NORTH AMERICAN DRÄGER Primus User manual

Technical Documentation

Primus Anaesthetic Workstation

Revision 6.0

5132.300 9036004

Because you care

Contents

General

1 Symbols and Definitions 3

2 Notes 3

Function Description

1 General 7

1.1 Medical purpose ..................................................................................................................... 7

1.2 Product classification ............................................................................................................. 8

1.3 Protection classes .................................................................................................................. 8

1.4 Short description of Primus ...................................................................................................9

1.4.1 Ventilator .................................................................................................................. 9

1.4.2 Breathing system ...................................................................................................... 9

1.4.3 Mixer (fresh gas metering) .................................................................................... 10

1.4.4 Monitor control panel .............................................................................................. 11

1.4.5 Options ................................................................................................................... 12

1.5 Primus component structure ............................................................................................... 12

1.5.1 NEUTRAL POINT PCB .......................................................................................... 12

1.5.2 Graphical User Interface (GUI) ............................................................................... 13

1.5.3 Mixer ....................................................................................................................... 13

1.5.4 VGC (Ventilation and Gas Controller) .................................................................... 13

1.5.5 Power pack ............................................................................................................. 13

1.5.6 Cylinder pressure regulator .................................................................................... 13

2 NEUTRAL POINT PCB 15

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Contents

3 GUI 17

3.1 Monitor Control Panel (MoBi) ...............................................................................................17

3.1.1 MONITOR CONTROL PANEL PCB ....................................................................... 19

3.2 S-Box (interface box) ............................................................................................................20

3.2.1 BACKPLANE PCB ..................................................................................................21

3.2.2 SpO2 sampling function (option) .............................................................................22

4 Patient gas module 23

4.1 Version PGM2 ...................................................................................................................... 23

4.1.1 ILCA2 function ........................................................................................................26

4.1.2 PGM2 with Pato O2 sensor ....................................................................................28

4.1.3 PGM2 with Servomex O2 sensor ...........................................................................30

4.1.4 Pneumatics of the PGM2 ........................................................................................32

4.2 Version PGM ........................................................................................................................ 34

4.2.1 PGM pneumatic components ................................................................................. 37

4.3 Operating modes .................................................................................................................. 39

4.3.1 "Reduced Accuracy" mode (PGM only) .................................................................. 39

4.3.2 "ISO" mode (ISO accuracy) (PGM/PGM2) ............................................................. 39

4.3.3 "Full Accuracy" mode (PGM only) ..........................................................................39

4.3.4 "Standby" response of the Primus (PGM/PGM2) ................................................... 39

4.3.5 IRIA/ILCA2 calibration ...........................................................................................39

4.3.6 Auto-Wake-up function ..........................................................................................39

4.3.7 O2 sensor/Servomex ..............................................................................................39

4.4 PGM/PGM2 electronics ........................................................................................................40

4.4.1 MOPS PCB (PGM/PGM2) ......................................................................................40

4.4.2 AMO IRIA PCB (PGM) ............................................................................................40

4.4.3 AMO ILCA2 PCB (PGM2) .......................................................................................40

4.4.4 AMO O2 PUMP PCB (PGM) ..................................................................................40

4.4.5 AMO MFM PCB (PGM2) ........................................................................................40

4.4.6 AMO FLOW ILCA PCB (PGM/PGM2) .................................................................... 41

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Contents

5 Mixer 43

5.1 Operating modes .................................................................................................................. 46

5.1.1 10 VA mode ............................................................................................................ 46

5.1.2 'Normal' mode ........................................................................................................ 46

5.2 Layout ................................................................................................................................... 46

5.2.1 MIXER PCB ............................................................................................................ 46

5.2.2 PRIMUS CPU PCB (mixer) .................................................................................... 47

5.3 Gas inlet block (AIR, O2 and N2O) ...................................................................................... 48

5.3.1 Pneumatic components, gas inlet block ................................................................. 50

5.3.2 Pressure status LEDs ............................................................................................. 52

5.4 Mixer block ........................................................................................................................... 55

5.5 Pneumatic system ................................................................................................................ 56

5.5.1 VMIX valves ........................................................................................................... 57

5.5.2 PDMIX and RM ...................................................................................................... 57

5.5.3 PTANK (pressure sensor) ....................................................................................... 57

5.5.4 VTANK valve .......................................................................................................... 57

5.5.5 VMGS (fresh gas flow valve) .................................................................................. 57

5.5.6 PDMGSHI / PDMGSLO (differential pressure sensors) ......................................... 57

5.5.7 PSYS (pressure sensor) ......................................................................................... 57

5.5.8 VSWAK (A-cone valve) .......................................................................................... 58

5.5.9 VBAK (safety valve) ............................................................................................... 58

5.5.10 TEMPTANK / TEMPBLOCK (temperature sensors) ............................................... 58

5.5.11 VSFC (safety O2 adjuster) ..................................................................................... 58

5.5.12 VO2+ (flush button) ................................................................................................ 58

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III

Contents

6 VGC 59

6.1 VGC electronics ....................................................................................................................61

6.1.1 VGC POWER PCB .................................................................................................61

6.1.2 PRIMUS ANALOG PCB .........................................................................................61

6.2 Piston cylinder unit (PCU) ....................................................................................................62

6.3 VGC pneumatic block ...........................................................................................................64

6.4 VGC pneumatic system ........................................................................................................65

6.5 Interface plate .......................................................................................................................67

6.6 Breathing system ..................................................................................................................69

6.6.1 Compact breathing system pneumatic components ............................................... 72

6.7 Automatic ventilation ............................................................................................................73

6.7.1 Inspiration ...............................................................................................................73

6.7.2 Expiration ................................................................................................................75

6.8 Manual ventilation .................................................................................................................77

6.8.1 Inspiration ...............................................................................................................77

6.8.2 Expiration ................................................................................................................78

6.9 Spontaneous breathing .........................................................................................................79

6.9.1 Inspiration ...............................................................................................................79

6.9.2 Expiration ................................................................................................................80

7 Ventilation modes with software version 2.n or higher 81

7.1 “Volume Mode” .....................................................................................................................81

7.2 “Pressure Mode” ...................................................................................................................84

7.3 “Pressure Support Mode” .....................................................................................................87

7.4 “Man./Spont Mode” ...............................................................................................................88

7.5 Switching ventilation modes .................................................................................................89

7.6 HLM mode ............................................................................................................................89

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8 Power pack 91

8.1 Power pack input .................................................................................................................. 91

8.2 Power switch ........................................................................................................................ 92

8.3 Output voltages and currents ............................................................................................... 92

8.4 Secondary connector ........................................................................................................... 93

8.5 UPS batteries ....................................................................................................................... 93

8.6 Power pack CAN communication ......................................................................................... 94

8.7 Power failure warning ........................................................................................................... 94

9 Operating modes 95

9.1 Cold start .............................................................................................................................. 95

9.2 Standby mode ...................................................................................................................... 95

9.3 Shutdown ............................................................................................................................. 95

9.4 Safety mode ......................................................................................................................... 95

9.4.1 Safety O2 flow ........................................................................................................ 95

9.5 Alarm system ........................................................................................................................ 96

10 Cylinder pressure reducer 97

11 Vaporizer 101

12 Bronchial aspirator 103

12.1 Intended use ....................................................................................................................... 103

12.2 Device types ....................................................................................................................... 103

12.2.1 Variants ................................................................................................................. 103

12.3 Bronchial aspirator with ejector .......................................................................................... 103

12.3.1 Pneumatics (ejector) ............................................................................................ 104

12.4 Bronchial aspirator with vacuum ........................................................................................ 105

12.4.1 Pneumatics (vacuum) ........................................................................................... 106

13 Block diagrams and pneumatic components layout 109

13.1 Introduction ......................................................................................................................... 109

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Maintenance Procedures

1 Safety precautions 123

2 Rear panel 125

2.1 Rear panel removal ............................................................................................................125

2.2 Rear panel fitting .................................................................................................................125

2.2.1 Rear panel final check ..........................................................................................125

3 Replacing bronchial suction device bacterial filter 127

4 Replacing filter mat on PGM fan 129

5 Replacing bacterial filter and Nafion tube in PGM 131

5.1 Removing the PGM ............................................................................................................131

5.1.1 Removing the PGM housing ................................................................................. 131

5.2 Replacing the bacterial filter ...............................................................................................133

5.3 Replacing the Nafion tube ................................................................................................. 133

5.4 Fitting the PGM housing (new) ...........................................................................................134

6 Cleaning or replacing filter mat in housing cover 137

6.1 Filter mat removal ...............................................................................................................137

6.1.1 Filter mat fitting .....................................................................................................138

7 Replacing filter mat in power pack 139

8 Replacing UPS batteries 141

8.1 Power pack removal ...........................................................................................................141

8.2 Removing UPS batteries ....................................................................................................142

8.3 Fitting UPS batteries ...........................................................................................................144

8.4 Fitting the power pack .........................................................................................................146

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9 Cleaning or replacing large and small filter mats in VGC 147

9.1 Removal of large filter mat ................................................................................................. 147

9.1.1 Fitting of large filter mat ........................................................................................ 149

9.2 Removal of small filter mat ................................................................................................. 149

9.2.1 Fitting of small filter mat ....................................................................................... 150

10 Replacing bag upper roller diaphragm 151

11 Replacing the lower rolling seal (VGC) 153

11.1 Removing the VGC ............................................................................................................ 153

11.2 Removing the piston-cylinder unit ...................................................................................... 158

11.2.1 Removing/Fitting the lower rolling seal ................................................................. 162

11.3 Mounting piston-cylinder unit .............................................................................................. 168

12 Replacing pressure regulators PRPN2O, PRPAIR, PRPO2 173

12.1 Removing gas inlet block pressure regulators ................................................................... 173

12.2 Fitting pressure regulators .................................................................................................. 174

13 Replacing CPU PRIMUS PCB lithium battery 179

13.1 Removing mixer ................................................................................................................. 179

13.2 Removing mixer cover ........................................................................................................ 182

13.3 Replacing the lithium battery .............................................................................................. 183

13.4 Fitting mixer cover .............................................................................................................. 184

13.5 Mixer fitting ......................................................................................................................... 184

14 Replacing PEEP diaphragm and MAN/SPONT diaphragm 185

15 Pressure regulator major overhaul 189

15.1 Safety precautions .............................................................................................................. 189

15.2 Required spare parts .......................................................................................................... 190

15.3 Service Equipment Required .............................................................................................. 191

15.4 Removing the pressure regulator ....................................................................................... 192

15.5 Replacing the “Major Overhaul” spare parts set ................................................................. 194

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VII

Contents

Schematics and Diagrams

1 Primus pneumatic components diagram 203

2 Schematics and Diagrams 209

Annex

Parts catalog

Test List

Technical Information

VIII

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General

Primus General

1 Symbols and Defini-

tions

WARNING

A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the equipment or other property.

NOTE

A NOTE provides additional information intended to avoid inconvenience during operation.

Definitions according to German standard DIN 31051:

Inspection = examination of actual condition

Maintenance = measures to maintain specified condition

Repair = measures to restore specified condition

Servicing = inspection, maintenance, and repair

2Notes

This Technical Documentation conforms to the IEC 60601-1 standard.

Read each step in every procedure thoroughly before beginning any test. Always use the proper tools and specified test equipment. If you deviate from the instructions and/or recommendations in this Technical Documentation, the equipment may operate improperly or unsafely, or the equipment could be damaged.

It is our recommendation to use only Dräger parts and supplies.

The maintenance procedures described in this Technical Documentation may be performed by qualified service personnel only. These maintenance procedures do not replace inspections and servicing by the manufacturer.

The information in this Technical Documentation is confidential and may not be disclosed to third parties without the prior written consent of the manufacturer.

This Technical Documentation is for the purpose of information only. Product descriptions found in this Technical Documentation are in no way a substitute for reading and studying the Instructions for Use/Operating Manual enclosed with the product at the time of delivery.

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General Primus

Know-how contained in this Technical Documentation is subject to ongoing change through research and development and Dräger Medical reserves the right to make changes to this Technical Documentation without notice.

NOTE

Unless otherwise stated, reference is made to laws, regulations or standards (as amended) applicable in the Federal Republic of Germany for equipment used or serviced in Germany. Users or technicians in all other countries must verify compliance with local laws or applicable international standards.

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Function Description

Primus Function Description

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.

Application:

– Inhalation anesthesia in rebreathing systems.

– Inhalation anesthesia in virtually closed systems for low-flow and mini-

mum-flow applications.

– Inhalation anesthesia in non-rebreathing systems with separate fresh gas

output for connection of “Bain” or “Magill” system, for example, with a fresh gas flow of 0.2 L/min to 18 L/min.

Changed ventilation modes (software 2.n or higher):

– Volume-controlled ventilation “Vol u m e Mode”. Switchable functions:

• Synchronization.

• Pressure support (optional).

– Pressure-controlled ventilation “Pressure Mode” Switchable functions:

• Synchronization.

• Pressure support (optional).

– Manual ventilation “MAN”.

– Spontaneous breathing “SPONT”.

– Pressure-assisted ventilation “Pressure Support” (optional).

Ventilation modes (up to software d1.06):

– Volume-controlled ventilation “IPPV, SIMV”.

– Pressure-controlled ventilation “PCV”

– Manual ventilation “MAN”.

– Spontaneous breathing “SPONT”.

Displayed values:

– Peak pressure “Ppeak”, mean pressure “Pmean”, plateau pressure

“Pplat, PEEP”.

– Expiratory minute volume “MV”, tidal volume “VT”, respiratory frequency

“f”.

– Inspiratory and expiratory concentrations of O2, N2O, anesthetic gas and

CO2.

– System compliance and leakage minute volume.

– Functional oxygen saturation “SpO2” and pulse rate (optional).

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Function Description Primus

Curve diagrams:

– Airway pressure “Paw”.

– Inspiratory and expiratory flow “V”.

– Inspiratory and expiratory concentrations of O2, CO2 and anesthetic gas.

– Plethysmogram (optional).

– P/V loops and flow/V loops (optional in software 2.n or higher).

Bargraph:

– Display of inspiratory tidal volume, expiratory tidal volume and leakage

tidal volume.

– Volumeter.

– Econometer (optional in software 2.n or higher).

Time trends of measured values (trends) are additionally available.

Monitoring:

– By programmable alarm limits which can be adjusted automatically to the

respective ventilation situation.

Monitored parameters:

– Airway pressure “Paw”.

– Expiratory minute volume “AMV”.

– Apnea (deactivated in heart-lung machine mode (HLM mode)).

– Inspiratory and expiratory anesthetic gas concentrations.

– Detection of anesthetic gas mixtures.

– Inspiratory O2 and N2O concentrations (breathing-phase independent

measurement in HLM mode).

– Inspiratory and expiratory CO2 concentrations (breathing-phase indepen-

dent measurement in HLM mode).

– Optional: Oxygen saturation (alarms deactivated in HLM mode), pulse

rate.

1.2 Product classification

– Class II b, according to rules 2, 9 and 11 of the Medical Products Direc-

tive.

1.3 Protection classes – Protection class I, type B according to EN 60601-1.

– With optional SpO2: Protection class I, type BF.

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Primus Function Description

1.4 Short description of Primus

1.4.1 Ventilator

The following sections provide an overview of the Primus components.

Figure 1 Ventilator with breathing system

The electronically controlled and driven ventilator has the following features:

– Tidal volumes of 20 mL (10 mL with software 2.n or higher) to 1400 mL at

frequencies of 3/min to 80/min.

– Peak flow of up to 150 L/min.

– Ventilation modes such as IPPV, PCB, SIMV (plus adjustable trigger, plus

adjustable PEEP) and MAN/SPONT (up to software 1.n).

– Ventilation modes such as volume mode, pressure mode, pressure sup-

port (optional) and MAN/SPONT with switchable synchronization and pressure assistance (optional).

1.4.2 Breathing system 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.

– Pneumatic interface to ventilator.

– Fresh gas isolation and minimized compliance.

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Function Description Primus

1.4.3 Mixer (fresh gas metering)

The electronic mixer offers the following features:

– Gas metering for O2, N2O and AIR.

– Metering range from 200 mL/min to 18 L/min.

– Alarm monitoring for the pressure values of the central supply (CS) and

the cylinder supply. LEDs on the front panel indicate the pressure status.

– ORC function for low-flow and minimum-flow applications.

– O2 flush and mechanical safety O2 adjuster (see Figure 2).

Figure 2 O2 flush (O2+), mechanical safety O2 adjuster

– Double Vapor plug-in system with interlock.

– Optional external A-cone as fresh gas outlet.

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Primus Function Description

1.4.4 Monitor control panel

Figure 3 Monitor control panel

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

The following parameters are monitored:

– Airway pressure.

– Inspiratory and expiratory flow.

– Circle system leakage.

– Inspiratory and expiratory O2 concentration.

– CO2 measurement and anesthetic gas measurement.

– Anesthetic gas detection.

– Quantitative measurement of mixed-gas values and MAC calculation

(age-relevant).

A data view, a trend view (graphical) and a log view can be selected.

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

– Free configuration of 3 real-time curves and different numerical values.

– Body-weight-relevant ventilator presettings (Vt and frequency) and age-

relevant calculation of minimum alveolar concentration (MAC ) according to “Mapleson” as well as age-relevant scaling of volumeter and influence on ventilation monitoring.

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Function Description Primus

The safety concept incorporates the following tests:

– Automatic self-test with mixer test, ventilator test and test of the breathing

system.

– Test and automatic calibration of all sensors.

1.4.5 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 chang-

ing parameters.

– P/V and flow/V loops (with software 2.n or higher).

– Econometer function (with software 2.n or higher).

– Additional ventilation modes (e.g. autoflow, CPAP).

– Additional languages available for display texts.

1.5 Primus component structure

Figure 4 Primus component structure

In the “Block diagrams” section, you will find a detailed block diagram of the

Primus.

1.5.1 NEUTRAL POINT PCB The NEUTRAL POINT PCB connects the components of the Primus to the

power supply, additional signal wires and the CAN bus.

More details are given in the following section on the NEUTRAL POINT PCB.

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Primus Function Description

1.5.2 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 anesthesia parameters are displayed.

– S-Box (Interface box). PC interfaces and optional measuring functions

such as SpO2 and BIS

– Patient Gas Module (PGM) for measurement of O2, CO2 and anesthetic

gas.

For more details refer to the section headed GUI.

1.5.3 Mixer The mixer comprises the following function units:

– Electronically controlled and monitored mixer.

– Vapor plug-in system for one or two conventional vaporizer types.

– External fresh gas outlet, A-cone (optional).

– Pressure monitoring for CS and compressed gas cylinders.

More details are given in the following section on the mixer.

1.5.4 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” applica-

tions.

For more details refer to the section headed VGC.

1.5.5 Power pack The power pack comprises:

– Switched-mode power supply unit.

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

two 12 V lead-gel batteries.

– Battery charging management.

For more details refer to the section headed Power pack.

1.5.6 Cylinder pressure regulator

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

For more details refer to the section headed Cylinder pressure regulators.

The function description relating to the NEUTRAL POINT PCB follows.

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Function Description Primus

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Primus Function Description

2 NEUTRAL POINT

PCB

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

Figure 5 Location of the Neutral Point PCB

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Function Description Primus

Figure 6 Component mounting diagram, NEUTRAL POINT PCB, for leg-

end see Table 1

Table 1 Legend to Figure 6

Item Connector

1 Monitor Control Panel (MoBi).

2 Monitor Control Panel (MoBi).

3 Ventilation and Gas Controller (VGC).

4Mixer B.

5Mixer A.

6 Safety O2 flow valve (microswitch).

7 Power switch (main switch).

8 Halogen lamp

9 Jack plug (production tests).

10 PGM.

11 Power pack A.

12 Power pack B.

13 Not assigned.

The function description relating to the GUI follows.

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Primus Function Description

3GUI The following section describes the user interface (“GUI = Graphical User

Interface”).

Figure 7 GUI block diagram

3.1 Monitor Control Panel (MoBi)

In the “Block diagrams” section, in the block diagram of the Primus, you will find a block diagram of the GUI.

The GUI has the following components:

– MoBi (monitor control panel).

– S-Box (Interface Box).

– Patient Gas Module (PGM). The function description relating to the

Patienten Gas Module (PGM) follows.

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Figure 8 Position of Monitor Control Panel (MoBi)

In the “Block diagrams” section, you will find a block diagram of the MoBi.

Function Description Primus

The user and Primus communicate via the MoBi. The MoBi display presents system and patient information. It is here that the user sets the parameters and ventilation modes.

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

Figure 9 Exploded view of MoBi, for legend see Ta b le 2

Table 2 Legend to Figure 9

Item Components

1 Front panel with membrane keypad. Includes keypad membrane

covering with design imprint, keys, LEDs (e.g. for CS gases), the carrier plate and the shielding, anti-glare glass screen.

2 12 inch color display (TFT, resolution: 800 x 600).

3 MONITOR CONTROL PANEL PCB (motherboard).

4 Backlight converter (display backlighting).

5 LCD800 PCB (adapter PCB for connection of different makes of

display).

6 Loudspeaker.

7 Rotary transducer.

8 Control knob (central operator control element).

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Primus Function Description

3.1.1 MONITOR CONTROL PANEL PCB

The following software is installed on the PCB:

– GUI software.

– Monitoring and evaluation software for the PGM.

– Software for Medibus connections and SpO2.

A 2-processor system is in operation on the PCB. It comprises a Display Master (DiMa) and a Communication Master (CoMa).

The powerful DiMa processor incorporates the following components:

– Motorola processor (MPC823) with 48 MHz clock frequency and 32-bit

address and data buses.

– Flash-PROM (program memory).

– RAM (data memory).

– CAN controller.

– RS232 interface for in-house development purposes.

– Serial communication channel for Ethernet.

The LCD controller is a programmable logic device (“PLD”). A “DRAM” serves as the video memory.

The CoMa processor system primarily controls communication with the other Primus components.

The CoMa incorporates the following components:

– Motorola processor (M68332) with 16.7 MHz clock frequency, internal 32-

bit bus and external 16-bit data bus.

– Flash-PROM (program memory).

– RAM (data memory).

– RS232 interface for communication with the SPO2, PGM and Medibus 1 -

3 modules.

– Real-time clock (RTC).

– Keyboard and rotary knob scan, LED actuation and sound output.

– CAN interface.

Both processor systems communicate by way of a Dual-Port RAM (DPR). This memory device is battery-buffered. The buffering is provided primarily by the UPS batteries of the Primus. If they fail, the lithium battery on the MONITOR CONTROL PANEL PCB ensures data is retained.

The operating voltage is provided by an unstabilized voltage of 20 V to 30 V (Vcc). DC converters on the MONITOR CONTROL PANEL PCB generate all other voltages on the PCB.

The MoBi is interconnected over the CAN bus with the other components of the Primus (power pack, mixer and VGC).

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Function Description Primus

3.2 S-Box (interface box)

Figure 10 Position of S-Box

In the “Block diagrams” section, you will find a block diagram of the S-Box.

Figure 11 Layout of the S-Box, for legend see Tab l e 3

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NORTH AMERICAN DRÄGER Primus User manual

Specifications and Main Features

Frequently Asked Questions

User Manual