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MicroGas 7650 Service Manual Feb 05

Service MANUAL may not be reproduced in part or in whole without the written consent of Linde Medical Sensors. Information contained in this publication may not be used for any purpose other than that for which it was originally supplied. Equipment has been designed and manufactured to meet the requirements of the following safety standards.

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100% found this document useful (1 vote)
1K views121 pages

MicroGas 7650 Service Manual Feb 05

Service MANUAL may not be reproduced in part or in whole without the written consent of Linde Medical Sensors. Information contained in this publication may not be used for any purpose other than that for which it was originally supplied. Equipment has been designed and manufactured to meet the requirements of the following safety standards.

Uploaded by

r2c1
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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LINDE MEDICAL SENSORS AG

MicroGas 7650-500
rapid

SERVICE MANUAL
SERVICE
MANUAL

SERVICE MANUAL

MicroGas 7650-500
rapid

Publ: 76500901 Issue 5


Issued: January 2005

Part No.: 76500901

Page 1
SERVICE
MANUAL

SALES AND SERVICE

Linde Medical Sensors AG Tel.: 41-61 278 81 11


Austrasse 25 Fax: 41-61 278 81 81
4051 Basel
Switzerland

Your local contact for sales and


service of MicroGas 7650:

to be entered by local company or agent

Copyright ©
All rights reserved. The information contained in this publication may
Linde Medical Sensors AG
not be used for any purpose other than that for which it was originally
2005
supplied. The publication may not be reproduced in part or in whole
without the written consent of Linde Medical Sensors.
In order to maintain and improve standards of manufacturing, methods
of functioning and to increase reliability, Linde Medical Sensors
equipments are periodically reviewed. For this reason, the contents of
this publication are subject to change without notice.

Manufactured by:
Linde Medical Sensors AG
Austrasse 25
4051 Basel
Switzerland

Page 2
SERVICE
MANUAL

QUALITY, RELIABILITY This equipment has been designed with an emphasis on QUALITY,
AND SAFETY RELIABILITY AND SAFETY, but Linde Medical Sensors AG will accept
responsibility for these aspects only when the following conditions are met:

a) Electrical installations of the room or building in which the equipment


is to be used must comply with regulations specified by the country in
which the equipment is to be used.

b) The equipment is used in accordance with the instructions for use


provided by Linde Medical Sensors.

c) All modifications and repairs to the equipment are carried out by Linde
Medical Sensors personnel, their authorized agents or Linde Medical
Sensors trained hospital technicians.

d) Modifications must not be carried out unless they conform with


approved Engineering Service Information issued according to the
appropriate Linde Medical Sensors procedure.

e) Equipment installation must be carried out in accordance with local


requirements regarding responsibility and warranty.

f) Only Linde Medical Sensors transcutaneous sensors and accessories


may be used. Other transcutaneous sensors and accessories may
cause improper monitor performance.

The equipment has been designed and manufactured to meet the


requirements of the following safety standards:
EN 60601-1, EN 60601-1-2, IEC 601-2-23, UL 2601-1 and CSA C22.2
No. 601.1-M90

This equipment is fully in conformance with the


requirements of the Council Directive 93/42 EEC of
14. June 1993 concerning Medical Devices.

Page 3
SERVICE
MANUAL

MANUAL STATUS RECORD


Revision No. Issue Date Affected Pages

Page 4
SERVICE
MANUAL

Content

1 General Information .............................................................................................................................12


1.1 Introduction ..........................................................................................................................................12
1.2 Principle of Operation ..........................................................................................................................12
1.3 Controls, Indicators and Connectors ...................................................................................................13
1.3.1 Front panel...........................................................................................................................................13
1.3.2 Rear panel ...........................................................................................................................................14
1.3.3 Underneath base .................................................................................................................................14

2 Specification.........................................................................................................................................15
2.1 IEC Equipment Classification ..............................................................................................................15
2.2 Inputs ...................................................................................................................................................15
2.2.1 Monitor .................................................................................................................................................15
2.2.2 Sensor Type COMBI•M .......................................................................................................................16
2.3 Controls................................................................................................................................................17
2.4 Outputs ................................................................................................................................................17
2.5 Calibrator .............................................................................................................................................18
2.6 Performance ........................................................................................................................................18
2.7 Alarms..................................................................................................................................................19
2.8 Alarm Indications .................................................................................................................................19
2.9 Fault Indications...................................................................................................................................20
2.10 Other Messages ..................................................................................................................................21
2.11 Power Supply and Earthing .................................................................................................................22
2.12 External Features ................................................................................................................................22
2.13 Environmental Operating Conditions...................................................................................................23
2.14 Environmental Transport and Storage Conditions ..............................................................................23
2.15 Electromagnetic Compatibility Declaration ..........................................................................................23
2.15.1 Electromagnetic Emissions..................................................................................................................24
2.15.2 Electromagnetic Immunity ...................................................................................................................24
2.15.3 Electromagnetic Immunity, RF portable equipment ............................................................................25
2.15.4 Recommended separation distances ..................................................................................................26
2.15.5 Cables length .......................................................................................................................................27
2.16 Communication Interface (Systems Connector)..................................................................................27
2.16.1 Overview ..............................................................................................................................................27
2.16.2 Connecting to the Systems Connector ................................................................................................28
2.16.3 Systems Connector pinouts.................................................................................................................28
2.16.4 Communication protocol ......................................................................................................................29
2.16.5 EasyLink ..............................................................................................................................................29
2.16.6 VueLink ................................................................................................................................................33
2.16.7 MonLink ...............................................................................................................................................35
2.16.8 Analog outputs .....................................................................................................................................37
2.17 Accessories .........................................................................................................................................38
2.18 Description of Warning Symbols .........................................................................................................39
2.19 ESD Precautionary Procedures...........................................................................................................39

3 Technical Description ..........................................................................................................................40


3.1 Main PCB.............................................................................................................................................40
3.2 Power supply PCB...............................................................................................................................40
3.3 Floating board ......................................................................................................................................40

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SERVICE
MANUAL

3.4 Display PCB.........................................................................................................................................41


3.5 Touchpanel ..........................................................................................................................................41
3.6 Calibrator assy.....................................................................................................................................41

4 Installation............................................................................................................................................42
4.1 Installation Checks...............................................................................................................................42
4.2 Location ...............................................................................................................................................42
4.3 Changing the Mains Voltage Setting ...................................................................................................43
4.4 External DC Supply .............................................................................................................................43
4.5 Changing the Setting of the Measuring Unit from mmHg to kPa ........................................................43

5 Maintenance and Fault Finding ...........................................................................................................44


5.1 Introduction ..........................................................................................................................................44
5.2 Routine Maintenance...........................................................................................................................44
5.2.1 Check Monitor.....................................................................................................................................45
5.2.2 Check Sensor .....................................................................................................................................45
5.2.3 Check Consumables............................................................................................................................45
5.3 Routine Safety and Performance Check .............................................................................................45
5.3.1 Inspection.............................................................................................................................................45
5.3.2 Performance test .................................................................................................................................46
5.3.3 Safety test ............................................................................................................................................46
5.4 Adjustement and Performance Check.................................................................................................46
5.4.1 Check inscriptions and labels ..............................................................................................................47
5.4.2 Inspect all plugs and cables ................................................................................................................47
5.4.3 Check fuses .........................................................................................................................................47
5.4.4 Check start-up .....................................................................................................................................47
5.4.5 Check retention of parameter and alarm settings ...............................................................................48
5.4.6 Check alarms .......................................................................................................................................48
5.4.7 Check battery.......................................................................................................................................48
5.4.8 Main PCB voltages ..............................................................................................................................49
5.4.9 Floating board supply and reference voltages ....................................................................................49
5.4.10 Heating circuit and Sensor Fault .........................................................................................................50
5.4.11 Check of PO2/PCO2 Measurement......................................................................................................51
5.4.12 Analog output (Systems Connector)....................................................................................................52
5.4.13 Pressure transducer and pressure switch ...........................................................................................52
5.4.14 Access to Sensor Memory...................................................................................................................52
5.4.15 Battery charger: ...................................................................................................................................53
5.4.16 Safety checks.......................................................................................................................................53
5.5 Electrical Safety Checks ......................................................................................................................53
5.6 Decontamination..................................................................................................................................53
5.6.1 Decontamination requirements............................................................................................................53
5.6.2 Risks ....................................................................................................................................................54
5.6.3 Precautions ..........................................................................................................................................54
5.6.4 DO's and DON'Ts ................................................................................................................................55
5.6.5 Decontamination procedures...............................................................................................................55
5.7 Replacement of Internal Battery ..........................................................................................................58
5.8 Fault Finding ........................................................................................................................................58
5.8.1 Sensor Fault.........................................................................................................................................58
5.8.2 Monitor Fault Codes ............................................................................................................................58
5.8.3 Gas System Faults (Calibrator assy)...................................................................................................59

Page 6
SERVICE
MANUAL

6 Removal and Refitting .........................................................................................................................60


6.1 Mains Fuses and Voltage Selector......................................................................................................60
6.1.1 Operating the Fuse Holder ..................................................................................................................60
6.1.2 Setting of the Mains Voltage Range ....................................................................................................60
6.1.3 Refitting the Fuse Holder .....................................................................................................................60
6.2 Case.....................................................................................................................................................60
6.2.1 Removing the Case Assembly ............................................................................................................60
6.2.2 Refitting the Case Assembly................................................................................................................60
6.3 Main PCB.............................................................................................................................................60
6.3.1 Access to Main PCB ............................................................................................................................60
6.3.2 Removal of the Main PCB ...................................................................................................................61
6.3.3 Refitting the Main PCB ........................................................................................................................61
6.4 Floating PCB........................................................................................................................................61
6.4.1 Access to Floating PCB .......................................................................................................................61
6.4.2 Removal of the Floating PCB ..............................................................................................................61
6.4.3 Removal of the sensor input socket assembly ....................................................................................61
6.4.4 Refitting the Floating PCB ...................................................................................................................61
6.5 Power Supply PCB ..............................................................................................................................61
6.5.1 Access to Power Supply PCB..............................................................................................................61
6.5.2 Removal of the Power Supply PCB.....................................................................................................61
6.5.3 Refitting of the Power Supply PCB ......................................................................................................61
6.6 Battery..................................................................................................................................................62
6.6.1 Removal of the Battery ........................................................................................................................62
6.6.2 Fitting a Battery....................................................................................................................................62
6.7 Display PCB.........................................................................................................................................62
6.7.1 Access to the Display PCB ..................................................................................................................62
6.7.2 Removal of the Display PCB ...............................................................................................................62
6.7.3 Refitting of the Display PCB ................................................................................................................62
6.8 Touch Panel.........................................................................................................................................62
6.8.1 Removal of the Touch Panel ...............................................................................................................62
6.8.2 Refitting of the Touch Panel ................................................................................................................62
6.9 Calibrator Assembly.............................................................................................................................63
6.9.1 Removal of Calibrator Assy. ................................................................................................................63
6.9.2 Refitting of the Calibrator Assy. ...........................................................................................................63

7 Parts List and Assembly Drawings ......................................................................................................64


7.1 Introduction ..........................................................................................................................................64
7.2 Recommended Spare Parts ................................................................................................................64
7.2.1 Recommended number of spare parts ................................................................................................64
7.3 General Assy. 7650 0120 ....................................................................................................................65
7.3.1 Parts List No. 7650 0120 Iss. 14 .........................................................................................................65
7.3.2 Drawing No. 7650 0120 Iss. 11 ...........................................................................................................67
7.4 Case Assy. 7650 0121.........................................................................................................................69
7.4.1 Parts List No. 7650 0121 Iss. 4 ...........................................................................................................69
7.4.2 Drawing No. 7650 0121 Iss. 4 .............................................................................................................70
7.5 Front Panel Assy. 7650 0124 ..............................................................................................................71
7.5.1 Parts List No. 7650 0124 Iss. 3 ...........................................................................................................71
7.5.2 Drawing No. 7650 0124 Iss. 3 .............................................................................................................72
7.6 Main PCB Assy. 7650 0811.................................................................................................................73
7.6.1 Parts List No. 7650 0811 Iss. 14 .........................................................................................................73
7.6.2 Drawing No. 7650 0811 Iss. 11 ...........................................................................................................75

Page 7
SERVICE
MANUAL

7.7 Power Supply PCB Assy. 7650 0812 ..................................................................................................77


7.7.1 Parts List No. 7650 0812 Iss. 10 .........................................................................................................77
7.7.2 Drawing No. 7650 0812 Iss. 9 .............................................................................................................78
7.8 Floating Screen Assy. 7650 0034........................................................................................................79
7.8.1 Parts List No. 7650 0034 Iss. 2 ...........................................................................................................79
7.8.2 Drawing No. 7650 0034 Iss. 2 .............................................................................................................80
7.9 Floating PCB Assy. 7650 0813............................................................................................................81
7.9.1 Parts List No. 7650 0813 Iss. 6 ...........................................................................................................81
7.9.2 Drawing No. 7650 0813 Iss. 7 .............................................................................................................83
7.10 Floating Screen Assy. 7650 0034B .....................................................................................................84
7.10.1 Parts List No. 7650 0034B Iss. 2 .........................................................................................................84
7.10.2 Drawing No. 7650 0034B Iss. 1...........................................................................................................85
7.11 Floating PCB Assy. 7650 0817............................................................................................................86
7.11.1 Parts List No. 7650 0817 Iss. 8 ...........................................................................................................86
7.11.2 Drawing No. 7650 0817 Iss. 4 .............................................................................................................88
7.12 Display PCB Assy. 7650 0814.............................................................................................................89
7.12.1 Parts List No. 7650 0814 Iss. 5 ...........................................................................................................89
7.12.2 Drawing No. 7650 0814 Iss. 7 .............................................................................................................90

8 Engineering Service Information .........................................................................................................91


8.1 Introduction ..........................................................................................................................................91

9 Circuit Diagrams ..................................................................................................................................92


9.1 Block Diagram 7650 0009 Iss. 1..........................................................................................................93
9.2 Interconnection Diagram 7650 0010 Iss. 1..........................................................................................94
9.3 Circuit Diagram of Main PCB 7650 0821 Iss. 9 - sheet 1/2.................................................................95
9.4 Circuit Diagram of Main PCB 7650 0821 Iss. 9 - sheet 2/2.................................................................96
9.5 Circuit Diagram of Power Supply PCB 7650 0822 Iss. 7 ....................................................................97
9.6 Circuit Diagram of Floating PCB 7650 0823 Iss. 7 - sheet 1/2............................................................99
9.7 Circuit Diagram of Floating PCB 7650 0823 Iss. 7 - sheet 2/2..........................................................100
9.8 Circuit Diagram of Floating PCB (new version) 7650 0827 Iss. 4 - sheet 1/2...................................101
9.9 Circuit Diagram of Floating PCB (new version) 7650 0827 Iss. 4 - sheet 2/2...................................102
9.10 Circuit Diagram of Display PCB 7650 0824 Iss. 5.............................................................................103
9.11 Touchpanel PCB 7650 0125 Iss. 5....................................................................................................104

10 Packing for Shipment.........................................................................................................................105


10.1 Introduction ........................................................................................................................................105
10.2 Repacking in Original Carton.............................................................................................................105
10.3 Repacking in a Different Carton ........................................................................................................106

11 Reporting Procedures........................................................................................................................107
11.1 Handling and Reporting of Incidents .................................................................................................107
11.2 Management of MFA, ESI, TB...........................................................................................................110

Page 8
SERVICE
MANUAL

PRECAUTIONS

Definitions
A WARNING! indicates that there is a risk of injury to the patient or to the operator.
A CAUTION! refers to a condition that can lead to damage or malfunction of the equipment.

WARNING!

Electrical shock hazard:

When operated by ac power, the monitor must only be connected to a grounded (3-wire)
supply. Ensure power and protective ground lines are connected correctly.

When the monitor is operated by an external battery which is connected to a battery


recharging device, this device must be medical grade (double isolation).

If any power supply or earthing arrangement is suspect, power the monitor only from
its internal or from an external battery.

Maintenance requiring removal of the case or covers must not be attempted by the
operator, but must be referred to linde medical sensors trained service personnel.

The use of accessories, sensors and cables other than those specified, with the
exception of sensors and cables sold by the manufacturer of the MicroGas 7650 system
as replacement parts, may result in increased emissions or decreased immunity of the
MicroGas 7650 system

Before cleaning the monitor, always switch it off and disconnect it from the ac mains
power supply.

Keep plugs and connectors meticulously clean and dry, do not allow any liquid to enter
the equipment.

The MicroGas 7650 should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, the MicroGas 7650 should be
observed to verify normal operation in the configuration in which it will be used.

Pins of connectors identified with this esd warning symbol should not be touched
and connections should not be made to these connectors unless esd precautionary
procedures described in the section 2.19 of this document are used.

When connecting other equipment to MicroGas 7650, consult the manufacturer of that
equipment or a qualified engineer to ensure that the safety of the patient, the operator
or the environment will not be impaired, connections must only be made to equipment
complying with en 60601-1. All combinations of equipment must be in compliance with
iec/en 60601-1-1 standard system requirements.

Explosion and flammability hazards:

Never operate the monitor in the presence of flammable anaesthetics or other


flammable substances, or in an environment which has increased oxygen
concentration.

Page 9
SERVICE
MANUAL

Patient injury hazard:

Prolonged exposure of the heated sensor may cause a skin burn, the recommendations
on sensor temperature and exposure time given in the operating manual should be read
carefully before using the instrument on a patient.

Patient safety and perfomance of this unit when connected to patients under-going
magnetic resonance diagnostic procedures are unknown, we advise that all sensors
and cables used on this unit are removed from patient during such procedures

Failure of operation:

If the monitor fails to operate as described, do not use it until the problem has been
corrected by Linde Medical Sensors trained service personnel.

Alarm-off mode:

If the alarm functions have been turned off, i.e. the alarm-off indicator is lit, no alarm
will sound if a PO2 or PCO2 value exceeds one of the preset alarm limits. Therefore, the
alarm-off mode should not be used in situations where its use could compromise
patient safety.

Page 10
SERVICE
MANUAL

CAUTION!
To clean the monitor and the sensor follow the instructions given in this manual. Do not
use any abrasive agent or any chemical that is not recommended in this manual.
Do not expose the monitor to high humidity or heat (for details see section 2.13).
Certain types of mobile telecommunications equipment could potentially interfere with
equipment operation. Mobile telecommunication equipment should not be used within
five meters of patient monitoring equipment.
Equipment is protected against defibrillator discharge. Parameter displays may be
temporarily affected during defibrillation, but will rapidly recover.
When this equipment is used with a defibrillator, the user must precisely follow the
instructions in the defibrillator operating manual.
To ensure protection of patient, operator and equipment from the effects of the
defibrillation and diathermy/electrosurgery, cables manufactured by Linde Medical
Sensors must be used.
Equipment is protected against electrostatic discharge. The PCO2 display may be
temporarly affected during discharge to chassis ground but will rapidly recover.
For use during electrosurgery the monitor, sensor and their cables are to be physically
separated from the electrosurgical equipment. The sensor must not be placed in the
electrical pathway between cutting and counter electrode. Electrosurgery will produce,
at most, a minimal transient disturbance in the reading and it will not affect the system
calibration.
If any function fails to operate correctly consult a Linde Medical Sensors trained
service personnel.
Where the equipment has been wetted accidentally, it should be wiped dry externally
and allowed to dry thoroughly before use.
This unit needs special precautions regarding EMC and needs to be installed and put
into service according to the emc information provided in the section 2.15 of this
document.

Page 11
SERVICE
MANUAL

1 General Information

1.1 Introduction
Linde Medical Sensors MicroGas 7650 is a blood gas monitor equipped with an integrated calibrator.
The device provides reliable, continuous measurement of transcutaneous oxygen and carbon
dioxide tensions by using a combined PO2/PCO2 sensor (type COMBI•M). The sensor is calibrated
fully automatically when it is placed into the built-in calibration chamber. When not in use, the sensor
is stored within the calibration chamber and the system is ready to use at any time. The monitor
detects and gives warning when the oxygen and/or the carbon dioxide tensions exceeds the alarm
limits, the values of which are adjustable by the operator. Fault conditions are indicated and routine
operating messages are also displayed. Power is supplied from AC mains or the internal
rechargeable battery or an external battery.

1.2 Principle of Operation


Since oxygen and carbon dioxide gases are able to diffuse through the body tissue and skin, it is
possible to detect them by means of a sensor applied to the skin surface. In order to create local
arterialization, the sensor is heated to a constant temperature which is higher than normal body
surface temperature.
In the COMBI•M sensor, the basic elements of a Clark-type PO2 sensor and a Severinghaus-type
PCO2 sensor are combined. Oxygen is measured amperometrically by reduction at a platinum
microcathode which is negatively polarized with respect to an Ag/AgCl reference electrode. The
current measured is proportional to the oxygen partial pressure. Carbon dioxide is measured
potentiometrically by determining the Ph of an electrolyte. A change of Ph is proportional to the
logarithm of a PCO2 change. The Ph is determined by measuring the potential between a
miniaturized Ph glass electrode and an Ag/AgCl reference electrode. The same Ag/AgCl electrode is
used for both measuring functions. The electrolyte is provided within a hydrophillic spacer which is
placed on top of the sensing area. The spacer is covered by a highly gas permeable, hydrophobic
membrane.
The COMBI•M sensor used with MicroGas 7650 differs from the previous sensor type "COMBI" by
three important improvements:
• The preparation of the Combi•M sensor is performed by a new simplified technique with the aid of
a one-step sensor preparator with integrated spacer, membrane and membrane retainer ring.
• The surface of the COMBI•M sensor is covered by a thin plate perforated at the positions of the
three electrodes. This plate provides an efficient protection of the sensitive membrane from
mechanical damage.
• The COMBI•M sensor contains a memory which allows the storage of the calibration values and of
other relevant sensor data. By evaluating these data in the monitor, any irregularity of the sensor
characteristics or the necessity of a new sensor preparation can be detected at an early stage. In
addition, the built-in memory allows the user to change the sensor from one monitor to the other
without the need of a recalibration.
The transcutaneous blood gas value has to be interpreted primarily as the blood gas partial pressure
prevailing at the level of the arterialized skin tissue. In general, this value correlates well with the
corresponding arterial blood gas partial pressure.

Page 12
SERVICE
MANUAL

1.3 Controls, Indicators and Connectors

1.3.1 Front panel

READY TO USE
JAN. 01/05 13:42

Left window LED-display indicating PO2 values between 0 and 999 mmHg (0 and 99.9
kPa) in steps of 1 mmHg (0.1 kPa) or - - - when PO2 display is switched off.
Middle window Illuminated LCD display showing parameter settings and operator messages.
Right window LED display indicating PCO2 values between 1 and 200 mmHg (0.1 and
20.0 kPa) in steps of 1 mmHg (0.1 kPa).
"Line connected and internal battery charging" indicator lamp
"Monitor on" indicator lamp
"Alarm mute/off" key, is used either to mute the alarm tone if an alarm
condition is indicated or to switch alarm detection facilities off.
"Alarm off" indicator lamp, illuminates when alarms are turned off or alarm
tone is muted.
P "Parameter" key is used to select all monitor and sensor parameters

"Down/Up" keys, used to alter the selected parameter settings. When


pressing one of these keys in the "ready to use" mode, the PO2/PCO2
displays are activated.
N "Normal parameter" key, is used to activate or to alter the memorized normal
parameter settings which may be selected individually by the operator.
"Start monitoring" key. Upon pressing this key, the site time clock is started
at the preset measuring time and the remaining measuring duration is
displayed. Five minutes later, the alarm detection facilities of the PO2 and
PCO2 limits are activated. By pressing this key for 2 seconds a calibration is
activated when the sensor is placed in the calibration chamber. The PO2 and
the PCO2 values are displayed during the calibration process.
autocal Calibration chamber for COMBI•M sensor, is also used for storing the
sensor in the "ready to use" mode.
Symbol of type BF equipment, defibrillator proof (EN 60601-1)

Page 13
SERVICE
MANUAL

1.3.2 Rear panel

POWER AC power compartment, containing line cord plug, fuses and voltage selector.
MONITOR Monitor on/off switch
SENSOR Sensor input socket
Connectors for equipotential ground

Equipotential ground connector adjacent to this symbol

INPUT Connector for external 12-24V battery


Attention, before using the connector adjacent to this symbol the instructions
given in the operating manual must be read.
Physiological effects (Sensor Connection)
Note that the sensor has a heated surface. Please operate strictly in accordance
with section 1.4.2 of the operating manual.
PARALLEL Connector for printer interface.
INTERFACE
SYSTEMS Connector for Linde Medical Sensors systems interface, including RS423, analog
CONNECTOR output and status data output.
Container with screw connector for Linde Medical Sensors gas cylinders (CAL-
Gas).

1.3.3 Underneath base


• CAUTION and ATTENTION Label
• CE-Label
• Label indicating service status of instrument and label indicating software revision status of
instrument (both for Linde Medical Sensors trained service personnel).
• Speaker

Page 14
SERVICE
MANUAL

2 Specification

2.1 IEC Equipment Classification

Power source
Either by AC line voltages of 200-240V (±10%) and 100-120V (±10%), 50/60Hz, or by internal
rechargeable battery, or by an external battery 12V-24V.

Electrical Safety (EN 60601-1)


Protection against electrical shock:
• Class I: when connected to AC line voltage 100-120 Vrms or 200-240 Vrms
• Class II: when connected to external Battery
Internally Powered Equipment: when supplied by the internal battery
Patient leakage current: Type BF
• at 200-240 Vrms: <20µA
• at 100-120 Vrms: <10µA
Protected against the effect of defibrillation

Protection against ingress of liquids


Not protected

Mode of operation
Suitable for continuous operation

Degree of mobility
Transportable

Degree of protection against hazards of explosions


Not protected - not suitable for use with flammable gases.

Electromagnetic compatibility (EMC)


The equipment complies with IEC 60601-1-2 (2001) and the relevant standards for emission and
immunity, see section 2.15, Electromagnetic Compatibility Declaration.

2.2 Inputs

2.2.1 Monitor

Mains supply
3 way mains input plug (rear panel)

Input DC supply
2 way socket (rear panel) for the connection to an external battery (12-24V)
Connector type: Redel SA, Type PAG-M02 GLAC GSG

Page 15
SERVICE
MANUAL

Polarity:

Sensor input
Nicolay, 20 way socket (rear panel)

2.2.2 Sensor Type COMBI•M


Clark-type PO2 sensor combined with Stow-Severinghaus type PCO2-Sensor, containing a heating
resistor, two calibrated precision thermistors and two pre-amplifying circuits. All components are
embedded in epoxy. One-step sensor preparation. Protection of sensor surface against mechanical
damage.
• Sensor diameter: 20 mm
• Sensor height: 10 mm
• Cable: 2.8 m length, highly flexible, polyurethane coated
• Heated area: approx. 40 mm2
• Skin temperature: approx. 1°C below selected sensor core temperature
• Temperature control and monitoring by 2 thermistors
• Heating resistor: 100 Ω
• Thermistor resistance, trimmed: 5600 Ω at 44 °C
• In Vitro response time, τ90%: < 25 sec for PO2
< 60 sec for PCO2
• Drift (in CAL-Gas): < 1%/h for PO2
< 1%/h for PCO2

Built-in memory (EEPROM) within sensor plug for:


• PO2 and PCO2 calibration values
• PO2 zero current and PCO2 slope
• Date and time of last calibration
• Date of last sensor preparation
• Date of last slope adjustment

Noise suppression
by two built-in preamplifiers

Operating time
two weeks at normal use between two preparations

Life time
Normal wear and tear will limit the lifetime of this sensor. However, provided the sensor and its cable
are handled with care, a usable safe lifetime of four years may be expected. Harsh treatment will
drastically reduce the lifetime of the sensor.

Page 16
SERVICE
MANUAL

Interference by anaesthetic gases (in vitro)


PO2 PCO2
75% N2O < 10 mmHg negligible
2% Halothane appr. 200 mmHg negligible
2% Enflurane negligible negligible
2% Isoflurane negligible negligible

Note: The influence of halothane on the transcutaneous PO2 value during in vivo monitoring is
significantly less.

2.3 Controls

Front panel
• Start monitoring key
• Parameter key
• Down/Up keys
• Normal parameter key
• Alarm mute/off key

Rear panel
Monitor on /off switch

2.4 Outputs

Displays
• PO2 display: 3 x 12.7mm high, 7 segments green LED
• PCO2 display: 3 x 12.7mm high, 7 segments green LED
• Middle display: Dot matrix LCD, 2 x 16 characters (2 lines) module, LED backlight and adjustable
viewing angle

Indicator lamps
• Line connected (yellow)
• Monitor on (green)
• Alarm off (yellow)

Loudspeaker
For audio signals, frequency 400 Hz

Systems Connector
1 x 37 way connector, carrying:
• analog outputs
• RS 423 digital interface
• status signals
Details see section 2.16

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Parallel Interface
1 x 25 way connector, carrying:
• Centronics parallel interface
• Outputs for printer
Note: Only equipment complying with IEC 601-1 may be connected.

2.5 Calibrator

Built-in one gas calibrator


Control of gas pressure and gas flow to the calibration chamber during calibration.

CAL-Gas cylinder
Composition: 12.0% 02, 7.0% CO2, rest N2
Volume: nominal 0.5 litre
Filling pressure: 10.8 bar at 21°C
Typical function time (at 6 calibrations per day): conventional → 1 month, rapid type → 2 months

2.6 Performance

PO2
0 to 999 mmHg (0 to 99.9 kPa) or --- when PO2 display is switched off

PCO2
1 to 200 mmHg (0.1 to 20.0 kPa), Resolution: 1 mmHg (0.1 kPa)

Heating
Sensor core temperature selectable between 37°C and 45°C in steps of 0.5°C
Accuracy of selection ± 0.2°C
Display of actual temperature flashing during ∆T > 0.3°C

Site timer
Timer counting down from an adjustable starting value during measurement and triggering an alarm
when selected measuring time has elapsed.
Site time adjustable between ½ and 24 hours in steps of ½ hour and step above 24:00 = infinite
(display --:--).

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2.7 Alarms

PO2
Minimum Maximum Default
low 0 mmHg (0.0 kPa) 99 mmHg (13.2 kPa) 50 mmHg (6.7 kPa)
high 5 mmHg (0.7 kPa) 999 mmHg (133.2 kPa) 100 mmHg (13.3 kPa)
(--- when PO2 display switched off)
Low limit to high limit separation is 5 mmHg (1.0 kPa)

PCO2
Minimum Maximum Default
low 0 mmHg (0.0 kPa) 99 mmHg (13.2 kPa) 25 mmHg (3.3 kPa)
high 5 mmHg (0.7 kPa) 200 mmHg (25.0 kPa) 50 mmHg (6.7 kPa)
Low limit to high limit separation is 5 mmHg (1.0 kPa)

2.8 Alarm Indications

Messages
TOO HIGH PO2
95 ALARM LIMIT

TOO LOW PO2


40 ALARM LIMIT

TOO HIGH PCO2


ALARM LIMIT 45

TOO LOW PCO2


ALARM LIMIT 25

Audible Indication
Three short tones repeating every two seconds

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2.9 Fault Indications


The monitor is capable of detecting various fault conditions. In such case, a message describing the
fault is displayed. Simultaneously (or in certain cases with a 5 minutes delay), an alarm sounds
consisting of a single long tone, repeated every 1½ seconds. The following fault messages may
appear:
CONNECT SENSOR The monitor has detected that no sensor is connected. This fault message
is reset after a sensor has been connected.
SENSOR FAULT Automatic shut down of heating in case of sensor fault.
ALARM
Triggered by one of the following conditions:
• actual temp. > set temp. + 1°C for 4 sec
• actual temp. < set temp. - 1°C for tmax (maximum time)
tmax is normally 30 sec but 5 min during warming up of the sensor
• (actual temp.- set temp.) > 0.3°C for tmax
• difference between thermistors > 0.6°C for 4 sec
• difference between thermistors > 0.3°C for tmax
MONITOR FAULT 04 Automatic shut down of the floating board supply voltage. The monitor
has detected an irregularity of one of its functions. If this message cannot
be reset by switching the monitor off and on again, the number should be
noted and a trained service technician has to be consulted. If the monitor
can be restarted, all settings have to be checked and readjusted if
necessary.
NO GAS FLOW This message appears when the gas cylinder installed in the monitor is
RENEW GAS BOTTLE empty or when no gas cylinder is fitted.
GAS FLOW If one of these messages appears during a calibration, the monitor has
DISTURBED F1/F2 detected an irregularity of the pressure control system. In such case, a
Linde Medical Sensors trained service technician has to be consulted.
CHARGE BATTERY The internal battery needs to be recharged. The monitor must therefore
MINIMUM 12 H be connected to AC power within a few minutes after appearance of this
message. The minimum charging time required is 12 hours.
alternating with:
Note: In case the internal battery has been discharged below a critical
CONNECT UNIT TO
level the displays are no more activated. After connecting the monitor to
MAINS POWER
AC power it is necessary to switch the monitor (→Off →On) to reactivate
them.
SITE TIME ELAPSED This message appears when the preset time limit of a monitoring period
has been passed. The sensor has to be removed from the application site
in this case.
The two fault messages described below are accompanied by the acoustic signal only if the fault
situation persists for more than 5 minutes:
PLACE SENSOR IN The monitor has detected that the sensor is exposed for too long (appr. 2
CAL. CHAMBER to 3 minutes) to air. When the sensor is not in use it must always be
stored in the calibration chamber.
PRESS START This display appears each time the sensor is removed from the calibration
MONITORING chamber in the "ready to use" mode. After the sensor has been attached
to the patient subsequently, the key should be pushed. If this is not
alternating with the
done, the fault alarm tone will sound after 5 minutes.
main parameters such
as:
95 44.0 45
50 4:00 25

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2.10 Other Messages


Beside the alarm and fault messages and beside N- and P- key messages (not described in this
manual) the following status indications are displayed.
7650 SYSTEM TEST Appears shortly after the monitor has been switched on and identifies the
system self-check.
7650 REV. 12.00 Appears at the end of the initial self-check period to identify the software
revision status of the monitor.
followed by:
(Revision numbers are examples)
FLOAT REV. 4.00
UPDATE SOFTWARE Upon appearance of this message, a trained service technician has to be
consulted.
UPDATE SENSOR Appears if a sensor type is connected which is not compatible with
MicroGas 7650 (for example, type COMBI instead of COMBI•M).
CALIBRATE SENSOR The monitor has detected a condition requiring a calibration of the sensor
(for example, after a new preparation). The sensor has to be inserted into
the calibration chamber. This message appears also when switching the
monitor on or when connecting the sensor to the monitor.
REMEMBRANE This message appears when more than 14 days have elapsed since the
SENSOR last sensor preparation, or if the monitor has detected an irregularity of the
sensor performance during a calibration.
REPEATING If the PO2 and/or PCO2 values are not stable within 10 minutes after the
CALIBRATION start of a calibration, the calibration is repeated once as indicated by this
message and the displays of the PO2 and PCO2 values are turned on.
CALIBRATE SENSOR This message appears when the sensor temperature has been changed
during a monitoring period by more than 2°C or when more than 24 hours
alternating with the
have elapsed since the last calibration.
main parameters such
as:
95 44.0 45
50 3:56 25
RENEW GAS BOTTLE Appears when the pressure within the gas cylinder is below 1 bar. The
████
number of fields █ indicates the remaining gas volume. One █
corresponds approximately to one calibration.
If the monitor is switched off and on again during this status or if the gas
cylinder is accidentally replaced by another one with a pressure of less
than one bar, the message RENEW GAS BOTTLE will appear again,
however, without the █ indicator-fields.
36 MIN SITE TIME This messages appears at the end of a monitoring period when only 10%
Remaining of the preset monitoring duration (maximum one hour) is remaining.
▲ Triangle indicators ▲ appear side to the PCO2 and/or PO2 alarm limit
values if an in vivo PCO2 and/or PO2 correction is applied (see section
3.3.4, P2-9 and P2-10 of the Operating Manual).
95▲44.0▲45
50▲3:56▲25
PRINTER FAULT This message appears after pressing the key continuously for 4
seconds (selection of printer mode) if:
• the printer or the interface is defective
• the printer is not connected to AC power or not switched on
• no printer is connected to MicroGas 7650
• there is no recording paper in the printer

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2.11 Power Supply and Earthing

Mains power supply


200 to 240 Vrms, ±10%, 50/60 Hz or 100 to 120 Vrms, ±10%, 50/60 Hz
Mains voltage range can be set externally (see section 4.3)

Power consumption
Max. 15.6VA

Fuses (rear panel)


Two 5 x 20mm, type T (Slo-Blo):
• 80mA, for 200 to 240 Vrms mains
• 160mA, for 100 to 120 Vrms mains

External battery
12V to 24V, ±10%

WARNING!
If the external battery is connected to a battery recharging device, this device
must be medical grade (double isolation).

Internal battery
Lead acid cell: 12V/1.8Ah, rechargeable
Charging time: 18 hours (12 hours minimum)
Operating time on battery: 30 to 120 minutes, depending on the mode of operation of the monitor
and the age of the battery.
To keep the charging state of the internal battery at maximum leave the monitor connected to AC
power. In case the system should not be connected to AC power for an extended period of time
(several months) it is recommended to disconnect the battery. As this requires the removal of the
outer case, this must be performed only by a Linde Medical Sensors trained technician.

Earthing
Earth connection via mains connector and equipotential earth (ground) terminal on rear panel.
All exposed metal parts are earthed.
Earth leakage: <100 µA

2.12 External Features


Dimensions shown do not include sensor and power cable, but includes the sensor spool.

Size
135mm (5.3 inches) high
300mm (11.8 inches) deep
266mm (10.5 inches) wide

Weight
5,6kg (12.3 Ibs) including gas cylinder, without sensor and power cord.

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Case
Wipe clean cover and front panel

2.13 Environmental Operating Conditions

Temperature
+15°C to +40°C (+59°F to +104°F)

Relative humidity
< 90% non-condensing

Ambient pressure
450 to 800 mmHg (600 to 1060 hPa)

2.14 Environmental Transport and Storage Conditions


(in original factory packaging)

Temperature
-20°C to 60°C

Relative Humidity
10% to 95%

Ambient pressure
375 to 800 mmHg (500 to 1060 hPa)

2.15 Electromagnetic Compatibility Declaration

WARNING!
The use of accessories, sensors and cables other than those specified, with the
exception of sensors and cables sold by the manufacturer of the MicroGas 7650
as replacement parts, may result in increased emissions or decreased immunity
of the MicroGas 7650.

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2.15.1 Electromagnetic Emissions


The MicroGas 7650 is intended for use in the electromagnetic environment specified below. The
customer or the user of the MicroGas 7650 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Groupe 1 The MicroGas 7650 uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
CISPR 11
likely to cause any interference in nearby electronic equipment.
RF emissions Class B The MicroGas 7650 is suitable for use in all establishments,
including domestic establishments and those directly
CISPR 11
connected to the public low-voltage power supply network that
Harmonic emissions Class A supplies buildings used for domestic purposes.
IEC 61000-3-2
Voltage fluctuations/ Complies
Flicker emissions
IEC 61000-3-3

2.15.2 Electromagnetic Immunity


The MicroGas 7650 is intended for use in the electromagnetic environment specified below. The
customer or the user of the MicroGas 7650 should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance level Electromagnetic environment -
test level guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or
discharge (ESD) ceramic tile. If floors are covered with
± 8 kV air ± 8 kV air synthetic material, the relative humidity
IEC 61000-4-2 should be at least 30 %.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or hospital
environment.
IEC 61000-4-4 ±1 kV for ±1 kV for
input/output lines input/output lines
Surge ±1 kV differential ±1 kV differential Mains power quality should be that of a
mode mode typical commercial or hospital
IEC 61000-4-5 environment.
± 2 kV common ± 2 kV common
mode mode
Voltage dips, short <5 % UT <5 % UT Mains power quality should be that of a
interruptions and (>95 % dip in UT) (>95 % dip in UT) typical commercial or hospital
voltage variations for 0,5 cycle for 0,5 cycle environment. If the user of the
on power supply MicroGas 7650 requires continued
40 % UT 40 % UT
input lines operation during power mains
(60 % dip in UT) (60 % dip in UT)
interruptions, it is recommended that
IEC 61000-4-11 for 5 cycles for 5 cycles
the MicroGas 7650 be powered from
70 % UT 70 % UT an uninterruptible power supply or a
(30 % dip in UT) (30 % dip in UT) battery.
for 25 cycles for 25 cycles
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic of a
magnetic field typical location in a typical commercial
or hospital environment.
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.

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2.15.3 Electromagnetic Immunity, RF portable equipment


The MicroGas 7650 is intended for use in the electromagnetic environment specified below. The
customer or the user of the MicroGas 7650 should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance Electromagnetic environment - guidance
test level level
Portable and mobile RF communications equipment should be used no closer to any part of the
MicroGas 7650, including cables, than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance

Conducted RF 3 Vrms 3 Vrms d = 1.2 √P

IEC 61000-4-6 150 kHz to


80 MHz

Radiated RF 3 V/m 3 V/m

IEC 61000-4-3 80 MHz to d = 1.2 √P 80 MHz to 800 MHz


2,5 GHz
d = 2.3 √P 800 MHz to 2,5 GHz

where P is the maximum output power rating of the


transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site survey,a
should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the MicroGas 7650 is used exceeds the applicable RF compliance
level above, the MicroGas 7650 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating
the MicroGas 7650.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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2.15.4 Recommended separation distances


The MicroGas 7650 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the MicroGas 7650 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the MicroGas 7650 as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W
d = 1.2 √P d = 1.2 √P d = 2.3 √P

0.01 0.12 m 0.12 m 0.23 m


0.1 0.38 m 0.38 m 0.73 m
1 1.2 m 1.2 m 2.3 m
10 3.8 m 3.8 m 7.3 m
100 12 m 12 m 23 m
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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2.15.5 Cables length

WARNING!
The use of accessories, sensors, and cables other than those specified may
result in increased emission and/or decreased immunity of the MicroGas 7650.
Cables and sensor Maximum length Complies with
COMBI•M sensor Type 82 RF emissions, CISPR 11,
3m Class B/Group 1
(part no 060 5000)
Harmonic emissions,
IEC 61000-3-2

MicroGas - PC Voltage fluctuations/flicker emission,


Interface Cable 2m IEC 61000-3-3

(part no 7650 0081) Electrostatic discharge (ESD),


IEC 61000-4-2

MicroGas - VueLink Electric fast transient/burst,


Adapter Cable 0.5 m IEC 61000-4-4

(part no 7650 0080) Surge,


IEC 61000-4-5

PHILIPS-VueLink Voltage dips, short interruptions and voltage


Interface Cable 2m variations on power supply input lines
IEC 61000-4-11
(25 pin "D" to 10 pin Philips,
shielded) Power frequency (50/60 Hz) magnetic field
IEC 61000-4-8
Printer Cable
2m Conducted RF
(25 pin "D" to 36 pin IEC 61000-4-6
Centronics, shielded)
Radiated RF,
IEC 61000-4-3

2.16 Communication Interface (Systems Connector)

2.16.1 Overview
Patient data can be obtained mainly through the serial interface and analog outputs of the "Systems
Connector" on the back of the MicroGas monitor by connecting it to an attached Personal Computer
(PC) or a Component Multiparameter System (CMS).
When connecting the MicroGas monitor to a PC or CMS, verify proper operation before clinical use.
Both the MicroGas monitor and the PC or CMS must be connected to a grounded AC outlet. The
communication protocol setting must be set as described in section 3.3 "Adjustment of parameters"
on second parameter level P2-15, of the MicroGas Operating Manual.
Any PC or non-medical device connected to the "Systems Connector" must be certified according to
IEC/EN 60950 Standard. All combinations of equipment must be in compliance with IEC/EN 60601-
1-1 Standard systems requirements. Anyone who connects a PC or a CMS to the MicroGas
"Systems Connector" configures a medical system and is therefore responsible for ensuring that the
system complies with the requirements of system standard IEC/EN 60601-1-1 and the
electromagnetic compatibility system standard IEC/EN 60601-1-2.

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2.16.2 Connecting to the Systems Connector


The MicroGas "Systems Connector" may be connected to the PC or CMS by using a cable
terminated with a shielded DB-37 connector. The cable should be no more than 2m in length.
The cable used must have a braided shield providing 100% coverage. The shield must have a 360-
degree connection to the metal shell on the DB-37 connector and to the connector on the PC or
CMS. Do not create sharp bends in the cable, as this may tear or break the shielding.
See connection details in section 2.16.5 for EasyLink, section 2.16.6 for VueLink and section 2.16.7
for MonLink.

2.16.3 Systems Connector pinouts


pin no. description
1 0V
2 RxD, RS423
3 TxD, RS423
4 RTS, RS423
5 CTS, RS423
6 not used
7 not used
8 0V
9 auxillary supply voltage 10 to 26 V, Imax = 300 mA
10 0V
11 PO2 analog output, 0-6 V = 0-300 mmHg
12 PCO2 analog output, 0-6 V = 0-300 mmHg
13 0V
14 0V
15 0V
16 to 19 not used
20 status signal ALARM ON, Open Collector, active low, Isink = 10 mA, Usource = 15 V
21 status signal ALARM RESET, Open Collector, active low, Isink = 10 mA, Usource = 15 V
22 status signal ALARM, Open Collector, active low, Isink = 10 mA, Usource = 15 V
23 status signal FAULT, Open Collector, active low, Isink = 10 mA, Usource = 15 V
24 not used
25 not used
26 status signal MONITOR ON, Open Collector, active low, Isink = 10 mA, Usource = 15 V
27 0V
28 0V
29 0V
30 PO2 analog output, 0-6 V = 0-300 mmHg
31 PCO2 analog output, 0-6 V = 0-300 mmHg
32 to 34 0V
35 to 37 not used

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2.16.4 Communication protocol


Through the Parameters Adjustment menu (see Operating Manual section 3.3.4 P2-15), the
following communication protocols are available on the serial interface:

EasyLink
Unconditionally real-time data transmission. Memory dump / download functions can be request
from the host device (PC or CMS)
Note: only since Main Software Rev. 12.00

VueLink
Compatible with the Philips VueLink Open Interface.
Note: only since Main Software Rev. 12.00

MonLink
Transmission of real-time data on host request. The protocol corresponds to the communication
protocol of previous software versions of MicroGas 7650 monitors.
These three possibilities are detailed below:

2.16.5 EasyLink

Easy operation
When the EasyLink communication protocol is set, the MicroGas monitor sends automatically real-
time data. The data format used is ASCII CSV (Coma Separated Values) which simplify the
treatment of data by the PC or CMS host device.

Easy connection
To connect the PC or CMS to the MicroGas "Systems Connector", you need only a 3 wire shielded
cable.
Example of connection to a PC serial COM port:
MicroGas DB-37 PC DB-9
pin 2 (RxD) ---------------- pin 3 (TXD)
pin 3 (TxD) ---------------- pin 2 (RxD)
pin 27 (GND) ---------------- pin 5 (GND)
pin 28 (GND) --shielding-- pin 5 (GND)

Principle
Real-time data is continuously sent to the serial port. A new line of data is send every second.
Column heading line will be send after every 60 data lines, or if one of the values in the column
heading changes.

Serial port settings


Baud rate of 4800, 8 bit data, even parity, 1 stop bit, without handshaking.

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Memory dump/download
The host device can request a memory dump/download of the last 18H patient data. Also, the results
can be downloaded to a printer or to a personal computer (PC). The monitor automatically stores the
measured patient data over the last 18 hours using the FIFO (First In, First Out) principle. Data are
stored whenever values are displayed e.g. during patient monitoring. The memory will indicate zero
values for those time intervals in which no values are displayed e.g. while the sensor is placed in the
calibration/storage chamber or while the monitor is turned off. The monitor should be turned on to
keep the memory active.

1. Heading and data lines content of real-time data output:


Head Data Content Description
bytes bytes
Column pos. 1: Date and time
Heading line: 12 $<date>, Date of the next data line,
format "yyyy.mm.dd"
$2002.30.07,
Data line: 9 <time>, Time of the actual data line,
format "hh:mm:ss"
11:22:33,
Column pos. 2: PCO2 value
Heading line: 20 PCO2[<unit>]<limit>, Indication of the PCO2 unit in "mmHg"
or "kPa_" and alarm limits "low:high"
PCO2[mmHg]0012:0123, valid for the next data lines.
PCO2[kPa_]01.2:12.3,
Data line: 5 <value>, PCO2 value in "mmHg" without decimal
point or in "kPa" with decimal point.
0123, Indication of "----" or "--.-" if no
23.4, value is available or is out of range.
--.-,
Column pos. 3: PCO2 alarm status
Heading line: 6 PCO2s, No heading parameter
Data line: 2 <code>, Possible codes are:
"N" no Alarm
N, "A" alarm active
A, "S" alarm silenced, reset
S,
Column pos. 4: PO2 value
Heading line: 14 PO2[<unit>]<limit>, Indication of the PO2 alarm limits
low:high" valid for the next data
PO2[mmHg]0010:0100, lines.
PO2[kPa_]01.0:10.0,
Data line: 4 <value>, Indication of "----" if no value is
available.
0100,
10.0,
----,
--.-,
Column pos. 5: PO2 alarm status
Heading line: 6 PO2s, No heading parameter
Data line: 2 <code>, Possible codes are:
"N" no Alarm
N, "A" alarm active
A, "S" alarm silenced, reset
S,
Column pos. 6: Sensor temperature
Heading line: 12 Temp[C]<set>, Indication of the temperature set
valid for the next data lines.
Temp[C]44.0,
Data line: 5 <value>, Indication of "--.-" if no value is
available.
41.9,
Column pos. 7: Site timer
Heading line: 6 Timer, No heading parameter
Data line: 6 <timer>, Site time left of the actual data
line, format "hh:mm"
02:15,

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Head Data Content Description


bytes bytes
Column pos. 8: Mode
Heading line: 5 Mode, No heading parameter

Mode,
Data line: 2 <mode>, Possible modes are:
"C" calibrating
C, "R" ready to use
R, "P" pre-measurement
P, "M" measurement
M, "?" other (connect sensor,
monitor fault)
Column pos. 9: General status
Heading line: 8 Status<cr><lf> No heading parameter

Status This is the last column of the heading


line, ending with "cr lf" (0x0D 0x0A)
bytes.
Data line: 3 <code><cr><lf> Possible codes are:
"N" no alarm
N "A" at least one alarm active
A "S" at least one alarm silenced
S "O" alarm switched off
O
This is the last column of the
data line, ending with "cr lf"
(0x0D 0x0A) bytes.
Total bytes 93 39
per line

(Expected recordable data + heading length: ~3.5 MB/day)

Column headings line example:


“$2002.07.31,PCO2[mmHg]0025:0050,PCO2N,PO2[mmHg]0050:0100,PO2N,Temp[C]44.0
,Timer,Mode,Status”

Data line example:


“11:22:33,0040,N,0100,N,43.9,04:00,R,N”

2. Memory dump (18 hours memory):


Memory dump request/stop sequence:
When EasyLink is selected the host can request a memory dump.
To request a memory dump, the following ASCII sequence must be send to the MicroGas Monitor:
MD<cr><lf> (4 bytes)
The EasyLink real time data output is interrupted and the memory dump starts.
After the memory dump is finished the monitor returns to the EasyLink real time data output.
Sending the memory dump request when a memory dump is still in progress will stop the memory
dump and return to the real time data output.
Memory dump response:
The memory dump response is organized as follows:
• 2160 data lines (2 data lines per minute for 18 hours)
• start of a data line = '$'
• end of data line = <CR>, <LF>
• memory dump closing byte = 0FE

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One data line represents 30 seconds of memorized values and consists of the following 15, comma
separated values (ASCII CSV):
1. Year.Month.Day 10 byte ASCII (incl. 2 '.')
2. Hour:Minute:Second 8 byte ASCII (incl. 2 ':')
* 3. PO2 value 3 byte ASCII
* 4. PCO2 value 3 byte ASCII
* 5. PO2 low alarm limit 3 byte ASCII
* 6. PO2 high alarm limit 3 byte ASCII
* 7. PCO2 low alarm limit 3 byte ASCII
* 8. PCO2 high alarm limit 3 byte ASCII
9. Set sensor temperature 4 byte ASCII (incl. dec. point)
10. PO2 in vivo correction factor 4 byte ASCII (incl. dec. point)
11. PCO2 temperature correction 4 byte ASCII (incl. dec. point)
* 12. PCO2 in vivo correction 3 byte ASCII
13. Status flag (10 bit) 5 byte ASCII (integer value in ASCII)
* 14. PO2 calibration value 3 byte ASCII
* 15. PCO2 correction value 3 byte ASCII
* = units are in mmHg if status flag bit 10 = 0 or in kPa/10 if status flag bit 10 = 1
Total length of one data line = 79 bytes (62 ASCII bytes, 14 commas, 1 start data line byte, 2 end
data line bytes)
Expected down load time at 4800 baud: approx. 6½ minutes
Description of status flags:
Integer as 5 byte ASCII value
bit value description
0 1 Alarm On
1 2 Calibration
2 4 Calibration terminated
3 8 Site time elapsed alarm
4 16 Range x 4
5 32 Sensor fault
6 64 Remembrane sensor
7 128 In vivo PCO2 correction Off
8 256 Gas flow ok
9 512 In vivo PO2 correction Off
10 1024 PO2 Off
11 2048 Monitor Fault
12 4096 units = kPa
13 - 15 not used

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2.16.6 VueLink
As part of a Philips Patient Monitoring Systems (Philips V24/26, Philips CMS and Philips IntelliVue,
here after called "Philips Monitor"), the MicroGas monitor is compatible with the following VueLink
Open Interface module:

Module type
Philips VueLink module M1032A #A05 #K6B (type B, Auxiliary-plus, with Open Interface cable).
Ordering information:
• M1032A #A05 VueLink Open Interface Module (type B, auxiliary-plus)
• M1032A #K6B VueLink Open Interface Cable, 4m, Standard 25 pin male connector

Connection
Connect the VueLink module to the MicroGas Systems Connector with the VueLink Open Interface
cable and the MicroGas-VueLink adapter cable (Part No 7650 0081)

Operation
When the VueLink protocol is selected (see Op. Man. section 3.3 P2-15), the VueLink module
plugged in to the Philips Monitor Module device will automatically recognize the MicroGas 7650
monitor and will appear as “7650” on the VueLink module setup menu.
See section “VueLink” of the Philips Monitor documentation for setting and configuration of the
VueLink module.

1. Available data:
The following real-time data are available on the Philips Monitor through the VueLink Interface:

Numeric values and settings


Philips Monitor Label description
“TcpCO2” PCO2 with alarm state
“TcpO2” PO2 with alarm state
“Temp” Sensor temperature
“TemSet” Sensor temperature set
“Timer” Site time remaining (format “hh.mm”)
“TimSet” Site time set (format “hh.mm”)

Wave forms
Philips Monitor Label aligned value description
“TcpCO2” “TcpCO2” PCO2 analog value
“TcpO2” “TcpO2” PO2 analog value

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2. Messages:

Alarm messages
Philips Monitor alarm corresponding text
“7650 PO2 LOW” "TOO LOW PO2"
“7650 PCO2 HIGH” "TOO HIGH PCO2"
“7650 PCO2 LOW” "TOO LOW PCO2"
“7650 PO2 HIGH” "TOO HIGH PO2"

Note: The following alarm philosophy is used on the Philips Monitor with the MicroGas 7650 VueLink
Module:
The alarm messages described above are “yellow” priority alarms.
The alarm signals are indicated on the display of the Philips Monitor by an alarm message on the
center of the upper line and by the blinking of the related measured value, if displayed.
The alarm signals disappear on the Philips Monitor if the related auditory alarm signals on the
MicroGas 7650 monitor are silenced.
Only one of the alarm messages described above is displayed at time. If more than one alarm
condition is present, only the alarm message with the highest priority is displayed.

INOP messages
Philips Monitor INOP corresponding text
“7650 SENSOR FAULT” "SENSOR FAULT"
“CONNECT 7650 SENS” "CONNECT SENSOR"
“7650 MONITOR. OFF” "MONITORING OFF"
“7650 SENSOR OFF” "PLACE SENSOR IN CAL CHAMBER"
“7650 TIME ELAPSED” "SITE TIME ELAPSED"
“7650 BATTERY LOW” "CHARGE BATTERY MINIMUM 12H"
“CAL. 7650 SENSOR” "CALIBRATE SENSOR"
"REMEMBRANE 7650 S" "REMEMBRANE SENSOR"
“7650 NO GAS FLOW” "NO GAS FLOW, RENEW GAS BOTTLE"

Note: The following INOP philosophy is used on the Philips Monitor with the VueLink Module:
An INOP message is indicated on the left of the upper line on the Philips Monitor display as long as
the related visual message is displayed on the MicroGas 7650 monitor.
Only one of the INOP messages described above is displayed at time. If more than one INOP
condition is present, only the INOP message with the highest priority is displayed.

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Auditory alarms
The above described VueLink messages do not generate auditory signals on the Philips Monitor.
Philips Monitor mode corresponding mode
“Calibr” Calibrating sensor
“Ready” Ready to use
“Applic” Sensor application, monitoring not started
“Monit.” Monitoring in progress

3. VueLink Task Window example:

7650

* tcpO2 87 mmHg Timer 2.29 H.M Temp 44.0 °C


* tcpCO2 39 mmHg TimSet H.M TemSet 44.0 °C

2.16.7 MonLink
The MonLink correspond to the interface achitecture of previous software versions of MicroGas 7650
monitors. Therefore, it is compatible with existing devices.

Serial port configuration


Baud rate = 9,6 kBd, ASCII 7 bit, Parity even, 1 Stop bit, Pins 2, 3, 4, 5

Communication protocol
The monitor is always assumed to be "slave" in the sense that it cannot transmit information unless
it has been requested to do so. The messages are always transmitted in "ASCII".
To initiate a communication the requesting device pulls RTS true and waits until the monitor replies
with CTS true. Transmission can then proceed.
There are three different request codes possible which MicroGas 7650 can understand. The format
of these codes and the corresponding replies are described below.

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1. Request code no. 1 status, “Monitor status record":

Request format: CRLF01$


A
CF
Reply format: CRLFrr n1n2CRLF[00 >ON ND]CRLF$
N

Example: 00 00
[00 >N ND]
$

2. Request code no. 2 values, "Value and status record":

Request format: CRLF02$


A
F kPa A
Reply format: CRLFrr n1n2CRLF00[PO2(Tc44.0_>1N_PO2=078mmHg>N]
S S

A
F kPa A
CRLF00[PCO2(Tc44.0)_>2N_PCO2=043mmHg>N]CRLF$
S S

Example: 00 00
00[PO2(Tc43.0)>2N_PO2=087mmHg>N]
00[PCO2(Tc43.0)>3N_PCO2=038mmHg>N]
$

3. Request code no. 3 limits, "Range and limits record":

Request format: CRLF03$


A
F
Reply format: CRLFrr n1n2CRLF00[PO2(Tc44.0)>1N_(0:50mmHg_1)_
S
A
kPa F
PO2(050:100mmHg)]CRLF[PCO2(Tc44.0)>2N_
S

kPa kPa
(0:50mmHg_1)_PCO2(025:050mmHg)]CRLF$

Example: 00 00
00[PO2(Tc44.0)>2N_(0:50mmHg_1)_PO2(050:100mmHg)]
[PCO2(Tc44.0)>3N_(0:50mmHg_1)_PCO2(25:50mmHg)]
$

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4. Legend of codes:
CR Carriage Return code (0x0D)
LF Line Feed code (0x0A)
_ Space code (0x20)
rr 00 = Request message ok
01 = Request code not recognized
02 = Invalid specifier in request message
03 = Request message corrupt
n1n2 configuration code number of monitor
between 00 and 99
00 Slot number (always 0)
PO2 Parameter 1 name
PCO2 Parameter 2 name
(Tc44.0) Sensortemperature
1 PO2 is waveform 1
2 PCO2 is waveform 2
A some parameter is in alarm
C parameter in alarm and accepted
O alarms have been switched off
N normal operation
S Standby and Calibration
F Fault
ND Normal Direct (real time data)
PO2=078mmHg/kPa PO2 measurement value in mmHg or kPa
(0:50mmHg/kPa 1) analog output, 50mmHg = 1V
PO2(50:100mmHg/kPa) PO2 low and high alarm limits
$ End of message

2.16.8 Analog outputs


PO2 analog output on pin 11 or 30:
0 to 6V = 0 to 300mmHg (20mV/mmHg) or 0 to 30.0kPa (20mV/0.1kPa)
PCO2 analog output on pin 12 or 31:
0 to 6V = 0 to 300mmHg (20mV/mmHg) or 0 to 30.0kPa (20mV/0.1kPa)

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2.17 Accessories

Sensor
060 5000 COMBI•M sensor Type 82

Accessories and disposables


060 5200 COMBI•M sensor supplies, consisting of:
• 12 sensor preparators
• one bottle COMBI sensor electrolyte
060 5300 Starter kit COMBI•M sensor including:
• Application set, consisting of:
• dispenser for adhesive rings
• one roll of 250 pcs. adhesive rings Ø 32 mm
• one bottle contact gel
• 3 sensor preparators
• one bottle of COMBI sensor electrolyte
060 7110 Application set, consisting of:
• dispenser for adhesive rings
• one roll of 250 pcs. adhesive rings Ø32mm
• one bottle contact gel
064 0210 CAL-Gas (box of 6 cylinders)
060 4210 COMBI sensor electrolyte (bottle of 10 ml)
060 3210 Contact gel (bottle of 10 ml)
060 3210.10 Contact gel (10 bottles of 10 ml)
060 7210 Adhesive rings (ext. diam. 32mm) for use with application set
(4 rolls of 250 pcs. each)
060 7230 Adhesive rings (ext. diam. 20mm) for use with application set
(4 rolls of 400 pcs. each)
7650 0080 MicroGas - VueLink Adapter Cable
7650 0081 MicroGas - PC Interface Cable

Manuals
7650 0910 Operating Manual, English
7650 0911 Operating Manual, German
7650 0914 Operating Manual, Italian
7650 0915 Operating Manual, French
7650 0916 Operating Manual, Spanish
7650 0901 Service Manual, English

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2.18 Description of Warning Symbols


Symbol of type BF equipment, defibrillator proof (EN 60601-1)
Equipotential ground connector adjacent to this symbol

Attention, before using the connector adjacent to this symbol the instructions given in the
operating manual must be read.

2.19 ESD Precautionary Procedures


ESD warning symbol:
Accessible pins of connectors identified with the ESD warning symbol should not be touched with
the fingers or with a hand-held tool unless the proper precautionary procedures described below
have been followed.
To prevent build up of electrostatic charge in the environment where the MicroGas is used, the
following methods can be used if applicable: air conditioning, humidification, conductive floor
coverings, non-synthetic clothing.
Before connecting the Combi•M sensor to the MicroGas, first touch the frame of the rear panel of the
MicroGas with one hand and then connect the sensor with the other hand.
It is recommended that all users of the MicroGas receive an explanation of the ESD warning symbol
and a training in ESD precautionary procedures.
The ESD training should include an introduction to the physics of electrostatic charge, the voltage
levels that can occur in normal practice and the damage that can be done to electronic components
if they are touched by an operator who is electrostatically charged. Further, an explanation should be
given of methods to prevent build-up of electrostatic charge, and how and why to discharge one's
body to earth or to the frame of the MicroGas prior to making a connection.

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3 Technical Description
Refer to Block Diagram 7650 0009 in section 9 (for more details see PCB circuit diagrams in section 9).
MicroGas 7650 includes the following assemblies:

3.1 Main PCB


The Main PCB contains the main processor, the I/O and memory decoding circuitry and all ROM and
RAM. A timer/counter provides the loudspeaker frequency, the floating dc/dc converter frequency
and the clock frequency for UART's and the parallel interface. A UART performs the serial
communication with the floating board and another UART plus RS423 level shifter enables the
communication with other Linde Medical Sensors systems (system connector). A parallel interface
enables to drive a parallel printer. A PIO provides the interface to the Display PCB and the touch
panel. A second PIO controls the loudspeaker, the calibrator valve and provides via a 10 bit DAC
plus two S&H circuits the analog outputs of PO2 and PCO2 on the system connector and provides
also the open collector status signals on the systems connector. It reads the pressure transducer
signals of the calibrator on a comparator and reads the calibrator status signals. A real time clock
(RTC) provides data and time and the time base (NMI) for the processor. There are also the
oscillator for the system clock and the reset circuits. A watch dog timer circuitry, a low 5V detector
and a low battery detector are also included. The PCB contains also +12V and -12V regulators and
provides the calibrator value voltage. With 3 jumpers the following pre-settings are possible:
• Normal/Service operation
• mmHg/kPa (units) display
• GLEM (France) alarming.

3.2 Power supply PCB


The PSU PCB contains the mains transformer, rectifiers, 5V switching regulator, battery charger, low
voltage (battery) detector and the on/off circuitry.

3.3 Floating board


On the Floating PCB the required isolation of the patient circuit is realised. The non-isolated
(grounded) and the isolated (floating) parts are separated by a 11mm wide creepage barrier. The
power of the isolated part is supplied by a pulse width controlled dc/dc converter via an isolation
transformer and an optocoupler as feedback to control the pulse width. It provides regulated 5V and
unregulated -5V. The communication between the two parts is performed by two optocouplers for
serial data transmission and receiving. The non-isolated side of the board contains only the circuitry
for driving the optocoupler and the dc/dc converter. The isolated side of the board is controlled by a
microcontroller (processor) which performs the following tasks:
1. Receiving and transmitting serial data via the two optocouplers
2. Switching of the analogue MUX
3. Handling the A-D converter
4. Sensor type detection
5. Temperature setting via D-A converter
6. Heating on/off
7. Setting the negative supply for the sensor (-2V/-4V), (only Floating Board 7650 0813)
8. reading/writing from/to the sensor memory
9. Calculation of the PO2 and PCO2 values and of the sensor temperature
10. Controlling of the sensor calibration
11. Controlling of the sensor temperature
Tasks 1, 5, 7 and 10 are performed upon a specific request from the main processor (Main PCB).
The other tasks are performed autonomous by the floating micro controller.

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The sensor heating is regulated by a analog PI-controller with Thermistor 1 as the actual
temperature and the DAC output as the set temperature.
The following adjustable reference voltages are provided:
+ 1.024 V ADC Ref
- 2.000 V Thermistor Ref and neg. supply of sensor
+ 2.500 V DAC Ref
+ 1.200 V Test Ref

3.4 Display PCB


The Display PCB contains the numeric LED controller and the LED digit driver circuitry, which
control the six 7-segment LED's and the alarm off LED bar. It contains also the alpha numeric, LED
backlighted LCD module, the LCD viewing angle adjustment circuitry and the backlight control
(on/off) circuitry. Control and data signals are provided by the Main PCB.

3.5 Touchpanel
The touchpanel contains the six tactile keys (snap dome), the green "monitor on" LED and the yellow
"mains" LED, the overlay and 3 window filters.

3.6 Calibrator assy


The electronic part of the calibrator assy consist of a bi-stable pulse valve consisting of two coils
(open/close), a pressure transducer to check the gasflow, the pressure switch to check the gas
bottle pressure and the calibration chamber switch to detect the presence of a sensor.

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4 Installation

WARNING!
The following installation and acceptance procedure should be performed by a
qualified technician.

CAUTION!
Do not connect the MicroGas to the ac mains power supply yet. Do not touch the
line voltage setting when the MicroGas is plugged into the ac mains power
supply. The ac mains fuses must have the correct current rating. When several
equipments are interconnected, the total earth leakage current may constitute a
hazard. If any power or earthing arrangement is suspect, the MicroGas must be
powered from its internal battery.

4.1 Installation Checks


On receipt of a new MicroGas, check the following points for damage:
• Transport packaging
• Case
• Front and rear panels
• Connector sockets
Check that the MicroGas is accompanied by the following accessories, and check that they are not
damaged:
• Operating manual
• Power cable assembly.
• Spare fuses: AC mains and DC
Check on the rear panel AC mains voltage plate, that the MicroGas has been set correctly for the AC
mains supply from which it will be powered. If it is necessary to change the AC mains voltage setting,
refer to section 4.3.
Check that the MicroGas is fitted with fuses of the correct current rating and type.
• 100 Vrms to 120 Vrms: 160mA (T)
• 200 Vrms to 240 Vrms: 80mA (T)
The fuse holder for these fuses is located just above the mains inlet plug on the rear panel. To open
the fuse holder see section 4.3.1.
Connect the MicroGas equipotential earth terminal to a potential equalization conductor, if it is a
mandatory requirement, or if a potential equalization conductor is available.
Plug the mains power cable into the rear panel AC mains power inlet and into a suitable mains
power outlet, which must provide a protective earth (ground).
Perform the routine maintenance as described in section 5.2.

4.2 Location
The monitor should be located close enough to the patient so that the sensor cable will not be
unduly stretched by movements that the patient might make. The alarms produced by MicroGas
7650 should be clearly audible from the operator's position. Lighting on and around the monitor
should be such that the displays and indicator lamps are clearly legible and visible.

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WARNING!
Never operate this equipment in the presence of flammable anaesthetics. Do not
operate this equipment (sensor excluded) in an environment which has abnormal
oxygen concentration. Do not expose the MicroGas to high humidity or heat.
Keep plugs and connectors meticulously clean and dry. Do not allow any liquid to
enter this equipment.

4.3 Changing the Mains Voltage Setting


The voltage selector is part of the mains inlet combi on the rear panel. The user has access to it
from the outside.
1. Disconnect the mains cord and pull out the fuse drawer by using a tool like a small screw driver.
2. Pull out the marked voltage selector, turn it so that the new voltage range will be visible from the
outside and then insert it again.
3. Insert the fuse drawer with the new fuses and check that the chosen voltage range is visible.

4.4 External DC Supply


If the unit is to be powered by an external battery (e.g. car battery) then assemble a two wire cable
16/02 Twin PVC with "Redel" plug type PAG-M02 GLAC 65G.
Polarity:

(view: socket MicroGas rear panel)


Mark the wires of the free end of the cable with + and - and connect them correctly to the + and -
pole of the battery.

4.5 Changing the Setting of the Measuring Unit from mmHg to kPa
1. Switch off the unit and disconnect from mains.
2. Follow section 6 steps 6.2 to 6.3 to get access to the Main PCB.
3. Set jumper JP1 on Main PCB to pins 1-2
4. Reassemble in reverse order.
5. Clean the area below the LED windows with soft cloth and alcohol.
6. Overpaint the mmHg indications with black permanent pen
7. Stick the kPa labels below the windows so that they cover the overpainted mmHg indication (take
care that they are parallel and inline to the windows
8. Check correct link placement and operation by:
• Connecting a sensor or a simulator
• Switch unit on
• Check decimal point is displayed XX.X on the PO2 and PCO2 displays
9. Carry out routine safety and performance check

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5 Maintenance and Fault Finding

5.1 Introduction
The recommended routine maintenance is split into two levels:
• Section 5.2 describes the routine maintenance procedure which should be carried out monthly on-
site by the operator.
• Section 5.3 describes the routine safety and performance check which should be performed at
regular intervals e.g. every two years or in accordance with local and governmental regulations.
In addition to the two routine maintenance procedures, section 5.4 describes the adjustment and
performance check procedure which shall be performed after a repair.

WARNING!
Electrical safety testing must be performed at least on the following occasions:

• Immediately following a check as described in section 5.3.

• Whenever the equipment has been repaired or adjusted.

• If the equipment has been damaged, or damage is suspected.

• If the equipment fails any of the tests, the fault must be found and rectified.
The equipment must then be fully re-tested and its electrical safety found to be
satisfactory, before it can be brought back into use.
Section 5.5 gives the procedure to be followed to check that the equipment is electrically safe.
Section 5.6 information on decontamination, which should be undertaken before any inspection,
service or repair.

WARNING!
If there is any risk that the equipment is contaminated, you must follow the
decontamination procedure given in section 5.6
Section 5.7 describes the replacement of the internal battery.
Section 5.8 describes monitor fault codes.

WARNING!
This equipment's cover must not be removed by unqualified persons. Disconnect
the equipment from the mains power supply before removing the cover. Take
extreme care if the mains power supply is re-connected when the equipment's
cover has been removed.

5.2 Routine Maintenance

Action
1. Check Monitor
2. Check Sensor
3. Check Consumables
The routine maintenance should be performed monthly according to the following procedure:

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5.2.1 Check Monitor


• Switch monitor off and disconnect it from AC power.
• Clean housing, front and rear panel with a soft cloth lightly moistened with warm soapy water. Use
only mild soap or detergents. Allow to dry completely before use.
• Inspect power cord assembly for any signs of mechanical damage to cable or connector. If
damaged, replace with a genuine Linde Medical Sensors replacement part. Do not attempt to
repair.
• Connect Monitor to AC power.
• Switch Monitor off and on again.
• Verify that during the following self-check, all display segments and control lamps are illuminated,
that all dots of the middle LCD are visible and that a tone sounds.
• Check parameter settings and readjust if required.

5.2.2 Check Sensor


• Check sensor and cable assembly for any signs of mechanical damage. In case of a damage,
replace sensor. Do not attempt to repair.
• Clean the prepared sensor and the cable with a soft cloth moistened with alcohol (carefully avoid
damaging the delicate sensor surface). Allow to dry completely before use.
• Remembrane sensor if required.

5.2.3 Check Consumables


• Check expiration date of all consumables. Replace if necessary.

5.3 Routine Safety and Performance Check


At normal use of the monitor there is no internal adjustment or new calibration of the monitor
required. It is recommended to perform a safety and performance check at regular intervals e.g.
every two years when the internal battery must be replaced (see section 5.7) or in accordance with
local and governmental regulations. The routine safety and performance check must be done by a
trained and authorized service technician only.

Action
1. Inspection
2. Performance test
3. Safety test

Equipment required
• Electrical Safety Tester
• MicroGas 7650 Service Manual
• Cal-Gas bottle, Part number 064 0210

5.3.1 Inspection
Check the general condition of the case, external controls, overlay and mains lead
Inspect the sensor cable and the sensor head
Remove the four screws from the base (refer to section 6), remove the case and perform an internal
inspection, check for possible fluid ingress and the security of the PCB's, plugs and sockets.
Re-assemble unit.

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5.3.2 Performance test


Connect the sensor at the rear and insert the sensor head into the "autocal" calibration chamber.

1. Switch the unit on at the rear and ensure that the following are displayed:
7650 SYSTEM TEST
followed by: 7650 REV. 12.00
followed by: FLOAT REV. 4.00
(numbers are example)
The unit should then enter the CALIBRATING mode.

2. Within 10 minutes ensure that the unit displays:


READY TO USE
(with actual date and time)
If the calibration takes up to 20 minutes then the sensor needs to be stabilized.
If REMEMBRANE SENSOR is displayed, remembrane the sensor and perform a new calibration.
If REMEMBRANE SENSOR occurs again, let the sensor be placed in the calibration chamber for
stabilization for up to 4 hours or exchange the sensor.

3. Remove the sensor from the "autocal" calibration chamber and leave the sensor head in air.
Within 2 minutes the unit will display a PCO2 reading of less than 5 mmHg (0.7 kPa) and a PO2
reading which amounts at least to the calibration value mulitplied by the factor 1.5.
(e.g. 90 mmHg x 1.5 = 135 mmHg or 12.0 kPa x 1.5 = 18.0 kPa)
4. Apply the sensor to the inside of your left upper arm by following the instructions, given in the
operating manual in section 3.6. Set the site timer to 30 minutes. Press the START key so that
the site timer runs down while you perform the following remaining steps in this section.

5. Allow approx. 10 minutes for the sensor to stabilize. Do not move to avoid erratic readings. Verify
that the readings are within the following limits:
• PCO2 = 34 mmHg to 45 mmHg (4.5 kPa to 6.0 kPa)
• PO2 = 60 mmHg to 90 mmHg (8.0 kPa to 12.0 kPa)

6. Ensure that the "Mains connected / internal battery charging" and the "Monitor On" indicator
lamps are on.

7. Test all front panel keys for operation.

8. Return to normal monitoring, enter in each alarm menu (of PO2 and PCO2) and change each
alarm limit, one after the other, in order to provoke alarm conditions. Verify that each alarm is
correctly indicated.

5.3.3 Safety test


Earth leakage, patient leakage, insulation and earth bonding tests should be carried out and the
results recorded (Details see section 5.5).

5.4 Adjustement and Performance Check


This procedure shall be performed following to a repair of the monitor (exchange or repair of a sub-
assembly). Depending on the type of the repair it may be sufficient to perform only parts of this
procedure. Following to this procedure the Electrical Safety Check (see section 5.5) must always be
performed. The Adjustment and Performance Check must be done by a trained and authorized
service technician only.

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Action
1. Check inscriptions and labels
2. Inspect all plugs and cables
3. Check fuses
4. Check start up
5. Check retention of parameter and alarm settings
6. Check alarms
7. Check battery
8. Check Main PCB voltages
9. Check floating board supply and voltage references
10. Check heating and sensor fault
11. Check PO2/PCO2 measurement
12. Check analog outputs
13. Check pressure transducer and pressure switch
14. Check access to sensor memory
15. Check battery charger
16. Check electrical safety

Equipment required
• DVM 5 digit
• Blood Gas Sensor Simulator II
• Dummy Sensor head
• Combi•M Sensor
• Cal-Gas bottle, part number 064 0210

Action details:

5.4.1 Check inscriptions and labels


Check that inscriptions and labels are complete and legible.

5.4.2 Inspect all plugs and cables


Inspect all cables for signs of damage or loose connections. Replace or re-connect as necessary.

5.4.3 Check fuses


Check that the fuses are the correct type and rating.

5.4.4 Check start-up


• Connect MicroGas to the AC mains supply. The front panel yellow power lamp ( ) shall light.
• Switch the monitor on (on/off switch on rear panel). The front panel green ON lamp () shall light.
• Check for the following displays

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During the first approx. 4 seconds:

Alarm LED ( ) lights

During the following approx. 4 seconds:


The Alarm LED D1 and all six seven segment LED's are switched off.
The central LC-display shows the following:
7650 REV. 12.00 (Revisionnumber = example)
followed by: FLOAT REV. 4.00
then the display changes to: CONNECT SENSOR
The LED-Backlight is flashing; on-off / sec
The Fault tone sounds
During all these display sequences, give your attention to the following:
• all displayed messages are displayed correctly
• all characters are correct, no missing dot
• uniform intensity of all displayed dots
• uniform brightness of all green segments of the LED's
• even, yellow illumination over the whole display area of the central display.

5.4.5 Check retention of parameter and alarm settings


Switch monitor off (rear panel). Wait for approx 10 seconds, switch monitor on again. Select with P-
key all parameters and alarms and check that the values have been retained (not overwritten by
default values) and that the actual date and time is displayed.

5.4.6 Check alarms


Check that PO2 and PCO2 high and low alarms can be activated. Connect a COMBI•M sensor (rear
panel) and perform a calibration, refer to operating manual section 3.2. Remove the sensor from the
calibration chamber and apply it to a patient or to yourself as described in section 3.6 of the
operating manual. Start a measurement as described in section 3.7 of the operating manual. Wait for
at least 5 minutes then alter each alarm limit so that the current value causes an alarm to be
activated. Disable alarms before adjusting limits. Enable alarms and press the alarm off/reset key as
soon as the audible alarm sounds. Change the limit so that the current value does not cause an
alarm. Repeat the process until maximum and minimum alarm limits have been tested for both
parameters.

5.4.7 Check battery


1. Disconnect mains cord. Ensure that the monitor operates from its internal battery.

2. If "Charge Battery" appears, connect the monitor to AC mains for at least 12 hours. Operate the
monitor again on battery and check that "Charge Battery" is not displayed. If it is, the battery may
need replacing.

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5.4.8 Main PCB voltages


1. Connect the Mains Supply to the rear panel Mains Socket.
Check that the yellow LED ( ) on the front panel lights.
The following measurements are to be performed on the Mainboard

2. Raw DC-Supply
Connect DVM\ to TP0
DVM⊕ to TP 5: 22,0 V to 30,0 V
DVM⊕ to TP 6: 21,5 V to 29,5 V

3. Check RAM and RTC supply:


DVM⊕ to TP2: 2,4 V to 2,6 V

4. Supply voltages:
• switch monitor on (rear panel on-off switch)
• check the green LED () is lit on the front panel
• measure the following voltages:
TP 5: 20,0 V to 26,8 V
TP 6: 19,2 V to 26,0 V
TP 7: 4,9 V to 5,1 V
TP 9: 19,3 V to 26,1 V
TP10: 11,8 V to 12,4 V
TP11: -10,0 V to -11,4 V

5.4.9 Floating board supply and reference voltages


1. Set Bloodgas Sensor simulator to:
Rotary Switch "SENSOR" = Combi
Rotary Switch "PCO2" = 2 (35mmHg)
Rotary Switch "PO2" = 2
Rotary Switch "TEMP.°C = 44
Switch "∆Th1°C = 0
Switch "∆Th2 Ω = OFF
Switch "Cathode" = shorted
Connect Simulator to Sensor input on the rear panel.
The display changes to the following:
- Numeric display shows PO2 and PCO2 values (depending on previous calibration)
- The central display changes to either:
a) S. REMEMBRANED ? or: b) CALIBRATE SENSOR
NO =▼ YES =▲

2. In case of text a) press key.


Central display shows: CALIBRATE SENSOR

3. Else continue with next step.


Set Monitor to:
- BAROMETRIC PR. = 750 mmHg
(9 x P key, followed by or key)
- PCO2 TEMP. CORR. FACTOR = 1.50
(select Parameter Level 2 via 11 x P key then during 2 sec. key, then another 6 x P key
followed by or key)
- PCO2 METABOLIC. CONSTANT = 0 mmHg (0.0kPa)
(Select Parameter level 2, then 7 x P key followed by or key)

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4. Screw the Calibration Gas Bottle into the Calibrator part of the monitor (Rear panel aperture)

5. Put a dummy sensor head into the calibration chamber; the central display changes to:
CALIBRATING
90 mmHg 35 (12.0 kPa 4.7)
and the gas value opens audible after maximum 60 seconds. While the unit is calibrating,
proceed with the test

6. Supply voltages:
DVM\ to TP9
+5V on TP7 = 4,85V to 5,15V
-5V on TP8 = -4,75V to -5,50V

7. Reference voltages:
a) -2V ref on TP12 = - 2,000V ±0,4 mV, if necessary readjust with potentiometer RV1
b) 1,024V ref on TP10 = +1,024V ±0,1 mV, if necessary readjust with potentiometer RV2
c) +2,5V ref on TP11 = +2,5V ±6 mV
d) Control reference on TP 17 = +1,205 V to + 1,260 V

5.4.10 Heating circuit and Sensor Fault


1. Heating adjustment:
DVM⊕ to TP 13, reading must be 0V ±20 mV, if necessary readjust with RV3.
Wait until the calibration has finished (max 90 sec since 5.4.2.5 if no readjustments have been
performed) and the central display shows:
READY TO USE
JUN. 01/99 14:30
Remove the dummy sensor head from the calibration chamber; the central display changes to:
100 44.0 50
50 4:00 25
alternating with:
PRESS START
MONITORING
Press key, the central display changes to monitoring mode:
100 44.0 50
50 4:00 25 (" : " is flashing)

2. Select 37,0°C on the sensor simulator


The displayed temperature flashes.

3. Select successively all temperature values between 37°C and 45°C on the sensor simulator and
compare the set temperature with the temperature indicated on the display.
Deviations shall not exceed 0,1°C.
At 44,0°C, flashing shall cease and recover at 44,5°C.

4. Leave the temperature setting on the simulator on 45,0°C. After 4 seconds, the message:
SENSOR FAULT
accurse together with the fault tone.

5. Leave temperature setting at 45°C. After again 4 seconds the message shall change to:
MONITOR FAULT 7

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6. Reset alarm by turning the monitor off then on again. Set simulator to 44.0°C.
In case of display showing:
S.REMEMBRANED ?
press ▲ key.
Display changes to:
CALIBRATE SENSOR
Then press key. Monitoring display alternate with:
CALIBRATE SENSOR

7. Connect DVM to sockets "+" and "GND" on sensor simulator.

8. Set temperature to 43,5°C on simulator.


The DVM reading shall increase and settle at a value between 6V and 9,5V.

9. Set temperature to 44,5°C on simulator.


DVM reading shall decrease and settle at a value less than 0,8V.

10.Set temperature to 44,0°C on simulator. Note displayed temperature. Set " ∆Th1°C" on simulator
to "-0,1°C". Displayed temperature shall decrease by 0,1°C. DVM reading shall show a step
change followed by an increase at a rate off approx. 150 mV/sec ±50%.

11.Set "∆Th1°C" on simulator to "+0,1°C". Displayed temperature shall increase by 0,2°C. DVM
reading shall show a step change followed by a decrease at a rate of approx. 150 mV/sec ±50%.

12.Set "∆Th1°C" to 0 on simulator and set "∆Th2Ω" to ON on simulator.


Turn ∆T2 - potentiometer to positive values until the temperature indication on the monitor starts
flashing. This shall occur at 36 Ω < ∆Th2 < 72 Ω. The DVM reading shall be independent of the
∆Th2 value.

13.Repeat step 12 with negative values of ∆Th2. Set "∆TH2" to OFF on simulator. Disconnect
multimeter.

Note: Take care that the temperature display does not flash more than 30 seconds, else SENSOR
FAULT will be displayed.

5.4.11 Check of PO2/PCO2 Measurement


1. Check that the sensor simulator is set according 5.4.9, step 1.

2. If the calibration was successful in 5.4.10, step 1. then the numeric display shall indicate now:
PO2 = 90 mmHg ±1 (12,0 kPa ±0,1), PCO2 = 35 mmHg ±1 ( 4,7 kPa ±0,1)

3. Select position 1 to 6 on "PO2" rotary switch of simulator.


Numeric display shall indicate the following values:
Simulator Numeric display
1 43 - 47 mmHg (5,7 - 6,3 kPa)
2 89 - 91 mmHg (11,8 - 12,2 kPa)
3 174 - 186 mmHg (23,2 - 24,8 kPa)
4 440 - 460 mmHg (58,6 - 61,4 kPa)
5 700 - 740 mmHg (93,3 - 98,7 kPa)
6 740 - 790 mmHg (don't care)

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4. Select all 4 positions on "PCO2" rotary switch of the simulator.


The values indicated on the monitor shall be:
Simulator Monitor
1 14 - 16 mmHg ( 1,8 - 2,2 kPa)
2 34 - 36 mmHg ( 4,5 - 4,8 kPa)
3 79 - 83 mmHg (10,5 - 11,1 kPa)
4 179 - 193 mmHg (EEE )

5.4.12 Analog output (Systems Connector)


1. Reference voltage adjustment: Connect DVM⊕ to TP14 on Main PCB, 0 V = TP0.
Adjust voltage with potentiometer RV 1 to: + 2,482 V ±1mV

2. PO2 output: Connect DVM⊕ to TP 22 on Main PCB.


Repeat PO2 measurement as described in section 5.4.11, step 3.
max. output = 6,0V, therefore only step 1, 2 and 3 of the simulator are possible
The DVM reading shall be: Displayed PO2 value multiplied by 20mV ±2%

3. PCO2 output: Connect DVM⊕ to TP23 on Main PCB.


Repeat PCO2 measurement as described in section 5.4.11, step 4.
The DVM reading shall be:
Displayed PCO2 value multiplied by 20 mV ±2%

5.4.13 Pressure transducer and pressure switch


1. Put a dummy sensor head into the calibration chamber.
The central display changes to:
CALIBRATING
90 mmHg 35 (12.0 kPa 4.7)
and the gas valve opens audible after maximum 60 seconds.

2. Screw out the gas bottle


The central display must change to:
NO GAS FLOW (flashing)
RENEW GAS BOTTLE
and the fault tone sounds

3. Screw in the gas bottle again. The central display changes back to the calibrating text and the
faulttone is muted.

5.4.14 Access to Sensor Memory


Select Parameter Level 2 on Monitor; 11 x P key than 2 seconds key, then again 13 x P key
The central display shall show:
LAST SLOPE ADJ.
JUNE 26/97
The date displayed shall be the date of the last Slope Adjustment of the Sensor Simulator.

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5.4.15 Battery charger:


1. Disconnect the dc-supply.
Set DVM to measure current and connect it to plug JP3 of the PSU PCB.
2. Connect unit to mains and switch it on.
3. Measure charger current.
DVM reading must be between 120 mA and 200 mA

5.4.16 Safety checks


See section 5.5

5.5 Electrical Safety Checks


WARNING!
Electrical safety can be assured by frequent safety testing. Safety testing, i.e. all
of the tests in this sub-section, must be performed at least on the following
occasions.
• Immediately following the routine safety and performance check.
• Whenever the equipment has been repaired or adjusted.
• If the equipment has been damaged, or damage is suspected.

If the equipment fails any of the tests, the fault must be found and rectified. The
equipment must then be re-tested and its electrical safety found to be
satisfactory, before it can be brought back into use.
Earth leakage current, patient leakage current, insulation and earth bonding tests must be performed
and the results recorded.
Equipment required: Electrical Safety Tester
Measurement and test values:
Earth leakage current normal/reverse < 500 uA
Patient leakage current < 20 µA at 200 - 240 Vrms
< 10 uA at 100 - 120 Vrms
Insulation > 50 MΩ
Earth bonding < 0.2 Ω

5.6 Decontamination

5.6.1 Decontamination requirements


Due to the nature and seriousness of diseases such as acquired immunodeficiency syndrome and
Hepatitis B, it is important that where equipment and accessories can come into contact with human
or animal tissues or fluids (particularly blood), they should always be regarded as contaminated and
potentially hazardous.
Contaminated equipment and accessories must be decontaminated in accordance with the hospital
decontamination and disinfection procedures appropriate for the device, or by the following procedure.
Decontamination must be carried out by properly trained staff.
If you are in any doubt regarding contamination or decontamination, consult your local infection
control officer.

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5.6.2 Risks
All human or animal tissues or fluids in the hospital and laboratory environment are capable of
transmitting infection. Therefore, special precautions must be taken in hospitals and laboratories that
deal with patients who have highly infectious disease.
Disease can enter by the following routes:
• Through broken skin
- needle or other sharp object
- contamination of cuts, abrasions or burns
• Ingestion (placing a contaminated object in or near the mouth, e.g. pen, finger)
• Direct contact with mucous membranes (e.g. eyes)
• Inhalation of contaminated dust or aerosols
Experience has proved that when proper precautions are taken, as outlined below, the risk of
infection is very small and certainly of a lower order of magnitude that other risks that are taken
routinely in daily life.

5.6.3 Precautions
The following precautions must be taken to avoid risk of infection. Different levels of compliance may
be observed in different areas, but only constant adherence to all precautions is sufficient to ensure
personal health and safety.

Containment
Although the hospital or laboratory is responsible for ensuring that any spillage of body fluids is
properly cleaned and that equipment is decontaminated, it cannot completely assure that all traces
of contaminant have been removed, particularly from internal parts of equipment which are
accessible only during servicing.

Sharps
Take particular care to avoid puncture wounds from needles or cuts and abrasions from sharp edges.

Protective clothing
A laboratory coat, surgeons' disposable gloves and a plastic apron must be worn for all service work
in clinical areas. Safety glasses and a paper face mask must also be worn if there is any risk of dust
or aerosol formation. Renew gloves frequently and wash hands thoroughly before putting on a new
pair.
Renew gloves immediately if they become punctured, cut or torn.
The correct method of removing disposable protective clothing is as important as wearing it in the
first place. Carefully fold aprons inwards and remove gloves by pulling them from the cuff to turn
them inside-out. Take care not to touch the contaminated outside surface.
Immediately after use, place all items of disposable protective clothing in the appropriate receptacle
for biological waste, as advised by the laboratory. Never re-use disposable protective equipment.

Personal hygiene
Scrupulous personal hygiene is probably the most important precaution in eliminating the risk of
infection. Always wash hands and face with soap and water and scrub nails after completing each
service, or when leaving the clinical laboratory to take a break.
Avoid hand contact with the mouth, eyes, ears and nose.

Eating and drinking


Never eat, drink or smoke in any contaminated area.

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Cuts and abrasions


Infection can enter the body through any cut, abrasion, chapped skin, open sore or spot, or skin
affected by eczema. Ensure that any cut, abrasion or sore is covered with a waterproof dressing.
Use hand cream to prevent chapping and do not touch any other infected area of skin until your
hands have been thoroughly washed.

Accidents
Action in the event of accidental contamination should be as follows:
• Cuts: Remove gloves or any other items clothing which could introduce contamination, encourage
the wound to bleed freely and wash it thoroughly under running water. Seek further advice and
treatment from any occupational health or casualty department, if such services are available.
Otherwise, minor cuts should be dried using a sterile gauze,and a waterproof dressing should then
be applied.
• Eye contact: Irrigate thoroughly with water and obtain medical attention if necessary.
• Skin contact: Wash gently under running water.
Note: Any cut or other injury sustained while servicing equipment must be reported to your Supervisor.

5.6.4 DO's and DON'Ts


• DO wear a laboratory coat, apron and gloves.
• DO disinfect contaminated surfaces.
• DO disinfect tools after use.
• DO wash thoroughly before leaving the contaminated area.
• DO dispose of gloves and aprons immediately after use, or if damaged.
• DO treat any cut or abrasion immediately.
• DO keep cuts and abrasions covered with a waterproof dressing.
• DO encourage any cut to bleed and then wash it under running water.

• DON'T put hands near mouth, eyes, ears or nose.


• DON'T eat, drink or smoke in any contaminated area.
• DON'T blow surfaces to remove dust; use a vacuum cleaner

5.6.5 Decontamination procedures

CAUTION!
DO NOT STERILIZE THE EQUIPMENT AND ACCESSORIES BY IRRADIATION,
STEAM OR ETHYLENE OXIDE. ELECTRONIC EQUIPMENT AND ACCESSORIES
NOT SUITABLE FOR AUTOCLAVING. USE A CHEMICAL DESINFECTION
SOLUTION AS DESCRIBED BELOW.
Please refer to section 5.2 of this manual for the recommended cleaning procedure for each device.

Chemical disinfection
Where an equipment has been used but is not visibly contaminated, first wipe its surface with cotton
wool swabs soaked in isopropyl alcohol (70%), and then dry the surface with a disposable cloth.
Where surfaces of equipment or accessories are visible contaminated, wipe the surface with cotton
wool swabs soaked in a surface disinfection solution containing e.g. quaternary ammonium
derivates, to remove all visible traces of soiling. Then apply the disinfection solution to the surfaces,
keeping them wet according to the recommandations of the disinfection solution manufacturer. Rinse
the surfaces with water and then dry them using disposable cloths.
Dispose of swabs in the receptacle for biological waste, immediately after use.
Take care that liquids do not enter the equipment or connectors.

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Use of other disinfectants


Other chemical disinfectant solutions are not suitable for use on delicate medical equipment and
accessories as they can cause permanent damage and corrosion. In particular, hypochlorites and
chlorinated ketone, ether or ester-based solvents must not be used.

Dust removal
Remove dust by using a vacuum cleaner, never blow surfaces to remove dust. Always wear gloves,
face mask and eye protection when replacing vacuum cleaner bags. Place the full bag inside a
polythene bag, seal with tape and place in the appropriate receptacle for biological waste.

Equipment requiring service


Where equipment or accessories are to be returned to the supplier or factory for service/repair, the
clinical user must ensure that the device has been properly decontaminated. A certificate of
decontamination must be completed by the person responsible for the device and this certificate
must accompany the device on its return for service or repair.
Where equipment is to be serviced on site, a certificate of decontamination will also be required by
the service engineer.

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Linde Medical Sensors AG Tel.: 41-61 278 81 11


Austrasse 25 Fax: 41-61 278 81 81
4051 Basel
Switzerland

CLEARANCE CERTIFICATE
for the Inspection, Servicing, Repair or Return of Medical and Laboratory Equipment.

TO: (Manufacturer/Supplier) .......................... Make & description of equipment:


........................................................................ ...........................................................................
........................................................................ ...........................................................................
Manufacturers Service Ref/
Returns Authorisation Ref: .............................. Model/Serial/Batch No........................................
Customers Ref/Order No: ............................... Other distinguishing Marks .................................

A. Has this equipment been exposed internally or externally to any of the following.
Please answer all questions by deleting Yes/No as applicable and by providing
details in Section B below.
1. Blood, body fluids, pathological 4. Chemicals or substances hazardous to health
specimens Yes/No Provide details below Yes/No

2. Other biohazard 5. Radioactive substances


Provide details below Yes/No State below name(s) and quantities of isotopes
and chesks made for residual activity Yes/No

3. Biodegradable material that could 6. Other hazards


become a hazard Provide details below Yes/No
Provide details below Yes/No

B. Please provide details of any hazards present as indicated above, include details of
names and quantities of agents as appropriate.

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

C. Your method of decontamination (please describe).

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

D. Are there likely to be areas of residual contamination (please specify).

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

I declare that the above information is true and complete to the best of my knowledge and
belief.

Authorised Signature:................................................ Date: .............................................................................

Name (printed): ......................................................... Position:........................................................................

Customer's Name:..................................................... Dept.: ............................................................................

Address: .................................................................... Tel.:...............................................................................

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5.7 Replacement of Internal Battery


The MicroGas monitor internal battery is recharged automatically while the monitor is connected to
mains. When the monitor is not in use and not connected to mains for more than 6 months, the
battery charge must be refreshed.
For a full charge connect the MicroGas monitor to mains power for 18 hours.
To keep the charging state of the internal battery at maximum, leave the monitor connected to AC
power. In case the system should not be connected to AC power for an extended period of time
(several months) it is recommended to disconnect the battery.
It is recommended to replace the internal battery every two years (see also section 5.3, Routine
Safety and Performance Check).
For disconnection, removal or replacement of the internal battery refer to section 6.6.

5.8 Fault Finding

5.8.1 Sensor Fault


Indication: display shows the flashing message "SENSOR FAULT" and the fault tone sounds.
Whenever a sensor fault is detected the sensor heating is automatically switched off.
The sensor fault is triggered by the following conditions:

1. The contents of the sensor memory has been lost, or the access to the sensor memory is not
possible.
Check sensor connector, flexi PCB, input buffer IC U9 and GAL IC U4, all located on the floating
board.
If the sensor memory is in doubt then the complete sensor must be replaced.

2. Temperature fault - one of the following condition is fulfilled:


• actual temp. > set temp. + 1°C for 4 sec
• actual temp. < set temp. - 1°C for tmax (maximum time)
• tmax is normally 30 sec but 5 min during warming up of the sensor.
• (actual temp.- set temp.) > 0.3°C for tmax
• difference between thermistors > 0.6°C for 4 sec.
• difference between thermistors > 0.3°C for tmax
Check the following on the floating board:
Sensor connector, Flexi PCB, multiplexer IC U8, DAC IC U10 and IC U11, heating regulator IC's
U12 and U13 and associated components. Check the concerned tracks on breaks and short
circuits.

5.8.2 Monitor Fault Codes


The monitor has detected an irregularity of one of its functions.
Indication: display shows the flashing message "MONITOR FAULT XX" (XX = code number) and the
fault tone sounds.
Whenever a Monitor fault is detected the supply voltage of the floating board is switched off
automatically and any measurement is stopped.

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Code Cause Remedy


3 Communication error between Floating Check floating supply voltage, opto-couplers
board and Main board. No reply from OC2 and OC3, microcontroller IC U3 on float
Floating board. board, UART IC U29 on main board and
ribbon cable 7650 0062.
5 Communication error Floating to Main pcb. Check optocouplers OC2 and OC3, micro-
Wrong data replied or parity error. controller IC U3 on float. board, UART IC
U29 on main board.
6 Sensor heating is switched off but Check heating circuit and analog multiplexer.
temperature is still higher than the selected Check transistors Q9 and Q10 on float.
temperature since 4 minutes. board.
7 Sensor heating is switched off but Refer to fault 6
temperature is higher than 44°C since 4
seconds
8 RAM error on main board. Check RAM circuit:
DBUS, control bus, voltage supply. If
necessary exchange RAM'S.
9 RAM error on floating board. Check floating board micro-processor
circuit. If necessary exchange it.
10 Microprocessor on Floating board does only Check on Floating board eProm, Micro-
communicate with the Main-board but is no processor, Multiplexer. If necessary
more performing the measurement task. exchange them.
12 AD-converter error on floating board. Check reference voltages:
Test ref., +1.024V ref., -2V ref., +2.5V ref.
(D10, D6, IC U14, Q7 and associated
components) and multiplexer.
20 Watch Dog Error: The main board processor Processor failure: Check D-bus, A-bus,
is interrupted by a non-maskable interrupt Control bus, EPROM, RAM, GAL IC U17
(NMI) because the watch dog timer has and IC U3. Check concerned sockets and
switched off (not retriggered) within 1 tracks an breaks and short circuits.
second.
21 Watch Dog Test error detected during power Check IC U3, GAL IC U17, Latch IC U26.
up. Check tracks on breaks and short circuits
30 Check sum of the instruction memory of the Check connections to EPROM IC U5, A-Bus,
main pcb is incorrect D-Bus and control-bus. If necessary
exchange EPROM

5.8.3 Gas System Faults (Calibrator assy)


Warning message Cause Remedy
GAS FLOW During calibration the monitor Exchange complete calibrator
DISTURBED F1/F2 has detected an irregularity of assy
the pressure control system
NO GAS FLOW Calibrator assy disadjusted (too Check comparator-circuit on
RENEW GAS BOTTLE high gas flow or thres-hold of main board IC U15 and U25 if
occurs too early (when more pressure switch too low or necessary exchange cali-brator
than 4 dot of the bottle filling defective comparator) assy (do not adjust)
bar graph are displayed)

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6 Removal and Refitting

WARNING!
This equipment's cover must not be removed by unqualified persons.

Disconnect the equipment from the mains power supply before removing the
cover. Take extreme care if the mains power supply is re-connected when the
equipment's cover has been removed.

6.1 Mains Fuses and Voltage Selector

6.1.1 Operating the Fuse Holder


1. Insert the tip of a small screwdriver under the tab of the fusedrawer (the mains cable assembly
must be umplugged).
2. Twist the screwdriver to lever up the fusedrawer and pull the fuse drawer out of its compartment.
3. The fuses are now easily accessible

6.1.2 Setting of the Mains Voltage Range


After the fusedrawer has been pulled out (6.1.1) also the voltage selector insert can be pulled out by
means of a pincers. If the alternative mains voltage range must be set turn round the insert and push
it back into its compartment. Check that the desired voltage range identification number is visible.

6.1.3 Refitting the Fuse Holder


1. Check that the fuses correspond to the desired mains voltage range.
2. Insert the fusedrawer into its compartment and push it flush with the surface of the AC mains inlet
assembly.

6.2 Case

6.2.1 Removing the Case Assembly


1. Remove the four pan head screws which are located on each side underneath the base of the
unit.
2. Pull forward the complete case assembly (Frontpanel, Touchpanel, Sensor spool and hood) until
the inside of the unit is free.
3. Turn the case assembly onto its left side and place it to the left side of the unit.

6.2.2 Refitting the Case Assembly


Refitting is the reverse of removal

6.3 Main PCB

6.3.1 Access to Main PCB


1. Remove the two screws that secure the interface plate of the Main PCB to the rear panel of the
chassis.
2. Remove the screw from the right-hand edge of the Main PCB (front view).
3. Hinge up the Main PCB. The component side of the Main PCB is then accessible.

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6.3.2 Removal of the Main PCB


1. With the Main PCB hinged up, disconnect the ribbon cable assemblies from PL3, PL4, PL5 and
PL6, and the loudspeaker cable assembly from PL7.
2. Close the Main PCB and remove the two screws that secure the hinge to the Main PCB.

6.3.3 Refitting the Main PCB


Refitting the Main PCB is the reverse of removal.

6.4 Floating PCB

6.4.1 Access to Floating PCB


1. With the Main PCB hinged up remove the two screws that secure the sensor input connector to
the rear panel.
2. Remove the screw that secures the insulation sleeve assembly to the inside of the front wall of
the chassis.
3. Hinge up the Floating PCB assembly. Remove the insulation sleeve by sliding it backwards.
4. Remove both screw on the inner can cover and remove the inner can cover. The component side
of the Floating PCB is then accessible.

6.4.2 Removal of the Floating PCB


1. With the Floating PCB hinged up, disconnect the ribbon cable assembly from plug JP1.
2. Remove the two screws that secure the hinge to the Floating PCB.

6.4.3 Removal of the sensor input socket assembly


1. Disconnect the flexi PCB from socket JP3.
2. Remove the two screws that secure the sensor input socket assembly (solder side of the PCB).

6.4.4 Refitting the Floating PCB


Refitting is the reverse of removal.

6.5 Power Supply PCB

6.5.1 Access to Power Supply PCB


Hinge up the Main PCB (6.3.1) and hinge up the Floating PCB assembly (6.4.1), the component side
of the Power Supply PCB is then accessible.

6.5.2 Removal of the Power Supply PCB


1. Disconnect the ribbon cable assembly from plug JP4, the on/off cable assembly from JP2, the dc-
input cable assembly from JP1, the battery cable assembly from JP3 and the five single wires
from J1, J2, J3, J4 and J5.
2. Remove the four screws that secure the PCB to the chassis bottom.

6.5.3 Refitting of the Power Supply PCB


Refitting is the reverse of removal.

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6.6 Battery

6.6.1 Removal of the Battery


1. Hinge up the Main PCB (6.3.1) and hinge up the Floating PCB (6.4.1)
2. Disconnect the battery leads
3. Remove the three screws (two on the left side and one on the right side of the battery clampfront
view) which secure the battery clamp.
4. Remove the battery clamp and lift the battery clear of the unit.

6.6.2 Fitting a Battery


Fitting a battery is the reverse of the removal. Take care when reconnecting the battery leads that
the battery polarity is correct.

6.7 Display PCB

6.7.1 Access to the Display PCB


Remove the case assembly (6.2.1) then the component side of the PCB is accessible.

6.7.2 Removal of the Display PCB


1. Disconnect the touch panel ribbon cable assembly from socket JP1.
2. Remove the four screws that secure the PCB to the front wall of the chassis.
3. Pull forward the PCB slightly and disconnect the ribbon cable assembly from plug JP3 on the
solder side of the PCB.

6.7.3 Refitting of the Display PCB


Refitting is the reverse of removal.
After the Display PCB is fitted make sure that the PCB can be pushed backwards against the four
springs (one per stud).

6.8 Touch Panel

6.8.1 Removal of the Touch Panel


1. Remove the case assembly (6.2.1), then remove the ribbon cable assembly from socket on touch
panel rear side.
2. Remove the six nuts on the inside of the front panel that secure the touch panel to the front
panel.

6.8.2 Refitting of the Touch Panel


Refitting is the reverse of removal

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MANUAL

6.9 Calibrator Assembly

6.9.1 Removal of Calibrator Assy.


1. Pull out the brief operating instructions card.
2. Remove the two pan head screws that secure the calibrator assy to the chassis bottom. The
screws are accessible through holes in the user card guide.
3. Hinge up the Main PCB (6.3.1) and hinge up the Floating PCB (6.4.1).
4. Disconnect the collored ribbon cable assembly from PL5 on the Main PCB.
5. Remove the screw that secures the calibrator assy to the rear panel.
6. Lift the calibrator assy clear of the unit

6.9.2 Refitting of the Calibrator Assy.


Refitting is the reverse of removal.
Note: When refitting the calibrator assy make sure that the positioning pin fits well to the positioning
hole which is located between the two fixing holes in the chassis bottom.

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7 Parts List and Assembly Drawings

7.1 Introduction
The following parts lists provide the component and assembly part numbers that may be used to
order spares and replacements.

7.2 Recommended Spare Parts


7.2.1 Recommended number of spare parts
LMS recommend that the following spares are held, according to the number of MicroGas 7650 to be
serviced. Add column A and B for 6 to 20 7650's, columns A, B and C together for 21 or more 7650's.
Note: For units with Model No. 7650 00XB and 7650 50X (CE-marked), do only use spare parts
which are marked in the table below with a ( * ) or where an Issue is listed with that or a higher issue.
Number installed
Description Part No. A (1-5) B (6-20) C (21+)
Case assembly 7650 0121 1 1
Case assembly rapid 7650 0126 1 1
Calibrator assembly 7650 0028 1 1
Front Panel assembly 7650 0124 1 1
Front Panel assembly rapid 7650 0127 1 1
Hood assembly 7650 0122 1 1
Sensor Spool assembly 7650 0123 1 1
Main PCB assembly 7650 0811 1 1
Power supply assembly 7650 0812 1 1
Display PCB assembly 7650 0814 1 1
Floating PCB assembly * 7650 0817 1 1
Floating Screen assembly * 7650 0034B 1 1
Inner can cover assembly * 7650 0039B 1 1
Inner can case * 7650 0254 1 1
Insulating Sleeve assembly 7650 0032 1
Touch Panel assembly 7650 0125 1 1
Prom Mainboard 7650 0401 Hold as Master Copy when needed
Prom Floatingboard 7650 0404 Hold as Master Copy when needed
Prom Mainboard (rapid version) 7650 0408 Hold as Master Copy when needed
Prom Mainboard USA (rapid version) 7650 0412 Hold as Master Copy when needed
Prom Floatingboard (rapid version) 7650 0409 Hold as Master Copy when needed
GAL Mainboard 7650 0402 Hold as Master Copy when needed
GAL Mainboard 7650 0403 Hold as Master Copy when needed
GAL Floatingboard 7650 0405 Hold as Master Copy when needed
GAL Floatingboard (rapid version) 7650 0410 Hold as Master Copy when needed
Battery 069 005 1 1
Battery Holder assembly 7650 0027 1
Mains Inlet assy 7650 0053 1
DC-Connector assembly EMC 7650 0083 1
Loudspeaker assy 7650 0056 1 1
Mains transformer 240V/18V 031 003 1
Isolation Transformer 7650 0051 1 1
Input socket assembly * 7650 0057B 1 1 1
Monitor on/off switch assembly 7650 0055 1 1
LCD – Module DCM 16202 064 038 1 1
LED Bar TDA4100 064 019 1 1 1
7 Segm. LED Controller ICM7218 054 387 1 1
7 Segm. LED 064 039 3 6 9
Any other, not listed electrical or electromechanical component are commonplace components that
could be available from your internal stock or obtainable locally.

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7.3 General Assy. 7650 0120

7.3.1 Parts List No. 7650 0120 Iss. 14


Item Part No. Qty. Description
1
2 7650 0204 1 Chassis silkscreened
3 7650 0028 1 Calibrator assy
4 7650 0814 1 Display board PCB assy
5 7650 0811 1 Main PCB assy
6 7650 034B 1 Floating screeen assy
7 7650 0812 1 Power supply PCB assy
8 7650 0061 1 Cable form assy, Main - p.s.
9 7650 0062 1 Cable form assy, Main - floating
10 7650 0063 1 Cable form assy, Main - display
11 7650 0065 1 Cable form assy, Battery - p.s.
12 7650 0066 1 Cable form assy, Touchp - display
13 7650 0231 4 Spring
14 7650 0225 2 Tie bar
15 702 218 4 Pcb FxG clip (moulding)
16
17 008 322 28 Pan head screw M3 x 8DIN 85A, steel zinc plate blue
18 008 047 8 Serrated lock washer for M4, DIN 6798A, spring steel / zinc plate blue
19 008 033 17 Serrated lock washer for M3 DIN 6798A spring steel / zinc plate blue
20 008 031 25 Washer for M3 DIN 125A, Stainless steel A2
21 008 034 17 Spring washer for M3 DIN 137A, Stainless steel 1.4310
22 008 030 6 Hexagon nut ~ 0,80 M3 DIN 934, Steel 8 / zinc plate blue
23
24 7650 0224 1 Mains inlet insul.
25 077 103 1 O-Ring seal Æ 23 x 3 silicone
26
27 7650 0326 1 Serial No. Label
28 7650 0408 1 EPROM (U5 Mainboard) rapid
7650 0412 EPROM (U5 Mainboard) rapid USA
29 7650 0402 1 GAL (U17 Mainboard)
30 7650 0403 1 GAL (U18 Mainboard)
31 7650 0409 1 EPROM (U6 Floating Board) rapid
32 7650 0410 1 GAL (U4 Floating Board) rapid
33 7650 0053 1 Mains inlet assy.
34 7650 0083 1 DC connector assy. EMC
35 7650 0055 1 Monitor On/Off switch assy.
36 7650 0056 1 Loudspeaker assy.
37 7650 0027 1 Battery holder assy.
38 7650 0064 1 Cable form assy. earth
39 7650 0076 1 Loudspeaker holder assy.
40 7650 0327 1 Battery installation label
41 7650 0210 1 Protection handle
42 7650 250 1 Earth plate
43
44 069 005 1 Battery 12V 1,9Ah
45 702 219 4 Foot moulding
46 004 324 1 Eq. pot. ground L1361/1
47 004 322 1 Eq. pot. ground, Terminal MC-PDAG-S6/15
48 105 235 1 Earth label
49 008 321 22 Linsenschraube eco-fix M3x6
50 008 323 2 Pan head screw M3x10 DIN 85A, steel, zinc plate blue
51 008 053 2 Serrated lock washer for M5, DIN 6798A Spring steel / zinc plate blue
52 008 008 1 Serrated lock washer for M6, DIN 6798A Spring steel / zinc plate blue

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Item Part No. Qty. Description


53 008 039 2 Hexagon nut ~0,8D, M4 DIN 439B, steel 04 / zinc plate blue
54 008 009 2 Hexagon nut, 2BA, nickel plated
55 008 011 1 Hexagon nut ~0,8D, M6 DIN 934, steel 8 / zinc plate blue
56 --- 2 Linsenschraube eco-fix M3x8
57 7650 0243 1 Chassis insul. strip.
58 --- 1 Befestigungsschelle H6P
59 7650 0257 1 PVC Ring
60 --- 1 Cable Clamp
61 --- 2 Spreizniete SPREIKO ø3 x 5.5
62 --- 4 Verriegelungsbügel kurz
63 500.84.011 1 Screw Warning Label

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7.3.2 Drawing No. 7650 0120 Iss. 11

sheet 1 / 2

Page 67
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sheet 2 / 2

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MANUAL

7.4 Case Assy. 7650 0121

7.4.1 Parts List No. 7650 0121 Iss. 4


Item Part No. Qty. Description
1 7650 0122 1 Hood assy.
2 7650 0123 1 Sensor spool assy
3 7650 0124 1 Front panel assy
4 --- 2 Linsenschraube eco-fix M4x8
5 008 321 2 Screw M3x6 Positiv DIN 7985A, steel zinc plate blue
6 --- 4 Linsenschraube eco-fix M3x6
7 008 033 2 Serrated lock washer for M3 DIN 67987A, spring steel, zinc plate blue

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7.4.2 Drawing No. 7650 0121 Iss. 4

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7.5 Front Panel Assy. 7650 0124

7.5.1 Parts List No. 7650 0124 Iss. 3


Item Part No. Qty. Description
1 7650 0125 1 Touch panel assy
2 7650 0300 1 Front panel moulding
3 008 030 6 Hexagon nuts ~0.8D M3 DIN 934, steel 8, zinc plate blue
4 008 031 6 Washer for M3 DIN 125A, stainless steel A2
5 008 034 6 Spring washer for M3 DIN 137A, stainless steel 1.4310
6 008 198 A/R Conductive seal
7 7650 0303 1 Front label
8 008 711 A/R Loctite 496
9 7650 0068 1 Cable form assy, Touch panel-F/P

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7.5.2 Drawing No. 7650 0124 Iss. 3

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7.6 Main PCB Assy. 7650 0811

7.6.1 Parts List No. 7650 0811 Iss. 14


Item Part No. Qty. Description/Part Reference
1 022007 2 CAP 2% 100V 12pF C8,C9
2 022010 2 CAP 5% 63V 22pF C1,C26
3 022012 1 CAP 2% 100V 33pF C28
4 022042 3 CAP 2% 100V 270pF C32,C33,C36
5 022090 2 CAP 10% 63V 470pF C2,C3
6 026028 1 CAP 10% 63V 10nF C34
7 003089 16 CAP 20% 63V 100n C4,C5,C10 to C22,C24
8 003184 1 TANT 20% 25V 1µF C30
9 003191 1 TANT 20% 10V 4µ7 C37
10 003195 5 TANT 20% 16V 10µF C6,C23,C29,C35,C38
11 003208 1 TANT 20% 16V 47µF C31
12 021054 1 ELKO 20% 16V AXIAL 330µF C27
13 021075 1 ELKO 20% 16V AXIAL 3300µF C25
14 049012 1 OSZI 4.915MHZ NCC-060C4.915 CO1
15 056075 7 DIODE 1N4448 D1,D2,D4,D5,D6,D10,D11
16 056008 1 REGULATOR LM336 D3
17 056058 1 DIODE SCHOTTKY 11DQ04 D9
18 056038 1 DIODE ZENER LM385Z-2.5 D8
19 004589 1 FUSE T 0.315A F1
20 700305 3 BERG 1*3 Units/Service/Alarm JP1,JP2,JP3
21 038194 1 EMC AXIAL FERRITE L1
22 072661 1 BERG 2*17 Keyboard/Display PL3
23 072665 2 BERG 2*5 Floatingboard/PSU PL4,PL6
24 072666 1 BERG 2*7 Calibrator PL5
25 072508 1 MOLEX 1*3 90° Speaker PL7
26 055017 2 TRANS SI PNP ZTX750 Q3,Q4
27 005182 1 TRANS SI NPN BC182 Q7
28 005304 2 VMOSTRANS VN10KM Q5,Q6
29 004959 1 Jumper 0E R23
30 001042 3 RES 1/4W 5% 56E R33,R34,R35
31 001045 1 RES 1/4W 5% 75E R11
32 001048 1 RES 1/4W 5% 100E R36
33 001610 3 RES 1/4W 1% 221E R14,R16,R26
34 001072 2 RES 1/4W 5% 1K R2,R3
35 001726 1 RES 1/4W 1% 2K21 R32
36 001083 2 RES 1/4W 5% 3K R6,R42
37 001088 7 RES 1/4W 5% 4K7 R21,R22,R24,R30,R31,R40,R44
38 001096 1 RES 1/4W 5% 10K R41
39 013114 1 RES 1/4W 0.1% 12K00 R8
40 001813 1 RES 1/4W 1% 12K1 R27
41 013124 1 RES 1/4W 0.1% 14K22 R15
42 001110 2 RES 1/4W 5% 39K R1,R25
43 001114 1 RES 1/4W 5% 56K R37
44 013134 2 RES 1/4W 0.1% 75K00 R5,R10
45 001911 1 RES 1/4W 1% 90K9 R19
46 013148 1 RES 1/4W 0.1% 82K5 R7
47 001120 4 RES 1/4W 5% 100K R17,R18,R38,R39
48 001922 1 RES 1/4W 1% 115K R20
49 013136 2 RES 1/4W 0.1% 150K0 R4,R9
50 001944 1 RES 1/4W 1% 182K R29
51 001971 1 RES 1/4W 1% 316K R28
52 019016 6 RES SIL 4K7 RNET1 to RNET6
54 001983 1 RES 1/4W 1% 392K R43

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Item Part No. Qty. Description/Part Reference


55 018406 1 RES TRIM 10K RV1
56 004951 24 TESTPIN, TESTPOINTS H-2088 TP0 to TP23
57 054034 1 PROCESSOR 80C88-2 U1
58 053222 1 IC HCMOS 74HC245 U2
59 054410 1 IC uP Sup. MAX695 U3
60 054376 2 IC CMOS RAM HM62256 U4,U24
62 054346 1 IC DAC AD7533L U6
63 051078 1 IC OP AMP AD648 U7
64 051110 1 IC DRIVER OC ULN2004A U8
65 052031 1 IC RS423 TX UA9636 U9
66 052030 1 IC RS423 RX UA9637 U10
67 052113 2 IC PIO AND RAM 82C55 U11,U14
68 052623 3 IC HCMOS 74HC574 U12,U13,U28
69 052110 1 IC TIMER 82C54 U16
71 051033 1 IC VOLTAGE CONV. SI 7661 U19
72 054331 1 IC CLOCK MSM6242K U20
73 053007 1 IC HEX BUFFER 7407 U21
74 053112 1 IC HCMOS INVERTER 74HC14 U23
75 051134 1 IC COMPERATOR LM393AN U25
76 053319 1 IC HCMOS 74HC573 U26
77 051092 1 VOLTAGE REG. LM2940C-12 U27
78 054409 1 IC DUART VL16C452 U29
79 053024 1 IC HCMOS 74HC32 U30
80 007744 2 IC S/H LF398 U32,U33
81 052035 1 IC HCMOS 74HC132 U34
82 051066 1 IC OP AMP LM11CN U15
83 004521 1 QUARZ 32.768KHz Y1
84 074026 1 20mm Fuse MTG ClipD/END 5229 F1
85 072055 2 SKT 20W LOW PROFILE TIN U17,U18
86 004297 1 SKT 24W LOW PROFILE TIN U16
87 072054 2 SKT 28W LOW PROFILE TIN U4,U24
88 072530 1 SKT 32W LOW PROFILE TIN U5
89 072052 3 SKT 40W LOW PROFILE TIN U1,U11,U14
90 072060 1 SKT 68W/4SIDE 2ROW U29
91 072252 1 D-SUB 37+BRKT Kontron Interface PL1
92 072251 1 D-SUB 25+BRKT Parallel Port PL2
93 7650 0233 1 Interface Plate Silkscreened -
94 7650 0229 2 Guard Profil -
95 008322 4 Screw M3x8 -
DIN 85A St.4.8/Zinc Plate
96 008321 1 Screw M3x6 -
DIN 85A St.4.8/Zinc Plate
98 008034 10 Crinkle Washer for M3 -
DIN 137A 1.4310
99 7650 0255 4 Jack Pin M3 -
101 008153 A/R Tape 4970 6mm Wide, -
Double Sided TESAFIX
102 008030 9 St.8/Zinc Plate Hex. Nut -
0.8 M3 DIN 934
104 7650 0801 1 PCB -
107 004975 1 Ty-Rap T18R -
108 008150 A/R Double Sided Adesive Tape -
109 7650 0355 1 Abschirmfeder (screening spring) -

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7.6.2 Drawing No. 7650 0811 Iss. 11

Page 75
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This side left blanc

Page 76
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MANUAL

7.7 Power Supply PCB Assy. 7650 0812

7.7.1 Parts List No. 7650 0812 Iss. 10


Item Part No. Qty. Description/Part Reference
1 026031 1 CAP MKT 10% 50V 1µF C3
2 003089 1 CAP CER 20% 63V 100n C9
3 003224 1 TANT 25V 20% 10µF C10
4 003448 3 ELKO 35V 20% RAD 220µF C2,C7,C8
5 021004 2 ELKO 35V 20% RAD 1000µF C1,C11
6 057016 1 BRIDGE RECTIF. B40C1500 D1
7 004991 2 DIODE 1N4001 D6,D9
8 056058 4 DIODE SCHOTTKY 11D04 D2,D3,D5,D7
9 054343 1 VOLT REF. TL431 D8
10 056075 2 DIODE 1N4448 D10,D11
11 055046 1 MOS POWER FET RFP8P08 Q1
12 005135 1 POWER TRANS. BD135 Q2
13 007703 1 VOLTAGE COMPERATOR LM311 U1
14 007741 1 OP-AMP LM741 U3
15 051094 1 SWITCH-MODE REG. 5V LM2575 U4
16 074007 2 FUSE 1A F1,F2
17 073045 5 AMP-TABS AMP1 J1 to J5
18 072305 1 MOLEX 1x2 P 0,1" FROM BATERY EXT. JP1
19 072306 1 MOLEX 1x3 P 0,1" FROM MAINSWITCH JP2
20 072715 1 MOLEX 1x2 (5281) TO BATTERY JP3
21 072665 1 BERG 2x5 TO MAINBOARD JP4
22 002309 1 RES. 1/2W 5% 6E8 R14
23 001679 1 RES. MF 1/4W 1% 825 R13
24 001766 1 RES. MF 1/4W 1% 4k75 R12
25 001786 2 RES. MF 1/4W 1% 6k81 R1,R10
26 001804 1 RES. MF 1/4W 1%10k0 R3
27 001835 2 RES. MF 1/4W 1% 20k0 R2,R4
28 001856 1 RES. MF 1/4W 1% 30k1 R11
29 001928 1 RES. MF 1/4W 1% 130k R9
30 001953 1 RES. MF 1/4W 1% 221k R5
31 031003 1 TRANSFORMER 240V/18V TRANSF.MAINS T1
32 034011 1 INDUCT. DSH 1-22-1, 0-400/A 400µH L1
33 004951 7 TEST-PIN TP TP1 to TP7
34 074026 2 20mm Fuse MTG Clip D/END 5229 F1,F2
35 7650 0802 1 PCB -
36 4 Linsen Blechschrauben mit Bund 2.9 x 9.5

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7.7.2 Drawing No. 7650 0812 Iss. 9

Page 78
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7.8 Floating Screen Assy. 7650 0034

7.8.1 Parts List No. 7650 0034 Iss. 2


Item Part No. Qty. Description
1 7650 0032 1 Insul. sleeve assy
2 7650 0813 1 Floating pcb assy
3 7650 0220 1 Inner can case
4 7650 0039 1 Inner can cover assy
6 008 321 4 Pan head screw M3x6 DIN 85A, steel, zinc plate blue
7 008 031 4 Serrated lock washer for M3 DIN 6798A, spring steel, zinc plate blue

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7.8.2 Drawing No. 7650 0034 Iss. 2

Page 80
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MANUAL

7.9 Floating PCB Assy. 7650 0813

7.9.1 Parts List No. 7650 0813 Iss. 6


Item Part No. Qty. Description/Part Reference
1 022006 2 CAP CERAMIC 100V 10pF C16,C17
2 022010 2 CAP CERAMIC 100V 22pF C36,C39
3 022046 2 CAP CERAMIC 100V 560pF C7,C18
4 026043 1 CAP MKT 50V 5% 1n5 C4
5 026044 1 CAP MKT 50V 10% 2n2 C3
6 026026 17 CAP MKT 63V 10% 0.1uF C11,C12,C14,C19 to C31,C42
7 026031 2 CAP MKT 50V 10% 1uF C13,C33
8 003191 6 TANT 10V 20% 4u7 C8,C9,C10,C15,C40,C32
9 003195 3 TANT 16V 20% 10uF C2,C37,C38
10 003196 2 TANT 20V 20% 15uF C34,C35
11 003210 1 TANT 35V 20% 47uF C1
12 021077 2 ELKO 10V 20% RAD SU-A 470uF C5,C6
13 072665 1 BERG 5X2 HEADER 5X2 JP1
15 072596 1 20 PIN ST CONNECTOR PCB JP3
16 004433 6 INDUCTOR 100uH L1,L2,L3,L4,L5,L6
17 706052 1 INDUCTOR 100uH L7
17A 001461 1 RES. MF 1/4W 1% 10R0 R39
18 001014 1 RES. CF 1/4W 5% 3E3 R34
18A 001573 2 RES. MF 1/4W 1% 100 R8,R22
19 001591 1 RES. MF 1/4W 1% 150 R10
20 001615 1 RES. MF 1/4W 1% 243 R61
21 001624 2 RES. MF 1/4W 1% 294 R1,R14
22 001679 1 RES. MF 1/4W 1% 825 R15
23 001683 1 RES. MF 1/4W 1% 909 R46
24 001804 16 RES. MF 1/4W 1% 10K R2,R3,R6,R7,R11,R12,R13,
R21,R25,R40,R44,R53,R56,
R57,R58,R60
25 001822 1 RES. MF 1/4W 1% 15K R45
26 001688 6 RES. MF 1/4W 1% 1K R4,R5,R9,R19,R20,R38
27 001770 3 RES. MF 1/4W 1% 5K11 R17,R18,R43
28 001786 2 RES. MF 1/4W 1% 6K81 R16,R59
29 001831 1 RES. MF 1/4W 1% 18K2 R55
30 001856 1 RES. MF 1/4W 1% 30k1 R49
31 001898 2 RES. MF 1/4W 1% 68K1 R35,R36
32 001992 1 RES. MF 1/4W 1% 475K R42
33 011941 1 RES. 1/4W 5% 22M R41
34 011942 1 RESISTOR 1G R24
35 001916 3 RES. MF 1/4W 1% 100K R23,R51,R54
36 001964 3 RES. MF 1/4W 1% 274K R26,R30,R37
37 013105 1 RES. MF 0.1% 30* R33
38 013106 1 RES. MF 0.1% 400* R32
39 013110 1 RES. MF 1/4W 0.1% 4K* R48
40 013111 1 RES. MF 1/4W 0.1% 5K* R47
41 013112 1 RES. MF 0.1% 5K403* R31
42 013114 1 RES. MF 0.1% 12K* R29
43 013104 2 RES. MF 0.05% 12K** R27,R28
44 013210 1 RES. MF 15ppm 909# R50
45 013211 1 RES. MF 15 ppm 1k3# R52
46 018406 1 POT CMT 20TN 10% VM 10K RV1
47 018466 1 POT CMT 20TN 10% VM 100 RV2
48 018409 1 POT CMT 20TN 10% VM 50K RV3
49 045015 1 RELAY V23026-A1 RL1
50 76500051 1 TRANSFORMER ASSY T1

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MANUAL

Item Part No. Qty. Description/Part Reference


51 004951 17 TEST - PIN TP TP1 to TP17
52 054343 1 VOLT. REF. TL431 D1
53 056058 2 DIODE SCHOTTKY 11DQ04 D2,D3
54 056075 3 DIODE 1N4448 D4,D5,D9
55 056008 1 VOLT. REF. LM336 D6
56 056039 1 VOLT. REF. LM385-1.2 D7
57 005036 1 DIODE ZENER 1/2W BZX79F3V6 D8
58 056041 1 DIODE 6V2 ZENER LOW I T-LVA462 D10
59 054352 3 OPTO-COUPL. OPI1264A OC1,OC2,OC3
60 005212 5 TRANS. PNP BC212 Q1,Q5,Q6,Q7,Q10
61 005182 2 TRANS. NPN BC182 Q2,Q4
62 054388 1 TRANS. FET 2N7010 or 2SK1113 or 2SK2200 Q3
63 055017 1 TRANS. PNP ZTX750 Q8
64 055016 1 TRANS. NPN ZTX650 Q9
65 051032 1 VOLTAGE REG. 8V 7808 U1
66 052078 1 TIMER ICM7555 U2
67 054022 1 SIGLE CHIP uP 80C32 U3
69 052623 1 LATCH 74HC574 U5
70 007733 1 OP-AMP LM308AN U14
71 054354 1 A/D CONVERTER ICL7109 U7
72 052111 1 MUX DG508 U8
73 053116 1 74HC366 U9
74 054353 1 D/A CONVERTER DAC832 U10
75 051063 1 OP-AMP OP07 U11
76 051066 1 OP-AMP LM11 U12
77 051091 1 OP-AMP ICL7611 U13
78 049013 1 9.8304Mhz Y1
79 072052 2 40 PIN DIL SOCKET U3,U7
80 072054 1 28 PIN DIL SOCKET U6
81 072055 2 20 PIN DIL SOCKET U4,U10
82 76500803 1 PCB
83* 76500052 1 INPUT SOCKET ASSEMBLY
84 008340 2 SCREW No 4 x 3/8"
85 76500057 1 INPUT SOCKET ASSEMBLY
86 76500232 2 SUPPORT (REWORKED)
87 022042 1 CAP MMK 100V 10% 270pF C41
88 019004 2 RES SIL 10k RNET1,RNET2
89 004766 A/R Lacing Cord

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7.9.2 Drawing No. 7650 0813 Iss. 7

Page 83
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MANUAL

7.10 Floating Screen Assy. 7650 0034B

7.10.1 Parts List No. 7650 0034B Iss. 2


Item Part No. Qty. Description
1 7650 0032 1 Insul. sleeve assy
2 7650 0817 1 Floating PCB assy
3 7650 0254 1 Inner can case
4 7650 0039B 1 Inner can cover assy
6 4 Screw M3x6 Pozidriv DIN 7985A, steel, zinc plate blue
7 008 033 4 Serrated lock washer for M3 DIN 6798A, spring steel, zinc plate blue

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7.10.2 Drawing No. 7650 0034B Iss. 1

Page 85
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MANUAL

7.11 Floating PCB Assy. 7650 0817

7.11.1 Parts List No. 7650 0817 Iss. 8


Item Part No. Qty. Description/Part Reference
1 022006 2 CAP CERAMIC 100V 10pF C16,C17
2 022010 6 CAP CERAMIC 100V 22pF C36,C39,C69,C70,C71,C72
3 022046 2 CAP CERAMIC 100V 560pF C7,C18
4 026043 2 CAP MKT 50V 5% 1n5 C4,C43
5 026044 1 CAP MKT 50V 10% 2n2 C3
6 026026 2 CAP MKT 63V 10% 0.1uF C11,C12
7 026031 1 CAP MKT 50V 10% 1uF C13
8 003191 3 TANT 10V 20% 4u7 C9,C40,C38
9 022090 3 CAP 63V 10% 470pF C74,C75,C76
10 003196 3 TANT 20V 20% 15uF C2,C34,C35
11 003210 1 TANT 35V 20% 47uF C1
12 021077 2 ELKO 10V 20% RAD SU-A 470uF C5,C6
13 003089 17 CAP 63V 20% 100nF C8,C10,C14,C15,C20,C22,
C24,C26,C28,C30,C32,C37,
C73,C77,C79,C80,C83
14 1 Header Connector W10, doc. no. 232.0101.1 JP1
15 072722 1 MOLEX 52045-1610 HEADER 16 JP2
16 001461 1 RES. MF 1/4W 1% 10E0 R39
17 001014 3 RES. CF 1/4W 5% 3E3 R34,R63,R64
18 001573 2 RES. MF 1/4W 1% 100 R8,R22
19 001591 1 RES. MF 1/4W 1% 150 R10
20 001615 1 RES. MF 1/4W 1% 243 R62
21 001624 2 RES. MF 1/4W 1% 294 R1,R14
22 001679 1 RES. MF 1/4W 1% 825 R15
23 001683 1 RES. MF 1/4W 1% 909 R46
24 001804 15 RES. MF 1/4W 1% 10K R2,R3,R6,R7,R11,R12,R13,
R21,R25,R40,R44,R53,R56,
R57,R58
25 1 RES. MF 1/4W 1% 8K2 R45
26 001688 6 RES. MF 1/4W 1% 1K R4,R5,R9,R19,R20,R38
27 001770 3 RES. MF 1/4W 1% 5K11 R17,R18,R43
28 2 RES. MF 1/4W 1% 3K6 R16
29 001831 1 RES. MF 1/4W 1% 18K2 R55
30 001856 1 RES. MF 1/4W 1% 30k1 R49
31 001898 2 RES. MF 1/4W 1% 68K1 R35,R36
32 001992 1 RES. MF 1/4W 1% 475K R42
33 011941 1 RES. 1/4W 5% 22M R41
34 011942 1 RESISTOR 1G R24
35 001916 3 RES. MF 1/4W 1% 100K R23,R51,R54
36 001964 3 RES. MF 1/4W 1% 274K R26,R30,R37
37 013105 1 RES. MF 0.1% 30* R33
38 013106 1 RES. MF 0.1% 400* R32
39 013110 1 RES. MF 1/4W 0.1% 4K* R48
40 013111 1 RES. MF 1/4W 0.1% 5K* R47
41 013112 1 RES. MF 0.1% 5K403* R31
42 013114 1 RES. MF 0.1% 12K* R29
43 013104 2 RES. MF 0.05% 12K** R27,R28
44 013210 1 RES. MF 15ppm 909# R50
45 013211 1 RES. MF 15 ppm 1k3# R52
46 018406 1 POT CMT 20TN 10% VM 10K RV1
47 018466 1 POT CMT 20TN 10% VM 100 RV2
48 018409 1 POT CMT 20TN 10% VM 50K RV3

Page 86
SERVICE
MANUAL

Item Part No. Qty. Description/Part Reference


49 001726 3 RES. 1/4W 1% 2k21 R82,R83,R84
50 76500051 1 TRANSFORMER RM8 T1
51 004951 17 TEST - PIN TP TP1 to TP17
52 054343 1 VOLT. REF. TL431 D1
53 056058 2 DIODE SCHOTTKY 11DQ04 D2,D3
54 056075 2 DIODE 1N4448 D4,D5
55 056008 1 VOLT. REF. LM336 D6
56 056039 1 VOLT. REF. LM385-1.2 D7
58 056041 1 DIODE 6V2 ZENER LOW I T-LVA462 D10
59 054352 3 OPTO-COUPL. OPI1264C OC1,OC2,OC3
60 005212 4 TRANS. PNP BC212 Q1,Q5,Q7,Q10
61 005182 2 TRANS. NPN BC182 Q2,Q4
62 054388 1 TRANS. FET RFD3055LE Q3
63 055017 1 TRANS. PNP ZTX750 Q8
64 055016 1 TRANS. NPN ZTX650 Q9
65 051032 1 VOLTAGE REG. 8V 7808 U1
66 052078 1 TIMER ICM7555 U2
67 054022 1 SINGLE CHIP uP 80C32 conventional version U3
68 SINGLE CHIP uP 80C528 rapid version U3
69 052623 1 LATCH 74HC574 U5
70 007733 1 OP-AMP LM308AN U14
71 054354 1 A/D CONVERTER ICL7109 U7
72 052111 1 MUX DG508 U8
73 053116 1 74HC366 U9
74 054353 1 D/A CONVERTER DAC832 U10
75 051063 2 OP-AMP OP07 U11,U12
76
77 051091 1 OP-AMP ICL7611 U13
78 049013 1 9.8304Mhz Y1
79 072052 2 40 PIN DIL SOCKET U3,U7
80 072054 1 28 PIN DIL SOCKET U6
81 072055 2 20 PIN DIL SOCKET U4,U10
82 76500807 1 PCB
84 008340 0 SCREW No 4 x 3/8"
85 76500057B 0 INPUT SOCKET ASSEMBLY (PART OF ASSY 7650 0059)
86 76500232 2 SUPPORT (REWORKED) TP18
87 022042 1 CAP MMK 100V 10% 270pF C41
88 019004 2 RES SIL 10k RNET1,RNET2
89 038195 1 EMC FERRITE FOR FLAT FLEX
90 004976 1 CABLE TIE 140mm
91 008150 A/R ADHESIVE TAPE DS 12mm
92 022105 1 CAP CER 50V 10% 220nF C84
93 1 RES. MF ¼W 1% 22k R65
94 1 RES. MF ¼W 1% 4K7 R66
95 026031 1 CAP MKT 50V 10% 1µF C19 not mounted

Page 87
SERVICE
MANUAL

7.11.2 Drawing No. 7650 0817 Iss. 4

Page 88
SERVICE
MANUAL

7.12 Display PCB Assy. 7650 0814

7.12.1 Parts List No. 7650 0814 Iss. 5


Item Part No. Qty. Description/Part Reference
1 003195 2 TANT 20% 16V 10uF C1,C4
2 026026 2 CAP 10% 63V 100nF C2,C3
3 064019 1 LED Telefunken TDA4100 D1
4 072711 1 Berg Header 3x1 90° HEADER 3 JP2
5 072661 1 Berg Header 2x17 BERG 2X17 JP3
6 005222 1 TRANS PNP BC212 Q1
7 054388 7 MOS FET 2N7010 or 2SK1113 or 2SK2200 Q2,Q9 to Q14
8 005182 7 TRANS NPN BC182 Q3 to Q8,Q15
9 001024 12 RES 1/4W 5% 10E R10 to R18,R35,R38,R39
10 001030 1 RES 1/4W 5% 18E R36
11 001072 2 RES 1/4W 5% 1K R34,R37
12 001752 1 MF 1/4W 1% 3K65 R9
13 001756 1 MF 1/4W 1% 3K92 R1
14 001761 1 MF 1/4W 1% 4K32 R2
15 001770 1 MF 1/4W 1% 5K11 R3
16 001775 2 MF 1/4W 1% 5K62 R4,R33
17 001780 1 MF 1/4W 1% 6K19 R5
18 001786 1 MF 1/4W 1% 6K81 R6
19 001790 1 MF 1/4W 1% 7K50 R7
20 001795 1 MF 8K25 R8
21 001096 7 RES 1/4W 5% 10K R26 to R32
22 001106 8 RES 1/4W 5% 27K R19 to R25,R40
23 004951 3 TEST-POINT GND,VCC,VEE TP0,TP1,TP2
24 054387 1 LED DRIVER ICM7218 BIPI U1
25 006771 1 MUX 4051 U2
26 064038 1 LCD MODUL OPTREX DMC16202 U3
27 064039 6 7-Segment LED LTS547A U4 to U9
28 072581 5 SLC TLA31 PRECICONTACT U4 to U9,D1
29 073086 56 HARWIN SOCKED H3153-01 U1,U3,JP1
30 072543 1 SSH GH-CC PRECICONTACT U3
31 073003 2 BERG CRIMP TO WIRE MINI PV JP2
32 072583 1 BERG MINI LATCH HOUSING JP2
33 004826 0.05 WIRE 0.025 RED JP2
34 004824 0.05 WIRE 0.025 BLACK JP2
35 76500222 4 DISTANCE SLEEVE 5mm U3
36 008223 4 PAN HEAD SCREW M2.5x10 DIN 85A ST.8 vzp. U3
37 008020 4 HEXAGON NUT 0.8 M2.5 DIN 934 ST.8 vzp. U3
38 008021 4 WASHER FOR M2.5 DIN 125A STAINLESS ST.A2 U3
39 008024 4 SPRING WASHER FOR M2.5 DIN 137A ST.1.4310
40 76500804 1 PCB

Page 89
SERVICE
MANUAL

7.12.2 Drawing No. 7650 0814 Iss. 7

Page 90
SERVICE
MANUAL

8 Engineering Service Information

8.1 Introduction
The information given in this service manual covers the most recent modifications to the equipment,
up to the date of issue. The modification status to which this manual has been prepared is detailed
below.
This section provides a place for Engineering Service Information Bulletins (ESI's) issued after
publication of this service manual. Information from previously issued ESI's has been incorporated
into the manual.
Whenever an ESI is received, the following action should be taken.
• Update the Equipment Modification record below.
• Insert the ESI in this section.

ESI Ref. No. Issue Date Description

Page 91
SERVICE
MANUAL

9 Circuit Diagrams

Page 92
SERVICE
MANUAL

9.1 Block Diagram 7650 0009 Iss. 1

Page 93
SERVICE
MANUAL

9.2 Interconnection Diagram 7650 0010 Iss. 1

Page 94
SERVICE
MANUAL

9.3 Circuit Diagram of Main PCB 7650 0821 Iss. 9 - sheet 1/2

TP1
RESET
+ C31
VCC VCC 47uF
VCC VCC VCC U2
2 18 D0
A1 B1
3 17 D1
A2 B2 32.768KHz
D6 R25 R23 R22 R21 4 16 D2

18
4K7 4K7 A3 B3
1N4448 39K 0E 5 15 D3 Y1
A4 B4
U23B U23C 6 14 D4 A0 4 17

VDD
A5 B5 A0 XT
7 13 D5 A1 5
A6 B6 A1
3 4 5 6 8 12 D6 A2 6 16
A7 B7 A2 XT
9 11 D7 A3 7
A8 B8 A3
74HC14 C26
+ C29
74HC14
19
G
1
STD
C1
22pF
10uF 1 3 22pF
DIR ALE
RD 8
RD
RNET3
74HC245 WR 10 14 D0 D0 2 1 VCC
WR D0
13 D1 D1 3
D1
CS7 2 12 D2 D2 4
CS0 D2
VCC U1 U12 15 11 D3 D3 5
CO1 NCC-060C4.915 CS1 D3
33 16 2 19 A0 D4 6
MN AD0 D1 Q1
14 1 15 3 18 A1 D5 7
VCC NC L1 AD1 D2 Q2 U20
22 14 4 17 A2 C14 D6 8
READY AD2 D3 Q3 MSM6242K
7 8 19 13 5 16 A3 D7 9
GND OUT CLK AD3 D4 Q4 100n
21 12 6 15 A4
RESET AD4 D5 Q5
FERRITE AD5
11 7
D6 Q6
14 A5 4K7
18
INTR AD6
10 8
D7 Q7
13 A6 U4
TP2 TP4 TP3 9 9 12 A7 A0 10 11 D0
VBATT V+ WDO VON AD7 D8 Q8 A0 D0
8 A1 9 12 D1
A8 A1 D1
VON VCC 7 11 A2 8 13 D2
A9 CLK A2 D2
6 1 A3 7 15 D3
A10 OC A3 D3
R37 5 A4 6 16 D4
A11 A4 D4 Resistor with + = 1%
56K R19 R24 4 74HC574 A5 5 17 D5
A12 A5 D5 Resistor with * = 0.1%
90K9 + 4K7 A13
3 A6 4
A6 D6
18 D6
U3 A14
2 A7 3
A7 D7
19 D7
1
VBATT RESET
16
A15
39 U13 A8 25
A8 No. Power Supply
2 15 IC Type Pins
VOUT RESET A16/S3
38 2
D1 Q1
19 A8 A9 24
A9 VCC
28 U VCC GND VBAT
D8 14 37 3 18 A9 A10 21
WDO A17/S4 D2 Q2 A10
LM385Z-2.5 13 36 4 17 A10 A11 23
5
CEIN
12
A18/S5
35 5
D3 Q3
16 A11 A12 2
A11
20 1 80C88-2 40 40 20
6
BAT.ON CEOUT
11
A19/S6
6
D4 Q4
15 A12 A13 26
A12 CS
22 2 74HC254 20 20 10
7
LL WDI
10 34 7
D5 Q5
14 A13 A14 1
A13 OE
27 3 MAX695 16 3 4 2
OSCIN PFO SSO D6 Q6 A14 WE 4 14 28
8
OSCSEL PFI
9 8 13 A14 HM62256 28
26 9
D7 Q7
12 A15 HM62256 5 27010 32 32 16
MAX695
DEN
27
D8 Q8
WR 12 74HC574 20 20 10
DT/R
28 IO/M 11 RD 13 74HC574 20 20 10
30
IO/M
1
CLK
CSB2 16 82C54 24 24 12
9 8 31
HLDA
32 RD
OC 17 GAL16V8 20 20 10
17
HOLD RD
29 WR 74HC574 18 GAL16V8 20 20 10
VCC VCC U23D 23
NMI WR
25 U24 20 MSM6242K 18 9 18
TEST ALE
24 A0 10 11 D0 22 74HC132 14 14 7
74HC14 INTA A0 D0 23 74HC14 14 14 7
U28 A1 9 12 D1
80C88-2 OR V20 2 19 A16 A2 8
A1 D1
13 D2 24 HM62256 28 14 28
D11 R43 3
D1 Q1
18 A17 A3 7
A2 D2
15 D3 28 74HC574 20 20 10
D2 Q2 A3 D3
1N4448 392K U30C 4
D3 Q3
17 A4 6
A4 D4
16 D4
U23E 10 5
D4 Q4
16 A5 5
A5 D5
17 D5
8 6 15 A6 4 18 D6
D5 Q5 A6 D6
11 10 9 7 14 A7 3 19 D7
D6 Q6 A7 D7
8 13 A8 25
D7 Q7 A8
74HC32 RESET 9
D8 Q8
12 A9 24
A9 VCC
28 RNET4
+ C38 74HC14 A17 A10 21
A10 C13
A0 9
10uF CEOUT 11 A11 23 A1 8
CLK A11 100n
CS13 1 A12 2 20 A2 7
OC A12 CS
A13 26 22 A3 6
A13 OE
R27 VCC 74HC574 A14 1 27 A4 5
A14 WE
+ 12K1 U16 A5 4
8 D0 U23A HM62256 A6 3
D0
7 D1 WR A7 2 1 VCC
D1
9 6 D2 1 2 RD
CLK0 D2
11 5 D3 CSB1 4K7
G0 D3
10 4 D4
OUT0 D4
3 D5 74HC14
D5
15 2 D6
CLK1 D6
14 1 D7
G1 D7
TP10 13
+12 OUT1
RD
22 RD U18 RNET5
18 23 WR IO/M 1 19 CS0 A8 2 1
CLK2 WR I1 O1 VCC
VON 16 19 A0 RD 2 18 CS1 U5 A9 3
G2 A0 I2 O2
U27 17 20 A1 WR 3 17 CS2 A0 12 13 D0 A10 4
+12V OUT2 A1 I3 O3 A0 O0
LM2940C-12 CEOUT 4 16 CS3 A1 11 14 D1 A11 5
I4 O4 A1 O1
1 3 VP 21 CS3 A17 5 15 CS4 A2 10 15 D2 A12 6
GND

I O CS I5 O5 A2 O2
A15 6 14 CS5 A3 9 17 D3 A13 7
I6 O6 A3 O3
82C54 A7 7
I7 O7
13 CS6 A4 8
A4 O4
18 D4 A14 8
CLK2 A6 8 12 CS7 A5 7 19 D5 A15 9
I8 O8 A5 O5
+ C35 A5 9 A6 6 20 D6
2

I9 A6 O6
10uF A4 11 A7 5 21 D7 4K7
I10 A7 O7
CS1 CS1 A8 27
A8
CS2 CS2 GAL16V8-25QNC A9 26
A9 NC
30
A10 23
A10
U17 A11 25 RNET6
C32 270pF A11
1 19 CS8 A12 4 A16 2 1 VCC
I1 O1 A12
RD 2 18 CS9 A13 28 A17 3
I2 O2 A13
VP TP11 R38 WR 3 17 A14 29 4
-12V I3 O3 A14
100K IO/M 4 16 A15 3 5
I4 O4 A15
U19 Q5 A4 5 15 A16 2
A16
6
I5 O5
1 8 CSB2 A8 6 14 7
NC V+ I6 O6
2 7 A7 7 13 CS13 22 8
C+ OSC I7 O7 CE
3 6 A6 8 12 CS10 CS0 24 9
GND LV VN10KM I8 O8 OE
+ C6 4
C- O
5 VEE A5 9
I9
1
VPP
10uF 11 VCC
31 4K7
PGM
SI 7661 C23 -12V VCC I10
+
10uF CSB1 GAL16V8-25QNC 27010 Mainboard Sheet 2
-RESET
C33 270pF WDO
VMZ
R39
100K A0
A0
Q6 A1
A1
A2
A2
CS4
TP5 CS4
CS5
VM VM CS5
VN10KM CS6
CS6
CS8
VCC CS8
CS9
CS9
CS10
CS10
R29 RD
RD
Q7 WR
+ BC182 CLK2
WR
CLK2
182K R41 RESET
10K RESET

D[0..7]
D[0..7]
TP6 INTER
LL
26V
CLK3
PL6
CLK1
1 V+ max. 26V PFO
2 NONMI
3 VCC
VCC
4
5 7650_012.SCH
TP7 TP12
6
7 VCC VV
8 C21 C22 C10 C11 C12 C15 C16 C17 C18 C19 C20
9 VON R11 + C27
100n 100n 100n 100n 100n 100n 100n 100n 100n 100n 100n 330uF
10 VP VV
near U1
TP9 75E U21F
From VON
Power Supply 13 12

TP0 + C25 7407


3300uF
GND

Page 95
SERVICE
MANUAL

9.4 Circuit Diagram of Main PCB 7650 0821 Iss. 9 - sheet 2/2
PT1

VEE VP
PT2 PL5 Calibrator
U29 U9 VV VV VV VV
1 Valve open
D0 14 24 2 7
2 Valve closed
D1 15
DB0 RTS0
25 8
I2 O2 3 Valve GND
D2 16
DB1 DTR0
26 5
VCC
R1 R18 R17 4 GND Press.Switch
17
DB2 SOUT0
45
VEE
1
5 - OUT Press.Trans.
D3 100K 100K
D4 18
DB3 INT0
28
REXT 6 GND Press.Switch
19
DB4 CTS0
31 4 39K
7 + OUT Press.Trans.
D5 PS1
D6 20
DB5 DSR0
41 3
GND
6 PS2
8 Press.Switch
D7 21
DB6 SIN0
12
I1 O1 9 Chamb.Switch
DB7 RTS1
11 UA9636
VP 10 VP (+12V)
DTR1
10
11 Valve Open
A0 35
SOUT1
60 U10 R3
12 Valve Closed
A1 34
A0 INT1
13 7 Q3 Q4 13 Valve GND
33
A1 CTS1
5 2
-
ZTX750 ZTX750 14 GND Chamb.Switch
A2 A2 DSR1 O1
WR 36 62 8 1K
IOW SIN1 +
RD 37 44 R2 PL4
IOR BDO
39 5 R14
RESET - R16 1
CLK2 4
CLK PD0
53 3
O2 C3 221E
+ + 221E VCC 2
52 6 C2 1K
PD1
51
+ 3 RXD
PD2 D4 D5 4
R30 50 UA9637 5
PD3 VON
VCC
29
30
RLSD0 PD4
49
48 470pF
1N4448 1N4448 6 Floating Board
RI0 PD5 470pF 7
4K7 47
8
PD6
CS5 32 46
CS0 PD7
57
9 TXD
INIT 10
56
AFD
R31 55
STB
8 58
VCC RLSD1 SLIN
6 59 PL2
RI1 INT2
4K7 STROBE 1
CS4 3 AUTO-FEED 14
CS1
R44 D1_ 2
63 ERROR 15
ERR 4K7
65 D2_ 3
SLCT
66 INIT 16
BUSY
-RESET 67 D3_ 4
PE
68 SELECT IN 17
ACK
1 D4_ 5
LPIOE
CS6 38 D5_ 18
CS2
6
VL16C452 GND 19
D6_ 7
20
TP19
INTER
D7_ 8
21
Parallel Port
D8_ 9
22
ACKNLG 10
U30A 2 U30B C8 23
3 5 U34D 74HC132 BUSY 11
INTER 12pF
1 6 12 U30D U21A 24
WDO
4 C9 11 13 PE 12
74HC32 12pF 13 11 1 2 25
CLK1 74HC32 13 12 CLK 12 SELECT 13
11DQ04 R26
+ 7407

+
D9 74HC32
LL U23F
U14 221E TP20
D0 34 4 C37 4u7 U8 74HC14
D0 PA0
D1 33 3 1N4448 R32 1 16 77KHz PL1
D1 PA1 IA OA 1
32 2 D10 2 15
D2
31
D2 PA2
1 + 3
IB OB
14 20
D3 D3 PA3 IC OC ALARM ON
D4 30
D4 PA4
40 2K21 4
ID OD
13 2 RxD
D5 29
D5 PA5
39 5
IE OE
12 21 ALARM RESET
D6 28
D6 PA6
38 6
IF OF
11 3 TxD
D7 27
D7 PA7
37 7
IG OG
10 22 ALARM
U6 4 RTS
23
RD 5
RD PB0
18 LSB 13
A10 R
16
TEST
9
5
FAULT
WR 36 19 12 CTS
WR PB1 A9 24
A0 9 20 11 1 ULN2004A
A0 PB2 A8 OUT1 6
A1 8 21 10
A1 PB3 A7 TP21 25
RESET 35 22 9 2
RESET PB4 A6 OUT2 PO2/PCO2 7
CS8 6 23 8 VEE
CS PB5 A5 VON 26
24
PB6
25
7
A4 VREF
15
33pF C28 TP22 8
MONITOR ON
PB7 6
A3 VP VEE PO2 F1

4
5 27
A2 U7A MONITOR CONNECTED
9
14 AUX +10V to +26V
4 2
-

4
1
PC0 A1 28
15 MSB 1
PC1 T 0.315A 10
16 DAC1020 3
+
PC2 VP U32 29
17 TP14
PC3 AD648 3 5 11
13 REF
PC4
12 30 pO2

8
PC5
11 LF398 12 OUT
pCO2
PC6 R6 31
10
PC7 VP 3K D1 VP VEE 13 OUT

2
6

7
82C55 AD648 U7B C4 32

4
1
14
WDO 5 R20 100nF 33
A0 1N4448
A1
A0
A1
U26 7 + 115K D3
U33 15 Kontron Interface
19 2
A2
A2 D0 18
Q1 D1
3 -
6
+ 3 5 34
Q2 D2 16
CS4 CS4 D1 17 4
Q3 D3 R28 C24 LM336D2 35
CS5 CS5 D2 16 5 LF398
Q4 D4 100nF RV1 17
CS6
CS8
CS6 D3 15
Q5 D5
6 + 36
CS8 D4 14 7 10K
CS9 Q6 D6 316K 1N4448 C5 18

2
6

7
CS9 D5 13 8
CS10 D6 Q7 D7 TP23 37
CS10 12 9 100nF PCO2 TP8 19
RD D7 Q8 D8 VCC
RD AF ALARM
WR WR 11
CLK2 CLK2 C
1
RESET RESET OC PL7
VCC
74HC573 RNET2 C34 3
4K7 10nF 2 Speaker

1
TP15 1
PR1 JP3
CS10
1 VEE VM
2
PL3
NONMI TP16
U34A U21B Link 1-2 = Normal Alarm
VMZ
PR2 1 R33
3 Link 2-3 = GLEM Alarm 34
33
Keyboard/Display

2
3
4
5
6
7
8
9
PFO 3 3 4
RNET1 ALARM 32
D[0..7] 2 31
9 56E
8 TP17 30
74HC132 7407
7 PS1 U21C 29
6 U34B 28
5 4 R34 27
5 6
4
TP18 6 26
3 PS2 5 25
U11 Resistorwith
with* +
VCC
1 2 7407
56E
34
D0 PA0
4 24 Resistor == 1%
0.1%
74HC132 U21D D0 33 3 23
U34C D1 PA1 22
4K7 D1 32 2
9 R35 D2 PA2
8
9 8 D2 31
D3 PA3
1 21 No. VP Power Supply
GND
CLK3 10 D3 30
D4 PA4
40 20 U IC Type Pins VCC VEE
D4 29 39 19
7407 56E D5 D5 PA5 18 6 16
8 14
28 38
74HC132 D6 PA6 17 7 DAC1020 3
D6 27 37 AD648 4
U21E
R36
D7 D7 PA7 16 8 ULN2004A 168 8
5 18 15 UA9636 8 8 5
C36 270pF 11 10 RD 36
RD PB0
19 14 9
UA9637 44
VCC WR PB1 13 1110 8 1 7
* R7 U25A 100E
WR 9
A0 PB2
20 82C55 40 26
12 82C55 26
8

82K5 LM393AN
A0 8
A1 PB3
21 14 40 7
3 7407 A1 35 22 11
15 LM11CN
R4 150K0 + RESET
RESET PB4 10 8 7 14
1 6
CS PB5
23
9
21 7407 14 7 4
CS9
* 2 24 23 74HC14 8 14 4 7
8 14
PB6
- 25 8
LM393N
VP TP13 PB7 7 2625 20
PT1 6 74HC573 20 10
14
29 VL16C452 68 4023
4

R8 PC0 5 2,7,9
22,27
R10 * VCC PC1
15
16 4
12K00 42,43
U15 PC2 VCC
3 64
7
5

17 54,61
* U25B PC3
13 2 30 74HC32
75K00
R5
3
+ LM393AN R42 R40
PC4
12 1 32 LM398 8 14 1 14 77
44
6 5 82C55 PC5
+ 3K 4K7 11 33 LM398 8 1 7
* 2
-
7 PC6
10 34 74HC132 14 14 7
6 JP1 PC7
75K00 LM11CN
+ C30
- JP2
1
4
8

1uF R15 1
R9 * * 14K22 2 Link 2-3 = mmHg 1 Link1-2
2-3==Service
Normal
150K0 Link 1-2 = KPa 2 Link
3
VEE 3
Units Service

Page 96
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9.5 Circuit Diagram of Power Supply PCB 7650 0822 Iss. 7

TP4 R12
4K75

1
U3

7
1
REF LM741
T1 3 R13
+
J4 1 8 TP1 6 Q2 TP6
2 BD135 D7
-
120 VAC D1 825 D11 SB140

1
18V B40C1500 1N4148 13.8V
Vm

4
5
J3 2 7 D2 220uF/63V D8
- + C2 TL431 R14
D10 6E8
3 6 SB140 1N4148
J2

120 VAC 18V + + +


D9
4 5 C1 C11 1N4001
J1 1000uF/63V 1000uF/63V
TRANSFORMER MAINS R10 R9 F2

6K81 130K 1A
JP3
R11 + C10 D6
1
30K1 10uF/35V 1N4001
2
MOLEX1X2
JP1 F1 D3
1 TO BATTERY
FROM BATTERY EXT 2
SB140
MOLEX1X2 1A

TP2

1
TO MAINBOARD
V+
JP2 JP4
1 1
FROM MAINSWITCH 2 2
3 3
4
MOLEX1X3
5
6
7
8
R1 9
6K81 R15 10
BERG2X5
10K

TP3
Q1
RFP8P10
1

TP5

T L1

1
Von 400uH
5V

TP7
REPLACEMENT FOR L4962 REPLACEMENT FOR LM2575
C9

1
100n/63V U4 U2 D5
LM2575 L4962 SB140 + + GND

C7 C8
R2 220uF/63V 220uF/63V
R5 20K0 1 2 7 2

ON/OFF
ON/OFF

VIN OUT VIN OUT

GND
GND
GND
GND
GND

OSC
FQ
FB
FB

221K

14
12
13

11
10

15
U1

5
4
3

5
8
5

LM311
2
+
7
3
-
R7 C6 R6 C5
15K0 2u2 4K32 2n2
+ J5
1
4
6

C3
1uF/50V R3 R4 C4
10K0 20K0 33n

Page 97
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This side left blanc

Page 98
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MANUAL

9.6 Circuit Diagram of Floating PCB 7650 0823 Iss. 7 - sheet 1/2

Page 99
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MANUAL

9.7 Circuit Diagram of Floating PCB 7650 0823 Iss. 7 - sheet 2/2

Page 100
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MANUAL

9.8 Circuit Diagram of Floating PCB (new version) 7650 0827 Iss. 4 - sheet 1/2
+5V
VCC
U4
I10
11 A15 TP5
9 +5V U6
I9 VCC
12 8
OE
22 C15
O8 I8
13 7 20 100n R19 R20 R12
O7 I7 CE
14 6 1K 1K 10K
O6 I6
15 5 C80 1 A15
O5 I5 A15 BC212
16 4 100n 27 A14
O4 I4 A14
17 3 A2 26 A13
O3 I3 A13
18 2 A1 2 A12 OC3
O2 I2 A12 Q5
19 1 A0 23 A11 4 1
O1 I1 A11 C A
21 A10 3 2 JP1
A10 R21 10K E K
+5V GAL16V8-25QNC 24 A9 R13 VCC
A9 1 2
D[0..7] 25 A8 10K
A8 OPI1264C 3 4
D7 19 3 A7
O7 A7 5 6
D6 18 4 A6
O6 A6 7 8
C79 D5 17 5 A5
O5 A5 9 10
D4 16 6 A4
100n O4 A4 C7 Q4 BC182
D3 15 7 A3
O3 A3 560pF HEADER 5X2
D2 13 8 A2 R14
O2 A2
D1 12
O1
9 A1 294 TP3
A1
SHEET 2 U9 D0 11 10 A0 XMT
O0 A0
2 3 D0 R25 R22 VCC
SC1 A1 Y1
4 5 D1 27C512 10K 100 TP6
SC0 A2 Y2
6 7 D2 VON
DOUT A3 Y3
10 9 D3
A4 Y4 +5V
P0 12 11 D4 RNET2
SK A5 Y5
P1 14 13 D5 9 A8 R5 R4
DIN A6 Y6 +5V
CS P2 8 A9 1K 1K
P3 1 7 A10
HO/F G1
P4 15 6 A11 TP2
ADR0 G2
P5 5 A12 RCV
ADR1
P6 74HC366 4 A13
ADR2 R2
3 A14
1 2 A15
P[0..6] 10K Q2 R6
10K 10K C18
BC212 Q1 BC182
+5V 560pF
OC2
RNET1
9 +5V 1 4
R23 D7 A C
C13 C12 C11 D6 8 2 3
100K K E
1u C10 D5 7
0.1u 0.1u R3 R7
D4 6 OPI1264C
100n R8
D3 5 10K R1 10K
+5V D2 4 294 100
U7 D1 3
40 1 D0 2 1 R24
V+ GND
39
REF IN- STATUS
2 TP4
38 3 D5 10K 0V
REF C- POL
37 4 D4 1G
REF C+ OR
36 5 D3 U5
REF2 REF IN+ B12
35 6 D2 D7 2 19 A7
TP7
AOUT IN HI B11 D1 Q1
34 7 D1 D6 3 18 A6 +5V
IN LO B10 D2 Q2 D2
33 8 4 17 U1 7808
COM. B9 D0 D5 D3 Q3 A5
32 9 5 16 11DQ04 TP1
INT B8 D7 D4 D4 Q4 A4 T1 VI VO
31 10 6 15 12 +8V
AZ D6 D3 A3

GND
B7 D5 Q5
30 11 7 14
BUFF B6 D5 D2 D6 Q6 A2
29 12 Y1 8 13 C5 2 C2
REF OUT B5 D4 D1 D7 Q7 A1
28 13 9 12 470u C1 15u
-5V V- B4 D3 D0 D8 Q8 A0
27 14 11 47u
+5V SEND B3 D2 R16
26 15 11
RUN/HOLD B2 D1 9.8304MHz CLK 3k6
25 16 1 1
OSC OUT B1 D0 OC C6
24 17 C16 C17 470u
OSC SEL TEST R9
23 18 9
OSC OUT LBEN 10pF 10pF 74HC574

4
C39 22 19 R45 1K
OSC IN HBEN RM8 Q3
22pF 21 20 +5V

V+

R
MODE CE LOAD D3 RFD3055LE 8k2
ICL7109 11DQ04 R10 2
R62 TR
R54 U3 80C528 150 3
Q
31 39 -5V 6
100K EA/VP P0.0 D0 C8 THR
38 243
P0.1 D1 100n TP8
19 37 R11 5 7
U10 X1 P0.2 D2 +5V R34 CV DIS
36 C4310K
P0.3 D3 3E3
35 R15 825 C3
17 P0.4 1n5 R49

V-
XFER 18 34 D4
1 X2 P0.5 D5 2n2 30K1
CS +5V 33
2 P0.6 D6 C4
WR1 32

1
9 18 P0.7 D7 A[0..15] R66 4k7 OC1
DACF RFB WR2 9 U2 1n5
19 RESET
ILE 21 1 4
8 P2.0 A8 A C
REF1 REF 22 C14 2 3 ICM7555
C40 P2.1 A9 K E
11 12 23
IOUT1 4u7 INT0 P2.2 A10 R17
DAC+ 13 24
13 D7 INT1 P2.3 A11 C19 5K11 D1 OPI1264C
B7 14 25
12 14 D6 T0 P2.4 A12 TL431
DAC- IOUT2 B6 15 26 100n
B5
15 D5 T1 P2.5 A13 1u
27
20 16 D4 P2.6 A14
VCC B4 1 28
4 D3 P0 P1.0 P2.7 A15
B3 2
10 5 D2 P1 P1.1
DGND B2 3 17 R18
6 D1 P2 P1.2 RD
B1 4 16 5K11
7650_072.SCH 3 7 D0 P3 P1.3 WR
AGND B0 5 29
P4 P1.4 PSEN
6 30
DAC832 P5 P1.5 ALE/P
11
7
P6 P1.6 TXD
8 10
P1.7 RXD
C9
C77
4u7
Power Supply 100n
U IC Type NO.Pins +5V GND
3 80C528 40 40 20
4 GAL16V8 20 20 10
5 74HC574 20 20 10
6 27C512 28 28 14
9 74HC366 16 16 8

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9.9 Circuit Diagram of Floating PCB (new version) 7650 0827 Iss. 4 - sheet 2/2
SC1
SC0
DOUT
R84 2K21
SK
+5V
R83 2K21
DIN
R82 2K21
CS
R58
+5V -5V
C75 C76 C72 C69 C70 C71
10K HEATING+ 470p 470p 22p 22p 22p 22p
R51
R57 D10 AOUT
C20 T-LVA462 ADR0
100n 100K ADR1
10K C41 ADR2
+5V
TP17 270p
R56 REF1
PCO2 +1V2 -5V -5V
+5V
JP2 10K R53 TP11
1
HEATER HIGH, VCC EEPROM C28 10K +5V +5V R48 4K* +2V5
100n C38 C83
-2V C37 +5V 4u7 100n 22p C36
2
100n R46

7
3
SENSOR CODE DIGITAL, SC0 909 U14 1
-2V 3 8
4
SENSOR CODE ANALOG R65 R47
+ 6
D7 U8 22K 2 5
5
DATA INPUT EEPROM C32 1
A0 A1
16 - Q7
2 15 5K* LM308AN
100n LM385-1.2 +5V EN A2 BC212
0V EEPROM, TH2, SENSOR CODE 3 14 D4

4
6 -5V V- GND
4 13 +5V 1N4448 R52
I1 V+
7
SERIAL CLOCK EEPROM 5
I2 I5
12 1K3#
PO2 6 11 -5V -5V
I3 I6
8
DATA OUTPUT EEPROM 7
I4 I7
10
8 9
OUT I8
THERMISTOR TH1 C30 D6
9 RV1 RV2
100n DG508 LM336 REF2
HEATER LOW TP16
10 10K 100
PCO2 SIGNAL COMBI-M SC MUX OUT TP10
11 D5
+1.024V
CHIP SELECT EEPROM 1N4448 R50
12
C73 909#
13
0V FOR TH1 100n
R55
14
SENSOR CODE DIGITAL, SC1 18K2

PO2 SIGNAL HEATING -


15
TP12
16
THERMISTOR TH2 -2V
C26
R41 22M
HEADER 16 100n +5V TP14
RV3 +5V..-3V
R42 475K C35 C34
50K
R63 R28 R27 R29 TP13 TP18
TH1 12K** 12K** 12K* ERR. VOLT. 0V
+5V
15u 15u
C22 3E3 +5V

8
7
1
100n R35
Q10

7
5
3 68K1 R38 ZTX750
+ 6 3 1K BC212 R44
R64 2 + 6 HO/F
TH2 - U12 2
- Q8
10K
C24 3E3 OP07 R36

4
U13
R26 R30 R31 68K1 R39 R43

1
4
8
100n ICL7611
274K 274K 5K403* 10E0 5K11
-5V R37 274K
+5V -5V
Q9
C74 ZTX650
470p R40
C84 220n U11 10K
OP07

7
R32 3
6 +
1 2 -5V
DAC-
400*
-
TP9 DAC+

4
8
0V TP15
R33 PRESET VOLTAGE
30* -5V
DACF

Page 102
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MANUAL

9.10 Circuit Diagram of Display PCB 7650 0824 Iss. 5


U9 U4 U5 U6 U7 U8
e 1 10 g e 1 10 g e 1 10 g e 1 10 g e 1 10 g e 1 10 g
E G E G E G E G E G E G
d 2 9 f d 2 9 f d 2 9 f d 2 9 f d 2 9 f d 2 9 f
D F D F D F D F D F D F
3 8 3 8 3 8 3 8 3 8 3 8
K K K K K K K K K K K K
c 4 7 a c 4 7 a c 4 7 a c 4 7 a c 4 7 a c 4 7 a
C A C A C A C A C A C A
dp 5 6 b dp 5 6 b dp 5 6 b dp 5 6 b dp 5 6 b dp 5 6 b
DP B DP B DP B DP B DP B DP B
LTS547AG LTS547AG LTS547AG LTS547AG LTS547AG LTS547AG

dpa b d c e f g

R35
10E

U3
R10 7
DB0
10E 8
DB1
VCC VCC VCC VCC VCC VCC 9
DB2
10
DB3
11
R31 DB4
R16 R27 R28 R29 R30 R32 12
10K DB5
10E 10K 2N7010 10K 2N7010 10K 2N7010 10K 2N7010 2N7010 10K 2N7010 13
(*) (*) (*) (*) (*) (*) DB6
14
DB7
Q9 Q10 Q11 Q12 Q13 Q14 3
R11 VEE
4
10E BC182 BC182 BC182 BC182 BC182 BC182 5
RS
RW
6
Q3 Q4 Q5 Q6 Q7 Q8 E
2
VCC VCC
VEE VEE VEE VEE VEE VEE VEE VEE 1
R17 GND
10E DMC16202
R8 R7 R6 R5 R4 R3 R2 R1
R19 R20 R21 R22 R23 R24
27K 27K 27K 27K 27K 27K R9
R12 3K92
VCC
10E 7K50 6K81 6K19 5K62 5K11 4K32
8K25 U2 3K65
13 3
X0 X
14
R18 X1
15 VCC
X2
10E 12 VCC
X3
1
X4
U1 5 16 R36
X5 VDD
1 2 18E
DIG4 X6
R13 27 2 4
DIG7 DIG6 X7
26 3 8
10E DIG5 DIG3 VSS
25 4 6
DIG2 DIG1 INH LCD BACKLIGHT
24 5 11
DIG8 ID6 A
23 6 10 7 JP2
SG ID5 B VEE
22 7 9
SF ID7 C 3
21 8
SE WR 2
20 9 4051 VEE
SC MODE 1
10 VCC VM
ID4 LCD VIEWING
18 11 ANGLE ADJUSTMENT HEADER 3
SD ID1 VEE R34 R33
17 12
SB ID0 VM 1K 5K62
16 13
SA ID2
15 14
D.P. ID3
19 VCC TO KEYBOARD R37
VCC
28 VCC Q15
R38 R39 GND BC182
R15 R14 JP1
10E 10E 10E 10E ICM7218 1K
1 14
2 13
ALARM LED 3 12
R40 R25 VEE VEE VCC VCC
D1 4 11
27K 27K 5 10
1 8 TP2 TP1
CA CD 6 9
2 7 1 1
AA AD T T 7 8
3 6
AB AC
4 5 DIL14
CB CC VEE VCC
VCC
TDA4100 C1 + C3 C2 + C4
100nF 100nF 10MF
Q1 10MF
1 TP0
T
BC212
2N7010
Q2 GND
(*)
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
1
2
3
4
5
6
7
8
9

R26
10K
JP3
BERG 2X17

(*) = 2N7010 or 2SK1113 or 2SK2200

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MANUAL

9.11 Touchpanel PCB 7650 0125 Iss. 5

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10 Packing for Shipment

10.1 Introduction
To ship the monitor for any reason, follow the instructions in this section.

Returning the MicroGas 7650


Contact Linde Medical Sensors Technical Service or your local Linde Medical Sensors
representative for shipping instructions. Unless otherwise instructed by Linde Medical Sensors
Technical Services, it is not necessary to return the sensor or other accessory items with the
monitor. Pack the MicroGas 7650 in its original shipping carton. If the original carton is not available,
use a suitable carton with appropriate packing material to protect the monitor during shipping.
Return the MicroGas by any shipping method that provides proof of delivery.

General instructions
Pack the monitor carefully. Failure to follow the instructions in this section may result in loss or
damage not covered by any applicable Linde Medical Sensors warranty. If the original shipping
carton is not available, use another suitable carton.

10.2 Repacking in Original Carton


If available, use the original carton and packing materials. See Figure below.
Pack the monitor as follows:
1. Place the monitor and, if necessary, accessory items in original packaging.

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MANUAL

2. Place in shipping carton and seal carton with packaging tape.


3. Label carton with shipping address and return address

10.3 Repacking in a Different Carton


If the original carton is not available, use the following procedure to pack the MicroGas 7650:
1. Place the monitor in a plastic bag.
2. Locate a corrugated cardboard shipping carton with a bursting strength of at least 1500 kPa.
3. Fill the bottom of the carton with at least 10 cm of packaging material.
4. Place the bagged unit on the layer of packaging material and fill the box completely with
packaging material.
5. Seal the carton with packaging tape.
6. Label the carton with the shipping address and return address.

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11 Reporting Procedures

11.1 Handling and Reporting of Incidents

1. Purpose
To ensure that the processes for monitoring adverse incidents, managing the related corrective
actions and reporting to the competent authorities are done in a controlled way and in
accordance with the legal requirements.

2. Scope
All products of Linde Medical Sensors (formerly “Kontron Instruments Medical Sensors”)

3. Definitions
- Adverse Incident (CD 93/42/EEC, Art. 10.1a.): Any malfunction or deterioration in the
characteristics and/or performance of a device, as well as any inadequacy in the labelling or
the instructions for use which might lead to (=“near“ incident) or might have led to the death of
a patient or a user or to a serious deterioration in his state of health. An Adverse Incident is
equivalent to a “MDR Reportable Event” as defined in 21 CFR, Ch. 1 , §803.3(q) and to an “
incident that meets the Mandatory Problem Reporting” as defined in the Canadian MDR,
Section 59(1).
- Recall (EN 46001, 3.15): When there is a risk of death or serious deterioration to the state of
health, recall is:
- the return of a medical device to the supplier,
- its modification by the supplier at the site of installation,
- its exchange or its destruction
in accordance with the instructions contained in an advisory notice.
A recall as defined above is equivalent to “Corrections and Removals” as defined in 21CFR
Ch.1 §806 in the USA.
The canadian definition of a recall according to the section 1 of Medical device Regulation is
different. A recall in Canada includes any action taken by the manufacturer not only after
becoming aware that the device may be hazarous to health, but also when it may fail to
conform with any claim made by the manufacturer relating to its effectiveness, benefits,
performance characteristics or safety or when it may not meet the requirements of the act or
the CMDR.
- Advisory Notice (EN 46001, 3.14): A notice issued to provide information and/or advise on
what action should be taken in the use, modification, disposal or return of a medical device.
- Competent Authority: Appointed state authority to operate the medical device vigilance
system on the market in accordance with legal requirements.
- Notified Body: Appointed body acknowledged by the EU to both approve for CE marking any
medical devices after assessing its compliance with the requirements of the MDD and to
operate surveillance audits. The Notified Body competent for LIMS is TÜV Product Service in
Munich, Germany.
- Designated Agent in the USA: According to 21 CFR Ch.1, §407.40, LIMS has to handle all
matters concerning the US Medical Device Reporting regulations via its designated agent in
the USA
- Importer of a Medical Device: According to the Canadian MDR, Section 59 to 62, LIMS will
handle all matters concerning the “Mandatory Problem Reporting” and a “Recall” via its
designated agent in Canada.

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4. Monitoring and identification of adverse incidents


Any LIMS employee shall immediately inform the SBKR, when he receives or otherwise
becomes aware of information from any source, that reasonably suggests that a device
marketed by LIMS may have caused or contributed to a death or serious injury, or has
malfunctioned and such device or similar device marketed by LIMS would be likely to cause or
contribute to a death or serious injury, if the malfunction were to recur.
The SBKR shall constantly monitor complaints and all product information available in the
quality assurance system of LIMS, to identify potential adverse incidents.
All distributors of LIMS products have committed themselves to notify LIMS immediately of any
adverse incident or near adverse incident. According to the Medical Device Reporting
regulations (21 CFR Ch. 1 , §804.25), the Designated Agent in the USA must submit to LIMS a
report not later than 10 working days after he receives or becomes aware of information about
an adverse incident.
When such incident is suspected, then the following will apply: The SBKR shall immediately call
a Review Committee made up of Managing Director, R&D Manager, Marketing Manager, QA
Manager, SBRA and SBKR to assess if it is or not the case of an adverse incident. (according
to the Form F187) The result of their assessment shall be documented in a report. This report
must contain any information evaluated by the Review Committee. If the result of their
assessment is negative (adverse incident not confirmed), the reasons for this decision must be
documented. The report has to be added to the Adverse Incident File (see chapter 10) also
when an adverse incident has not been confirmed.
If the result of their assessment is positive, the SBRA shall inform the Notified Body in the EU
(TÜV Product Service) and, when products delivered to the USA or Canada are affected as
well, the Designated Agent in these countries. If remedial actions should be required to prevent
an unreasonable risk of substantial harm to the public health, the SBRA shall alert the
Designated Agent in the USA, indicating that a Five-day Report according to 21 CFR, Ch. 1 ,
§803.53, has to be submitted to FDA.
Immediately thereafter, the SBKR shall prepare a corrective action plan which must be
submitted to the Review Committee within two working days.

5. Preparation of corrective action plan


- The SBKR shall
- identify quantity and location (country) of the products concerned that have been delivered,
by serial number or lot number.
- identify reasons for the problem behind the incident by coordinating a Product Failure
Investigation according to QS-RL 053.
- provide, together with R&D, recommendations for a MFA notice, including technical reasons
and consideration of patient and user risks.
- The SBRA shall
- prepare drafts of initial adverse incident reports to the Competent Authorities of those
countries where the incident has happened or might happen. The reports should include a
statement to the effect that the report is made without prejudice and does not imply any
admission of liability for the incident or ist consequences.

6. Corrective action plan


The Review Committee shall decide within additional two working days on the corrective actions
which have to be taken and their timing. The following checklist must be considered for
guidance.
- Stop shipment of products affected.
- Drafts of adverse incident reports to the competent authorities
- Recall of products affected via a MFA notice
- Draft of a “Corrections and Removals Report” to the US FDA (see QS-RL 068, chapter 4.1)
- Letter to distributors
- Letter to customers (to be mailed via distributors)
- Review of all written documents by a lawyer
The corrective action plan should be established in relationship to the seriousness of the
problem, the quantity of already delivered products and the technical solutions available. A copy
of the corrective action plan will be added to the Adverse Incident File (see chapter 10).

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7. Implementation of corrective action plan


- Stop shipment of products affected: This shall be implemented immediately according to QS-
RL 055.
- Letter to distributors: Following the decisions taken by the Review Commitee, the LIMS
Managing Director (GL) shall issue immediately a letter to the Managing Directors of the
distributors of the countries affected with following contents:
- Products affected (with serial numbers or lot numbers)
- Description of the identified problem (reported incident or potential incident or fault)
- Consequences of the problem on patients or operators (and materials or other equipments, if
applicable).
- Advice on stop shipment from distributors.
- Advice on short term checks or by-pass solutions or any possible precautions to be taken for
installed bases.
- Information on MFA notice to be issued shortly and on type of intended recall.
- A sample letter to users advising of any potential risk and short term precautions to take.
- Instructions to distributors about whether the letter to users must or may be issued.
- Recall of products affected via a MFA notice: This shall be implemented according to QS-RL
068 within the timescale specified in the MFA.
- “Corrections and Removals Report” to the US FDA: This shall be implemented according to
QS-RL 068.

8. Reporting of Incidents
Adverse Incidents must be reported to the Competent Authority of the country where the
incident has occurred. In addition, the Competent Authorities of those countries must receive a
report, where the same or a similar type of device produced by LIMS is in use and would be
likely to cause or contribute to a death or a serious injury, if the malfunction were to recur.
LIMS will submit the formal reports to the Competent Authorities in the EU and to the Designated
Agent in the USA (21 CFR Ch. 1 , §803.58) and Canada. For the USA and Canada, SBRA will
prepare draft reports which contain all information (as available) required for the formal reports.
The SBRA will forward the reports to their Designated Agent in the USA and in Canada as
expeditiously as possible and early enough to allow them to submit the formal reports within the
time limits given below. The time runs from LIMS being first informed of the incident, to the
relevant Competent Authority receiving the notice.

The procedures and time limits for submitting the reports are as follows:
- Switzerland: The report must be prepared according to the Swiss MepV (Information at
INFO_VIG. doc) and has to be sent directly to the Swiss Federal Office of Public Health within
10 days for incidents and 30 days for near incidents.
- Member States of the EEA (European Economic Area): The report must be prepared according
to the guideline MEDDEV 2.12/1 and has to be sent to the Competent Authorities of all member
states concerned. Incidents must be reported within 10 days, near incidents within 30 days.
- Countries outside the EEA, except the USA and Canada: The report must be prepared
according to the guideline MEDDEV 2.12/1 and has to be sent to the Competent Authority of
Germany (Bundesinstitut für Arzneimittel und Medizinprodukte). This is requested as the
Notified Body of LIMS is located in Germany. Incidents must be reported within 10 days, near
incidents within 30 days.
- USA: The report must be prepared according to 21 CFR Ch.1, §803, Subpart E by the
Designated Agent of LIMS in the USA. LIMS has to provide all relevant information to the
Designated Agent, who has to submit the report to the FDA within 30 days. If the special
conditions according to §803.53 apply, the report has to be submitted within five days.
- Canada: The reporting shall be done according to the sections 59 to 62 of the Canadian MDR
and the guidance “Mandatory and Voluntary Problem reporting for Medical devices”.
A preliminary report must be prepared according to the section 60 (2) of the CMDR and shall
be sent o the competent authorities within 10 days for incidents and 30 days for near
incidents. For incidents that occurs outside Canada, as soon as possible after indication of
intention to take corrective actions (see CMDR Section 60 (1)(b)).
A final report according to the section 61 of the CMDR shall be submitted within the time
established in the preliminary report.
According to section 62 of the CMDR, a summary report can be requested by the competent
authorities and shall be submitted within 30 days of the request.

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9. Follow-up of corrective action plan


- Recall of products: The progress of the recall and its completeness is monitored by the SBKR
as outlined in QSRL 068.
- Supplemental reports to the Competent Authorities: The SBRA is responsible for issuing
supplemental reports and the final report to the Competent Authorities according to the
guidelines and regulations mentioned above. This shall be done in coordination with the
Designated Agent in the USA, if applicable.

10. Retention of documents


The SBKR is responsible for establishing and maintaining an Adverse Incident File (US term:
“MDR Event File”) which is a part of the Complaint File (see QS-RL 020). The Adverse Incident
File must contain all documents of the regular Complaint File and, in addition, the following:
- Assessment report of Review Committee (see chapter 4)
- Corrective action plan (see chapter 6)
- Copies of all reports to the Competent Authorities
- All information supplied to distributors, customers and related documentation
- Copies of correspondence related to the Adverse Incident
- The product failure investigation report (see QS-RL 053) shall contain the aditional information
required by 21 CFR Ch. 1 , §820.198d.
The Adverse Incident File must be retained as a quality record for 13 years following the
termination of the supply of the relevant product.

11. Associated Documents


QS-Richtlinien Nr.:
100.93.017 Korrektur- und Vorbeugungsmassnahmen (Kap. 14)
100.93.020 Rückmeldung von Kunden (Kap. 14)
100.93.053 Produktfehler – Untersuchung (Kap. 4)
100.93.055 Lieferungsstopp (Kap. 14)
100.93.068 Management of MFA, ESI and TB (Kap. 14)
100.93.010 Qualitätssystem-Aufzeichnungen (Kap. 16)

Form:
F187 Entscheidungskriterien zur Meldepflicht bei einem Vorfall mit einem
medizinischen Gerät

11.2 Management of MFA, ESI, TB

1. Purpose
To define the rules for the preparation and management of information and actions
relating to Mandatory Field Actions (MFA), Engineering Service Information (ESI) and
Technical Bulletins (TB).

2. Scope
All products of Linde Medical Sensors (formerly Kontron Instruments Medical Sensors).
For MFAs, this procedure is linked to the Procedure on Handling and Reporting of
Incidents (QS-RL 070) and cannot be operated without it.

3. Definitions

MFA:
Mandatory Field Action notice: An advisory notice which has the purpose to instruct
distributors to carry out prescribed remedial actions in order to avoid potential risks
either to the patient or user within a specified period, in any case not to exceed one
month after receipt. An MFA is issued in the case of a recall following an adverse
incident (see QS-RL 070). The MFA requires that distributors confirm that the
prescribed actions have been taken.

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ESI:
Engineering Service Information: This advisory notice is intended to supply information
revealing a serious failure in expected performance, where patient or user safety is not
jeopardised, and to suggest corrective action. As with the MFA, the provision of an ESI
indicates an obligation to undertake the necessary actions on the products concerned,
as defined by their serial numbers or lot numbers.
The obligation to undertake such repairs, placed on the distributor, take the following two forms
as defined in the first page of the ESI document (Annex C):

ESI Code 1 Mandatory for completion within a maximum of six months on all products
concerned.
ESI Code 2 Should be carried out on all products concerned at the time of next repair, next
preventive maintenance, visit or after a customer complaint.

TB:
Technical Bulletin: The Technical Bulletin (TB) is an advisory notice designed to provide
information concerning the optimization of performance or expected useful life of the product,
for example:
- Means of improving the product's performance
- New options and features for an existing product
- Software evolution
- Service policy
The issue of a TB typically happens following a design change, bug fix, product improvement,
upgrade or evolution, customer complaint.
Unlike the MFA and ESI, the issue of a Technical Bulletin does not necessarily require any
action by the distributor who receives it. No follow-up is required from SBKR.

SBKR:
is a technical support function at LIMS responsible for installed base serviceability, user
satisfaction and after-sales service, acting as interface with relevant engineering and
manufacturing functions.

SBRA:
is the person responsible for regulatory affairs who is in contact with the notified body, the
competent authorities in the EU, in the USA, Canada and other countries via our local
distributor/agent..

4. Implementation

4.1 Mandatory Field Action (MFA)

SBKR:
Must prepare the MFA in the english language using the form and the contents described in
Annex B.

Must use accredited design and production documents. Documents drawn up on the purpose
(such as diagrams) may also be attached to the MFA, if necessary.

If applicable, the parts list (kit specification) must always be attached to the MFA.

The validation section of the document (Annex B) must be signed at the foot of the first page by
the designated persons (Managing Director and SBRA) before being issued. Whilst pending,
the document should be marked "provisional".

Must prepare a list specific to each distributor identifying the serial number of each product or
the lot numbers affected and include this information in the MFA delivered to the distributors
(see Annex A). This list of serial numbers or lot numbers is drawn up using factory records.
Where the product affected does not have serial or lot numbers (i.e. an accessory or
component), then the Annex A must contain information about delivery notes, delivery dates
and quantities affected for each distributor.

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Shall ensure that the contents of the MFA are approved by the QA Manager, the R&D Manager,
the Production Manager and the Marketing Manager.
Optional requirement: the form F178 may be used to provide documented evidence of the
approval process.

SBRA:
Must submit copies of the MFA notice to the competent authorities in the EU according to the
requirements outlined in the EC Guidelines MEDDEV 3/93 rev.3, §5.7.

Must prepare a draft of a “Corrections and Removals Report” to the US FDA. This report is
required according to 21 CFR, Ch. 1 , §806, and has to be submitted to FDA by the Designated
Agent in the USA (SensorMedics Corp.) within 10 working days of initiating the recall. The draft
report has to contain all information (as available) required by the Designated Agent to prepare
the formal report. The SBRA will forward the draft as expediously as possible and early enough
to allow the Designated Agent to submit the formal report in time.

Must prepare a draft of a recall notification according to the Canadian MDR Section 64, using
the Guidance for Medical devices Complaint handling and Recalls, which has to be submitted to
the competent authorities in Canada by our designated agent before undertaking the recall.

Distributors / Agents:
Are responsible to submit the formal recall notification to the competent authorities if applicable
and implement all the requirements of the MFA document within the specified time from receipt
of the MFA and in any case within one month from such a date.
Must confirm to SBKR within the same timescale that all actions required in the MFA have been
carried out by serial numbers or lot numbers using the form as per Annex A (F179).
Must submit the formal completion report to the competent authorities if applicable.

SBKR:
Is responsible to audit that all MFAs have been performed in a timely manner (by means of a
document audit: all Annexes A or equivalent have been returned and are completed) and to
ensure that adequate measures are taken to complete the remaining ones.

4.2 Engineering Service Information (ESI)

SBKR:
Must prepare the ESI according to the following rules:

ESI Code 1: Mandatory for completion within a maximum of six months on all products
concerned.
ESI Code 2: Mandatory and to be carried out on all products concerned at the time of next
repair, next preventive maintenance or after a customer complaint.

After the issue of an ESI Code 1, SBKR must carry out the following 3 actions:

1. Prepare a list specific to each distributor identifying the serial numbers or lot numbers of the
products affected and include this information in the ESI delivered to the distributor (see
Annex A). This list of serial or lot numbers is drawn up using factory records. Where the
product affected does not have serial or lot numbers (i.e. an accessory or component), then
the Annex A must contain information about delivery notes, delivery dates and quantities
affected for each distributor.

2. Ensure that modifications to the products so identified must be carried out within the
timescale established after receipt of the ESI and associated kits.

3. As in the case of an MFA, and using the same procedure, SBKR must receive confirmation
of completion of any modifications and ensure consistent operation.
Shall ensure that for all ESI (code 1 and 2):

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- The ESI is prepared in the english language using the form and the contents described in
Annex C.

- Accredited design and production documents are used. Documents drawn up on the purpose
(such as diagrams) may also be attached to the ESI, if necessary.

- If applicable, the parts list (kit specification) is attached to the ESI.

- The validation section of the document (Annex C) are signed at the foot of the first page by the
designated persons (SBKR and EL) before being issued. Whilst pending, the document
should be marked "provisional".

- The contents of the ESI are approved by the QA Manager, the R&D Manager, the Production
Manager and the Marketing Manager. Optional requirements: the form F178 may be used to
provide documented evidence of the approval process.

SBRA:
Must prepare a draft of a recal notification according to the Canadian MDR Section 64, using
the Guidance for Medical devices Complaint handling and Recalls, which has to be submitted to
the competent authorities in Canada by our designated agent before undertaking the recall.

Distributors / Agents:
Are responsible to submitt the formal recall notification to the competent authorities if applicable
and implement all the requirements of the ESI code 1 document within a maximum of 6 months
from receipt of the ESI and relevant kits (if necessary).
Must confirm to SBKR within the same timescale that all actions required in the ESI code1 have
been carried out by serial numbers or lot numbers using the form as per Annex A (F179).
Must implement all the requirements of the ESI code 2 document on all products concerned at
the time of next repair, next preventive maintenance visit or after a customer complaint.
When an ESI is issued under Code 2, there is no fixed timescale for effecting modifications.
However, progress reports must be supplied to SBKR by means of the document described in
Annex A (F179).
Must submitt the formal completion report to the competent authorities if applicable.

SBKR:
Is responsible to audit that all ESI code 1 have been performed timely (by means of a document
audit: all annexes A or equivalent have been returned and are completed) and to ensure that
adequate measures are taken to complete the remaining ones.

4.3 Technical Bulletin (TB)

SBKR
Must prepare the TB in the english language using the form and the contents described in
Annex D.

Must use accredited design and production documents. Documents drawn up on the purpose
(such as diagrams) may also be attached to the TB, if necessary.

If applicable, the parts list (kit specification) must always be attached to the TB.

The validation section of the document (Annex D) must be signed at the foot of the first page by
the designated persons (SBKR and EL) before being issued. Whilst pending, the document
should be marked "provisional".

Shall ensure that the contents of the TB are approved by the QA Manager, the R&D Manager,
the Production Manager and the Marketing Manager.

Optional requirements: the form F178 may be used to provide documented evidence of the
approval process.

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Distributors
Are responsible to consider and implement (as necessary) all the requirements of the TB
document.

4.4 Distribution List

SBKR:
Shall establish and maintain a distribution list for MFA, ESI and TB. The distribution list must
contain as addresses at least the following:
- Service Manager of each distributor
- General Manager of each distributor
- QA Manager of each distributor.
Shall adjust the distribution list according to distributor or personnel changes.

4.5 Document control

SBKR:
Shall ensure that:
- each MFA, ESI, TB document carries a registration and issue (revision) number.
- registers containing the registration number and short description of all issued MFA, ESI and
TB are maintained
- where document re-issue is necessary, the issue number is incremented.
- the original of each document is kept by SBKR and will be retained for 13 years.
- written confirmation from the distributors that the prescribed MFA or ESI code 1 has been
implemented are maintained.
- for an adverse incident, the MFA and the confirmation from the distributors are kept in the
Adverse Incident File (CAR A File, see QS-RL 070).

5. Associated documents
Annex A List of units to be modified (F179)
Annex B Example - MFA (F175)
Annex C Example - ESI (F176)
Annex D Example - TB (F177)
Annex E Approval of MFA, ESI, TB (F178)
QS-RL 100.93.070 Handling and Reporting of Incidents (Kap. 14)

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Annex A

PRODUCT NAME MFA or ESI number

Insert here the name of the Affiliate or Distributor


LIST OF UNITS TO BE MODIFIED BY :

This form must be returned within x days for


a MFA, six months for an ESI code 1 and once a
year for an ESI code 2.

UNIT DATE OF COMMENTS NAME AND STAMP


Serial or MODIFICATION
Lot No.

Stamp of the company


Name of the Service Manager:

Date:

Stamp:

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Annex B

MANDATORY FIELD ACTION


LINDE MEDICAL SENSORS AG
Product: Austrasse 25
Product Number: CH-4051 Basel , Switzerland
Tel.: +41 (0)61 278 81 11
Date of Issue: Fax.: +41 (0)61 278 81 81
MFA Ref. No.:
Contact: H.R. Vogt

Priority Code: This is a Mandatory Field Action.


It must be performed within x days.

Problem or
Subject: Identification of the problem or subject
Hazard associated with the product

Cause: How/why the problem occurred (only if appropriate)

Affected Products: Identification of affected products (only if appropriate)

Solution or
Remedy: Description of the solution or how to solve the problem
(return, disposal or correction of the affected product)

Additional
Information: Various information if appropriate like:
- instructions for notification of users
- method of response to the Mandatory Field Action

Caution: Warning relative to safety during product modification if necessary

VALIDATED REFERENCE DOCUMENT Ref. No.:


Name: J.P. Palma SBRA Name: P. Eberhard Managing Director

Signature: Date: Signature: Date: Page: 1 of 1

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Annex C

ENGINEERING SERVICE INFORMATION


LINDE MEDICAL SENSORS AG
Product : Austrasse 25
Part number: CH-4051 Basel , Switzerland
Date of Issue: Tel.: +41 (0)61 278 81 11
ESI Ref. No.: Fax.: +41 (0)61 278 81 81
Contact: H.R. Vogt

Priority Code: Code 1: Mandatory, must be performed within 6 month


Code 2: Should be carried out at the time of next repair, preventive
maintenance or visit, or after a customer complaint

Problem or
Subject: Identification of the problem or subject

Cause: How/why the problem occurred (only if appropriate)

Affected Products: Identification of affected products

Solution or
Remedy: Description of the solution or how to solve the problem
(correction of the affected product)

Additional
Information: Various information if appropriate like:
- instructions for notification of users
- method of response to the ESI

Caution: Warning relative to safety during product modification if necessary

VALIDATED REFERENCE DOCUMENT Ref. No.:


Name: H. R. Vogt SBKR Name: P. Eberhard R & D Manager

Signature: Date: Signature: Date: Page: 1 of 1

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Annex D

TECHNICAL BULLETIN
LINDE MEDICAL SENSORS AG
Product : Austrasse 25
Part Number: CH-4051 Basel , Switzerland
Date of Issue: Tel.: +41 (0)61 278 81 11
Fax.: +41 (0)61 278 81 81
TB Ref. No.:
Contact: H.R. Vogt

TITLE / SUBJECT OF TECH BULLETIN

The Tech Bulletin to be drafted here.

VALIDATED REFERENCE DOCUMENT Ref. No.:


Name: H. R. Vogt SBKR Name: P. Eberhard R & D Manager

Signature: Date: Signature: Date: Page: 1 of 1

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Annex E

APPROVAL TO
TECHNICAL BULLETIN
ENGINEERING SERVICE INFORMATION
MANDATORY FIELD ACTION

With reference to the requirements of the procedure 100.93.068 (Management of MFA / ESI / TB) this is the
approval form for the attached copy of:

• TECHNICAL BULLETIN (TB)


Ref. No.:

• ENGINEERING SERVICE INFORMATION (ESI)


Ref. No.:

• MANDATORY FIELD ACTION (MFA)


Ref. No.:

For Approval Signature Date

R & D Manager

QA Manager

Production Manager

Marketing Manager

SBKR: Date:

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