Box, block diagram

The S-Box as standard includes the BACKPLANE PCB and thus the
externally available Medibus ports (COM 1-3), IV-System (Ethernet for TIVA)
and a CAN port (SABUS exclusively for debug purposes).

The S-Box is prepared for the SpO2 option.

3.3.1 BACKPLANE PCB The BACKPLANE PCB is the base component for additional modules and
the insulated interfaces to external devices.

The "Block diagrams" section includes a "Block diagrams".

The BACKPLANE PCB has the following functions:


– Electrical isolation and level conversion of the three Medibus ports
(RS232)
– Connects the MoBi with the CAN (SABUS) and Ethernet (TCP/IP)
No.2310_0000005920

connectors
– Connects the optional hardware (SPO2, IV-System) to the MoBi (from
software version 1.n).

22 Primus Technical Documentation IPM


Function descriptions
GUI

3.3.2 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 or
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.
No.2310_0000005920

Technical Documentation IPM Primus 23


Function descriptions
Patient gas module

4 Patient gas module

The patient gas module is an integrated component of the GUI function unit
(see "GUI").

There are three versions of the patient gas module:


– PGM
– PGM2
– PGM3

The Block diagrams section includes the "Block diagrams".

Differences between PGM, PGM2 and PGM3:

PGM PGM2 PGM3


Anaesthetic gas mea- IRIA ILCA2
surement
O2 measurement Electrochemical O2 cell SERVOMEX or PATO O2 Electrochemical O2 cell
sensor
O2 measurement elec- AMO O2 PUMP PCB AMO MFM PCB AMO O2 PUMP PCB
tronics
Pump flow 150 mL 200 mL
Flush flow 200 mL 250 mL 200 mL

4.1 Patient gas module PGM


The following diagram shows the position of the PGM with the rear panel
open.

No.2310_0000005920
5047

Fig. 16 Position of patient gas module (PGM)

24 Primus Technical Documentation IPM


Function descriptions
Patient gas module

One component of the PGM is the water trap. The water trap is accessible
from the front (see Fig. 17).

5048

Fig. 17 Water trap position


5049

Fig. 18 Exploded view of PGM


No.2310_0000005920

Item Components (to Fig. 18)


1 Connection board

Technical Documentation IPM Primus 25


Function descriptions
Patient gas module

Item Components (to Fig. 18)


2 IRIA cuvette
3 IRIA = "Infrared Rapidly Identifying Analyzer". Sensor head of
anaesthetic gas analyzer.
4 Bacterial filter.
5 Fan.
6 Water trap.
7 Filter mat.
8 O2 cell (fast O2 analysis).
9 MOPS PCB (electronics).
10 AMO IRIA PCB (anaesthetic gas analysis).
11 AMO O2 PUMP PCB (O2 analysis)
12 Pump.
13 ILCA solenoid valve (room air/sampling gas).
14 AMO FLOW ILCA PCB (actuation and monitoring of valve, pump
and flow values).
15 ILCA component carrier (for items 9 - 14).
16 ILCA solenoid valve (leakage).
17 Plate (Teflon plate).

IRIA is a patient gas analyzer module for N2O, CO2 and the anaesthetic
gases Halothane, Enflurane, Isoflurane, Desflurane and Sevoflurane. The
gas analyzer is able to detect these anaesthetic gases automatically.

The CO2, O2 parameters measured by the PGM and the anaesthetic gas are
shown as a real-time curve.

Some parameters (see instructions for use) are displayed on the GUI as
digital values.

Measurement principle The measurement principle of the IRIA is based on the infrared absorption
method. A heated filament (Fig. 19/1) is the radiation source. The infrared
radiation passes through a filter wheel (Fig. 19/2) which allows through
wavelengths from the broadband infrared radiation in the near (NIR) and mid
(MIR) ranges. Those wavelengths are use to measure CO2/N2O (NIR
approx. 3 µm) and anaesthetic gas (MIR approx. 9 µm).
5050

No.2310_0000005920

Fig. 19 Schematic of the IRIA measurement principle

26 Primus Technical Documentation IPM


Function descriptions
Patient gas module

Item Designation (to Fig. 19)


1 Emitter with filament
2 Filter wheel with 8 filters
3 Cuvette
4 Detector
5 Output signal to evaluation electronics

Function There are a total of 8 filters on the filter wheel:


– 3 filters for the anaesthetic gases
– 2 reference filters for NIR and MIR
– 1 zeroing filter
– 1 filter each for CO2 and N2O

In the beam path downstream of the filter wheel is the cuvette (Fig. 19/3).
There the sampling gas weakens the infrared radiation to a greater or lesser
extent depending on its composition. These signal changes are received by
the detector (Fig. 19/4) and passed on to the evaluation electronics (Fig.
19/5).

From those signals, the associated electronic circuit generates the values for
CO2, N2O and the anaesthetic gases Halothane, Isoflurane, Desflurane and
Sevoflurane.

4.2 Pneumatic assembly (PGM)


The "Block diagrams" section includes a "Block diagrams".
No.2310_0000005920

Technical Documentation IPM Primus 27


Function descriptions
Patient gas module
5051

Fig. 20 Pneumatic assembly diagram of PGM

Item Meaning (to Fig. 20)


1 Goretex membrane (flow 15 mL).
2 Goretex membrane (flow 135 mL).
3 Electrical connection between the ILCA solenoid valve and the AMO Flow ILCA PCB.
IRIA Sensor head of anaesthetic gas analyzer.
Pu Pump 200 mL (DC diaphragm pump).
R1/R2 Restrictors.
P Pressure sensor in the IRIA cuvette.
ΔP Differential pressure sensor.
O2 sensor Electrochemical O2 cell (fast O2 analysis).

Water trap There are two different types of water trap.

If the "WaterLock 2" water trap is installed, see 4.3 "WaterLock 2" water trap.

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


paragraphs.
No.2310_0000005920

The sampling gas flows into the water trap. In the water trap are two Goretex
membranes (Fig. 20/1, 2). The moisture in the sampling gas cannot pass
through the Goretex membranes. This prevents water reaching the IRIA (flow

28 Primus Technical Documentation IPM


Function descriptions
Patient gas module

135 mL/minute). Consequently no water can penetrate the bypass branch


(flow approx. 15 mL/minute) either. An approximately 9 cm long Teflon tube
(Fig. 20/S2) serves as a resistor, and meters the flow in the bypass branch.

When the water in the water container reaches the level of the membranes,
the membranes are obstructed 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. 20/S1). This dries the
gas. The sampling gas then passes on to the ILCA solenoid valve.
Depending on the valve switching state, either the sampling gas or, during
calibration, the room air reaches the IRIA. The sampling gas is routed
through the IRIA cuvette. The sampling gas then passes on to the O2 sensor.

When the device is in Leak Test mode, or the PGM in Standby, the pump (Pu)
is shut off. Whenever the pump is off, the solenoid valve (Fig. 20/V2)
interrupts the gas flow to the system. This does not increase the leakage
value.

The following low-pass filter comprises the restrictor (Fig. 20/R1) and the
volume (Fig. 20/C1).

Dimensioning of R1 – R1 is small enough for the pump not to be placed under additional strain.
– R1 is large enough so that the pump pressure surges occurring in the
IRIA cuvette do not impair the signal-to-noise ratio of the gas sampling.
– The flow is measured by way of the differential pressure of restrictor R1
plus the upstream filter (B). The measuring range is 0 mbar to 350 mbar.
The measured value is also used for pump control.

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

The flow through the pump (Pu) in measuring mode is approx.


150 mL/minute (flush flow approx. 200 mL/minute). 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 tube.
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Technical Documentation IPM Primus 29


Function descriptions
Patient gas module

4.3 "WaterLock 2" water trap


Design

5053

Fig. 21 Water trap

Item Components (to Fig. 21)


1 Water trap
2 Water trap holder (housing for component carrier).
3 Component carrier

Functional principle
5056

Fig. 22 Functional principle

Item Designation (to Fig. 22)


1 PTFE membranes
2 Luer-Lock connection
3 Self-locking filters
No.2310_0000005920

4 Mount and component carrier


5 Flow to sensors (70% of total flow).
6 Flow to pump (30% of total flow).

30 Primus Technical Documentation IPM


Function descriptions
Patient gas module

Item Designation (to Fig. 22)


7 Blue connection (to drain water trap).
8 Reservoir
9 Gas analyzer

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

The sampling gas passes through the "Luer-Lock" connection (Fig. 22/2) into
the water trap.

The condensate in the sampling gas is filtered out by two water-repellant


PTFE diaphragms (Fig. 22/1).

Based on the size of the diaphragms and the downstream self-sealing filters
(Fig. 22/3) a 70/30 flow split is produced.

The filtered condensate is captured in the reservoir (Fig. 22/8).

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.
22/7). When the water trap is in the mount, the "blue connection" is closed off
by a blanking plug.
5057

Fig. 23 Sectional view of the water trap in the mount (seen from above)

If one of the PTFE diaphragms (Fig. 23/1) is permeable to condensate, the


following occurs:
– The downstream self-sealing filter (Fig. 23/2) expands and seals the gas
path to the gas analyzer module (Fig. 23/9).
– At the same time the corresponding self-sealing filter changes its colour
from "white" to "blue".
– The base unit displays an error message.

4.4 Operating modes (PGM)

4.4.1 "Reduced Accuracy" The gas analyzer of the PGM is in so-called "Reduced Accuracy" mode after
mode about 5 minutes. During that time, the measured values are outside the
No.2310_0000005920

specified accuracy. During that time, a calibration of the zero point is carried
out every 2 minutes.

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Function descriptions
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4.4.2 ISO mode (ISO accuracy) Following "Reduced Accuracy" mode the gas analyzer has ISO accuracy.
After a maximum of 30 minutes the switch is made to "Full Accuracy" mode.

4.4.3 Full Accuracy mode After power-up, the IRIA takes around 30 minutes to reach its operating
temperature for maximum accuracy. During this time, a calibration of the zero
point is carried out every 2 hours.

4.4.4 Standby response of The filter wheel in the IRIA and the sampling gas pump are switched off after
Primus approximately 30 minutes. After 90 minutes the emitter and the heater are
shut off. This is done to extend service life and reduce noise.

4.4.5 IRIA calibration The IRIA 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.

4.4.6 Auto-Wake-up function When the Primus 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“. If Primus detects a
respiration phase, alarm monitoring is activated.

4.4.7 O2 sensor The O2 concentration is measured at the tubing system's Y-piece.

The electrochemical O2 sensor is calibrated during the cold start. In


operation, the electrochemical O2 sensor is calibrated automatically every
8 hours. During calibration, the ILCA solenoid valve is switched to room air.

When the zero point of the IRIA is calibrated the plausibility of the
electrochemical O2 sensor signal is checked.

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.

4.5 Electronics (PGM)

4.5.1 MOPS PCB The Block diagrams section includes a "Block diagrams".

"MOPS" stands for "Modular Platform for Sensors". It is a modular concept


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 gas analyzers (for example "ILCA2" and "IRIA")
can be configured for specific user needs using standard components.
No.2310_0000005920

The MOPS PCB calculates the values of the patient parameters and controls
the sensor head signals.

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Function descriptions
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4.5.2 AMO IRIA PCB "AMO" stands for "Adapter MOPS". The PCB has the following tasks:
– Convert digital target values from the MOPS PCB into analog voltages for
the IRIA emitter.
– Generate the IRIA supply voltage.
– Data transfer from the IRIA sensor to the MOPS PCB (data evaluation).

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

4.5.4 AMO FLOW ILCA PCB The AMO FLOW ILCA PCB controls the pump and valves of the PGM. The
PCB is 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 to 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.
– The output stage for valve actuation.
– Service LEDs for the pump voltage, the valves and the supply voltage.
– The temperature-compensated differential pressure sensor for flow
measurement. The sensor offset is corrected with a digital potentiometer.
– Analog electronics for evaluation of 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.

4.6 Patient gas module PGM2


The following illustration shows the position of the PGM2 (device rear panel
open).
No.2310_0000005920

Technical Documentation IPM Primus 33


Function descriptions
Patient gas module

5061

Fig. 24 Position of PGM2

One component of the PGM2 is the water trap. The water trap is accessible
from the front (see Fig. 25).
5048

Fig. 25 Water trap position


No.2310_0000005920

34 Primus Technical Documentation IPM


Function descriptions
Patient gas module

5064

Fig. 26 Exploded view of PGM2

Item Components (to Fig. 26)


1 ILCA2 sensor head
2 Solenoid valve V1
3 Pump (200 mL)
4 Insulating foil
5 MOPS PCB (main processor)
6 PCB mounting frame
7 AMO ILCA2 PCB (anaesthetic gas measurement).
8 AMO Flow ILCA PCB (flow measurement, pump control, and valve
control).
9 AMO MFM PCB (O2 analysis).
10 SERVOMEX or PATO O2 sensor.
11 Filter mat
12 Bacterial filter
No.2310_0000005920

13 Holder for WaterLock (water trap).


14 WaterLock
15 Fan

Technical Documentation IPM Primus 35


Function descriptions
Patient gas module

Item Components (to Fig. 26)


16 Solenoid valve V2
17 Adapter board (connection board).

The PGM2 automatically detects and measures the anaesthetic gases


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 device
displays the warning "AGas mixture".

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

The parameters measured by the PGM2 etCO2, inCO2 etN2O, inN2O, etO2
and inO2 are displayed on the GUI as digital values.

4.6.1 PGM2 with 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. 27) changes
the thermal conductivity of the gas mixture. The change in thermal
conductivity is used to determine the oxygen content.
606

Fig. 27 Oxygen molecules' orientation in a magnetic field

Design The PATO O2 sensor consists of the PATO SA SH PCB and the sensor head.
The assemblies are contained in a housing.
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Function descriptions
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5087

Fig. 28 Block diagram: PATO O2 sensor

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. 29 Structure of the PATO system

Item Components (to Fig. 29)


1 Electromagnets
2 Sensor element
3 Cuvette
4 Electromagnets
No.2310_0000005920

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Function descriptions
Patient gas module

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

608

Fig. 30 PATO sensor element

Item Designation (to Fig. 30)


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

Function The gas mixture to be measured continuously flows through the gas channel.
In the flow cell itself an exchange of the gas mixture occurs only due to
diffusion. At this point there is no active flow.

The heating element in the PATO sensor element heats up the gas mixture.
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.

4.6.2 PGM2 with SERVOMEX


O2 sensor

Measurement principle The SERVOMEX O2 sensor utilizes one principle. Oxygen molecules are
attracted very much more strongly by a magnetic field (paramagnetism). The
molecules of other gases are in some cases even repelled by the magnetic
field (diamagnetism).
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Function descriptions
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SERVOMEX sensor head

5075

Fig. 31 Schematic view of the SERVOMEX O2 sensor

Function Permanent magnets (Fig. 31/7, 12) in the sensor of the oxygen analyzer
provide a symmetrical magnetic field (Fig. 31/11). The magnet field contains
two nitrogen-filled quartz spheres (Fig. 31/9) arranged in the form of
dumbbells at the location of the highest field strength. The dumbbell is
suspended rotating from a taut platinum band. A reel of platinum wire is
wound around the dumbbell as a feedback coil (Fig. 31/10).

When oxygen flows through the measuring cell (Fig. 31/1, 6), the magnetic
field (Fig. 31/11) changes based on the paramagnetic effect of the oxygen
dependent on its concentration. This rotates the quartz spheres (Fig. 31/9) of
the dumbbells out of the magnetic field.

The mirror (Fig. 31/8) on the dumbbell pivot reflects a light beam (Fig. 31/5)
onto a photocell pair (Fig. 31/4). The photocells are connected to an amplifier
(Fig. 31/) of which the output signal supplies the feedback coil (Fig. 31/10) of
the dumbbell. The dumbbell is rotated back by the current in the feedback coil
(10) until the light beam (Fig. 31/5) is illuminating both photocells (Fig. 31/4)
equally by means of the mirror (Fig. 31/8). Then the system is at equilibrium.
The current flowing through the feedback coil (Fig. 31/10) is proportional to
the partial pressure of the oxygen and thus to the oxygen concentration,
No.2310_0000005920

which is indicated on the display instrument (Fig. 31/2).

Technical Documentation IPM Primus 39


Function descriptions
Patient gas module

4.6.3 Pneumatics of the PGM2 The "Block diagrams" section includes a pneumatic assembly diagram for the
PGM2.
5077

Fig. 32 Pneumatic assembly diagram of PGM2

Item Meaning (to Fig. 32)


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.

Water trap There are two different types of water trap.

If the "WaterLock 2" water trap is installed, see 4.3 "WaterLock 2" water trap.

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


No.2310_0000005920

paragraphs.

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Function descriptions
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The sampling gas flows into the water trap. In the water trap are two Goretex
membranes (Fig. 32/1, 2). The moisture in the sampling gas cannot pass
through the Goretex membranes. This prevents water from reaching the
ILCA2 (flow approx. 180 mL/minute). Consequently no water can penetrate
the bypass branch (flow approx. 20 mL/minute) either. An approximately
10 cm long Teflon tube (Fig. 32/S2) serves as a resistor, and meters the flow
in the bypass branch.

When the water in the water container reaches the level of the membranes,
the membranes are obstructed 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. 32/S1). This dries the
gas. The sampling gas then passes on to the ILCA2 solenoid valve (Fig. 32
/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 device is in Leak Test or Standby mode, the pump (Fig. 32/Pu) of
the PGM2 is shut off. Whenever the pump is off, the solenoid valve (Fig.
32/V2) interrupts the gas flow to the system. This does not increase the
leakage value.

The following low-pass filter comprises the restrictor (Fig. 32/R1) and the
volume (C1).

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

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

Pump The flow through the pump (Pu) in measuring mode is approx.
200 mL/minute (flush flow approx. 250 mL/minute). 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 ILCA2 solenoid valve (Fig. 32/V1) is
tested with the pressure sensor (Fig. 32/P, in the sensor head). In this case
the pressure drop via R2 and the filter (Fig. 32/A) must be significantly less
than the minimum pressure drop through the water trap and the sampling gas
tube.

Replacing a flow measurement, the pressure is measured with a differential


pressure sensor (Fig. 32 /ΔP) upstream and downstream of the low pass.
The AMO FLOW ILCA PCB controls the pump with the pressure signal as the
input variable.

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


No.2310_0000005920

calibration is performed periodically. For this, room air is drawn in by the


diaphragm pump through the ILCA2 solenoid valve (Fig. 32/zero calibration
valve) and passed through the sensors. The solenoid valve ILCA2 is
controlled by the AMO Flow ILCA PCB.

Technical Documentation IPM Primus 41


Function descriptions
Patient gas module

Further measures to safeguard measurement accuracy:


– The cuvette is heated so the intensity of the light beam cannot be 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 (Fig. 32/P) is measured and entered as a correction variable
into the system.

4.7 Patient gas module PGM3


The following illustration shows the position of the PGM3 (device rear panel
open).
5082

Fig. 33 Position of PGM3

One component of the PGM3 is the water trap. The water trap is accessible
from the front (see Fig. 34). No.2310_0000005920

42 Primus Technical Documentation IPM


Function descriptions
Patient gas module

5048

Fig. 34 Water trap position


5081

Fig. 35 Exploded view of PGM3

Item Components (to Fig. 35)


1 ILCA2 sensor head
2 Solenoid valve V1
No.2310_0000005920

3 OLC pump (200 mL)


4 MOPS PCB (main processor)

Technical Documentation IPM Primus 43


Function descriptions
Patient gas module

Item Components (to Fig. 35)


5 PCB mounting frame
6 AMO ILCA2 PCB (anaesthetic gas analysis)
7 AMO Flow ILCA PCB (flow measurement, pump control, and valve
control).
8 AMO MFM PCB (O2 analysis)
9 ILCA2 module
10 Fan
11 WaterLock
12 Holder for WaterLock (water trap)
13 Filter mat
14 Electrochemical O2 sensor
15 Bacterial filter
16 Solenoid valve V2/3
17 Adapter board (connection board)

The PGM3 automatically detects and measures the anaesthetic gases


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 formation are shown 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.

4.7.1 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 electro-chemical 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.
No.2310_0000005920

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Function descriptions
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4.7.2 PGM3 pneumatic The "Block diagrams" section includes a "Block diagrams".
assembly
5083

Fig. 36 Pneumatic assembly diagram of PGM3

Item Meaning (to Fig. 35)


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.

Water trap There are two different types of water trap.

If the "WaterLock 2" water trap is installed, see 4.3 "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. The moisture in the sampling gas cannot pass through the
Goretex membranes. This prevents water from reaching the ILCA2 (flow
approx. 180 mL/minute). Consequently no water can penetrate the bypass
branch (flow approx. 20 mL/minute) either. An approximately 9 cm long
No.2310_0000005920

Teflon tube serves as a resistor, and meters the flow in the bypass branch.

Technical Documentation IPM Primus 45


Function descriptions
Patient gas module

When the water in the water container reaches the level of the membranes,
the membranes are obstructed 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. This dries the gas. The
sampling gas then passes on to the ILCA solenoid valve (Fig. 36/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 device is in Leak Test mode, or the PGM3 in Standby, the OLC
pump is switched off. Whenever the OLC pump is off, the solenoid valve (Fig.
36/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 additional strain.
– R1 is large enough so that the pump pressure surges occurring in the
IRIA cuvette do not impair the signal-to-noise ratio of the gas sampling.
– The pressure drop at R1 is measured. The measured value is applied to
control the pump.

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/minute (flush flow approx. 200 mL/minute). 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.

4.8 ILCA2 function (PGM2/PGM3)


ILCA2 is a patient gas analyzer module for N2O, CO2 and the anaesthetic
gases Halothane, Enflurane, Isoflurane, Desflurane and Sevoflurane and for
measurement of anaesthetic gas mixtures. ILCA 2 conforms to the
measurement accuracy specified by ISO standard.

The gas analyzer can automatically detect the anaesthetic in use.

Measurement principle The measurement principle of the ILCA2 module is based on the absorption
of infrared light by the various media (see Fig. 37). The sensor head consists
of a double measuring head with one emitter each which emits a broad
spectrum of infrared light. The light beam falls through a cuvette, as a result
of which the measured gas is likewise drawn in with the aid 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
No.2310_0000005920

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
more light is absorbed and the smaller the sensor signal will be.

46 Primus Technical Documentation IPM


Function descriptions
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11528

Fig. 37 Principle of multi-channel detectors with IR filters

Item Beam path A Beam path B


1 Sensor window Sensor window
2 Infrared light Infrared light
3 Anaesthetic gas detector 3 CO2 detector
4 Reference detector 2 Reference detector 1
5 Beam splitter Beam splitter
6 Anaesthetic gas detector 1 Anaesthetic gas detector 4
7 Sensor chip Sensor chip
8 Infrared filter Infrared filter
9 Anaesthetic gas detector 2 N2O detector

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

The "Block diagrams" section includes a "Block diagrams".

Sensor head The sensor head contains 2 PCBs with the following functions:
– Preamplifier PCB for the two multi-channel detectors.
– Base PCB with emitter activation, temperature control, measurement of
the absolute pressure and a serial EEPROM with the serial number,
No.2310_0000005920

setup and calibration data for operation of the sensor head.

Technical Documentation IPM Primus 47


Function descriptions
Patient gas module

The module rack of the ILCA2 module comprises 4 additional PCBs with the
following functions:
– AMO FLOW ILCA PCB – Control of the diaphragm pump and the zero
calibration solenoid valve. A serial EEPROM stores the required data
such as the serial number, hardware and software update, control
parameters etc.
– AMO ILCA2 PCB: Here the necessary supply voltages are generated and
the data transfer from the ILCA2 sensor to the MOPS PCB is
implemented.
– AMO MFM PCB – This PCB 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 – Mainly supplies the data for processing via a RS232
interface.

4.8.2 MOPS PCB The "Block diagrams" section includes a "Block diagrams".
(PGM2/PGM3)
"MOPS" stands for "Modular Platform for Sensors". It is a modular concept
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.

4.8.3 AMO ILCA2 PCB "AMO" stands for "Adapter MOPS". The PCB has the following tasks:
(PGM2/PGM3) – 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).

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

4.8.5 AMO MFM PCB (PGM2) The PCB has the following task:
– Transfer the O2 sensor data (SERVOMEX) to the MOPS PCB (data
evaluation).
No.2310_0000005920

4.8.6 AMO FLOW ILCA PCB The AMO FLOW ILCA PCB controls the pump and the valves. The PCB is
(PGM2/PGM3) 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.

48 Primus Technical Documentation IPM


Function descriptions
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The AMO FLOW ILCA PCB holds the following components:


– A DC/DC converter generates the pump voltage (2.5 to 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 for valve actuation.
– 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 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.

4.9 Operating modes (PGM2/PGM3)

4.9.1 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.

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

4.9.3 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.

4.9.4 Auto-Wake-up function When the Primus 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“. If a respiration phase is
detected, alarm monitoring is activated.

4.9.5 O2 sensor (PATO/ELCH) The electrochemical O2 sensor (ELCH) or the PATO O2 sensor is calibrated
during the cold start. In operation, the electrochemical O2 sensor is calibrated
automatically every 8 hours. The PATO O2 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 checked. The PATO O2 sensor is
calibrated to 21 % O2.

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.
No.2310_0000005920

Technical Documentation IPM Primus 49


Function descriptions
Mixer

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.

5100

Fig. 38 Mixer position, with open rear panel


5102

Fig. 39 Mixer without hood


No.2310_0000005920

Item Components (to Fig. 39)


1 PRIMUS CPU PCB

50 Primus Technical Documentation IPM


Function descriptions
Mixer

Item Components (to Fig. 39)


2 Gas supply block
3 Mixer block
4 A-cone valve
5 Fresh gas tank
6 MIXER PCB

5103

Fig. 40 Block diagram of fresh gas dosage

Item Component (to Fig. 40)


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 regulators

The item numbers and abbreviations occurring in this section relate to Fig.
40.

On the MoBi (1) the user selects the carrier gas AIR or N2O as well as the
fresh gas flow and the O2 concentration.
No.2310_0000005920

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).

Technical Documentation IPM Primus 51


Function descriptions
Mixer

At the inlet of the fresh gas tank (6) the flow (V) is measured. With the flow
measurement the switching times for the gas inlet valves (7) are 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.

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 is powered from the
mains via its power plug or is powered up in battery mode.

5.1.1 10 VA mode Internal leakage may mean that the O2 concentration in the Primus 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 and the
cylinder supply are read and the status of the gas supply is indicated by
LEDs on the front panel (see 5.3.2 Pressure status of LEDs).

When the Primus 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 operating 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 Block diagrams section includes a "Block diagrams".

The MIXER PCB comprises the following components:


– DC/DC converter (+5 V, +15 V, -15 V, +24 V) with voltage monitoring
– Amplifiers of pressure and temperature sensors
– Valve power switch and monitoring circuits
– Fan actuator and monitor
– Logic component 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
No.2310_0000005920

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.

52 Primus Technical Documentation IPM


Function descriptions
Mixer

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 mode).

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 Block diagrams section includes a "Block diagrams".
PCB
The PRIMUS CPU PCB is based on a 2-processor system (Master and
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)

For data exchange a dual-port RAM is located between the processor


systems. A logic circuit prevents the two processors from simultaneously
writing to one memory cell.

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.

5.3 Gas supply block (AIR, O2 and N2O)


The Block diagrams section includes a "Block diagrams".

On the underside of the gas supply block are the ISO ports for the pipeline
gases (Fig. 41/1) e.g. NIST or DISS and the compressed gas cylinder ports
for N2O and O2 (Fig. 41/2).
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Technical Documentation IPM Primus 53


Function descriptions
Mixer

5104

Fig. 41 Ports for pipeline supply/compressed gas cylinder

Optional outlets for an endotracheal suction device with AIR (Fig. 42/1) and
for an O2 flowmeter (Fig. 42/2) are prepared.
5108

Fig. 42 Optional outlets for AIR (1) and O2 (2)

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 or N2O compressed gas cylinder, as appropriate. 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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54 Primus Technical Documentation IPM


Function descriptions
Mixer

5110

Fig. 43 Detail, gas inlet block

Item Component (to Fig. 43)


1 Pressure regulators (N2O, AIR, O2) regulate the input pressure to
the mixer to 2.3 bar ± 0.1 bar.
2 Sintered-metal 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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Technical Documentation IPM Primus 55


Function descriptions
Mixer

5.3.1 Pneumatic assembly,


gas inlet block

5112

Fig. 44 Pneumatic assembly diagram, gas inlet block

Fig./Item Component (to Fig. 44)


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
PRPO2 Pressure regulator, O2 line
PRPAIR Pressure regulator, AIR line
PRPN2O Pressure regulator, N2O line
PRCO2 Pressure regulator, O2 compressed gas cylinder
PRCN2O Pressure regulator, N2O compressed gas cylinder
1 Gas supply block (complete)
No.2310_0000005920

2 HP ISO port O2 (NIST or DISS)


3 Pipeline supply ISO port O2 (NIST or DISS)
4 Sintered-metal filter in pipeline supply ISO port

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Function descriptions
Mixer

Fig./Item Component (to Fig. 44)


5 Non-return valve, O2 pipeline inlet
6 ISO O2 outlet (optional)
7 ISO AIR outlet (optional)
8 To flush button and safety O2 adjuster
9 To the pipeline supply inlet valves of the flowmeter.

The item numbers and abbreviations occurring in this section relate to Fig.
44.

For the following description the O2 gas path was chosen.

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

By way of the sintered-metal filter (4) the gas passes to the pressure sensor
"PPO2". The relative pressure sensor generates 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 input 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 gas supply for an external endotracheal suction device (7) or an


external O2 flowmeter (6) is provided for.

5.3.2 Pressure status of 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.
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Technical Documentation IPM Primus 57


Function descriptions
Mixer

5116

Fig. 45 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" mode, the LEDs are either green or unlit.

The input condition for the following table is:


– Primus is off, but mains power supply is connected.

LED status, Primus off


Gas feed Pressure value LED status
O2 pipeline sup- p < 2.7 bar Off
ply
p = 2.7 bar Green
AIR CS p < 2.7 bar Off
p = 2.7 bar Green
N2O-CS p < 2.7 bar Off
p = 2.7 bar Green
O2 cylinder p < 20 bar Off
p = 20 bar Green
Pressure sensor not connected Off
AIR cylinder p < 20 bar Off
p = 20 bar Green
Pressure sensor not connected Off
No.2310_0000005920

N2O cylinder p < 10 bar Off


p = 10 bar Green
Pressure sensor not connected Off

58 Primus Technical Documentation IPM


Function descriptions
Mixer

The input condition for the following table is:


– Primus is on. The mixer is in normal mode.

LED status, Primus in


normal mode Gas feed Pressure value LED status
O2 pipeline sup- p < 2.7 bar Off
ply
p = 2.7 bar Green
Pressure sensor error Flashing green
AIR CS p < 2.7 bar Off
p = 2.7 bar Green
Error Flashing
N2O-CS p < 2.7 bar Off
p = 2.7 bar Green
Pressure sensor error Flashing green
O2 cylinder p < 20 bar and O2 pipeline supply Off
pressure = 2.7 bar
p = 20 bar Green
p < 20 bar and O2 pipeline supply Flashing red at 1.4
pressure <2.7 bar to 2.8 Hz
Pressure sensor not connected Off
AIR cylinder p < 10 bar and N2O pipeline sup- Flashing red at 1.4
ply pressure <2.7 bar to 2.8 Hz
p = 10 bar Green
Pressure sensor not connected Off
p < 10 bar and N2O pipeline sup- Off
ply pressure = 2.7 bar
N2O cylinder p < 10 bar and N2O pipeline sup- Off
ply pressure = 2.7 bar
p = 10 bar Green
p < 10 bar and N2O pipeline sup- Flashing red at 1.4
ply pressure <2.7 bar to 2.8 Hz
Pressure sensor not connected Off
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Technical Documentation IPM Primus 59


Function descriptions
Mixer

5.4 Mixer block

5117

Fig. 46 Mixer block

Item Component (to Fig. 46) 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 mea- PDMIX
suring bridge
14 Fresh gas flow valve (proportional valve) VMGS
15 A-cone valve VSWAK
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Function descriptions
Mixer

5.5 Pneumatic system

5118

Fig. 47 Pneumatic assembly diagram, mixer

Item Component/Meaning (to Fig. 47)


1 Gas supply block
2 A-cone valve (optional)
3 Mixer, flow dosage
4 Vaporizer
I to compact breathing system
II to A-cone or breathing system (MV3) changeover valve for airway
pressure measurement
III to A-cone outlet

The Block diagrams section includes a "Block diagrams".

The abbreviations occurring in the following sections relate to Fig. 47 and Fig.
46.

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
No.2310_0000005920

measurement system "RM".

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Function descriptions
Mixer

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/minute, the "VMIX" valves are opened
72 times a minute. The following equation illustrates the TANK filling process
(72 L/minute x 0.25 L = 18 L/minute).

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). If a constant usable "TANK" volume of
0.25 L is used then 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
measurement 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. The fresh gas flow valve
valve) delivers a fresh gas flow of 0.2 to 18 L/minute. The flow measurement at the
fresh gas outlet is used to control 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".

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.


No.2310_0000005920

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

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Function descriptions
Mixer

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/minute +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/minute ±
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 a constant inlet pressure
outlet) (2.3 bar ±0,1 bar) for the flow control and the external O2 outlet VCAUXO2
(see Fig. 48).
5119

Fig. 48 Position of VCAUXO2 (option)

5.5.13 VO2+ (flush button) Mechanical flush button. Output min. 35 L/minute.
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Function descriptions
VGC

6 VGC

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

5140

Fig. 49 Position of VGC

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

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 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 about 10 seconds).
– CAN bus.
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64 Primus Technical Documentation IPM


Function descriptions
VGC

5141

Fig. 50 Exploded view of VGC

Item Components (to Fig. 50)


1 MV4, Pneutronics
2 MV2, calibration and ventilation
3 Electrical connections for inspiratory and expiratory flow sensor
4 Piston cylinder unit (PCU) or piston cylinder unit with heater (optional)
5 VGC POWER PCB
6 BSE PCB
7 PRIMUS CPU PCB
8 Electronics fan
No.2310_0000005920

9 PRIMUS ANALOG PCB (VGC)


10 Bacterial filter

Technical Documentation IPM Primus 65


Function descriptions
VGC

Item Components (to Fig. 50)


11 Non-return valveRV3
12 VGC pneumatic block
13 Interface plate
14 Interface plate fan
15 Light barrier
16 Breathing system heating contacts
17 Cover

6.1 VGC electronics


The "Block diagrams" section includes a "Block diagrams".

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).
– Actuation 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.
– Pump 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 one
vacuum sensor.
– 12-bit A/D converter for the airway pressure sensors and flow sensors.
– Incremental encoder evaluation. Evaluation of direction of rotation,
rotation angle and velocity of the PCU piston 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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66 Primus Technical Documentation IPM


Function descriptions
VGC

6.1.3 BSE PCB

5142

Fig. 51 Position of BSE module in the VGC

The BSE module is located to the right of the VGC housing. The BSE module
is only visible when the VGC is pulled out. The BSE PCB and a separate
loudspeaker deliver an acoustic signal for inspiration and expiration.

The digitized flow signal is generated by the VGC CPU PCB (Fig. 50/7),
passes through the Analog PCB (Fig. 50/9) and reaches the BSE PCB (for
block diagram, see Fig. 52).

Two BSE module variants are available. The variants are identifiable by the
following characteristics:
– BSE module (block diagram, see Fig. 52) without headphone output
socket
– BSE module (block diagram, see Fig. 53) with one headphone output
socket

The following single components are likewise present on the PCB:


– +12 V voltage regulator (option)
– +5 V voltage regulator
– +3.3 V voltage regulator
– Level transformer 24 V/12 V (optional)
– RS232 interface (optional)
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Function descriptions
VGC
5143

Fig. 52 Block diagram of BSE module (without headset socket)

No.2310_0000005920
5145

Fig. 53 Block diagram of BSE module (with headset socket)

68 Primus Technical Documentation IPM


Function descriptions
VGC

By way of the serial interface (Fig. 52 /X5 or Fig. 53/Serial) the digitized flow
signal reaches the processor of the BSE PCB. The processor multiplies the
sound signal at the flow amplitude. The sound signal is stored in a FLASH
PROM.

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


converter. The volume is selected on the Primus "Config" menu and set by
the processor.

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

6.2 Piston cylinder unit (PCU)


5147

Fig. 54 Design of piston cylinder unit

Item Components (to Fig. 54)


1 Ventilation volume dependent on piston position
2 Bottle
3 Rolling seal (loose)
4 Piston
5 Diaphragm (fixed)
6 Piston motor
No.2310_0000005920

7 Perforated disk for incremental encoder


8 Incremental encoder
9 Rubber buffer

Technical Documentation IPM Primus 69


Function descriptions
VGC

Item Components (to Fig. 54)


10 Light barrier
11 Spindle nut
12 Spindle

The items cited in the following text relate to Fig. 54.

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

The spindle (12) is permanently fixed to the piston. The spindle nut (11) is
permanently mounted on the hollow shaft 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 (9) to the drive housing.

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


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

The piston motor (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 (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 (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. From software version 2.n, the piston motor (6) is
additionally switched on as an active brake as soon as the light barrier (10) is
touched. This prevents the spindle (12) sticking at the bottom position.
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Function descriptions
VGC

6.3 VGC pneumatic block

5150

Fig. 55 Exploded view of VGC pneumatic assembly

Item Components (to Fig. 55)


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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Function descriptions
VGC

6.4 VGC pneumatic assembly


The "Block diagrams" section includes a "Block diagrams".

5151

Fig. 56 VGC pneumatic assembly and breathing system

Item Component/Meaning (to Fig. 56)


5 VGC ventilator unit
6 Breathing system
I Fresh gas inlet
II From A-cone valve (if fitted)
E Suction ejector
BF Bacterial filter
BPG Airway pressure gauge (optional, only in connection with
VCAUXO2)
M2 Vacuum pump motor
MV1 PEEP/Pmax valve
MV2 Calibration and vent valve
No.2310_0000005920

MV3 Breathing system or A-cone output switching valve


MV4 PEEP valve/control valve
PAWe Expiratory airway pressure sensor

72 Primus Technical Documentation IPM


Function descriptions
VGC

Item Component/Meaning (to Fig. 56)


Pu Vacuum sensor
R1 Restrictor to smooth pressure peaks
R2 Restrictor to reduce vacuum (when pump "VP" off)
RV3 PCU vacuum non-return valve
V Volume
VP Vacuum pump

The position numbers mentioned in this section refer to Fig. 56.

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 ventilation mode is switched from automatic to MAN/SPONT, the


vacuum pump is shut off. The vacuum is reduced with R2. The non-return
valve RV3 prevents the vacuum in the diaphragm volume from also being
reduced. This considerably speeds up the switch 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.

The airway pressure gauge measures the airway pressure (optional, only in
conjunction with VCAUXO2).
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6.5 Interface plate

5152

Fig. 57 Layout of interface plate measuring points

Item Connection/meaning (to Fig. 57 and Fig. 58)


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"
8 ILCA2 sampling gas return line (optional)
9 Expiratory flow sensor (electric)
10 IRIA sampling gas return line
11 Inspiratory flow sensor (electric)
12 A-cone airway pressure
13 IRIA sampling gas return line
14 Fresh gas
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15 Piston of piston cylinder unit

The following diagram Fig. 58 permits allocation of the measuring


points/connections on the interface plate to the pneumatics diagram.

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5157

Fig. 58 Allocation of measuring points/connections, for previous legend

6.6 Breathing system


There are two different breathing system types. The difference lies in the
design of the APL valve (adjustable pressure-limiting valve, see Fig. 59).
5158

Fig. 59 APL valves, new type (1) and old type (2)
No.2310_0000005920

The old type (Fig. 59/2) has a mechanism to switch between MAN and
SPONT modes. The new type (Fig. 59/1) uses a lockout function.

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This results in different types of breathing system cover (see Breathing


system cover Fig. 60/1). The valve plate (Fig. 60/5) and the breathing system
housing (Fig. 60/6) remain unchanged.

5159

Fig. 60 Overview of the breathing system

Item Components (to Fig. 60)


1 Breathing system cover with fixing screws
2 Valve "RV1"
3 Breathing system heating contacts
4 Valve "RV2" (new design)
5 Valve plate
6 Breathing-system housing
No.2310_0000005920

7 Fixing screws
8 Absorber canister

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Item Components (to Fig. 60)


9 Absorber insert
10 Expiratory flow sensor "Flowe"
11 Breathing bag connector "Bag"
12 Expiratory socket
13 Inspiratory socket with downstream inspiratory flow sensor "Flowi"
14 APL bypass valve "V2"
15 Valve "V1", PEEP diaphragm
16 Expiratory valve "Ve"
17 Inspiratory valve "Vi"
18 "APL" valve, new type
19 "APL" valve, old 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. 50/7) 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-supported ventilation, Pressure Support for
spontaneously breathing patients

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

In the "MAN" switch position, the compact 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" switch 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 allocation of the components to the pneumatics


diagram.
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6.6.1 Breathing system The "Block diagrams" section includes a "Block diagrams".
pneumatic assembly

5157

Fig. 61 Pneumatic assembly breathing system and VGC

Item / Abbrevia- Components (to Fig. 61)


tion
6 Breathing system pneumatic assembly
A CO2 absorbers
AGSS Anaesthetic gas scavenging system
APL APL valve
BAG Breathing bag
BPG Airway pressure gauge (optional, only in connection
with VCAUXO2).
FG Fresh gas opening
FLOWe Expiratory flow sensor
FLOWi Inspiratory flow sensor
PAWe Expiratory pressure sensor
No.2310_0000005920

PCU Piston cylinder unit


Pz Inspiratory pressure sensor
RV1 Fresh gas isolation valve

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Item / Abbrevia- Components (to Fig. 61)


tion
RV2 AGSS non-return valve
V1 PEEP valve
V2 APL bypass valve
Ve Expiratory valve
Vi Inspiratory valve

6.7 Automatic ventilation


A prerequisite for automatic ventilation (IPPV or Volume Mode and
Pressure Mode) is that the patient is supplied with a sufficient amount of
fresh gas.

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.

6.7.1 Inspiration
5160

Fig. 62 Block diagram of mandatory inspiration

The abbreviations occurring in the following text relate to Fig. 62.


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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 breathing
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 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.

Advantage of this method:


– The fresh gas isolation valve "RV1" minimizes the inspiratory compliance
(without CO2 absorber and breathing bag).

6.7.2 Expiration
5161

No.2310_0000005920

Fig. 63 Block diagram of mandatory expiration

The abbreviations mentioned in this section refer to Fig. 63.

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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 CO2 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.

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 CO2 absorber is high as long as the
fresh gas flow is lower than the minute tidal volume "AMV".
– No non-physiological vacuum in the expiration 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.

To reduce the dead space volume of the ventilator, the piston of the VGC is
moved to the top end position 1100 mL.

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


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6.8.1 Inspiration

5162

Fig. 64 Block diagram of manual inspiration

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

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.
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6.8.2 Expiration

5163

Fig. 65 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 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 breathing bag.
– At the same time, fresh gas flows continuously during inspiration and
expiration into the breathing bag.

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. To reduce the dead space
volume of the ventilator, the piston of the PCU is moved to the top end
position. The APL bypass valve "V2" is not actuated.
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6.9.1 Inspiration

5164

Fig. 66 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. 67 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 CO2
absorber.
– At the same time, fresh gas flows into the breathing bag.
– If the pressure in the breathing bag is greater than the opening pressure
of "RV2", the surplus gas mixture flows into the anaesthetic gas
scavenging system AGSS.

6.10 Ventilation modes


As from Primus software version 2.n, the designation of the ventilation modes
for synchronization and pressure support of spontaneously breathing patients
is amended to the following four terms:
– "Volume Mode".
No.2310_0000005920

– "Pressure Mode".
– "Pressure Support Mode"(optional)

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– "Man./Spont Mode".
– "Volume AutoFlow"(optional)

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. 68 Volume-controlled ventilation with constant inspiratory flow

The following parameters determine the breathing cycle (see Fig. 68):
– Frequency 1/freq
– Inspiratory timeTinsp
– Inspiratory flow level
– Inspiration interruption time TIP:Tinsp
– Tidal volumes "VT"
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5167

Fig. 69 Synchronization of volume-controlled ventilation and spontaneous breathing

Synchronization is activated as soon as a value for the trigger sensitivity has


been entered. The message "sync" is displayed on-screen in the ventilation
mode status field.

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

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


(Fig. 69/1) in the pressure curve and in the flow curve (trigger indicator). The
active flow trigger window (Fig. 69/2) corresponds to the last 25 % of the
relevant expiratory time.
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5168

Fig. 70 Synchronization of volume-controlled ventilation and Pressure Support of spontaneous breathing

If, during volume-controlled ventilation, a value is entered for the level of the
pressure support ΔPps, pressure support is activated.

The message PressSupp is displayed on-screen in the ventilation mode


status field.

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

If the patient was being ventilated without synchronization when pressure


support was activated, automatic activation of synchronization is triggered
with the last trigger setting used.

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


with the set value.

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


automatically.
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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. 71 Pressure-controlled ventilation with decelerating flow

Pressure-controlled breathing with fixed pressure limit Pinsp and frequency


1/freq. Synchronization and adjustable pressure support for spontaneous
breath (optional) are switchable.

A continuous flow is applied to the patient during the inspiratory time Tinsp.
The rate of rise of the curve can be preset between the slope rise time
TSlope. The maximum time delay between the controlled ventilated breaths
is set by way of the frequency. To keep the frequency constant in the event of
premature triggering, the time is equalized in the next cycle.

Changes in ventilation compliance and the ventilation parameters will impair


the tidal volume.
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5170

Fig. 72 Synchronization of pressure-controlled ventilation and spontaneous breathing

Synchronization is activated as soon as a trigger value has been entered.

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


field.

The flow trigger sensitivity controls the synchronization.

A breath triggered by the patient is indicated by a continuous line (Fig. 72/1)


in the pressure curve and in the flow curve (trigger indicator). The active flow
trigger window (Fig. 72/2) corresponds to the last 25 % of the relevant
expiratory time.
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5171

Fig. 73 Synchronization of pressure-controlled ventilation and Pressure Support of spontaneous breathing

Activation of pressure support during pressure-controlled ventilation is


triggered by entering a value for the level of pressure support ΔPps. The
message "PressSupp" is displayed on-screen in the ventilation mode status
field.

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

If the patient was being ventilated without synchronization when pressure


support was activated, automatic activation of synchronization is triggered
with the last "Trigger" setting used.

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


with the set value.

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


automatically.
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6.10.3 "Pressure Support "Pressure Support Mode" is an optional ventilation mode which has to be
Mode" activated.

Ventilation mode
Pressure support for spontaneous breathing: Effective in all mechanical
ventilation modes. At the same time, this option is an independent ventila-
tion mode.

The patient's spontaneous breathing attempts are supported by the follow-


ing factors:
– The flow trigger sensitivity controls the synchronization.
– The pressure setting is a characteristic indicator of the pressure sup-
port.

The rate of rise of the curve can be preset with the slope rise time TSlope.

Additionally, an apnoea ventilation can be set by way of the minimum fre-


quency Freqmin.

If the patient is not breathing spontaneously, the ventilator is activated auto-


matically dependent on the preset minimum frequency Freqmin. The sub-
sequent ventilated breath is not a mandatory ventilated breath. The patient
can stop the mandatory ventilated breath at any time by his/her own breath-
ing activity.

No.2310_0000005920
5172

Fig. 74 Spontaneous breathing support

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The sensitivity of the flow trigger and the ΔPps level control the
synchronization of pressure support to spontaneous breathing attempts. The
rate of rise of the curve can be preset with the slope rise time TSlope.

Additionally, the apnoea ventilation can be adjusted via the minimum


frequency 1/freqmin. 1/freqmin controls automatic triggering of the ventilator
if the patient is not breathing spontaneously.Wenn der Patient nicht
spontan atmet, dann steuert 1/freqmin This is not a mandatory ventilated
breath by the ventilator. The patient can stop the breath triggered by the
ventilator at any time by his/her own breathing activity. This breath is not
provided with a trigger indicator.

6.10.4 "Man./Spont Mode"


Ventilation mode
Manual ventilation or supported ventilation and spontaneous breathing

6.10.5 "Volume
AutoFlow"(optional)
5174

Fig. 75 Pressure-supported ventilation with guaranteed tidal volume

"Volume AutoFlow" 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 breath.
No.2310_0000005920

"Volume AutoFlow" combines the advantages of the pressure-controlled and


volume-controlled ventilation modes. The preset tidal volume VT is applied in
a pressure-controlled ventilation mode. The inspiratory pressure adjusts

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automatically to the preset tidal volume, limited by a maximum pressure


PMAX. When ventilation is started with "Volume AutoFlow", the first
mandatory breath is a pressure-controlled one, in order to define the required
pressure level, where it is not already known from a previous ventilation
mode.

Primus automatically adjusts the inspiratory pressure to the changing lung


conditions; this is done in steps of max. ±3 mbar per respiratory cycle.

The tidal volume applied during a respiratory cycle is limited to 130 % of the
preset tidal volume. When volume limitation is active, the inspiratory pressure
of the next mandatory breath is reduced to 75 % of the target pressure,
though limited to max. 15 mbar above the PEEP.

Synchronization with Synchronization is activated by entering a value for the trigger sensitivity. This
ventilation with guaranteed can be defined by way of the "Additional Settings" button.
volume

6.10.6 Switching ventilation On switching to a different ventilation mode, the parameter presets of the
modes previous mode are transferred or derived appropriately.

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


Trigger) are transferred directly.

Switching ventilation Transferring 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 preset fre-
quency Freq.. In this case only the mechanically
applied minute volume is used.

Pressure-supported breaths by the patient are not


taken into consideration.
Automatic ventilation The preset PEEP, ΔPps and the trigger are trans-
modes to Pressure ferred.
Support (optional)
If ΔPps and/or Trigger is set to "OFF", the last val-
ues used are transferred to the pressure support;
otherwise the configured defaults.
Pressure support The preset PEEP, ΔPps and the trigger are trans-
(optional) to automatic ferred.
ventilation modes
The other parameters correspond to the last set-
tings used; otherwise to the configured defaults.

6.10.7 HLM mode HLM mode (HLM = Heart-Lung Machine) enables alarm-free patient
monitoring during extracorporeal oxygenization of the patient by means of a
heart-lung machine.
No.2310_0000005920

The following conditions apply in HLM mode:


– All gas concentrations are measured independently of the respiratory
phase.

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– The CO2 apnoea alarm, the pressure apnoea alarm and the SpO2
monitoring alarms are deactivated.

HLM mode remains active on switching from one ventilation mode to another.
Switching to Standby mode deactivates HLM mode.
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Function descriptions
Power supply unit

7 Power supply unit

This section describes the power supply unit. The power supply unit consists
of the electronics component and two UPS batteries (UPS = uninterruptible
power supply).

5228

Fig. 76 Position of power supply unit

The "Block diagrams" section includes a block diagram for the power supply
unit.

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 power 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 earth connection with a 6.3 mm contact.
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7.2 Power switch

5230

Fig. 77 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 off Applies to:


U1: 24 V, 10 mA Always available. Battery buffered RAM in the
GUI.
U2: 24 V, 10 VA Available as soon as the power Pressure sensors of the pipe-
plug is plugged in or the device is line supply and compressed
switched on. gas cylinders. Pipeline LEDs,
mixer LEDs
U3: 24 V, 1-23 A Present 10 seconds after the Has an OFF-delay of - GUI - mixer - VGC
power switch is switched on approx. 10 s after oper-
U4: 12 V, 1-10 A - IRIA - ILCA - VGC - small
(independent of mains voltage). ation of the power
pneutronic valves.
switch.
U5: 12 V, 10 VA Available as soon as the device is Fan for VGC and mixer.
No.2310_0000005920

switched on.
U6: 12 V, 10 VA Fan for IRIA and optical DIVA.

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

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Function descriptions
Power supply unit

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. 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 by the 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. If the battery voltage is below 20 V the power supply unit cannot be
powered up.

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).
No.2310_0000005920

– 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 error.

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– Date: To determine how long the device was switched off.


– Switch off power supply unit. The power supply unit shuts off 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 command “Horn on” is issued over the CAN bus. 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.

8.1 Cold start


When the Primus 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 following "self-test" the device checks its system components. Any
errors detected are indicated on the display. If no errors occurred, the Primus
switches to Standby mode 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 components are switched off from the central power switch. Only
the charging circuit for the UPS batteries is permanently in operation.

When the Primus 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 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".

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.
No.2310_0000005920

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


a result, anaesthetic gas measurement is possible. This operating mode is
usually activated by the user under the following conditions:

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Function descriptions
Operating modes

– In case of a total system failure. Primus switches to Safety mode.


– Mains power failure or UPS batteries flat.

In this case the control range of the O2 flow is 4 L/minute to 12 L/minute. If


the "safety O2 flow" is activated in normal mode, the display shows a warning.
The mixer electronics additionally limit the fresh gas flow to 3 L/minute. In this
case the fresh gas settings are highlighted in grey (from software version
1.n).

8.5 Alarm system


The Primus 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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Technical Documentation IPM Primus 101


Function descriptions
Anaesthetic vaporizer (Vapor)

9 Anaesthetic vaporizer (Vapor)

The interlock system prevents 2 vaporizers from operating simultaneously.

The active vaporizer enriches the mixed gas with anaesthetic.

There is a detailed description in the relevant instructions for use.

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102 Primus Technical Documentation IPM


Function descriptions
Bronchial suction device

10 Bronchial suction device

10.1 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.

10.2 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).

10.2.1 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.

10.3 Bronchial suction device with ejector


15741

Fig. 78 Front view of the bronchial suction device with ejector

The front panel has the following parts:


– Manometer (Fig. 78/1).
– Rotary knob for setting suction flow (Fig. 78/2).
– Rotary knob for fine adjustment of regulated suction flow (Fig. 78/3).
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The system vacuum is indicated on the control element (manometer).

Technical Documentation IPM Primus 103


Function descriptions
Bronchial suction device

10.3.1 Pneumatic assembly


(ejector)

7036

Fig. 79 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.
79.

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
No.2310_0000005920

event of malfunctions, the non-return valve makes sure no positive pressure


is present in the vacuum system.

104 Primus Technical Documentation IPM


Function descriptions
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.

10.4 Bronchial suction device with vacuum


15742

Fig. 80 Front view of the bronchial suction device with vacuum

The front panel has the following parts:


– Manometer (Fig. 80/1).
– Vacuum regulator (Fig. 80/2).
– Mode switch (Fig. 80/3).

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


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Technical Documentation IPM Primus 105


Function descriptions
Bronchial suction device

10.4.1 Pneumatics (vacuum)

7037

Fig. 81 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.
81.

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.
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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.

106 Primus Technical Documentation IPM


Function descriptions
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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Technical Documentation IPM Primus 107


Function descriptions
Block diagrams

11 Block diagrams

11.1 Introduction
The following block diagrams and the pneumatics diagram form part of the
Primus function description.
5236

Fig. 82 Primus block diagram, detailed

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108 Primus Technical Documentation IPM


Function descriptions
Block diagrams
5238

Fig. 83 MoBi block diagram


5242

Fig. 84 S-Box block diagram (new version), detailed


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Technical Documentation IPM Primus 109


Function descriptions
Block diagrams

5035

Fig. 85 S-Box block diagram (old version), detailed


5051

Fig. 86 PGM pneumatic assembly diagram, detailed


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110 Primus Technical Documentation IPM


Function descriptions
Block diagrams
5077

Fig. 87 PGM2 pneumatic assembly diagram, detailed


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Technical Documentation IPM Primus 111


Function descriptions
Block diagrams
5244

Fig. 88 PGM3 pneumatic assembly diagram, detailed

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112 Primus Technical Documentation IPM


Function descriptions
Block diagrams
5247

Fig. 89 ILCA2 sensor head block diagram


5249
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Fig. 90 MOPS PCB block diagram

Technical Documentation IPM Primus 113


Function descriptions
Block diagrams
5250

Fig. 91 VGC block diagram

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114 Primus Technical Documentation IPM


Function descriptions
Block diagrams
5251

Fig. 92 PRIMUS CPU PCB block diagram (PCB is built-in to mixer and VGC)
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Technical Documentation IPM Primus 115


Function descriptions
Block diagrams
5253

Fig. 93 Mixer PCB block diagram

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116 Primus Technical Documentation IPM


Function descriptions
Block diagrams
5255

Fig. 94 Voltage supply/UPS block diagram


7003

Fig. 95 Primus pneumatic assembly diagram from software version 2.n, see following legend (for changes see
(X))
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Technical Documentation IPM Primus 117


Function descriptions
Block diagrams
7005

Fig. 96 Primus pneumatic assembly diagram to software version 1.6n, see following legend

Item – Short name Component name (Key to Fig. 95 and Fig. 96)
1 Gas inlet block
2 A-cone valve (optional)
3 Mixer
4 Vaporizer plug-in system
5 Ventilator
6 Breathing system
A Absorber
AGSS Anaesthetic gas scavenging system
APL APL valve
BAG Breathing bag
CYLINDER N2O N2O compressed gas cylinder
CYLINDER O2 O2 compressed gas cylinder
E Suction ejector
FG OUTLET Fresh gas outlet
Flowe Expiratory flow sensor
Flowi Inspiratory flow sensor
IRIA IRIA (anaesthetic gas measurement)
PCU Piston cylinder unit
M1 Motor of piston cylinder unit
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M2 Motor PEEP pressure


MV1 PEEP/Pmax valve
MV2 Calibration valve

118 Primus Technical Documentation IPM


Function descriptions
Block diagrams

Item – Short name Component name (Key to Fig. 95 and Fig. 96)
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 central supply line
PIPE N2O N2O pipeline supply
PIPE O2 O2 pipeline supply
PPAIR AIR pipeline supply pressure
PPN2O N2O pipeline supply pressure
PPO2 O2 pipeline supply pressure
PRCN2O Pressure regulator for N2O compressed gas cylinder
PRPAIR Pressure regulator for AIR pipeline supply
PRPN2O Pressure regulator for N2O pipeline supply
PRPO2 Pressure regulator for O2 pipeline supply
PSYS System pressure
Pu Vacuum sensor, current vacuum
Pz Inspiratory airway pressure sensor
R1 Restrictor to smooth pressure peaks
R2 Resistance to reduce vacuum (pump off)
RM Fresh gas measuring path (upstream of TANK)
RMGS Fresh gas measuring path
RV1 Fresh gas isolation non-return valve
RV2 AGSS non-return valve
RV3 PCU Vacuum non-return valve (from software version 2.n).
SAMPLE O2 O2 connection for external O2 flowmeter (optional)
SUCTION SYSTEM Connection for external bronchial suction device (optional)
TANK Fresh gas tank
V Volume
V1 PEEP valve diaphragm
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V2 Auto-Man/Spont-ON/OFF valve
VBAK A-cone safety valve

Technical Documentation IPM Primus 119


Function descriptions
Block diagrams

Item – Short name Component name (Key to Fig. 95 and Fig. 96)
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 flow adjuster
VSWAK A-cone valve
VTANK TANK valve (safety valve)
VU Vacuum valve (-200 mbar).

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120 Primus Technical Documentation IPM


Maintenance instructions

This chapter describes the measures required to maintain the specified


condition of the device.

1 General information on use of maintenance instructions ......................................................... 122


2 Safety instructions .................................................................................................................... 123
3 AGSS filter................................................................................................................................ 125
4 Filter of the endotracheal suction system ................................................................................. 127
5 Top rolling seal (VGC) .............................................................................................................. 129
6 Water trap................................................................................................................................. 131
7 O2 sensor (fuel cell) .................................................................................................................. 133
8 Flow sensors ............................................................................................................................ 135
9 Filter mat of patient gas module (PGM).................................................................................... 136
10 Filter mat of power supply unit.................................................................................................. 137
11 Large and small dust filter (VGC) ............................................................................................. 138
12 O-rings in vaporizer plug-in system .......................................................................................... 141
13 Replacing the O-rings for the water trap................................................................................... 142
14 Removing and fitting the rear panel.......................................................................................... 146
15 Nafion tube and bacterial filter (PGM) ...................................................................................... 147
16 Filter mat in the housing cover ................................................................................................. 153
17 Gas inlet sintered-metal filter .................................................................................................... 155
18 PEEP diaphragm, switching diaphragm and O-rings (breathing system)................................. 158
19 Bottom rolling seal with O-ring (VGC) ...................................................................................... 164
20 UPS lead-gel batteries.............................................................................................................. 180
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Technical Documentation IPM Primus 121


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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122 Primus Technical Documentation IPM


Maintenance instructions
Safety instructions

2 Safety instructions

The anaesthesia workstation may be serviced only by qualified professionals


who:
– have successfully completed a device-specific training;
– have the necessary service equipment;
– have access to the most recent service documentation;
– have access to original Dräger parts (parts catalogue).

Also, when carrying out maintenance refer to the hospital's internal work
safety and hygiene rules and also observe the following safety instructions:

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).
– On the power supply unit push aside the mechanical lock of the
inlet connector for non-heating apparatus. On the power supply
unit pull the inlet connector for non-heating apparatus out of
socket.

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

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

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


electrical safety test.

Technical Documentation IPM Primus 123


Maintenance instructions
Safety instructions

NOTE
Dispose of the exchanged replacement articles in accordance with local
waste disposal regulations.

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124 Primus Technical Documentation IPM


Maintenance instructions
AGSS filter

3 AGSS filter

3.1 Introduction

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

These instructions describe the replacement procedure.

3.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

3.3 Replacing the AGSS filter


The AGSS filter (Fig. 97/3) is a component part of the flowmeter tube.
1. Take the anaesthetic gas scavenging system (AGSS) out of the 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) onto the flowmeter tube.
No.2310_0000005920

6. Fit the container for the buffer volume (Fig. 97/1) onto the AGSS.
7. Place the AGSS into the mount.

Technical Documentation IPM Primus 125


Maintenance instructions
AGSS filter

8. After complete servicing, perform the function test and electrical safety
test according to the test instructions.

The replacement procedure is complete.

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126 Primus Technical Documentation IPM


Maintenance instructions
Filter of the endotracheal suction system

4 Filter of the endotracheal suction system

4.1 Introduction

NOTE
For replacement interval of "filter of the endotracheal suction system", see
instructions for use.

These instructions describe the replacement procedure.

4.2 Preconditions
The following preconditions must be met:
 The bronchial suction device is freely accessible.
 The bronchial suction device is switched off.
 The safety instructions are followed (see "Safety instructions").

4.3 Replacing the filter


1. Remove the filter (see Fig. 98/1).
18290

Fig. 98 Filter when removing


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Technical Documentation IPM Primus 127


Maintenance instructions
Filter of the endotracheal suction system

2. When fitting the new filter pay attention to its orientation. Insert the filter
with the white side (see Fig. 98/1) into the bronchial suction device (the
suction tube is connected to the transparent side of the filter).

18291

Fig. 99 Position of filter when fitting

3. Perform a function test of the bronchial suction device according to the


test instructions.

The replacement procedure is complete.

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128 Primus Technical Documentation IPM


Maintenance instructions
Top rolling seal (VGC)

5 Top rolling seal (VGC)

5.1 Introduction

NOTE
For replacement interval of "top rolling seal" see instructions for use.

These instructions describe the replacement procedure.

5.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

5.3 Replacing top bag rolling seal


1. Unlock the VGC and remove it from the Primus.
2. Loosen the three fixing screws for the breathing system and remove the
breathing system from the VGC.

CAUTION
Risk of blocking the motor spindle!
If you press too heavily on the piston in the following procedure the motor
spindle may lock in the bottom end position.
– Do not apply too much force on the piston when performing the next
step. This is to avoid that the motor spindle gets stuck in the lower limit
position.
– As of software version 2.01, the piston is moved to the bottom position.
With this software version there is no need to press the piston down
manually.
3. If the piston is at the upper position, the top bag rolling seal cannot be
inserted. In this case carefully push the piston down by hand. As far as
possible, apply force to the middle of the piston (see Fig. 100).
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5301

Fig. 100 Upper piston position

Technical Documentation IPM Primus 129


Maintenance instructions
Top rolling seal (VGC)

4. Replace the top bag rolling seal.


5. Fit the VGC in the reverse order of its removal.
6. After complete servicing, perform the function test and electrical safety
test according to the test instructions.

The replacement procedure is complete.

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130 Primus Technical Documentation IPM


Maintenance instructions
Water trap

6 Water trap

6.1 Introduction

NOTE
For replacement interval of "water trap" see instructions for use.

These instructions describe how to replace the water trap (type:


WaterLock2®).

6.2 Preconditions
The following preconditions must be met for replacement:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

6.3 Replacing the water trap


1. Unlock the water trap (Fig. 101/1) and take it out of the mount (Fig.
101/2).
14942

Fig. 101 Example: Water trap in mount

CAUTION
Risk of corrupted measurement results due to silicone spray!
Silicone could penetrate into the sensors and corrupt the measurement
results.
Do not apply any silicone spray onto the O-rings of the water trap mount.
2. Take the new water trap out of its packaging.

NOTE
No.2310_0000005920

Write the replacement date on the rear of the water trap.


3. Hold the water trap by the grooved surfaces and slide it into the mount.
The new water trap must engage perceptibly.

Technical Documentation IPM Primus 131


Maintenance instructions
Water trap

CAUTION
Risk of particle contamination of the device!
Without a water trap, there is a risk of contaminating the device with ambient
air particles.
Start up the device only with a water trap.
4. After complete servicing, perform the function test and electrical safety
test according to the test instructions.

The replacement is complete.

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132 Primus Technical Documentation IPM


Maintenance instructions
O2 sensor (fuel cell)

7 O2 sensor (fuel cell)

7.1 Introduction

NOTE
For replacement interval of "O2 sensor (fuel cell)" see instructions for use.

These instructions describe the replacement procedure. Replacement of O2


sensor does not apply to consumption-free O2 measurement (optional).

7.2 Preconditions
The following preconditions must be met for replacement:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

7.3 Replacing the O2 sensor


The O2 sensor is located on the rear of the device.
1. Unscrew the screw (Fig. 102/1).
5271

Fig. 102 Position of screw (1) and O2 sensor (2)

2. Remove the spent O2 sensor (Fig. 102/2) from the screw and insert the
new O2 sensor into the screw.
3. Screw the screw in.

NOTE
The spent O2 sensor is special waste.
Dispose of the spent O2 sensor in accordance with local waste disposal
No.2310_0000005920

regulations. Spent O2 sensors can be returned to Dräger Medical.

Technical Documentation IPM Primus 133


Maintenance instructions
O2 sensor (fuel cell)

4. After complete servicing, perform the function test and electrical safety
test according to the test instructions.

The replacement is complete.

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134 Primus Technical Documentation IPM


Maintenance instructions
Flow sensors

8 Flow sensors

8.1 Introduction

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

These instructions describe how to replace the two flow sensors.

8.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

8.3 Replacing the flow sensors


The flow sensors are located in the device's breathing system.
1. Remove the inspiratory port and the expiratory port (Fig. 103/1).
5272

Fig. 103 Position of ports (1) and flow sensors (2)

2. Remove the spent flow sensors (Fig. 103/2) from the breathing system
and insert the new flow sensors in the breathing system.

NOTE
The spent flow sensors are classed as special waste.
Dispose of spent flow sensors in accordance with local waste disposal
regulations, as infectious special waste.
3. Fit the inspiratory port and the expiratory port.
4. After complete servicing, perform the function test and electrical safety
test according to the test instructions.
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The replacement procedure is complete.

Technical Documentation IPM Primus 135


Maintenance instructions
Filter mat of patient gas module (PGM)

9 Filter mat of patient gas module (PGM)

9.1 Introduction

NOTE
For replacement interval of "patient gas module filter mat" see instructions
for use.

These instructions describe the replacement procedure.

9.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

9.3 Replacing the filter mat


1. Remove the filter mat on the rear of the PGM (see Fig. 104) and replace it
with a new filter mat.
5290

Fig. 104 Position of filter mat

2. After complete servicing, perform the function test and electrical safety
test according to the test instructions.

The replacement procedure is complete.


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136 Primus Technical Documentation IPM


Maintenance instructions
Filter mat of power supply unit

10 Filter mat of power supply unit

10.1 Introduction

NOTE
For replacement interval of "power supply unit filter mat" see instructions for
use.

These instructions describe the replacement procedure.

10.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

10.3 Replacing the filter mat


1. Remove the two filter cover screws (see Fig. 105) on the rear of the
power supply unit.
5291

Fig. 105 Position of screws

2. Replace the filter mat.


3. Fit the filter cover in the reverse order of its removal.
4. After complete servicing, perform the function test and electrical safety
test according to the test instructions.

The replacement is complete.


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Technical Documentation IPM Primus 137


Maintenance instructions
Large and small dust filter (VGC)

11 Large and small dust filter (VGC)

11.1 Introduction

NOTE
For interval for cleaning or replacing "large and small dust filter (VGC)" see
instructions for use or test instructions.

These instructions describe the procedures for cleaning or replacement.

11.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

11.3 Replacing the large dust filter


Removal 1. Unlock the VGC and pull it out of the device as far as possible.

NOTE
The mount of the large dust filter is held in place at five points (see Fig. 106).
The filter mount is located under the VGC.
5296

Fig. 106 Position of five attachment points in VGC (example)

CAUTION
Risk of damage to filter mount if fitted incorrectly!
If the filter mount is fitted incorrectly its plastic tabs may snap off.
In the following procedures release the plastic tabs of the filter mount with
care.
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Maintenance instructions
Large and small dust filter (VGC)

2. Press on a corner of the filter mount under the VGC to release the filter
mount (see Fig. 107).

5297

Fig. 107 Position of filter mount

3. Carefully release the remaining plastic tabs of the filter mount (see Fig.
108).
5298

Fig. 108 Filter mount with large dust filter

4. Remove the dust filter from the filter mount.


5. Insert the cleaned dust filter (yearly) or the new dust filter (every 3 years)
into the filter mount.

Fitting 6. First clip the filter mount in towards the device body.
7. Fit the filter mount fully in the reverse order of its removal.
8. After installation, check that the filter mount is fully contacting the
housing.
9. Do not yet slot the VGC back into the device. Continue with
11.4 Replacing the small dust filter.
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Maintenance instructions
Large and small dust filter (VGC)

11.4 Replacing the small dust filter


Removal 1. Remove the four screws from the cover plate on the side of the VGC
housing (see Fig. 109).

5299

Fig. 109 Screws on cover plate

2. Set the cover plate down safely.


3. Take out the dust filter (see Fig. 110).
5300

Fig. 110 VGC, small dust filter

4. Insert the cleaned dust filter (yearly) or the new dust filter (every 3 years)
into the housing.

Fitting 5. Fit the cover plate in the reverse order of its removal.
6. After fitting, check that the cover plate is fully contacting the housing.
7. Check that the VGC can be slotted back into the housing and locked in
place without problem.
8. After complete servicing, perform the function test and electrical safety
test according to the test instructions.

The replacement procedure is complete.


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Maintenance instructions
O-rings in vaporizer plug-in system

12 O-rings in vaporizer plug-in system

12.1 Introduction

NOTE
For replacement interval of "vaporizer plug-in system O-rings" see
instructions for use.

These instructions describe the replacement procedure.

12.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

12.3 Replacing the O-rings


Removal 1. Remove the relevant vaporizer from the plug-in system.
2. Use a suitable tool to remove the old O-rings (Fig. 111/1).
4878

Fig. 111 Position of O-rings (example)

NOTE
Dispose of the old O-rings in accordance with local waste disposal
regulations.

Fitting 3. Fit the new O-rings (Fig. 111/1) on the vaporizer plug-in system.
4. Mount the respective vaporizer on the plug-in system.
5. After complete servicing, perform the function test and electrical safety
test according to the test instructions.

The replacement procedure is complete.


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Technical Documentation IPM Primus 141


Maintenance instructions
Replacing the O-rings for the water trap

13 Replacing the O-rings for the water trap

Introduction These maintenance instructions describe how to replace the O-rings in the
holder of the "WaterLock 2" (and "Infinity ID WaterLock 2") water trap.

NOTE
The test instructions contain information on the replacement intervals for the
O-rings and for the water trap itself.

13.1 Preconditions
The following preconditions must be met for replacement:
– The device is switched off.
– The water trap has been removed from the mount.
– The water trap holder is freely accessible.
– One of the following lubricants is available to grease the O-rings:
– "BARRIERTA 1-SL/OX" (material number 1564706)
– "OXIGENOEX S4 RoHS" (material number 1554123)

13.2 Procedure
1. Remove the three old O-rings (Fig. 112/1-2) as follows:
14941

Fig. 112 O-ring position (example)

NOTE
The procedure described here presents an example for replacement of the
O-rings.
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Maintenance instructions
Replacing the O-rings for the water trap

a) At the faulty O-ring, feed the tip of an angled pair of pincers (Fig.
113/1) between the sealing ring and socket.

23137

Fig. 113 Angled pincers at O-ring

b) Lift off the old O-rings.

NOTE
The tool cited in the following step is used to close off the sockets
temporarily. The tool prevents lubricant from penetrating into the inside of
the device through the open sockets (Fig. 112/1) for example.
2. Make a tool as shown from an approximately 0.8 mm thick length of wire.
Refer to Fig. 114.
23132

Fig. 114 Bent-wire tool

3. Coat the new O-rings lightly with lubricant grease.


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Maintenance instructions
Replacing the O-rings for the water trap

NOTE
A cotton-wool bud (Fig. 115/1) to hold the O-ring will help in applying a small
but adequate amount of grease.

23205

Fig. 115 Greased O-ring on cotton-wool bud

NOTE
In the following step pay attention to the different types of O-ring (Fig. 112/1
and Fig. 112/2).
4. Install the three new O-rings in the reverse order of the old ones' removal
as follows:
a) Close off the larger sockets with the wire tool. See Fig. 115/2.
b) Strip down the greased O-rings with the angled pincers to the tip of
the sealed socket. See Fig. 116/1.
23222

Fig. 116 Stripping O-ring down to sealed socket

NOTE
A PE tube (e.g. material number 1194925) size 2.7x0.65 mm will help push
on the new O-rings.
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Maintenance instructions
Replacing the O-rings for the water trap

c) Slot the O-rings into the recess in the socket with a tube for example.
See Fig. 117/1.

23211

Fig. 117 Pushing on an O-ring with a tube

5. After mounting the O-rings:


a) Clean surplus grease from the sockets and the water trap holder.
b) Remove the wire tool from the closed-off sockets.
6. Insert the water trap.
7. Check the device's function according to the test instructions.

The replacement is complete.


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Technical Documentation IPM Primus 145


Maintenance instructions
Removing and fitting the rear panel

14 Removing and fitting the rear panel

14.1 Introduction
These instructions describe how to remove and fit the rear panel.

14.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

14.3 Rear panel


Removal 1. Remove the five screws from the rear panel (see Fig. 118).
5418

Fig. 118 Fixing screws on the rear panel of the device

2. Remove the rear panel from the device and place it down safely.

Fitting 3. Re-assemble using the reverse (logical) sequence of that used for
disassembly.
4. Check that all screws are tightened securely.
5. Check that the rear panel has been fitted with no mechanical strain.
6. Perform the function test and electrical safety test according to the test
instructions.

The removal/fitting procedure is complete.


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146 Primus Technical Documentation IPM


Maintenance instructions
Nafion tube and bacterial filter (PGM)

15 Nafion tube and bacterial filter (PGM)

15.1 Introduction

NOTE
For replacement interval of "Nafion tube and bacterial filter (PGM)" see
instructions for use.

These instructions describe the replacement procedure.

15.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").
 The rear panel has been removed (see "Removing and fitting the rear
panel").

15.3 Removing the PGM


1. Remove the two screws on the PGM (see Fig. 119).
6346

Fig. 119 Position of screws

2. Lift the PGM slightly and take it out of the housing.


3. Place the PGM on an anti-static surface.
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Maintenance instructions
Nafion tube and bacterial filter (PGM)

4. Remove the three screws (see Fig. 120).

5278

Fig. 120 Position of screws

5. Remove the four screws (see Fig. 121).


5281

Fig. 121 Position of screws on side panel

6. Slide the top cover aside to the left (see Fig. 122).
5283

Fig. 122 Top cover


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Maintenance instructions
Nafion tube and bacterial filter (PGM)

7. Detach the top cover and place it next to the housing. Tilt the side panel
slightly (Fig. 123/1) and place the adapter board (Fig. 123/2) next to the
housing.

5284

Fig. 123 PGM housing, open

8. Continue with 15.4 Replacing bacterial filter.

15.4 Replacing bacterial filter


1. Remove the bacterial filter (Fig. 124/1) and replace it with the new one.
Make sure the orientation of the bacterial filter is correct!

NOTE
The white silicone tube (to the bacterial filter) can be reused, provided that it
is neither cracked nor dirty.
5285

Fig. 124 Bacterial filter

2. Continue with 15.5 Replacing the Nafion tube.


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Maintenance instructions
Nafion tube and bacterial filter (PGM)

15.5 Replacing the Nafion tube

NOTE
If the surface of the Nafion tube is contaminated by particles or condensate,
the dryer function will be severely impaired.
Always use gloves when replacing the Nafion tube.
5286 1. Remove the old Nafion tube (Fig. 125) and replace it with the new one.

Fig. 125 Nafion tube connections

2. Continue with 15.6 Fitting the PGM.

15.6 Fitting the PGM


1. Fit the PGM housing in the reverse order of its removal, as described
under 15.3 Removing the PGM.
Make sure the following conditions are met when carrying out the work:
– All electrical connections are attached.
– All tubes are connected and laid without kinking.
– All components in the PGM are firmly screwed in place.
– The housing interlocks on both sides fit into each other (see Fig.
126/1).
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Maintenance instructions
Nafion tube and bacterial filter (PGM)

– The Teflon plate (Fig. 126/2) is fitted.

5287

Fig. 126 Housing interlocks (one side) and insulating foil

2. Mount the top cover, lift slightly at the rear (see Fig. 127), and slide it
completely over the housing.
5288

Fig. 127 Fitting the cover

3. Lift the PGM slightly and insert it into the housing.


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Maintenance instructions
Nafion tube and bacterial filter (PGM)

4. Secure the PGM by two screws (see Fig. 128).

6346

Fig. 128 Position of screws

5. Fit the rear panel (see instructions: "Removing and fitting the rear panel").
6. After complete servicing, perform the function test and electrical safety
test according to the test instructions.

The replacement procedure is complete.

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152 Primus Technical Documentation IPM


Maintenance instructions
Filter mat in the housing cover

16 Filter mat in the housing cover

16.1 Introduction

NOTE
For cleaning and replacement intervals for the "filter mat in the housing
cover" see instructions for use.

These instructions describe the procedures for cleaning and replacement.

16.2 Preconditions
The following preconditions must be met for replacement:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

16.3 Cleaning or replacing filter mat in housing cover


Removing the housing 1. Remove the four screws on the housing cover (see Fig. 129).
cover
5292

Fig. 129 Position of screws on housing cover

2. On the rear of the device loosen the three screws (see Fig. 130) about
four turns.
5293

Fig. 130 Position of screws on device rear


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Maintenance instructions
Filter mat in the housing cover

3. Raise the housing cover at the rear just enough to push it forward away
from the device (see Fig. 131).

5294

Fig. 131 Removing the housing cover

4. Place the housing cover safely aside.


5. Clean or replace the filter mat (see Fig. 132).
5295

Fig. 132 Position of filter mat

Fitting the housing cover 6. Fit the housing cover in the reverse order of its removal.
7. Check that the housing cover is mounted horizontally on the housing.
8. Check that all screws are present and tightened securely.
9. After complete servicing, perform the function test and electrical safety
test according to the test instructions.

The cleaning or replacement procedure is complete.


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154 Primus Technical Documentation IPM


Maintenance instructions
Gas inlet sintered-metal filter

17 Gas inlet sintered-metal filter

17.1 Introduction

NOTE
For replacement interval of "gas inlet sintered-metal filters" see instructions
for use.

These instructions describe the replacement procedure.

17.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 All compressed gas supply tubes have been removed from the device.
 The safety instructions are followed (see "Safety instructions").

17.3 Replacing the sintered-metal filters


On the underside of the gas inlet are the NIST connections (Fig. 133/1) of the
pipeline supply gases and of the N2O and O2 compressed gas cylinders (Fig.
133/2).
5104

Fig. 133 Position of connections on gas inlet (looking from below)

Removal The steps can be carried out with the mixer fitted.

In the following procedure of the sintered-metal filter in the Nist connection for
O2 is replaced by way of example. The procedure applies likewise to the
other NIST connections.

WARNING
Danger to life!
Risk of mixing up NIST connections.
– Never remove all NIST connections simultaneously.
No.2310_0000005920

– Replace only the sintered-metal filter of the NIST connection which


is currently removed. Then refit the NIST connection concerned,
etc.

Technical Documentation IPM Primus 155


Maintenance instructions
Gas inlet sintered-metal filter

1. Remove the two screws from the NIST O2 connection.


2. Unscrew the sintered-metal filter from the NIST O2 connection (see Fig.
134).

5363

Fig. 134 Removing the sintered-metal filter

Fitting 3. Screw in the new sintered-metal filter into the NIST connection hand-
tight.
4. Check that the O-ring in the NIST connection is undamaged and replace
the O-ring as necessary.
5. Fit the NIST connection by two screws. Make sure the O-ring is not
trapped. The marking on the fitted NIST connection (see Fig. 135) must
be readable for the user.
6. Replace the other sintered-metal filters one after the other.
7. Check that the marking on the gas inlet block matches the marking on the
installed NIST connections (see Fig. 135). The marking also applies to
the cylinder connections for N2O and O2 on the second line.
5365

Fig. 135 NIST and cylinder connection markings

WARNING
No.2310_0000005920

Danger to life!
Risk of mixing up NIST connections.
Always perform the leak test and gas type test after carrying out work
on the gas inlet!

156 Primus Technical Documentation IPM


Maintenance instructions
Gas inlet sintered-metal filter

8. After complete servicing, perform the electrical safety test, the function
test, the leak test and the gas type test according to the test instructions.

The maintenance procedure is complete.


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Technical Documentation IPM Primus 157


Maintenance instructions
PEEP diaphragm, switching diaphragm and O-rings (breathing system)

18 PEEP diaphragm, switching diaphragm and O-rings (breathing system)

18.1 Introduction

NOTE
For replacement intervals of the "PEEP diaphragm, MAN/SPONT switching
diaphragm and O-rings (breathing system)", see the instructions for use.

These instructions describe the replacement procedure and the subsequent


function test.

18.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 The safety instructions are followed (see "Safety instructions").

18.2.1 Test equipment required The following test equipment must be available:
 1 x connector for endotracheal tubes (7 mm stainless steel), fitted in the
test lung
 1 x test lung (8403201), comprising: Face mask elbow, 7 mm catheter
connector and manual breathing bag
 1 x microbial filter (6733895) (set of 5)

18.3 Replacing the diaphragms


1. Unlock the VGC and remove it from the device.
2. Disconnect the absorber canister from the breathing system.
3. Loosen the five screws on the breathing system cover (see Fig. 136).
5369

Fig. 136 Screws in the breathing system cover

4. Remove the breathing system cover and place it on a suitable surface.


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Maintenance instructions
PEEP diaphragm, switching diaphragm and O-rings (breathing system)

NOTE
Underneath the valve block (Fig. 137/1) are the diaphragm sets of the PEEP
valve V1 (Fig. 137/2) and the MAN/SPON switching valve V2 (Fig. 137/3).

5366

Fig. 137 Valve block (1)

5. Turn the valve plate round and remove the four valve block screws (see
Fig. 138).
5367

Fig. 138 Position of screws

6. Replace the following components:


– the diaphragm assembly of the PEEP valve V1 (Fig. 139/1),
– the two O-rings (Fig. 139/2),
– the diaphragm set of the MAN-SPON switching valve V2 (Fig. 139/3).
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Technical Documentation IPM Primus 159


Maintenance instructions
PEEP diaphragm, switching diaphragm and O-rings (breathing system)

NOTE
When assembling, make sure the two O-rings, the metal ring of valve V1
(Fig. 139/1) and the spring of valve V2 (Fig. 139/3) are in place!

5368

Fig. 139 Position V1 (1), the two O-rings (2) and V2 (3)

7. Fit the valve block (see Fig. 138) by four screws. After fitting the valve
block, valves V1 and V2 must be moveable by fingers. The spring effect
of V2 must be perceptible.
8. Refit the breathing system and the VGC in the reverse order of their
removal.
9. Set up the device and perform the power-on self-test on it.

If the power-on self-test was passed, continue with 18.4 Test procedure after
replacing the PEEP diaphragms.

18.4 Test procedure after replacing the PEEP diaphragms

18.4.1 Fault description – PEEP After replacing the "PEEP diaphragm", in some isolated cases (in ventilation
valve in conjunction with a preset PEEP pressure) "valve sticking" or "noise" may
occur.

"Valve sticking" may be caused by too much friction between the disk (Fig.
140/4) and the guide pin (Fig. 140/1).

"Noise" may be caused by too little friction between the disk (Fig. 140/4) and
guide pin (Fig. 140/1).

An optimally fitted valve is in-between these assembly states, and is identified


by checking the ventilation patterns.
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Maintenance instructions
PEEP diaphragm, switching diaphragm and O-rings (breathing system)

19389

Fig. 140 Exploded view of valve plate

Item Component Item Component


(to Fig. 140)
1 Guide pin. 5 Sealing washer.
2 Diaphragm cover. 6 Diaphragm.
3 Bushing 7 Control pressure chamber.
4 Disk. 8 Valve plate.

Continue with 18.4.2 "Valve sticking" test condition.

18.4.2 "Valve sticking" test Procedure:


condition 1. Detach the manual breathing bag with the tube from the socket.
2. Connect the test lung (8403201, comprising: face mask elbow, 7 mm
catheter connector and manual breathing bag) by the Y-piece.
3. Insert a microbial filter in the expiratory ventilation channel.
4. On the device, under "Configuration / Parameter settings / Curve scaling /
Flow" adjust the flow scale accordingly (e.g. to 30 L/min or to "auto").
5. Set the following parameters on the device:

Pressure Controls
Fresh gas = 0.2 L/minute
O2 = 21%
Frequency = 12 (1/minute)
Tinsp. = 1.0 /seconds
PEEP = 10 mbar
Pinsp. = 30 mbar

6. Assess the ventilation curve displayed on the device according to the


following two criteria:

Assessment criteria for "no During expiration, the Paw curve (Fig. 141/1) runs virtually horizontally at the
sticking" PEEP level (10 mbar).
(GOOD criterion) No expiratory flow (Fig. 141/2) after 1/2 to a maximum of 2/3 of the expiration
No.2310_0000005920

time.

Technical Documentation IPM Primus 161


Maintenance instructions
PEEP diaphragm, switching diaphragm and O-rings (breathing system)

19394

Fig. 141 "Pressure Control" ventilation curve without "valve sticking"

If there is no "valve sticking", proceed with 18.4.4 "Noise" test condition.

Assessment criteria for The expiratory flow (Fig. 142/1) does not fall steeply (sharp kink) or is
"valve sticking" (BAD present until about two thirds of the expiration time has elapsed or until the
criterion) end of the expiration time.
Both criteria may also occur in the check.
25294

Fig. 142 "Pressure Control" ventilation curve with "valve sticking"

If "valve sticking" is occurring, proceed with 18.4.3 "Valve sticking" remedy.

18.4.3 "Valve sticking" remedy 1. Remove the diaphragm again and turn it 90 degrees (repeatedly as
required).
2. If there are deposits on the guide pin or the disk, the components must be
thoroughly cleaned. It may also be necessary to replace the disk.

If "valve sticking" is no longer occurring, proceed with 18.4.4 "Noise" test


condition.

18.4.4 "Noise" test condition Procedure:


No.2310_0000005920

1. Insert microbial filters in the expiratory and inspiratory ventilation


channels between the ventilation tube and sockets.

162 Primus Technical Documentation IPM


Maintenance instructions
PEEP diaphragm, switching diaphragm and O-rings (breathing system)

Setting on the device 2. Set the following parameters on the device:

Pressure Controls
Fresh gas = 0.2 L/minute
O2 = 21%
Frequency = 12 (1/minute)
Tinsp. = 1.0 seconds
PEEP = 20 mbar
Pinsp. = 40 mbar

3. Assess the ventilation curve according to the following criterion:

"Noise" assessment At the beginning of expiration the valve starts to oscillate, which causes
criterion noise. The oscillation (Fig. 143/1) is clearly visible on the flow curve.
19396

Fig. 143 "Pressure Control" ventilation curve with PEEP oscillation

If there is no "noise", proceed with 18.4.6 Final test.

If "noise" is occurring, proceed with 18.4.5 "Noise" remedy.

18.4.5 "Noise" remedy 1. Remove the diaphragm again and turn it 90 degrees (repeatedly as
required).
2. Then replace the diaphragm again as necessary.

If "noise" is no longer occurring, proceed with 18.4.6 Final test.

18.4.6 Final test 1. Following a complete servicing as per the test instructions, perform the
function test.

The replacement procedure is complete.


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Technical Documentation IPM Primus 163


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

19 Bottom rolling seal with O-ring (VGC)

19.1 Introduction

NOTE
For replacement interval of "bottom rolling seal" see instructions for use.

These instructions describe the replacement procedure.

19.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device is switched off.
 The device has been disconnected from the central gas supply and the
compressed gas cylinders.
 The safety instructions are followed (see "Safety instructions").

19.3 Removing the VGC


1. Unlock the VGC and pull it out of the device as far as possible.
2. Loosen the three fixing screws for the breathing system and remove the
breathing system from the VGC.

CAUTION
Risk of blocking the motor spindle!
If you press too heavily on the piston in the following procedure the motor
spindle may lock in the bottom end position.
– Do not apply too much force on the piston when performing the next
step. This is to avoid that the motor spindle gets stuck in the lower limit
position.
– As of software version 2.01, the piston is moved to the bottom position.
Therefore, it is no longer necessary to push down the piston when
opening the VGC.
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Maintenance instructions
Bottom rolling seal with O-ring (VGC)

3. If the piston of the piston cylinder unit (PCU) is still at the upper position,
carefully push it down to the lower position by hand (see Fig. 144). This
will help to fit the top bag rolling seal later.

5303

Fig. 144 Position of top bag rolling seal

4. Take the bag top rolling seal out of the VGC (see Fig. 144).
The piston of the PCU is located under the top bag rolling seal.
5. Remove the four chain box cover fixing screws (see Fig. 145 ).
5304

Fig. 145 Chain box cover screws


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Technical Documentation IPM Primus 165


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

6. Unplug the three pneumatic connectors and the two electrical connectors
(see Fig. 146).

5305

Fig. 146 Position of connections

7. Loosen the two chain box fixing screws just enough so that the washers
do not fall down (see Fig. 147 and Fig. 148)
5306

Fig. 147 Position of screws


5307

Fig. 148 Position of lock washers

CAUTION
Possible damage to chain box!
If the running rails of the VGC in front of the chain box are removed, the
No.2310_0000005920

chain box will be damaged.


Remove the chain box before the running rails of the VGC are detached.

166 Primus Technical Documentation IPM


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

8. Loosen the screw (Fig. 149/1) on the right side running rail of the VGC
one quarter turn. Otherwise the screw will scrape on the rail. Remove the
two screws (Fig. 149/2).

5308

Fig. 149 VGC, removing right side running rail

9. Loosen the fixing screw (Fig. 150/1) on the left side running rail of the
VGC one quarter turn. Otherwise the screw will scrape on the rail.
Remove the two screws (Fig. 150/2).
5309

Fig. 150 VGC, removing left side running rail

10. Withdraw the VGC from the housing such that it can be lifted out
subsequently. The VGC housing is secured by four screws to prevent it
from falling down.
11. Remove the six screws from the VGC (see Fig. 151).
5310

Fig. 151 VGC, removing fixing screws


No.2310_0000005920

12. Remount the breathing system on the VGC and secure it by the three
screws.

Technical Documentation IPM Primus 167


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

13. Lift the VGC together with the breathing system (total weight approx.
15 kg) vertically out of the VGC housing (see Fig. 152).

5311

Fig. 152 Taking VGC out of housing

14. Place the VGC on a static-dissipative mat.

CAUTION
Electrostatic discharge!
Electrostatic discharge may damage electrostatic sensitive devices.
When handling electrostatic sensitive devices, use an anti-static mat and
wrist strap.
15. Loosen the three screws on the breathing system and remove the
breathing system from the VGC.
16. Continue with 19.4 Removing the piston cylinder unit (PCU).

19.4 Removing the piston cylinder unit (PCU)

CAUTION
Possible damage to the perforated disk of the incremental encoder (PCU)!
The perforated disk of the incremental encoder is deformed even by slight
mechanical pressure (for position see Fig. 153).
Exercise great care when reaching into the opening above the perforated
disk.
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Maintenance instructions
Bottom rolling seal with O-ring (VGC)

5313

Fig. 153 VGC, position of incremental encoder perforated disk

1. Place the VGC upside down on the static-dissipative mat.


2. Remove the screw of the PCB unit (see Fig. 154).
5315

Fig. 154 Position of PCB unit screw

3. Swivel the PCB unit aside to the left.


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Technical Documentation IPM Primus 169


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

4. On the PRIMUS ANALOG PCB unplug the three electrical connectors to


the PCU (see Fig. 155).

5316

Fig. 155 Position of connections to PCU

5. Remove the four PCU screws (see Fig. 156 and Fig. 157).
5317

Fig. 156 PCU, position of screws (1)


No.2310_0000005920
5318

Fig. 157 PCU, position of screws (2)

6. Place the motor section of the PCU upside down on a suitable surface.

170 Primus Technical Documentation IPM


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

7. Continue with 19.5 Removing/installing the bottom rolling seal.

19.5 Removing/installing the bottom rolling seal


1. Remove the three screws from the cylinder of the bag rolling seal (see
Fig. 158).

5319

Fig. 158 Position of screws on cylinder

2. Lift the cylinder out of the PCU (see Fig. 159).


5320

Fig. 159 PCU, removing cylinder


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Technical Documentation IPM Primus 171


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

The bottom rolling seal (subsequently referred to as the rolling seal for short)
is attached to the cylinder by the snap ring (Fig. 160/A) and the O-ring (Fig.
160/B).

5321

Fig. 160 Position of snap ring (A) and O-ring (B)

3. Remove the snap ring and the O-ring (see Fig. 161 and Fig. 162).
5322

Fig. 161 PCU, removing the snap ring


No.2310_0000005920
5323

Fig. 162 PCU, removing the O-ring

172 Primus Technical Documentation IPM


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

CAUTION
Faulty rolling seal due to incorrect installation!
The rolling seal can be installed the wrong way round. If it is, however, a
wide bulge occurs under the snap ring (see Fig. 163).
To avoid errors, follow the instructions precisely (as from 4.) and compare
the illustrations against the result achieved.

5324

Fig. 163 PCU, incorrect installation of the rolling seal

4. Fold the new rolling seal over the cylinder such that a narrow bulge is
created under the snap ring groove (see Fig. 164).
5328

Fig. 164 PCU, folding rolling seal correctly

5. Insert the snap ring into the groove of the rolling seal (see Fig. 165).
5329

Fig. 165 PCU, mounting rolling seal snap ring


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Technical Documentation IPM Primus 173


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

NOTE
The old O-ring (part number G603379) for fixing the bottom rolling seal can
become porous due to UV light.
Fit the new O-ring (part number 8604831). This O-ring is resistant to UV
light.
6. Fit the rolling seal O-ring (see Fig. 166) The O-ring must be seated firmly
5323 in the groove.

Fig. 166 PCU, installing the rolling seal O-ring

7. Continue with 19.6 Fitting the piston cylinder unit (PCU).

19.6 Fitting the piston cylinder unit (PCU)


1. Place the cylinder into the PCU.

NOTE
Possible leakage during RV2 leak test!
To avoid leakage, secure the three screws (see Fig. 158) with silicone
adhesive at the screw seats when fitting.

No.2310_0000005920

174 Primus Technical Documentation IPM


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

2. Secure the three screws (see Fig. 158) with silicone adhesive at the
screw seats and then tighten them.

5319

Fig. 167 Position of screws on cylinder

3. Check that the end of the rolling seal is correctly seated in the guide
groove (see Fig. 168).
5330

Fig. 168 PCU, rolling seal end


No.2310_0000005920

Technical Documentation IPM Primus 175


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

4. Place the motor section of the PCU upside down on the lower PCU
section (see Fig. 169).

5331

Fig. 169 PCU, Mounting PCU motor section

5. The gap between the motor section of the PCU and the lower PCU
section must be uniform. If the gap is not uniform, check carefully whether
the rolling seal is seated unevenly in the guide groove (see Fig. 170).
Correct the position of the rolling seal as necessary (see Fig. 168).
5332

Fig. 170 PCU, checking the rolling seal position

6. Tighten the four PCU screws.


No.2310_0000005920

176 Primus Technical Documentation IPM


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

7. Insert the PCU cables and the pneumatic tube into the cable holders (see
Fig. 171).

5333

Fig. 171 VGC, cable guide 1

8. Connect the three PCU cables to the PRIMUS ANALOG PCB (see Fig.
172).
5316

Fig. 172 PRIMUS ANALOG PCB, connections to the PCU

9. Lift the PCB unit. Make sure no tubes are bent or cables trapped as you
do so.
No.2310_0000005920

Technical Documentation IPM Primus 177


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

10. Tighten the screw of the PCB unit (see Fig. 173).

5315

Fig. 173 Position of screw

11. Push the PCU cables into the holders according to the labelling on the
cylinder (see Fig. 174).
5334

Fig. 174 VGC, cable guide 2

12. Fit the VGC in the reverse order of its removal (see 19.3 Removing the
VGC).
13. Connect the device to the central gas supply and the compressed gas
No.2310_0000005920

cylinders.

178 Primus Technical Documentation IPM


Maintenance instructions
Bottom rolling seal with O-ring (VGC)

14. After complete servicing, perform the function test and electrical safety
test according to the test instructions.

The replacement procedure is complete.


No.2310_0000005920

Technical Documentation IPM Primus 179


Maintenance instructions
UPS lead-gel batteries

20 UPS lead-gel batteries

20.1 Introduction

NOTE
For replacement interval of "UPS lead-gel batteries" see instructions for use.

These instructions describe the replacement procedure. In the following the


"UPS lead-gel batteries" are designated as just "batteries" for short.

20.2 Preconditions
The following preconditions must be met:
 The device is freely accessible.
 The device has been switched off and the mains power has been cut.
 The safety instructions are followed (see "Safety instructions").

20.3 Removing the power supply unit


1. Disconnect the compressed gas supply tubes as necessary.
2. Remove the four screws from the power supply unit (see Fig. 175).
5370

Fig. 175 Position of screws on power supply unit


No.2310_0000005920

3. Move the top of the power supply unit out a little.

180 Primus Technical Documentation IPM


Maintenance instructions
UPS lead-gel batteries

4. Unplug the four connectors (temperature sensor (Fig. 176/1), supply


voltages (Fig. 176/2), batteries (Fig. 176/3), protective conductor (Fig.
176/4)).

5371

Fig. 176 Position of connectors on power supply unit

5. Take out the power supply unit and place it on a suitable base surface.
6. Continue with 20.4 Removing the batteries.

20.4 Removing the batteries


The retaining strap for the two batteries is attached by a Velcro strip (see Fig.
177).
5372

Fig. 177 Position of Velcro strip on retaining strap

In order to illustrate the required procedure, the following images show a


removed holder with batteries.
No.2310_0000005920

Technical Documentation IPM Primus 181


Maintenance instructions
UPS lead-gel batteries

1. Do not fully detach the retaining strap (see Fig. 178).

5373

Fig. 178 Retaining strap, partially detached

CAUTION
Risk of injury if batteries are removed incorrectly!
The two batteries weigh about 13 kg. The batteries may slip out of place and
knock into each other.
When removing, lift both batteries simultaneously and take them out
together.
2. Take out the two batteries.
3. Dispose of the used batteries in accordance with local regulations.
4. Continue with 20.5 Installing the batteries.

No.2310_0000005920

182 Primus Technical Documentation IPM


Maintenance instructions
UPS lead-gel batteries

20.5 Installing the batteries


1. Interconnect the two new batteries electrically (see Fig. 179).

5374

Fig. 179 Positive and negative battery terminals

2. Hold the retaining strap upwards (see Fig. 180). Push the batteries all the
way into the holder until they lock in place.
5373

Fig. 180 Lifting the retaining strap


No.2310_0000005920

Technical Documentation IPM Primus 183


Maintenance instructions
UPS lead-gel batteries

3. Tighten the retaining strap and secure it with the Velcro strip (see Fig.
181).

5375

Fig. 181 Fitting the retaining strap

4. Continue with 20.6 Fitting the power supply unit.

20.6 Fitting the power supply unit


1. Fit the power supply unit in the reverse order of its removal (see
20.3 Removing the power supply unit).

CAUTION
Risk of cable damage if the power supply unit is not installed correctly!
If the power supply unit is not installed correctly cables will be trapped and
damaged.
Pay attention to the cable routing when installing the power supply unit.
2. After complete servicing, perform the function test and electrical safety
test according to the test instructions.
3. Inform the user that the "batteries" have been replaced. Fully charge the
"UPS lead-gel batteries" according to the instructions for use.

The replacement procedure is complete.


No.2310_0000005920

184 Primus Technical Documentation IPM


Parts catalog and test instructions

Parts catalog

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

Test Instructions

This chapter contains the measures required to determine the actual


condition of the device.

1 Parts catalog............................................................................................................................. 186


2 Test Instructions / Service Card IPM ........................................................................................ 342
3 Result Sheet Test instructions / Service Card IPM................................................................... 392
No.2310_0000005920

Technical Documentation IPM Primus 185


Parts catalog and test instructions
Parts catalog

1 Parts catalog

No.2310_0000005920

186 Primus Technical Documentation IPM


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Primus

3009

Warning
Revision 8.0
All servicing and/or test procedures on the 9500302
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

Important notes 4
1 Device configuration 4
1.1 Device configuration ................................................................................................................ 5
1.1.1 Serial numbers of base unit and breathing system.................................................... 5
1.1.2 Serial numbers – options ........................................................................................... 5
2 Maintenance parts 5
2.1 Maintenance parts, yearly........................................................................................................ 6
2.1.1 Base unit.................................................................................................................... 6
2.1.2 Disposable absorber, Drägersorb CLIC (new) (if present)......................................... 6
2.1.3 Disposable absorber, Drägersorb CLIC (old) (if present) .......................................... 6
2.2 Maintenance parts, 2-yearly..................................................................................................... 7
2.2.1 Base unit.................................................................................................................... 7
2.2.2 Disposable absorber, Drägersorb CLIC (new) (if present)......................................... 8
2.2.3 Disposable absorber, Drägersorb CLIC (old) (if present) .......................................... 8
2.3 Maintenance parts, 3-yearly..................................................................................................... 8
2.3.1 Base unit.................................................................................................................... 8
2.3.2 Disposable absorber, Drägersorb CLIC (new) (if present)......................................... 9
2.3.3 Disposable absorber, Drägersorb CLIC (old) (if present) .......................................... 9
2.4 Maintenance parts, 4-yearly..................................................................................................... 9
2.4.1 Base unit.................................................................................................................... 10
2.4.2 Disposable absorber, Drägersorb CLIC (new) (if present)......................................... 10
2.4.3 Disposable absorber, Drägersorb CLIC (old) (if present) .......................................... 10
2.4.4 CLIC Adapter MX50090 (if present)........................................................................... 11
2.5 Maintenance parts, 6-yearly..................................................................................................... 11
2.5.1 Base unit.................................................................................................................... 11
2.5.2 Disposable absorber, Drägersorb CLIC (new) (if present)......................................... 12
2.5.3 Disposable absorber, Drägersorb CLIC (old) (if present) .......................................... 12
2.6 Maintenance parts as required ................................................................................................ 13
2.6.1 Maintenance parts as per instructions for use ........................................................... 13
3 Electrical safety 13
3.1 Electrical safety according to IEC 62353 ................................................................................. 13
3.1.1 Visual check............................................................................................................... 14
3.1.2 Protective earth resistance ........................................................................................ 15
3.1.3 Protective earth resistance measuring points............................................................ 16
3.1.4 Application component for device leakage current .................................................... 16
3.1.5 Equipment leakage current........................................................................................ 16
3.1.6 Applied part leakage current, mains on applied part, type BF ................................... 17
3.2 Electrical safety according to IEC 60601-1 .............................................................................. 18
3.2.1 Visual check............................................................................................................... 19
3.2.2 Protective earth resistance ........................................................................................ 20
No.1709_0000007693

3.2.3 Protective earth resistance measuring points............................................................ 20


3.2.4 Earth leakage current ................................................................................................ 21
3.2.5 Application component for patient leakage current.................................................... 22
No.2310_0000005920

3.2.6 Patient leakage current, optional "SpO2" .................................................................. 22

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4 Function and condition test 23


4.1 Condition.................................................................................................................................. 23
4.1.1 Accompanying documents ........................................................................................ 23
4.1.2 Base unit ................................................................................................................... 23
4.2 Uninterruptible power supply "UPS" ........................................................................................ 24
4.2.1 UPS function ............................................................................................................. 24
4.3 Patient gas module "PGM" ...................................................................................................... 24
4.3.1 Leak test.................................................................................................................... 25
4.3.2 Plausibility test of PGM values .................................................................................. 25
4.3.3 PGM alarm response and measured value display................................................... 26
4.3.4 Accuracy of the gas measurement in room air and at 100% O2 ............................... 26
4.3.5 Accuracy of gas measurement with test gas ............................................................. 26
4.3.6 Monitoring pumping power ........................................................................................ 29
4.4 Pneumatic device check .......................................................................................................... 29
4.4.1 Pipeline supply test ................................................................................................... 29
4.4.2 Pipeline supply leak test............................................................................................ 30
4.4.3 O2 Flush flow and button mechanism (yearly) .......................................................... 30
4.4.4 Leakage test on Drägersorb Clic (if fitted)................................................................. 31
4.4.5 APL valve linearity test (yearly) ................................................................................. 32
4.4.6 Fresh gas branch leak test ........................................................................................ 34
4.4.7 A-cone (if present) (yearly) ........................................................................................ 35
4.4.8 Final test.................................................................................................................... 36
4.5 Ventilation, interlock function, alarms and monitor .................................................................. 36
4.5.1 Manual ventilation ..................................................................................................... 36
4.5.2 Spontaneous breathing ............................................................................................. 36
4.5.3 Pressure controlled ventilation (Pressure Mode) ...................................................... 36
4.5.4 Vaporizer interlock function ....................................................................................... 37
4.5.5 Audible and visual alarms.......................................................................................... 37
4.5.6 Screen brightness, alarm tone and ventilation tone volume...................................... 38
4.6 Options (if present) .................................................................................................................. 38
4.6.1 Tightening torque of the monitor arm fixing screws ................................................... 38
4.6.2 External O2 flowmeter............................................................................................... 39
4.6.3 SpO2 measurement .................................................................................................. 40
4.7 Gas type .................................................................................................................................. 40
4.7.1 Pipeline supply gas type test..................................................................................... 40
4.7.2 Cylinder inlets gas type test ...................................................................................... 41
4.8 Final action .............................................................................................................................. 42
4.8.1 Device handover ....................................................................................................... 42
5 Test equipment 43
5.1 Test equipment list ................................................................................................................... 43
5.1.1 Test equipment subject to mandatory calibration ...................................................... 43
5.1.2 Test equipment not subject to mandatory calibration ................................................ 45
5.1.3 Additionally required items ........................................................................................ 49
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Device configuration

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 1.0.
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 versions earlier than 2.0:
International: Man./Spont = France: Man./Spont.
International: IPPV mode = France: VC
International: PCV mode = France: VPC
Country-specific ventilation mode terms in software version 2.0 or higher:
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)
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.

1 Device configuration
No.1709_0000007693

This section records the device configuration.


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Maintenance parts

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
[________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


Prerequisites None
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]

2 Maintenance parts

This chapter contains interval-related maintenance parts, measures, and


tests that can only be performed on an open device.
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Maintenance parts

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.

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 2 Water trap holder.
6870529 O-ring 1 Water trap holder.
Result Base unit
Next replacement: [________dat]

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]

2.1.3 Disposable absorber, Drägersorb CLIC (old) (if present)

Replacement by specialist. Replace the service set (quantity 1) with the num-
No.1709_0000007693

ber MX08000.
Result Disposable absorber, Drägersorb CLIC (old) (if present)
Next replacement: [________dat]
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Maintenance parts

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.
Measures have been taken against electrostatic discharge.

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.

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


MX08467, includes the following 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 2 Water trap holder.
6870529 O-ring 1 Water trap holder.
No.1709_0000007693

Result Base unit


Next replacement: [________dat]
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Maintenance parts

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]

2.2.3 Disposable absorber, Drägersorb CLIC (old) (if present)

Replacement by specialist. Replace the service set (quantity 1) with the num-
ber MX08001.
Result Disposable absorber, Drägersorb CLIC (old) (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.
Measures have been taken against electrostatic discharge.

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.

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


MX08468, includes the following maintenance parts:
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Maintenance parts

Part number Maintenance part Quan- Location/Remark


tity
8603662 Filter mat 80 x 80 x 10 1 Power supply unit.
8603057 Battery 2 Power supply unit (UPS bat-
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 2 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-
ber M36045.
Result Disposable absorber, Drägersorb CLIC (new) (if present)
Next replacement: [________dat]

2.3.3 Disposable absorber, Drägersorb CLIC (old) (if present)

Replacement by specialist. Replace the service set (quantity 1) with the num-
ber MX08000.
Result Disposable absorber, Drägersorb CLIC (old) (if present)
Next replacement: [________dat]

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.


No.1709_0000007693

The device has been switched off and the mains power has been cut.
Measures have been taken against electrostatic discharge.
No.2310_0000005920

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Maintenance parts

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.

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


MX08467, includes the following 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 2 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 Disposable absorber, Drägersorb CLIC (old) (if present)

Replacement by specialist. Replace the service set (quantity 1) with the num-
No.1709_0000007693

ber MX08001.
Result Disposable absorber, Drägersorb CLIC (old) (if present)
Next replacement: [________dat]
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Maintenance parts

2.4.4 CLIC Adapter MX50090 (if present)

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


Result CLIC Adapter MX50090 (if present)
Next replacement: [________dat]

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.
Measures have been taken against electrostatic discharge.

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
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.1709_0000007693
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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.
8603057 Battery 2 Power supply unit (UPS bat-
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 2 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]

2.5.3 Disposable absorber, Drägersorb CLIC (old) (if present)


No.1709_0000007693

Replacement by specialist. Replace the service set (quantity 1) with the num-
ber MX08001.
Result Disposable absorber, Drägersorb CLIC (old) (if present)
No.2310_0000005920

Next replacement: [________dat]

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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]

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.
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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 —A, 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.

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]
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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
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.
[________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.1709_0000007693

N Neutral conductor
PE Protective earth
No.2310_0000005920

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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 —A.


Result Reference value
[________—A]

Test The recurrent test value must not exceed 500 —A.
Result Recurrent test
[________—A]

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.1709_0000007693

1 Tester
2 Device under test
No.2310_0000005920

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 —A.


Result Reference value
[________—A]

Test The recurrent test value must not exceed 5000 —A.
Result Recurrent test
[________—A]

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.1709_0000007693

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Electrical safety

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 —A, 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]
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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]
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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 —A.
Result Normal condition (N.C.)
[________—A]

Test Single fault condition (S.F.C.): The value must not exceed 1000 —A.
Result Single fault condition (S.F.C.)
[________—A]
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Action

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.


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Test Normal condition (N.C.): The value must not exceed 100 —A.
Result Normal condition (N.C.)
[________—A]
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Function and condition test

Test Single fault condition (S.F.C.): The value must not exceed 500 —A.
Result Single fault condition (S.F.C.)
[________—A]

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.
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Result Base unit


[________OK]
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4.2 Uninterruptible power supply "UPS"


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

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".
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4.3.1 Leak test


Test set-up

25482
Fig. 7 Test setup: "Leak test"

Item Designation
1 Syringe
2 Tube clamp
3 Digital barometer (7900217)
4 T-piece
5 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 (1) all the way in. Prepare the test setup with no
tube clamp (2).
• 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).
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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-
ance:

Gas type Tolerance


AGas * 0.0 vol.% to 0.2 vol.%
CO2 0.0 vol.% to 0.2 vol.%
N2O 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.
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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:

Test gas Device with sensor module/mini-module:


Desflurane Tolerance limits for measured values
Desflurane AAC* ±0.5 vol%
CO2 AAC* ±0.83 vol%
N2O AAC* ±6.8 vol%
AAC* = Actual Analyzed Concentration. The AAC can be found in the
"CERTIFICATE OF ANALYSIS" accompanying the test gas cylinder.

Test gas mixed gas (7910349)


See following table for calculation of tolerance limits:

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%
N2O AAC* ±7.60 vol%
AAC* = Actual Analyzed Concentration. The AAC can be found in the
"CERTIFICATE OF ANALYSIS" accompanying the test gas cylinder.
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Test set-up

25470
Fig. 8 Test setup with test gas cylinder

Item Designation
1 Test gas cylinder (7910345 (Desflurane) or 7910349 (mixed gas))
2 Shut-off valve (component of the pressure regulator)
3 Pressure regulator (7910346)
4 Tube (1180703)
5 Calibration adapter (8290301)
6 Bag (6726425)
7 Sampling gas line
8 To the water trap
Action • Prepare the test setup.
• Set the handwheel of the test cylinder pressure regulator and open the
shut-off valve.

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 Accuracy of gas measurement with test gas
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[________OK]
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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.

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 con-
nector (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).
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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
2 minutes.
[________OK]

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]
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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.
The Drägersorb Clic adapter mount has been uncapped.
The APL valve is switched to the "MAN" position and set to maximum pres-
sure.
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]
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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.

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").
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• Set the following parameters:


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Test Instructions / Service Card IPM

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Function and condition test

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.
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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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Function and condition test

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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Function and condition test

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-
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Test The flow reading is 5 ±0.5 L per minute.
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Function and condition test

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.

4.7 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.
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Action • Disconnect the O2 from the pipeline supply and relieve the O2 pressure on
the gas supply block.
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Function and condition test

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.
Action • Disconnect the AIR from the pipeline supply and relieve the AIR pressure
on the gas supply block.
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.
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Test On the device front panel only the O2 cylinder supply indicator is lit steadily
green.
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Function and condition test

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.
Test On the device front panel only the AIR cylinder supply indicator is lit steadily
green.
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]
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Test equipment

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.

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.
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Test equipment

Designation Part number Comments


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

Torque wrench, 6 to 50 Nm 7900909

Torque spanner set, complete; refer to 7900964


calibration instruction 7910934.

Flowmeter, block of 3, measuring range 7901161


0.02 to 15 L/min

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.


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Test equipment

Designation Part number Comments


Manometer, digital, 0 to 20 bar 7910724.

Stopwatch 7911336

MiniOx O2 analyzer with sensor. 7911610

Torque wrench, 0 to 5 Nm 7911766

Flowmeter, 0 to 16 L/minute 2M86553

Result Test equipment calibrated in a valid manner used.


[________OK]

5.1.2 Test equipment not subject to mandatory calibration

NOTE
Use the following test equipment or equivalent aids.

Designation Part number Comments


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


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Test equipment

Designation Part number Comments


Barrierta I SL/OX, grease, 18 grams 1564706

Bag 6726425

T-piece (socket) 6800187

Reducer 7900044

Retaining clip 7900469

Socket wrench set, 1/4” 7900905

Shorting cable, Nellcor 7901068

Rubber plug 7901297

Fitting 6, G1/4 external 7901435

Fitting 7901435 No image available.


Gas distributor, DIN 7901495.

Syringe 7901541
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Test equipment

Designation Part number Comments


Rubber plug 7901665

Loctite 221 7901966

Patient adapter 7910195

Plastic-jaw pliers 7910296

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


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Test equipment

Designation Part number Comments


Calibration adapter 7911176

Probe cable 7911196

Pin-type face wrench set, adjustable 7911784

Test adapter for connecting cable 7911821

Valve crater key 7912205

O2 adapter 8405807

Connecting socket M06258

Connecting sleeve M13506

Tool for valve crater MX08817


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Test equipment

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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3 Result Sheet Test instructions / Service Card IPM

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Result Sheet Test Instructions / Service Card IPM


Primus

Order number: 9500302

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

Test Result Test Result


1 Device configuration 3.1.2 Protective earth resistance
1.1 Device configuration … 3.1.2.1 Maximum measured value. ȍ
1.1.1 Serial numbers of base unit and breathing system … 3.1.2.2 Maximum measured value of ME system. ȍ
… 1.1.1.1 Device serial number txt … 3.1.3 Protective earth resistance measuring points OK
… 1.1.1.2 Breathing system cover (if present) txt … 3.1.4 Application component for device leakage cur- OK
rent
… 1.1.1.3 Valve plate (8603857) txt
3.1.5 Equipment leakage current
… 1.1.1.4 Respiratory gas block (8602804) txt
… 3.1.5.1 Reference value —A
1.1.2 Serial numbers – options
… 3.1.5.2 Recurrent test —A
… 1.1.2.1 Endotracheal suction device (if present) txt
3.1.6 Applied part leakage current, mains on applied
… 1.1.2.2 Vacuum suction (if fitted) txt part, type BF
2 Maintenance parts … 3.1.6.1 Reference value —A
2.1 Maintenance parts, yearly … 3.1.6.2 Recurrent test —A
… 2.1.1 Base unit dat 3.2 Electrical safety according to IEC 60601-1
… 2.1.2 Disposable absorber, Drägersorb CLIC (new) (if dat … 3.2.1 Visual check OK
present)
… 3.2.2 Protective earth resistance ȍ
… 2.1.3 Disposable absorber, Drägersorb CLIC (old) (if dat
present) … 3.2.3 Protective earth resistance measuring points OK
2.2 Maintenance parts, 2-yearly 3.2.4 Earth leakage current
… 2.2.1 Base unit dat … 3.2.4.1 Normal condition (N.C.) —A
… 2.2.2 Disposable absorber, Drägersorb CLIC (new) (if dat … 3.2.4.2 Single fault condition (S.F.C.) —A
present) … 3.2.5 Application component for patient leakage cur- OK
… 2.2.3 Disposable absorber, Drägersorb CLIC (old) (if dat rent
present) 3.2.6 Patient leakage current, optional SpO2
2.3 Maintenance parts, 3-yearly … 3.2.6.1 Normal condition (N.C.) —A
… 2.3.1 Base unit dat … 3.2.6.2 Single fault condition (S.F.C.) —A
… 2.3.2 Disposable absorber, Drägersorb CLIC (new) (if dat 4 Function and condition test
present)
4.1 Condition
… 2.3.3 Disposable absorber, Drägersorb CLIC (old) (if dat
… 4.1.1 Accompanying documents OK
present)
… 4.1.2 Base unit OK
2.4 Maintenance parts, 4-yearly
4.2 Uninterruptible power supply UPS
… 2.4.1 Base unit dat
… 4.2.1 UPS function OK
… 2.4.2 Disposable absorber, Drägersorb CLIC (new) (if dat
present) 4.3 Patient gas module "PGM"
… 2.4.3 Disposable absorber, Drägersorb CLIC (old) (if dat … 4.3.1 Leak test OK
present) … 4.3.2 Plausibility test of PGM values OK
… 2.4.4 CLIC Adapter MX50090 (if present) dat … 4.3.3 PGM alarm response and measured value dis- OK
2.5 Maintenance parts, 6-yearly play
… 2.5.1 Base unit dat … 4.3.4 Accuracy of the gas measurement in room air OK
and at 100% O2
… 2.5.2 Disposable absorber, Drägersorb CLIC (new) (if dat
present) … 4.3.5 Accuracy of gas measurement with test gas OK
… 2.5.3 Disposable absorber, Drägersorb CLIC (old) (if dat … 4.3.6 Monitoring pumping power OK
present) 4.4 Pneumatic device check
2.6 Maintenance parts as required … 4.4.1 Pipeline supply test OK
… 2.6.1 Maintenance parts as per instructions for use OK … 4.4.2 Pipeline supply leak test OK
3 Electrical safety … 4.4.3 O2 Flush flow and button mechanism (yearly) OK
3.1 Electrical safety according to IEC 62353 … 4.4.4 Leakage test on Drägersorb Clic (if fitted) OK
… 3.1.1 Visual check OK
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… 4.4.5 APL valve linearity test (yearly) OK

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Test Result
… 4.4.6 Fresh gas branch leak test OK
… 4.4.7 A-cone (if present) (yearly) OK
… 4.4.8 Final test OK
4.5 Ventilation, interlock function, alarms and monitor
… 4.5.1 Manual ventilation OK
… 4.5.2 Spontaneous breathing OK
… 4.5.3 Pressure controlled ventilation (Pressure Mode) OK
… 4.5.4 Vaporizer interlock function OK
… 4.5.5 Audible and visual alarms OK
… 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
4.7 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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Result Sheet Test instructions / Service Card IPM

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Manufacturer: As of 2015-08:
Dräger Medical GmbH
changes to
Dräger Medical GmbH Drägerwerk AG & Co. KGaA
Moislinger Allee 53 – 55
23542 Lübeck
Germany

+49 1805 3723437

FAX +49 451 882 - 3779

http://www.draeger.com

Subject to change without notice


Will not be replaced in the event of modifications.

© Copyright 2014 by Dräger Medical GmbH, Lübeck, Germany.

Revision 3.0
9036742
5132.300
No.2310_0000005920

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