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9180 Electrolyte Analyzer

Instructions for Use

©2013 Roche
Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
www.roche.com

9180 Electrolyte Analyzer

Revision history
Manual Version

Software Version

Revision date

1.0

April 2004

2.0

April 2005

3.0

January 2007

4.0

April 2007

5.0

March 2008

6.0

March 2012

7.0 (not published)

February 2013

7.1

July 2013

Changes

Edition notice
9180 Electrolyte Analyzer
Every effort has been made to ensure that all the information contained in this
manual is correct at the time of publishing. 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.

Copyrights
© 2013, 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.
While every effort is made to ensure its correctness, Roche assumes no responsibility
for errors or omissions which may appear in this document.
Subject to change without notice.

Brands
ROCHE MICROSAMPLER, SNAPPAK, ISETROL are trademarks of Roche.

Roche
Instructions for Use · Version 7.1

July 2013
3

1.1 . 0 4381092001 Local Service Contact Roche 4 July 2013 Instructions for Use · Version 7. July 2013 First edition: April 1996 REF/No.9180 Electrolyte Analyzer Contact addresses Manufacturer Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany Edition Version 7.

1 A-33 A-36 A-40 A-46 10 Troubleshooting Troubleshooting Service functions Service codes Deleting data E-5 E-9 E-14 E-16 July 2013 5 .9180 Electrolyte Analyzer Table of contents Revision history Edition notice Copyrights Brands Contact addresses Edition Local Service Contact Table of contents Preface How to use this manual Conventions used in this manual Introduction and specifications 3 3 3 3 4 4 4 5 7 7 7 Part A 1 Safety information Important information Operating safety information A-5 A-6 2 General description Introduction Measurement and calibration procedures Measurement evaluation Important safety instructions Standby mode Part B 5 System components System description Operation B-5 Part C 6 Installation and Shutdown Installation Shutdown C-5 C-18 7 Measurement Preanalytics Interference Limitations of clinical analysis Measuring procedure Normal ranges (reference values) Correlation factors Additional settings A-9 A-10 A-11 A-11 A-13 8 Quality control A-17 A-21 A-23 A-23 Maintenance 3 Specification Performance parameters Linearity Interferences Limitations Relationship of ionized calcium to total calcium Bibliography Sample throughput Sample volumes Sample types Calibrations Environmental parameters Product data Printer Display System components Quality control Material setup Performing a QC measurement Printing a QC report C-25 C-29 C-33 C-34 C-38 C-39 C-41 C-45 C-46 C-48 C-49 Part D 9 Maintenance A-24 A-24 A-25 A-25 A-25 A-25 A-26 A-29 A-29 A-29 Maintenance Disinfection Daily maintenance Weekly maintenance Monthly maintenance Semi annual maintenance Annual maintenance Unscheduled maintenance Troubleshooting D-5 D-5 D-6 D-8 D-10 D-13 D-14 D-15 Part E 4 Theoretical foundation Reference and critical values Principles of Operation Electrode specifications Calibration procedure Roche Instructions for Use · Version 7.

9180 Electrolyte Analyzer Appendix Part F 11 Appendix Description of reports Specifications of the solutions Program flow chart Maintenance schedule Order information Glossary Index F-5 F-7 F-8 F-9 F-10 F-13 Part G Index Roche 6 July 2013 Instructions for Use · Version 7.1 .

specification functions and use of controls. Roche Instructions for Use · Version 7. o This Instructions for Use should be easily accessible at all times. Symbols The following symbols are used: Symbol Used for a Start of procedure o List item e Cross-reference h Call-up (software reference) Tip Attention All sections / passages that are marked with this symbol describe procedures and/or indicate conditions or dangers that could damage or lead to a malfunction in the 9180 Electrolyte Analyzer. Conventions used in this manual Visual cues are used to help locate and interpret information in this manual quickly. there is a table of contents at the beginning of the book and each chapter. product labeling and maintenance procedures. accurately and efficiently conduct basic electrolyte testing in the convenience of the laboratory. operating techniques. In addition.9180 Electrolyte Analyzer Preface The 9180 Electrolyte Analyzer is a powerful tool designed to quickly. users and third parties). To help you find information quickly. a complete index can be found at the end. Warning Sections marked with this symbol contain information that must be observed to avoid potential injuries (to patients. This section explains formatting conventions used in this manual. How to use this manual o Keep this Instructions for Use in a safe place to ensure that it is not damaged and remains available for use.1 July 2013 7 . emergency procedures. This manual has detailed descriptions of 9180 Electrolyte Analyzer features and general operational concepts.

Serial number (model plate) Do not use if package damaged. (expiry date) The product should not be used after expiry of the specified date. Batch code Consumables: use by. Packaging with this label may be opened by trained personnel only. Valid only for Roche MICROSAMPLER PROTECT: Method of sterilization using ethylene oxide (a) DIN EN ISO 15223-1: Medical devices .Symbols to be used with medical device labels. ESD protective measures All sections / text passages that are marked with this symbol refer to components that require special care with respect to electrostatic discharges.1 . In Vitro Diagnostic Medical Device Manufacturer (according to In Vitro Diagnostic guidelines 98/79/EG) Catalogue number Caution. consult accompanying documents.. apply the last day of the respective month.Part 1: General requirements (b) DIN EN ISO 780: Packaging ..9180 Electrolyte Analyzer Symbol Used for Risk of infection! All sections and parts of texts that are marked with this symbol describe procedures that may involve risk of infection. IVD symbols The symbols are used in accordance with DIN EN ISO 15223-1(a) and DIN EN ISO 780(b). Symbol Description Conformité Européenne: This product complies with the requirements in the guideline for In Vitro Diagnostic 98/79/EC. Consult Instructions for Use. Temperature limitation The conditions necessary to preserve the product's shelf life before opening.Pictorial marking for the handling of goods Roche 8 July 2013 Instructions for Use · Version 7. If a day is not indicated. labelling and information to be supplied .

particularly with carcinogenic. soils or the environment. These substances or their by-products can cause substantial damage to sensitive environmental areas. do not inhale vapors. Danger symbol: T: Toxic (on the packaging of the reference electrode). do not allow the substance to enter sewers. Observe the specific disposal regulations.(Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment) (b) DIN EN 980: Symbols for use in the labelling of medical devices Other symbols The following symbols are listed as additional information: Symbol Description Danger symbol: Xi: Irritant.1 July 2013 9 . Characteristics of this type of item are severe. Caution: Depending on the potential for damage. Any substances with carcinogenic. If you feel unwell. control. and laboratory use . Caution: Avoid contact with eyes and skin. N: S45/60/61/7 Rating: If released into aquatic and non aquatic environments. Danger of sensitization during contact with skin (when classified with R 43). Danger symbol: N: Dangerous to the environment (on the packaging of the reference electrode). genetic or reproductive (danger to reproductive capabilities) effects. Always observe the regulations when handling such substances.9180 Electrolyte Analyzer Symbol Description Valid only for BS2 Blood Sampler: Method of sterilization using irradiation Biological risk! (according to the standard EN 61010-2-101(a)) (Instrument) Biological risk! (according to the standard DIN EN 980(b)) (Consumables) (a) IEC/EN 61010-2-101: Safety requirements for electrical equipment for measurement. S26-37 Rating: Although not corrosive. including fatal risks. or repeated contact with skin or mucous membrane may result in inflammation. momentary. can cause immediate or delayed damage to ecosystems through a change in environmental conditions. longer-lasting. swallowing or skin contact with even small quantities can lead to serious health risks. Caution: Avoid any contact with the human body. Store upright Roche Instructions for Use · Version 7. Xi: R36/37/38. contact a doctor immediately. T: R23/33/50-53 Rating: Inhalation. genetic or reproductive dangers are indicated appropriately. possibly irreversible damage to health through repeated or prolonged contact.

Roche 10 July 2013 Instructions for Use · Version 7.1 . protective goggles and suitable protective clothing must be worn.9180 Electrolyte Analyzer Symbol Description "Grüner Punkt" (in Germany) Protective gloves.

. . . . . . . . . . . . . . A-7 3 Specification . . . . . . . . . . . . . . . . . A-3 2 General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-31 July 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Introduction and specifications A 1 Safety information . . . A-15 4 Theoretical foundation . .

.

... In this chapter Chapter 1 Important information . trouble-free operation of the instrument and must be read and understood by the user...................9180 Electrolyte Analyzer 1 Safety information Table of contents Safety information The information provided in this chapter is essential for the safe.........1 July 2013 A-3 ................... A-5 Operating safety information .................................................................................................................................. A-6 Roche Instructions for Use · Version 7............

1 .1 Safety information 9180 Electrolyte Analyzer Table of contents Roche A-4 July 2013 Instructions for Use · Version 7.

the long term measurement accuracy. existing safety mechanisms may be impaired. operation. July 2013 A-5 . protective gloves. like laboratory clothing. Suitable protective equipment. Only accessories and supplies either delivered by or approved by Roche are to be used with the instrument. Operation of the instrument with solutions whose composition is not consistent with that of the original solutions can negatively affect.1 If the instrument is not used according to the Instructions for Use. This instrument is intended to be used only for the specialized purpose described in the instructions. In addition.g. The quality control requirements must be completed at least once daily for safety reasons. 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. above all. protective goggles and if necessary mouth protectors. 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. a face mask is required if there is a risk of splashes. and safety are explained to ensure smooth operation. must be worn to prevent direct contact with biological working materials. but also on a series of marginal conditions (e. Observe the documentation! CAUTION Roche Instructions for Use · Version 7. The most important prerequisites for use. 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.9180 Electrolyte Analyzer 1 Safety information Important information Important information These Instructions for Use contain vital warning and safety information. Since the measurements of the instrument depend not only on the correct characteristic function. These items are manufactured especially for use with this instrument and meet the highest quality requirements. pre-analysis). Deviations in the composition of the solutions can also decrease the service life of the electrodes. results obtained from the instrument should be submitted for an expert opinion before taking additional measures based on the supplied measurements. Instrument repairs are to be performed only by the manufacturer or qualified service personnel. Suitable disinfection and sterilization procedures must be applied.

In order to preserve this condition and ensure safe operation. o Service must be carried out by authorized personnel only. (a) IEC/EN 61010-1: Safety requirements for electrical equipment for measurement.1 . o The instrument meets the conditions for overvoltage category II. control and laboratory use (Part 1: General requirements) (b) IEC/EN 61010-2-101: Safety requirements for electrical equipment for measurement. WARNING WARNING o The power cord must be plugged into a grounded power receptacle. o Any rupture of the ground lead inside or outside the instrument or a loose ground connection may result in hazardous operating conditions for the operating personnel. o The instrument is not suitable for operation with a direct current power supply. Intentional disconnection of the grounding is not permitted.1 Safety information 9180 Electrolyte Analyzer Operating safety information Operating safety information The instrument has been constructed and tested according to the following European Standards: o IEC/EN 61010-1(a) o IEC/EN 61010-2-101(b) o IEC/EN 61010-2-081 + A1(c) o It was delivered from the factory in flawless condition with regards to safety features. o Recurring inspections are to be carried out based on local regulations. o The power cable must conform to country-specific requirements. control and laboratory use (Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes) (d) IEC/EN 62353: Medical electrical equipment . Orders can be placed via the local Roche organization only.Recurrent test and test after repair of medical electrical equipment Roche A-6 July 2013 Instructions for Use · Version 7. When using an extension cord. According to IEC/EN 62353(d) recurring inspections are to be carried out every 24 months. control. The instrument does not contain any user-serviceable parts. o The instrument meets the conditions for contamination level 2. o This instrument is classified under the protection class I according to IEC/EN 61010-1. o If objects or liquids enter 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 user must observe the notices and warnings that are contained in these Instructions for Use. o Use only the original mains plug delivered with the instrument. and laboratory use (Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment) (c) IEC/EN 61010-2-081: Safety requirements for electrical equipment for measurement. o Do not operate the instrument in an explosive environment or in the vicinity of explosive anesthetic mixtures containing oxygen or nitrous oxide. Observe the regulations and safety instructions in the respective chapters of the Instructions for Use. make sure it is properly grounded.

.....................................................1 July 2013 A-7 ........... A-10 Calibration procedure .... A-13 Roche Instructions for Use · Version 7................................................................................. A-10 Measurement evaluation ........................... A-9 Measurement and calibration procedures ........................ A-12 Disinfection .......................... A-12 Disposal of the reference electrode ......... In this chapter Chapter 2 Introduction ......................................................................................................................... electrodes....... A-10 Measurement procedure ....................................................................... A-12 Standby mode .............................. A-11 Important safety instructions ......................................................... and solutions.................. A-12 Handling solutions ................................................................................................. and instrument .................................................. A-12 Handling electrodes ........ A-11 Disposal of SnapPak............................................................................................................................................................................. A-11 Sample collection and handling ................................................................................................. as well as precautionary measures against special dangers and the proper handling of sensors................................................................................9180 Electrolyte Analyzer 2 General description Table of contents General description This chapter contains a general description of the instrument......................................................................................................................

1 .2 General description 9180 Electrolyte Analyzer Table of contents Roche A-8 July 2013 Instructions for Use · Version 7.

As the user becomes familiar with the operation of the unit.9180 Electrolyte Analyzer 2 General description Introduction Introduction This manual will help guide through setting up the analyzer and analyzing samples.1 July 2013 A-9 . Figure A-1 Roche Instructions for Use · Version 7. the manual may be used as a reference for day-to-day routines and as a guide for maintenance and troubleshooting.

The ion concentration in the sample is then determined by using a calibration curve determined by measured points of standard solutions with precisely known ion concentrations. potassium. A difference in ion concentrations between the inner electrolyte and the sample causes an electro-chemical potential to form across the membrane of the active electrode. Calibration procedure A 2-point calibration is performed automatically every 4 hours in [READY] mode and a 1-point calibration is automatically performed with every measurement. chloride. There are six different electrodes used in the 9180 Electrolyte Analyzer: sodium. A calibration cycle can also be initiated manually at times when no sample measurements are performed. The galvanic chain is closed through the sample on one side by the reference electrode. A galvanic measuring chain within the electrode determines the difference between the two potential values on either side of the membrane. inner electrolyte and inner electrode close the other side. reacting to the electrical charge of the ion causing a change in the membrane potential. reference electrolyte and the "open terminal". It is very important that the main door be closed during sampling to provide shielding from sources of electromagnetic and electrostatic interference. section Measurement principle on page A-36. The membrane is an ion exchanger. which is built up in the film between the sample and the membrane. The potential is conducted by a highly conductive. lithium and a reference electrode. Each electrode has an ion-selective membrane that undergoes a specific reaction with the corresponding ions contained in the sample being analyzed. The membrane.1 . An automatic calibration procedure is also performed shortly after power-on or reset. ionized calcium. or measuring voltage. Roche A-10 July 2013 Instructions for Use · Version 7. The reference electrode is connected to ground as well as to the amplifier.2 General description 9180 Electrolyte Analyzer Measurement and calibration procedures Measurement and calibration procedures Measurement procedure The 9180 Electrolyte Analyzer methodology is based on the ion selective electrode (ISE) measurement to determine the measurement values e see Chapter 4 Theoretical foundation. inner electrode to an amplifier.

o Aseptic procedures are required when cleaning the sampling probe to avoid contamination. 2=normal.). etc.level 3. which can chemically react with plastic. at least once daily one QC measurement has to be performed in alternating levels (1=low.g. Do not use ammonia-based or alcohol-based cleaners. 3=high) (e. 3=high) after each electrode exchange.9180 Electrolyte Analyzer 2 General description Measurement evaluation Measurement evaluation The validity of the test results from the 9180 Electrolyte Analyzer must be carefully examined by a clinical-medical specialist who will take the patient's clinical condition into consideration before any clinical decisions are reached based on the test results. always follow these precautions when working with the 9180 Electrolyte Analyzer: o Keep the analyzer away from all sources of liquids such as sinks and wash basins. o Dispose of SnapPak according to local regulations. after startup of the instrument as well as after monthly. In order to ensure the quality of the measurement results. e For further information.level 1. QC measurements must be performed more often. A quality control program for electrolytes includes the analysis of sample materials with known ranges of expected values and the comparison of these values with analyzer results. day 4 . all necessary regulations concerning hygiene must be observed.level 1. Important safety instructions For your own safety and the proper operation of your equipment. Dangerous pathogenic agents could be present. see Chapter 8 Quality control. semi annual and annual maintenance steps. after each replacement of the SnapPak. 2=normal. o Use approved protective gloves to avoid direct contact with sample. day 1 . Roche Instructions for Use · Version 7. day 2 .level 2.1 July 2013 A-11 . see Chapter 7 Measurement.. CAUTION o Always handle blood samples and collection devices with appropriate care. When required by local regulations. complete a quality control test on 3 levels (1=low. Sample collection and handling While handling samples. on or around the analyzer. Additionally. e For further information. day 3 .

Always wear gloves! e For further information. Disposal of the reference electrode This electrode contains mercury.2 General description 9180 Electrolyte Analyzer Important safety instructions Disposal of SnapPak. Therefore dispose of it in accordance with applicable regulations (hazardous waste!). The shelf life of the electrodes is limited. Roche A-12 July 2013 Instructions for Use · Version 7. see Chapter 3 Specification. Please read the label and the packaging for the correct storage temperature and the maximum shelf life. The temperature of the solutions should be adapted to the ambient temperature before use. Roche recommends following a disinfection procedure in addition to regulations specific to the laboratory. see Chapter 9 Maintenance. Handling solutions Store the wash/calibrating solutions according to the specified packaging requirements. the solution's concentration may change and cause calibration errors. Do not mix the individual components. electrodes and the instrument according to applicable laboratory regulations (biologically contaminated–hazardous waste!). Disinfection The purpose of this disinfection is to minimize risk when handling items that were in contact with biological samples. CAUTION e For further information. Please read the label and the packaging for the correct storage temperature and the maximum shelf life. electrodes. The shelf life of the solutions is limited. Do not use damaged SnapPaks. see Chapter 3 Specification. and instrument Dispose of used SnapPak.1 . Handling electrodes Store the electrodes according to the packaging specifications. e For further information. These disinfection procedures should be performed periodically to minimize the risk of infections. Do not freeze! If frozen.

Roche Instructions for Use · Version 7. until [Go to Standby Mode?] appears. Depending on the duration of the standby mode. o Press YES. If sampling will be delayed for an extended period of time. o Press YES again. such as evenings and weekends. To exit from Standby mode: o Press YES. then NO.1 July 2013 A-13 . you may place the analyzer into Standby mode to suspend automatic calibration.9180 Electrolyte Analyzer 2 General description Standby mode Standby mode The 9180 Electrolyte Analyzer is designed to calibrate automatically every four hours during normal operation. [Leave Standby Mode?] will be displayed. o Press YES. section Service codes on page E-14. e For instructions see Chapter 10 Troubleshooting . After that. The analyzer shows a Standby mode status on the display. The analyzer can be programmed to automatically enter Standby mode. the analyzer returns to [READY]. To enter standby mode: o Press NO until [OPERATOR FUNCTIONS?] appears. an automatic calibration can be performed.

2 General description 9180 Electrolyte Analyzer Standby mode Roche A-14 July 2013 Instructions for Use · Version 7.1 .

..... A-17 Measurement parameters ......... A-18 Material: RNA EQUIL Reduced Bovine Hemoglobin Solution (Level 2).............................................. A-21 Correlation to flame .................................................................................................... A-24 Sample throughput ...............................1 July 2013 A-15 ........ A-22 Interferences .......................................................................... n=80 ........9180 Electrolyte Analyzer 3 Specification Table of contents Specification In this chapter................................................................................. A-25 Sample volumes .... as well as product and environmental data are described................................................ A-20 Linearity .................. n=80 .......................................................................... n=80 ............................................................................................... n=80 ........................................................................................................ A-19 Material: Aqueous Standard Solution (Level 2)......flame-correlated ................ n=80 .................... A-23 Relationship of ionized calcium to total calcium ............................................................. A-20 Material: Urine........................................... A-25 Sample types .................................................................... A-17 Material: ISETROL Protein Based Aqueous Control Material (Level 1)........................................... In this chapter Chapter 3 Performance parameters ............. A-18 Material: ISETROL Protein Based Aqueous Control Material (Level 3)....................................................................................................... n=80 ......................... the performance data........................................... n=80 ..................................... n=80 ..................... A-25 Roche Instructions for Use · Version 7...................................................... A-21 Correlation to direct ISE ............................. A-17 Reproducibility ........................................................... A-19 Material: Acetate Dialysate Solution......................................................................................... A-22 Correlation to direct ISE ....................................................................................................................................................... A-19 Material: Bicarbonate Dialysate Solution...........................................................................not flame-correlated ................ A-18 Material: Aqueous Standard Solution (Level 1)............. A-21 Linearity in aqueous standard solutions .......................................................... n=80 .................. n=80 ............................................................................................ A-23 Limitations ........................ A-21 Linearity in serum ........................................ A-18 Material: ISETROL Protein Based Aqueous Control Material (Level 2)..................................................................... A-19 Material: Pooled Human Serum............................................................................................................................................ A-22 Correlation to chloridometry ......................................................................................................................................................... A-24 Bibliography ..

................................. A-26 Temperature / humidity / stability ...... A-25 Environmental parameters ........................................................................................... A-26 Instrument ........... A-29 Display ................................................................. A-28 QC material ......... A-29 Dimensions .................................................. A-27 Urine diluent ........................................................................................ A-29 Classification (according IEC/ISO) ............ A-29 Roche A-16 July 2013 Instructions for Use · Version 7...........................................................................................................................................................................................1 .................................................................................................................... A-28 ISETROL Electrolyte Control ........................................................................................................................................................................................................... A-26 Solutions ............................................................... A-29 Printer ........................................ A-26 Electrodes ............................................................................................................................................................................................. A-28 Product data ................................................................................................................................................................................................................................3 Specification 9180 Electrolyte Analyzer Table of contents Calibrations ................................................................................. A-29 Electrical data ..................................................................... A-27 SnapPak ................................................................................................................................

Roche Instructions for Use · Version 7. see Chapter 7 Measurement.5 ­ 120 mmol/L U* 60 ­ 120 mmol/L B/S/A/D/Q 50 ­ 200 mmol/L U 1 ­ 300 mmol/L Ca B/S/A/D/Q 0.0 mmol/L Cl- 2+ Table A-1 B whole blood S serum or plasma A dialysis solutions containing acetate D dialysis solutions containing bicarbonate Q aqueous QC material U urine samples (dilution required.8 ­ 15 mmol/L U 4.1 July 2013 A-17 . Between-Day (Sdd) and Total (ST) Precision is determined from 2 runs per day with 2 replicates per run for 20 days on two 9180 Electrolyte Analyzers.1 ­ 6.9180 Electrolyte Analyzer 3 Specification Performance parameters Performance parameters Measurement parameters + Na K+ specified for: specified range: B/S/A/D/Q 40 ­ 205 mmol/L U 1 ­ 300 mmol/L B/S/Q 1. Values for sodium and potassium are the average of all instruments. section Urine samples on page C-37) U* urine samples (second dilution required. ionized calcium and lithium are determined from the measurement of two of each respective unit configuration.5 ­ 15 mmol/L A/D 0.0 mmol/L Li+ B/S/Q 0.2 ­ 5. see Chapter 7 Measurement. while values of chloride. All values are reported in mmol/L. section Urine samples on page C-37) Reproducibility Typical Within-Run (Swr).

010 1.90 0.38 0.43 0.42 0.66 0.67 0.014 2.026 6.4 0.1 .41 0.015 0.18 0.74 0.44 Chloride 76.039 0.53 0.41 Table A-2 Material: ISETROL Protein Based Aqueous Control Material (Level 2).52 0.011 0.20 0.29 0.6 0.72 0.043 0.97 0.023 0.17 0.88 Chloride 100.95 ionized Calcium 0.036 0.63 0.46 0.31 ionized Calcium 1.35 0.045 4.78 Potassium 2.025 0.035 3.40 0.44 0.07 0.28 0.10 Lithium 1.33 0.012 1.72 0.18 Table A-4 Material: RNA EQUIL Reduced Bovine Hemoglobin Solution (Level 2).48 0.042 3.036 0.29 Lithium 2.027 0.57 0.62 Chloride 123.58 0.51 0.89 0.035 1.041 1.21 0.35 0.008 0.2 0.025 0. n=80 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 134.63 0.3 Specification 9180 Electrolyte Analyzer Performance parameters Material: ISETROL Protein Based Aqueous Control Material (Level 1).43 0.45 0.8 0.2 0.18 0.10 0.07 0.89 0.53 0.52 0.87 0.40 0.79 0.30 0.48 0.55 0.007 1.20 0.24 0.36 0.82 0.004 0.21 0.026 0.021 0.024 1.082 3.42 0.76 0.55 0.33 Potassium 4.89 0.018 4.010 2.56 Potassium 5.95 Lithium N/A Table A-5 Roche A-18 July 2013 Instructions for Use · Version 7.76 0. n=80 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 114.024 0.48 0.034 1. n=80 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 158.45 0.31 Table A-3 Material: ISETROL Protein Based Aqueous Control Material (Level 3).04 0.94 ionized Calcium 2.82 Chloride 102.18 0.40 0.72 1.36 0.7 0.016 1.59 0.32 0.021 1.063 2.42 0.29 0.4 0.19 0.66 Lithium 0.47 Potassium 4.8 0.40 0.57 ionized Calcium 1.75 0. n=80 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 141.32 0.40 0.

22 0.85 0.80 0.56 0.020 1.44 0.19 0.57 Chloride 115.029 0.1 0.004 0.004 0.75 0.33 0. n=80 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 150.78 2.17 1.17 0.023 13.022 0.033 1.16 0.49 0.78 0.07 0.55 0.011 6.60 0.30 0.018 0.032 1.13 0.77 0.85 1.41 0.18 0.015 8.48 Table A-6 Material: Aqueous Standard Solution (Level 2).24 1.29 Lithium 0.43 0.11 0.92 Chloride 82.05 ionized Calcium 2.115 6.043 0.97 0.092 5.14 ionized Calcium 0. n=80 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 113.21 0.155 2.0 0.07 0.51 0.67 0.96 0.87 1.40 0.55 0.23 0.34 0.47 0.33 0.38 Potassium 4.42 0.82 0. n=80 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 138.005 1.34 Potassium 4.25 0.196 3.81 2.41 0.8 0.1 July 2013 A-19 .9180 Electrolyte Analyzer 3 Specification Performance parameters Material: Aqueous Standard Solution (Level 1).041 1.39 0.20 0.27 0. n=80 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 86.09 0.004 1.9 0.053 2.039 3.95 Potassium 1.13 Chloride 106.10 1.8 0.32 Chloride 107.50 Lithium N/A Table A-9 Roche Instructions for Use · Version 7.007 0.031 2.19 0.049 2.043 2.007 0.98 1.034 0.00 0.30 0.014 0.09 0.041 0.16 ionized Calcium 1.96 0.27 0.36 0.37 ionized Calcium 1.07 Potassium 2.93 1.76 Lithium 0.88 0.8 0.45 0.36 0.64 0.28 0.40 0.008 2.94 0.029 1.62 Table A-7 Material: Pooled Human Serum.92 0.043 1.37 0.0 0.36 0.08 0.24 0.23 0.86 0.28 Table A-8 Material: Acetate Dialysate Solution.051 1.57 0.76 Lithium 5.2 0.

3 Specification

9180 Electrolyte Analyzer

Performance parameters

Material: Bicarbonate Dialysate Solution, n=80
Parameter

Mean

Swr

(CV %)

Sdd

(CV %)

ST

(CV %)

Sodium

135.2

0.45

0.33

0.59

0.44

0.72

0.54

Potassium

1.58

0.023

1.46

0.031

1.95

0.037

2.37

Chloride

107.3

0.37

0.35

0.63

0.59

0.86

0.80

ionized Calcium

1.68

0.012

0.72

0.016

0.96

0.027

1.63

Lithium

N/A

Swr

(CV %)

Sdd

(CV %)

ST

(CV %)

Table A-10

Material: Urine, n=80
Parameter

Mean

Sodium

51.5

1.98

3.84

3.06

5.94

3.65

7.08

Potassium

48.4

0.65

1.34

0.97

2.00

1.11

2.29

Chloride

85.9

0.53

0.62

0.66

0.76

0.99

1.16

ionized Calcium

N/A

Lithium

N/A

Table A-11

Roche
A-20

July 2013
Instructions for Use · Version 7.1

9180 Electrolyte Analyzer

3 Specification
Linearity

Linearity
Linearity in aqueous standard solutions
Aqueous linearity standards were gravimetrically prepared from N.I.S.T. traceable
salts and measured on each of six 9180 Electrolyte Analyzers, two of each
configuration: Na/K/Cl, Na/K/Ca and Na/K/Li.
Parameter

Slope

Intercept

Correlation coefficient

Sy·x

Range [mmol/L]

n

Sodium

0.99993

0.0128

0.99995

0.666

51 ­ 196

300

Potassium

0.99838

0.0119

0.99919

0.194

2.0 ­ 12.6

300

Chloride

0.97556

-0.1775

0.99994

0.674

56 ­ 194

100

ionized Calcium

1.01552

-0.0078

0.99980

0.037

0.4 ­ 3.3

100

Lithium

0.99850

0.0087

0.99985

0.038

0.3 ­ 5.3

100

Table A-12

Linearity in serum
Linearity in serum was established with the analysis of two specimen sets in nonclinical tests: commercially prepared serum linearity standards for sodium, chloride
and potassium with normal protein content, and a group of random patient serum
samples. All samples were analyzed in pairs on each of two of 9180 Electrolyte
Analyzers in each configuration:
Na/K/Cl, Na/K/Ca and Na/K/Li, and in pairs on each of the following instrument
types for comparison to various methods:
Direct ISE, not flame correlated (listed as 98X)

983 Na/K/Cl-Analyzer
984 Na/K/Ca-Analyzer
985 Na/K/Li-Analyzer

Direct ISE, flame correlated (listed as 91XX)

9130 Na/K/Cl-Analyzer
9140 Na/K/Ca-Analyzer

Flame Absorbance Emission Spectroscopy

IL 943 Flame Photometer

Chloridometry

Labconco Digital Chloridometer

Correlation to flame
IL 943 Flame Photometer
Parameter

Slope

Intercept

Correlation Coefficient

Sy·x

Range [mmol/L]

n

Sodium

0.9617

5.83

0.9908

Potassium

1.0249

0.015

0.9991

2.04

104 ­ 178

50

0.075

1.8 ­ 11.5

50

Lithium

0.9803

0.0011

0.9822

0.028

0.11 ­ 0.71

15

Table A-13

Roche
Instructions for Use · Version 7.1

July 2013
A-21

3 Specification

9180 Electrolyte Analyzer

Linearity

Correlation to direct ISE - not flame-correlated
98X Electrolyte Analyzers
Parameter

Slope

Intercept

Correlation Coefficient

Sy·x

Range [mmol/L]

n

Sodium

0.9895

-6.35

0.9992

0.61

110 ­ 186

50

Potassium

1.0223

-0.25

0.9996

0.05

2.0 ­ 11.6

50

Chloride

0.9631

-1.01

0.9995

0.51

70 ­ 152

50

ionized Calcium

0.8898

0.107

0.9960

0.021

0.67 ­ 1.66

50

Lithium

0.9923

0.008

0.9985

0.010

0.11 ­ 0.71

15

Table A-14

Correlation to direct ISE - flame-correlated
91XX Electrolyte Analyzers
Parameter

Slope

Intercept

Correlation Coefficient

Sodium

0.9856

-2.02

0.9856

Potassium

0.9992

0.02

0.9994

Chloride

1.0026

-5.31

0.9989

ionized Calcium

1.0023

0.040

0.9954

Sy·x

Range [mmol/L]

n

1.21

104 ­ 179

50

0.05

1.9 ­ 11.8

50

0.73

70 ­ 152

50

0.022

0.62 ­ 1.54

50

Table A-15

Correlation to chloridometry
Labconco Digital Chloridometer
Parameter

Slope

Intercept

Correlation Coefficient

Sy·x

Range [mmol/L]

n

Chloride

1.0222

2.75

0.9923

2.03

66 ­ 145

50

Table A-16

Roche
A-22

July 2013
Instructions for Use · Version 7.1

Use only lithium-free sampling containers for the determination of lithium measurement values! If sample containers are used which contain lithium as an anticoagulant. As with any clinical reaction. e For further information. users must be alert to the possible effect on results due to unknown interference from medications or endogenous substances.6 .5 mmol/L for blood/serum) Na+. The 9180 Electrolyte Analyzer reports lithium in the range of 95 . A comprehensive discussion concerning these and other interfering substances. hemolysis should be avoided. the influence on chloride is clinically insignificant.169. in extremely high levels. Opening and closing the fist with a tourniquet in place results in an increase in potassium levels by as much as 10 to 20 %. serum and plasma analyte concentrations. and the serum should be separated from the cells as soon as possible after collection. At therapeutic levels of salicylate concentration. ammonium and iodide. their blood. The lithium electrode shows a slight sensitivity to the ionized calcium present in the sample and results in a negative bias of the lithium result. The lithium electrode response is dependent on the actual sodium concentration of the sample. is known to interfere with the chloride electrode and results in a positive bias of the chloride result. No significant effect on serum has been demonstrated from bromide.180 mmol/L (89. see Interference on page C-29. It is recommended that the blood sample is obtained without a tourniquet. possibly endangering the patient's health.1 July 2013 A-23 . Roche Instructions for Use · Version 7. serum or plasma concentrations. this may lead to incorrect patient measurements. Since the concentration of potassium inside erythrocytes is much greater than that in extra cellular fluid. and their possible physiological involvement is beyond the scope of this Instructions for Use.9180 Electrolyte Analyzer 3 Specification Interferences Interferences Salicylate. or that the tourniquet be released after the needle has entered the vein and 2 minutes elapsed before the sample is withdrawn. Limitations A number of substances have been reported to cause physiological changes in blood. All patient results must be evaluated by the laboratory and the physician in light of the total clinical status of the patient. which may result in incorrect clinical decisions. the influence of ionized calcium is clinically insignificant. At normal physiological ionized calcium concentrations.

2nd Ed.Med. o Henry. Sep.. Duben-Engelkirk JL.3 Specification 9180 Electrolyte Analyzer Relationship of ionized calcium to total calcium Relationship of ionized calcium to total calcium The ratio of ionized calcium to total calcium in a healthy population is around 0. Approved Guideline—Second Edition. CLSI DocumentEP5-A2. (Philadelphia: W.281. Offord KP: Comparative studies of total and ionized serum calciumvalues in normal subjects and in patients with renal disorders. Clin Chem 22: 1968-72. These relationships may be altered when using citrate in blood. 150-157. 2nd Ed. (Eds.Lippincott Co.1993. Protection of Laboratory Workers fromOccupationally Acquired Infections..Lab.B. 1990) S.B. Burton David. Clinical Chemistry A Fundamental Textbook.117. 1840-1842. o Burritt MF. 161-164. Donald F.1 . (2005).. 1837. 376. Inc.. o Toffaletti J.1994) pp. 2nd Ed. or when the acid-base metabolism is disturbed.890-95 o Clinical and Laboratory Standards Institute. 432. Norbert W.). Tietz Textbook of Clinical Chemistry. 262-284... 2nd Ed. Clinical Chemistry .2180-2206. Saunders. Robert H. Louis: Mosby Year Book Inc.1354-1360. 2nd Ed. Roche A-24 July 2013 Instructions for Use · Version 7. (Philadelphia: J.1986). Clinical Physiology of Acid-Base and Electrolyte Disorders. 720-721 o Tietz.B. Co. Larry E & Williams. Clinical Chemistry Principles Procedures Correlations..B. p.50 or 50%(a). Gitelman JH.(New York: McGraw-Hill..B. Senhauser Donald A..1992. 456-459. p. Vol. 720-721. 4th Ed.. (Philadelphia: J. 98-99. 118-119. Administration and Supervision in Laboratory Medicine. (Philadelphia: W. o Burtis C. Clinical Guide to Laboratory Tests. 797-798. o Calbreath. Ed. 510-511.. o Clinical and Laboratory Standards Institute. 1993) pp. o National Committee for Clinical Laboratory Standards. (New York..). NCCLS Document H24-T. 1845. Norbert W. Textbook of Clinical Chemistry.Path. Bibliography o Bishop ML.. (2004).1816. pp.. (Philadelphia: W. (St.) Principles of Laboratory Instruments. Fody EP. (a) Tietz.. Co. pp. o Tietz.. Additives for Blood Collection Devices: Heparin. Lippincott Co. (Philadelphia: W. 456-459. Harper and Row. 510-511. o Rose. Tentative Standard. Mayo Clinic Proc. Pierides AM. 2nd Ed.Clinical Guide to Laboratory Tests. 1990). (Philadelphia: W.Ed. 55:606. Evaluation of Precision Performance ofQuantitative Measurement Methods. 1976. 1989) pp..B.... Approved Guideline—Third Edition.Principles and Technics. CLSI Document M29-A3. 346-348. R.Ed. Saunders Co. Savory J: Separation and quantification of serum constituents associated with calcium by gel filtration. 1993) pp. 1974) o Kost GJ. o Schoeff.. Co...1980. Ashwood E (Eds. (1988).Saunders.J.).B. (Eds. Saunders Co. Saunders.371.98-99. o Snyder John R. 1992) pp. Norbert W.Arch. 390-395. 118-119..

9180 Electrolyte Analyzer 3 Specification Sample throughput Sample throughput 45 samples per hour with printout 60 samples per hour without printout Sample volumes 95 μL typical Sample types Whole blood. dialysis solutions containing acetate and bicarbonate. plasma.1 July 2013 A-25 . serum. urine. QC material Calibrations 1-point calibration after each sample 2-point calibration every 4 hours Roche Instructions for Use · Version 7.

if T  15 to  31 °C 20 .90 %.85 % (not condensing) July 2013 Instructions for Use · Version 7.95 %. if T > 31 to  33 °C Storage and transportation conditions: Roche A-26 Temperature 15 to 30 °C (dry) Humidity 15 .1 .3 Specification 9180 Electrolyte Analyzer Environmental parameters Environmental parameters Temperature / humidity / stability Instrument Operating conditions: Ambient temperature 15 to 32 °C Relative humidity < 85 % (not condensing) Storage and transportation conditions: Temperature -20 to 40 °C Humidity < 85 % (not condensing) Electrodes Operating conditions: Operating temperature 15 to 33 °C Relative humidity 20 .

4 mmol/L K Cl Li Storage temperature: 15 .9180 Electrolyte Analyzer 3 Specification Environmental parameters Solutions SnapPak Contains the following reagents: Standard A For calibration of sodium. Contents: 85 mL Active ingredients: Na+ 100 mmol/L + 1. chloride.8 mmol/L Cl- 72 mmol/L K Ca 2+ + Li 1.0 mmol/L - 115 mmol/L 2+ 0. potassium.1 July 2013 A-27 .5 mmol/L 0.3 mmol/L Storage temperature: 15 .30 °C Stability: Expiration date and lot number are printed on each container label On-board stability: 14 weeks Table A-19 Roche Instructions for Use · Version 7. Contents: 350 mL Active ingredients: Na+ 150 mmol/L K+ 5.9 mmol/L Cl Ca + Li 0. Contents: 85 mL Active ingredients: Na+ 150 mmol/L + 5. potassium. chloride. ionized calcium and lithium in the 9180 Electrolyte Analyzer. potassium. ionized calcium and lithium in the 9180 Electrolyte Analyzer.30 °C Stability: Expiration date and lot number are printed on each container label On-board stability: 14 weeks Table A-18 Standard C For calibration of sodium.3 mmol/L Storage temperature: 15 . chloride. ionized calcium and lithium in the 9180 Electrolyte Analyzer.9 mmol/L + 1.30 °C Stability: Expiration date and lot number are printed on each container label On-board stability: 14 weeks Table A-17 Standard B For calibration of sodium.0 mmol/L - 115 mmol/L Ca2+ 0.

when used. Use of calibration solutions. Table A-21 QC material ISETROL Electrolyte Control Storage conditions in original packaging Temperature Roche A-28 15 to 30 °C < 24 months July 2013 Instructions for Use · Version 7. Contents: 85 mL Active ingredients: Potassium chloride Storage temperature: 15 . holds human body fluids which may be potentially infectious. electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee.30 °C Stability: Expiration date and lot number are printed on each container label. WARNING Dispose of the SnapPak according to local regulations (hazardous waste!).2 mol/L Table A-20 On-board stability refers to the SnapPak installed in the analyzer. The SnapPak has to be exchanged at the latest after 14 weeks.30 °C Stability: Expiration date and lot number are printed on each container label On-board stability: 14 weeks 1. Contents: Each dispensing bottle contains 500 mL of solution Active ingredients: Sodium chloride 120 mmol/L Storage temperature: 5 . Urine diluent For use as a diluent for the measurement of urine samples in the 9180 Electrolyte Analyzer.3 Specification 9180 Electrolyte Analyzer Environmental parameters Reference Solution A salt bridge for calibration and measurement in the 9180 Electrolyte Analyzer. WARNING A waste container is provided with the SnapPak which.1 . handle with appropriate care to avoid skin contact or ingestion.

5 cm Dimensions Depth 29.5 cm Width 31.) Classification (according IEC/ISO) Safety category I Overvoltage category II Contamination level 2 Height 33. 16 characters per line Display Roche Instructions for Use · Version 7.6 AT (2 pcs.1 July 2013 A-29 .9180 Electrolyte Analyzer 3 Specification Product data Product data Electrical data Mains voltage range 100 to 240 VAC Frequency 50/60 Hz Required power 50 W Main fuse 250 VAC / 1.5 cm Weight < 6 kg Type thermal printer Resolution 16 characters / line Printer Printing speed 4 mm / sec Paper width 38 mm Paper length about 30 m Type monochrome-LCD Resolution 2 lines.

3 Specification 9180 Electrolyte Analyzer Display Roche A-30 July 2013 Instructions for Use · Version 7.1 .

........................................................................ A-37 Electrode specifications ............................................ A-40 Construction ..... A-44 Use and care .....1 July 2013 A-31 ..................................... A-45 Reference electrode .............................................................................. A-34 Ionized calcium ............................................................................ A-45 Reference electrode housing ............................................................................................. A-33 Sodium .......................................................................................................................... A-44 Reference electrode assembly . A-41 Chloride electrode ....................... A-46 Use and care ................. A-42 Use and care ................................................................................................................................................................................................................................................................................................................................. A-45 Use and care ............................................................................................................................................... A-43 Construction ................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... A-45 Construction ...............................................................................................................................................................................................9180 Electrolyte Analyzer 4 Theoretical foundation Table of contents Theoretical foundation In this chapter Chapter 4 Reference and critical values ................................. A-36 Measurement principle .......................................................................................................................................................................... A-44 Construction ............................................................. A-33 Potassium ...................... A-41 Use and care .......................... A-40 Use and care ... A-42 Construction ... A-43 Lithium electrode .......................................................................................... A-35 Principles of Operation ............................ A-40 Potassium electrode ...................................................................................................................................................... A-43 Use and care ............................................................................................ A-42 Calcium electrode .................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... A-41 Construction .... A-46 Roche Instructions for Use · Version 7..................... A-35 Lithium ................................... A-40 Sodium electrode ............................................................ A-34 Chloride . A-36 Physical principle .............................................................................................................................

....................................... A-46 Roche A-32 July 2013 Instructions for Use · Version 7......... A-46 ISE calibration ..1 .........................................................................................................................4 Theoretical foundation 9180 Electrolyte Analyzer Table of contents Calibration procedure ....................................

p.(a) Reference intervals are useful because they attempt to describe the typical results found in a defined population of apparently healthy people. 2252 (b) see Chapter 16 of "Tietz' Textbook of Clinical Chemistry and Molecular Diagnostics".146 mmol/L 133 . different reference intervals and results may be obtained in different laboratories.145 mmol/L 138 . Critical values: o Serum or plasma:(a) (a) Tietz Textbook of Clinical Chemistry and Lower Limit Upper Limit 120 mmol/L 160 mmol/L Molecular Diagnostics: 4th Edition 2006.145 mEq/L Adult > 90 years 132 . 48 h. depending on calibration and other technical considerations. should not be used as absolute indicators of health and disease. p. Hence.1 July 2013 A-33 . 2294 f. 128 . WARNING Sodium Reference values:(a) Premature. cord 116 .166 mEq/L Newborn 133 .146 mEq/L Child 138 .145 mmol/L 136 .146 mmol/L 139 .9180 Electrolyte Analyzer 4 Theoretical foundation Reference and critical values Reference and critical values The result of laboratory tests have little practical utility until clinical studies have ascribed various states of health and disease to intervals of values.(b) The reference intervals presented in this chapter are for general information purposes only.148 mmol/L 128 . 4th Edition 2006. Reference intervals.146 mEq/L Infant 139 . 2317 (a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. p.146 mEq/L (a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006. cord 126 .140 mmol/L 116 . 4th Edition 2006 Roche Instructions for Use · Version 7. Different methods may yield different values.145 mEq/L Adult 136 .140 mEq/L Premature. although useful as guideline for clinicians.146 mmol/L 132 .166 mmol/L 126 .148 mEq/L Newborn. Individual laboratories should generate their own set of reference intervals.

plasma:(a) Cord 96 .6 .12. 2260 Lower Limit Upper Limit 80 mmol/L 120 mmol/L th (a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4 Edition 2006. 2317 Roche A-34 July 2013 Instructions for Use · Version 7.9 mmol/L 3.4 .104 mmol/L 96 .110 mEq/L 0 . cord 5.3 mmol/L 4. cord 5.5.5 .6 .4 mEq/L (a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006.5 mmol/L 3.0 mEq/L Newborn 3.111 mmol/L 98 .7 . p. 3.104 mEq/L Premature 95 .113 mEq/L Adults 98 .0 mmol/L 5.4.4.5. 2317 Chloride Reference values: o Serum.7 mEq/L Adult 3.5.0 mmol/L 3.1 .10.6. p.12.4 .4 Theoretical foundation 9180 Electrolyte Analyzer Reference and critical values Potassium Reference values: o o Serum(a) Plasma (heparin)(a) Premature. p.30 days 98 .4 .4.1 mmol/L 3.4 .8 mmol/L th (a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4 Edition 2006. female 3.5.110 mmol/L 95 .4.4.5 mEq/L Adult.3 mEq/L Child 3. male 3.7 mmol/L 3.0 .0 .10.1 .2 mmol/L Newborn 2.8 mmol/L 7. 2291 Lower Limit Upper Limit Adult 2.0 .5 .5.113 mmol/L 98 .7 . Critical values: o Serum or plasma:(a) p.111 mEq/L (a) Tietz Textbook of Clinical Chemistry and Critical values: o Serum or plasma:(a) Molecular Diagnostics: 4th Edition 2006.107 mmol/L 98 .2 mEq/L Premature.0 .107 mEq/L Adults.1 .2 mmol/L 5. 48 h.5.0 mEq/L Newborn.4 mmol/L 3.4.5 .5 . > 90 years 98 .6.8 mmol/L 6.1 mEq/L Adult.9 mEq/L Infant 4.

1 July 2013 A-35 .061 mmol/L 5.6 .0.18 +/.20 years 1. p.20 mg/dL Newborn 5 days 1.21 mg/dL Children 1 .86 +/.1.1.0. p.30 +/.4 mg/dL 1. Thomas Lothar.20 +/. 2309 Roche Instructions for Use · Version 7.01 mg/dL 1. 2309 Toxic range: o Serum.70 +/.28 mg/dL (a) Labor und Diagnose: Indikation und Bewertung von Laborbefunden für die medizinische Diagnostik. 2317 Lithium Therapeutic range: o Serum. 7th Edition.75 mmol/L or 3.0.24 mg/dL Newborn 1 day 1.5.40 +/.0. p.0 mmol/L (a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006.41 mg/dL Molecular Diagnostics: 4th Edition 2006.35 mmol/L 4.9180 Electrolyte Analyzer 4 Theoretical foundation Reference and critical values Ionized calcium Reference values: o Whole blood.24 mg/dL Newborn 3 days 1.22 +/.0. serum.059 mmol/L 4.0.0.069 mmol/L 4.053 mmol/L 4.0.10 +/.15 .6.13 +/.051 mmol/L 4. 332 Critical values: o Plasma:(a) Adult (a) Tietz Textbook of Clinical Chemistry and Lower Limit Upper Limit 0. Plasma:(a) 0.0.0. Plasma:(a) > 2. plasma:(a)(b) Adult female & male Cord blood 1.6 mmol/L or 6.2 mmol/L (a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006.52 +/. p.

The membrane. which is built up in the film between the sample and the membrane. A galvanic measuring chain within the electrode determines the difference between the two potential values on either side of the membrane. the reference electrolyte and the “open terminal”. An ion-selective membrane undergoes a specific reaction with the type of electrolyte contained in the sample.chemical potential to form on the membrane of the active electrode.1 . Since the reference electrode is on ground. understanding how the instrument performs sampling analysis is relatively simple. The ion concentration in the sample is then determined and displayed by using a calibration curve determined by two measured points of standard solutions with precisely known ion concentrations (two-point calibration). the analyzer compares an unknown value against a known value to compute the sample’s electrolyte level. The galvanic chain is closed through the sample on one side by the reference electrode. Although the technology itself is quite complicated. The reference electrode is connected to ground as well as the second input of the amplifier.4 Theoretical foundation 9180 Electrolyte Analyzer Principles of Operation Principles of Operation Measurement principle The 9180 Electrolyte Analyzer is a sophisticated medical instrument that uses the Ion Selective Electrode (ISE) measurement principle to precisely determine electrolyte values. The different ion concentrations between the inner electrolyte and the sample cause an electro. reacting to the electrical change of the ion causing a change in the membrane potential. The membrane is an ion exchanger. C B D E A F G A Glass capillary C Voltmeter E Ion-selective electrode B Reference electrode D Inner solution F Ion-selective membrane G Measured solution Figure A-2 Roche A-36 Measurement principle July 2013 Instructions for Use · Version 7. Basically. inner electrolyte and inner electrode close the other side (see Figure A-2). amplification of the electrode potential allows further signal processing. and by using the measured voltage of the sample and the Standard-A (one-point calibration). The potential is conducted by the inner electrode to the input of an amplifier. or measuring voltage.

m.1 E = E  S  log  fi  c i  E measured electrical potential E’ e.9180 Electrolyte Analyzer 4 Theoretical foundation Principles of Operation Physical principle An ion-selective electrode is connected with a reference electrode to form a measuring system (see Figure A-3).31 J/Kmol) T temperature n valence of measured ion F Faraday constant (96.f. of the system in standard solution ai activity of ion measured R general gas constant (8.496 A·s/g) fi ci activity coefficient S slope of the electrode concentration of measured ion July 2013 A-37 . the Nernst equation applies: 1. ln  f  c  E = E  R ---------i i nF (+) for cations (–) for anions The equation can also be written: 3. Roche Instructions for Use · Version 7. ln a E = E  R ---------i nF or 2.  T.  T. When immersed in a solution that contains the relative ion.

c i sample E = E sample – E s tan dard = S  log ----------------------c i standard E Roche A-38 the difference between the measured potentials of the sample and the standard S the potential difference of the electrode.standard concentration of the measured ions in the sample concentration of the measured ions in the standard solutions July 2013 Instructions for Use · Version 7. E s tan dard = E + S  log  f i  c i standard  6.1 .4 Theoretical foundation 9180 Electrolyte Analyzer Principles of Operation D E F G H I C B J K L A P O N M A Glass capillary G K+ electrode M Chloride-selective membrane B Reference electrode H Amplifier N Sample C Reference solution (KCl) I Display O Potassium-selective membrane D Reference electrode housing J Cl. E sample = E + S  log  f i  c i sample  5.electrode P Sodium-selective glass capillary E Ground K Inner electrode F Na+ electrode L Inner electrolyte Figure A-3 Physical principle If the ion concentration of one measuring solution is known.sample ci. 4. the ion concentration of the sample can be determined on the basis of the difference of two measured potentials. determined from the potential difference of two measured standard solutions ci.

This activity is a criterion of the ion’s ability to interact with other ions. c i sample = c i s tan dard  10 E  S As demonstrated by these equations. in which each ion binds a proportion of its energy.1 July 2013 A-39 . The correlation is affected by the total number of ions in the solution. Since sodium is the predominant ion in whole blood and serum. Roche Instructions for Use · Version 7. The ion concentration is calculated on the basis of the ion activity.9180 Electrolyte Analyzer 4 Theoretical foundation Principles of Operation The unknown ion concentration in the sample can now be determined by: 7. the known value of the sodium concentration makes it possible to ascertain and adjust for total ion effect and strength. the ion selective electrodes do not measure the ion concentration but the activity of the ions concerned.

Proper care should be used in handling and storage of the electrode. filled with electrolyte solution for Na+ electrodes Pin connector: silver.serial number .5 digits of lot D Electrolyte chamber Figure A-4 number Sodium electrode Use and care Sodium electrodes are manufactured for use in 9180 Electrolyte Analyzers. section Important safety instructions on page A-11.1 . Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode since these will damage the plastic housing. dry place only after the electrode has been cleaned and rinsed with distilled water and dried with a lint-free cloth. Sodium electrode The sodium electrode is a glass capillary electrode used for in-vitro diagnostic measurement of sodium ions present in fluid samples. silver chloride (Ag / AgCl) B C D E A G F A Glass capillary E Inner electrode B Marking F Connecting pin C O-ring seal G Marking . Store the electrode in a clean. Roche A-40 July 2013 Instructions for Use · Version 7. The o-ring seal should be installed in the electrode during storage.4 Theoretical foundation 9180 Electrolyte Analyzer Electrode specifications Electrode specifications e For technical safety information see Chapter 2 General description. It is designated with a Na+ marking on the top surface of the housing. Construction Electrode housing: transparent acrylic plastic Measuring capillary: sodium selective glass Electrolyte chamber: airtight.

5 digits of lot D O-ring seal E Ion-selective membrane Figure A-5 number Potassium electrode Use and care Potassium electrodes are manufactured for use in 9180 Electrolyte Analyzer. It is designated with a K+ marking on the top surface of the housing. Proper care should be used in handling and storage of the electrode. silver chloride (Ag / AgCl) C D E F B A H G A Inner electrode F Electrolyte chamber B Sample path G Connecting pin C Marking H Marking .1 July 2013 A-41 . Roche Instructions for Use · Version 7.serial number . Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode since these will damage the plastic housing. Store the electrode in a clean. Construction Electrode housing: transparent acrylic plastic Measuring membrane: potassium ion selective Electrolyte chamber: airtight. filled with electrolyte solution for K+ electrodes Pin connector: silver.9180 Electrolyte Analyzer 4 Theoretical foundation Electrode specifications Potassium electrode The potassium electrode is a membrane electrode used for in-vitro diagnostic measurement of potassium ions present in fluid samples. The o-ring seal should be installed in the electrode during storage. dry place only after the electrode has been cleaned and rinsed with distilled water and dried with a lint-free cloth.

Roche A-42 July 2013 Instructions for Use · Version 7.electrodes Pin connector: silver. Proper care should be used in handling and storage of the electrode. dry place only after the electrode has been cleaned and rinsed with distilled water and dried with a lint-free cloth.4 Theoretical foundation 9180 Electrolyte Analyzer Electrode specifications Chloride electrode The chloride electrode is a membrane electrode used for in-vitro diagnostic measurement of chloride ions present in fluid samples.1 .serial number .5 digits of lot D O-ring seal E Ion-selective membrane Figure A-6 number Chloride electrode Use and care Chloride electrodes are manufactured for use in 9180 Electrolyte Analyzer. Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode since these will damage the plastic housing. The o-ring seal should be installed in the electrode during storage. silver chloride (Ag / AgCl) C D E F B A H G A Inner electrode F Electrolyte chamber B Sample path G Connecting pin C Marking H Marking . It is designated with Cl. filled with electrolyte solution for Cl.marking on the top surface of the housing. Store the electrode in a clean. Construction Electrode housing: transparent acrylic plastic Measuring membrane: chloride ion selective Electrolyte chamber: airtight.

5 digits of lot D O-ring seal E Ion-selective membrane Figure A-7 number Calcium electrode Use and care Calcium electrodes are manufactured for use in 9180 Electrolyte Analyzer. Construction Electrode housing: transparent acrylic plastic Measuring membrane: calcium ion selective Electrolyte chamber: airtight. Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode since these will damage the plastic housing. silver chloride (Ag / AgCl) C D E F B A H G A Inner electrode F Electrolyte chamber B Sample path G Connecting pin C Marking H Marking . dry place only after the electrode has been cleaned and rinsed with distilled water and dried with a lint-free cloth. Proper care should be used in handling and storage of the electrode.9180 Electrolyte Analyzer 4 Theoretical foundation Electrode specifications Calcium electrode The calcium electrode is a membrane electrode used for in-vitro diagnostic measurement of calcium ions present in fluid samples. It is designated with a Ca2+ marking on the top surface of the housing.serial number . Store the electrode in a clean. Roche Instructions for Use · Version 7. The o-ring seal should be installed in the electrode during storage.1 July 2013 A-43 . filled with electrolyte solution for Ca2+ electrodes Pin connector: silver.

1 . Proper care should be used in handling and storage of the electrode. silver chloride (Ag / AgCl) C D E F B A H G A Inner electrode F Electrolyte chamber B Sample path G Connecting pin C Marking H Marking . The o-ring seal should be installed in the electrode during storage. It is designated with a Li+ marking on the top surface of the housing. dry place only after the electrode has been cleaned and rinsed with distilled water and dried with a lint-free cloth.5 digits of lot D O-ring seal E Ion-selective membrane Figure A-8 number Lithium electrode Use and care Lithium electrodes are manufactured for use in 9180 Electrolyte Analyzer.4 Theoretical foundation 9180 Electrolyte Analyzer Electrode specifications Lithium electrode The lithium electrode is a membrane electrode used for in-vitro diagnostic measurement of lithium ions present in fluid samples. Store the electrode in a clean.serial number . filled with electrolyte solution for Li+ electrodes Pin connector: silver. Roche A-44 July 2013 Instructions for Use · Version 7. Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode since these will damage the plastic housing. Construction Electrode housing: transparent acrylic plastic Measuring membrane: lithium ion selective Electrolyte chamber: airtight.

serial number . The o-ring seals should be installed in the housing during storage. Construction The reference electrode assembly consists of two parts: the reference electrode housing and the reference electrode. C D E B A H G F A O-ring seal (a) E Exit .1 July 2013 A-45 .reference solution B Marking F O-ring seal (c) C Glass capillary G O-ring seal (b) D Entrance . Proper care should be used in handling and storage of the electrode housing. reference electrolyte solution establishes the electrical contact between the reference electrode and the sample. dry place only after the Reference Electrode has been removed and the housing cleaned and rinsed with distilled water and dried with a lint-free cloth.reference solution H Marking . At the same time a glass capillary allows a small amount of reference electrolyte to pass into the measuring capillary. Roche Instructions for Use · Version 7. thus establishing electrical contact between the sample and the reference electrode (see Figure A-9). Never use strong or abrasive cleaners such as alcohol or amphyl on the housing. reference electrolyte is pumped into the housing.5 digits of lot number Figure A-9 Reference elctrode assembly Use and care Reference electrode housings are manufactured for use in 9180 Electrolyte Analyzer. Reference electrode housing In the reference electrode housing. At the beginning of each measurement.9180 Electrolyte Analyzer 4 Theoretical foundation Electrode specifications Reference electrode assembly The reference electrode assembly is a device used as an electrical junction between the sample and electrical ground. Store the Reference Electrode Housing in a clean.

novel approach for the simultaneous calibration of Na+. Ca2+ and Cl. K+. Make sure that the transport housing is filled with reference electrolyte solution (you may use the reference electrolyte solution remaining in the reference electrode housing at the time of disassembly). A G B C F E D A Platinum wire E Calomel (Hg2 Cl2) B Cable housing F Mercury (Hg) C Glass tube G Serial number D Cotton wool Figure A-10 Reference electrode Use and care Reference electrodes are manufactured for use in 9180 Electrolyte Analyzer. Proper care should be used in handling and storage of the reference electrode.4 Theoretical foundation 9180 Electrolyte Analyzer Calibration procedure Reference electrode The reference electrode completes the electrical circuit between the reference electrolyte and electrical ground. Roche A-46 July 2013 Instructions for Use · Version 7.mercury (Hg)-platinum wireconnecting pin junction (see Figure A-10). This is accomplished by a cotton wool (saturated with reference electrolyte). using only two aqueous base solutions. Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode.sensors. Store the reference electrode in the transport housing provided with the electrode at the time of purchase.calomel (Hg2 Cl2). Never rinse the reference electrode with distilled water! Never allow the reference electrode to become dry! CAUTION Calibration procedure ISE calibration The 9180 Electrolyte Analyzer uses a patented.1 .

. . . . . . B-3 July 2013 . . . . . . . . . . . . . . . . . . . . .System components 5 B System components . . . . . . . .

.

...........................................B-6 Printer .....................................................................................................................B-7 Sample probe mechanism .....................................................................................................................................................................................................................................................................................................................................................................................................................................B-8 SnapPak .............................................................B-9 Serial port .........................................................B-6 Keypad ..........................................................................................B-5 Analyzer components ...................................................B-7 Peristaltic pump ...............1 July 2013 B-3 ................................9180 Electrolyte Analyzer 5 System components Table of contents System components In this chapter Chapter 5 System description ...... B-10 Roche Instructions for Use · Version 7....................B-7 Measuring chamber .........................B-9 Rear panel .................B-8 Valves ...........................................................................................................................................................B-5 Display ............................................................................................................................................................................

1 .5 System components 9180 Electrolyte Analyzer Table of contents Roche B-4 July 2013 Instructions for Use · Version 7.

1 July 2013 B-5 .9180 Electrolyte Analyzer 5 System components System description System description Analyzer components B C D E A A ISE SnapPakTM D Front cover B Display E Sample door C Keypad Figure B-1 Roche Instructions for Use · Version 7.

With these keys. Na K Cl READY Figure B-3 Keypad The communication with the analyzer is performed through a keypad with YES and NO keys. including: sample measurement. programming and quality control testing can be performed. displaying the activities of the analyzer. Figure B-4 Roche B-6 July 2013 Instructions for Use · Version 7.5 System components 9180 Electrolyte Analyzer System description B C D A E F A Peristaltic pump D Sample door B Thermal printer E Valves C Measuring chamber F Discharge point Figure B-2 Display The analyzer communicates to the user through a dot matrix display. all analyzer functions. data input.1 . alpha-numeric read-out allows up to 16 characters per line. This two line. sample results and other programmed information.

Figure B-5 Measuring chamber The measuring chamber consists of the movable left locking device that holds the electrodes in place.1 July 2013 B-7 . electrode voltages. the right electrode holder with sample sensor connector. and amount of liquid remaining in the SnapPak as well as cleaning and maintenance information. the electrodes. calibration values. The unit is configured to allow convenient storage of a second roll of paper in the paper tray.9180 Electrolyte Analyzer 5 System components System description Printer The thermal printer uses heat-sensitive paper to output information in 16 columns. and the measuring chamber base. Figure B-6 Peristaltic pump A peristaltic pump transports all sample and operating fluids inside the instrument. The analyzer will print measured values. Figure B-7 Roche Instructions for Use · Version 7.

1 . Figure B-9 Roche B-8 July 2013 Instructions for Use · Version 7. Figure B-8 Valves Valves control the movement of the liquid within the analyzer.5 System components 9180 Electrolyte Analyzer System description Sample probe mechanism The sample probe mechanism is located behind the sample door at the front of the unit.

as well as the power switch/ power receptacle module and an RS232 interface port.9180 Electrolyte Analyzer 5 System components System description SnapPak The self-contained SnapPak is constructed to ensure that waste cannot spill out of the package. Figure B-11 Roche Instructions for Use · Version 7.1 July 2013 B-9 . Attention Do not touch the contact surface of the smart memory chip! Figure B-10 Rear panel The rear panel of the unit contains a serial number plate.

Roche B-10 July 2013 Instructions for Use · Version 7. This must be checked by suitably qualified personnel. A higher leakage current can be expected when using the serial interface. e Refer to COMPACT 2/3 Instructions for Use for details. depending on the local regulations. The analyzer can be connected to COMPACT 2/ 3 systems via the 9-pin DB-9 connector to output a common measurement report.5 System components 9180 Electrolyte Analyzer System description Serial port The analyzer is equipped with a serial RS232 interface and allows data to be exchanged with commercially available computer systems.1 . The interface is always active. Measurement data is transferred after each measurement and calibration data is transferred after each calibration. and data is sent independently of the printer setup.

. . . . . . . . . . . . . . . . . . . . . . . . . . C-43 July 2013 . . . C-3 7 Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-23 8 Quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Operation C 6 Installation and Shutdown . . . . .

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...................................... C-20 5....................................................1 July 2013 C-3 ............................................... C-6 Preparing the Analyzer for Operation ....................................................................................................................... C-18 1........................... Installing the relief clamps and removing the pump windings ............................9180 Electrolyte Analyzer 6 Installation and Shutdown Table of contents Installation and Shutdown In this chapter Chapter 6 Installation .............................................................................. Start-up ................ C-13 6.......................................................................................................................... Removing the electrodes and the shutdown plug ..... Setting date and time ............... C-17 Shutdown ....................................................... C-12 5................... Selecting language .... Installing the printer paper .......................................................... C-19 3... C-11 1................................................................................................................................................................................................. Installing shutdown plug ................................... Turning the analyzer "off" ........................... Daily Maintenance (manual) ............. C-19 4............. C-5 Accessories .................................................................................... C-5 Setting up .................................. Washing the lines ................................. C-6 Electrodes and measurement chamber .............................................................. Installing the SnapPak ................................... C-20 6..... C-11 2.................... C-12 4...................................................................................... C-22 Roche Instructions for Use · Version 7...................................................... C-11 3.......................... C-5 Location ............................................................... C-18 2............ Selecting parameter configuration ............... C-14 7..................................................... Installing the transport housing ......................................................................................................

6 Installation and Shutdown

9180 Electrolyte Analyzer

Table of contents

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9180 Electrolyte Analyzer

6 Installation and Shutdown
Installation

Installation
Location
Location is important for optimal operation of your analyzer. Before you begin setup,
choose a site that is convenient for your sampling needs and meets the following
physical requirements of the unit:
o

Ambient temperature + 15°C to + 32°C.

o

Avoid exposure to direct sunlight, vibration and strong electromagnetic fields
(electric motors, transformers, X-ray equipment, cellular phones, etc.).

o

Use a stable and level work surface.

o

Maximum relative humidity of 85 % (15 % - 85 %).

o

Ample room to allow air to circulate freely around the unit.

o

Avoid exposure to explosive gases or vapors.

o

Check for correct voltage: 100 to 240 VAC, 50/60 Hz.

After setting up the 9180 Electrolyte Analyzer in a location that meets the above
requirements, perform the following steps to ensure the instrument is ready for
operation:
o

Refer to the packing slip to check for the completeness of the shipment.

o

If the shipment is incomplete, please inform your Roche representative
immediately.

If the instrument was damaged during shipment, immediately inform the company
that made the delivery. Retain all packaging materials and products as this may be
needed as evidence in the event of a damage claim.

WARNING

Do not remove the analyzer from the shipping carton by pulling upward on the polystyrene
(styrofoam) packing materials. These packaging materials do not provide strength to
support the analyzer.

Accessories
The following parts are delivered as standard equipment with the 9180 Electrolyte
Analyzer:
o

Printer paper

o

Electrode Dummy

o

Quad Ring, 1.78x1.02 mm

o

Fuse set

o

Sample probe stylet

o

Syringe, 10 mL, with tapered tip

o

Quick Reference Guide

You also need a supply of lint-free tissues and disposable sample cups, which should
be kept in a location convenient to the analyzer.

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6 Installation and Shutdown

9180 Electrolyte Analyzer

Installation

Setting up
Prior to beginning the actual installation, it is recommended to completely read
through this chapter to develop an understanding of the procedures that are required.
Begin by placing the analyzer on a secure table top that allows plenty of working
space and is convenient to a power connection.
Open the analyzer main door. Locate and carefully remove the five red relief clamps.
Save the clamps for reuse to prevent damaging the tubes, if the analyzer is later shut
down for any reason.
TIP:
Save the relief clamps for reuse to prevent damaging the tubes, if the analyzer is later shut
down (see section Shutdown on page C-18).

(A)

(B)

Figure C-1

Slip the two pump windings around the analyzer pump rollers, making sure not to
overstretch the tubing.
Electrodes and measurement chamber
The next procedure involves preparing and installing the electrodes in the
measurement chamber.
o

Remove the reference housing and electrodes from their protective boxes and
place them on a soft, clean surface. Check to make sure each electrode has an oring on the left side.

Figure C-2

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Rinse. Figure C-3 o Carefully screw the reference electrode into the reference electrode housing and place it with the other electrodes.9180 Electrolyte Analyzer 6 Installation and Shutdown Installation o Unscrew the red transport housing from the reference electrode and check that the o-ring on the electrode is properly seated.1 July 2013 C-7 . Figure C-5 Roche Instructions for Use · Version 7. o Unclamp the left electrode holder by moving the clamp forward. A B C A Reference electrode housing B Reference electrode C Red transport housing Figure C-4 o Slide the measurement chamber forward until it locks in the front position. dry and save the transport housing for storage of the reference electrode in the event the analyzer is turned off or taken out of service for any reason.

Check that an o-ring is present in the right electrode holder. Figure C-7 Roche C-8 July 2013 Instructions for Use · Version 7.1 . lithium or a dummy electrode. Also.6 Installation and Shutdown 9180 Electrolyte Analyzer Installation o Locate the sample sensor cable and ensure that it is securely inserted in the receptacle above the measurement chamber. the potassium electrode is replaced by a dummy electrode. Figure C-6 Now install the electrodes in the measurement chamber. ionized calcium. note that all electrodes have a lip on the bottom that rests on the flat edge of the measurement chamber to aid in proper positioning. TIP: The electrode on the right may be one of the following: chloride. if no third test is needed. beginning on the right and working to the left (the reference electrode will be installed last). o Check to make sure that the lettering on the electrode corresponds with the proper electrode station number on the tray. If sodium and lithium are selected.

9180 Electrolyte Analyzer 6 Installation and Shutdown Installation o After all electrodes have been installed. Figure C-9 Roche Instructions for Use · Version 7. Figure C-8 o Slide the measurement chamber back until it snaps into position. close the clamp on the left electrode holder by lifting it upward until it locks in the back position. and ensure that the electrodes are properly seated.1 July 2013 C-9 .

see section 7. + Na K + - Cl / Ca 2+ / Li + Parameter configurations Na+ Na+ Na+ Na+ Na+ K+ K+ Dummy K+ Dummy Dummy Cl- Cl- Ca2+ Ca2+ Electrode pos./ Ca2+ / Li+ Table C-1 Parameter configurations Na+ Na+ (Na+) Na+ K+ Dummy Dummy Ca2+ Li+ Li+ Li+ Li+ Parameter configurations Use of calibration solutions. electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee. Selecting parameter configuration on page C-17. Na+ K + Cl. Figure C-10 Possible parameter configuration are the following: Electrode pos.6 Installation and Shutdown 9180 Electrolyte Analyzer Installation o Plug the tubing connector of the reference housing assembly in the receptacle below the left side of the measurement chamber. Roche C-10 July 2013 Instructions for Use · Version 7.1 . e For details.

50/60 Hz). Selecting language Before the analyzer is powered on. the language setting must be selected. 2. The factoryset language is English. Figure C-12 Roche Instructions for Use · Version 7.9180 Electrolyte Analyzer 6 Installation and Shutdown Installation Preparing the Analyzer for Operation 1. TIP: If you decide to change the language after the unit is powered on. then plug the cord into a grounded electrical outlet (100 . Figure C-11 o Push the power switch to the ON (I) position.1 July 2013 C-11 . o Remove the paper tray and use a pen to set the switch to the desired language position as indicated on the label. Start-up o Locate the power switch on the back of the unit and make sure that it is in the OFF (O) position. The unit will automatically begin to operate. you must cycle the power to activate the new language.240 V. o Plug the power cord into the power receptacle module on the back of the unit.

press YES and the cursor will move to the month. TIP: After start-up. the analyzer will automatically scroll through the numbers. date and time should be set and the printer paper inserted. the analyzer will prompt: [STATUS: NO SnapPak]. To accept this value. Use the NO key to make changes. Setting date and time The analyzer will display a default date and time and will allow the operator to input the correct date and time: Date: 01-JAN-02 dd-mmm-yy Time: 00:00 hh:mm To enter the correct date and time: o Press NO. Installing the SnapPak Use of calibration solutions. the actual date will be displayed. Save the protective strip for the case of a shutdown or disposal. o Remove the protective strip and slide the SnapPak into position on the left side of the analyzer. or press NO to make a change. To accept this value. begin using the keypad interface to communicate with the instrument. the analyzer will prompt [ok?]. press YES. o After entering the time. then faster. 3. Now.6 Installation and Shutdown 9180 Electrolyte Analyzer Installation Now that the 9180 Electrolyte Analyzer is functioning. o By keeping the NO key depressed. o Record the installation date of the SnapPak on the label on the SnapPak. the YES key to accept the displayed values or information. until the actual day is displayed.1 . press YES. first slowly. o Press NO. To accept this value. o Press NO. electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee. until the actual month is displayed. o Follow the same procedure to enter the current time. Press YES if the date and time entered are correct. o After pressing YES at the last prompt. 4. until the actual year is displayed. Figure C-13 Roche C-12 July 2013 Instructions for Use · Version 7.

Roche Instructions for Use · Version 7.1 July 2013 C-13 . press YES. To change the roll: o Place a new paper roll in the paper tray and thread it into the feeder slot. Figure C-15 TIP: By pressing the paper advance button once. o Again. press YES. Save the protective strip to use to close the nipples on the SnapPak prior to disposing. Please make sure that you insert the paper roll correctly. the paper will automatically advance 10 lines. 5. Figure C-14 o Press the paper feed button to completely feed the paper throught the printer.9180 Electrolyte Analyzer 6 Installation and Shutdown Installation Once the protective strip is removed. o At the prompt [New SnapPak Installed?]. Installing the printer paper TIP: The printer paper is heat sensitive on one side only. at the prompt [Are you sure?]. be sure to keep the SnapPak upright to avoid spillage. The thermal printer paper supplied by Roche Diagnostics contains an indicator strip to alert you when the paper roll should be changed.

6 Installation and Shutdown 9180 Electrolyte Analyzer Installation Do not pull the paper out of the printer to avoid damage to the printer. Figure C-16 Roche C-14 July 2013 Instructions for Use · Version 7. The process involves cleaning and conditioning the sample path and electrodes. In some cases. an alarm will sound and the unit will discontinue its current operation.1 . when the analyzer prompts you for an action and you do not respond within a set period of time. Select [Perform Daily Cleaning?] by pressing YES. along with a package of lint-free tissues that will be used to dry the probe. This procedure is called daily maintenance. Now perform the initial Daily Maintenance. o At the prompt [Open Sample Door Introduce Sample]. which prepares the 9180 Electrolyte Analyzer for calibration. until [DAILY MAINTENANCE?] is displayed. Check expiration date on the bottles of the Cleaning Solution and the Electrolyte Conditioning Solution. Daily Maintenance (manual) Prior to performing the first calibration or running the first sample. and YES to select. the 9180 Electrolyte Analyzer needs to undergo a simple cleaning and conditioning procedure that helps ensure that the analyzer will perform properly. o Pour a small amount of Cleaning Solution into a clean container. The bottles containing Cleaning Solution and Electrolyte Conditioning Solution should be ready. 6. lift the sample door and the pump will begin to aspirate. because it must be performed each day the analyzer is used to conduct sampling. To start the daily maintenance: o Press the NO key.

Close the sample door. and use a lint-free tissue to remove the cleaning solution from the probe. o At the prompt [Open Sample Door Introduce Sample].1 July 2013 C-15 . pour a small amount of conditioning solution into a clean container.9180 Electrolyte Analyzer 6 Installation and Shutdown Installation o Hold the Cleaning Solution under the probe. o Answer the prompt [Perform Daily Conditioning?] by pressing YES. Figure C-18 Roche Instructions for Use · Version 7. lift the sample door and the pump will begin to aspirate. until [Wipe Probe/Close Sample Door] is displayed. Figure C-17 o While the analyzer displays [Thank You!] and a brief countdown.

6 Installation and Shutdown

9180 Electrolyte Analyzer

Installation

o

Hold the Electrolyte Conditioning Solution under the probe, until
[Wipe Probe/Close Sample Door], use a lint-free tissue to remove the
conditioning solution from the probe. Close the sample door.

Figure C-19

o

After the analyzer has displayed [Thank You!] and a brief countdown, the
prompt [Remain in Daily Maintenance?] can be answered with NO, and an
automatic calibration will be started.

It is very important that the main door is closed during calibration, since it provides
shielding from sources of electromagnetic and electrostatic interference.
Before working on ESD critical parts discharge yourself by touching the discharge point
(see Figure B-2 on page B-6).
Calibration is an automatic process. During this time, the analyzer is conducting
measurement operations to ensure the accuracy of the instrument. Occasionally, additional
time is required, and the analyzer displays an asterisk.

o

Roche
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After finishing the calibration, the analyzer returns to [READY] and is now ready
for QC.

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9180 Electrolyte Analyzer

6 Installation and Shutdown
Installation

7. Selecting parameter configuration
After completion of the daily maintenance procedure, the analyzer starts an
automatic calibration for sodium and potassium.
To select a different parameter configuration, interrupt the calibration by pressing
NO.
o

Continue pressing NO, until [OPERATOR FUNCTIONS?] is displayed. Press
YES.

o

Press NO until the prompt [Select Parameter Configuration?] is displayed, see
Table C-1. Press YES and the current configuration will be displayed. The default
configuration is the following:
Sel. Parameter:
[Na] [K] [ ] ok?

o

Press NO until the desired configuration is displayed. Press YES to accept this
selection.

If [(Na)][ ][Li] is selected, only lithium is reported. Install the sodium electrode and
calibrate for lithium.
In order to ensure the quality of the measurement results, complete a quality control test
on 3 levels (1=low, 2=normal, 3=high) after each electrode exchange, after each
replacement of the SnapPak, after startup of the instrument as well as after monthly, semi
annual and annual maintenance steps.
Additionally, at least once daily one QC measurement has to be performed in alternating
levels (1=low, 2=normal, 3=high) (e.g., day 1 - level 1, day 2 - level 2, day 3 - level 3, day 4
- level 1, etc.). When required by local regulations, QC measurements must be performed
more often.
A quality control program for electrolytes includes the analysis of sample materials with
known ranges of expected values and the comparison of these values with analyzer
results.
e For further information, see Chapter 8 Quality control.

The 9180 Electrolyte Analyzer is now ready to operate.

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6 Installation and Shutdown

9180 Electrolyte Analyzer

Shutdown

Shutdown
A complete shutdown of the analyzer may be indicated to prepare the analyzer for
shipping or in case the analyzer is not being used for an extended period of time. For
this procedure, you will need a special shutdown kit (not supplied with the analyzer).
Never attempt to turn the power off for an extended period of time without performing a
complete shutdown of the analyzer.
WARNING

In case the analyzer is not being used for several days only, it is not recommended to
perform a complete shutdown, but to put the analyzer in Standby Mode.

To perform the shutdown, you will need the following items:
o

One shutdown plug (supplied with shutdown kit).

o

Five solenoid relief clamps (supplied with analyzer and shutdown kit).

o

Two reference electrode transport housings (supplied with shutdown kit).

o

Two containers, one filled with at least 100 mL of distilled water, the other one
empty.

o

Protective strip for SnapPak (supplied with shutdown kit).

Starting at the [READY] display, do the following:
o

Press NO until [OPERATOR FUNCTIONS?] is displayed. Press YES.

o

Select [Take out of Operation?] and press YES.

o

Confirm [Are you sure?] by pressing YES.

1. Installing shutdown plug
The analyzer prompts [Shut Down Plug & Water Installed?].
o

Remove the SnapPak and push the protective strip firmly onto the SnapPak
connector.

o

Fill one container of the shutdown kit about halfway with distilled water.

o

Insert the shutdown plug carefully into the SnapPak receptacle.

o

Place the blue marked line into the disposable container filled with distilled water.

o

Place the red marked line into the empty container.

o

Begin the tubing wash procedure by pressing YES.

Figure C-20
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Upon completion. o Pour the remaining reference solution in the reference housing into a transport housing. making sure all electrodes are seated properly. o Temporarily place the reference electrode on a clean. Installing the transport housing o The analyzer will prompt [Transport Ref Housing Installed?]. Figure C-21 3. o Press YES. o Pull the electrode holder forward and remove the reference electrode assembly.1 July 2013 C-19 . soft cloth.9180 Electrolyte Analyzer 6 Installation and Shutdown Shutdown 2. The electrode holder remains in the forward position. [All Electrodes & Plug Removed?] will be displayed. o Remove the line with the blue mark from the distilled water and place it on a cloth. o Carefully unscrew the reference electrode from the reference electrode housing. e See Figure C-22. Washing the lines The analyzer will take approximately one minute to flush all lines with water. o The second transport housing is screwed into the reference housing. o Place the reference housing back into the electrode holder and move the lever backwards. During this cycle. o Carefully screw the reference electrode into the filled transport housing. all lines are purged of distilled water. A A Line with the blue mark Figure C-22 Roche Instructions for Use · Version 7. o Press YES.you will receive the prompt [Remove Water and Press YES]. o Upon completion.

o Unscrew the transport housing from the reference housing. placing them on a soft cloth. The relief clamps can be installed at the following positions: o o o o o A B C V R Figure C-24 o Press YES. Figure C-23 5. o Empty the reference housing and place all electrodes into their protective boxes.6 Installation and Shutdown 9180 Electrolyte Analyzer Shutdown 4. Never insert the solenoid relief clamps with the SnapPak in place. o Move the lever back and push the empty electrode holder into its back position. Installing the relief clamps and removing the pump windings The display will prompt [All 5 Relief Clamps Inserted?]. o Move the lever on the left side forward and remove all electrodes. WARNING Roche C-20 July 2013 Instructions for Use · Version 7. Removing the electrodes and the shutdown plug o Remove the shutdown plug from the SnapPak receptacle. o Unplug the reference connector below the left side of the electrode holder.1 . o Press YES. o Install the red relief clamps making sure that they are snapped securely into position.

printer settings. e See Chapter 10 Troubleshooting. Also. all QC values and statistics will be deleted and the sample number is reset to 0. all service codes are deactivated. A deletion of all data is recommended in case the analyzer is used by different laboratory later on. o Repeat the same procedure for the rear pump winding. The prompt [Do You Wish to DELETE All Data?] will appear. date/ time and SnapPak volume are reset to default. Roche Instructions for Use · Version 7. QC and normal ranges as well as correlation factors.1 July 2013 C-21 . Figure C-25 o Press YES. section Clearing all data on page E-16. o Grasp the front winding close to the pump roller and gently pull it off the roller. o By pressing YES. o Press NO to retain all data.9180 Electrolyte Analyzer 6 Installation and Shutdown Shutdown o The prompt [Pump Windings Relieved?] appears.

e see Chapter 9 Maintenance. July 2013 Instructions for Use · Version 7. o Unplug the power cord from the receptacle.1 . section Clean sample probe and fill port on page D-8. o Clean all external surfaces of the analyzer as well as the areas accessible through the main door and sample door.6 Installation and Shutdown 9180 Electrolyte Analyzer Shutdown 6. o Use the original packaging when transporting the analyzer. dry or with water moistened cloth. Electrical contacts may only be cleaned with a clean. o Close the front door. Never use disinfectants or Roche Deproteinizer! Roche C-22 o Shutdown is complete. o Turn the analyzer off. Turning the analyzer "off" o The prompt [Shutdown Complete Turn Power Off] will appear.

... C-26 Capillary tubes ..................................................... C-33 General .............. C-34 Direct ISE ............ C-34 Sample measurement ................................................................................................................ C-26 Roche MICROSAMPLER PROTECT ....................................................................................................................................................................................................................................................... C-31 Limitations of clinical analysis ............................................................... C-25 Sample collection containers ................................................................................................................................................................................................................................................................................................................................ C-25 Safety ..................................................................................................................................... C-25 Sample requirements ..................... C-36 Dialysate samples ............................................................................................................................................ C-37 Roche Instructions for Use · Version 7.... C-30 Substances with effect .................... C-28 Interference ........................................................................................................................................................................................................................ C-25 Acceptable anticoagulants ................................................................................ C-28 Dialysate ..... C-25 Sample collection ....... C-33 Measuring procedure .............................................................................................................................................................................................................................................................1 July 2013 C-23 ............ C-26 Sample handling ................................................................... C-26 Syringes .................................................................................................................... C-27 Plasma .. C-27 Whole blood .................................. C-31 Effect of the substances (plasma samples) ...................... C-33 Electrolytes ... C-27 Serum ................................................................................... C-29 Plasma samples ................................................................................... C-31 Effect of the substances (whole blood samples) .............................................................................................................................. C-27 Aqueous solutions ...............................9180 Electrolyte Analyzer 7 Measurement Table of contents Measurement In this chapter Chapter 7 Preanalytics .......................................................................................................................................................................................................................................................................................................................................................................................................... C-29 Substances without effect ............... C-29 Whole blood samples ..................................................................................................

......................................................................................................................................... C-42 Roche C-24 July 2013 Instructions for Use · Version 7....................................................................................................................................1 .................... C-37 Normal ranges (reference values) ...................................................... C-39 Additional settings ....................................................................................................................................... C-41 Printer settings . C-38 Correlation factors ..................................................7 Measurement 9180 Electrolyte Analyzer Table of contents Urine samples .............................. C-41 Interface settings .........................................

“Protection of Laboratory Workers from Occupationally Acquired Infections. e See.9180 Electrolyte Analyzer 7 Measurement Preanalytics Preanalytics Sample collection Safety Follow the usual applicable safety precautions when drawing blood samples. which can lead to a distortion of the measured values. such as EDTA. if necessary. oxalate. protective gloves. for example. possibly endangering the patient's health. Other clot inhibitors. which may result in incorrect clinical decisions. electrolyte-balanced heparin anticoagulation salts. It should be noted that non-electrolyte-balanced heparin binds ionized calcium. this may lead to incorrect patient measurements. (2004)”. Use only lithium-free sampling containers for the determination of lithium measurement values! If sample containers are used which contain lithium as an anticoagulant. there always exists the danger of transmission of HIV. masks must be worn in order to prevent direct contact with biological substances. citrate. Approved Guideline—Third Edition. and ammonium. safety glasses and. Employ suitable blood sampling techniques in order to reduce risk to personnel. are recommended. Acceptable anticoagulants For whole blood and plasma samples. “Procedures for the Collection of Arterial Blood Specimens. CLSI document H11-A4. The puncture site may never be squeezed! Mixing the blood sample with tissue fluid may lead to the premature onset of clotting despite sufficient heparinization of the sample collection containers! Incorrect sample collection or the use of an unsuitable sample collection container may lead to errors and discrepancies in the measurement values. Suitable safety equipment such as laboratory clothing. If there is a danger of splashes. Sample requirements Blood for analysis must be drawn by qualified personnel. hepatitis B and C viruses or other pathogens transmissible by blood. for detailed information about blood sampling. storage. for further information on safe handling of specimens. Approved Standard—Fourth Edition.based materials have significant influence on parameters and may not be used for this reason. When handling blood samples. Electrolyte-balanced sodium heparin can also be used as anticoagulant in the electrolyte analysis. Suitable disinfection procedures must be used.1 July 2013 C-25 . a safety visor is also required. and handling. e Please refer to CLSI document M29-A3. (2005)”. fluoride. Roche Instructions for Use · Version 7. which have no influence on the electrolyte levels.

This will minimize the effects of the clot inhibitor on the thinning of the blood. Roche MICROSAMPLER PROTECT To make arterial sample collection technically easier. from capillary tubes or the Roche MICROSAMPLER PROTECT. The 9180 Electrolyte Analyzer will accept samples directly from syringes. with the use of an adapter. Do not use sampling containers containing silicone! Syringes If using another manufacturer's product with liquid heparin as a clot inhibitor. remove these rods before inserting the sample in order to avoid clogging the sample path of the instrument. The Roche MICROSAMPLER PROTECT consists of one curved plastic capillary tube (~220 μL) in a plastic container and is ideally suited to atraumatic arterial blood collection. the collection container should not be larger than required for the blood volume. especially the ISE parameters! Capillary tubes Capillary tubes must have a minimum volume of 100 μL. When using stirring rods like those offered by a few manufacturers. use the sample collection systems manufactured by Roche. Improper use of syringes with liquid heparin will affect the parameters. the Roche MICROSAMPLER PROTECT was developed. this may lead to incorrect patient measurements. Use only heparinized syringes. possibly endangering the patient's health. Each laboratory should determine the permissibility of sample containers that are used. Roche C-26 July 2013 Instructions for Use · Version 7. which may result in incorrect clinical decisions.7 Measurement 9180 Electrolyte Analyzer Preanalytics Sample collection containers TIP: When possible.1 . collection tubes. Use only lithium-free sampling containers for the determination of lithium measurement values! If sample containers are used which contain lithium as an anticoagulant. These products vary from manufacturer to manufacturer and sometimes from lot to lot. The use of sample containers or clot inhibitors other than those manufactured by Roche may lead to adulteration of the samples and errors and differences in the measurement values. Roche developed a specialized sample collection container for this purpose and recommends its use for this reason. sample cups and.

o Samples that are measured within 15 minutes may be retained at room temperature. Plasma samples older than 1 hour must be re-centrifuged in order to remove fibrin clumps that may have formed. process the sample in a centrifuge to separate the cellular. from lot to lot. and at times. close the sample container tightly and cool it to 4 . If a sample has been cooled. place them temporarily in ice water. Contact with ambient air will cause a loss of CO2 in the sample and the subsequent rise in pH will cause a reduction in ionized calcium. Despite proper sampling procedures. Each laboratory should determine the permissibility of sample containers that are used. If it is necessary to store the sample. errors can arise in the analysis: o due to insufficient mixing of the sample after sampling and before the measurement o due to ambient air contamination caused by air bubbles that are not removed after sampling o due to changes in metabolism in the sample Serum After the appearance of spontaneous clotting.8 °C. during which the cellular components of the blood are removed from plasma. Transfer the serum to a suitable sample container and seal. Immediately after withdrawing the sample with syringes. Whole blood Withdraw whole blood samples using heparinized syringes. Roche Instructions for Use · Version 7. anaerobic conditions must be followed for all sample types. following the standard documentation procedure. thoroughly mix the sample with anticoagulant. Variations in these products exist between manufacturers. Complete the measurement within 30 minutes (but not after more than 60 minutes).9180 Electrolyte Analyzer 7 Measurement Preanalytics Sample handling For ionized calcium values.1 July 2013 C-27 . o If unable to measure samples within 15 minutes. Remove air bubbles from the sample collection container immediately after the sampling procedure. Properly label the samples.33 °C) before analysis. Plasma Plasma samples are obtained by centrifuging heparinized whole blood.8 °C. or the Roche MICROSAMPLER PROTECT and analyze the samples as soon as possible after sampling. capillaries. close the sample container tightly and cool it to 4 . If a sample has been cooled. warm it to room temperature (15 . Complete the analysis as quickly as possible. This can be done by rolling the sample between both hands or shaking. warm it to room temperature (15 . solid components and the fibrin from the watery serum.33 °C) before analysis. If it is necessary to store the sample.

The Standard Mode ALWAYS reports direct ISE values and is not affected by correlation factors or the setting of QCC. the dialysate mode is not available. always bring the sample to room temperature. such as Standard A. e see Chapter 10 Troubleshooting.7 Measurement 9180 Electrolyte Analyzer Preanalytics Aqueous solutions Aqueous samples. though preferably capped and placed in the refrigerator. If lithium is activated. Prior to measurement. Dialysate samples can be stored longer than whole blood. section Service codes on page E-14.1 . Roche C-28 July 2013 Instructions for Use · Version 7. have to be measured in the Standard Mode. Dialysate Either acetate or bicarbonate dialysate fluids may be analyzed.

000 mmol/L K.000 mmol/L K.0034 mmol/L Cl. Plasma samples Substance Concentration Tested analyte Acetoacetic acid (3-Oxobutyric acid) 2.0675 mmol/L Cl. Ca.0063 mmol/L Cl.200 mmol/L Cl. possible sources of interference cannot be identified during ongoing operation. While the precision can be determined by internal QC and the correctness can be determined by verifying reference samples.425 mmol/L Cl. Li Chlorpromazine 0. For this reason. Ca.324 mmol/L Cl. Li EDTA (Ethylenediaminetetraacetic acid) 0. 27 of the Clinical and Laboratory Standard Institutes (CLSI). Approved Guideline EP-7 Vol. Na.152 mmol/L Cl. Na. Substances that violate the specified limits of correctness and cause a significant deviation of the measured value.620 mmol/L Cl. The deviations as a function of the concentrations are specified in Table C-4 and Table C-5. Interferents can be a significant source of error in clinical analyses. Cl Magnesium acetate 15.546 mmol/L Cl. Na. Substances that impair precision. Li Paracetamol 1. No.1 Substances without effect (plasma samples) July 2013 C-29 .200 mmol/L K. Na. refer to Interference Testing in Clinical Chemistry. Cl. but for which the deviation is within the limits of correctness (see Table C-4 and Table C-5) and 3. Li Calcium chloride 5. The results of the interference measurements have been divided into 3 categories: 1.292 mmol/L K. but show no effect on the measurement parameters and thus do not violate the specifications. Cl Acetylcysteine 10. Li Hemoglobin 2. Substances without effect The following substances were tested. Li Aspirin (Acetylsalicylic acid) 3. Li Isoniazid 0. Li Ampicillin 0.9180 Electrolyte Analyzer 7 Measurement Interference Interference The measuring module and measuring sensors were tested with respect to their interference stability with the given chemical substances and pharmaceuticals. Cl. Li Table C-2 Roche Instructions for Use · Version 7.000 mmol/L Li Cefoxitin 1. Substances that do not impair precision and thus show no effect of interference (refer to Table C-2 and Table C-3).000 g/L Cl. 2. Li Lithium acetate 3. Li Metronidazole 0. Li Ibuprofen 2. the effect of potentially interfering substances was determined.701 mmol/L K. Cl. 25. Li Doxycycline 0. e For additional information.

Li Benzalkonium chloride 0.0 Cl. Cl. Li Rifampicin 0. c=1% Whole blood samples Substance Concentration Tested analyte Acetone 12. Li Sodium bromide 37. Ca. total 0.34 mmol/L Cl. Ca.0781 mmol/L Cl. Cl Vancomycin 0. Cl. Cl.620 mmol/L K.000 mmol/L Li Potassium thiocyanate 6.442 mmol/L K.1 . Cl Sodium iodide 2. Ca. Li Aspirin (Acetylsalicylic acid) 3. Li Ethanol 86. Na. Cl. Cl Triglyceride 37. Cl (a)[1] Table C-2 Substances without effect (plasma samples) (a) Lipidem was used to represent the Triglycerides. Cl Sodium Bicarbonate (Sodium Hydrogen Carbonate) 35.990 mmol/L K.431 mmol/L K. Na Bilirubin. Ca. Li Propofol 1. Ca.000 U/L K. Na. Na. Ca. Li Salicylic acid 4. Cl. Li pH (high) ~8.7 Measurement 9180 Electrolyte Analyzer Interference Substance Concentration Tested analyte Phenobarbital 0. Na. Cl. Li Sodium heparin 3000. Ca.0% K. Na.069 mmol/L K. Li Table C-3 Roche C-30 Substances without effect (whole blood samples) July 2013 Instructions for Use · Version 7. Li Creatinine 0.000 mmol/L K. Na.5 mmol/L Ca Sodium iodide 2. Na. Cl.99 mmol/L Ca.342 mmol/L K.880 mmol/L Li Protein human (high) >9. Na.8 mmol/L Ca. Cl. Ca.0285 mmol/L Ca.105 mmol/L K.0 % K. Ca.0 mmol/L K. Li Sodium fluoride 0. Ca. Li Potassium chloride 7.000 mmol/L Cl. Cl.

95 ± 2.0107 mmol/L Li 0.13 Effect of the substances (whole blood samples) Roche Instructions for Use · Version 7.13 0.05 ± 0.88 4.71 ± 12.28 4.10 0.08 4.7 mmol/L Cl 99.7 -7.08 2.720 mmol/L Cl 104.0071 mmol/L Li 0.0 mmol/L Li 0.31 0.01 0.7 -5.01 0.08 3.02 ± 0.47 ± 20.00 2.50 Ca 1.2 5.880 mmol/L Cl 104.46 4.53 ± 0.3 12.63 ± 4.50 [mmol/L] Magnesium acetate 15.500 mmol/L Ca 1.000 mmol/L 1.23 ± 0.18 ± 1.1 Ca 11.12 4.3 mmol/L Cl 99.08 0.0143 mmol/L Li 0.35 * 4.02 0.32 2.32 0.13 Cl 103.2 2.0 mmol/L Li 0.01 0.21 ± 0.68 4.08 0.02 4.00 0.00 Li 0.58 4.08 Na 137.11 ± 0.5 56.08 7.04 ± 0.54 4.13 Cl 103.4 mmol/L Cl 99.750 mmol/L Ca 1.1 mmol/L 18.13 0.14 ± 0.04 0.00 1.33 ± 0.8 -2.8 51.0285 mmol/L Li 0.47 ± 0.13 170. Effect of the substances (whole blood samples) Substance Concentration of Parameter the substance Parameter Effect of the substance ± Trueness concentration (MV) [mmol/L] [mmol/L] [mmol/L] Benzalkonium chloride Table C-5 0.26 ± 0.90 2.02 ± 0.12 Effect of the substances (plasma samples) * Sodium value is over 169.54 4.01 0.01 0.250 mmol/L Ca 1.06 0.00 5.2 8.73 ± 1.08 6.72 4.00 37.10 ± 0.0214 mmol/L Li 0.02 0.12 9.02 0.23 ± 0.160 mmol/L Cl 104.5 31.5 mmol/L and therefore no Lithium value can be evaluated.36 0.01 0.32 0.07 0.07 0.01 0.70 ± 0.0 mmol/L Cl 99.13 ± 0.00 Li 0.08 3.1 July 2013 C-31 .00 4.17 ± 1.440 mmol/L Cl 104.23 2.10 0.8 mmol/L Sodium chloride Table C-4 138.375 mmol/L Ca 1.03 0.46 ± 0.87 Li 0.81 0.00 3.250 mmol/L Potassium thiocyanate Na Cl 104.79 0.56 ± 8.00 7.03 0.35 * 0.00 180.59 ± 0.05 0.07 0.9 -4.500 mmol/L Ca 1.35 -0.5 mmol/L Sodium bromide 28.34 * 0.9180 Electrolyte Analyzer 7 Measurement Interference Substances with effect Effect of the substances (plasma samples) Substance Concentration of Parameter the substance Parameter Effect of the substance ± Trueness concentration (MV) [mmol/L] [mmol/L] 2.06 ± 0.08 0.

82 ± 0.1 6.12 Cl 105.13 4.00 Ca 1.64 0.29 ± 0.01 0.06 0.46 4.1 .29 ± 0.08 Li 0.44 0.17 mmol/L K 3.46 2.20 Cl 103.31 0.06 0.19 ± 0.21 ± 0.22 -0.12 ± 0.12 1.0 4.24 ± 0.01 0.00 2.5 mmol/L 28.50 Cl 105.00 Li 0.12 Na 138.7 -3.00 Ca 1.51 4.58 4.21 -0.43 0.8800 mmol/L Na 138.11 0.02 0.34 mmol/L K 3.10 K 4.06 0.2 13.8 66.99 ± 0.44 0.26 2.8 7.20 3.01 0.30 4.07 ± 0.56 * 0.2 3.23 ± 0.64 0.0 mmol/L Table C-5 C-32 4.45 0.5 mmol/L and therefore no Lithium value can be evaluated.7200 mmol/L Salicylic acid Sodium bromide 37.8 47.1 5.00 Effect of the substances (whole blood samples) * Roche K Cl Sodium value is over 169.43 ± 0.07 ± 0.20 Cl 102.01 0.3 mmol/L Cl 102.20 2.00 Ca 1.43 0.40 ± 0.52 ± 1.56 * 0.08 Li 0.12 Na 139.96 ± 0.26 mmol/L K 3.31 4.66 0.57 -0.24 ± 0.4 mmol/L 7.8 mmol/L 9.7 mmol/L Cl 102.37 4.08 ± 0.44 ± 0.02 0.09 mmol/L K 3.20 5.63 0.07 ± 0.13 ± 0.73 4.20 Cl 107.77 4.34 2.1 mmol/L 18.0036 mmol/L Li 0.05 ± 0. July 2013 Instructions for Use · Version 7.20 107.00 Li 0.00 Li 0.1 30.05 0.19 ± 0.64 4.12 4.02 ± 0.21 -0.07 2.07 0.91 ± 4.06 0.1600 mmol/L 3.01 0.50 Cl 105.00 K 3.19 2.08 Li 0.13 6.75 ± 1.10 K 4.2 -3.04 ± 0.4400 mmol/L 1.06 0.11 ± 0.19 ± 0.38 0.11 ± 1.7 Measurement 9180 Electrolyte Analyzer Interference Substance Concentration of Parameter the substance Parameter Effect of the substance ± Trueness concentration (MV) [mmol/L] [mmol/L] [mmol/L] Potassium thiocyanate 0.00 Li 0.31 ± 0.02 0.00 4.10 K 3.9 -1.20 Cl 107.03 0.01 0.46 ± 8.2 9.20 1.76 ± 0.23 4.51 0.50 Cl 104.

Roche Instructions for Use · Version 7. Hence. Electrolytes It is well-known. taking a blood sample while a pressure bandage is present should be avoided. With respect to the 9180 Electrolyte Analyzer. But since it is not possible to check all medication or substances. see section Interferences on page A-23. In general. that the potassium value of a patient can vary by up to 20 % from the normal state. A detailed discussion of these phenomena can be found at different places in the technical literature. simply because of the presence of a pressure bandage. General The literature lists various substances which may negatively impact upon the measurement result of the blood and plasma/serum sample material. an attempt was made to identify or evaluate these possible influences. the user should be immediately informed with abnormal deviations of the measurement results—as with every clinical analysis—and evaluate the complete picture of the patient or perform expanded measurements in his own laboratory. for example.9180 Electrolyte Analyzer 7 Measurement Limitations of clinical analysis Limitations of clinical analysis The determined performance data can be influenced by known and unknown factors as described below.1 July 2013 C-33 . e For details. if necessary. a local hemolysis caused by pressure should be avoided prior to taking a blood sample.

.level 3.level 2.e.level 1.. Sample measurement The 9180 Electrolyte Analyzer provides fast and easy operation. and must be analyzed in the urine mode. Roche C-34 July 2013 Instructions for Use · Version 7. Suitable blood drawing techniques must be used to minimize risk for operating personnel. the generally valid safety precautions must be followed. a danger of transmission of HIV. which may result in incorrect clinical decisions. 2=normal. safety glasses and. Additionally. When required by local regulations. 3=high) (e. If there is a danger of splashes. complete a quality control test on 3 levels (1=low. Omitting QC measurements or ignoring QC measurement results may lead to incorrect patient measurements. day 1 . day 4 . A quality control program for electrolytes includes the analysis of sample materials with known ranges of expected values and the comparison of these values with analyzer results.level 1. day 3 . In order to ensure the quality of the measurement results. Urine samples require dilution. possibly endangering the patient's health. It is very important that the main door is closed during sampling to provide shielding from sources of electromagnetic and electrostatic interference. day 2 . 2=normal. When handing blood samples. Whenever [READY] appears. at least once daily one QC measurement has to be performed in alternating levels (1=low. the analyzer is ready to perform sample measurements.). if necessary. Hepatitis B and C viruses or other bloodborne pathogens exists. masks must be worn in order to prevent direct contact with biological substances. semi annual and annual maintenance steps. QC measurements must be performed more often. Suitable disinfection and sterilization procedures must be used. Instructions for analyzing urine samples: see section Urine samples on page C-37. a safety visor is also required.g. after startup of the instrument as well as after monthly. etc. Suitable safety equipment such as laboratory clothing. protective gloves.7 Measurement 9180 Electrolyte Analyzer Measuring procedure Measuring procedure SAFETY INSTRUCTIONS When drawing blood samples. after each replacement of the SnapPak. 3=high) after each electrode exchange. all three QC levels must be measured).1 . QC measurements must be performed in their entirety (i.

o Hold the ampoule under the probe until [Wipe Probe Close Sample Door] is displayed. Figure C-26 It is very important that the main door be closed during sampling to provide shielding from sources of electromagnetic and electrostatic interference. Roche Instructions for Use · Version 7. The prompt [Introduce Sample] will be displayed and the pump will start to aspirate.9180 Electrolyte Analyzer 7 Measurement Measuring procedure o Open the sample door. Figure C-27 It is very important that the sample probe is carefully cleaned each time following a sample introduction. o Use a lint-free tissue to clean the probe. then close the sample door when prompted.1 July 2013 C-35 .

7 Measurement 9180 Electrolyte Analyzer Measuring procedure The analyzer will display [Thank You!] and a brief countdown will begin..1 .9 4. At completion of analysis. Sample: STANDARD Sample No. o Press YES.... Roche C-36 July 2013 Instructions for Use · Version 7.1 mmol/L mmol/L mmol/L Figure C-28 Values that are higher or lower than the programmed normal range will be indicated by an arrow pointing up or down.. o Press NO until [QC/STD/DIALYSATE URINE SAMPLE?] appears. section Service codes on page E-14). o The prompt [PRINT FUNCTIONS?] appears.5 mmol/L for blood/serum) or below 95 mmol/L (below 89.. the results may be printed by following these steps: o Press NO. and the report will print. Press YES to confirm. If the Na+ result is above 180 mmol/L (above 169. Na K Cl 143. o The analyzer returns to [READY]. the test results will be displayed and printed.. o Press YES. WARNING If an additional sample report is desired or the automatic sample report is turned off. Direct ISE The Standard Mode ALWAYS reports direct ISE values and is not affected by correlation factors or the setting of QCC (see Chapter 10 Troubleshooting.... press YES and then NO.6 mmol/L for blood/serum). ... until [Standard Sample?] is displayed.1 - ROCHE 9180 ELEKTROLYT ISE NA-K-CL HOSPITAL WEST Name: .9 K = 4.. o The measurement results will be displayed.93 103.. the Li+ value cannot be derived..:28 Na=143.. o The prompt [Print last Sample Report?] is displayed.93 Cl=103...

g. As soon as [READY] will be displayed. diluted with urine diluent...:30 Na=263 K = 18....... e see section Correlation factors on page C-39. - ROCHE 9180 ELEKTROLYT ISE NA-K-CL HOSPITAL WEST - Name: . the analyzer is ready for measurements. accurately dilute the sample with Urine Diluent in the ratio of 1 part urine to 2 parts diluent (e.... If lithium is selected. Urine samples.. Press YES..1 July 2013 C-37 . until [QC/STD/DIALYSATE/URINE SAMPLE?] is displayed. are analyzed in the urine mode. Sample: URINE Sample No.3 Cl=118 Na=142 K =  Cl=156 mmol/L mmol/L mmol/L ROCHE 9180 ELEKTROLYT ISE NA-K-CL HOSPITAL WEST mmol/L mmol/L mmol/L Figure C-29 Ca2+ and Li+ are not measured in urine.. Separate correlation factors for bicarbonate and acetate permit optimization of absolute measurement. To enter this mode: Na 263 K 18.. o Press NO. o Upon completion of measurement... o Press NO. . the dialysate mode provides measurements identical to those performed in the standard mode.. Due to interfering substances inherent in some dialysate solutions.. To enter the dialysate mode: o Press NO.... Press YES. until [Bicarbonate Sample?] or [Acetate Sample?] appears..... the analyzer will display and print the results.. Press YES and follow the instructions. which may be necessary for certain dialysate compositions.... Thoroughly mix the sample and analyze in the urine mode. Roche Instructions for Use · Version 7. 1 mL urine and 2 mL urine diluent).. the dialysate mode is not available.. until [QC/STD/DIALYSATE/URINE SAMPLE?] appears.. Sample: URINE Name: . .. until [Urine Sample?] is displayed.:29 Sample No. it may be necessary to establish correlation factors to obtain correct results.9180 Electrolyte Analyzer 7 Measurement Measuring procedure Dialysate samples Dialysate samples are measured in the dialysate mode... In the default analyzer setting.3 Cl 118 o Press NO. Urine samples Before measuring urine..

if activated) of the first urine measurement. o Ignore the Na+ value (and Cl-. and press YES to advance to the next position. o Press YES and the cursor will advance to the last position. o Dilute the diluted urine (already diluted 1:2 with urine diluent) with distilled water in the ratio of 1:1 (e. Repeat this for all numbers of the normal range. The measurement must be repeated using the following procedure: o Record the Na+ value (as well as Cl-. press NO. o If the code has been entered correctly. o Press YES and the cursor will advance to the second position. press YES. 1 mL of diluted urine and 1 mL distilled water). For safety and security. Starting from the [READY] screen. until the prompt [PROGRAM INSTRUMENT?] appears. July 2013 Instructions for Use · Version 7. and outside the measurement range of the analyzer. o Press NO until [Program Normal Ranges?] is displayed. keep pressing the NO key until the correct character appears. the code "KEY" has to be entered as follows: o Press NO. o Press NO.7 Measurement 9180 Electrolyte Analyzer Normal ranges (reference values) WARNING If the result of the urine sample is given with ↑↑↑↑ the K+ value of the sample is higher than 60 mmol/L. Normal ranges (reference values) The normal ranges can be adapted to the respective laboratory-specific requirements. Values that are higher or lower than the programmed normal range will be indicated by an arrow pointing up or down. o The correlation factors can be changed through the programming menu. and select with YES.g. until the character K appears. Press YES. In order to proceed with the programming. o Press NO. o Multiply the K+ value by 2 and record. TIP: If the desired character was missed. the analyzer can only be programmed or have existing parameters changed by entering the correct password.. o Thoroughly mix the sample. if activated). until the character E appears. o Run a second urine measurement with the twice-diluted urine sample. WARNING The analyzer prompts [Enter Code: AAA].1 . o The analyzer will display the normal ranges of the current parameter configuration: Na low =xxx Na high=xxx ok? Normal ranges can be entered by pressing NO: o Roche C-38 Press NO until the desired number is displayed. until Y appears.

the display prompts [Program Corr Factors?]. o Press NO. press YES. A separate set of correlation factors is available for dialysate and urine samples. press NO.1 If the code has been entered correctly. until the character E appears. the values are NOT affected by correlation factors. The code "KEY" has to be entered as follows: o Press NO. o Press YES and the cursor will advance to the last position. Verify correctness of the ranges: Na low =xxx Na high=xxx ok? If an incorrect number was entered inadvertently. and the analyzer allows the operator to retype the normal range. July 2013 C-39 . The correlation factors can be changed through the programming menu. until the character K appears. until the prompt [PROGRAM INSTRUMENT?] appears. Repeat the above procedure for all parameters. see Chapter 10 Troubleshooting. plasma and QC samples. serum. press NO. The measurement range as well as normal and QC ranges are ALWAYS checked against the DISPLAYED values. WARNING The analyzer prompts [Enter Code: AAA]. Correlation factors The correlation factors allow correlation of the measurement results of the 9180 Electrolyte Analyzer to other electrolyte analyzers. Activated correlation values are taken into consideration when sampling whole blood. o Press NO. keep pressing the NO key until the correct character appears. For safety and security. o Press YES and the display will advance to the next parameter. o Roche Instructions for Use · Version 7. and select with YES. section Service codes on page E-14). the analyzer can only be programmed or have existing parameters changed by entering the correct password. Therefore. This allows programming the correlation factors. Starting from the [READY] screen. TIP: If the desired character was missed. They are not used for standard samples analyzed in the [QC/STD/DIALYSATE/URINE SAMPLE] mode. After all activated parameters have been programmed. In case the QC samples were switched to report direct ISE values (Code QCC. o Press YES and the cursor will advance to the second position. you may have to adjust the QC and normal ranges to your correlation factors. until Y appears. the new values will be displayed.9180 Electrolyte Analyzer 7 Measurement Correlation factors o After entering the normal ranges.

since these parameters are not measured in urine mode. press NO. The current values will be displayed.000ok? o If the Na+ intercept (b) and the slope (m) are correct. Corr Factors?] and/or [Program Acetate Corr Factors?]. Roche C-40 July 2013 Instructions for Use · Version 7. until [Program Corr. o At the prompt [Program Urine Corr Factors?]. Factors?] is displayed. Ca2+ and Li+. The intercept and slope values may be adjusted by pressing NO to change the number. Pressing NO shows the prompt [Input/Verify Corr Factors?] and allows the operator to input or to verify correlation factors for each parameter. Follow the same procedure for the intercept (b) and slope (m) for K+. press YES. Only activated parameters can be programmed. the analyzer prompts [Reset Correlat.0 Na(m) = 1. and by pressing YES to accept the number. The programmed factors are automatically applied to acetate and bicarbonate measurements. press YES. or Na+/K+/Ca2+ are activated. Factor(Default)?]. o Press YES. o Pressing YES deletes all current correlation factors. A separate set of correlation factors is available for urine samples. If Na+/K+.7 Measurement 9180 Electrolyte Analyzer Correlation factors o Press NO. Pressing YES to the prompt [Input/Verify Corr Factors?] will allow the operator to change the correlation factors or to verify correlation factors already programmed. Na+/K+/Cl-. o Program the factors as described above. such as: Na(b) = +00.1 . Cl-. o To change these values. a separate set of bicarbonate and acetate correlation factors can be programmed: o At the prompt [Program Bicarb. o Program these factors as described above. The programmed factors are automatically applied to blood/serum and QC samples. The analyzer will then advance to the other correlation programming functions. Note that there are no urine correlation factors available for Ca2+ and Li+. press YES.

This setting allows the operator to enter a comment (one line up to 16 characters) which will be printed on each report. until [Program Instrument?] is displayed. press the YES key. TIP: If the desired character was missed. o Press YES and the cursor will advance to the last position. O Press YES to print two measurement reports after each measurement. [Automatic Cal Report?] is displayed. O Press NO to print one measurement report after each measurement. o Press NO. The code "KEY" has to be entered as follows: o Press NO. [Enter Comment:] is displayed. a measurement report is printed automatically after each measurement. keep pressing the NO key until the correct character appears. a calibration report is not printed automatically. o Press YES. July 2013 C-41 . o Press NO. For safety and security.1 o The analyzer displays [Enter Comment Line?]. until the character K appears. The programming advances to the settings for the calibration report. o Press NO. until [Program Printer Setup?] is displayed. These settings can be changed in the programming menu. O Press NO to deactivate the automatic calibration report. until [Patient Report off?] is displayed. until the character E appears. O Press NO to automatically print a measurement report after each measurement. o Press YES. o Press YES and the cursor will advance to the second position. o o O Press YES to deactivate the automatic measurement report. TIP: A copy of the last measurement report and the last calibration report as well as the QC report can be printed in the menu [PRINT FUNCTIONS?]. until Y appears. Roche Instructions for Use · Version 7. o If the code was entered correctly. WARNING The analyzer prompts [Enter Code: AAA]. o Press NO. O Press YES to automatically print a calibration report after each calibration. [Print two Patient Reports?] is displayed. With factory settings. the analyzer can only be programmed or have existing parameters changed by entering the correct password.9180 Electrolyte Analyzer 7 Measurement Additional settings Additional settings Printer settings The 9180 Electrolyte Analyzer allows easy programming of printer settings by the operator for printing automatic measurement and calibration reports. Press YES.

o Repeat this procedure for all characters. July 2013 Instructions for Use · Version 7.1 .7 Measurement 9180 Electrolyte Analyzer Additional settings Roche C-42 o Press NO to select the desired letters A-Z or numbers 0-9 above the cursor. o Press YES to advance the cursor to the next character.

........................... C-49 Roche Instructions for Use · Version 7.............................................................................9180 Electrolyte Analyzer 8 Quality control Table of contents Quality control In this chapter Chapter 8 Quality control ........................................................................................................................................... C-46 Performing a QC measurement .............................................. C-48 Printing a QC report ......................................................................................1 July 2013 C-43 ........................ C-45 General QC concept ......................................................................................... C-45 Material setup ...................

1 .8 Quality control 9180 Electrolyte Analyzer Table of contents Roche C-44 July 2013 Instructions for Use · Version 7.

2=normal. When required by local regulations. Roche offers an aqueous QC material called ISETROL that should be used to ensure that the 9180 Electrolyte Analyzer provides measurements of high quality in order to protect patients.level 2. day 1 . all three QC levels must be measured). the parameter must not be used for further measurements! QC measurement results that are greater than the target value ± 2SD. 3=high) (e.g. In order to ensure the quality of the measurement results. possibly endangering the patient's health.. at least once daily one QC measurement has to be performed in alternating levels (1=low. complete a quality control test on three levels (1=low. must be treated accordingly. If QC measurement results fall outside the target value range ± 3SD. after each replacement of the SnapPak.1 July 2013 C-45 .level 3. etc. electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee. after startup of the instrument as well as after monthly. but less than the target value ± 3SD.). The QC measurement results within the target value range ± 2SD are acceptable.level 1. Use of calibration solutions.e. day 2 .level 1. A quality control program for electrolytes includes the analysis of sample materials with known ranges of expected values and the comparison of these values with analyzer results. 3=high) after each electrode exchange. Omitting QC measurements or ignoring QC measurement results may lead to incorrect patient measurements. 2=normal. semi annual and annual maintenance steps. day 4 . The following control material is recommended: o ISETROL The target values listed in the package insert sheet should be taken as 2 SD values (SD = standard deviation). General QC concept Roche always strives to ensure the highest quality standards for its products. Quality control is an important element of this claim. Roche Instructions for Use · Version 7. This quality awareness is the result of a sense of responsibility toward the customer and the well-being of the patient. day 3 . QC measurements must be performed more often.. which may result in incorrect clinical decisions.9180 Electrolyte Analyzer 8 Quality control Quality control Quality control QC measurements must be performed in their entirety (i. Additionally.

until the character E appears. To ensure the accuracy of the analyzer. o If the code has been entered correctly. o To enter the lot number. For safety and security. o Press YES and the cursor will advance to the second position. only ISETROL should be used for quality control. The code "KEY" has to be entered as follows: o Press NO. o Press NO. The analyzer is ready for programming and the display reads [Program QC Level 1 Ranges?].8 Quality control 9180 Electrolyte Analyzer Material setup Material setup TIP: Lot number. and the system returns to the prompt [Enter Code:]. The ISETROL electrolyte control is made specifically for use in the 9180 electrolyte analyzer. If the current lot information does not have to be changed and only the programmed QC ranges need to be verified. press YES. WARNING The analyzer prompts [Enter Code: AAA]. date of expiration. until Y appears. the following display appears: [CODE ERROR! RETRY?]. o Press NO. o Press YES and the cursor will advance to the last position. and select with YES. sample type and normal ranges from the text included in the recommended QC material. TIP: If a wrong code is entered accidentally. keep pressing the NO key until the correct character appears. press NO. until the character K appears. enter the lot number and the target ranges into the analyzer. If the pack of ISETROL electrolyte control is new.1 . go to the display [Program QC Level 1 Ranges?] and press YES. the analyzer shows a preset lot number which still has to be changed. press NO. TIP: If the desired character was missed. o The analyzer display reads [Current Lot:xxxx Change Lot #?] TIP: When a lot number is entered for the first time. press NO. Press YES. Each level has its own lot number which can be found on the information sheet enclosed with the ISETROL pack. until the prompt [PROGRAM INSTRUMENT?] appears. Roche C-46 July 2013 Instructions for Use · Version 7. the analyzer can only be programmed or have existing parameters changed by entering the correct password. To exit this menu. The QC material must be defined prior to the QC measurement. Starting from the [READY] screen.

o Press YES to display [Enter last 4 Dig of Lot: xxxx]. The analyzer uses these normal ranges to mark abnormal patient data. the prompt [Program Normal Ranges?] is displayed. and the analyzer display reads [Print old Values and Statistics?]. Roche Instructions for Use · Version 7. o After entering the lot number. After programming of QC Level 3 has been completed. This programming function allows the normal ranges to be set individually. Press NO until the desired number is displayed above the cursor and move to the next digit with YES. standard deviation (SD) and coefficient of variation (CV) of the saved data. If an incorrect lot number is entered. If this function is selected. Repeat this process for all 4 digits. all statistical data saved for this QC lot will be deleted automatically. The analyzer now shows the upper and lower ranges of the QC level parameters. a log containing the following information is printed: mean value. Repeat this process for QC Level 2 and QC Level 3. the following display appears: [Additional Parameters?]. press NO to return to the prompt [Enter last 4 Dig of Lot: xxxx]. o Press NO. section QC report on page F-5. This option can also be used to program the deactivated parameters.: Na low = 040 Na high = 205 o Press YES to display the next parameter range. o After all activated parameters have been programmed. o Enter the new lot number. o After you press YES. The display [NEW LOT! Delete old Data?] appears. check the correctness of the entry and confirm with YES.9180 Electrolyte Analyzer 8 Quality control Material setup o Press YES.1 July 2013 C-47 .g. o Programming of QC Level 1 is complete after all ranges have been displayed. e. e see Chapter 11 Appendix. both on the display and on the printed log.

g. the results will be briefly displayed. at least once daily one QC measurement has to be performed in alternating levels (1=low.). 3=high) (e. TIP: Introduce the QC material directly from the ampoule! o Hold the ampoule under the probe until [Wipe Probe/Close Sample Door] is displayed. day 2 .1 3. Additionally. day 1 . after each replacement of the SnapPak. complete a quality control test on 3 levels (1=low.05 77. after startup of the instrument as well as after monthly.level 1. such as: Na K Cl 125.30 °C and brought to room temperature before use.1 . The prompt [Open Sample Door Introduce Sample] will be displayed. It is very important that the sample probe be carefully cleaned each time following a sample introduction. When required by local regulations. o Open the sample door: The prompt [Introduce Sample] appears. o Gently tap the head of the ampoule with the fingernail to remove any liquid.. 3=high) after each electrode exchange.8 Quality control 9180 Electrolyte Analyzer Performing a QC measurement Performing a QC measurement In order to ensure the quality of the measurement results. The values can be stored and the statistics be printed at any time. semi annual and annual maintenance steps. day 4 .level 1. QC measurements must be performed more often. Press YES. 2=normal. during which the QC will be analyzed. o Use a lint-free tissue to clean the probe. Upon completion.level 3. o Starting from the [READY] screen. then close the sample door. [QC Level 1 Sample?] will be displayed. Protect fingers by using gloves and tissue while breaking ampoule. since it provides shielding from sources of electromagnetic and electrostatic interference. o Press YES. day 3 . o Carefully open the ampoule by breaking off the top. o Take a Level 1 ampoule from the ISETROL box and mix it carefully. etc. ISETROL should be stored at 15 . TIP: Up to 35 QC measurements can be stored per level. o Roche C-48 The instrument will display [QC Level 1 in progress] and a countdown will begin. press NO until [QC/STD/DIALYSATE/ URINE SAMPLE?] appears. 2=normal.level 2. It is very important that the main door be closed during sampling.8 July 2013 Instructions for Use · Version 7.

o If the values are rejected.In case the value is outside the measurement range .  or ERR). If correlation factors are changed or QC values switched to direct ISE. press YES. until [READY] is displayed. ALL values in memory are recalculated and printed per the new setting. and press YES. the analyzer will return to [READY]. the analyzer will return to the [QC Level 1 Sample?] display. the analyzer prompts [Remain in QC/Std. followed by the prompt [QC Level 2 Sample?]. If the values have been saved. until [PRINT FUNCTIONS?] appears. standard deviation (1 SD) and coefficient of variation (CV). Responding YES to the [Remain in QC/Std. press the NO key. Printing a QC report The 9180 Electrolyte Analyzer will store in memory the last 35 QC measurement values for each of the three QC levels.9180 Electrolyte Analyzer 8 Quality control Printing a QC report The 9180 Electrolyte Analyzer “flags” values that are above or below the programmed target ranges by using an “up” or “down” arrow. press NO and the analyzer returns to the [READY] display. press NO. o Press NO twice. o To print a report of these values along with their mean. press NO. allowing to repeat the QC Level 1 measurement by pressing YES. To reject the values. or to skip to QC Level 2 . After printing. the analyzer returns to [QC Level 1 Sample?]./Urine Sample?] prompt. At completion of QC Level 3 measurement. o The prompt [Store values in memory?] appears. To discontinue QC measurement.1 July 2013 C-49 . follow the outlined instructions for Level 1. it will automatically be rejected. For further QC measurements (Level 2 and Level 3). [Values Accepted!] will be displayed shortly. Roche Instructions for Use · Version 7. the analyzer will print all QC values grouped by level./Urine Sample?]. [Print QC Values and Statistics?] appears. o Press YES. If measurements for all levels have been completed. o To save the values in memory. being sure to use a Level 2 or Level 3 ISETROL.

8 Quality control 9180 Electrolyte Analyzer Printing a QC report Roche C-50 July 2013 Instructions for Use · Version 7.1 .

. . . . . . . . . D-3 July 2013 . . . . . . .Maintenance 9 D Maintenance . . . . . . . . . . . . . . . . . . . . . . . . .

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..............................................D-5 Disinfection .....................................................9180 Electrolyte Analyzer 9 Maintenance Table of contents Maintenance In this chapter Chapter 9 Maintenance ...................................................................................D-15 Replacing electrodes .............................................................................. D-6 Weekly maintenance ...................................................D-14 Exchanging main tubing harness ..........................................................................................................................................D-5 Recommended disinfectants .........D-14 Unscheduled maintenance ....D-17 Replacing sample probe and fill port ...............................................D-5 Sample probe mechanism .........D-6 Daily maintenance ..............................................................................................................................................................................................................................................................................................................................................................D-20 Roche Instructions for Use · Version 7....................................................................... D-8 Clean sample probe and fill port ..................................................................................................D-10 Cleaning the reference electrode housing ..........................................................D-15 Checking reagent fluid level and changing the SnapPak ....D-5 Surfaces of the instrument ...................................................................D-8 Cleaning analyzer surfaces ...................................................D-9 Monthly maintenance ......................................................................................................................................D-20 Yearly maintenance .....................................................................................D-10 Semi annual maintenance .................................................................................................................................................................................................................................D-13 Exchanging the pump tubing set .........D-18 Replacing printer paper ..................................................................................................................1 July 2013 D-3 .....D-13 Annual maintenance ...................................................................

9 Maintenance 9180 Electrolyte Analyzer Table of contents Roche D-4 July 2013 Instructions for Use · Version 7.1 .

Never use disinfectants or Roche Deproteinizer! IMPORTANT: Do not attempt to disinfect any part of the instrument before shutting it down and unplugging it from the power source. In addition. Before plugging the instrument back in and turning it on. contain biological fluids and therefore represents a possible infectious risk. Perform these disinfections procedures regularly.. protective goggles and if necessary mouth protectors. Electrical contacts may only be cleaned with a clean. Never use disinfectant sprays. Regularly disinfect the following parts of the instrument: o Sample probe mechanism consisting of sample probe and fill port o Surfaces of the instrument o All areas which can become contaminated with biological liquids and therefore pose a potential infection hazard Sample probe mechanism e See section Clean sample probe and fill port on page D-8. must be worn to prevent direct contact with biological working materials. Surfaces of the instrument e See section Cleaning analyzer surfaces on page D-9. fill port. like laboratory clothing. Handle these components with care and according to regulations surrounding potentially infectious materials. Suitable protective equipment.9180 Electrolyte Analyzer 9 Maintenance Maintenance Maintenance After use. Never use alcohol based disinfectants! Do not use any type of bleaching agent. including tubing. dry or with water moistened cloth.1 July 2013 D-5 . components of the 9180 Electrolyte Analyzer. Exception: Roche Deproteinizer. Suitable disinfection procedures must be applied. protective gloves. Roche Instructions for Use · Version 7. a face mask is required if there is a risk of splashes. Disinfection The purpose of this procedure is to minimize the risk of infections when replacing items that were in contact with blood. SnapPak etc. always wait 15 minutes to allow the disinfectant to evaporate.

Select [Perform Daily Cleaning?] by pressing YES. This procedure is called "daily maintenance" because it must be performed once each day the analyzer is used to conduct testing. local irritation to the skin. until [DAILY MAINTENANCE?] is displayed.1 . eyes. o First Aid measures After inhalation: breathe fresh air. and mucous membranes is possible. WARNING Electrical contacts may only be cleaned with a clean. Never use disinfectants or Roche Deproteinizer! Daily maintenance Prior to running the first sample of the day.9 Maintenance 9180 Electrolyte Analyzer Daily maintenance Recommended disinfectants Surfaces Protein remover (Roche Deproteinizer) o Potential dangers Due to the alkaline and oxidizing character of this preparation. remove contaminated clothing. contact a doctor. pour a small amount of Cleaning Solution into a clean container. Roche D-6 o Press the NO key. July 2013 Instructions for Use · Version 7. o At the prompt [Open Sample Door Introduce Sample]. dry or with water moistened cloth. After eye contact: rinse eyes with generous amounts of water. the 9180 Electrolyte Analyzer needs to undergo a simple cleaning and conditioning procedure that helps ensure the unit will perform properly. After drinking: drink large amounts of water. Exception: Roche Deproteinizer. cleaning should be performed once a week instead of daily (see section Weekly maintenance on page D-8). In case cleaning and/or conditioning has not been performed within the last 24 hours. TIP: If fewer than 5 samples are analyzed each day. After skin contact: wash with generous amounts of water. avoid vomiting. contact an eye doctor. drink large amounts of water. Do not use any type of bleaching agent. Lift the sample door and the pump will begin to aspirate. the analyzer will automatically print on each sample report [Perform Daily Maintenance!]. and YES to select.

press YES. since it provides shielding from sources of electromagnetic and electrostatic interference. press NO at the prompt [Remain in Daily Maintenance?].9180 Electrolyte Analyzer 9 Maintenance Daily maintenance o Hold the Cleaning Solution under the probe until [Wipe Probe/Close Sample Door] is displayed.1 July 2013 D-7 . An automatic calibration will be started. o At the prompt [Open Sample Door Introduce Sample]. lift the sample door and the pump will begin to aspirate. Close the sample door. o Hold the conditioning solution under the probe until [Wipe Probe/Close Sample Door] is displayed. Wipe the sample probe from top to bottom in order to avoid injury. pour a small amount of conditioning solution into a clean container. Roche Instructions for Use · Version 7. o At the prompt [Perform Daily Conditioning?]. Close the sample door. Before working on ESD critical parts discharge yourself by touching the discharge point (see Figure B-2 on page B-6). use a lint-free tissue to remove the conditioning solution from the probe. and use a lint-free tissue to remove the cleaning solution from the probe. It is very important that the main door is closed during calibration. Figure D-1 o While the analyzer displays [Thank You!] and a brief countdown. o After the analyzer displays [Thank You!] and a brief countdown.

1 . and additionally as needed.9 Maintenance 9180 Electrolyte Analyzer Weekly maintenance Weekly maintenance At least on a weekly basis. o The exterior surfaces should be wiped clean with a soft. you should clean the sample fill port and sample probe as well as the exterior analyzer surfaces. probe and surrounding area with a damp cotton swab. Never use strong or abrasive cleaners and no cleaners containing alcohol on the 9180 Electrolyte Analyzer. WARNING Roche D-8 July 2013 Instructions for Use · Version 7. damp cloth. o Clean the fill port. o If the analyzer attempts to perform sample analysis. Clean sample probe and fill port Figure D-2 Starting from the [READY] screen. [NO SAMPLE] will be briefly displayed. perform the following actions: o Open the sample door. and it will return to the [READY] screen. Use a slightly damp cloth to avoid getting fluid inside the analyzer.

g. Electrical contacts may only be cleaned with a clean. Never use disinfectants or Roche Deproteinizer! o Regularly. All visible impurities are to be removed. Before plugging the instrument back in and turning it on. If the grooves in the front door or the areas around the measuring chamber window are concerned. Use swabs or cellulose that have been soaked with Deproteinizer. decontaminate the surfaces of the analyzer including the front door with an undiluted disinfectant (Deproteinizer). WARNING IMPORTANT: Do not attempt to disinfect the entire instrument before shutting it down and unplugging it from the power source. The minimum deproteinizing disinfection contact time of 15 minutes is to be strictly followed. Dispose of used disinfectants according to applicable regulations (hazardous waste!). Subsequently.. according to the lab-specific regulations.9180 Electrolyte Analyzer 9 Maintenance Weekly maintenance Cleaning analyzer surfaces Never use alcohol based disinfectants! Never use disinfectant sprays.1 July 2013 D-9 . use a small commercial plastic brush to clean them. always wait 15 minutes to allow the disinfectant to evaporate. o Very dirty surfaces (e. Roche Instructions for Use · Version 7. the deproteinizing disinfection procedure takes place as described above. dry or with water moistened cloth. contaminated with blood) should first be cleaned with swabs or cellulose that have been soaked with Deproteinizer disinfectant.

9 Maintenance 9180 Electrolyte Analyzer Monthly maintenance Monthly maintenance Cleaning the reference electrode housing Monthly maintenance involves cleaning the reference electrode housing. the prompt [Perform Daily Cleaning?] appears.1 . Figure D-3 o Slide the measuring chamber forward until it locks in the front position. o Unclamp the left electrode holder by moving the clamp forward. press NO to access [DAILY MAINTENANCE?]. and should be performed prior to daily maintenance. To complete this procedure. o Press YES. o Do not press any keys. a small amount of deproteinizer is needed. o From the [READY] screen. o Remove the reference electrode assembly from the analyzer Figure D-4 Roche D-10 July 2013 Instructions for Use · Version 7. o Release the tubing of the reference electrode from the receptacle below the left side of the measuring chamber. o Open the front cover of the analyzer.

9180 Electrolyte Analyzer 9 Maintenance Monthly maintenance o Unscrew the reference electrode from the reference housing. Store the reference electrode in the red transport housing filled with reference solution. o Carefully screw the reference electrode into the reference electrode housing and place the assembly into the left side of the measuring chamber. Ensure the electrodes are seated properly. o Close the clamp on the left electrode holder by lifting it until it locks in the back position. o Unscrew the red transport housing from the reference electrode and check that the o-ring on the electrode is properly seated. WARNING o Pour deproteinizer solution into a small container and submerge the reference housing into it. The reference connector and tubing do not need to be submerged.1 Plug the tubing of the reference electrode into the receptacle below the left side of the measuring chamber. Thoroughly rinse the housing with tap water and dry. It is important that reference electrode always be stored in reference solution and never allowed to dry. WARNING o After 15 minutes. ensuring that no air bubbles remain in the housing. Save the transport housing. Figure D-6 o Roche Instructions for Use · Version 7. Figure D-5 TIP: The reference solution can be taken from the reference electrode housing. July 2013 D-11 . remove the reference housing from the deproteinizer.

after each replacement of the SnapPak. Additionally. not completely dried). day 3 . day 4 .level 2. QC results may be falsified or electrodes may not be calibrated.level 1. day 1 . Roche D-12 July 2013 Instructions for Use · Version 7.g. 3=high) after each electrode exchange. QC measurements must be performed more often. etc. complete a quality control test on 3 levels (1=low. semi annual and annual maintenance steps. day 2 .). and close the front cover of the analyzer. you may perform daily maintenance by pressing YES. If Roche Deproteinizer is not used for cleaning or if the reference electrode housing is not cleaned correctly (cleaned for too long. Press YES and a complete calibration cycle will be performed. o If daily maintenance is not needed. after startup of the instrument as well as after monthly.level 1. 3=high) (e. When required by local regulations.9 Maintenance 9180 Electrolyte Analyzer Monthly maintenance o Slide the measuring chamber back until it snaps into position. Figure D-7 WARNING o At this time. In order to ensure the quality of the measurement results.1 .. at least once daily one QC measurement has to be performed in alternating levels (1=low. 2=normal. 2=normal. not rinsed long enough.level 3. press NO until [CALIBRATION?] is displayed.

In order to ensure the quality of the measurement results. When required by local regulations.g. QC measurements must be performed more often. day 1 . at least once daily one QC measurement has to be performed in alternating levels (1=low. Press YES and [Perform Daily Cleaning?] will appear. after each replacement of the SnapPak. 2=normal. o Next. disconnect one tube at a time from the old pump winding plate and reconnect to the same place on the new pump winding plate. being careful not to cross the tubes. complete a quality control test on 3 levels (1=low. do not press any keys. 2=normal. Figure D-8 o Install the new pump winding plate and slip the new pump windings over the pump rollers. press NO until [DAILY MAINTENANCE?] is displayed.. after startup of the instrument as well as after monthly.level 1.level 3. 3=high) after each electrode exchange. Press YES to initiate a calibration cycle.level 2. To make sure that the pump does not turn on during this procedure. When changing the pump tubing set. semi annual and annual maintenance steps. day 2 . Dispose of the pump tubing set according to applicable regulations (hazardous waste!).1 July 2013 D-13 . 3=high) (e. Additionally. proceed as follows: o Remove the front cover and slip the two pump windings from the pump rollers.). Roche Instructions for Use · Version 7. day 4 .9180 Electrolyte Analyzer 9 Maintenance Semi annual maintenance Semi annual maintenance Exchanging the pump tubing set Every six months the peristaltic pump tubing has to be replaced. day 3 . etc. Then. o Press NO until [CALIBRATION?] is displayed.level 1.

and press YES.9 Maintenance 9180 Electrolyte Analyzer Annual maintenance Annual maintenance Exchanging main tubing harness Once a year or as needed. TIP: Each valve consists of the solenoid coil inside the analyzer. In addition. use the tubing diagram in the front door as a guide for installation. o Then remove the pinch bars. Press YES. protective gloves. o Re-install the new main harness in reverse order. Suitable protective equipment. o Remove the SnapPak and slide out the white SnapPak receptacle. o Open the sample flap and pull out the fill port. then slide the pinch bar on and snap on the valve cap in the direction of the arrow. a face mask is required if there is a risk of splashes. the pinch bar and the valve cap. Roche D-14 o Press NO until [CALIBRATION?] is displayed. until [SERVICE FUNCTIONS?] appears. the main tubing harness should be replaced. o Press YES to start a calibration. o Press NO to activate the next valve. o Press NO. protective goggles and if necessary mouth protectors. sliding them in the direction of the arrow. must be worn to prevent direct contact with biological working materials. Take special care to reconnect the tubes to the correct nipples of the pump winding.1 . like laboratory clothing. Notice the text on the display. o Remove the valve caps. Suitable disinfection and sterilization procedures must be applied. TIP: It may be necessary to pull on the metal tip of the valve in order to put the valve cap into position. o At the [READY] screen press NO. o Disconnect the tubing with the green band from the left side electrode holder. For further details concerning the position of the valves. July 2013 Instructions for Use · Version 7. o Disconnect the reference electrode and pull out the white reference electrode receptacle. see tubing diagram inside the front door. Dispose of the main tubing harness according to applicable regulations (hazardous waste!). Disconnect the tubes from the pump winding plate and pull out the tubing harness. TIP: It is recommended to replace the sample probe and the fill port at the same time as the main tubing harness is replaced (see section Replacing sample probe and fill port on page D-18). until [Test Pinch Valves?] appears. o Activate each valve by pressing YES.

2=normal. day 2 . When required by local regulations. July 2013 D-15 .e. etc. after each replacement of the SnapPak.level 2.level 1. o Unclamp the left electrode holder by moving the clamp forward. 3=high) after each electrode exchange. o Install electrode in its labeled position in the measuring chamber. at least once daily one QC measurement has to be performed in alternating levels (1=low. Additionally.. complete a quality control test on 3 levels (1=low. Note that the electrode has a lip on the bottom that rests on the flat edge of the measuring chamber to aid in proper positioning.1 o Remove the new electrode from its protective box and check for the presence of an o-ring in the left side of the electrode. day 4 level 1. after startup of the instrument as well as after monthly. Figure D-9 Figure D-10 Roche Instructions for Use · Version 7. 2=normal. semi annual and annual maintenance steps. Unscheduled maintenance Replacing electrodes o Slide the measuring chamber forward until it locks in the front position. day 1 . day 3 .). 3=high) (i. o Remove the used electrode from the measuring chamber.9180 Electrolyte Analyzer 9 Maintenance Unscheduled maintenance In order to ensure the quality of the measurement results. QC measurements must be performed more often.level 3.

2=normal.). after startup of the instrument as well as after monthly. 2=normal.1 . day 3 .9 Maintenance 9180 Electrolyte Analyzer Unscheduled maintenance Figure D-11 o Close the clamp on the left electrode holder by lifting it until it locks in the back position. When required by local regulations. Additionally. Roche D-16 July 2013 Instructions for Use · Version 7. day 4 . after each replacement of the SnapPak.level 1. In order to ensure the quality of the measurement results. semi annual and annual maintenance steps. electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee. Calibration and QC Measurement to verify the performance of the electrode . Dispose of the electrodes according to applicable regulations (hazardous waste!). e For further information.Use of calibration solutions.g. Ensure that the electrodes are seated properly. complete a quality control test on 3 levels (1=low.level 2. the 9180 Electrolyte Analyzer needs to undergo Daily Maintenance. 3=high) after each electrode exchange.level 3. etc. see Chapter 8 Quality control. o Slide the measuring chamber back until it snaps into position. Figure D-12 After installing a new electrode. day 2 . 3=high) (e.level 1. A quality control program for electrolytes includes the analysis of sample materials with known ranges of expected values and the comparison of these values with analyzer results. QC measurements must be performed more often.. day 1 . at least once daily one QC measurement has to be performed in alternating levels (1=low.

WARNING Dispose of the SnapPak according to applicable regulations (hazardous waste!). o Prepare the new SnapPak by carefully removing the protective strip. just grasp the extended portion and slide it out. o Write the installation date on the label of the new SnapPak. Press YES. o The prompt [Check/Change SnapPak?] will be displayed.9180 Electrolyte Analyzer 9 Maintenance Unscheduled maintenance Checking reagent fluid level and changing the SnapPak The 9180 Electrolyte Analyzer monitors the level of solutions in the SnapPak and displays the amount remaining. WARNING Once the protective strip is removed. Press YES. To check the status of fluid remaining in the SnapPak: o In the [READY] screen. protective goggles and if necessary mouth protectors. o Roche Instructions for Use · Version 7. In addition. be sure to keep the SnapPak upright to avoid spillage. Save this cover to close the connectors prior to disposal of the used SnapPak. the display prompts [STATUS: NO SnapPak]. the printer will print the current status of the SnapPak. Use of calibration solutions. Suitable protective equipment. protective gloves. In addition. press the NO key. electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee. Suitable disinfection and sterilization procedures must be applied. o The analyzer will display the amount of fluid remaining. like laboratory clothing. until [OPERATOR FUNCTIONS?] is displayed. July 2013 D-17 . o To change the SnapPak. Do not remove the SnapPak during a calibration or measurement procedure. a face mask is required if there is a risk of splashes. Figure D-13 As soon as the analyzer detects that the SnapPak has been removed.1 Slide the new SnapPak into position on the left side of the analyzer. must be worn to prevent direct contact with biological working materials.

Roche D-18 o Open the front door.. day 4 . The 9180 Electrolyte Analyzer will automatically reset the SnapPak counter to 100% and commence system calibration. QC measurements must be performed more often. Figure D-14 o Press YES to indicate that a new SnapPak is installed. Replacing sample probe and fill port TIP: It is recommended to replace the sample probe and the fill port at the same time as the main tubing harness is replaced (see section Exchanging main tubing harness on page D-14).level 3. o Remove the needle carefully (to prevent injury) from the holder. a face mask is required if there is a risk of splashes. day 2 . semi annual and annual maintenance steps. 2=normal.level 1. When required by local regulations. etc.).level 1. protective gloves.level 2. must be worn to prevent direct contact with biological working materials. 2=normal.9 Maintenance 9180 Electrolyte Analyzer Unscheduled maintenance o The analyzer will prompt [New SnapPak Installed?]. press NO until [DAILY MAINTENANCE?] is displayed. July 2013 Instructions for Use · Version 7. press YES. day 3 . after each replacement of the SnapPak. 3=high) (e. To make sure that the pump does not turn on during this procedure. o Open the sample door. do not press any keys. Again. 3=high) after each electrode exchange. In addition. o Press NO if you reinstall the SnapPak that was removed. after startup of the instrument as well as after monthly. Suitable disinfection and sterilization procedures must be applied. like laboratory clothing. Then. at least once daily one QC measurement has to be performed in alternating levels (1=low. protective goggles and if necessary mouth protectors. at the prompt [Are you sure?]. In order to ensure the quality of the measurement results.1 . Suitable protective equipment. Additionally. complete a quality control test on 3 levels (1=low. day 1 . Press YES and [Perform Daily Cleaning?] will appear.g. Unplug the tubing.

o Press NO until [CALIBRATION?] will be displayed. A B A Sample probe needle B Fill port Figure D-15 Then replace the fill port as follows: o Remove the fill port holder from the sample probe mechanism.1 July 2013 D-19 . o Mount the fill port holder at its default position. Roche Instructions for Use · Version 7. Dispose of the sample probe and the fill port according to applicable regulations (hazardous waste!). Unplug the tubing.9180 Electrolyte Analyzer 9 Maintenance Unscheduled maintenance o Attach the new needle to the tubing and snap the needle back into the holder. o Carefully remove the fill port from the fill port holder. o Press YES to start the calibration. o Close the sample door and the front cover. o Mount the new fill port into the fill port holder in the reverse order and attach the tubing.

Roche D-20 July 2013 Instructions for Use · Version 7. o Place a new paper roll in the paper tray and thread it into the feeder slot. o Press the paper feed button to completely feed the paper through the printer. Yearly maintenance The yearly maintenance work must be conducted by customer service or fully qualified technicians only. o Cut the end of the roll to make a square edge. o Remove the remaining paper by pressing the paper feed button. Figure D-16 By pressing the paper advance button once. Please make sure that you insert the paper roll correctly. the paper will automatically advance 10 lines. The thermal printer paper supplied by Roche contains an indicator strip to alert you when the paper roll should be changed. o Close the front cover and tear off any excess paper. CAUTION The components have been tested during development of the device to identify worn parts. e Please refer to the Service Manual for details. To change the roll: o Open the front cover of the analyzer.9 Maintenance 9180 Electrolyte Analyzer Unscheduled maintenance Replacing printer paper The printer paper is heat sensitive on one side only. Do not pull the paper out of the printer to avoid damage to the printer. They must be replaced at the annual service to prevent potential malfunctions.1 .

. . . . . . . . . .Troubleshooting 10 E Troubleshooting . . . . . . . E-3 July 2013 . . . . . . . . . . . . . . . . . . . . .

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........................................................................................................................................................................................................................................................................................................................................................E-12 Testing the valves ....E-9 Testing the electrodes ..E-11 Testing the pump ........................................................................................................................E-12 Testing the interface .............................................................................................................................................................................E-15 Deleting data ...................................................1 July 2013 E-3 .................................................................E-14 List of service codes .......................E-11 Testing the sample door ..........E-13 Service codes ................................................................................................E-11 Testing the language switch ..................................................E-14 Entering service codes ..E-10 Testing the sample sensor ................................................E-16 Clearing all data ...................................................E-13 Status-LEDs ................................................................................................................................................E-9 Not calibrated potassium electrode .........................................................................................................................................................................................................................................................................................................E-14 Removing service codes ......E-16 Roche Instructions for Use · Version 7......................................................................................................................E-12 Testing the amplifier .............E-5 Error messages ........................................................................................................................9180 Electrolyte Analyzer 10 Troubleshooting Table of contents Troubleshooting In this chapter Chapter 10 Troubleshooting .......................................................E-16 Clearing sample count ..............E-5 Service functions ....................................E-10 Testing the SnapPak sensor ................................................................................................................................................................................................................................

10 Troubleshooting 9180 Electrolyte Analyzer Table of contents Roche E-4 July 2013 Instructions for Use · Version 7.1 .

which must detect its presence without encountering any air bubbles. (Li+ activated) Table E-1 Roche Instructions for Use · Version 7. Detection of Standard C aspiration is the same as for Standard B. o See remedy for Standard B. If Standard A is aspirated properly. you should contact Roche for technical assistance. clean the sample sensor. any scientific measuring device may occasionally malfunction. not calibrated Possible causes: o o Status: Not calibrated o o No stable value for Standard A The slope A-B or A-C is outside the range (see Testing the electrodes on page E-9) o o o o o Standard A not detected As the analyzer aspirates a sample of Standard A. If less than 5 % remains. replace the SnapPak.1 July 2013 E-5 . Clean or replace the electrode. If your 9180 Electrolyte Analyzer does not perform correctly after conducting the basic steps outlined in this chapter. If necessary. requiring the operator to identify the cause of the problem. Ensure the sample sensor is securely plugged in and perform the sample sensor test to ensure that the sensor is operating correctly. Check the fluid remaining in the SnapPak. Check for clots or crystals that may have formed in the Standard A tubing or the electrode chamber. However. perform external electrode test using serum or plasma (see section Not calibrated potassium electrode on page E-10). but Standard B is not detected. replace the SnapPak. The following information lists displayed messages and recommends steps that should help you return your 9180 Electrolyte Analyzer to operation. blockages and air bubbles. Check the fluid remaining in the SnapPak. trouble-free service. o o o o o Standard B not detected Standard C not detected Perform daily maintenance. the solution is detected by the sample sensor. see Action. Check if the electrode holder is locked in the back position. If the sample sensor is unable to properly detect the presence of Standard A solution in a programmed time period. check Standard B tubing for crystallization. Error messages Message Cause Action Calibration has been interrupted Perform calibration to return the instrument to the [READY] mode Na/K/Cl/Ca/Li A specific electrode could not be calibrated. If no crystallization or leaks are found. Check for leaks. Replace the SnapPak. Ensure that electrodes are properly plugged in. Is K+ still not calibrated. If less than 5 % remains. Replace the peristaltic pump tube set to ensure correct aspiration of Standard A. o Replace the SnapPak.9180 Electrolyte Analyzer 10 Troubleshooting Troubleshooting Troubleshooting Your 9180 Electrolyte Analyzer is designed to provide long. Detection of Standard B aspiration is the same as for Standard A. above error message will be displayed.

sample door remaining open more than 20 seconds after samples are in place air bubbles in the sample a sample volume too small to analyze no sample being aspirated through the sampling mechanism. Since this test utilizes Standard A.120 units when air is detected. the analyzer may not detect the presence of cleaning solution: o o o o o air bubbles in the cleaning solution too small volume of cleaning solution the cleaning solution not being aspirated properly through the sampling mechanism o o Check for the presence of o-rings and for proper sealing of the electrodes. Ensure that the reference tubing is securely connected to the receptacle. o o Please close sample door No sample o o o o Cleaning fluid not detected Clean sample sensor by using the Electrode Maintenance procedure. Ensure that the sample sensor is plugged in and perform the Sample Sensor Test to verify that it is operating correctly Table E-1 Roche E-6 July 2013 Instructions for Use · Version 7. To check sample sensor response. Check for aspiration of cleaning solution and look for presence of clots in the sampling system. Perform a calibration to remove the error message. this message will be displayed. Check the peristaltic pump tube set. or when the door has been opened and no sample is detected. This message occurs when the sample door is not closed within 20 seconds after the sample is in place. Replace pump tubing. the sensor must provide a reading of 80 . This test is performed at the beginning of each calibration cycle. make sure that it is aspirated properly into the measuring chamber. Check sample aspiration and look for the presence of clots in the sampling system. o Close the sample door within time allowed. For proper functioning. Check for the proper sealing of the pump windings.10 Troubleshooting 9180 Electrolyte Analyzer Troubleshooting Message Check Sample Sensor Check Reference Housing Cause Action The sample sensor is calibrated with air during each calibration. section Monthly maintenance on page D-10). perform the Sample Sensor Test Open the sample door and press the YES button to aspirate various fluids through the sensor. Close the sample door within time allowed. water). For transparent fluids (e. Under certain conditions. o o o o o o o Check for proper filling of the reference housing. the analyzer may not detect the presence of a sample and an error message will occur: o Repeat the sample to see if it is detected properly on a second trial. replace the SnapPak. the reading should decrease by at least 40 units. Check for the presence of o-rings and for proper sealing of the electrodes. Check for correct drying of the measuring chamber during the wash cycle. Perform a calibration to remove the error message. Clean the reference housing (see Chapter 9 Maintenance. For blood samples (not transparent). o When the analyzer fails to detect a flow of Reference Solution into the measuring chamber. o Under certain conditions. The pump can be stopped at any time by pressing NO. you can do so by closing the sample door during sample aspiration.g. Ensure that the sample sensor is plugged in and perform the Sample Sensor Test to verify that it is operating correctly. Replace the peristaltic pump tube set. If not. o o o o If you wish to abort a sample.1 . the reading should increase by at least 40 units.

If necessary. If none of the electrodes passes the calibration: a stable reading of Standard A could not be obtained within 6 aspirations of Standard A the slope A-B or A-C is outside of the limits Clog check fluid path If the unit is unable to clear the sample path or to aspirate any of the 3 Standards at the beginning of a calibration: the cause: a defective reference housing (increased discharge of KCl). activated. arrows up instead of the K+-result indicate that further dilution of the sample is necessary (see Chapter 7 Measurement. Check if the electrode holder is locked in the back position. Check the peristaltic pump tube set. In the case of a urine sample. Ensure the sample sensor cable is securely plugged in. Ensure that the sample sensor is plugged in and perform the Sample Sensor Test to verify that it is operating correctly. Ensure that the sample sensor is securely plugged in and perform a sample sensor test to ensure the sensor is operating correctly. Check for air bubbles in the sample. Make sure room temperature is within specified limits (15°C to 32°C / 60°F to 90°F). Check for small air bubbles in the sample after aspiration into the sample chamber. Ensure that electrodes are properly plugged in. Check for proper aspiration of Standard A. the concentration of the sample is outside of the measurement range (see Chapter 3 Specification). Check for proper sample preparation (see Chapter 7 Measurement). Check for aspiration of conditioning solution and look for presence of clots in the sampling system. the temperature displayed should be approx. the calibration report will print an arrow up or down instead of the actual temperature. Table E-1 Roche Instructions for Use · Version 7. Make sure that the electrode O-rings are present and seated properly. the tubing to the sample sensor and in the sample sensor. With the front door opened. Replace reference electrode housing. section Urine samples on page C-37). The temperature sensor is located in the right side electrode holder.9180 Electrolyte Analyzer 10 Troubleshooting Troubleshooting Message Conditioning fluid not detected Cause Under certain conditions. Perform daily maintenance. Check for proper sample preparation (see Chapter 7 Measurement). Check for proper filling of the reference housing. Check for proper operation of the reference electrode assembly. Make sure there are no leaks in the fluid path. Check for the proper sealing of the pump windings. If necessary. Perform a calibration to remove the error message. clean the sample sensor. Replace the SnapPak. Check for a clog or crystallization in the fluid path: especially in the sample probe. the analyzer may not detect the presence of conditioning solution o o o Check electrodes air bubbles in the conditioning solution too small a volume of conditioning solution the conditioning solution not being aspirated properly through the sampling mechanism. clean the reference electrode housing or replace the reference electrode. Action o o o o o o o o o o o o o o o In case the unit displays arrows up or arrows down instead of the sample results. if the temperature measured is out of range (Range 10. o o o o With Ca2+ Err.1 July 2013 E-7 . o o o o o o Check for the presence of o-rings and for proper sealing of the electrodes. no valid voltage reading could be obtained from the electrode. o o If this message is displayed instead of the sample results.0°C 40°C). Perform the Amplifier Test to measure the actual temperature. 5°C above the actual room temperature.

6 . the temperature displayed should be approx. this message will be displayed and printed instead of the Li+ value.5 mmol/L for blood/serum). Make sure room temperature is within specified limits (15°C to 32°C / 60°F to 90°F). Ensure the sample sensor cable is securely plugged in. Roche E-8 July 2013 Instructions for Use · Version 7. the analyzer will automatically print [Change SnapPak] at the end of each sample report.40°C). If the Na+ value of the sample is outside of this range. o **Check Temp** (Ca2+ activated) This message is printed at the end of the sample report and displayed while the measurement is in process in case the temperature of the sample is outside the range (Range: 10°C . If the error persists. This message appears at the end of a measuring report if daily maintenance is not performed. Interface error The interface test (see section Testing the interface on page E-12) was not successful. section Checking reagent fluid level and changing the SnapPak on page D-17). then the sample results will appear on the display. With the front door opened.1 . o First turn analyzer off. The onboard stability is 14 weeks. o o o o o Check for proper sample preparation (see Chapter 7 Measurement). o STATUS: NO SnapPak o o o o Insert a SnapPak if none is inserted. Paper jam or printer If the printer attempts to print to the paper and the paper jams in the feeder. Perform Daily Maintenance defect No SnapPak inserted SnapPak expired Perform daily maintenance e For details. this message will be displayed briefly. o Check if pins 2 and 3 of the serial port were connected properly.180 mmol/L (89. see Daily maintenance on page D-6.10 Troubleshooting 9180 Electrolyte Analyzer Troubleshooting Message Change SnapPak Cause Action When the monitored fluid level in the ISE SnapPak reaches 5 % remaining. Remove the jammed paper and re-insert the printer into the analyzer. Table E-1 To ease removal of jammed paper. contact Technical Support. then remove the printer by placing your index finger behind the back edge of the printer module and pull it forward. the printer head can be moved by turning the spindle gear on the left side. o Replace the SnapPak (seeChapter 9 Maintenance. This message is present only in printed form. 5°C above the actual room temperature. *** Li Calculation not possible The lithium result can only be calculated for a Na+ range: 95 . Turn analyzer back on.169. Perform the Amplifier Test to measure the actual temperature. Check if the SnapPak is expired. Paper jams should be cleared as soon as possible to avoid damaging the printer.

Roche Instructions for Use · Version 7. o Press YES and the electrode voltages will be displayed. perform daily maintenance or replace the electrode. o After introducing the sample.1 o After testing the electrodes against the standard solutions. o To exit this function. o The prompt [Test Standard C?] will be displayed. Electrode o Press NO. the analyzer will display [Thank you!] shortly. Press YES. o Press NO to exit and after a short [Please Wait] message. o Record these values. Starting at the [READY] display. o The instrument will prompt [Open Sample Door Introduce Sample]. o Compare the measured values to the following table: Standard A Standard B Standard C Allowed difference A-B + A-C Na -600 to +2400 -1600 to +2000 -600 to +2400 +250 to +680 -50 to +50 + -700 to +1000 -2500 to +500 -700 to +100 +470 to +1200 -40 to +40 - -3100 to -100 -1000 to +3000 -3100 to -100 -370 to -860 -3100 to +1000 -2300 to +2500 -3100 to +1000 -350 to -660 -150 to +150 -3100 to +1900 -3600 to +1400 -2600 to +3400 +1 to +760 -1730 to -285 K Cl Ca2+ + Li unused If the voltage difference A-B or A-C is outside the allowable difference. and enter YES. o The prompt [Test Standard B?] will be displayed. press NO. o Press YES and the electrode voltages will be displayed. followed by the electrode voltages. o Record these values. o Record these values. o Press NO to exit or to perform other service functions. o Press YES and the prompt [Test Standard A?] will be displayed. until [Test Electrodes?] is displayed. July 2013 E-9 . the 9180 Electrolyte Analyzer will prompt [Test External Sample?]. o Press YES and the electrode voltages will be displayed. o Check for stable readings.9180 Electrolyte Analyzer 10 Troubleshooting Service functions Service functions The 9180 Electrolyte Analyzer has various built-in functions that you can access to evaluate the performance of the instrument. Testing the electrodes The voltage levels of the electrodes can be tested by using standard solutions or an external sample. press NO until [SERVICE FUNCTIONS?] is displayed. o To exit this function. press NO. the prompt [Remain in Test Electrodes?] will appear.

Press YES. o Test the sample for 15 minutes. The display will be like: External: 236 Pump: NO=OFF o Roche E-10 Press NO to exit and after a short [Please Wait] message.1 . o Repeat the procedure a second time. the prompt [Test SnapPak Sensor?] will appear. o Press NO. until the prompt [Wipe Probe/Close Sample Door] is displayed. o The sample is aspirated.10 Troubleshooting 9180 Electrolyte Analyzer Service functions Not calibrated potassium electrode If the potassium electrode cannot be calibrated after an electrode exchange. Prepare a serum or plasma sample and introduce the sample: o The prompt [Open Sample Door Introduce Sample] appears. Testing the sample sensor The dry sample sensor should indicate a value of 80-120. then a serum or plasma sample should be introduced as an external sample. o Press YES and the analyzer will display the current sample sensor reading: Dry: 80-120: 99 YES=Pump/NO=Exit o Press YES introduce an external sample through the probe. aspiration of a clear fluid should increase this value by at least 40 Units. o Press NO. until [Test Sample Sensor?] is displayed. o Call up the procedures for testing electrodes e see Testing the electrodes on page E-9. July 2013 Instructions for Use · Version 7. until [Test External Sample?] is displayed. Introduce the sample.

o Change the language settings with a pen. o Press NO to exit or to perform other service functions. Testing the language switch o Press NO. o Press YES and the current language switch status will be displayed: o Open the front door and remove the printer paper tray.1 o Open the sample door to see the changes of the status. English ᣣᧄ⺆ Deutsch Polski Français Português Español Spare 3 Italiano Spare 4 Figure E-1 Testing the sample door o Press NO. a calibration should be performed to prime all fluid lines. o Press NO to exit or to perform other service functions. o Press NO to exit or to perform other service functions. If the SnapPak has been removed during this test. July 2013 E-11 .9180 Electrolyte Analyzer 10 Troubleshooting Service functions Testing the SnapPak sensor o Press NO. until [Test Sample Door?] is displayed. During insertion the detection of the SnapPak can be a delayed up to 10 seconds. "O" means that the SnapPak either is not installed or is not inserted correctly. o Press YES and the current status will be displayed: Sample Door: C C=closed O=open Roche Instructions for Use · Version 7. To activate a new language setting. until [Test Language Switch?] is displayed. o Press YES and the current SnapPak sensor status will be displayed: SnapPak: I I=In O=Out o "I" on the display indicates that the SnapPak is inserted properly. turn the analyzer off and back on. until [Test SnapPak Sensor?] is displayed.

until [Test Pinch Valves?] is displayed. Press YES. o Open the front cover and press YES to begin the pump test. o Check that there was no interface error. July 2013 Instructions for Use · Version 7. The analyzer will display: ---Test Pump!--- The following tests will be performed and displayed: o Very low speed o Low speed o Medium speed o Fast speed An audible change should be heard at the pump’s speed change. o Press NO.10 Troubleshooting 9180 Electrolyte Analyzer Service functions Testing the pump o Press NO. otherwise the interface may get damaged. until [Test Pump?] is displayed. WARNING Roche E-12 o The analyzer will display [Interface Test] and tries to send some characters and checks if they are received within a set time period. o Press and the following will be displayed: Testing the valves Test Valve A: YES/NO = ON/OFF o Press YES to move the valve to the open position. o Close the front cover and press NO to exit or to perform other service functions. press NO to exit or to perform other service functions. o Press NO to exit or to perform other service functions.1 . o Jump pins 2 and 3 of the serial interface making sure not to short the jumper to ground. until [Test Interface? Jump Pins 2 & 3] is displayed. o Press NO to move the valve back to the closed position. o After [Test Valve R] is finished. Testing the interface Be sure not to short pin 2 or pin 3 to ground. o Press NO. o Press NO once more to test the next valve.

contact technical support. until [Test Amplifier?] is displayed. If this is not the case. o Press YES and the analyzer will display the current amplifier values: Na=#### K=#### Cl/Ca/Li=#### o Press NO and the ground voltage will be displayed: GND =0 -2500mV=-2499 o Press NO and the temperature will be displayed: Temp(mV) =-#### Temp(°C) = ##.9180 Electrolyte Analyzer 10 Troubleshooting Service functions Testing the amplifier o Press NO. bottom) July 2013 E-13 .1 Status LEDs (back panel. Status-LEDs The 5 status LEDs at the bottom of the chassis back panel are lit simultaneously during normal operation.# o Press NO to exit or to perform other service functions. Figure E-2 Roche Instructions for Use · Version 7.

If an incorrect code is entered during the process. ECO becomes OCE. o Repeat this procedure for the other characters. and enter YES. Enter the service code as follows: o Press NO. o The prompt [Enter Code: AAA] will appear. keep pressing the NO key until the correct character appears. until the first character appears.10 Troubleshooting 9180 Electrolyte Analyzer Service codes Service codes The [Enter Service Code?] menu allows the programming of various functions into the 9180 Electrolyte Analyzer. Roche E-14 July 2013 Instructions for Use · Version 7. To clear all service codes at one time. TIP: If the desired character was missed. MGL becomes LGM. press NO until [SERVICE FUNCTIONS?] is displayed.1 . enter the reversed sequence of the code letters (example: DEC becomes CED. etc. Removing service codes To remove a service code. o Pressing YES after the third character will activate the service code. Entering service codes o Starting at the [READY] display. o Press YES and the cursor will advance to the second position. enter CDC. o Press NO until [Enter Service Code?] is displayed.). the analyzer will prompt [Code Error! Retry?]. Press YES to correct the code or NO to exit.

Roche Instructions for Use · Version 7. Table E-2 With the exception of FIF. SFC This code allows the input of a percentage for the SnapPak counter. Note that QC and standard measurements are always reported in mmol/L independent of the MGL setting. This feature mainly helps to conserve reagents. which cannot be reset by the operator. urine samples in low resolution. Pressing YES to [ok?] will return the analyzer to the ready screen. MGL This service code allows you to report Ca2+ values in mg/dL instead of mmol/L.1 July 2013 E-15 . LEM This service code will print the last 20 error messages with the date and time of occurrence. This allows you to compare the Ca2+ values to the ISETROL assay ranges. The service codes currently set can be printed on the calibration report. if no samples are run between two calibrations (4 hrs. In order to disable this code enter the code CCQ. FIF This service code will automatically print the voltage levels of the electrodes on sample and calibration reports. When the unit automatically enters the Standby Mode. the current setting of the leasing counter. ECO This service code will automatically put the instrument into Standby Mode. Ca2+ activated NOB This service code disables the beep. SLC When this code is set. is printed on the calibration report. NOTE: The default condition is that this code is disabled. it is always necessary to perform a calibration to get back to the [READY] prompt. When the code is disabled (using CCQ) QC measurements will be reported as flame equivalent values with correlation factors applied. either enter IFI or turn the power off and back on. the unit automatically converts the current high and low values of the normal ranges to mg/dL. QC and standard samples are always shown in high resolution. When this code is set.).9180 Electrolyte Analyzer 10 Troubleshooting Service codes List of service codes Code Action DEC This service code will increase the resolution by one digit for all parameters in blood and serum samples. press NO and enter the correct percentage between 0 and 100 % using the NO and YES keys. the analyzer displays: SnapPak Counter: xxx% ok? If this percentage is not correct. To disable this code. MEL will erase all error messages stored. QCC When this code is enabled (using QCC) QC measurements will be reported in direct ISE values without correlation factors. When this code is activated. This code should only be used by trained service technicians. all service codes are permanently stored in memory and will be retained during power failures.

printer settings.10 Troubleshooting 9180 Electrolyte Analyzer Deleting data Deleting data Clearing sample count To reset the sample count to 0. carry out the following procedure: o Open the [READY] display and press NO until the display [OPERATOR FUNCTIONS?] appears. It is recommended that all data be deleted if the analyzer is to be used by other persons at a later date. This function can be performed optionally upon completion of decommissioning. Roche E-16 July 2013 Instructions for Use · Version 7.1 . press the YES and NO keys simultaneously and switch the analyzer off and on again. QC and normal values as well as correlation factors. o Press NO until [Reset Sample Number?] appears. All service codes will be deactivated. o When the prompt [Are you sure?] appears. Clearing all data To reset the analyzer software to the default values. Press YES. date/time and liquid content of the SnapPak will be reset to default values. press YES again. Confirm with YES. All QC data and analyzer settings will be lost! CAUTION All QC values and statistics will be deleted and the sample number reset to 0.

F-3 12 Glossary . F-13 July 2013 . . . . . .Appendix F 11 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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................................................................F-10 Electrodes ................................................................................................................................................F-5 Calibration report ................................................................................................................................F-5 QC report ..................................................................9180 Electrolyte Analyzer 11 Appendix Table of contents Appendix In this chapter Chapter 11 Description of reports .................................................................................................F-8 Maintenance schedule .....................................................................................F-5 Measurement report ..............................................................................................................................................................................F-7 Program flow chart .................................................................................................F-6 Specifications of the solutions ....................................................................................F-12 Roche Instructions for Use · Version 7....F-10 Solutions ..................................................................................1 July 2013 F-3 .......................................................F-11 QC material ........................................................................F-11 Accessories ..F-9 Order information .................................................................................................................................

11 Appendix 9180 Electrolyte Analyzer Table of contents Roche F-4 July 2013 Instructions for Use · Version 7.1 .

46 1 Cl-values 120.51 1 Cl-values 103........5 Na= 263 K = 18..36 Sample No......93  mmol/L Cl=103....1 mmol/L *** Level 2 *** Lot Number: 1261 *** Level 3 *** Lot Number: 1373 Na/K/Cl 1 Na-values 145......0 1 K-values 2.. Sample: STANDARD Name: ..0 mmol/L mmol/L mmol/L *PEFORM DAILY * MAINTENANCE! * Table F-1 QC report ..35 Sample No. Sample: URINE Sample No.....4 1 K-values 4.56 Cl=114.5 1 K-values 6.ROCHE 9180 ELECTROLYTE ISE NA-K-CL 26SEP03 08:27 HOSPITAL WEST ....37 Na=151..ROCHE 9180 ELECTROLYTE ISE NA-K-CL 26SEP03 08:31 HOSPITAL WEST Name: .9180 Electrolyte Analyzer 11 Appendix Description of reports Description of reports Measurement report - ROCHE 9180 ELECTROLYTE ISE NA-K-CL 26SEP03 08:16 HOSPITAL WEST .. Sample: SERUM Name: ..3 Cl= 118 mmol/L mmol/L mmol/L Na=143..... ....1 July 2013 F-5 .6 Na/K/Cl 1 Na-values 160..... ..9 mmol/L K = 4....71 1 Cl-values 69...ROCHE 9180 ELECTROLYTE ISE NA-K-CL 26SEP03 09:21 HOSPITAL WEST QUALITY CONTROL *** Level 1 *** Lot Number: 1150 Na/K/Cl 1 Na-values 118..7 K = 5...6 Table F-2 Roche Instructions for Use · Version 7. .

2°C SnapPak: 83% Remaining Corr.5 .= 0.000 Urine Factors: Na Offs.= 0.= 0.0 Na Slope= 1. .1 .000 Cl Offs.5 .0 Cl: 50 200 *** Level 3 *** Lot number:1373 Na: 40 145 K : 1. .1 Cl: 97 111 QC Ranges: Units: [mmol/L] *** Level 1 *** Lot number:1150 Na: 40 145 K : 1. REPORT* Daily Maintenance Performed Last: 26SEP03 08:16 Standard A Na = -369mV (4) K = -1052mV (4) Cl = -183mV (4) Difference A-B: Na = 584mV ( ) K = 1056mV ( ) Cl = -689mV ( ) Temp.000 K Offs.000 Cl Offs. Factors: Na Offs.= 0.0 Na Slope= 1.0 K Slope= 1.000 Acetate Factors: Na Offs.NOB.= 0. = 26.5 .000 Normal Ranges: Units: [mmol/L] Na: 136 145 K : 3. .0 Na Slope= 1.5 5.000 Cl Offs.0 K Slope= 1.0 Na Slope= 1.15.0 K Slope= 1.15.0 K Slope= 1.000 Bicarb.= 0.000 Cl Offs. Table F-3 Roche F-6 July 2013 Instructions for Use · Version 7.000 K Offs.= 0.000 K Offs.0 Cl: 50 200 *** Level 2 *** Lot number:1261 Na: 40 145 K : 1.ROCHE 9180 ELECTROLYTE ISE NA-K-CL 26SEP03 09:01 HOSPITAL WEST *CALIBR.11 Appendix 9180 Electrolyte Analyzer Description of reports Calibration report . .0 Cl: 50 200 Service Codes: .0 Cl Slope= 1. . .0 Cl Slope= 1.= 0.= 0.= 0.0 Cl Slope= 1.= 0.15.0 Cl Slope= 1. . Factors: Na Offs.= 0.000 K Offs.

electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee. holds human body fluids which may be potentially infectious.9180 Electrolyte Analyzer 11 Appendix Specifications of the solutions Specifications of the solutions Use of calibration solutions.1 July 2013 F-7 . The SnapPak contains the following solutions: o Standard A o Standard B o Standard C o Reference solution Caution: A waste container is provided inside the SnapPak which. when used. Reagents are to be used for in-vitro diagnostic use only. handle with appropriate care to avoid skin contact or ingestion! Roche Instructions for Use · Version 7.

Corr Factors? NO Remain in QC/Std /Urine Sample? NO Remain in Operator Func? NO Urine Sample? NO NO Program Corr Factors? NO Take out of Operation? NO Acetate Sample? NO Program Normal Ranges? NO Reset Sample Number? YES NO Program QC Level 3 Ranges? Bicarbonate Sample? YES NO Select Parameter Configuration? Program QC Level 2 Ranges? NO Program QC Level 1 Ranges? NO Enter Code: AAA YES PROGRAM INSTRUMENT? NO Calibration NO NO NO NO Set Time/Date? NO Go to Standby Mode? NO Check/Change SnapPak? YES OPERATOR FUNCTIONS? Standard Sample? NO Remain in Daily Maintenance? NO Remain in Print Functions? YES NO NO QC Level 3 Sample? NO Print QC Values and Statistics? NO Perform Daily Conditioning? NO QC Level 2 Sample? NO Print Cal Report? YES Perform Daily Cleaning? DAILY MAINTENANCE? YES NO QC Level 1 Sample? QC/STD/DIALYSATE URINE SAMPLE? YES NO Print last Sample Report? PRINT FUNCTIONS? NO Calibration YES CALIBRATION? NO 11 Appendix 9180 Electrolyte Analyzer Program flow chart Program flow chart Figure F-1 Instructions for Use · Version 7.1 July 2013 .Na K Cl READY Roche F-8 YES NO YES NO NO NO Remain in Program Func? NO NO Remain in Service Func? NO Program Interface? NO Enter Service Code? NO Program Printer Setup? NO Test Amplifier? NO Program Urine Corr Factors? NO NO Test Interface? Jump Pins 2 & 3 NO Test Pinch Valves? NO Test Pump? NO Test Sample Door? NO Test Language Switch? NO Test SnapPak Sensor? NO Test Sample Sensor? NO Test Electrodes? YES SERVICE FUNCTIONS? Program Acetate Corr Factors? NO Program Bicarb.

July 2013 F-9 .1 UNSCHEDULED MAINTENANCE Change main tubing harness ANNUALLY Change pump tubing SEMI-ANNUALLY Clean reference electrode housin MONTHLY Clean analyzer surfaces Clean sample probe/fill port WEEKLY Perform conditioning Perform cleaning DAILY Month: ……………………. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 9180 Electrolyte Analyzer Maintenance schedule 9180 Electrolyte Analyzer 11 Appendix Maintenance schedule Maintenance schedule TIP: This page can be used as template for duplication.Roche Instructions for Use · Version 7.

11 Appendix 9180 Electrolyte Analyzer Order information Order information To measure the respective parameters. Electrodes Parameter Cl– Na+ K+ Ca2+ Li+ Chloride Electrode 03110451180 X + + + + Sodium Electrode 03110419180 + X + + + Potassium Electrode 03110338180 + + X + + Calcium Electrode 03110354180 + + + X + Lithium Electrode 03110664180 + + + + X Reference Electrode 03112306180 X X X X X Reference Electrode Housing 03112284180 X X X X X Dummy Electrode(a) 03110192035 + + + + + Table F-4 (a) replaces an unused electrode Roche F-10 X Has to be installed + Dummy or electrode has to be used for proper filling of the measuring chamber July 2013 Instructions for Use · Version 7.1 . the following products are required.

9180 Electrolyte Analyzer

11 Appendix
Order information

Solutions
Parameter
Cl–

Na+

K+

Ca2+

Li+

Deproteinizer
03110435180

X

X

X

X

X

Electrode Filling Solution
03110770035

X

X

X

X

X

Sodium Electrode Conditioner
03110362180

+

X

+

+

+

Urine Diluent
03110249180

X

X

X

X

X

Cleaning Solution
03111555180

X

X

X

X

X

SnapPak 918x
03112349180

X

X

X

X

X

SnapPak Dialysate 918x (a)
03112357182

X

X

X

X

X

Table F-5
(a) available in Japan only

X

Has to be installed

+

Dummy or electrode has to be used for proper filling of the measuring chamber

QC material
Parameter
Cl

ISETROL
03112888180

O

Na

+

O

K+

Ca2+

Li+

O

O

O

Table F-6

O

Roche
Instructions for Use · Version 7.1

Can be used

July 2013
F-11

11 Appendix

9180 Electrolyte Analyzer

Order information

Accessories
Parameter
Cl–

Na+

K+

Ca2+

Li+

Adapter for Capillaries
03113817035

O

O

O

O

O

Caps for Roche MICROSAMPLER
03112152180(a)

O

O

O

O

O

Printer Paper
03112292018

O

O

O

O

O

Roche MICROSAMPLER PROTECT, non sterile
05772494001 (200 pcs.)(a)

O

O

O

O

O

Roche MICROSAMPLER PROTECT, sterile
05772583001 (50 pcs.)(a)

O

O

O

O

O

Roche MICROSAMPLER PROTECT, with accessories
05772591001(b)

O

O

O

O

O

Capillary Tubes, ~200 μL
03113477180(a)

O

O

O

O

O

BS2 Blood Sampler
03113493035(a)

O

O

O

O

O

Capillary Tubes, ~115 μL
03113507035(a)

O

O

O

O

O

Caps for Capillary Tubes
03113647035

O

O

O

O

O

Plastic Capillary Tubes, 140 μL
05174791001(a)

O

O

O

O

O

Table F-7
(a) not available in USA.
(b) available in USA only.

O

Roche
F-12

Can be used.

July 2013
Instructions for Use · Version 7.1

9180 Electrolyte Analyzer

Glossary
Alkaline - Shutdown kit

Glossary

A

P

Alkaline Basic.

Peristaltic pump see "Pump"

Arterial blood Blood taken from an artery

Plasma Plasma samples are obtained by centrifuging
heparinized whole blood to separate the cellular
component of the blood.

D
Dummy electrode This is a flow-through electrode
with no measurement function used as a placeholder.

E
Electrodes Flow-through electrodes with visible
well counter.

PP Abbreviation for Peristaltic pump
Printer A quiet thermal printer.
Pump The sample and the aspirate fluids are
transported by a peristaltic pump.

Q
QC Abbreviation for “Quality Control”.

I
ISE measuring chamber The ISE measuring
chamber with its sensors is used to measure the Na+, K+,
Ca2+, Cl– and Li+ electrolyte values.

QC materials See ISETROL.
Quality Control The known target ranges of QC
materials are compared with the QC results of the
instrument.

ISETROL QC material for checking ISE.

R
L
Locking lever Used to lock the sensors in the
measuring chamber.

M

Reference electrode The reference electrode is a
counter-electrode to the measuring electrodes. Its signal
remains constant because of the reference solution
regardless of the composition of the sample.
Reference housing The Reference housing and
Reference electrode form the reference electrode unit,
which establishes the contact to the sample.

MC Abbreviation for “Measuring chamber”.
Measuring chamber The ISE measuring chamber is
behind the front panel of the instrument.

N
Needle mechanism Used to input samples and
aspirate fluids from the SnapPak. It comprises the sample
needle and the filler funnel with funnel holder behind the
sample flap.

Relief clamps Used to protect the valves during
transport of the instrument. They must be removed
before operating the instrument.

S
Sample sensor The sample sensor positions the
sample (optically) while filling the measuring chamber
and is connected to the measuring chamber.
Sampling rate Number of samples per hour.

NIST standards Accurate sera with certified expected
values

Roche
Instructions for Use · Version 7.1

Shutdown kit Used to rinse the tubing with distilled
water when the instrument is put out of operation.
July 2013
F-13

Roche F-14 July 2013 Instructions for Use · Version 7. T Transport housing The transport housing protects the Reference electrode during transport.Glossary 9180 Electrolyte Analyzer SnapPak .Transport housing SnapPak All aspirate fluids and a waste fluid container are included in the SnapPak.1 .

. . . . . . . . . . . . . . .Index 13 G Index . . . G-3 July 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.

F-6 Capillary tubes. A-12. A-12 Disposal of SnapPak. E-16 Clearing sample count. E-14 Error messages. A-9 General QC concept. A-29. A-42 Classification (according IEC/ISO). -7 I Important information. B-7 – Rear panel. F-6 – Measurement. and instrument. B-8 – Serial port.9180 Electrolyte Analyzer Index Index A Accessories. A-12 Handling electrodes. C-29 – Substances with effect. B-10 – SnapPak. electrodes. C-45 H Handling – Electrodes. F-5 Roche Instructions for Use · Version 7. A-29 Cleaning analyzer surfaces. electrodes. F-5 Dialysate. C-5 Additional settings. C-28 Dimensions. E-16 Contact addresses. A-5 Installation. A-25 Callibration report.1 General description – Introduction. F-5 – QC. E-16 Description of reports. C-26 Checking reagent fluid level and changing the SnapPak. B-5 – Display. A-12 Disposal of the reference electrode. B-8 Annual maintenance – Exchanging main tubing harness. D-14 Exchanging the pump tubing set. B-6 Disposal – Reference electrode. C-41 – Printer. A-12 Handling solutions. A-43 Calibration procedure. 3 Electrical data. C-5 – Location. A-24 G C Calcium electrode. A-29 Disinfection. A-12 – SnapPak. A-12 Document information. B-9 – Sample probe mechanism. B-9 – Valves. B-7 – Printer. D-5 Display. A-29 Entering service codes. D-10 Clearing all data. C-29 Introduction. B-7 – Peristaltic pump. C-28 B – Calibration. A-46 Calibrations. A-10 – ISE calibration. B-6 – Measuring chamber. D-6 Deleting data. 3 E Edition notice. A-12 – Solutions. 3 Correlation factors. A-23. C-41 Analyzer components. A-9 ISE calibration. D-9 Cleaning the reference electrode housing. B-6 – Keypad. D-17 Chloride electrode. and instrument. C-39 D Daily maintenance. C-5 Interferences. A-46 July 2013 G-3 . A-12 How to Use This Manual. E-5 Exchanging main tubing harness. 4 Copyrights. C-31 – Substances without effect. D-14 Aqueous solutions. D-13 Bibliography.

C-48 Quality control – General QC concept. C-33 Linearity – Aqueous standard solutions. C-29 – Substances with effect. C-5 M Maintenance. 8 – version. F-12 – Electrodes. A-29 – Electrical data.flame-correlated. C-27 Potassium electrode. A-21 List of service codes. A-17 Performing a QC measurement. C-11 Principle – Measurement. C-49 Operating safety information. D-5 Maintenance schedule. A-22 – Correlation to direct ISE . -3 Order information. F-10 – QC material. F-10 – Accessories. F-11 P Performance parameters.not flame-correlated. A-22 – Serum. F-5 Measuring chamber. C-33 – General. A-41 Preanalytics. A-37 Printer. A-29 Program flow chart. A-6 Operator’s Manual – conventions used. F-8 Q QC material. A-10 Measurement report. A-17 – Reproducibility. A-36 – Physical. A-37 Principles of Operation – Measurement principle. C-46 Measurement – Interferences.Index K Keypad. C-48 Peristaltic pump. A-21 Linearity in serum. A-36 Measurement procedure. A-28 – ISETROL Electrolyte Control. A-28 QC report. A-29 – Dimensions. C-45 – Material setup. A-21 Linearity in aqueous standard solutions. A-37 Plasma. C-34 Procedures – Calibration. C-25 Preparing the Analyzer for Operation. B-7 Printer settings. E-15 Lithium electrode. A-36 – Physical principle. A-22 – Correlation to direct ISE . F-11 – Solutions. A-29. A-29 – Classification (according IEC/ISO). Service codes – List. A-11 Measurement parameters. C-41 Printing a QC report. A-17 Measurement principle. A-21 – Correlation to chloridometry. C-38 O 9180 Electrolyte Analyzer – IVD symbols. B-7 Measuring procedure. A-44 Local Service Contact. B-7 Physical principle. C-29 Measurement evaluation. -7 – how to use. F-9 Material setup. A-10 – Measurement. F-5 Quality contro – Performing a QC measurement. C-34 Monthly maintenance – Cleaning the reference electrode housing. B-6 L Limitations of clinical analysis. -7 Roche G-4 July 2013 Instructions for Use · Version 7. C-46 – Printing a QC report. A-10 Product data. C-49 Procedure – Measurement. 4 Location. D-10 N Normal ranges.1 . C-31 – Substances without effect. C-33 – Electrolytes.

A-40 Software – version. E-9 – Testing – Amplifier. E-9 Testing the interface. A-26 – Electrodes. E-13 Symbols. C-34 – Dialysate samples. B-9 Reference and critical values. E-12 Testing the sample door. E-13 Testing the electrodes. A-27 – Urine diluent. C-28 – Plasma. C-37 – Direct ISE. C-28 – Dialysate. A-26 Testing the amplifier. A-40 Specifications of the solutions. E-9 – Interface. E-12 SnapPak. C-25 Sample collection and handling. E-12 – Language switch. E-11 Testing the pump. 3 Troubleshooting. E-11 – Status-LEDs. E-5 – Service functions. E-13 – Electrodes. E-11 – Sample sensor. A-33 Reference electrode. C-37 Sample probe mechanism. A-25 Sample volumes. A-24 Removing service codes. E-10 – SnapPak sensor. A-11 Sample collection containers – Capillary tube. A-27. A-28 Specification – Calcium electrode. D-15 Replacing sample probe and fill port. D-13 Serial port. C-26 S Safety information – Important information. A-25 Semi annual maintenance – Exchanging the pump tubing set. C-27 – Whole blood. A-35 – Potassium. E-12 Theoretical foundation – Reference and critical values. B-8 Sample throughput. E-11 Testing the sample sensor. A-13 Status-LEDs. A-5 – Operating safety information. A-33 Trademarks. E-10 Testing the SnapPak sensor. C-36 – Urine samples. B-9 Sodium electrode. E-14 – Remove. A-34 – Ionized calcium. A-17 Roche MICROSAMPLER PROTECT. D-18 Reproducibility. E-11 Testing the valves. D-15 July 2013 G-5 . C-27 Sample measurement. C-27 Service codes. C-26 Sample handling – Aqueous solutions. A-44 – Potassium electrode. A-34 – Sodium. A-43 – Chloride electrode.9180 Electrolyte Analyzer R Rear panel. A-45 Relationship of ionized calcium to total calcium. E-9 U Unscheduled maintenance. E-13 – Valves. E-14 Replacing electrodes. A-6 Sample collection. A-45 – Sodium electrode. E-5 – Error messages.1 Index – Pump. E-12 – Sample door. C-26 System description. D-15 – Checking reagent fluid level and changing the SnapPak. E-14 Service functions. B-10 Serum. E-11 Roche Instructions for Use · Version 7. B-5 T Temperature / humidity / stability. E-14 – Enter. -3 Solutions. A-35 – Lithium. A-41 – Reference electrode. C-27 – Serum. A-42 – Lithium electrode. E-12 Testing the language switch. A-26 – Instrument. F-7 Standby mode. A-27 – SnapPak. -7 Syringes. C-26 – Syringes. C-26 – Roche MICROSAMPLER. A-33 – Chloride. A-25 Sample types. D-17 – Replacing electrodes.

D-9 Roche G-6 July 2013 Instructions for Use · Version 7.1 . B-8 W Weekly maintenance.Index 9180 Electrolyte Analyzer – Replacing printer paper. D-8 – Cleaning analyzer surfaces. D-20 – Replacing sample probe and fill port. D-18 Urine diluent. A-28 V Valves.