Bayer HealthCare Clinitek 500 User manual

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

l)
@1998,
2003Bay6r
HealthcareLLC
AllRightsBeserved
Printed
inlreland
SECONDEDITION
Unlessotherwise
noted,
alltrademarl$are
the
property
of
BayerHealth0are
LLC.
Manufacturedfor:
@ Bayer
HealthCare
BayerHealth0areLLC
Elkhart,lN46514
USA
tt
BayerDiagnosticsManufacturingLtd.
Chapel
Lane,
Swords,Co.Dublin,lreland
50241761 Revised5/03

TABLE
OFGONTENTS
Eectian Page
INTRODUCTION
General
Description
andIntendedUse
.. ..........1.1
Components
and
MechanicalOperation..... ......1.1
0pticalsystem. ......1.3
Calibration ....1.3
Specifications...... .........1.4
TablesofResults. ....1.5
INSIALLATION
General
lnformation .
........2.1
Environmental
Factors ......2.1
Unpacking ....2.1
lnstrumentSetup
. ...2.2
lnterfacing
to
a
Printer ......2.5
lnterfacing
toaComputer.... ......2.6
lnterfacing
toaBarCode
Reader.
..... .....2.6
lnitial
InstrumentCheck .....2.6
SELECTING
YOUROPTIONS
General
Information .........3.1
SetupRoutine..... .........3.3
A.Setup
Menu#1
(Date;Time;Computerport;Printer)..... ........3.4
B.
PasswordScreen. .....3.5
C.Setup
Menu
#2
(Language;
Result
units;Plussystem;Test)
.. .....3.6
D.Setup
Menu#3
(Date,
Timeformat;
Date,Timeseparator). ........3.7
E.Setup
Menu
#4
(Tests
toreport;
Mark
positives;
Positivelevels;
Normal
levels
- SG/pH,Creatinine) ...
..3.7
F.Setup
Menu#5
(Color;Choicesforcolor,
clarity;
Use
defaults).. ......3.9
G.Setup
Menu
#6
(Positive
levels-Color,
Clarity;
Flagsforreports) .......3.11
H.Setup
Menu/7
(Editflaggedresults;EntersamplelD;Tech
lD).... .......312
l. Setup
Menu#8
(Computer
port
options;
Barcodereader;Password) .....3.12
J.Setup
Menu#9
(Resetto
defaults;
Performhardwaretests). ......3.15
$'Jlilffllffi'ff#i:l:
:::::::::::::
::::::::::::::::::::::
::::::::
:::::3:19
INSTRUMENTOPERATION
General
lnformation ...
......4.1
Getting
Ready
toRun ..
.....4.1
Testing0ontrols .....4.3
Testing
Routine
Specimens ......
...4.4
A.
Basic
0peration .....
..4.4
B.lflDsareUsed
ina
Loadlist ...4.6
C.
lflDsareUsed
Without
aLoadlist. ...4.7
D.
Printing/TransmittingResults ........4.8
ill
Revised5/01

TABLE
OFCONTENTS
Section Page
4
Continued INSTRUMENT
OPERATION
End-of-RunReports. ....,...4.8
EditingResultsin
the
Confirmatory
Report. ...
..4.8
RecallingResults ....4.9
Operating
Notes. .....4.10
CAREOF
THEINSTRUMENT
General0leaning .....5.1
Daily0leaning..... .........5.1
Disinfection ...5.3
ChangingthePaper .........5.4
SUPPLIES&OPTIONAL
EOUIPMENT ........6.1
MINORREPAIR
General
lnformation ....
.....7.1
PrinterRepracemeni:..:::.::::::::.:::::..... ..........7.1
Calibrating
theTouchScreen .......7.3
TROUBLESHOOTINGANDSERUICE
Generallnformation .........8.1
WhentoCallforAssistance ......8.1
Whereto0allforAssistance..... .......8.1
TroubleshootingChart. ......8.4
PreserviceChecklist. ........8.10
SUPPLIES&
REPLACEMENT
PARTS
Suppliesi0ptionalEquipment... ....9.1
ReplacementParts ..........9.1
Appendix
cPl COMPUTERANDPRINTER
INTERFACE
General
Information. ......CPl.1
Cable
and
Pin
Specifications
- Serial
Port ...
CPl.1
Cable
andPinSpecifications-
ParallelPort... ......CP|.1
IND INDEX ....
rND.1
IV Revised5/03

Section
1
INTRODUCTION
General
Descriptionand
lntended
Use
TheCLINITEK@500UrineChemistry
Analyzer
(Figure
1-1)is
asemiautomated,benchtop
instrumentdesigned
to
"read"
traditionalBayerReagent
Strips
for
Urinalysis
(e.9.,
MULTISTIX@10
SG)
andBayer
MULTISTIX
PRO'
familyofReagent
Strips.
Theinstrumentsystem
includes
a
pr0gram
cardthatcontainsthe
programming
necessary
for
theCLINITEK
500instrumentto
readthese
Reagent
Strips.Strips
canbelaid
on
theinstrument
atany
time
(if
specimen
lDsarenot
used);
asensordetects
the
strip's
presence,
whichactivatesthestripmovement
and
read-
ingcycle.Communicationbetween
theinstrument
and
theuser
isthroughthe
useofa
touchscreen
and
inter-
activesoftware.
Figure1-1
Dependingon
the
product
being
used,Bayer
Reagent
Strips
contain
reagent
areas
fortesting
glucose,
bilirubin,
ketone
(acetoacetic
acid),specific
gravity,
occult
blood,
pH,protein,
urobilinogen,nitrite,and
leukocytes.
Inaddi-
tiontothesetests,MULTISTIXPRO
ReagentStrips
also
contain
protein-low
andcreatinine
reagentareas.
Asin-
gleprotein
resultisreportedfrom
thetwo
protein
tests;
this
reading
iscomparedtothecreatinine
resuli
to
pro-
vide
a
protein-to-creatinine
ratio.
Theinstrumentcan
also
determineand
reportthe
color
oftheurine,
andthe
clar-
ity
canbeentered
for
eachspecimen.
Theinstrumentis
a
reflectance
spectrophotometer
that
analyzesthecolorand
intensity
ofthelight
reflectedf
rom
thereagentareaandreportstheresultsinclinically
mean-
ingfulunits
(see
Tables1-1through
1-6).Nocalculations
are
required
bytheuser.Calibrationis
performed
auto-
maticallyeachtimeaReagent
Strip
isanalyzed.
Gomponents
and
Mechanical
0peration
Figures1-2and1-3
showthe
majorcomponentsof
the
CLINITEK@
500instrument.The
pr0gram
card
isinserted
intothecard
receptacle
ffi.Thestripsare
transported
across
thereadarea
@,
whereincubationand
readingof
the
tests
occur.
Alltestresults
are
printed
by
the
internal
thermal
printer
@(unless
thisoptionhasbeenselected
as
"OFF"
by
the
operator).
Allcommunicationsbetween
theoperator
andtheinstrument
are
madethrough
the
interactivetouchdisplay
@.
Responsekeysanddialogue
are
displayedonthescreen;responsesaremadeby
touch-
ingthe
appropriate
keysymbolonthe
screen.
Revised
5/01 1.1

INTRODUCTION
Thefixed
platform
@consistsof
threesections:
the
strip
loading
statioq@
,
theincubation/read
station
@,
andthewastebin
@.nReagentStrip
is
placed
onto
the
instrumentat
the
strip
loading
station.
Detection
ofastrip
bythestripsensor
@causes
theinstrument
tobegin
cycling.
The
strip
ismovedtowardthe
incubation/read
stationbythe
push
barffi.Thestrip
isthenmoved
through
theincubation/readstationbyaseriesof
pins;
the
pins
movethe
strip
atarateofabout/z
inch
every
7seconds.
Figure1-3
Tworeadheads,
locatedinsidethereadarea,scan
the
lengthof
each
Reagent
Strip
ataspecific
time
intheincu-
bationcycle.
Thefirstreadheadreads
thereagentareas
requiring
shorter
incubation
times;thesecond
readsthose
requiringlongerincubationtimes.
The
pins
continue
to
move
the
stripalong
the
platform
until
itdrops
into
the
waste
bin.
Figure1-4
shows
therearview
of
the
GLINITEK
500
instrument.Thelinecord
is
connected
into
the
line
cord
receptacle
@.
Theinstrumentisturnedonby
pressing
the
power
switch
@to
the
0N
("-") position.
Theinter-
faceconnectors
@
arethe
points
atwhichacomputer,
printer,
and/or
handheldbarcodereadermaybeinter-
facedwiththeinstrument.Anextra
port
isavailable
for
futureuse.Theinstrument
is
cooledbyalan@.
Figure1-4
All
programming
fortheinstrumentis
contained
ina
replaceable
pr0gram
card
ffi,shown
inFigure1-5.The
card
is
pr0grammed
withsuchinformationaserror
messages,operatingsequence,and
thewavelengths
andalgorithmsusedtoconvertreflectance
into
clinically
meaningful
results.lt
alsocontains
the
customizedSetup
informationselectedby
the
user.
The
card
is
easily
replace-
able
forfuturesoftwareupdates.
1.2 Revised9/98

Figure
1-5
The
instrumentstorestheoperating
parameters,
plus
upto500
patient
resultsand200control
results,
ina
battery-backed
RAMmemory.This
memory
issaved
regardless
of
whetherthe
power
is
on
oroff.The
operat-
ing
parameters(including
thoseselected
by
theuser)are
alsostoredon
the
pr0gram
cardand
canbe
copied
to
otherCLINITEK500
instruments.
0ptical
System
Theinstrument
contains
tworeadheads,each
ofwhich
containsan
incandescent
lampand
photodiode
pack.
Whenastrip
ismovedinto
position
underthe
readhead,
thecalibrationcycleis
performed(see
"Calibration"
next),
thenthereadheadscanstheentirelengthof
thestrip,
mea-
suring
thelightreflectanceofeachreagent
pad.
A
portion
of
the
lightstrikingthe
pad
isreflected back
to
the
pho-
todiode
pack.
Thelightreflectedatspecific
wavelengths
fromthetest
pad
isdependentuponthedegree
of
color
change
inthe
pad
andisdirectly
relatedtothe
concen-
trationofthe
particular
constituentin
the
urine.
The
photodiodepack
contains
fourfilters,one
each
at
400-510nm
(blue),
510-586
nm
(green),
586-660
nm
(red),
and825-855
nm
(lR).
Thelightintensity
detected
by
the
photodiodepack
is
converted
intoelectrical
im-
pulses,
whichare
processed
bytheinstrument's
micro-
processor
andconverted
into
clinically
meaningful
results.
Theresults
canbe
printed
by
theinternal
printer;
theycan
also
be
sent
toacomputer and/oraformor
80-column
printer.
Galibration
Calibration
is
performed
ateachreadhead
immediately
beforeeachReagent
Strip
isread.
Thefixed
platform
contains
twowhitecalibrationbarsthatare
positioned
directlyundereach
readhead.As
astrip
comes
into
posi-
tion
undera
readhead,theinstrumentiscalibrated
for
that
scanningcycle
byreadingthecalibrationbar.
TheReagent
Strip
isthenscanned
and
the
data
storedin
memory.
Revised9/99 1.3

INTRODUCTION
Specilications
PowerRequired:
100-240VAC
-+10%,
50-60
Hz
Maximum
Power
Input:
72VA
FuseRating:
(not
user-replaceable)
2A,250
V2AG,
SB(T)
*Line
Leakage
Current:
<0.5
milliamperesinnormal
condition
<3.5
milliamperesin
single
fault
condition
Heal0utput:
ApproximatelV
246BTU/hour
Dimensions:
Depth
- 32.4
cm
(12.8
in.)
Width
- 37.7cm
(14.8
in.)
Height
-28.2
cm
(11.1
in.)
Weight:
7.4k9
(16.3lb.)
Ambient0peratingTemperalure
Range:
18'Cto30"C
(64"Fto
86"F)
Ambient0peratingHumidityRange:
20%to80%
relative
humidity
0ptimum0peratingGonditions:
22'C
to26'C
(72't
to79"F);
35%
to55%relativehumidity
NOTE:
Because
ofthe
nature
of
theurobilinogen
and
leukocyte
reagents
foundon
BayerReagentStrips,
thesetwo
results
maybedecreasedat
temperatures
below
22'C
(72"F)
and
increasedattemperatures
above
26"C
(79'F).
SafetyStandards:
The
CLINITEK@500UrineChemistry
Analyzer
(Mo_del
6470)
islisted
by
the
Undenruriters'Laboratoriei
(@)
and
the
CanadianStandards
Association
(@.)
as
cer-
tifiedand
complieswiththesafetystandards
specified
in
UL
3101and
CSA-C22.2.
No.
1010.1.
Theinstru-
*Testing
protocol
andallowable
limits
as
specilied
bythesafety
standards
forlaboratory
equipmentoutlined
inUL3101-1
,CSA22.2
N0.1010.1,and
IEC
1010-1.
mentmeetsthe
provisions
of
theIVDDirective98n9ftC
(0ct./1998)(((), whichincludestheEMCDirective
89/336Amendment92131|EECand
the
Low
Voltage
Safety
Directive7
3123IEEC.
The
safetystandardsspecify
thattheinstrument
must
operatesafely
inthefollowingconditions:
. indoor
useonly
. installation
category
ll
(lEC
1010)
. pollution
degree2
(lEC
1010)
. maximumaltitude2000meters
(6560
feet)
Warning:
Theinstrumentisfor
professional,
invitrodiagnostic
use
(@) andmust
be
usedinthemannerspecified
inthe
0perating
Manualin
order
toprovide thesafety
and
performance
standardsspecified.
Symbols
on
Back
of
Analyzer:
Centronics
Port
(Parallel)
lorPrinter
SerialPort
(RJ45)
forBar
Code
Reader
Not
a
telephone
jack
SerialPort
(RJ45)-
notcurrentlyactive
SerialPort
(ElA-2320)
forhost
computer
SN SerialNumber
ASTMSoltware
Interface:
Conforms
toASTM
E1381-91.,
"Specification
tor
Low-
LevelProtocoltoTransferMessagesbetween
clinical
laboratoryinstrument
andcomputersystems"
and
ASTME
1394-91,
"Specification
forTransferring
InformationBetween
Clinical
InstrumentsandComputer
Systems."
!il1il]il
@
P
o*
1.4 Revised
5/03

TraditionalBayerReagenl
Strips TABLES
OF
RESULTS
'Color
may
be
precoded
with
"1T."
or
'DK."
when
determined
by
theinstrument.
lf
determined
visually, Shadedareas
=
default
abnormal
results
defaultdescriptions
can
bechanged
by
theuser;
"0THER"
can
alsoberepofted.
tReportedresults
aredefaultdescriptions
thatcanbechanged
bytheuser.
Table
1'1
TraditionalBayer
Reagent
Strips
ENGLISH
- CONV.
Units
- Conventional
Tesl AbbreviationUnits RepofledResults
NormalSystem Plus Syslem
Glucose GLU mg/dL NEGATIVE .2+.
TRACE ,3+.
1+ ,, .*.t ,,
'
Bilirubin BIL
NEGATIVE ;4
ffi,'.ii'W-ffi':#
:ffi
Ketone KFT mg/dL
SpecificGravity SG <=1.005 1.020
1.010 1.025
1.015 >=1.030 NoDifference
Occult
Blood BLO NEGATIVE -ortl$ l I
*L!|nc4,:y il;;+ i
pH pH 5.0
5.5
6.0
6.5 8.0
7.0 8.5
7.5 >=9.0 NoDifference
Protein PRO mg/dL NEGATIVE ;i|':ll*sq
ffiry'tffi.
ffi
ffi
Urobilinogen URO E.U./dL 0.2
1.0 tl' ffi No
Ditference
Nitrite NIT NEGATIVE ffi NoDitference
Leukocytes LEU NEGATIVE il Sr,:"1
Color' c0L YELLOW
ORANGE
ilW..NwifiitilD)rl NoDitference
Glaritltt
(detsmln€d viulv) CLA CLEAR NoDitference
RF.'il
Revised5/01 1.5

INTRODUGTION TraditionalBayerReagentSlrips
Test Abbreviation
Units ReportedResults
NormalSystem Plus
System
Glucose GLU NEGATIVE ,',,': 3+
l + :ii: i:, i ,,
l+
2+
NEGATIVE :'2+
TRACE ts+
1+
Bilirubin BIL NEGATIVE iii::::,
,:::
::::
::::2T:::
ti; ;'i:, 3+rri::::;,. NoDifference
Ketone KEI NEGATIVE ':i= ,,,iir 3#
i: : ;,i',:'i
" 4+ B'|-
Hff
iii:tiiiijl
Specific
Gravity SG <=1.005 1.020
1.010 1.025
1.015 >=1.030 NoDitference
0ccultBlood BLD NEGATIVE i,::::ti;,
.-:: ,::
[+:::i
+i-;; ,;;, 2+
+z-
XNTACT;:,1 3+ NoDifference
pH pH 5.0
5.5
6.0
6.5 8.0
7.0 8.5
7.5 >=9.0 NoDifference
Protein PRO NEGATIVE rit:.:-.
i::
::,:',,,r
2+'.
+/it ,;:i, ,r I 3+
,i+t,=n* li,, , , ,
NEGATIVE
.T.RACE
,'1i+
24
' ''i:di
a:j
Urobilinogen UBG umol/L 3'2 i:ii:r
'll
r:-r::r
ilr:::rii0s
16 >=131
$$illrii.
iii:illftxix.'i
,ril:,a.
,,r,
:.::..r NoDitference
Nitrite NIT NEGATIVE ii;:
FOSITIVE NoDitference
Leukocytes LEU NEGATIVE ' 3*
'i1t .. 4+
2+ ,i, l,l
NEGATIVE 2+
TTt' ,,'r,
'iii
,,i '*
Color' c0L YELL0W , 'r'
IGREEN
ORANGE i BLUE
RED ;i: BROWN NoDifference
Clarityt
(detemin€d vislly) CLA CLEAR ,',- '1lF,,llRSIFj
|loffit' ;.+ioryrn't NoDitference
*Color
maybe
preceded
with
'1T."
or
"DK."
whendetermined
by
theinstrument.
lfdebrminedvisually, Shaded
areas
=
default
abnormal
results
defaultdescriptionscanbe
changedbytheuser;
'OTHER"
canalsobe
reported
t Reportedresults
aredefault
descriptions
thatcanbechanged
by
the
user.
Table
1-2
Traditional
Bayer
Reagent
Strips
ENGLISH
_ NORDIC
Units
- Nordic
Plus
System
1.6 Revised5/01

TraditionalBayer
Reagent
Strips
Test AbbreviationUnits ReportedResults
NormalSystem Plus
System
Glucose GLU mmol/L NEGATIVE
a;5
.l
:t4 ;
g8
>=55 NEGATIVE
ff$tt... U+
0+
Bilirubin BIL NEGATIVE MODERAIE
. LARGTNEG.ATIVE .;:r
r;. iir. 21
a i : 6:i
rtt I i .: v I
Ketone KET mmol/L NEGATIVE ,,, 3.9
TRACE ' .- >=7.8
1.5 ',,, NEGATIVE
fffi*,1i1
ii|
*.:r'r,,1,',.,.,iii
er
G#
SpecificGravity SG <=1.005 1.020
1.010 1.025
1.015 >=1
.030 No
Difference
OccultBlood BLD Ery/uL NEGATIVE : Ca25
TRACE-LYSED Ca80
TRACE.INTACT Ga2OO
NEGATIVE
tBffif.tY$r0,.,,
TB E-nlrlTST
:1i#r
-nffil
$#
pH pH 5.0
5.5
6.0
o.c
7.0
/.c
8.0
8.5
>=9.0 NoDifference
Protein PRO g/L NEGATIVE 1.0
TRACE
' >;i.O
03i,',1
NEGATIVE ":,,,:
'2+
TRACE 3+
l
l+
Urobilinogen UBG umol/L 3.2 ,i 66
16 >=131
3$ i::,::: ' iNoDitference
Nitrite NIT NEGATIVE POSITIV€ No
Ditference
Leukocytes LEU Leu/uL NEGATIVE Ca.I25
H;l l':
' ' casoo ;:::t:il;,.2W:
{.r*
Color- c0L YELL0W .;,',,,...,..,
i GRmi$}.
ORANGE
RED i.'i: :, gnOWN NoDifference
ClaritYt
(d€temin€d visally) CLA CLEAR ii
sr-clorlDY i
CI€UDY lNoDifference
*Color
may
be
preceded
with
'1T."
or
"DK."
when
determined
by
theinstrument.
lfdeterminedvisually, Shadedareas
=
defaultabnormal
results
detaultdescriptions
can
bechangedby
the
user;
"0THER"
can
alsobereported.
tReportedresults
aredefuultdescriptions
thatcanbechanged
bytheuser.
Table1-3
Traditional
Bayer
Reagent
Strips
ENGLISH
- S.I.
Units
- International
(S.1.)
Revised5/01 1.7

INTRODUCTION MULTISTIXPROReagent
Strips
Test Abbreviation Units Printed/Displayed
Results
NormalSystem +/-System
Glucose GLU mg/dL NEGATIVE : ,-,'
:,,500
100
250",
Bilirubin BIL NEGATIVE MODERAT.E
SMALL LARGENEGATIVE l
1+ 3+
Ketone KFI mg/dL NEGATIVE
TRACE
"t5
-:'':40
:irF=80 NEGATIVE
.,,,,.-..=:':.==..,,:,,8
il[*t'.=t'.,
=.t==,-"-'=="4+
Specific
Gravity SG <=1.005 1.020
1.010 1.025
1.015 >=1.030 NoDitference
OccultBlood BLO NEGATIVE :'1;.:;
ii,
$MAlT'i:'i
TRACE-LYSED
' ::,,
M0DERATE,,,
TRASE'INTACT I.ARGE.
NEGATIVE
TRACE-LYSID
l
TnAcE;illrn0t,
1+
2+
$+
pH pH 5.0
5.5
6.0
b.c
7.0 8.0 8.5
>=9.0 NoDitference
Urobilinogen URO E.U./dL0.2
1.0
2i0
4.0
i
i;$.0
INoDitference
Nitrite NIT NEGATIVE POSITIVE No
Ditference
Leukocytes LEU NEGATIVE ...
MODERATE
TBACI "":i',
'UnGf
SMALL
NEGATIVE 2+
TRAfiE
T;'' i 3*
1+'t ,: - ':
Protein PRO mg/dL NEGATIVE ,.,..........-:
l|CIO
I
11 300
30
NEGATIVE ' :'2-i
LOW 3+
l:
Creatinine CRE mg/dL 10
50
100
200
300 NoDitference
Protein-to-
Creatinine
Ratio P:C mg/g
NORMAL
DILUTE'
NORMAL
150ASNOHMAL
3OOAFNORMAL
>$00
A8fioRMALr
NoDifference
Color. c0L YELLOW . . GREEN
ORANGE : .BLUE
RED
i: BB0WN NoDifference
Claritv**
(dst€min€d vis@lly) CLA CLEAR .. i,;,T,,Ufi8f[]
SL
CLOUDY 'OTHEN
CLOUDY:" i,
" iNoDitlerence
tSpecimen
istoo
dilute
to
accuratelydetermine
ntio
result.Repeat
teston
new
specimen. Shadedareas
- default
abnormalresults
*Color
may
be
preceded
with
"1T."
or
"DK."
whendeterminedby
theinstrument.
lf
determined
visually,
default
descriptions
can
bechangedbytheuser;
"OTHER"
canalso
bereported.
"Reported
resultsare
defauh
descriptions
that
can
bechanged
by
the
user.
Iable
1-4
MULTISTIX
PRO
Reagent
Strips
ENGLISH
- CONV.
Units
- Conventional
1.8 Revised5/01

MULTISTIXPROReagent
Strips
Tesl AbbreviationUnits Printed/Displayed
Results
NormalSvslem +/- System
Glucose GLU NEGATIVE
ti
2*,,, )' 3.* NEGATIVE
lTfii\ffl'l',.
iif:uF,:::i:,,:!::titi'i,,,:
ZT
3#
Bilirubin BIL NEGATIVE 2+
1+, r 3+ NoDifference
Ketone Kfl NEGATIVE 3+
.tl
1+ ' 4+
tt :t :
a,
z-r
NEGATIVE
$.fiI6Fr-i....'
r{:+:..::tr:,i'.....',
:::
2t+
s$
SpecificGravity SG <=1.005 1.020
1.010 1.025
1.015 >=1.030 NoDifference
0ccultBlood BLD NEGATIVE
+/-
+r* INTAGT,
t,,+
t'+
3+ No
Difference
pH pH 5.0
5.5
6.0
6.5 8.0
7.0 8.5
7.5 >=9.0 NoDitference
Urobilinogen UBG umol/L 3.2
16
33
,.,'.6E
*lSrt NoDifference
Nitrite NIT NEGATIVE POSITIVE NoDifference
Leukocytes LEU NEGATIVE ,,,''
:" 3+
il+..,,r ' ,,,
',tt 4+
t2+ ,, i'
NEGATIVE
TRAcE
1+
?#
i3+
Protein PRO s/L NEGATIVE 16xtr
.,,....i;r
lw r
. ::::,:
flt-,
S.*i NoDifference
Creatinine CRE mmol/L 0.9
4.4
8.8
17.7
26.5 NoDitference
Protein-to-
Creatinine
Ratio P:C mg/mmol
NORMAL
DILUTE'
NORMAL NoDifference
Color* c0L YELL0W 5;,,:.],GREGNi
ORANGE
,I;RED ,'' -, BRowNj NoDifference
Claritv**
(d€iemin€d viMlv) CLA NoDitference
tSpecimen
istoo
dilutetoaccuratelydetermine
ratio
result.Repeatteston
new
specimen. Shaded
areas
=
defaultabnormal
results
'Color
maybe
preceded
with
"1T."
or
"DK."
whendetermined
by
theinstrument.
lfdetermined visually,
default
descriptions
canbechanged
bytheuser;
"oTHER"
canalsobe
reported.
'*Reported
resultsaredefaultdescriptions
that
can
bechanged
bytheuser.
Table
1-5
MULTISTIXPRO
Reagent
Strips
ENGLISH
- NORDIC
Units
- NordicPlusSystem
Revised5/01 1.9

INTRODUCTION MULTISTIXPROReagent
Strips
Test AbbreviationUnits Prinled/Displayed
Results
NormalSystem +/-
Svstem
Glucose GLU mmol/L NEGATIVE
5.5
14
--.,,!,t
t=5fl.;NEGATIVE ,:irr r'::,,:':?+l
ffi$i rr1 ,||iiF$+
Bilirubin BIL NEGATIVE .MODERATE
SMALL LARGENEGATIVE
tf -12ft
-t3'#
Ketone KFT mmol/L NEGATIVE liiiiiiil'-
r':, S.9,
[iffifit.
.,.iiiiiiii,
[..=-':.:,.
,,,,,,'',.i'*lili
INEGATTVE :,: 2+
RAGE
i:'i..:i
SpecificGravity SG <=1.005 1.020
1.010 1.025
1.015 >=1
.030 NoDitference
0ccultBlood BLD Ery/uL NEGATIVE Ca75.
fnlcetvsgD cano-
TRACE.INTAGT ': CAMO
NEGATTVE
TRACE-LYSED .2+
TRACE.INTACT 3+
pH pH 5.0
5.5
6.0
6.5 8.0
7.0 8.5
7.5 >=9.0 No
Difference
Urobilinogen UBG umol/L 3.2 66
13
r' ',,
ii NoDitference
Nitrite NIT NEGATIVE i: POSITIVE No
Ditference
Leukocytes LEU Leu/uL , Ch:.U5,'i
",1,,,.o*o;X
Protein PRO slL NEGATIVE ;:: 1.0
8:lu r 30NEGATIVE 2+
ll*i' ,,;:.,,,,
::i.urio
t*
Creatinine CRE mmol/L 0.9
4.4
8.8
17.7
26.5 NoDitference
Protein-to-
Creatinine
Ratio P:C mg/mmol
NORMAL
DILUTET
NORMAL
:li{'i;r"-:;.
- NoRffi ':l :
'ss.g
ABNoRMifL
>56.6ABNORMAL
NoDitference
Color* c0L NoDitference
Clarity**
(dgtmin€d vis@lly) CLA No
Ditference
lSpecimen
is
toodilutetoaccuratelydetermine
ratio
result.Repeat
test
on
newspecimen. Shadedareas
=
defaultabnormal
results
'Color
may
be
preceded
with
"1T."
or
"DK."
whendetermined
by
theinstrument.
lfdeterminedvisually,
. .
defaultdescriptions
canbechangedby
theuser;
"oTHER"
can
alsobereported.
" Reportedresults
aredefault
descriptions
that
can
bechanged
bytheuser.
Table1-6
MULTISTIX
PRO
Reagent
Strips
ENGLISH
- S-I.
Units
- International
(S.1.)
1
.10 Revised5/01

Section
2
INSTALLATION
General
Information
Thissection
provides
detailed
installation
instructions
fortheCLINITEK@ 500UrineChemistry
Analyzer.
The
installationsteps
must
be
followedcorrectly
toensure
proper
installation,operation,and
service.
Readthis
0perating
Manualcarefullybeforeattempting
to
operate
the
CLINITEK
500instrument.Followall
instructionscarefully.
The
CLINITEK
500isa
precision
instrumentand
must
be
handled
accordingly.
Roughhandlingor
dropping
of
theinstrument
will
disturb
internal
calibrated
optics
and
electronics
and/orcauseotherdamage.
Always
handle
theinstrument
withcare.
Environmental
Factors
Aswithallsensitiveelectronic
instruments,
prolonged
exposure
toexcessivehumidityand
temperatureshould
beavoided.
Temperatureshouldbe
heldrelativelycon-
stanttoobtain
thehighestdegreeofoperating
stability.
The
ambient
temperaturerange
for
operating
theinstru-
ment
is18'Cto30"C
(64'F
to86'F);
theoptimum
temperature
rangeis22'Cto26"C
(72'F
to
79"F).At
temperatures
under22'C,urobilinogenand
leukocyte
results
may
bedecreased,
andattemperatures
above
26'C,increased.
The
ambientoperating
humidityrange
is20%
to
80%
relativehumidity.
Place
theinstrumentwhereit
willnotbesubjected
to
extremetemperature
variations.Avoid
proximity
toopen
windows,directsunlight,ovens,
hot
plates,
open
burn-
ers,radiators,
anddryicebaths.Do
not
place
it
on
the
samebench
asasourceofvibration,
suchasacentrifuge.
The
CLINITEK
500instrumentshould
notbeused
inan
explosiveatmosphere.
Thebenchspaceshould
be
large
enough
to
allow
free
aircirculation
around
the
instrument
(3
inches/7.6cmonallsides).
Unpacking
1.
2.
Youshouldhavereceivedtwocartons:one
carton
contains
the
CLINITEK@500
instrumentandabox
of
accessory
parts;
theother
(the
"lnstallation
Pack")
containsthe
power
cordandoperating
manual
that
areappropriate
for
your
country.Carefully
remove
the
contentsofeachcarton.
Inspectthe
shipping
cartons,
accessory
box,and
instrumentforvisiblesigns
of
damage.
lf
damage
totheinstrument
exists,
immedi-
atelyfileacomplaint
withthe
carrier.
Thefollowingitems,
shown
inFigure2-1,are
packed
withtheinstrument:
@ Fixed
platform,
holddown
plate,
andwastebin
liner
@ Movingtable
(2)
@ Printer
paper
@ Push
bar
(2)
ffi Program
card
S Holddown
plate
(extra)
Figure2-1
Revised9/99 2.1

INSTALLATION
3.
Theremaining
items
shown
inFigure2-1are
packed
intheInstallationPackandshipped
in
a
separatecon-
tainerfromtheinstrument:
@ Operating
manual:
Binderand
manual
pages
(Manual
pages
may
besuppliedseparately
by
your
Bayerrep-
resentative.Dependingonthelanguage
oftheoperating
manual
you
havereceived,theremayalsobea
Warranty
RegistrationCardand/oraCustomer
InformationCard.)
@ Powercord
Makesure
alltheseitemshavebeen
includedwith
your
instrument,
and
keepthemforfuture
use.
Afterthe
instrument
hasbeenunpacked,
place
itona
firm,level
work
surface
inthe
designated
work
area.
Theinstrumentshouldappearlevel,
bothside
toside
and
fronttoback.Thebackandsides
ofthe
instru-
mentshould
beatleast3inchesfromanadjacent
wall
or
instrument.
N0TE:Retain
the
CLINITEK500shipping
carton
and
packing
for
at
least
several
weeks.lf
theinstrument
everneeds
to
beshipped,
the
shipping
carton
will
affordthebest
protection
against
damage.
Locatethe
piece
offoam
packing
thatisunderthe
read
areacover.Gently
pull
downand
forwardon
thefoam
toremoveit
(Figure
2-2).
IMP0RTANT:Besuretoremove
thefoambefore
continuing!
5. lf
you
havenot
alreadydoneso,
insertthe
pages
of
your
Operating
Manualintothebinder.
Instrument
Setup
1.Ensurethattheinstrument
power
switchis
inthe
0FF
("O")
position.
Then
plug
theinstrumentlinecord
into
theinstrumentandintoanappropriate
ground-
edACelectricaloutlet.
2. Locatethe
bar-coded
serialnumber.which
isfound
insidetheinstrumentnearthefrontleft
c0rner
(Figure
2-3).Writetheinstallation
dateandserial
number
in
the
spaces
provided
inthe
"Preservice
Checklist"
in
Section8andon
theManufacturer's
Warranty
Page
thatisfoundattheendofthismanual
(contact
your
Bayer
representative
for
your
warrantyinformation
if
this
page
isnotincludedin
your
manual).
Figure2-3
3. lf aWarrantyRegistrationCard
isfound
at
the
front
of
your
manual,writetheinstallation
date
and
instru-
ment
serial
number
on
this
card.
Aftertheinstrument
hasbeensuccessfullyinstalled,completely
fillout
the
WarrantyRegistration
Cardand
mail.
4.
2.2
Figure2-2
Revised9/99

4Installthe
moving
tableas
follows:
a.Hold
thetablewith
thesmall
rectangular
tabfac-
ingtotheback.
b.Alignthetwo
grooves
onthebottom
ofthe
table
with
the
edgesofthe
platform
onwhich
thetable
rests
(Figure
2-4).
Figure2-4
c.Gently
push
the
tableinas
far
as
itwill
go.
ltmust
be
pushedpast
adetent
in
order
tobecorrectly
in
position.
5.Next,installthefixed
platform.
(The
holddownshould
alreadybe
securelyinstalledontothe
platform.
lfitis
not
installed,
or
isloose,refertoSection
5,
"Daily
Cleaning,"Step
11-a,for
directions
on
installing
the
holddown.)
Alignthetwo
grooves
on
thebottomof
the
platform
withthe
armsextending
from
theinstru-
ment,asshown
inFigure2-5.
(The
ledges
onthe
left
and
right
sidesof
the
holddown
align
just
outside
the
readareacover,andthetopedgeof
the
platform
aligns
just
under
the
cover.)Gently
push
the
platform
inas
farasitwill
go.
(lt
mustbe
pushed
past
aslight
detent
to
be
correctly
positioned.)
CAUTI0N:
lf
the
platform
does
not
push
inat
least
halfway
withonlyvery
gentle
pressure,
donot
force
it!Ensurethatthemovingtableiscorrectly
positioned
andattempttoreinstall
the
platform.
N0TE:Withtheinitialinstallation,
you
may
need
to
usefirm
pressure
topush the
platform
the
final
%inch
(1
.3
cm).
lfthe
platform
isnotfullyseated,
or
ifitis
slightlycrooked,
the
strips
may
jam
as
theyare
pushed
alongthe
platform.
Figure2-5
6.Holdthe
push
barbyitsindentedendand,
with
this
end
slightly
upward,insertthe
peg
onthe
otherend
ofthebarintothehole
inthe
pusher
mechanism
(Figure
2-6).Lowerthe
push
bar
into
place.
Revised9/99 2.3

INSTALLATION
Figure2-6
7. Holdthe
program
card
withthelabelfacing
fonruard
and
the
arrows
pointing
inandup.
Insertthecard
into
thecard
receptacle
(Figure
2-7)and
press
itinfirmly
until
thebutton
above
thereceptacleis
pushed
out.
When
properly
inserted,the
edgeof
thecard
willbe
flush
withthe
sideoftheinstrument.
Figure2-7
8. Install arollof
printerpaper
and
re-install
the
printer
cover
as
follows:
a.Noticethelargetab
on
the
backsideof
the
instru-
mentthat
securesthecoverin
place(Figure
2-8).
Pressinfirmlyonthe
bottomedgeof
the
taband
liftthe
cover0ff.
Figure2-8
b.0btaina newroll
of
paper;
unrollseveral
inchesand
trimthe
end
into
a
long
"V".
Holdthe
rolljustabove
the
printer,
withthe
paper
unrolling
fromunder-
neath.Feedthe
endofthe
paper
under
the
roller,
thenrotatethe
paper
advancewheelina
clockwise
direction
(toward
the
back)untilseveral
inches
of
paper
areexposedabovethe
printer
(Figure
2-9).
2.4 Revised
9/99

"1.
Interfacing
to
aPrinter
The
CLINITEK500
canbeinterfaced
tomost80-
column,
continuousfeed
printers
or
to
the
CLINITEK@
Form
Printervia
the
printer
(parallel)
port
thatisfound
ontherear
oftheinstrument.
Some
printers
may
include
aninterface
cablethatis
appropriate
for
use;ifnot,
you
will
needto
obtain
the
cable
separately.
Referto
Appendix
CPl,
"COMPUT-
ERANDPRINTER
INTERFACE,"
for
the
pin
specifica-
tionsfor
themale
connector.
The
otherend
of
the
cable
willbe
dependent
uponthe
particularprinter.
Appropriate
cables
areavailable
atmostretail
com-
puter
stores.
Connectthe
appropriate
end
of
the
interface
cable
to
the
printer
port
on
the
CLINITEK
500
(labeled
"@")
(see
@Figure
2-11
Iorlocation);
connecttheother
endto
the
printer.
Figure
2-9
c. Set the
paper
into
position
behindthe
printer.
Then,
place
thefronttabs
ofthecoverintotheir
slotsand
feed
theend
ofthe
paper
throughthe
openingin
thecover.
Snap
thecoverinto
place.
9. lf notalreadyinstalled,
place
a
liner
intothewaste
bin
(Figure
2-10).
Figure
2-10
2.
#'1
,,ll
$i
ffi
^..bb
g9*"$.
c
wr$
Figure
2-11
Revised
5/01 2.5

lnterlacingtoa
Printer
The
CLINITEK500canbeinterfacedtomost80-
column,
continuousfeed
printers
ortothe
CLINITEK'
FormPrinter
viathe
printer
(parallel)
port
that
isfound
on
therearoftheinstrument.
1.Some
printers
mayinclude
an
interfacecablethat
is
appropriatefor
use;
ifnot,
you
willneedtoobtain
the
cableseparately.
RefertoAppendix
CPl,
"COMPUT-
ERANDPRINTERINTERFACE,"forthe
pin
specifica-
tionsforthemaleconnector.Theotherendof
the
cablewillbedependentuponthe
particularprinter.
Appropriate
cablesareavailableatmost
retailcom-
puter
stores.
2.Connect the
appropriate
end
of
theinterfacecable
to
the
printerport
ontheCLINITEK500
(labeled
"@")
(see
@Figure2-11Iorlocation);connecttheother
end
tothe
printer.
Figure
2-9
c. Set
the
paper
into
position
behind
the
printer.
Then,
place
thefronttabs
of
the
cover
intotheirslotsand
feedtheend
ofthe
paper
throughtheopening
in
thecover.Snapthe
cover
into
place.
9. lfnotalready
installed,
place
aliner
intothewastebin
(Figure
2-10).
Figure2-10
F.
::.$ ffi
^l-'it*
l9*$. c
Figure2-11
,rG
Revised5/01 2.5