Operator’s Manual - Block Scientific

1 operator s Manual132387 Rev. D, 2006-06 Analyzer 132387 Rev. B, 2004-10 operator s ManualAnalyzer132387 Rev. D, 2006-06 2003 Bayer HealthCare. All rights , Clinitek Status, Multistix, Multistix PRO, Combistix, Uristix,Labstix, Neostix, Clinitest and Chek-Stix are trademarks of and Cidex are trademarks of Johnson & is a trademark of Lafayette Pharmaceuticals, is a trademark of Linden is a trademark of Pats 5,408,535; 5,477,326; 5,877,863; 6,239,445; D456,082;D489,816 Origin: UKThe information in this Manual was correct at the time of , Bayer HealthCare continues to improve products and reservesthe right to change specifications, equipment, and maintenanceprocedures at any time without this instrument is used in a manner differently than specifiedin this Manual , the protection provided by the equipment maybe Diagnostics Mfg (Sudbury) LtdSudbury, CO10 2XQ, UKBayer HealthCare LLCS ubsidiary of Bayer CorporationTarrytown, NY 10591-5097 USAiii132387 Rev. B, 2004-10 Table of ContentsA Brief Description.

2 VUnderstanding the Symbols and Display Icons .. vii1 Unpacking & Set Up .. 1-1 Unpacking .. 1-1 Set Up .. 1-2 Analyzer Set Up .. 1-2 Plugging Analyzer In .. 1-2 Installing Batteries .. 1-2 Inserting Test Strip Table .. 1-3 Loading Test Table Insert .. 1-3 Interfacing to a Computer .. 1-3 Analyzer Software Upgrades .. 1-4 Loading the Printer Paper or Label Roll .. 1-5 Warranty Registration .. 1-6 Powering Up .. 1-7 Powering Down .. 1-82 Interacting with the Touch Screen .. 2-1 Screens .. 2-1 Keyboards .. 2-43 Start-Up Wizard .. 3-14 Testing .. 4-1 Quick Tests .. 4-1 Urinalysis Strip Test .. 4-1 Cassette Test .. 4-6 Full Tests .. 4-11 Urinalysis Strip Test .. 4-11 Cassette Test .. 4-19iv132387 Rev. D, 2006-065 Instrument Set Up .. 5-1 Instrument Set Up .. 5-1 Language Settings .. 5-2 Password .. 5-3 operator and Patient Information .. 5-4 Date and Time Settings .. 5-10 Test Sequence Number .. 5-12 Instrument Settings .. 5-13 Restore Default Settings .. 5-21 Diagnostics .. 5-22 System Information.

3 5-236 Recall Results .. 6-1 Patient Results .. 6-1 Sending Data to a PC .. 6-37 Troubleshooting .. 7-1 List of Errors and Advisory Messages .. 7-4 Problem Checklist .. 7-88 Quality Control Testing .. 8-1 Information regarding CLIA Waiver .. 8-29 Cleaning and .. 9-1 Changing Batteries .. 9-710 Appendices .. 10-1 Appendix A: Local Technical Support Providers andDistributors .. 10-1 Appendix B: Tables of Results .. 10-4 Appendix C: Specifications .. 10-10 Appendix D: Instrument Default Settings English .. 10-12 Appendix E: System Overview & Principles .. 10-14 Appendix F: CLIA Waiver Performance Characteristics 10-21 Appendix G: Training & Educational Materials .. 10-23 Appendix H: Safety Information .. 10-2411 Brief Description132387 Rev. D, 2006-06 What does the analyzer do?Your Clinitek Status analyzer isa portable instrument for readingBayer urinalysis strips and Clinitest immunoassay cassettes. No specialtraining is needed to use thisinstrument. Several different Bayerurinalysis strips ( , Multistix 10SG) can be used with the analyzeras well as the Clinitest hCGPregnancy analyzer can be set up to beas simple or sophisticated as youprefer.

4 You may simply insert adipped urinalysis strip or a Clinitestcassette into the analyzer and theresult will be reported (this is calleda Quick Test).Or, you have the option to enteran operator ID, Patient Name andPatient ID. This added informationwill be reported along with the testresults (this is called a Full Test).The touch screen displaysinstructions and prompts youthrough operation of the analyzer. Inaddition, you enter informationthrough the touch I have to calibrate?You do not have to do anything tocalibrate. The instrument performsa system test each time it is turnedon. Then, each time a test is run,the instrument automaticallycalibrates. The white calibration bar(on the test table) provides NIST traceable does it work?Testing starts (in the Quick Testmode) when either the Strip Testor Cassette Test is selected on themain menu the Strip Test keyprompts you to adjust the test tableto accept a urinalysis strip. Thenyou touch the START key. Youhave 8 seconds to dip the test strip,blot the edge of the strip and placeit on the test strip table.

5 The table ispartially pulled into the instrumentfor calibration and then pulledcompletely into the instrument toread the test the Cassette Test keyprompts you to adjust the test tableto accept a cassette. Then youtouch the START key. You have8 seconds to draw the sample intoa pipette and dispense it into thesample well of the cassette. Theanalyzer automatically calibratesand then pulls the table completelyinto the instrument where thecassette is the Full Test mode for either aStrip Test or Cassette Test, youare prompted to enter an OperatorID, Patient Name and/or Patient IDprior to running a Brief DescriptionviA Brief Description132387 Rev. D, 2006-06 How do I get results?Results will be displayed on thetouch screen and printed (ifdesired). The results can also betransferred to a computer using a9-pin null modem serial cable andthe RS-232 serial port on the backof the analyzer stores results from200 patient tests. You are able torecall past patient test results onthe analyzer using the RecallResults is the analyzer powered?

6 The analyzer can be pluggedinto an electrical outlet for use onthe bench top, or it can be poweredby batteries and freely moved fromone testing site to another. Thebatteries fit into an opening on thebottom of the about this operator sManual?The operator s Manual containsthe directions you need to unpackthe analyzer, use it for your dailyBayer urinalysis and Clinitestimmunoassay testing and keep it ingood working you read through theOperator s Manual , you will findthese symbols:In the operator s Manual , you willnotice some text is in bold/italic text identifies screen names. NOTES: contain useful tipson using the analyzer. Notesappear in italicized text identifies a button(touch sensitive area) on thescreen. CAUTION: should befollowed carefully to ensure youranalyzer operates correctly andis not damaged. Cautionsappear in bold the Symbols and Display Icons132387 Rev. D, 2006-06 Instrument and Labeling SymbolsThis section describes the symbols that appear on the exterior of theClinitek Status instrument, the power supply provided with the instrument,the carton in which the instrument was delivered and the supplies of reagentstrips and cassettes which you will use with the that the input supply is direct currentIdentifies that the instrument is type B equipment, whichprovides a particular degree of protection against electric shockIdentifies that the instrument is class 1 type equipment, whichhas basic insulation and additional safety grounding precautionsDouble insulated product or transformer may also identifyclass 2 equipment (power supply only)

7 Identifies that the instrument is listed by UnderwritersLaboratories as meeting and Canadian requirements forsafetyThe CE mark identifies that the product complies with theapplicable directives of the European UnionManufacturerEuropean authorized representativeIndicates a power on/off buttonCaution, consult accompanying documentsIn vitro diagnostic deviceConsult instructions for useUnderstanding the Symbols and Display IconsviiiUnderstanding the Symbols and Display Icons132387 Rev. D, 2006-06 Indicates a serial portTemperature limitation (18 - 30 C)Contents sufficient for (n) tests (100)Use by YYYY-MMCatalog numberSerial numberBatch codeBiohazardIndicates that this equipment is classified as Waste Electricaland Electronic Equipment under the European WEEED irective. It must be recycled or disposed of in accordancewith applicable local on recycled materialsIndicates compliance with RESY packaging standardsKeep this way upFragile, handle with care1001830ixUnderstanding the Symbols and Display Icons132387 Rev.

8 D, 2006-06 VDE Testing and Certification Institute - GermanyManufacturer s mark (FRIWO) and manufacturing location(Hong Kong)Manufacturer s mark (FRIWO) and manufacturing location(Geratebau, Germany)Encapsulated safety isolating transformer (short-circuit proof)Positive Temperature Coefficient (PTC) - A thermistor deviceused to protect the transformer from short-circuits or is an auto reset cut-out (TCO) This safety device disconnects thesupply voltage to the transformer at a specific operation temperature is stated protection rating protected against the entry of solidobjects >1 mm but no protection from dryKeep away from sunlight and heatxUnderstanding the Symbols and Display Icons132387 Rev. B, 2004-10 Display IconsThe Bayer logo is shown in the top left of the display while some of thesystem diagnostic tests are being carried out after power-up. There areseven other icons which display in the same position to show the mode ofthe instrument. They also appear on the selection area for each icons are:Instrument Set UpThis is displayed when the instrument is being set up to suit theusers Test ( , Multistix 10SG)Shown when a test is being carried out using a reagent strip forurinalysis, and when results are displayed following a strip Test ( , Clinitest hCG)Displayed when a cassette test is being carried out and whenresults are shown after a cassette recallUsed to show that results are being recalled from theinstrument s icon is displayed when results are being transfer to Personal ComputerShows that data, including results, is being transferred to a when an error is being are two icons which may appear in the title powerThis has a maximum of four segments which show the levelof battery power.

9 It will be shown in the top right corner of thetitle bar when the instrument is battery in the top of the title bar when the printer paper/label roll needs Unpacking & Set Up132387 Rev. D, 2006-06 Clinitek Status analyzerTest tableTest table insertPower SupplyUnpacking 2 Remove each of the wrappingsand check for the following items: 1 Carefully remove the contentsof the shipping carton. Check thecarton and instrument for visiblesigns of damage; if seen,immediately contact the A, Local Technical SupportProviders and Distributors).Paper RollClinitek Status Check Cassette (notshown)Depending on the model you havereceived, there may also be a WarrantyRegistration Card, Unpacking/Setup Guide,and/or Quick Reference Guide If you are using a reagent stripthat has 4 or fewer test pads, , Uristix 4, you must use a shorttest table insert. This has to be orderedseparately (for a list of suppliers seeAppendix A, Local Technical SupportProviders and Distributors). Do not touch the whitecalibration bar.

10 If the power cord is not the styleyou need, contact your local Bayeroffice (for a list of contacts see1 Do not remove the CheckCassette from its foil packaging. TheCheck Cassette should be availableif you need to call Bayer forassistance with an analyzer the cassette in the pocketlocated inside the back cover of yourOperator s Manual . Unpacking341-21 Unpacking & Set Up132387 Rev. D, 2006-06 The best temperature for usingthe instrument is between 22 C and26 C (72 F and 79 F). Do not placethe analyzer outside or nearwindows, ovens, hot plates, UpSet UpAnalyzer Set UpPlace the instrument on a levelwork surface where thetemperature and humidity are Analyzer InPlug the appropriate end of thepower cord into the power inletsocket located on the rear of theClinitek Status analyzer. Plug theother end of the power cord into anAC electrical wall Batteries (Optional)Place the analyzer on its side andremove the battery cover bypressing down on the tab andpulling out. Place the 6 newAA-size batteries into the the battery cover and turnthe instrument back onto its Unpacking & Set Up132387 Rev.)