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