.

@
CLINITCKs@@
istryAnalyzer
UrineChem

( (

Healthcare
LLC
2003Bay6r
@1998,
AllRightsBeserved
in lreland
Printed
SECOND
EDITION
noted,
Unless
otherwise
alltrademarl$
aretheproperty
LLC.
Health0are
of Bayer

Manufactured
for:

Bayer
Diagnostics
Manufacturing
Ltd.
Lane,Swords,
Chapel
Co.Dublin,
lreland
50241761

BayerHealthCare
t

Bayer
Health0are
LLC
Elkhart,lN46514USA

Revised
5/03

TABLE
OFGONTENTS
Page

Eectian
INTRODUCTION
ed
s e. .
t i no dnI n t e n dU
G e n e rDael s c r i p a
C o m p o n eanntdsM e c h a n i c a l O p e r a t i o n . . . . .
0pticalsystem.
Calibration
Specifications......
TablesofResults.

INSIALLATION
G e n elrnaflo r m a t i o n
Factors
Environmental
Unpacking
.
lnstrument
Setup
toa Printer
lnterfacing
l n t e r f a tcoi nagC o m p u t e r . . . .
. ... .
Reader.
toa BarCode
lnterfacing
Instrument
Check
lnitial
YOUR
OPTIONS
SELECTING
G e n eIrnaflo r m a t i o n
SetupRoutine.....
u trei nr tpeorr)t.;. . . .
1 a t e ; T i m e ; C o m pP
A . S e t uMpe n u #( D
B. PasswordScreen.
..
units;
Plussystem;
Test)
Result
#2(Language;
Menu
C.Setup
(Date,
Date,
Time
separator).
Timeformat;
Menu#3
D.Setup
Markpositives;
to report;
#4(Tests
Menu
E. Setup
levels SG/pH,
Creatinine)
Normal
Positive
levels;
(Color;Choicesforcolor,
clarity;
defaults)..
Use
Menu#5
F. Setup
(Positive
Flagsfor
reports)
Clarity;
levels-Color,
#6
Menu
G.Setup
lD)....
(Editflagged
results;Entersample
lD;Tech
Menu/7
H.Setup
portoptions;
Barcode
reader;
Password)
Menu
#8(Computer
l. Setup
(Resetto
Perform
hardwaretests).
defaults;
Menu#9
J. Setup

..........1.1
......1.1
......1.3
....1.3
.........1.4
....1.5

. . .. . . .. . 2 . 1
......2.1
. .. . 2 . 1
...2.2
. .. ...2.5
......2.6
.. ...2.6
.. ...2.6
.........3.1
.........3.3
........3.4
.....3.5
. . . . .3.6
........3.7
.. . ..3.7
......3.9
.......3.11
.......312
.. ...3.12
......3.15

:::::3:1
:::::::
::::::
:::::::::::
::::::
:::::::::::::
$'Jlilffllffi'ff#i:l:
INSTRUMENT
OPERATION
lnformation
General
toRun
Ready
Getting
Testing0ontrols
Routine
Testing
Specimens
Basic
A.
0peration
ina Loadlist
B. lf lDsareUsed
a Loadlist.
Without
C. lf lDsareUsed
D. Printing/TransmittingResults

Revised
5/01

. .. . .....4.1
.. .. ...4.1
.....4.3
....... ..4.4
. ......4.4
. . .4.6
...4.7
........4.8

ill

TABLE
OFCONTENTS
Page

Section
4
Continued

INSTRUMENT
OPERATION
E n d - o f -R e
up
no r t s .
Report.
Editing
Results
intheConfirmatory
Recalling
Results
O p e r a tNi nogt e s .
CARE
OFTHEINSTRUMENT
General0leaning
Daily0leaning.....
Disinfection
ChangingthePaper
S U P P L I&EO
SP T I O NEAOLU I P M E N T
MINOR
REPAIR
G e n e rl na fl o r m a t i o n
PrinterRepracemeni:..:::.::::::::.:::::.....
S cre en
C a l i b ra tithnegT o u ch

Appendix
cPl

IND

IV

....,...4.8
... ..4.8
....4.9
.....4.10
.....5.1
.........5.1
. . .5.3
.........5.4
........6.1
. . . .. . . . . 7 . 1
..........7.1
. . .. ...7.3

TROUBLESHOOTING
AND
SERUICE
G e n elrnaflo r m a t i o n
WhentoCallforAssistance
Whereto0allforAssistance.....
TroubleshootingChart.
PreserviceChecklist.

.........8.1
......8.1
.......8.1
......8.4
........8.10

PARTS
SUPPLIES
& REPLACEMENT
Suppliesi0ptionalEquipment...
ReplacementParts

....9.1
..........9.1

INTERFACE
COMPUTER
ANDPRINTER
In lfo rma ti o n .
Ge n e ra
- Serial
Port
andPinSpecifications
Cable
Par allelPor t...
C a b laen dP i nS p e ci fi c ations-

INDEX

... ...C Pl .1
. . . CPl.1
... ...C P| .1

. . . r. N D . 1

Revised
5/03

1
Section

INTRODUCTION
that
Theinstrument
isa reflectance
spectrophotometer
f rom
analyzes
thecolorandintensity
ofthelightreflected
meanthereagent
areaandreportstheresultsinclinically
Tables
1-1through
ingfulunits(see
1-6).Nocalculations
auto(Figure arerequired
bytheuser.Calibration
is performed
Analyzer
TheCLINITEK@
500Urine
Chemistry
matically
each
time
a
Reagent
is
analyzed.
Strip
instrument
designed
1-1)isa semiautomated,
benchtop
for Urinalysis
to "read"
traditional
Bayer
Reagent
Strips
(e.9.,
PRO'
MULTISTIX
MULTISTIX@
10SG)andBayer
includes
family
ofReagent
Theinstrument
system
Strips.
necessary
cardthatcontains
theprogramming
a pr0gram
Reagent
these
fortheCLINITEK
500instrument
to read
Figures
1-2and
1-3showthe
majorcomponents
ofthe
atanytime(if
canbelaidontheinstrument
Strips.
Strips
pr0gram
is
inserted
500
instrument.
The
card
CLINITEK@
the
strip's
lDsarenotused);
a sensor
detects
specimen
presence,
andread- intothecardreceptacle
whichactivates
thestripmovement
ffi. Thestripsaretransported
of
thereadarea
incubation
andreading
across
and
theinstrument
ingcycle.
Communication
between
@,where
Alltestresults
areprinted
bytheinternal
andinter- thetestsoccur.
theuseof a touchscreen
theuseristhrough
printer
(unless
thermal
this
option
has
beenselected
active
software.
@
Allcommunications
between
as"OFF"
bytheoperator).
the
andtheinstrument
through
theoperator
aremade
interactive
touchdisplay
keysanddialogue
@. Response
onthescreen;
responses
aremade
bytoucharedisplayed
ingtheappropriate
keysymbol
onthescreen.

Description
and
General
lntended
Use

andMechanical
Gomponents
0peration

Figure
1-1
Reagent
Bayer
Depending
ontheproduct
beingused,
glucose,
reagent
fortesting
bilirubin,
contain
areas
Strips
gravity,
(acetoacetic
occultblood,
ketone
acid),specific
pH,protein,
Inaddiurobilinogen,
nitrite,
andleukocytes.
Stripsalso
tionto these
tests,MULTISTIX
PROReagent
protein-low
A sinreagent
areas.
contain
andcreatinine
gleprotein
tests;
result
is reported
fromthetwoprotein
resulito prothisreading
iscompared
to thecreatinine
Theinstrument
canalso
videa protein-to-creatinine
ratio.
andtheclarthecoloroftheurine,
determine
andreport
itycanbeentered
foreachspecimen.

Revised
5/01

1.1

INTRODUCTION
Figure
1-4shows
therearviewoftheGLINITEK
500
the
Thefixedplatform
ofthreesections:
@ consists
is
into
line
instrument.
The
line
cord
connected
the
cord
station
striploading
statioq@, theincubation/read
@,
receptacle
isturnedonbypressing
ontothe
andthewaste
bin@ . n Reagent
Stripisplaced
@. Theinstrument
Theinterswitch
ofa strip thepower
Detection
instrument
atthestriploading
station.
@to the0N("-") position.
points
face
connectors
are
the
at
which
a
computer,
to begin
theinstrument
bythestripsensor
@
@ causes
barcodereader
maybeinterand/orhandheld
Thestripis moved
toward
theincubation/readprinter,
cycling.
port
for
Anextra is available
through facedwiththeinstrument.
stationbythepushbarffi.Thestripisthenmoved
iscooled
use.Theinstrument
byalan@.
theincubation/read
station
bya series
of pins;thepins future
inchevery7 seconds.
movethestripata rateof about/z

Figure
1-4
Figure
1-3
located
inside
thereadarea,
scanthe
Tworeadheads,
lengthof eachReagent
Stripata specifictimeintheincuthereagent
areas
Thefirstreadhead
reads
bation
cycle.
reads
those
incubation
requiring
times;the
second
shorter
to
Thepinscontinue
requiring
longer
incubation
times.
movethestripalongtheplatform
untilit dropsintothe
waste
bin.

1.2

Allprogramming
fortheinstrument
is contained
in a
pr0gram
1-5.The
replaceable
cardffi, shownin Figure
withsuchinformation
as error
cardis pr0grammed
messages,
operating
sequence,
andthewavelengths
intoclinically
andalgorithms
usedto convert
reflectance
results.
lt alsocontains
thecustomized
meaningful
Setup
information
selected
bytheuser.Thecardiseasilyreplaceupdates.
ableforfuturesoftware

Revised
9/98

System
0ptical
ofwhich
Theinstrument
tworeadheads,
each
contains
pack.
contains
anincandescent
lampandphotodiode
readhead,
intoposition
Whena stripis moved
underthe
"Calibration"
(see
next),
thecalibration
cycle
isperformed
thenthereadhead
scans
theentire
length
ofthestrip,meapad.A portion
ofeachreagent
suringthelightreflectance
ofthelightstrikingthepadis reflected
backto thephopack.Thelightreflected
wavelengths
todiode
atspecific
of color
fromthetestpadis dependent
uponthedegree
inthepadandis directlyrelated
to theconcenchange
tration
oftheparticular
constituent
intheurine.

1-5
Figure
plus
parameters,
stores
theoperating
Theinstrument
ina
results,
results
and200control
upto 500patient
RAMmemory.
Thismemoryis saved
battery-backed
is onoroff.Theoperatregardless
thepower
ofwhether
(including
bytheuser)are
thoseselected
ingparameters
to
cardandcanbecopied
alsostored
onthepr0gram
other
CLINITEK
500instruments.

pack
at
Thephotodiode
fourfilters,
oneeach
contains
nm
400-510
nm(blue),
nm(green),
586-660
510-586
(red),
detected
nm(lR).Thelightintensity
and825-855
packisconverted
imintoelectrical
bythephotodiode
pulses,
processed
microwhich
are
bytheinstrument's
processor
results.
intoclinically
meaningful
andconverted
printer;
theycan
Theresults
canbeprinted
bytheinternal
80-column
be
to
a
and/or
a
form
or
also sent computer
printer.

Galibration
immediately
isperformed
ateachreadhead
Calibration
Thefixedplatform
before
eachReagent
Stripis read.
twowhitecalibration
barsthatarepositioned
contains
intoposiAsastripcomes
directly
undereachreadhead.
forthat
tionunder
theinstrument
iscalibrated
a readhead,
thecalibration
bar.TheReagent
scanning
cyclebyreading
stored
inmemory.
Stripisthenscanned
andthedata

Revised
9/99

1.3

INTRODUCTION

Specilications

mentmeets
theprovisions
98n9ftC
oftheIVDDirective
(0ct./1998)
(((), which
includes
theEMC
Directive
89/336
Amendment
92131|EEC
andtheLowVoltage
Directive
73123
Safety
IEEC.
must
Thesafety
thattheinstrument
standards
specify
inthefollowing
conditions:
operate
safely
. indoor
useonly
. installation
ll (lEC
1010)
category
. pollution
degree
2 (lEC
1010)
. maximum
(6560
altitude
2000meters
feet)
Warning:
Theinstrument
isforprofessional,
in vitrodiagnostic
use(@) andmustbeused
inthemanner
specified
inthe0perating
Manual
inorderto provide
thesafety
andperformance
standards
specified.
onBackofAnalyzer:
Symbols

Power
Required:
-+10%,
100-240
VAC
50-60Hz
Power
Maximum
Input:
72VA
(notuser-replaceable)
Fuse
Rating:
2AG,
2A,250
SB(T)
V
*LineLeakage
Current:
innormal
<0.5milliamperes
condition
milliamperes
in
fault
<3.5
single condition
Heal0utput:
246BTU/hou
r
ApproximatelV
Dimensions:
- 32.4
in.)
Depth
cm(12.8
in.)
Width 37.7
cm(14.8
-28.2 cm(11.1
in.)
Height
Port
Centronics
(Parallel)
lor Printer
Weight:
7 . 4 k (91 6 . 3 l b . )
Serial
Port(RJ45)
Range:
Ambient
0perating
Temperalure
forBarCode
Reader
(64"Fto
18'Cto30"C
86"F)
Ambient
0perating
Humidity
Range:
jack
Nota telephone
20%to80%relative
humidity
0ptimum
0perating
Gonditions:
Serial
Port(RJ45)notcurrently
active
22'Cto 26'C(72'tto79"F);
humidity
35%to 55%relative
Serial
Port(ElA-2320)
and
Because
NOTE:
ofthenature
oftheurobilinogen
forhostcomputer
reagents
Reagent
Strips,
leukocyte
foundonBayer
these
tworesults
maybedecreased
attemperatures
SerialNumber
attemperatures SN
22'C(72"F)
andincreased
below
26"C(79'F).
above
Interface:
ASTM
Soltware
"Specification
to
ASTM
torLowConforms
E1381-91.,
Safety
Standards:
clinical
Level
Protocol
toTransfer
Messages
between
(Mo_del
TheCLINITEK@
Analyzer
500UrineChemistry
and
laboratory
instrument
(@)
andcomputer
systems"
islisted
6470)
bytheUndenruriters'Laboratoriei
"Specification
for Transferring
ASTME 1394-91,
(@.)ascerAssociation
andtheCanadian
Standards
Information
Between
Instruments
andComputer
Clinical
specified
withthesafety
standards
tified
andcomplies
Systems."
Theinstruin UL3101andCSA-C22.2.
No.1010.1.

!il1il]il
@

P
o*

*Testing
protocol
by the safety
limitsas specilied
andallowable
for laboratory
in UL3101-1
standards
equipment
outlined
, CSA22.2
N 0 . 1 0 1 0a. 1
n ,dI E C
1010-1.

1.4

5/03
Revised

TABLES
OFRESULTS

Traditional
Bayer
Reagenl
Strips

Tesl

Repofled
Results

Abbreviation
Units

PlusSyslem

NormalSystem
Glucose

GLU

Bilirubin

BIL

Ketone

KFT

Specific
Gravity

SG

Blood
Occult

BLO

NEGATIVE
TRACE
1+
,, .*.t

mg/dL

.2+.
, 3+.
,, '

:ffi
ffi,'.ii'W-ffi':#
NEGATIVE ;4

mg/dL

<=1.005
1.010
1.015

1.020
1.025
>=1.030

NEGATIVE

-ortl$ l I

NoDifference

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

5.0
5.5
6.0

pH

pH

Protein

PRO

mg/dL

Urobilinogen

URO

E.U./dL 1 . 0

Nitrite

NIT

Leukocytes

LEU

6.5
7.0
7.5

NoDifference

ffi
ffiry'tffi.

;i|':ll*sq

NEGATIVE

0.2

8.0
8.5
>=9.0

ffi

tl'

ffi
ffi

NEGATIVE

NoDitference
NoDitference

NEGATIVE
il

Sr,:"1
Color'

c0L

Glaritltt

CLA

YELLOW
ORANGE

ilW..NwifiitilD)rl

NoDitference

CLEAR
(detsmlnd viulv)

NoDitference
RF.'il

'Color
lf determined
visually,
maybeprecoded
bytheinstrument.
with"1T."or 'DK."whendetermined
default
descriptions
canalsoberepofted.
canbechanged
bytheuser;"0THER"
t Reported
bytheuser.
resultsaredefaultdescriptions
thatcanbechanged

= default
results
Shaded
areas
abnormal

1'1
Table
Reagent
Traditional
Bayer
Strips
- CONV.
ENGLISH
- Conventional
Units

Revised
5/01

1.5

INTRODUGTION

Test

Traditional
Bayer
Reagent
Slrips

Reported
Results

Units
Abbreviation

PlusSystem

NormalSystem
3+
,',, ':
i
,,
l+
i:,

NEGATIVE
TRACE
1+

Glucose

GLU

NEGATIVE
:ii:
l+
2+

Bilirubin

BIL

NEGATIVE iii::::,,:::::::::::2T:::
;'i:,
ti;
3+
r

NoDifference

B'|Hff

NEGATIVE ':i= ,,,iir 3#

Ketone

KEI

i:

;,i',:'i

4+

"

SG

0ccultBlood

BLD

+i-;;
,;;,
+z-XNTACT;:,1

pH

pH

5.0
5.5
6.0

Protein

PRO

6.5
7.0
7.5

3'2
umol/L 16

UBG

Nitrite

NIT

NEGATIVE

Leukocytes

LEU

NEGATIVE
'i1t
..

Clarityt

CLA

(detemind vislly)

2+
3+

NoDifference

8.0
8.5
>=9.0

NoDifference

2+'. NEGATIVE
NEGATIVE rit:.:-.i::::,:',,,r
+/it ,;:i,
3+ .T.RACE
,r I
,i+t,=n*
l i , , , , , ,'1i+

Urobilinogen

c0L

NoDitference

i,::::ti;,
.- :: ,::[+:::i

NEGATIVE

Color'

iii:tiiiijl

1.020
1.025
>=1.030

<=1.005
1.010
1.015

Gravity
Specific

'llr:-r::rilr:::rii0s
i:ii:r
>=131

NoDitference

ii;: FOSITIVE

NoDitference

$$illrii.
,ril:,a.,,r,:.::..r
iii:illftxix.'i

2+

,i,

:'2+
ts+

'

3*
4+

l,l

NEGATIVE

' ''i:di
a:j

2+

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

'r'IGREEN
BLUE
BROWN

YELL0W
ORANGE
RED ;i:

CLEAR

,',- '1lF,,llRSIFj

NoDifference

|loffit' ;.+ioryrn't

*Color
lf debrmined
visually,
bytheinstrument.
maybepreceded
with'1T."or "DK."whendetermined
canalsobereported
bytheuser;'OTHER"
default
descriptions
canbechanged
t Reported
bytheuser.
thatcanbechanged
results
descriptions
aredefault

24

NoDitference

= default
results
areas
Shaded
abnormal

1-2
Table
Reagent
Bayer
Strips
Traditional
_ NORDIC
ENGLISH
- Nordic
PlusSystem
Units

1.6

Revised
5/01

Reagent
Traditional
Bayer
Strips

Test

Reported
Results

Abbreviation
Units

NormalSystem

g8 NEGATIVE
>=55

NEGATIVE

Glucose

GLU

mmol/L

a ; 5. l
:t4

Bilirubin
Ketone

Specific
Gravity

Occult
Blood

pH

Protein

Urobilinogen

KET

MODERAIENEG.ATIVE
. LARGT
a
i
rtt

,, ,
NEGATIVE
'
mmol/L TRACE
.',,,
1.5

SG

<=1.005
1.010
1.015

BLD

NEGATIVE :
Ery/uL TRACE-LYSED
TRACE.INTACT

PRO

UBG

Nitrite

NIT

Leukocytes

LEU

Color-

c0L

ClaritYt

CLA

g/L

NEGATIVE
TRACE'
0
3
i
,

H;l

YELL0W
ORANGE
RED i.'i:
CLEAR

sr-clorlDY
CIUDY

er
G#

NoDifference
:1i#r

-nffil
$#

NoDifference

1.0 NEGATIVE
>;i.O TRACE
,
1 l+

'
,i

l':'

>=9.0

/.c

NEGATIVE

(dtemind visally)

8.0
8.5

66
>=131

":,,,:'2+
3+
l

NoDitference

i
POSITIV

NEGATIVE

Leu/uL

.:

Ca25 NEGATIVE
Ca80 tBffif.tY$r0,.,,
Ga2OO TB E-nlrlT
ST

o.c

'

6:i
i

ii|*.:r'r,,1,',.,.,iii

7.0

3.2
umol/L 16
:
3$ i::,::

.;:rr;. iir. 21

3.9 NEGATIVE
>=7.8 fffi*,1i1
1.020
1.025
>=1
.030

5.0
5.5
6.0

pH

U+

0+

ff$tt...

NEGATIVE

BIL

PlusSystem

Ca.I25

' casoo

NoDitference
;:::t:il;,.2W:
{.r*

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

NoDifference

ii

NoDifference

*Color
lf determined
visually,
maybepreceded
bytheinstrument.
with'1T."or "DK."whendetermined
canalsobereported.
detault
descriptions
bytheuser;"0THER"
canbechanged
t Reported
bytheuser.
results
thatcanbechanged
aredefuult
descriptions

= default
results
Shaded
areas
abnormal

Table
1-3
Reagent
Bayer
Strips
Traditional
- S.I.
ENGLISH
(S.1.)
Units International

Revised
5/01

1.7

INTRODUCTION

Test

MULTISTIX
PROReagent
Strips

Results
Printed/Displayed
+/- System
NormalSystem

Units
Abbreviation

NEGATIVE :

Glucose

GLU

2
Bilirubin

BIL

Ketone

KFI

NEGATIVE
SMALL

NEGATIVE

Gravity
Specific

SG

Occult
Blood

BLO

pH

mg/dL TRACE

"t5

pH

URO

"

NEGATIVE
MODERAT.E
LARGE 1 +
3+
-:'':40 NEGATIVE
.,,,,.-..=:':.==..,,:,,8
=.t==,-"-'=="4+
:irF=80
l

il[*t'.=t'.,

1.020
<=1.005
1.025
NoDitference
1.010
>=1
.030
1.015
NEGATIVE :'1;.:;ii,$MAlT'i:'iNEGATIVE
' ::,,
M0DERATE,,,
TRACE-LYSID
TRACE-LYSED
l
TRASE'INTACT
I.ARGE.TnAcE;illrn0t,
b.c
8.0
5.0
7.0
8.5
NoDitference
5.5
>=9.0
6.0

0.2
Urobilinogen

,-,' :,,500

mg/dL 100

E.U./dL 1 . 0

4.0i
i;$.0 I

NoDitference

POSITIVE

NoDitference

1+
2+
$+

2i0
Nitrite

NEGATIVE

NIT

Leukocytes

LEU

Protein

PRO

NEGATIVE
NEGATIVE . .. MODERATE
" " : i ' , ' U n G f TRAfiE
i
TBACI
T;''
- ':
,
:
1+'t
SMALL
'
l|CIO
NEGATIVE
,.,......
....-:
I NEGATIVE
300 LOW
mg/dL
11
30
200
10
300
NoDitference
mg/dL 50
100
l

Creatinine

Protein-toCreatinine
Ratio

CRE

P:C

Color.

c0L

Claritv**
(dstmind vis@lly)

CLA

mg/g

DILUTE'
NORMAL
NORMAL
150ASNOHMAL
3OOAFNORMAL
>$00A8fioRMALr

YELLOW . . GREEN
ORANGE
: .BLUE
i:
BB0WN
RED
CLEAR ..
i,;,T,,Ufi8f[]
' OTHEN
SLCLOUDY
CLOUDY:" i," i

t Specimen
testonnewspecimen.
Repeat
istoodiluteto accurately
ntio result.
determine
*Color
lf determined
visually,
bytheinstrument.
maybepreceded
with"1T."or "DK."whendetermined
canalsobereported.
descriptions
bytheuser;"OTHER"
default
canbechanged
"Reportedresults
bytheuser.
thatcanbechanged
aredefauh
descriptions

2+
3*

:'2-i
3+

NoDifference

NoDifference

NoDitlerence
- default
abnormal
results
Shaded
areas

Iable1-4
Reagent
PRO
Strips
MULTISTIX
- CONV.
ENGLISH
- Conventional
Units
1.8

Revised
5/01

MULTISTIX
PROReagent
Strips

Tesl

Printed/D
isplayed
Results
+/- System
NormalSvslem

Abbreviation
Units

3.* NEGATIVE

NEGATIVE
Glucose

ti
2*,,, )'

GLU

lTfii\ffl'l',.

iif:uF,:::i:,,:!::titi'i,,,:

Bilirubin

BIL

NEGATIVE
r
1+,

Ketone

Kfl

1+

NEGATIVE

'

2+
3+
3+
l

tt

:t :

z-r

Specific
Gravity

SG

<=1.005
1.010
1.015

0ccultBlood

BLD

NEGATIVE
+/+r* INTAGT,

pH

pH

5.0
5.5
6.0

UBG

Nitrite

NIT

Leukocytes

LEU
PRO

Creatinine

CRE

2t+

s$

:::
r{:+:..::tr:,i'.....',

1.020
1.025
>=1.030

NoDifference

t,,+

6.5
7.0
7.5

t'+
3+

NoDifference

8.0
8.5
>=9.0

NoDitference

,.,'.6E
*lSrt

3.2
umol/L 1 6
33

NoDifference

POSITIVE
NoDifference
:
3+ NEGATIVE
NEGATIVE ,, ,''
NEGATIVE

'

il+..,,r
t2+

,,

Protein

NoDifference

NEGATIVE
4 + $.fiI6Fr-i....'

a ,

Urobilinogen

ZT

3#

',tt "
,,,
i'

NEGATIVE
16xtr.,,....i;r
lw r . ::::,:

s/L

0.9
mmol/L 4.4
8.8

4+ TRAcE

?#
i3+

1+

flt-,
S.*i

NoDifference

17.7
26.5

NoDitference

DILUTE'
NORMAL
NORMAL

Protein-toCreatinine
Ratio

P:C

Color*

c0L

Claritv**
(diemind viMlv)

CLA

mg/mmol

YELL0W
5;,,:.],GREGNi
ORANGE
BRowNj
,I;RED ,'' -,

NoDifference

NoDifference

NoDitference

tSpecimen
Repeat
testonnewspecimen.
istoodiluteto accurately
ratioresult.
determine
'Color
lf determined
visually,
bytheinstrument.
maybepreceded
with"1T."or"DK."whendetermined
canalsobereported.
descriptions
bytheuser;"oTHER"
default
canbechanged
'*Reported
bytheuser.
thatcanbechanged
results
aredefault
descriptions

= default
results
areas
abnormal
Shaded

1-5
Table
Reagent
MULTISTIX
PRO
Strips
- NORDIC
ENGLISH
- Nordic
PlusSystem
Units
Revised
5/01

1.9

INTRODUCTION

Test

MULTISTIX
PROReagent
Strips

Abbreviation
Units

Glucose

GLU

Bilirubin

BIL

Ketone

KFT

Specific
Gravity

SG

0ccultBlood

BLD

mmol/L

Prinled/Displayed
Results
+/- Svstem
NormalSystem
--.,,!,tNEGATIVE ,:irr r'::, ,:':?+l
NEGATIVE
t=5fl.;
5.5
14
NEGATIVE
SMALL

ffi$i

.MODERATE
NEGATIVE
LARGE t f

NEGATIVE liiiiiiil'r':,

pH

pH

Urobilinogen

UBG

Nitrite

NIT

Leukocytes

LEU

Protein

PRO

Creatinine

CRE

mmol/L

TRACE.INTAGT
6.5
5.0
7.0
5.5
7.5
6.0
3.2

13
r'

-12ft
-t3'#

:,: 2+

1.020
1.025
NoDitference
>=1.030
Ca75. NEGATTVE

Ery/uL fnlcetvsgD

':

',,ii

NEGATIVE i :

cano-TRACE-LYSED

CAMO TRACE.INTACT
8.0
NoDifference
8.5
>=9.0
66
NoDitference
POSITIVE
, Ch:.U5,'i

.2+
3+

NoDitference

",1,,,.o*o;X

Leu/uL

NEGATIVE

slL

S.9, NEGATTVE
RAGE i:'i..:i

[..=-':.:,.
.,.iiiiiiii,
[iffifit.
I
,,,,,,'',.i'*lili
<=1.005
1.010
1.015
NEGATIVE

umol/L

rr1 ,||iiF$+

1.0 NEGATIVE

;::

30

8:lu r
0.9

mmol/L 4.4

17.7
26.5

2+

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

8.8
Protein-toCreatinine
Ratio

P:C

DILUTET
NORMAL
NORMAL
':l :
mg/mmol :li{'i;r"-:;. NoRffi

'ss.g
ABNoRMifL

NoDitference

>56.6
ABNORMAL
Color*

Clarity**
(dgtmind

vis@lly)

c0L

NoDitference

CLA

NoDitference

lSpecimen
testonnewspecimen.
Repeat
istoodiluteto accurately
ratioresult.
determine
'Color
lf determined
visually,
bytheinstrument.
maybepreceded
with"1T."or "DK."whendetermined
"oTHER"
canalsobereported.
descriptions
canbechanged
bytheuser;
. . default
" Reported
bytheuser.
thatcanbechanged
results
descriptions
aredefault

= default
results
Shaded
areas
abnormal

Table
1-6
Reagent
PRO
Strips
MULTISTIX
S-I.
ENGLISH
- International
(S.1.)
Units
1. 1 0

Revised
5/01

2
Section

INSTALLATION
Information
General

Unpacking

provides
havereceived
twocartons:
onecarton
instructions 1 .Youshould
installation
Thissection
detailed
anda boxof
containstheCLINITEK@
500instrument
The
for the CLINITEK@
500 UrineChemistryAnalyzer.
parts;
Pack")
accessory
theother(the"lnstallation
to ensure
correctly
installation
stepsmustbefollowed
power
that
proper
contains
the
manual
cord
and
operating
Read
this
service.
installation,
operation,
and
your
the
for
remove
areappropriate
country.Carefully
to operate
the
Manual
carefully
before
attempting
0perating
Inspectthe
cartons,
contents
ofeachcarton.
shipping
carefully.
500instrument.
Followallinstructions
CLINITEK
of
accessory
instrument
for
visible
signs
box,
and
instrument
andmust
TheCLINITEK
500isa precision
immedilf
to
the
instrument
damage.
damage
exists,
of
Rough
handling
or dropping
behandled
accordingly.
withthecarrier.
atelyfilea complaint
and
willdisturb
internal
optics
theinstrument
calibrated
items,
inFigure
2-1,arepacked
shown
handle 2. Thefollowing
Always
and/orcause
otherdamage.
electronics
withtheinstrument:
withcare.
theinstrument
plate,
platform,
holddown
andwastebinliner
@ Fixed
(2)
table
@ Moving
paper
Printer
@
@ Pushbar(2)
prolonged
instruments,
Aswithallsensitive
electronic
card
ffi Program
should
to excessive
humidity
andtemperature
exposure
plate(extra)
S Holddown
conTemperature
should
beheldrelatively
beavoided.
stability.
thehighest
degree
of operating
stantto obtain
theinstruforoperating
Theambient
temperature
range
mentis 18'Cto 30"C(64'Fto 86'F);theoptimum
rangeis 22'Cto26"C(72'Fto 79"F).At
temperature
under22'C,urobilinogen
andleukocyte
temperatures
above
may
and
at
temperatures
results bedecreased,
humidity
range
Theambient
26'C,increased.
operating
humidity.
is20%to 80%relative
to
theinstrument
where
it willnotbesubjected
Place
proximity
to
open
variations.
Avoid
extreme
temperature
hotplates,
openburnwindows,
direct
sunlight,
ovens,
anddryicebaths.
Donotplaceit onthe
ers,radiators,
suchasa centrifuge.
asasource
ofvibration,
same
bench
notbeusedinan
TheCLINITEK
500instrument
should
belarge
Thebench
space
should
explosive
atmosphere.
to allowfreeaircirculation
aroundtheinstrument
enough
(3 inches/7.6
cmonallsides).

Factors
Environmental

Figure
2-1

Revised
9/99

2.1

INSTALLATION
itemsshown
in Figure
2-1arepacked
Theremaining
ina separate
conintheInstallation
Pack
andshipped
tainer
f romtheinstrument:
pages
manual:
Binder
andmanual
Operating
@

pages
(Manual
repmaybesupplied
byyourBayer
separately
of theoperating
resentative.
Depending
onthelanguage
youhavereceived,
manual
theremayalsobea Warranty
Information
Card.)
Registration
Cardand/or
a Customer

cord
@ Power
with
Makesurealltheseitemshavebeenincluded
yourinstrument,
themforfutureuse.
andkeep
place
it ona
3 . Aftertheinstrument
hasbeenunpacked,
workarea.
inthedesignated
firm,levelworksurface
bothsideto side
Theinstrument
should
appearlevel,
andfrontto back.Thebackandsidesof theinstruwall
beatleast
3 inches
fromanadjacent
mentshould
or instrument.
N0TE:RetaintheCLINITEK
500shippingcartonand
packing
forat leastseveral
weeks.
lf theinstrument
will
to beshipped,
theshipping
carton
everneeds
damage.
afford
thebestprotection
against
read
thatisunderthe
4 . Locate
thepiece
offoampacking
areacover.Gentlypulldownandforwardonthefoam
to remove
it (Figure
2-2).
IMP0RTANT:
Besureto removethefoambefore
continuing!

thepages
of
5. lf youhavenotalready
doneso,insert
yourOperating
Manual
intothebinder.

Instrument
Setup
power
1. Ensure
thattheinstrument
switch
isinthe0FF
plug
("O")position.
Then
theinstrument
linecord
groundintotheinstrument
andintoanappropriate
edACelectrical
outlet.
2. Locate
thebar-coded
serialnumber.
whichis found
(Figure
inside
theinstrument
nearthefrontleftc0rner
in
2-3).Writetheinstallation
number
dateandserial
provided
in
thespaces
in the"Preservice
Checklist"
Page
Section
8 andontheManufacturer's
Warranty
your
(contact
thatisfoundattheendofthismanual
if
Bayer
foryourwarranty
representative
information
thispage
is notincluded
inyourmanual).

Figure
2-3
3. lf a Warranty
Registration
Cardisfoundatthefront
writetheinstallation
ofyourmanual,
dateandinstrumentserial
number
Aftertheinstrument
onthiscard.
filloutthe
hasbeen
successfully
installed,
completely
Warranty
Registration
mail.
Cardand

Figure
2-2

2.2

Revised
9/99

4 Install
themoving
tableasfollows:

tabfaca. Holdthetablewiththesmallrectangular
ingto theback.
of thetable
onthebottom
b. Alignthetwogrooves
onwhichthetable
withtheedges
oftheplatform
rests(Figure
2-4).

lf theplatform
CAUTI0N:
doesnotpushin at least
pressure,
halfway
donotforce
withonlyverygentle
positioned
it! Ensure
thatthemoving
tableiscorrectly
theplatform.
andattempt
to reinstall
youmayneed
to
N0TE:
Withtheinitial
installation,
thefinal
usefirm pressure
to pushthe platform
or
%inch(1.3cm).lf theplatform
is notfullyseated,
if it isslightly
thestripsmayjamastheyare
crooked,
pushed
alongtheplatform.

Figure
2-4
push
thetableinasfarasitwillgo.lt must
c. Gently
pasta detent
in
inorderto becorrectly
bepushed
position.
(Theholddown
should
installthe
fixedplatform.
5. Next,
lf it is
installed
ontotheplatform.
already
besecurely
5, "Daily
referto Section
notinstalled,
or is loose,
the
fordirections
oninstalling
Cleaning,"
Step11-a,
grooves
of
Alignthetwo
onthebottom
holddown.)
withthearmsextending
fromtheinstrutheplatform
ontheleft
inFigure
2-5.(Theledges
ment,asshown
justoutside
the
align
andrightsides
oftheholddown
platform
aligns
readareacover,
andthetopedgeofthe
justunder
pushtheplatform
inas
thecover.)
Gently
pastaslight
detent
farasit willgo.(ltmustbepushed
positioned.)
to becorrectly

Revised
9/99

Figure
2-5
6. Holdthepushbarbyitsindented
endand,withthis
peg
endslightly
upward,
insert
the
ontheotherend
mec hani s m
of thebarintotheholein thepusher
(Figure
2-6).Lower
thepushbarintoplace.

2.3

INSTALLATION
paper
theprinter
8. Install
a rollof printer
andre-install
cover
asfollows:
a. Notice
thelarge
tabonthebacksideoftheinstrumentthatsecures
2-8).
thecoverin place(Figure
Press
infirmlyonthebottom
edgeof thetaband
liftthecover0ff.

Figure
2-6
fonruard
7. Holdtheprogram
cardwiththelabelfacing
pointing
thecardinto
andthearrows
inandup.Insert
(Figure
it infirmly
thecardreceptacle
2-7)andpress
out.
thereceptacle
is pushed
untilthebutton
above
properly
When
inserted,
theedge
ofthecardwillbe
flushwiththesideoftheinstrument.

Figure
2-8
b. 0btain
inches
and
anewrollofpaper;
unrollseveral
trimtheendintoalong"V".Hold
above
therolljust
theprinter,
withthepaper
fromunderunrolling
neath.
Feed
theendofthepaper
theroller,
under
paper
thenrotate
the
advance
wheel
inaclockwise
(toward
of
direction
theback)
inches
untilseveral
paper
(Figure
2-9).
areexposed
above
theprinter

Figure2-7

2.4

9/99
Revised

Interfacing
to a Printer

Figure
2-9
c. Setthepaper
intoposition
behind
theprinter.
Then,
place
thefronttabs
ofthecover
intotheirslotsand
feedtheendofthepaper
through
theopening
in
thecover.
Snapthecoverintoplace.
place
9. lf notalready
installed,
a linerintothewaste
bin
(Figure
2-10).

TheCLINITEK
500canbeinterfaced
to most80s to theC LIN IT EK@
column,
continuous
feedpr interor
FormPrinter
portthatis found
viatheprinter
(parallel)
ontherearoftheinstrument.
" 1 .Someprinters
mayinclude
aninterface
cable
thatis
appropriate
foruse;if not,youwillneed
to obtain
the
"COMPUTcableseparately.
Refer
to Appendix
CPl,
ERANDPRINTER
INTERFACE,"
for thepinspecificationsforthemaleconnector.
Theotherendof the
cable
printer.
willbedependent
upontheparticular
Appropriate
cables
areavailable
at mostretailcomputerstores.
2. Connect
theappropriate
endoftheinterface
to
cable
portontheCLINITEK
theprinter
"@")
500(labeled
(see@ Figure
2-11Iorlocation);
connect
theother
printer.
endto the

ffi
^..bb

#'1
,,ll

wr$

g9*"$.c

$i

Figure2-11
Figure2-10

Revised
5/01

2.5

lnterlacing
toa Printer

2-9
Figure
Then,
intoposition
theprinter.
c. Setthepaper
behind
place
thefronttabsofthecover
intotheirslotsand
in
feedtheendofthepaper
through
theopening
thecover.
Snapthecoverintoplace.
place
installed,
bin
a linerintothewaste
9. lf notalready
(Figure
2-10).

TheCLINITEK
500canbeinterfaced
to most80continuous
feedprinters
or to theCLINITEK'
column,
portthatis found
(parallel)
viatheprinter
FormPrinter
ontherearoftheinstrument.
1. Someprinters
mayinclude
cable
thatis
aninterface
the
appropriate
foruse;if not,youwillneed
to obtain
Refer
to Appendix
cableseparately.
CPl,"COMPUTERANDPRINTER
INTERFACE,"
forthepinspecificationsforthemaleconnector.
Theotherendof the
printer.
cable
willbedependent
upontheparticular
Appropriate
cables
areavailable
at mostretailcomputerstores.
to
2. Connect
theappropriate
endoftheinterface
cable
"@")
portontheCLINITEK
theprinter
500(labeled
(see@ Figure
2-11Iorlocation);
connect
theother
printer.
endto the

ffi

F.
::.$

^l-'it*

l9*$. c
,rG

Figure2-11
Figure2-10

Revised
5/01

2.5

INSTALLATION
The
tothe0N("-") position.
thepower
switch
accompanies 1 . Press
manualthat
readtheoperating
3. Carefully
push
illuminatthe
will
be
will
move
and
display
printer
bar
withitsoperation
familiar
andbecome
the
of
name
theinstrument
andaseries
ed,firstshowing
before
using.
to
initializes.
lt thenchanges
thesystem
dotswhile
version
thetitlescreen,
whichshows
thesoftware
andcopywiththeinstrument
name
numbers,
along
interseveral
rightinformation.
Thesystem
thendoes
to a host
500canalsobeinterfaced
TheCLINITEK
itsstatus
nalchecks
Each
checkand
andprocedures.
viathe
Information
System)
orLIS(Laboratory
computer
performed.
Verify
thetesting
isbeing
isdisplayed
while
port
requireThe
cable
Null
cable.
modem
serial anda
yourhand
thefan
near
thatthefanis onbyholding
arefoundinAppendix
forinterfacing
toacomputer
ments
leftcorner
ontherearof
cover
located
attheupper
Connect
ANDPRINTER
INTERFACE."
CPl,"COMPUTER
theinstrument.
theappropriate
endoftheintejacecableto theporton
,,@u(@ in Figure
willbedisplayed
NOTE:
lf anerror
occurs,
amessage
2-11);
500labele6
thecLINITEK
you
to
the
off,then
thatinstructs either turn power
portonthe
theother
endto theappropriate
connect
customer
backonafter
several
seconds,
ortocontact
givenwiththe
following
theinstructions
computer,
(see
AND
8,
TROUBLESHO0TING
service
Section
computer.
SERVTCE).
which
totheReady/Run
screen,
Thedisplay
changes
pointfortesting
the
is thestarting
andselecting
to meet
theinstrument
options
thatwillcustomize
(Product
is
No.6469)
BarCode
Reader
A Handheld
yourlaboratory's
the
Thescreen
alsoshows
needs.
lt
500Analyzer.is
for usewiththeCLINITEK
available
thatis
forUrinalysis
name
Reagent
Strip
oftheBayer
'lHlll")
port(labeled
theRJ45interface
connected
through
programmed
(forexample,foruseontheinstrument
thatisincludBCR
toAppendix
2-11).Refer
@ inFigure
"MULTIST|X
10SG").
information.
for
the
Handheld
Reader
complete
edwith
as,for
TheReady/Run
screen
willbedisplayed
example:

lnterlacing
to a Gomputer

Reader
to aBatGode
Interfacing

lnitialInstrument
Gheck

properly
installed,
AftertheCLINITEK
500hasbeen
perform
Theactions
initialinstrument
check.
thefollowing
are
operation
thatshould
occurduringinstrument
this
during
occur
inthischeck.
lf problems
described
procedure
to
refer
isdisplayed,
or if anerrormessage
AND
SERVICE.
Section
8,TROUBLESHOOTING

tr
tr

@
@

tr

2.6

tr@

Use l{ULTISTIX10 SG.

PIace strip,

ID:
SEO#:

00001
reported)

CoIor-(not
Ct a r . i t y - ( n o t
llenu

reported)

Tech ID:
09-05-98

10: 32 Al{

5/03
Revised

willbe
read,
thetestresults
VerifythattheReagent
Stripnamebeingdisplayed 5 . Afterthestriphasbeen
printed
printer.
the
should
by
internal
The
instrument
strip
the
any
other
agrees
with stripto beused.
Useof
produce
a resultfor eachreagent
areathatis within
do
willcause
erroneous
results.
lf thestripnames
thelimitsgivenin thepackage
insertfor thecontrol
theselected
before
notagree,
stripmustbechanged
urine.
the
testing.
through
beginning
Thestripisselected
Routine,
described
inSection
3.
Setup
lf theinstrument
or if
doesnotperform
asexpected,
printed
valthe
results
withtheexpected
donotagree
immerse
Reagent
3. Completely
a Bayer
Stripintoa negAND
ues,referto Section8, TROUBLESH00TING
Negative
ativecontrolurine,suchasCHEK-STIX@
SERVICE.
thestrip.
Stripssolution.
lmmediately
remove
Control
length 7. Before
Whileremoving,
slowly
runtheedge
oftheentire
beginning
normal
instrument
use,carefully
thesideofthetubeto
oftheReagent
Stripagainst
with
review
thefollowing
to become
familiar
sections
remove
excess
urine.Donofblottheedgeofthestrip
theinstrument
techniques,
and
software,
operating
testresults.
apaper
towel,
against
asdoing
somayaffect
cleaning
requirements:
Section
3 SELECTING
YOUR
OPTIONS
4. Place
theReagent
areasup,onto
Strip,withreagent
pushbar
4 INSTRUMENT
(Figure
Section
OPERATI0N
thestriploading
station
2-12).The
pushing
5 CARE
INSTRUMENT
the
Section
OFTHE
should
begin
moving
immediately,
almost
onthe
stripintothereadarea,
andthekeysshown
Withsatisfactory
completion
oftheinitialinstrument
(partially
lit)
display
willbeshown
as dimmed
is readyfor roucheck,theCLINITEK
500Analyzer
symbols.
tinetesting.EntertheSetupRoutine
andfollowthe
prompts
for
displayed
to customize
thesoftware
yourlaboratory.
to Section
Refer
3 forcomplete
information.

Figure2-12

Revised
9/99

2.7

3
$ection

YOUR
OPTIONS
SELECTING
Information
General
the operator
andthe
between
All interaction
is throughthetouchscreen.
500Analyzer
CLINITEK@
are
forinformation
andrequests
Messages,
options,
"keys"
to
with
thatcanbetouched
along
displayed,
isallthat
A lighttouch
respond
inthedesired
manner.
toactivate
thekey.Donolusean$hinghard
isnecessary
pointed
(lf a keydoesnot
touch
screen.
or
onlhe
press
lhan
rather
respond, it fora slightlylongerlime,
hader.)
. lf an optionkeyis aclive,thekeysymbol
is disyou
played
key
is
touched,
fullylit.Whenever
anactive
orintheinstrueither
inthedisplay
willseea change
ment
operation.
. lf an optionkeyis nolactive,thekeysymbol
is
if
it
tonewillsound is
anda unique
double
dimmed
touched.
andthey
keys
onvarious
screens,
aredisplayed
Several
theyaredishave
thesame
function
whenever
willalways
played:
screen;
to theReady/Run
thescreen
r t Returns
tEl
whenexiting
theSetupRoutine
mustbetouched
lf thiskey
made.
to save
thechanges
Retum
to inorder
Beady/is touched
froma screen
in whichdatais
Run
first,
wasnottouched
requested
and<l (Enter)
This
besaved.
willNOT
anydatathatwasentered
in
the
upper
on
most
screens,
always
keyappears
rightcorner.
therunorthelaststrip.lf theruniscanCancels
areimmediately
celled,
allstripsontheplatform
are
to thewastebinandno results
moved
onthe
forthem.Thiskeyis displayed
reported
active(fullylit)
Runscreen
andbecomes
lt is
assoonasthefirststripina runisdetected.
in place
of
in theupper
rightcorner,
located
theA key.

9/99
Revised

tobedisTouching
thiskeycauses
aHelp
screen
pertaining
played
to the
thathasinformation
Touch
the
the
key
was
touched.
screen
fromwhich
( keyfromtheHelpscreen
to the
to return
previous
onall
Thekeyisnotdisplayed
screen.
to
appears
always
screens
but,whendisplayed,
(Stop
(Return
toReady)
orO
theleftofthe.l
Run)key.

tr
tr

In a
thedisplay
to thenextscreen
Changes
areaddiseries.
Thiskeyisdisplayed
onlyifthere
in
appears
ilen itional
screens
tobeviewed
andalways
Screenthelower
rightcorner.

screen
totheprevious
thedisplay
back
Changes
are
Thiskeyisdisplayed
onlyifthere
inaseries.
and
intheseries
to beviewed
Prevlousearlier
screens
Screenalways
immerightcorner,
appears
inthelower
(Next
location.
diately
above
the) t<ey
Screen)
thathas
Mustbetouched
inorder
toaccept
data
numentered,
been
suchaslDandsequence
withisexited
bers,date,
andtime.lf thescreen
data
outfirsttouching
L thenewlyentered is
is
in memory
notsaved;any
datapreviously
retained.
Moves
thecursor
onespace
totherightfromits
position.
lfthecursor
isatitsright-most
current
position,
Moving
touching
thiskeyhasnoeffect.
new
thecursor
anycharacters;
doesnoterase
incorcharacters
canbeentered
directly
overthe
rectcharacters.
totheleft.ThecharMoves
thecursor
onespace
position
erased
is usually
acteratthecurrent
ismoved
totheleft.lf thecurbefore
thecursor
position,
not
thecursor
does
sorisatitsleft-most
inconifthiskeyisdisplayed
move.
Exception:
junction
theexistwiththe+ key(Move
Right),
is
ingcharacters
arenoterased
asthecursor
moved.

3.1

YOUR
OPTIONS
SELEGTING

list
fromadisplayed
Allowsoneormorerecords
printed.
to be

list
fromadisplayed
Allows
oneormorerecords
toa computer.
to beresent

theprevious
storedresultor
MoveUpdisplays
numorder(lower
sequence
entryindescending
Move be0.Move
stored
10
the
record
Up
displays
Up
displayed
lowerthanthecurrently
tenpositions
lower-numif
there
fewer
than
ten
record:
are
results,
the
oldeststoredresult0rentryis
bered
IUlove
U p1 0 displayed.

PilnI

Rssend

tothefunction
keys,
threedifferent
typesof
Inaddition
in
inorder
toassist
theoperator
keys
willbedisplayed
result
0r
thenextstored
MoveDown
displays
lf thekeyis
menus.
thedesired
optioninvarious
selecting
num- displayed
sequence
order(higher
entryinascending
thekeycanbetouched
asa fullylitsymbol,
Move ber).MoveDown
record
stored
10displays
the
thelistof options.
to select
theoptionor cyclethrough
Down
displayed lf thekeyisdisplayed
higher
thanthecurrently
tenpositions
theoptionis
asadimmed
symbol,
if therearefewerthantenhigher-num- notavailable
record;
forselection.
result
0r
results,
themostrecently
stored
Movo bered
the option
Touching
an actionkeyselects
Down
10 entry
isdisplayed.
nextto thekey.Thedisplay
always
described
AcNion changes
to another
screen,
either
to startthe
Key
by1 each
thedisplayed
number
Plusincreases
routine
or to display
anappropriate
selected
timethekeyistouched.
thatdefines
howtheselected
optionwill
screen
Plus
work.
by1 each
thedisplayed
number
Minusdecreases
options
are
Thecyclekeyis usedwhenseveral
timethekeyistouched.
Each
timethekeyistouched,
a difavailable.
Mlnus
When
isdisplayed
forselection.
ferent
option
is
isdisplayed,
theselection
thedesired
option
to allow
thedisplay
to thefullalphabet
Changes
complete.
a
in,forexample,
characters
entryof alphabetic
lotnumber.
lD,Tech
lD,orcontrol
Alphabetspecimen
theuse
keysareusedtoselect
orreject
Selection
inthe
ofanoption.lf acheckmark(.,/ ) appears
shown
on
record
orallrecords
Allows
a single
SelsGtion
(turned
is
on);
key
the
option
selected
symbol,
is
screen
to bedeleted.
A second
thescreen
Key
is
not
is
the
if
the
key
symbol
empty,
option
Delete always
how
fromwhichyoucanselect
displayed,
(turned
off).
selected
(oneorall)orto
manyrecords
areto bedeleted
thatallrecords
areto bedeleted.
confirm

M
W

tr
tr

3.2

Revised
9/99

Routine
Setup

Set opti ons.

whentheinstrubeentered
TheSetupRoutine
should
paraminstalled
thevarious
mentis initially
to select
your
thisroutine
laboratory.
Thereafter,
etersdesired
by
Tech ID:
of the
infrequently.
Several
will probably
beentered
Controts
thedateand
forexample,
canbeaccessed
freely;
options
thecomthisroutine,
through
timecanbechanged
Setup
puterportturned0n or lff, andtheprinterselected.
the
through
Access
toadditional
options
canbeprotected
Pri nt
useof a password.
aflowchart
shows
Table
3-1, attheendofthissection,
lilemor y
whichisselectandtheSetupRoutine,
oftheMenuOption
edfromtheMenu0ption.
Menu
fromtheOption
theSetup
keysymbol
screen, Touch
Enter
theSelupRoutine
fromtheReady/Run
theSetup
Routine.
toenter
forexample:
shown
below;

tr
tr
tr
E
tr

U s e 1 4 U L T I S T I X1 0 S G .
Ptace strip.

tr
E
E
E

tr

tr@

ID:
SEA #: 00001
reported)

CoIor-(not
Ctarity-(not
ilenu

is made
maybeerased
if a change
NOTE:
Memory
All results
andloadlistto anyofseveral
Setupoptions.
whenthe
inmemory
willbedeleted
edlDnumbers
stored
first,
ismade.
Awarning
screen
willbedisplayed
change
thechange
andyouwillbegiven
theoptionofnotmaking
andnumthestoredresults
to theSetupoption,saving
patient
have
been
results
bers.Besureall
andcontrol
printed
is not
transferred
andthata loadlist
and/or
making
thechanges.
stored
inmemory
before

reported)

Tech ID:
09-05-98 10:52 Ail

( E ) nexttothewordMenu
thekeysymbol
Touch
forexample:
the0ption
Menu;
todisplay

Revised
5/01

3.3

YOUR
SELECTING
OPTIONS
numerEnter
thecorrect
datebytouching
theproper
ic keys,or touchthearrowkeysto movethe
ThefirstSetup
menu
isdisplayed;
forexample:
and
tothedigitthatneeds
to bechanged
cursor
correct
number.
Themessage
willchange
enterthe
Set options.
fromonepartofthedatetothenext,
asyoumove
"Enter
theprompt,
forexample,
day,"then
showing
"0"
"Enter
year."
Besureto entertheleading
where
needed.
Date: 09-05-98
thedatehasbeen
touch<l . Amesc. When
entered,
if aninvaliddateisentered;
sagewillbedisplayed
in theorder
besurethedatehasbeen
entered
Time: 10:34 Ail
lf thedateisvalid,thedisshown
ontheprompts.
playreturns
menu.
tothefirstSelup
Computer port-0F F
2. Time:
theTimekeyistouched,
thedisplay
changes
a. When
(in
format)
to
the
time
show
current
the
selected
Pri nter
keypad
bywhich
thetimecanbe
andthenumeric
the
tothatdisplayed
forchanging
changed,
similar
you
thekeysymbol
nexttotheoption
Touch
thatappears
canbe
date.(Thetimeformatandseparator
below.
want
tochange.
Each
option
isdescribed
through
Menu
#3,StepD).
changed
Setup
thepropb. Enter
theappropriate
digits
bytouching
1. Date:
thearrowkeysto
ernumeric
keysand/or
touch
changes
theDate
keyistouched,
thedisplay
a. When
totheappropriate
move
thecursor
digitthatneeds
by
keypad
toshow
thecurrent
dateanda numeric
asyou
to
be
changed.
The
message
will
change
(thedate
format
and
which
thedate
canbechanged
part
the
time
to
next,
showmove
from
one
of
the
#3,
Menu
separator
canbechanged
through
Setup
prompts
"Enter
"Enter
minutes."
ingthe
hour"
and
D).Forexample:
Step
"0"where
needed.
Besuretoenter
theleading
c. lf thetimeformat
is"12Hour,"
touch
theAM/PM
Enter ilonth:
key
to
from
AM
to
PM
or
vice-versa.
cycle
change
r.05_i3
(lfthetimeformat
"24
cycle
is Hour,"
theAM/PM
keyisnotactive.)
touch<J. Amesd. When
thetimehasbeen
entered,
timeisentered.
sage
willbedisplayed
ifahinvalid
thedisplay
returns
tothefirst
lf thetimeisvalid,
menu.
Setup
porl:
3. Gomputet
porlcyclekeytochange
theselecTouch
theGomputer
tionbetween
upontheselecOFF
and0N.Depending
tionmade,
results
to a computer.
canbetransferred
portareselected
Thespecifications
forthecomputer
laterintheSetup
Routine.

A. Setup
Menu
#1

tr
tr

ZEE E
WEE E
NEE
E

3.4

Revised
5/01

printer
(see
The
NOTE
2 below).
external
option
4. Printer:
"Form
for
use
Printer
3"
option
is
appropriate
to
change
several
thePrinter
keysymbol
a. Touch
printer
fromBayer
withtheStarForm
Printet
available
options:
Product
No.
lf youare
as
5257.
Corporation
printer
toprint
Theinternal
canbeused
i. Internal:
print
format
unsure
of
which
t0
use,
a record
patient
fortheforresults,
withseveral
options
each
option
to
determine
which
oneprousing
thelnternal
o/f.Touch
mat,0rit canbeturned
printed
placement
results
vides
thebest
ofthe
or
keytoselect
thedesired
option
ofOFF
cycle
with
the
form
and
that
works
appropriately
on
patient
lines
between
0N,with2,6,or12blank
yourform
printer.
"Cable
and
Appendix
See
CPl,
result
sets.
- Parallel
Poft"
foradditional
PinSpecifications
lines
between
N0TE:
There
arealways
twoblank
information
onthethree
formats.
result
control
sets.
Printer,
N0TE
2: lf using
theCLINITEK
Form
"12blank
lines
between
header:
When
ii. Gustom
youmustalsosettheMode
onthe
Switches
patient
fortheinternal
result
sets"isselected
"Compute/'
printerto
(both
DS1-1
andDS1-2
printer,
is printed
attheendofeach
a header
refer
Forfurther
information,
switches
D0WN).
printed
The
thatprinter.
report
obtained
through
forthe
to Section
5 inthe0perating
Manual
canbe
header
default
is"MlCR0SCOPICS";this
Form
Printer.
CLINITEK
to
contain
all
if desired,
orchanged
customized,
touch
have
b. When
allprinter
options
been
selected,
atall.
if youdonotwanta header
blanks
( to return
menu.
tothefirstSetup
WhentheGuslom
header
optionkeyis
isdisplayed,
keyboard
touched,
analphabetic
B. Password
Screen
spaces
canbe
fromwhichupto 24letters
and
to
Touch<l when
theentryiscorrect
entered.
havebeen
fromthefirst
lf allselections
completed
tothe Setup
it inmemory
thedisplay
store
andreturn
menu,
touch) to move
tothepassword
either
menu.
Printer
0ption
depending
screen
ordirectly
to thesecond
Setupmenu,
password
protection
of theremaining
printer
instead uponwhether
iii. External:
Anexternal
canbeused
(see
has
l-3laterinthis
screens
been
selected
Step
printer.
This
to,theinternal
of,orinaddition
section).
printer
continucanbea formor8O-column,
printer.
protection
cycle
key
Touch
theExtenal
ous-page
thedislf password
hasnotbeenrequested,
"0N,
"OFF";
password
play
80
tochange
theselection
between
in StepCnefi.lf a
asdescribed
changes
"0N,FormPrinter
1";"0N,Form is beingused,a numeric
fromwhich
column";
screen
isdisplayed
2";and"0N,Form
Printer
3."
Printer
thepassthepassword
Touchrl when
canbeentered.
entered.
lf it hasbeen
entered
correctly,
"0N,Form
1"ifyouare wordhasbeen
Printer
N0TE
1:Select
lf
it
is incorin
the
display
changes
as
describe.d
Step
C.
you
Form
Printer
orif
thePrinter
Products
using
you
the
code
rect,
message
is
and
can
enter
a
displayed
printer
butprintasinwant
tousean80-column
again.
page.
glerecord
theCLINITEK@
oneach
lf using
"0N.
2"asthe
Form
Printer.
Form
Printer
select

Revised
5101

3.5

YOUR
OPTIONS
SELECTING
Menu
#2
G. Setup
isdisplayed
as,
menu
Routine
Thesecond
oftheSetup
forexample:
S e t o p t i o n s.

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

Resutt unitsConventionaI

PIus system-0FF

T e s t - I 4 U L T I S T I X1 O S G

tr
tr

1. Eachofthemenuoptionsfeature
cyclekeysthat,when
forthe
ofoptions
touched,
display
thenextina series
menuitem.
. Language:
inthelanAllscreens
willbedisplayed
guage
for
Also,
thedefault
selection
thatisselected.
upon
several
otheroptions
maychange,
depending
(forexample,
thedateandtime
thelanguage
selected
formats,
testname[Reagent
Striptype],andreportingofcolor).
. Resull
have
options
units:Several
ofthelanguages
fortheunitsinwhichresults
aredisplayed.
Seethe
1 for the
Tables
of Results
at theendof Section
foreachoption.
results
thataredisplayed
andprinted
(AswithLanguage,
forseveral
selection
thedefault
upontheresult
otheroptions
maychange,
depending
unitsselected.)

3.6

. Plussystem:
Results
canbedisplayed
andprinted
"+" symbols)
(which
rather
inthePlus
uses
system
thaninclinical
mg/dl.
units
such
as
. Test:
Reagent
Many
configurations
ofBayer
Strips
However,
canbeusedontheCLINITEK
500Analyzer.
inevery
country.
notallconfigurations
areavailable
withthe
BesuretheReagent
Stripselected
agrees
name
oftheBayer
Reagent
used.
Stripbeing
thedesired
2. Touch
thecyclekeysasneeded
to obtain
Thetable
liststheoptions
thatareavailoption.
below
able
foreach
ofthecycle
keys:
Language:

Result
units:

Plussyslem:

English
Frangais
Deutsch
Italiano
Kanji
Espafiol
Portugu0s
Chinese

(withEnglish,
Deutsch,
Frangais,
andChinese)
Conventional
Nordic.

OFF
ON

s.t.

.English
only

TestJ
MULTISTIXO.IO
COMBISTIXo
SG- LONG
SG
- LONG
HEMA.COMBISTIX@
MULTISTIX'9
SG
MULTISTIXO
URISTIX'LONG
8 SG
MULTISTIX'SG
LIFESTIXo .I1
MULTISTIX
PRO'
MULTISTIX@
SGL
MULTISTIX@
MULTISTIX
PRO'1OLB
MULTISTIX
PROO
l()LS
N.MULTISTIX'SG
MULTISTIX
PRO'1OSB
NEPHROSTIX'L
PRO'1O
L MULTISTIX
URO-HEMACOMBISTIX'SG
MULTISTIX
PRO'7G
URO-LABSTIX'SG
7PH
MULTISTIX
PRO@
URO.LABSTIX@
SGL
MULTISTIX'9
MULTISTIX
PRO@
68
MULTISTIXPRO@6K
URO-HEMACOMBISTIX'
URO.LABSTIX@
tNotallReagent
inallcountries.
Strips
areavailable

5/01
Revised

E. Setup
Menu
#4

D. Setup
Menu
#3

fromthethird
When
allselections
have
been
made
made
fromthesecond
When
allselections
have
been
touch) to moveto thenextmenuintheSetup
menu,
touch) to movetothethirdmenuintheSetup menu,
Routine;for
example:
Routine;for
example:
Set options.

Set opt i ons.

tr
@
tr
tr tr
tr tr

Date f ornat-ltlonthlDaylYear

Date separator-"-"

Ti me format-1 2 Hour

feature
Aswiththeprevious
menu,eachoftheoptions
Theavailable
cycle
keys.
options
are:
Datefomal:

Month/Dayffear
Day/Monthffear
Year/Month/Day
Timeformat:
1 2H o u r
24Hour

Daleseparator:
r _r,

'

, "

rr lt,
I

Timeseparator:
,,
:,,
,
a,

,,

aa

,,

Tests to

report

and the i r order

llark posi tives-0N

Positive

teveIs for

N o r m at

tevets

for

N o r m a[

[eveLs for

tests

SG/pH
CRE

tr
tr

1. Tests
toreport
andtheirorder:
parameter
istested
on
Even
if ananalyte
orphysical
you
to not
theCLINITEK
500Analyzer, maychoose
the
theorderinwhich
report
it;youcanalsoselect
lantests
lf "English
istheselected
arereported.
S.1."
guage,
colorisalsoincluded
asthelasttestif not
already
selected,
it canbeadded
totheendofthelist.
(determined
Youcanalsochoose
to include
clarity
thismenu
option.
visually)as
areported
resultthrough
will
When
theaction
keyistouched,
thedisplay
12.For
show
keys,
labeled
1through
aseries
ofcycle
example:

thekeysasneeded
to selectthe
options.
Touch
desired

Revised
5/01

3.7

YOUR
SELECTING
OPTIONS
SeIect tests
their order.

to

r@eru

t@r,.

t@.r,

,,Esc

report

@
7
@
8@

trE

and

BLO

pH

10

PRO

11

URO

12

E
E

NIT

LEU

ffi

thenumber
Thenumber
offullylitkeys
willequal
plusone,withexception
ofthe
oftestsbeingreported,
P:Cratio- seeStep1-abelow).
Each
timea newtest
fullylit
is added
to thelist,thenextkeybecomes
thenumber
oftestsonthe
untilthenumber
equals
Bayer
Reagent
selected
Stripplustwo(colorand
(Note
clarity). thatonlyoneproteinresultis reported
testswhen
fromtheprotein-low
andprotein-high
PRO@
Reagent
usingMULTISTIX
Strips.)lf thetests
touch
reported
being
andtheirorder
areallcorrect,
(
previous
you
menu.
lf want
the keyto return
tothe
proceed
to make
changes,
asfollows:
PRO
a. P:CRatio:lf youareusing
a MULIISTIX
a proReagent
Strip,
theinstrument
willcalculate
(P:C)ratio.TheP:Cratiowill
tein-to-creatinine
inthe
bereported
appear
always
andwillalways
ltsordercan/asfposition
ofthereported
results.
notbechanged
thistestwillnot
and,therefore,
forselecting
theteststo report.
appear
onthescreen
are
clarity
b. Selecting
Color/Glarity:
lf color
and/or
youcanquickly
notlisted,
andeasily
addoneorboth
tothelistbytouching
thelastfullylitkeyuntilthe
(COL
Touch
testname
isshown.
desired
orCLA)
thenextkey(whichisnowfullylit)toaddtheother
inthe
testname.
Color
andclarity
willbereported
positions
you
changes.
lasttwo
if
make
nofurther

3.8

theorderinwhichtestsare
c. lf youwantto change
reported,
touch
thecycle
keyatthefirstposition
youwant
tochange.
Anytest(s)
listed
notalready
willbedisplayed
first;then
ablank
willbedisplayed
andalltestsfromthatposition
onwillbeerased
andmustbere-entered.
Touch
thecycle
keyuntil
thedesired
testis displayed.
Aseachtestis
selected,
thenexttestinthelistwillbethefirst
position.
testdisplayed
forthefollowing
d. Select
thedesired
testforeach
oftheremaining
positions.
lf youwantto remove
a testfromthe
(notreported),
reporting
order
select
thetestsyou
in
dowant
to report
andleave
blank
description
a
position.
thefinal
thecorrect
testsandorderaredisplayed,
e. When
touch
{.
positives:
2. Malk
(.)
Allpositive
results
withanasterisk
canbemarked
in thedisplayed
andprintedreport,aswellasinthe
datatransferred
to acomputer.
Touch
thecyclekeyto
theselection
change
between
0NandOFF.
youwillbeunable
to make
l'l0TE:lf thisoptionisOFF,
selections
for several
otheroptions(seeSteps
E-3,E-4,E-5,G-1
G-3laterin this
, G-2,and/or
section).
Positive
levels
lortests:
Thelowest
resultthatisconsidered
to bepositive
can
foreach
fromthedefault
levels,
if desired,
bechanged
parameters
ofthechemistry
tests.(Thephysical
ofSG,
pH,color,
arechanged
in othermenu
andclarity
positives"
(Step
is
lf "Mark
E-2previously)
options.)
positive
(.)
all
results
are
marked
with
an
asterisk
0N,
in thedisplayed
andprintedreport,aswellasinthe
to a hostcomputer.
These
levels
are
datatransferred
to determine
whichspecialsousedbytheAnalyzer
mensmeet
thecriteria
fortheconfirmatory
andmicrothe
When
theaction
keyistouched,
scopic
reports.
positive
thelowest
level
forthefirstfour
display
shows
(Tests
testsselected
intheprevious
toreport).
screen

Revised
5/01

test,the
lf Protein
hasbeen
selected
asa reported
b. When
alllimits
have
been
set,touch{ to return
forProtein,
firstscreen
shows
three
different
options
totheprevious
menu.
option
groups
Reagent
oneforeachofthedifferent
of Bayer
posN0TE:
Thisoption
canbeselected
onlyif "Mark
ThereportStripsthatcanbeusedontheinstrument.
previously)
(Step
itives"
E-2
is
0N.
edresults
forprotein
varyslightly,
depending
upon
levels
5. Normal
forCRE:
group
(see
which
Reagent
is
the
Tables
of
Stripsused
pH,thelowerandupperlimitsof the
As
with
SG
and
inSection
1).Thefirstoption
isforthetraofResults
normal
range
for
creatinine
canbeselected
bytouch10SG);
Bayer
Reagent
ditional
Strips(e.9.,MULTISTIX
you
ing
this
key.
However,
must
be
using
a
MULTISTIX
thesecond
isforMULTISTIX
PRO
68andMULTISTIX
PRO
Reagent
inorderforthis
tobeactive.
Strip
option
(not
PRO
6Kstrips available
inallcountries);
andthe
Each
limit
is
limitmust
set
separately,
but
the
upper
thirdisforallotherMULTISTIX
PRO
strips.Byselectbe
equal
to
or
higher
than
the
lower
limit.
group,
youcan
ingthefirstpositive
level
foreach
(Step
thenselect
adifferent
C-1
stripforuseintesting
a. Touch
the* or - keysnexttothelimityouwant
previously)
without
having
tochange
theselection
of
tochange
to raise
number.
orlower
thedisplayed
level
thefirstpositive
oftheprotein
test.
Witheach
touch,
thenumber
willchange
byone
reporting
it
is
limit
level
until
equal
to
the
opposite
NOTE:
Nitrite
isnotlisted,
since
it hasonlyoneposiorisatthehighest
orlowest
reporting
level.
tivelevel.
Also,
theP:Cratioisnotlisted,
since
these
"N0RMAL"
results
already
include
adescription
or
of
b. When
bothlimits
have
been
set,touch{ toreturn
"ABNORMAL."
totheprevious
menu.
option
poswantto
change,
a. Touch
thecycle
keyforthetestyou
N0TE:
Thisoption
canbeselected
onlyif "Mark
previously)
repeating
untilthedesired
level
isdisplayed.
(Step
itives" E-2
is0N.
touch
alltests
onthefirstscreen
arecorrect,
b. When
Menu
#5
(ifadditional
tests F. Setup
theremaining
tests
) todisplay
When
have
coralloptions
onthefourth
menu
been
arereported).
proceed
menu;
rectly
set,
touch
to
to
the
next
Setup
)
c. When
alltests
arecorrectly
set,touch{ asneedfor
example:
edto return
totheprevious
menu.
option
4. Normal
levels
forSG/pH:
Set opt i ons.
considered
to
Thelowerandupperlimitsoftherange
bytouching
benormalfor
SGandpHcanbeselected
limitissetseparately;
however,
theupper
thiskey.Each
CoIorlimit.
limitmustbehigher
thanorequal
tothelower
d e t e r m i n e d b y A n aI y z e r
the* or - keysnexttothelimityouwant
a. Touch
tochange
to raise
thedisplayed
number.
orlower
CoIor choices
Witheach
touch,
thenumber
willchange
byone
limit
reporting
level
totheopposite
untilit isequal
reporting
level.
orisatthehighest
orlowest
Cl.arity choices

Use defautt C0L/CLA

duri ng run-0N

Revised
5/01

tr
tr

3.9

YOUR
SELEGTING
OPTIONS
1 . Golor:

finished
c. When
withthefirstfourcol0rs,
touch)
lf colorhasbeen
selected
as0neoftheteststo be
(BLUE,
to display
thelastthreedefault
colors
(inStepE-1previously),
it caneitherbedeterreported
BROWN,
andOTHER).
Remove
or addcolor
minedbytheCLINITEK
or beentered
500Analyzer
options,
orchange
theirdescriptions,
asneeded,
manually
bythetechnician
froma visualdeterminathentouch{ asneeded
to return
totheprevious
thecyclekeyto select
thedesired
option
tion.Touch
option
menu.
("determined
lf
bytech").
byAnalyzer"
0r "entered
choices:
Glarity
"entered
bytech"isselected,
thecolorcanbeentered
(Step
lf
clarity
isselected
E-1),it
asa reported
result
justbefore
eachspecimen
aspartofa loadlist
and/or
canbedetermined
visually
only.Youcanspecify
upto
istested.
fiveoptions
fromwhichto select
thespecimen
clarionly
N0TE:
bytheAnalyzer
Colorcanbedetermined
previously,
ty.AswithColorchoices
anyofthedefault
the
Reagent
if theBayer
usedcontains
Stripbeing
options
canberemoved
fromthereporting
listandthe
leukocyte
test.Results
reported
bytheAnalpermay
name
ofeach
option
canbecustomized.
Thisisbecause
bedifferent
fromthecolorseen
visually.
a. Thefirstthreechoices
areshowninitially(CLEAR,
thehuman
eyeand
oftheinherent
differences
between
SLCLOUDY
andCL0UDY);the
screen
dissecond
theoptical
system
oftheinstrument.
plays
(TURBID
twoadditional
options
andOTHER).
2. Golor
choices:
Remove
oraddoptions,
theirdescriporchange
lf thecoloroptionabove
is"entered
bytech,"youcan
inthe
tions,
asneeded,
oneach
ofthetwoscreens,
specify
upto seven
fromwhichto selectthe
options
same
manner
F-2previously.
asinStep
canbe
specimen
color.
Anyofthedefault
options
( asneeded
b. Touch
toreturn
option
totheprevious
fromthereporting
of each
removed
list;thename
menu.
option
canalsobecustomized.
4. Usedefault
C0UGLA
during
run:
inia. Thefirstfourdefault
colorswillbedisplayed
Thefirstreporting
value
forcolorand/or
claritycanbe
lf the
tially(YELL0W
RED,
GREEN).
ORANGE,
displayed
asthedefault
valuebysetting
thisoptionto
thecoloris
selection
keycontains
a check
mark,
0N.lt isavaihble
onlyif coloris beingreported
andis
the
included
inthelist;touching
thekeyremoves
"entered
bytech"and/or
isbeingreported.
Each
clarity
first
check,
deleting
theoption
fromthelist.(The
priorto
default
valuecanthenbechanged,
if needed,
asa
option
mustbeselected
shown
andisalways
testing
the
thespecimen.
lf thisoption
issetto 0FF,
key.)
dimmed
description
linesforcolorand/orclarityareblank(no
the
b. Thecolorname
canbechanged
bytouching
default
valuedisplayed)
untilthecyclekeyistouched.
willchange
worddescribing
thecolor.
Thedisplay
by
Useofthedefault
valuecanbeturned0NandOFF
tothealphabetic
keyboard.
theG keytoerase
Use
touching
thecycle
key.
name,
thenew
theexisting
if necessary,
andenter
Touch<J
name
of upto 15letters
andspaces.
when
done
to return
totheprevious
screen.

3.10

Revised
5/01

Menu
#6
G. Setup

Color:

when
all
tothenextSetup
menu
Touch
) to move
havebeenmadeonthefifthmenu.Thenew
selections
as,forexample:
menu
isdisplayed

tevets for

C0L/CLA

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

FI a g s f o r

m ic r o s c o p ic s

tr
tr

levels
forG0UGLA:
1. Posilive
wasselected
asa testto be
lf either
coloror clarity
to beposthefirstresult
thatisconsidered
reported,
testsand
Aswiththechemistry
itivecanbeselected.
(Step
is0N,these
E-2previously)
if "Markpositives"
which
to determine
levels
areusedbytheAnalyzer
and
meet
thecriteria
fortheconfirmatory
specimens
reports.
Positive
results
arealsomarked
microscopic
(.) inthedisplayed
report
andprinted
withanasterisk
When
toa hostcomputer.
andinthedatatransferred
thefirst
keyistouched,
thedisplay
shows
theselection
level
thatisconsidered
to bepositive.
keyuntilthedisplay
theappropriate
cycle
a. Touch
youwantto havemarked
as
thefirstlevel
shows
positive.
Allresults
laterinthelistarealsocalled
positive.
any
lf youhave
notchanged
or removed
(Step
are:
theoptions
ofthedescriptions F-2),

Revised
5/01

Clarity:

TURBID
GREENI CLEAR
BLUE I SLCLOUDY OTHER
BROWNI CLOUDY
-OTHER

- lf visually
determined

Set options.

P o s it i v e

YELLOW
ORANGE
RED

made
have
been
b. Touch
{ whenbothselections
previous
to
the
menu.
to return
option
2. Flags
forconfirmatory
tests:
canbeselectUptofivetests(ofthosetobereported)
hasaposreport.
lf aspecimen
edfortheconfirmatory
andif "Mark
itiveresultforanyof thetestsselected,
positives"
therecord
willbe
is 0N(seeStepE-2),
flagged
andcanberecalled
aspartof a confirmatory
onthese
report.
Further
testing
canthenbeperformed
testing
specimens
andtheresults
oftheconfirmatory
if desired.
entered
intotherecord,
will
thedisplay
theaction
keyistouched,
a. When
Touch
showalistofallteststhataretoberepofted.
theselection
boxnextto thetestsyouwantto
mark
include
intheconfirmatory
report;
a check
touch
inthebox.
Toremove
aselection,
willappear
blank.
theboxagain
andtheboxwillbecome
to
made
have
been
b. Touch
theselections
{ when
totheprevious
menu.
return
option
Flags
formicroscopics:
report,upto fivetestscan
Aswiththeconfirmatory
report.
Thisreport
forthemicroscopics
beselected
thatmayrequire
canbeusedto listthosespecimens
thetestsforthe
a microscopic
examination.
Select
report
inthesame
manneros
fortheconfirmatory
option
totheprevious
report,
thentouch{ to return
positives"
("Mark
must
be
0Nin
E-2]
menu.
lStep
order
toobtain
thereport.)

3.11

YOUR
SELECTING
OPTIONS
Menu
#7
H. Setup

l. Setup
#8
Menu

When
alloptions
havebeen
selected
onthesixthmenu,
touch) to progress
to thenextmenuin theSetup
Routine.
Themenu
isdisplayed
as,forexample:

When
have
been
selected
alloptions
ontheseventh
tothenextSetup
menu.
The
menu,
touch) to progress
menu
isdisplayed
as,forexample:
Set opti ons.

Set opt i ons.

Computer port
Edit

B ar
Enter sampIe IDs-0FF

Tech ID-0FF

results:
1 . Editllagged

tr
tr

andselectResults
thathavebeen
flagged
aspositive
(forexamreport
canbeedited
edfortheconfirmatory
performed).
ple,if confirmatory
Touch
hasbeen
testing
asdesired.
thecyclekeytoturntheoption0NorOFF,
Positives"
Thisoption
canbeselected
onlyif "Mark
(Step
E-2previously)
is0N.
Enler
sample
lDs:
foreachspecAnidentification
number
canbeentered
prior
part
imen,eitheras ofa loadlistorimmediately
is setto 0N.
to testing
thespecimen,
if thisoption
as
Touch
thecyclekeyto turntheoption0Nor OFF,
desired.
Tech
lD:
Thetechnician
whois performing
thetestingcanbe
this
bysetting
identified
onthetestresults,
if desired,
results
control
to0N.TheTech
lDcanappear
on
option
lt isshown
onlyoronbothpatient
andcontrolresults.
when
changed
ontheReady/Run
screen
andiseasily
(see"Getting
to Run,"
Step4, in
Ready
necessary
thedesired
4).Touch
thecyclekeyto select
Section
(OFF;0N,
bothpatient
controlresults
only;0N,
option
results).
andcontrol

3j2

opt i ons

fl.agged resuIts-0FF
c o d e r e a d er o p t i o n s

Passrord for

set

or

reset

setup-0F F

passuord

tr
tr

portoptions:
1. Gomputer
toa hostcomputer
or LIS
lf youaresending
results
param(Laboratory
Information
theinterface
System),
port
Touch
theGompuler
etersmustbespecified.
keytodisplay
a newmenu.
options
to
feature
keys
a. Thefirstthreemenu
options
cycle
parameters.
table
thecorrect
Thefollowing
select
forthese
shows
thepossible
selections
options:
Port

Baud:
1200

Parity:
I Data,
glllof{e
|

0 N 1 2 4 0 0 1 7 / E V E N

oFF

4800.

T|O D D

9600

7/N0NE

19200

5/01
Revised

isselected
astheoutlf either
orCT200
CT200+
putformat,
theuseofchecksum
andhandshake
(refer
to yourcomputer
mustalsobespecified
lt isalsovery
fortherequirements).
specification
made
on
thatyoucheck
theselections
important
yourCLINITEK
200instrument
200+or CLINITEK
in the
identically
andenterthe parameters
r (e.9.,ID/col
or/clarity/mark
CLlNITEK500Analyze
positives
thatthe
Thiswillhelpensure
0Nor0FF).
inthesame
format
asyoursoftdataistransferred
iswritten
to accept.
wareprogram
currently
in
transmitted
N0TE
1:Twostopbitsarealways
formats;
theCT200+
onestopbitis
andCT200
intheCCS
format.
transmitted
results
format
isselected,
N0TE
2: lf the"CT200"
Reagent
PRO
obtained
usinganyoftheMULTISTIX
Thisis
willnotbesentto thecomputer.
Strips
PRO
MULTISTIX
thenewtestsonthe
because
Format:I Ghecksum:*
0utput
| Handshake:*
200
bytheCLINITEK
Strips
arenotrecognized
ON
ccs
0N
|
(andtherefore
softAnalyzer
byitscorresponding
OFF
OFF
CT2OO+ I
program).
wareinterface
cT200
parameters
then
thecorrect
foralloptions,
c. Select
.Notavailable
inCCS
format.
toreturn
totheprevious
$etup
touch{ asneeded
menu.
youselect
upon
willdepend
format
Theoutput
options:
pro- 2. Barcodereader
interface
whetheryou
already
have
asoftware
for
BarCode
Reader
isavailable
Anoptional
Handheld
gramthatallows
fromeither
of results
thetransfer
can
This
reader
with
the
500
Analyzer.
use
CLINITEK
200
Urine
a CLINITEK@
200+or a CLINITEK@
oneach
identification
labels
beused
toscanbarcoded
or LlS.
Analyzer
to a hostcomputer
Chemistry
the
specitube,
rather
than
entering
specimen
cup
or
("CT200+"
formats
isselected
When
oneofthese
mustbeconmenlDmanually.
TheAnalyzer
software
500
or "CT200"),
thedatafromtheCLINITEK
parameters
thebarcoded
for
figured
to
the
appropriate
format
inthesame
willbetransmitted
instrument
reader
the
Bar
code
labels
being
Touching
used.
print(the
instrument
asthatsentbytheselected
new
menu.
the
display
to
a
options
keywillchange
however,
donotmimictheselected
ed results,
instrument).
TheHandheld
Reader
canaccept
anyoffour
a. Label:
used
format
being
formats.
The
ditferent
bar
code
inthe
Alternatively,
results
canbetransmitted
you
key,
or
the
Label
cycle
can
be
selected
using
"CCS."
The
byselecting
CLINITEK
500format
parameters
fromyour
forthisformatareavailable
Bayer
representative
oroffice.
to
results
Theportmustbe0Ninordertotransfer
accompaRefer
tothespecifications
a computer.
ontherequired
nyingthecomputer
forinformation
parameters
forBaud,
Data,
andParity.
portcanalsobeturned
0N
Thecomputer
N0TE:
whichis
menu,
through
thefirstSetup
or OFF
propassword
regardless
ofwhether
unrestricted
(see
lf useof
isbeing
tection
used
Stepl-3later).
(from0Nto OFF
orviceversa)
theportischanged
changed
isautomatically
theselection
inonemenu,
menu.
intheother
porloptions
b. ThefourthoptionontheGomputer
forthe
Format
menuallows
selection
oftheOutput
isdisA newmenu
results
sentto a computer.
played
andtheirpossiwiththefollowing
options
bleselections:

Revised
5/01

3.13

YOUR
OPTIONS
SELEGTING
to a maximum
canbeignored
of 18).Characters
(atthebeginning
asleading
ofthebar
characters
(at
code),
trailing
oracombicharacterstheend),
nation
ofboth.lf youneed
to ignore
anyleading
characters,
touch
thecycle
keyuntilthedesired
("0"to "9").
number
isdisplayed
d. Trailing
can
char.to ignore:
Trailing
characters
keyuntilthe
alsobeignored
bytouching
thecycle
("0"t0 "9").
desired
number
isdisplayed
e. When
allselections
havebeenmade
onthismenu,
touch{ to return
totheprevious
menu.
Password
forsetup:
Youcanchoose
to require
inorder
entryofa password
to restrict
Routine
option
access
to mostoftheSetup
password
menus
is
bysetting
thisoptionto 0N.The
requested
following
thefirstoptionmenuoftheSetup
y o u w i l l b e i n s t r u c t etd0 " s c a n b ar c o d e
Routine,
unless
andallfurther
menus
arenotaccessible
password
password
thecorrect
isentered.
lf the
option
Iabe[. Verify that information on screen
are
alloptionmenus
inthe$etupRoutine
thatisrepresentative issettoOFF,
i s correct."Scan
a label
freelyaccessible.
Touch
thecyclekeyto turntheuse
of thequalityandsizebeingusedandfor which
youknowtheresults
The
ofthepassword
0NorOFF.
thatshouldbeobtained.
onthescreen; 4. Setorresetpassword:
results
ofthetestwillbedisplayed
value
compare
thedisplayed
resultwiththeknown
youcanseta personal
lf thepassword
isbeingused,
to determine
ofthelabelandusethisinformation
password
password.
orresetanexisting
TheAnalyzer
tothe
Return
if anycharacters
need
to bedeleted.
password
alsohasa default
whichis
o1"84437,"
previous
menu
when
finished.
personal
password
always
The
active.
canbeentered
isdisbytouching
theactionkey.Anumeric
keyboard
N0TE:
Youmaywantto testmorethanonelabel,
played,
fromwhichyoucanenterupto6 digits.Touch
sources.
iftheyareprinted
fromdifferent
especially
youwillbe
hasbeenentered;
lf youusemorethanoneformat,testat leastone
<Jwhenthepassword
prompted
password
lf
to re-enter
the
forverification.
BCRthat
labelin eachformat.Referto Appendix
thesamedigitsareentered
time,thedisforcomplete
thesecond
Reader
accompanies
theHandheld
playwillreturn
to theprevious
menuafterdisplaying
information.
"eN e n p a s s n o r d h a s b e e n s e t . "
t
h
e
m
e
s
s
a
g
Reader
can
Leading
char.to ignore:
TheHandheld
youwillneedto enterthepasslf anerroris made,
reada barcodethatcontains
upto 30characters;
for
wordagainandthenre-enter
thesamepassword
canbedishowever,
a maximum
of 13characters
verification.
played,
bytheAnalyzer.
stored,
andtransmitted
(up
Allcharacters
inexcess
of13mustbeignored

thefordetect
canallowthereader
toautomatically
Auto
detect;
Code
matgpe.Thelabel
are:
options
andCode
2 of5);Codabar;
39;l-2of5 (lnterleaved
128.
"Autodetect"
1:Select
N0TE
onlyif morethanone
readformat
isused;
faster
andmoreconsistent
formatbeingusedis
ingswilloccurif thespecific
selected.
N0TE
2: lf usingProduct
No.6469(theCLINITEK@
Inc.),
BarCodeReaderfrom
HandHeldProducts,
with"Autodetect"
theLabeloption
willbeinactive,
deterselected.
ThisBarCode
Reader
automatically
mines
thecorrect
format.
barcode
used
Testbarcode:
Thebarcodelabelbeing
can
should
betested
toensure
thattheinformation
Aftertouching
theTestbatcodekey,
beread.

3.1 4

Revised
5/01

pofi:Thistestsends
b . Serial
datafromtheserial

J. Setup
Menu
#9
When
alloptions
have
ontheeighth
been
selected
intheSetup
menu,
touch) to progress
tothefinalmenu
Routine.
Themenu
isdisplayed
as,forexample:
Set opt i ons.

Reset atI

features

to defautts

Perform hardware tests

1 . Reset
allfeatures
to defaults:

tothe
Youcanreturnalloptions
intheSetupRoutine
theuseofthis
manufacture/s
default
settings
through
from
key.A confirmation
willbedisplayed,
screen
you
reset.
are
which musttouch
YESbefore
theoptions
willbe
Allstored
resulls
andloadlisled
lDnumbers
if lheoptions
deleted
areresel.
2. Perform
hardware
lests:
different
hardware
testscanbeperformed
Several
thismenu
Youmaybeasked
byaBayer
through
option.
Representative
to perform
one0rmoreofthesetests
When
inordertoassistintroubleshooting
a problem.
theactionkeyistouched,
a newmenuofsixditferent
thetotal
isdisplayed.
Thescreen
options
alsodisplays
number
ofstripsthathavebeenreadbytheAnalyzer.
the
keyistouched,
a. Stripsensol:
When
theaction
s c r e edni s p l a yt hs ep r o m p"tp r a . " t e s t s t r i p
thepreson tabre." lf thestripsensordetects
e n c eo f a s t r i pt,h em e s s a g" se t . i p d e t e c t e d "
will bedisplayed.

Revised
5/01

port,through
a connector,
andbackintothesame
port.Thedatasentandreceived
should
beidentical.
i. Obtain
a loopback
connector,
either
bymaking
yourownorbyordering
fromBayer
Instrument
(seeSection
Pafts").
Service
9,"Replacement
Theconnector
isa serial
male
connec25-pin
pins2 and3 areconnected
toronwhich
and
pins4 and5 areconnected.
the
ii. Touch
theSerialportactionkeyto display
plug
testscreen.
Asinstructed
onthescreen,
theloopback
connector
intotheserifporton
(labeled
theback
oftheinstrument
l#), then
touchQ to begin
thetest.Thetestwillcon(bytouching
( ).
tinue
untilyouexitthescreen
Touch
Thistestmaybeusedto determine
screen:
properly.
if thetouchscreen
When
is functioning
isdistheTouch
screen
keyistouched,
a screen
played
thatisfilledwithsmallboxes.
Aseachbox
(V) should
(it
istouched,
a check
mark
appear
center
disappears
whentouched
Touch
the
again).
ofeach
box,saving
the( keyfor
last.
d . Barcodereader:
Thistestis identical
to theTest
barcodeoptiondescribed
inStepl-2-bsoyoucan
test
testyourreader
withoutexitingthehardware
your
lf yourHandheld
screen.
Reader
isnotreading
quality
youshould
to
labels,
testlabels
ofa known
whether
determine
theproblem
lieswiththelabels
youareusingor withtheHandheld
itself.
Reader
yourHandheld
Thepackage
Reader
containing
includes
thathave
twosheets
of barcoded
labels
beenprinted
to theminimum
ofthe
specifications
barcodereader.
lf theselabels
cannot
beread,the
problem
is probably
withyourreader.
lf theyread
properly,
youareusingmaynotbe
thelabels
acceptable.
thedesired
label
Scan
andcompare
thedisplayed
resultwiththeknownvalueof the
label.Return
to theprevious
menuwhenfinished.

3.15

YOUR
OPTIONS
SELECTING

WhenSetupis Gomplete
Touch
G tosave!

that
toensure
Thedisplay
e. Display:
canbetested
(thelighted
are
allpixels
elements
onthedisplay)
When
the
being
litandturned
offappropriately.
willbelit
keyistouched,
theentire
screen
Display
parameyouhave
will
When
finished
thesetup
Thisseries
selecting
forseveral
seconds,
thenbeblank.
to the ters,touch.! to return
returning
thedisplay
to theReady/Run
twicemorebefore
berepeated
pixels, screen.
youmade
previous
if you
Thechanges
faulty
willNOTbesaved
menu.
lfthere
arenumerous
thedisplay donottouch
incritical
orif theyarelocated
areas,
.a.
mayneed
to bereplaced.
It issuggested
thatyouprintacopyofthesetupreport
external toverifyyourselections
andto retaininyourfiles.Touch
f. Printer:
Theinternal
and/or
80-column
printer
fromtheReady/Run
thentouchPrinl.From
to ensure
thatallcharacters Menu
screen,
canbetested
printed
theoptionSelup
thattheexter- thePrintmenuthatis displayed,
select
arebeing
correctly.
Ensure
printer,
(lf printing
Touch report.
make
a
used).
fromtheinternal
nalprinter
isturned
on(ifoneisbeing
printmayfade
onthe photocopy
ofthereport,
thePrinter
keyandfollow
thedirections
sincethethermal
The overtime.)
Examine
theprintout
foritsreadability.
screen.
menu.
returns
totheprevious
display
automatically
Thesetupparameters
arestoredbothintheCLINITEK
500Analyzer
andintheprogram
card.lf a newprogram
touch{ to return cardisinstalled,
3. When
alltests
have
completed,
been
youcanselect
setup
to useyourcurrent
to
toanyprevious
Setup
menu,
ortouch
A toreturn
if
configuration
fromtheAnalyzer
memory.
Conversely,
theReady/Run
screen.
you receive
but have
a newCLINITEK
500Analyzer,
youroldprogram
retained
to useyour
card,youcanselect
program
current
setup
configuration
fromthe
card.lf both
theAnalyzer
andtheprogram
cardarenew,youcanuse
previously
theprintout
thedesired
obtained
to reselect
parameters.

3.16

Revised
5/01

FLOW
CHART
SOFTWARE
Ready/RunScreen
ID
SEQ#
Color
Clarity

MenuOption
TechlD
Touchto enter
TechlD

Controls
Touchto enter
controlLot# and
to runcontrols

SetupMenu#1
Date
Time
Computerport
Printer
Internal
Customheader
External

II

(Enterpassword,if required)

II

SetupMenu#2
Language
Resultsunits
Plussystem
Test

II

Setup
Touchto enter
SetupRoutine

Print
Touchto print:
. lD list
. Calibration
confirmation
. Setupreport

--Setup Menu#4
Teststo reportandtheirorder
Markpositives
Positivelevelsfor tests
Normallevelsfor SG/pH
Normallevelsfor CRE

SetupMenu#5
Color(byTechor Analyzer)
Colorchoices
Claritychoices
UsedefaultCOUCLAduringrun

II
\t
SetupMenu#6
Positivelevelsfor COUCLA
tests
Flagsfor confirmatory
Flagsfor microscopics

{/
SetupMenu#3
Dateformat
Dateseparator
Timeformat
Timeseparator

Memory
Touchto select:
. Allpatientresults
. Allcontrolresults
. Lastbatch
Resultscanbe viewed,
printed,sentto a
computer,or deleted

SetupMenu#7
Editflaggedresults
EntersamplelDs
TechlD

II
{/
SetupMenu#8
Computerportoptions
Port
Baud
Data,Parity
OutputFormat
Barcodereaderoptions
Password
for setup
Set or resetpassword

II

SetupMenu#9
Resetall featuresto defaults
Performhardwaretests
Stripsensor
Serialport
Touchscreen
Barcodereader
Display
Printer

Table3-1
Revised
5/01

3.17

4
Section

INSTRUMENT
OPERATION
lf youneed
toaccess
anyofthemenuitemsshownon
thedisplay,
thismustbedonebefore
a runisstarted.
which
run,
most
the
key
a
of
symbols
aredimmed,
(Section
Following
initial
installation
2)andselection During
means
theoptions
TheO key($top
arenotavailable.
500
of yoursetupoptions(Section
3),theCLINITEK@
on
Run)
is
run
depending
always
available
during
a
and,
operation.
Analyzer
is ready
for routine
UrineChemistry
keys
the
the
Setup
options
selected,
Golor
and/or
Glarity
anytesting.
readthissection
before
beginning
Carefully
maybeavailable.
poinledorhardto make
Donotuseanything
CAUTI0N:
is
lf akeyisdisplayed
thatoption
asafullylitsymbol,
works
eraser
onthetouch
screen.
A pencil
selections
for
key
symavailable
selection.
Touching
the
specified
well.
bolcauses
thefollowing
actions:
lD:allows
identification
numbers
to beentered.
specimen
the
lf lDnumbers
have
been
entered
intoa loadlist,
number
inthelistisdisplayed.
ofthenextspecimen
to beleft
TheCLINITEK
500instrument
isdesigned
to
Thenumber
isupdated
each
timea stripismoved
procedures).
(except
onat alltimes
during
cleaning
theread
area.
screen
Either
thescreen
saverdisplay
ortheReady/Run
The
number
to bechanged.
#: allows
thesequence
(shown
theinstrument SEO
below)
willbedisplayed
whenever
number
the
being
displayed
represents
sequential
simsaverisbeingdisplayed,
isnotinuse.(lfthescreen
thatwillbeassigned
tothenextspecimen.
plytouchthescreen
totheReady/Run number
anywhere
to return
to
Thenumber
increments
each
timeastripismoved
Forexample:
screen.)
theread
area.
displays
thenextoptionintheseries
ofcolorselecColor:
U s e i l U L T I S T I X1 0 S G .
color
tions
that
made
for
visually
determined
canbe
PIace strip.
previously
the
results.
lf colorwas
through
entered
loadlist,
forthenextspecimen
thatentryisdisplayed
to betested;
either
thedefault
description
otherwise,
ID:
key
isdisplayed
isblank
orthedisplay
untilthecycle
in
made
istouched,
upon
theselection
depending
SEO #: 00001
bythe
Section
3, StepF-4.(lf colorisdetermined
Col.or-YELLOU
shows
instrument
reported,
thedisplay
orisnotbeing

Information
General

Ready
to Run
Getting

tr@

tr
tr

E
E

" ( b y A n at y z e r ) " 0 r " ( n o t r e p o r t e d ) , "r e s p e c t i v e l y . )

Ctarity-CLEAR

ofclarity
displays
thenextoption
intheseries
Glarity:
the
displays
selections
that
can
be
made.
0therwise,
ilenu
Tech ID: 118
thatclarity
arethesame
asfortheGolotkey,except
09-05-98 10:32 All
cannot
bedetermined
bytheinstrument.
takesyoutotheOption
Menu,
fromwhichseverresults
are Menu:
lf lDsarenotbeing
andcolor/clarity
used
quickly
orchanged
al
additional
options
can
be
selected
(if beingreported),
is ready
to
theinstrument
displayed
prior
to
run.
beginning
a
useimmediately
andenterstheRunmodeassoonasa
thepushbar
is
Whenever
strip detected
ontheplatform.
(available
Run):
cancels
therunin progress
O (Stop
the
is positioned
station,
attheleftsideoftheloading
onlyduring
theRunmode).
placement
ofa strip;howinstrument
is ready
to accept
(ttelp):
the
information
about
displays
additional
to theright,theinstrument ? Ready/Run
ever,if thebaris positioned
screen.
willbe
is notreadyandanystripplaced
ontheplatform
ignored.

Revised
5/01

4.1

INSTRUMENT
OPERATION
if
the"TechlD"(technician
identification)
steps: 4. Change
thefollowing
Before
starling
eachrun,perform
needed:
1. Check
thatthenameof theReagent
StripbeingdislD"keyisdimmed,
theoption
can
played
N0TE:
lf the"Tech
Reagent
tothename
oftheBayer
corresponds
bechanged
to 0Nasdirected
inSection
3,StepH-3.
urinforroutine
forUrinalysis
thatistobeused
Strip
alysis.
UseofanyReagenl
Stripolherthanlheone
theMenukeysymbolto
theOption
a. Touch
display
do
lf thenames
listed
willGause
erroneous
resulls.
forexample:
Menu;
the
through
notagree,
select
thecorrect
stripname
C-2.
Set opt i ons.
Routine,
inSection
3,Step
asdirected
Setup
hasbeen
TheCLINITEK
500Analyzer
IMP0RTANT:
forusewithBayer
Brand
Reagent
Strips.
optimized
maynotbevalidfor
Theperformance
characteristics
Tech I D: 118
maycause
theuseofwhich
anyotherbrand
ofstrips,
results.
doesnotwarBayer
Corporation
erroneous
C o n tr o I s
withany
500Analyzer
rantuseof theCLINITEK
Bayer
Brand
Reagent
Strips.
reagent
stripotherthan
Setup
2. Inspect
thestriploading
station
andpushbarfor
Print
positioning.
lf contaminants
andcorrect
cleanliness
present,
push
platform,
andmovremove
the
bar,
are
i l e m or y
5,"Daily
inSection
ingtable,
andclean
asdescribed
Cleaning."
witheach
number)
increments
3, The'SEQ#' (sequence
willbe
b. Touch
theTechlDkey.Anumeric
keyboard
placed
the
Change
ontotheinstrument.
stripthatis
displayed.
number
if desired:
starting
c. Enter
theidentification
ofupto 13digits.Thekey#.The
nexttothewordSEO
thekeysymbol
a. Touch
board
alsoincludes
theH-Zkey,which
allows
from
keyboard,
display
willchange
to a numeric
to beentered.
Touch
alphabetic
characters
thenewnumber
which
canbeentered.
to the
from
the
alphabetic
screen
to
return
J
canbereset
thedesired
number.
Thenumber
b. Enter
j
numeric
keyboard,
thentouch tostore
theTech
with
keylabeled
to"00001"
bytouching
thespecial
lDandreturn
tothe0ption
Menu
screen.
lf anerror
ismade,
orifyouonlyneed
thatnumber.
in
lf youwantto printthelDlist(ifa loadlist
exists
theappropriate memory),
touch
tochange
oneortwodigits,
a
of
the
last
or
confirmation
calibration,
tothedigitto
key(+ 0rG) to move
thecursor
parameters,
reportof thesetup
touchthePrintkey
number.
thecorrect
bechanged
andenter
fromthe0ptionMenuandselect
thedesired
option.
touch
hasbeen
entered,
thecorrect
number
c. When
Touch
tothe0ption
Menu.
{ to return
number
intomemory.
<l toenterthe
therun,
6. lf youwantto runcontrols
before
starting
touchtheGontrols
keyfromthe0ptionMenu
andpronext.
ceed
asdirected

tr
tr
tr
tr
tr

4.2

5/01
Revised

INSTRUMENT
OPERATION
if
the"TechlD"(technician
identification)
steps: 4. Change
Before
thefollowing
starling
eachrun,perform
needed:
1. Check
thatthenameof theReagent
StripbeingdislD"keyisdimmed,
theoption
can
played
N0TE:
lf the"Tech
Reagent
tothename
oftheBayer
corresponds
bechanged
to 0Nasdirected
inSection
3,StepH-3.
urinforroutine
forUrinalysis
thatistobeused
Strip
thanlheone
alysis.
UseofanyReagent
$tripother
theMenukeysymbolto
the0ption
a. Touch
display
do
resulls.
lf thenames
listed
willGause
erroneous
forexample:
Menu;
the
through
notagree,
select
thecorrect
stripname
C-2.
Set opt i ons.
Routine,
inSection
3,Step
asdirected
Setup
hasbeen
TheCLINITEK
500Analyzer
IMPORTANT:
forusewithBayer
Brand
Reagent
Strips.
optimized
maynotbevalidfor
Theperformance
characteristics
Tech I D: 118
maycause
brand
theuseofwhich
anyother
ofstrips,
results.
doesnotwarBayer
Corporation
erroneous
C o n tr o I s
withany
500Analyzer
rantuseof theCLINITEK
Bayer
Brand
Reagent
Strips.
reagent
stripotherthan
Setup
2. Inspect
thestriploading
station
andpushbarfor
Print
positioning.
lf contaminants
andcorrect
cleanliness
platform,
present,
push
andmovremove
are
the
bar,
i l e m or y
5,"Daily
andclean
inSection
ingtable,
asdescribed
Cleaning."
witheach
number)
increments
3, The'SEQ#' (sequence
willbe
b. Touch
theTechlDkey.Anumeric
keyboard
placed
the
Change
ontotheinstrument.
stripthatis
displayed.
number
if desired:
starting
c. Enter
theidentification
ofupto 13digits.Thekey#.The
thekeysymbol
nexttothewordSEO
a. Touch
board
alsoincludes
theH-Zkey,which
allows
from
keyboard,
display
willchange
to a numeric
to beentered.
Touch
alphabetic
characters
thenewnumber
which
canbeentered.
to the
from
the
alphabetic
screen
to
return
J
canbereset
thedesired
number.
Thenumber
b. Enter
j
numeric
keyboard,
thentouch tostore
theTech
with
keylabeled
to"00001"
bytouching
thespecial
totheOption
lDandreturn
Menu
screen.
lf anerror
ismade,
orifyouonlyneed
thatnumber.
in
lf youwantto printthelDlist(ifa loadlist
exists
theappropriate memory),
touch
tochange
oneortwodigits,
a
of
the
last
or
confirmation
calibration,
tothedigitto
key(r 0re) to move
thecursor
parameters,
reportof thesetup
touchthePrintkey
number.
thecorrect
bechanged
andenter
fromtheOption
thedesired
option.
Menuandselect
touch
hasbeen
entered,
thecorrect
number
c. When
Touch
tothe0ption
Menu.
{ to return
thenumber
intomemory.
<l toenter
therun,
6. lf youwantto runcontrols
before
starting
touchtheGontrols
keyfromthe0ptionMenu
andpronext.
ceed
asdirected

tr
E
tr
tr
tr

4.2

5/01
Revised

a. Notice
thecontrol
number
displayed
sequential
(e.9.,
immediately
to theleftofthelotnumber
shouldberun0na regNegative
andpositive
controls
"c0035").
you
touch
thisnumber,
lf want
toreset
ofthe
a checkontheperformance
ularbasisto provide
thekeylabeled
C0001.
operation.
BayerReagent
Stripsandontheinstrument
b. Enter
thelotidentification
ofthefirstcontrolto be
provides
thattheReagent
Testing
controls
confidence
touch
tested.
lf
alphabetic
characters
areneeded,
resultErrors
andbeingreadproperly.
Stripsarereacting
keyboard.
theH-Zkeyto display
thealphabetic
lt is
ingfromusertechniques
canalsobedetected.
return
tothe
Touch
the
letters
to
after
entering
<J
thefollowing
thatcontrols
suggested
berununder
numeric
display.
conditions:
youareready
totestthecontrol.
c. Touch
rl when
. Atthestartoftheday's
run;
"pracestri p."Completely
. When
3. Thedisplay
willprompt
Strips;
using
a newbottle
ofReagent
. Whenever
immerse
Reagent
Strip
allreagent
areas
oftheBayer
testresults
areindoubt;
. When
the
in
lmmediately
remove
the
control
solution.
operators.
training
newinstrument
of
run
the
edge
Reagent
While
removing,
slowly
Strip.
Stripsfor
Positive
Control
andNegative
CHEK-STIX@
theside
theentirelength
oftheReagent
Stripagainst
500
foruseontheCLINITEK
areavailable
Urinalysis
of
the
container
to
remove
excess
control
solution.
prepared
Strips
usingtheControl
Analyzer.
Thesolutions
up,onto
thereagent
strip,withreagent
areas
provide
positive,
whenused 4 . Place
negative,
reactions
ordefined
tothe
station,
ofthestriploading
for Urinalysis. thestripsupports
Bayer
withtraditional
Reagent
Strips
(y) andagainst
rightofthesmall
embossed
arrow
froma normal,healthy
Alternatively,
a urinespecimen
platform
(Figure
the
rear
4-1).
wall
of
the
Additional
specimen.
individual
canbeusedasa negative
Control
Positive
andNegative
information
onCHEK-STIX
andin
canbefound
inSection
6 ofthismanual
Strips
inseft
fortheControl
thepackage
Strips.
PRO@
Reagent
Strips,qualiN0TE:lf usingMULTISTIX
availty control
beperformed
usingcommercially
should
thatinclude
values
foreachtestonthestrip;
ablecontrols
for usewith
Control
Stripsarenotsuitable
CHEK-STIX
products.
these
Forinformation
aboutcontrolmanufacInthe
turers,contactyour
Bayer
officeorrepresentative.
DepartService
UnitedStates,
calltheBayer
Customer
mentat1-800-348-81
00.
proceed
asfollows:
Totestcontrol
specimens,
byfol1 . Prepare
theappropriate
control
solution(s)
insertor
lowingthedirections
foundinthepackage
label.
onthebottle
Figure
4-1
2 . TouchtheMenukeysymbolfromtheReady/Run
key(if notalready
screen,
thentouchtheControls
keyboard,
toa numeric
done).
Thedisplay
willchange
can
the
controls
fromwhichthelot identification
of
andtheconnumber
reset,
beentered,
thesequential
trolrunstarted.

Testing
Gontrols

Revised
5/03

4.3

INSTRUMENT
OPERATION
product.
afresh
d. Deterioration
ofthecontrol
to
0btain
BesuretheReagent
NOTE:
Stripis lyingparallel
product
conbottle
ofcontrol
afresh
andprepare
beagainst
thepushbar.Theendofthestripshould
procedure.
platform
lf
trol
then
repeat
the
solution,
control
notbetouchtherearwallofthe
andshould
give
withthefresh
control
failsto
results
solution
lmproper
station.
ingthebottomofthestriploading
proceed
placement
intheexpected
values,
toStep
e.
to jamorthe
maycausetheinstrument
thereadheads. e. CLINITEK
under
stripto beincorrectly
aligned
Perform
an
500instrument
malfunction.
procedure
(see
2).
lnitial
Instrument
Section
Check
Repeat
2-bthrough
4 foreachadditional
Steps
prolf theInitial
Instrument
orthecontrol
Check
control.
andan
cedure
cannot
besuccessfully
completed
the
along
Thestrip(s)willautomatically
beadvanced
problem
instrument
malfunction
or
reagent
strip
forreadstriploading
station,
under
thereadheads
issuspected,
seeSection
8,TROUBLESH00TING
be
willthen
ing,thenintothewaste
bin.Theresults
AND
SERVICE,
or
contact
theCustomer
Service
printed
(unless
turned
0FF
havebeen
allprinters
Department
for
assistance.
lf
through
theSetupRoutine)and
storedinmemory.
port
the
as
isselected
thecomputer is0NandGCS
(seeSection
format
output
3,Stepl-1),thecontrol
results
willalsobetransmitted
tothehostcomputer.
Operation
the A. Basic
run,press
7 . Afterallcontrols
havebeen
,! (after
Thestepsdescribed
inthissection
regardarethesame
symbol
isdisplayed
to exitthecontrolscreen.
again)
youarerunning
the
use
less
of
whether
with
or
without
produce
stated of lD numbers.
Thecontrol
thevalues
solution
should
to
underRead
thissection
completely
package
results
intheproduct's
insert.
lf thecontrol
how
the
instrument
theRunMode.
stand
operates
during
of
sources
falloutside
ofthese
values,
thefollowing
1. lf clarity
isbeing
reported
entered
and/or
colorbeing
errormayhave
occurred:
bythetechnician,
thecolorand/or
clarity
select
setup.
Check
a. lmproper
technique
orinstrument
key(s)
foreach
thecycle
description
specimen.
Touch
to
thattheReagent
used
corresponds
Stripbeing
is being
asneeded
untiltheappropriate
description
given
theReagent
ontheReady/Run displayed.
Stripname
(Alternatively,
by
the
clarity
enter
color
and
procedure
as
repeat
thecontrol
screen.
Carefully
providtheappropriate
scanning
barcoded
symbols
above.
described
should
edwiththeHandheld
BarCode
Reader.)This
due
b. Deterioration
oftheReagent
Striptestareas
however,
tothenextstep;
bedonebefore
continuing
or heat.
to exposure
to light,
moisture
ambient
youcanchange
thedescription
upto thepointat
Reagent
Strips
a freshbottle
oftheBayer
Obtain
which
thestripismoved.
procedure.
lf
being
usedandrepeat
thecontrol
the
within
freshReagent
failtogiveresults
Strips
proceed
expected
values,
to Stepc.
a
Prepare
c. Deterioration
ofthecontrol
solution.
profresh
thecontrol
control
solution
andrepeat
withlf freshsolution
failstogiveresults
cedure.
proceed
intheexpected
values,
toStep
d.

Testing
Routine
Specimens

4.4

Revised
5/01

assoon
oftheReagent
Stripisdetected
areas
of a Bayer 4. Thepresence
immerse
allreagent
2. Completely
placed
instrument
lf
the
it
is
on
the
loading
station.
as
well-mixed,
uncentrifuged
Reagent
Stripin fresfi,
of
detection
waspreviously
screen,
attheReady/Run
theReagent
Strip.While
remove
urine.lmmediately
and
thetiming
thefirststripimmediately
activates
removing,
slowlyruntheedgeoftheentirelengthof
thestrip
Thepushbarmoves
movement
functions.
thesideof theurinecontheReagent
Stripagainst
andthe
the
loading
to
the
read
area
along
station
excess
urine.Donafblottheedge
tainerto remove
theplat# increments.
Thestripismoved
along
SEO
towel.
a paper
ofthestripagainst
secseven
formbya series
of pinsthatmove
every
performance
hasbeenoptiTheinstrument
NOTE:
passing
for
readheads
each
of
the
two
onds,
under
for usewithunblotted
strips,andresultsmay
mized
the
waste
analysis
andtheninto
bin.
differif thestripsareblotted.
isalready
intheRunMode,
N0TE:
lf theinstrument
facing
withreagent
areas
theReagent
Place
Strip,
the
after
there
may
be
of
up
to
seven
seconds
a
delay
staofthestriploading
up,ontothestripsupports
push
placed
the
the
loading
station
before
strip
is
on
(r7)
arrow
embossed
tion,to therightofthesmall
Theamount
depends
onthestabarmoves.
ofdelay
(Figure
4-2).
therearwalloftheplatform
andagainst
being
forthestrips
currently
tusofthetiming
cycle
analyzed.
to betested:
newspecimen
5. Foreach
description.
thecolor
and/or
clarity
a. Enter
forthespecimen
theReagent
Strip
b. Dipandplace
justentered.
to move
thestrips
across
Theinstrument
continues
tothewaste
thereadareauntilthefinalstripismoved
station
ontheloading
bin.A newstripcanbeplaced
tothen.
atanytimeprior
N0TE:
Youwillhaveverylittletimeto enterthe
it is
thestrip.Therefore,
afterplacing
color/clarity
thecolor
andclarthatyouenter
strongly
suggested
Strip.
theReagent
ityofeach
specimen
beforedipping
onprintforinformation
6. SeePartDlaterinthissection
4-2
Figure
theresults.
ingand/or
transmitting
to
BesuretheReagent
Stripis lyingparallel
NOTE:
thepushbar.Theendofthestripshouldbeagainst
notbetouchtherearwalloflheplatfomandshould
lmproper
station.
ingthebottomofthestriploading
jam
placement
or the
to
maycausetheinstrument
under
thereadheads.
aligned
stripto beincorrectly

Revised
9/99

4.5

INSTRUMENT
OPERATION
thelDforthefirstspecimen.
lf alphabetic
charthatrequires 2. Enter
occurs
7. Cancelling
a run:lf a problem
the
actersareneeded,
touchthe H-Zkeyto display
ofallreadtherunto bestopped
before
completion
j
(touch
to
the
numer(Stop
alphabetic
keyboard
to
return
intheupper
ings,
touch
theI keysymbol Run)
ic keyboard).
from
Alternatively,
scanthelDnumber
rightcorner.
Youwillbegiventheoptionofcancelling
BarCode
Reader.
a barcoded
labelusingtheHandheld
theentire
runorcancelling
onlythelaststripthatwas
placed
runiscancelled, N0TE:DoNOTtouchor scanj fromthelDentry
lf theentire
ontheplatform.
platform
immediately screen
onthe
willbemoved
allstrips
untilafterthecolorandclarityhavebeen
(andno
tothewaste
bin.Noresults
willbereported
entered.
read
# assigned)
foranystripthathadnotbeen
SEO
if desired,
by
Enter
thecolorandclaritydescriptions,
pressing
prior
the
specito
at bothreadheads
@;
as
touching
the
and/or
key
symbols
Color
Clarity
lf onlythelast
mens
forthose
strips
mustberetested.
"Use
needed
thecorrect
lf
to display
description.
therunwillcontinue
andanewstrip
stripiscancelled,
run"
was
the
default
C0UCLA
during
setto
0N,
default
#.
using
thesame
SEQ
canbetested,
values
of"YELLOW"
and"CLEAR"
willbedisplayed;
if it wassetto OFF,
thedescriptions
for bothwill be
B. ll lDsareUsedina Loadlist:
blankuntilthekeyistouched.
Alternatively,
scanthe
using
the
appropriate
colorandclarity
barcodes,
asa loadlist
lDscanbeentered
Upto 100specimen
Handheld
Reader
the
bar
code
and
special
color/clarity
therun,asdescribed
below.
before
starting
cardprovided
withtheReader.
to enter
1. Touch
screen
thelDkeyf romtheReady/Run
j (orscan
thej code
fromthecolor/clariforthefirstspecimen.
ThelDentryscreen 4. Touch
thenumber
into
ty card)to enter
thenumber,
color,
andclarity
isdisplayed
as,forexample:
(Awarning
memory.
tonewillsound
if anentryis
missing.)
Thenumber
to thelettofthelDwillincreEnter ID, C0L, CLA:
mentto indicate
theloadlist
orderofthenextlDto be
entered;
thenumber
inthelower
rightcorner
ofthe
display
willalsoincrement
to showthetotalnumber
oflDsintheloadlist.
NOTE:
There
is noneed
to scanthe j barcodeif
youarescanning
ANDif:
barcoded
lDnumbers
. neither
isbeing
colornorclarity
used
4_

@t:ll;;
@:l;ll"-

E trE
M

ZE E E E
@
WE E
f:l
EE E
EE
t-r

T o t at :

01

. clarity
deteris notbeing
used
andcoloris being
mined
bytheAnalyzer.
Repeat
2 to4 above
foTeachspecimen.
Steps
NOTE:
lD numbers
AREallowed
bythe
Duplicate
system.

keyThelDnumber
canbeentered
usingthenumeric
and/or
lf colorisbeing
bythetechnician
board.
entered
atthe
thesemustbeentered
clarityisbeingreported,
the
whilerunning
sametime.Theycanthenbeedited
priortodipping
eachReagent
immediately
specimens,
Strip.

4.6

Revised
5/01

number
or
change,
a loadlisted
6 . Toreview,
ordelele
entered,
thathasalready
been
color/clarity
description
numthedesired
todisplay
usetheft andI keys
to helpyoulocate
ber,usingtheloadlist
ordernumber
location:
theproper
or deleted
N0TE:
ThelDnumber
cannot
bechanged
through
theRunmode;
mustbemade
during
changes
mode.
thisscreen
whiletheinstrument
isintheReady
thelDnumber
a. Change
usingthe3 keyto move
cortheleftasneeded.
thenenterthe
thecursorto
rectnumber.
thenumber
bytouching
fromtheloadlist
b. Delete
you
given
onlythe
will
the
to
delete
be
option
Bt;
lDnumber
being
displayed
oralllDsinmemory.
Touch
thedesired
option.
as
c. Editthe colorand/orclaritydescription
in
describedStep
3 above.
j
and
newnumber
0rscan toacceptthe
d. Touch
descriptions.
color/clarity
you
intotheloadlist,
7. When
all lDshavebeenentered
print
touch
can thelistbytouching
E. Then
.! to
testing
spectotheReady/Run
to begin
return
screen
(ThelDlistcanalsobeprinted
bytouching
imens.
Print
thentouching
Menu
fromtheReady/Run
screen,
lDlist.)
andselecting
lDscan
noadditional
NOTE:
isstarted,
0ncetesting
be
to theloadlist.
norcananlDnumber
beadded
orcanordeleted
changed
untiltheruniscompleted
lDsinthe
lf theruniscancelled,
theremaining
celled.
loadlist
canbeedited,
butnonewlDscanbeadded
untiltheruniscomplete.
asdescribed
8. Testeachspecimen
inthesamemanner
previously
("Basic
The
in StepA
0peration").
andthe
Ready/Run
screen
willshoweachlDnumber
inthesame
order
asthey
descriptions
color/clarity
into
loadlist.
For
each
specimen:
were
entered the

Revised
5/01

a. Gheck
thatthelDnumber
descripandcolor/clarity
tionsarecorrect
to betestforthespecimen
about
as
ed.Editthecolorandclarity,
if necessary,
described
inStepA-1.
inSteps
b. Dipandplace
a Reagent
Stripasdescribed
A-2andA-3.
has
9. Whenthestripforthelastloadlisted
specimen
youwillnotbeallowed
beenmoved
tothereadarea,
to place
Thepush
anyadditional
stripsonthetable.
will
barwillstayat therightsideandthedisplay
C h a n g e t 0 " c o m p t e t i nRgu n . P t e a s e u a i t . "

C. lf lDsareUsed
Without
a Loadlist
prior
lDscanalsobeentered
immediately
Specimen
totesting
each
specimen,
asfollows:
1. Touch
thelDkeytoenter
thenumber
forthefirstspec(see
imen.
ThelDentry
isdisplayed
StepB-1
screen
above).
2. Enteror scanthelDnumber
forthespecimen
about
to betested;
if needed,
enterorscanthecolorand
(see
clarity
B-2andB-3forcomdescriptions
Steps
plete
corthisinformation
hasbeen
directions).
When
rectly
entered,
touchrl (orscanthe j codefrom
thecolor/clarity
card).
NOTE:
There
is noneed
to scanthe j barcodeif
youarescanning
ANDif:
lDnumbers
barcoded
. neither
colornorclarity
isbeing
used
01

. claritv
deteris notbeing
usedandcoloris being
mined
bytheAnalyzer.
willchange
to allowentryofthenextlD
3. Thedisplay
push
number,
move
to theleftsoa
andthe
barv0ill
Dipand
stripcanbeplaced
ontheloading
station.
place
A-2and
inSteps
a Reagent
asinstructed
Strip,
A-3.
N0TE:
without
a stripbeing
lf another
lDisentered
a loaddetected,
theinstrument
automatically
creates
list(see
StepBpreviously).

4.7

INSTRUMENT
OPERATION
staattheloading
4. Whena Reagent
Stripis detected
two
entered,
lDnumber
hasbeen
tionaftera single
occur
onthedisplay:
changes
. Thenumber
to the
to theleftof thelDchanges
tested.
being
number
ofthespecimen
sequence
timea stripis
Thisnumber
willincrement
each
moved
tothereadarea.
. Theprompt
each
changes
atthetopofthedisplay
j
pressed
(after
lD
and
the
is
entering
time
"p
prompt
r a.
tothe
color/clarity
ofa specimen)
"
the
totheread
area,
stripismoved
st ri p."Aftera

End-of-Run
Reports

Results
D. Printing
andTransmitting

Editing
Results
intheGonfirmatory
Report

forconfirlf youmarked
anyanalytes
to beflagged
positives"
microscopic
tests
matory
and/or
andif "Mark
is 0N(intheSelupRoutine),
oneortwoend-of-run
The
reports
maybedisplayed
whentheruniscompleted.
will
Microscopic
Report
Confirmatory
and/or
screens
plustheabbreviashowtheSEQ
# andlDoftherecord,
for
tionfor eachanalyte
thatwaspositive
andmarked
flagging.
maybedisplayed
onone
Uptofiverecords
the
additional
records
bytouching
screen;
canbeviewed
in boththe
it andV keys.lf therearerecords
p r o m pr te t u r nt so " E n t e r r D , C O L ,C L A . "
Reports,
theConfirmatory
Confirmatory
andMicroscopic
Report
willbedisplayed
first./f resulfsaretobeedited,
specimen:
5. Foreach
Report
thismustbedonebefore
exiting
theConfirmatory
lDnumber,
andclarity.
color,
a. Enterthe
(see"Editing
by
Results"
next).
Youcanprinta report
orscanj .
b. Touch
toexit
touching
lE. Thentouchl!, whenyouareready
screen.
theReagent
forthespecimen thereport
c. Dipandplace
Strip
justentered.
willbedisplayed
if there
areany
il0TE:A thirdreport
more
records
for
which
was
reported
for
one
0r
an
error
screen
NOTE:
Thedisplay
remains
atthelDEntry
This
report
will
last,
any
specanalytes.
be
displayed
and
immethroughoutthe
entirerunwhenlDsareentered
imens
listed
should
beretested.
priortotesting
thespecimen.
diately

lf youperform
confirmatory
testing
onanyofthespeccomputtotheprinter
and/or
Results
aretransmitted
thisis done
results,
been imensandwantto editthereported
areas
onthestriphave
erassoonasallreagent
Report
Youmustfirsthave
screen.
fortheconfirmatory fromtheConfirmatory
read.However,
if a record
isflagged
"End-of-Runspecified
Report
one0rmoretestsfortheConfirmatory
flagged
results"
is0N(see
report
and"Edit
results"
have
selected
for
the
"Edit
flagged
after
and
0N
not
transmitted
until
Reports"
next),thatrecordis
(Section
G-2
3, Steps
optionin theSelupRoutine
reports
have
been
exited.
theend-of-run
andH-1).
Report
use
1. WhiletheConfirmatory
isbeingdisplayed,
tothe
tnei andV keys
to move
thehighlighting
thentouch.l to select
therecord.
desired
record,

4.8

Revised
5/01

(positive)
tests
Theresults
obtained
fortheflagged
Touch
thecyclekeynextto thetest
willbedisplayed.
tochange
thedisplayed
resulttothenextoption
name
key
reported
results.
0ncethecycle
oftheavailable
printed
and
theresultforthattestwillbe
istouched,
point(!),evenif theresult
stored
withanexclamation
to itsoriginalvalue.ltthe
selected
outputforis reset
(see
the"!"will
3,Stepl-1b),
matis"CCS"
Section
( when
editwiththeresults.
Touch
betransmitted
ingis complete
forthatrecord
to returnto theConReport.
firmatory
record.
for eachdesired
Repeat
Steps1 and2 above
When
allediting
iscomplete,
touchC to exitthe
theEditroutine,
Report.
Confirmatory
1nceyouleave
youwillnotbeableto edittherunanyfurther.
they
Report,
4. lf there
arerecords
intheMicroscopic
and
next.AfterboththeConfirmatory
willbedisplayed
results
Report
havebeen
exited,
Microscopic
screens
Report
fortherecords
included
intheConfirmatory
printer
(all
other
to
the
computer
aresent
and/or
printed/
assoonastheyare
records
are
transmitted
available).

Results
Recalling
are
records
and200controlrecords
Upto 500patient
oneor more
in memory.
lf youwantto recall
stored
proceed
records,
asfollows:
thentouch
1. Touch
Menuto display
theOptionMenu,
Memory.
to recall
records,
allcon2. Youcanchoose
allpatient
patient
The
records.
trolrecords,
orthelastbatch
of
is shown
nextto the
number
of records
inmemory
Touch
thedesired
option.
firsttwooptions.

Revised
5/01

groupwillbe
Thefirst(earliest)
record
oftheselected
wasstoredis
displayed.
Thedateandtimetherecord
lD(ifavailable),
SEQ
shown,
alongwiththetechnician
Allresults
#, andlDfortherecord.
arethenlisted;
positive
(asdefined
results
through
theSetupRoutine)
(.)
with
results
withanasterisk andedited
areflagged
(!).
anexclamation
4 . Locate
thefirstrecordyouwantto review
usingthe
movement
keysshown
Thenextloweronthedisplay.
is recalled
record
in memory
or higher-numbered
i and* t<eys
10
when-tne
record
areused;the
lowerorhigher
isrecalled
whenthef l0 and010keys
areused.
Printingrecords
lf youwantto print
frommemory:
oneormorerecords,
touch
E; youwillbegiven
printing
several
options:
Therecord
thatwasdisa. Prinlonlythisresult:
played
canbe
whentheE keywastouched
printed.TheSEO
willcon# andlDofthatrecord
menu.
to bedisplayed
tinue
ontheprintoption
Youcanspecify
thebeginb. Printa groupofresults:
allrecords
ningandending
records
tobeprinted;
group
inthesequential
willbeprinted.
Usethe
(lowest
movement
keys
todisplay
thefirstrecord
printed,
you
thentouchrI
#) wantto have
SEO
to be
theselection
to thelastrecord
to change
printed.
Thisrecord
musthave
a SE0# thatis
Touch
higher
thanorthesame
asthefirstrecord.
printing.
<l to begin
(control)
that
results:
Allrecords
c. Printallpalient
is
when
thisoption
wererecalled
canbeprinted
selected.
to the
Afterprintingis complete,
titescreenreturns
inStep2
first(earliest)
record
ofthegroup
selected
previously.
(lf "Print
wasselectof results"
a group
fromwhich
the
first
returns
to
screen
ed, display
the
to return
Touch{ asneeded
thegroupwasselected.
tothefirstrecord.)

4.9

INSTRUMENT
OPERATION
lf youwantto
records
frommemory:
6 . Resending
or
toa hostcomouter
resend
oneor morerecords
O; youwillbegiven
as
thesame
options
LlS,touch
givenpreviously
frommemory:
for printingrecords
. Send
onlythisresult
. Send
a group
ofresults
.
. Send
(control)
results
allpatient
manner
inthesame
therecords
to beresent
Select
5 above.
asinStep
lf youwantto delete
7 . Deleting
resultsfrommemory:
touch
results
frommemory,
allpatient
or control
the
to confirm
theE key.
Youwillthenbeasked
deletion.
menu
touch{ to returntotheprevious
8 . When
done,
screen.
ortouch
totheReady/Run
.! to return
.

Notes
Operating
setofresults
witha FormPrinter:Each
Whenprinting
intothe
inmemory
isstored
untila formisinserted
When
asbeinginplace, .
FormPrinter.
aformisdetected
each
Check
thenextsetofresults
issenttotheprinter.
thatall
formimmediately
afterit is printedto ensure
printed
lf
readable.
results
have
been
andareclearly
problem
printed
form,immediately .
thereisa
withthe
reprint
thelastreport
asfollows:
FormPrinter,usethe
NOTE:
lf usingtheCLINITEK@
"Reprint"
rather
thantouching
keyontheFormPrinter,
display.
theReprintlastresultkeyontheinstrument
lastresult
theselection
keynextto Reprint
a. Touch
asthemesthatisdisplayed
screen
onthesame
Sage" e. i nt i ng- p I ea s e wa i t . " As long as the

key,thelastsetof
in theselection
V appears
results
willbereprinted
timeaformisinserteach
edintotheprinter.

4.10

(Aform
b. lnsert
a newformintotheForm
Printer.
last
NOT
Reprint
must beinserted
before
touching
willbelost.)
result
orthelastsetofresults
printed
touch
c. When
thereport
hasbeen
correctly,
theselection
keyagain
to remove
tner/. Thenext
setofresults
willbeprinted
when
aformisinserted.
jammed
lf a stripshouldbecome
underthereadhead
totheextent
thatmovement
isprevented,
ofthestrips
touch
to
Ready/Run
stop
the
run
and
return
to
the
O
provided
screen.
Record
theinformation
ontheResults
Error
Report
to determine
thespecimen(s)
thatmust
Then
beretested.
turntheinstrument
offandremove
(seeSection
thefixedplatform
5,"Daily
Cleaning,"
jammed
platreinstallthe
Step
4).Remove
the
strip,
thespeciform,andturntheinstrument
on.Retest
men(s)
forwhich
werenoresults.
there
Galibration
confirmation:
A reportofthemostrecent
Touch
successful
calibration
if desired.
canbeprinted
Print
Menu
fromtheReady/Run
thentouch
screen,
Thedateandtime
andselect
Galibration
confirmation.
ofthelatest
willbeprinted.
successful
calibration
print(fromtheinternal
printer)willfadewith
Thermal
time,
when
to light.
Theprintwill
especially
exposed
alsofadeif covered
withtransparent
tapeor when
exposed
toextremes
intemperature
orhumidity.
Theinstrument
whenlheinternal
doesnotdetect
printeris outofpaperandtherefore
printwillcontinue
thelast
ingresults
even
ifthere
isnopaper.
However,
feetof paper
a pinkedge;
several
ontherollcontain
Any
therollshould
bechanged
when
thisappears.
printed
youdonothave
results
can
records
forwhich
then
bereprinted
thelastbatch
ofrecords,
byrecalling
printing
theappropriate
records.
Empty
thewastebinas it startsto fill to prevent
jamming
problems
theread
withstrips
astheyleave
station.

5/01
Revised

5
Section

CARE
OFTHEINSTRUMENT
3. Remove
thewaste
binliner(ifbeing
used)
anddiscard
theusedReagent
intoanappropriate
container,
Strips
procedures.
your
according
to
laboratory
standard
free
KeeptheexterioroftheCLINITEK@
500instrument
thefixedplatformbypullingtheentireassemmaybecleaned 4. Remove
lf needed,
theexterior
ofdustatalltimes.
you(Figure
blytowards
5-2).
Donotuseany
usinga dampcloth
anda milddetergent.
grease,
or lubrication
typeof solvent,
oil,
silicone
spray,
onanypartoftheinstrument.

General
Gleaning

DailyGleaning
table,reagent
stripholdThefixedplatform,
moving
pushbatandlinershould
at
allbecleaned
downplate,
whichleastonceeachdayor afterrunning
300strips,
toenter
lf thedisplay
isused
everismorefrequent.
screen
becleaned
lD,color,
or clarity
during
therun,it should
steps.
onceeachdayalso,asdirected
inthefollowing
(andthe
screen
1. Withtheinstrument
attheReady/Run
runcompleted),
turntheAnalyzer
off.
lf theinstrument
isturned
offlramanyscreen
NOTE:
(andwiththeruncompleted),
otherthanReady/Run
Figure
5-2
position
and
tablemaynotbeinitslowest
themoving
platform.
youwillbeunable
to reinstallthe
See"General
(Figure
5. Remove
themoving
table
inthesame
manner
inSection
information.
lnformation"
8 forfurther
5-3).
and
thepushbarbytiltingit slightly
upwards
2. Remove
pulling
straight
out(Figure
5-1).

Figure
5-3
5-1
Figure

Revised
5/03

5.1

GARE
OFTHEINSTRUMENT
platefromthefixedplatform
theholddown
6. Remove
upagainst
thetabatthebackoftheplate
bypressing
(Figure
5-4).Thenpulltheotherendfromitsretainfor
is important
inghole.Removal
oftheholddown
proper
cleaning.

piece
8. Rinse
each
thoroughly
anddrywitha paper

towel
orsoftcloth.
Allow
thecalibration
barsonthe
platform
toairdry.
for
N0TE:
After
inspect
thecalibration
bars
cleaning,
marks,
lf thebarscanscratches,
ordiscoloration.
(see
notbecleaned,
theplatform
mustbereplaced
Parts").
Section
9,"Replacement
9. lf youwantto disinfect
theparts,dothatnow,
laterinthis
asinstructed
in"Disinfection,"
found
section.
1 0 .Reinstallthe
moving
table
asfollows:
thetable
rectangular
tabfaca. Hold
withthesmall
ingtotheback.
thetwogrooves
ofthetable
b. Align
onthebottom
withtheedges
thetable
oftheplatform
onwhich
rests.
push
thetable
inasfarasitwillgo.lt must
c. Gently
pasta detent
inorder
to becorrectly
bepushed
inposition.
Figure
5-4
1 1 .Reinstallthe
holddown
andfixedplatform:
theholddown
withthearrow
sidefacing
a. Position
(pushbar,platform,
table
holddown,
7. Clean
eachpiece
pointing
Place
the
the
to
the
up
and
arrow
back.
andliner)withwarmwaterandmildsoap.Donotuse
pin
the
hole
at
on
the
front
of
the
holddown
into
avoid
theplatform,
When
cleaning
anytypeofsolvent.
platform.
the
tab
the
front
the
fixed
Then
align
of
bars;usea
wiping
thetwowhitecalibration
across
withtheslotatthe
atthebackoftheholddown
plain
to clean
wetted
with
water,
cotton-tipped
swab,
platform
into
of
the
theholddown
back
and
snap
thebars.
place.
Make
thewhitecalibration
barsare
sure
NOTE:
lf theholddown
and/orpushbarareextremely
visible.
to loosen
inorder
dirty,theymayneed
to besoaked
holddown,
moving
table,
thedriedresidue.
Anextra
soyou
withyourinstrument
andpushbararesupplied
yourinstrument
while
theoriginal
canreassemble
pieces
andmay
aresoaking.
Thelinerisdisposable
periodically.
to bereplaced
need

5.2

Revised
9/99

when
touseonthepieces
solutions
aresafe
ofthefixed 2. Several
onthebottom
b. Alignthetwogrooves
once
a
for
no
longer
than
10
minutes
platform
they
are
used
the
instrufrom
withthearmsextending
solutions:
oneofthefollowing
(Theledges
oftheholddown day.Prepare
ment.
onthesides
justoutside
andthetop
theread
cover,
align
area
. Household
(5%sodium
hypochlorite)-can
Bleach
justunder
thecover.)
edge
oftheplatform
aligns
as
toasmuch
either
fullstrength
ordiluted
beused
push
inasfarasitwillgo.(lt
theplatform
Gently
add5 mL
dilution.
Tomake
a1:20
dilution,
a1:20
pasta slightdetent
to becormustbepushed
for
toacontainer
andadd95mLofwater,
ofbleach
positioned.)
rectly
dilution,
volume
a 1:10
atotal
of100mL.(Tomake
10mLofbleach
and90mLofwater.)
combine
lf theplatform
doesnotpushinwith
GAUTI0N:
gentle
plessure,
that
it! Ensure
donotlorce
only
beusedonthedisplay
NOTE:
Bleach
CANNOT
positioned
and
themoving
tableis correctly
screen.
to reinstall
theplatform.
attempt
. Cidef*andTheracide@*-these
products
(ortheir
endand,withthis
12. Holdthepushbarbyitsflattened
disforuseingeneral
equivalent)
canbepurchased
insertthepeg0ntheotherend
endslightlyupward,
according
infection.
Prepare
andusethesolution
mechanism.
ofthebarintotheholeinthepusher
thatcome
withtheproduct.
tothedirections
pushbarintoplace.
Lowerthe
alcohol
oranyprod.
GAUTION:
DoNOT
useisopropyl
(ora new)linerintothewaste
bin.
1 3 .Place
theclean
phenol(suchasAmphyl@*),
asthese
uctconlaining
bars.
willcause
damage
tothecalibration
witha soft,
whenneeded,
1 4 .Clean
thedisplay
screen,
witha
nonabrasive
cloththathasbeen
dampened
pieces
forno
inthesolution
immerse
the
3 . Completely
(donotusebleach).
Donotspray
mildglasscleaner
thoroughRinse
eachpiece
longerthan10minutes.
Donotuse
theglasscleaner
directly
ontothescreen.
lywithclear
water.
theymay
since
laboratory
wipes,
suchasKimwipes@,
witha paper
towelorsoftcloth,using
4. Dryeachpiece
thesceen.
scratch
table.
thepinsonthemoving
carewhendryingaround
power
1 5 .Turn
theinstrument
on.
to air
barsontheplatform
Allowthewhitecalibration
dry.
in"Daily
thepieces
asdirected
Cleaning,"
5 . Reinstall
10to 13.
Steps
platform,
table
thepushbar,holddown,
Todisinfect
perform
Thisprothefollowing
steps.
anddisplay
screen,
out
cedure
canalsobeusedwhentakingtheinstrument
ofservice.
thedisIMP0RTANT
Refer
tothelabeling
accompanying
products
instructions
ontheiruse.
infection
forcomplete
1. Remove,
clean,
anddrythepushbar,fixedplatform,
in "Daily
tableasdirected
holddown,
andmoving
(The
not
bedis7.
liner
should
1to
Cleaning,"
Steps
ordevelops
When
it becomes
contaminated
infected.
container
it intoanappropriate
discard
anycracks,
andusea newliner.)

Disinfection

*Gider(registered
isa 3.2%glutaraldehyde
trademark
ofJohnson
& Johnson)
solution.
(registered
Inc.,Lafayette,
trademark
Pharmaceuticals,
Thencide
ofLafayette
lN)isa quaternary
ammonium
soluti0n.
L&FProducts,
trademark
of National
Laboratories,
Amphyl(registered
NJ)isa phenol
solution.
Montvale,

Revised
5/03

5.3

OFTHEINSTRUMENT
CARE
lf thereis paper
remaining
ontheroll,liftuptheroll
if needed,
usingeither
thedisplay
6. Disinfect
screen,
paper
and
tear
the
therollandtheprinter.
(or
between
only;
orTheracide
solution theirequivalent)
Cidex
paper
gently
pull
in its
theprinter
Then
the
through
onthescreen
doNOTusebleach.
Wipethesolution
thewheelonthe
normal
direction
of travelor rotate
clothandallowto remain
usinga soft,nonabrasive
remove
rightsideto advance
thepaper.
Otherwise,
DoN0Tsprayor pourthedisinfecfor 10minutes.
the
empty
core.
a clean,
soft
Rinse
using
tantdirectly
ontothescreen.
withwater,
thendry.
clothdampened
(Product
No.5773);
unroll
4 . Obtain
a newrollof paper
several
inches
andtrimtheendintoa long"V".Hold
NOTE:
Repeated
or prolonged
soaks
overa longperiod
withthepaper
unrolling
therolljustabove
theprinter,
a slight
maycause
oftimewithglutaraldehyde
solutions
paper
the
platform
the
under
fromunderneath.
Feed
theendof
anda
andtable,
fadingor discoloration
of the
wheel
ina clockroller,
thenrotate
thepaper
advance
these
to the pushbar;however,
cloudyappearance
(toward
inches
wisedirection
theback)untilseveral
willnotaffectperformance.
changes
(Figure
5-6).
of paper
areexposed
above
theprinter

thePaper
Ghanging
screen.
1. Besuretheinstrument
isattheReady/Run
tabonthebacksideoftheinstrument
2. Notice
thelarge
(Figure
in
5-5).Press
thecoverin place
thatsecures
firmlyonthebottom
edgeofthetabandliftthecover
off.

Figure
5-6
Then,
theprinter.
5. Setthepaper
intoposition
behind
place
thefronttabsof thecoverintotheirslotsand
inthe
feedtheendofthepaper
through
theopening
cover.
Snapthecoverintoplace.
Figure5-5

5.4

Revised
5/01

6
Section

EOUIPMENT
SUPPLIES
& OPTIONAL
BayerReagent
Stripsfor
Urinalysis

(e.9.MULTISTIX@
10SG)
Manydifferent
configurations
ofBayer
Reagent
Strips
your
canbeusedontheCLINITEK@
500Analyzer.
Contact
availBayerofficeor representative
for theconfigurations
ableinyourcountry.

Positive
andNegative
CHEK-STIX@

StripsforUrinalysis
Gontrol

Pak(Product
Number
1364)
Combo
1360)
Positive
Number
Gontrol
Strips(Product
Positive
Stripsfor
CHEK-STIX@
andNegative
Control
provide
performance
(Figure
for
check
Urinalysis
6-1)
a
theCLINITEK
500Instrument/Reagent
StripSystem.
thatthe
CHEK-STIX
Control
Stripsprovide
confidence
Reagent
Stripsarereacting
andbeingreadproperly.
resulting
fromusertechnique
Errors
canalsobedetected.

indistilled
CHEK-STIX
Control
Strips
arereconstituted
waterto
make
Instrucupa CHEK-STIX
controlsolution.
package
the
tionsareincluded
inthe
insert
andon bottle
thatshould
label,
andtestresults
beobtained
arelisted
insert.
inthepackage
for use
NOTE:
CHEK-STIX
ControlStripsarenotsuitable
withMULTISTIX
PRO@
Reagent
Strips.
TheControl
Pak,
which
Strips
areavailable
asa Combo
contains
onebottleeachof thePositive
Control
Strips
(25strips/bottle).
ThePositive
andNegative
Control
Strips
product
Control
Stripsarealsoavailable
asa separate
(onebottleof 25strips).

Handheld
BarGode
CLINITEK@
Rgadgf (Product
Number
646e)
( F i gur e
TheCLINITEK@
Handheld
BarCodeReader
portonthe
to theRJ45interface
6-2)canbeconnected
500instrument.
TheHandheld
Reader
canbe
CLINITEK
usedto entertheidentification
numbers
frombarcoded
labels,
rather
thanmanually
before
entering
eachnumber
thespecimen
is tested.
Colorandclaritycanalsobe
with
fromspecial
barcodes
thatareincluded
scanned
theHandheld
Reader.

Figure6-1

Figure
6-2

Revised
5/03

6.1

PMENT
PTIONAL
EOUI
SUPPLIES/O
500WasteBinLiners
CLINITEK@
(Product
Number
6472)
plas500WasteBinLinersarereusable
TheCLINITEK@
500
tic linersthatfit intothewastebinoftheCLINITEK
for
method
Theyprovide
instrument.
a safe,convenient
package
Each
contains
of usedReagent
removal
Strips.
5 liners.

FormPrinter
STAR
(Product
Number
5257)
(Figure
from
FormPrinter
6-3)is available
TheSTAR
lt
can
with
the
instrument.
Bayer
foruse
500
CLINITEK
printthen
totheinstrument
andallresults
beinterfaced
forms(Product
forms.Three-copy
edontomulti-copy
ribboncassettes
Number
5163A)and replacement
(Product
for
RC200P)
fromBayer
Number
areavailable
usewiththeprinter.

Figure
6-3

6.2

Revised
5/03

7
Sectian

MINOR
REPAIR
Information
General
isa selfAnalyzer
TheCLINITEK@
500UrineChemistry
verylittlemaintenance.
contained
instrument
thatrequires
opershould
Withproper
careanduse,theinstrument
The
attention.
atereliably
witha minimum
of operator
is thereplaceonlyminorrepair
thatcanbeperformed
necessary.
mentoftheprinter,
should
thiseverbecome
if
t h, eto u chscre eca
I na d d i t i o n
n nb ere ca l ibr ated,
performing
provided
needed.
Thissection
is
asanaidin
referto Section
theseprocedures;
foranyotherrepairs,
for instructions
8, TROUBLESH00TING
ANDSERVICE,
onobtaining
service
foryourinstrument.

Replacement
Printer

Figure
7-1

Remove
therollof paper
fromtheprinter
bytearing
thepaper
thengenbetween
therollandtheprinter,
pull
paper
pr
inter
in
i
tsnor m al
tly
the
thr ough
the
thewheel
ontherightside
direction
oftravel
or rotate
to advance
thepaper.
Procedure:
4 . Toremove
theprinter:
1. WARNING:TURNTHE INSTRUMENT
OFFAND
thatis
remove
theclearplastic
shield
a. Carefully
REMOVE
THEAC ELECTRICAL
CORDFR(IMTHE
not
to thefrontof theprinter.
Becareful
adhered
OUTLET.
pads.
to teartheadhesive
printer
bypressing
2. Remove
thecoverontheinternal
b. Theprinter
hooks
under
a ledge
atthefrontand
and
cover
in onthelever
onthebackof theprinter
position
snapsinto
attherearwitha smalllever
liftinguponthecover(FigureT-1\.
(Figure
7-2).Press
outontheleverandliftupon
theprinter.
themodule
Raise
outof itscavityby
liftingupandback.

Tools
Required:
None
Parts
Required:
(PartNo.40451012)
Printer

Revised
9/99

7.1

MINOR
REPAIR
Unsnap
theconnector
bylifting
uponbothsides
(2mm).
ofthetopplate;
itwillraise
1/16"
byabout
gently
pull
the
Then
from contheinterface
cable
(Figure
the
nector
7-4).(Youmayneed
to wiggle
cable
slightly
to loosen
it initially.)

FigureT-2
through
c. Theprinter
isconnected
totheinstrument
(Figure
interface
7-3)fortransa flat14-pin
cable
fer of dataffi. Thecableslidesintoa connector
intoposidownto secure
thecable
@ thatsnaps
tion.

Figur eT- 4
5. Toreplace
theprinter:
printer
a. 0btainthereplacement
andsetit partially
intoposition
inthecavity
oftheinstrument.
b. Slide
theinterface
cable
intothenarrow
slotonthe
topplateoftheconnector.
lt willslideinveryeasilyto aninitial
firmlybutcarestop;atthispoint,
fullypressthecablestraightdownuntilit stops
again.
Besur ebothsidesof thecabl ar
e eful l y
inserted.
Press
downon bothsidesof theconpulluponthe
nector
untilit snaps
shut.Gently
to ensure
inplace.
lf it pulls
cable
thatit issecured
this
outeasily,
unsnap
theconnector
andrepeat
step.

Figure7-3

7.2

Revised
9/98

the
bylowering
Place
theprinter
fullyintoposition
frontofthemodule
downandforwardunderthe
lf thetouch
when
screen
doesnotrespond
correctly
andpress
ledge.
Thenlower
thebackofthemodule
key
is
touched,
the
screen
may
need
to
calibrated.
a
be
firmly
intoplace.
down
untilit snaps
Thisiseasily
done,
asfollows:
infrontand
theclearshield
to itsposition
d . Replace
poweroff.Waitseveral
1. Turntheinstrument
seconds,
the
ontopoftheprinterandpressgentlyagainst
power
the
then
turn
back
on.
pads.
adhesive
(which
the
thetitlescreen
isdisplayed
contains
in Section 2. When
therollof paper,
Replace
asinstructed
version
andcopyright
information),
touch
software
5,"Periodic
Maintenance."
thescreen
anywhere.
500instrument.
f. PluginandturnontheCLINITEK
theinstrument 3 . T h ed i s p l a y wpi lrlO m p" rto u c ht h e t o p t e r t c o r Test
thenewprinter
byprinting
Touch
ne." andan"X"willbedisplayed
in onecorner.
parameters
(fromtheReady/Run
screen,
setup
"X".
thescreen,
when
directly
ontopofthe Repeat
touchMenu,thenPrint,thenSetupreport)or by
"
T
o
u
c
h
p
r
o
m
p
t
r
i sht
t
h
e
c
h
a
n
g
e
t
s
0
t
h
e
b
o
t
t
o
m
performing
several
Reagent
Striptests.(lfyouhad
cor
ner
."
W
hen
the
touch
scr
een
has
r
ec al i be
en
theinternalprinter
turned
off priortoreplacement
in
the
brated,
the
display
will
automatically
continue
ofthemodule,
besureto turnit backonthrough
normal
sequence
ofscreens.
Routine.)
theSetup

theTouch
Galibrating
Screen

N O T El :f " p r i n t e r E r r o r " i s d i s p l a y ewdh e n

to print,checkfor a tightandproper
attempting
connection
oftheinterface
cable.

Revised
9/98

7.3

I
Sectian

ANDSERVICE
TROUBLESHOOTING
. Turnthepoweronandletthesystem
initialize.
Anerror
is notin
willbedisplayed
because
thefixedplatform
500Analperwillgiveyoutroublefree place,
YourCLINITEK@
tablewillberotated
intothe
butthemoving
forusingandcleanif youfollowthedirections
operation
position.
correct
prob- .
ingtheinstrument.
lf anoperational
orinstrument
power
offagain.
lemoccurs,
however,
maybedisplayed Turnthe
anerrornumber
platform.
ofthe . Installthe
ontheAnalyzer
screen,
alongwithanexplanation
problem.
Thissection
liststhevarious . Turnthepower
ofthemanual
on.
and
withprobable
causes
errors
andmessages,
along
the
remedies
correct
recommended
to quickly
andeasily
toGalllorAssistance:
problem.
persists
therec- When
lf theproblem
afterfollowing
continues
to bedisplayed
after
remedy,
record
theerrornumber
beingdis- . lf theerrormessage
ommended
performing
thesteps
described
onthescreen
andin
yourBayer
played
office
andcontact
Customer
Service
theTroubleshooting
Chart;
forassistance.
isrequired
assistance
concerning
aninstruthe . lf additional
Reagent
seem
to becausing
lf theBayer
Strips
problem;
ment
problem,
thatcomes
readthedirection
insert
carefully
might
help
.
withtheReagent
for
information
that
Strips
lf theproblem
isbeyond
thescope
or
ofthismanual;
solve
theproblem.
. lf theproblem
failcannot
besolved
andaninstrument
theinstrulf anerrornumber
isdisplayed
thatrequires
ureisapparent:
mentto beturnedoff, allsamples
thatwerein process OurCustomer
Department
isavailable
to help
Service
to beretested.
Thenor- you.Before
whentheerroroccurred
willneed
please
calling,
complete
the"Preservice
reports
whentheinstrumalend-of-run
willbedisplayed
(youmaywantto makea
laterinthissection
thathadbeen Checklist"
mentis turnedbackonfor samples
photocopy
will
first).Thisinformation
ofthechecklist
priortotheerror.
processed
Representative
to identify
the
helptheCustomer
Service
willcontinue
torun probable
Withsome
errors,
theinstrument
cause
oftheproblem.
Return
to theREADY/RUN
whiletheerroris displayed.
it isdisplayed)
bytouching
ther! key(when
screen
toGallforAssistanoe:
error Where
to correct
theerror.
lf another
before
attempting
the
contact
ll youarelocated
intheUnited
States,
the
displayed,
occurs
whiletheprevious
erroris being
Department
of
Bayer
HealthCare
by
Customer
Service
initsplace.
newerrorwillbedisplayed
tollfree:
is turnedoff tromanyscreen calling
N0TE:lf theinstrument
1-800-348-8100
(andwiththeruncompleted),
the
otherthanReady/Run
position.
tablemaynotbeinitslowest
lf thefixed
moving
to 8:00PMEastern
Theofficeisopenfrom8:00'AM
platform
isthenremoved,
themoving
tablewillbepulled time,Monday
through
Friday.
to reinstall
outatthesametime.Youwillthenbeunable
ina country
thantheUnited
lf youarelocated
other
table
thefixedplatform
because
thepinsofthemoving
you:
the
Bayer
office
nearest
Slates,
call
Toresolve
willbeintheway.
thisproblem:

Information
General

Revised
5/03

8.1

TRO
HOOTI
NG/SERVI
CE
UBLES
AUSTRALIA
Bayer
Diagnostics
2 KeithCampbell
Court
Scoresby
VIC3179
(tollfree):
Telephone
1800034490
BELGIUM
Bayer-Diagnostics
Division
Zaventemsesteenweg,
97
B-1831
Diegem
Tel.:021725.18.80
CANADA
Bayer
Inc.
Healthcare
Division
77Belfield
Road
Toronto,
MgW1G6
Ontario
Telephone:
416-248-077
1
1-888-406-2222
CENTRAT
EASTERN
EUROPE
Bayer
Diagnostics
GmbH
-MOE*
Weissenseestrasse
101
D-81
539Munich,
Germany
Tel.:49-89-69927
191
Fax:49-89-69927
248
CZECH
REPUBTIC
Bayer
s.r.o.
Diagnostics
Division
Litvinovska
609/3
GZ-1
9000PRAHA
9-Prosek
T e l .0: 2 - 6 6 1 0 1 - 1 1 1
Fax:02-66101
199
DENMARK
BayerA/S
Diagnostics
Norgaardsvej
32
DK-2800
Lyngby
Telephone:
45235000
AFRICA
EASTERN
MEDITERRANEAN,
MIDDLE
EAST,
yourlocaldistributor
Please
contact
or:
Bayer
Export
Division,
M.E.E.R.A.
52,quaideDionBouton
92807Puteaux
Cedex
France
-49.06.56.00
Tel.:33-01

8.2

FINTAND
Bayer
0y
Diagnostics
7
Suomalaistentie
02270
Espoo
Telephone:
09-887
887
GREEGE
Bayer
Hellas
AG
BGDiagnostics
54A,Akakion
St.
15125Amaroussion
Athens
Tel.:1-6883700
HUNGARY
Hungaria
Kft.
Bayer
Palya
utca4-6
H-1012
Budapest
T e l .0: 1 - 2 1125 4 0
1575
Fax:01-212
INOIA
Bayer
Diagnostics
IndiaLimited
589,Sayajipura
AjwaRoad
Baroda
39001I
Gujarat
Tel.:265
462720
ITALY
Bayer
S.p.A.
Divisione
Diagnostici
ViaGrosio
10/4
20151
Milano
Tel.:02-3978.3956
KOREA
Bayer-Sankyo
Co.,Ltd.
Pharmaceutical
Ind.
c/oHanil
1 KA2-Dong
656-408
Sungsu
Sungdong-Ku
Seoul
Tel.:2 4609600

Revised
5/01

MALAYSIA
Bayer
Malaysia
Sdn.Bhd.
19th& 20thFloor
Wisma
MPSA
Persiaran
Perbandaran
40708ShahAlam,Selangor
DarulEhsan
Tel.:3-550-2852
NETHERLANDS
Bayer
BV
Division
Diagnostics
1/P.0.Box80
Energieweg
AB
3641RT/3640
Mijdrecht
Telephone:
0297-280660
NEWZEALAI'|D
Ltd.
Bayer
NewZealand
Heath
CareDivision
3 ArgusPlace
Glenfield
Auckland
(9)4444133
ext.311
Telephone:

"

NORWAY
Bayer
AS
Brennaveien
18
1483Slrytta
Telephone:67068600
P0LAND
Bayer
Sp.z.o.o.
Diagnostics
Division
ul.Stawki
2
Warszawa
00-193
Tel.:22-635
6818
Fax:22-635
5987
P0RTUGAL
Bayer
Portugal
SA
RuaQuinta
doPinheiro,
5
Outurela
2795Carnaxide
Tel.:(01)4164311

Revised
9/98

FEDERATION
RUSSIAN
A/0BaYer
Vertretung
Moscowu
BolshoiTrjechgornyi
Pereulok,
1
Geb.20
123422Moscow
Tel.:095-2342072
Fax095-234
2070
SOUTHEASTASIA
(Singapore)
Bayer
Pte,Ltd.
Regional
Headquarters
BG-DS
9 Benoi
Sector
629844
SingaPore
TelePhone:
65261-3389
SWEDEI1
AB
BaYer
AoDiagnostika
Box5237
40224G0teborg
TelePhone:031-839800
TAMAN
Bayer-Sankyo
Co.Ltd.
NO35
1OF-1,
Fu-Hsing
N.Road
Taipei
Telephone:
2-2741-2550
THATLAND
BaYerThai
Co.Ltd.
Diagnostics
Business
Group
BaYer
House
130/1NorthSathorn
Road
10500
Bangkok
2-23270
Telephone:
00
U.K.
Bayer
Plc-Diagnostics
Division
BaYer
House
Hill
Strawberry
Newbury
RG141JA
Telephone:01635
566211
Fax01635
566277

8.3

HOOTING/SERVI
CE
TRO
UBLES
CHART
TROUBLESHOOTING
SYMPTOM

CAUSE
POSSIBLE

REMEDY

made
to
Changes
are
SetupRoutine
notsaved.

key(l!)
TheReturn
to Ready/Run
wasnottouched
afterchanges
weremade.

havebeenmade
to
Always
touch$-r afterallchanges
theSetup
Routine.

Display
isblank.

1. Nopower.

1 . Listen
forthefan;if it isnotrunning,
turntheinstru-

program
card.
inserted
2. lmproperly

program
cardor defective
3. Defective
system
electronics.

mentpoweroff.Checkthat
thepowercordisfirmly
plugged
intotheinstrument
andintoa liveACelectricaloutlet.
Thenturnthepowerbackon.
poweroff,thenremove
thepro2. Turntheinstrument
gramcardandreinsert
it firmly,making
surethat
pointing
thelabelisfacing
fonrvard,
withthearrows
inandup.Whenproperly
inserted,
theedge
ofthe
Turnthe
cardwillbeflushwiththeinstrument
case.
powerbackon.
yourBayer
Customer
Contact
Service
office.

Fixedplatformcannot
beinstalled.

Themoving
tableis notinthelowest
position
(seeNOTE
in "General
inthissection).
lnformation"
earlier

initialize.
lgnore
Turnthepoweronandletthesystem
Turnthepoweroffagain,
theerrorthatisdisplayed.
install
theplatform,
thenturnthepoweron.lf still
platform,
yourBayer
unable
to installthe
contact
Customer
Service
office.

Printout
doesnot
contain
allreports.

"Missing"
flagged
reports
havebeen
and
Report,
fortheConfirmatory
"Editflagged
is0N.
results"

Thelistofflagged
reports
willbedisplayed
whenthe
runis complete,
willbeprinted
after
andthereports
havebeenexited.
theEnd-of-Run
Report
screens

Pushbardoesnot
moveto therightafter
onto
a stripis placed
theplatform.

moved
along
1. Other
stripsarebeing
theplatform.

priorto movement
1 . Allowupto 7 seconds
to elapse

problem.
2. Stripsensor

8.4

ofthepushbar.Thetimelapse
depends
upon
thetimingcyclefor movement
of thestrips
theplatform.
across
(andwiththeruncomthe
From Ready/Run
screen
pleted),
power
turntheinstrument off,waitseveral
continthenturnit backon.lf theproblem
seconds,
your
Customer
office.
ues,contact Bayer
Service

Revised
9/99

SYMPTOM
Pushbardoesnot
movebackto theleft
a strip.
aftermoving

ina
1 .Thelaststriphasbeenplaced
is
instrument
loadlisted
run,orthe
forentryofanlD.
waiting
2. A verydarkurineis beingtested;
to verify
is unable
thestripsensor
presence
the
ofthestripuntilit
reaches
thefirstreadhead.

Pushbarmoves
to
therightwhenit
(astrip
shouldn't
hasnotbeenplaced
ontheplatform).

wasaccidentally
1. Thestripsensor
or
sleeve,
triggered
bya hand,
otherforeign
object.
problem.
2. Stripsensor

Testresults
arenot
beingprinted
bythe
printer.
internal

printer
issetto OFF.
1 .Internal
inprinter.
installed
2. Nopaper
(accompanied
by
ismisfed
3 . Paper
noise).
anunusual
to the
connection
4. Loose
electrical
printer.
printer.
5. Defective

needs
to berecalibrated.
Touch
does
1 . Screen
screen
notrespond
correctly.
2. Delective
screen.

Revised
5/01

REMEDY

POSSIBLE
CAUSE

properly.
Begin
a
1. Theinstrument
isfunctioning
runis comnewloadlisted
run(after
thecurrent
plete)
requested.
thelDnumber
being
orenter
atthefirst
2. Presence
ofthestripwillbeverified
(21
3 cycles
readhead,
requiring
anadditional
thenmovebackto
Thepushbarshould
seconds).
manner.
theleft.Continue
testing
inthenormal
'1.

Thepushbarwillmovebackto theleftafter
(21seconds);
inthe
testing
3 cycles
continue
your
Besureyoudonotplace
normal
manner.
asthese
handor otherobjects
ontheplatform,
fora Reagent
Strip.
canbemistaken
(withtheruncompleted
screen
2. FromtheReady/Run
station
clearofallstripsand
andthestriploading
powerofi wait
foreign
turntheinstrument
objects),
thenturnit backontorecalibrate
several
seconds,
contact
lf theproblem
continues,
thestripsensor.
yourBayer
Service
office.
Customer
printer
to 0Nthrough
theSetup
1 . Settheinternal
(seeSection
Routine
3,StepA-4).
inSection
5,
asinstructed
2 . Install
a newrollof paper
"Changing
thePaper."
path.
thepaper
3 . Open
theprinter
cover
andcheck
(seeSection
the
Reinstall
if necessary
5,"Changing
Paper").
cable
remove
andreinstall
theinterface
4. Carefully
Replacement,"
7, "Printer
to theprinter(seeSection
4 and5).
Steps
(seeSection
3,StepJ-2f).
RunthePrintertest
yourBayer
officeif it
Customer
Service
Contact
printcorrectly.
doesn't
inSection
7,"Calibrating
1 . Recalibrate
asinstructed
theTouch
Screen."
yourBayer
office.
2. Contact
Customer
Service

8.5

CE
TRO
HOOTING/SERVI
UBLES

ERROR
DISPLAY

POSSIBLE
GAUSE

REMEDY

Enor01
Error02
Error03
Error04
Error05

error.
Instrument
optical

powerofi wait
Turntheinstrument
several
seconds,
thenturnit backon.

Error06-2

A Reagent
Stripthathadbeendetected
wasnotdetected
atthefirstreadhead
readhead.
atthesecond

to the
Touch
therunandreturn
@ to cancel
thenturnofftheinstrument
Ready/Run
screen,
power.
thestrip
Remove
thefixedplatform
to locate
(seeSection
5,"Daily
Cleaning").
Check
thepinson
themoving
tableto ensure
thatnonearebentor
procedure
in
thenperform
the"Daily
broken,
Cleaning"
yourprintout
Section
5.Check
of results,
ortheResults
ErrorReport
displayed
attheendoftherun,to determinethespecimen(s)
forwhichtherearenoresults;
retest
thosespecimens.

Error07-1

A Reagent
Stripeitheris notfully
onthe
wetted
or is upside-down
platform.

lf theerroris because
ofanupside-down
strip,remove
thepushbar,fixedplatform,
andclean
andholddown
your
(seeSection
Thencheck
5,"Daily
Cleaning").
printout
of results,
ortheResults
ErrorReport
the
attheendoftherun,to determine
displayed
the
forwhichtherearenoresults.
Retest
specimen(s)
thatthestripisdipped
appropriate
specimen,
ensuring
ontothe
completely
intothespecimen
andis placed
platform
withthepadsfacingup.

Error08-n
Error09-n

A Reagent
Striphasbecome
processing.
misaligned
during

Check
therightsideofthereadstation
areaandremove
bin.
anystripsthathavenotfallenintothewaste
yourprintout
Error
of results,
ortheResults
Check
the
Report
displayed
attheendoftherun,to determine
Retest
specimen(s)
forwhichtherearenoresults.
thattheendofthestripis
thosespecimens,
ensuring
placed
against
therearwalloftheplatlom(withEnor
thebottom
ofthestriploading
08-1) andnottouching
themovlf theerrorrepeats,
remove
station.
andclean
pushbar,andholddown
(see
fixedplatform,
ingtable,
tableto
themoving
Section
5,"DailyCleaning").
Check
thenreinstall
ensure
thatnopinsarebentor broken,
islullypushed
theparts.Ensure
thatthefixedplatform
inonbothsides.

8.6

9/99
Revised

DISPLAY
ERROR

REMEDY

POSSIBLE
CAUSE

Error10-n

Instrument
optical
error.

poweroff,thenremove
andclean
Turntheinstrument
the
takingcareto carefully
clean
thefixedplatform,
Cleaning").
Check
bars(seeSection
5,"Daily
calibration
yourprintout
disof results,
ortheResults
ErrorReport
played
thespeciattheendoftherun,to determine
those
forwhichtherearenoresults;
retest
men(s)
specimens.

Error21

memory
error.
Internal

poweroff,waitseveral
seconds,
Turntheinstrument
thenturnit backon.

Error23

1. Moving
tableismisaligned.

poweroff.Remove
thepushbar,
Turntheinstrument
table(youmayhaveto pull
fixedplatform,
andmoving
firmlyto remove).
Turnthepowerbacko4 allowthe
to move
to reinitialize
andthetablemechanism
system
position
(another
enorwillbedisplayed),
to itslowest
themoving
table(ensuring
thenturnoffagain.
Reinstall
fixedplatform,
andpush
it is pushed
incompletely),
Turnthe
in Section
5,"DailyCleaning."
bar,asdirected
poweronagain.
yourBayer
Service
office.
Contact
Customer

error.
2. lnstrument
mechanical

Error24
Error25

platform
or
1. Fixed
is misaligned
pushbaris installed
incorrectly
(misaligned
down).
orupside

error.
mechanical
2. Instrument

Error26

9/99
Revised

'1.

goweroff.Inspect
the
Turntheinstrument
foranyobvious
signsof misalignment
instrument
installation
ofthepushbar,fixedplalor incorrect
Remove
if needed,
form,or holddown.
andreinstall,
Besure
inSection
5,"Daily
Cleaning."
asdirected
nearest
thefeetonthepushbarareonthebottom,
Turnthepowerbackon.
theplatform.
yourBayer
Customer
Service
office.
Contact

(seeSection
5,
if missing
platform
table
andplatform,
is missing
or notinstalled lnstallthe
Fixed
push
"Daily
in
lf already
installed,
carefully
properly.
Cleaning").
to makesureit isfully
onthesidesoftheplatform
remove
lf theerrorcontinues,
andreinstall
engaged.
theplatform,
asinstructed
inSection
5.

8.7

ANDSERVIGE
TROUBLESHOOTING

ERROR
DISPLAY

REMEDY

POSSIBLE
CAUSE

Error27

installed
or
isimproperly
Holddown
is
missing,
or dirty.

5,
inSection
Remove
thefixedplatform
asinstructed
"Daily
or
if missing,
Installthe
holddown
Cleaning."
theholddown,
cleanit if it appears
dirty.Reinstall
theplatit is properly
installed,
thenreplace
ensuring
(lftheholddown
appears
formontotheinstrument.
replace
witha newholddown.)
damaged
ordiscolored,
yourprintout
Error
Check
of results,
ortheResults
the
Report
attheendoftherun,to determine
displayed
those
retest
forwhichtherearenoresults;
specimen(s)
specimens.

Error28

as
Stripthatwasdetected
A Reagent
wasnot
ontheplatform
beingplaced
atthefirstreadhead.
detected

atler
ll a stripwasneverplaced0rwasremoved
yourprintout
orthe
beingplaced:
Check
of results,
Results
ErrorReport
displayed
attheendoftherun,lo
the
if a resultsetis missing
and,if so,retest
determine
yourhandorother
specimen.
Besureyoudonotplace
asthesecanbe
objects
onthestriploading
station,
repeatmistaken
fora Reagent
Strip.lf theerroroccurs
poweroff,wailseveral
seconds,
edly,turntheinstrument
thestripsensor.
thenturnit backontorecalibrate
themoving
ll a stripwaspresenl:
Remove
andclean
(seeSection
5,
table,
andholddown
fixedplatform,
"Daily
Cleaning").

Error29

foamisstillinplace
1 . Shipping

'1.

(firsttimetheinstrument
ispowered
bya loudnoise).
on,accompanied
barerror.
2 . Calibration

powero/fandremove
thefoam
Turntheinstrument
(seeSection
2,"Unpacking,"
Step4).
powerlff, thenremove
thefixed
Turntheinstrument
platform
(seeSection
and
Cleaning")
5,"Daily
ormisaligninspect
thecalibration
barsfordamage
barsand
ment.Clean
theplatform
andcalibration
platform.
reinstallthe
Turnthepowerbackon.

Error30
Error31
Error34

error.
Instrument
mechanical

yourBayer
Customer
Service
office.
Contact

Error36

memory
Bothareas
of instrument
parameters
where
factory
calibration
havebeencorrupled.
arestored

powerofi waitseveralseconds,
Turntheinstrument
your
contact
thenturnit backon.lf theenorrepeats,
Bayer
Service
office.
Gustomer

8.8

Revised
5/01

ANDSERVICE
TROUBLESHOOTING

ERROR
DISPLAY

POSSIBLE
CAUSE

REMEDY

Error50

Printer
Error

printer
Check
thatyourexternal
isturnedonandis online.Verifythatbothendsoftheinterface
cableare
thatyourprinter
has
securely
connected
andcheck
paper.

Error51
Error52

(51)orsample
memory
Control
results
(52)isalmost
full.
results
memory

Nearly
200control
resultsetsor nearly
500patient
result
withoutbeing
setshavebeenstoredin memory
is
transferred
to a computer.
Check
thatyourcomputer
turnedo4 thattheinterface
issecurely
connected
cable
forthe
atbothends,andthatthesetupparameters
computer
interface
arecorrect.
Transfer
atleastsome
lf unable
to transfer
records,
contact
oftherecords.
yourBayer
Customer
Service
office.

Error53
Error54

(53)or
memory
Control
results
(54)is
sample
results
memory
full.
completely

result
Twohundred
control
resultsetsor500patient
in memory
without
being
setshavebeenstored
Noadditional
testing
sentto a computer.
canoccur
Check
untilat leastsomeoftherecords
aretransmitted.
isturnedon,lhaltheinterface
cable
thatyourcomputer
is securely
connected
at bothends,
andthatthesetup
parameters
forthecomputer
interface
arecorrect,

Error55

(seeSection
Printa Setupreport
Setupis
3,"When
memory
Bothareas
of instrument
parameters.
to viewthedefault
lf you
Complete")
arestored
where
theSetupparameters
printed
andsaved
a copyoftheSetupreport
Themanufacturer'spreviously
havebeencorrupted.
ofyourcustomized
selections,
compare
thetwo
havebeenrestored.
defaults
reports.
Reselect
theoptions
thatneed
to bechanged.

Enor56

System
error.

Revised
5/01

powerofi waitseveral
Turntheinstrument
seconds,
youl
thenturnit backon.lf theerrorrepeats,
contact
Bayer
Customer
Service
office.

8.9

5tltl
CLINITEK@

Ghecklist
Preservice
page.)
photocopies
ofthisclean
(Suggestion:
Make
information:
record
thefollowing
Forreference,
Number:
Model/
Serial
-

Installation
Date:
YES NO

YES NO
1. Does
thefancomeonwhentheinstrument
isturned
on?
. lf N0,istheinstrument
firmlyplugged
outlet
andinto
intoa liveACelectrical
theinstrument?
sequence
of screens
2. lstheappropriate
isfirst
whentheinstrument
displayed
turnedon?(See
Section
2 fora description
ofthescreens.)
. lf N0,istheProgram
firmlyin place
Card
(SeeSection
2,
oriented?
andproperly
"lnstrument
Setup,"
Step5.)
properly?
operating
3. ls thetouchscreen
tf N0:
. Have
youperformed
theTouch
Screen
(SeeSection
3,StepJ-3c.)
Test?
. Have
yourecalibrated
thetouchscreen?
(See
7.)
Section
properly
proceed
while
theinstrument
4. Does
Reagent
Strips?
analping
properly
(i.e.,
lstheprinter
functioning
messages
and
aretheappropriate
printed)?
patient
results
being
tf N0:
. lstheinternal
printer
oranexternal
3,StepA-4.)
turned
0N?(SeeSection
. lstherepaper
intheprinter?
. Have
youperformed
theprintertest?
(SeeSection
3,StepJ-2f.)

nn
tr!
! n

nn
nn
ntr

nn
trn
n !

nn
nn
nn
nn

results
being
displayed/printed
Arereasonable
samples?
forthecontrols
andpatient
rfN0:
. Doeslhe
Reagent
name
oftheBayer
Strip
agree
screen
displayed
ontheReady/Run
used?
withthestripbeing

8.10

n!
nn
n tr
nn

. AretheBayer
withintheir
Reagent
Strips
expiration
dating?
. lsthebottleofControl
withinits
Strips
expiration
dating
andistheControl
withinitsuselife(8hours)?
Solution
. lstheinstrument
intheproper
operating
(See
2.)
environment
andlocation?
Section
. lsthefixedplatform
(See
5.)
clean?
Section
levelbeing
7. Whatisthesoftware
revision
(Turn
used?
theAnalyzer
ofi waitabout
15seconds,
thenturnit backon;the
software
version
is displayed
afterthe
initialization
screen.)
Areanyerrormessages
orwarnings
being
displayed?
. lf so,whatarethey?(Listtheerrordescription
andanynumbers
thataredisplayed.)

youperformed
theappropriate
steps
9. Have
fortheerrorbeing
suggested
onthedisplay
displayed?

! !

nn

ll anextemal
deviceis beingused:
printer
10. lsthe
and/or
hostcomputer/LlS
connected
andturnedon?

ntr

parameters
fortransmission
11. Have
thecorrect
(through
theSetup
menus)?
beenselected

!tr

printing
printer
properly
the
12. lstheexternal
testresults?

nn

13. lsthecomputer
receiving
theproper
data
(e.9.,
withthescreen
correspond
dotheresults
display)?

! n

! n

5/01
Revised

I
Eection

PARTS
& REPLACEMENT
SUPPUES
Parts
Equipment Replacement
Supplies/0ptional
Gatalog
Number
1364
1360
6469
5773
6472
5257
RC200P
5256

Description
forUrinalysis
Bayer
Reagent
Strips
PakControl
Combo
CHEK-STIX@
for Urinalysis
Strips
Positive
ControlStrips
CHEK-STIX@
forUrinalysis
BarCode
CLINITEK@
500Handheld
Reader
(5 rolls)
Thermal
Printer
Paper
Liners
Waste
Bin
500
CLINITEK@
(package
of 5)
FormPrinter
STAR
Ribbon
FormPrinter
STAR
(1)
Cassette
Ribbon
FormPrinter
CLINITEK@
Cartridge
CLINITEK@
3-CopyForms(10x 100)

Pafi
Number
**
**
99964708
50084369
95002457
50210070
71520103
50577530
40451012
50062319
50540224

Description
ACpower
cord
Manual
CLINITEK@
500Operating
Manual
500Service
CLINITEK@
Color/Clarity
Card(forusewith
Reader)
Handheld
BarCode
platform
Fixed
andholddown
plate
Holddown
Loopbackconnector
Moving
table
Printer
Printer
cover
Pushbar

Where
to0rder:

Partsare
IntheUnited
theabove
Replacement
Slates,
available
directly
f rom:
EntryDept.
Service
Customer
Order
Where
to0rder:
Bayer
HealthCare
LLC
P.0.Box2004
andoptional
IntheUnited
States,
theabove
supplies
Mishawaka,
lN46546-9979
CLINITEK'
fromyourauthorized
equipment
areavailable
1-800-348-81
00
500distributor.
Bayer
thenearest
oftheUnited
States,
contact
Outside
Bayer office(seeSection
nearest
contactthe
oftheUnited
Outside
States,
"Where
8,
to CallforAssistance").
5163A

(see
to Call
forAssistance").
8,"Where
office
Section

*Contact
yourBayer
for theconfiguraofficeor representative
numbers
inyourcountry.
tionsandcatalog
available

Revised
5/03

**Contact
yourBayerofficeor representative
for thepartnumber
foryourlocation.
appropriate

9.1

CPI
Appendix

INTERFACE
ANDPRINTER
COMPUTER
-three specialformats
ofdataaregen2. FormPrinters
printers
whenthe
various
form
erated
forusewith
"0N,
1,"
Form
Printer
issetto
External
Printer
option
canbe
Analyzer
500Urine
Chemistry
TheCLINITEK@
"0N,
"0N,
the
3"
in
Printer
Printer
2,"
or
Form
F0rm
Inforor LIS(Laboratory
interfaced
to a hostcomputer
(Section
3,Step
A-4a-iii).
Routine
port
viatheserial ontheinstrument Setup
mation
System)
",P"). lt canalsobeinterfaced
(labeled
toan80-column . FormPrinler
thatisappropriate
1 creates
aformat
port
(Centronics)
lt
theparallel
through
FormPrinter.
orformprinter
Products
forusewiththePrinter
"@").This
(labeled
thespecifications adds
contains
the
appendix
line
so
ofeach
tothebeginning
9 spaces
interthese
toaccomplish
fortheinterface
cables
needed
location
ontheCLINITEK@
results
alignintheproper
towritea program
information
needed
key
faces.
Additional
includes
a "Reprint"
Report
Form.
Thedisplay
witha computer
theCLINITEK
500Analyzer
to interface
needs
to bereprinted.
thatcanbeused
if a record
Service
Bayer
Customer
fromyournearest
canbeobtained
. FormPrinter
for usewiththe
2 is appropriate
Department
orotfice.
Theresults
aretransmitted
FormPrinter.
CLINITEK@
line.
infrontofeach
without
spaces
anyadditional
- Serial
Port
Gable
andPinSpecilications
keyonthe
using
the"Reprint"
Records
arereprinted
Form
Printer.
withtheCLINITEK
normally
tointerface
Thecable
used
. FormPrinter
3 canbeusedwiththeStarForm
crossThiscable
isa Nullmodem
cable.
500instrument
simple
(Bayer
No.5257)
andother
Printer
Product
espins2 and3,4and5,and6 and20;pins1 and7 are
printers.
to
a
command
This
format
includes
form
of
fordefinitions
through.
Refer
to Table
GPI-1
straight
printing
printer
prevents
a record
it from
that
the
handshaking.
thepinassignments
andhardware
acommand
lt alsoincludes
untilaformisinolace.
The
theformoutofthefrontoftheprinter.
toeject
- Parallel
andPinSpecifications
Cable
"Reprint"
key
a
includes
500display
CLINITEK
to bereprinted.
Port
needs
thatcanbeusedif a record
withthisformat.
Extra
spaces
arenottransmitted
portisofthe"Centronics"
(parallel
data)
Theprinter
andisprovided
witha DB-25
connector
to use,printarecord
style
ofinterface
lf youareunsure
ofwhichformat
printers:
two
types
of
to determine
forusewitheither
of
Printer
options
using
each
oftheForm
oftheprinted
thebestplacement
which
oneprovides
printer
a Centronics results
80-column having
1. Anystandard
withyour
ontheformandworksappropriately
- theExternal
must
Printer
option
styleofinterface
formprinter.
in theSetupRoutine
besetto "0N,80 Column"
that
cable
(Section
The
3, StepA-4a-iii). interface
printer
to the
the80-column
is usedto connect
male
a DB-25
must
contain
500instrument
CLINITEK
to
(standard
Refer
IBMconfiguration).
connector
pin
fordefinitions
ofthe assignments.
Table
GPI-2

Inlormation
General

Revised
5/01

cPt.1

INTERFACE
NTER
COMPUTER/PRI

- Serial
Port
Gable
forlnterlace
PinAssignments
Pin
Number
'l

2
3
4
5
6
7
20

Signal
Name
CHAS
GND
TXD
RXD
RTS
CTS
DSR
S I GG N D
DTR
(Allotherpinsareunused.)

Function
Protective
Ground
Data
Transmit
Data
Receive
ToSend
Request
ToSend
Clear
DataSetReady
Ground
Signal
Ready
DataTerminal

Type
Ground
Data
Data
Control
Control
Control
Ground
Control

Signal
Source
N/A
CLINITEK
5OO
Computer
5OO
CLINITEK
Computer
Computer
N/A
CLINITEK
5OO

Handshaking:
Hardware
Receive
Data
RXD
Transmit
TXD
Data
DTR
DataTerminal
Ready

forsoftware
handshaking
anddatafor lDs.
controlcharacters
Thisinputreceives
information.
control
characters,
andinstrument
testdata,
sends
Thisoutput
theinstrument
andthe
l/0 isconfigured
fora computer
is onwhenever
Thissignal
is on.
instrument
thislinewhenever
it is ready
to receive
data.lf notsupplied
mustraise
Thecomputer
DSR
DataSetReady
pin6 mustbejumpered
to pin20.
bythecomputer,
to thecomputer
thatit maysenddata.
line,whenhigh,indicates
Thisoutput
Request
RTS
ToSend
before
sending
eachcharacter
and,if high,thenextcharacter
Thisinputis checked
ClearTo
Send
CTS
pin5 mustbeiumpered
to pin4.
bythecomputer,
is sent.lf notsupplied
linesareNOTimplemented:
Thefollowing
signal
PinB
DataGarrier
Detect
DCD
Pin22
RingIndicator
RNG

TableGPI-1

cPt.2

5/01
Revised

- DB-25
MaleGonnector
forInterlace
Gable
PinAssignments
Pin
Number
'l

2
3
4
5
6
7
I
9
11
12
18

Signal
Name
STROBE.L
Data1
Data2
Data3
Data4
Data5
Data6
DataT
Data8
BUSY
PRINTER
OUT
S I GG N D

DataStrobe
DataLine
Parallel
Parallel
DataLine
DataLine
Parallel
DataLine
Parallel
Parallel
DataLine
DataLine
Parallel
DataLine
Parallel
Parallel
DataLine
BusyLine
Printer
OutLine
Signal
Ground

Signal
Source
CLINITEK
5OO
5OO
CLINITEK
CLINITEK
5OO
CLINITEK
5OO
5OO
CLINITEK
CLINITEK
5OO
5OO
CLINITEK
5OO
CLINITEK
CLINITEK
5OO
Printer
Printer
N/A

NOTES:
(Data
lowsignal.
active
1. STROBE-L
Strobe): "-1"indicates
ground.
to thesignal
25arealsoconnected
Ground):Pins19through
2. SIGGND(Signal

TableCPI-2

Revised
9/99

cPr.3

IND
Appendix

INDEX
Computer
BarCode
Reader
. CPl.1
software
specification
. . B C R . 4 interface
b a r c o sd pe e c i f i c a t i o n s . . . . .
resendingresultsto.... ...4.9-4.10
....8CR.1
connecting
general
Port
6.1,BCR.1 Computer
information
.......2.6
i
n
t
e
r
facingto....
(leading/trailing)
...3.14
..
ignorecharacters
....3.12-3.13
options
...8CR.4
maintenance
...3.12-3.13
baud.
.....8CR.2
operating
....3.13
checksum
...9.1
ordering
.....3.12-3.13
data/parity.
BCR.3
.
.
.
.
3.14,
supported
barcode
formats
....3.13
handshake
. 3.14,
3.15
thebarcode
formats.
....
testing
.......3.13
...,8CR.2-BCR.3 o u t p u t f o r m a t .
troubleshooting..
.....3.13
BCR.2
ccs..
withcolor/clarity . .4.4,4.6,4.7,
using
.....3.13
C
l
l
N
l
T
E
K
e
m
u
l
a
t
i
o
n
s
.
4
.
7
,
8
C
R
.
2
....4.6,
u s i n g w i t h s al D
m. p. .l e
p
i
n
a
s
s
i
g
n
m
e
n
t
s
.
.
.....CPl.2
Calibration
setting
. . 3.4,3.12-3.13
on/off
......1.3
explanation
printing
Report
4.2,4.10 Confirmatory
confirmation
results
..3.12,4.e-4.9
editing
.....7.3
touchscreen
.......4.8
e n d - o f -rreupno r t .
...4.6
CancellingaRun.
printing
. . .4.8
(see
Maintenance)
Care
oftheInstrument
.
.
.
.
.
..3.11
s
e
l
e
c
t
i
n
g
t
e
s
t
s
t
o
f
l
a
g
.
.
.
(see
CCS Computer
Setup)
Controls
Clarity
9.1
.
.... 4.3,6.1,
(using
4.6
CHEK-STIX@Control
Strips
. . . 3.10,
default)
autoentry
printingresults
...4.9
........4.7
changing
...4.9
recallingresults
.....3.10
customizingnames
4.34.4
. 4.1,4.4,4.64.7 testing.
intorecord
entering
resettingsequencenumber....4.3
. . . . . . . 3.8
on/off)
selecting
asatest(setting
...4.3
entering
lotidentification...
.......3.10
selectingoptions
.
.
.
..4.4
t
r
o
u
b
l
e
s
h
o
o
t
i
n
g
.
.
.
.
.3.11
....
.
abnormallevels
setting
Creatinine
(see
Maintenance)
Cleaning
....3.9
settingnorm
a nagl e .
(Normal
Clinical
Units
System)
1 . 5 - 1 . 7 Date
reportedresultsin...
........3.4
changing
(see
Port)
Emulations
Computer
CLINITEK
....3.7
format
Color
........3.7
separator
.! . . . .
4.6
(using
. . . 3.10,
default)
autoentry
. . . . . . . . 4 , 7 Default
Settings
changing
r
e
s
etting.
.......3.15
.....3.10
customizingnames
. 4.1,4.4,4.9-q.7Delete
intorecord
entering
...4.7
loadlist
.....3.10
howdetermined...
.
.4.10
(setting
memory
.
.
.
.
.
.
3.8
.
on/off)
asatest
selecting
....3.7-3.8
testsfrom
report.
.......3.10
selectingoptions
(seeMaintenance)
s e t t i n g a b n o r m a l l e v e l s . . . . . . . . 3 . 1 1 Disinfection
(see
Display
Touch
Screen)
BarCodes .... 4.4,4.6,4.7,8CR.2
Color/Clarity

Revised
5/03

IND.1

INDEX
.. .2.2-2.5
instrument
Editing
printerinterface
...2.5
...3.12,4.84.9
results
confirmatory
programcard..
...2.4
...4.7
loadlist
.3.3-3.16
S e t uRpo u t i n e . , . . .
Reports
End-of-Run
....2.1-2.2
unpacking
.....4.8
confirmatory
....3.1-3.2
....4.8 KeySymbols
error..
. . . . . . 4 . 8 Language
microscopic
...3.6
options.
printing
...4.8
.
.
.
.
.
...3.6
s
e
l
e
c
t
i
n
g
Errors
List
. . . 8 . 1 , 8 . 6 - 8 . 9Load
codes.
4.7
. 3.3,3.15,
printingreport.
deleting
...4.8
....4.7
editing
........8.1
recovery.
...4.6
entering
........8.1
reporting
printing
4.2,4.7
. . .8.4-8.5
symptoms.
. . .4.H.7
tests
when
using.
8.1,8.4-8.9 running
troubleshooting..
Maintenance
Fixed
Platform
........5.4
p r o b l eim
changingpaper.
...5.1,8.1
nstalling
...5.1-5.3
dailycleaning....
(see
Positives)
Flags
alsoMarking
...5.3-5.4
. . 3 . 1 1 , 4 . 8 disinfection
confirmatories...
......5.3
s
o
l
u
t
i
o
n
s
.
.
3
.
1
1
,
4
.
8
microscopics....
g
e
n
e
r
a
l
c
l
e
a
n
i
n
g
.
.
.
......5.1
Tests
Hardware
(see
Positives
alsoFlags)
. .3.15 Marking
reader
barcode
4.8
3.11,
3.8-3.9,
abnormals/positives
...3.16
display
....3.8
settingon/off.
printer
...3.16
. . . . . . 3 . 1 5 Memory
s e r ipaol r t
...1.3
capacity
. . . . .3.15
strip
sensor
4.10
3.15,
clearing
3.3,
. . . .3.15
touch
screen
p
r
i
n
t
i
n
g
f
r
o
m
.
.
.
.
.4.9
....4.1
HelpKey
Report
Microscopic
ID
.......4.8
e n d - o f -rreupno r t .
....4.3
c o n t lr oo tl . . .
printing
. . .4.8
sample
.
.
.
.
.
..3.11
s
e
l
e
c
t
i
n
g
t
e
s
t
s
t
o
f
l
a
g
.
.
.
......4.7
changing
...3.15
4.1,4.6,4.7 N u m b eSr ot rfi p s R u n . .
entering
(see
Tests)
printing
alsoRunning
. . . . . . . 4 . 2 0peration
.....1.2,4.44.5
mechanical
.......3.12
settio
nn
g / o. f f
(see
lD
lD,
tech)
0perator
tech
.....1.3
....4.2 OpticalSystem.
changing/entering.
....6.1,9.1
.......3.12 0ptionalEquipment
s e t t io
nn
g / o. f f
Paper,
Thermal
lnstallation
........5.4
changing
. . . 2.6,BCR.1
reader
barcode
...9.1
ordering
......2.6
computerinterface
precautions
.....4.10
....2.1
environmentalfactors
..2.6-2.7
initialcheck.

IND.2

5/03
Revised

(Components)
Parts
ofthelnstrument.. 1.1-1.3 Reports
end-of-run
.......4.8
Password
. . . . . . . 3 . 1 4 c o n r i r m.a. .t .o.:r. y: : : : : . : . :::. . . :: . . . . . . 4 . g
changing
flaggedresults
....4.8
...3.14
default
microscopics.....
......4.8
...3.5
entering
order
oftests.
3.7-3.8
...3.14
settingon/off.
pH
Results
deleting
frommemory
.3.3,3.15,4.10
....3.9
s e t t i n go r mraaln g e .
flagging
abnormals
(see
.
.
. .3.8,3.11,4.8
Pixels
Touch
Screen)
recalling
...4.9
Plus
System
reprinting
........4.9
1.5-1.7
results
reported
with.
resending
tocomputer
. . .4.9
........3.6
selecting
selecu
t i nn igt s . .
........3.6
Printer
Tablesof....
.1.F1.7
external
Tests
. . .4.10 Running
formprinter,
useof
b a s oi cp e r a t i o n . . .
...4.44.6
interfacespecifications.... .CPl.1
....4.2
b
e
f
o
r
e
s
t
a
r
t
i
n
g
.....2.5
interfacingto....
pinassignments..
nn
g .a
........4.6
. . . C P 1 . 3 c a n c e l lri u
entering
color/clarity
....4.4,4.6,4.7
.......3.5
options.
lDsasspecimens
entering
arerun. .
. . . .4.7
........3.5
s e t t i on ng / o. f f
e
n
t
e
r
i
n
g
l
D
s
i
n
t
o
l
o
a
d
l
i
s
t
.
.
.
.
....4.6
testing
.......3.16
4.6
using
default
color/clarity
. . . 3.10,
internal
u s i n gl oaaldi s t
.....4.H.7
......5.4
changingpaper.
precautions
usinglDs
....4.6-4.8
...4.10
withoutlDs...
4.44.6
replacing.
. .7.1-7.3
....1.4
Standards
. . . . . . 3 . 5 Safety
s e l e c t i n g c uhsetaodme r
......4.1
. . . . 3.5 S c r e e n S a v e r .
setting
blank
linesbetween
results
(see
Password)
Security
.
.
.
.
.
.
.
.
3
.
5
s e t t i on ng / o. f f
Number
. . . . . . . 3 . 1 6 Sequence
testing
changing
.....4.1,4.2
Printing
i fr u ni s s t o p p e d .
........4.6
....4.8
flaggedresults
Port
Serial
.
4
.
2
.
4
.
1
0
lastcalibration....
..2.6,CP1.1-CP|.2
l o aldi s t .
.....4.2.4.7 connectingto....
(see
setup
Computer
Port) ;
....4.9
results
parameters
testing
...3.15
4.2
. .3.16,
.
setup
Service
Program
Card
.....8.1-8.3
. .n.
...1.2-1.3 wheretocall...
e x p l a n aotf.i o
whentocall...
...8.1
.......2.4
i n s t a l l a t. i.o. .n o f
.....8.10
.....2.6,4.1 preservicechecklist
Ready/RunScreen
Routine
. .7.1-7.3 Setup
Repairs
printingse
p taur pa m e t e r s .
.....3.16
........9.1
ReplacementParts.
...3.2-3.16
selecting
options

Revised
5/01

IND.3

INDEX
positive
levels.
(see
selecting
Flags)
Sieves
selectingthoseto
report.
Specific
Gravity
(see
Tests)
Testing
Running
....3.9
Strips
o r mraal n g e .
setting
Time
Specifications
......CP1.1 changing
computer
printer.
format
. CPl.1
external
separator
.......1.4
instrument
Touch
Screen
lD,sample)
lD(see
Specimen
. 4.1,4.6
c a l i b r aotfi. o. .n.
Key
Stop
useof
. .4.10
Strip
Jams
testing
Strip
Sensor
problems
function
....8.4,8.5
pixels.
...3.15
testing
Troubleshooting
.
6.1,
9.1
Supplies
chart.
Tests
g e n e irnaflo r m a t i o n
changingorderforreport. ......3.8
Bayer
Reagent
used. . .3.6,4.2 U n p a c k i n g .
selecting
Stripbeing

IND.4

3.11
3.8-3.9,
....3.7-3.8
........3.4
....3.7
........3.7
.......7.3
. 3.1,4.1
...3.15
......3.15
.......3.15
. 8.4-8.9
......8.1
.....2.1-2.2

5/03
Revised