Roche 91xx Service manual

91xx pH/Electrolyte Analyzers

Service Manual

Roche Diagnostics GmbH D-68298 Mannheim Germany www.roche-diagnostics.com

91xx pH/Electrolyte Analyzers

Version History

Edition notice

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

For more information, see:

Software on page G-5 Service Manual on page G-6

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.

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.

For the order numbers of replacement parts, refer to:

91xx pH/Electrolyte Analyzers Spare Part List

Roche Diagnostics April 2007 Service Manual · Version 2.0 3

Copyrights

Trademarks

91xx pH/Electrolyte Analyzers

For an overview of possible revisions and available software versions, see:

Software on page G-5 Service Manual on page G-6

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.

COBAS, LIFE NEEDS ANSWERS, ROCHE MICROSAMPLER, SNAPPAK, ISETROL are trademarks of Roche.

Contact addresses

Manufacturer

All other trademarks are the property of their respective owners.

Roche Diagnostics GmbH

D-68298 Mannheim / Germany

www.roche.com

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91xx pH/Electrolyte Analyzers

Ver s io n Hi s 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

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

4 Description of modules

Description of modules A-23 Mechanical assemblies A-23 Fluidic Module A-27 Electronics A-33

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

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

Roche Diagnostics April 2007 Service manual · Version 2.0 5

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

91xx pH/Electrolyte Analyzers

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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91xx pH/Electrolyte Analyzers

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

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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.

For more information about instructions, refer to:

9180 Electrolyte Analyzers Instructions for Use

For the order numbers of replacement parts, refer to:

91xx pH/Electrolyte Analyzers Spare Part List

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

Keep this Service manual in a safe place to ensure that it is not damaged and remains available for use.

This Service manual should be easily accessible at all times.

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:

o 91xx pH/Electrolyte Analyzers Instructions for Use o 9180 Electrolyte Analyzer Short Instruction o 91xx pH/Electrolyte Analyzers Service manual (PDF or iSDoc version in

GRIPS)

o 91xx pH/Electrolyte Analyzers Spare Part List (PDF or iSDoc version in

GRIPS)

Roche Diagnostics April 2007 Service manual · Version 2.0 9

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:

Symbol Used for

a Start of procedure o List item

h Call-up (software reference)

Cross-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)

91xx pH/Electrolyte Analyzers

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.

For more information about ESD protection measures, see ESD protection measures on page A-8.

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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 safetyrelated notes in the manual, accompanying this instrument.

Please consult instructions for use

Serial number (model plate)

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91xx pH/Electrolyte Analyzers

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.

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.

T: R23/33/50-53

N: S45/60/61/7

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.

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.

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

XI: R36/37/38, S 26-37

(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

CMOS Complementary Metal-Oxide Semiconductor

EEPROM Electrically erasable programmable read-only memory

e.g. exempli gratia – for example

EC European community

EN European standard

ESD Electrostatic Discharge

HIV Human Immunodeficiency Virus

HW Hardware

IEC International Electrical Commission

ISE Ion selective electrode

IVD In vitro Diagnostics

LCD Liquid Cristal Display

LED Light Emitting Diode

MC Measuring chamber

MOS Metal-Oxide Semiconductor

MSDS Material safety data sheet

PCB Printed Circuit Board

QC Quality control

REF Reference solution

SBC board Mainboard of the instrument

SW Software

TTL Transisitor-Transistor Logic

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91xx pH/Electrolyte Analyzers

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System Description

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

April 2007

91xx pH/Electrolyte Analyzers 1 Safety information

Tab l e o f c onte nt s

Safety information

In this chapter

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

Chapter

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Tab l e o f c onte nt s

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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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1 Safety information 91xx pH/Electrolyte Analyzers

Operating safety information

The instrument has been constructed and tested according to the following European Standards:

o IEC/EN 61010-1:2001 o IEC/EN 61010-2-101:2002 (valid for 9180 Electrolyte Analyzers SN > 12001 only) o IEC/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

o This instrument is classified under the protection class I according to

IEC/EN 61010-1.

o The instrument meets the conditions for overvoltage category II. o The instrument meets the conditions for contamination level 2. o Do not operate the instrument in an explosive environment or in the vicinity of

explosive anesthetic mixtures containing oxygen or nitrous oxide.

o If 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.

o The instrument is suitable for long-term operation indoors.

The power cord may be plugged into a grounded socket only. When using an extension cord, make sure it is properly grounded.

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.

The instrument is not suitable for operation with a direct current power supply. Use only the original mains plug delivered with the instrument.

Important notes and warnings

Never operate the analyzer in the vicinity of volatile or explosive gases (e.g. anesthetic gases, etc.)!

The instrument must be connected to a 2-pin, grounded socket.

The power cable and the plug must be undamaged. Damaged power cables and plugs must be replaced immediately.

Before opening the back panel switch off the instrument and disconnect the power cable.

Replace damaged fuses with the specified type of fuse.

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91xx pH/Electrolyte Analyzers 1 Safety information

Disinfectants

Service and repair work must be done only as specified in this manual. Unqualified service or repair work may result in warranty claims not being granted.

Use only suitable tools and test instruments for service and repair work.

Do not allow fluids to enter the interior of the instrument, because this may damage the electronics.

Use only slightly moistened cloths or cotton sticks to clean the instrument.

Disinfectants

Use only liquid disinfectant such as protein remover (Roche deproteinizer) or an alcohol-based (about 70%) surface disinfectant.

Do not spray disinfectant directly onto the instrument because this could cause malfunctions in the electronics.

Do not use any type of bleaching agent. Exception: Roche Deproteinizer.

Deproteinizer

Composition Aqueous NaOCl solution with active chlorine (≤ 2%)

Hazards identification Due to the basic and oxidizing character of the reagent ("Deproteinizer") local

First aid measures

Other disinfectants

Do not attempt to clean/decontaminate any part of the instrument before shutting it down and unplugging it from the power source.

Before plugging in the instrument again and switching it on always wait for 15 minutes to allow the disinfectant to evaporate.

irritations after contact with eyes, skin or mucous membranes cannot be excluded.

After inhalation: After skin contact: After eye contact: After drinking:

breath fresh air, drink large amounts of water

wash with generous amounts of water, remove contaminated clothing

rinse eyes with generous amounts of water, contact an eye specialist

drink large amounts of water, avoid vomiting, contact a doctor

Use standard alcohol-based (70%) disinfectants to clean the surface of the instrument. Read the product information first.

Never use standard disinfectant to clean the tubes and tubing paths under any circumstances!

Do not use any type of bleaching agent. Exception: Roche Deproteinizer.

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1 Safety information 91xx pH/Electrolyte Analyzers

ESD protection measures

ESD = Electrostatic Sensitive Device

Explanation of the phenomenon

The most frequent cause of electrostatic discharge is friction of various materials such as plastic, synthetic fiber, hard rubber or paper.

It can also be caused by bending or applying pressure to a material.

Discharges that are dangerous to components occur when "charged" bodies or components do not have a discharge connection (ground) to discharge the electrostatic charge.

The discharges normally do not have a high capacity, but there are often voltage differences in the range of several thousand volts. The discharges are perceived as small shocks or visible sparks.

Examples: o Shoes with rubber soles:

Friction is caused by walking. A person develops an electrical charge different from the ground. A discharge occurs when an object (e.g. door handle) is contacted.

o Synthetic fiber clothing:

Discharge is audible and is visible in darkness.

The dryer the air the greater the risk of electrical discharge caused by friction.

Eectrostatic charges are less likely to build up in humid air, particularly when saturated with water vapor.

The probability of ESD phenomena is therefore particularly great in a northern hemisphere winter in centrally heated rooms where the humidity is low.

Influence of electrostatic charges on components

If a person with an electrostatic charge touches a component, a discharge over a connection of an IC or semiconductor element may occur. The resulting voltages may damage the component.

Critical situations can occur while repairing or testing components if they are lying on a more or less conductive surface (e.g. table top) and a person with an electrostatic charge touches them. A discharge through a critical component connection can also occur in this case.

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91xx pH/Electrolyte Analyzers 1 Safety information

ESD protection measures

Why is ESD protection so important today?

Formerly, current controlling semiconductors were mostly used (TTL, normal transistors, etc.).

Today the principle of current logic is virtually the only technology in use in MOS and CMOS components.

Currents generated by an electrostatic discharge (as much as several kV!) destroy the sensitive component inputs or cause hidden damage. This damage is generally not immediately detectable.

Another effect is that the clearances inside the ICs continuously become smaller. The internal wires become thinner and thinner, the allowable maximum input voltages become smaller and the effects of any discharges become more and more critical.

How can ESD protection be guaranteed?

A continuous discharge is required when working on an electronic assembly. Do this as follows:

o Use ESD wrist bands (special wrist bands connected to a protective ground). o Repairs and tests on assemblies must only be conducted on tables with ESD mats

connected to grounds or ESD wrist bands.

o Always pick up components at the edge (e.g. like a photo). o Components must always be transported in ESD packages or appropriate storage

or shipping containers (use original packaging!).

o Shoes with rubber soles or clothing of synthetic fibers must not be worn in

workshops where electronic components are repaired.

o Use a humidifier if necessary to maintain optimum humidity in the work area. o Do not touch assemblies or components with the hand after testing. o Always transport and ship assemblies or components for repair in ESD protective

packaging only. This will prevent further damage that may result in misinterpretation of the original cause of the fault.

The ESD mat consists of materials that have a very low, defined conductivity (1012 ohms). The following materials prevent charges caused by friction from building up and protect the component from damage.

ESD mats

ESD packages

Shipping containers

Conclusion

Of course, not all circuit boards and electronic assemblies require such careful handling. An electrical board that only carries simple plug connectors does not require ESD packaging.

In cases of doubt always use ESD packaging.

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ESD protection measures

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91xx pH/Electrolyte Analyzers 2 Specifications

Tab l e o f c onte nt s

Specifications

In this chapter

Specifications .............................................................................................................A-13

Specifications .......................................................................................................A-13

9110 ................................................................................................................A-13

9120/9130/9140/9180/9181 ...........................................................................A-13

Operating Parameters .........................................................................................A-13

9110 ................................................................................................................A-13

9120/9130/9140/9180/9181 ...........................................................................A-14

Common operating parameter .....................................................................A-14

Classifications ......................................................................................................A-15

Product data ...................................................................................................A-15

Approvals .......................................................................................................A-15

Chapter

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Tab l e o f c onte nt s

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91xx pH/Electrolyte Analyzers 2 Specifications

Specifications

9110

Sample types Whole blood, Serum, Plasma, QC solutions

Reported parameters Measuring range Resolution

pH 6.00 - 8.00 0.001 pH units

Ta b le A -1 9110 reported parameters

9120/9130/9140/9180/9181

Sample types Whole blood, Serum, Plasma

Reported parameters Measuring range Resolution

Sodium (Na+) 40 - 205 mmol/L 0.1 mmol/L

Potassium (K

Chloride (Cl

Calcium (Ca

Lithium (Li

Ta b le A -2 9120, 9130, 9140, 9180, 9181 reported parameters (1)

Sample type Urine

Reported parameters Measuring range Resolution

Sodium (Na+) 1 - 300 mmol/L 1.0 mmol/L

Potassium (K

Chloride (Cl

Ta b le A -3 9120, 9130, 9140, 9180, 9181 reported parameters (2)

Calcium and Lithium are not measured in urine samples.

Lithium is not measured in dialysate samples.

) 1.5 - 15 mmol/L

(0.8 - 15 mmol/L dialysate)

–

) 50 - 200 mmol/L 0.1 mmol/L

) 0.2 - 5.0 mmol/L 0.01 mmol/L

) 0.1 - 6.0 mmol/L 0.001 mmol/L

) 4.5 - 120 mmol/L

(60 - 120 mmol/L with add. dilution)

–

) 1 - 300 mmol/L 1.0 mmol/L

0.01 mmol/L

0.1 mmol/L

Operating Parameters

9110

Sample types Whole blood, serum, plasma, aqueous and QC solutions

Sample device Syringe, sample cup, capillary, Roche MICROSAMPLER

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2 Specifications 91xx pH/Electrolyte Analyzers

Specifications

Sample size 25 μL

Analysis time 70 seconds

Sample rate o 40 per hour with printout

o 50 per hour without printout

pH Sensor pH sensitive flow-through glass capillary electrode in transparent acrylic plastic

Reference System Open liquid junction, flow-through electrode

Calibration o Fully automatic

o 1 point with each sample o 2 point every 3 hours

Warm-up t ime 10 minutes

9120/9130/9140/9180/9181

Sample types Whole blood, serum, plasma, urine, dialysate (acetate or bicarbonate)

Sample device Syringe, sample cup, capillary, Roche MICROSAMPLER

Sample size 95 μL

Analysis time 50 seconds

Sample rate o 45 per hour with printout

o 60 per hour without printout

Sodium (Na

Potassium (K

Chloride (Cl

Calcium (Ca

Lithium (Li

) sensor Ion-selective, flow-through, glass capillary electrode

) sensor Ion-selective, flow-through, liquide membrane electrode

–

) sensor Ion-selective, flow-through, liquide membrane electrode

Reference system Open liquid junction, flow-through electrode

Calibration o Fully automatic

o 1 point with each sample o 2 point every 3 hours (9180/9181 every 4 hours)

Warm-up t ime 10 minutes

Common operating parameter

Standby mode Suspends calibrations

Te mp e ra t ur e Room temperature, 15 - 32°C, 60 - 90 °F

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91xx pH/Electrolyte Analyzers 2 Specifications

Specifications

Humidity maximum 85 % relative humidity, non-condensing

Data management Quality control memory storage, 3 levels, 35 values; calculation of mean, standard

deviation and coefficien of variation (CV)

Diganostic programs user-controlled diagnostics, YES/NO operation via the display

Electronics Microprocessor-controlled

Display LCD dot-matrix, 2 lines, 16 characters per line

Printer Integral thermal printer, 16 characters width

Autosampler (9181 only) Integral turntable, 18 positions, 2 mL or 0.25 mL sample cups

Interface RS232C serial port

DataLink Data link to COMAPCT 2/3 (9180/9181)

Electrical requirements 100 - 240 VAC, 50/60 Hz (90 - 250 VAC for 9110), self adjusting

Nominal power consumption 50 W

Dimensions

Classifications

Product data

Safety category I

Device type B (according to ÖVE-MG/EN 60601-1,

Mode of operation continuous operation

Protection classification IP 20

Height 335 mm (12.2")

Width 315 mm (12.4")

Depth 295 mm (12.0")

Weight approx. 6 kg (13 lbs)

Ta b le A -4 Instrument dimensions

IEC 601-1)

Explosion protection the device is not designed for operation in explosive environments.

Approvals

CSA, CE, FCC Class B

CLIA Complexity Category: Moderate

Test System Code: 04739

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2 Specifications 91xx pH/Electrolyte Analyzers

Specifications

FDA 510(k) numbers: K932642 (9110)

K961458 (9180)

K972673 (9181)

Analyte Codes: Na

Special requirements for IVD

products

: 5805

: 4910

–

: 1018

: 1004

: 3712

EN 61010-2: 2001-12

EN 61010-2: 2002-01

(9180 SN > 12001 only)

Data subject to change without notice. Technical information is supplied for general informational purposes only!

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