Clinitek500 User Manual

Urine Chemistry Analyzer
ating
er
Op nual
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©1998 Bayer Corporation
All Rights Reserved
Printed in Ireland
FIRST EDITION
Bayer Corporation
Elkhart, IN 46515 USA
50241553 ii Revised 9/98

TABLE OF CONTENTS
Section Page
1 INTRODUCTION
General Description and Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1
Components and Mechanical Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1
Optical System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3
Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4
Tables of Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5
2 INSTALLATION
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1
Environmental Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1
Instrument Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2
Interfacing to a Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5
Interfacing to a Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5
Interfacing to a Bar Code Reader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5
Initial Instrument Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5
3 SELECTING YOUR OPTIONS

Setup Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2
A. Setup Menu #1 (Date; Time; Computer port; Printer) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3
B. Password Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5
C. Setup Menu #2 (Language; Result units; Plus system; Test) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5
D. Setup Menu #3 (Date, Time format; Date, Time separator). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.6
E. Setup Menu #4 (Tests to report; Positive levels; Normal levels) . . . . . . . . . . . . . . . . . . . . . . . . . 3.7
F. Setup Menu #5 (Color; Choices for color, clarity; Use defaults) . . . . . . . . . . . . . . . . . . . . . . . . . 3.8
G. Setup Menu #6 (Positive levels — Color, Clarity; Flags for reports) . . . . . . . . . . . . . . . . . . . . . 3.9
H. Setup Menu #7 (Edit flagged results; Enter sample ID; Tech ID). . . . . . . . . . . . . . . . . . . . . . . . . 3.10
I. Setup Menu #8 (Computer port options; Bar code reader; Password) . . . . . . . . . . . . . . . . . . . 3.11
J. Setup Menu #9 (Reset to defaults; Perform hardware tests) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.13
When Setup is Complete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.14
4 INSTRUMENT OPERATION
Getting Ready to Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1
Testing Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3
Testing Routine Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4
A. Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4
B. If IDs are Used in a Loadlist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.6
C. If IDs are Used Without a Loadlist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.7
End-of-Run Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.8
Editing Results in the Confirmatory Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.8
Recalling Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.8
Operating Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.9
Revised 9/98 iii

TABLE OF CONTENTS
Section Page
5 CARE OF THE INSTRUMENT
General Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1
Daily Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1
Disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3
Changing the Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4
6 ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.1
7 MINOR REPAIR
Printer Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1
Calibrating the Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.3
8 TROUBLESHOOTING AND SERVICE

When to Call for Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.1
Where to Call for Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.1
Troubleshooting Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.4
Preservice Checklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.9
9 ACCESSORIES & REPLACEMENT PARTS

Accessory Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.1
Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.1
Appendix
CPI COMPUTER AND PRINTER INTERFACE
General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CPI.1
Cable and Pin Specifications — Serial Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CPI.1
Cable and Pin Specifications — Parallel Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CPI.1
iv Revised 9/98
Section 1
INTRODUCTION
General Description and The instrument is a reflectance spectrophotometer that
analyzes the color and intensity of the light reflected from
Intended Use the reagent area and reports the results in clinically mean-
ingful units (see Tables 1-1 through 1-3). No calculations
The CLINITEK® 500 Urine Chemistry Analyzer (Figure are required by the user. Calibration is performed auto-
1-1) is a semiautomated, benchtop instrument designed matically each time a Reagent Strip is analyzed.
to “read” Bayer Reagent Strips for Urinalysis. The instru-
ment system includes a program card that contains the
programming necessary for the CLINITEK 500 instrument Components and Mechanical
to read these Reagent Strips. Strips can be laid on the Operation
instrument at any time (if specimen IDs are not used); a
sensor detects the strip’s presence, which activates the Figures 1-2 and 1-3 show the major components of the
strip movement and reading cycle. Communication CLINITEK® 500 instrument. The program card is inserted
between the instrument and the user is through the use into the card receptacle ‹!£. The strips are transported
of a touch screen and interactive software. across the read area ‹@£, where incubation and reading of
the tests occur. All test results are printed by the internal
thermal printer ‹#£ (unless this option has been selected
as “OFF” by the operator). All communications between
the operator and the instrument are made through the
interactive touch display ‹$£. Response keys and dialogue
are displayed on the screen; responses are made by touch-
ing the appropriate key symbol on the screen.
‹$£ ‹#£
Figure 1-1
Depending on the product being used, Bayer Reagent

Strips contain reagent areas for testing glucose, bilirubin,
ketone (acetoacetic acid), specific gravity, occult blood,
pH, protein, urobilinogen, nitrite, and leukocytes. The
instrument can also determine and report the color of the
urine, and the clarity can be entered for each specimen.
‹@£ ‹!£
Figure 1-2
Revised 9/98 1.1

INTRODUCTION
The fixed platform ‹%£ consists of three sections: the Figure 1-4 shows the rear view of the CLINITEK 500
strip loading station 5a , the incubation/read station 5b , instrument. The line cord is connected into the line cord
and the waste bin 5c . A Reagent Strip is placed onto the receptacle ‹*£. The instrument is turned on by pressing
instrument at the strip loading station. Detection of a strip the power switch ‹(£ to the ON (“—”) position. The inter-
by the strip sensor ‹^£ causes the instrument to begin face connectors ‹)£ are the points at which a computer,
cycling. The strip is moved toward the incubation/read printer, and/or handheld bar code reader may be inter-
station by the push bar ‹&£. The strip is then moved through faced with the instrument. An extra port is available for
the incubation/read station by a series of pins; the pins future use. The instrument is cooled by a fan ‹_£.
move the strip at a rate of about 1⁄2 inch every 7 seconds.
‹_£
‹^£ 5c
‹&£ 5a ‹%£ 5b
{ ‹)£
Figure 1-4
‹*£ ‹(£
Figure 1-3
All programming for the instrument is contained in a
Two readheads, located inside the read area, scan the replaceable program card ‹+£, shown in Figure 1-5. The
length of each Reagent Strip at a specific time in the incu- card is programmed with such information as error
bation cycle. The first readhead reads the reagent areas messages, operating sequence, and the wavelengths
requiring shorter incubation times; the second reads those and algorithms used to convert reflectance into clinically
requiring longer incubation times. The pins continue to meaningful results. It also contains the customized Setup
move the strip along the platform until it drops into the information selected by the user. The card is easily replace-
waste bin. able for future software updates.
1.2 Revised 9/98

Optical System
The instrument contains two readheads, each of which
contains an incandescent lamp and photodiode pack.
When a strip is moved into position under the readhead,
the calibration cycle is performed (see “Calibration” next),
then the readhead scans the entire length of the strip, mea-
suring the light reflectance of each reagent pad. A portion
of the light striking the pad is reflected back to the pho-
todiode pack. The light reflected at specific wavelengths
from the test pad is dependent upon the degree of color
change in the pad and is directly related to the concen-
tration of the particular constituent in the urine.
‹+£ The photodiode pack contains four filters, one each at

400–510 nm (blue), 510–586 nm (green), 586–660 nm
Figure 1-5 (red), and 825–855 nm (IR). The light intensity detected
by the photodiode pack is converted into electrical im-
The instrument stores the operating parameters, plus pulses, which are processed by the instrument’s micro-
up to 500 patient results and 200 control results, in a processor and converted into clinically meaningful results.
battery-backed RAM memory. This memory is saved The results can be printed by the internal printer; they can
regardless of whether the power is on or off. The operat- also be sent to a computer and/or a form or 80-column
ing parameters are also stored on the program card and printer.
can be copied to other CLINITEK 500 instruments.
Calibration
Calibration is performed at each readhead immediately
before each Reagent Strip is read. The fixed platform
contains two white calibration bars that are positioned
directly under each readhead. As a strip comes into posi-
tion under a readhead, the instrument is calibrated for that
scanning cycle by reading the calibration bar. The Reagent
Strip is then scanned and the data stored in memory.
Revised 9/98 1.3

INTRODUCTION
Specifications Safety Standards:

The CLINITEK® 500 Urine Chemistry Analyzer (Model
Power Required: 6470) conforms to EMC Directive 89/336 Amendment
100–240 VAC ⫾10%, 50–60 Hz 92/31/EEC and to the Low Voltage Safety Directive
73/23/EEC. The instrument is listed by the Underwriters’
Maximum Power Input: Laboratories (UL) and the Canadian Standards Asso-
72 VA ciation (CSA) as certified and complies with the safety
Fuse Rating: (not user-replaceable) standards specified in UL 3101 and CSA-C22.2,
2A, 250 V, 2AG, SB(T) No. 1010.1.
*Line Leakage Current: The safety standards specify that the instrument must
<0.5 milliamperes in normal condition operate safely in the following conditions:
<3.5 milliamperes in single fault condition • indoor use only
Dimensions: • installation category II (IEC 1010)
Depth — 32.4 cm (12.8 in.) • pollution degree 2 (IEC 1010)
Width — 37.7 cm (14.8 in.) • maximum altitude 2000 meters (6560 feet)
Height — 28.2 cm (11.1 in.)
Symbols on Back of Analyzer:
Weight:
7.4 kg (16.3 lb.) Centronics Port
(Parallel) for Printer
Ambient Operating Temperature Range:
18°C to 30°C (64°F to 86°F) Serial Port (RJ45)
for Bar Code Reader
Ambient Operating Humidity Range:
20% to 80% relative humidity
Not a telephone jack
Optimum Operating Conditions:
22°C to 26°C (72°F to 79°F); Serial Port (RJ45)—
35% to 55% relative humidity not currently active
NOTE: Because of the nature of the urobilinogen and
leukocyte reagents found on Bayer Reagent Strips, Serial Port (EIA-232D)
these two results may be decreased at temperatures for host computer
below 22°C (72°F) and increased at temperatures
above 26°C (79°F). Year 2000 Compliance:
The CLINITEK 500 Analyzer is year 2000 compliant.
*Testing protocol and allowable limits as specified by the safety

standards for laboratory equipment outlined in UL 3101-1, CSA 22.2
No. 1010.1, and IEC 1010-1.
1.4 Revised 9/98

TABLES OF RESULTS
Reported Results
Test Abbreviation Units
Normal System Plus System
NEGATIVE 500 NEGATIVE 2⫹
Glucose GLU mg/dL 100 >=1000 TRACE 3⫹
250 1⫹
NEGATIVE MODERATE NEGATIVE 2⫹
Bilirubin BIL
SMALL LARGE 1⫹ 3⫹
Ketone KET mg/dL TRACE >=80 TRACE 3⫹
15 1⫹
<=1.005 1.020
Specific Gravity SG 1.010 1.025 No Difference
1.015 >=1.030
NEGATIVE SMALL NEGATIVE 1⫹
Occult Blood BLO TRACE-INTACT MODERATE TRACE-INTACT 2⫹
TRACE-LYSED LARGE TRACE-LYSED 3⫹
5.0 6.5 8.0
pH pH 5.5 7.0 8.5 No Difference
6.0 7.5 >=9.0
Protein PRO mg/dL TRACE >=300 TRACE 3⫹
30 1⫹
0.2 4.0
Urobilinogen URO E.U./dL 1.0 >=8.0 No Difference
2.0
Nitrite NIT NEGATIVE POSITIVE No Difference
Leukocytes LEU TRACE LARGE TRACE 3⫹
SMALL 1⫹
YELLOW GREEN
Color* COL ORANGE BLUE No Difference
RED BROWN
CLEAR TURBID
Clarity† CLA SL CLOUDY OTHER No Difference
(determined visually)
CLOUDY
*Color may be preceded with “LT.” or “DK.” when determined by the instrument. If determined visually, Shaded areas = default abnormal results
* default descriptions can be changed by the user; “OTHER” can also be reported.
† Reported results are default descriptions that can be changed by the user.
Table 1-1
ENGLISH — CONV.
Units — Conventional
Revised 9/98 1.5

INTRODUCTION
Reported Results
NEGATIVE 3⫹ NEGATIVE 2⫹
Glucose GLU 1⫹ 4⫹ TRACE 3⫹
2⫹ 1⫹
NEGATIVE 2⫹
Bilirubin BIL No Difference
1⫹ 3⫹
Ketone KET 1⫹ 4⫹ TRACE 3⫹
2⫹ 1⫹
<=1.005 1.020
1.015 >=1.030
NEGATIVE 1⫹
Occult Blood BLD ⫹Ⲑ⫺ INTACT 2⫹ No Difference
⫹Ⲑ⫺ 3⫹
5.0 6.5 8.0
6.0 7.5 >=9.0
Protein PRO ⫹Ⲑ⫺ 3⫹ TRACE 3⫹
1⫹ 1⫹
3.2 66
Urobilinogen UBG umol/L 16 >=131 No Difference
33
Leukocytes LEU 1⫹ 4⫹ TRACE 3⫹
2⫹ 1⫹
YELLOW GREEN
RED BROWN
CLEAR TURBID
CLOUDY
Table 1-2
ENGLISH — NORDIC
Units — Nordic Plus System
1.6 Revised 9/98

Reported Results
Glucose GLU mmol/L 5.5 >=55 TRACE 3⫹
14 1⫹
Bilirubin BIL
SMALL LARGE 1⫹ 3⫹
NEGATIVE 3.9 NEGATIVE 2⫹
Ketone KET mmol/L TRACE >=7.8 TRACE 3⫹
1.5 1⫹
<=1.005 1.020
1.015 >=1.030
NEGATIVE Ca 25 NEGATIVE 1⫹
Occult Blood BLD Ery/uL TRACE-INTACT Ca 80 TRACE-INTACT 2⫹
TRACE-LYSED Ca 200 TRACE-LYSED 3⫹
5.0 6.5 8.0
6.0 7.5 >=9.0
NEGATIVE 1.0 NEGATIVE 2⫹
Protein PRO g/L TRACE >=3.0 TRACE 3⫹
0.3 1⫹
3.2 66
Urobilinogen UBG umol/L 16 >=131 No Difference
33
NEGATIVE Ca 125 NEGATIVE 2⫹
Leukocytes LEU Leu/uL Ca 15 Ca 500 TRACE 3⫹
Ca 70 1⫹
YELLOW GREEN
RED BROWN
CLEAR TURBID
CLOUDY
Table 1-3
ENGLISH — S.I.
Units — International (S.I.)
Revised 9/98 1.7

Section 2
INSTALLATION
General Information Unpacking
This section provides detailed installation instructions 1. You should have received two cartons: one carton
for the CLINITEK® 500 Urine Chemistry Analyzer. The contains the CLINITEK® 500 instrument, the fixed plat-
installation steps must be followed correctly to ensure form, and a box of accessory parts; the other (the
proper installation, operation, and service. Read this “Installation Pack”) contains the power cord and oper-
Operating Manual carefully before attempting to operate the ating manual that are appropriate for your country.
CLINITEK 500 instrument. Follow all instructions carefully. Carefully remove the contents of each carton. Inspect
The CLINITEK 500 is a precision instrument and must the shipping cartons, accessory box, and instrument
be handled accordingly. Rough handling or dropping of for visible signs of damage. If damage to the instru-
the instrument will disturb internal calibrated optics and ment exists, immediately file a complaint with the
electronics and/or cause other damage. Always handle carrier.
the instrument with care. 2. The following items, shown in Figure 2-1, should be
included with the instrument (all but the fixed plat-
form are found in the accessory box):
Environmental Factors
As with all sensitive electronic instruments, prolonged ‹&£ ‹*£ ‹!£
exposure to excessive humidity and temperature should
be avoided. Temperature should be held relatively con-
stant to obtain the highest degree of operating stability.
The ambient temperature range for operating the instru-
ment is 18°C to 30°C (64°F to 86°F); the optimum
temperature range is 22°C to 26°C (72°F to 79°F). At
temperatures under 22°C, urobilinogen and leukocyte
results may be decreased, and at temperatures above
26°C, increased. The ambient operating humidity range
is 20% to 85% relative humidity.
Place the instrument where it will not be subjected to
extreme temperature variations. Avoid proximity to open
windows, direct sunlight, ovens, hot plates, open burn-
ers, radiators, and dry ice baths. Do not place it on the
same bench as a source of vibration, such as a centrifuge.
‹^£ ‹%£ ‹$£ ‹#£ ‹@£
The CLINITEK 500 instrument should not be used in an
explosive atmosphere.
Figure 2-1
2. ‹!£ Fixed platform and holddown plate

2. ‹@£ Moving table (2)
2. ‹#£ Printer paper
2. ‹$£ Push bar (2)
2. ‹%£ Program card
2. ‹^£ Holddown plate (extra)
Revised 9/98 2.1

INSTALLATION
2. The following items should be packed in the 5. If you have not already done so, insert the pages of
Installation Pack: your Operating Manual into the binder.
2. ‹&£ Operating manual: Binder and manual pages
(Manual pages may be supplied separately by your Bayer rep-
resentative. Depending on the language of the operating
manual you have received, there may also be a Warranty
Instrument Setup
Registration Card and/or a Customer Information Card.)
1. Plug the instrument line cord into the instrument and
2. ‹*£ Power cord
into an appropriate grounded AC electrical outlet.
2. Make sure all these items have been included with
2. Locate the bar-coded serial number, which is found
your instrument, and keep them for future use.
inside the instrument near the front left corner (Figure
3. After the instrument has been unpacked, place it on a 2-3). Write the installation date and serial number in
firm, level work surface in the designated work area. the spaces provided in the “Preservice Checklist” in
The instrument should appear level, both side to side Section 8 and on the Manufacturer’s Warranty Page
and front to back. The back and sides of the instru- that is found at the end of this manual (contact your
ment should be at least 3 inches from an adjacent wall Bayer representative for your warranty information if
or instrument. this page is not included in your manual).
3. NOTE: Retain the CLINITEK 500 shipping carton and
packing for at least several weeks. If the instrument
ever needs to be shipped, the shipping carton will
afford the best protection against damage.
4. Locate the piece of foam packing that is under the read
area cover. Gently pull down and forward on the foam
to remove it (Figure 2-2).
Figure 2-3
3. If a Warranty Registration Card is found at the front

of your manual, write the installation date and instru-
ment serial number on this card. After the instrument
has been successfully installed, completely fill out the
Warranty Registration Card and mail.
Figure 2-2
2.2 Revised 9/98

4. Install the moving table as follows: CAUTION: If the platform does not push in with only
4. a. Hold the table with the small square tab facing to very gentle pressure, do not force it! Ensure that the
the back. moving table is correctly positioned and attempt to
reinstall the platform.
4. b. Align the two grooves on the bottom of the table
with the edges of the platform on which the table
rests (Figure 2-4).
Figure 2-5
6. Hold the push bar by its flattened end and, with this
Figure 2-4 end slightly upward, insert the peg on the other end
of the bar into the hole in the pusher mechanism
2. c. Gently push the table in as far as it will go. It must (Figure 2-6). Lower the push bar into place.
be pushed past a detent in order to be correctly in
position.
5. Next, install the fixed platform. (The holddown should
already be installed onto the platform. If it is not, or
is loose, refer to Section 5, “Daily Cleaning,” Step
10-a, for directions on installing the holddown.) Align
the two grooves on the bottom of the platform with
the arms extending from the instrument, as shown in
Figure 2-5. (The ledges on the left and right sides of
the holddown align just outside the read area cover,
and the top edge of the platform aligns just under the
cover.) Gently push the platform in as far as it will go.
(It must be pushed past a slight detent to be correctly
positioned.)
5.
Figure 2-6
Revised 9/98 2.3

INSTALLATION
7. Hold the program card with the label facing forward

and the arrows pointing in and up. Insert the card into
the card receptacle (Figure 2-7) and press it in firmly
until the button above the receptacle is pushed out.
When properly inserted, the edge of the card will be
flush with the side of the instrument.
Figure 2-8
8. b. Obtain a new roll of paper; unroll several inches and

trim the end into a long “V”. Hold the roll just above
the printer, with the paper unrolling from under-
neath. Feed the end of the paper under the roller,
then rotate the paper advance wheel in a clockwise
Figure 2-7 direction (toward the back) until several inches of
paper are exposed above the printer (Figure 2-9).
8. Install a roll of printer paper and re-install the printer
cover as follows:
a. Notice the large tab on the back side of the instru-
ment that secures the cover in place (Figure 2-8).
Press in firmly on the bottom edge of the tab and
lift the cover off.
Figure 2-9
2.4 Revised 9/98

8. c. Set the paper into position behind the printer. Then, Interfacing to a Bar Code Reader
place the front tabs of the cover into their slots and
feed the end of the paper through the opening in A Handheld Bar Code Reader (Product No. 6471) is
the cover. Snap the cover into place. available for use with the CLINITEK 500 Analyzer. It is
connected through the RJ45 interface port (labeled
Interfacing to a Printer “ ”). Refer to Appendix BCR that is included with the
Handheld Reader for complete information.
The CLINITEK 500 can be interfaced to most 80-
column, continuous feed printers or to the CLINITEK® Initial Instrument Check
Form Printer via the printer (parallel) port that is found
on the rear of the instrument. After the CLINITEK 500 has been properly installed,
1. Some printers may include an interface cable that is perform the following initial instrument check. The actions
appropriate for use; if not, you will need to obtain the that should occur during instrument operation are
cable separately. Refer to Appendix CPI, “COMPUT- described in this check. If problems occur during this
ER AND PRINTER INTERFACE,” for the pin specifica- procedure or if an error message is displayed, refer to
tions for the male connector. The other end of the Section 8, TROUBLESHOOTING AND SERVICE.
cable will be dependent upon the particular printer. 1. Press the power switch to the ON (“—”) position. The
Appropriate cables are available at most retail com- fan at the rear of the instrument will turn on and the
puter stores. push bar will move. The display will be illuminated,
2. Plug the appropriate end of the interface cable into first showing the instrument name and a series of dots
the printer port on the CLINITEK 500 (labeled “ ”); while the system initializes. It then changes to the title
plug the other end into the printer. screen, which shows the software version numbers,
3. Carefully read the operating manual that accompanies along with the instrument name and copyright infor-
the printer and become familiar with its operation mation. The system then does several internal checks
before using. and procedures. Each check and its status is displayed
while the testing is being performed.
1. NOTE: If an error occurs, a message will be displayed
Interfacing to a Computer that instructs you either to turn the power off, then
back on after several seconds, or to contact customer
The CLINITEK 500 can also be interfaced to a host service (see Section 8, TROUBLESHOOTING AND
computer or LIMS (Laboratory Information Management SERVICE).
System) via the serial port and a Null modem cable. The
cable requirements for interfacing to a computer are found
in Appendix CPI, “COMPUTER AND PRINTER INTER-
FACE.” Plug the appropriate end of the interface cable
into the port on the CLINITEK 500 labeled “ ”; plug
the other end into the appropriate port on the computer,
following the instructions given with the computer.
Revised 9/98 2.5

INSTALLATION
2. The display changes to the Ready/Run screen, which 3. Completely immerse a Bayer Reagent Strip into a neg-
is the starting point for testing and selecting the ative control urine, such as CHEK-STIX® Negative
options that will customize the instrument to meet Control Strips solution. Immediately remove the strip.
your laboratory’s needs. The screen also shows the While removing, slowly run the edge of the entire length
name of the Bayer Reagent Strip for Urinalysis that is of the Reagent Strip against the side of the tube to
programmed for use on the instrument. remove excess urine. Do not blot the edge of the strip
2. The Ready/Run screen will be displayed in the against a paper towel, as doing so may affect test results.
selected language as, for example: 4. Place the Reagent Strip, with reagent areas up, onto
the strip loading station. The push bar should begin
Use MULTISTIX 10 SG.
moving almost immediately, pushing the strip into the
Place strip. read area, and the keys shown on the display will be
shown as dimmed (partially lit) symbols.
5. After the strip has been read, the test results will be
ID: printed by the internal printer. The instrument should
produce a result for each reagent area that is within
SEQ #: 00001 the limits given in the package insert for the control
urine.
Color-(not reported)
6. If the instrument does not perform as expected, or if
Clarity-(not reported)
the printed results do not agree with the expected val-
ues, refer to Section 8, TROUBLESHOOTING AND
Menu Tech ID: SERVICE.
09-05-98 10:32 AM 7. Before beginning normal instrument use, carefully
review the following sections to become familiar with
2. Verify that the Reagent Strip name being displayed the instrument software, operating techniques, and
agrees with the strip to be used. Use of any other strip cleaning requirements:
will cause erroneous results. If the strip names do
7. Section 3 SELECTING YOUR OPTIONS
not agree, the selected strip must be changed before
7. Section 4 INSTRUMENT OPERATION
beginning testing. The strip is selected through the
7. Section 5 CARE OF THE INSTRUMENT
Setup Routine, described in Section 3.
8. With satisfactory completion of the initial instrument
check, the CLINITEK 500 Analyzer is ready for rou-
tine testing. Enter the Setup Routine and follow the
displayed prompts to customize the software for
your laboratory. Refer to Section 3 for complete
information.
2.6 Revised 9/98

Section 3
SELECTING YOUR OPTIONS

General Information Cancels the run or the last strip. If the run is can-
celled, all strips on the platform are immediately
All interaction between the operator and the Stop moved to the waste bin and no results are
Run
CLINITEK® 500 Analyzer is through the touch screen. reported for them. This key is displayed on the
Messages, options, and requests for information are Run screen and becomes active (fully lit)
displayed, along with “keys” that can be touched to as soon as the first strip in a run is detected. It is
respond in the desired manner. A light touch is all that located in the upper right corner, in place of
is necessary to activate the key. Do not use anything hard the key.
or pointed on the touch screen. (If a key does not
respond, press it for a slightly longer time, rather than Changes the display to the next screen in a
harder.) series. This key is displayed only if there are addi-
Next itional screens to be viewed and always appears in
• If an option key is active, the key symbol is dis- Screen
the lower right corner.
played fully lit. Whenever an active key is touched, you
will see a change either in the display or in the instru- Changes the display back to the previous screen
ment operation. in a series. This key is displayed only if there are
• If an option key is not active, the key symbol is Previous earlier screens in the series to be viewed and
Screen
dimmed and a unique double tone will sound if it is always appears in the lower right corner, imme-
touched. diately above the key (Next Screen) location.
Several keys are displayed on various screens, and they
Must be touched in order to accept data that has
will always have the same function whenever they are dis-
been entered, such as ID and sequence num-
played:
bers, date, and time. If the screen is exited with-
Returns the screen to the Ready/Run screen. If Enter out first touching , the newly entered data is
this key is touched from a screen in which data is not saved; any data previously in memory is
Return to requested and (Enter) was not touched first, retained.
Ready/
Run any data that was entered will NOT be saved. This
key appears on most screens, always in the upper Moves the cursor one space to the right from its
right corner. current position. If the cursor is at its right-most
Move position, touching this key has no effect. Moving
Touching this key causes a Help screen to be dis- Right the cursor does not erase any characters; new
played that has information pertaining to the characters can be entered directly over the incor-
Help screen from which the key was touched. Touch the rect characters.
key from the Help screen to return to the
previous screen. The key is not displayed on all Moves the cursor one space to the left. The char-
screens but, when displayed, always appears to acter at the current position is usually erased
the left of the key (Return to Ready). Move before the cursor is moved to the left. If the cur-
Left
sor is at its left-most position, the cursor does not
move. Exception: if this key is displayed in con-
junction with the key (Move Right), the exist-
ing characters are not erased as the cursor is
moved.
Revised 9/98 3.1

Move Up displays the previous stored result or In addition to the function keys, three different types of
entry in descending order (lower sequence num- keys will be displayed in order to assist the operator in
Move ber). Move Up 10 displays the record stored selecting the desired option in various menus. If the key is
Up
ten positions lower than the currently displayed displayed as a fully lit symbol, the key can be touched
record; if there are fewer than ten lower-num- to select the option or cycle through the list of options.
bered results, the oldest stored result or entry is If the key is displayed as a dimmed symbol, the option is
Move not available for selection.
Up 10 displayed.
Move Down displays the next stored result or Touching an action key selects the option
entry in ascending order (higher sequence num- described next to the key. The display always
Action
Move ber). Move Down 10 displays the record stored Key changes to another screen, either to start the
Down
ten positions higher than the currently displayed selected routine or to display an appropriate
record; if there are fewer than ten higher-num- screen that defines how the selected option will
bered results, the most recently stored result or work.
Move
Down 10 entry is displayed.
The cycle key is used when several options are
available. Each time the key is touched, a dif-
Cycle
Plus increases the displayed number by 1 each Key ferent option is displayed for selection. When
time the key is touched. the desired option is displayed, the selection is
Plus complete.
Minus decreases the displayed number by 1 each Selection keys are used to select or reject the use
time the key is touched. of an option. If a check mark ( ) appears in the
Minus Selection key symbol, the option is selected (turned on);
Key
if the key symbol is empty, the option is not
Changes the display to the full alphabet to allow selected (turned off ).
entry of alphabetic characters in, for example, a
Alphabet specimen ID, Tech ID, or control lot number.
Setup Routine
Allows a single record or all records shown on
the screen to be deleted. A second screen is The Setup Routine should be entered when the instru-
Delete always displayed, from which you can select how ment is initially installed to select the various param-
many records are to be deleted (one or all) or to eters desired by your laboratory. Thereafter, this routine
confirm that all records are to be deleted. will probably be entered infrequently. Several of the
options can be accessed freely; for example, the date and
Allows one or more records from a displayed list time can be changed through this routine, the com-
to be printed. puter port turned on or off, and the printer selected.
Print Access to additional options can be protected through the
use of a password.
3.2 Revised 9/98

Enter the Setup Routine from the Ready/Run screen, A. Setup Menu #1
shown at the end of Section 2. Touch the key symbol next
The first Setup menu is displayed; for example:
to the word Menu to display the Option Menu; for
example:
Set options.
Set options.
Date: 09-05-98
Tech ID:
Time: 10:34 AM
Controls
Setup Computer port-OFF
Print
Printer
Memory
Touch the key symbol that appears next to the option you
want to change. Each option is described below.
Touch the Setup key from the Option Menu to enter the
Setup Routine. 1. Date:
NOTE: If a change is made to any of several Setup options, 1. a. When the Date key is touched, the display changes
all results and loadlisted ID numbers stored in mem- to show the current date and a numeric keypad by
ory will be deleted when the change is made. A warning which the date can be changed; for example:
screen will be displayed first, and you will be given the
option of not making the change to the Setup option, sav-
Enter Month:
ing the stored results and numbers. Be sure all patient and 0
Ù9-05-98
control results have been printed and/or transferred and
that a loadlist is not stored in memory before making the
changes.
Revised 9/98 3.3

1. b. Enter the correct date by touching the proper numer- 3. Computer port:
ic keys, or touch the arrow keys to move the 3. Touch the Computer port cycle key to change the selec-
cursor to the digit that needs to be changed and tion between OFF and ON. Depending upon the selec-
enter the correct number. The message will change tion made, results can be transferred to a computer.
as you move from one part of the date to the next, The specifications for the computer port are selected
showing the prompt, for example, “Enter day,” then later in the Setup Routine.
“Enter year.” Be sure to enter the leading “0” 4. Printer:
where needed. 4. a. Touch the Printer key symbol to change several
1. c. When the date has been entered, touch . A mes- printer options:
sage will be displayed if an invalid date is entered; 4. a. iii. Internal: The internal printer can be used to print
be sure the date has been entered in the order patient results, with several options for the for-
shown on the prompts. If the date is valid, the dis- mat, or it can be turned off. Touch the Internal
play returns to the first Setup menu. cycle key to select the desired option of OFF or
2. Time: ON, with 2, 6, or 12 blank lines between patient
2. a. When the Time key is touched, the display changes result sets.
to show the current time (in the selected format) 4. a. iii. NOTE: There are always two blank lines between
and the numeric keypad by which the time can be control result sets.
changed, similar to that displayed for changing the
date. 4. a. iii. Custom header: A header is printed at the end
of each printed report obtained through the inter-
2. b. Enter the appropriate digits by touching the prop- nal printer when “12 blank lines between patient
er numeric keys and/or touch the arrow keys to result sets” is selected. The default header is
move the cursor to the appropriate digit that needs “MICROSCOPICS”; this can be customized, if
to be changed. The message will change as you desired, or changed to contain all blanks if you
move from one part of the time to the next, show- do not want a header at all.
ing the prompts “Enter hour” and “Enter minutes.”
Be sure to enter the leading “0” where needed. 4. a. iii. When the Custom header option key is
touched, an alphabetic keyboard is displayed,
2. c. If the time format is “12 Hour,” touch the AM/PM from which up to 24 letters and spaces can be
cycle key to change from AM to PM or vice-versa. entered. Touch when the entry is correct to
(If the time format is “24 Hour,” the AM/PM cycle store it in memory and return the display to the
key is not active.) Printer Option menu.
2. d. When the time has been entered, touch . A mes-
sage will be displayed if an invalid time is entered.
If the time is valid, the display returns to the first
Setup menu.
3.4 Revised 9/98

4. a. iii. External: An external printer can be used instead C. Setup Menu #2
of, or in addition to, the internal printer. This
The second menu of the Setup Routine is displayed as,
printer can be a form or 80-column, continu-
for example:
ous-page printer. Touch the External cycle key
to change the selection between “OFF”; “ON, 80
column”; and “ON, Form.” Set options.
4. a. iii. NOTE: If the internal printer is OFF and the exter-

nal printer is set to “ON, Form,” only patient and
Language-English
control results can be printed; reports (such as
Setup, Confirmatory, or Microscopic) cannot be
printed. Result units-
Conventional
4. b. When all printer options have been selected, touch
to return to the first Setup menu.
Plus system-OFF
B. Password Screen
If all selections have been completed from the first
Test-MULTISTIX 10 SG
Setup menu, touch to move either to the password
screen or directly to the second Setup menu, depending
upon whether password protection of the remaining 1. Each of the menu options feature cycle keys that, when
screens has been selected (see Step I-3 later in this touched, display the next in a series of options for the
section). menu item.
If password protection has not been requested, the dis- 1. • Language: All screens will be displayed in the lan-
play changes as described in Step C next. If a password guage that is selected. Also, the default selection for
is being used, a numeric screen is displayed from which several other options may change, depending upon
the password can be entered. Touch when the pass- the language and result units selected (for example,
word has been entered. If it has been entered correctly, the date and time formats, test name [Reagent Strip
the display changes as described in Step C. If it is incor- type], and reporting of color).
rect, a message is displayed and you can enter the code
again. 1. • Result units: Several of the languages have options
for the units in which results are displayed. See the
Tables of Results at the end of Section 1 for the
results that are displayed and printed for each option.
Revised 9/98 3.5

1. • Plus system: Results can be displayed and printed D. Setup Menu #3

in the Plus system (which uses “⫹” symbols) rather
When all selections have been made from the second
than in clinical units such as mg/dL.
menu, touch to move to the third menu in the Setup
1. • Test: Many configurations of Bayer Reagent Strips Routine; for example:
can be used on the CLINITEK® 500 Analyzer. However,
not all configurations are available in every country.
Set options.
Be sure the Reagent Strip selected agrees with the
name of the Bayer Reagent Strip being used.
2. Touch the cycle keys as needed to obtain the desired Date format-Month/Day/Year
option. The table below lists the options that are avail-
able for each of the cycle keys:
Date separator-"-"
Language: Result units: Plus system:

Time format-12 Hour
English (with English, OFF
Français Français, and ON
Deutsch Deutsch)
Time separator-":"
Italiano Conventional
Kanji Nordic*
Español S.I.
*English only As with the previous menu, each of the options feature
cycle keys. The available options are:
Test:
MULTISTIX® 10 SG N-MULTISTIX® SG
MULTISTIX® 9 SG NEPHROSTIX® L Date format: Date separator:
MULTISTIX® 8 SG URO-HEMACOMBISTIX® SG L
MULTISTIX® SG URO-LABSTIX® SG
MULTISTIX® SG L URO-LABSTIX® SG L
Month/Day/Year “–”
MULTISTIX® Day/Month/Year “.”
Year/Month/Day “/”
Time format: Time separator:

12 Hour “:”
24 Hour “,”
“.”
Touch the keys as needed to select the desired options.
3.6 Revised 9/98

E. Setup Menu #4 1. When the action key is touched, the display will show
a series of cycle keys, labeled 1 through 12. The num-
When all selections have been made from the third
ber of fully lit keys will equal the number of tests being
menu, touch to move to the next menu in the Setup
reported, plus one. Each time a new test is added to
Routine; for example:
the list, the next key becomes fully lit until the number
equals the number of tests on the selected Bayer
Set options. Reagent Strip plus two (color and clarity). If the tests
being reported and their order are all correct, touch
the key to return to the previous menu. If you want
to make changes, proceed as follows:
Tests to report and their order
1. a. Selecting Color/Clarity: If color and/or clarity are
not listed, you can quickly and easily add one or both
to the list by touching the last fully lit key (it will not
Positive levels for tests
have a description next to it) until the desired test
name (COL or CLA) is shown. Touch the next key
(which is now fully lit) to add the other test name.
Color and clarity will be reported in the last two posi-
Normal levels for SG/pH tions if you make no further changes.
1. b. If you want to change the order in which tests are
reported, touch the cycle key at the first position
1. Tests to report and their order: you want to change. Any test(s) not already listed
1. Even if an analyte or physical parameter is tested on will be displayed first; then a blank will be displayed
the CLINITEK 500 Analyzer, you may choose to not and all tests from that position on will be erased
report it; you can also select the order in which the and must be re-entered. Touch the cycle key until
tests are reported. The default order is the same as the the desired test is displayed.
order of tests on the selected Bayer Reagent Strip. If
“English S.I.” is the selected language, color is also 1. b. NOTE: The abbreviations for the tests are always
included as the last test; if not already selected, it can displayed in the same order, beginning with the
be added to the end of the list. You can also choose to next test in the list from what is currently being
include clarity (determined visually) as a reported result displayed: glucose, bilirubin, ketone, specific grav-
through this menu option. ity, occult blood, pH, protein, urobilinogen, nitrite,
leukocytes, color, and clarity.
1. c. Select the desired test for each of the remaining
positions. If you want to remove a test from the
reporting order (not reported), select the tests you
do want to report and leave a blank description in
the final position.
1. d. When the correct tests and order are displayed,
touch .
Revised 9/98 3.7

2. Positive levels for tests: F. Setup Menu #5

2. The lowest result that is considered to be positive can
When all options on the fourth menu have been cor-
be changed from the default levels, if desired, for each
rectly set, touch to proceed to the next Setup menu;
of the chemistry tests. (The physical parameters of SG,
for example:
pH, color, and clarity are changed in other menu
options.) All positive results are marked with an aster-
isk (*) in the displayed and printed report, as well as Set options.
in the data transferred to a host computer. These lev-
els are also used by the Analyzer to determine which
specimens meet the criteria for the confirmatory and Color-
microscopic reports. When the action key is touched, determined by Analyzer
the display shows the lowest positive level for the first
four tests selected in the previous screen (Tests to Color choices
report).
2. NOTE: Nitrite is not listed, since it has only one posi- Clarity choices
tive level.
2. a. Touch the cycle key for the test you want to change, Use default COL/CLA
repeating until the desired level is displayed. during run-ON
2. b. When all tests on the first screen are correct, touch

to display the remaining tests (if more than four 1. Color:
are reported). 1. If color has been selected as one of the tests to be
2. c. When all tests are correctly set, touch as need- reported (in Step E-1 previously), it can either be deter-
ed to return to the previous option menu. mined by the CLINITEK 500 Analyzer or be entered
3. Normal levels SG/pH: manually by the technician from a visual determina-
3. The lower and upper limits of the range considered to tion. Touch the cycle key to select the desired option
be normal for SG and pH can be selected by touching (“determined by Analyzer” or “entered by tech”). If
this key. Each limit is set separately; however, the upper “entered by tech” is selected, the color can be entered
limit must be higher than or equal to the lower limit. as part of a loadlist and/or just before each specimen
is tested.
3. a. Touch the + or – keys next to the limit you want
to change to raise or lower the displayed number. 1. NOTE: Color can be determined by the Analyzer only
With each touch, the number will change by one if the Bayer Reagent Strip being used contains the
reporting level until it is equal to the opposite limit leukocyte test.
or is at the highest or lowest reporting level.
3. b. When all limits have been set, touch to return
to the previous option menu.
3.8 Revised 9/98

2. Color choices: 4. Use default COL/CLA during run:
2. If the color option above is “entered by tech,” you can 4. The first reporting value for color and/or clarity can be
specify up to seven options from which to select the displayed as the default value by setting this option to
specimen color. Any of the default options can be ON. It is available only if color is “entered by tech”
removed from the reporting list; the name of each and/or clarity is being reported. Each default value can
option can also be customized. then be changed, if needed, prior to testing the spec-
2. a. The first four default colors will be displayed ini- imen. If this option is set to OFF, the description lines
tially (YELLOW, ORANGE, RED, GREEN). If the for color and/or clarity are blank (no default value
selection key contains a check mark, the color is displayed) until the cycle key is touched. Use of the
included in the list; touching the key removes the default value can be turned ON and OFF by touching
check, deleting the option from the list. (The first the cycle key.
option must be selected and is always shown as a
dimmed key.) G. Setup Menu #6
2. b. The color name can be changed by touching the Touch to move to the next Setup menu when all
word describing the color. The display will change selections have been made on the fifth menu. The new
to the alphabetic keyboard. Use the key to erase menu is displayed as, for example:
the existing name, if necessary, and enter the new
name of up to 15 letters and spaces. Touch Set options.
when done to return to the previous screen.
2. c. When finished with the first four colors, touch
to display the last three default colors (BLUE, Positive levels for COL/CLA
BROWN, and OTHER). Remove or add color
options, or change their descriptions, as needed,
then touch as needed to return to the previous
option menu. Flags for confirmatory tests
3. Clarity choices:
3. If clarity is selected as a reported result (Step E-1), you
can specify up to five options from which to select the Flags for microscopics
specimen clarity. As with Color choices previously, any
of the default options can be removed from the report-
ing list and the name of each option can be customized.
1. Positive levels for COL/CLA:
3. a. The first three choices are shown initially (CLEAR,
1. If either color or clarity was selected as a test to be
SL CLOUDY, and CLOUDY); the second screen dis-
reported, the first result that is considered to be pos-
plays two additional options (TURBID and OTHER).
itive can be selected. As with the chemistry tests, these
Remove or add options, or change their descrip-
levels are used by the Analyzer to determine which
tions, as needed, on each of the two screens, in the
specimens meet the criteria for the confirmatory and
same manner as in Step F-2 previously.
microscopic reports, and all positive results are marked
3. b. Touch as needed to return to the previous option with an asterisk (*) in the displayed and printed report
menu. and in the data transferred to a host computer. When
the selection key is touched, the display shows the first
level that is considered to be positive.
Revised 9/98 3.9

1. a. Touch the appropriate cycle key until the display 3. Flags for microscopics:
shows the first level you want to have marked as 3. As with the confirmatory report, up to five tests can
positive. All results later in the list are also called be selected for the microscopics report. This report
positive. If you have not changed or removed any can be used to list those specimens that may require
of the descriptions (Step F-2), the options are: a microscopic examination. Select the tests for the
report in the same manner as for the confirmatory
Color: Clarity: report, then touch to return to the previous option
YELLOW GREEN CLEAR TURBID menu.
ORANGE BLUE SL CLOUDY OTHER
RED BROWN CLOUDY H. Setup Menu #7
*OTHER When all options have been selected on the sixth menu,
*If visually determined touch to progress to the next menu in the Setup
Routine. The menu is displayed as, for example:
1. b. Touch when both selections have been made
to return to the previous option menu. Set options.
2. Flags for confirmatory tests:
2. Up to five tests (of those to be reported) can be select-
ed for the confirmatory report. If a specimen has a pos-
Edit flagged results-OFF
itive result for any of the tests selected, the record will
be flagged and can be recalled as part of a confirma-
tory report. Further testing can then be performed on
these specimens and the results of the confirmatory Enter sample IDs-OFF
testing entered into the record, if desired.
2. a. When the action key is touched, the display will
show a list of all tests that are to be reported. Touch
Tech ID-OFF
the selection box next to the tests you want to
include in the confirmatory report; a check mark
will appear in the box. To remove a selection, touch
the box again and the box will become blank. 1. Edit flagged results:
2. b. Touch when the selections have been made to 1. Results that have been flagged as positive and select-
return to the previous option menu. ed for the confirmatory report can be edited (for exam-
ple, if confirmatory testing has been performed). Touch
the cycle key to turn the option ON or OFF, as desired.
3.10 Revised 9/98

2. Enter sample IDs: 1. Computer port options:
2. An identification number can be entered for each spec- 1. If you are sending results to a host computer or LIMS
imen, either as part of a load list or immediately prior (Laboratory Information Management System), the
to testing the specimen, if this option is set to ON. interface parameters must be specified. Touch the
Touch the cycle key to turn the option ON or OFF, as Computer port options key to display a new menu.
desired. 1. a. The first three menu options feature cycle keys to
3. Tech ID: select the correct parameters. The following table
3. The technician who is performing the testing can be shows the possible selections for these options:
identified on the test results, if desired, by setting this
option to ON. The Tech ID can appear on control results Port: Baud: Data, Parity:
only or on both patient and control results. It is shown
on the Ready/Run screen and is easily changed when 1200
necessary. Touch the cycle key to select the desired ON 2400 8/none
option (OFF; ON, control results only; ON, both patient OFF 4800 7/even
and control results). 9600 7/odd
19200
I. Setup Menu #8 1. a. The port must be ON in order to transfer results to
When all options have been selected on the seventh a computer. Refer to the specifications accompa-
menu, touch to progress to the next Setup menu. The nying the computer for information on the required
menu is displayed as, for example: parameters for Baud, Data, and Parity.
1. a. NOTE: The computer port can also be turned ON
Set options. or OFF through the first Setup menu, which is
unrestricted regardless of whether password pro-
tection is being used (see Step I-3 later). If use of
Computer port options the port is changed (from ON to OFF or vice versa)
in one menu, the selection is automatically changed
in the other menu.
Bar code reader options
1. b. The fourth option on the Computer port options
menu allows selection of the Output Format for the
Password for setup-OFF results sent to a computer. A new menu is dis-
played with the following options and their possi-
ble selections:
Set or reset password
Output Format: Checksum:* Handshake:*
CCS ON ON
CT200⫹ OFF OFF
CT200
*Not available in CCS format.
Revised 9/98 3.11

1. b. The output format you select will depend upon 2. a. Label: The Handheld Reader can accept any of four
whether you already have a software interface pro- different bar code formats. The format being used
gram that allows the transfer of results from either can be selected using the Label cycle key, or you
a CLINITEK® 200+ or a CLINITEK® 200 Urine can allow the reader to automatically determine the
Chemistry Analyzer to a host computer or LIMS. format type. The label options are: Auto detect; Code
When one of these formats is selected (“CT200+” 39; I-2 of 5 (Interleaved 2 of 5); Codabar; and Code
or “CT200”), the data from the CLINITEK 500 128.
instrument will be transmitted in the same format 2. a. NOTE: Select “Auto detect” only if more than one
as that sent by the selected instrument (the print- format is used; faster and more consistent read-
ed results, however, do not mimic the selected ings will occur if the specific format being used is
instrument). selected.
1. b. Alternatively, results can be transmitted in the 2. b. Test bar code: The bar code label being used
CLINITEK 500 format by selecting “CCS.” The should be tested to ensure that the information can
parameters for this format are included in the doc- be read. After touching the Test bar code key,
ument “CLINITEK Communication Specification,” you will be instructed to “Scan bar code
available from your Bayer representative or office. label. Verify that information on screen
1. b. If either CT200+ or CT200 is selected as the out- is correct.” Scan a label that is representative
put format, the use of checksum and handshake of the quality and size being used and for which
must also be specified (refer to your computer you know the results that should be obtained. The
specification for the requirements). It is also strong- results of the test will be displayed on the screen;
ly suggested that you check the selections made compare the displayed result with the known value
on your CLINITEK 200+ or CLINITEK 200 instru- of the label and use this information to determine
ment and enter the parameters identically in the if any characters need to be deleted. Return to the
CLINITEK 500 Analyzer (e.g., ID/color/clarity ON previous menu when finished.
or OFF). This will help ensure that the data is trans- 2. b. NOTE: You may want to test more than one label,
ferred in the same format as your software pro- especially if they are printed from different sources.
gram currently is written to accept. If you use more than one format, test at least one
1. c. Select the correct parameters for all options, then label in each format. Refer to Appendix BCR that
touch as needed to return to the previous Setup accompanies the Handheld Reader for complete
menu. information.
2. Bar code reader options: 2. c. Leading char. to ignore: The Handheld Reader can
2. An optional Handheld Bar Code Reader is available for read a bar code that contains up to 30 characters;
use with the CLINITEK 500 Analyzer. This reader can however, a maximum of 13 characters can be dis-
be used to scan barcoded identification labels on each played, stored, and transmitted by the Analyzer.
specimen cup or tube, rather than entering the speci- All characters in excess of 13 must be ignored (up
men ID manually. The Analyzer software must be con- to a maximum of 18). Characters can be ignored
figured to the appropriate parameters for the barcoded as leading characters (at the beginning of the bar
labels being used. Touching the Bar code reader code), trailing characters (at the end), or a combi-
options key will change the display to a new menu. nation of both. If you need to ignore any leading
characters, touch the cycle key until the desired
number is displayed (“0” to “9”).
3.12 Revised 9/98

2. d. Trailing char. to ignore: Trailing characters can Set options.
also be ignored by touching the cycle key until the
desired number is displayed (“0” to “9”).
2. e. When all selections have been made on this menu,
touch to return to the previous menu. Reset all features to defaults
3. Password for setup:

3. A password can be required to allow access to most
of the Setup Routine option menus, if desired, by set- Perform hardware tests
ting this option to ON. The password is requested fol-
lowing the first option menu of the Setup Routine, and
all further menus are not accessible unless the correct
password is entered. If the password option is set to
OFF, all option menus in the Setup Routine are freely
accessible. Touch the cycle key to turn the use of the
password ON or OFF. 1. Reset all features to defaults:
4. Set or reset password: 1. You can return all options in the Setup Routine to the
4. If the password is being used, you can set a personal manufacturer’s default settings through the use of this
password or reset an existing password. The Analyzer key. A confirmation screen will be displayed, from
also has a default password of “84437,” which is which you must touch YES before the options are reset.
always active. The personal password can be entered All stored results and loadlisted ID numbers will be
by touching the action key. A numeric keyboard is dis- deleted if the options are reset.
played, from which you can enter up to 6 digits. Touch 2. Perform hardware tests:
when the password has been entered; you will be 2. Several different hardware tests can be performed
prompted to re-enter the password for verification. If through this menu option. You may be asked by a Bayer
the same digits are entered the second time, the dis- Representative to perform one or more of these tests
play will return to the previous menu after displaying in order to assist in troubleshooting a problem. When
the message “New password has been set.” the action key is touched, a new menu of six different
If an error is made, you will need to enter the pass- options is displayed. The screen also displays the total
word again and then re-enter the same password for number of strips that have been read by the Analyzer.
verification.
2. a. Strip sensor: When the action key is touched, the
J. Setup Menu #9 screen displays the prompt “Place test strip
on table.” If the strip sensor detects the pres-
When all options have been selected on the eighth ence of a strip, the message “Strip detected”
menu, touch to progress to the final menu in the Setup will be displayed.
Routine. The menu is displayed as, for example:
2. b. Serial port: This test sends data from the serial
port, through a connector, and back into the same
port. The data sent and received should be identical.
Revised 9/98 3.13

2. b. iii. Obtain a loopback connector, either by making previous menu. If there are numerous faulty pixels,
your own or by ordering from Bayer Instrument or if they are located in critical areas, the display
Service (see Section 9, “Replacement Parts”). may need to be replaced.
The connector is a serial 25-pin male connec- 2. f. Printer: The internal and/or 80-column external
tor on which pins 2 and 3 are connected and printer can be tested to ensure that all characters
pins 4 and 5 are connected. are being printed correctly. Ensure that the exter-
2. b. iii. Touch the Serial port action key to display the nal printer is turned on (if one is being used). Touch
test screen. As instructed on the screen, plug the Printer key and follow the directions on the
the loopback connector into the serial port on screen. Examine the printout for its readability. The
the back of the instrument (labeled ), then display automatically returns to the previous menu.
touch to begin the test. The test will con-
tinue until you exit the screen (by touching ). 3. When all tests have been completed, touch to return
2. c. Touch screen: This test may be used to determine to any previous Setup menu, or touch to return to
if the touch screen is functioning properly. When the Ready/Run screen.
the Touch screen key is touched, a screen is dis-
played that is filled with small boxes. As each box
is touched, a check mark ( ) should appear (it
When Setup is Complete
disappears when touched again). Touch the center When you have finished selecting the setup parame-
of each box, saving the key for last. ters, touch to return the display to the Ready/Run
2. d. Bar code reader: This test is identical to the Test screen. It is suggested that you print a copy of the setup
bar code option described in Step I-2-b so you can report to verify your selections and to retain in your files.
test your reader without exiting the hardware test Touch Menu from the Ready/Run screen, then touch Print.
screen. If your Handheld Reader is not reading your From the Print menu that is displayed, select the option
labels, you should test labels of a known quality to Setup report. (If printing from the internal printer, make
determine whether the problem lies with the labels a photocopy of the report, since the thermal print may
you are using or with the Handheld Reader itself. fade over time.)
The package containing your Handheld Reader NOTE: You must have selected “ON” for the internal print-
includes two sheets of barcoded labels that have er and/or “ON, 80 column” for the external printer in order
been printed to the minimum specifications of the to access the Print key. Refer to Step A-4 previously to
bar code reader. If these labels cannot be read, the select one of these printers, if needed.
problem is probably with your reader. If they read The setup parameters are stored both in the CLINITEK
properly, the labels you are using may not be 500 Analyzer and in the program card. If a new program
acceptable. Scan the desired label and compare card is installed, you can select to use your current setup
the displayed result with the known value of the configuration from the Analyzer memory. Conversely, if
label. Return to the previous menu when finished. you receive a new CLINITEK 500 Analyzer, but have
2. e. Display: The display can be tested to ensure that retained your old program card, you can select to use your
all pixels (the lighted elements on the display) are current setup configuration from the program card. If both
being lit and turned off appropriately. When the the Analyzer and the program card are new, you can use
Display key is touched, the entire screen will be lit the printout obtained previously to reselect the desired
for several seconds, then be blank. This series will parameters.
be repeated twice more before returning to the
3.14 Revised 9/98

Section 4
INSTRUMENT OPERATION
General Information If you need to access any of the menu items shown on
the display, this must be done before a run is started.
Following initial installation (Section 2) and selection During a run, most of the key symbols are dimmed, which
of your setup options (Section 3), the CLINITEK® 500 means the options are not available. The key (Stop
Urine Chemistry Analyzer is ready for routine operation. Run) is always available during a run and, depending on
Carefully read this section before beginning any testing. the Setup options selected, the Color and/or Clarity keys
may be available.
CAUTION: Do not use anything pointed or hard to make
selections on the touch screen. If a key is displayed as a fully lit symbol, that option is
available for selection. Touching the specified key sym-
bol causes the following actions:
Getting Ready to Run ID: allows specimen identification numbers to be entered.
If ID numbers have been entered into a loadlist, the
The CLINITEK 500 instrument is designed to be left number of the next specimen in the list is displayed.
on at all times (except during cleaning procedures). The number is updated each time a strip is moved to
Either the screen saver display or the Ready/Run screen the read area.
will be displayed whenever the instrument is not in use.
(If the screen saver is being displayed, simply touch the SEQ #: allows the sequence number to be changed. The
screen anywhere to return to the Ready/Run screen.) For number being displayed represents the sequential
example: number that will be assigned to the next specimen.
The number increments each time a strip is moved to
the read area.
Use MULTISTIX 10 SG.
Place strip. Color: displays the next option in the series of color selec-
tions that can be made for visually determined color
results. If color was previously entered through the
ID: loadlist, that entry is displayed for the next specimen
to be tested; otherwise, either the default description
SEQ #: 00001
is displayed or the display is blank until the cycle key
is touched, depending upon the selection made in
Color-YELLOW
Section 3, Step F-4. (If color is determined by the
Clarity-CLEAR
instrument or is not being reported, the display shows
“(by Analyzer)” or “(not reported),” respectively.)
Menu Clarity: displays the next option in the series of clarity
Tech ID: 118
09-05-98 10:32 AM selections that can be made. Otherwise, the displays
are the same as for the Color key, except that clarity
cannot be determined by the instrument.
If IDs are not being used and color/clarity results are
displayed (if being reported), the instrument is ready to Menu: takes you to the Option Menu, from which sever-
use immediately and enters the Run mode as soon as a al additional options can be quickly selected or changed
strip is detected on the platform. Whenever the push bar prior to beginning a run.
is positioned at the left side of the loading station, the
instrument is ready to accept placement of a strip; how-
ever, if the bar is positioned to the right, the instrument
is not ready and any strip placed on the platform will be
ignored.
Revised 9/98 4.1

(Stop Run): cancels the run in progress (available 4. Change the “Tech ID” (technician identification) if
only during the Run mode). needed:
(Help): displays additional information about the 4. NOTE: If the “Tech ID” key is dimmed, the option can
Ready/Run screen. be changed to ON as directed in Section 3, Step H-3.
Before starting each run, perform the following steps: 4. a. Touch the Menu key symbol to display the Option
Menu; for example:
1. Check that the name of the Reagent Strip being dis-
played corresponds to the name of the Bayer Reagent Set options.
Strip for Urinalysis that is to be used for routine urin-
alysis. Use of any Reagent Strip other than the one
listed will cause erroneous results. If the names do
not agree, select the correct strip name through the Tech ID: 118
Setup Routine, as directed in Section 3, Step C-2.
Controls
1. IMPORTANT: The CLINITEK 500 Analyzer has been
optimized for use with Bayer Brand Reagent Strips. Setup
The performance characteristics may not be valid for
any other brand of strips, the use of which may cause Print
erroneous results. Bayer Corporation does not war-
rant use of the CLINITEK 500 Analyzer with any Memory
reagent strip other than Bayer Brand Reagent Strips.
2. Inspect the strip loading station and push bar for
cleanliness and correct positioning. If contaminants 4. b. Touch the Tech ID key. A numeric keyboard will be
are present, remove the push bar, platform, and mov- displayed.
ing table, and clean as described in Section 5, “Daily 4. c. Enter the identification of up to 13 digits. The key-
Cleaning.” board also includes the key, which allows
3. The “SEQ #” (sequence number) increments with each alphabetic characters to be entered. Touch
strip that is placed onto the instrument. Change the from the alphabetic screen to return to the
starting number if desired: numeric keyboard, then touch to store the Tech
3. a. Touch the key symbol next to the word SEQ #. The ID and return to the Option Menu screen.
display will change to a numeric keyboard, from 5. If you want to print the ID list (if a loadlist exists in
which the new number can be entered. memory), confirmation of the last calibration, or a
3. b. Enter the desired number. The number can be reset report of the setup parameters, touch the Print key
to “00001” by touching the special key labeled with from the Option Menu and select the desired option.
that number. If an error is made, or if you only need Touch to return to the Option Menu.
to change one or two digits, touch the appropriate 6. If you want to run controls before starting the run,
key ( or ) to move the cursor to the digit to touch the Controls key from the Option Menu and pro-
be changed and enter the correct number. ceed as directed next.
3. c. When the correct number has been entered, touch
to enter the number into memory.
4.2 Revised 9/98

Testing Controls 2. a. Notice the control sequential number displayed
immediately to the left of the lot number (e.g.,
Negative and positive controls should be run on a reg- “C0035”). If you want to reset this number, touch
ular basis to provide a check on the performance of the the key labeled C0001.
Bayer Reagent Strips and on the instrument operation.
Testing controls provides confidence that the Reagent 2. b. Enter the lot identification of the first control to be
Strips are reacting and being read properly. Errors result- tested. If alphabetic characters are needed, touch
ing from user techniques can also be detected. It is the key to display the alphabetic keyboard.
suggested that controls be run under the following Touch after entering the letters to return to the
conditions: numeric display.
• At the start of the day’s run; 2. c. Touch when you are ready to test the control.
• When using a new bottle of Reagent Strips; 3. The display will prompt “Place strip.” Completely
• When changing instrument operators; immerse all reagent areas of the Bayer Reagent Strip
• Whenever test results are in doubt. in the CHEK-STIX solution. Immediately remove the
CHEK-STIX® Positive and Negative Control Strips for Reagent Strip. While removing, slowly run the edge
Urinalysis are available for use on the CLINITEK 500 of the entire length of the Reagent Strip against the
Analyzer. The solutions prepared using the Control Strips side of the container to remove excess CHEK-STIX
provide positive, negative, or defined reactions when used solution.
with Bayer Reagent Strips for Urinalysis. Alternatively, a 4. Place the reagent strip, with reagent areas up, onto
urine specimen from a normal, healthy individual can be the strip supports of the strip loading station, to the
used as a negative specimen. Additional information on right of the small embossed arrow ( ) (Figure 4-1).
CHEK-STIX Positive and Negative Control Strips can be
found in Section 6 of this manual and in the package insert
for the Control Strips.
To test control specimens, proceed as follows:
1. Prepare the appropriate CHEK-STIX solution(s) by fol-
lowing the directions found in the package insert or
on the bottle label.
1. NOTE: Use freshly prepared CHEK-STIX solution only.
See the package insert or bottle label for stability
information.
2. Touch the Menu key symbol from the Ready/ Run
screen, then touch the Controls key (if not already
done). The display will change to a numeric keyboard,
from which the lot identification of the controls can
be entered, the sequential number reset, and the con-
Figure 4-1
trol run started.
Revised 9/98 4.3

4. NOTE: Be sure the Reagent Strip is lying parallel to 8. d. Deterioration of the CHEK-STIX Control Strips.
the surface of the platform. The end of the strip should Obtain a fresh bottle of CHEK-STIX Control Strips
be against the rear wall of the platform and should not and prepare a fresh CHEK-STIX solution, then
be touching the bottom of the strip loading station. repeat the control procedure. If the solution from
Improper placement may cause the instrument to the fresh control strip fails to give results within
jam or the strip to be incorrectly aligned under the the expected values, proceed to Step e.
readheads. 8. e. CLINITEK 500 instrument malfunction. Perform an
5. Repeat Steps 2-b through 4 for each additional Initial Instrument Check procedure (see Section 2).
control. If the Initial Instrument Check or the control pro-
6. The strip(s) will automatically be advanced along the cedure cannot be successfully completed and an
strip loading station, under the readheads for read- instrument malfunction or reagent strip problem
ing, then into the waste bin. The results will then be is suspected, see Section 8, TROUBLESHOOTING
printed (unless all printers have been turned OFF AND SERVICE, or contact the Customer Service
through the Setup Routine) and stored in memory. Department for assistance.
7. After all controls have been run, press (after the
symbol is displayed again) to exit the control screen. Testing Routine Specimens
8. The CHEK-STIX solution should produce the values A. Basic Operation
stated in the CHEK-STIX package insert. If the control
The steps described in this section are the same regard-
results fall outside of these values, the following
less of whether you are running with or without the use
sources of error may have occurred:
of ID numbers. Read this section completely to under-
8. a. Improper technique or instrument setup. Check stand how the instrument operates during the Run Mode.
that the Reagent Strip being used corresponds to
1. If clarity is being reported and/or color being entered
the Reagent Strip name given on the Ready/Run
by the technician, select the color and/or clarity
screen. Carefully repeat the control procedure as
description for each specimen. Touch the cycle key(s)
described above.
as needed until the appropriate description is being
8. b. Deterioration of the Reagent Strip test areas due displayed. (Alternatively, enter the color and clarity by
to exposure to light, ambient moisture or heat. scanning the appropriate barcoded symbols provid-
Obtain a fresh bottle of the Bayer Reagent Strips ed with the Handheld Bar Code Reader.) This should
being used and repeat the control procedure. If be done before continuing to the next step; however,
fresh Reagent Strips fail to give results within the you can change the description up to the point at
expected values, proceed to Step c. which the strip is moved.
8. c. Deterioration of the CHEK-STIX solution. Prepare
a fresh CHEK-STIX solution and repeat the control
procedure. If fresh solution fails to give results
within the expected values, proceed to Step d.
4.4 Revised 9/98

2. Completely immerse all reagent areas of a Bayer 4. The presence of the Reagent Strip is detected as soon
Reagent Strip in fresh, well-mixed, uncentrifuged as it is placed on the loading station. If the instrument
urine. Immediately remove the Reagent Strip. While was previously at the Ready/Run screen, detection of
removing, slowly run the edge of the entire length of the first strip immediately activates the timing and
the Reagent Strip against the side of the urine con- movement functions. The push bar moves the strip
tainer to remove excess urine. Do not blot the edge along the loading station to the read area and the
of the strip against a paper towel. SEQ # increments. The strip is moved along the plat-
2. NOTE: The instrument performance has been opti- form by a series of pins that move every seven sec-
mized for use with unblotted strips, and results may onds, passing under each of the two readheads for
differ if the strips are blotted. analysis and then into the waste bin.
3. Place the Reagent Strip, with reagent areas facing 4. NOTE: If the instrument is already in the Run Mode,
up, onto the strip supports of the strip loading sta- there may be a delay of up to seven seconds after the
tion, to the right of the small embossed arrow ( ) strip is placed on the loading station before the push
(Figure 4-2). bar moves. The amount of delay depends on the sta-
tus of the timing cycle for the strips currently being
analyzed.
5. Repeat Steps 1 to 3 for each new specimen to be test-
ed. The instrument continues to move the strips across
the read area until the final strip is moved to the waste
bin. A new strip can be placed on the loading station
at any time prior to then.
5. NOTE: You will have very little time to enter the
color/clarity after placing the strip. Therefore, it is
strongly suggested that you enter the color and clar-
ity of each specimen before dipping the Reagent Strip.
6. Results are transmitted to the printer and/or computer
as soon as all reagent areas on the strip have been
read. However, if a record is flagged for the confirm-
atory report and “Edit flagged results” is ON (see “End-
Figure 4-2 of-Run Reports” later in this section), that record is
held for printing until after the end-of-run reports have
been exited.
3. NOTE: Be sure the Reagent Strip is lying parallel to
the surface of the platform. The end of the strip should
be against the rear wall of the platform and should not
be touching the bottom of the strip loading station.
Improper placement may cause the instrument to
jam or the strip to be incorrectly aligned under the
readheads.
Revised 9/98 4.5

7. If a problem occurs that requires the run to be stopped 2. Enter the ID for the first specimen. If alphabetic char-
before completion of all readings, touch the key acters are needed, touch the key to display the
(Stop Run) symbol in the upper right corner. You will alphabetic keyboard (touch to return to the numer-
be given the option of cancelling the entire run or can- ic keyboard). Alternatively, scan the ID number from
celling only the last strip that was placed on the plat- a barcoded label using the Handheld Bar Code Reader.
form. If the entire run is cancelled, all strips on the 2. NOTE: Do NOT touch from the ID entry screen
platform will be moved immediately to the waste bin. until after the color and clarity have been entered.
No results will be reported (and no SEQ # assigned)
for any strip that had not been read at both readheads 3. Enter the color and clarity descriptions, if desired, by
prior to pressing ; the specimens for those strips touching the Color and/or Clarity key symbols as
must be retested. If only the last strip is cancelled, the needed to display the correct description. If “Use
run will continue and a new strip can be tested, using default COL/CLA during run” was set to ON, the default
the same SEQ #. values of “YELLOW” and “CLEAR” will be displayed;
if it was set to OFF, the descriptions for both will be
blank until the key is touched. Alternatively, scan the
B. If IDs are Used in a Loadlist: appropriate color and clarity bar codes, using the
Specimen IDs can be entered as a loadlist before start- Handheld Reader and the special color/clarity bar code
ing the run, as described below. sheet provided with the Reader.
1. Touch the ID key from the Ready/Run screen to enter 4. Touch to enter the number, color, and clarity into
the number for the first specimen. The ID entry screen memory. (A warning tone will sound if an entry is
is displayed as, for example: missing.) The number to the left of the ID will incre-
ment to indicate the loadlist order of the next ID to be
Enter IDs, COL, CLA:
entered; the number in the lower right corner of the
1______________ display will also increment to show the total number
Color- of IDs in the loadlist.
YELLOW
5. Repeat Steps 2 to 4 above for each specimen.
Clarity-
CLEAR 5. NOTE: Duplicate ID numbers ARE allowed by the
system.
6. To review, change, or delete a loadlisted number or
color/clarity description that has already been entered,
use the and keys to display the desired num-
ber, using the loadlist order number to help you locate
the proper location:
6. NOTE: The ID number cannot be changed or deleted
Total: 0 during the Run mode. All changes must be made
through this screen while the instrument is in the
1. The ID number can be entered using the numeric key- Ready mode.
board. If color is being entered by the technician and/or
clarity is being reported, these must be entered at the
same time. They can then be edited while running the
specimens, immediately prior to dipping each Reagent
Strip.
4.6 Revised 9/98

6. a. Change the ID number using the key to move C. If IDs are Used Without a Loadlist
the cursor to the left as needed, then enter the cor- Specimen IDs can also be entered immediately prior
rect number. to testing each specimen, as follows:
6. b. Delete the number from the loadlist by touching 1. Touch the ID key to enter the number for the first spec-
; you will be given the option to delete only the imen. The ID entry screen is displayed (see Step B-1
ID number being displayed or all IDs in memory. above).
Touch the desired option.
2. Enter or scan the ID number for the specimen about
6. c. Edit the color and/or clarity description as to be tested; if needed, enter or scan the color and
described in Step 3 above. clarity descriptions (see Steps B-2 and B-3 for com-
6. d. Touch to accept the new number and color/clar- plete directions). When this information has been cor-
ity descriptions. rectly entered, press .
7. When all IDs have been entered into the loadlist, you 3. The display will change to allow entry of the next ID
can print the list by touching . Then touch to number, and the push bar will move to the left so a
return to the Ready/Run screen to begin testing spec- strip can be placed on the loading station. Dip and
imens. (The ID list can also be printed by touching place a Reagent Strip, as instructed in Steps A-2 and
Menu from the Ready/Run screen, then touching Print A-3.
and selecting ID list.) 3. NOTE: If another ID is entered without a strip being
7. NOTE: Once testing is started, no additional IDs can detected, the instrument automatically creates a load-
be added to the loadlist, nor can an ID number be list (see Step B previously).
changed or deleted until the run is completed or can- 4. When a Reagent Strip is detected at the loading sta-
celled. If the run is cancelled, the remaining IDs in the tion after a single ID number has been entered, two
loadlist can be edited, but no new IDs can be added changes occur on the display:
until the run is complete.
4. • The number to the left of the ID changes to the
8. Test each specimen in the same manner as described sequence number of the specimen being tested.
in Step A previously (“Basic Operation”). The This number will increment each time a strip is
Ready/Run screen will show each ID number and the moved to the read area.
color/clarity descriptions in the same order as they
were entered into the loadlist. For each specimen: 4. • The prompt at the top of the display changes each
time is pressed (after entering the ID and
8. a. Check that the ID number and color/clarity descrip- color/clarity of a specimen) to the prompt “Place
tions are correct for the specimen about to be test- strip.” After a strip is moved to the read area, the
ed. Edit the color and clarity, if necessary, as prompt returns to “Enter IDs, COL, CLA.”
described in Step A-1.
5. For each specimen:
8. b. Dip and place a Reagent Strip as described in Steps
A-2 and A-3. 5. a. Enter the ID number, color, and clarity.
9. When the strip for the last loadlisted specimen has 5. b. Press .
been moved to the read area, you will not be allowed 5. c. Dip and place the Reagent Strip for the specimen
to place any additional strips on the table. The push just entered.
bar will stay at the right side and the display will 5. NOTE: The display remains at the ID Entry screen
change to “Completing Run. Please Wait.” throughout the entire run when IDs are entered imme-
diately prior to testing the specimen.
Revised 9/98 4.7

End-of-Run Reports 3. Repeat Steps 1 and 2 above for each desired record.
When all editing is complete, touch to exit the
If you marked any analytes to be flagged for confir- Confirmatory Report. Once you leave the Edit routine,
matory and/or microscopic tests (in the Setup Routine), you will not be able to edit the run any further.
one or two end-of-run reports may be displayed when 4. After both the Confirmatory and Microscopic Report
the run is completed. The Confirmatory and/or Micro- screens have been exited, results for the records
scopic Report screens will show the SEQ # and ID of the included in the Confirmatory Report are sent to the
record, plus the abbreviation for each analyte that was printer and/or computer (all other records are printed/
positive and marked for flagging. Up to five records may transmitted as soon as they are available).
be displayed on one screen; additional records can be
viewed by touching the and keys. If there are
records in both the Confirmatory and Microscopic Recalling Results
Reports, the Confirmatory Report will be displayed first.
If results are to be edited, this must be done before exit- Up to 500 patient records and 200 control records are
ing the Confirmatory Report (see “Editing Results” next). stored in memory. If you want to recall one or more
You can print a report by touching . Then touch records, proceed as follows:
when you are ready to exit the report screen. 1. Touch Menu to display the Option Menu, then touch
NOTE: A third report will be displayed if there are any Memory.
records for which an error was reported for one or more 2. You can choose to recall all patient records, all con-
analytes. This report will be displayed last, and any spec- trol records, or the last batch of patient records. The
imens listed should be retested. number of records in memory are both shown next
to the first two options. Touch the desired option.
Editing Results in the Confirmatory Report 3. The first (earliest) record of the selected group will be
displayed. The date and time the record was stored is
If you perform confirmatory testing on any of the spec- shown, along with the technician ID (if available), SEQ
imens and want to edit the reported results, this is done #, and ID for the record. All results are then listed;
from the Confirmatory Report screen. You must first have positive results (as defined through the Setup Routine)
specified one or more tests for the Confirmatory Report are flagged with an asterisk (*) and edited results with
and have selected ON for the “Edit flagged results” option an exclamation (!).
in the Setup Routine (Section 3, Steps G-2 and H-1).
4. Locate the first record you want to review using the
1. While the Confirmatory Report is being displayed, use movement keys shown on the display. The next lower-
the and keys to move the highlighting to the or higher-numbered record in memory is recalled
desired record, then touch to select the record. when the and keys are used; the record 10
2. The results obtained for the flagged (positive) tests lower or higher is recalled when the and keys
will be displayed. Touch the cycle key next to the test are used.
name to change the displayed result to the next option
of the available reported results. Once the cycle key
is touched, the result for that test will be printed and
transmitted with an exclamation point (!), even if the
result is reset to its original value. Touch when
editing is complete for that record to return to the
Confirmatory Report.
4.8 Revised 9/98

5. Printing records from memory: If you want to print • a. Touch the selection key next to Reprint last result
one or more records, touch ; you will be given that is displayed on the same screen as the mes-
several printing options: sage “Printing-Please wait.” As long as the
5. a. Print only this result: The record that was disappears in the selection key, the last set of
played when the key was touched can be results will be reprinted each time a form is insert-
printed. The SEQ # and ID of that record will con- ed into the printer.
tinue to be displayed on the print option menu. • b. Insert a new form into the Form Printer. (A form
5. b. Print a group of results: You can specify the begin- must NOT be inserted before touching Reprint last
ning and ending records to be printed; all records result or the last set of results will be lost.)
in the sequential group will be printed. Use the • c. When the report has been printed correctly, touch
movement keys to display the first record (lowest the selection key again to remove the . The next
SEQ #) you want to have printed, then touch set of results will be printed when a form is inserted.
to change the selection to the last record to be • If a strip should become jammed under the readhead
printed. This record must have a SEQ # that is to the extent that movement of the strips is prevented,
higher than or the same as the first record. Touch touch to stop the run and return to the Ready/Run
to begin printing. screen. Record the information provided on the Results
5. c. Print all patient (control) results: All records that Error Report to determine the specimen(s) that must
were recalled can be printed when this option is be retested. Then turn the instrument off and remove
selected. the fixed platform (see Section 5, “Daily Cleaning,”
5. After printing is complete, the screen returns to the Step 4). Remove the jammed strip, reinstall the plat-
record that was displayed before the key was form, and turn the instrument on. Retest the speci-
touched. men(s) for which there were no results.
6. Deleting results from memory: If you want to delete • Calibration confirmation: A report of the most recent
all patient or control results from memory, touch successful calibration can be printed if desired. Touch
the key. You will then be asked to confirm the Menu from the Ready/Run screen, then touch Print
deletion. and select Calibration confirmation. The date and time
of the latest successful calibration will be printed.
7. When done, touch to return to the previous menu
or touch to return to the Ready/Run screen. • Thermal print (from the internal printer) will fade with
time, especially when exposed to light. The print will
also fade if covered with transparent tape or when
Operating Notes exposed to extremes in temperature or humidity.
• The instrument does not detect when the internal
• When printing with the Form Printer: Each set of printer is out of paper and therefore will continue print-
results is stored in memory until a form is inserted into ing results even if there is no paper. However, the last
the Form Printer. When a form is detected as being in several feet of paper on the roll contain a pink edge;
place, the next set of results is sent to the printer. Check the roll should be changed when this appears. Any
each form immediately after it is printed to ensure that records for which you do not have printed results can
all results have been printed and are clearly readable. be reprinted by recalling the last batch of records, then
If there is a problem with the printed form, immedi- printing the appropriate records.
ately reprint the last report as follows:
Revised 9/98 4.9

Section 5
CARE OF THE INSTRUMENT

General Cleaning 3. Remove the fixed platform by pulling the entire assem-
bly towards you (Figure 5-2).
Keep the exterior of the CLINITEK® 500 instrument free
of dust at all times. If needed, the exterior may be cleaned
using a damp cloth and a mild detergent. Do not use any
type of solvent, oil, grease, silicone spray, or lubrication
on any part of the instrument.
Daily Cleaning
The fixed platform, moving table, reagent strip hold-
down plate, and push bar should all be cleaned at least
once each day, as directed in the following steps. If the
display screen is used to enter ID, color, or clarity during
the run, it should be cleaned once each day also.
1. With the instrument at the Ready/Run screen (and the
run completed), turn the Analyzer off.
Figure 5-2
2. Remove the push bar by tilting it slightly upwards and
pulling straight out (Figure 5-1). 4. Remove the moving table in the same manner (Figure
5-3).
Figure 5-1
Figure 5-3
Revised 9/98 5.1

5. Remove the holddown plate from the fixed platform 7. Rinse each piece thoroughly and dry with a paper
by pressing up against the tab at the back of the plate towel or soft cloth. Allow the calibration bars on the
(Figure 5-4). Then pull the other end from its retain- platform to air dry.
ing hole. 7. NOTE: After cleaning, inspect the calibration bars for
scratches, marks, or discoloration. If the bars can-
not be cleaned, the platform must be replaced (see
Section 9, “Replacement Parts”).
8. If you want to disinfect the parts, do that now,
as instructed in “Disinfection,” found later in this
section.
9. Reinstall the moving table as follows:
9. a. Hold the table with the small square tab facing to
the back.
9. b. Align the two grooves on the bottom of the table
with the edges of the platform on which the table
rests.
9. c. Gently push the table in as far as it will go. It must
be pushed past a detent in order to be correctly
Figure 5-4 in position.
10. Reinstall the holddown and fixed platform:
6. Clean each piece (push bar, platform, holddown, and
table) with warm water and mild soap. Do not use any 10. a. Position the holddown with the arrow side facing
type of solvent. When cleaning the platform, avoid up and the arrow pointing to the back. Place the
wiping across the two white calibration bars; use a pin on the front of the holddown into the hole at
cotton-tipped swab, wetted with plain water, to clean the front of the fixed platform. Then align the tab
the bars. at the back of the holddown with the slot at the
back of the platform and snap the holddown into
6. NOTE: If the holddown and/or push bar are extremely
place. Make sure the white calibration bars are
dirty, they may need to be soaked in order to loosen
visible.
the dried residue. An extra moving table, holddown,
and push bar are supplied with your instrument so you
can reassemble your instrument while the original
pieces are soaking.
5.2 Revised 9/98

11. b. Align the two grooves on the bottom of the fixed 2. Several solutions are safe to use on the pieces when
platform with the arms extending from the instru- they are used for no longer than 10 minutes once a
ment. (The ledges on the sides of the holddown day. Prepare one of the following solutions:
align just outside the read area cover, and the top 2. • Household Bleach (5% sodium hypochlorite)—can
edge of the platform aligns just under the cover.) be used either full strength or diluted to as much as
Gently push the platform in as far as it will go. (It a 1:20 dilution. To make a 1:20 dilution, add 5 mL
must be pushed past a slight detent to be cor- of bleach to a container and add 95 mL of water, for
rectly positioned.) a total volume of 100 mL. (To make a 1:10 dilution,
11. b. CAUTION: If the platform does not push in with combine 10 mL of bleach and 90 mL of water.)
only gentle pressure, do not force it! Ensure that 2. • NOTE: Bleach CANNOT be used on the display
the moving table is correctly positioned and screen.
attempt to reinstall the platform.
2. • Cidex®* and Theracide®*—these products (or their
11. Hold the push bar by its flattened end and, with this equivalent) can be purchased for use in general dis-
end slightly upward, insert the peg on the other end infection. Prepare and use the solution according
of the bar into the hole in the pusher mechanism. to the directions that come with the product.
Lower the push bar into place.
2. CAUTION: Do NOT use isopropyl alcohol or any prod-
12. Clean the display screen, when needed, with a soft, uct containing phenol (such as Amphyl®*), as these
nonabrasive cloth that has been dampened with a will cause damage to the calibration bars.
mild glass cleaner (do not use bleach). Do not spray
the glass cleaner directly onto the screen. Do not use 3. Completely immerse the pieces in the solution for no
laboratory wipes, such as Kimwipes®, since they may longer than 10 minutes. Rinse each piece thorough-
scratch the sceen. ly with clear water.
13. Turn the instrument power on. 4. Dry each piece with a paper towel or soft cloth, using
care when drying around the pins on the moving table.
Allow the white calibration bars on the platform to air
Disinfection dry.
5. Reinstall the pieces as directed in “Daily Cleaning,”
To disinfect the push bar, holddown, platform, table Steps 9 to 11.
and display screen, perform the following steps:
IMPORTANT: Refer to the labeling accompanying the dis-
infection products for complete instructions on their use.
1. Remove, clean, and dry the push bar, fixed platform,
holddown, and moving table as directed in “Daily
Cleaning,” Steps 1 to 7.
*Cidex (registered trademark of Johnson & Johnson) is a 3.2% glutaraldehyde

solution.
Theracide (registered trademark of Lafayette Pharmaceuticals, Inc., Lafayette,
IN) is a quaternary ammonium solution.
Amphyl (registered trademark of National Laboratories, L&F Products,
Montvale, NJ) is a phenol solution.
Revised 9/98 5.3

6. Disinfect the display screen, if needed, using either 3. If there is paper remaining on the roll, lift up the roll
Cidex or Theracide solution (or their equivalent) only; and tear the paper between the roll and the printer.
do NOT use bleach. Wipe the solution on the screen Then gently pull the paper through the printer in its
using a soft, nonabrasive cloth and allow to remain normal direction of travel or rotate the wheel on the
for 10 minutes. Do NOT spray or pour the disinfec- right side to advance the paper. Otherwise, remove
tant directly onto the screen. Rinse using a clean, soft the empty core.
cloth dampened with water, then dry. 4. Obtain a new roll of paper (Product No. 5773); unroll
NOTE: Repeated or prolonged soaks over a long period several inches and trim the end into a long “V”. Hold
of time with glutaraldehyde solutions may cause a slight the roll just above the printer, with the paper unrolling
fading or discoloration of the platform and table, and a from underneath. Feed the end of the paper under the
cloudy appearance to the push bar; however, these roller, then rotate the paper advance wheel in a clock-
changes will not affect performance. wise direction (toward the back) until several inches
of paper are exposed above the printer (Figure 5-6).
Changing the Paper

1. Be sure the instrument is at the Ready/Run screen.
2. Notice the large tab on the back side of the instrument
that secures the cover in place (Figure 5-5). Press in
firmly on the bottom edge of the tab and lift the cover
off.
Figure 5-6
5. Set the paper into position behind the printer. Then,

place the front tabs of the cover into their slots and
feed the end of the paper through the opening in the
cover. Snap the cover into place.
Figure 5-5
5.4 Revised 9/98

Section 6
ACCESSORIES
CHEK-STIX® Positive and Negative The Control Strips are available as a Combo Pak, which
contains one bottle each of the Positive Control Strips
Control Strips for Urinalysis and Negative Control Strips (25 strips/bottle). The Positive
Combo Pak (Product Number 1364) Control Strips are also available as a separate product
Positive Control Strips (Product Number 1360) (one bottle of 25 strips).
CHEK-STIX® Positive and Negative Control Strips for
Urinalysis (Figure 6-1) provide a performance check for
the CLINITEK® 500 Instrument/Reagent Strip System. CLINITEK® Handheld Bar Code
CHEK-STIX Control Strips provide confidence that the Reader (Product Number 6471)
Reagent Strips are reacting and being read properly. The CLINITEK® Handheld Bar Code Reader (Figure
Errors resulting from user technique can also be detected. 6-2) can be connected to the RJ45 interface port on the
CLINITEK 500 instrument. The Handheld Reader can be
used to enter the identification numbers from barcoded
labels, rather than manually entering each number before
the specimen is tested. Color and clarity can also be
scanned from special bar codes that are included with
the Handheld Reader.
Figure 6-1
CHEK-STIX Control Strips are reconstituted in distilled

water to make up a CHEK-STIX control solution.
Instructions are included in the package insert and on the
bottle label, and test results that should be obtained are
listed in the package insert.
Figure 6-2
Revised 9/98 6.1

Section 7
MINOR REPAIR
General Information
The CLINITEK® 500 Urine Chemistry Analyzer is a self-
contained instrument that requires very little maintenance.
With proper care and use, the instrument should oper-
ate reliably with a minimum of operator attention. The
only minor repair that can be performed is the replace-
ment of the printer, should this ever become necessary.
In addition, the touch screen can be recalibrated, if
needed. This section is provided as an aid in performing
these procedures; for any other repairs, refer to Section
8, TROUBLESHOOTING AND SERVICE, for instructions
on obtaining service for your instrument.
Printer Replacement Figure 7-1
Tools Required: 3. Remove the roll of paper from the printer by tearing
None the paper between the roll and the printer, then gen-
Parts Required: tly pulling the paper through the printer in its normal
Printer (Part No. 40451012) direction of travel.
4. To remove the printer:
Procedure:
4. a. Carefully remove the clear plastic shield that is
1. WARNING: TURN THE INSTRUMENT OFF AND adhered to the front of the printer. Be careful not
REMOVE THE AC ELECTRICAL CORD FROM THE to tear the adhesive pads.
OUTLET.
4. b. The printer hooks under a ledge at the front and
2. Remove the cover on the internal printer by pressing snaps into position at the rear with a small lever
in on the lever on the back of the printer cover and (Figure 7-2). Press out on the lever and lift up on
lifting up on the cover (Figure 7-1). the printer. Raise the module out of its cavity by
lifting up and back.
Revised 9/98 7.1

MINOR REPAIR
4. c. Unsnap the connector by lifting up on both sides

of the top plate; it will raise by about 1/16" (2 mm).
Then gently pull the interface cable from the con-
nector (Figure 7-4). (You may need to wiggle the
cable slightly to loosen it initially.)
Figure 7-2
4. c. The printer is connected to the instrument through

a flat 14-pin interface cable (Figure 7-3) for trans-
fer of data ‹!£. The cable slides into a connector
‹@£ that snaps down to secure the cable into posi-
tion. Figure 7-4
5. To replace the printer:

5. a. Obtain the replacement printer and set it partially
into position in the cavity of the instrument.
5. b. Slide the interface cable into the narrow slot on the
top plate of the connector. It will slide in very eas-
ily to an initial stop; at this point, firmly but care-
fully press the cable straight down until it stops
again. Be sure both sides of the cable are fully
inserted. Press down on both sides of the con-
nector until it snaps shut. Gently pull up on the
cable to ensure that it is secured in place. If it pulls
out easily, unsnap the connector and repeat this
step.
‹!£ ‹@£
Figure 7-3
7.2 Revised 9/98

5. c. Place the printer fully into position by lowering the Calibrating the Touch Screen
front of the module down and forward under the
ledge. Then lower the back of the module and press If the touch screen does not respond correctly when
down firmly until it snaps into place. a key is touched, the screen may need to be calibrated.
This is easily done, as follows:
5. d. Replace the clear shield to its position in front and
on top of the printer and press gently against the 1. Turn the instrument power off. Wait several seconds,
adhesive pads. then turn the power back on.
5. e. Replace the roll of paper, as instructed in Section 2. When the title screen is displayed (which contains the
5, “Periodic Maintenance.” software version and copyright information), touch
the screen anywhere.
5. f. Plug in and turn on the CLINITEK 500 instrument.
Test the new printer by printing the instrument 3. The display will prompt “Touch the top left cor-
setup parameters (from the Ready/Run screen, ner” and an “X” will be displayed in one corner. Touch
touch Menu, then Print, then Setup report) or by the screen, directly on top of the “X”. Repeat when
performing several Reagent Strip tests. (If you had the prompt changes to “Touch the bottom right
turned the internal printer off prior to replacement corner.” When the touch screen has been recali-
of the module, be sure to turn it back on through brated, the display will automatically continue in the
the Setup Routine.) normal sequence of screens.
5. f. NOTE: If “Printer Error” is displayed when
attempting to print, check for a tight and proper
connection of the interface cable.
Revised 9/98 7.3

Section 8
TROUBLESHOOTING AND SERVICE

General Information will be in the way. To resolve this problem, turn the power
on and let the system initialize. An error will be displayed
Your CLINITEK® 500 Analyzer will give you troublefree because the fixed platform is not in place, but the mov-
operation if you follow the directions for using and cleaning table will be rotated into the correct position. Turn
ing the instrument. If an operational or instrument prob- the power off again, install the platform, then turn the
lem occurs, however, an error number may be displayed power on.
on the Analyzer screen, along with an explanation of the
problem. This section of the manual lists the various
errors and messages, along with probable causes and When to Call for Assistance:
recommended remedies to quickly and easily correct the • If the error message continues to be displayed after
problem. If the problem persists after following the rec- performing the steps described on the screen and in
ommended remedy, record the error number being dis- the Troubleshooting Chart;
played and contact your Bayer Customer Service office • If additional assistance is required concerning an instru-
for assistance. ment problem;
If the Bayer Reagent Strips seem to be causing the • If the problem is beyond the scope of this manual; or
problem, carefully read the direction insert that comes
with the Reagent Strips for information that might help • If the problem cannot be solved and an instrument fail-
solve the problem. ure is apparent:
If an error number is displayed that requires the instru- Our Customer Service Department is available to help
ment to be turned off, all samples that were in process you. Before calling, please complete the “Preservice
when the error occurred will need to be retested. The nor- Checklist” later in this section (you may want to make a
mal end-of-run reports will be displayed when the instru- photocopy of the checklist first). This information will
ment is turned back on for samples that had been help the Customer Service Representative to identify the
processed prior to the error. probable cause of the problem.
With some errors, the instrument will continue to run

while the error is displayed. Return to the READY/RUN Where to Call for Assistance:
screen by touching the key (when it is displayed) If you are located in the United States, contact the
before attempting to correct the error. If another error Customer Service Department of Bayer Corporation by
occurs while the previous error is being displayed, the calling toll free:
new error will be displayed in its place. 1-800-348-8100
NOTE: If the instrument is turned off from any screen The office is open from 8:00 AM to 8:00 PM Eastern
other than Ready/Run (and with the run completed), the time, Monday through Friday.
moving table may not be in its lowest position. If the fixed
platform is then removed, the moving table will be pulled If you are located in a country other than the United
out at the same time. You will then be unable to reinstall States, call the Bayer office nearest you:
the fixed platform because the pins of the moving table
Revised 9/98 8.1

TROUBLESHOOTING/SERVICE
AUSTRALIA FINLAND
Bayer Australia Ltd. Bayer Oy
Healthcare Division Diagnostics
875 Pacific Highway Suomalaistentie 7
Pymble NSW 2073 02270 Espoo
Telephone: 02 93916400 Telephone: 09-887 887
BELGIUM GREECE
Bayer—Diagnostics Division Bayer Hellas AG
Zaventemsesteenweg, 97 BG Diagnostics
B-1831 Diegem 54A, Akakion St.
Tel.: 02/725.18.80 151 25 Amaroussion
CANADA Athens
Bayer Inc. Tel.: 1-6883700
Healthcare Division HUNGARY
77 Belfield Road Bayer Hungaria Kft.
Toronto, Ontario M9W 1G6 Palya utca 4-6
Telephone: 416-248-0771 H-1012 Budapest
Telephone: 1-800-268-7200 Tel.: 01-212 1540
CENTRAL EASTERN EUROPE Fax: 01-212 1575
Bayer Diagnostics GmbH INDIA
–MOE– Bayer Diagnostics India Limited
Weissenseestrasse 101 589, Sayajipura
D-81539 Munich, Germany Ajwa Road
Tel.: 49-89-69927 191 Baroda 390 019
Fax: 49-89-69927 248 Gujarat
CZECH REPUBLIC Tel.: 265 462720
Bayer s.r.o. ITALY
Diagnostics Division Bayer S.p.A.
Litvinovska 609/3 Divisione Diagnostici
CZ-190 00 PRAHA 9-Prosek Via Grosio 10/4
Tel.: 02-66101-111 20151 Milano
Fax: 02-66101 199 Tel.: 02-3978.3956
DENMARK KOREA
Bayer A/S Bayer-Sankyo Co., Ltd.
Diagnostics c/o Hanil Pharmaceutical Ind.
Norgaardsvej 32 656-408 Sungsu 1 KA 2-Dong
DK-2800 Lyngby Sungdong-Ku
Telephone: 45 23 50 00 Seoul
EASTERN MEDITERRANEAN, MIDDLE EAST, AFRICA Tel.: 2 4609 600
Please contact your local distributor or:
Bayer
Export Division, E.M.M.E.A.
13, rue Jean Jaurès
92807 Puteaux Cedex
France
Tel.: 33.01.49 06 85 00
8.2 Revised 9/98

MALAYSIA RUSSIAN FEDERATION
Bayer Malaysia Sdn. Bhd. A/O Bayer
19th & 20th Floor Vertretung Moscowu
Wisma MPSA Bolshoi Trjechgornyi Pereulok, 1
Persiaran Perbandaran Geb. 20
40708 Shah Alam, Selangor 123 022 Moscow
Darul Ehsan Tel.: 095-234 2072
Tel.: 3-550-2852 Fax: 095-234 2070
NETHERLANDS SOUTHEAST ASIA
Bayer BV Bayer (Singapore) Pte, Ltd.
Diagnostics Division Regional Headquarters BG-DS
Energieweg 1/P.O. Box 80 9 Benoi Sector
3641 RT/3640 AB Singapore 629844
Mijdrecht Telephone: 65 261-3389
Telephone: 0297-280660 SWEDEN
NEW ZEALAND Bayer AB
Bayer New Zealand Ltd. Ao Diagnostika
Heath Care Division Box 5237
3 Argus Place 402 24 Göteborg
Glenfield Telephone: 031-839800
Auckland TAIWAN
Telephone: (9)4444133 ext. 311 Bayer-Sankyo Co. Ltd.
NORWAY 10F-1, NO 35
Bayer AS Fu-Hsing N. Road
Brennaveien 18 Taipei
1483 Skytta Telephone: 2-2741-2550
Telephone: 67068600 THAILAND
POLAND Bayer Thai Co. Ltd.
Bayer Sp.z.o.o. Diagnostics Business Group
Diagnostics Division Bayer House
ul. Stawki 2 130/1 North Sathorn Road
00-193 Warszawa Bangkok 10500
Tel.: 22-635 6818 Telephone: 2-232 70 00
Fax: 22-635 5987 U.K.
PORTUGAL Bayer Plc—Diagnostics Division
Bayer Portugal SA Bayer House
Rua Quinta do Pinheiro, 5 Strawberry Hill
Outurela Newbury RG14 1JA
2795 Carnaxide Telephone: 01635 566211
Tel.: (01) 416 43 11 Fax: 01635 566277
Revised 9/98 8.3

TROUBLESHOOTING CHART
SYMPTOM POSSIBLE CAUSE REMEDY
Display is blank. 1. No power. 1. Listen for the fan; if it is not running, turn the instru-
ment power off. Check that the power cord is firmly
plugged into the instrument and into a live AC elec-
trical outlet. Then turn the power back on.
2. Improperly inserted program card. 2. Turn the instrument power off, then remove the pro-
gram card and reinsert it firmly, making sure that
the label is facing forward, with the arrows pointing
in and up. When properly inserted, the edge of the
card will be flush with the instrument case. Turn the
power back on.
3. Defective program card or defective 3. Contact your Bayer Customer Service office.
3. system electronics.
Push bar does not 1. Other strips are being moved along the 1. Allow up to 7 seconds to elapse prior to movement
move to the right after 1. the platform. 1. of the push bar. The time lapse depends upon
a strip is placed onto 1. the timing cycle for movement of the strips
the platform. 1. across the platform.
2. Strip detector problem. 2. From the Ready/Run screen (and with the run com-
2. pleted), turn the instrument power off, wait several
seconds, then turn it back on. If the problem contin-
ues, contact your Bayer Customer Service office.
Push bar does not A very dark urine is being tested; the Presence of the strip will be verified at the first
move back to the left strip detector is unable to verify the readhead, requiring an additional 3 cycles
after moving a strip presence of the strip until it reaches (21 seconds). The push bar should then move back
(other than at the end the first readhead. to the left. Continue testing in the normal manner.
of a loadlisted run or
while waiting for
entry of an ID).
Push bar moves to 1. The strip detector was accidentally 1. The push bar will move back to the left after
the right when it 1. triggered by a hand, sleeve, or 1. 3 cycles (21 seconds); continue testing in the
shouldn’t (a strip 1. other foreign object. 1. normal manner. Be sure you do not place your
has not been placed 1. hand or other objects on the platform, as these
on the platform). 1. can be mistaken for a Reagent Strip.
2. Strip detector problem. 2. From the Ready/Run screen (with the run completed
and the strip loading station clear of all strips and
foreign objects), turn the instrument power off, wait
several seconds, then turn it back on to recalibrate
the strip detector. If the problem continues, contact
your Bayer Customer Service office.
8.4 Revised 9/98

SYMPTOM POSSIBLE CAUSE REMEDY
Test results are not 1. Internal printer is set to OFF. 1. Set the internal printer to ON through the Setup
being printed by the 1. Routine (see Section 3, Step A-4).
internal printer. 2. No paper installed in printer. 2. Install a new roll of paper as instructed in Section 5,
“Periodic Maintenance.”
3. Loose electrical connection to the 3. Carefully remove and reinstall the interface cable
3. printer. 3. to the printer (see Section 7, “Printer Replacement,”
Steps 4 and 5).
4. Defective printer. 4. Run the Printer test (see Section 3, Step J-2f).
Contact your Bayer Customer Service office if it
doesn’t print correctly.
Touch screen does 1. Screen needs to be recalibrated. 1. Recalibrate as instructed in Section 7, “Calibrating
not respond correctly. 1. the Touch Screen.”
2. Defective screen. 2. Contact your Bayer Customer Service office.
ERROR DISPLAY POSSIBLE CAUSE REMEDY
Error 01 Instrument optical error. Turn the instrument power off, wait
Error 02 several seconds, then turn it back on.
Error 03
Error 04
Error 05
Error 06-2 A Reagent Strip that had been detected Touch to cancel the run and return to the
at the first readhead was not detected Ready/Run screen, then turn off the instrument
at the second readhead. power. Remove the fixed platform to locate the strip
(see Section 5, “Daily Cleaning”). Check the pins on
the moving table to ensure that none are bent or
broken, then perform the “Daily Cleaning” procedure in
Section 5. Check your printout of results, or the Results
Error Report displayed at the end of the run, to deter-
mine the specimen(s) for which there are no results;
retest those specimens.
Error 07-1 A Reagent Strip either is not fully If the error is because of an upside-down strip, remove
wetted or is upside-down on the and clean the push bar, fixed platform, and holddown
platform. (see Section 5, “Daily Cleaning”). Then check your
printout of results, or the Results Error Report
displayed at the end of the run, to determine the
specimen(s) for which there are no results. Retest the
appropriate specimen, ensuring that the strip is dipped
completely into the specimen and is placed onto the
platform with the pads facing up.
Revised 9/98 8.5

Error 08-n A Reagent Strip has become Check your printout of results, or the Results Error
Error 09-n misaligned during processing. Report displayed at the end of the run, to determine the
specimen(s) for which there are no results. Retest
those specimens, ensuring that the end of the strip is
placed against the rear wall of the platform (with Error
08-1) and not touching the bottom of the strip loading
station. If the error repeats, remove and clean the mov-
ing table, fixed platform, push bar, and holddown (see
Section 5, “Daily Cleaning”). Check the moving table to
ensure that no pins are bent or broken, then reinstall
the parts.
Error 10-n Instrument optical error. Turn the instrument power off, then remove and clean
the fixed platform, taking care to carefully clean the
calibration bars (see Section 5, “Daily Cleaning”). Check
your printout of results, or the Results Error Report dis-
played at the end of the run, to determine the speci-
men(s) for which there are no results; retest those
specimens.
Error 21 Internal memory error. Turn the instrument power off, wait several seconds,
then turn it back on.
Error 23 1. Moving table is misaligned. Turn the instrument power off. Remove the push bar,
fixed platform, and moving table (you may have to pull
firmly to remove). Turn the power back on, allow the
system to reinitialize and the table mechanism to move
to its lowest position (another error will be displayed),
then turn off again. Reinstall the moving table (ensuring
it is pushed in completely), fixed platform, and push
bar, as directed in Section 5, “Daily Cleaning.” Turn the
power on again.
2. Instrument mechanical error. Contact your Bayer Customer Service office.
Error 24 1. Fixed platform or push bar is 1. Turn the instrument power off. Inspect the
Error 25 1. misaligned. 1. instrument for any obvious signs of misalignment
1. or incorrect installation of the push bar, fixed plat-
form, or holddown. Remove and reinstall, if needed,
as directed in Section 5, “Daily Cleaning.” Turn the
power back on.
2. Instrument mechanical error. 2. Contact your Bayer Customer Service office.
8.6 Revised 9/98

Error 26 Fixed platform is missing or not installed Install the table and platform, if missing (see Section 5,
properly. “Daily Cleaning”). If already installed, carefully push in
on the sides of the platform to make sure it is fully
engaged. If the error continues, remove and reinstall
the platform, as instructed in Section 5.
Error 27 Holddown is improperly installed or Touch if necessary to cancel the run. Remove the
missing, or is dirty. fixed platform as instructed in Section 5, “Daily
Cleaning.” Install the holddown if missing, or clean it if
it appears dirty. Reinstall the holddown, ensuring it is
properly installed, then replace the platform onto the
instrument. (If the holddown appears damaged or dis-
colored, replace with a new holddown.) Check your
printout of results, or the Results Error Report dis-
played at the end of the run, to determine the speci-
men(s) for which there are no results; retest those
specimens.
Error 28 A Reagent Strip that was detected as If a strip was never placed or was removed after
being placed on the platform was not being placed: Check your printout of results, or the
detected at the first readhead. Results Error Report displayed at the end of the run, to
determine if a result set is missing and, if so, retest the
specimen. Be sure you do not place your hand or other
objects on the strip loading station, as these can be
mistaken for a Reagent Strip. If the error occurs repeat-
edly, turn the instrument power off, wait several seconds,
then turn it back on to recalibrate the strip sensor.
If a strip was present: Remove and clean the moving
table, fixed platform, and holddown (see Section 5,
“Daily Cleaning”).
Error 29 Calibration bar error. Turn the instrument power off, then remove the fixed
platform (see Section 5, “Daily Cleaning”) and inspect
the calibration bars for damage or misalignment. Clean
the platform and calibration bars and reinstall the plat-
form. Turn the power back on.
Error 30 Instrument mechanical error. Contact your Bayer Customer Service office.
Error 31
Error 34
Revised 9/98 8.7

TROUBLESHOOTING AND SERVICE
Error 50 Printer Error Check that your external printer is turned on and is on-
line. Verify that both ends of the interface cable are
securely connected and check that your printer has
paper.
Error 51 Control results memory (51) or sample Nearly 200 control result sets or nearly 500 patient
Error 52 results memory (52) is almost full. result sets have been stored in memory without being
transferred to a computer. Check that your computer is
turned on, that the interface cable is securely connected
at both ends, and that the setup parameters for the
computer interface are correct. Transfer at least some
of the records. If unable to transfer records, contact
your Bayer Customer Service office.
Error 53 Control results memory (53) or Two hundred control result sets or 500 patient result
Error 54 sample results memory (54) is sets have been stored in memory without being
completely full. sent to a computer. No additional testing can occur
until at least some of the records are transmitted. Check
that your computer is turned on, that the interface cable
is securely connected at both ends, and that the setup
parameters for the computer interface are correct.
Error 55 System was unable to store Setup After clearing the error screen, print both setup
changes to the Program Card; configurations, if desired, to determine which you
default values have been stored want to use, then select that option. (The Analyzer
instead. Displayed when Analyzer memory will usually contain the latest Setup changes.)
is first turned on. If the error repeats the next time the instrument is
turned on, contact your Bayer Customer Service office.
Error 56 System error. Turn the instrument power off, wait several seconds,
then turn it back on. If the error repeats, contact your
Bayer Customer Service office.
8.8 Revised 9/98

CLINITEK® 500
Preservice Checklist
For reference, record the following information:
Model / Serial Number: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Installation Date: _______________
YES NO YES NO
01. Does the fan come on when the instrument 06. • Are the Bayer Reagent Strips within their
is turned on? expiration dating?
01. • If NO, is the instrument firmly plugged 06. • Is the bottle of Control Strips within its
into a live AC electrical outlet and into expiration dating and is the Control
the instrument? Solution within its use life (8 hours)?
02. Is the appropriate sequence of screens 06. • Is the instrument in the proper operating
displayed when the instrument is first environment and location? (See Section 2.)
turned on? (See Section 2 for a description 06.
of the screens.) 06. • Is the fixed platform clean? (See Section 5.)
02. • If NO, is the Program Card firmly in place 07. What is the software revision level being
and properly oriented? (See Section 2, used? (Turn the Analyzer off, wait about
“Instrument Setup,” Step 5.) 15 seconds, then turn it back on; the
software version is displayed after the
03. Is the touch screen operating properly? initialization screen.) ________
03. If NO: 08. Are any error messages or warnings being
03. • Have you performed the Touch Screen displayed?
Test? (See Section 3, Step J-3c.) 08. • If so, what are they? (List the error description
03. • Have you recalibrated the touch screen? and any numbers that are displayed.)
(See Section 7.) 08. ________________________________________________
04. Does the instrument proceed properly while 08. ________________________________________________
analyzing Reagent Strips? 09. Have you performed the appropriate steps
05. Is the printer functioning properly (i.e., suggested on the display for the error being
are the appropriate messages and displayed?
patient results being printed)? If an external device is being used:
05. If NO: 10. Is the printer and/or host computer/LIMS
05. • Is the internal or an external printer connected and turned on?
turned ON? (See Section 3, Step A-4.)
11. Have the correct parameters for transmission
05. • been selected (through the Setup menus)?
05. • Is there paper in the printer?
05. • Have you performed the printer test? 12. Is the external printer properly printing the
05. • (See Section 3, Step J-2f.) test results?
06. Are reasonable results being displayed/printed 13. Is the computer receiving the proper data
for the controls and patient samples? (e.g., do the results correspond with the screen
display)?
06. If NO:
06. • Does the name of the Bayer Reagent Strip
displayed on the Ready/Run screen agree
with the strip being used?
Revised 9/98 8.9

Section 9
ACCESSORIES & REPLACEMENT PARTS

Accessory Items Replacement Parts
Product Part
Number Description Number Description
1364 CHEK-STIX® Combo Pak Control * AC power cord
Strips for Urinalysis 99964708 CLINITEK® 500 Service Manual
1360 CHEK-STIX® Positive Control Strips 95002125 Fixed platform and holddown
for Urinalysis 50210070 Holddown plates (2)
6471 CLINITEK® 500 Handheld Bar Code 71520103 Loopback connector
Reader 50577530 Moving table
5773 Thermal Printer Paper (5 rolls) 40451012 Printer
50062319 Printer cover
Where to Order: 50540223 Push bar
In the United States, the above Accessory items are
available from your authorized CLINITEK® 500 distributor. Where to Order:
In the United States, the above Replacement Parts are
Outside of the United States, contact the nearest Bayer available directly from:
office (see Section 8, “Where to Call for Assistance”). Customer Service Order Entry Dept.
Bayer Corporation
P.O. Box 2004
Mishawaka, IN 46546-9979
Outside of the United States, contact the nearest Bayer
office (see Section 8, “Where to Call for Assistance”).
*Contact your Bayer office or representative for the part number

of the appropriate power cord for your location.
Revised 9/98 9.1

Appendix CPI
COMPUTER AND PRINTER INTERFACE

General Information Cable and Pin Specifications — Parallel
Port
The CLINITEK® 500 Urine Chemistry Analyzer can be
interfaced to a host computer or LIMS (Laboratory The printer (parallel data) port is of the “Centronics”
Information Management System) via the serial port on style of interface with a DB-25 connector and is provided
the instrument (labeled “ ”). It can also be interfaced for use with either of two types of printers:
to an 80-column or form printer through the parallel
(Centronics) port (labeled “ ”). This appendix contains 1. Any standard 80-column printer having a Centronics
the specifications for the interface cables needed to accom- style of interface — the External Printer option must
plish these interfaces. Additional information needed to be set to “ON, 80 Column” in the Setup Routine
write a program to interface the CLINITEK 500 Analyzer (Section 3, Step A-4a-iii). The interface cable that
with a computer can be obtained from your nearest Bayer is used to connect the 80-column printer to the
Customer Service Department or office. CLINITEK 500 instrument must contain a DB-25 male
connector (standard IBM configuration). Refer to
Cable and Pin Specifications — Serial Port Table CPI-2 for definitions of the pin assignments.
The cable normally used to interface with the CLINITEK 2. CLINITEK® Form Printer — a special format of data is
500 instrument is a Null modem cable. This cable cross- generated for this form printer when the External Printer
es pins 2 and 3, 4 and 5, and 6 and 20; pins 1 and 7 are option is set to “ON, Form” in the Setup Routine
straight through. Refer to Table CPI-1 for definitions of (Section 3, Step A-4a-iii). The Form Printer includes
the pin assignments and hardware handshaking. an interface cable to connect the printer to the
CLINITEK 500 instrument.
Revised 9/98 CPI.1

COMPUTER/PRINTER INTERFACE
Pin Assignments — Serial Port

Pin Signal Signal
Number Name Function Type Source
1 CHAS GND Protective Ground Ground N/A
2 TXD Transmit Data Data CLINITEK 500
3 RXD Receive Data Data Computer
4 RTS Request To Send Control CLINITEK 500
5 CTS Clear To Send Control Computer
6 DSR Data Set Ready Control Computer
7 SIG GND Signal Ground Ground N/A
20 DTR Data Terminal Ready Control CLINITEK 500
(All other pins are unused.)
Hardware Handshaking:
RXD Receive Data This input receives control characters for software handshaking and data for IDs.
TXD Transmit Data This output sends test data, control characters, and instrument information.
DTR Data Terminal Ready This signal is on whenever the instrument I/O is configured for a computer and the
instrument is on.
DSR Data Set Ready The computer must raise this line whenever it is ready to receive data. If not supplied
by the computer, pin 6 must be jumpered to pin 20.
RTS Request To Send This output line, when high, indicates to the computer that it may send data.
CTS Clear To Send This input is checked before sending each character and, if high, the next character
is sent. If not supplied by the computer, pin 5 must be jumpered to pin 20.
The following signal lines are NOT implemented:
DCD Data Carrier Detect Pin 8
RNG Ring Indicator Pin 22
Table CPI-1
CPI.2 Revised 9/98

Pin Assignments — DB-25 Male Connector
Pin Signal Signal
Number Name Function Note Source
1 STROBE-L Data Strobe 1 CLINITEK 500
2 Data 1 Parallel Data Line CLINITEK 500
11 BUSY Busy Line Printer
12 PRINTER OUT Printer Out Line Printer
18 SIG GND Signal Ground 2 N/A
NOTES:
1. STROBE-L (Data Strobe): “-L” indicates active low signal.
2. SIG GND (Signal Ground): Pins 19 through 25 are also connected to the signal ground.
Table CPI-2
Revised 9/98 CPI.3

Urine Chemistry Analyzer
Please record the following information.
Keep this sheet in the operating manual for future reference.
Date of Installation Model/Serial Number
MANUFACTURER’S WARRANTY
(U.S. Customers Only)
Bayer Corporation (“Bayer”) warrants to the original 3. Bayer reserves the right to make changes in design
purchaser that this instrument will be free from defects of this instrument without obligation to incorpo-
in materials and workmanship for a period of one year rate such changes into previously manufactured
from the later of the date of original purchase or instal- instruments.
lation (except as noted below). During the stated one-year
period, Bayer shall replace with a reconditioned unit or, at Disclaimer of Warranties
its option, repair at no charge a unit that is found to be THIS WARRANTY IS EXPRESSLY MADE IN LIEU OF
defective. ANY AND ALL OTHER WARRANTIES EXPRESS OR
This warranty is subject to the following exceptions IMPLIED (EITHER IN FACT OR BY OPERATION OF LAW)
and limitations: INCLUDING THE WARRANTIES OF MERCHANTABILITY
1. A 90-day warranty only will be extended for con- AND FITNESS FOR USE WHICH ARE EXPRESSLY
sumable parts and/or accessories. EXCLUDED, AND IS THE ONLY WARRANTY GIVEN BY
BAYER.
2. This warranty is limited to repair or replacement
due to defects in parts or workmanship. Parts
required which were not defective shall be replaced
Limitations of Liability
at additional cost, and Bayer shall not be required IN NO EVENT SHALL BAYER BE LIABLE FOR INDI-
to make any repairs or replace any parts which are RECT, SPECIAL OR CONSEQUENTIAL DAMAGES, EVEN IF
necessitated by abuse, accidents, alteration, mis- BAYER HAS BEEN ADVISED OF THE POSSIBILITY OF
use, neglect, maintenance by other than Bayer, or SUCH DAMAGES.
failure to operate the instrument in accordance with For warranty service, purchaser must contact the
instructions. Further, Bayer assumes no liability for Customer Service Department of Bayer Corporation by
malfunction or damage to Bayer instruments caused calling toll free 1-800-348-8100, for assistance and/or
by the use of reagents other than reagents manu- instructions for obtaining repair of this instrument.
factured or recommended by Bayer.
Revised 9/98

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Urine Chemistry Analyzer

50241553 ii Revised 9/98

3 SELECTING YOUR OPTIONS

Revised 9/98 iii

8 TROUBLESHOOTING AND SERVICE

9 ACCESSORIES & REPLACEMENT PARTS

Depending on the product being used, Bayer Reagent

Revised 9/98 1.1

1.2 Revised 9/98

‹+£ The photodiode pack contains four filters, one each at

Revised 9/98 1.3

Specifications Safety Standards:

*Testing protocol and allowable limits as specified by the safety

1.4 Revised 9/98

Revised 9/98 1.5

1.6 Revised 9/98

Revised 9/98 1.7

2. ‹!£ Fixed platform and holddown plate

Revised 9/98 2.1

3. If a Warranty Registration Card is found at the front

2.2 Revised 9/98

Revised 9/98 2.3

7. Hold the program card with the label facing forward

8. b. Obtain a new roll of paper; unroll several inches and

2.4 Revised 9/98

Revised 9/98 2.5

2.6 Revised 9/98

SELECTING YOUR OPTIONS

Revised 9/98 3.1

3.2 Revised 9/98

Setup Computer port-OFF

Revised 9/98 3.3

3.4 Revised 9/98

4. a. iii. NOTE: If the internal printer is OFF and the exter-

Revised 9/98 3.5

1. • Plus system: Results can be displayed and printed D. Setup Menu #3

Language: Result units: Plus system:

Time format: Time separator:

Touch the keys as needed to select the desired options.

3.6 Revised 9/98

Revised 9/98 3.7

2. Positive levels for tests: F. Setup Menu #5

2. b. When all tests on the first screen are correct, touch

3.8 Revised 9/98

Revised 9/98 3.9

3.10 Revised 9/98

*Not available in CCS format.

Revised 9/98 3.11

3.12 Revised 9/98

3. Password for setup:

Revised 9/98 3.13

3.14 Revised 9/98

Revised 9/98 4.1

4.2 Revised 9/98

Revised 9/98 4.3

4.4 Revised 9/98

Revised 9/98 4.5

4.6 Revised 9/98

Revised 9/98 4.7

4.8 Revised 9/98