Primus Technical Documentation Rev 2.0

Page 1

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.

Page 2

No.2310_0000005920

This page intentionally left blank.

2

Primus

Technical Documentation IPM

Page 4

No.2310_0000005920

This page intentionally left blank.

4

Primus

Technical Documentation IPM

Page 5

General

This chapter contains general notes and definitions that are important for the

use of this documentation.

General notes ...........................................................................................................................

6

No.2310_0000005920

1

Technical Documentation IPM

Primus

5

Page 6

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.

6

Primus

Technical Documentation IPM

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.

Technical Documentation IPM

Primus

7

Page 8

No.2310_0000005920

This page intentionally left blank.

8

Primus

Technical Documentation IPM

Page 9

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 .........................................................................................................................

10

15

17

24

50

64

96

100

102

103

108

No.2310_0000005920

1

2

3

4

5

6

7

8

9

10

11

Technical Documentation IPM

Primus

9

Page 10

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.

Primus

Technical Documentation IPM

No.2310_0000005920

1.2.2

–

Page 11

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

–

Technical Documentation IPM

Primus

11

Page 12

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.

Primus

Technical Documentation IPM

No.2310_0000005920

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

Page 13

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

13

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

14

Primus

Technical Documentation IPM

Page 15

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

No.2310_0000005920

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).

Primus

15

Page 16

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.

No.2310_0000005920

8

16

Primus

Technical Documentation IPM

Page 17

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.

Technical Documentation IPM

Primus

17

Page 18

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

Primus

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

19

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)

Primus

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".

Technical Documentation IPM

Primus

21

Page 22

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).

Primus

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.

Technical Documentation IPM

Primus

23

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)

Primus

Technical Documentation IPM

Page 25

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