Roche 9180 Instructions For Use Manual
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Roche 9180 Instructions For Use Manual

Electrolyte analyzer
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9180 Electrolyte Analyzer
Instructions for Use

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  • Page 1: In This Chapter Chapter

    9180 Electrolyte Analyzer Instructions for Use...

  • Page 2: Publication Information

    Table 1 Revision history Edition notice This publication is intended for users of the 9180 Electrolyte Analyzer. Every effort has been made to ensure that all the information contained in this publication is correct at the time of publishing. However, the manufacturer of this product may need to update the publication information as output of product surveillance activities, leading to a new version of this publication.
  • Page 3 For conditions of warranty, contact your local sales representative or refer to your warranty contract partner. Always leave software updates to a Roche Service representative, or perform such updates with their assistance. Copyright © 1996-2022, F. Hoffmann-La Roche Ltd. All rights reserved.

  • Page 4: Contact Addresses

    Sandhofer Strasse 116 68305 Mannheim Germany Made in Switzerland www.roche.com Roche affiliates A list of all Roche affiliates can be found at: www.roche.com/about/business/roche_worldwide.htm eLabDoc Electronic user documentation can be downloaded using the eLabDoc e-service on Roche DiaLog: www.dialog.roche.com For more information, contact your local affiliate or Roche Service representative.

  • Page 5: Table Of Contents

    9180 Electrolyte Analyzer Table of contents System components Publication information Contact addresses Edition 5 System components Local Service Contact System description Table of contents Preface Operation Intended use Intended user Use environment 6 Installation and shutdown Symbols and abbreviations Installation What is new in publication version 10.0...

  • Page 6: In This Chapter Chapter

    9180 Electrolyte Analyzer Appendix 11 Appendix Description of reports Specifications of the solutions Program flow chart Maintenance schedule Available accessories and consumables 12 Glossary Index Index Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 7: Preface

    9180 Electrolyte Analyzer Preface Intended use The 9180 Electrolyte Analyzer is intended for in vitro testing of samples of whole blood , serum or plasma, and urine for the quantitative measurement of electrolytes , Ca , and Cl ) and Lithium using electrochemical technologies (potentiometry and amperometry) for aid in diagnosis and in monitoring.

  • Page 8: In This Chapter Chapter

    9180 Electrolyte Analyzer Symbols used on the instrument Symbol Description Catalogue number Serial number Global Trade Item Number Unique Device Identifier Contents Manufacturer Date of manufacture Alternating current Temperature limitation Humidity limitation Air pressure limitation Fragile handle with care Keep dry...

  • Page 9: In This Chapter Chapter

    9180 Electrolyte Analyzer Symbol Description Stacking limit Caution Operator’s manual/operating instructions Caution, consult accompanying documents Device for near-patient testing Device not for self-testing Electrostatic-sensitive device (ESD) Table 3 Symbols used on the instrument Symbols used on consumables Symbol Description Catalogue number...

  • Page 10: In This Chapter Chapter

    9180 Electrolyte Analyzer Symbol Description Consumable contents Control material Fragile handle with care Store upright Do not reuse Manufacturer Sterilized using radiation Sterilized using ethylene oxide Install before Sufficient for <n> tests Operator’s manual/operating instructions Caution, consult accompanying documents Table 4...

  • Page 11: In This Chapter Chapter

    9180 Electrolyte Analyzer Abbreviation Definition Coefficient of variation German Institute of Standardization European community International Electrotechnical Commission Ion selective electrode International Organization of Standardization In vitro diagnostic IVDD In vitro diagnostic directive IVDR In vitro diagnostic regulation Potassium chloride Liquid crystal display...
  • Page 12 Regulatory adaptations The following information was added as part of the adaptation to the EU regulation 2017/746 on in vitro diagnostic medical devices: Information about incident reporting Link to the worldwide list of Roche affiliates Download information about electronic user documentation Minor changes Minor changes have been applied throughout the publication.
  • Page 13 QR code on the top right-hand corner of the name plate. New approvals section Compliance of all applicable directives and guidelines for the 9180 Electrolyte Analyzer can now be found in the approvals section at the front of the Instructions for Use.
  • Page 14 9180 Electrolyte Analyzer Roche Diagnostics Instructions for Use · Version 10.0...
  • Page 15 Introduction and specifications Safety information ........................... 17 General description .......................... 27 Specifications ............................ 33 Theoretical foundation ........................49...
  • Page 17 9180 Electrolyte Analyzer 1 Safety information Table of contents Safety information This chapter provides information about the safe operation of the 9180 Electrolyte Analyzer. Chapter In this chapter Safety classifications......................18 Safety precautions.........................19 Operator qualification ....................19 Safe and proper use of the system................19 Installation and deinstallation ..................20...

  • Page 18: Safety Classifications

    1 Safety information 9180 Electrolyte Analyzer Safety classifications Safety classifications This section explains how precautionary information is presented in this manual. The safety precautions and important user notes are classified according to the ANSI Z535.6 Standard. Familiarize yourself with the following meanings and icons: Safety alert The safety alert symbol is used to alert you to potential physical injury hazards.

  • Page 19: Safety Precautions

    As an operator, ensure that you know the relevant safety precaution guidelines and standards and the information and procedures contained in these instructions. CAUTION Do not carry out operation and maintenance unless Roche Diagnostics has trained you to do so. Leave maintenance, installation, or service that is not described to trained Roche Service representatives.

  • Page 20: Installation And Deinstallation

    Do not attempt to work in any electronic equipment. Do not remove any cover of the system except those covers specified in the instructions. Only Roche Service representatives may install, service, and repair the system. Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 21: Biohazardous Materials

    9180 Electrolyte Analyzer 1 Safety information Safety precautions Biohazardous materials Infectious samples Contact with samples containing material of human origin may result in infection. All materials and mechanical components associated with samples containing material of WARNING human origin are potentially biohazardous.

  • Page 22: Mechanical Safety

    Wear appropriate personal protective equipment. Observe the instructions given in the Instructions for Use. Observe the information given in Material Safety Data Sheets (available for Roche Diagnostics reagents and cleaning solutions). If reagents, detergents, or other cleaning solutions come into contact with your skin, wash the affected area immediately with soap and water and apply a disinfectant.

  • Page 23: Incorrect Results

    Software and data security Unreliable validation due to Roche shall not be held liable for any consequences resulting from subsequent, unauthorized changes to the unauthorized modifications to the accepted validation settings included in the system validation settings at the customer’s request.

  • Page 24: Instrument Damage

    1 Safety information 9180 Electrolyte Analyzer Safety precautions Unreliable validation due to Roche shall not be held liable for any consequences resulting from subsequent, unauthorized changes to the unauthorized modifications to the accepted validation and calculation rules included validation and calculation rules in the system at the customer’s request, as well as test results.

  • Page 25: Consumables

    The safety labels on the system comply with the following standards: ANSI Z535, IEC 61010-2-101, IEC 61010-1, IEC 60417, ISO 7000, or ISO 15223-1. Only Roche Service representatives may replace damaged labels. For replacement labels, contact your Roche Service representative.
  • Page 26 1 Safety information 9180 Electrolyte Analyzer Safety labels on the instrument and consumables Direct exposure of the Sodium Electrode Conditioner to the skin or eyes may lead to serious irritation. While handling Sodium Electrode Conditioner, wear appropriate personal protective equipment.
  • Page 27 9180 Electrolyte Analyzer 2 General description Table of contents General description This chapter contains a general description of the instrument, precautionary information against specific hazards and the proper handling of sensors, and solutions. Chapter In this chapter Introduction..........................29 Measurement and calibration procedures.................30 Measurement procedure ....................30...
  • Page 28 2 General description 9180 Electrolyte Analyzer Table of contents Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 29: Introduction

    9180 Electrolyte Analyzer 2 General description Introduction Introduction This manual will help guide you through setting up the analyzer and analyzing samples. As you become familiar with the analyzer, this manual may be used as a reference for day-to-day routines, maintenance and troubleshooting.

  • Page 30: Measurement And Calibration Procedures

    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. Measurement principle (p. 53) There are six different electrodes used in the 9180 Electrolyte Analyzer: sodium, potassium, chloride, calcium, lithium and a reference electrode.

  • Page 31: Measurement Evaluation

    Measurement evaluation Measurement evaluation The validity of the test results from the 9180 Electrolyte Analyzer has to 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.

  • Page 32: Standby Mode

    Standby mode Standby mode The 9180 Electrolyte Analyzer is designed to calibrate automatically every four hours during normal operation. If sampling will be delayed for an extended time, such as evenings and weekends, you may place the analyzer into Standby mode to suspend automatic calibration.
  • Page 33 9180 Electrolyte Analyzer 3 Specifications Table of contents Specifications In this chapter, the measurement parameters and product and environmental data are described. Chapter In this chapter Performance parameters .....................35 Measurement parameters....................35 Reproducibility .......................35 Material: ISETROL Protein Based Aqueous Control Material (Level 1), n=80...
  • Page 34 3 Specifications 9180 Electrolyte Analyzer Table of contents Environmental parameters....................44 Temperature / humidity / stability ................44 Instrument ........................44 Electrodes........................44 Solutions..........................45 SnapPak ........................45 Urine Diluent......................46 Sodium Electrode Conditioner................46 QC material........................47 ISETROL Electrolyte Control.................47 Deproteinizer......................47 Product data..........................48 Electrical data .........................48 Classification (according to IEC/ISO) ................48 Dimensions ........................48...

  • Page 35: Performance Parameters

    ) precision is determined from 2 runs per day with 2 replicates per run for 20 days on 2 9180 Electrolyte Analyzers. Values for sodium and potassium are the average of all instruments. Values of chloride, calcium, and lithium are determined from the measurement of two of each respective unit configuration.

  • Page 36: Material: Isetrol Protein Based Aqueous Control Material (Level 2), N=80

    3 Specifications 9180 Electrolyte Analyzer Performance parameters Material: ISETROL Protein Based Aqueous Control Material (Level 2), n=80 Parameter Mean (CV %) (CV %) (CV %) Sodium 141.2 0.40 0.28 0.30 0.21 0.46 0.33 Potassium 4.35 0.024 0.55 0.023 0.53 0.036 0.82...

  • Page 37: Material: Aqueous Standard Solution (Level 2), N=80

    9180 Electrolyte Analyzer 3 Specifications Performance parameters Material: Pooled Human Serum, n=80 Parameter Mean (CV %) (CV %) (CV %) Sodium 138.8 0.30 0.22 0.36 0.28 0.47 0.34 Potassium 4.49 0.034 0.75 0.041 0.92 0.051 1.13 Chloride 106.8 0.18 0.17 1.00...

  • Page 38: Linearity

    All samples were analyzed in pairs on each of 2 9180 Electrolyte Analyzers in each configuration:...

  • Page 39: Correlation To Direct Ise - Not Flame-Correlated

    9180 Electrolyte Analyzer 3 Specifications Linearity Correlation to direct ISE - not flame-correlated 98X Electrolyte Analyzers Parameter Slope Intercept Correlation Sy·x Range [mmol/L] coefficient Sodium 0.9895 -6.35 0.9992 0.61 110 - 186 Potassium 1.0223 -0.25 0.9996 0.05 2.0 - 11.6 Chloride 0.9631...

  • Page 40: Interferences

    3 Specifications 9180 Electrolyte Analyzer Interferences Interferences Salicylate, in extremely high levels, is known to interfere with the chloride electrode and results in a positive bias of the chloride result. At therapeutic levels of salicylate concentration, the influence on chloride is clinically insignificant.

  • Page 41: Bibliography

    9180 Electrolyte Analyzer 3 Specifications Relationship of ionized calcium to total calcium Relationship of ionized calcium to total calcium Approximately 50% of calcium circulates as free calcium ions (Ca ), also described as ionized calcium, and is physiologically active. 40% of calcium is bound to plasma proteins (largely albumin) and the remaining 10% is complexed with small anions (e.g.
  • Page 42 3 Specifications 9180 Electrolyte Analyzer Bibliography Schoeff LE, Williams RH (eds.). Principles of Laboratory Instruments. St. Louis: Mosby; 1993; 150-157, 161-164. Snyder JR, Senhauser DA (eds.). Administration and Supervision in Laboratory Medicine. 2nd Ed. Philadelphia: J.B.Lippincott; 1989; 262-284. Tietz, NW (ed.). Clinical Guide to Laboratory Tests. 2nd Ed. Philadelphia: W.B.

  • Page 43: Sample Throughput

    9180 Electrolyte Analyzer 3 Specifications Sample throughput Sample throughput Measurement time: Below 75 seconds per sample. Additional printout takes up to 20 seconds Sample volumes 95 μL typical Sample types Whole blood, serum, plasma, urine, QC material Calibrations 1-point calibration with each measurement...

  • Page 44: Environmental Parameters

    3 Specifications 9180 Electrolyte Analyzer Environmental parameters Environmental parameters Temperature / humidity / stability Instrument Operating conditions: Ambient temperature 15 to 32 °C Relative humidity 20 to 85% relative humidity (no condensation Altitude 0 to 2500 m above sea level...

  • Page 45: Solutions

    Expiration date and lot number are printed on each container label On-board stability: 14 weeks Table 3-17 Reference Solution A salt bridge for calibration and measurement in the 9180 Electrolyte Analyzer. Stability: Expiration date and lot number are printed on each container label On-board stability:...

  • Page 46: Urine Diluent

    3 Specifications 9180 Electrolyte Analyzer Environmental parameters Urine Diluent For use as a diluent for the measurement of urine samples in the 9180 Electrolyte Analyzer. Active ingredients: Sodium chloride 120 mmol/L Storage temperature: 15 - 30 °C Stability: Expiration date and lot number are printed on each container label.

  • Page 47: Product Data

    9180 Electrolyte Analyzer 3 Specifications 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 / 1.6 AT (2 pcs.) Classification (according to IEC/ISO) Safety category...

  • Page 48: Product Data

    3 Specifications 9180 Electrolyte Analyzer Display Roche Diagnostics Instructions for Use · Version 10.0...
  • Page 49 9180 Electrolyte Analyzer 4 Theoretical foundation Table of contents Theoretical foundation Chapter In this chapter Reference and critical values....................51 Reference / normal ranges ....................51 Critical ranges.........................52 Principles of operation......................53 Measurement principle....................53 Physical principle ......................54 Electrode specifications.......................57 Sodium electrode ......................57 Construction......................57 Use and care......................57...
  • Page 50 4 Theoretical foundation 9180 Electrolyte Analyzer Table of contents Calibration procedure ....................64 ISE calibration ......................64 Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 51: Reference And Critical Values

    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. Reference intervals are useful because they attempt to describe the typical results found in a defined population of apparently healthy people.

  • Page 52: Critical Ranges

    4 Theoretical foundation 9180 Electrolyte Analyzer Reference and critical values Critical ranges Normal values depend, amongst other factors, on the patient, age, gender, lifestyle habits (e.g. smoking), underlying disease (e.g. asthma), therapy (e.g. state after an infusion). This especially applies to critical ranges, as these are based on the normal values.

  • Page 53: Principles Of Operation

    Principles of operation Principles of operation Measurement principle The 9180 Electrolyte Analyzer uses the ion selective electrode (ISE) measurement principle to precisely determine electrolyte values. An ion-selective membrane undergoes a specific reaction with the type of electrolyte contained in the sample. The membrane is an ion exchanger, which reacts to the electrical change of the ion.

  • Page 54: Physical Principle

    4 Theoretical foundation 9180 Electrolyte Analyzer Principles of operation Glass capillary D Inner solution Measured solution Reference electrode Ion-selective electrode Voltmeter Ion-selective membrane Figure 4-1 Measurement principle Physical principle An ion-selective electrode is connected with a reference electrode to form a measuring system (see Figure 4-2 Physical principle (p.
  • Page 55 9180 Electrolyte Analyzer 4 Theoretical foundation Principles of operation Glass capillary electrode M Chloride-selective membrane Reference electrode Amplifier N Sample Reference solution (KCl) Display O Potassium-selective membrane D Reference electrode housing electrode Sodium-selective membrane Ground Inner electrode electrode Inner electrolyte...
  • Page 56 4 Theoretical foundation 9180 Electrolyte Analyzer Principles of operation These equations show that the ion selective electrodes do not measure the ion concentration, but the activity of the ions. This activity is a criterion of the ion’s ability to interact with other ions, in which each ion binds a proportion of its energy.

  • Page 57: Electrode Specifications

    Sodium electrode Use and care Sodium electrodes are manufactured for use in 9180 Electrolyte Analyzers. Proper care should be used in handling and storage of the electrode. Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode since these will damage the plastic housing.

  • Page 58: Potassium Electrode

    Potassium electrode Use and care Potassium electrodes are manufactured for use in 9180 Electrolyte Analyzers. Proper care should be used in handling and storage of the electrode. Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode since these will damage the plastic housing.

  • Page 59: Chloride Electrode

    Chloride electrode Use and care Chloride electrodes are manufactured for use in 9180 Electrolyte Analyzers. Proper care should be used in handling and storage of the electrode. Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode since these will damage the plastic housing.

  • Page 60: Calcium Electrode

    Calcium electrode Use and care Calcium electrodes are manufactured for use in 9180 Electrolyte Analyzers. Proper care should be used in handling and storage of the electrode. Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode since these will damage the plastic housing.
  • Page 61 Lithium electrode Use and care Lithium electrodes are manufactured for use in 9180 Electrolyte Analyzers. Proper care should be used in handling and storage of the electrode. Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode since these will damage the plastic housing.

  • Page 62: Lithium Electrode

    4 Theoretical foundation 9180 Electrolyte Analyzer Electrode specifications Reference electrode assembly The reference electrode assembly is a device used as an electrical junction between the sample and electrical ground. Construction The reference electrode assembly consists of two parts: the reference electrode housing and the reference electrode.

  • Page 63: Reference Electrode Assembly

    Do not rinse the reference electrode with distilled water. Do not allow the reference electrode to become dry. Calibration procedure ISE calibration The 9180 Electrolyte Analyzer uses a patented, novel approach for the simultaneous calibration of Na , Ca and Cl sensors, using only two aqueous base solutions.

  • Page 64: Reference Electrode

    4 Theoretical foundation 9180 Electrolyte Analyzer Electrode specifications Roche Diagnostics Instructions for Use · Version 10.0...
  • Page 65 System components System components .......................... 67...
  • Page 67 9180 Electrolyte Analyzer 5 System components Table of contents System components Chapter In this chapter System description .......................69 Analyzer components....................69 Display........................70 Keypad........................70 Printer........................71 Measuring chamber....................71 Peristaltic pump .......................71 Sample probe mechanism..................72 Valves.........................72 SnapPak ........................72 Rear panel .........................73 Name plate ........................73 Roche Diagnostics Instructions for Use ·...
  • Page 68 5 System components 9180 Electrolyte Analyzer Table of contents Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 69: System Description

    9180 Electrolyte Analyzer 5 System components System description System description Analyzer components D Front cover ISE SnapPak Display Sample door Keypad Figure 5-1 Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 70: Display

    5 System components 9180 Electrolyte Analyzer System description D Sample door Peristaltic pump Thermal printer Valves Measuring chamber Discharge point Figure 5-2 Display The analyzer communicates to the user through a dot matrix display. This two line, alpha-numeric read-out allows up to 16 characters per line, displaying the activities of the analyzer, sample results and other programmed information.

  • Page 71: Printer

    9180 Electrolyte Analyzer 5 System components System description Printer The thermal printer uses heat-sensitive paper to output information in 16 columns. The analyzer will print measured values, calibration values, electrode voltages, and amount of liquid remaining in the SnapPak as well as cleaning and maintenance information.

  • Page 72: Sample Probe Mechanism

    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. Figure 5-8 Valves Valves control the movement of the liquid within the analyzer.

  • Page 73: Rear Panel

    9180 Electrolyte Analyzer 5 System components System description Figure 5-10 Rear panel The rear panel of the unit contains a name plate (Name plate (p. 73)), as well as the power switch/ power receptacle module. Figure 5-11 Name plate Refer to Symbols used on the instrument (p. 8) to find the meaning of the symbols used on the name plate.
  • Page 74 5 System components 9180 Electrolyte Analyzer System description Roche Diagnostics Instructions for Use · Version 10.0...
  • Page 75 Operation Installation and shutdown....................... 77 Measurement............................ 97 Quality control ..........................117...
  • Page 77 9180 Electrolyte Analyzer 6 Installation and shutdown Table of contents Installation and shutdown Chapter In this chapter Installation..........................79 Location...........................79 Accessories........................80 Setting up ........................80 Electrode and measuring chamber................81 Preparing the analyzer for operation................86 1. Selecting language....................86 2. Start-up........................86 3. Setting date and time...................87 4.
  • Page 78 6 Installation and shutdown 9180 Electrolyte Analyzer Table of contents Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 79: Installation

    Refer to the packing slip to make sure that you have received all of the parts and components that are part of the delivery of the analyzer. If there are any missing parts or components, contact your Roche Service representative immediately.

  • Page 80: Accessories

    (see Analyzer components (p. 69)) before performing any action on the analyzer. Use of non-approved consumables Use of consumables that were not produced by Roche, including but not limited to electrodes, calibration and cleaning solutions, QC-material and related accessories, may WARNING result in incorrect results.

  • Page 81: Electrode And Measuring Chamber

    Use of non-approved consumables may null and void the warranty NOTICE Use of consumables that were not produced by Roche, including but not limited to electrodes, calibration and cleaning solutions, QC-material and related accessories, may result in malfunction of the analyzer and may render the warranty null and void.
  • Page 82 6 Installation and shutdown 9180 Electrolyte Analyzer Installation Unscrew the red transport housing from the reference electrode and check that the o-ring on the electrode is properly seated. Rinse, 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.
  • Page 83 9180 Electrolyte Analyzer 6 Installation and shutdown Installation Locate the sample sensor cable and ensure that it is securely inserted in the receptacle above the measuring chamber. Check that an o-ring is present in the right electrode holder. Figure 6-6 Now install the electrodes in the measuring chamber, beginning on the right and working to the left (the reference electrode will be installed last).
  • Page 84 6 Installation and shutdown 9180 Electrolyte Analyzer Installation After all electrodes have been installed, close the clamp on the left electrode holder by lifting it upward until it locks into the back position, and ensure that the electrodes are properly seated.
  • Page 85 9180 Electrolyte Analyzer 6 Installation and shutdown Installation Possible parameter configuration are the following: Electrode position Parameter configurations Dummy Dummy Dummy / Ca / Li Table 6-1 Parameter configurations Electrode position Parameter configurations Dummy Dummy / Ca / Li Table 6-2 Parameter configurations 7.

  • Page 86: Preparing The Analyzer For Operation

    6 Installation and shutdown 9180 Electrolyte Analyzer Installation Preparing the analyzer for operation 1. Selecting language Before the analyzer is turned on, the language setting has to be selected. The factory- set language is English. Remove the paper tray and use a pen to set the switch to the desired language position as indicated on the label.

  • Page 87: Setting Date And Time

    Use of non-approved consumables may null and void the warranty NOTICE Use of consumables that were not produced by Roche, including but not limited to electrodes, calibration and cleaning solutions, QC-material and related accessories, may result in malfunction of the analyzer and may render the warranty null and void.

  • Page 88: Installing The Printer Paper

    The printer paper is heat-sensitive on one side only. Make sure that you insert the paper roll correctly. The thermal printer paper supplied by Roche Diagnostics contains an indicator strip to alert you when the paper roll should be changed. To change the roll: Place a new paper roll in the paper tray and thread it into the feeder slot.

  • Page 89: Daily Maintenance (Manual)

    6. Daily Maintenance (manual) Before performing the first calibration or measurement, the 9180 Electrolyte Analyzer needs to undergo a simple cleaning and conditioning procedure that ensures the analyzer will perform properly. This daily maintenance has to be performed each day before the analyzer is used.
  • Page 90 6 Installation and shutdown 9180 Electrolyte Analyzer Installation Hold the Cleaning Solution under the probe until Wipe Probe/Close Sample Door is displayed. Use a lint-free tissue to remove the cleaning solution from the probe. Close the sample door. Figure 6-17...

  • Page 91: Selecting Parameter Configuration

    If [(Na)][ ][Li] is selected, only lithium is reported. Install the sodium electrode and calibrate for lithium. 8. QC Perform QC measurements on 3 levels. Quality control (p. 117). The 9180 Electrolyte Analyzer is now ready to operate. Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 92: Shutdown

    Shutdown Performing the shutdown procedure is necessary before sending the analyzer to Roche for service or before the analyzer remains inactive for an extended time. For this procedure, you need a special shutdown kit (not supplied with the analyzer). Failure to shut down the analyzer during an extended period of inactivity may...

  • Page 93: Installing The Transport Housing

    9180 Electrolyte Analyzer 6 Installation and shutdown Shutdown Figure 6-20 2. Installing the transport housing The analyzer will prompt Transport Ref Housing Installed? Pull the electrode holder forward and remove the reference electrode assembly. Carefully unscrew the reference electrode from the reference electrode housing.

  • Page 94: Washing The Lines

    6 Installation and shutdown 9180 Electrolyte Analyzer Shutdown 3. Washing the lines The analyzer will take approximately one minute to flush all lines with water. Upon completion, you will receive the prompt Remove Water and press YES. Remove the line with the blue mark from the distilled water and place it on a cloth.

  • Page 95: Installing The Relief Clamps And Removing The Pump Windings

    9180 Electrolyte Analyzer 6 Installation and shutdown Shutdown 5. Installing the relief clamps and removing the pump windings The display will prompt All 5 Relief Clamps Inserted? Install the red relief clamps making sure that they are snapped securely into position.

  • Page 96: Turning The Analyzer "Off

    6 Installation and shutdown 9180 Electrolyte Analyzer Shutdown Repeat the same procedure for the rear pump winding. Figure 6-25 Press YES. The prompt Do You Wish to DELETE All Data? will appear. By pressing YES, all QC values and statistics will be deleted and the sample number is reset to 0.
  • Page 97 9180 Electrolyte Analyzer 7 Measurement Table of contents Measurement Chapter In this chapter Preanalytics ...........................99 Sample collection ......................99 Safety..........................99 Sample requirements ....................99 Acceptable anticoagulants ................... 100 Sample collection containers ..................100 Syringes ........................100 Capillary tubes....................... 101 Sample handling......................101 Whole blood ......................
  • Page 98 7 Measurement 9180 Electrolyte Analyzer Table of contents Correlation factors ......................113 Additional settings ......................115 Printer settings......................115 Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 99: Preanalytics

    9180 Electrolyte Analyzer 7 Measurement Preanalytics Preanalytics Sample collection Safety Inappropriate collecting and handling of samples of human origin may result in infection Inappropriate collecting and/or handling samples of human origin may lead to the WARNING transmission of blood or urine borne pathogens.

  • Page 100: Acceptable Anticoagulants

    Sample collection containers The 9180 Electrolyte Analyzer accepts samples directly from syringes, collection tubes, sample cups and, with the use of an adapter, from capillary tubes. Using sample containers with lithium anticoagulant may lead to incorrect Li...

  • Page 101: Capillary Tubes

    9180 Electrolyte Analyzer 7 Measurement Preanalytics Sample handling When measuring calcium values, make sure that the sample is not exposed to ambient air. Incorrect calcium values will occur if the sample is exposed to ambient air. Contact with ambient air results in a loss of CO in the sample.

  • Page 102: Serum

    7 Measurement 9180 Electrolyte Analyzer Preanalytics Plasma samples older than 1 hour have to be re-centrifuged in order to remove fibrin clumps that may have formed. Each laboratory should determine which sample containers should be used with the analyzer. Aqueous solutions Aqueous samples, such as Standard A, have to be measured in the Standard Mode.

  • Page 103: Interference

    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. Interferents can be a significant source of error in clinical analyses. While the...

  • Page 104: Whole Blood Samples

    7 Measurement 9180 Electrolyte Analyzer Interference Substance Concentration Tested analyte Paracetamol 1.324 mmol/L Cl, Li Phenobarbital 0.431 mmol/L K, Ca, Na, Cl, Li pH (high) ~8.0 Cl, Li Potassium chloride 7.000 mmol/L Potassium thiocyanate 6.880 mmol/L Protein human (high) >9.0%...

  • Page 105: Substances With Effect

    9180 Electrolyte Analyzer 7 Measurement Interference Substances with effect Effect of the substances (plasma samples) Substance Concentration of Parameter Parameter Effect of the ± Trueness the substance concentration (MV) substance [mmol/L] [mmol/L] [mmol/L] Magnesium acetate 15.000 mmol/L 138.1 2.59 ± 0.32 2.50...

  • Page 106: Effect Of The Substances (Whole Blood Samples)

    7 Measurement 9180 Electrolyte Analyzer Interference Effect of the substances (whole blood samples) Substance Concentration of Parameter Parameter Effect of the ± Trueness the substance concentration (MV) substance [mmol/L] [mmol/L] [mmol/L] 138.7 -3.21 ± 0.26 2.50 6.8800 mmol/L 104.8 7.96 ± 0.46 4.00...

  • Page 107: Limitations Of Clinical Analysis

    Further information on this topic can be found in the technical literature. An attempt was made to identify and/or evaluate these possible influences with the 9180 Electrolyte Analyzer. However, it is not possible to review all medication or substances. Therefore, the user should be immediately informed about abnormal deviations from measurement results, as with any clinical analysis.

  • Page 108: Measuring Procedure

    If QC results do not match their expected results, perform the QC measurements again. If QC results still do not to match their expected results, contact Roche Technical Support. Do not use the analyzer for diagnostic purposes until QC results match their expected results.
  • Page 109 9180 Electrolyte Analyzer 7 Measurement Measuring procedure Urine samples require dilution and have to be analyzed in the urine mode. Urine samples (p. 111) Open the sample door. The prompt Introduce Sample will be displayed and the pump will start to aspirate.

  • Page 110: Direct Ise

    7 Measurement 9180 Electrolyte Analyzer Measuring procedure The analyzer will display Thank You! and a brief countdown will begin. After the analysis is finished, the test results will be displayed and printed out. ROCHE 9180 143.9 4.93 103.1 ELEKTROLYT ISE...

  • Page 111: Urine Samples

    9180 Electrolyte Analyzer 7 Measurement Measuring procedure As soon as READY will be displayed, the analyzer is ready for measurements. Urine samples, diluted with Urine Diluent, are analyzed in the urine mode. To enter this mode: Press NO until QC/STD/DIALYSATE/URINE SAMPLE? is displayed. Press YES.

  • Page 112: Normal Ranges (Reference Values)

    7 Measurement 9180 Electrolyte Analyzer Normal ranges (reference values) Normal ranges (reference values) Normal ranges can be adapted to laboratory-specific requirements. Values that are higher or lower than the programmed normal range will be indicated by an arrow pointing up or down.

  • Page 113: Correlation Factors

    Correlation factors Correlation factors allow you to correlate measurement results from the 9180 Electrolyte Analyzer to other electrolyte analyzers. Activated correlation values are only considered when measuring whole blood, serum, plasma and QC samples in standard mode. They are not used for standard samples analyzed in QC/STD/DIALYSATE/URINE SAMPLE modes.
  • Page 114 7 Measurement 9180 Electrolyte Analyzer Correlation factors If the Na intercept (b) and the slope (m) are correct, press YES. To change these values, press NO. The intercept and slope values may be adjusted by pressing NO to change the number, and by pressing YES to accept the number.

  • Page 115: Additional Settings

    Additional settings Printer settings The 9180 Electrolyte Analyzer is preset only to print out measurement reports automatically after each measurement. However, you can program these settings to control which reports are automatically printed out at the end of each measurement or calibration.
  • Page 116 7 Measurement 9180 Electrolyte Analyzer Additional settings Press NO to select the desired letters A-Z or numbers 0-9 above the cursor. Press YES to advance the cursor to the next character. Repeat this procedure for all of the characters. Roche Diagnostics...
  • Page 117 9180 Electrolyte Analyzer 8 Quality control Table of contents Quality control Chapter In this chapter Quality control........................119 General QC concept ....................119 Material setup ........................121 Performing a QC measurement ..................123 Printing a QC report......................125 Roche Diagnostics...
  • Page 118 8 Quality control 9180 Electrolyte Analyzer Table of contents Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 119: Quality Control

    If QC results do not match their expected results, perform the QC measurements again. If QC results still do not to match their expected results, contact Roche Technical Support. Do not use the analyzer for diagnostic purposes until QC results match their expected results.
  • Page 120 8 Quality control 9180 Electrolyte Analyzer Quality control Risk of delayed results The target values for all quality control levels are lot-specific. Verify that the lot numbers on the package insert sheet match those on the QC CAUTION ampoule and the analyzer.

  • Page 121: Material Setup

    ISETROL pack. Use of non-approved QC materials and other consumables Use of QC materials that were not produced by Roche may lead to incorrect patient results, which may endanger patient lives. WARNING...
  • Page 122 8 Quality control 9180 Electrolyte Analyzer Material setup Press YES, and the analyzer display reads Print old Values and Statistics? After you press YES, a log containing the following information is printed: mean value, standard deviation (SD) and coefficient of variation (CV) of the saved data.

  • Page 123: Performing A Qc Measurement

    QC will be analyzed. Upon completion, the results will be briefly displayed, such as: 125.1 3.05 77.8 The 9180 Electrolyte Analyzer "flags" values that are above or below the programmed target ranges by using an "up" or "down" arrow. Roche Diagnostics Instructions for Use · Version 10.0...
  • Page 124 8 Quality control 9180 Electrolyte Analyzer Performing a QC measurement The prompt Store values in memory? appears. To save the values in memory, press YES. To reject the values, press NO. If the values are rejected, the analyzer will return to the QC Level 1 Sample?

  • Page 125: Printing A Qc Report

    Printing a QC report Printing a QC report The 9180 Electrolyte Analyzer stores the last 35 QC measurement values for each of the three QC levels. To print a report of these values along with their mean, standard deviation (1 SD) and coefficient of variation (CV), press NO until PRINT FUNCTIONS? appears, and press YES.
  • Page 126 8 Quality control 9180 Electrolyte Analyzer Printing a QC report Roche Diagnostics Instructions for Use · Version 10.0...
  • Page 127 Maintenance Maintenance........................... 129...
  • Page 129 9180 Electrolyte Analyzer 9 Maintenance Table of contents Maintenance Chapter In this chapter Maintenance........................131 Disinfection........................131 Recommended disinfectants ..................132 Daily maintenance......................133 Weekly maintenance ......................135 Clean sample probe and fill port................135 Cleaning surfaces of the analyzer................136 Monthly maintenance.......................
  • Page 130 9 Maintenance 9180 Electrolyte Analyzer Table of contents Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 131: Disinfection

    WARNING Treat these components as infectious waste. Dispose of the system and consumables according to the local regulations. For more information, contact your Roche Service representative. Wear appropriate personal protective equipment.

  • Page 132: Recommended Disinfectants

    9 Maintenance 9180 Electrolyte Analyzer Disinfection Operating the analyzer or plugging the analyzer into a power source after disinfection may result in electrical shock or fire Disinfectants may need up to 15 minutes to evaporate from the components and surfaces WARNING of the analyzer.

  • Page 133: Daily Maintenance

    (see Analyzer components (p. 69)) before performing any action on the analyzer. Before performing the first sample of the day, the 9180 Electrolyte Analyzer needs to undergo a simple cleaning and conditioning procedure that ensures the analyzer will perform properly.
  • Page 134 9 Maintenance 9180 Electrolyte Analyzer Daily maintenance Hold the Cleaning Solution under the probe until Wipe Probe/Close Sample Door is displayed. Then, use a lint-free tissue to remove the cleaning solution from the probe. Close the sample door. Figure 9-1 While the analyzer displays Thank You! and a brief countdown, pour a small amount of Sodium Electrode Conditioner into a clean container.

  • Page 135: Weekly Maintenance

    9180 Electrolyte Analyzer 9 Maintenance Weekly maintenance Weekly maintenance You should clean the sample fill port, sample probe and exterior surfaces of the analyzer once a week, and additionally as needed. Contact with the sample probe may result in infection Contact with the sample probe during measurements or maintenance actions may result in infection.

  • Page 136: Cleaning Surfaces Of The Analyzer

    9 Maintenance 9180 Electrolyte Analyzer Weekly maintenance Cleaning surfaces of the analyzer Operating the analyzer or plugging the analyzer into a power source after disinfection may result in electrical shock or fire Disinfectants may need up to 15 minutes to evaporate from the components and surfaces WARNING of the analyzer.

  • Page 137: Monthly Maintenance

    9180 Electrolyte Analyzer 9 Maintenance Monthly maintenance Monthly maintenance Cleaning the reference electrode housing Risk of instrument damage or wrong results due to ESD discharge Considerable electrostatic discharge can be emitted from contacting the metallic components of the analyzer. WARNING Do not remove any cover of the analyzer except those covers specified in the instructions.
  • Page 138 9 Maintenance 9180 Electrolyte Analyzer Monthly maintenance Unclamp the left electrode holder by moving the clamp forward. Figure 9-4 Remove the reference electrode assembly from the analyzer Unscrew the reference electrode from the reference housing. Store the reference electrode in the red transport housing filled with reference solution.
  • Page 139 9180 Electrolyte Analyzer 9 Maintenance Monthly maintenance Unscrew the red transport housing from the reference electrode and check that the o-ring on the electrode is properly seated. Save the transport housing. Carefully screw the reference electrode into the reference electrode housing and place the assembly into the left side of the measuring chamber.

  • Page 140: Semi-Annual Maintenance

    Treat the pump tubing set as biohazardous waste and dispose it according to the local regulations. For more information, contact your Roche Service representative. Take extra care when working with protective gloves. They can easily be pierced or cut, leading to infection.

  • Page 141: Annual Maintenance

    Failure to annually replace the main tubing harness may lead to leaks in the tubing NOTICE system Continued use of the 9180 Electrolyte Analyzer without replacing the main tubing harness at least once a year may lead to leaks in the tubing system. This may result in malfunction and/or damage to the analyzer.

  • Page 142: Unscheduled Maintenance

    Treat used electrodes as biohazardous waste and dispose it according to the local regulations. For more information, contact your Roche Service representative. Take extra care when working with protective gloves. They can easily be pierced or cut, leading to infection.

  • Page 143: Replacing Electrodes

    Use of non-approved consumables may null and void the warranty NOTICE Use of consumables that were not produced by Roche, including but not limited to electrodes, calibration and cleaning solutions, QC-material and related accessories, may result in malfunction of the analyzer and may render the warranty null and void.
  • Page 144 9 Maintenance 9180 Electrolyte Analyzer Unscheduled maintenance Remove the new electrode from its protective box and check for the presence of an o-ring in the left side of the electrode. Install the electrode in its labeled position in the measuring chamber. 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.

  • Page 145: Checking Reagent Fluid Level And Changing The Snappak

    Use of non-approved consumables may null and void the warranty NOTICE Use of consumables that were not produced by Roche, including but not limited to electrodes, calibration and cleaning solutions, QC-material and related accessories, may result in malfunction of the analyzer and may render the warranty null and void.
  • Page 146 STATUS: NO SnapPak. In addition, the printer will print out the current status of the SnapPak. If your 9180 Electrolyte Analyzer has a serial number greater than 21000, visually inspect the connector pins for moisture, dirt and damage on its surface after each SnapPak exchange.

  • Page 147: Replacing Sample Probe And Fill Port

    In addition, inappropriate disposal may contaminate the environment. Treat the main tubing harness as biohazardous waste and dispose it according to the local regulations. For more information, contact your Roche Service representative. Take extra care when working with protective gloves. They can easily be pierced or cut, leading to infection.

  • Page 148: Replacing Printing Paper

    The printer paper is heat-sensitive on one side only. Make sure that you insert the paper roll correctly. The thermal printer paper supplied by Roche contains an indicator strip to alert you when the paper roll should be changed. To change the roll: Open the front cover of the analyzer.

  • Page 149: Replacing The Mains Fuse

    Only replace the mains fuses with the 1.6 A / 250 VAC slow blow fuses in your fuse set delivered with the 9180 Electrolyte Analyzer. If your mains fuses are blown, immediately re-order these fuses with your Roche representative. Make sure to always keep two extra 1.6 A / 250 VAC slow blow fuses with your other 9180 Electrolyte Analyzer accessories and consumables.
  • Page 150 9 Maintenance 9180 Electrolyte Analyzer Unscheduled maintenance 11 After replacing the mains fuse, QC measurements on 3 levels have to be performed to verify the performance of the instrument. Roche Diagnostics Instructions for Use · Version 10.0...
  • Page 151 Troubleshooting Troubleshooting..........................153...
  • Page 153 9180 Electrolyte Analyzer 10 Troubleshooting Table of contents Troubleshooting Chapter In this chapter Troubleshooting......................... 155 Error messages......................155 Service functions ....................... 159 Testing the electrodes ....................159 Potassium electrode not calibrated..............160 Testing the sample sensor ..................160 Testing the SnapPak sensor..................160 Testing the language switch ..................
  • Page 154 10 Troubleshooting 9180 Electrolyte Analyzer Table of contents Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 155: Troubleshooting

    9180 Electrolyte Analyzer 10 Troubleshooting Troubleshooting Troubleshooting The following table displays error messages and possible actions to help troubleshoot errors with your 9180 Electrolyte Analyzer. If an error persists, contact Roche Technical Support. Error messages Message Cause Action Status: Not calibrated...
  • Page 156 10 Troubleshooting 9180 Electrolyte Analyzer Troubleshooting Message Cause Action Check Sample Sensor The sample sensor is calibrated with air Clean the sample sensor by using the Electrode during each calibration. For proper Maintenance procedure. operation, the sensor should read between 80 Check for correct drying of the measuring chamber and 120 units.
  • Page 157 9180 Electrolyte Analyzer 10 Troubleshooting Troubleshooting Message Cause Action Conditioning fluid not Under certain conditions, the analyzer may Ensure that the o-rings are in the correct position and detected not detect the presence of sealing the electrodes. Sodium Electrode Conditioner...
  • Page 158 10 Troubleshooting 9180 Electrolyte Analyzer Troubleshooting Message Cause Action Change SnapPak Fluid level in the ISE SnapPak is 5% or less. Replace the SnapPak (Checking reagent fluid level and changing the SnapPak (p. 145)). *** Li Calculation not The lithium result can only be calculated for a possible range of 95 - 180 mmol/L (89.6 -...

  • Page 159: Service Functions

    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. Starting at the READY display, press NO until SERVICE_FUNCTIONS? is displayed, and then press YES.

  • Page 160: Potassium Electrode Not Calibrated

    10 Troubleshooting 9180 Electrolyte Analyzer Service functions Potassium electrode not calibrated If the potassium electrode cannot be calibrated after an electrode exchange, then a serum or plasma sample should be introduced as an external sample. Call up the procedure for testing electrodes.

  • Page 161: Testing The Language Switch

    9180 Electrolyte Analyzer 10 Troubleshooting Service functions Press NO to exit or to perform other service functions. Testing the language switch Press NO until Test Language Switch? is displayed. Press YES and the current language switch status will be displayed.

  • Page 162: Testing The Pump

    10 Troubleshooting 9180 Electrolyte Analyzer Service functions Testing the pump Press NO until Test Pump? is displayed. Open the front cover and press YES to begin the pump test. The analyzer will display: ---Test Pump!--- Very low, low, medium and fast speed tests are performed.

  • Page 163: Status Leds

    Press NO to exit or to perform other service functions. Status LEDs The 5 status LEDs at the bottom of the chassis back panel light up simultaneously during normal operation. If not, contact Roche Technical Support. Figure 10-2 Status LEDs (back panel, bottom) Roche Diagnostics Instructions for Use ·...

  • Page 164: Service Codes

    9180 Electrolyte Analyzer Service codes Service codes The Enter Service Code? menu allows the programming of various functions into the 9180 Electrolyte Analyzer. Entering service codes Starting at the READY display, press NO until SERVICE FUNCTIONS? is displayed, and press YES.

  • Page 165: List Of Service Codes

    9180 Electrolyte Analyzer 10 Troubleshooting Service codes List of service codes Code Action Increases the resolution by one digit for all parameters in blood and serum samples. QC and standard samples are shown in high resolution. Urine samples are shown in low resolution.

  • Page 166: Deleting Data

    10 Troubleshooting 9180 Electrolyte Analyzer Deleting data Deleting data Clearing sample count To reset the sample count to 0, perform the following steps: Open the READY display and press NO until OPERATOR FUNCTIONS? appears. Confirm by pressing YES. Press NO until Reset Sample Number? appears. Press YES.
  • Page 167 Appendix Appendix ............................169 Glossary ............................179...
  • Page 169 9180 Electrolyte Analyzer 11 Appendix Table of contents Appendix Chapter In this chapter Description of reports....................... 171 Measurement report ....................171 QC report ........................171 Calibration report ....................... 172 Specifications of the solutions ..................173 Program flow chart ......................174 Maintenance schedule ......................
  • Page 170 11 Appendix 9180 Electrolyte Analyzer Table of contents Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 171: Description Of Reports

    9180 Electrolyte Analyzer 11 Appendix Description of reports Description of reports Measurement report ROCHE 9180 ROCHE 9180 ROCHE 9180 ELEKTROLYT ISE ELEKTROLYT ISE ELEKTROLYT ISE NA-K-CL NA-K-CL NA-K-CL 26SEP03 08:16 26SEP03 08:27 26SEP03 08:31 HOSPITAL WEST HOSPITAL WEST HOSPITAL WEST Name: ..

  • Page 172: Calibration Report

    11 Appendix 9180 Electrolyte Analyzer Description of reports Calibration report ROCHE 9180 Corr. Factors: Normal Ranges: ELECTROLYTE ISE Na Offs.= Units: [mmol/L] NA-K-CL Na Slope= 1.000 136 - 26SEP03 09:01 Offs.= 3.5 - HOSPITAL WEST Slope= 1.000 97 - *CALIBR. REPORT* Cl Offs.=...

  • Page 173: Specifications Of The Solutions

    Use of non-approved consumables may null and void the warranty NOTICE Use of consumables that were not produced by Roche, including but not limited to electrodes, calibration and cleaning solutions, QC-material and related accessories, may result in malfunction of the analyzer and may render the warranty null and void.

  • Page 174: Program Flow Chart

    11 Appendix 9180 Electrolyte Analyzer Program flow chart Program flow chart The software functionality to test dialysis solutions is not covered by the IVD purpose and is not covered by the CE mark. Figure 11-4 Program flow chart Roche Diagnostics...

  • Page 175: Maintenance Schedule

    9180 Electrolyte Analyzer 11 Appendix Maintenance schedule Maintenance schedule This page can be used as a template for duplication. Figure 11-5 Maintenance schedule template Roche Diagnostics Instructions for Use · Version 10.0...

  • Page 176: Available Accessories And Consumables

    11 Appendix 9180 Electrolyte Analyzer Available accessories and consumables Available accessories and consumables To measure the respective parameters, the following products are required. Electrodes Parameter Chloride Electrode 03110451180 Sodium Electrode 03110419180 Potassium Electrode 03110338180 Calcium Electrode 03110354180 Lithium Electrode 03110664180...

  • Page 177: Solutions

    9180 Electrolyte Analyzer 11 Appendix Available accessories and consumables Solutions Parameter Deproteinizer 03110435180 Sodium Electrode Conditioner 03110362180 Urine Diluent 03110249180 Cleaning Solution 03111555180 SnapPak 03112349180 Table 11-2 Solutions order information Can be used QC material Parameter ISETROL 03112888180 Table 11-3...

  • Page 178: Supplementary Equipment

    11 Appendix 9180 Electrolyte Analyzer Available accessories and consumables Supplementary equipment Parameter Printer Paper 03112292018 Table 11-4 Supplementary equipment order information Can be used Roche Diagnostics Instructions for Use · Version 10.0...
  • Page 179 9180 Electrolyte Analyzer Alkaline - Transport housing Glossary Sampling rate Number of samples per hour Service code Three-letter codes that are entered by Alkaline A basic solution with a pH greater than 7 the user to perform special functions on the analyzer, Arterial blood Oxygenated blood found in arteries such as putting the analyzer into standby mode.
  • Page 180 9180 Electrolyte Analyzer Transport housing - Transport housing Roche Diagnostics Instructions for Use · Version 10.0...
  • Page 181 Index Index ............................... 183...
  • Page 183 9180 Electrolyte Analyzer Index Index Electrode specifications, 57 – Calcium electrode, 60 Abbreviations, 10 – Chloride electrode, 59 Accessories, 80 – Lithium electrode, 61 Additional settings, 115 – Potassium electrode, 58 – Printer settings, 115 – Reference electrode assembly, 62 Annual maintenance, 141 –...
  • Page 184 Index 9180 Electrolyte Analyzer – Linearity in serum, 38 – Whole blood, 101 Lithium electrode, 61 Preface, 7 – Conventions used in this manual, 7 Preparing the analyzer for operation, 86 – Installing the printer paper, 88 – Installing the SnapPak, 87 Maintenance, 131 –...
  • Page 185 9180 Electrolyte Analyzer Index – Installation and deinstallation, 20 – Removing service codes, 164 – Instrument damage, 24 – Service functions, 159 – Mechanical safety, 22 – Status LEDs, 163 – Operating conditions, 20 – Testing the amplifier, 162 – Operator qualification, 19 –...
  • Page 186 9180 Electrolyte Analyzer Roche Diagnostics Draft 2 Instructions for Use · Version 10.0...

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