. @ ( (CLINITCKs@@Urine Chem istry An alyzer

l )

@1998, 2003 Bay6r Healthcare LLCAll Rights BeservedPrinted in lrelandSECOND EDITION

Unless otherwise noted,all trademarl$ are the property

of Bayer Health0are LLC.

Manufactured for:

@ Bayer HealthCareBayer Health0are LLCElkhart, lN 46514 USA

t tBayer Diagnostics Manufacturing Ltd.Chapel Lane, Swords, Co. Dublin, lreland

50241761 Revised 5/03

TABLE OF GONTENTSEectian Page

INTRODUCTIONGenera l Descr ip t ion and In tended Use . . . . . . . . . . . .1 .1Components and Mechan ica lOpera t ion . . . . . . . . . . .1 .10pt ica lsys tem. . . . . . .1 .3Ca l ib ra t ion . . . .1 .3S p e c i f i c a t i o n s . . . . . . . . . . . . . . . 1 . 4Tab leso fResu l ts . . . . .1 .5

INSIALLATIONGenera l ln format ion . . . . . . . . .2 .1Environmental Factors . . . . . .2.1Unpack ing . . . .2 .1lnstrument Setup . . . .2.2lnterfacing to a Printer . .. ...2.5ln te r fac ing toaCompute r . . . . . . . . . . 2 .6lnterfacing to a Bar Code Reader. . . . . . . . . . .2.6lni t ial Instrument Check . . . . .2.6

SELECTING YOUR OPTIONSGenera l In format ion . . . . . . . . .3 .1S e t u p R o u t i n e . . . . . . . . . . . . . . 3 . 3

A. Setup Menu#1 (Date;T ime;Computerpor t ; Pr in ter ) . . . . . . . . . . . . .3 .4B. PasswordScreen. . . . . .3.5C. Setup Menu #2 (Language; Result units; Plus system; Test) . . . . . . .3.6D. Setup Menu#3 (Date, Timeformat; Date, Time separator). . . . . . . . .3.7E. Setup Menu #4 (Tests to report; Mark positives;

Positive levels; Normal levels - SG/pH, Creatinine) .. . ..3.7F. Setup Menu#5 (Color;Choicesforcolor, clar i ty; Use defaults) . . . . . . . .3.9G. Setup Menu #6 (Positive levels-Color, Clarity; Flagsfor reports) .......3.11H. Setup Menu/7 (Edit f lagged results;Entersample lD;Tech lD).. . . . . . . . . .312l. Setup Menu #8 (Computer port options; Bar code reader; Password) .. ...3.12J. Setup Menu#9 (Resetto defaults; Perform hardwaretests). ......3.15

$'Jlilff l lff i ' ff#i:l: :::::: :: :: ::: :: :::: ::::::: :::::: ::: ::: ::::: :::::3:19INSTRUMENT OPERATION

General lnformation . . . . . . . . .4.1Gett ing Ready to Run .. . . . . .4.1Testing0ontrols . . . . .4.3Testing Routine Specimens .. . . . . . . .4.4

A. Basic 0perat ion . . . . . . .4.4B. lf lDs are Used in a Loadlist . . .4.6C. lf lDs are Used Without a Loadlist. ...4.7D. Print ing/Transmitt ingResults . . . . . . . .4.8

i l lRevised 5/01

TABLE OF CONTENTS

Section Page4

ContinuedINSTRUMENT OPERATION

End-of -Run Repor ts . . . . . , . . .4 .8Editing Results in the Confirmatory Report. ... ..4.8

Recal l ing Results . . . .4.9Operat ing Notes. . . . . .4 .10

CARE OF THE INSTRUMENTGenera l0 lean ing . . . . .5 .1D a i l y 0 l e a n i n g . . . . . . . . . . . . . . 5 . 1Disinfection . . .5.3C h a n g i n g t h e P a p e r . . . . . . . . . 5 . 4

SUPPLIES & OPTIONAL EOUIPMENT . . . . . . . .6 .1

MINOR REPAIRGenera l ln fo rmat ion . . . . . . . . .7 .1P r i n t e r R e p r a c e m e n i : . . : : : . : : : : : : : : . : : : : : . . . . . . . . . . . . . . . 7 . 1Cal ibrat ing the Touch Screen . . . . . . .7.3

TROUBLESHOOTING AND SERUICEGenera l ln format ion . . . . . . . . .8 .1

WhentoCal l forAss is tance . . . . . .8 .1Where to0a l l f o rAss is tance . . . . . . . . . . . . 8 .1

Troubleshoot ingChar t . . . . . . .8 .4Preserv iceCheckl is t . . . . . . . . .8 .10

SUPPLIES & REPLACEMENT PARTSSuppl ies i0pt ionalEquipment . . . . . . .9 .1Rep lacementPar t s . . . . . . . . . . 9 .1

AppendixcPl COMPUTER AND PRINTER INTERFACE

General Informat ion. . . . . . . CPl.1Cable and Pin Specifications - Serial Port . . . CPl.1Cable and Pin Speci f icat ions- Paral le lPort . . . . . . . . .CP|.1

IND INDEX . . . . r N D . 1

IV Revised 5/03

Section 1INTRODUCTIONGeneral Description andlntended Use

The CLINITEK@ 500 Urine Chemistry Analyzer (Figure1-1) is a semiautomated, benchtop instrument designedto "read" traditional Bayer Reagent Strips for Urinalysis(e.9., MULTISTIX@ 10 SG) and Bayer MULTISTIX PRO'family of Reagent Strips. The instrument system includesa pr0gram card that contains the programming necessaryfor the CLINITEK 500 instrument to read these ReagentStrips. Strips can be laid on the instrument at any time (ifspecimen lDs are not used); a sensor detects the strip'spresence, which activates the strip movement and read-ing cycle. Communication between the instrument andthe user is through the use of a touch screen and inter-active software.

Figure 1-1

Depending on the product being used, Bayer ReagentStrips contain reagent areas for testing glucose, bilirubin,ketone (acetoacetic acid), specific gravity, occult blood,pH, protein, urobil inogen, nitrite, and leukocytes. In addi-tion to these tests, MULTISTIX PRO Reagent Strips alsocontain protein-low and creatinine reagent areas. A sin-gle protein result is reported from the two protein tests;this reading is compared to the creatinine resuli to pro-vide a protein-to-creatinine ratio. The instrument can alsodetermine and report the color of the urine, and the clar-ity can be entered for each specimen.

The instrument is a reflectance spectrophotometer thatanalyzes the color and intensity of the light reflected f romthe reagent area and reports the results in clinically mean-ingf ul units (see Tables 1-1 through 1-6). No calculationsare required by the user. Calibration is performed auto-matically each time a Reagent Strip is analyzed.

Gomponents and Mechanical0peration

Figures 1-2and 1-3 showthe majorcomponents of theCLINITEK@ 500 instrument. The pr0gram card is insertedinto the card receptacle ffi. The strips are transportedacross the read area @, where incubation and reading ofthe tests occur. All test results are printed by the internalthermal printer @ (unless this option has been selectedas "OFF" by the operator). All communications betweenthe operator and the instrument are made through theinteractive touch display @. Response keys and dialogueare displayed on the screen; responses are made by touch-ing the appropriate key symbol on the screen.

Revised 5/01 1 . 1

INTRODUCTION

The fixed platform @ consists of three sections: thestrip loading statioq@ , the incubation/read station @,and the waste bin @ . n Reagent Strip is placed onto theinstrument at the strip loading station. Detection of a stripby the strip sensor @ causes the instrument to begincycling. The strip is moved toward the incubation/readstation by the push barffi. The strip is then moved throughthe incubation/read station by a series of pins; the pinsmove the strip at a rate of about/z inch every 7 seconds.

Figure 1-3

Two readheads, located inside the read area, scan thelength of each Reagent Strip at a specific time in the incu-bation cycle. The first readhead reads the reagent areasrequiring shorter incubation times;the second reads thoserequiring longer incubation times. The pins continue tomove the strip along the platform until it drops into thewaste bin.

Figure 1-4 shows the rear view of the GLINITEK 500instrument. The line cord is connected into the line cordreceptacle @. The instrument is turned on by pressingthe power switch @to the 0N ("-") position. The inter-face connectors @ are the points at which a computer,printer, and/or handheld bar code reader may be inter-faced with the instrument. An extra port is available forfuture use. The instrument is cooled by alan@.

Figure 1-4

All programming for the instrument is contained in areplaceable pr0gram card ffi, shown in Figure 1-5. Thecard is pr0grammed with such information as errormessages, operating sequence, and the wavelengthsand algorithms used to convert reflectance into clinicallymeaningful results. lt also contains the customized Setupinformation selected by the user. The card is easily replace-able for future software updates.

1.2 Revised 9/98

Figure 1-5

The instrument stores the operating parameters, plusup to 500 patient results and 200 control results, in abattery-backed RAM memory. This memory is savedregardless of whether the power is on or off.The operat-ing parameters (including those selected by the user) arealso stored on the pr0gram card and can be copied toother CLINITEK 500 instruments.

0ptical SystemThe instrument contains two readheads, each of which

contains an incandescent lamp and photodiode pack.When a strip is moved into position underthe readhead,the calibration cycle is performed (see "Calibration" next),then the readhead scans the entire length of the strip, mea-suring the light reflectance of each reagent pad. A portionof the light striking the pad is reflected back to the pho-todiode pack. The light reflected at specific wavelengthsfrom the test pad is dependent upon the degree of colorchange in the pad and is directly related to the concen-tration of the particular constituent in the urine.

The photodiode pack contains four filters, one each at400-510 nm (blue), 510-586 nm (green), 586-660 nm(red), and 825-855 nm (lR). The light intensity detectedby the photodiode pack is converted into electrical im-pulses, which are processed by the instrument's micro-processor and converted into clinically meaningful results.The results can be printed by the internal printer; they canalso be sent to a computer and/or a form or 80-columnprinter.

GalibrationCalibration is performed at each readhead immediately

before each Reagent Strip is read. The fixed platformcontains two white calibration bars that are positioneddirectly under each readhead. As a strip comes into posi-tion under a readhead, the instrument is calibrated for thatscanning cycle by reading the calibration bar. The ReagentStrip is then scanned and the data stored in memory.

Revised 9/99 1 . 3

INTRODUCTION

SpecilicationsPower Required:

100-240 VAC -+10%, 50-60 HzMaximum Power Input:

72VAFuse Rating: (not user-replaceable)

2A,250 V 2AG, SB(T)*Line Leakage Current:

Traditional Bayer Reagenl Strips TABLES OF RESULTS

'Color may be precoded with "1T." or 'DK." when determined by the instrument. lf determined visually, Shaded areas = default abnormal resultsdefault descriptions can be changed by the user; "0THER" can also be repofted.

t Reported results are default descriptions that can be changed by the user.

Table 1'1Traditional Bayer Reagent Strips

ENGLISH - CONV.Units - Conventional

Tesl AbbreviationUnitsRepofled Results

NormalSystem Plus Syslem

Glucose GLU mg/dLNEGATIVE .2+ .TRACE , 3+.1+ ,, .*.t ,,

'

Bilirubin BIL

NEGATIVE ;4ffi,'.ii'W-ffi':#:ffiKetone KFT mg/dL

Specific Gravity SG=1.030

No Difference

Occult Blood BLONEGATIVE -ortl$ l I

*L! | nc4,: y il;;+ i

pH pH5.05.56.0

6.5 8.07.0 8.57.5 >=9.0

No Difference

Protein PRO mg/dLNEGATIVE ;i|':ll*sqffiry'tffi. ffiffi

Urobilinogen URO E.U./dL0.21.0

tl' ffi No DitferenceNitrite NIT NEGATIVE ffi No DitferenceLeukocytes LEU

NEGATIVEi l

Sr,:"1

Color' c0LYELLOWORANGEilW..NwifiitilD)rl No Ditference

Glaritltt(detsmlnd viulv) CLA

CLEARNo Ditference

RF.'il

Revised 5/01 1 . 5

INTRODUGTION Traditional Bayer Reagent Slrips

Test AbbreviationUnitsReported Results

NormalSystem Plus System

Glucose GLUNEGATIVE ,',, ': 3+l + :ii: i:, i ,, l+2+

NEGATIVE :'2+TRACE ts+1 +

Bilirubin BIL NEGATIVE iii::::, ,::: :::: ::::2T:::

t i ; ; ' i : , 3 +r r i : : : : ; , . No Difference

Ketone KEINEGATIVE ':i= ,,, iir 3#

i: : ;,i',: 'i

"

4+ B'|-Hffiii:tiiiijl

Specific Gravity SG=1 .030

No Ditference

0ccult Blood BLDNEGATIVE i,::::ti;, .- :: ,:: [+:::i+i-;; ,;;, 2++z- XNTACT;:,1 3+

No Difference

pH pH5.05.56.0

6.5 8.07.0 8.57.5 >=9.0

No Difference

Protein PRONEGATIVE rit:.:-. i:: ::,:',,,r 2+'.+/it ,;:i, ,r I 3+

, i + t , = n * l i , , , , ,NEGATIVE.T.RACE,'1i+

24' ''i:di

a:j

Urobilinogen UBG umol/L3'2 i:ii:r 'll r:-r::r ilr:::rii0s16 >=131$$illrii. iii:illftxix.'i ,ril: ,a. ,,r, :.::..r

No Ditference

Nitrite NIT NEGATIVE ii;: FOSITIVE No Ditference

Leukocytes LEUNEGATIVE ' 3*

' i1t . .

4+2+ , i , l , l

NEGATIVE 2+

TTt' ,,'r, ' i i i , ,i '*

Color' c0LYELL0W , 'r' IGREENORANGE i BLUERED ;i: BROWN

No Difference

Clarityt(detemind vislly) CLA

CLEAR ,',- '1lF,,llRSIFj|loffit ' ;.+ioryrn't No Ditference

*Color may be preceded with '1T." or "DK." when determined by the instrument. lf debrmined visually, Shaded areas = default abnormal resultsdefault descriptions can be changed by the user; 'OTHER" can also be reported

t Reported results are default descriptions that can be changed by the user.

Table 1-2Traditional Bayer Reagent Strips

ENGLISH _ NORDICUnits - Nordic Plus System

1 . 6 Revised 5/01

Traditional Bayer Reagent Strips

Test AbbreviationUnitsReported Results

NormalSystem Plus System

Glucose GLU mmol/LNEGATIVEa;5

. l:t4 ;

g8>=55

NEGATIVE

ff$tt...U+0+

Bilirubin BIL NEGATIVE MODERAIE.

LARGTNEG.ATIVE .;:r r;. iir. 21a i : 6 : ir t t I i . : v I

Ketone KET mmol/LNEGATIVE ,, , 3.9TRACE '

.- >=7.8

1 .5 ' , , ,NEGATIVEfffi*,1i1ii| *.:r'r,,1,',.,.,iii

erG#

Specific Gravity SG=1 .030

No Difference

Occult Blood BLD Ery/uLNEGATIVE : Ca 25TRACE-LYSED Ca80TRACE.INTACT Ga 2OO

NEGATIVEtBffif.tY$r0,.,,TB E-nlrlT ST

:1i#r-nffil$#

pH pH5.05.56.0

o.c

7.0/ . c

8.08.5

>=9.0No Difference

Protein PRO g/LNEGATIVE 1.0TRACE ' >;i.O0 3 i , ' , 1

NEGATIVE ":,, ,: '2+TRACE 3+

ll +

Urobilinogen UBG umol/L3.2 ,i 6616 >=1313$ i::,:: : ' i

No Ditference

Nitrite NIT NEGATIVE POSITIV No Ditference

Leukocytes LEU Leu/uLNEGATIVE Ca.I25

H;l l': ' ' casoo

; : : : t : i l ; , .2W:{.r*

Color- c0LYELL0W

.;,',,,...,.., i GRmi$}.ORANGERED i.' i: :, gnOWN

No Difference

ClaritYt(dtemind visally) CLA

CLEAR iisr-clorlDY iCIUDY l

No Difference

*Color may be preceded with '1T." or "DK." when determined by the instrument. lf determined visually, Shaded areas = default abnormal resultsdetault descriptions can be changed by the user; "0THER" can also be reported.

t Reported results are defuult descriptions that can be changed by the user.

Table 1-3Traditional Bayer Reagent Strips

ENGLISH - S.I .Units - International (S.1.)

Revised 5/01 1 . 7

INTRODUCTION MULTISTIX PRO Reagent Strips

Test AbbreviationUnitsPrinted/Displayed Results

NormalSystem +/- System

Glucose GLU mg/dLNEGATIVE : ,-,' :,,5001002 5 0 " ,

Bilirubin BIL NEGATIVE MODERAT.ESMALL LARGENEGATIVE

l

1 + 3 +

Ketone KFI mg/dLNEGATIVETRACE"t5

-:' ': 40:irF=80

NEGATIVE .,, , , .-. .=: ' : .==..,, : , ,8

il[*t'.=t'., =.t==,-"-'=="4+

Specific Gravity SG=1 .030

No Ditference

Occult Blood BLONEGATIVE :'1;.:; ii, $MAlT'i:'iTRACE-LYSED ' ::,, M0DERATE,,,TRASE'INTACT I.ARGE.

NEGATIVETRACE-LYSID lTnAcE;illrn0t,

1 +2+$+

pH pH5.05.56.0

b.c7.0

8.08.5

>=9.0No Ditference

Urobilinogen URO E.U./dL0.21 .02i0

4.0 ii;$.0 I No Ditference

Nitrite NIT NEGATIVE POSITIVE No Ditference

Leukocytes LEUNEGATIVE . .. MODERATETBACI " " : i ' , 'UnGfSMALL

NEGATIVE 2+TRAfiE T;'' i 3*1 + ' t , : - ' :

Protein PRO mg/dLNEGATIVE ,.,...... ....-: l|CIO I11 30030

NEGATIVE ' :'2-iLOW 3+l :

Creatinine CRE mg/dL1 050100

200300 No Ditference

Protein-to-CreatinineRatio

P:C mg/g

NORMAL DILUTE'NORMAL

150 ASNOHMAL3OOAFNORMAL>$00 A8fioRMALr

No Difference

Color. c0LYELLOW . . GREENORANGE : .BLUERED i: BB0WN

No Difference

Claritv**(dstmind vis@lly) CLACLEAR

.. i,;,T,,Ufi8f[]SL CLOUDY ' OTHENCLOUDY:" i,

" i

No Ditlerence

t Specimen is too dilute to accurately determine ntio result. Repeat test on new specimen. Shaded areas - default abnormal results*Color may be preceded with "1T." or "DK." when determined by the instrument. lf determined visually,default descriptions can be changed by the user; "OTHER" can also be reported.

"Reported results are defauh descriptions that can be changed by the user.

Iable 1-4MULTISTIX PRO Reagent Strips

ENGLISH - CONV.Units - Conventional

1 . 8 Revised 5/01

MULTISTIX PRO Reagent Strips

Tesl AbbreviationUnits Printed/D isplayed ResultsNormalSvslem +/- System

Glucose GLUNEGATIVEt i2*,,, )'

3.* NEGATIVElTfii\ffl'l',.iif:uF,:::i:,,:!::titi'i,,,:

ZT

3#

Bilirubin BIL NEGATIVE 2+1 + , r 3 + No Difference

Ketone KflNEGATIVE 3+. t l

1 + ' 4 +t t : t :

a ,z-r

NEGATIVE$.fiI6Fr-i....'r{:+:..::tr:,i'.....', :::

2t+s$

Specific Gravity SG=1 .030

No Difference

0ccult Blood BLDNEGATIVE+/-+r* INTAGT,

t,,+t'+3+

No Difference

pH pH5.05.56.0

6.5 8.07.0 8.57.5 >=9.0

No Ditference

Urobilinogen UBG umol/L3.21 633

,.,'. 6E*lSrt No Difference

Nitrite NIT NEGATIVE POSITIVE No Difference

Leukocytes LEUNEGATIVE ,, ,'' :

" 3+

il+.., ,r '

, , , ' , t t 4+

t2+ ,,

i'

NEGATIVETRAcE1 +

?#i3+

Protein PRO s/LNEGATIVE16xtr .,,....i;rlw r . ::::,:

flt-,S.*i No Difference

Creatinine CRE mmol/L0.94.48.8

17.726.5 No Ditference

Protein-to-CreatinineRatio

P:C mg/mmol

NORMAL DILUTE'NORMAL

No Difference

Color* c0LYELL0W 5;,,:.],GREGNiORANGE

,I;RED , ' ' - , BRowNjNo Difference

Claritv**(diemind viMlv) CLA No Ditference

tSpecimen is too dilute to accurately determine ratio result. Repeat test on new specimen. Shaded areas = default abnormal results'Color may be preceded with "1T." or "DK." when determined by the instrument. lf determined visually,default descriptions can be changed by the user; "oTHER" can also be reported.

'*Reported results are default descriptions that can be changed by the user.

Table 1-5MULTISTIX PRO Reagent Strips

ENGLISH - NORDICUnits - Nordic Plus System

Revised 5/01 1 . 9

INTRODUCTION MULTISTIX PRO Reagent Strips

Test AbbreviationUnitsPrinled/Displayed Results

NormalSystem +/- Svstem

Glucose GLU mmol/LNEGATIVE5.514

--.,,!,tt=5fl.;

NEGATIVE ,:ir r r ' ::, ,: ' :?+l

ffi$i rr1 ,||iiF$+Bilirubin BIL NEGATIVE

.MODERATESMALL LARGE

NEGATIVEt f

-12ft-t3'#

Ketone KFT mmol/LNEGATIVE lii i i i i i l '- r':, S.9,

[iffifit. .,.iiiiiiii, [..=-':.:,. ,,,,,,'',.i'*lili INEGATTVE :,: 2+RAGE i:' i..:i

Specific Gravity SG=1 .030

No Ditference

0ccult Blood BLD Ery/uLNEGATIVE Ca75.fnlcetvsgD cano-TRACE.INTAGT ': CA MO

NEGATTVETRACE-LYSED .2+TRACE.INTACT 3+

pH pH5.05.56.0

6.5 8.07.0 8.57.5 >=9.0

No Difference

Urobilinogen UBG umol/L3.2 66

13 r' ',, i i No DitferenceNitrite NIT NEGATIVE i : POSITIVE No Ditference

Leukocytes LEU Leu/uL, Ch:.U5,'i" , 1 , , , . o * o ; X

Protein PRO slLNEGATIVE ;: : 1.0

8:lu r 30NEGATIVE 2+

ll*i' , ,;:.,,,, ::i.urio t*

Creatinine CRE mmol/L0.94.48.8

17.726.5 No Ditference

Protein-to-CreatinineRatio

P:C mg/mmol

NORMAL DILUTETNORMAL

:li{'i;r"-:;. - NoRffi ':l :'ss.g ABNoRMifL>56.6 ABNORMAL

No Ditference

Color* c0L No Ditference

Clarity**(dgtmind vis@lly) CLA No Ditference

lSpecimen is too dilute to accurately determine ratio result. Repeat test on new specimen. Shaded areas = default abnormal results'Color may be preceded with "1T." or "DK." when determined by the instrument. lf determined visually,

. . default descriptions can be changed by the user; "oTHER" can also be reported.

" Reported results are default descriptions that can be changed by the user.

Table 1-6MULTISTIX PRO Reagent Strips

ENGLISH - S-I.Units - International (S.1.)

1 . 1 0 Revised 5/01

Section 2INSTALLATIONGeneral Information

This section provides detailed installation instructionsfor the CLINITEK@ 500 Urine Chemistry Analyzer. Theinstallation steps must be followed correctly to ensureproper installation, operation, and service. Read this0perating Manual carefully before attempting to operate theCLINITEK 500 instrument. Follow all instructions carefully.

The CLINITEK 500 is a precision instrument and mustbe handled accordingly. Rough handling or dropping ofthe instrument will disturb internal calibrated optics andelectronics and/or cause other damage. Always handlethe instrument with care.

Environmental FactorsAs with all sensitive electronic instruments, prolonged

exposure to excessive humidity and temperature shouldbe avoided. Temperature should be held relatively con-stant to obtain the highest degree of operating stability.The ambient temperature range for operating the instru-ment is 18'C to 30"C (64'F to 86'F); the optimumtemperature range is 22'Cto 26"C (72'F to 79"F). Attemperatures under 22'C, urobil inogen and leukocyteresults may be decreased, and at temperatures above26'C, increased. The ambient operating humidity rangeis 20% to 80% relative humidity.

Place the instrument where it will not be subjected toextreme temperature variations. Avoid proximity to openwindows, direct sunlight, ovens, hot plates, open burn-ers, radiators, and dry ice baths. Do not place it on thesame bench as a source of vibration, such as a centrifuge.The CLINITEK 500 instrument should not be used in anexplosive atmosphere. The bench space should be largeenough to allow free air circulation around the instrument(3 inches/7.6 cm on all sides).

Unpacking1 .

2.

You should have received two cartons: one cartoncontains the CLINITEK@ 500 instrument and a box ofaccessory parts; the other (the "lnstallation Pack")contains the power cord and operating manual thatare appropriate for your country. Carefully remove thecontents of each carton. Inspectthe shipping cartons,accessory box, and instrument for visible signs ofdamage. lf damage to the instrument exists, immedi-ately file a complaint with the carrier.The following items, shown in Figure 2-1, are packedwith the instrument:@ Fixed platform, holddown plate, and waste bin liner@ Moving table (2)@ Printer paper@ Push bar (2)ffi Program cardS Holddown plate (extra)

Figure 2-1

Revised 9/99 2.1

INSTALLATION

3.

The remaining items shown in Figure 2-1 are packedin the Installation Pack and shipped in a separate con-tainer f rom the instrument:@ Operating manual: Binder and manual pages(Manual pages may be supplied separately by your Bayer rep-

resentative. Depending on the language of the operatingmanual you have received, there may also be a WarrantyRegistration Card and/or a Customer Information Card.)

@ Power cordMake sure all these items have been included withyour instrument, and keep them for future use.After the instrument has been unpacked, place it on afirm, level work surface in the designated work area.The instrument should appearlevel, both side to sideand front to back. The back and sides of the instru-ment should be at least 3 inches from an adjacent wallor instrument.N0TE: Retain the CLINITEK 500 shipping carton andpacking for at least several weeks. lf the instrumentever needs to be shipped, the shipping carton wil lafford the best protection against damage.Locate the piece offoam packing that is underthe readarea cover. Gently pull down and forward on the foamto remove it (Figure 2-2).IMP0RTANT: Be sure to remove the foam beforecontinuing!

5. lf you have not already done so, insert the pages ofyour Operating Manual into the binder.

Instrument Setup1. Ensure that the instrument power switch is in the 0FF

("O") position. Then plug the instrument l ine cordinto the instrument and into an appropriate ground-ed AC electrical outlet.

2. Locate the bar-coded serial number. which is foundinside the instrument near the front left c0rner (Figure2-3). Write the installation date and serial number inthe spaces provided in the "Preservice Checklist" inSection 8 and on the Manufacturer's Warranty Pagethat is found at the end of this manual (contact yourBayer representative for your warranty information ifthis page is not included in your manual).

Figure 2-3

3. lf a Warranty Registration Card is found at the frontof your manual, write the installation date and instru-ment serial number on this card. After the instrumenthas been successfully installed, completely fill out theWarranty Registration Card and mail.

4.

2.2

Figure 2-2

Revised 9/99

4 Install the moving table as follows:a. Hold the table with the small rectangular tab fac-

ing to the back.b. Align the two grooves on the bottom of the table

with the edges of the platform on which the tablerests (Figure 2-4).

Figure 2-4

c. Gently push the table in as far as it wil l go. lt mustbe pushed past a detent in order to be correctly inposition.

5. Next, installthe fixed platform. (The holddown shouldalready be securely installed onto the platform. lf it isnot installed, or is loose, refer to Section 5, "DailyCleaning," Step 11-a, for directions on install ing theholddown.) Align the two grooves on the bottom ofthe platform with the arms extending from the instru-ment, as shown in Figure 2-5. (The ledges on the leftand right sides of the holddown align just outside theread area cover, and the top edge of the platform alignsjust under the cover.) Gently push the platform in asfar as it will go. (lt must be pushed past a slight detentto be correctly positioned.)

CAUTI0N: lf the platform does not push in at leasthalfway with only very gentle pressure, do not forceit! Ensure that the moving table is correctly positionedand attempt to reinstall the platform.N0TE: With the init ial installation, you may need touse firm pressure to push the platform the final%inch (1 .3 cm). lf the platform is not fully seated, orif it is slightly crooked, the strips may jam as they arepushed along the platform.

Figure 2-5

6. Hold the push bar by its indented end and, with thisend slightly upward, insert the peg on the other endof the bar into the hole in the pusher mechanism(Figure 2-6). Lower the push bar into place.

Revised 9/99 2.3

INSTALLATION

Figure 2-6

7. Hold the program card with the labelfacing fonruardand the arrows pointing in and up. Insert the card intothe card receptacle (Figure 2-7) and press it in firmlyuntil the button above the receptacle is pushed out.When properly inserted, the edge of the card will beflush with the side of the instrument.

Figure2-7

8. Install a roll of printer paper and re-install the printercover as follows:a. Notice the large tab on the back side of the instru-

ment that secures the cover in place (Figure 2-8).Press in firmly on the bottom edge of the tab andlift the cover 0ff.

Figure 2-8

b. 0btain a new roll of paper; unrollseveral inches andtrim the end into a long "V". Hold the rolljust abovethe printer, with the paper unrolling from under-neath. Feed the end of the paper under the roller,then rotate the paper advance wheel in a clockwisedirection (toward the back) until several inches ofpaper are exposed above the printer (Figure 2-9).

2.4 Revised 9/99

"1 .

Interfacing to a PrinterThe CLINITEK 500 can be interfaced to most 80-

column, cont inuous feed pr inters or to the CLINITEK@Form Printer via the printer (parallel) port that is foundon the rear of the instrument.

Some printers may include an interface cable that isappropriate for use; if not, you will need to obtain thecable separately. Refer to Appendix CPl, "COMPUT-ER AND PRINTER INTERFACE," for the pin specifica-tions for the male connector. The other end of thecable wil l be dependent upon the particular printer.Appropriate cables are available at most retail com-puter stores.Connect the appropriate end of the interface cable tothe printer port on the CLINITEK 500 (labeled "@")(see @ Figure 2-11 Ior location); connect the otherend to the printer.

Figure 2-9

c. Set the paper into position behind the printer. Then,place the fronttabs ofthe cover into their slots andfeed the end of the paper through the opening inthe cover. Snap the cover into place.

9. lf not already installed, place a liner into the waste bin(Figure 2-10).

Figure 2-10

2.

#'1, , l l$iffi

^ . .bbg9*"$. cwr$

Figure 2-11

Revised 5/01 2.5

lnterlacing to a PrinterThe CLINITEK 500 can be interfaced to most 80-

column, continuous feed printers or to the CLINITEK'Form Printer via the printer (parallel) port that is foundon the rear of the instrument.1. Some printers may include an interface cable that is

appropriate for use; if not, you will need to obtain thecable separately. Refer to Appendix CPl, "COMPUT-ER AND PRINTER INTERFACE," forthe pin specifica-tions for the male connector. The other end of thecable wil l be dependent upon the particular printer.Appropriate cables are available at most retail com-puter stores.

2. Connect the appropriate end of the interface cable tothe printer port on the CLINITEK 500 (labeled "@")(see @ Figure 2-11 Ior location); connect the otherend to the printer.

Figure 2-9

c. Set the paper into position behind the printer. Then,place the front tabs of the cover into their slots andfeed the end of the paper through the opening inthe cover. Snap the cover into place.

9. lf not already installed, place a liner into the waste bin(Figure 2-10).

Figure 2-10

F.::.$ ffi

^l-'it*

l9*$. c

Figure 2-11

, r G

Revised 5/01 2.5

INSTALLATION

3. Carefully read the operating manualthat accompaniesthe printer and become familiar with its operationbefore using.

lnterlacing to a GomputerThe CLINITEK 500 can also be interfaced to a host

computer or LIS (Laboratory Information System) via theserial port and a Null modem cable. The cable require-ments for interfacing to a computer are found in AppendixCPl, "COMPUTER AND PRINTER INTERFACE." Connectthe appropriate end of the intejace cable to the port onthe cLINITEK 500 labele6 ,,@u (@ in Figure 2-11);connect the other end to the appropriate port on thecomputer, following the instructions given with thecomputer.

Interfacing to aBat Gode ReaderA Handheld Bar Code Reader (Product No. 6469) is

available for use with the CLINITEK 500 Analyzer. lt isconnected through the RJ45 interface port (labeled 'lHlll")@ in Figure 2-11). Refer to Appendix BCR that is includ-ed with the Handheld Reader for complete information.

lnitial Instrument GheckAfter the CLINITEK 500 has been properly installed,

perform the following initial instrument check. The actionsthat should occur during instrument operation aredescribed in this check. lf problems occur during thisprocedure or if an error message is displayed, refer toSection 8, TROUBLESHOOTING AND SERVICE.

1 .Press the power switch to the 0N ("-") position. Thepush bar will move and the display will be illuminat-ed, first showing the instrument name and a series ofdots while the system initializes. lt then changes tothe title screen, which shows the software versionnumbers, along with the instrument name and copy-right information. The system then does several inter-nal checks and procedures. Each checkand its statusis displayed while the testing is being performed. Verifythat the fan is on by holding your hand near the fancover located at the upper left corner on the rear ofthe instrument.NOTE: lf an error occurs, a message will be displayedthat instructs you either to turn the power off,thenback onafter several seconds, or to contact customerservice (see Section 8, TROUBLESHO0TING ANDSERVTCE).The display changes to the Ready/Run screen, whichis the starting point for testing and selecting theoptions that will customize the instrument to meetyour laboratory's needs. The screen also shows thename of the Bayer Reagent Strip for Urinalysis that isprogrammed for use on the instrument (for example, -"MULTIST|X 10 SG").

The Ready/Run screen will be displayed as, forexample:

U s e l { U L T I S T I X 1 0 S G .P I a c e s t r i p ,

trtr@@tr

tr@I D :

S E O # : 0 0 0 0 1

C o I o r - ( n o t r e p o r t e d )

C t a r . i t y - ( n o t r e p o r t e d )

l l e n u T e c h I D :0 9 - 0 5 - 9 8 1 0 : 3 2 A l {

2.6 Revised 5/03

Verify that the Reagent Strip name being displayedagrees with the strip to be used. Use of any other stripwill cause erroneous results. lf the strip names donot agree, the selected strip must be changed beforebeginning testing. The strip is selected through theSetup Routine, described in Section 3.Completely immerse a Bayer Reagent Strip into a neg-ative control urine, such as CHEK-STIX@ NegativeControl Strips solution. lmmediately remove the strip.While removing, slowly run the edge of the entire lengthof the Reagent Strip against the side of the tube toremove excess urine. Do nof blot the edge of the stripagainst a paper towel, as doing so may affect test results.Place the Reagent Strip, with reagent areas up, ontothe strip loading station (Figure 2-12).The push barshould begin moving almost immediately, pushing thestrip into the read area, and the keys shown on thedisplay wi l l be shown as dimmed (part ial ly l i t )symbols.

Figure2-12

After the strip has been read, the test results will beprinted by the internal printer. The instrument shouldproduce a result for each reagent area that is withinthe limits given in the package insert for the controlur ine.lf the instrument does not perform as expected, or ifthe printed results do not agree with the expected val-ues, refer to Section 8, TROUBLESH00TING ANDSERVICE.Before beginning normal instrument use, carefullyreview the following sections to become familiar withthe instrument software, operating techniques, andcleaning requirements:Section 3 SELECTING YOUR OPTIONSSection 4 INSTRUMENT OPERATI0NSection 5 CARE OF THE INSTRUMENTWith satisfactory completion of the initial instrumentcheck, the CLINITEK 500 Analyzer is ready for rou-tine testing. Enter the Setup Routine and follow thedisplayed prompts to customize the software foryour laboratory. Refer to Section 3 for completeinformation.

5.

3.

4.

7.

Revised 9/99 2.7

$ection 3SELECTING YOUR OPTIONSGeneral Information

All interact ion between the operator and theCLINITEK@ 500 Analyzer is through the touch screen.Messages, options, and requests for information aredisplayed, along with "keys" that can be touched torespond in the desired manner. A light touch is all thatis necessary to activate the key. Do nol use an$hing hardor pointed on lhe touch screen. (lf a key does notrespond, press it for a slightly longerlime, rather lhanhader.). lf an option key is aclive, the key symbol is dis-

played fully lit. Whenever an active key is touched, youwill see a change either in the display or in the instru-ment operation.

. lf an option key is nol active, the key symbol isdimmed and a unique double tone will sound if it istouched.Several keys are displayed on various screens, and they

will always have the same function whenever they are dis-played:r ttEl

Retum toBeady/Run

Returns the screen to the Ready/Run screen;must be touched when exiting the Setup Routinein order to save the changes made. lf this keyis touched from a screen in which data isrequested and

SELEGTING YOUR OPTIONS

EMoveUp

mIUloveUp 10

MMoveDown

WMovo

Down 10

trPlus

trMlnus

@Alphabet

EDelete

Move Up displays the previous stored result orentry in descending order (lower sequence num-be0. Move Up 10 displays the record storedten positions lower than the currently displayedrecord: if there are fewer than ten lower-num-bered results, the oldest stored result 0r entry isdisplayed.Move Down displays the next stored result 0rentry in ascending order (higher sequence num-ber). Move Down 10 displays the record storedten positions higher than the currently displayedrecord; if there are fewer than ten higher-num-bered results, the most recently stored result 0rentry is displayed.

Plus increases the displayed number by 1 eachtime the key is touched.

Minus decreases the displayed number by 1 eachtime the key is touched.

Changes the display to the full alphabet to allowentry of alphabetic characters in, for example, aspecimen lD, Tech lD, or control lot number.

Allows a single record or all records shown onthe screen to be deleted. A second screen isalways displayed, from which you can select howmany records are to be deleted (one or all) or toconfirm that all records are to be deleted.

Allows one or more records from a displayed listto be printed.

Allows one or more records from a displayed listto be resent to a computer.

In addition to the function keys, three different types ofkeys will be displayed in order to assist the operator inselecting the desired option in various menus. lf the key isdisplayed as a fully lit symbol, the key can be touchedto select the option or cycle through the list of options.lf the key is displayed as a dimmed symbol, the option isnot available for selection.

Touching an action key selects the optiondescribed next to the key. The display alwayschanges to another screen, either to start theselected routine or to display an appropriatescreen that defines how the selected option willwork.

The cycle key is used when several options areavailable. Each time the key is touched, a dif-ferent option is displayed for selection. Whenthe desired option is displayed, the selection iscomplete.

Selection keys are used to select or reject the useof an option. lf a check mark (.,/ ) appears in thekey symbol, the option is selected (turned on);if the key symbol is empty, the option is notselected (turned off).

rPilnI

ERssend

AcNionKey

SelsGtionKey

3.2 Revised 9/99

Setup RoutineThe Setup Routine should be entered when the instru-

ment is init ially installed to select the various param-eters desired by your laboratory. Thereafter, this routinewill probably be entered infrequently. Several of theoptions can be accessed freely; for example, the date andtime can be changed through this routine, the com-puter port turned 0n or lff, and the printer selected.Access to additional options can be protected through theuse of a password.

Table 3-1 , at the end of this section, shows a flow chartof the Menu Option and the Setup Routine, which is select-ed from the Menu 0ption.

Enter the Selup Routine from the Ready/Run screen,shown below; for example:

U s e 1 4 U L T I S T I X 1 0 S G .P t a c e s t r i p .

trEEEtr

tr@I D :

S E A # : 0 0 0 0 1

C o I o r - ( n o t r e p o r t e d )

C t a r i t y - ( n o t r e p o r t e d )

i l e n u T e c h I D :0 9 - 0 5 - 9 8 1 0 : 5 2 A i l

Touch the key symbol ( E ) next to the word Menuto display the 0ption Menu; for example:

Touch the Setup key symbol from the Option Menuto enter the Setup Routine.NOTE: Memory may be erased if a change is madeto any of several Setup options. All results and loadlist-ed lD numbers stored in memory will be deleted when thechange is made. A warning screen will be displayed first,and you will be given the option of not making the changeto the Setup option, saving the stored results and num-bers. Be sure all patient and control results have beenprinted and/or transferred and that a loadlist is notstored in memory before making the changes.

S e t o p t i o n s .

trtrtrEtr

T e c h I D :

C o n t r o t s

S e t u p

P r i n t

l i l emo r y

Revised 5/01 3.3

SELECTING YOUR OPTIONS

S e t o p t i o n s .

D a t e : 0 9 - 0 5 - 9 8

T i m e : 1 0 : 3 4 A i l

C o m p u t e r p o r t - 0 F F

P r i n t e r

trtr

A. Setup Menu #1The first Setup menu is displayed; for example:

Touch the key symbol that appears next to the option youwant to change. Each option is described below.

1. Date:a. When the Date key is touched, the display changes

to show the current date and a numeric keypad bywhich the date can be changed (the date format andseparator can be changed through Setup Menu #3,Step D). For example:

Enter the correct date by touching the proper numer-ic keys, or touch the arrow keys to move thecursor to the digit that needs to be changed andenterthe correct number. The message will changeas you move from one part of the date to the next,showing the prompt, for example, "Enter day," then"Enter year." Be sure to enter the leading "0"where needed.When the date has been entered, touch

4. Printer:a. Touch the Printer key symbol to change several

printer options:i. Internal: The internal printer can be used to print

patient results, with several options for the for-mat, 0r it can be turned o/f. Touch the lnternalcycle key to select the desired option of OFF or0N, with 2,6,or 12 blank lines between patientresult sets.N0TE: There are always two blank lines betweencontrol result sets.

ii. Gustom header: When "12 blank lines betweenpatient result sets" is selected for the internalprinter, a header is printed at the end of eachprinted report obtained through that printer. Thedefault header is "MlCR0SCOPICS";this can becustomized, if desired, or changed to contain allblanks if you do not want a header at all.

When the Guslom header option key istouched, an alphabetic keyboard is displayed,from which up to 24 letters and spaces can beentered. Touch

SELECTING YOUR OPTIONS

G. Setup Menu #2The second menu of the Setup Routine is displayed as,

for example:

1 . Each of the menu options feature cycle keys that, whentouched, display the next in a series of options for themenu item.. Language: All screens will be displayed in the lan-

guage that is selected. Also, the default selection forseveral other options may change, depending uponthe language selected (for example, the date and timeformats, test name [Reagent Strip type], and report-ing of color).

. Resull units: Several of the languages have optionsforthe units in which results are displayed. See theTables of Results at the end of Section 1 for theresults that are displayed and printed for each option.(As with Language, the default selection for severalother options may change, depending upon the resultunits selected.)

. Plus system: Results can be displayed and printedin the Plus system (which uses "+" symbols) ratherthan in clinical units such as mg/dl.

. Test: Many configurations of Bayer Reagent Stripscan be used on the CLINITEK 500 Analyzer. However,not all configurations are available in every country.Be sure the Reagent Strip selected agrees with thename of the Bayer Reagent Strip being used.

2. Touch the cycle keys as needed to obtain the desiredoption. The table below lists the options that are avail-able for each of the cycle keys:

S e t o p t i o n s .

L a n g u a g e - E n g L i s h

R e s u t t u n i t s -C o n v e n t i o n a I

P I u s s y s t e m - 0 F F

T e s t - I 4 U L T I S T I X 1 O S G

trtrLanguage:

EnglishFrangaisDeutschItalianoKanji

EspafiolPortugu0sChinese

Result units:(with English,

Frangais, Deutsch,and Chinese)Conventional

Nordic.s.t.

.English only

Plus syslem:

OFFON

TestJMULTISTIXO.IO SG COMBISTIXo SG - LONGMULTISTIX'9 SG HEMA.COMBISTIX@ - LONGMULTISTIXO 8 SG URISTIX'- LONGMULTISTIX'SG LIFESTIXoMULTISTIX@ SG L MULTISTIX PRO' .I1MULTISTIX@ MULTISTIX PRO'1OLBN.MULTISTIX'SG MULTISTIX PROO l()LSNEPHROSTIX'L MULTISTIX PRO'1OSBURO-HEMACOMBISTIX'SG L MULTISTIX PRO' 1OURO-LABSTIX'SG MULTISTIX PRO'7GURO.LABSTIX@ SG L MULTISTIX PRO@ 7PHMULTISTIX'9 MULTISTIX PRO@ 68URO-HEMACOMBISTIX' MULTISTIXPRO@6KURO.LABSTIX@

tNot all Reagent Strips are available in all countries.

3.6 Revised 5/01

D. Setup Menu #3When all selections have been made from the second

menu, touch ) to move to the third menu in the SetupRoutine;for example:

S e t o p t i o n s .

D a t e f o r n a t - l t l o n t h l D a y l Y e a r

D a t e s e p a r a t o r - " - "

T i m e f o r m a t - 1 2 H o u r trtrAs with the previous menu, each of the options featurecycle keys. The available options are:

Touch the keys as needed to selectthe desired options.

E. Setup Menu #4When all selections have been made from the third

menu, touch ) to move to the next menu in the SetupRoutine;for example:

1. Tests to report and their order:Even if an analyte or physical parameter is tested onthe CLINITEK 500 Analyzer, you may choose to notreport it; you can also select the order in which thetests are reported. lf "English S.1." is the selected lan-guage, color is also included as the last test if notalready selected, it can be added to the end of the list.You can also choose to include clarity (determinedvisually)as a reported resultthrough this menu option.

When the action key is touched, the display willshow a series of cycle keys, labeled 1 through 12.Forexample:

S e t o p t i o n s .

T e s t s t o r e p o r t a n d t h e i r o r d e r

l l a r k p o s i t i v e s - 0 N

P o s i t i v e t e v e I s f o r t e s t s

N o r m a t t e v e t s f o r S G / p H

N o r m a [ [ e v e L s f o r C R E

tr@trtrtr trtr

Date fomal:

Month/DayffearDay/MonthffearYear/Month/Day

Dale separator:r

_ r ,

' , "

r r l t ,I

Time format:12 Hour24 Hour

Time separator:, ,

: , ,a, ,,

,aa ,,

Revised 5/01 3.7

SELECTING YOUR OPTIONS

S e I e c t t e s t st h e i r o r d e r .

r @ e r u 5

t @ r , . 6

t @ . r , 7

, , E s c 8

t o r e p o r t a n d

B L O 9

P R O 1 1

U R O 1 2

trEN I T

L E U

@EEffi

1 0

E@@@

p H

The number of fully lit keys will equal the numberof tests being reported, plus one, with exception of theP:C ratio - see Step 1-a below). Each time a new testis added to the list, the next key becomes fully lituntil the number equals the number of tests on theselected Bayer Reagent Strip plus two (color andclarity). (Note that only one protein result is reportedfrom the protein-low and protein-high tests whenusing MULTISTIX PRO@ Reagent Strips.) lf the testsbeing reported and their order are all correct, touchthe ( key to return to the previous menu. lf you wantto make changes, proceed as follows:a. P:C Ratio: l f you are using a MULIISTIX PRO

Reagent Strip, the instrument will calculate a pro-tein-to-creatinine (P:C) ratio. The P:C ratio willalways be reported and will always appear in the/asf position of the reported results. lts order can-not be changed and, therefore, this test will notappear on the screen for selecting the tests to report.

b. Selecting Color/Glarity: lf color and/or clarity arenot listed, you can quickly and easily add one or bothto the list by touching the last fully litkey until thedesired test name (COL or CLA) is shown. Touchthe next key (which is now fully lit) to add the othertest name. Color and clarity will be reported in thelast two positions if you make no further changes.

c. lf you want to change the order in which tests arereported, touch the cycle key at the first positionyou want to change. Any test(s) not already listedwill be displayed first; then a blank will be displayedand all tests from that position on will be erasedand must be re-entered. Touch the cycle key untilthe desired test is displayed. As each test isselected, the next test in the list will be the firsttest displayed for the following position.

d. Select the desired test for each of the remainingpositions. lf you want to remove a test from thereporting order (not reported), select the tests youdo want to report and leave a blank description inthe final position.

e. When the correct tests and order are displayed,touch {.

Malk positives:All positive results can be marked with an asterisk (.)in the displayed and printed report, as well as in thedata transferred to a computer. Touch the cycle key tochange the selection between 0N and OFF.l'l0TE: lf this option is OFF, you will be unable to makeselections for several other options (see StepsE-3, E-4, E-5, G-1 , G-2, and/or G-3 later in thissection).Positive levels lor tests:The lowest result that is considered to be positive canbe changed from the default levels, if desired, for eachof the chemistry tests. (The physical parameters of SG,pH, color, and clarity are changed in other menuoptions.) lf "Mark positives" (Step E-2 previously) is0N, all positive results are marked with an asterisk (.)in the displayed and printed report, as well as in thedata transferred to a host computer. These levels arealso used by the Analyzer to determine which speci-mens meet the criteria for the confirmatory and micro-scopic reports. When the action key is touched, thedisplay shows the lowest positive level for the first fourtests selected in the previous screen (Tests to report).

2.

3.8 Revised 5/01

lf Protein has been selected as a reported test, thefirst screen shows three different options for Protein,one for each of the different groups of Bayer ReagentStrips that can be used on the instrument. The report-ed results for protein vary slightly, depending uponwhich group of Reagent Strips is used (see the Tablesof Results in Section 1). The first option is for the tra-ditional Bayer Reagent Strips (e.9., MULTISTIX 10 SG);the second is for MULTISTIX PRO 68 and MULTISTIXPRO 6K strips (not available in all countries); and thethird is for all other MULTISTIX PRO strips. By select-ing the first positive level for each group, you canthen select a different strip for use in testing (Step C-1previously) without having to change the selection ofthe first positive level of the protein test.NOTE: Nitrite is not listed, since it has only one posi-tive level. Also, the P:C ratio is not listed, since theseresults already include a description of "N0RMAL" or"ABNORMAL."a. Touch the cycle keyforthetestyou wantto change,

repeating until the desired level is displayed.b. When alltests on the first screen are correct, touch

) to display the remaining tests (if additional testsare reported).

c. When alltests are correctly set, touch { as need-ed to return to the previous option menu.

4. Normal levels for SG/pH:The lower and upper limits of the range considered tobe normalfor SG and pH can be selected by touchingthis key. Each limit is set separately; however, the upperlimit must be higher than or equal to the lower limit.a. Touch the * or - keys next to the limit you want

to change to raise or lower the displayed number.With each touch, the number will change by onereporting level until it is equal to the opposite limitor is at the highest or lowest reporting level.

b. When all limits have been set, touch { to returnto the previous option menu.

N0TE: This option can be selected only if "Mark pos-itives" (Step E-2 previously) is 0N.

5. Normal levels for CRE:As with SG and pH, the lower and upper limits of thenormal range for creatinine can be selected by touch-ing this key. However, you must be using a MULTISTIXPRO Reagent Strip in orderforthis option to be active.Each limit is set separately, but the upper limit mustbe equal to or higher than the lower limit.a. Touch the * or - keys next to the limit you want

to change to raise or lower the displayed number.With each touch, the number will change by onereporting level until it is equal to the opposite limitor is at the highest or lowest reporting level.

b. When both limits have been set, touch { to returnto the previous option menu.

N0TE: This option can be selected only if "Mark pos-itives" (Step E-2 previously) is 0N.

F. Setup Menu #5When all options on the fourth menu have been cor-

rectly set, touch ) to proceed to the next Setup menu;for example:

S e t o p t i o n s .

C o I o r -d e t e r m i n e d b y A n a I y z e r

C o I o r c h o i c e s

C l . a r i t y c h o i c e s

U s e d e f a u t t C 0 L / C L Ad u r i n g r u n - 0 N

trtr

Revised 5/01 3.9

SELEGTING YOUR OPTIONS

Golor:lf color has been selected as 0ne of the tests to bereported (in Step E-1 previously), it can either be deter-mined by the CLINITEK 500 Analyzer or be enteredmanually by the technician from a visual determina-tion. Touch the cycle key to select the desired option("determined by Analyzer" 0r "entered by tech"). lf"entered by tech" is selected, the color can be enteredas part of a loadlist and/or just before each specimenis tested.N0TE: Color can be determined by the Analyzer onlyif the Bayer Reagent Strip being used contains theleukocyte test. Results reported by the Analper maybe different from the color seen visually. This is becauseof the inherent differences between the human eye andthe optical system of the instrument.Golor choices:lf the color option above is "entered by tech," you canspecify up to seven options from which to select thespecimen color. Any of the default options can beremoved from the reporting list; the name of eachoption can also be customized.a. The first four default colors will be displayed ini-

tially (YELL0W ORANGE, RED, GREEN). lf theselection key contains a check mark, the color isincluded in the list; touching the key removes thecheck, deleting the option from the list. (The firstoption must be selected and is always shown as adimmed key.)

b. The color name can be changed by touching theword describing the color. The display will changeto the alphabetic keyboard. Use the G keyto erasethe existing name, if necessary, and enter the newname of up to 15 letters and spaces. Touch

G. Setup Menu #6Touch ) to move to the next Setup menu when all

selections have been made on the fifth menu. The newmenu is displayed as, for example:

S e t o p t i o n s .

P o s i t i v e t e v e t s f o r C 0 L / C L A

F I a g s f o r c o n f i r n a t o r y t e s t s

F I a g s f o r m i c r o s c o p i c s

trtr1. Posilive levels for G0UGLA:

lf either color or clarity was selected as a test to bereported, the first result that is considered to be pos-itive can be selected. As with the chemistry tests andif "Mark positives" (Step E-2 previously) is 0N, theselevels are used by the Analyzer to determine whichspecimens meet the criteria for the confirmatory andmicroscopic reports. Positive results are also markedwith an asterisk (.) in the displayed and printed reportand in the data transferred to a host computer. Whenthe selection key is touched, the display shows the firstlevel that is considered to be positive.a. Touch the appropriate cycle key until the display

shows the first level you want to have marked aspositive. All results later in the list are also calledpositive. lf you have not changed or removed anyof the descriptions (Step F-2), the options are:

2.

b. Touch { when both selections have been madeto return to the previous option menu.

Flags for confirmatory tests:Up to five tests (of those to be reported) can be select-ed for the confirmatory report. lf a specimen has a pos-itive result for any of the tests selected, and if "Markpositives" is 0N (see Step E-2), the record will beflagged and can be recalled as part of a confirmatoryreport. Further testing can then be performed on thesespecimens and the results of the confirmatory testingentered into the record, if desired.a. When the action key is touched, the display will

show a list of all tests that are to be repofted. Touchthe selection box next to the tests you want toinclude in the confirmatory report; a check markwill appear in the box. To remove a selection, touchthe box again and the box will become blank.

b. Touch { when the selections have been made toreturn to the previous option menu.

Flags for microscopics:As with the confirmatory report, up to five tests canbe selected for the microscopics report. This reportcan be used to list those specimens that may requirea microscopic examination. Select the tests for thereport in the same manneros for the confirmatoryreport, then touch { to return to the previous optionmenu. ("Mark positives" lStep E-2] must be 0N inorder to obtain the report.)

Color: I Clarity:YELLOW GREEN I CLEAR TURBIDORANGE BLUE I SL CLOUDY OTHER

BROWN I CLOUDYRED BROWN-OTHER

- lf visually determined

Revised 5/01 3.11

SELECTING YOUR OPTIONS

1 .

H. Setup Menu #7When all options have been selected on the sixth menu,

touch ) to progress to the next menu in the SetupRoutine. The menu is displayed as, for example:

S e t o p t i o n s .

E d i t f l . a g g e d r e s u I t s - 0 F F

E n t e r s a m p I e I D s - 0 F F

T e c h I D - 0 F F

trtrEdit llagged results:Results that have been flagged as positive and select-ed forthe confirmatory report can be edited (for exam-ple, if confirmatory testing has been performed). Touchthe cycle key to turn the option 0N or OFF, as desired.This option can be selected only if "Mark Positives"(Step E-2 previously) is 0N.Enler sample lDs:An identification number can be entered for each spec-imen, either as part of a load list or immediately priorto testing the specimen, if this option is set to 0N.Touch the cycle key to turn the option 0N or OFF, asdesired.Tech lD:The technician who is performing the testing can beidentified on the test results, if desired, by setting thisoption to 0N. The Tech lD can appear on control resultsonly or on both patient and control results. lt is shownon the Ready/Run screen and is easily changed whennecessary (see "Getting Ready to Run," Step 4, inSection 4). Touch the cycle key to select the desiredoption (OFF;0N, controlresults only;0N, both patientand control results).

l. Setup Menu #8When all options have been selected on the seventh

menu, touch ) to progress to the next Setup menu. Themenu is displayed as, for example:

1. Gomputer port options:lf you are sending results to a host computer or LIS(Laboratory Information System), the interface param-eters must be specified. Touch the Gompuler portoptions key to display a new menu.a. The first three menu options feature cycle keys to

select the correct parameters. The following tableshows the possible selections for these options:

S e t o p t i o n s .

C o m p u t e r p o r t o p t i o n s

B a r c o d e r e a d e r o p t i o n s

P a s s r o r d f o r s e t u p - 0 F F

s e t o r r e s e t p a s s u o r d

trtr

Port I Baud: I Data, Parity:1200 | glllof{e

0 N 1 2 4 0 0 1 7 / E V E NoFF | 4800. I T|ODD

9600 | 7/N0NE1 9200

3 j 2 Revised 5/01

The port must be 0N in order to transfer results toa computer. Refer to the specifications accompa-nying the computer for information on the requiredparameters for Baud, Data, and Parity.N0TE: The computer port can also be turned 0Nor OFF through the first Setup menu, which isunrestricted regardless of whether password pro-tection is being used (see Step l-3 later). lf use ofthe port is changed (from 0N to OFF or vice versa)in one menu, the selection is automatically changedin the other menu.

b. The fourth option on the Gomputer porl optionsmenu allows selection of the Output Format for theresults sent to a computer. A new menu is dis-played with the following options and their possi-ble selections:

0utput Format: I Ghecksum:* | Handshake:*ccs | 0N ON

OFFCT2OO+ I OFFcT200.Not available in CCS format.

The output format you select will depend uponwhetheryou already have a software interface pro-gram that allows the transfer of results from eithera CLINITEK@ 200+ or a CLINITEK@ 200 UrineChemistry Analyzer to a host computer or LlS.When one of these formats is selected ("CT200+"or "CT200"), the data from the CLINITEK 500instrument will be transmitted in the same formatas that sent by the selected instrument (the print-ed results, however, do not mimic the selectedinstrument).

Alternatively, results can be transmitted in theCLINITEK 500 format by select ing "CCS." Theparameters for this format are available from yourBayer representative or office.

lf either CT200+ or CT200 is selected as the out-put format, the use of checksum and handshakemust also be specified (refer to your computerspecification for the requirements). lt is also veryimportant that you check the selections made onyour CLINITEK 200+ or CLINITEK 200 instrumentand enter the parameters identically in theC Ll N ITE K 500 Analyze r (e.9., I D/col o r/clarity/markpositives 0N or 0FF). This will help ensure that thedata is transferred in the same format as your soft-ware program currently is written to accept.N0TE 1: Two stop bits are always transmitted inthe CT200+ and CT200 formats; one stop bit istransmitted in the CCS format.N0TE 2: lf the "CT200" format is selected, resultsobtained using any of the MULTISTIX PRO ReagentStrips will not be sent to the computer. This isbecause the new tests on the MULTISTIX PROStrips are not recognized by the CLINITEK 200Analyzer (and therefore by its corresponding soft-ware interface program).

c. Select the correct parameters for all options, thentouch { as needed to return to the previous $etupmenu.

2. Bar code reader options:An optional Handheld Bar Code Reader is available foruse with the CLINITEK 500 Analyzer. This reader canbe used to scan barcoded identification labels on eachspecimen cup or tube, rather than entering the speci-men lD manually. The Analyzer software must be con-figured to the appropriate parameters for the barcodedlabels being used. Touching the Bar code readeroptions key will change the display to a new menu.a. Label: The Handheld Reader can accept any of four

ditferent bar code formats. The format being usedcan be selected using the Label cycle key, or you

Revised 5/01 3.13

SELEGTING YOUR OPTIONS

can allow the reader to automatically detect the for-mat gpe. The label options are: Auto detect; Code39; l-2 of 5 (lnterleaved 2 of 5); Codabar; and Code128.N0TE 1: Select "Auto detect" only if more than oneformat is used; faster and more consistent read-ings will occur if the specific format being used isselected.N0TE 2: lf using Product No. 6469 (the CLINITEK@Bar Code Readerfrom Hand Held Products, Inc.),the Label option will be inactive, with "Auto detect"selected. This Bar Code Reader automatically deter-mines the correct bar code format.Test bar code: The bar code label being usedshould be tested to ensure that the information canbe read. After touching the Test bat code key,you wi l l be inst ructed t0 "s can ba r codeI a b e [ . V e r i f y t h a t i n f o r m a t i o n o n s c r e e ni s correct." Scan a label that is representativeof the quality and size being used and for whichyou know the results that should be obtained. Theresults of the test will be displayed on the screen;compare the displayed result with the known valueof the label and use this information to determineif any characters need to be deleted. Return to theprevious menu when finished.N0TE: You may want to test more than one label,especially if they are printed from different sources.lf you use more than one format, test at least onelabel in each format. Refer to Appendix BCR thataccompanies the Handheld Reader for completeinformation.Leading char. to ignore: The Handheld Reader canread a bar code that contains up to 30 characters;however, a maximum of 13 characters can be dis-played, stored, and transmitted by the Analyzer.All characters in excess of 13 must be ignored (up

to a maximum of 18). Characters can be ignoredas leading characters (at the beginning of the barcode), trailing characters (at the end), or a combi-nation of both. lf you need to ignore any leadingcharacters, touch the cycle key until the desirednumber is displayed ("0" to "9").

d. Trailing char. to ignore: Trailing characters canalso be ignored by touching the cycle key until thedesired number is displayed ("0" t0 "9").

e. When allselections have been made on this menu,touch { to return to the previous menu.

Password for setup:You can choose to require entry of a password in orderto restrict access to most of the Setup Routine optionmenus by setting this option to 0N. The password isrequested following the first option menu of the SetupRoutine, and all further menus are not accessible unlessthe correct password is entered. lf the password optionis set to OFF, all option menus in the $etup Routine arefreely accessible. Touch the cycle key to turn the useof the password 0N or OFF.Set or reset password:lf the password is being used, you can set a personalpassword or reset an existing password. The Analyzeralso has a default password o1"84437," which isalways active. The personal password can be enteredby touching the action key. A numeric keyboard is dis-played, from which you can enter up to 6 digits. Touch

J. Setup Menu #9When all options have been selected on the eighth

menu, touch ) to progress to the final menu in the SetupRoutine. The menu is displayed as, for example:

S e t o p t i o n s .

R e s e t a t I f e a t u r e s t o d e f a u t t s

P e r f o r m h a r d w a r e t e s t s

Reset all features to defaults:You can return all options in the Setup Routine to themanufacture/s default settings through the use of thiskey. A confirmation screen will be displayed, fromwhich you musttouch YES before the options are reset.All stored resulls and loadlisled lD numbers will bedeleted if lhe options are resel.Perform hardware lests:Several different hardware tests can be performedthrough this menu option. You may be asked by a BayerRepresentative to perform one 0r more of these testsin order to assist in troubleshooting a problem. Whenthe action key is touched, a new menu of six ditferentoptions is displayed. The screen also displays the totalnumber of strips that have been read by the Analyzer.a. Strip sensol: When the action key is touched, the

screen d isp lays the prompt "pra." test s t r i pon tabre." l f the str ip sensor detects the pres-ence of a s t r ip , the message "s t . i p detected"will be displayed.

Serial pofi: This test sends data from the serialport, through a connector, and back into the sameport. The data sent and received should be identical.i. Obtain a loopback connector, either by making

your own or by ordering from Bayer InstrumentService (see Section 9, "Replacement Pafts").The connector is a serial 25-pin male connec-tor on which pins 2 and 3 are connected andpins 4 and 5 are connected.

ii. Touch the Serial port action key to display thetest screen. As instructed on the screen, plugthe loopback connector into the serif port onthe back of the instrument (labeled l#), thentouch Q to begin the test. The test will con-tinue until you exit the screen (by touching ( ).

Touch screen: This test may be used to determineif the touch screen is functioning properly. Whenthe Touch screen key is touched, a screen is dis-played that is filled with small boxes. As each boxis touched, a check mark (V) should appear (itdisappears when touched again). Touch the centerof each box, saving the ( keyfor last.Bar code reader: This test is identical to the Testbar code option described in Step l-2-b so you cantest your reader without exiting the hardware testscreen. lf your Handheld Reader is not reading yourlabels, you should test labels of a known quality todetermine whether the problem lies with the labelsyou are using or with the Handheld Reader itself.The package containing your Handheld Readerincludes two sheets of barcoded labels that havebeen printed to the minimum specifications of thebar code reader. lf these labels cannot be read, theproblem is probably with your reader. lf they readproperly, the labels you are using may not beacceptable. Scan the desired label and comparethe displayed result with the known value of thelabel. Return to the previous menu when finished.

b.

1 .

2.

d .

Revised 5/01 3.15

SELECTING YOUR OPTIONS

e. Display: The display can be tested to ensure thatall pixels (the lighted elements on the display) arebeing lit and turned off appropriately. When theDisplay key is touched, the entire screen will be litfor several seconds, then be blank. This series willbe repeated twice more before returning to theprevious menu. lf there are numerous faulty pixels,or if they are located in critical areas, the displaymay need to be replaced.

f. Printer: The internal and/or 80-column externalprinter can be tested to ensure that all charactersare being printed correctly. Ensure that the exter-nal printer is turned on (if one is being used). Touchthe Printer key and follow the directions on thescreen. Examine the printout for its readability. Thedisplay automatically returns to the previous menu.

3. When alltests have been completed, touch { to returnto any previous Setup menu, or touch A to return tothe Ready/Run screen.

When Setup is GompleteTouch G to save!

When you have finished selecting the setup parame-ters, touch .! to return the display to the Ready/Runscreen. The changes you made will NOT be saved if youdo not touch .a.

It is suggested that you print a copy of the setup reportto verify your selections and to retain in your files. TouchMenu from the Ready/Run screen, then touch Prinl. Fromthe Print menu that is displayed, select the option Selupreport. (lf printing from the internal printer, make aphotocopy of the report, since the thermal print may fadeover time.)

The setup parameters are stored both in the CLINITEK500 Analyzer and in the program card. lf a new programcard is installed, you can select to use your current setupconfiguration from the Analyzer memory. Conversely, ifyou receive a new CLINITEK 500 Analyzer, but haveretained your old program card, you can select to use yourcurrent setup configuration from the program card. lf boththe Analyzer and the program card are new, you can usethe printout obtained previously to reselect the desiredparameters.

3 . 1 6 Revised 5/01

SOFTWARE FLOW CHART

Ready/Run ScreenIDSEQ #ColorClarity

Menu Option

Tech lDTouch to enter

Tech lD

ControlsTouch to enter

control Lot # andto run controls

SetupTouch to enterSetup Routine

PrintTouch to print:

. lD list

. Calibrationconfirmation

. Setup report

MemoryTouch to select:

. Allpatient results

. Allcontrol results

. Last batchResults can be viewed,

printed, sent to acomputer, or deleted

Setup Menu #1DateTimeComputer portPrinter

InternalCustom headerExternal

IIv

(Enter password, if required)IIv

Setup Menu #2LanguageResults unitsPlus systemTest

II{/

Setup Menu #3Date formatDate separatorTime formatTime separator

--- Setup Menu #4Tests to report and their orderMark positivesPositive levels for testsNormal levels for SG/pHNormal levels for CRE

Color (by Tech or Analyzer)Color choicesClarity choicesUse default COUCLA during run

II\t

Setup Menu #6Positive levels for COUCLAFlags for confirmatory testsFlags for microscopics

Setup Menu #7Edit flagged resultsEnter sample lDsTech lD

II{/

Setup Menu #8Computer port options

PortBaudData, ParityOutput Format

Bar code reader optionsPassword for setupSet or reset password

IIv

Setup Menu #9Reset all features to defaultsPerform hardware tests

Strip sensorSerialportTouch screenBar code readerDisplayPrinter

ISetup Menu #5

Revised 5/01

Table 3-1

3.17

Section 4INSTRUMENT OPERATIONGeneral Information

Following initial installation (Section 2) and selectionof your setup options (Section 3), the CLINITEK@ 500Urine Chemistry Analyzer is ready for routine operation.Carefully read this section before beginning any testing.CAUTI0N: Do not use anything poinled or hard to makeselections on the touch screen. A pencil eraser workswell.

Getting Ready to RunThe CLINITEK 500 instrument is designed to be left

on at all times (except during cleaning procedures).Either the screen saver display or the Ready/Run screen(shown below) will be displayed whenever the instrumentis not in use. (lf the screen saver is being displayed, sim-ply touch the screen anywhere to return to the Ready/Runscreen.) For example:

lf lDs are not being used and color/clarity results aredisplayed (if being reported), the instrument is ready touse immediately and enters the Run mode as soon as astrip is detected on the platform. Whenever the push baris positioned at the left side of the loading station, theinstrument is ready to accept placement of a strip; how-ever, if the bar is positioned to the right, the instrumentis not ready and any strip placed on the platform will beignored.

lf you need to access any of the menu items shown onthe display, this must be done before a run is started.During a run, most of the key symbols are dimmed, whichmeans the options are not available. The O key ($topRun) is always available during a run and, depending onthe Setup options selected, the Golor and/or Glarity keysmay be available.

lf a key is displayed as a fully lit symbol, that option isavailable for selection. Touching the specified key sym-bol causes the following actions:lD: allows specimen identification numbers to be entered.

lf lD numbers have been entered into a loadlist, thenumber of the next specimen in the list is displayed.The number is updated each time a strip is moved tothe read area.

SEO #: allows the sequence number to be changed. Thenumber being displayed represents the sequentialnumber that will be assigned to the next specimen.The number increments each time a strip is moved tothe read area.

Color: displays the next option in the series of color selec-tions that can be made for visually determined colorresults. lf color was previously entered through theloadlist, that entry is displayed for the next specimento be tested; otherwise, either the default descriptionis displayed or the display is blank until the cycle keyis touched, depending upon the select ion made inSection 3, Step F-4. (lf color is determined by theinstrument or is not being reported, the display shows" (by Ana tyzer ) " 0 r " (no t repor ted) , " respec t ive ly . )

Glarity: displays the next option in the series of clarityselections that can be made. 0therwise, the displaysare the same as for the Golot key, except that claritycannot be determined by the instrument.

Menu: takes you to the Option Menu, from which sever-al additional options can be quickly selected or changedprior to beginning a run.

O (Stop Run): cancels the run in progress (availableonly during the Run mode).

? (ttelp): displays additional information about theReady/Run screen.

U s e i l U L T I S T I X 1 0 S G .P I a c e s t r i p .

trtr@EE

tr@I D :

S E O # : 0 0 0 0 1

C o l . o r - Y E L L O U

C t a r i t y - C L E A R

i l e n u T e c h I D : 1 1 80 9 - 0 5 - 9 8 1 0 : 3 2 A l l

Revised 5/01 4.1

INSTRUMENT OPERATION

Before starling each run, perform the following steps:1. Check that the name of the Reagent Strip being dis-

played corresponds to the name of the Bayer ReagentStrip for Urinalysis that is to be used for routine urin-alysis. Use of any Reagenl Strip olher than lhe onelisted will Gause erroneous resulls. lf the names donot agree, select the correct strip name through theSetup Routine, as directed in Section 3, Step C-2.IMP0RTANT: The CLINITEK 500 Analyzer has beenoptimized for use with Bayer Brand Reagent Strips.The performance characteristics may not be valid forany other brand of strips, the use of which may causeerroneous results. Bayer Corporation does not war-rant use of the CLINITEK 500 Analyzer with anyreagent strip otherthan Bayer Brand Reagent Strips.

2. Inspect the strip loading station and push bar forcleanliness and correct positioning. lf contaminantsare present, remove the push bar, platform, and mov-ing table, and clean as described in Section 5, "DailyCleaning."

3, The 'SEQ #' (sequence number) increments with eachstrip that is placed onto the instrument. Change thestarting number if desired:a. Touch the key symbol next to the word SEO #. The

display will change to a numeric keyboard, fromwhich the new number can be entered.

b. Enter the desired number. The number can be resetto "00001" by touching the special key labeled withthat number. lf an error is made, or if you only needto change one or two digits, touch the appropriatekey (+ 0r G) to move the cursor to the digit tobe changed and enter the correct number.

c. When the correct number has been entered, touch

INSTRUMENT OPERATION

Before starling each run, perform the following steps:1. Check that the name of the Reagent Strip being dis-

played corresponds to the name of the Bayer ReagentStrip for Urinalysis that is to be used for routine urin-alysis. Use of any Reagent $trip other than lhe onelisted will Gause erroneous resulls. lf the names donot agree, select the correct strip name through theSetup Routine, as directed in Section 3, Step C-2.IMPORTANT: The CLINITEK 500 Analyzer has beenoptimized for use with Bayer Brand Reagent Strips.The performance characteristics may not be valid forany other brand of strips, the use of which may causeerroneous results. Bayer Corporation does not war-rant use of the CLINITEK 500 Analyzer with anyreagent strip otherthan Bayer Brand Reagent Strips.

2. Inspect the strip loading station and push bar forcleanliness and correct positioning. lf contaminantsare present, remove the push bar, platform, and mov-ing table, and clean as described in Section 5, "DailyCleaning."

3, The 'SEQ #' (sequence number) increments with eachstrip that is placed onto the instrument. Change thestarting number if desired:a. Touch the key symbol next to the word SEO #. The

display will change to a numeric keyboard, fromwhich the new number can be entered.

b. Enter the desired number. The number can be resetto "00001" by touching the special key labeled withthat number. lf an error is made, or if you only needto change one or two digits, touch the appropriatekey (r 0r e) to move the cursor to the digit tobe changed and enter the correct number.

c. When the correct number has been entered, touch

Testing GontrolsNegative and positive controls should be run 0n a reg-

ular basis to provide a check on the performance of theBayer Reagent Strips and on the instrument operation.Testing controls provides confidence that the ReagentStrips are reacting and being read properly. Errors result-ing from user techniques can also be detected. lt issuggested that controls be run under the followingconditions:

. At the start of the day's run;

. When using a new bottle of Reagent Strips;

. Whenever test results are in doubt;

. When training new instrument operators.CHEK-STIX@ Positive and Negative Control Strips for

Urinalysis are available for use on the CLINITEK 500Analyzer. The solutions prepared using the Control Stripsprovide positive, negative, or defined reactions when usedwith traditional Bayer Reagent Strips for Urinalysis.Alternatively, a urine specimen from a normal, healthyindividual can be used as a negative specimen. Additionalinformation on CHEK-STIX Positive and Negative ControlStrips can be found in Section 6 of this manual and inthe package inseft for the Control Strips.N0TE: lf using MULTISTIX PRO@ Reagent Strips, quali-ty control should be performed using commercially avail-able controls that include values for each test on the strip;CHEK-STIX Control Strips are not suitable for use withthese products. For information about control manufac-turers, contactyour Bayer office or representative. In theUnited States, call the Bayer Customer Service Depart-ment at 1 -800-348-81 00.

To test control specimens, proceed as follows:Prepare the appropriate control solution(s) by fol-lowing the directions found in the package insert oron the bottle label.Touch the Menu key symbol from the Ready/Runscreen, then touch the Controls key (if not alreadydone). The display will change to a numeric keyboard,from which the lot identification of the controls canbe entered, the sequential number reset, and the con-trol run started.

3.

4.

a. Notice the control sequential number displayedimmediately to the left of the lot number (e.9.,"c0035"). lf you want to reset this number, touchthe key labeled C0001.

b. Enter the lot identification of the first control to betested. lf alphabetic characters are needed, touchthe H-Z key to display the alphabetic keyboard.Touch

INSTRUMENT OPERATION

7.

NOTE: Be sure the Reagent Strip is lying parallel tothe push bar. The end of the strip should be againstthe rear wall of the platform and should not be touch-ing the bottom of the strip loading station. lmproperplacement may cause the instrument to jam or thestrip to be incorrectly aligned under the readheads.Repeat Steps 2-b through 4 for each addit ionalcontrol.The strip(s)willautomatically be advanced along thestrip loading station, under the readheads for read-ing, then into the waste bin. The results willthen beprinted (unless all printers have been turned 0FFthrough the Setup Routine)and stored in memory. lfthe computer port is 0N and GCS is selected as theoutput format (see Section 3, Step l-1), the controlresults will also be transmitted to the host computer.After all controls have been run, press ,! (after thesymbol is displayed again) to exit the control screen.The control solution should produce the values statedin the product's package insert. lf the control resultsfall outside of these values, the following sources oferror may have occurred:a. lmproper technique or instrument setup. Check

that the Reagent Strip being used corresponds tothe Reagent Strip name given on the Ready/Runscreen. Carefully repeat the control procedure asdescribed above.

b. Deterioration of the Reagent Strip test areas dueto exposure to light, ambient moisture or heat.Obtain a fresh bottle of the Bayer Reagent Stripsbeing used and repeat the control procedure. lffresh Reagent Strips fail to give results within theexpected values, proceed to Step c.

c. Deterioration of the control solution. Prepare afresh control solution and repeat the control pro-cedure. lf fresh solution fails to give results with-in the expected values, proceed to Step d.

d. Deterioration of the control product. 0btain a freshbottle of control product and prepare a fresh con-trol solution, then repeat the control procedure. lfthe fresh control solution fails to give results with-in the expected values, proceed to Step e.

e. CLINITEK 500 instrument malfunction. Perform anlnitial Instrument Check procedure (see Section 2).lf the Initial Instrument Check or the control pro-cedure cannot be successfully completed and aninstrument malfunction or reagent strip problemis suspected, see Section 8, TROUBLESH00TINGAND SERVICE, or contact the Customer ServiceDepartment for assistance.

Testing Routine SpecimensA. Basic Operation

The steps described in this section are the same regard-less of whether you are running with or without the useof lD numbers. Read this section completely to under-stand how the instrument operates during the Run Mode.1. lf clarity is being reported and/or color being entered

by the technician, select the color and/or claritydescription for each specimen. Touch the cycle key(s)as needed until the appropriate description is beingdisplayed. (Alternatively, enter the color and clarity byscanning the appropriate barcoded symbols provid-ed with the Handheld Bar Code Reader.)This shouldbe done before continuing to the next step; however,you can change the description up to the point atwhich the strip is moved.

4.4 Revised 5/01

2. Completely immerse all reagent areas of a BayerReagent Strip in fresfi, well-mixed, uncentrifugedurine. lmmediately remove the Reagent Strip. Whileremoving, slowly run the edge of the entire length ofthe Reagent Strip against the side of the urine con-tainer to remove excess urine. Do naf blot the edgeof the strip against a paper towel.NOTE: The instrument performance has been opti-mized for use with unblotted strips, and results maydiffer if the strips are blotted.Place the Reagent Strip, with reagent areas facingup, onto the strip supports of the strip loading sta-tion, to the right of the small embossed arrow (r7)and against the rear wall of the platform (Figure 4-2).

Figure 4-2

NOTE: Be sure the Reagent Strip is lying parallel tothe push bar. The end of the strip should be againstthe rear wall of lhe platfom and should not be touch-ing the bottom of the strip loading station. lmproperplacement may cause the instrument to jam or thestrip to be incorrectly aligned under the readheads.

4. The presence of the Reagent Strip is detected as soonas it is placed on the loading station. lf the instrumentwas previously at the Ready/Run screen, detection ofthe first strip immediately activates the timing andmovement functions. The push bar moves the stripalong the loading station to the read area and theSEO # increments. The strip is moved along the plat-form by a series of pins that move every seven sec-onds, passing under each of the two readheads foranalysis and then into the waste bin.N0TE: lf the instrument is already in the Run Mode,there may be a delay of up to seven seconds after thestrip is placed on the loading station before the pushbar moves. The amount of delay depends on the sta-tus of the timing cycle for the strips currently beinganalyzed.

5. For each new specimen to be tested:a. Enter the color and/or clarity description.b. Dip and place the Reagent Strip for the specimenjust entered.The instrument continues to move the strips acrossthe read area until the final strip is moved to the wastebin. A new strip can be placed on the loading stationat any time prior to then.N0TE: You will have very little time to enter thecolor/clarity after placing the strip. Therefore, it isstrongly suggested that you enter the color and clar-ity of each specimen beforedipping the Reagent Strip.

6. See Part D later in this section for information on print-ing and/or transmitting the results.

Revised 9/99 4.5

INSTRUMENT OPERATION

7. Cancelling a run: lf a problem occurs that requiresthe run to be stopped before completion of all read-ings, touch the I key symbol (Stop Run) in the upperright corner. You will be given the option of cancellingthe entire run or cancelling only the last strip that wasplaced on the platform. lf the entire run is cancelled,all strips on the platform will be moved immediatelyto the waste bin. No results will be reported (and noSEO # assigned) for any strip that had not been readat both readheads prior to pressing @; the speci-mens for those strips must be retested. lf only the laststrip is cancelled, the run will continue and a new stripcan be tested, using the same SEQ #.

B. ll lDs are Used in a Loadlist:Up to 100 specimen lDs can be entered as a loadlist

before starting the run, as described below.1 . Touch the lD key f rom the Ready/Run screen to enter

the number for the first specimen. The lD entry screenis displayed as, for example:

The lD number can be entered using the numeric key-board. lf color