primus_ie_technical_documentation_rev_3-0.pdf
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Technical Documentation IPM
Primus IE
Anaesthesia workstation
Warning
All servicing and/or test procedures on the
device require detailed knowledge of this
documentation. Use of the device requires
detailed knowledge and observance of the
relevant Instructions for Use.
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Table of contents
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Table of contents
General
1 General notes ...........................................................................................................................
Function descriptions
1 General.....................................................................................................................................
2 Neutral Point PCB ....................................................................................................................
3 GUI ...........................................................................................................................................
4 Patient gas module (PGM2 IE/PGM3 IE) .................................................................................
5 Mixer.........................................................................................................................................
6 VGC..........................................................................................................................................
7 Power supply unit .....................................................................................................................
8 Operating modes ......................................................................................................................
9 Anaesthetic vaporizer ...............................................................................................................
10 RFID unit M21 EAST ................................................................................................................
11 Trolley brake.............................................................................................................................
12 Front lighting and vaporizer lighting..........................................................................................
13 Bronchial suction device...........................................................................................................
14 Block diagrams and pneumatic assembly diagram ..................................................................
Maintenance instructions
1 General information on use of maintenance instructions .........................................................
2 Safety instructions ....................................................................................................................
3 AGSS filter................................................................................................................................
4 Replacing bronchial suction device bacterial filter ....................................................................
5 Replacing the top rolling seal (VGC) ........................................................................................
6 O2 sensor on PGM3 IE .............................................................................................................
7 Flow sensors ............................................................................................................................
8 Replacing the filter mat on the fan (PGM2 IE/PGM3 IE) ..........................................................
9 Replacing filter mat in power supply unit ..................................................................................
10 Large and small filter mats in the VGC .....................................................................................
11 O-rings on vaporizer plug-in system .........................................................................................
12 Replacing the O-rings for the water trap...................................................................................
13 Rear panel ................................................................................................................................
14 Bacterial filter and Nafion tube .................................................................................................
15 Filter mat in the housing cover .................................................................................................
16 Replacing sintered-metal filters of pipeline supply connections ...............................................
17 PEEP diaphragm, switching diaphragm and O-rings (breathing system).................................
18 Replacing the bottom rolling seal (VGC) ..................................................................................
19 Replacing UPS batteries ..........................................................................................................
Parts catalog and test instructions
1 Parts catalog.............................................................................................................................
2 Test Instructions / Service Card IPM ........................................................................................
3 Result Sheet Test instructions / Service Card IPM...................................................................
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General
This chapter contains general notes and definitions that are important for the
use of this documentation.
General notes ...........................................................................................................................
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General
General notes
1
General notes
1.1
Notes on use
Read through the following notes thoroughly before applying this
documentation.
The warnings set out here apply to all parts of this documentation.
Dräger reserves the right to make changes to the device and/or to this
documentation without prior notice. This documentation is intended solely as
an information resource for maintenance personnel or technical specialists.
1.2
Copyright and other protected rights
The content of this documentation, in particular its design, text, software,
technical drawings, configurations, graphics, images, data and their selection
and its composition and any amendments to it (content) are protected by
copyright. The content must not (in whole or in part) be modified, copied,
distributed, reproduced, republished, displayed, transmitted or sold without
the prior written consent of Dräger.
1.3
Definitions
WARNING
An important advisory indicating a potentially hazardous situation
which may result in death or serious injury if not prevented.
CAUTION
An important advisory indicating a potentially hazardous situation which may
result in minor or moderate injury to the user or patient or in damage to the
medical product or other assets if not prevented.
NOTE
A NOTE provides additional information intended to avoid inconvenience
during operation and/or servicing.
1.4
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
General safety precautions
Read through each section thoroughly before beginning servicing. Always
use the correct tools and the specified test equipment. Otherwise the device
may not work correctly or may be damaged.
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Term
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General
General notes
WARNING
The device must be regularly inspected and serviced by maintenance
personnel. Repairs and complex maintenance work on the medical
product must be carried out by qualified specialists.
If you require a service contract, or for any necessary repair work,
Dräger recommends DrägerService. Dräger recommends using
original Dräger parts for servicing.
If the aforementioned instructions and recommendations are ignored,
the correct functioning of the medical product may be put at risk. Pay
attention to the "Servicing" section of the Instructions for Use.
WARNING
Non-conforming test values
If test values do not conform to specifications, the safety of the patient
may be put at risk.
–
Do not put the device into operation if test values do not conform to
specifications.
–
Contact your local service organization.
WARNING
Impermissible modifications to the device
If impermissible modifications are made to the device, the safety of the
patient may be put at risk.
Do not modify the device without Dräger's permission.
WARNING
Risk of infection
The unit may transmit pathogens following use on the patient.
–
Before carrying out any servicing, ensure that the device and its
components have been handed over by the user cleaned and
disinfected.
–
Service only cleaned and disinfected units and unit components.
WARNING
Risk to patient.
Ensure that no patient is connected to the device before starting
maintenance or repair work.
NOTE
No.2410_0000007950
Where reference is made to legislation, regulations and standards, in
respect of devices used and serviced in Germany they are based on the
laws of Germany. Users and technicians in other countries must comply with
their national laws and/or international standards.
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Function descriptions
This chapter contains descriptions of the device's technical functions.
General.....................................................................................................................................
Neutral Point PCB ....................................................................................................................
GUI ...........................................................................................................................................
Patient gas module (PGM2 IE/PGM3 IE) .................................................................................
Mixer.........................................................................................................................................
VGC..........................................................................................................................................
Power supply unit .....................................................................................................................
Operating modes ......................................................................................................................
Anaesthetic vaporizer ...............................................................................................................
RFID unit M21 EAST ................................................................................................................
Trolley brake.............................................................................................................................
Front lighting and vaporizer lighting..........................................................................................
Bronchial suction device...........................................................................................................
Block diagrams and pneumatic assembly diagram ..................................................................
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Function descriptions
General
1
General
In the following documentation "Primus Infinity Empowered" is referred to for
short as "Primus IE".
1.1
Intended use
The stipulations in the relevant instructions for use apply.
1.2
Short description of the Primus IE
The following sections provide an overview of the Primus IE components.
Ventilator
7385
1.2.1
Fig. 1
Ventilator with breathing system
The electronically controlled and driven ventilator has the following features:
–
1.2.3
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Breathing system
Mixer (fresh gas dosage)
The breathing system comprises the following components:
–
Integrated CO2 absorber, either reusable or disposable.
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Electronic interfaces for inspiratory and expiratory flow measurement.
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Direct patient section heating is integrated into the valve plate of the
breathing system.
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Pneumatic interface to ventilator.
–
Fresh gas isolation and minimized compliance.
The electronic fresh gas mixer offers the following features:
–
Gas flow control for O2, N2O and AIR.
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Dosage range from 200 mL/min to 18 L/min.
Primus IE
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No.2410_0000007950
1.2.2
Ventilation modes such as volume mode, pressure mode, pressure
support (optional) and MAN/SPONT with switchable synchronization and
pressure support (optional).
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Function descriptions
General
Alarm monitoring for the pressure values of the pipeline gas supply and
the cylinder supply. LEDs on the front panel indicate the pressure status.
–
SORC function for low-flow and minimum-flow applications.
–
O2 flush and mechanical safety O2 adjuster (see Fig. 2).
7386
–
Fig. 2
–
Double vaporizer plug-in system with interlock.
–
Auto Exclusion System (optional).
–
Optional external A-cone as fresh gas outlet.
Monitor control panel
7387
1.2.4
O2 flush (O2+), mechanical safety O2 adjuster
Fig. 3
Monitor control panel
No.2410_0000007950
The following parameters are monitored:
Technical Documentation IPM
–
Airway pressure.
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Inspiratory and expiratory flow.
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Circle system leakage.
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Inspiratory and expiratory O2 concentration.
Primus IE
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Function descriptions
General
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CO2 measurement and anaesthetic gas measurement.
–
Anaesthetic gas detection.
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Quantitative measurement of mixed gas values and MAC calculation
(age-relevant).
–
A data view, a trend view (graphical) and a log view can be selected.
–
Free configuration of three real-time curves and different numerical
values.
–
Body-weight-relevant ventilator presettings (Vt and frequency) and agerelevant calculation of minimum alveolar concentration (MAC ) according
to "Mapleson" as well as age-relevant scaling of volumeter and influence
on ventilation monitoring.
The safety concept incorporates the following tests:
1.2.5
Automatic self-test with mixer test, ventilator test and test of the breathing
system.
–
Test and automatic calibration of all sensors.
Primus IE is ready for the following options:
–
Integrated SpO2 measurement.
–
Consumption-free O2 measurement.
–
PAW preview – display of expected airway pressure curve when
changing parameters.
–
P/V and Flow/V loops.
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Econometer function.
–
Additional ventilation modes (e.g. autoflow, CPAP).
–
Additional languages available for display texts.
Primus IE component structure
7388
1.3
Options
–
Primus IE component structure
In the "Block diagrams" section you will find a "Primus IE block diagram,
detailed".
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Primus IE
Technical Documentation IPM
No.2410_0000007950
Fig. 4
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Function descriptions
General
1.3.1
Neutral Point PCB
The Neutral Point PCB connects the components of the Primus IE to the
power supply, additional signal wires and the CAN bus.
For more information see the following section on "Neutral Point PCB".
1.3.2
Graphical User Interface
(GUI)
The GUI has the following components:
–
On the Monitor Control Panel (MoBi) the ventilation mode is displayed.
Limit and target values are specified and the ventilation and anaesthesia
parameters are displayed.
–
Interface Box (I-Box). PC ports and optional measuring functions such as
SpO2.
–
Patient Gas Module (PGM) for measurement of O2, CO2 and anaesthetic
gas.
For more information see "GUI".
1.3.3
Mixer
The mixer comprises the following function units:
–
Electronically controlled and monitored mixer.
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Vaporizer plug-in system for one or two conventional vaporizer types.
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External fresh gas outlet, A-cone (optional).
–
Pressure monitoring for pipeline supply and compressed gas cylinders.
For more information on the "Mixer" see the following section.
1.3.4
RFID unit
The RFID unit "M21 EAST" reads out the transponder data. The data is
transmitted to the CPU PCB of the mixer via an RS232 interface.
1.3.5
VGC (Ventilation and
Gas Controller)
The VGC comprises the following function units:
–
Electronically controlled and driven ventilator.
–
Integrated breathing system for "low flow" and "minimum flow"
applications.
For more information see "VGC".
1.3.6
Power supply unit
The power supply unit comprises:
–
Switched-mode power supply unit.
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Uninterruptible power supply (UPS) with one battery pack consisting of
two 12 V lead-gel batteries.
–
Battery charging management.
For more information see "Power supply unit".
Cylinder pressure
regulator
The cylinder pressure regulators reduce the pressure of the optional
compressed gas cylinders.
No.2410_0000007950
1.3.7
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Function descriptions
Neutral Point PCB
2
Neutral Point PCB
7390
The Neutral Point PCB is the central signal and voltage distributor.
Position of Neutral Point PCB (rear panel of the device)
Fig. 6
Neutral Point PCB component layout
Item
1
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No.2410_0000007950
5022
Fig. 5
Connector
Monitor control panel B (MoBi)
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Function descriptions
Neutral Point PCB
Item
Connector
2
Monitor control panel A (MoBi)
3
Ventilation and Gas Controller (VGC)
4
Mixer B
5
Mixer A
6
Safety O2 flow valve (microswitch)
7
Power switch (main switch)
8
Halogen lamp
9
Jack plug (production tests)
10
PGM
11
Power supply unit A
12
Power supply unit B
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Unassigned
No.2410_0000007950
The function description relating to the "GUI" follows.
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Function descriptions
GUI
3
GUI
The following section describes the user interface ( "GUI = GUI").
8834
In the Block diagrams section you will find a detailed "Block diagrams and
pneumatic assembly diagram".
Fig. 7
GUI block diagram
The GUI has the following components:
MoBi (monitor control panel).
–
S-Box (Interface Box).
–
Patient Gas Module = PGM (for function description see document:
"Block diagrams and pneumatic assembly diagram").
No.2410_0000007950
–
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Function descriptions
GUI
MoBi (monitor control panel)
8835
3.1
Fig. 8
Position of monitor control panel
In the Block diagrams section you will find a detailed "Block diagrams and
pneumatic assembly diagram".
The user and Primus IE communicate via the monitor control panel (MoBi).
The MoBi display presents system information and patient data. It is here that
the user sets the parameters and ventilation modes.
No.2410_0000007950
The Patient Gas Module (PGM) is connected to the GUI.
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Function descriptions
8836
GUI
Fig. 9
Exploded view of MoBi
Item
3.1.1
MONITOR CONTROL PANE
L PCB
Components
1
Front panel with keypad. Includes keypad membrane covering with
design imprint, keys, LEDs (e.g. for pipeline supply gases).
2
Carrier frame and the shielding, anti-glare glass screen
3
12 inch colour display (TFT, resolution: 800 x 600)
4
Carrier plate
5
MONITOR CONTROL PANEL PCB (motherboard)
6
Backlight Converter PCB (display backlighting)
7
Loudspeaker
8
Rotary encoder
9
Turn knob (central operator control element)
The following software is installed here:
–
GUI software.
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Monitoring and evaluation software for the PGM.
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Software for Medibus ports and SpO2.
A 2-processor system is in operation on the PCB. It comprises a Display
Master (DiMa) and a Communication Master (CoMa).
18
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Motorola processor (MPC823) with 48 MHz clock frequency and 32-bit
address and data buses.
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Flash-PROM (program memory).
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RAM (data memory).
–
CAN controller.
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Technical Documentation IPM
No.2410_0000007950
The powerful DiMa processor incorporates the following components:
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Function descriptions
GUI
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RS232 interface for in-house development purposes.
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Serial communication channel for Ethernet.
The LCD controller is a programmable logic device ("PLD"). A "DRAM"
serves as the video memory.
The CoMa processor system primarily controls communication with the
other Primus components.
The CoMa incorporates the following components:
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Motorola processor (M68332) with 16.7 MHz clock frequency, internal 32bit bus and external 16-bit data bus.
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Flash-PROM (program memory).
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RAM (data memory).
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RS232 interface for communication with the SPO2, PGM and Medibus 12 modules.
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Real-time clock (RTC).
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Keyboard and turn knob scan, LED actuation and sound output.
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CAN interface.
Both processor systems communicate by way of a Dual-Port RAM (DPR).
This memory device is battery-buffered. The buffering is provided primarily by
the UPS batteries of the Primus. If they fail, the lithium battery on the
MONITOR CONTROL PANEL PCB ensures data is retained.
The operating voltage is provided by an unstabilized voltage of 20 V to 30 V
(Vcc). DC converters on the MONITOR CONTROL PANEL PCB generate all
other voltages on the PCB.
No.2410_0000007950
The MoBi is interconnected over the CAN bus with the other components of
the Primus IE (power supply unit, mixer and VGC).
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Function descriptions
GUI
S-Box (interface box)
8838
3.2
Fig. 10
Position of S-Box (rear panel of the device)
By default, the S-Box includes the externally accessible Medibus interfaces
(COM 1-2), IV-System (syringe pumps).
5043
The S-Box is ready for retrofitting of the SpO2 measuring function (option)
(see 3.2.2 SpO2 sampling function (option)).
20
S-Box layout
Primus IE
No.2410_0000007950
Fig. 11
Technical Documentation IPM
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Function descriptions
GUI
Item
Components
1
Drawer unit components fully mounted
2
BACKPLANE PCB
3
SpO2 ADAPTER PCB (SpO2 PCB not shown)
8839
The BACKPLANE PCB (see Fig. 12) is the base component for additional
modules and the insulated interfaces to external devices.
Fig. 12
3.2.1
BACKPLANE PCB
S-Box block diagram, detailed
In the Block diagrams section you will find a detailed "Block diagrams and
pneumatic assembly diagram".
In the "Block diagrams" section you will find a
The BACKPLANE PCB has the following functions:
SpO2 sampling function
(option)
No.2410_0000007950
3.2.2
Technical Documentation IPM
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Electrical isolation and level conversion of the two Medibus ports
(RS232).
–
Interface to the IV system (Ethernet for TIVA).
–
Connects the SpO2 sampling function (option) to the MoBi.
The SpO2 sampling function has the following tasks:
–
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.
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Function descriptions
GUI
The SpO2 sensor essentially comprises two LEDs (light-emitting diodes)
which alternatingly emit infrared light with typical wavelengths of 920 nm and
660 nm respectively. An opposing photodetector measures the radiant
intensity. The sensor is placed on a part of the body on which arterial blood
vessels can be X-rayed, such as the fingers, toes or bridge of the nose.
The module from Nellcor detects the "DS-100A" SpO2 sensor only. The
sensor is identifiable by the fact that all nine pins are present on the
connector.
The "DS-100A" SpO2 sensor is connected without a pre-amplifier to the
module. The module communicates through a serial port with the
MONITOR CONTROL PANEL PCB. On the BACKPLANE PCB the module is
electrically isolated with 1.5 kV.
No.2410_0000007950
The function description relating to the "Patient gas module
(PGM2 IE/PGM3 IE)" follows.
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Technical Documentation IPM
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Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)
4
Patient gas module (PGM2 IE/PGM3 IE)
8834
The PGM (patient gas module) is an integral part of the GUI functional unit
(see also function description: "GUI").
Fig. 13
GUI block diagram
The two types of the "patient gas module" differ by the following
characteristics:
Component
PGM2 IE
Anaesthetic gas measurement.
PGM3 IE
ILCA2
O2 sampling.
PATO sensor.
Electrochemical O2 cell.
O2 measurement
electronics.
AMO MFM PCB.
AMO O2 PUMP PCB
Pump flow.
200 mL
Flush flow.
200 mL
8840
No.2410_0000007950
The water trap is an integral part of the PGM2 IE/PGM3 IE (for position see
Fig. 14).
Fig. 14
Technical Documentation IPM
Water trap position (example: "WaterLock")
Primus IE
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Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)
PGM2 IE
4.1.1
Übersicht PGM2 IE
The following illustration shows the position of the PGM2 IE (rear panel
open).
8841
4.1
Position of PGM2 IE (unit rear panel)
Fig. 16
Exploded view of PGM2 IE
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Primus IE
No.2410_0000007950
8842
Fig. 15
Technical Documentation IPM
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Function descriptions
Patient gas module (PGM2 IE/PGM3 IE)
Item
Component
PGM2 IE
2
ILCA2 sensor head
3
Fan
4
PGM IE Adapter PCB
5
Screws
6
PU tube, 1.6 mm, natural, to water trap
7
Water trap mount
8
Screws
9
Damper
10
Filter mat
11
PATO O2 sensor with PCB
12
ILCA2 (for detail see Fig. 17)
13
ILCA solenoid valves
No.2410_0000007950
8844
1
Fig. 17
Second exploded view of PGM2 IE (example with "WaterLock")
Technical Documentation IPM
Primus IE
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