Bayer - Clinitek 50 - User Manual
Bayer - Clinitek 50 - User Manual
Bayer Corporation
Elkhart, IN 46514 USA
A Brief Description . . . . . . . . . . . . . . . . . . . . iv
1 Unpacking and Setup . . . . . . . . . . . . . . . . . . . 1
Unpacking . . . . . . . . . . . . . . . . . . . . . . 1
Installing the battery pack . . . . . . . . . . . . . 4
Loading the paper roll . . . . . . . . . . . . . . . 5
Powering up . . . . . . . . . . . . . . . . . . . . . 6
Final paper work . . . . . . . . . . . . . . . . . . 7
2 Selecting your Options . . . . . . . . . . . . . . . . . . 8
Location of results and number of copies . . . . 8
Listing the tests . . . . . . . . . . . . . . . . . . . 8
C HA PTE R
iii
A Brief Description
What does this instrument do? after the key is pressed to blot
Your CLINITEK® 50 Urine the edge of the wet reagent test
Chemistry Analyser is a portable strip (if required for the test) and
instrument for reading Bayer place it on the test strip table. The
Reagent Strips for Urinalysis. No table is then pulled into the instru-
special training is needed to use ment, where the test strip is read.
the instrument. Several different The instrument measures the
Bayer Reagent Strip products colour and amount of light that is
(e.g., MULTISTIX® 10 SG) can be reflected from the test pads on the
used with the Analyser; refer to strip. It then converts these mea-
the bottle label for the tests that surements into meaningful results.
are included with each product.
How do I get results?
The Analyser can also report the
Results can be either printed or
colour of the urine sample. The
displayed. The results can also be
CLINITEK® line of tests from
transferred to a computer using a
Bayer can also be read.
special cable that is plugged into
The Analyser can be plugged
the computer port on the back of
into an electrical outlet for use on
the instrument.
the benchtop, or it can be
powered by batteries and freely What about this User’s Guide?
moved from one testing site to The User’s Guide contains the
another. The battery pack, which directions you need to unpack the
is purchased separately, fits into instrument, use it for your daily
an opening on the bottom side of urine testing, and keep it in good
the instrument. working condition. The User’s
Guide is provided in several
Do I have to calibrate?
languages; please recycle the
You do not have to do anything
Guides you will not be using.
extra to calibrate. The instrument
performs a “self-test” and calibra- As you read through the User’s
tion each time it is turned on. Guide,
✏ you will find these symbols:
Then, each time a test is run, the
NOTES contain useful tips
instrument calibrates again, using
on using your instrument. They
the white plastic bar located on the
appear in italicized type.
end of the test strip table.
How does it work? CAUTIONS should be
Testing starts when either of the followed carefully to ensure your
two Start keys (labeled “ ”) is instrument operates correctly and
pressed. You have 10 seconds is not damaged. Cautions appear
in bold type like this.
iv
Unpacking and Setup 1
Unpacking
1 Carefully remove the 2 Remove each of the
contents of the shipping carton. wrappings and check for the
Check the carton and instrument following items:
for visible signs of damage; if
seen, immediately contact the
carrier.
1 4
2 5
1
3 Place the instrument on a
level work surface where the
The best temperature
for using the instrument is
temperature and humidity are between 22°C and 26°C (72°F
fairly constant. to 79°F). Do not place the
instrument near such things
as an outside window, oven,
hot plate, or radiator.
2
6 Insert the test strip table into
the instrument, holding it by the
end opposite the white bar and
with the flat side facing up. Do
not touch the white bar. Push
the table in about halfway.
3
Installing the
Battery Pack
4
Loading the Paper Roll
5
4 Feed the paper through the
printer cover opening and snap
To prevent damage
to the printer, do not tear
the cover into position. the paper without the cover
✏ in place.
The cover must be latched
in order for the instrument to
function.
Powering Up
1 Press the power switch on
the back of the instrument to
the “––” (ON) position.
6
3 Press the key under the word
NORMAL if you want the results
to appear in clinical units. Press
the key under +/– if you prefer
plus
✏and minus signs.
The screens shown in
Steps 2 and 3 appear the first
three times the instrument is
turned on or three times after a
change is made to either screen.
7
2 Selecting Your Options
✏
Location of Results One copy of each set of
and Number of Copies results will be printed if you do
not change this option.
✏
Listing the Tests You can print or display a
list of the Bayer Reagent Strips
1 Press the key under the word and CLINITEK ® Tests that can be
LIST. read by your instrument through
this option. If the CLINITEK Test
2 If you selected PRINTER as you want to use is not listed, you
your output, the list is printed. If must update the software in your
DISPLAY was selected, press the Analyser before using the prod-
key to display each test name, uct. See page 25 to order the
then press EXIT. Software Update Kit.
8
Setting the Time Setting the Date
1 Press the key under the 1 Press the key under the
word SET. word SET.
2 Press the key under TIME 2 Press the key under DATE
and select the 12 hour (AM/PM) and select a date format:
format or the 24 hour (military) MDY Month-Day-Year
format. DMY Day-Month-Year
YMD Year-Month-Day
3 Press the key to adjust
the hour. 3 Press the key to adjust
✏ the first number.
If you press and hold
the key, the numbers will
4 Press the ➞ key, then press
advance more quickly.
to adjust the second number.
9
✏
Reporting the Urine Colour will be reported
Colour automatically when using Bayer
Reagent Strips that include the
1 Press the key under the leucocyte test pad if this option
word SET. is set to YES. If there is no
leucocyte pad, lines for manual
2 Press MORE, then press entry of the colour and clarity
COLOR. Press the YES or NO are printed.
key to make your selection. ✏
Colour results reported
3 Press EXIT as needed. by the instrument may be
different from the colour seen
visually. This is because of the
inherent differences between
the human eye and the optical
system of the instrument.
✏
Setting the Sequence The sequence number
Number will not be displayed or printed
unless you change this option.
1 If you want to have the
sequence number appear, press
the key under the word SET.
10
✏
Clearing the Memory You can connect the
and Marking Positives instrument to a computer to
transfer results. Fifty sets of
1 If you want to clear the results are stored (for transfer
instrument’s memory of all test only) if the memory is not
results, or to turn off the cleared.
asterisk, press the key under
the word SET.
11
3 Testing Controls
Positive and negative control You should test controls:
solutions should be tested on a ▲ at the start of the day;
regular basis. This provides a ▲ when you open a new bottle
check to ensure that the test of test strips;
strips are reacting properly and
the instrument is reading the ▲ whenever test results are
strips properly. Testing controls in doubt;
also helps detect errors caused ▲ when training instrument
by incorrect user technique. operators.
✏
CHEK-STIX® Positive and If the test you are running is
Negative Control Strips are not included in the CHEK-STIX
available for use in your quality insert, you will need to purchase
control program for routine urine a different control product that
testing (see page 25 for product includes values for that test.
numbers). Prepare the control For information about control
solutions as instructed in the manufacturers, contact your
package insert that comes with local Bayer office (see page 24).
the control product. Then test the
control solution using the same
procedure as you use when test- ✏
ing patient urines. Expected values are found
in the package insert that comes
Record the control results. If with the control product.
any results are not within the
expected range, notify the lab
supervisor or physician. Refer to
the bottle label and/or package
insert for storage information
and expiration date.
12
Testing Specimens 4
Testing Routine Urines
✏
Before beginning the day’s Testing can be started only
testing, check the test strip from the READY FOR TEST
table to make sure it is clean. screen. Be sure the Reagent
If it looks dirty, remove the Strip name agrees with the strip
table and clean it, as described being used.
on page 17. ✏
The urine specimen should Replace the cap as soon
be fresh, well-mixed, and as you remove each strip from
uncentrifuged. If the urine depth the bottle.
is less than about 7.6 cm
(3 inches), pour the specimen
into a narrow tube, such as a
URIN-TEK® Specimen Tube.
13
3 Blot the strip to remove
excess urine by touching the
edge to a paper towel. Do not
drag the strip across the towel;
touch the edge only.
14
6 Remove the used Reagent Summary of Steps:
Strip and discard it in the 1 Dip a new Reagent Strip
proper container, according into the urine sample.
to your standard laboratory
2 Press as the strip is
procedures.
✏ removed from the urine; at the
same time, drag the strip edge
Wipe the test strip table
against the side of the container.
with a damp, lint-free tissue.
Do this as often as needed to 3 Blot by touching the edge
prevent urine from building up. of the strip to a paper towel.
Also, wipe the table after testing 4 Place it on the test strip
a urine that is visibly bloody or table within 10 seconds.
that gives a very high result on 5 Discard the strip when the
any test pad. test is finished.
Testing with
CLINITEK® Tests
Refer to the insert included with
the CLINITEK® product you are
using for directions on using the
test with the CLINITEK® 50
Analyser.
Getting Results
Operating Notes
The instrument does not Ifyou never erase the memory
detect when the internal printer or reset the sequence number,
is out of paper. However, a pink the number will continue to
edge will appear on the last increase until 999 is reached.
several feet of paper. Change The next number will then be 001.
the roll shortly after you see this.
16
Cleaning the Instrument 5
Daily Cleaning
The test strip table must be
kept clean if the instrument is
to provide accurate test results
and operate correctly. Clean
the table and check the white
bar at the end of every day.
1 Remove the test strip table
by pulling it straight out of the
instrument.
2 Wet a cotton-tipped stick
with distilled water. Thoroughly
scrub the trough and surround-
ing areas. Do not touch the
white bar. Rinse the entire table
(both top and bottom) with
distilled water. Discard the stick
according to your standard labo-
ratory procedures.
3 Dry the table thoroughly
(except for the white bar) with
a soft cloth or lint-free tissue.
4 Check the white bar for Do not use anything
dust, marks, or scratches. If it that will scratch the white
is dirty, wet a new cotton-tipped bar. Do not use solvents of
stick and gently wipe the bar. any kind to clean the bar.
Allow the white bar to air dry
and check it again. If it is
scratched or scuffed, or if it
cannot be cleaned, replace
the table (see page 26).
5 If you want to disinfect the
table, do that now. Or insert the
table into the instrument,
pushing it in about halfway.
17
Disinfecting the Table
18
3 Fill a tall, narrow container
to a depth of about 10 cm
(4 inches) with the solution
you have prepared.
Removing Heavy
Buildup
If the table is cleaned each day,
heavy buildup should not occur.
However, if the urine has dried
on the table for many days,
you may need to use a stronger
solution to clean the table
completely.
19
3 Wet a cotton-tipped stick Do not touch the white
with the NaOH. Thoroughly bar with the NaOH!
clean the trough and side areas
of the table until all urine is
removed.
General Cleaning
Always keep the outside of the Do not use any type of
CLINITEK® 50 instrument clean solvent, oil, grease, silicone
and free of dust. You can wipe spray, or lubrication on the
the outside with a damp (not instrument.
wet) cloth and a mild detergent.
Wipe the display screen with The keypad and display may
a soft, nonabrasive cloth that be disinfected using the same
has been dampened with a mild solutions as for the test strip
glass cleaner. Do not spray the table (see page 18). Wipe the
glass cleaner directly onto the solution on and allow to remain
screen. Do not use laboratory for 10 minutes. Rinse using a
wipes, such as Kimwipes®, since clean cloth dampened with
they may scratch the screen. water, then dry.
20
Appendix
21
Error Message Possible Cause
and Remedy
READ ING PROBLEM - RETEST The test strip is either upside down or
HELP CONT was not fully dipped. Discard the test
strip, press CONT, and retest with a
new test strip.
22
If you need additional help, our Customer Service Department is here to assist you.
Before you call, please fill out this checklist (you may want to make a photocopy of the
page first). Then call the nearest Bayer office using the list on the next page.
Serial Number __ __ __ __ __ __ __ __ __ __ __
——————————————————————————————————
11. Please record any error messages that have been displayed:
——————————————————————————————————
——————————————————————————————————
23
Where to Call
for Service
Canada
Bayer Inc. Healthcare Division
77 Belfield Road
Toronto, Ontario M9W 1G6
Telephone: 416-248-0771
U.K.
Bayer Plc, Bayer Diagnostics
Bayer House
Strawberry Hill
Newbury RG14 1JA
Telephone: 01635 566211
Australia
Bayer Australia Ltd.
Healthcare Division
875 Pacific Highway
Pymble NSW 2073
Telephone: 61 2 391-6400
Telephone: 1-800-028-251
24
Ordering Accessories
Product
No. Description
Where to Order:
You can order these accessory
items through your nearest
Bayer office. The address and
phone number are found on
page 24.
25
Ordering Replacement Parts
Part
No. Description
Where to Order:
You can order these replace-
ment parts through your nearest
Bayer office. The address and
phone number are found on
page 24.
26
Specifications
Manufactured by
Authorized Representative
27
Abbre- Printed/Displayed Results
Test Units
viation Normal System + / – System
YELLOW GREEN
Colour* ORANGE BLUE No Difference
RED BROWN
NEGATIVE 40 NEGATIVE 2+
Ketone KET mg/dL TRACE > = 80 TRACE 3+
15 1+
0.2 4.0
Urobilinogen URO E.U./dL 1.0 > = 8.0 No Difference
2.0
Table 1
ENGLISH — CONV.
Units — Conventional
28
Abbre- Printed/Displayed Results
Test Units
viation Normal System + / – System
YELLOW GREEN
Colour* ORANGE BLUE No Difference
RED BROWN
NEGATIVE 28 NEGATIVE 2+
Glucose GLU mmol/L 5.5 > = 55 TRACE 3+
14 1+
NEGATIVE Ca 25 NEGATIVE 1+
Occult
BLD Ery/µL TRACE-LYSED Ca 80 TRACE-LYSED 2+
Blood
TRACE-INTACT Ca 200 TRACE-INTACT 3+
3.2 66
Urobilinogen UBG µmol/L 16 > = 131 No Difference
33
Table 2
ENGLISH — S.I.
Units — International (S.I.)
29
Abbre- Printed/Displayed Results
Test Units
viation Normal System + / – System
YELLOW GREEN
Colour* ORANGE BLUE No Difference
RED BROWN
NEGATIVE 3+ NEGATIVE 2+
Glucose GLU 1+ 4+ TRACE 3+
2+ 1+
NEGATIVE 2+
Bilirubin BIL No Difference
1+ 3+
NEGATIVE 3+ NEGATIVE 2+
Ketone KET 1+ 4+ TRACE 3+
2+ 1+
NEGATIVE 1+
Occult
BLD +/– 2+ No Difference
Blood
+ / – INTACT 3+
NEGATIVE 2+ NEGATIVE 2+
Protein PRO +/– 3+ TRACE 3+
1+ 1+
3.2 66
Urobilinogen URO µmol/L 16 > = 131 No Difference
33
NEGATIVE 3+ NEGATIVE 2+
Leucocytes LEU 1+ 4+ TRACE 3+
2+ 1+
*Colour may be preceded with “LT.” or “DK.” Shaded areas = abnormal results
Table 3
ENGLISH — NORDIC
Units — Nordic Plus System
30
Be kind to the environment.
Please recycle the User’s
Guides you do not use.