9180 Electrolyte Analyzer Instructions for Use
COBAS is a trademark of Roche. ©2007 Roche Diagnostics Roche Diagnostics GmbH D-68298 Mannheim Germany www.roche-diagnostics.com
The contents of this manual, including all graphics and photographs are the property of Roche Diagnostics. No part of this document may be reproduced or transmitted in any form or by any means, electronic, or mechanical, for any purpose, without the express written permission of Roche Diagnostics.
Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing. However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development.
COBAS, ROCHE OMNI, and MYLABONLINE are trademarks of Roche. This instructions for use manual is published by the Roche Diagnostics Technical Publication department. Questions or comments regarding the contents of this instructions for use can be directed to: Roche Diagnostics Technical Publications Department 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-50457 USA Additional copies of this document can be obtained by sending a message to
[email protected] or leaving a message at the Technical Publication Hotline at 1-800-845-7355, mailbox 26699. © 2007 Roche Diagnostics. All rights reserved. U.S. order number 0575-02-0507
Roche 9180 Analyzer Instructions for Use
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Revisions Revisions to this document are provided by Roche Diagnostics when necessary. No part of this document may be reproduced in any form or by any means without prior written consent.
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Publication Reference Number
Date
Revision purpose
575-01-0803 Revision 2.0
July 2005
Title-2-4 new standards references, removed IVD symbol, and updated trademark statement. 1-5, 1-25, 3-4, 4-1, 4-4, 5-11: Updated QC procedure. 1-2: New “Install by” and “Use by” symbols. 2-1: New K+ range for urine. 3-7: New urine measurement range and dilution multiplication factors. 3-10: m=d/c corrected in fig. 3-8 3-11 and 3-12: new sections 3.6 “Additional Settings” 3.6.1, “Printer Settings,” 3.6.2, Interface Settings” 3.6.3, and “Enter Codes” from 4-2. 5-7. 5-8, 5-10, 5-13: New “perform QC after maintenance” statement in sections 5.4.1, 5.5.1, 5.6.1,and 5.7.2. 5-9: Additional steps in valve procedure. 6-1, 6-5, 6-6: New text for “Na/D/Cl/Ca/Li not calibrated,” and “Check electrode holder lock,” and “Interface Error.” 6-8: new section 6.2.2.1 “not calibrated potassium electrode.” 6-9: new fig. 6-1 Language switch settings. 6-12: modified Service code QCC action. 8-15: m=d/c corrected in correlation factor worksheet. Corrections for U.S. English throughout.
Roche 9180 Analyzer Instructions for Use
Revisions Continued... Publication Reference Number 575-02-0507 Revision 4.0
Date
May 2007
Revision purpose
spelling & US language mistakes corrected symbols modified: symbols “Biohazard” triangle (all chapters), “Biohazard” (Consumables), “Toxic”, “Dangerous to Environment”, “Irritant” Title (5) modified: Safety Information: standards references Title (Safety Information), 1.4.1, 3.1.1, 5, 5.6.1, 5.7.2, 5.7.3 modified: general maintenance safety (protective clothing), from cobas b 221 system 1.5.1 / 1-11 new: Serial Interface 1.6.1 / 1-12 modified: Fig. 1-13 (arrows) 1.7 6) / 1-29 new: link to chapter 6, “Delete all Data” 2.11.1 / 2-11 ff. modified: SnapPak storage temperature: 15 – 30 °C 2.12.1 / 2-14 new: 2 main fuse specifications 3.1.1 / 3-2 new: note on silicone / sample containers 3.5.1 removed: determination of correlation factors 4-2 ff. modified: QC material setup: updated rd 5.1.1 / 5-1 new: 3 item “… each area contaminated with biological …” in list of parts to be decontaminated 5.1.1 / 5-1 removed: “Roche recommends …” 5.2.1 / 5-3 new: note: “wipe sample probe ..:” 5.3.2 / 5-4 new: “dispose of used decontamination materials …” 6.2.10 new: Status LEDs 6.4 new: Deleting Data 7.1 new: clinical significane (Li new, others from cobas b 221 system) 8 removed: correlation worksheet
US Supplement
Roche 9180 Analyzer Instructions for Use
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US.1 General Information Warranty Roche Diagnostics warrants the instrument (except for consumable items and lamps) against defects in materials and workmanship for a period of one year. Roche Diagnostics, at its option, will either replace or repair free of charge on an f.o.b Indianapolis, Indiana basis, all parts proven to be defective and subject to such warranty. Field-installed options and used equipment carry a ninety (90) day parts and labor warranty. Any component part(s) and labor necessary to complete a repair are guaranteed for thirty (30) days. This warranty does not apply to an instrument not installed by a Roche Diagnostics representative (or an authorized agent of Roche Diagnostics) and/or not used according to instructions or damaged by accident, alteration, misuse, tampering and/or abuse. We warrant that the services provided under a Roche Diagnostics warranty will be free from defects of workmanship for a period of thirty (30) days from the date of service. WE HEREBY DISCLAIM ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE INSTRUMENT, PARTS AND SERVICES PROVIDED, EXCEPT THE LIMITED WARRANTY SET FORTH ABOVE. WE ARE NOT LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO, LOST PROFITS OR REVENUES, LOSS OF THE USE OF THE CAPITAL, COST OF SUBSTITUTE EQUIPMENT, FACILITIES OR SERVICES AND DOWN-TIME COSTS, RESULTING FROM OR ARISING IN CONNECTION WITH THE PERFORMANCE, DELAY IN PERFORMANCE OR NONPERFORMANCE OF ANY TERMS OR CONDITIONS OF A ROCHE DIAGNOSTICS WARRANTY OR SERVICE AGREEMENT OR FROM THE USE OR MISUSE OF THE INSTRUMENT (OR ANY SUBSTITUTE THEREFORE) OR ANY MATERIAL OR WORKMANSHIP DELIVERED HEREUNDER, EVEN IF WE HAVE BEEN ADVISED, KNEW OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES. YOUR EXCLUSIVE REMEDY UNDER THIS LIMITED WARRANTY WILL BE RE-PERFORMANCE OF ANY SERVICE WHICH PROVES TO BE DEFECTIVE.
Service and the Roche Technical Support Center Roche Diagnostics provides 24-hour, 7-day-a-week emergency telephone assistance. In addition, onsite service is provided in a timely manner. Call the following number to reach the Roche Technical Support Center: 1-800-526-2272 During normal working hours the Roche Technical Support Center answers all calls pertaining to Roche Diagnostics products. If Technical Support cannot resolve a problem by phone, a Roche Diagnostics representative is dispatched in accordance with the service contract. During other than normal working hours and on holidays, the Roche Technical Support Center is responsible for handling customer emergency problems. This is accomplished with the use of an answering service and paging system. As during normal hours, if Technical Support cannot resolve a particular problem, a Roche Diagnostics representative is dispatched. Refer questions relating to service policy to your local Roche Diagnostics representative at 1-800-845-7355.
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Roche 9180 Analyzer Instructions for Use
US.1 General Information If it becomes necessary to consult the Roche Technical Support Center in order to troubleshoot a chemistry or instrument problem, please be prepared with the following information: for a chemistry problem: • • • • • • • •
account number software version (found on the INSTRUMENT INFO screen) assay(s) affected description of the problem catalog and lot numbers of reagents, calibrators and controls in use calibration results from the last few calibrations performed control material results patient results (with correlation results, if relevant).
for an instrument problem: • • • • •
account number software version (found on the INSTRUMENT INFO screen) instrument serial number (found on the INSTRUMENT INFO screen) description of the problem including relevant alarm(s) other instrument or maintenance related information.
Having this information available assists in rapid resolution. It is helpful if the caller is conversant with the problem, preferably the primary trained operator or the designated key operator. In some cases, the Technical Support Center may ask that you return product to us so that we can test it in our laboratory. For these times, we will ask that you not discard the reagent or part in question and save it until you have contacted the Roche Technical Support Center. Roche may also ask you to retain the reagent or part for an extended period of time during the investigation of a complaint. In addition, to also assist us in troubleshooting with you, we ask that you keep some of our assayed controls on hand. If you do not have these and are using other manufacturer’s materials, we will experience a delay in resolving your concern as we wait for your control material order to arrive.
Contacting Service Representatives In order for us to comply with federal record keeping requirements, if you need to contact your Roche Diagnostics service representative, call the Roche Technical Support Center at 1-800-526-2272. They, in turn, will notify your representative to contact you.
Customer Training Training for the Roche 9180 analyzer is provided by Roche Diagnostics. Contact your local Roche representative for any questions or information on Roche 9180 analyzer training.
Test Specific Information Information specific to a particular assay can be found in the package insert.
Ordering Information Replacement parts, consumable materials, reagents, calibrators and controls should be ordered as necessary from Roche Diagnostics. When ordering, please use the Roche Diagnostics catalog number and reference name for each item. To place an order, contact Roche Diagnostics Customer Service at the following number: 1-800-428-5076 Roche 9180 Analyzer Instructions for Use
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US.1 General Information Customer Communications As the need arises, you will receive various customer communications concerning information about your Roche 9180 System. These updates are usually in one of the following forms: • Customer Bulletins – Customer Bulletins are printed on special Roche Diagnostics letterhead with a denoting Analyzer, Software or Reagent banner. They contain information that is vital because it directly affects the performance of your system and/or reagents. Communicate bulletin information internally to all analyzer operators. File bulletins for reference until you are notified by Roche Diagnostics to discard them. • Urgent Product Recall – Urgent Product Recalls are printed on Roche Diagnostics letterhead with the words Urgent Product Recall printed at the top. These require immediate attention by the operator and are to be filed for reference until further notice. • Customer Bulletin Index – This is an index of current bulletins that you should have on file. If you find that you are missing any bulletin, call the Roche Technical Support Center at 1-800-526-2272. • Customer Letter – Customer Letters are printed on special Roche Diagnostics letterhead and contain general information or attachments that you may remove and place in your files. You may discard Customer Letters after reading them and following any applicable instructions contained in them. • Product Announcement – Product Announcements (PA) are printed on special Roche Diagnostics letterhead titled PA and usually announce product launches. They contain specific details about a new product such as features and benefits, kit configuration and pricing. PAs may or may not be discarded depending on your laboratory’s preference. Customer communications can also be viewed on the internet. Go to http://www.MYLABONLINE.com and select Documentation.
CLIA/CLSI Guidelines Roche Diagnostics documentation, which includes: this operator’s manual, reagent package inserts and active customer bulletins, conforms with the guidelines in effect at the time of publication listed in the Code of Federal Regulations (CFR) and the Clinical and Laboratory Standards Institute (formerly NCCLS) General Laboratory Practices and Safety Guidelines. Roche Diagnostics documentation also meets the Centers for Medicare and Medicaid Services (formerly HCFA) interpretation of the requirements for the Clinical Laboratories Improvement Act (CLIA ’88). Customizable test procedures in a NCCLS-approved format are available on the internet. Go to http://www.MYLABONLINE.com and select Documentation > Point of Care > Blood Gas > Test Information.
Technical Publications Hotline The Technical Publications departments are responsible for most of the written documentation you receive from Roche Diagnostics. This includes: manuals, training material and customer communications. To reach the Technical Publications group, call the following number and leave a message with your request. We will get back to you, or fill your request, as soon as possible.
[email protected] or 1-800-845-7355, mailbox 26699 US-6
Roche 9180 Analyzer Instructions for Use
US.2 Technical Publications and RD Documentation To Change Addresses or Contact Names To change your mailing address or the contact name for your account leave a voice message or send the information electronically either through electronic mail or through the MyLabOnline website. Please provide your name and account number in your message. Your account number is provided to you by a Roche Diagnostics representative when your analyzer is installed. •
Computer access: http://www.mylabonline.com, access Customer Support, then click on Contact Change • To email, use:
[email protected] • To leave a message, call: 1-800-845-7355, mailbox 26699
Roche 9180 Analyzer Instructions for Use
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End US Supplement
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Roche 9180 Analyzer Instructions for Use
Roche Diagnostics GmbH D-68298 Mannheim / Germany www.roche.com
Copyright © 2007 Roche Diagnostics GmbH, all rights reserved The contents of this document may not be reproduced in any form or communicated to any third party without the prior written consent of Roche Diagnostics. While every effort is made to ensure its correctness, Roche Diagnostics assumes no responsibility for errors or omissions which may appear in this document. Subject to change without notice. ROCHE MICROSAMPLER, SNAPPAK, ISETROL are trademarks of Roche. REF/No. 0 4381092001 Rev. 4.0, April 2007
First edition: April 1996
– Important information! – Always follow! – These Instructions for Use contain vital warning and safety information. This instrument is intended to be used only for the specialized purpose described in the instructions. The most important prerequisites for use, operation, and safety are explained to ensure smooth operation. No warranty or liability claims will be covered if the instrument is used in ways other than those described or if the necessary prerequisites and safety measures are not observed. The instrument may be operated only by persons whose qualifications enable them to comply with the safety measures that are necessary during operation of the instrument. Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if necessary mouth protectors, must be worn to prevent direct contact with biological working materials. In addition, a face mask is required if there is a risk of splashes. Suitable disinfection and sterilization procedures must be applied. Adjustments and maintenance performed with removed covers and connected power may be attempted only by a qualified technician who is aware of the associated dangers. Instrument repairs are to be performed only by the manufacturer or qualified service personnel. Only accessories and supplies either delivered by or approved by Roche are to be used with the instrument. These items are manufactured especially for use with this instrument and meet the highest quality requirements. Operation of the instrument with solutions whose composition is not consistent with that of the original solutions can negatively affect, above all, the long term measurement accuracy. Deviations in the composition of the solutions can also decrease the service life of the electrodes. The quality control requirements must be completed at least once daily for safety reasons. Since the measurements of the instrument depend not only on the correct characteristic function, but also on a series of marginal conditions (e.g. pre-analysis), results obtained from the instrument should be submitted for an expert opinion before taking additional measures based on the supplied measurements.
Explanation: Meaning: "Caution (refer to accompanying documents). Please refer to safety-related notes in the manual accompanying this instrument".
– Important information! – Always follow! –
– Operating safety information – The instrument has been constructed and tested according to the following European Standards: • • •
IEC/EN 61010-1:2001 IEC/EN 61010-2-101:2002 IEC/EN 61010-2-081:2002 + A1:2003
It was delivered from the factory in flawless condition with regards to safety features. In order to preserve this condition and ensure safe operation, the user must observe the notices and warnings that are contained in these Instructions for Use. •
This instrument is classified under the protection class I according to IEC 1010-1 / EN 61010-1.
•
The instrument meets the conditions for overvoltage category II.
•
The instrument meets the conditions for contamination level 2.
•
Do not operate the instrument in an explosive environment or in the vicinity of explosive anesthetic mixtures containing oxygen or nitrous oxide.
•
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.
•
The instrument is suitable for long-term operation indoors.
CAUTION: •
The power cord must be plugged into a grounded power receptacle. When using an extension cord, make sure it is properly grounded.
•
Any rupture of the ground lead inside or outside the instrument or a loose ground connection may result in hazardous operating conditions for the operating personnel. Intentional disconnection of the grounding is not permitted.
•
The instrument is not suitable for operation with a direct current power supply. Use only the original mains plug delivered with the instrument.
– Operating safety information –
Contents - Instructions for Use
Contents - Instructions for Use
1 Introduction 1.1 General notes ................................................................................................................... 1-2 1.2 Measurement and calibration procedures ................................................................ 1-5 1.3 Measurement evaluation .............................................................................................. 1-5 1.4 Important safety instructions ....................................................................................... 1-6 1.5 System description ......................................................................................................... 1-7 1.6 Installation ...................................................................................................................... 1-12 1.7 Shutdown ........................................................................................................................ 1-26 1.8 Standby mode ................................................................................................................ 1-30
2 Specifications 2.1 Performance parameters .............................................................................................. 2-1 2.2 Linearity ............................................................................................................................ 2-5 2.3 Interferences .................................................................................................................... 2-6 2.4 Limitations ........................................................................................................................ 2-7 2.5 Relationship of ionized calcium to total calcium ..................................................... 2-7 2.6 Bibliography ..................................................................................................................... 2-8 2.7 Sample throughput ......................................................................................................... 2-9 2.8 Sample volumes .............................................................................................................. 2-9 2.9 Sample types .................................................................................................................... 2-9 2.10 Calibrations ...................................................................................................................... 2-9 2.11 Environmental parameters .......................................................................................... 2-10 2.12 Product data ................................................................................................................... 2-14 2.13 Printer .............................................................................................................................. 2-14 2.14 Display ............................................................................................................................. 2-14
3 Measurement 3.1 Preanalytics ...................................................................................................................... 3-1 3.2 Limitations of clinical analysis ..................................................................................... 3-3 3.3 Measuring procedure .................................................................................................... 3-4 3.4 Normal ranges ................................................................................................................. 3-8 3.5 Correlation factors .......................................................................................................... 3-8 3.6 Additional settings ........................................................................................................ 3-10
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1
Contents - Instructions for Use
4 Quality control 4.1 General QC concept ........................................................................................................4-1 4.2 Material setup ..................................................................................................................4-2 4.3 Performing a QC measurement ....................................................................................4-4 4.4 Printing a QC report ........................................................................................................4-5
5 Maintenance 5.1 Decontamination .............................................................................................................5-1 5.2 Daily maintenance ...........................................................................................................5-2 5.3 Weekly maintenance .......................................................................................................5-4 5.4 Monthly maintenance .....................................................................................................5-5 5.5 Semi annual maintenance .............................................................................................5-8 5.6 Annual maintenance .......................................................................................................5-9 5.7 Unscheduled maintenance ......................................................................................... 5-10
6 Troubleshooting 6.1 Error messages .................................................................................................................6-1 6.2 Service functions .............................................................................................................6-7 6.3 Service codes ................................................................................................................ 6-11 6.4 Deleting data ................................................................................................................. 6-13
7 Theoretical foundations 7.1 Clinical significance ........................................................................................................7-1 7.2 Principles of Operation ...................................................................................................7-7 7.3 Electrode specifications .............................................................................................. 7-10 7.4 Calibration procedure .................................................................................................. 7-16
8 Appendix 8.1 Description of reports .....................................................................................................8-1 8.2 Specifications of the solutions .....................................................................................8-3 8.3 Specification of the QC solutions .................................................................................8-7 8.4 Declaration of conformity ........................................................................................... 8-10 8.5 Program flow chart ....................................................................................................... 8-13 8.6 Maintenance schedule ................................................................................................ 8-14
9 Index
2
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
1 Introduction 1.1 General notes ................................................................................................................... 1-2 1.1.1
Symbols.............................................................................................................................................................1-2 Used in the Instructions for Use ...............................................................................................................................1-4
1.2 Measurement and calibration procedures ................................................................ 1-5 1.2.1
Measurement procedure............................................................................................................................1-5
1.2.2
Calibration procedure..................................................................................................................................1-5
1.3 Measurement evaluation .............................................................................................. 1-5 1.4 Important safety instructions ....................................................................................... 1-6 1.4.1
Sample collection and handling ..............................................................................................................1-6
1.4.2
Disposal of SnapPak, electrodes, and instrument ............................................................................1-6 Disposal of the reference electrode ........................................................................................................................1-6
1.4.3
Handling electrodes .....................................................................................................................................1-6
1.5 System description ......................................................................................................... 1-7 1.5.1
Analyzer components ..................................................................................................................................1-7 Display ................................................................................................................................................................................1-8 Keypad ...............................................................................................................................................................................1-8 Printer .................................................................................................................................................................................1-8 Measuring chamber ......................................................................................................................................................1-9 Peristaltic pump ..............................................................................................................................................................1-9 Sample probe mechanism ..........................................................................................................................................1-9 Valves .............................................................................................................................................................................. 1-10 SnapPak .......................................................................................................................................................................... 1-10 Rear panel ...................................................................................................................................................................... 1-11 Serial port ....................................................................................................................................................................... 1-11
1.6 Installation ...................................................................................................................... 1-12 1.6.1
Location ......................................................................................................................................................... 1-12 Accessories ................................................................................................................................................................... 1-13
1.6.2
Setting up ...................................................................................................................................................... 1-13
1.6.3
Electrodes and measurement chamber............................................................................................. 1-14
1.6.4
Preparing the Analyzer for Operation................................................................................................. 1-18 1. Selecting language ................................................................................................................................................ 1-18 2. Start-up ...................................................................................................................................................................... 1-18 3. Setting date and time ........................................................................................................................................... 1-19 4. Installing the SnapPak .......................................................................................................................................... 1-20 5. Installing the printer paper ................................................................................................................................. 1-20 6. Daily Maintenance (manual) ............................................................................................................................. 1-22
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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1 Introduction
7. Selecting parameter configuration .................................................................................................................. 1-24
1.7 Shutdown ........................................................................................................................ 1-26 1. Installing shutdown plug ..................................................................................................................................... 1-26 2. Installing the transport housing ........................................................................................................................ 1-27 3. Washing the lines ................................................................................................................................................... 1-27 4. Removing the electrodes and the shutdown plug ..................................................................................... 1-28 5. Installing the relief clamps and removing the pump windings ............................................................. 1-28 6. Turning the analyzer "off" ................................................................................................................................... 1-29
1.8 Standby mode ................................................................................................................ 1-30
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Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
1
Introduction The 9180 Electrolyte Analyzer is a powerful tool designed to quickly, accurately and efficiently conduct basic electrolyte testing in the convenience of the laboratory. This manual will help guide through setting up the analyzer and analyzing samples. As the user become familiar with the operation of the unit, the manual may be used as a reference for day-to-day routines and as a guide for maintenance and troubleshooting.
Fig. 1-1
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1-1
1 Introduction
1.1
General notes
1.1.1 Symbols This product fulfills the requirements of the directive 98/79/EC on in vitro diagnostic medical devices.
Lot number
Electrodes: This date indicates the limit of the maximum storage time of an electrode. The electrode must be used in the instrument no later than the imprinted date. If the installation takes place on the imprinted date, it still falls within the specifications. The calculation of the “Install before” date is based on the production date of the electrode. Consumables: use by... (expiry date) The consumables must be completely consumed by the indicated date. If a day is not indicated, apply the last day of the respective month. Storage note The conditions necessary to preserve the product's shelf life before opening.
For in vitro diagnostic use
„Grüner Punkt“ (Germany)
Manufacturer—according to In Vitro Diagnostic guidelines 98/79/EC
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Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
Danger symbol: T: Toxic (on the packaging of the reference electrode)
T:R23/33/50-53
Rating: Inhalation, swallowing or skin contact with even small quantities can lead to serious health risks, including fatal risks. Characteristics of this type of item are severe, possibly irreversible damage to health through repeated or prolonged contact, particularly with carcinogenic, genetic or reproductive (danger to reproductive capabilities) effects. Caution: Avoid any contact with the human body. If you feel unwell, contact a doctor immediately. Any substances with carcinogenic, genetic or reproductive dangers are indicated appropriately. Always observe the regulations when handling such substances. Danger symbol: N: Dangerous to the environment (on the packaging of the reference electrode)
N:S45/60/61/7
Rating: If released into aquatic and non aquatic environments, can cause immediate or delayed damage to ecosystems through a change in environmental conditions. These substances or their by-products can cause substantial damage to sensitive environmental areas. Caution: Depending on the potential for damage, do not allow the substance to enter sewers, soils or the environment. Observe the specific disposal regulations. Danger symbol: Xi: Irritant
XI: R36/37/38, S 26-37
Rating: Although not corrosive, momentary, longer-lasting, or repeated contact with skin or mucous membrane may result in inflammation. Danger of sensitization during contact with skin (when classified with R 43). Caution: Avoid contact with eyes and skin, do not inhale vapors.
Store upright
Risk of infection! (according to the standard DIN EN 61010-2-101:2002) (Instrument)
Risk of infection! (according to the standard DIN ISO 15223-1:2005) (Consumables)
Reference and/or ordering number
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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1 Introduction
IMPORTANT: read and follow Instructions for Use!
Please read and follow the information on the packaging insert / instructions for use.
Serial number (model plate)
Do not use content if the packaging is damaged
Protective gloves, protective goggles and suitable protective clothing must be worn
Used in the Instructions for Use Sections marked with this symbol (see Instructions for Use) contain information that must be observed to avoid potential injuries (to patients, users and third parties).
Risk of infection!
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, and therefore should never be attempted. TIP: All sections / text locations marked with "TIP" describe safe procedures that are intended to provide the user with additional help.
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Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
1.2
Measurement and calibration procedures
1.2.1 Measurement procedure The 9180 Electrolyte Analyzer methodology is based on the ion selective electrode (ISE) measurement to determine the measurement values (see chapter 7, section "The measurement principle"). There are six different electrodes used in the 9180 Electrolyte Analyzer: sodium, potassium, chloride, ionized calcium, lithium and a reference electrode. Each electrode has an ionselective membrane that undergoes a specific reaction with the corresponding ions contained in the sample being analyzed. The membrane is an ion exchanger, reacting to the electrical charge of the ion causing a change in the membrane potential, or measuring voltage, 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 galvanic chain is closed through the sample on one side by the reference electrode, reference electrolyte and the "open terminal". The membrane, inner electrolyte and inner electrode close the other side. 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. The potential is conducted by a highly conductive, inner electrode to an amplifier. The reference electrode is connected to ground as well as to the amplifier. 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.
1.2.2 Calibration procedure A 2-point or a 3-point calibration is performed automatically every 4 hours in [READY] mode and a 1-point calibration is automatically performed with every measurement. An automatic calibration procedure is also performed shortly after power-on or reset. A calibration cycle can also be initiated manually at times when no sample measurements are performed.
1.3
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. In order to ensure the quality of the measurement results, complete a quality control test on 3 levels (low, normal, 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 (low, normal, 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. For further information, see chapter 4: "Quality control".
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1-5
1 Introduction
1.4
Important safety instructions For your own safety and the proper operation of your equipment, always follow these precautions when working with the 9180 Electrolyte Analyzer: •
Keep the analyzer away from all sources of liquids such as sinks and wash basins. Don’t use ammonia-based or alcohol-based cleaners, which can chemically react with plastic, on or around the analyzer.
• • • •
Always handle blood samples and collection devices with appropriate care. Use approved protective gloves to avoid direct contact with sample. Aseptic procedures are required when cleaning the sampling probe to avoid contamination. Dispose of SnapPak according to local regulations.
1.4.1 Sample collection and handling Universal precautions must be observed when collecting blood specimens. It is recommended that all blood specimens be handled as potentially infectious specimens capable of transmitting human immunodeficiency virus (HIV), hepatitis B virus (HBV), or other bloodborne pathogens. Proper blood collection technique must be followed in order to minimize risk to the laboratory staff. Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if necessary mouth protectors, must be worn to prevent direct contact with biological working materials. In addition, a face mask is required if there is a risk of splashes. Suitable disinfection and sterilization procedures must be applied. Please refer to NCCLS document M29-A2, "Protection of Laboratory Workers from Occupationally Acquired Infections", Approved Guidelines - Second Edition 2001, for further information on safe handling of these specimens. For further information, see chapter 3: "Measurement".
1.4.2 Disposal of SnapPak, electrodes, and instrument Dispose of used SnapPak, electrodes and the instrument according to applicable laboratory regulations (biologically contaminated–hazardous waste!) Disposal of the reference electrode This electrode contains mercury. Therefore dispose of it in accordance with applicable regulations (hazardous waste!). T:R23/33/50-53
N:S45/60/61/7
1.4.3 Handling electrodes • • •
1-6
Store electrodes according to packaging instructions. The shelf life of the electrodes is limited. Please see electrode label and packaging for correct storage temperature and maximum shelf life.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
1.5
System description
1.5.1 Analyzer components display
keypad
front cover
sample door
ISE SnapPak TM
Fig. 1-2
thermal printer
measuring chamber
peristaltic pump
sample door
valves Fig. 1-3
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1-7
1 Introduction
Display The analyzer communicates to the user through a dot matrix display. This two line, alphanumeric read-out allows up to 16 characters per line, displaying the activities of the analyzer, sample results and other programmed information.
Na K Cl
READY
Fig. 1-4
Keypad The communication with the analyzer is performed through a keypad with YES and NO keys. With these keys, all analyzer functions, including: sample measurement, data input, programming and quality control testing can be performed.
Fig. 1-5
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. The unit is configured to allow convenient storage of a second roll of paper in the paper tray.
Fig. 1-6
1-8
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
Measuring chamber The measuring chamber consists of the movable left locking device that holds the electrodes in place, the electrodes, the right electrode holder with sample sensor connector, and the measuring chamber base.
Fig. 1-7
Peristaltic pump A peristaltic pump transports all sample and operating fluids inside the instrument.
Fig. 1-8
Sample probe mechanism The sample probe mechanism is located behind the sample door at the front of the unit.
Fig. 1-9
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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1 Introduction
Valves Valves control the movement of the liquid within the analyzer.
Fig. 1-10
SnapPak The self-contained ISE SnapPak is constructed to ensure that waste cannot spill out of the package.
Fig. 1-11
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Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
Rear panel The rear panel of the unit contains a serial number plate, as well as the power switch/power receptacle module and an RS232 interface port.
Fig. 1-12
Serial port The analyzer is equipped with a serial RS232 interface and allows data to be exchanged with commercially available computer systems. The analyzer can be connected to COMPACT 2/ 3 systems via the 9-pin DB-9 connector to output a common measurement report. Measurement data is transferred after each measurement and calibration data is transferred after each calibration. The interface is always active, and data is sent independently of the printer setup. Refer to COMPACT 2/3 Instructions for Use for details. A higher leakage current can be expected when using the serial interface. This must be checked by suitably qualified personnel, depending on the local regulations.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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1 Introduction
1.6
Installation
1.6.1 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: • • • • • • •
Ambient temperature + 15°C to + 32°C Avoid exposure to direct sunlight, vibration and strong electromagnetic fields (electric motors, transformers, X-ray equipment, cellular phones, etc.). Use a stable and level work surface. Maximum relative humidity of 85 % (15 % - 85 %) Ample room to allow air to circulate freely around the unit, see Fig. 1-13. Avoid exposure to explosive gases or vapors. Check for correct voltage: 100 to 240 VAC, 50/60 Hz.
340 mm
350 mm 330 mm
Fig. 1-13
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: • •
Refer to the packing slip to check for the completeness of the shipment. 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. 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.
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Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
Accessories The following parts are delivered as standard equipment with the 9180 Electrolyte Analyzer: • • • • • • •
Printer paper Electrode Dummy Quad Ring, 1.78x1.02 mm Fuse set Sample probe stylet Syringe, 12 mL, with tapered tip 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.
1.6.2 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").
Fig. 1-14
•
Fig. 1-15
Slip the two pump windings around the analyzer pump rollers, making sure not to overstretch the tubing.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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1 Introduction
1.6.3 Electrodes and measurement chamber The next procedure involves preparing and installing the electrodes in the measurement chamber. •
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 o-ring on the left side.
Fig. 1-16
•
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.
Fig. 1-17
•
Carefully screw the reference electrode into the reference electrode housing and place it with the other electrodes.
reference electrode housing
reference electrode
red transport housing Fig. 1-18
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Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
• •
Slide the measurement chamber forward until it locks in the front position. Unclamp the left electrode holder by moving the clamp forward.
Fig. 1-19
•
Fig. 1-20
Locate the sample sensor cable and ensure that it is securely inserted in the receptacle above the measurement chamber. Check that an o-ring is present in the right electrode holder
Fig. 1-21
Now install the electrodes in the measurement chamber, beginning on the right and working to the left (the reference electrode will be installed last). TIP: The electrode on the right may be one of the following: chloride, ionized calcium, lithium or a dummy electrode, if no third test is needed. If sodium and lithium are selected, the potassium electrode is replaced by a dummy electrode.
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1 Introduction
•
Check to make sure that the lettering on the electrode corresponds with the proper electrode station number on the tray. Also, 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.
Fig. 1-22
•
After all electrodes have been installed, 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.
Fig. 1-23
•
Slide the measurement chamber back until it snaps into position.
Fig. 1-24
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Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
•
Plug the tubing connector of the reference housing assembly in the receptacle below the left side of the measurement chamber.
Fig. 1-25
Possible parameter configurations are the following: Electrode pos.
Parameter configuration
Na +
Na +
Na +
Na +
Na +
Na +
K+
K+
K+
Dummy
K+
Dummy
Cl - / Ca ++ / Li +
Dummy
Cl -
Cl -
Ca 2+
Ca 2+
Electrode pos.
Parameter configuration
Na +
Na +
Na +
(Na + )
Na +
K+
K+
Dummy
Dummy
Ca 2+
Cl - / Ca ++ / Li +
Li +
Li +
Li +
Li +
Fig. 1-26 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. For details, see section "7. Selecting parameter configuration".
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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1 Introduction
1.6.4 Preparing the Analyzer for Operation 1. Selecting language Before the analyzer is powered on, the language setting must 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.
TIP: If you decide to change the language after the unit is powered on, you must cycle the power to activate the new language.
2. Start-up • •
Locate the power switch on the back of the unit and make sure that it is in the OFF (O) position. Plug the power cord into the power receptacle module on the back of the unit, then plug the cord into a grounded electrical outlet (100 - 240 V, 50/60 Hz).
Fig. 1-27
•
Push the power switch to the ON (I) position. The unit will automatically begin to operate.
Fig. 1-28
1-18
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
Now that the 9180 Electrolyte Analyzer is functioning, begin using the keypad interface to communicate with the instrument. Use the NO key to make changes, the YES key to accept the displayed values or information. TIP: After start-up, date and time should be set and the printer paper inserted.
3. 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 Time: 00:00
To enter the correct date and time: • • • • • • •
Press NO, until the actual day is displayed. To accept this value, press YES and the cursor will move to the month. By keeping the NO key depressed, the analyzer will automatically scroll through the numbers, first slowly, then faster. Press NO, until the actual month is displayed. To accept this value, press YES . Press NO, until the actual year is displayed. To accept this value, press YES . Now, the actual date will be displayed. Follow the same procedure to enter the current time. After entering the time, the analyzer will prompt [ok?] . Press YES if the date and time entered are correct, or press NO to make a change. After pressing YES at the last prompt, the analyzer will prompt: [STATUS: NO SnapPak] .
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1 Introduction
4. Installing the SnapPak Use of calibration solutions, electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee. • •
Record the installation date of the SnapPak on the label on the SnapPak. Remove the protective strip and slide the SnapPak into position on the left side of the analyzer. Save the protective strip for the case of a shutdown or disposal.
Fig. 1-29
Fig. 1-30
Once the protective strip is removed, be sure to keep the SnapPak upright to avoid spillage. Save the protective strip to use to close the nipples on the SnapPak prior to disposing. • •
At the prompt [New SnapPak Installed?] , press YES . Again, at the prompt [Are you sure?] , press YES .
5. Installing the printer paper TIP: The printer paper is heat sensitive on one side only. Please 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: •
1-20
Place a new paper roll in the paper tray and thread it into the feeder slot.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
Fig. 1-31
•
Press the paper feed button to completely feed the paper through the printer.
Fig. 1-32
TIP: By pressing the paper advance button once, the paper will automatically advance 10 lines. Do not pull the paper out of the printer to avoid damage to the printer.
Now perform the initial Daily Maintenance.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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1 Introduction
6. Daily Maintenance (manual) Prior to performing the first calibration or running the first sample, the 9180 Electrolyte Analyzer needs to undergo a simple cleaning and conditioning procedure that helps ensure that the analyzer will perform properly. This procedure is called daily maintenance, because it must be performed each day the analyzer is used to conduct sampling. The process involves cleaning and conditioning the sample path and electrodes, which prepares the 9180 analyzer for calibration. The bottles containing Cleaning Solution A and Electrolyte Conditioning Solution should be ready, along with a package of lint-free tissues that will be used to dry the probe. Check expiration date on the bottles of the Cleaning Solution A and the Electrolyte Conditioning Solution. In some cases, when the analyzer prompts you for an action and you do not respond within a set period of time, an alarm will sound and the unit will discontinue its current operation. To start the daily maintenance: • • •
Press the NO key, until [DAILY MAINTENANCE?] is displayed, and YES to select. Select [Perform Daily Cleaning?] by pressing YES . Pour a small amount of Cleaning Solution A into a clean container. At the prompt [Open Sample Door Introduce Sample] , lift the sample door and the pump will begin to aspirate.
Fig. 1-33
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Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
•
Hold the Cleaning Solution A under the probe, until [Wipe Probe/Close Sample Door] is displayed, and use a lint-free tissue to remove the cleaning solution from the probe. Close the sample door.
Fig. 1-34
• • •
While the analyzer displays [Thank You!] and a brief countdown, pour a small amount of conditioning solution into a clean container. Answer the prompt [Perform Daily Conditioning?] by pressing YES . At the prompt [Open Sample Door Introduce Sample] , lift the sample door and the pump will begin to aspirate.
Fig. 1-35
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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1 Introduction
•
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.
Fig. 1-36
•
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 interference. 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.
After finishing the calibration, the analyzer returns to [READY] and is now ready for QC.
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 . • •
Continue pressing NO, until [OPERATOR FUNCTIONS?] is displayed. Press YES . Press NO until the prompt [Select Parameter Configuration?] is displayed, see Fig. 1-26. Press YES and the current configuration will be displayed. The default configuration is the following: Sel. Parameter: [Na][K][ ] ok?
•
1-24
Press NO until the desired configuration is displayed. Press YES to accept this selection.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
TIP: 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 (low, normal, 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 (low, normal, 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. For further information, see chapter 4: "Quality control". The 9180 Electrolyte Analyzer is now ready to operate.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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1 Introduction
1.7
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. 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: • • • • •
One shutdown plug (supplied with shutdown kit). Five solenoid relief clamps (supplied with analyzer and shutdown kit). Two reference electrode transport housings (supplied with shutdown kit). Two containers, one filled with at least 100 mL of water, the other one empty. Protective strip for SnapPak (supplied with shutdown kit).
Starting at the [READY] display, do the following: • • •
Press NO until [OPERATOR FUNCTIONS?] is displayed. Press YES . Select [Take out of Operation?] and press YES . Confirm [Are you sure?] by pressing YES .
1. Installing shutdown plug The analyzer prompts [Shut Down Plug & Water Installed?] . • • • • • •
Remove the SnapPak and push the protective strip firmly onto the SnapPak connector. Fill one container of the shutdown kit about halfway with distilled water. Insert the shutdown plug carefully into the SnapPak receptacle. Place the blue marked line into the disposable container filled with distilled water. Place the red marked line into the empty container. Begin the tubing wash procedure by pressing YES .
Fig. 1-37
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Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
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. Temporarily place the reference electrode on a clean, soft cloth. Pour the remaining reference solution in the reference housing into a transport housing. Carefully screw the reference electrode into the filled transport housing. The second transport housing is screwed into the reference housing. Place the reference housing back into the electrode holder and move the lever backwards, making sure all electrodes are seated properly. The electrode holder remains in the forward position.
Fig. 1-38
•
Fig. 1-39
Press YES .
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. Press YES . During this cycle, all lines are purged of distilled water. Upon completion, [All Electrodes & Plug Removed?] will be displayed.
Fig. 1-40
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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1 Introduction
4. Removing the electrodes and the shutdown plug • • • • • • •
Remove the shutdown plug from the SnapPak receptacle. Unplug the reference connector below the left side of the electrode holder. Move the lever on the left side forward and remove all electrodes, placing them on a soft cloth. Move the lever back and push the empty electrode holder into its back position. Unscrew the transport housing from the reference housing. Empty the reference housing and place all electrodes into their protective boxes. Press YES .
Fig. 1-41
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.
Fig. 1-42
•
1-28
Press YES .
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
1 Introduction
Never insert the solenoid relief clamps with the SnapPak in place. • • •
The prompt [Pump Windings Relieved?] appears. Grasp the front winding close to the pump roller and gently pull it off the roller. Repeat the same procedure for the rear pump winding.
Fig. 1-43
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. QC and normal ranges as well as correlation factors, printer settings, date/ time and SnapPak volume are reset to default. Also, all service codes are deactivated. A deletion of all data is recommended in case the analyzer is used by different laboratory later on. • Press NO to retain all data. See chapter 6.4.2: "Clearing all data". • •
6. Turning the analyzer "off" • • • • •
• •
The prompt [Shutdown Complete Turn Power Off] will appear. Turn the analyzer off. Unplug the power cord from the receptacle. Close the front door. Clean all external surfaces of the analyzer as well as the areas accessible through the main door and sample door (see chapter 5: "Maintenance", section "Clean sample probe and fill port"). Shutdown is complete. Use the original packaging when transporting the analyzer.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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1 Introduction
1.8
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 period of time, such as evenings and weekends, you may place the analyzer into Standby mode to suspend automatic calibration. TIP:
The analyzer can be programmed to automatically enter Standby mode. For instructions see chapter 6, section "Service codes".
To enter standby mode: • • •
Press NO until [OPERATOR FUNCTIONS?] appears. Press YES , then NO, until [Go to Standby Mode?] appears. Press YES .
The analyzer shows a Standby mode status on the display. To exit from Standby mode: • •
Press YES , [Leave Standby Mode?] will be displayed. Press YES again.
Depending on the duration of the standby mode, an automatic calibration can be performed. After that, the analyzer returns to [READY] .
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2 Specifications
2 Specifications 2.1 Performance parameters .............................................................................................. 2-1 2.1.1
Measurement parameters..........................................................................................................................2-1
2.1.2
Reproducibility................................................................................................................................................2-1 Material: ISETROL Protein Based Aqueous Control Material (Level 1), n=80 ........................................2-2 Material: ISETROL Protein Based Aqueous Control Material (Level 2), n=80 ........................................2-2 Material: ISETROL Protein Based Aqueous Control Material (Level 3), n=80 ........................................2-2 Material: RNA EQUIL Reduced Bovine Hemoglobin Solution (Level 2), n=80 .......................................2-2 Material: Aqueous Standard Solution (Level 1), n=80 ....................................................................................2-3 Material: Aqueous Standard Solution (Level 2), n=80 ....................................................................................2-3 Material: Pooled Human Serum, n=80 ..................................................................................................................2-3 Material: Acetate Dialysate Solution, n=80 ..........................................................................................................2-3 Material: Bicarbonate Dialysate Solution, n=80 .................................................................................................2-4 Material: Urine, n=80 ....................................................................................................................................................2-4
2.2 Linearity ............................................................................................................................ 2-5 2.2.1
Linearity in aqueous standard solutions...............................................................................................2-5
2.2.2
Linearity in serum..........................................................................................................................................2-5 Correlation to flame .......................................................................................................................................................2-5 Correlation to direct ISE - not flame-correlated .................................................................................................2-6 Correlation direct ISE - flame-correlated ..............................................................................................................2-6 Correlation to chloridometry ......................................................................................................................................2-6
2.3 Interferences .................................................................................................................... 2-6 2.4 Limitations ........................................................................................................................ 2-7 2.5 Relationship of ionized calcium to total calcium ..................................................... 2-7 2.6 Bibliography ..................................................................................................................... 2-8 2.7 Sample throughput ......................................................................................................... 2-9 2.8 Sample volumes .............................................................................................................. 2-9 2.9 Sample types .................................................................................................................... 2-9 2.10 Calibrations ...................................................................................................................... 2-9 2.11 Environmental parameters .......................................................................................... 2-10 2.11.1 Temperature / humidity / stability........................................................................................................ 2-10 Instrument ...................................................................................................................................................................... 2-10 Electrodes ...................................................................................................................................................................... 2-10 Solutions ......................................................................................................................................................................... 2-11 SnapPak .......................................................................................................................................................................... 2-11 Urine diluent ................................................................................................................................................................. 2-13 QC material .................................................................................................................................................................... 2-13
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2-I
2 Specifications
2.12 Product data .................................................................................................................. 2-14 2.12.1 Electrical data............................................................................................................................................... 2-14 2.12.2 Classification ................................................................................................................................................ 2-14 2.12.3 Dimensions ................................................................................................................................................... 2-14
2.13 Printer .............................................................................................................................. 2-14 2.14 Display ............................................................................................................................ 2-14
2-II
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2 Specifications
2
Specifications
2.1
Performance parameters
2.1.1 Measurement parameters specified for:
Na +
B/S/A/D/Q U
K+
Cl -
specified range:
40 − 205 mmol/L 1 − 300 mmol/L
B/S/Q
1.5 − 15 mmol/L
A/D
0.8 − 15 mmol/L
U
4.5 − 60 mmol/L
U*
60 − 120 mmol/L
B/S/A/D/Q
50 − 200 mmol/L
U
1 − 300 mmol/L
Ca 2+
B/S/A/D/Q
0.2 − 5.0 mmol/L
Li +
B/S/Q
0.1 − 6.0 mmol/L
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, see chapter 3.3.4: "Urine samples") U* .... urine samples (second dilution required, see chapter 3.3.4: "Urine samples")
2.1.2 Reproducibility Typical Within-Run (S wr ), Between-Day (S dd ) and Total (S T ) Precision is determined from 2 runs per day with 2 replicates per run for 20 days on two 9180 Electrolyte Analyzers. Values for sodium and potassium are average of all instruments, while values of chloride, ionized calcium and lithium are determined from the measurement of two of each respective unit configuration. All values are reported in mmol/L.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2-1
2 Specifications
Material: I S ETROL Protein Based Aqueous Control Material (Level 1), n=80 Parameter
Sodium Potassium Chloride ionized Calcium Lithium
Mean
114.6 2.82 76.7 2.07 0.40
S wr
0.48 0.025 0.29 0.015 0.010
(CV %)
0.42 0.87 0.38 0.72 2.40
S dd
0.76 0.035 0.52 0.024 0.018
(CV %)
0.66 1.24 0.67 1.18 4.57
ST
0.89 0.041 0.72 0.034 0.026
(CV %)
0.78 1.44 0.94 1.66 6.41
Material: I S ETROL Protein Based Aqueous Control Material (Level 2), n=80 Parameter
Sodium Potassium Chloride ionized Calcium Lithium
Mean
141.2 4.35 102.4 1.35 1.04
S wr
0.40 0.024 0.18 0.016 0.012
(CV %)
0.28 0.55 0.18 1.21 1.19
S dd
0.30 0.023 0.20 0.021 0.035
(CV %)
0.21 0.53 0.20 1.55 3.36
ST
0.46 0.036 0.32 0.042 0.045
(CV %)
0.33 0.82 0.31 3.10 4.31
Material: I S ETROL Protein Based Aqueous Control Material (Level 3), n=80 Parameter
Sodium Potassium Chloride ionized Calcium Lithium
Mean
158.8 5.74 123.2 0.63 2.59
S wr
0.51 0.027 0.36 0.010 0.025
(CV %)
0.32 0.48 0.29 1.52 0.97
S dd
0.76 0.026 0.89 0.007 0.063
(CV %)
0.48 0.45 0.72 1.07 2.44
ST
0.90 0.036 1.17 0.014 0.082
(CV %)
0.56 0.62 0.95 2.29 3.18
Material: R NA EQU I L Reduced Bovine Hemoglobin Solution (Level 2), n=80
2-2
Parameter
Mean
Sodium Potassium Chloride ionized Calcium Lithium
134.8 4.89 100.4 1.10 N/A
S wr
0.53 0.039 0.43 0.008
(CV %)
0.40 0.79 0.43 0.75
S dd
0.45 0.021 0.42 0.004
(CV %)
0.33 0.42 0.41 0.40
ST
0.63 0.043 0.58 0.011
(CV %)
0.47 0.88 0.57 0.95
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2 Specifications
Material: Aqueous Standard Solution (Level 1), n=80 Parameter
Sodium Potassium Chloride ionized Calcium Lithium
Mean
150.0 4.97 115.0 0.96 0.30
S wr
(CV %)
0.55 0.022 0.11 0.004 0.004
0.37 0.44 0.09 0.41 1.27
S dd
0.34 0.018 0.08 0.004 0.005
(CV %)
0.23 0.36 0.07 0.39 1.60
ST
0.57 0.029 0.16 0.007 0.008
(CV %)
0.38 0.57 0.14 0.76 2.48
Material: Aqueous Standard Solution (Level 2), n=80 Parameter
Sodium Potassium Chloride ionized Calcium Lithium
Mean
113.2 1.82 82.9 2.43 5.42
S wr
(CV %)
0.51 0.033 0.27 0.014 0.043
0.45 1.88 0.33 0.56 0.78
S dd
0.96 0.043 0.67 0.032 0.155
(CV %)
0.85 2.36 0.80 1.33 2.86
ST
1.07 0.053 0.87 0.043 0.196
(CV %)
0.95 2.92 1.05 1.76 3.62
Material: Pooled Human Serum, n=80 Parameter
Sodium Potassium Chloride ionized Calcium Lithium
Mean
138.8 4.49 106.8 1.19 0.17
S wr
0.30 0.034 0.18 0.007 0.011
(CV %)
0.22 0.75 0.17 0.55 6.19
S dd
0.36 0.041 1.00 0.031 0.015
(CV %)
0.28 0.92 0.93 2.64 8.40
ST
0.47 0.051 1.24 0.039 0.023
(CV %)
0.34 1.13 1.16 3.29 13.28
Material: Acetate Dialysate Solution, n=80 Parameter
Mean
Sodium Potassium Chloride ionized Calcium Lithium
86.1 2.09 107.8 1.77 N/A
S wr
0.85 0.029 0.25 0.020
(CV %)
0.98 1.41 0.24 1.13
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
S dd
1.81 0.041 0.23 0.092
(CV %)
2.10 1.94 0.21 5.20
ST
1.78 0.049 0.40 0.115
(CV %)
2.07 2.32 0.37 6.50
2-3
2 Specifications
Material: Bicarbonate Dialysate Solution, n=80 Parameter
Mean
Sodium Potassium Chloride ionized Calcium Lithium
135.2 1.58 107.3 1.68 N/A
S wr
0.45 0.023 0.37 0.012
(CV %)
0.33 1.46 0.35 0.72
S dd
0.59 0.031 0.63 0.016
(CV %)
0.44 1.95 0.59 0.96
ST
0.72 0.037 0.86 0.027
(CV %)
0.54 2.37 0.80 1.63
Material: Urine, n=80
2-4
Parameter
Mean
Sodium Potassium Chloride ionized Calcium Lithium
51.5 48.4 85.9 N/A N/A
S wr
1.98 0.65 0.53
(CV %)
3.84 1.34 0.62
S dd
3.06 0.97 0.66
(CV %)
5.94 2.00 0.76
ST
3.65 1.11 0.99
(CV %)
7.08 2.29 1.16
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2 Specifications
2.2
Linearity
2.2.1 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
Sodium Potassium Chloride ionized Calcium Lithium
0.99993 0.99838 0.97556 1.01552 0.99850
0.0128 0.0119 -0.1775 -0.0078 0.0087
0.99995 0.99919 0.99994 0.99980 0.99985
0.666 0.194 0.674 0.037 0.038
Range [mmol/L]
51 2.0 56 0.4 0.3
− − − − −
196 12.6 194 3.3 5.3
n
300 300 100 100 100
2.2.2 Linearity in serum Linearity in serum was established with the analysis of two specimen sets in non-clinical 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
Sodium Potassium Lithium
0.9617 1.0249 0.9803
5.83 0.015 0.0011
0.9908 0.9991 0.9822
2.04 0.075 0.028
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
Range [mmol/L]
n
104 − 178 1.8 − 11.5 0.11 − 0.71
50 50 15
2-5
2 Specifications
Correlation to direct I S E - not flame-correlated 98X Electrolyte Analyzers Parameter
Sodium Potassium Chloride ionized Calcium Lithium
Slope
0.9895 1.0223 0.9631 0.8898 0.9923
Intercept
-6.35 -0.25 -1.01 0.107 0.008
Correlation Coefficient
0.9992 0.9996 0.9995 0.9960 0.9985
Sy·x
0.61 0.05 0.51 0.021 0.010
Range [mmol/L]
110 2.0 70 0.67 0.11
− − − − −
186 11.6 152 1.66 0.71
n
50 50 50 50 15
Correlation direct I S E - flame-correlated 91XX Electrolyte Analyzers Parameter
Sodium Potassium Chloride ionized Calcium
Slope
0.9856 0.9992 1.0026 1.0023
Intercept
-2.02 0.02 -5.31 0.040
Correlation Coefficient
0.9856 0.9994 0.9989 0.9954
Sy·x
1.21 0.05 0.73 0.022
Range [mmol/L]
104 1.9 70 0.62
− − − −
179 11.8 152 1.54
n
50 50 50 50
Correlation to chloridometry Labconco Digital Chloridometer Parameter
Chloride
2.3
Slope
1.0222
Intercept
2.75
Correlation Coefficient
0.9923
Sy·x
2.03
Range [mmol/L]
66 − 145
n
50
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. 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. At normal physiological ionized calcium concentrations, the influence of ionized calcium is clinically insignificant. Use only lithium-free sampling containers for the determination of lithium measurement values! If sample containers are used which contain lithium as an anticoagulant, this may lead to incorrect patient measurements, which may result in incorrect clinical decisions, possibly endangering the patient's health.
2-6
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2 Specifications
2.4
Limitations A number of substances have been reported to cause physiological changes in blood, serum and plasma analyte concentrations. A comprehensive discussion concerning these and other interfering substances, their blood, serum or plasma concentrations, and their possible physiological involvement is beyond the scope of this Instructions for Use. No significant effect on serum has been demonstrated from bromide, ammonium and iodide. As with any clinical reaction, users must be alert to the possible effect on results due to unknown interference from medications or endogenous substances. All patient results must be evaluated by the laboratory and the physician in light of the total clinical status of the patient. Opening and closing the fist with a tourniquet in place results in an increase in potassium levels by as much as 10 to 20 %. It is recommended that the blood sample is obtained without a tourniquet, or that the tourniquet be released after the needle has entered the vein and 2 minutes elapsed before the sample is withdrawn. Since the concentration of potassium inside erythrocytes is much greater than that in extra cellular fluid, hemolysis should be avoided, and the serum should be separated from the cells as soon as possible after collection. The lithium electrode response is dependent on the actual sodium concentration of the sample. The 9180 Electrolyte Analyzer reports lithium in the range of 95 - 180 mmol/L (89.6 - 169.5 mmol/L for blood/serum) Na + .
2.5
Relationship of ionized calcium to total calcium The ratio of ionized calcium to total calcium in a healthy population is around 0.50 or 50 % 1 . These relationships may be altered when using citrate in blood, or when the acidbase metabolism is disturbed.
1. Tietz, Norbert W., Ed., Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W.B.Saunders, Co., 1990) p.98-99, 118-119, 456-459, 510-511, 720-721.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2-7
2 Specifications
2.6
Bibliography Bishop ML, Duben-Engelkirk JL, Fody EP. Clinical Chemistry Principles Procedures Correlations, 2nd Ed., (Philadelphia: J.B.Lippincott Co.),1992,p.281. Burritt MF, Pierides AM, Offord KP: Comparative studies of total and ionized serum calcium values in normal subjects and in patients with renal disorders. Mayo Clinic Proc. 55:606, 1980. Burtis C, Ashwood E (Eds.), Tietz Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W.B. Saunders, Co.,1994) pp.1354-1360,2180-2206. Calbreath, Donald F., Clinical Chemistry A Fundamental Textbook, (Philadelphia: W.B. Saunders Co., 1992) pp.371, 376, 390-395. Henry, R.J., Clinical Chemistry - Principles and Technics, (New York, Harper and Row, 1974) Kost GJ.Arch.Path.Lab.Med., Vol.117, Sep.1993, p.890-95 National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Occupationally Acquired Infections, Second Edition; Approved Guidelines; NCCLS Document M29-A2, (2001). National Committee for Clinical Laboratory Standards. Additives for Blood Collection Devices: Heparin; Tentative Standard; NCCLS Document H24-T, (1988). National Committee for Clinical Laboratory Standards. Evaluation of Precision Performance of Clinical Chemistry Devices, Second Edition; Tentative Guideline. NCCLS Document EP5-T2, (1992). Rose, Burton David, Clinical Physiology of Acid-Base and Electrolyte Disorders, 4th Ed., (New York: McGraw-Hill, Inc., 1993) pp. 346-348, 432, 797-798. Schoeff, Larry E & Williams, Robert H. (Eds.) Principles of Laboratory Instruments, (St. Louis: Mosby Year Book Inc., 1993) pp. 150-157, 161-164. Snyder John R., Senhauser Donald A, (Eds.), Administration and Supervision in Laboratory Medicine, 2nd Ed, (Philadelphia: J.B.Lippincott Co., 1989) pp.262-284. Tietz, Norbert W.,Ed.,Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W.B. Saunders Co., 1990), pp.98-99, 118-119, 456-459, 510-511, 720-721 Tietz, Norbert W.,Ed., Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W.B. Saunders, Co.,1986), pp.1816, 1837, 1840-1842, 1845. Toffaletti J, Gitelman JH, Savory J: Separation and quantification of serum constituents associated with calcium by gel filtration. Clin Chem 22: 1968-72, 1976.
2-8
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2 Specifications
2.7
Sample throughput 45 per hour with printout 60 per hour without printout
2.8
Sample volumes 95 μL typical
2.9
Sample types Whole blood, serum, plasma, dialysis solutions containing acetate and bicarbonate, urine, QC material
2.10 Calibrations 1-point calibration after each sample 2-point or 3-point calibration every 4 hours
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2-9
2 Specifications
2.11 Environmental parameters 2.11.1 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 - 95 %, if T ≥ 15 to ≤ 31 °C 20 - 90 %, if T > 31 to ≤ 33 °C
Storage conditions in original package:
Temperature ........................................................
15 to 30 °C (dry)
Humidity ...........................................................................
15 - 85 % (not condensing)
Transportation conditions in original packaging:
2-10
Temperature .....................................................................
-5 to 40 °C
Humidity .............................................................
15 - 85 % (not condensing)
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2 Specifications
Solutions SnapPak Contains the following reagents: Standard A For calibration of sodium, potassium, ionized calcium and lithium in the 9180 Electrolyte Analyzer. Contents:
350 mL
Active ingredients:
Na +
150 mmol/L
K+
5.0 mmol/L
Cl -
115 mmol/L
Ca 2+
0.9 mmol/L
+
Additives: Storage temperature: Stability: On-board stability:
0.3 mmol/L Li Germicides 15 - 30 °C Expiration date and lot number are printed on each container label 14 weeks
Standard B For calibration of sodium, potassium, ionized calcium and lithium in the 9180 Electrolyte Analyzer. Contents:
85 mL
Active ingredients:
Na +
100 mmol/L
K+
1.8 mmol/L
Cl -
72 mmol/L
Ca 2+
1.5 mmol/L
Additives: Storage temperature: Stability: On-board stability:
0.3 mmol/L Li + Germicides 15 - 30 °C Expiration date and lot number are printed on each container label 14 weeks
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2-11
2 Specifications
Standard C For calibration of sodium, potassium, ionized calcium and lithium in the 9180 Electrolyte Analyzer. Contents:
85 mL
Active ingredients:
Na +
150 mmol/L
K+
5.0 mmol/L
-
115 mmol/L
Ca 2+
0.9 mmol/L
Cl
+
Additives: Storage temperature: Stability: On-board stability:
1.4 mmol/L Li Germicides 15 - 30 °C Expiration date and lot number are printed on each container label 14 weeks
Reference Solution A salt bridge for calibration and measurement in the 9180 Electrolyte Analyzer. Contents: Active ingredients: Additives: Storage temperature: Stability: On-board stability:
85 mL Potassium chloride 1.2 mmol/L Germicides 15 - 30 °C Expiration date and lot number are printed on each container label 14 weeks
On-board stability refers to the SnapPak installed in the analyzer. The SnapPak has to be exchanged at the latest after 14 weeks. Dispose of the SnapPak according to local regulations (hazardous waste!). Use of calibration solutions, electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee. A waste container is provided with the SnapPak which, when used, holds human body fluids which may be potentially infectious; handle with appropriate care to avoid skin contact or ingestion.
2-12
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2 Specifications
Urine diluent For use as a diluent for the measurement of urine samples in the 9180 Electrolyte Analyzer. Contents: Active ingredients: Additives: Storage temperature: Stability:
Each dispensing bottle contains 500 mL of solution Sodium chloride 120 mmol/L Germicides 5 - 30 °C Expiration date and lot number are printed on each container label
QC material ISETROL Electrolyte Control Storage conditions in original packaging
Temperature ............................
15 to 30 °C
Transportation conditions in original packaging
Temperature ............................
2 to 30 °C 2 to 45 °C < 5 days
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
2-13
2 Specifications
2.12 Product data 2.12.1 Electrical data Mains voltage range ..................... 100 to 240 VAC Frequency .................................... 50/60 Hz Required power ........................... 50 W Main fuse .................................... 1.6 A (slow blow) (2 pcs.)
2.12.2 Classification Safety Category ............................ I Overvoltage category ................... II Contamination level .................... 2
2.12.3 Dimensions Height ......................................... 33.5 cm Width .......................................... 31.5 cm Depth .......................................... 29.5 cm Weight ........................................ < 6 kg
2.13 Printer Type ........................................ thermal printer Resolution ............................... 16 characters / line Printing speed ......................... 4 mm / sec. Paper width ............................. 38 mm Paper length ............................ about 30 m
2.14 Display Type ........................................ monochrome LCD Resolution ............................... 2 lines, 16 characters per line
2-14
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3 Measurement
3 Measurement 3.1 Preanalytics ...................................................................................................................... 3-1 3.1.1
Sample collection ..........................................................................................................................................3-1 Safety ..................................................................................................................................................................................3-1 Sample requirements ....................................................................................................................................................3-1 Acceptable anticoagulants .........................................................................................................................................3-1 Sample collection containers ....................................................................................................................................3-2
3.1.2
Sample handling............................................................................................................................................3-2 Whole blood .....................................................................................................................................................................3-2 Serum .................................................................................................................................................................................3-2 Plasma ................................................................................................................................................................................3-2 Aqueous solutions .........................................................................................................................................................3-3 Dialysate ............................................................................................................................................................................3-3
3.2 Limitations of clinical analysis ..................................................................................... 3-3 3.2.1
General ..............................................................................................................................................................3-3
3.2.2
Electrolytes.......................................................................................................................................................3-3
3.3 Measuring procedure .................................................................................................... 3-4 3.3.1
Sample measurement..................................................................................................................................3-4
3.3.2
Direct ISE ..........................................................................................................................................................3-6
3.3.3
Dialysate samples..........................................................................................................................................3-6
3.3.4
Urine samples.................................................................................................................................................3-7
3.4 Normal ranges ................................................................................................................. 3-8 3.5 Correlation factors .......................................................................................................... 3-8 3.6 Additional settings ........................................................................................................ 3-10 3.6.1
Printer settings ............................................................................................................................................ 3-10
3.6.2
Interface settings........................................................................................................................................ 3-11
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3-I
3 Measurement
3-II
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3 Measurement
3
Measurement
3.1
Preanalytics
3.1.1 Sample collection Safety Follow the usual applicable safety precautions when drawing blood samples. When handling blood samples, there always exists the danger of transmission of HIV, hepatitis B and C viruses or other pathogens transmissible by blood. Employ suitable blood sampling techniques in order to reduce risk to personnel. Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if necessary mouth protectors, must be worn to prevent direct contact with biological working materials. In addition, a face mask is required if there is a risk. Please refer to NCCLS document M29-A2, "Protection of Laboratory Workers from Occupationally Acquired Infections", Approved Guidelines - Second Edition 2001, for further information on safe handling of specimens.
Sample requirements Only qualified personnel may perform the collection of blood needed for analytical purposes. 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. See, for example, NCCLS document H11-A3, "Procedures for the collection of arterial blood specimens – Third Edition", Approved Standard, 1999, for detailed information about blood sampling, storage, and handling.
Acceptable anticoagulants The only clot inhibitors that may be used for analyses in the 9180 Electrolyte Analyzer are heparin salts. Other clot inhibitors, such as EDTA, citrate, oxalate, fluoride, and ammonium-based materials have significant influence on parameters and may not be used for this reason. Use only lithium-free sampling containers for the determination of lithium measurement values! If sample containers are used which contain lithium as an anticoagulant, this may lead to incorrect patient measurements, which may result in incorrect clinical decisions, possibly endangering the patient's health.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3-1
3 Measurement
Sample collection containers TIP: When possible, use the sample collection systems manufactured by Roche Diagnostics. The 9180 Electrolyte Analyzer will accept samples directly from syringes, collection tubes, sample cups and, with the use of an adapter, from capillary tubes or the Roche MICROSAMPLER 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, this may lead to incorrect patient measurements, which may result in incorrect clinical decisions, possibly endangering the patient's health. Do not use sampling containers containing silicone!
3.1.2 Sample handling For ionized calcium values, anaerobic conditions must be followed for all sample types. Contact with ambient air will cause a loss of CO 2 in the sample and the subsequent rise in pH will cause a reduction in ionized calcium. Whole blood Withdraw whole blood samples using heparinized syringes, capillaries, or the microsampler. Analyze the samples as soon as possible after sampling. Remove air bubbles from the sample collection container immediately after the sampling procedure. If brief storage is required, do not cool the sample as the erythrocytes could burst and release the intracellular potassium, creating an inaccurate potassium value in the sample. Serum After the appearance of spontaneous clotting, process the sample in a centrifuge to separate the cellular, solid components and the fibrin from the watery serum. Transfer the serum to a suitable sample container and seal. If it is necessary to store the sample, close the sample container tightly and cool it to 4 - 8 °C. If a sample has been cooled, warm it to room temperature (15 - 33 °C) before analysis. Plasma Plasma samples are obtained by centrifuging heparinized whole blood, during which the cellular components of the blood are removed from plasma. Complete the analysis as quickly as possible. If it is necessary to store the sample, close the sample container tightly and cool it to 4 8 °C. If a sample has been cooled, warm it to room temperature (15 - 33 °C) before analysis. Plasma samples older than 1 hour must be re-centrifuged in order to remove fibrin clumps that may have formed.
1. is a trademark of Roche!
3-2
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3 Measurement
Each laboratory should determine the acceptability of its own blood collection syringes, capillaries and tubes and the serum or plasma separation products. Variations in these products exist between manufacturers, and at times, from lot to lot.
Aqueous solutions Aqueous samples, such as Standard A, have to be measured in the Standard Mode. The Standard Mode ALWAYS reports direct ISE values and is not affected by correlation factors or the setting of QCC (see chapter 6.3: "Service codes").
Dialysate Either acetate or bicarbonate dialysate fluids may be analyzed. Dialysate samples can be stored longer than whole blood, though preferably capped and placed in the refrigerator. Prior to measurement, always bring the sample to room temperature. If lithium is activated, the dialysate mode is not available.
3.2
Limitations of clinical analysis The determined performance data can be influenced by known and unknown factors as described below.
3.2.1 General The literature lists various substances which may negatively impact upon the measurement result of the blood and plasma/serum sample material. A detailed discussion of these phenomena can be found at different places in the technical literature. With respect to the 9180 Electrolyte Analyzer, an attempt was made to identify or evaluate these possible influences. But since it is not possible to check all medication or substances, 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, if necessary.
3.2.2 Electrolytes It is well-known, for example, that the potassium value of a patient can vary by up to 20 % from the normal state, simply because of the presence of a pressure bandage. Hence, taking a blood sample while a pressure bandage is present should be avoided. In general, a local hemolysis caused by pressure should be avoided prior to taking a blood sample.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3-3
3 Measurement
3.3
Measuring procedure QC measurements must be performed in their entirety (i.e., all three QC levels must be measured). Omitting QC measurements or ignoring QC measurement results may lead to incorrect patient measurements, which may result in incorrect clinical decisions, possibly endangering the patient's health. In order to ensure the quality of the measurement results, complete a quality control test on 3 levels (low, normal, 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 (low, normal, 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.
3.3.1 Sample measurement The 9180 Electrolyte Analyzer provides fast and easy operation. Whenever [READY] appears, the analyzer is ready to perform sample measurements. It is very important that the main door is closed during sampling to provide shielding from sources of electromagnetic interference. Urine samples require dilution, and must be analyzed in the urine mode. Instructions for analyzing urine samples: see chapter 3.3.4: "Urine samples". •
Open the sample door. The prompt [Introduce Sample] will be displayed and the pump will start to aspirate.
Fig. 3-1
It is very important that the main door be closed during sampling to provide shielding from sources of electromagnetic interference.
3-4
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3 Measurement
• •
Hold the ampoule under the probe until [Wipe Probe Close Sample Door] is displayed. Use a lint-free tissue to clean the probe, then close the sample door when prompted.
Fig. 3-2
It is very important that the sample probe is carefully cleaned each time following a sample introduction. The analyzer will display [Thank You!] and a brief countdown will begin. At completion of analysis, the test results will be displayed and printed. Na K Cl 143.9 4.93 103.5
- ROCHE 9180 ELECTROLYTE ISE NA-K-CL HOSPITAL WEST Name: .......... .......... Sample: STANDARD Sample No.28 Na=143.9 K = 4.93 Cl=103.1
Fig. 3-3
mmol/L mmol/L mmol/L
Fig. 3-4
Values that are higher or lower than the programmed normal range will be indicated by an arrow pointing up or down. If the Na+ result is above 180 mmol/L (above 169.5 mmol/L for blood/serum) or below 95 mmol/L (below 89.6 mmol/L for blood/serum), the Li+ value cannot be derived.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3-5
3 Measurement
If an additional sample report is desired or the automatic sample report is turned off, the results may be printed by following these steps: • • • • • • •
Press NO. The prompt [PRINT FUNCTIONS?] appears. Press YES . The prompt [Print last Sample Report?] is displayed. Press YES . The measurement results will be displayed, and the report will print. The analyzer returns to [READY] .
3.3.2 Direct I S E •
Press NO until [QC/STD/DIALYSATE URINE SAMPLE?] appears; press YES and then NO, until [Standard Sample?] is displayed. Press YES to confirm. The Standard Mode ALWAYS reports direct ISE values and is not affected by correlation factors or the setting of QCC (see chapter 6.3: "Service codes").
3.3.3 Dialysate samples Dialysate samples are measured in the dialysate mode. In the default analyzer setting, the dialysate mode provides measurements identical to those performed in the standard mode. Separate correlation factors for bicarbonate and acetate permit optimization of absolute measurement, which may be necessary for certain dialysate compositions (see chapter 3: "Correlation factors"). To enter the dialysate mode: • •
Press NO, until [QC/STD/DIALYSATE/URINE SAMPLE?] appears. Press YES . Press NO, until [Bicarbonate Sample?] or [Acetate Sample?] appears. If lithium is selected, the dialysate mode is not available.
Due to interfering substances inherent in some dialysate solutions, it may be necessary to establish correlation factors to obtain correct results.
3-6
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3 Measurement
3.3.4 Urine samples Before measuring urine, accurately dilute the sample with Urine Diluent in the ratio of 1 part urine to 2 parts diluent (e.g., 1 mL urine and 2 mL urine diluent). Thoroughly mix the sample and analyze in the urine mode. 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 . Press NO, until [Urine Sample?] is displayed. Press YES and follow the instructions. Upon completion of measurement, the analyzer will display and print the results. Na 263
Fig. 3-5
K 18.3
Cl 118
- ROCHE 9180 ELECTROLYTE ISE NA-K-CL HOSPITAL WEST
- ROCHE 9180 ELECTROLYTE ISE NA-K-CL HOSPITAL WEST
Name: .......... .......... Sample: URINE
Name: .......... .......... Sample: URINE
Sample No.29
Sample No.30
Na=263 K = 18.3 Cl=118
Na=142 K = ↑↑↑ Cl=156
Fig. 3-6
mmol/L mmol/L mmol/L
mmol/L mmol/L mmol/L
Fig. 3-7
Ca 2+ and Li + are not measured in urine. If the result of the urine sample is given with ↑↑↑↑ the K + value of the sample is higher than 60 mmol/L, and outside the measurement range of the analyzer. The measurement must be repeated using the following procedure:
• • • • • •
Record the Na + value (as well as Cl - , if activated) of the first urine measurement. Dilute the diluted urine (already diluted 1:2 with urine diluent) with distilled water in the ratio of 1:1 (e.g., 1 mL of diluted urine and 1 mL distilled water). Thoroughly mix the sample. Run a second urine measurement with the twice-diluted urine sample. Ignore the Na + value (and Cl - , if activated). Multiply the K + value by 2 and record.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3-7
3 Measurement
3.4
Normal ranges 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. The correlation factors can be changed through the programming menu. Follow the instructions for [PROGRAM INSTRUMENT?] in chapter 4.2 and enter the password. • •
Press NO until [Program Normal Ranges?] is displayed. Press YES . 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 : Press NO until the desired number is displayed, and press YES to advance to the next position. Repeat this for all numbers of the normal range. After entering the normal ranges, the new values will be displayed. Verify correctness of the ranges: Na low =xxx Na high=xxx
ok?
TIP: If an incorrect number was entered inadvertently, press NO , and the analyzer allows the operator to retype the normal range. •
Press YES and the display will advance to the next parameter.
Repeat the above procedure for all parameters. After all activated parameters have been programmed, the display prompts [Program Corr Factors?] . This allows programming the correlation factors.
3.5
Correlation factors The correlation factors allow to correlate the measurement results of the 9180 Electrolyte Analyzer to other electrolyte analyzers. Activated correlation values are taken into consideration when sampling whole blood, serum, plasma and QC samples. They are not used for standard samples analyzed in the [QC/STD/DIALYSATE/URINE SAMPLE] mode. A separate set of correlation factors is available for dialysate and urine samples. In case the QC samples were switched to report direct ISE values (Code QCC, see 'Service Codes'), the values are NOT affected by correlation factors. The measurement range as well as normal and QC ranges are ALWAYS checked against the DISPLAYED values. Therefore, you may have to adjust the QC and normal ranges to your correlation factors. The correlation factors can be changed through the programming menu. Follow the instructions for [PROGRAM INSTRUMENT?] in chapter 4.2 and enter the password.
3-8
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3 Measurement
• • •
Press NO, until [Program Corr. Factors?] is displayed. Press YES , the analyzer prompts [Reset Correlat. Factor(Default)?] . Pressing YES deletes all current correlation factors. The analyzer will then advance to the other correlation programming functions. Pressing NO shows the prompt [Input/Verify Corr Factors?] and allows the operator to input or to verify correlation factors for each parameter. 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.
The current values will be displayed, such as: Na(b) = +00.0 Na(m) = 1.000ok? • •
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. The programmed factors are automatically applied to blood/serum and QC samples.
Follow the same procedure for the intercept (b) and slope (m) for K + , Cl - , Ca 2+ and Li + . Only activated parameters can be programmed. If Na + /K + , Na + /K + /Cl - , or Na + /K + /Ca 2+ are activated, a separate set of bicarbonate and acetate correlation factors can be programmed: • •
At the prompt [Program Bicarb. Corr Factors?] and/or [Program Acetate Corr Factors?] , press YES . Program these factors as described above.
The programmed factors are automatically applied to acetate and bicarbonate measurements. A separate set of correlation factors is available for urine samples. • •
At the prompt [Program Urine Corr Factors?] , press YES . Program the factors as described above.
Note that there are no urine correlation factors available for Ca 2+ and Li + , since these parameters are not measured in urine mode.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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3 Measurement
3.6
Additional settings
3.6.1 Printer settings The 9180 Electrolyte Analyzer allows easy programming of printer settings by the operator for printing automatic measurement and calibration reports. With factory settings, a measurement report is printed automatically after each measurement, a calibration report is not printed automatically. These settings can be changed in the programming menu. •
Press NO, until [Program Instrument?] is displayed. Press YES . For safety and security, the analyzer can only be programmed or have existing parameters changed by entering the correct password.
The analyzer prompts [Enter Code: AAA] . The code " KEY " has to be entered as follows: • • • • •
Press Press Press Press Press
NO, until the character K appears. YES and the cursor will advance to the second position. NO, until the character E appears. YES and the cursor will advance to the last position. NO, until Y appears.
TIP: If the desired character was missed, keep pressing the NO key until the correct character appears. • • •
•
•
If the code was entered correctly, press the YES key. Press NO, until [Program Printer Setup?] is displayed. Press YES , until [Patient Report off?] is displayed. - Press YES to deactivate the automatic measurement report. The programming advances to the settings for the calibration report. - Press NO to automatically print a measurement report after each measurement. [Print two Patient Reports?] is displayed. - Press YES to print two measurement reports after each measurement. - Press NO to print one measurement report after each measurement. [Automatic Cal Report?] is displayed. - Press YES to automatically print a calibration report after each calibration. - Press NO to deactivate the automatic calibration 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?] . • • • •
3-10
The analyzer displays [Enter Comment Line?] . This setting allows the operator to enter a comment (one line up to 16 characters) which will be printed on each report. Press YES , [Enter Comment:] is displayed. 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 characters.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
3 Measurement
3.6.2 Interface settings The 9180 Electrolyte Analyzer can be interfaced with a COMPACT 2 blood gas analyzer to combine ISE measurement results with pH and blood gas measurement results on one measurement report. For this, the optional Interface Kit is required. If Ca 2+ is activated on the 9180 Electrolyte Analyzer, a pH-corrected Ca 2+ value will be calculated and printed on the combined measurement report. •
Press NO, until [Program Instrument?] is displayed. Press YES . For safety and security, the analyzer can only be programmed or have existing parameters changed by entering the correct password.
The analyzer prompts [Enter Code: AAA] . The code " KEY " has to be entered as follows: • • • • •
Press Press Press Press Press
NO, until the character K appears. YES and the cursor will advance to the second position. NO, until the character E appears. YES and the cursor will advance to the last position. NO, until Y appears.
TIP: If the desired character was missed, keep pressing the NO key until the correct character appears. • • • •
If the code was entered correctly, press the YES key. Press NO, until [Program Interface?] is displayed. Press YES . The prompt [Activate Data Link?] is displayed. Press YES , if the 9180 Electrolyte Analyzer is to be connected to a COMPACT 2.
Connect the 9180 Electrolyte Analyzer with the COMPACT 2: • • •
Shut down both analyzers and remove the power cord. Connect the interface filter provided in the interface kit to the interface of the 9180 Electrolyte Analyzer. Connect one end of the cable to the interface filter, connect the other end to the COM2 interface of the COMPACT 2.
Perform settings on the COMPACT 2: • •
In the menu of the COMPACT 2, change to the [Interface] menu and select [COM2] . For details, see Instructions for Use of the COMPACT 2. Select the [9180] option.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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3-12
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
4 Quality control
4 Quality control 4.1 General QC concept ....................................................................................................... 4-1 4.2 Material setup .................................................................................................................. 4-2 4.3 Performing a QC measurement ................................................................................... 4-4 4.4 Printing a QC report ........................................................................................................ 4-5
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4 Quality control
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Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
4 Quality control
4
Quality control QC measurements must be performed in their entirety (i.e., all three QC levels must be measured). Omitting QC measurements or ignoring QC measurement results may lead to incorrect patient measurements, which may result in incorrect clinical decisions, possibly endangering the patient's health.
4.1
General QC concept Roche Diagnostics always strives to ensure the highest quality standards for its products. This quality awareness is the result of a sense of responsibility toward the customer and the well-being of the patient. Quality control is an important element of this claim. 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. In order to ensure the quality of the measurement results, complete a quality control test on three levels (low, normal, 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 (low, normal, 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. The following control material is recommended: •
ISETROL
The target values listed in the package insert sheet should be taken as 2 SD values (SD = standard deviation). The QC measurement results within the target value range ± 2SD are acceptable. If QC measurement results fall outside the target value range ± 3SD, the parameter must not be used for further measurements! QC measurement results that are greater than the target value ± 2SD, but less than the target value ± 3SD, must be treated accordingly.
Use of calibration solutions, electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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4 Quality control
4.2
Material setup TIP: Lot number, date of expiration, sample type and normal ranges from the text included in the recommended QC material. The QC material must be defined prior to the QC measurement. •
Starting from the [READY] screen, press NO, until the prompt [PROGRAM INSTRUMENT?] appears, and select with YES . For safety and security, the analyzer can only be programmed or have existing parameters changed by entering the correct password.
The analyzer prompts [Enter Code: AAA] . The code " KEY " has to be entered as follows: • • • • •
Press Press Press Press Press
NO, until the character K appears. YES and the cursor will advance to the second position. NO, until the character E appears. YES and the cursor will advance to the last position. NO, until Y appears.
TIP: If the desired character was missed, keep pressing the NO key until the correct character appears. •
If the code has been entered correctly, press YES . The analyzer is ready for programming and the display reads [Program QC Level 1 Ranges?] .
TIP: If a wrong code is entered accidentally, the following display appears: [CODE ERROR! RETRY?] . Press YES , and the system returns to the prompt [Enter Code:] . To exit this menu, press NO . If the pack of ISETROL electrolyte control is new, enter the lot number and the target ranges into the analyzer. Each level has its own lot number which can be found on the information sheet enclosed with the ISETROL pack. The ISETROL electrolyte control is made specifically for use in the 9180 electrolyte analyzer. To ensure the accuracy of the analyzer, only ISETROL should be used for quality control. • •
To enter the lot number, go to the display [Program QC Level 1 Ranges?] and press YES . The analyzer display reads [Current Lot:xxxx Change Lot #?]
TIP: When a lot number is entered for the first time, the analyzer shows a preset lot number which still has to be changed. If the current lot information does not have to be changed and only the programmed QC ranges need to be verified, press NO . • • •
4-2
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. Press NO. The display [NEW LOT! Delete old Data?] appears.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
4 Quality control
If this function is selected, all statistical data saved for this QC lot will be deleted automatically. • • •
Press YES to display [Enter last 4 Dig of Lot: xxxx] . Enter the new lot number. Press NO until the desired number is displayed above the cursor and move to the next digit with YES . Repeat this process for all 4 digits. After entering the lot number, check the correctness of the entry and confirm with YES .
TIP: If an incorrect lot number is entered, press NO to return to the prompt [Enter last 4 Dig of Lot: xxxx] . The analyzer now shows the upper and lower ranges of the QC level parameters, e.g.:
• •
•
Na low
=
040
Na high
=
205
Press YES to display the next parameter range. After all activated parameters have been programmed, the following display appears: [Additional Parameters?] . This option can also be used to program the deactivated parameters. Programming of QC Level 1 is complete after all ranges have been displayed.
Repeat this process for QC Level 2 and QC Level 3. After programming of QC Level 3 has been completed, the prompt [Program Normal Ranges?] is displayed. This programming function allows the normal ranges to be set individually. The analyzer uses these normal ranges to mark abnormal patient data, both on the display and on the printed log (see chapter 8.1.2: "QC report").
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4 Quality control
4.3
Performing a QC measurement In order to ensure the quality of the measurement results, complete a quality control test on 3 levels (low, normal, 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 (low, normal, 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. TIP: Up to 35 QC measurements can be stored per level. The values can be stored and the statistics be printed at any time. ISETROL should be stored at 15 - 30 °C and brought to room temperature before use. It is very important that the main door be closed during sampling, since it provides shielding from sources of electromagnetic interference. • •
Starting from the [READY] screen, press NO until [QC/STD/DIALYSATE/URINE SAMPLE?] appears. Press YES , [QC Level 1 Sample?] will be displayed. Press YES .
The prompt [Open Sample Door Introduce Sample] will be displayed. • • •
Take a Level 1 ampoule from the ISETROL box and mix it carefully. Gently tap the head of the ampoule with the fingernail to remove any liquid. Carefully open the ampoule by breaking off the top. Protect fingers by using gloves and tissue while breaking ampoule.
•
Open the sample door: The prompt [Introduce Sample] appears.
TIP: Introduce the QC material directly from the ampoule! • •
Hold the ampoule under the probe until [Wipe Probe/Close Sample Door] is displayed. Use a lint-free tissue to clean the probe, then close the sample door. It is very important that the sample probe be carefully cleaned each time following a sample introduction.
•
4-4
The instrument will display [QC Level 1 in progress] and a countdown will begin, during which the QC will be analyzed. Upon completion, the results will be briefly displayed, such as: Na
K
↓Cl
125.1
3.05
77.8
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
4 Quality control
The 9180 Electrolyte Analyzer “flags” values that are above or below the programmed target ranges by using an “up” or “down” arrow. • •
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?] display, allowing to repeat the QC Level 1 measurement by pressing YES , or to skip to QC Level 2. In case the value is outside the measurement range (↑↑↑↑, ↓↓↓↓ or ERR ), it will automatically be rejected.
If the values have been saved, [Values Accepted!] will be displayed shortly, followed by the prompt [QC Level 2 Sample?] . For further QC measurements (Level 2 and Level 3), follow the outlined instructions for Level 1, being sure to use a Level 2 or Level 3 ISETROL. TIP: To discontinue QC measurement, press the NO key, until [READY] is displayed. At completion of QC Level 3 measurement, the analyzer prompts [Remain in QC/Std./ Urine Sample?] . If measurements for all levels have been completed, press NO and the analyzer returns to the [READY] display. TIP: Responding YES to the [Remain in QC/Std./Urine Sample?] prompt, the analyzer returns to [QC Level 1 Sample?] .
4.4
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. •
• •
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 . Press NO twice, [Print QC Values and Statistics?] appears. Press YES , the analyzer will print all QC values grouped by level.
After printing, the analyzer will return to [READY] . If correlation factors are changed or QC values switched to direct ISE, ALL values in memory are recalculated and printed per the new setting.
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4 Quality control
4-6
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
5 Maintenance
5 Maintenance 5.1 Decontamination ............................................................................................................. 5-1 5.1.1
Decontamination ...........................................................................................................................................5-1 Sample probe mechanism ..........................................................................................................................................5-1 Surfaces of the instrument .........................................................................................................................................5-1 Recommended disinfectants .....................................................................................................................................5-2
5.2 Daily maintenance .......................................................................................................... 5-2 5.3 Weekly maintenance ...................................................................................................... 5-4 5.3.1
Clean sample probe and fill port .............................................................................................................5-4
5.3.2
Cleaning analyzer surfaces........................................................................................................................5-4
5.4 Monthly maintenance .................................................................................................... 5-5 5.4.1
Cleaning the reference electrode housing ..........................................................................................5-5
5.5 Semi annual maintenance ............................................................................................ 5-8 5.5.1
Exchanging the pump tubing set ............................................................................................................5-8
5.6 Annual maintenance ...................................................................................................... 5-9 5.6.1
Exchanging main tubing harness............................................................................................................5-9
5.7 Unscheduled maintenance ......................................................................................... 5-10 5.7.1
Replacing electrodes................................................................................................................................. 5-10
5.7.2
Checking reagent fluid level and changing the SnapPak........................................................... 5-12
5.7.3
Replacing sample probe and fill port.................................................................................................. 5-13
5.7.4
Replacing printer paper ........................................................................................................................... 5-14
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
5 Maintenance
5
Maintenance After use, components of the 9180 Electrolyte Analyzer, including tubing, fill port, SnapPak etc., contain biological fluids and therefore represents a possible infectious risk. Handle these components with care and according to regulations surrounding potentially infectious materials. Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if necessary mouth protectors, must be worn to prevent direct contact with biological working materials. In addition, a face mask is required if there is a risk of splashes. Suitable disinfection and sterilization procedures must be applied.
5.1
Decontamination
5.1.1 Decontamination The purpose of this procedure is to minimize the risk of infections when replacing items that were in contact with blood. Perform these decontamination procedures regularly. Never use alcohol based disinfectants! Never use disinfectant sprays. IMPORTANT: Do not attempt to decontaminate any part of the instrument before shutting it down and unplugging it from the power source. Before plugging the instrument back in and turning it on, always wait 15 minutes to allow the disinfectant to evaporate. Regularly decontaminate the following parts of the instrument: • • •
Sample probe mechanism consisting of sample probe and fill port Surfaces of the instrument All areas which can become contaminated with biological liquids and therefore pose a potential infection hazard
Sample probe mechanism See “Clean sample probe and fill port” on page 5-4.
Surfaces of the instrument See “Cleaning analyzer surfaces” on page 5-4.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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5 Maintenance
Recommended disinfectants Surfaces
Protein remover (Roche deproteinizer) •
•
5.2
Potential dangers Due to the alkaline and oxidizing character of this preparation, local irritation to the skin, eyes, and mucous membranes is possible. First Aid measures After inhalation: breath fresh air, drink large amounts of water After skin contact: wash with generous amounts of water, remove contaminated clothing. After eye contact: rinse eyes with generous amounts of water, contact an eye doctor After drinking: drink large amounts of water, avoid vomiting, contact a doctor.
Daily maintenance Prior to running the first sample of the day, the 9180 Electrolyte Analyzer needs to undergo a simple cleaning and conditioning procedure that helps ensure the unit will perform properly. This procedure is called "daily maintenance" because it must be performed once each day the analyzer is used to conduct testing. In case cleaning and/or conditioning has not been performed within the last 24 hours, the analyzer will automatically print on each sample report [Perform Daily Maintenance!] . TIP: If fewer than 5 samples are analyzed each day, cleaning should be performed once a week instead of daily (see "Weekly maintenance").
• •
•
5-2
Press the NO key, until [DAILY MAINTENANCE?] is displayed, and YES to select. Select [Perform Daily Cleaning?] by pressing YES . At the prompt [Open Sample Door Introduce Sample] , pour a small amount of Cleaning Solution A into a clean container. Lift the sample door and the pump will begin to aspirate. Hold the Cleaning Solution A under the probe until [Wipe Probe/Close Sample Door] is displayed, and use a lint-free tissue to remove the cleaning solution from the probe. Close the sample door.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
5 Maintenance
Fig. 5-1
• • • •
•
Fig. 5-2
While the analyzer displays [Thank You!] and a brief countdown, pour a small amount of conditioning solution into a clean container. At the prompt [Perform Daily Conditioning?] , press YES . At the prompt [Open Sample Door Introduce Sample] , lift the sample door and the pump will begin to aspirate. Hold the conditioning solution under the probe until [Wipe Probe/Close Sample Door] is displayed, use a lint-free tissue to remove the conditioning solution from the probe. Close the sample door. After the analyzer displays [Thank You!] and a brief countdown, press NO at the prompt [Remain in Daily Maintenance?] . An automatic calibration will be started.
It is very important that the main door be closed during calibration, since it provides shielding from sources of electromagnetic interference. Wipe the sample probe from top to bottom in order to avoid injury.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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5 Maintenance
5.3
Weekly maintenance At least on a weekly basis, and additionally as needed, you should clean the sample fill port and sample probe as well as the exterior analyzer surfaces.
5.3.1 Clean sample probe and fill port Starting from the [READY] screen, perform the following actions: • • • •
Open the sample door. Clean the fill port, probe and surrounding area with a damp cotton swab. If the analyzer attempts to perform sample analysis, [NO SAMPLE] will be briefly displayed, and it will return to the [READY] screen. The exterior surfaces should be wiped clean with a soft, damp cloth. Never use strong or abrasive cleaners and no cleaners containing alcohol on the 9180 Electrolyte Analyzer. Use a slightly damp cloth to avoid getting fluid inside the analyzer.
Fig. 5-3
5.3.2 Cleaning analyzer surfaces Never use alcohol based disinfectants! Never use disinfectant sprays. IMPORTANT: Do not attempt to decontaminate any part of the instrument before shutting it down and unplugging it from the power source. Before plugging the instrument back in and turning it on, always wait 15 minutes to allow the disinfectant to evaporate. •
•
Regularly, according to the lab-specific regulations, decontaminate the surfaces of the analyzer including the front door with an undiluted disinfectant (Deproteinizer). Use swabs or cellulose that have been soaked with Deproteinizer. The minimum deproteinizing disinfection contact time of 15 minutes is to be strictly followed. Very dirty surfaces (e.g., contaminated with blood) should first be cleaned with swabs or cellulose that have been soaked with Deproteinizer disinfectant. If the grooves in the front door or the areas around the measuring chamber window are concerned, use a small commercial plastic brush to clean them. All visible impurities are to be removed. Subsequently, the deproteinizing disinfection procedure takes place as described above. Dispose of used disinfectants according to applicable regulations (hazardous waste!).
5-4
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
5 Maintenance
5.4
Monthly maintenance
5.4.1 Cleaning the reference electrode housing Monthly maintenance involves cleaning the reference electrode housing, and should be performed prior to daily maintenance. To complete this procedure, a small amount of deproteinizer is needed. • • • • •
From the [READY] screen, press NO to access [DAILY MAINTENANCE?] . Press YES , the prompt [Perform Daily Cleaning?] appears. Do not press any keys. Open the front cover of the analyzer. Release the tubing of the reference electrode from the receptacle below the left side of the measuring chamber.
Fig. 5-4
• •
Slide the measuring chamber forward until it locks in the front position. Unclamp the left electrode holder by moving the clamp forward.
Fig. 5-5
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
Fig. 5-6
5-5
5 Maintenance
• •
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.
Fig. 5-7
TIP: The reference solution can be taken from the reference electrode housing. It is important that reference electrode always be stored in reference solution and never allowed to dry. •
Pour deproteinizer solution into a small container and submerge the reference housing into it, ensuring that no air bubbles remain in the housing.
The reference connector and tubing do not need to be submerged.
• • • •
After 15 minutes, remove the reference housing from the deproteinizer. Thoroughly rinse the housing with tap water and dry. 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. Close the clamp on the left electrode holder by lifting it until it locks in the back position. Ensure the electrodes are seated properly.
Fig. 5-8
5-6
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
5 Maintenance
• •
Plug the tubing of the reference electrode into the receptacle below the left side of the measuring chamber. Slide the measuring chamber back until it snaps into position, and close the front cover of the analyzer.
Fig. 5-9
• •
Fig. 5-10
At this time, you may perform daily maintenance by pressing YES . If daily maintenance is not needed, press NO until [CALIBRATION?] is displayed. Press YES and a complete calibration cycle will be performed. In order to ensure the quality of the measurement results, complete a quality control test on 3 levels (low, normal, 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 (low, normal, 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.
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5 Maintenance
5.5
Semi annual maintenance
5.5.1 Exchanging the pump tubing set To make sure that the pump does not turn on during this procedure, press NO until [DAILY MAINTENANCE?] is displayed. Press YES and [Perform Daily Cleaning?] will appear. Then, do not press any keys. When changing the pump tubing set, proceed as follows: • •
Remove the front cover and slip the two pump windings from the pump rollers. 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.
Fig. 5-11 • •
Fig. 5-12
Install the new pump winding plate and slip the new pump windings over the pump rollers, being careful not to cross the tubes. Press NO until [CALIBRATION?] is displayed. Press YES to initiate a calibration cycle.
Dispose of the pump tubing set according to applicable regulations (hazardous waste!). In order to ensure the quality of the measurement results, complete a quality control test on 3 levels (low, normal, 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 (low, normal, 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.
5-8
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
5 Maintenance
5.6
Annual maintenance
5.6.1 Exchanging main tubing harness Once a year or as needed, the main tubing harness should be replaced. Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if necessary mouth protectors, must be worn to prevent direct contact with biological working materials. In addition, a face mask is required if there is a risk of splashes. Suitable disinfection and sterilization procedures must be applied. • • • •
At the [READY] screen press NO, until [SERVICE FUNCTIONS?] appears, and press YES . Press NO, until [Test Pinch Valves?] appears. Press YES . Remove the valve caps, sliding them in the direction of the arrow. Then remove the pinch bars.
TIP: Each valve consists of the solenoid coil inside the analyzer, the pinch bar and the valve cap. For further details concerning the position of the valves, see tubing diagram inside the front door. • • • • •
• •
Disconnect the reference electrode and pull out the white reference electrode receptacle. Disconnect the tubing with the green band from the left side electrode holder. Open the sample flap and pull out the fill port. Remove the SnapPak and slide out the white SnapPak receptacle. Disconnect the tubes from the pump winding plate and pull out the tubing harness. Re-install the new main harness in reverse order, use the tubing diagram in the front door as a guide for installation. Take special care to reconnect the tubes to the correct nipples of the pump winding. Activate each valve by pressing YES , then slide the pinch bar on and snap on the valve cap in the direction of the arrow. Press NO to activate the next valve. Notice the text on the display.
TIP: It may be necessary to pull on the metal tip of the valve in order to put the valve cap into position. Dispose of the main tubing harness according to applicable regulations (hazardous waste!). 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 5.7.3: Replacing sample probe and fill port). • •
Press NO until [CALIBRATION?] is displayed. Press YES to start a calibration.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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5 Maintenance
In order to ensure the quality of the measurement results, complete a quality control test on 3 levels (low, normal, 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 (low, normal, high) (i.e,. 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.
5.7
Unscheduled maintenance
5.7.1 Replacing electrodes • •
Slide the measuring chamber forward until it locks in the front position. Unclamp the left electrode holder by moving the clamp forward.
Fig. 5-13
•
Fig. 5-14
Remove the used electrode from the measuring chamber.
Fig. 5-15
• •
5-10
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 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.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
5 Maintenance
Fig. 5-16 • •
Fig. 5-17
Close the clamp on the left electrode holder by lifting it until it locks in the back position. Ensure that the electrodes are seated properly. Slide the measuring chamber back until it snaps into position.
Fig. 5-18
Fig. 5-19
After installing a new electrode, the 9180 Electrolyte Analyzer needs to undergo Daily Maintenance, Calibration and QC Measurement to verify the performance of the electrode. Use of calibration solutions, electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee. Dispose of the electrodes according to applicable regulations (hazardous waste!). In order to ensure the quality of the measurement results, complete a quality control test on 3 levels (low, normal, 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 (low, normal, 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. For further information, see chapter 4: "Quality control".
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
5-11
5 Maintenance
5.7.2 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. To check the status of fluid remaining in the SnapPak: • • •
In the [READY] screen, press the NO key, until [OPERATOR FUNCTIONS?] is displayed. Press YES . The prompt [Check/Change SnapPak?] will be displayed. Press YES . The analyzer will display the amount of fluid remaining. Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if necessary mouth protectors, must be worn to prevent direct contact with biological working materials. In addition, a face mask is required if there is a risk of splashes. Suitable disinfection and sterilization procedures must be applied.
•
To change the SnapPak, just grasp the extended portion and slide it out.
Fig. 5-20
As soon as the analyzer detects that the SnapPak has been removed, the display prompts [STATUS: NO SnapPak] . In addition, the printer will print the current status of the SnapPak. Do not remove the SnapPak during a calibration or measurement procedure.
Dispose of the SnapPak according to applicable regulations (hazardous waste!). • •
Prepare the new SnapPak by carefully removing the protective strip. Save this cover to close the connectors prior to disposal of the used SnapPak. Write the installation date on the label of the new SnapPak. Use of calibration solutions, electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee. Once the protective strip is removed, be sure to keep the SnapPak upright to avoid spillage.
5-12
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
5 Maintenance
•
Slide the new SnapPak into position on the left side of the analyzer. The analyzer will prompt [New SnapPak Installed?] .
Fig. 5-21 •
•
Fig. 5-22
Press YES to indicate that a new SnapPak is installed. Again, at the prompt [Are you sure?] , press YES . The 9180 Electrolyte-Analyzer will automatically reset the SnapPak counter to 100 % and commence system calibration. Press NO if you reinstall the SnapPak that was removed. In order to ensure the quality of the measurement results, complete a quality control test on 3 levels (low, normal, 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 (low, normal, 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.
5.7.3 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 5.6.1: Exchanging main tubing harness). Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if necessary mouth protectors, must be worn to prevent direct contact with biological working materials. In addition, a face mask is required if there is a risk of splashes. Suitable disinfection and sterilization procedures must be applied. To make sure that the pump does not turn on during this procedure, press NO until [DAILY MAINTENANCE?] is displayed. Press YES and [Perform Daily Cleaning?] will appear. Then, do not press any keys. • • • •
Open the front door. Open the sample door. Remove the needle carefully (to prevent injury) from the holder. Unplug the tubing. Attach the new needle to the tubing and snap the needle back into the holder.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
5-13
5 Maintenance
Fig. 5-23
Then replace the fill port as follows: • • • • • • •
Remove the fill port holder from the sample probe mechanism. Carefully remove the fill port from the fill port holder. Unplug the tubing. Mount the new fill port into the fill port holder in the reverse order and attach the tubing. Mount the fill port holder at it’s default position. Close the sample door and the front cover. Press NO until [CALIBRATION?] will be displayed. Press YES to start the calibration. Dispose of the sample probe and the fill port according to applicable regulations (hazardous waste!).
5.7.4 Replacing printer paper TIP: The printer paper is heat sensitive on one side only. Please 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: • • • •
5-14
Open the front cover of the analyzer. Remove the remaining paper by pressing the paper feed button. Place a new paper roll in the paper tray and thread it into the feeder slot. Press the paper feed button to completely feed the paper through the printer.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
5 Maintenance
Fig. 5-24
Fig. 5-25
TIP: By pressing the paper advance button once, the paper will automatically advance 10 lines. • •
Close the front cover and tear off any excess paper. Cut the end of the roll to make a square edge.
Do not pull the paper out of the printer to avoid damage to the printer.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
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5 Maintenance
5-16
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6 Troubleshooting
6 Troubleshooting 6.1 Error messages ................................................................................................................ 6-1 6.2 Service functions ............................................................................................................ 6-7 6.2.1
Testing the electrodes .................................................................................................................................6-7 Not calibrated potassium electrode ........................................................................................................................6-8
6.2.2
Testing the sample sensor .........................................................................................................................6-8
6.2.3
Testing the SnapPak sensor......................................................................................................................6-8
6.2.4
Testing the language switch .....................................................................................................................6-9
6.2.5
Testing the sample door .............................................................................................................................6-9
6.2.6
Testing the pump ..........................................................................................................................................6-9
6.2.7
Testing the valves....................................................................................................................................... 6-10
6.2.8
Testing the interface ................................................................................................................................. 6-10
6.2.9
Testing the amplifier.................................................................................................................................. 6-10
6.2.10 Status-LEDs.................................................................................................................................................. 6-11
6.3 Service codes ................................................................................................................. 6-11 6.3.1
Entering service codes ............................................................................................................................. 6-11
6.3.2
Removing service codes .......................................................................................................................... 6-11
6.3.3
List of service codes.................................................................................................................................. 6-12
6.4 Deleting data .................................................................................................................. 6-13 6.4.1
Clearing sample count ............................................................................................................................. 6-13
6.4.2
Clearing all data.......................................................................................................................................... 6-13
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6-I
6 Troubleshooting
6-II
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6 Troubleshooting
6
Troubleshooting Your 9180 Electrolyte Analyzer is designed to provide long, trouble-free service. However, any scientific measuring device may occasionally malfunction, requiring the operator to identify the cause of the problem. The following information lists displayed messages and recommends steps that should help you return your 9180 Electrolyte Analyzer to operation. If your 9180 Electrolyte Analyzer does not perform correctly after conducting the basic steps outlined in this chapter, you should contact Roche Diagnostics for technical assistance.
6.1
Error messages Message
Cause
Action
Status: Not calibrated
Calibration has been interrupted
Perform system calibration to return the instrument to the [READY] mode
Na/K/Cl/Ca/Li not calibrated
A specific electrode could not be calibrated. Possible causes: • No stable value for Standard A • The slope A-B or A-C is outside the range (see chapter 6.2.1: "Testing the electrodes")
• Perform daily maintenance. • Check if the electrode holder is locked in the back position. • Check for leaks, blockages and air bubbles. • Clean or replace the electrode. • Check the fluid remaining in the SnapPak. If less than 5 % remains, replace the SnapPak. • Is K still not calibrated, perform external electrode test using serum or plasma (see chapter 6.2.1.1: "Not calibrated potassium electrode").
Standard A not detected
As the analyzer aspirates a sample of Standard A, the solution is detected by the sample sensor, which must detect its presence without encountering any air bubbles. If the sample sensor is unable to properly detect the presence of Standard A solution in a programmed time period, above error message will be displayed.
• Check the fluid remaining in the SnapPak. If less than 5 % remains, replace the SnapPak. • Check for clots or crystals that may have formed in the Standard A tubing or the electrode chamber. • Replace the SnapPak. • Ensure the sample sensor is securely plugged in and perform the sample sensor test to ensure that the sensor is operating correctly. If necessary, clean the sample sensor. • Replace the peristaltic pump tube set to ensure correct aspiration of Standard A.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6-1
6 Troubleshooting
6-2
Message
Cause
Action
Standard B not detected
Detection of Standard B aspiration is the same as for Standard A. If Standard A is aspirated properly, but Standard B is not detected, check Standard B tubing for crystallization. If no crystallization or leaks are found, see Action.
• Replace the SnapPak.
Standard C not detected (Li activated)
Detection of Standard C aspiration is the same as for Standard B.
• See remedy for Standard B.
Check Sample Sensor
The sample sensor is calibrated with air during each calibration. For proper functioning, the sensor must provide a reading of 80 - 120 units when air is detected. To check sample sensor response, perform the Sample Sensor Test Open the sample door and press the YES button to aspirate various fluids through the sensor. For transparent fluids (e.g. water), the reading should increase by at least 40 units. For blood samples (not transparent), the reading should decrease by at least 40 units. The pump can be stopped at any time by pressing NO.
• Clean sample sensor by using the Electrode Maintenance procedure. • Check for correct drying of the measuring chamber during the wash cycle. • Replace the peristaltic pump tube set. • Perform a calibration to remove the error message.
Check Reference Housing
When the analyzer fails to detect a flow of Reference Solution into the measuring chamber, this message will be displayed. This test is performed at the beginning of each calibration cycle.
• Check for proper filling of the reference housing. • Ensure that the reference tubing is securely connected to the receptacle. • Since this test utilizes Standard A, make sure that it is aspirated properly into the measuring chamber. If not, replace the SnapPak. • Clean the reference housing. (See chapter 5.4: "Monthly maintenance").
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6 Troubleshooting
Message
Cause
Action
Please close sample door
This message occurs when the sample door is not closed within 20 seconds after the sample is in place, or when the door has been opened and no sample is detected.
• Close the sample door within time allowed.
No sample
Under certain conditions, the analyzer may not detect the presence of a sample and an error message will occur: • 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. If you wish to abort a sample, you can do so by closing the sample door during sample aspiration.
• Repeat the sample to see if it is detected properly on a second trial. • Close the sample door within time allowed. • Check sample aspiration and look for the presence of clots in the sampling system. • Check for the presence of o-rings and for proper sealing of the electrodes. • Ensure that the sample sensor is plugged in and perform the Sample Sensor Test to verify that it is operating correctly. • Replace pump tubing.
Cleaning fluid not detected
Under certain conditions, the analyzer may not detect the presence of cleaning solution: • air bubbles in the cleaning solution • too small volume of cleaning solution • the cleaning solution not being aspirated properly through the sampling mechanism
• Check for the presence of o-rings and for proper sealing of the electrodes. • Check for aspiration of cleaning solution and look for presence of clots in the sampling system. • Check for the proper sealing of the pump windings. • Ensure that the sample sensor is plugged in and perform the Sample Sensor Test to verify that it is operating correctly
Conditioning fluid not detected
Under certain conditions, the analyzer may not detect the presence of conditioning solution • air bubbles in the conditioning solution • too small a volume of conditioning solution • the conditioning solution not being aspirated properly through the sampling mechanism.
• Check for the presence of o-rings and for proper sealing of the electrodes. • Check for aspiration of conditioning solution and look for presence of clots in the sampling system. • Check for the proper sealing of the pump windings. • Ensure that the sample sensor is plugged in and perform the Sample Sensor Test to verify that it is operating correctly.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6-3
6 Troubleshooting
Message
Cause
Action
Paper jam or printer defect
If the printer attempts to print to the paper and the paper jams in the feeder, this message will be displayed briefly, then the sample results will appear on the display.
• First turn analyzer off, then remove the printer by placing your index finger behind the back edge of the printer module and pull it forward. Remove the jammed paper and re-insert the printer into the analyzer. Turn analyzer back on. TIP: To ease removal of jammed paper, the printer head can be moved by turning the spindle gear on the left side. Paper jams should be cleared as soon as possible to avoid damaging the printer.
6-4
Check electrodes
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
• Ensure that electrodes are properly plugged in. • Check for proper operation of the reference electrode assembly. If necessary, clean the reference electrode housing or replace the reference electrode. • Perform daily maintenance. • Replace the SnapPak.
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).
• Make sure that the electrode Orings are present and seated properly. • Make sure there are no leaks in the fluid path. • Check for a clog or crystallization in the fluid path: especially in the sample probe, the tubing to the sample sensor and in the sample sensor. • Ensure that the sample sensor is securely plugged in and perform a sample sensor test to ensure the sensor is operating correctly. If necessary, clean the sample sensor. • Replace reference electrode housing.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6 Troubleshooting
Message
Cause
Action
↑↑↑↑ ↓↓↓↓
In case the unit displays arrows up or arrows down instead of the sample results, the concentration of the sample is outside of the measurement range (see chapter 2: "Specifications").
• In the case of a urine sample, arrows up instead of the K + -result indicate that further dilution of the sample is necessary (see chapter 3.3.4: "Urine samples"). • Check for proper sample preparation (see chapter 3). • Check for small air bubbles in the sample after aspiration into the sample chamber. • Check for proper aspiration of Standard A.
↑↓
With Ca 2+ activated, the calibration report will print an arrow up or down instead of the actual temperature, if the temperature measured is out of range (Range 10.0°C - 40°C). The temperature sensor is located in the right side electrode holder.
• Ensure the sample sensor cable is securely plugged in. • Make sure room temperature is within specified limits (15°C to 32°C / 60°F to 90°F). • Perform the Amplifier Test to measure the actual temperature. • With the front door opened, the temperature displayed should be approx. 5°C above the actual room temperature.
Err.
If this message is displayed instead of the sample results, no valid voltage reading could be obtained from the electrode.
• Check for proper sample preparation (see chapter 3). • Check if the electrode holder is locked in the back position. • Check for proper filling of the reference housing. • Check for air bubbles in the sample.
Change SnapPak
When the monitored fluid level in the ISE SnapPak reaches 5 % remaining, the analyzer will automatically print [Change SnapPak] at the end of each sample report. This message is present only in printed form.
• Replace the SnapPak (see chapter 5.7.2: "Checking reagent fluid level and changing the SnapPak").
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6-5
6 Troubleshooting
Message
Cause
*** Li Calculation not possible
The lithium result can only be calculated for a Na + range: 95 - 180 mmol/L (89.6 - 169.5 mmol/L for blood/ serum). If the Na + value of the sample is outside of this range, this message will be displayed and printed instead of the Li + value.
Interface error
The interface test (see chapter 6.2.8: "Testing the interface") was not successful.
• Check if pins 2 and 3 of the serial port were connected properly. • If the error persists, contact Technical Support.
**Check Temp**
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 - 40°C).
• Check for proper sample preparation (see chapter 3). • Ensure the sample sensor cable is securely plugged in. • Make sure room temperature is within specified limits (15°C to 32°C / 60°F to 90°F). • Perform the Amplifier Test to measure the actual temperature. • With the front door opened, the temperature displayed should be approx. 5°C above the actual room temperature.
(Ca 2+ activated)
6-6
Action
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6 Troubleshooting
6.2
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 enter YES .
6.2.1 Testing the electrodes The voltage levels of the electrodes can be tested by using standard solutions or an external sample. • • • •
Press NO, until [Test Electrodes?] is displayed. Press YES and the prompt [Test Standard A?] will be displayed. Record these values. Press YES and the electrode voltages will be displayed.
• • • •
To exit this function, press NO. The prompt [Test Standard B?] will be displayed. Record these values. Press YES and the electrode voltages will be displayed.
• • • • •
To exit this function, press NO. The prompt [Test Standard C?] will be displayed. Record these values. Press YES and the electrode voltages will be displayed. Compare the measured values to the following table:
Electrode
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
K+
-700 to
+1000 -2500 to
+500
-700 to
+100
+470 to
+1200
-40 to
+40
Cl -
-3100 to
-100 -1000 to
+3000 -3100 to
-100
-860 to
-370
Ca 2+
-3100 to
+1000 -2300 to
+2500 -3100 to
+1000
-660 to
-350
Li +
-3100 to
+1900 -3600 to
+1400 -2600 to
+3400
+1 to
unused -150 to
+150
+760 -1730 to
-285
TIP: If the voltage difference A-B or A-C is outside the allowable difference, perform daily maintenance or replace the electrode. • • • • • •
After testing the electrodes against the standard solutions, the 9180 Electrolyte Analyzer will prompt [Test External Sample?] . Press YES . The instrument will prompt [Open Sample Door Introduce Sample] . After introducing the sample, the analyzer will display [Thank you!] shortly, followed by the electrode voltages. Check for stable readings. Press NO to exit and after a short [Please Wait] message, the prompt [Remain in Test Electrodes?] will appear. Press NO to exit or to perform other service functions.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6-7
6 Troubleshooting
6.2.1.1 Not calibrated potassium electrode 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 procedures for testing electrodes (see "Testing the electrodes" on page 6-7). Press NO, until [Test External Sample?] is displayed. Press YES .
Prepare a serum or plasma sample and introduce the sample: • • • •
The prompt [Open Sample Door Introduce Sample] appears. Introduce the sample. The sample is aspirated, until the prompt [Wipe Probe/Close Sample Door] is displayed. Test the sample for 15 minutes. Repeat the procedure a second time.
6.2.2 Testing the sample sensor The dry sample sensor should indicate a value of 80-120, aspiration of a clear fluid should increase this value by at least 40 Units. • •
Press NO, until [Test Sample Sensor?] is displayed. Press YES and the analyzer will display the current sample sensor reading: Dry: 80-120: 99 YES=Pump/NO=Exit
•
Press YES introduce an external sample through the probe. The display will be like: External: 236 Pump: NO=OFF
•
Press NO to exit and after a short [Please Wait] message, the prompt [Test SnapPak Sensor?] will appear.
6.2.3 Testing the SnapPak sensor • •
Press NO, until [Test SnapPak Sensor?] is displayed. Press YES and the current SnapPak sensor status will be displayed: SnapPak: I I=In O=Out
•
Remove the SnapPak to test the SnapPak sensor. If the SnapPak has been removed during this test, a calibration should be performed to prime all fluid lines.
•
6-8
Press NO to exit or to perform other service functions.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6 Troubleshooting
6.2.4 Testing the language switch • • • •
Press NO, until [Test Language Switch?] is displayed. Press YES and the current language switch status will be displayed: Open the front door and remove the printer paper tray. Change the language settings with a pen.
To activate a new language setting, turn the analyzer off and back on. •
Press NO to exit or to perform other service functions. English
ᣣᧄ⺆
Deutsch
Polski
Français
Português
Español
Spare 3
Italiano
Spare 4
Fig. 6-1
6.2.5 Testing the sample door • •
Press NO, until [Test Sample Door?] is displayed. Press YES and the current status will be displayed: Sample Door: C C=closed O=open
• •
Open the sample door to see the changes of the status. Press NO to exit or to perform other service functions.
6.2.6 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!---
The following tests will be performed and displayed: Very low speed Low speed Medium speed Fast speed An audible change should be heard at the pump’s speed change.
• • • •
•
Close the front cover and press NO to exit or to perform other service functions.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6-9
6 Troubleshooting
6.2.7 Testing the valves • •
Press NO, until [Test Pinch Valves?] is displayed. Press YES and the following will be displayed: Test Valve A: YES/NO = ON/OFF
• • • •
Press YES to move the valve to the open position. Press NO to move the valve back to the closed position. Press NO once more to test the next valve. After [Test Valve R] is finished, press NO to exit or to perform other service functions.
6.2.8 Testing the interface • •
Press NO, until [Test Interface? Jump Pins 2 & 3] is displayed. Jump pins 2 and 3 of the serial interface making sure not to short the jumper to ground. Press YES . Be sure not to short pin 2 or pin 3 to ground, otherwise the interface may get damaged.
• • •
The analyzer will display [Interface Test] and tries to send some characters and checks if they are received within a set time period. Check that there was no interface error. Press NO to exit or to perform other service functions.
6.2.9 Testing the amplifier • •
Press NO, until [Test Amplifier?] is displayed. Press YES and the analyzer will display the current amplifier values: Na=#### K=#### Cl/Ca/Li=####
•
Press NO and the ground voltage will be displayed: GND =0 -2500mV=-2499
•
Press NO and the temperature will be displayed: Temp(mV) =-#### Temp(°C) = ##.#
•
6-10
Press NO to exit or to perform other service functions.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6 Troubleshooting
6.2.10 Status-LEDs The 5 status LEDs at the bottom of the chassis back panel are lit simultaneously during normal operation. If this is not the case, contact technical support.
Fig. 6-2 Status LEDs (back panel, bottom)
6.3
Service codes The [Enter Service Code?] menu allows the programming of various functions into the 9180 Electrolyte Analyzer.
6.3.1 Entering service codes • • •
Starting at the [READY] display, press NO until [SERVICE FUNCTIONS?] is displayed, and enter YES . Press NO until [Enter Service Code?] is displayed. The prompt [Enter Code: AAA] will appear.
Enter the service code as follows: • • • •
Press NO, until the first character appears. Press YES and the cursor will advance to the second position. Repeat this procedure for the other characters. Pressing YES after the third character will activate the service code.
TIP: If the desired character was missed, keep pressing the NO key until the correct character appears. If an incorrect code is entered during the process, the analyzer will prompt [Code Error! Retry?] . Press YES to correct the code or NO to exit.
6.3.2 Removing service codes To remove a service code, enter the reversed sequence of the code letters (example: DEC becomes CED, ECO becomes OCE, MGL becomes LGM, etc.). To clear all service codes at one time, enter CDC.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6-11
6 Troubleshooting
6.3.3 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. QC and standard samples are always shown in high resolution, urine samples in low resolution.
ECO
This service code will automatically put the instrument into Standby Mode, if no samples are run between two calibrations (4 hrs.). This feature mainly helps to conserve reagents. When the unit automatically enters the Standby Mode, it is always necessary to perform a calibration to get back to the [READY] prompt.
FIF
This service code will automatically print the voltage levels of the electrodes on sample and calibration reports. This code should only be used by trained service technicians. To disable this code, either enter IFI or turn the power off and back on.
LEM
This service code will print the last 20 error messages with the date and time of occurrence. MEL will erase all error messages stored.
MGL Ca 2+ activated
This service code allows you to report Ca 2+ values in mg/dL instead of mmol/L. When this code is set, the unit automatically converts the current high and low values of the normal ranges to mg/dL. Note that QC and standard measurements are always reported in mmol/L independent of the MGL setting. This allows you to compare the Ca 2+ values to the ISETROL assay ranges.
NOB
This service code disables the beep.
SLC
When this code is set, the current setting of the leasing counter, which cannot be reset by the operator, is printed on the calibration report.
SFC
This code allows the input of a percentage for the SnapPak counter. When this code is activated, the analyzer displays: SnapPak Counter: xxx% ok?
If this percentage is not correct, press NO and enter the correct percentage between 0 and 100 % using the NO and YES keys. Pressing YES to [ok?] will return the analyzer to the ready screen. QCC
When this code is enabled (using QCC) QC measurements will be reported in direct ISE values without correlation factors. In order to disable this code enter the code CCQ. When the code is disabled (using CCQ) QC measurements will be reported as flame equivalent values with correlation factors applied. NOTE: The default condition is that this code is disabled.
With the exception of FIF, all service codes are permanently stored in memory and will be retained during power failures. The service codes currently set can be printed on the calibration report.
6-12
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
6 Troubleshooting
6.4
Deleting data
6.4.1 Clearing sample count To reset the sample count to 0, carry out the following procedure: • • •
Open the [READY] display and press NO until the display [OPERATOR FUNCTIONS?] appears. Confirm with YES . Press NO until [Reset Sample Number?] appears. Press YES . When the prompt [Are you sure?] appears, press YES again.
6.4.2 Clearing all data To reset the analyzer software to the default values, press the YES and NO keys simultaneously and switch the analyzer off and on again. This function can be performed optionally upon completion of decommissioning. CAUTION: all QC data and analyzer settings will be lost! All QC values and statistics will be deleted and the sample number reset to 0. QC and normal values as well as correlation factors, printer settings, date/time and liquid content of the SnapPak will be reset to default values. All service codes will be deactivated. It is recommended that all data be deleted if the analyzer is to be used by other persons at a later date.
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6 Troubleshooting
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7 Theoretical foundations
7 Theoretical foundations 7.1 Clinical significance ....................................................................................................... 7-1 7.1.1
Sodium ..............................................................................................................................................................7-1
7.1.2
Potassium .........................................................................................................................................................7-2
7.1.3
Chloride.............................................................................................................................................................7-3
7.1.4
Ionized calcium ..............................................................................................................................................7-4
7.1.5
Lithium...............................................................................................................................................................7-6
7.2 Principles of Operation .................................................................................................. 7-7 7.2.1
The measurement principle.......................................................................................................................7-7
7.2.2
Physical principle...........................................................................................................................................7-8
7.3 Electrode specifications .............................................................................................. 7-10 7.3.1
Sodium electrode ....................................................................................................................................... 7-10 Construction .................................................................................................................................................................. 7-10 Use and care ................................................................................................................................................................. 7-10
7.3.2
Potassium electrode .................................................................................................................................. 7-11 Construction .................................................................................................................................................................. 7-11 Use and care ................................................................................................................................................................. 7-11
7.3.3
Chloride electrode...................................................................................................................................... 7-12 Construction .................................................................................................................................................................. 7-12 Use and care ................................................................................................................................................................. 7-12
7.3.4
Calcium electrode ...................................................................................................................................... 7-13 Construction .................................................................................................................................................................. 7-13 Use and care ................................................................................................................................................................. 7-13
7.3.5
Lithium electrode........................................................................................................................................ 7-14 Construction .................................................................................................................................................................. 7-14 Use and care ................................................................................................................................................................. 7-14
7.3.6
Reference electrode assembly .............................................................................................................. 7-15 Construction .................................................................................................................................................................. 7-15 Reference electrode housing ................................................................................................................................. 7-15 Use and care ................................................................................................................................................................. 7-15 Reference electrode ................................................................................................................................................... 7-16 Use and care ................................................................................................................................................................. 7-16
7.4 Calibration procedure .................................................................................................. 7-16 7.4.1
ISE calibration.............................................................................................................................................. 7-16
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7 Theoretical foundations
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7 Theoretical foundations
7
Theoretical foundations
7.1
Clinical significance
7.1.1 Sodium The vast majority of sodium in organisms is located in the extracellular area (about 97 %). Even with greatly varying supply with nourishment, the sodium concentration in serum is subject to strong regula tion. In the kidneys, sodium is glomerularly filtered and most of this (about 60 - 70 %) is reabsorbed in the proximal tubule. The most important function of the sodium is to maintain constant osmolarity in the extracellular fluid. For that reason, the levels of sodium and water are always closely interrelated. However, in pathological conditions, there may be marked tissue hypo or hyperhydration with values in the standard range. Conversely, an increased, respec tively a decreased sodium concentration is found in serum due to a loss or gain of water when there is a normal level of sodium. An increased sodium level in serum occurs when there is: • • •
• • •
a decreased supply of liquid increased loss of water through the kidneys - central diabetes insipidus - renal diabetes insipidus - osmotic diuresis (e.g. mannitin fusions) through the intestine - infection deseases (especially dysentery and cholera) excessive supply of hypertonic saline solution (infusion therapy dosed too high) increase of aldosterone-induced sodium reabsorption - primary hyperaldosteronism (CONN syndrome) - secondary hyperaldosteronism
Reduced sodium level in serum occurs following: • • •
excessive supply of liquid without sufficient absorption of sodium excessive water supply with normal level of sodium in the organism (for example: congestive heart failure) disturbance of sodium reabsorption caused by aldosterone deficiency - suprarenal gland insufficiency (M. ADDISON) - adrenogenital syndrome with saline loss (aldosterone insufficiency with high grade enzyme defect)
Normal values: Adult:
135 - 148 mmol/L
Newborn:
134 - 144 mmol/L
Child:
138 - 144 mmol/L
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7 Theoretical foundations
Critical values a : Na + < 120 mmol/L Na + > 160 mmol/L a. Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001
7.1.2 Potassium About 97% of potassium within the organism is intracellular. Transport into the cells is regulated by the Na/K ATPase localized in the cell membrane. Only about 3% of the potassium is contained in the extracellular fluid. Potassium is glomerularly filtered and most of it (about 90%) is reabsorbed in the proximal tubule and in Henle's loop. Reabsorption or excretion in the distal tubules is influenced especially by aldosterone and the blood pH value. Due to the high intracellular concentration of potassium, the serum potassium values do not always reflect the potassium level of the organism. Therefore, the data obtained from the serum may be interpreted only with careful consideration of the patient's clinical situation and acid-base status. Consider the following examples: diabetic coma, during which the flow of potassium into the cell is reduced due to the lack of insulin, and acute intoxication with heart glycosides with accompanying inhibition of the Na/K ATPase membrane. In both cases exists, despite a more or less greatly increased serum potassium level, intracellular potassium deficiency. Increased potassium concentration in serum occurs during: •
•
•
7-2
decreased excretion through the kidneys - acute and chronic kidney insufficiency (especially pronounced with oliguria and anuria) - Aldosterone deficiency with suprarenal gland insufficiency (M. ADDISON) - dosage of potassium-saving diuretic - oral potassium substitution with (possibly unknown) mild limitation of kidney functions displacement between intracellular and extracellular potassium - severe insulin deficiency - intoxication with heart glycosides - severe acidosis - (each 0.1 reduction of the blood pH results in a rise in potassium of 0.4 to 1.2 mmol/ L serum) - malignant hyperthermia release of potassium on massive cell destruction - hemolytic crisis - transfusions with cold or very cold blood - cytostatic therapy for leukemia and others - burns - severe soft tissue injuries
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
7 Theoretical foundations
Hypokalemia is observed during: •
•
•
gastrointestinal potassium losses - laxative abuse - massive diarrhea - fistulas in the area of the gastrointestinal tract - villous papillary adenoma - VERNER-MORRISON syndrome (pancreatic cholera) increased renal excretion - primary hyperaldosteronism (CONN syndrome) - secondary hyperaldosteronism - cirrhosis of the liver (caused by decreased aldosterone breakdown) - therapy with loop diuretics and thiazides - CUSHING syndrome - Aldosterone producing suprarenal gland carcinoma - overdose of mineral corticoids - renal tubular acidosis displacement between intracellular and extracellular potassium - severe alkalosis - insulin therapy for diabetic coma (potassium substitution required!)
Normal values: Adult:
3.5 – 4.5 mmol/L
Newborn:
3.7 – 5.9 mmol/L
Child:
3.4 – 4.7 mmol/L
Critical values a : K + < 2.8 mmol/L K + > 6.2 mmol/L a. Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001
7.1.3 Chloride Chloride is the most important anion in bodily fluids. Chloride is located – like sodium – mostly in the extracellular area. Erythrocytes represent the highest intracellular content. The concentration of chloride in serum, like the level of sodium, is held constant within tight limits in healthy people. Chloride is glomerulary filtered in the kidneys and is tubularly reabsorbed by passively following the sodium. Chloride may be exchanged for bicarbonates during disturbances to the acid/base status, causing chloride to adopt the additional task (in addition to maintaining the isotones in the extracellular area) of working with sodium to regulate the acid/base status. Changes to the chloride and sodium concentrations in serum usually occur in parallel. Exceptions to this occur during disturbances to the acid/base status caused by the previously mentioned exchange of chloride for bicarbonates as well as during massive chloride loss with gastric juices during extended periods of vomiting (hypochloremic alkalosis).
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7 Theoretical foundations
Normal values a : Adult:
98 - 107 mmol/L
Newborn:
98 - 113 mmol/L
a. Tietz Textbook of Clinical Chemistry, 3rd Edition 1999
Critical values a : Cl - < 75 mmol/L Cl - > 126 mmol/L a. Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001
7.1.4 Ionized calcium Approximately 99% of calcium in the human body is localized in bone substance – mostly in the form of hydroxylapatite. About 1% of the cations are located in the extracellular area. Only very small amounts exist intracellularly; the calcium ions here act especially as activators for numerous enzymes and play a role in the effect mechanism of hormones. It is possible to exchange calcium in the extracellular fluid for that in bones. In addition, hydroxylapatite serves as a reserve holder from which calcium can be rapidly mobilized when needed. Calcium is present in plasma in 3 forms: About 50% are ionized and biologically active, about 40% are bound to proteins (especially albumin) and • about 10% are present in complex bonds with citrate, phosphate, bicarbonate, lactate, and others. Protein bonding is dependent on the concentration of albumin in plasma and on the pH level of the blood: • •
With lower total albumin and an acidic pH level, fewer calcium ions are bound, causing the ionized proportion to increase. This also explains why, despite a low level of calcium in serum during severe acidosis (due to chronic kidney insufficiency), tetanic reactions do not occur. The portion of calcium suitable for ultrafiltration (ionized and complex bound) is glomerularly filtered in the kidneys and up to 95 - 99% reabsorbed in the proximal and distal tubule. A small portion of the calcium can also be excreted via the intestine. The regulation of calcium exchange is closely related to the regulation of the phosphate level. Therefore, the concentrations of both substances in serum and the excretion with urine should always be seen and judged in relationship to each other. The level of calcium in plasma is decisive for calcium-phosphate exchange. Three hormones play roles in the regulation. They affect the maintenance of the extracellular calcium concentration via the reabsorption of calcium ions from the intestine, the release or storage processes in bones and the extent of the renal excretion.
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7 Theoretical foundations
Parathormone and 1.25-dihydroxycholecalciferol: •
lead to an increase of the calcium concentration in plasma
Calcitonin: •
reduces the level of calcium
Increased concentrations of calcium in serum occur during: • •
• •
disturbances to the hormonal regulation of primary and tertiary hyperparathyreoidism increased release from the bones - osteolysis through bone metastasis - plasmocytome - paraneoplastic symptom (through ectopic production of parathormone or similar substances or prostaglandin E2) - long-lasting immobilization vitamin D intoxication within the scope of therapeutic measures sarcoidosis
Reduced calcium levels in serum will be noticed as a result of: •
•
•
insufficient calcium reabsorption - undernourishment - malabsorption syndrome - vitamin D3 deficiency - deficiency of 1.25-dihydroxycholecalciferol - chronic kidney insufficiency - hypoparathyreoidism - hypomagnesium greatly decreased concentration of albumin in the serum (Note: ionized calcium is in the normal range!) - nephrotic syndrome - cirrhosis of the liver acute pancreatitis
Normal values: Adult:
1.12 – 1.32 mmol/L
Child:
1.10 – 1.50 mmol/L
Critical values a : Ca 2+ < 0.82 mmol/L or 3.28 mg/dL Ca 2+ > 1.55 mmol/L or 6.20 mg/dL a. Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001
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7 Theoretical foundations
7.1.5 Lithium 1 In clinical practice, lithium is given orally in a carbonate or citrate form in the treatment of recurrent bipolar affective disorders. Bipolar disorders are psychotic illnesses characterized by alternating mania and depression (typical manic-depressive symptoms). The mechanism of action of lithium is thought to be based on its effect on the synthesis, storage, release and reuptake of monoamine neurotransmitters. Onset of the acute antimanic effect of lithium usually occurs within five to seven days; full therapeutic effect requires 10 - 21 days. Lithium is absorbed quickly by the gastrointestinal tract; approximately 90 - 95 % of the lithium dosage is excreted through the kidneys. GFR disorders reduce lithium elimination. Excretion through perspiration, saliva and feces is negligible in normal circumstances. The therapeutic range of lithium is very narrow. To avoid intoxication (dizziness, nausea, trembling, and, ultimately, coma and shock), the lithium level must be determined every 4 - 5 days at the start of therapy. A blood sample is taken 8 - 12 hours after the last lithium dose is administered. If the patient is clinically stable and the lithium level constant, the monitoring interval can be extended to 1 - 3 months. Therapeutic range a : 0.6 - 1.2 mmol/L Toxic range: Li + > 2 mmol/L a. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Eds: Burtis C & Ashwood E & Bruns D. Elsevier Saunders 4th Ed., USA 2006
1Gelenberg AJ, Kane JM, Kekller MB et al. Comparison of standard and low serum levels of lithium for maintenance
treatment of bipolar disorder. N Engl J Med 1989; 321:1489-93.
7-6
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7 Theoretical foundations
7.2
Principles of Operation
7.2.1 The 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. Although the technology itself is quite complicated, understanding how the instrument performs sampling analysis is relatively simple. Basically, the analyzer compares an unknown value against a known value to compute the sample’s electrolyte level. An ion-selective membrane undergoes a specific reaction with the type of electrolyte contained in the sample. The membrane is an ion exchanger, reacting to the electrical change of the ion causing a change in the membrane potential, or measuring voltage, 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 galvanic chain is closed through the sample on one side by the reference electrode, the reference electrolyte and the “open terminal”. The membrane, inner electrolyte and inner electrode close the other side (see Fig. 7-1). The different ion concentrations between the inner electrolyte and the sample cause an electro-chemical potential to form on the membrane of the active electrode. The potential is conducted by the inner electrode to the input of an amplifier. The reference electrode is connected to ground as well as the second input of the amplifier. Since the reference electrode is on ground, amplification of the electrode potential allows further signal processing. 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), and by using the measured voltage of the sample and the Standard-A (one-point calibration). voltmeter reference electrode
inner solution ion-selective electrode
glass capillary
ion-selective membrane
measured solution
Fig. 7-1
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7 Theoretical foundations
7.2.2 Physical principle An ion-selective electrode is connected with a reference electrode to form a measuring system (see Fig. 7-2). When immersed in a solution that contains the relative ion, the Nernst equation applies:
⋅ T- ⋅ ln a E = E′ ± R ---------i n⋅F
1. or
⋅ T- ⋅ ln ( f ⋅ c ) E = E′ ± R ---------i i n⋅F
2.
(+) for cations (–) for anions
The equation can also be written:
E = E′ ± S ⋅ log ( f i ⋅ c i )
3.
E E’ a R T n F f c S
the measured electrical potential the e.m.f. of the system in a standard solution activity of the ion measured the general gas constant (8.31 J/Kmol) temperature valence of the measured ion Faraday constant (96.496 A·s/g) the activity coefficient the concentration of the measured ion the slope of the electrode
i
i
i
Na + electrode reference electrode housing
K + electrode
ground
amplifier
display
reference solution (KCl) reference electrode
Cl - electrode
glass capillary
inner electrode inner electrolyte sample sodium-selective membrane
potassium-selective membrane
chloride-selective membrane
Fig. 7-2
If the ion concentration of one measuring solution is known, the ion concentration of the sample can be determined on the basis of the difference of two measured potentials.
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7 Theoretical foundations
4. E sample = E′ + S ⋅ log ( f i ⋅ c i, sample ) 5. E s tan dard = E′ + S ⋅ log ( f i ⋅ c i, standard )
c
i, sample 6. ΔE = E sample – E s tan dard = S ⋅ log ----------------------c i, standard
ΔE
the difference between the measured potentials of the sample and the standard
S
the potential difference of the electrode, determined from the potential difference of two measured standard solutions
c i,sample
concentration of the measured ions in the sample
c i,standard
concentration of the measured ions in the standard solutions
The unknown ion concentration in the sample can now be determined by: 7. c i, sample = c i, s tan dard ⋅ 10
ΔE ⁄ S
As demonstrated by these equations, the ion selective electrodes do not measure the ion concentration but the activity of the ions concerned. 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. The ion concentration is calculated on the basis of the ion activity. The correlation is affected by the total number of ions in the solution. Since sodium is the predominant ion in whole blood and serum, the known value of the sodium concentration makes it possible to ascertain and adjust for total ion effect and strength.
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7 Theoretical foundations
7.3
Electrode specifications
7.3.1 Sodium electrode The sodium electrode is a glass capillary electrode used for in-vitro diagnostic measurement of sodium ions present in fluid samples. It is designated with a Na + marking on the top surface of the housing. Construction Electrode housing: Measuring capillary: Electrolyte chamber: Pin connector:
transparent acrylic plastic sodium selective glass airtight, filled with electrolyte solution for Na + electrodes silver, silver chloride (Ag / AgCl) O-ring seal electrolyte chamber inner electrode
glass capillary serial number
connecting pin
Fig. 7-3
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 attack the plastic housing. Store the electrode in a clean, dry place only after the electrode has been cleaned and rinsed with distilled water and dried with a lint-free cloth. The o-ring seal should be installed in the electrode during storage.
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7 Theoretical foundations
7.3.2 Potassium electrode The potassium electrode is a membrane electrode used for in-vitro diagnostic measurement of potassium ions present in fluid samples. It is designated with a K + marking on the top surface of the housing. Construction Electrode housing: Measuring membrane: Electrolyte chamber: Pin connector:
transparent acrylic plastic potassium ion selective airtight, filled with electrolyte solution for K + electrodes silver, silver chloride (Ag / AgCl) ion-selective membrane O-ring seal electrolyte chamber
measuring capillary serial number inner electrode
connecting pin
Fig. 7-4
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 attack the plastic housing. Store the electrode in a clean, dry place only after the electrode has been cleaned and rinsed with distilled water and dried with a lint-free cloth. The o-ring seal should be installed in the electrode during storage.
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7 Theoretical foundations
7.3.3 Chloride electrode The chloride electrode is a membrane electrode used for in-vitro diagnostic measurement of chloride ions present in fluid samples. It is designated with a Cl - marking on the top surface of the housing. Construction Electrode housing: Measuring membrane: Electrolyte chamber: Pin connector:
transparent acrylic plastic chloride ion selective airtight, filled with electrolyte solution for Cl - electrodes silver, silver chloride (Ag / AgCl) ion-selective membrane O-ring seal electrolyte chamber
measuring capillary serial number inner electrode
connecting pin
Fig. 7-5
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 attack the plastic housing. Store the electrode in a clean, dry place only after the electrode has been cleaned and rinsed with distilled water and dried with a lint-free cloth. The o-ring seal should be installed in the electrode during storage.
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7 Theoretical foundations
7.3.4 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 Ca 2+ marking on the top surface of the housing. Construction Electrode housing: Measuring membrane: Electrolyte chamber: Pin connector:
transparent acrylic plastic calcium ion selective airtight, filled with electrolyte solution for Ca 2+ electrodes silver, silver chloride (Ag / AgCl) ion-selective membrane O-ring seal electrolyte chamber
measuring capillary serial number inner electrode
connecting pin
Fig. 7-6
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 attack the plastic housing. Store the electrode in a clean, dry place only after the electrode has been cleaned and rinsed with distilled water and dried with a lint-free cloth.
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7 Theoretical foundations
7.3.5 Lithium electrode The lithium electrode is a membrane electrode used for in-vitro diagnostic measurement of lithium ions present in fluid samples. It is designated with a Li+ marking on the top surface of the housing. Construction Electrode housing: Measuring membrane: Electrolyte chamber: Pin connector:
transparent acrylic plastic lithium ion selective airtight, filled with electrolyte solution for Li + electrodes silver, silver chloride (Ag / AgCl) ion-selective membrane O-ring seal electrolyte chamber
measuring capillary serial number inner electrode
connecting pin
Fig. 7-7
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 attack the plastic housing. Store the electrode in a clean, dry place only after the electrode has been cleaned and rinsed with distilled water and dried with a lint-free cloth. The o-ring seal should be installed in the electrode during storage.
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7 Theoretical foundations
7.3.6 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. Reference electrode housing In the reference electrode housing, reference electrolyte solution establishes the electrical contact between the reference electrode and the sample. At the beginning of each measurement, reference electrolyte is pumped into the housing. At the same time a glass capillary allows a small amount of reference electrolyte to pass into the measuring capillary, thus establishing electrical contact between the sample and the reference electrode (see Fig. 7-8).
entrance of ref. solution
exit of ref. solution
glass capillary
O-ring seal (c) O-ring seal (b) O-Ring seal (a)
serial number
Fig. 7-8
Use and care Reference electrode housings are manufactured for use in 9180 Electrolyte Analyzers. Proper care should be used in handling and storage of the electrode housing. Never use strong or abrasive cleaners such as alcohol or amphyl on the housing. Store the Reference Electrode Housing in a clean, 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. The o-ring seals should be installed in the housing during storage.
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7 Theoretical foundations
Reference electrode The reference electrode completes the electrical circuit between the reference electrolyte and electrical ground. This is accomplished by a cotton wool (saturated with reference electrolyte)-calomel (Hg 2 Cl 2 )- mercury (Hg)-platinum wire-connecting pin junction (see Fig. 7-9).
platinum wire
cable housing glass tube
cotton wool mercury (Hg)
calomel (Hg 2 Cl 2 )
Fig. 7-9
Use and care Reference electrodes are manufactured for use in 9180 Electrolyte Analyzers. Proper care should be used in handling and storage of the reference electrode. Never use strong or abrasive cleaners such as alcohol or amphyl on the electrode. Store the reference electrode in the transport housing provided with the electrode at the time of purchase. 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). Never rinse the reference electrode with distilled water! Never allow the reference electrode to become dry!
7.4
Calibration procedure
7.4.1 I S E calibration The 9180 Electrolyte Analyzer uses a patented, novel approach for the simultaneous calibration of Na + , K + , Ca 2+ and Cl - sensors, using only two aqueous base solutions, eliminating the need of any gas supply system and its related disadvantages.
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8 Appendix
8 Appendix 8.1 Description of reports .................................................................................................... 8-1 8.1.1
Measurement report ....................................................................................................................................8-1
8.1.2
QC report ..........................................................................................................................................................8-1
8.1.3
Calibration report ..........................................................................................................................................8-2
8.2 Specifications of the solutions ..................................................................................... 8-3 8.3 Specification of the QC solutions ................................................................................ 8-7 8.3.1
Roche ISETROL ..............................................................................................................................................8-7
8.4 Declaration of conformity ........................................................................................... 8-10 8.5 Program flow chart ....................................................................................................... 8-13 8.6 Maintenance schedule ................................................................................................ 8-14
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8 Appendix
8
Appendix
8.1
Description of reports
8.1.1 Measurement report - ROCHE 9180 ELECTROLYTE ISE NA-K-CL 26SEP03 08:16 HOSPITAL WEST
- ROCHE 9180 ELECTROLYTE ISE NA-K-CL 26SEP03 08:27 HOSPITAL WEST
- ROCHE 9180 ELECTROLYTE ISE NA-K-CL 26SEP03 08:31 HOSPITAL WEST
Sample No.35
Name: .......... .......... Sample: SERUM
Name: .......... .......... Sample: URINE
Na=151.7 K = 5.56 Cl=114.5
Sample No.36
Sample No.37
Na= 263 K = 18.3 Cl= 118
Na=143.9 mmol/L K = 4.93 ↓ mmol/L Cl=103.1 mmol/L
Name: .......... .......... Sample: STANDARD
mmol/L mmol/L mmol/L
*PERFORM DAILY * * MAINTENANCE! * Fig. 8-1
mmol/L mmol/L mmol/L
Fig. 8-2
Fig. 8-3
8.1.2 QC report - ROCHE 9180 ELECTROLYTE ISE NA-K-CL 26SEP03 09:21 HOSPITAL WEST QUALITY CONTROL *** Level 1 *** Lot Number:1150
*** Level 2 *** Lot Number:1261
*** Level 3 *** Lot Number:1373
Na/K/Cl 1 Na-values 118.0 1 K-values 2.71 1 Cl-values 69.6
Na/K/Cl 1 Na-values 145.4 1 K-values 4.51 1 Cl-values 103.6
Na/K/Cl 1 Na-values 160.5 1 K-values 6.46 1 Cl-values 120.0
Fig. 8-4
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8 Appendix
8.1.3 Calibration report - ROCHE 9180 ELECTROLYTE ISE NA-K-CL 26SEP03 09:01 HOSPITAL WEST *CALIBR. REPORT* DailyMaintenance 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. = 26.2°C SnapPak: 83% Remaining
Corr. Factors: Na Offs.= 0.0 Na Slope= 1.000 K Offs.= 0.0 K Slope= 1.000 Cl Offs.= 0.0 Cl Slope= 1.000 Bicarb. Factors: Na Offs.= 0.0 Na Slope= 1.000 K Offs.= 0.0 K Slope= 1.000 Cl Offs.= 0.0 Cl Slope= 1.000 Acetate Factors: Na Offs.= 0.0 Na Slope= 1.000 K Offs.= 0.0 K Slope= 1.000 Cl Offs.= 0.0 Cl Slope= 1.000 Urine Factors: Na Offs.= 0.0 Na Slope= 1.000 K Offs.= 0.0 K Slope= 1.000 Cl Offs.= 0.0 Cl Slope= 1.000
Normal Ranges: Units: [mmol/L] Na: 136 145 K : 3.5 5.1 Cl: 97 111
QC Ranges: Units: [mmol/L] *** Level 1 *** Lot number:1150 Na: 40 145 K : 1.5 - 15.0 Cl: 50 200 *** Level 2 *** Lot number:1261 Na: 40 145 K : 1.5 - 15.0 Cl: 50 200 *** Level 3 *** Lot number:1373 Na: 40 145 K : 1.5 - 15.0 Cl: 50 200 Service Codes: , , , ,NOB, , , , ,
Fig. 8-5
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8 Appendix
8.2
Specifications of the solutions Use of calibration solutions, electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee. Reagents are to be used for in-vitro diagnostic use only.
The SnapPak contains the following solutions: Standard A Standard B Standard C Reference solution Caution: A waste container is provided inside the SnapPak which, when used, holds human body fluids which may be potentially infectious; handle with appropriate care to avoid skin contact or ingestion!
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8 Appendix
Safety Data Sheet 14.03.02
Date:
Date of printing
06.08.02
Pag
1
of
3
1. Name of substance/preparation and company 1.1 Commercial product:
SNAPPAK, 9180 9181
Cat.-No.: 1.2 Company:
3112349 Roche Diagnostics GmbH Sandhoferstr. 116 D-68305 Mannheim Tel. ++49-621-7590 Information obtainable from: ++49-621-759-2763 or ++49-621-759-4848
1.3 In Emergencies:
Central Works Security Roche Diagnostics GmbH ++49-621-759-2203 Centre for Detoxification: Mainz ++49-6131-232466-232467 München ++49-89-19240
2. Composition/Information on constituents Kit contains: Bottle 1 (3x):
Notes:
Classification: not necessary Contains: No hazardous substances in reportable quantities. There is at present no information or indication of hazardous property.
3. Hazards identification Warnings:
The usual precautions taken when handling chemicals should be observed.
Notes:
Substance slightly hazardous to water and ground water
4. First aid measures First aid:
Eye contact: Flush eyes with water. Skin contact: Wash off with water. Ingestion: Seek medical advice.
Instructions for physician:
Symptomatic treatment by a physician.
5. Fire-fighting measures Extinguishing media:
No restriction
Thermal decomposition:
Dangerous decomposition is not anticipated.
6. Accidental release measures After spillage:
Dilute spilled substance with plenty of water and absorb.
Absorbent material:
No restriction.
Damage limitation:
Special measures to limit damage are not necessary.
7. Handling and storage 7.1 Handling:
Substance or preparation itself does not burn. No special requirements.
7.2 Storage: Do not store with:
8-4
Store at room temperature. No restriction
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
8 Appendix
Safety Data Sheet 14.03.02
Date:
Commercial product:
Date of printing
06.08.02
Pag
2
of
3
SNAPPAK, 9180 9181
8. Exposure controls/personal protection TLV: Respiratory protection: Eye protection: Hand protection: Hygiene:
undefined none prot.glasses One-way gloves Wash hands before breaks and at the end of the work.
9. Physical and chemical properties Bottle 1 Physical state: Miscible with water: pH: Flash point:
liquid yes 7,0 not determined
10. Stability and reactivity Hazardous Reactions:
None known when used appropriately.
Hazardous decomposition None products:
11. Toxicological information LD50 oral LD50 LD50 skin LD50 inhal
not known not known not known not known
Toxicologic information: Intoxication has so far not become known.
12. Ecological information Hazards:
Substance slightly hazardous to water and ground water
13. Disposal considerations Waste disposal route:
Small quantities may be disposed off in waste water.
Disposal of emptied packs:
Dispose of empty packs via local recycling or waste disposal routes - if necessary, clean them beforehand.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
8-5
8 Appendix
Safety Data Sheet 14.03.02
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Commercial product:
Date of printing
06.08.02
Pag
3
of
3
SNAPPAK, 9180 9181
14. Transport information RID/ADR: ICAO/IATA: IMDG-Code:
UN-No.: MFAG: EMS:
Proper Shipping Name: Notes:
Is not subject to current regulations for transportation of hazardous goods (GGVS/ADR, GGVE/RID, IMDG, IATA/ICAO).
15. Regulatory Notes:
This product must be not labeled in accordance with EEC directive 67/548 and 99/45.
16. Other information The information herein is believed to be correct as of the date hereof but is provided without warranty of any kind. The recipient of our product is responsible for ensuring that, where applicable, existing laws and guidelines are observed. Special permission has been granted in accordance with EU Directive 99/45, Article 9, which permit small packages of up to 125 ml or g containing materials that are harmful to health or irritant to be unlabelled with the hazard identification information given in the safety data sheet.
8-6
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
8 Appendix
8.3
Specification of the QC solutions
8.3.1 Roche I S ETROL
Safety Data Sheet 14.03.02
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Date of printing
06.08.02
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1
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3
1. Name of substance/preparation and company 1.1 Commercial product:
ISETROL electrollyte control, L 1
Cat.-No.: 1.2 Company:
3112888 Roche Diagnostics GmbH Sandhoferstr. 116 D-68305 Mannheim Tel. ++49-621-7590 Information obtainable from: ++49-621-759-2763 or ++49-621-759-4848
1.3 In Emergencies:
Central Works Security Roche Diagnostics GmbH ++49-621-759-2203 Centre for Detoxification: Mainz ++49-6131-232466-232467 München ++49-89-19240
2. Composition/Information on constituents Contains: No hazardous substances in reportable quantities. Notes:
There is at present no information or indication of hazardous property.
3. Hazards identification Warnings:
The usual precautions taken when handling chemicals should be observed.
Notes:
Substance slightly hazardous to water and ground water
4. First aid measures First aid:
Eye contact: Flush eyes with water. Skin contact: Wash off with water. Ingestion: Seek medical advice.
Instructions for physician:
Symptomatic treatment by a physician.
5. Fire-fighting measures Extinguishing media:
No restriction
Thermal decomposition:
Dangerous decomposition is not anticipated.
6. Accidental release measures After spillage:
Dilute spilled substance with plenty of water and absorb.
Absorbent material:
No restriction.
Damage limitation:
Special measures to limit damage are not necessary.
7. Handling and storage 7.1 Handling:
Substance or preparation itself does not burn. No special requirements.
7.2 Storage: Do not store with:
Store at room temperature. No restriction
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
8-7
8 Appendix
Safety Data Sheet 14.03.02
Date:
Commercial product:
Date of printing
06.08.02
Pag
2
of
3
ISETROL electrollyte control, L 1
8. Exposure controls/personal protection TLV: Respiratory protection: Eye protection: Hand protection: Hygiene:
undefined none prot.glasses One-way gloves Wash hands before breaks and at the end of the work.
9. Physical and chemical properties Physical state: Miscible with water: pH: Flash point:
liquid yes no data available no data available
10. Stability and reactivity Hazardous Reactions:
None known when used appropriately.
Hazardous decomposition None products:
11. Toxicological information LD50 oral LD50 LD50 skin LD50 inhal
not known not known not known not known
Toxicologic information: Intoxication has so far not become known.
12. Ecological information Hazards:
Substance slightly hazardous to water and ground water
13. Disposal considerations Waste disposal route:
Small quantities may be disposed off in waste water.
Disposal of emptied packs:
Dispose of empty packs via local recycling or waste disposal routes - if necessary, clean them beforehand.
14. Transport information RID/ADR: ICAO/IATA:
UN-No.:
IMDG-Code:
MFAG: EMS:
Proper Shipping Name: Notes:
8-8
Is not subject to current regulations for transportation of hazardous goods (GGVS/ADR, GGVE/RID, IMDG, IATA/ICAO).
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
8 Appendix
Safety Data Sheet 14.03.02
Date:
Commercial product:
Date of printing
06.08.02
Pag
3
of
3
ISETROL electrollyte control, L 1
15. Regulatory Notes:
This product must be not labeled in accordance with EEC directive 67/548 and 99/45.
16. Other information The information herein is believed to be correct as of the date hereof but is provided without warranty of any kind. The recipient of our product is responsible for ensuring that, where applicable, existing laws and guidelines are observed. Special permission has been granted in accordance with EU Directive 99/45, Article 9, which permit small packages of up to 125 ml or g containing materials that are harmful to health or irritant to be unlabelled with the hazard identification information given in the safety data sheet.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
8-9
8 Appendix
8.4
8-10
Declaration of conformity
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
8 Appendix
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
8-11
8 Appendix
8-12
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
Na K Cl
READY
YES
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007 NO
NO
NO
NO
Remain in Program Func?
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. 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
NO
Remain in Print Functions?
YES
NO
NO
QC Level 3 Sample?
NO
QC Level 2 Sample?
Print Cal Report?
Print QC Values and Statistics?
Perform Daily Conditioning?
NO
NO
Perform Daily Cleaning?
YES
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
8.5
YES
NO
8 Appendix
Program flow chart
8-13
8-14
UNSCHEDULED MAINTENANCE
Change main tubing harness
ANNUALLY
Change pump tubing
SEMI-ANNUALLY
Clean reference electrode housing
MONTHLY
Clean analyzer surfaces
Clean sample probe/fill port
WEEKLY
Perform conditioning
Perform cleaning
DAILY
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
8.6
1
Month:...........................
9180 Electrolyte Analyzer Maintenance schedule
8 Appendix
Maintenance schedule TIP: This page can be used as template for duplication.
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
9 Index
9 Index A Additional settings Interface settings .................................................... 3-11 Printer settings ........................................................ 3-10 Analyzer components .................................................... 1-7 Appendix ............................................................................. 8-1
B
Potassium electrode .............................................. 7-11 Reference electrode ............................................... 7-16 Reference electrode assembly ............................ 7-15 Sodium electrode ................................................... 7-10 Environmental parameters ......................................... 2-10 Solutions .................................................................... 2-11 SnapPak ............................................................. 2-11 Error messages ................................................................... 6-1 Exchanging Main tubing harness ............................................... 5-9 Pump tubing set ....................................................... 5-8
G
Bibliography ...................................................................... 2-8
C Calibrations ........................................................................ 2-9 Classification ................................................................... 2-14 Cleaning Analyzer surfaces ..................................................... 5-4 Reference electrode housing ............................... 5-5 Sample probe mechanism .................................... 5-4 Clear all data ........................................................................ 6-13 Sample count .......................................................... 6-13 Clinical significance Chloride ...................................................................... 7-3 Ionized calcium ........................................................ 7-4 Lithium ........................................................................ 7-6 Potassium ................................................................... 7-2 Sodium ........................................................................ 7-1 Correlation factors .......................................................... 3-8
D Declaration of conformity ......................................... 8-10 Decontamination ............................................................. 5-1 Description of reports .................................................... 8-1 Dimensions ...................................................................... 2-14 Display ....................................................................... 1-8, 2-14 Disposal of... Electrodes ................................................................... 1-6 Instrument ................................................................. 1-6 Reference electrode ................................................. 1-6 SnapPak ....................................................................... 1-6
E Electrical data .................................................................. 2-14 Electrode specifications ............................................... 7-10 Electrodes Calcium electrode ................................................. 7-13 Chloride electrode ................................................. 7-12 Lithium electrode .................................................. 7-14
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
General notes ..................................................................... 1-2
I Installation ........................................................................ 1-12 Preparing the Analyzer for Operation ........... 1-18 Selecting language .................................................. 1-18 Interferences ....................................................................... 2-6
K Keypad .................................................................................. 1-8
L Limitations .......................................................................... 2-7 Limitations of clinical analysis .................................... 3-3 Electrolytes ................................................................. 3-3 General ......................................................................... 3-3 Linearity ............................................................................... 2-5 Correlation to direct ISE - flame-correlated . 2-6 Correlation to direct ISE - not flame-correlated 2-6
Electrolytes in serum ......................................2-5, 2-6 in aqueous standard solutions ............................ 2-5 in serum ....................................................................... 2-5 Location ............................................................................. 1-12
M Maintenance Annual .......................................................................... 5-9 Exchanging main tubing harness .............. 5-9 Cleaning reference electrode housing .............. 5-5 Daily .............................................................................. 5-2 Monthly ....................................................................... 5-5 Semi annual ................................................................ 5-8 Exchanging the peristaltic pump tubes .. 5-8 Unscheduled maintenance ................................. 5-10 Material setup .................................................................... 4-2 Measurement and calibration procedures ............. 1-5
9-1
9 Index
Measuring chamber .........................................................1-9 Measuring procedure ......................................................3-4
N Normal ranges ...................................................................3-8
P Performance parameters ...............................................2-1 Peristaltic pump ................................................................1-9 Preanalytics .........................................................................3-1 Acceptable anticoagulants ....................................3-1 Sample collection .....................................................3-1 Sample collection containers ...............................3-2 Sample handling .......................................................3-2 Sample requirements ..............................................3-1 Printer .........................................................................1-8, 2-14 Printing QC report ....................................................................4-5 Product data .....................................................................2-14 Program flow chart ........................................................8-13
Q QC Material setup ............................................................4-2
R Rear panel ..........................................................................1-11 Recommended decontaminants ................................5-2 Replacing Electrodes ..................................................................5-10 Printer paper ............................................................5-14 Sample probe ...........................................................5-13 Reports Calibration report ....................................................8-2 Measurement report ...............................................8-1 QC report ....................................................................8-1
S Sample collection .............................................................3-1 Sample handling ...............................................................3-2 Aqueous solutions ...................................................3-3 Dialysate ......................................................................3-3 Plasma ..........................................................................3-2 Serum ............................................................................3-2
9-2
Whole blood .............................................................. 3-2 Sample measurement ..................................................... 3-4 Dialysate samples ..................................................... 3-6 Direct ISE .................................................................... 3-6 Urine samples ........................................................... 3-7 Sample probe mechanism ............................................ 1-9 Sample throughput ......................................................... 2-9 Sample types ...................................................................... 2-9 Sample volumes ................................................................ 2-9 Serial port .......................................................................... 1-11 Service codes .................................................................... 6-11 Service functions .............................................................. 6-7 Testing the amplifier ............................................ 6-10 Testing the electrodes ............................................ 6-7 Not calibrated potassium electrode ......... 6-8 Testing the interface ............................................. 6-10 Testing the language switch ................................ 6-9 Testing the pump .................................................... 6-9 Testing the sample door ....................................... 6-9 Testing the sample sensor .................................... 6-8 Testing the SnapPak sensor ................................. 6-8 Testing the valves ................................................... 6-10 Shutdown .......................................................................... 1-26 SnapPak ............................................................................. 1-10 Specification of the QC solutions .............................. 8-7 Specifications ..................................................................... 2-1 Measurement parameters .................................... 2-1 Reproducibility ......................................................... 2-1 Roche ISETROL ....................................................... 8-7 Standby mode ................................................................. 1-30 Symbols ................................................................................ 1-2 System description .......................................................... 1-7
T Temperature / humidity / stability ......................... 2-10 Electrodes ................................................................. 2-10 Instrument ............................................................... 2-10 QC material ............................................................. 2-13 Urine diluent ........................................................... 2-13 Theoretical foundations ................................................ 7-1 Troubleshooting ............................................................... 6-1
V Valves .................................................................................. 1-10
Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007
