USER’S GUIDE - yeec · Your CLINITEK® 50 Urine Chemistry Analyser is a portable ... What about this User’s Guide? ... lines for manual entry of the colour and clarity

USER’S GUIDE

�1996 Bayer Corporation

All Rights ReservedPrinted in the U.S.A.

Unless otherwise noted, alltrademarks are the property

of Bayer Corporation.

Revised 5/03 99E65109

Bayer CorporationElkhart, IN 46514 USA

Bayer Diagnostics Europe Ltd.Chapel Lane, Swords, Co. Dublin, Ireland

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Contents

A Brief Description . . . . . . . . . . . . . . . . . . . . iv

1 Unpacking and Setup . . . . . . . . . . . . . . . . . . . 1Unpacking . . . . . . . . . . . . . . . . . . . . . . 1Installing the battery pack . . . . . . . . . . . . . 4Loading the paper roll . . . . . . . . . . . . . . . 5Powering up . . . . . . . . . . . . . . . . . . . . . 6Final paper work . . . . . . . . . . . . . . . . . . 7

2 Selecting your Options . . . . . . . . . . . . . . . . . . 8Location of results and number of copies . . . . 8Listing the tests . . . . . . . . . . . . . . . . . . . 8Setting the time . . . . . . . . . . . . . . . . . . . 9Setting the date . . . . . . . . . . . . . . . . . . . 9Reporting the urine colour . . . . . . . . . . . . .10Setting the sequence number . . . . . . . . . . .10Clearing the memory and marking positives . .11

3 Testing Controls . . . . . . . . . . . . . . . . . . . . . .12

4 Testing Specimens . . . . . . . . . . . . . . . . . . . .13Testing routine urines . . . . . . . . . . . . . . .13

Summary of steps . . . . . . . . . . . . . . .15Testing with CLINITEK® Tests . . . . . . . . . . .15Getting results . . . . . . . . . . . . . . . . . . .15

If results are printed . . . . . . . . . . . . . .15If results are displayed . . . . . . . . . . . . .15

When you are finished testing . . . . . . . . . .16Operating notes . . . . . . . . . . . . . . . . . .16

5 Cleaning the Instrument . . . . . . . . . . . . . . . . .17Daily cleaning . . . . . . . . . . . . . . . . . . . .17Disinfecting the table . . . . . . . . . . . . . . . .18Removing heavy buildup . . . . . . . . . . . . .19General cleaning . . . . . . . . . . . . . . . . . .20

Appendix . . . . . . . . . . . . . . . . . . . . . . . . . .21Solving problems . . . . . . . . . . . . . . . . . .21

If the display is blank . . . . . . . . . . . . . .21Error messages and remedies . . . . . . . .22Problem checklist . . . . . . . . . . . . . . . .23Where to call for service . . . . . . . . . . . .24

Ordering accessories . . . . . . . . . . . . . . .25Ordering replacement parts . . . . . . . . . . . .26Specifications . . . . . . . . . . . . . . . . . . . .27Tables of results . . . . . . . . . . . . . . . . . .28

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A Brief Description

What does this instrument do?Your CLINITEK® 50 Urine

Chemistry Analyser is a portable instrument for reading BayerReagent Strips for Urinalysis. Nospecial training is needed to usethe instrument. Several differentBayer Reagent Strip products(e.g., MULTISTIX® 10 SG) can beused with the Analyser; refer tothe bottle label for the tests thatare included with each product.The Analyser can also report thecolour of the urine sample. TheCLINITEK® line of tests fromBayer can also be read.

The Analyser can be pluggedinto an electrical outlet for use onthe benchtop, or it can bepowered by batteries and freelymoved from one testing site to another. The battery pack, whichis purchased separately, fits intoan opening on the bottom side ofthe instrument.

Do I have to calibrate?You do not have to do anything

extra to calibrate. The instrumentperforms a “self-test” and calibra-tion each time it is turned on.Then, each time a test is run, theinstrument calibrates again, usingthe white plastic bar located on theend of the test strip table.

How does it work?Testing starts when either of the

two Start keys (labeled “ ”) ispressed.You have 10 seconds

after the key is pressed to blotthe edge of the wet reagent teststrip (if required for the test) andplace it on the test strip table. Thetable is then pulled into the instru-ment, where the test strip is read.The instrument measures thecolour and amount of light that isreflected from the test pads on thestrip. It then converts these mea-surements into meaningful results.

How do I get results?Results can be either printed or

displayed. The results can also betransferred to a computer using aspecial cable that is plugged intothe computer port on the back ofthe instrument.

What about this User’s Guide?The User’s Guide contains the

directions you need to unpack theinstrument, use it for your dailyurine testing, and keep it in goodworking condition. The User’sGuide is provided in severallanguages; please recycle theGuides you will not be using.

As you read through the User’sGuide, you will find these symbols:

NOTES contain useful tipson using your instrument. Theyappear in italicized type.

CAUTIONS should be followed carefully to ensure yourinstrument operates correctly andis not damaged. Cautions appearin bold type like this.

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1 Carefully remove thecontents of the shipping carton.Check the carton and instrumentfor visible signs of damage; ifseen, immediately contact thecarrier.

2 Remove each of thewrappings and check for thefollowing items:

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Unpacking and Setup 1Unpacking

1 CLINITEK 50® Analyser2 Test strip table

(Do not touch the white bar!)If you will be using a Reagent Stripthat has four or fewer test pads, youmust use a short test strip table,which must be ordered separately(see page 26). (The CLINITEK® line oftests are all run using the long table.)

3 Printer cover

4 Power transformer

5 Power cordIf the power cord is not the style youneed, contact your local Bayer office (see page 24).

6 Paper roll

Depending on the model you have received, there may also be a WarrantyRegistration Card, Customer InformationCard, Unpacking/Setup Guide, and/orQuick Reference Guide included.

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3 Place the instrument on alevel work surface where thetemperature and humidity arefairly constant.

4 Locate the following:

1 Display2 (START) Keys

Either green key can be pressed to start a test.

3 Option KeysEach dark grey key corresponds to one of four words that may be shown on the bottom line of the display; press the key beneath the word to select that choice.

If you will be using the optional battery pack instead ofthe power cord and transformer,skip Step 5.

5 Plug the power cord into the transformer, then plug thetransformer cord into theinstrument. Plug the power cord into an appropriatelygrounded AC electrical wall outlet.

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The best temperaturefor using the instrument is between 22°C and 26°C (72°Fto 79°F). Do not place theinstrument near such thingsas an outside window, oven,hot plate, or radiator.

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6 Insert the test strip table intothe instrument, holding it by theend opposite the white bar andwith the flat side facing up. Donot touch the white bar. Pushthe table in about halfway.

7 If you will be sending resultsto a computer, you must obtain a special Computer Cable/Connector Kit (see page 25 toorder). The kit includes all the information you need to connectand use the cable.

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2 Turn the instrument over and snap the battery pack into the opening.

3 Plug the cord into the power inlet.

1 If you will be using the optional battery pack, place six AA-size batteries into the battery compartment.

Installing theBattery Pack

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If changing the paper, leave the cover down and pullout the remaining paper. Thenraise the cover and remove the empty core to continue.

3 Pulling toward the back,gently pull the end of the paperuntil the full width of the paper is completely exposed.

1 Insert the two tabs on theprinter cover into the two openingson the instrument. Rest the coveron its back edge.

2 Trim the end of the paper so it has a large “V” shape at least 5 cm (2 inches) long. With the paper unrolling from underneath,insert the paper under the printerroller until the tip comes throughthe other side of the roller.

Loading the Paper Roll

Do not pull the paper straight up or toward the front, as this will damage the printer.

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The cover must be latchedin order for the instrument tofunction.

1 Press the power switch onthe back of the instrument to the “––” (ON) position.

2 If you want to use thelanguage and units shown on the screen, press the key under the word YES. If you want another language and/orunits, press the key under theword NO.

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4 Feed the paper through theprinter cover opening and snapthe cover into position.

To prevent damage to the printer, do not tear the paper without the cover in place.

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Powering Up

Refer to pages 28 to 30 for the test abbreviations and results that are used with eachof the three options for English.For tests not shown in these tables, refer to the insertincluded with the product.

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1 Find the bar-coded serialnumber label on the bottom ofthe instrument. Write thisnumber and today’s date on theProblem Checklist on page 23.

2 Fill out and mail the WarrantyRegistration Card and CustomerInformation Card if these areincluded with your instrument.

3 Press the key under the wordNORMAL if you want the resultsto appear in clinical units. Pressthe key under +/– if you preferplus and minus signs.

The screens shown in Steps 2 and 3 appear the firstthree times the instrument isturned on or three times after achange is made to either screen.

4 The instrument brieflydisplays two screens while itdoes an internal check. Whenthe check is complete, theREADY screen appears. Lookfor the names of the productsthat can be used – they areshown after the words “READY FOR TEST.”

Final Paper Work

Do not use any ReagentStrip product other than whatis shown on the display. Usingthe wrong Reagent Strip willgive you incorrect results.

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CLINITEK® Tests are automatically identified by the instrument; if your software can-not identify a test, the test is re-jected and the display will show “STRIP PROBLEM – RETEST.”

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1 If you want more than oneprinted copy or if you preferresults to be displayed on thescreen, press the key underthe word OUTPUT.

2 Selecting Your Options

2 Press the key under yourchoice.

3 If you pressed PRINTER,you can choose to have more than one copy of the results.Press the key under your choice.

Location of Resultsand Number of Copies

One copy of each set of results will be printed if you donot change this option.

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1 Press the key under the wordLIST.

2 If you selected PRINTER asyour output, the list is printed. IfDISPLAY was selected, press the

key to display each test name,then press EXIT.

Listing the Tests You can print or display alist of the Bayer Reagent Stripsand CLINITEK® Tests that can beread by your instrument throughthis option. If the CLINITEK Testyou want to use is not listed, youmust update the software in yourAnalyser before using the prod-uct. See page 25 to order theSoftware Update Kit.

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1 Press the key under the word SET.

2 Press the key under DATEand select a date format:

MDY Month-Day-YearDMY Day-Month-YearYMD Year-Month-Day

3 Press the key to adjust the first number.

4 Press the ➞ key, then pressto adjust the second number.

5 Press the ➞ key, then pressto adjust the third number.

6 Press EXIT.

4 Press the ➞ key, then pressto adjust the minutes.

5 Press EXIT.

If you press and holdthe key, the numbers will advance more quickly.

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Setting the Time Setting the Date


2 Press the key under TIMEand select the 12 hour (AM/PM)format or the 24 hour (military)format.

3 Press the key to adjust the hour.✏


2 Press MORE, then pressCOLOR. Press the YES or NOkey to make your selection.

3 Press EXIT as needed.

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Reporting the Urine Colour

Setting the SequenceNumber

Colour will be reportedautomatically when using BayerReagent Strips that include theleucocyte test pad if this option is set to YES. If there is noleucocyte pad, lines for manualentry of the colour and clarityare printed.

The sequence number will not be displayed or printedunless you change this option.

If you are already using sequence numbers and thenumber is greater than 001, you will first be given the optionof setting it to 001.

Colour results reportedby the instrument may be different from the colour seen visually. This is because of theinherent differences between the human eye and the opticalsystem of the instrument.

1 If you want to have thesequence number appear, pressthe key under the word SET.

2 Press MORE, then pressSEQ#.

3 Press YES to use sequencenumbers (or press NO if youdon’t want them displayed).


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Clearing the Memoryand Marking Positives

You can connect the instrument to a computer totransfer results. Fifty sets of results are stored (for transferonly) if the memory is notcleared.

Check whether your software program can accept theasterisk that marks positiveresults. Press NO if it cannot.

1 If you want to clear theinstrument’s memory of all test results, or to turn off the asterisk, press the key under the word SET.

2 Press MORE, then pressCMPTR.

3 Press YES to clear the memory and reset the sequencenumber to 001.

4 Then select whether positives will be marked with an asterisk (* ).


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3 Testing Controls

Positive and negative control solutions should be tested on aregular basis. This provides acheck to ensure that the teststrips are reacting properly andthe instrument is reading thestrips properly. Testing controlsalso helps detect errors causedby incorrect user technique.

CHEK-STIX® Positive andNegative Control Strips areavailable for use in your qualitycontrol program for routine urinetesting (see page 25 for productnumbers). Prepare the controlsolutions as instructed in thepackage insert that comes withthe control product. Then test thecontrol solution using the sameprocedure as you use when test-ing patient urines.

Record the control results. Ifany results are not within the expected range, notify the labsupervisor or physician. Refer tothe bottle label and/or packageinsert for storage informationand expiration date.

Expected values are found in the package insert that comeswith the control product.

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If the test you are running isnot included in the CHEK-STIXinsert, you will need to purchasea different control product thatincludes values for that test.For information about controlmanufacturers, contact your local Bayer office (see page 24).

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You should test controls:

▲ at the start of the day;

▲ when you open a new bottleof test strips;

▲ whenever test results are in doubt;

▲ when training instrumentoperators.

Testing Specimens 4Testing Routine Urines

Testing can be started onlyfrom the READY FOR TESTscreen. Be sure the ReagentStrip name agrees with the stripbeing used.

Before beginning the day’s testing, check the test strip table to make sure it is clean.If it looks dirty, remove the table and clean it, as describedon page 17.

The urine specimen should be fresh, well-mixed, and uncentrifuged. If the urine depthis less than about 7.6 cm(3 inches), pour the specimen into a narrow tube, such as aURIN-TEK® Specimen Tube.

1 Dip a Bayer Reagent Stripinto the urine. Be sure all the test pads are wet.

2 Immediately remove theReagent Strip from the urine,dragging the edge of the stripagainst the side of the containeras you remove the strip. At thesame time, press either green

(START) key.You now have 10seconds to complete Steps 3and 4.

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Replace the cap as soonas you remove each strip fromthe bottle.

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Refer to the direction insert included with yourReagent Strips for complete information on using the strips.

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You must place the test strip while the messagePLACE TEST ON TABLE is on the screen. It will appearfor 10 seconds.

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5 The table is automaticallypulled into the instrument for reading. Results are available inone minute. Be sure not to moveor bump the table.

3 Blot the strip to removeexcess urine by touching theedge to a paper towel. Do notdrag the strip across the towel;touch the edge only.

4 Place the Reagent Strip,with the test pads facing up,into the middle trough of the teststrip table. Slide the strip alongthe table until it touches the endof the trough.

If results are printed:The test results are automaticallyprinted. Press the PRINT key toreprint the last set of test results.Press PAPER, if desired, to addblank lines after the results.

If results are displayed:To view results, press the keyrepeatedly. When all results havebeen displayed and recorded,press EXIT. To display theresults again, press DISPL.

Getting Results

Testing with CLINITEK® Tests

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Wipe the test strip table with a damp, lint-free tissue.Do this as often as needed toprevent urine from building up.Also, wipe the table after testinga urine that is visibly bloody orthat gives a very high result onany test pad.

Thermal print will fade with time. Also, do not coverthermally printed results with transparent tape.

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6 Remove the used ReagentStrip and discard it in the proper container, accordingto your standard laboratoryprocedures.

Refer to the insert included withthe CLINITEK® product you areusing for directions on using thetest with the CLINITEK® 50Analyser.

Summary of Steps:1 Dip a new Reagent Strip into the urine sample.

2 Press as the strip isremoved from the urine; at thesame time, drag the strip edgeagainst the side of the container.

3 Blot by touching the edge of the strip to a paper towel.

4 Place it on the test strip table within 10 seconds.

5 Discard the strip when thetest is finished.

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1 Clean the test strip table andcheck the white bar at the endof each day or after testing 50strips, whichever is more often.Follow the directions for “DailyCleaning,” given on page 17.

2 Be sure the test table is empty.Then gently push the table abouthalfway into the instrument.

3 The instrument can be left on when it is not being used.However, if you are using thebattery pack, turn the instrumentoff to save battery power.

When You AreFinished Testing

You will be prompted to clean the table after every 50strips. Press CONT to return to the READY FOR TEST screen.

� The instrument does notdetect when the internal printeris out of paper. However, a pinkedge will appear on the last several feet of paper. Changethe roll shortly after you see this.

Operating Notes

� If you never erase the memoryor reset the sequence number,the number will continue toincrease until 999 is reached.The next number will then be 001.

If the battery pack is installed, a unique tone willsound after 15 minutes ofnonuse to remind you to turn the instrument off. It will repeatin 5 minutes, then again every minute.

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The test strip table must be kept clean if the instrument is to provide accurate test results and operate correctly. Clean the table and check the whitebar at the end of every day.

1 Remove the test strip tableby pulling it straight out of theinstrument.

2 Wet a cotton-tipped stickwith distilled water. Thoroughlyscrub the trough and surround-ing areas. Do not touch thewhite bar. Rinse the entire table(both top and bottom) withdistilled water. Discard the stickaccording to your standard labo-ratory procedures.

3 Dry the table thoroughly (except for the white bar) with a soft cloth or lint-free tissue.

4 Check the white bar fordust, marks, or scratches. If it is dirty, wet a new cotton-tippedstick and gently wipe the bar.Allow the white bar to air dryand check it again. If it isscratched or scuffed, or if itcannot be cleaned, replace the table (see page 26).

5 If you want to disinfect thetable, do that now. Or insert thetable into the instrument,pushing it in about halfway.

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Cleaning the Instrument 5Daily Cleaning

Do not use anything that will scratch the white bar. Do not use solvents ofany kind to clean the bar.

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Disinfecting the Table

1 Remove, clean, and dry the table.

2 Several solutions are safe to use on the table when theyare used for no longer than 10minutes once a day. Prepare one of the following solutions:

Use of any other solutionmay damage the table.�

� Cidex®*, Theracide®*, andAmphyl®* — these products(or their equivalent) can bepurchased for use in general disinfection. Prepare and use the solution according to the directions that come with theproduct.

� Household Bleach (5%sodium hypochlorite) — can be used either full strength or diluted to as much as a 1:20 dilution. To make a 1:20 dilution,add 5 mL of bleach to a container and add 95 mL of water, for a total volume of 100 mL. (To make a 1:10 dilution, combine 10 mL ofbleach and 90 mL of water.)

� Isopropyl Alcohol (70% to85%) — can be used fullstrength.

*Cidex (registered trademark of Johnson & Johnson)is a 3.2% glutaraldehyde solution.Theracide (registered trademark of Lafayette Pharmaceuticals, Inc., Lafayette, IN) is a quaternary ammonium solution.Amphyl (registered trademark of NationalLaboratories, L&F Products, Montvale, NJ) isa phenol solution.

3 Fill a tall, narrow containerto a depth of about 10 cm(4 inches) with the solutionyou have prepared.

4 Place the table into the solution, making sure the whitebar remains above the liquid level.

5 Soak the table for no longerthan 10 minutes, then rinse itthoroughly with water.

6 Dry the table with a soft clothor tissue and insert it into the instrument.

If the table is cleaned each day,heavy buildup should not occur.However, if the urine has driedon the table for many days,you may need to use a strongersolution to clean the tablecompletely.

1 Obtain a small volume of0.1N sodium hydroxide (NaOH).

2 Remove the table from theinstrument and clean it.

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Removing HeavyBuildup

Be sure the solution does not come in contact withthe white bar! Do not coverthe container while the table is soaking.

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Do not touch the white bar with the NaOH!�

General Cleaning

Always keep the outside of theCLINITEK® 50 instrument cleanand free of dust.You can wipethe outside with a damp (notwet) cloth and a mild detergent.

Wipe the display screen with a soft, nonabrasive cloth thathas been dampened with a mildglass cleaner. Do not spray theglass cleaner directly onto thescreen. Do not use laboratorywipes, such as Kimwipes®, sincethey may scratch the screen.

The keypad and display maybe disinfected using the samesolutions as for the test striptable (see page 18). Wipe thesolution on and allow to remainfor 10 minutes. Rinse using aclean cloth dampened withwater, then dry.

Do not use any type of solvent, oil, grease, siliconespray, or lubrication on the instrument.

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3 Wet a cotton-tipped stick with the NaOH. Thoroughlyclean the trough and side areasof the table until all urine isremoved.

4 Rinse the table thoroughlywith water to remove the NaOH.

5 Wipe the surface of the tableand the grooves on the underside of the table with a dampcloth. Then dry the table with asoft cloth or tissue and insert itinto the instrument.

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Solving Problems

Your CLINITEK® 50 Analyser willgive you trouble-free operation ifyou follow the directions for usingand cleaning the instrument. If a problem occurs, however, anerror message will be displayed.Follow the steps on the nextpage to help solve the problem.

If the printer is being used,most error messages will alsoshow the word HELP. You canpress the key under this word toprint a description of the errorand how to correct it. Press thekey under the word CONT tocontinue. With most errors, thedisplay will return to the READYFOR TEST screen; with certainerrors, you will be told to turn thepower off, then on again.

If the Bayer Reagent Strips or CLINITEK® Test seem to be causing the problem, carefullyread the direction insert thatcomes with the Reagent Stripsor Test for information that mighthelp solve the problem.

Appendix

If the Display is Blank

If there are no words on the display after the instrument hasbeen turned on, check for eachof these possible causes:

� The printer cover is notlatched: If the cover is un-latched, the instrument turns itself off; it turns on again whenthe cover is snapped shut. If atest was being read or resultsbeing printed when the coverwas raised, the results will belost and the specimen must beretested.

� The power cord is notplugged in: Check the connections at the instrument,transformer, and wall outlet.

� The batteries in the batterypack are dead: Place fresh batteries into the pack.

� The instrument is broken:Contact your local Bayer office (see page 24).

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Error Message

The batteries do not have enough powerto test any more strips. Turn the poweroff and replace the batteries.

The test strip is either upside down orwas not fully dipped. Discard the teststrip, press CONT, and retest with a new test strip.

A test strip is either not present or notpositioned properly; the short table is being used when the long table is required; or the test being used cannotbe identified by the software. Discard the strip, then press CONT and retestusing a new test strip and the correcttable, or press LIST to see if your testcan be used.

The test table is not in its correctposition. The instrument or table mayhave been moved or bumped duringtesting, or the bottom of the table maybe dirty. Discard the strip. Remove andclean the table, then reinsert. PressCONT and retest with a new test strip.

Error 3: The table is not present or is notpushed in far enough to allow movement.Push the table in about halfway.

Error 5: The long table is being usedwhen the short table is required. Insertthe proper table and retest with a newtest strip.

All other Errors: Discard the strip. Turnthe instrument off, wait several seconds,then turn it back on. If the error occursagain, contact your local Bayer office(see page 24).

Possible Causeand Remedy

REPLACE BATTERIES

READING PROBLEM-RETEST

HELP CONT

STRIP PROBLEM-RETEST

HELP CONT

TABLE PROBLEM-RETEST

HELP CONT

INSTRUMENT ERROR X

HELP CONT

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Serial Number __ __ __ __ __ __ __ __ __ __ __

Installation Date __________________________YES NO

1. Have you reviewed the error messages on page 22? � �

2. Does the test table move out to the “load” position when the Analyser is first turned on? � �

3. If Step 2 is NO —• Is the power cord plugged into a live electrical outlet, into the

transformer, and then into the Analyser? � �

• If using the battery pack, are the batteries fully charged and correctly placed in the pack and the cord plugged into the Analyser? � �

4. Does the display show the expected messages? (If the display is blank, see page 21 for possible causes.) � �

5. Does the test table move into the Analyser shortly after the key is pressed? � �

6. Does a test strip dipped into a negative control provide correct results? � �

• Has a second test strip been tried? � �

7. Is the name of the Bayer Reagent Strip shown on the display the same as the product being used? (If using any of the CLINITEK Tests, is the name of the product you are using included in the listof available tests? See page 8.) � �

8. Does the display or printout show the correct test namesand reasonable results? � �

9. Is the test table or the white bar dirty, scratched, or damaged? � �

10. Does the test table operate correctly? � �

If not, describe: ———————————————————————————

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11. Please record any error messages that have been displayed:

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If you need additional help, our Customer Service Department is here to assist you.Before you call, please fill out this checklist (you may want to make a photocopy of thepage first). Then call the nearest Bayer office using the list on the next page.

CLINITEK® 50 Problem Checklist

Where to Callfor Service

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Call the Bayer office that is nearest you:

CanadaBayer Inc. Healthcare Division77 Belfield RoadToronto, Ontario M9W 1G6Telephone: 416-248-0771

U.K.Bayer Plc, Bayer DiagnosticsBayer HouseStrawberry HillNewbury RG14 1JATelephone: 01635 566211

AustraliaBayer Australia Ltd.Healthcare Division875 Pacific HighwayPymble NSW 2073Telephone: 61 2 391-6400Telephone: 1-800-028-251

East Asia, Pakistan, Sri Lanka,Bangladesh

Bayer (Singapore) Pte, Ltd.Regional Headquarters BG-DS9 Benoi SectorSingapore 629844Telephone: 65 261-3389Fax: 65 266-3376

ProductNo. Description

6511 Battery Pack and Batteries

5773 Thermal Printer Paper (5 rolls)

1364 CHEK-STIX® Combo Pak Control Strips(1 bottle each — Positive and Negative Control Strips)

1360 CHEK-STIX® Positive Control Strips for Urinalysis(1 bottle of 25 strips)

6517 Computer Cable/Connector Kit

6521 Software Update Kit (Cable and software disk can also be ordered separately)

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Ordering Accessories

Where to Order:You can order these accessoryitems through your nearestBayer office. The address andphone number are found onpage 24.

PartNo. Description

95001874 Test Strip Table — Long (labeled “L”)(for use with Bayer Reagent Strips with five or more tests and with all CLINITEK® Tests)

95001875 Test Strip Table — Short (labeled “S”)(for use with Bayer Reagent Strips with four or fewer tests except for CLINITEK® line of tests)

50062316 Printer Cover

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Ordering Replacement Parts

Where to Order:You can order these replace-ment parts through your nearestBayer office. The address andphone number are found onpage 24.

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Specifications

Power Required:Power Transformer:

Input: 100-250 V~, 50/60 Hz, 0.5-0.3 A

Output: +9 V , 2.78 A

Optional Battery Pack —Holds 6 “AA” standard alkaline orrechargeable NiCad batteries

Up to 200 tests can be run whenusing new alkaline batteries,fewer with rechargeable batteries.

Instrument Fuse:4A, 63V, Quick-Acting(not replaceable by the user)

Line Leakage Current:<0.5 milliamperes in normal

condition<3.5 milliamperes in single

fault condition(Testing protocol and allowable limits as specified by the safety standards for laboratory equipment outlined in UL 3101-1,CSA 22.2, No. 1010.1, and IEC 1010-1.)

Computer Interface:Customized RJ11 Cable

(For use in connecting to a computer only)

Dimensions:Depth — 23.5 cm (9.2 in.)Width — 15.2 cm (6.0 in.)Height — 15.5 cm (6.1 in.)

Weight:Instrument only — 1.25 kg (2.8 lbs.)Instrument with Battery Pack —

1.42 kg (3.1 lbs.)

Ambient Operating TemperatureRange:

18°C to 30°C (64°F to 86°F)Optimum Operating TemperatureRange:

22°C to 26°C (72°F to 79°F)Ambient Operating Humidity Range:

20% to 85% Relative Humidity

Safety Standards:The CLINITEK® 50 UrineChemistry Analyser is listed

by the Underwriters’ Laboratories, Inc.(UL) and the Canadian StandardsAssociation (CSA) as certified andcomplies with the safety standardsspecified in UL 3101 and CSA-C22.2,No.1010.1.

The instrument meets the provisions ofthe IVD Directive 98/79/EC (Oct./1998).

Warning:This instrument is for in vitro diagnosticuse ( ) and must be used in the manner specified in this User’s Guide in order to provide the safety and performance standards specified.

Symbols:

DC Voltage Power Input

Computer Interface

Refer to User’s Guide for complete information on using this instrument.

Manufactured by

Authorized Representative

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Table 1

ENGLISH — CONV.Units — Conventional

Abbre- Printed/Displayed ResultsTest viation Units Normal System + / – System

YELLOW GREEN

Colour* ORANGE BLUE No Difference

RED BROWN

NEGATIVE 500 NEGATIVE 2+

Glucose GLU mg/dL 100 > = 1000 TRACE 3+

250 1+

Bilirubin BILNEGATIVE MODERATE NEGATIVE 2+

SMALL LARGE 1+ 3+


Ketone KET mg/dL TRACE > = 80 TRACE 3+

15 1+

Specific < = 1.005 1.020

Gravity SG 1.010 1.025 No Difference

1.015 > = 1.030

OccultNEGATIVE SMALL NEGATIVE 1+

Blood BLO TRACE-LYSED MODERATE TRACE-LYSED 2+

TRACE-INTACT LARGE TRACE-INTACT 3+

5.0 6.5 8.0

pH pH 5.5 7.0 8.5 No Difference

6.0 7.5 > = 9.0


Protein PRO mg/dL TRACE > = 300 TRACE 3+

30 1+

0.2 4.0

Urobilinogen URO E.U./dL 1.0 > = 8.0 No Difference

2.0

Nitrite NIT NEGATIVE POSITIVE No Difference

NEGATIVE MODERATE NEGATIVE 2+

Leucocytes LEU TRACE LARGE TRACE 3+

SMALL 1+

*Colour may be preceded with “LT.” or “DK.” Shaded areas = abnormal results

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YELLOW GREEN


RED BROWN


Glucose GLU mmol/L 5.5 > = 55 TRACE 3+

14 1+

Bilirubin BILNEGATIVE MODERATE NEGATIVE 2+

SMALL LARGE 1+ 3+

NEGATIVE 3.9 NEGATIVE 2+

Ketone KET mmol/L TRACE > = 7.8 TRACE 3+

1.5 1+

Specific < = 1.005 1.020


1.015 > = 1.030

OccultNEGATIVE Ca 25 NEGATIVE 1+

Blood BLD Ery/µL TRACE-LYSED Ca 80 TRACE-LYSED 2+

TRACE-INTACT Ca 200 TRACE-INTACT 3+

5.0 6.5 8.0


6.0 7.5 > = 9.0

NEGATIVE 1.0 NEGATIVE 2+

Protein PRO g/L TRACE > = 3.0 TRACE 3+

0.3 1+

3.2 66

Urobilinogen UBG µmol/L 16 > = 131 No Difference

33


NEGATIVE Ca 125 NEGATIVE 2+

Leucocytes LEU Leu/µL Ca 15 Ca 500 TRACE 3+

Ca 70 1+


Table 2

ENGLISH — S.I.Units — International (S.I.)

30


YELLOW GREEN


RED BROWN

NEGATIVE 3+ NEGATIVE 2+

Glucose GLU 1+ 4+ TRACE 3+

2+ 1+

Bilirubin BILNEGATIVE 2+

1+ 3+ No Difference


Ketone KET 1+ 4+ TRACE 3+

2+ 1+

Specific < = 1.005 1.020


1.015 > = 1.030

OccultNEGATIVE 1+

Blood BLD + / – 2+ No Difference

+ / – INTACT 3+

5.0 6.5 8.0


6.0 7.5 > = 9.0


Protein PRO + / – 3+ TRACE 3+

1+ 1+

3.2 66

Urobilinogen URO µmol/L 16 > = 131 No Difference

33



Leucocytes LEU 1+ 4+ TRACE 3+

2+ 1+


Table 3

ENGLISH — NORDICUnits — Nordic Plus System

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