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:
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Technical Publications Department 9115 Hague Road
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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.
Publication Date Revision purpose
Reference Number
575-01-0803 July 2005 Title-2-4 new standards references,
Revision 2.0 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.
575-02-0507 May 2007 Revision 4.0
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 cobas b cobas b cobas b 221 systemcobas b
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 5.1.1 / 5-1 new: 3rd 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
cobas b cobas b cobas b
cobas b 221 system)
8 removed: correlation worksheet
Publication Date Revision purpose
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, on-site 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.
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.
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.
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]
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 writ-ten consent of Roche Diagnostics. While every effort is made to ensure its correctness, Roche Diagnostics assumes no
respon-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 require-ments.
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 measure-ments of the instrument depend not only on the correct characteristic function, but also on a series of mar-ginal 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".
The instrument has been constructed and tested according to the following European Stan-dards:
• 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 exten-sion cord, make sure it is properly grounded.
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
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
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 ... 1-111.6 Installation ... 1-12
1.6.1 Location ... 1-12 Accessories ... 1-13 1.6.2 Setting up ... 1-137. 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" ... 1-291.8 Standby mode ... 1-30
1
Introduction
The 9180 Electrolyte Analyzer is a powerful tool designed to quickly, accurately and effi-ciently 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.
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)
Danger symbol: T: Toxic (on the packaging of the reference electrode) Rating: Inhalation, swallowing or skin contact with even small quantities can lead to serious health risks, including fatal risks. Characteristics of this type of item are severe, 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, con-tact a doctor immediately. Any substances with carcinogenic, genetic or reproductive dangers are indicated appropriately. Always observe the reg-ulations when handling such substances.
Danger symbol: N: Dangerous to the environment (on the packaging of the reference electrode)
Rating: If released into aquatic and non aquatic environments, can cause immediate or delayed damage to ecosystems through a change in environ-mental conditions.
These substances or their by-products can cause substantial damage to sen-sitive environmental areas.
Caution: Depending on the potential for damage, do not allow the sub-stance to enter sewers, soils or the environment. Observe the specific dis-posal regulations.
Danger symbol: Xi: Irritant
Rating: Although not corrosive, momentary, longer-lasting, or repeated contact with skin or mucous membrane may result in inflammation. Dan-ger 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)
T:R23/33/50-53
N:S45/60/61/7
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 par-ties).
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 intend-ed to provide the user with additional help.
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 measure-ment 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 ion-selective membrane that undergoes a specific reaction with the corresponding ions con-tained in the sample being analyzed. The membrane is an ion exchanger, reacting to the elec-trical 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 poten-tial is conducted by a highly conductive, inner electrode to an amplifier. The reference elec-trode is connected to ground as well as to the amplifier.
The ion concentration in the sample is then determined by using a calibration curve deter-mined 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 cal-ibration cycle can also be initiated manually at times when no sample measurements are per-formed.
1.3
Measurement evaluation
The validity of the test results from the 9180 Electrolyte Analyzer must be carefully exam-ined by a clinical-medical specialist who will take the patient's clinical condition into con-sideration 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
1.4
Important safety instructions
For your own safety and the proper operation of your equipment, always follow these pre-cautions 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 contamina-tion.
• 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 recommend-ed that all blood specimens be handlrecommend-ed as potentially infectious specimens capable of trans-mitting human immunodeficiency virus (HIV), hepatitis B virus (HBV), or other blood-borne 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 gog-gles and if necessary mouth protectors, must be worn to prevent direct contact with biolog-ical working materials. In addition, a face mask is required if there is a risk of splashes. Suit-able disinfection and sterilization procedures must be applied.
Please refer to NCCLS document M29-A2, "Protection of Laboratory Workers from
Occupa-tionally Acquired Infections", Approved Guidelines - Second Edition 2001, for further
infor-mation on safe handling of these specimens. For further inforinfor-mation, see chapter 3: "Mea-surement".
1.4.2 Disposal of SnapPak, electrodes, and instrument
Dispose of used SnapPak, electrodes and the instrument according to applicable lab-oratory 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!).
1.4.3 Handling electrodes
• 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.
1.5
System description
1.5.1 Analyzer components
Fig. 1-2 front cover sample door keypad display ISE SnapPakTM measuring chamber thermal printerDisplay
The analyzer communicates to the user through a dot matrix display. This two line, alpha-numeric read-out allows up to 16 characters per line, displaying the activities of the analyz-er, sample results and other programmed information.
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, pro-gramming 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
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
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.
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.
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.
Fig. 1-13
After setting up the 9180 Electrolyte Analyzer in a location that meets the above require-ments, 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 evi-dence in the event of a damage claim.
Do not remove the analyzer from the shipping carton by pulling upward on the poly-styrene (styrofoam) packing materials. These packaging materials do not provide strength to support the analyzer.
340 mm
350 mm
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").
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.
Fig. 1-18
red transport housing reference electrode reference electrode
• Slide the measurement chamber forward until it locks in the front position. • Unclamp the left electrode holder by moving the clamp forward.
• 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
• Check to make sure that the lettering on the electrode corresponds with the proper elec-trode station number on the tray. Also, note that all elecelec-trodes 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.
• 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:
Fig. 1-26 Parameter configurations
Electrode pos. Parameter configuration
Na+ Na+ Na+ Na+ Na+ Na+
K+ K+ K+ Dummy K+ Dummy
Cl- / Ca++ / Li+ Dummy Cl- Cl- Ca2+ Ca2+
Electrode pos. Parameter configuration
Na+ Na+ Na+ (Na+) Na+
K+ K+ Dummy Dummy Ca2+
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.
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].
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.
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:
• Place a new paper roll in the paper tray and thread it into the feeder slot.
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.
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 pre-pares 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 cur-rent 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.
• 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.
• 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 cal-ibration 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 cal-ibration 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 config-uration is the following:
Sel. Parameter: [Na][K][ ] ok?
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 replace-ment of the SnapPak, after startup of the instrureplace-ment as well as after monthly, semi annual and annual maintenance steps.
Additionally, at least once daily one QC measurement has to be performed in alter-nating 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 ana-lyzer results. For further information, see chapter 4: "Quality control".
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 perform-ing 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.
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 hous-ing.
• 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 back-wards, making sure all electrodes are seated properly. The electrode holder remains in the forward position.
• Press YES.
3. Washing the lines
The analyzer will take approximately one minute to flush all lines with water. Upon com-pletion, 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.
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.
• Press YES. Fig. 1-42
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.
• 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 labora-tory 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. Fig. 1-43
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 eve-nings 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 instruc-tions 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 per-formed. After that, the analyzer returns to [READY].
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
2.12 Product data ... 2-14
2.12.1 Electrical data... 2-14 2.12.2 Classification ... 2-14 2.12.3 Dimensions ... 2-142.13 Printer ... 2-14
2.14 Display ... 2-14
2
Specifications
2.1
Performance parameters
2.1.1 Measurement parameters
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 (Swr), Between-Day (Sdd) and Total (ST) Precision is determined from
2 runs per day with 2 replicates per run for 20 days on two 9180 Electrolyte Analyzers. Val-ues for sodium and potassium are average of all instruments, while valVal-ues of chloride, ion-ized calcium and lithium are determined from the measurement of two of each respective unit configuration. All values are reported in mmol/L.
specified for: specified range:
Na+ B/S/A/D/Q 40 − 205 mmol/L U 1 − 300 mmol/L K+ 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 Cl- B/S/A/D/Q 50 − 200 mmol/L U 1 − 300 mmol/L Ca2+ B/S/A/D/Q 0.2 − 5.0 mmol/L Li+ B/S/Q 0.1 − 6.0 mmol/L
Material: I S ETROL Protein Based Aqueous Control Material (Level 1), n=80
Material: I S ETROL Protein Based Aqueous Control Material (Level 2), n=80
Material: I S ETROL Protein Based Aqueous Control Material (Level 3), n=80
Material: R NA EQU I L Reduced Bovine Hemoglobin Solution (Level 2), n=80
Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 114.6 0.48 0.42 0.76 0.66 0.89 0.78 Potassium 2.82 0.025 0.87 0.035 1.24 0.041 1.44 Chloride 76.7 0.29 0.38 0.52 0.67 0.72 0.94 ionized Calcium 2.07 0.015 0.72 0.024 1.18 0.034 1.66 Lithium 0.40 0.010 2.40 0.018 4.57 0.026 6.41 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 141.2 0.40 0.28 0.30 0.21 0.46 0.33 Potassium 4.35 0.024 0.55 0.023 0.53 0.036 0.82 Chloride 102.4 0.18 0.18 0.20 0.20 0.32 0.31 ionized Calcium 1.35 0.016 1.21 0.021 1.55 0.042 3.10 Lithium 1.04 0.012 1.19 0.035 3.36 0.045 4.31 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 158.8 0.51 0.32 0.76 0.48 0.90 0.56 Potassium 5.74 0.027 0.48 0.026 0.45 0.036 0.62 Chloride 123.2 0.36 0.29 0.89 0.72 1.17 0.95 ionized Calcium 0.63 0.010 1.52 0.007 1.07 0.014 2.29 Lithium 2.59 0.025 0.97 0.063 2.44 0.082 3.18 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 134.8 0.53 0.40 0.45 0.33 0.63 0.47 Potassium 4.89 0.039 0.79 0.021 0.42 0.043 0.88 Chloride 100.4 0.43 0.43 0.42 0.41 0.58 0.57 ionized Calcium 1.10 0.008 0.75 0.004 0.40 0.011 0.95 Lithium N/A
Material: Aqueous Standard Solution (Level 1), n=80
Material: Aqueous Standard Solution (Level 2), n=80
Material: Pooled Human Serum, n=80
Material: Acetate Dialysate Solution, n=80
Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 150.0 0.55 0.37 0.34 0.23 0.57 0.38 Potassium 4.97 0.022 0.44 0.018 0.36 0.029 0.57 Chloride 115.0 0.11 0.09 0.08 0.07 0.16 0.14 ionized Calcium 0.96 0.004 0.41 0.004 0.39 0.007 0.76 Lithium 0.30 0.004 1.27 0.005 1.60 0.008 2.48 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 113.2 0.51 0.45 0.96 0.85 1.07 0.95 Potassium 1.82 0.033 1.88 0.043 2.36 0.053 2.92 Chloride 82.9 0.27 0.33 0.67 0.80 0.87 1.05 ionized Calcium 2.43 0.014 0.56 0.032 1.33 0.043 1.76 Lithium 5.42 0.043 0.78 0.155 2.86 0.196 3.62 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 138.8 0.30 0.22 0.36 0.28 0.47 0.34 Potassium 4.49 0.034 0.75 0.041 0.92 0.051 1.13 Chloride 106.8 0.18 0.17 1.00 0.93 1.24 1.16 ionized Calcium 1.19 0.007 0.55 0.031 2.64 0.039 3.29 Lithium 0.17 0.011 6.19 0.015 8.40 0.023 13.28 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 86.1 0.85 0.98 1.81 2.10 1.78 2.07 Potassium 2.09 0.029 1.41 0.041 1.94 0.049 2.32
Material: Bicarbonate Dialysate Solution, n=80 Material: Urine, n=80 Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 135.2 0.45 0.33 0.59 0.44 0.72 0.54 Potassium 1.58 0.023 1.46 0.031 1.95 0.037 2.37 Chloride 107.3 0.37 0.35 0.63 0.59 0.86 0.80 ionized Calcium 1.68 0.012 0.72 0.016 0.96 0.027 1.63 Lithium N/A Parameter Mean Swr (CV %) Sdd (CV %) ST (CV %) Sodium 51.5 1.98 3.84 3.06 5.94 3.65 7.08 Potassium 48.4 0.65 1.34 0.97 2.00 1.11 2.29 Chloride 85.9 0.53 0.62 0.66 0.76 0.99 1.16
ionized Calcium N/A
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.
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 983 Na/K/Cl Analyzer
(listed as 98X) 984 Na/K/Ca Analyzer
985 Na/K/Li Analyzer
Direct ISE, flame correlated 9130 Na/K/Cl Analyzer (listed as 91XX) 9140 Na/K/Ca Analyzer
Flame Absorbance Emission Spectroscopy IL 943 Flame Photometer
Chloridometry Labconco Digital Chloridometer
Correlation to flame
Parameter Slope Intercept Correlation Coefficient Sy·x Range [mmol/L] n
Sodium 0.99993 0.0128 0.99995 0.666 51 − 196 300
Potassium 0.99838 0.0119 0.99919 0.194 2.0 − 12.6 300 Chloride 0.97556 -0.1775 0.99994 0.674 56 − 194 100 ionized Calcium 1.01552 -0.0078 0.99980 0.037 0.4 − 3.3 100
Correlation to direct I S E - not flame-correlated
98X Electrolyte Analyzers
Correlation direct I S E - flame-correlated
91XX Electrolyte Analyzers
Correlation to chloridometry
Labconco Digital Chloridometer
2.3
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 concentra-tion, 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 mea-surement values! If sample containers are used which contain lithium as an antico-agulant, this may lead to incorrect patient measurements, which may result in incorrect clinical decisions, possibly endangering the patient's health.
Parameter Slope Intercept Correlation Coefficient Sy·x Range [mmol/L] n
Sodium 0.9895 -6.35 0.9992 0.61 110 − 186 50
Potassium 1.0223 -0.25 0.9996 0.05 2.0 − 11.6 50
Chloride 0.9631 -1.01 0.9995 0.51 70 − 152 50
ionized Calcium 0.8898 0.107 0.9960 0.021 0.67 − 1.66 50
Lithium 0.9923 0.008 0.9985 0.010 0.11 − 0.71 15
Parameter Slope Intercept Correlation Coefficient Sy·x Range [mmol/L] n
Sodium 0.9856 -2.02 0.9856 1.21 104 − 179 50
Potassium 0.9992 0.02 0.9994 0.05 1.9 − 11.8 50
Chloride 1.0026 -5.31 0.9989 0.73 70 − 152 50
ionized Calcium 1.0023 0.040 0.9954 0.022 0.62 − 1.54 50
Parameter Slope Intercept Correlation Coefficient Sy·x Range [mmol/L] n
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 with-out 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 sam-ple.
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 acid-base 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.
2.6
Bibliography
Bishop ML, Duben-Engelkirk JL, Fody EP. Clinical Chemistry Principles Procedures Corre-lations, 2nd Ed., (Philadelphia: J.B.Lippincott Co.),1992,p.281.
Burritt MF, Pierides AM, Offord KP: Comparative studies of total and ionized serum calci-um 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 Perfor-mance of Clinical Chemistry Devices, Second Edition; Tentative Guideline. NCCLS Docu-ment 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. Saun-ders, 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.
2.7
Sample throughput
45 per hour with printout 60 per hour without printout2.8
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
2.11 Environmental parameters
2.11.1 Temperature / humidity / stability
Instrument
Electrodes
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)
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:
Temperature... -5 to 40 °C
Solutions SnapPak
Contains the following reagents:
Standard A
For calibration of sodium, potassium, ionized calcium and lithium in the 9180 Electrolyte Analyzer.
Standard B
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 Ca2+ 0.9 mmol/L Li+ 0.3 mmol/L Additives: Germicides Storage temperature: 15 - 30 °C
Stability: Expiration date and lot number are printed on each container label On-board stability: 14 weeks
Contents: 85 mL
Active ingredients: Na+ 100 mmol/L
K+ 1.8 mmol/L Cl- 72 mmol/L Ca2+ 1.5 mmol/L Li+ 0.3 mmol/L Additives: Germicides Storage temperature: 15 - 30 °C
