Primus IE Technical Documentation Rev 3.0

Page 1

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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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.

–

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.

The electronic fresh gas mixer offers the following features:

–

Gas flow control for O2, N2O and AIR.

–

Dosage range from 200 mL/min to 18 L/min.

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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

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The following parameters are monitored:

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–

Airway pressure.

–

Inspiratory and expiratory flow.

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Circle system leakage.

–

Inspiratory and expiratory O2 concentration.

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Function descriptions

General

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CO2 measurement and anaesthetic gas measurement.

–

Anaesthetic 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.

–

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.

–

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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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.

–

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 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.

–

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.

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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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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").

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–

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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.

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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.

–

Monitoring and evaluation software for the PGM.

–

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).

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–

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

address and data buses.

–

Flash-PROM (program memory).

–

RAM (data memory).

–

CAN controller.

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The powerful DiMa processor incorporates the following components:

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Function descriptions

GUI

–

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 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 12 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 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.

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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)).

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S-Box layout

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Fig. 11

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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)

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3.2.2

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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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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

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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")

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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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8842

Fig. 15

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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

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1

Fig. 17

Second exploded view of PGM2 IE (example with "WaterLock")

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