MicroGas 7650 Service Manual Feb 05
MicroGas 7650 Service Manual Feb 05
MicroGas 7650-500
rapid
SERVICE MANUAL
SERVICE
MANUAL
SERVICE MANUAL
MicroGas 7650-500
rapid
Page 1
SERVICE
MANUAL
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:
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.
Page 3
SERVICE
MANUAL
Page 4
SERVICE
MANUAL
Content
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
Page 5
SERVICE
MANUAL
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
Page 6
SERVICE
MANUAL
Page 7
SERVICE
MANUAL
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!
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.
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.
Page 9
SERVICE
MANUAL
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.
Page 12
SERVICE
MANUAL
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
Page 13
SERVICE
MANUAL
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
Page 14
SERVICE
MANUAL
2 Specification
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.
Mode of operation
Suitable for continuous operation
Degree of mobility
Transportable
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)
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
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
Page 17
SERVICE
MANUAL
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
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 --:--).
Page 18
SERVICE
MANUAL
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)
Messages
TOO HIGH PO2
95 ALARM LIMIT
Audible Indication
Three short tones repeating every two seconds
Page 19
SERVICE
MANUAL
Page 20
SERVICE
MANUAL
Page 21
SERVICE
MANUAL
Power consumption
Max. 15.6VA
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
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.
Page 22
SERVICE
MANUAL
Case
Wipe clean cover and front panel
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)
Temperature
-20°C to 60°C
Relative Humidity
10% to 95%
Ambient pressure
375 to 800 mmHg (500 to 1060 hPa)
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.
Page 23
SERVICE
MANUAL
Page 24
SERVICE
MANUAL
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.
Page 25
SERVICE
MANUAL
Page 26
SERVICE
MANUAL
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
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.
Page 27
SERVICE
MANUAL
Page 28
SERVICE
MANUAL
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.
Page 29
SERVICE
MANUAL
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.
Page 30
SERVICE
MANUAL
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
Page 31
SERVICE
MANUAL
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
Page 32
SERVICE
MANUAL
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:
Wave forms
Philips Monitor Label aligned value description
“TcpCO2” “TcpCO2” PCO2 analog value
“TcpO2” “TcpO2” PO2 analog value
Page 33
SERVICE
MANUAL
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.
Page 34
SERVICE
MANUAL
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
7650
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.
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.
Page 35
SERVICE
MANUAL
Example: 00 00
[00 >N ND]
$
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]
$
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)]
$
Page 36
SERVICE
MANUAL
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
Page 37
SERVICE
MANUAL
2.17 Accessories
Sensor
060 5000 COMBI•M sensor Type 82
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
Page 38
SERVICE
MANUAL
Attention, before using the connector adjacent to this symbol the instructions given in the
operating manual must be read.
Page 39
SERVICE
MANUAL
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:
Page 40
SERVICE
MANUAL
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
3.5 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.
Page 41
SERVICE
MANUAL
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.
4.2 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.
Page 42
SERVICE
MANUAL
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.
4.5 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
Page 43
SERVICE
MANUAL
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:
• 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.
Action
1. Check Monitor
2. Check Sensor
3. Check Consumables
The routine maintenance should be performed monthly according to the following procedure:
Page 44
SERVICE
MANUAL
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.
Page 45
SERVICE
MANUAL
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.
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.
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.
Page 46
SERVICE
MANUAL
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:
Page 47
SERVICE
MANUAL
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.
Page 48
SERVICE
MANUAL
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
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
Page 49
SERVICE
MANUAL
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
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
Page 50
SERVICE
MANUAL
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
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%.
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.
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)
Page 51
SERVICE
MANUAL
3. Screw in the gas bottle again. The central display changes back to the calibrating text and the
faulttone is muted.
Page 52
SERVICE
MANUAL
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
Page 53
SERVICE
MANUAL
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.
Page 54
SERVICE
MANUAL
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.
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.
Page 55
SERVICE
MANUAL
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.
Page 56
SERVICE
MANUAL
CLEARANCE CERTIFICATE
for the Inspection, Servicing, Repair or Return of Medical and Laboratory Equipment.
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
B. Please provide details of any hazards present as indicated above, include details of
names and quantities of agents as appropriate.
..........................................................................................................................
..........................................................................................................................
..........................................................................................................................
..........................................................................................................................
..........................................................................................................................
..........................................................................................................................
I declare that the above information is true and complete to the best of my knowledge and
belief.
Page 57
SERVICE
MANUAL
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.
Page 58
SERVICE
MANUAL
Page 59
SERVICE
MANUAL
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.
6.2 Case
Page 60
SERVICE
MANUAL
Page 61
SERVICE
MANUAL
6.6 Battery
Page 62
SERVICE
MANUAL
Page 63
SERVICE
MANUAL
7.1 Introduction
The following parts lists provide the component and assembly part numbers that may be used to
order spares and replacements.
Page 64
SERVICE
MANUAL
Page 65
SERVICE
MANUAL
Page 66
SERVICE
MANUAL
sheet 1 / 2
Page 67
SERVICE
MANUAL
sheet 2 / 2
Page 68
SERVICE
MANUAL
Page 69
SERVICE
MANUAL
Page 70
SERVICE
MANUAL
Page 71
SERVICE
MANUAL
Page 72
SERVICE
MANUAL
Page 73
SERVICE
MANUAL
Page 74
SERVICE
MANUAL
Page 75
SERVICE
MANUAL
Page 76
SERVICE
MANUAL
Page 77
SERVICE
MANUAL
Page 78
SERVICE
MANUAL
Page 79
SERVICE
MANUAL
Page 80
SERVICE
MANUAL
Page 81
SERVICE
MANUAL
Page 82
SERVICE
MANUAL
Page 83
SERVICE
MANUAL
Page 84
SERVICE
MANUAL
Page 85
SERVICE
MANUAL
Page 86
SERVICE
MANUAL
Page 87
SERVICE
MANUAL
Page 88
SERVICE
MANUAL
Page 89
SERVICE
MANUAL
Page 90
SERVICE
MANUAL
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.
Page 91
SERVICE
MANUAL
9 Circuit Diagrams
Page 92
SERVICE
MANUAL
Page 93
SERVICE
MANUAL
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
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
SERVICE
MANUAL
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
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
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
SERVICE
MANUAL
Page 98
SERVICE
MANUAL
9.6 Circuit Diagram of Floating PCB 7650 0823 Iss. 7 - sheet 1/2
Page 99
SERVICE
MANUAL
9.7 Circuit Diagram of Floating PCB 7650 0823 Iss. 7 - sheet 2/2
Page 100
SERVICE
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
Page 101
SERVICE
MANUAL
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
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
SERVICE
MANUAL
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
Page 103
SERVICE
MANUAL
Page 104
SERVICE
MANUAL
10.1 Introduction
To ship the monitor for any reason, follow the instructions in this section.
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.
Page 105
SERVICE
MANUAL
Page 106
SERVICE
MANUAL
11 Reporting Procedures
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.
Page 107
SERVICE
MANUAL
Page 108
SERVICE
MANUAL
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.
Page 109
SERVICE
MANUAL
Form:
F187 Entscheidungskriterien zur Meldepflicht bei einem Vorfall mit einem
medizinischen Gerät
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.
Page 110
SERVICE
MANUAL
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
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.
Page 111
SERVICE
MANUAL
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.
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):
Page 112
SERVICE
MANUAL
- 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.
- 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.
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.
Page 113
SERVICE
MANUAL
Distributors
Are responsible to consider and implement (as necessary) all the requirements of the TB
document.
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.
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)
Page 114
SERVICE
MANUAL
Annex A
Date:
Stamp:
Page 115
SERVICE
MANUAL
Annex B
Problem or
Subject: Identification of the problem or subject
Hazard associated with the product
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
Page 116
SERVICE
MANUAL
Annex C
Problem or
Subject: Identification of the problem or subject
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
Page 117
SERVICE
MANUAL
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
Page 118
SERVICE
MANUAL
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:
R & D Manager
QA Manager
Production Manager
Marketing Manager
SBKR: Date:
Page 119