Roche 91 Series User manual

91xx pH/Electrolyte Analyzers
Service Manual

COBAS
is a trademark of Roche.
©2007 Roche Diagnostics
Roche Diagnostics GmbH
D-68298 Mannheim
Germany
www.roche-diagnostics.com

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91xx pH/Electrolyte Analyzers
Version History
e For more information, see:
Software on page G-5
Service Manual on page G-6
Edition notice
91xx pH/Electrolyte Analyzers
Service Manual
This Service Manual is for the maintenance and repair of 91xx pH/Electrolyte
Analyzers (9110 pH Analyzers and 9120, 9130, 9140, 9180 and 9181 Electrolyte
Analyzers).
91xx pH/Electrolyte Analyzers Every effort has been made to ensure that all the information contained in this
manual is correct at the time of printing. However, Roche Diagnostics GmbH reserves
the right to make any changes necessary without notice as part of ongoing product
development.
Any customer modification to the instrument will render the warranty or service
agreement null and void.
Software updates are done by Roche Service representatives.
9180 Electrolyte Analyzers SN > 12001 are IVD compliant.
Intended use
This manual contains all of the information required for maintenance and repair of
91xx pH/Electrolyte Analyzers (9110 pH Analyzers and 9120, 9130, 9140, 9180 and
9181 Electrolyte Analyzers).
The user must be familiar with the function and operation of the instrument to fully
understand the processes described here.
e For more information about 91xx pH/Electrolyte Analyzers, refer to corresponding
Instructions for Use.
Observe the service and repair procedures described in this manual and use only
genuine Roche replacement parts and Roche-approved materials to guarantee the full
functionality of the 91xx pH/Electrolyte Analyzers.
e For the order numbers of replacement parts, refer to:
91xx pH/Electrolyte Analyzers Spare Part List
Manual Version Software Version Version date Changes
1.0 n/a July 2004 First edition
2.0 n/a April 2007 New template
Language Order Number
English 03077063001

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4Service Manual · Version 2.0
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e For an overview of possible revisions and available software versions, see:
Software on page G-5
Service Manual on page G-6
Copyrights
© 2007 Roche Diagnostics GmbH, All rights reserved.
The contents of this document may not be reproduced in any form or communicated
to any third party without the prior written consent of Roche Diagnostics. Every
effort is made to ensure its correctness. Subject to change without notice.
Trademarks
COBAS, LIFE NEEDS ANSWERS, ROCHE MICROSAMPLER, SNAPPAK, ISETROL
are trademarks of Roche.
All other trademarks are the property of their respective owners.
Contact addresses
Manufacturer Roche Diagnostics GmbH
D-68298 Mannheim / Germany
www.roche.com

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Contents
Ver sion His to r y 3
Edition notice 3
Intended use 3
Copyrights 4
Trademarks 4
Contact addresses 4
Contents 5
Preface 9
How to use this manual 9
Where to Find Information 9
Conventions used in this manual 10
System Description Part A
1 Safety information
Important information A-5
Operating safety information A-6
Important notes and warnings A-6
Disinfectants A-7
Deproteinizer A-7
Other disinfectants A-7
ESD protection measures A-8
Explanation of the phenomenon A-8
Influence of electrostatic charges on components A-8
Why is ESD protection so important today? A-9
How can ESD protection be guaranteed? A-9
Conclusion A-9
2 Specifications
Specifications A-13
Specifications A-13
Operating Parameters A-13
Classifications A-15
3 Interface specifications
Interface specifications A-19
Interface information A-19
Example data string information A-20
Data Link Information (9180/9181 only) A-20
4 Description of modules
Description of modules A-23
Mechanical assemblies A-23
Fluidic Module A-27
Electronics A-33
5 Electronic diagrams
Electronic diagrams A-39
9110 analyzer block diagram A-39
9120, 9130, 9140, 9180 analyzer block diagram A-40
9181 analyzer block diagram A-41
System interconnect - 9110, 9120, 9130, 9140 A-42
SBC PCB - power supply - 9110, 9120, 9130, 9140
A-43
SBC PCB - valve drivers - 9110, 9120, 9130, 9140
A-44
SBC PCB - pump motor driver / door detect - 9110,
9120, 9130, 9140 A-45
SBC PCB - input amplifiers - 9110, 9120, 9130, 9140
A-46
SBC PCB - temperature circuit - 9110, 9120, 9130,
9140 A-47
SBC PCB - analog selector and A/D converter - 9110,
9120, 9130, 9140 A-48
SBC PCB - microprocessor - 9110, 9120, 9130, 9140
A-49
SBC PCB - printer display drivers - 9110, 9120, 9130,
9140 A-50
Printer daughter PCB - 9110, 9120, 9130, 9140, 9180,
9181 A-51
Lamp PCB - 9110, 9120, 9130, 9140 A-52
Display daughter PCB - 9110 A-53
Preheater PCB - 9110 A-54
Display daughter PCB - 9120, 9130, 9140 A-55
System interconnect - 9180, 9181 A-56
SBC PCB - power supply - 9180, 9181 A-57
SBC PCB - valve drivers - 9180, 9181 A-58
SBC PCB - pump motor driver/door detect - 9180,
9181 A-59
SBC PCB - input amplifier - 9180, 9181 A-60
SBC PCB - temperature circuit - 9180, 9181 A-61
SBC PCB - analog selector and A/D converter - 9180,
9181 A-62
SBC PCB - microprocessor - 9180, 9181 A-63
SBC PCB - microprocessor - 9180, 9181 A-64
SBC PCB - Fluid pack detector - 9180, 9181 A-65
Lamp PCB - 9180, 9181 A-66
Display daughter PCB - 9180 A-67
Software operation Part B
6 Software operation 9110
Software operation 9110 B-5
Overview B-5
Overall program operation flow B-6
Main menu B-7
Measurement sequence B-8
Print functions menu B-9
QC sample menu B-10
Daily maintenance menu B-11
Operator functions menu B-12
Program instrument menu B-13

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Service functions menu B-14
Calibration sequence B-15
7 Software operation 9120, 9130, 9140
Software operation 9120, 9130, 9140 B-19
Overview B-19
Overall program operating flow B-20
Main menu B-21
Measurement sequence B-22
Print functions menu B-23
QC/standard/urine sample menu B-24
Daily maintenance menu B-25
Operator functions menu B-26
Program instrument menu B-27
Service functions menu B-28
Calibration sequence B-29
8 Software operation 9180
Software operation 9180 B-33
Overview B-33
Overall program operation flow B-34
Main menu B-35
Measurement sequence B-36
Print functions menu B-37
QC/standard/dialysate/urine sample menu B-38
Daily maintenance menu B-39
Operator functions menu B-40
Program instrument menu B-41
Service functions menu B-42
Calibration sequence (1) (Example Na/K/Li
calibration) B-43
Calibration sequence (2) (Example Na/K/Li
calibration) B-44
Power-up B-45
9 Software operation 9181
Software operation 9181 B-49
Overview B-49
Overall program operting flow B-50
Main menu B-51
Manual measurement sequence B-52
Automated measurement sequence B-53
Print functions menu B-54
QC/std/dialysate/urine sample menu B-55
Daily maintenance menu B-56
Operator functions menu B-57
Program instrument menu B-58
Service functions menu B-59
Calibration sequence (1) (example Na/K/Li
calibration) B-60
Calibration sequence (2) (example Na/K/Li
calibration) B-61
Power-up sequence B-62
10 Service functions
Service functions B-65
TEST ELECTRODES B-65
TEST SAMPLE SENSOR B-65
TEST SnapPak SENSOR (9180 and 9181 only) B-65
TEST LANGUAGE SWITCH (9180 and 9181 only)
B-65
TEST SAMPLE DOOR (except 9181) B-66
TEST PROBE (9181 only) B-66
TEST AUTOSAMPLER (9181 only) B-66
TEST PUMP B-66
TEST PINCH VALVES B-67
TEST INTERFACE B-67
TEST AMPLIFIER B-67
ENTER SERVICE CODE B-67
Miscellaneous functions B-69
Maintenance Part C
11 Adjustments
Adjustments C-5
Sample contacts adjustment (9110 only) C-5
Sample sensor adjustment (9120/9130/9140/9180/
9181 only) C-5
Temperature Adjustment (9110/9140/9180/9181
only) C-6
12 Maintenance
Maintenance C-9
Daily maintenance C-9
Weekly maintenance C-9
Monthly maintenance C-9
Six month maintenance C-9
Annual preventive maintenance C-9
Troubleshooting Part D
13 Troubleshooting
Error messages and troubleshooting D-5
Status-LEDs D-5
STATUS: NOT CALIBRATED D-5
STANDARD A NOT DETECTED D-5
STANDARD B NOT DETECTED, STANDARD C
NOT DETECTED (9180/9181 only) D-6
CHECK SAMPLE CONTACTS(9110), CHECK
SAMPLE SENSOR (9120/30/40/80/81) D-6
CHECK REFERENCE HOUSING D-7
PLEASE CLOSE SAMPLE DOOR (except 9181) D-7
NO SAMPLE D-8
CLEANING FLUID NOT DETECTED D-8
CONDITIONING FLUID NOT DETECTED (except
9110) D-8
INTERFACE ERROR D-9

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PAPER JAM OR PRINTER DEFECT D-9
CHECK ELECTRODES D-9
## NOT CAL’D D-9
CLOG IN SAMPLE PATH (9110 only), CLOG
CHECK FLUID PATH (except 9110) D-11
↑↑↑↑ ↓↓↓↓ (Out of range) D-11
↑ ↓ (Temparature out of range) D-11
ERR D-12
PERFORM DAILY MAINTENANCE (except 9110)
D-12
REPLACE FLUID PACK D-12
CHECK TEMPERATURE (9140/9180/9181 only)
D-12
VALVE OVERTEMP! CHECK VALVES D-13
ERROR: UPPER NEEDLE SENSOR D-13
ERROR: LOWER NEEDLE SENSOR D-13
WHEEL MISSING OR SAMPLER DEFECT D-13
SAMPLER JAMMED OR DEFECTIVE D-14
Glossary Part E
Glossary E-3
Index Part F
15 Index
Versions Part G
16 Versions
Software G-5
Service Manual G-6
Version 1.0 G-6
Version 2.0 G-6

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91xx pH/Electrolyte Analyzers
Preface
This manual contains all of the information required for the maintenance and repair
of the 91xx pH/Electrolyte Analyzers.
The user must be familiar with the function and operation of the instrument to fully
understand the processes described here.
e For more information about instructions, refer to:
9180 Electrolyte Analyzers Instructions for Use
Observe the service and repair procedures described in this manual and use only
genuine Roche replacement parts and Roche-approved materials to guarantee the full
functionality of the 91xx pH/Electrolyte Analyzers.
e For the order numbers of replacement parts, refer to:
91xx pH/Electrolyte Analyzers Spare Part List
e For an overview of possible revisions and available software versions, see:
Software on page G-5
Service Manual on page G-6
How to use this manual
To help finding information quickly, there is a table of contents at the beginning of
the book and each chapter. In addition, a complete index can be found at the end.
Where to Find Information
In addition to the Service manual, the following documents are also provided to assist
in finding desired information quickly:
o91xx pH/Electrolyte Analyzers Instructions for Use
o9180 Electrolyte Analyzer Short Instruction
o91xx pH/Electrolyte Analyzers Service manual (PDF or iSDoc version in
GRIPS)
o91xx pH/Electrolyte Analyzers Spare Part List (PDF or iSDoc version in
GRIPS)
o Keep this Service manual in a safe place to ensure that it is not damaged and remains available
for use.
o This Service manual should be easily accessible at all times.

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Conventions used in this manual
Visual cues are used to help locate and interpret information in this manual quickly.
This section explains formatting conventions used in this manual.
Symbols The following symbols are used:
For more information about ESD protection measures, see ESD protection measures
on page A-8.
Symbol Used for
aStart of procedure
oList item
e
Cross-reference
hCall-up (software reference)
Note
All sections or text locations marked with "NOTE" describe safe
procedures that are intended to provide the user with additional help.
Caution
All sections or text passages that are marked with this symbol describe
procedures or indicate conditions or dangers that could damage or
lead to malfunctions in the instrument, and which therefore should
never be attempted.
Warning
Sections marked with this symbol contain information that must be
observed for the prevention of personal injury (to patients, users or
third parties).
Risk of infection!
(according to the standard DIN EN 61010-2-101:2002) (Instrument)
Risk of infection!
(according to the standard DIN ISO 15223-1:2005) (Consumables)
High Voltage
Passages that are marked with this symbol warn of an immediate
danger in connection with electrical wiring or components.
ESD protection measures
All sections or passages that are marked with this symbol warn of
specific dangers in connection with static discharge. Packages that are
marked with this symbol must only be opened by trained technical
staff.

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IVD symbols Instruments: applicable for 9180 Electrolyte Analyzers SN > 12001.
The IVD symbols are used in accordance with DIN EN 980:2003, ISO 15223:2000 (as
per the In Vitro Diagnostics Directive 98/79/EC), and DIN EN ISO 780:1997.
Symbol Description
This product complies with the requirements in the directive
98/79/EC on in vitro diagnostic medical devices.
Lot designation
Consumables: use by... (expiry date)
The consumables must be completely consumed by the indicated
date.
If a day is not indicated, apply the last day of the respective month.
Store at ...
The conditions necessary to preserve the product's shelf life before
opening.
For in vitro diagnostic use
"Grüner Punkt" (in Germany)
Manufacturer — according to directive 98/79/EC on in vitro
diagnostic medical devices
Store upright
Risk of infection!
(according to the standard DIN ISO 15223-1:2005) (Consumables)
Catalogue number
Caution (refer to accompanying documents). Please refer to safety-
related notes in the manual, accompanying this instrument.
Please consult instructions for use
Serial number (model plate)

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Other symbols The following symbols are listed as additional information:
Symbol Description
Electrodes:
This date indicates the limit of the maximum storage time of an
electrode. The electrode must be installed in the instrument no later
than the imprinted date.
If the installation takes place on the imprinted date, it still falls within
the specifications. The calculation of the “Install before” date is based
on the production date of the elctrode.
T: R23/33/50-53
Danger symbol: T: Toxic (on the packaging of the reference electrode)
Rating: Inhalation, swallowing or skin contact with even small
quantities can lead to serious health risks, including fatal risks.
Characteristics of this type of item are severe, possible irreversible
damage to health through repeated or prolonged contact, particular
with carcinogenic, genetic or reproductive (danger to reproductive
capabilities) effects.
Caution: Avoid any contact with the human body. If you feel unwell,
contact a doctor immediately. Any substances with carcinogenic,
genetic or reproductive dangers are indicated appropriately. Always
observe the regulations when handling such substances.
N: S45/60/61/7
Danger symbol: N: Dangerous to the environment (on the packaging
of the reference electrode)
Rating: If released into aquatic and non aquatic environments, can
cause immediate or delayed damage to ecosystems through a change
in environmental conditions.
These substances or their by-products can cause simultaneous
damage to sensitive environmental areas.
Caution: Depending on the potential for damage, do not allow the
substance to enter sewers, soils or the environment. Observe the
specific disposal regulations.
XI: R36/37/38, S 26-37
Danger symbol: Xi: Irritant
Rating: Although not corrosive, momentary, longer-lasting, or
repeated contact with skin or mucous membrane may result in
inflammation. Danger of sensitization during contact with skin
(when classified with R 43).
Caution: Avoid contact with eyes and skin, do not inhale vapors.
Do not use content if the packaging is damaged
Protective gloves, protective goggles and suitable protective clothing
must be worn

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Abbreviations The following abbreviations are used:
Abbreviation Definition
A
ADC Analogue to digital converter
ANSI American National Standards Institute
C
CMOS Complementary Metal-Oxide Semiconductor
E
EEPROM Electrically erasable programmable read-only memory
e.g. exempli gratia – for example
EC European community
EN European standard
ESD Electrostatic Discharge
H
HIV Human Immunodeficiency Virus
HW Hardware
I
IEC International Electrical Commission
ISE Ion selective electrode
IVD In vitro Diagnostics
L
LCD Liquid Cristal Display
LED Light Emitting Diode
M
MC Measuring chamber
MOS Metal-Oxide Semiconductor
MSDS Material safety data sheet
P
PCB Printed Circuit Board
Q
QC Quality control
R
REF Reference solution
S
SBC board Mainboard of the instrument
SW Software
T
TTL Transisitor-Transistor Logic

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April 2007
1 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
2 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11
3 Interface specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-17
4 Description of modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21
5 Electronic diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-37
System Description A

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Ta b le o f c o n te n t s
Safety information
Important information ...............................................................................................A-5
Operating safety information .....................................................................................A-6
Important notes and warnings ...................................................................................A-6
Disinfectants ................................................................................................................A-7
Deproteinizer .........................................................................................................A-7
Other disinfectants ................................................................................................A-7
ESD protection measures ............................................................................................A-8
Explanation of the phenomenon ..........................................................................A-8
Influence of electrostatic charges on components ...............................................A-8
Why is ESD protection so important today? ........................................................A-8
How can ESD protection be guaranteed? .............................................................A-9
Conclusion .............................................................................................................A-9
In this chapter Chapter 1

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Ta b le o f c o n te n t s

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Important information
Important information
This Service Manual contains vital warning and safety information.
This instruments are intended to be used only for the specialized purpose described
in the instructions. The most important prerequisites for use, operation, and safety
are explained to ensure smooth operation. No warranty or liability claims will be
covered if the instrument is used in ways other than those described or if the
necessary prerequisites and safety measures are not observed.
The instrument may be operated only by persons whose qualifications enable them to
comply with the safety measures that are necessary during operation of the
instrument.
Suitable protective equipment, like laboratory clothing, protective gloves, protective
goggles and if necessary mouth protectors, must be worn to prevent direct contact
with biological working materials. In addition, a face mask is required if there is a
risk.
Adjustments and maintenance performed with removed covers and connected power
may be attempted only by a qualified technician who is aware of the associated
dangers.
Instrument repairs are to be performed only by the manufacturer or qualified service
personnel.
Only accessories and supplies either delivered by or approved by Roche are to be used
with the instrument. These items are manufactured especially for use with this
instrument and meet the highest quality requirements.
Operation of the instrument with solutions whose composition is not consistent with
that of the original solutions can negatively affect, above all, the long term
measurement accuracy. Deviations in the composition of the solutions can also
decrease the service life of the electrodes.
The quality control requirements must be completed at least once daily for safety
reasons. Because accurate measurement results depend not only on the proper
functioning of the instrument, but also on a number of other factors (such as
preanalytics), the results produced by the instrument should be examined by a
trained expert before subsequent decisions are reached that are based on the
measurement values.
Explanation:
"Caution, refer to accompanying documents“

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Operating safety information
Operating safety information
The instrument has been constructed and tested according to the following European
Standards:
oIEC/EN 61010-1:2001
oIEC/EN 61010-2-101:2002 (valid for 9180 Electrolyte Analyzers SN > 12001 only)
oIEC/EN 61010-2-081:2002 + A1:2003
It was delivered from the factory in flawless condition with regards to safety features.
In order to preserve this condition and ensure safe operation, the user must respect
the notices and warnings that are contained in this Service Manual
oThis instrument is classified under the protection class I according to
IEC/EN 61010-1.
oThe instrument meets the conditions for overvoltage category II.
oThe instrument meets the conditions for contamination level 2.
oDo not operate the instrument in an explosive environment or in the vicinity of
explosive anesthetic mixtures containing oxygen or nitrous oxide.
oIf an object or liquid enters the internal areas of the instrument, remove the
instrument from its power supply and allow an expert to check it thoroughly
before using it again.
oThe instrument is suitable for long-term operation indoors.
Important notes and warnings
o The power cord may be plugged into a grounded socket only. When using an extension cord,
make sure it is properly grounded.
o Any rupture of the ground lead inside or outside the instrument or a loose ground connection
may result in hazardous operating conditions. Intentional disconnection of the grounding is not
permitted.
o The instrument is not suitable for operation with a direct current power supply. Use only the
original mains plug delivered with the instrument.
o Never operate the analyzer in the vicinity of volatile or explosive gases
(e.g. anesthetic gases, etc.)!
o The instrument must be connected to a 2-pin, grounded socket.
o The power cable and the plug must be undamaged. Damaged power cables and plugs must be
replaced immediately.
o Before opening the back panel switch off the instrument and disconnect the power cable.
o Replace damaged fuses with the specified type of fuse.