primus_technical_documentation_rev_2-0.pdf
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Technical Documentation IPM
Primus
Anaesthesia workstation
Warning
All servicing and/or test procedures on the
device require detailed knowledge of this
documentation. Use of the device requires
detailed knowledge and observance of the
relevant Instructions for Use.
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Table of contents
Table of contents
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General
1 General notes ...........................................................................................................................
Function descriptions
1 General.....................................................................................................................................
2 NEUTRAL POINT PCB ............................................................................................................
3 GUI ...........................................................................................................................................
4 Patient gas module...................................................................................................................
5 Mixer.........................................................................................................................................
6 VGC..........................................................................................................................................
7 Power supply unit .....................................................................................................................
8 Operating modes ......................................................................................................................
9 Anaesthetic vaporizer (Vapor) ..................................................................................................
10 Bronchial suction device...........................................................................................................
11 Block diagrams .........................................................................................................................
Maintenance instructions
1 General information on use of maintenance instructions .........................................................
2 Safety instructions ....................................................................................................................
3 AGSS filter................................................................................................................................
4 Filter of the endotracheal suction system .................................................................................
5 Top rolling seal (VGC) ..............................................................................................................
6 Water trap.................................................................................................................................
7 O2 sensor (fuel cell) ..................................................................................................................
8 Flow sensors ............................................................................................................................
9 Filter mat of patient gas module (PGM)....................................................................................
10 Filter mat of power supply unit..................................................................................................
11 Large and small dust filter (VGC) .............................................................................................
12 O-rings in vaporizer plug-in system ..........................................................................................
13 Replacing the O-rings for the water trap...................................................................................
14 Removing and fitting the rear panel..........................................................................................
15 Nafion tube and bacterial filter (PGM) ......................................................................................
16 Filter mat in the housing cover .................................................................................................
17 Gas inlet sintered-metal filter ....................................................................................................
18 PEEP diaphragm, switching diaphragm and O-rings (breathing system).................................
19 Bottom rolling seal with O-ring (VGC) ......................................................................................
20 UPS lead-gel 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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No.2310_0000005920
Term
Page 7
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.2310_0000005920
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...................................................................................................................
Mixer.........................................................................................................................................
VGC..........................................................................................................................................
Power supply unit .....................................................................................................................
Operating modes ......................................................................................................................
Anaesthetic vaporizer (Vapor) ..................................................................................................
Bronchial suction device...........................................................................................................
Block diagrams .........................................................................................................................
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Function descriptions
General
1
General
1.1
Medical purpose
Primus is an anaesthetic workstation for automatic and manual ventilation
and spontaneous breathing, usable for adults, children and infants. For
details see relevant instructions for use.
1.2
Short description of Primus
The following sections provide an overview of the Primus components.
Ventilator
4906
1.2.1
Fig. 1
Ventilator with breathing system
The electronically controlled and driven ventilator features the following
functions:
10
Breathing system
Tidal volume from 20 mL (5 mL from software version 4.n) (10 mL from
software version 2.n) to 1400 mL at frequencies from 3/min to 80/min
(100/min from software version 4.n).
–
Peak flow up to 150 L/min
–
Ventilation modes such as IPPV, PCV, SIMV (plus adjustable trigger, plus
adjustable PEEP) and MAN/SPONT (up to software 1.n).
–
Ventilation modes such as volume mode, pressure mode, pressure
support (optional) and MAN/SPONT with switchable synchronization and
pressure support (optional).
The breathing system comprises the following components:
–
Integrated absorber, either reusable or disposable.
–
Electronic interfaces for inspiratory and expiratory flow measurement.
–
Direct patient section heating is integrated into the valve plate of the
breathing system.
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No.2310_0000005920
1.2.2
–
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Function descriptions
General
Mixer (fresh gas dosage)
Pneumatic interface to ventilator
–
Fresh gas isolation and minimized compliance
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
1.2.3
–
Fig. 2
O2 flush (O2+), mechanical safety O2 adjuster
Double vaporizer plug-in system with lock
–
Auto Exclusion system
–
Optional external A-cone as fresh gas outlet
No.2310_0000005920
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Function descriptions
General
Monitor control panel
4901
1.2.4
Fig. 3
Monitor control panel
The parameters for fresh gas flow control, ventilation, and gas monitoring are
displayed on a 12-inch colour screen.
The following parameters are monitored:
–
Airway pressure
–
Inspiratory and expiratory flow
–
Circle system leakage
–
Inspiratory and expiratory O2 concentration
–
CO2 and anaesthetic gas measurement
–
Anaesthetic gas recognition
–
Quantitative measurement of mixed-gas values and MAC calculation
(age-relevant)
A data view, a trend view (graphical) and a log view can be selected.
12
–
Free configuration of 3 real-time curves and different numerical values.
–
Ventilator presets dependent on body weight (Vt and frequency) and agedependent calculation of the minimum alveolar concentration (MAC)
according to "Mapleson" as well as age-dependent scaling of the
volumeter and influence on ventilation monitoring.
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As from software release 2.n the following settings are possible:
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Function descriptions
General
The safety concept incorporates the following tests:
1.2.5
Automatic self-test with mixer test, ventilator test and test of breathing
system.
–
Test and automatic calibration of all sensors.
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
Primus component structure
4907
1.3
Options
–
Fig. 4
Primus component structure
The "Block diagrams" section includes a "Block diagrams".
1.3.1
NEUTRAL POINT PCB
The NEUTRAL POINT PCB connects the components of the Primus to the
power supply, additional signal wires and the CAN bus.
For more information see the following section on "NEUTRAL POINT PCB".
Graphical user interface
(GUI)
No.2310_0000005920
1.3.2
Technical Documentation IPM
The GUI comprises the following components:
–
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
SpO2.
–
Patient Gas Module (PGM) for measurement of O2, CO2 and anaesthetic
gas.
Primus
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Page 14
Function descriptions
General
For more information see "GUI".
1.3.3
Mixer
The mixer comprises the following function units:
–
Electronically controlled and monitored mixer
–
Vaporizer plug-in system for one or two conventional vaporizer types
–
External fresh gas outlet, A-cone (optional)
–
Pressure monitoring for pipeline supply and compressed gas cylinders
For more information see the following section on "Mixer".
1.3.4
VGC (Ventilation and
Gas Controller)
The VGC comprises the following function units:
–
Electronically controlled and driven ventilator
–
Integrated breathing system for "Low Flow" and "Minimum Flow"
applications
–
The BSE module (option) delivers an acoustic signal for inspiration and
expiration.
For more information see "VGC".
1.3.5
Power supply unit
The power supply unit comprises:
–
Switched-mode power supply unit
–
Uninterruptible power supply (UPS) consisting of two 12 V lead-gel
batteries.
–
Battery charge management
For more information see "Power supply unit".
Cylinder pressure
regulator
The cylinder pressure regulators reduce the pressure of the optional
compressed gas cylinders.
No.2310_0000005920
1.3.6
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Function descriptions
NEUTRAL POINT PCB
2
NEUTRAL POINT PCB
5021
The NEUTRAL POINT PCB is the central signal and voltage distributor.
Position of Neutral Point PCB
Fig. 6
NEUTRAL POINT PCB component layout
5022
Fig. 5
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Item
Technical Documentation IPM
Connector (to Fig. 6)
1
Monitor Control Panel B (MoBi).
2
Monitor Control Panel A (MoBi).
3
Ventilation and Gas Controller (VGC).
4
Mixer B.
5
Mixer A.
6
Safety O2 flow valve (microswitch).
7
Power switch (main switch).
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Function descriptions
NEUTRAL POINT PCB
Item
Connector (to Fig. 6)
Halogen lamp
9
Jack plug (production tests).
10
PGM.
11
Power supply unit A.
12
Power supply unit B.
13
Not assigned.
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Function descriptions
GUI
3
GUI
5028
The following section describes the user interface ( "GUI = Graphical User
Interface").
Fig. 7
GUI block diagram
The "Block diagrams" section includes a "Block diagrams".
The GUI comprises the following components:
MoBi (monitor/control panel)
–
S-Box (interface box)
–
Patient Gas Module (PGM), see "Patient gas module".
Monitor/control panel (MoBi)
5029
3.1
–
Fig. 8
Position of monitor/control panel (MoBi)
The "Block diagrams" section includes a "Block diagrams".
No.2310_0000005920
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.
The Patient Gas Module (PGM) is connected to the GUI.
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Function descriptions
5031
GUI
Fig. 9
Exploded view of MoBi
Item
3.1.1
MONITOR/CONTROL
PANEL PCB
Components (to Fig. 9)
1
Front panel with keypad. Includes keypad membrane covering with
design imprint, keys LEDs (e.g. for pipeline supply gases), the carrier plate and the shielding, anti-glare glass screen.
2
12-inch colour display (TFT, resolution: 800 x 600).
3
MONITOR/CONTROL PANEL PCB (motherboard).
4
Backlight converter (display backlight).
5
LCD800 PCB (Adapter PCB for connection of different makes of
display).
6
Loudspeaker.
7
Rotary knob.
8
Adjuster (central operator control element).
The following software is installed on the PCB:
–
GUI software
–
Monitoring and evaluation software for the PGM
–
Software for Medibus ports and SpO2
A 2-processor system is in operation on the PCB. The system comprises a
Display Master (DiMa) and a Communication Master (CoMa).
18
–
Motorola processor (MPC823) with 48 MHz clock frequency and 32-bit
address and data buses.
–
Flash-PROM (program memory)
–
RAM (data memory)
–
CAN controller
–
RS232 interface for in-house development purposes
–
Serial communication channel for Ethernet
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Technical Documentation IPM
No.2310_0000005920
The powerful DiMa processor incorporates the following components:
Page 19
Function descriptions
GUI
The LCD controller is a programmable logic device ("PLD"). A "DRAM"
serves as the video memory.
The CoMa processor system primarily controls communication with the other
Primus components.
The CoMa incorporates the following components:
–
Motorola processor (M68332) with 16.7 MHz clock frequency, internal 32bit bus and external 16-bit data bus
–
Flash-PROM (program memory)
–
RAM (data memory)
–
RS232 interface for communication with the SPO2, PGM and Medibus 13 modules
–
Real-time clock (RTC)
–
Keyboard and turn knob scan, LED actuation and sound output
–
CAN interface
Both processor systems communicate by way of a Dual-Port RAM (DPR).
This memory block is battery-buffered. The buffering is provided primarily by
the UPS batteries of the Primus. If the UPS batteries fail, the lithium battery
on the MONITOR/CONTROL PANEL PCB ensures data is retained.
The operating voltage is provided by an unstabilized voltage of 20 V to 30 V
(Vcc). DC converters on the MONITOR/CONTROL PANEL PCB generate all
other voltages on the PCB.
The MoBi is interconnected over the CAN bus with the other components of
the Primus (power supply unit, mixer and VGC).
S-Box (new version)
5033
No.2310_0000005920
3.2
Fig. 10
Technical Documentation IPM
Position of S-Box (device rear panel)
Primus
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Page 20
Function descriptions
GUI
As standard the S-Box includes the externally accessible Medibus ports
(COM 1-2), IV-System (syringe pumps).
5043
The S-Box is prepared for conversion to the SpO2 measurement function
(option) – see 3.3.2 SpO2 sampling function (option)).
Fig. 11
S-Box layout
Item
Components (to Fig. 11)
1
Drawer unit components fully mounted
2
BACKPLANE PCB
3
SpO2 ADAPTER PCB (SpO2 PCB not shown)
5035
The BACKPLANE PCB (see Fig. 12) is the base component for additional
modules and the insulated interfaces to external devices.
Fig. 12
BACKPLANE PCB
The "Block diagrams" section includes a "Block diagrams".
The BACKPLANE PCB has the following functions:
20
–
Electrical isolation and level conversion of the two Medibus ports (RS232)
–
Interface to the IV system (Ethernet for TIVA)
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Technical Documentation IPM
No.2310_0000005920
3.2.1
S-Box, block diagram, detailed
Page 21
Function descriptions
GUI
–
3.2.2
SpO2 sampling function
(option)
Connection of SpO2 measurement function (option) to 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
The SpO2 sensor essentially comprises two LEDs (light-emitting diodes)
which alternatingly emit infrared light with typical wavelengths of 920 nm or
660 nm respectively. An opposing photodetector measures the radiant
intensity. The sensor is placed on a part of the body on which arterial blood
vessels can be X-rayed, such as the fingers, toes or bridge of the nose.
The module from Nellcor detects the "DS-100A" SpO2 sensor only. The
sensor is identifiable by the fact that all nine pins are present on the
connector.
The "DS-100A" SpO2 sensor is connected without a pre-amplifier to the
module. The module communicates through a serial port with the
MONITOR/CONTROL PANEL PCB. On the BACKPLANE PCB the module is
electrically isolated with 1.5 kV.
S-Box (old version)
5042
3.3
No.2310_0000005920
Fig. 13
Position of S-Box (device rear panel)
The "Block diagrams" section includes a "Block diagrams".
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Function descriptions
5040
GUI
Fig. 14
S-Box layout
Item
Components (to Fig. 11)
Drawer unit components fully mounted
2
BACKPLANE PCB
3
SpO2 ADAPTER PCB (SpO2 PCB not shown)
5039
1
Fig. 15
S-Box, block diagram
The S-Box as standard includes the BACKPLANE PCB and thus the
externally available Medibus ports (COM 1-3), IV-System (Ethernet for TIVA)
and a CAN port (SABUS exclusively for debug purposes).
The S-Box is prepared for the SpO2 option.
3.3.1
BACKPLANE PCB
The BACKPLANE PCB is the base component for additional modules and
the insulated interfaces to external devices.
The "Block diagrams" section includes a "Block diagrams".
22
–
Electrical isolation and level conversion of the three Medibus ports
(RS232)
–
Connects the MoBi with the CAN (SABUS) and Ethernet (TCP/IP)
connectors
–
Connects the optional hardware (SPO2, IV-System) to the MoBi (from
software version 1.n).
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Technical Documentation IPM
No.2310_0000005920
The BACKPLANE PCB has the following functions:
Page 23
Function descriptions
GUI
3.3.2
SpO2 sampling function
(option)
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
The SpO2 sensor essentially comprises two LEDs (light-emitting diodes)
which alternatingly emit infrared light with typical wavelengths of 920 nm or
660 nm respectively. An opposing photodetector measures the radiant
intensity. The sensor is placed on a part of the body on which arterial blood
vessels can be X-rayed, such as the fingers, toes or bridge of the nose.
The module from Nellcor detects the "DS-100A" SpO2 sensor only. The
sensor is identifiable by the fact that all nine pins are present on the
connector.
No.2310_0000005920
The "DS-100A" SpO2 sensor is connected without a pre-amplifier to the
module. The module communicates through a serial port with the
MONITOR/CONTROL PANEL PCB. On the BACKPLANE PCB the module is
electrically isolated with 1.5 kV.
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Page 24
Function descriptions
Patient gas module
4
Patient gas module
The patient gas module is an integrated component of the GUI function unit
(see "GUI").
There are three versions of the patient gas module:
–
PGM
–
PGM2
–
PGM3
The Block diagrams section includes the "Block diagrams".
Differences between PGM, PGM2 and PGM3:
PGM
PGM2
PGM3
Anaesthetic gas measurement
IRIA
ILCA2
O2 measurement
Electrochemical O2 cell
SERVOMEX or PATO O2
sensor
Electrochemical O2 cell
O2 measurement electronics
AMO O2 PUMP PCB
AMO MFM PCB
AMO O2 PUMP PCB
Pump flow
150 mL
200 mL
Flush flow
200 mL
250 mL
4.1
200 mL
Patient gas module PGM
5047
No.2310_0000005920
The following diagram shows the position of the PGM with the rear panel
open.
Fig. 16
24
Position of patient gas module (PGM)
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Function descriptions
Patient gas module
5048
One component of the PGM is the water trap. The water trap is accessible
from the front (see Fig. 17).
Water trap position
Fig. 18
Exploded view of PGM
No.2310_0000005920
5049
Fig. 17
Item
1
Technical Documentation IPM
Components (to Fig. 18)
Connection board
Primus
25