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TD Primus EN 9036742 PDF
TD Primus EN 9036742 PDF
Primus
Anaesthesia workstation
Warning
No.2310_0000005920
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
No.2310_0000005920
No.2310_0000005920
This chapter contains general notes and definitions that are important for the
use of this documentation.
1 General notes
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.
1.3 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
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.
No.2310_0000005920
No.2310_0000005920
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
1 General
1.2.1 Ventilator
4906
1.2.2 Breathing system The breathing system comprises the following components:
– Integrated absorber, either reusable or disposable.
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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
4901
The parameters for fresh gas flow control, ventilation, and gas monitoring are
displayed on a 12-inch colour screen.
A data view, a trend view (graphical) and a log view can be selected.
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
1.3.1 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
No.2310_0000005920
SpO2.
– Patient Gas Module (PGM) for measurement of O2, CO2 and anaesthetic
gas.
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.
1.3.6 Cylinder pressure The cylinder pressure regulators reduce the pressure of the optional
regulator compressed gas cylinders.
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The NEUTRAL POINT PCB is the central signal and voltage distributor.
5021
5 Mixer A.
6 Safety O2 flow valve (microswitch).
7 Power switch (main switch).
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3 GUI
The following section describes the user interface ( "GUI = Graphical User
Interface").
5028
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.
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5031
The CoMa processor system primarily controls communication with the other
Primus components.
The MoBi is interconnected over the CAN bus with the other components of
the Primus (power supply unit, mixer and VGC).
5033
5043
The BACKPLANE PCB (see Fig. 12) is the base component for additional
modules and the insulated interfaces to external devices.
5035
3.2.1 BACKPLANE PCB The "Block diagrams" section includes a "Block diagrams".
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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 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.
5040
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).
3.3.1 BACKPLANE PCB The BACKPLANE PCB is the base component for additional modules and
the insulated interfaces to external devices.
connectors
– Connects the optional hardware (SPO2, IV-System) to the MoBi (from
software version 1.n).
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 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 patient gas module is an integrated component of the GUI function unit
(see "GUI").
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5047
One component of the PGM is the water trap. The water trap is accessible
from the front (see Fig. 17).
5048
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
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.
If the "WaterLock 2" water trap is installed, see 4.3 "WaterLock 2" water trap.
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
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.
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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Functional principle
5056
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.
Based on the size of the diaphragms and the downstream self-sealing filters
(Fig. 22/3) a 70/30 flow split is produced.
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)
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.
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.
When the zero point of the IRIA is calibrated the plausibility of the
electrochemical O2 sensor signal is checked.
4.5.1 MOPS PCB The Block diagrams section includes a "Block diagrams".
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.
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.
5061
One component of the PGM2 is the water trap. The water trap is accessible
from the front (see Fig. 25).
5048
5064
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.
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
Design The PATO O2 sensor consists of the PATO SA SH PCB and the sensor head.
The assemblies are contained in a housing.
No.2310_0000005920
5087
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
Sensor element On the sensor element there is a heating element and a thermocouple.
608
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 measuring and control signals are amplified and then converted into
digital signals, and vice versa, by means of an AD/DA converter.
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).
No.2310_0000005920
5075
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
4.6.3 Pneumatics of the PGM2 The "Block diagrams" section includes a pneumatic assembly diagram for the
PGM2.
5077
If the "WaterLock 2" water trap is installed, see 4.3 "WaterLock 2" water trap.
paragraphs.
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.
One component of the PGM3 is the water trap. The water trap is accessible
from the front (see Fig. 34). No.2310_0000005920
5048
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.
4.7.2 PGM3 pneumatic The "Block diagrams" section includes a "Block diagrams".
assembly
5083
If the "WaterLock 2" water trap is installed, see 4.3 "WaterLock 2" water trap.
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.
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.
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
11528
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
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
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.
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).
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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.
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.
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
5103
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.
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A CAN bus (2) transfers the setup parameters to the mixer electronics (3).
The mixer electronics generate the actuation signals for the gas inlet
valves (7).
At the inlet of the fresh gas tank (6) the flow (V) is measured. With the 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.
5.1.1 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).
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".
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
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the unstabilized 18 V to 30 V supply voltage and the 12 V fan power from the
power supply unit as well as the CAN bus.
The mixer fan is switched on 10 seconds before the other components and is
powered directly by the power supply unit (see 5.1.1 10 VA mode).
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 system has an isolated serial port and a CAN bus.
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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Optional outlets for an endotracheal suction device with AIR (Fig. 42/1) and
for an O2 flowmeter (Fig. 42/2) are prepared.
5108
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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5110
5112
The item numbers and abbreviations occurring in this section relate to Fig.
44.
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".
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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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.
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5118
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
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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".
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".
5.5.8 VSWAK (A-cone valve) The A-cone valve actuated by the MIXER PCB has a bistable switching
response.
The valve is switched with a time-limited voltage pulse. The polarity of the
voltage pulse determines the switching direction.
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
5.5.13 VO2+ (flush button) Mechanical flush button. Output min. 35 L/minute.
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6 VGC
The following section describes the VGC (Ventilation and Gas Controller).
The VGC consists of the ventilator and the breathing system.
5140
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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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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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
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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 BSE module comprises the BSE PCB and a separate loudspeaker. The
four LEDs on the BSE PCB indicate the operating conditions and voltages.
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.
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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The components of the pneumatic block are detailed in the following section.
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5151
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".
So that the vacuum is reduced when the vacuum pump is shut off, the
vacuum valve is bridged by a restrictor "R2".
The airway pressure gauge measures the airway pressure (optional, only in
conjunction with VCAUXO2).
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5157
Fig. 59 APL valves, new type (1) and old type (2)
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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.
5159
7 Fixing screws
8 Absorber canister
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.
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.
6.6.1 Breathing system The "Block diagrams" section includes a "Block diagrams".
pneumatic assembly
5157
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
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.
6.7.2 Expiration
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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.
6.8.1 Inspiration
5162
6.8.2 Expiration
5163
The inspiratory valve "Vi" is closed, and prevents expiratory gas from flowing
back into the inspiratory branch.
6.9.1 Inspiration
5164
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
During expiration, the inspiratory valve "Vi" remains closed thus preventing
the expiratory gas from flowing back into the inspiratory branch.
– "Pressure Mode".
– "Pressure Support Mode"(optional)
– "Man./Spont Mode".
– "Volume AutoFlow"(optional)
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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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.
If, during volume-controlled ventilation, a value is entered for the level of the
pressure support ΔPps, pressure support is activated.
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.
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.
The sensitivity of the flow trigger and the ΔPps level control the
synchronization of pressure support.
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 rate of rise of the curve can be preset with the slope rise time TSlope.
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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.
6.10.5 "Volume
AutoFlow"(optional)
5174
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.
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.
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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.
No.2310_0000005920
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
The "Block diagrams" section includes a block diagram for the power supply
unit.
The power supply unit input processes alternating voltages from 100 to 240 V
(45 to 65 Hz).
The power supply unit has an earth connection with a 6.3 mm contact.
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5230
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.
switched on.
U6: 12 V, 10 VA Fan for IRIA and optical DIVA.
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.
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 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).
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– 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.
8 Operating modes
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.
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.
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.
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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.
7036
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
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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.
7037
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.
11 Block diagrams
11.1 Introduction
The following block diagrams and the pneumatics diagram form part of the
Primus function description.
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Fig. 92 PRIMUS CPU PCB block diagram (PCB is built-in to mixer and VGC)
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Fig. 95 Primus pneumatic assembly diagram from software version 2.n, see following legend (for changes see
(X))
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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
No.2310_0000005920
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
No.2310_0000005920
V2 Auto-Man/Spont-ON/OFF valve
VBAK A-cone safety valve
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).
No.2310_0000005920
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
2 Safety instructions
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.
No.2310_0000005920
NOTE
Dispose of the exchanged replacement articles in accordance with local
waste disposal regulations.
No.2310_0000005920
3 AGSS filter
3.1 Introduction
NOTE
For replacement interval of "AGSS filter" see instructions for use.
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").
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.
8. After complete servicing, perform the function test and electrical safety
test according to the test instructions.
No.2310_0000005920
4.1 Introduction
NOTE
For replacement interval of "filter of the endotracheal suction system", see
instructions for use.
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").
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
No.2310_0000005920
5.1 Introduction
NOTE
For replacement interval of "top rolling seal" see instructions for use.
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").
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).
No.2310_0000005920
5301
No.2310_0000005920
6 Water trap
6.1 Introduction
NOTE
For replacement interval of "water trap" see instructions for use.
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").
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
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.
No.2310_0000005920
7.1 Introduction
NOTE
For replacement interval of "O2 sensor (fuel cell)" see instructions for use.
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").
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
4. After complete servicing, perform the function test and electrical safety
test according to the test instructions.
No.2310_0000005920
8 Flow sensors
8.1 Introduction
NOTE
For replacement interval of "flow sensor" see instructions for use.
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").
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.
No.2310_0000005920
9.1 Introduction
NOTE
For replacement interval of "patient gas module filter mat" see instructions
for use.
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").
2. After complete servicing, perform the function test and electrical safety
test according to the test instructions.
10.1 Introduction
NOTE
For replacement interval of "power supply unit filter mat" see instructions for
use.
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").
11.1 Introduction
NOTE
For interval for cleaning or replacing "large and small dust filter (VGC)" see
instructions for use or test instructions.
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").
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
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.
No.2310_0000005920
2. Press on a corner of the filter mount under the VGC to release the filter
mount (see Fig. 107).
5297
3. Carefully release the remaining plastic tabs of the filter mount (see Fig.
108).
5298
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.
No.2310_0000005920
5299
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.
12.1 Introduction
NOTE
For replacement interval of "vaporizer plug-in system O-rings" see
instructions for use.
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").
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.
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
NOTE
The procedure described here presents an example for replacement of the
O-rings.
No.2310_0000005920
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
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
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
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
NOTE
A PE tube (e.g. material number 1194925) size 2.7x0.65 mm will help push
on the new O-rings.
No.2310_0000005920
c) Slot the O-rings into the recess in the socket with a tube for example.
See Fig. 117/1.
23211
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").
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.
15.1 Introduction
NOTE
For replacement interval of "Nafion tube and bacterial filter (PGM)" see
instructions for use.
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").
5278
6. Slide the top cover aside to the left (see Fig. 122).
5283
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
NOTE
The white silicone tube (to the bacterial filter) can be reused, provided that it
is neither cracked nor dirty.
5285
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.
5287
2. Mount the top cover, lift slightly at the rear (see Fig. 127), and slide it
completely over the housing.
5288
6346
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.
No.2310_0000005920
16.1 Introduction
NOTE
For cleaning and replacement intervals for the "filter mat in the housing
cover" see instructions for use.
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").
2. On the rear of the device loosen the three screws (see Fig. 130) about
four turns.
5293
3. Raise the housing cover at the rear just enough to push it forward away
from the device (see Fig. 131).
5294
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.
17.1 Introduction
NOTE
For replacement interval of "gas inlet sintered-metal filters" see instructions
for use.
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").
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
5363
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
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!
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.
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.
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)
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
5. Turn the valve plate round and remove the four valve block screws (see
Fig. 138).
5367
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.
18.4.1 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).
19389
Pressure Controls
Fresh gas = 0.2 L/minute
O2 = 21%
Frequency = 12 (1/minute)
Tinsp. = 1.0 /seconds
PEEP = 10 mbar
Pinsp. = 30 mbar
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.
19394
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
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.
Pressure Controls
Fresh gas = 0.2 L/minute
O2 = 21%
Frequency = 12 (1/minute)
Tinsp. = 1.0 seconds
PEEP = 20 mbar
Pinsp. = 40 mbar
"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
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.
18.4.6 Final test 1. Following a complete servicing as per the test instructions, perform the
function test.
19.1 Introduction
NOTE
For replacement interval of "bottom rolling seal" see instructions for use.
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").
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.
No.2310_0000005920
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
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
6. Unplug the three pneumatic connectors and the two electrical connectors
(see Fig. 146).
5305
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
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
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
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
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
12. Remount the breathing system on the VGC and secure it by the three
screws.
13. Lift the VGC together with the breathing system (total weight approx.
15 kg) vertically out of the VGC housing (see Fig. 152).
5311
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).
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.
No.2310_0000005920
5313
5316
5. Remove the four PCU screws (see Fig. 156 and Fig. 157).
5317
6. Place the motor section of the PCU upside down on a suitable surface.
5319
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
3. Remove the snap ring and the O-ring (see Fig. 161 and Fig. 162).
5322
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
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
5. Insert the snap ring into the groove of the rolling seal (see Fig. 165).
5329
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.
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
2. Secure the three screws (see Fig. 158) with silicone adhesive at the
screw seats and then tighten them.
5319
3. Check that the end of the rolling seal is correctly seated in the guide
groove (see Fig. 168).
5330
4. Place the motor section of the PCU upside down on the lower PCU
section (see Fig. 169).
5331
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
7. Insert the PCU cables and the pneumatic tube into the cable holders (see
Fig. 171).
5333
8. Connect the three PCU cables to the PRIMUS ANALOG PCB (see Fig.
172).
5316
9. Lift the PCB unit. Make sure no tubes are bent or cables trapped as you
do so.
No.2310_0000005920
10. Tighten the screw of the PCB unit (see Fig. 173).
5315
11. Push the PCU cables into the holders according to the labelling on the
cylinder (see Fig. 174).
5334
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.
14. After complete servicing, perform the function test and electrical safety
test according to the test instructions.
20.1 Introduction
NOTE
For replacement interval of "UPS lead-gel batteries" see instructions for use.
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").
5371
5. Take out the power supply unit and place it on a suitable base surface.
6. Continue with 20.4 Removing the batteries.
5373
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
5374
2. Hold the retaining strap upwards (see Fig. 180). Push the batteries all the
way into the holder until they lock in place.
5373
3. Tighten the retaining strap and secure it with the Velcro strip (see Fig.
181).
5375
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.
Parts catalog
Test Instructions
1 Parts catalog
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No.2310_0000005920
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.
No.2310_0000005920
3ULPXV
Table of contents
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
3ULPXV
Table of contents
3ULPXV
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
3ULPXV
Maintenance parts
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]
2 Maintenance parts
3ULPXV
Maintenance parts
NOTE
The service set includes all standard maintenance parts.
The maintenance parts for the options need to be ordered separately.
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]
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]
No.2310_0000005920
3ULPXV
Maintenance parts
NOTE
The service set includes all standard maintenance parts.
The maintenance parts for the options need to be ordered separately.
3ULPXV
Maintenance parts
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]
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]
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.
No.2310_0000005920
3ULPXV
Maintenance parts
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]
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]
The device has been switched off and the mains power has been cut.
Measures have been taken against electrostatic discharge.
No.2310_0000005920
3ULPXV
Maintenance parts
NOTE
The service set includes all standard maintenance parts.
The maintenance parts for the options need to be ordered separately.
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]
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]
No.2310_0000005920
3ULPXV
Maintenance parts
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.
3ULPXV
Maintenance parts
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]
Replacement by specialist. Replace the service set (quantity 1) with the num-
ber MX08001.
Result Disposable absorber, Drägersorb CLIC (old) (if present)
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3ULPXV
Electrical safety
NOTE
The replacement of maintenance parts is described in the instructions for use
and is carried out by the user.
3 Electrical safety
NOTE
The device conforms to the conditions of protection class I, type BF.
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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
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.
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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Electrical safety
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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Electrical safety
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).
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
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N Neutral conductor
PE Protective earth
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Electrical safety
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 recurrent test value must not exceed 500 A.
Result Recurrent test
[________A]
Item Designation
No.1709_0000007693
1 Tester
2 Device under test
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3ULPXV
Electrical safety
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 recurrent test value must not exceed 5000 A.
Result Recurrent test
[________A]
NOTE
All measures labelled in these test instructions with (applied part) must only
be performed if the device is fitted with applied parts.
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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.
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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Electrical safety
769
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]
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Electrical safety
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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Electrical safety
Action
NOTE
This test is only required if the "SpO2" option is fitted. Install the device under
test insulated.
Test set-up
425
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.
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]
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.
3ULPXV
Function and condition test
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3ULPXV
Function and condition test
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]
3ULPXV
Function and condition test
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Function and condition test
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.
3ULPXV
Function and condition test
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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3ULPXV
Function and condition test
Action • Close the shut-off valve and the handwheel of the test cylinder pressure
regulator.
• Remove the 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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Function and condition test
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.
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Function and condition test
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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Function and condition test
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.
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Function and condition test
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).
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).
3ULPXV
Function and condition test
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]
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Function and condition test
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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Function and condition test
3ULPXV
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
3ULPXV
Function and condition test
Action • Quit the "Standard config." menu with the "Close config." button.
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Function and condition test
2934
Result The fixing screws for the monitor arms have been tightened with a
torque of 12 Nm +1 Nm.
[________OK]
18523
Item Designation
1 Flowmeter, block of 3 (7901161).
2 Flowmeter tube.
3 Outlet of the external O2 flowmeter.
4 Fine control valve.
Action • Prepare the test setup.
• Connect the device only to the O2 pipeline supply.
• Close the fine control valve of the external O2 flowmeter.
Test The flow readout must not exceed 10 mL/minute.
Action • Set the fine control valve of the external O2 flowmeter tube to 5 L per min-
No.1709_0000007693
ute.
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 • Switch the device to "Standby" mode and then switch it off at the main
switch.
• Disconnect the device from the pipeline supply.
NOTE
The "pipeline supply gas type test" only has to be performed after replacing
the sintered-metal filter elements of the gas supply block.
O2 pipeline supply
Test On the device front panel only the O2 pipeline supply indicator is lit steadily
green.
No.1709_0000007693
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.
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.
Test On the device front panel only the O2 cylinder supply indicator is lit steadily
green.
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Function and condition test
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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.
5 Test equipment
This section sets out the test equipment required for the tests in this test pro-
cedure.
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
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Test equipment
Stopwatch 7911336
NOTE
Use the following test equipment or equivalent aids.
3ULPXV
Test equipment
Bag 6726425
Reducer 7900044
Syringe 7901541
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Test equipment
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Test equipment
O2 adapter 8405807
No.2310_0000005920
3ULPXV
Test equipment
No.2310_0000005920
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
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
No.2310_0000005920
Report:
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No.2310_0000005920
http://www.draeger.com
Revision 3.0
9036742
5132.300
No.2310_0000005920