Bayer Clinitek 50 User manual

USER’S GUIDE
1996 Bayer Corporation
All Rights Reserved
Printed in the U.S.A.
Unless otherwise noted, all
trademarks are the property
of Bayer Corporation.
Revised 3/02 99915549
Contents
iii
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 . . . . . . . . . . . . . . . . . . 8
2 Selecting your Options . . . . . . . . . . . . . . . . . . 9
Location of results and number of copies . . . . 9
Setting the time . . . . . . . . . . . . . . . . . . .10
Setting the date . . . . . . . . . . . . . . . . . . . 10
Reporting the urine color . . . . . . . . . . . . . 11
Setting the sequence number . . . . . . . . . . .11
Clearing the memory and marking positives . .12
Printing the instr ument setup . . . . . . . . . . .12
3 Testing Controls . . . . . . . . . . . . . . . . . . . . . . 13
4 Testing Routine Urines . . . . . . . . . . . . . . . . . . 14
Procedure . . . . . . . . . . . . . . . . . . . . . .14
Summary of steps . . . . . . . . . . . . . . .16
Getting results . . . . . . . . . . . . . . . . . . . 16
If results are printed . . . . . . . . . . . . . . 16
If results are displayed . . . . . . . . . . . . . 16
When you are finished testing . . . . . . . . . . 17
Operating notes . . . . . . . . . . . . . . . . . . 17
5 Cleaning the Instrument . . . . . . . . . . . . . . . . . 18
Daily cleaning . . . . . . . . . . . . . . . . . . . . 18
Disinfecting the table . . . . . . . . . . . . . . . . 19
Removing heavy buildup . . . . . . . . . . . . . 20
General cleaning . . . . . . . . . . . . . . . . . .21
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . .22
Solving problems . . . . . . . . . . . . . . . . . .22
If the display is blank . . . . . . . . . . . . . . 22
Error messages and remedies . . . . . . . . 23
Problem checklist . . . . . . . . . . . . . . . .24
Where to call for ser vice . . . . . . . . . . . . 25
Ordering accessories . . . . . . . . . . . . . . . 26
Ordering replacement par ts . . . . . . . . . . . . 27
Specifications . . . . . . . . . . . . . . . . . . . . 28
Tables of results . . . . . . . . . . . . . . . . . .29
CHAPTER
iv
A Brief Description
What does this instrument do?
Your CLINITEK®50 Urine Chemistry Analyzer is a portable instrument for reading traditional Bayer Reagent Strips for Urinalysis (e.g., MULTISTIX®10 SG), Bayer MULTISTIX PRO®Reagent Strips, and CLINITEK®Microalbumin Reagent Strips. Refer to the bottle label or carton for the tests that are included with each product. The Analyzer can also report the color of the urine sample. No spe­cial training is needed to use the instrument.
The Analyzer can be plugged into an electrical outlet for use on the benchtop, or it can be powered by batteries and freely moved from one testing site to another.The battery pack, which is purchased separately, fits into an opening on the bottom side of the instrument.
Do I have to calibrate?
You do not have to do anything extra to calibrate .The instrument performs a “self-test”and calibra­tion each time it is turned on. Then, each time a test is run, the instrument calibrates again, using the white plastic bar located on the end of the test strip table.
How does it work?
Testing starts when either of the two Start keys (labeled “ ”) is pressed.You have 10 seconds after the key is pressed to blot
the edge of the wet reagent test strip (if required for the test) and place it on the test strip table.The table is then pulled into the instru­ment, where the test strip is read. The instrument measures the color and amount of light that is reflected from the test pads on the strip.It then converts these mea­surements into meaningful results.
How do I get results?
Results can be either printed or displayed.The results can also be transferred to a computer using a special cable that is plugged into the computer port on the back of the instrument.
What about this User’s Guide?
The User’s Guide contains the directions you need to unpack the instrument, use it for your daily urine testing, and keep it in good working condition.The User’s Guide is provided in several languages; please recycle the Guides you will not be using.
As you read through the User’ s Guide, you will find these symbols:
NOTES contain useful tips
on using your instrument. They
appear in italicized type.
CAUTIONS should be followed carefully to ensure your instrument operates correctly and is not damaged.Cautions appear
in bold type like this.
1 Carefully remove the
contents of the shipping carton. Check the carton and instrument for visible signs of damage;if seen, immediately contact the carrier.
2 Remove each of the
wrappings and check for the following items:
1
Unpacking
1 CLINITEK
®
50 Analyzer
2
Test strip table
(Do not touch the white bar!)
If you will be using a Reagent Strip that has four or fewer test pads, you must use a short test strip table, which must be ordered separately (see page
27).(CLINITEK
®
Microalbumin Strips
are run using the long table.)
3 Printer cover 4 Power transformer
5 Power cord
If the power cord is not the style you need, contact your Bayer office (see page 25).
6 Paper roll
Depending on the model you have received, there may also be a Warranty Registration Card, Customer Information Card, Unpacking/Setup Guide, and/or Quick Reference Guide included.
1
2
6
4
5
3
Unpacking and Setup
1
3 Place the instrument on a
level work surface where the temperature and humidity are fairly constant.
4 Locate the following:
1 Display 2 (START) Keys
Either green key can be pressed to start a test.
3 Option Keys
Each dark gray key corresponds to one of four words that may be shown on the bottom line of the display;press the key beneath the word to select that choice.
If you will be using the optional battery pack instead of the power cord and transf ormer, skip Step 5.
5 Plug the power cord into
the transformer, then plug the transformer cord into the instrument. Plug the power cord into an appropriate grounded AC electrical wall outlet.
2
The best temperature for using the instrument is between 22°C and 26°C (72°F to 79°F). Do not place the instrument near such things as an outside window,oven, hot plate, or radiator.
1
2
3
3
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.
7 If you will be sending results
to a computer, you must obtain a special Computer Cable/ Connector Kit (see page 26 to order).The kit includes all the information you need to connect and use the cable.
4
2 Turn the instrument over
and snap the battery pack into the opening.
3 Plug the cord into the
power inlet.
1 If you will be using the
optional battery pack, place six AA-size batteries into the battery compartment.
Installing the Battery Pack
5
If changing the paper, leave the cover down and pull out the remaining paper.Then raise the cover and remove the empty core to continue.
3 Pulling toward the back,
gently pull the end of the paper until the full width of the paper is completely exposed.
1 Insert the two tabs on the
printer cover into the two openings on the instrument. Rest the cover on its back edge.
2 Trim the end of the paper so
it has a large “V”shape at least 2 inches (5 cm) long.With the paper unrolling from underneath, insert the paper under the printer roller until the tip comes through the other side of the roller.
Loading the Paper Roll
Do not pull the paper straight up or toward the front, as this will damage the printer.
The cover must be latched in order for the instrument to function.
1 Press the power switch on
the back of the instrument to the “––” (ON) position.
2 If you want to use the
language and units shown on the screen, press the key under the word YES. If you want another language and/or units, press the key under the word NO.
6
4 Feed the paper through the
printer cover opening and snap the cover into position.
To prevent damage to the printer,do not tear the paper without the cover in place.
Powering Up
Refer to pages 29 to 34 for the test abbreviations and results that are used with each of the three options for English. For tests not shown in these tables, refer to the insert included with the product.
7
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.
4 If you want to use the Bayer
Reagent Strip shown on the screen, press the key under the word YES. If you want to use a different strip, press the key under the word NO.
The MULTISTIX PRO
®
and CLINITEK Microalbumin Strips are not included in this list.
5 Your selections will be printed.
If they are correct, press the key under YES. If they are not correct, press NO and repeat Steps 2 to 4.
The screens shown in
Steps 2, 3, and 4 appear only the first time the instrument is turned on.
1 Find the bar-coded serial
number label on the bottom of the instrument.Write this number and today’s date on the Problem Checklist on page 24.
2 Fill out and mail the Warranty
Registration Card and Customer Information Card if these are included with your instrument.
Final Paper Work
8
6 The instrument briefly
displays two screens while it does an internal check.When the check is complete, the READY screen appears. Look for the names of the products that can be used — they are shown after the words “READY FOR TEST.”
MULTISTIX PRO and CLINITEK Microalbumin Reagent Strips are automatically identified by the instrument; if your software cannot identify a test, the test is rejected and the display will show “STRIP PROBLEM – RETEST.”
Do not use any traditional Bayer Reagent Strip product other than what is shown on the display. Using the wrong Reagent Strip will give you incorrect results.
9
1 If you want more than one
printed copy or if you prefer results to be displayed on the screen, press the key under the word OUTPUT.
3 If you pressed PRINTER,
you can choose to have more than one copy of the results. Press the key under your choice.
Location of Results and Number of Copies
One copy of each set of
results will be printed if you do not change this option.
2 Press the key under your
choice.
Selecting Your Options
2
10
1 Press the key under the
word SET.
2 Press the key under DA TE
and select a date format:
MDY Month-Day-Year DMY Day-Month-Year YMD Year-Month-Day
3 Press the key to adjust
the first number.
4 Press the key, then press
to adjust the second number.
5 Press the key, then press
to adjust the third number.
6 Press EXIT.
4 Press the key, then press
to adjust the minutes.
5 Press EXIT.
If you press and hold the key, the numbers will advance more quickly.
Setting the Date
1 Press the key under the
word SET.
2 Press the key under TIME
and select the 12 hour (AM/PM) format or the 24 hour (military) format.
3 Press the key to adjust
the hour.
Setting the Time
11
1 Press the key under the
word SET.
2 Press MORE, then press
COLOR. Press the YES or NO
key to make your selection.
3 Press EXIT as needed.
Reporting the Urine
Color
Setting the Sequence Number
Color will be reported automatically when using Bayer Reagent Strips that include the leukocyte test pad if this option is set to YES. If there is no leukocyte pad, lines for manual entry of the color and clarity are printed.
The sequence number will not be displayed or printed unless you change this option.
If you are already using sequence numbers and the number is greater than 001, you will first be given the option of setting it to 001.
Color results reported by the instrument may be different from the color seen visually.This is because of the inherent differences between the human eye and the optical system of the instrument.
1 If you want to have the
sequence number appear, press the key under the word SET.
2 Press MORE, then press
SEQ#.
3 Press YES to use sequence
numbers (or press NO if you don’t want them displayed).
4 Press EXIT as needed.
12
Clearing the Memory and Marking Positives
You can connect the instrument to a computer to transfer results.Fifty sets of results are stored (for transfer only) if the memory is not cleared.
Check whether your software program can accept the asterisk that marks positive results.Press NO if it cannot.
1 If you want to clear the
instrument’s memory of all test results, or to turn off the asterisk, press the key under the word SET.
2 Press MORE, then press
CMPTR.
3 Press YES to clear the
memory and reset the sequence number to 001.
4 Then select whether
positives will be marked with an asterisk (
*
).
5 Press EXIT as needed.
Printing the Instrument Setup
If you want to print a list of your instrument’s setup selections, press the key under the word
LIST.
13
Positive and negative control solutions should be tested on a regular basis.This provides a check to ensure that the test strips are reacting properly and the instrument is reading the strips properly.Testing controls also helps detect errors caused by incorrect user technique.
CHEK-STIX
®
Positive and Negative Control Strips are available for use in your quality control program for routine urine testing (see page 26 for product numbers).Prepare the control solutions as instructed in the package insert that comes with the control product.Then test the control solution using the same procedure as you use when testing patient urines.
Record the control results.If 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.
Expected values are found in the package insert that comes with the control product.
If using a MULTISTIX PRO
®
or CLINITEK®Microalbumin Reagent Strip, quality control should be performed using commercially-availab le controls that include values for each test on the strip; CHEK-STIX Control Strips are not suitable for use with these products.For informa­tion about control manufacturers, contact your local Bayer office or representative.In the United States, call the Bay er Technical Care Center at 1-877-229-3711.
You should test controls:
at the start of the day;when you open a new bottle
of test strips;
whenever test results are
in doubt;
when training instrument
operators.
Te s ting Controls
3
14
Procedure
Testing can be started only from the READY FOR TEST screen. Be sure the Reagent Strip name agrees with the strip being used, unless using MULTISTIX PRO
®
or CLINITEK
®
Microalbumin Reagent Strips, which are automatically identified after testing begins.
Before beginning the day’s testing, check the test strip table to make sure it is clean. If it looks dirty, remove the table and clean it, as described on page 18.
The urine specimen should be fresh, well-mixed, and uncentrifuged. If the urine depth is less than about 3 inches (7.6 cm), pour the specimen into a narrow tube, such as a URIN-TEK
®
Specimen Tube.
1
Dip a Bayer Reagent Strip into the urine. Be sure all the test pads are wet.
2
Immediately remove the Reagent Strip from the urine, dragging the edge of the strip against the side of the container as you remove the strip. At the same time, press either green
(START) key.You now have 10 seconds to complete Steps 3 and 4.
Replace the cap as soon as you remove each strip from the bottle.
Refer to the direction insert included with your Reagent Strips for complete information on using the strips.
4
Te s ting Routine Urines
15
You must place the test strip while the message PLACE STRIP ON TABLE is on the screen. It will appear for 10 seconds.
5 The table is automatically
pulled into the instrument for reading. Results are available in one minute.Be sure not to move or bump the table.
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.
4 Place the Reagent Strip,
with the test pads facing up,
into the middle trough of the test strip table.Slide the strip along the table until it touches the end of the trough.
16
If results are printed:
The test results are automatically printed. Press the PRINT key to reprint the last set of test results. Press PAPER, if desired, to add blank lines after the results.
If results are displayed:
To view results, press the key repeatedly. When all results have been displayed and recorded, press EXIT. To display the results again, press DISPL.
Getting Results
Wipe the test strip table with a damp, lint-free tissue. Do this as often as needed to prevent urine from building up. Also, wipe the table after testing a urine that is visibly bloody or that gives a very high result on any test pad.
Thermal print will fade with time. Also, do not cover thermally printed results with transparent tape.
6 Remove the used Reagent
Strip and discard it in the proper container.
Summary of Steps:
1 Dip a new Reagent Strip
into the urine sample.
2 Press as the strip is
removed from the urine;at the same time, drag the strip edge against the side of the container.
3 Blot by touching the edge
of the strip to a paper towel.
4 Place it on the test strip
table within 10 seconds.
5 Discard the strip when the
test is finished.
17
1 Clean the test strip table and
check the white bar at the end of each day or after testing 50 strips, whichever is more often. Follow the directions for “Daily Cleaning,” given on page 18.
2 Be sure the test table is empty.
Then gently push the table about halfway into the instrument.
3 The instrument can be left
on when it is not being used. However, if you are using the battery pack, turn the instrument off to save battery power.
When You Are Finished Testing
You will be prompted to clean the table after every 50 strips. Press CONT to return to the READY FOR TEST screen.
The instrument does not detect when the internal printer is out of paper.However, a pink edge will appear on the last several feet of paper. Change the roll shortly after you see this.
Operating Notes
If you never erase the memory or reset the sequence number, the number will continue to increase until 999 is reached. The next number will then be 001.
If the battery pack is installed, a unique tone will sound after 15 minutes of nonuse to remind you to turn the instrument off.It will repeat in 5 minutes, then again every minute.
18
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 surround­ing areas.Do not touch the white bar.Rinse the entire table (both top and bottom) with distilled water.
3 Dry the table thoroughly
(except for the white bar) with a soft cloth or lint-free tissue.
4 Check the white bar for
dust, marks, or scratches.If it is dirty, wet a new cotton-tipped stick and gently wipe 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 27).
5 If you want to disinfect the
table, do that now. Or insert the table into the instrument, pushing it in about halfway.
Daily Cleaning
Do not use anything that will scratch the white bar.Do not use solvents of any kind to clean the bar.
5
Cleaning the Instrument
19
Disinfecting the Table
1 Remove, clean, and dry
the table.
2 Several solutions are safe
to use on the table when they are used for no longer than 10 minutes once a day. Prepare one of the following solutions:
Use of any other solution
may damage the table.
Cidex
®
*
, Theracide
®
*
, and
Amphyl
®
*
— these products (or their equivalent) can be purchased for use in general disinfection.Prepare and use the solution according to the directions that come with the product.
Household Bleach (5% sodium hypochlorite) — can be used either full strength or diluted to as much as a 1:20 dilution.To make a 1:20 dilution, add 5 mL of bleach to a container and add 95 mL of water, for a total volume of 100 mL. (To make a 1:10 dilution, combine 10 mL of bleach and 90 mL of water.)
Isopropyl Alcohol (70% to 85%) — can be used full strength.
*
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.
20
3 Fill a tall, narrow container
to a depth of about 4 inches (10 cm) with the solution you have prepared.
4 Place the table into the
solution, making sure the white bar remains above the liquid le v el.
5 Soak the table for no longer
than 10 minutes, then rinse it thoroughly with water.
6 Dry the table with a soft cloth
or tissue and insert it into the instrument.
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.
1 Obtain a small volume of
0.1N sodium hydroxide (NaOH).
2 Remove the table from the
instrument and clean it.
Removing Heavy Buildup
Be sure the solution does not come in contact with the white bar! Do not cover the container while the table is soaking.
21
Do not touch the white
bar with the NaOH!
General Cleaning
Always keep the outside of the CLINITEK
®
50 instrument clean and free of dust.You can wipe the outside with a damp (not wet) cloth and a mild detergent.
Wipe the display screen with a soft, nonabrasive cloth that has been dampened with a mild glass cleaner.Do not spray the glass cleaner directly onto the screen. Do not use laboratory wipes, such as Kimwipes
®
, since
they may scratch the screen.
The keypad and display may be disinfected using the same solutions as for the test strip table (see page 19). Wipe the solution on and allow to remain for 10 minutes. Rinse using a clean cloth dampened with water, then dry.
Do not use any type of solvent, oil, grease, silicone spray, or lubrication on the instrument.
3 Wet a cotton-tipped stick
with the NaOH.Thoroughly clean the trough and side areas of the table until all urine is removed.
4 Rinse the table thoroughly
with water to remove the NaOH.
5 Wipe the surface of the table
and the grooves on the under­side of the table with a damp cloth.Then dry the table with a soft cloth or tissue and insert it into the instrument.
22
Solving Problems
Your CLINITEK®50 Analyzer will give you troub le-free operation if you follow the directions for using and cleaning the instrument. If a problem occurs, however, an error message will be displayed. Follow the steps on the next page to help solve the problem.
If the printer is being used, most error messages will also show the word HELP. You can press the key under this word to print a description of the error and how to correct it.Press the key under the word CONT to continue.With most errors, the display will return to the READY FOR TEST screen;with certain errors, you will be told to turn the power off, then on again.
If the Bayer Reagent Strips seem to be causing the problem, carefully read the direction insert that comes with the Reagent Strips for information that might help solve the problem.
If the Display is Blank
If there are no words on the display after the instrument has been turned on, check for each of these possible causes:
The printer cover is not
latched: This might occur only
if the serial number of your instrument begins with “6510A.” If the cover is unlatched, the instrument turns itself off; it turns on again when the cover is snapped shut. If a test was
being read or results being printed when the cover was raised, the results will be lost and the specimen must be retested.
The power cord is not
plugged in: Check the
connections at the instrument, transformer, and wall outlet.
The batteries in the battery
pack are dead: Place fresh
batteries into the pack.
The instrument is broken:
Contact Customer Service (see page 25).
Appendix
23
Error Message
The batteries do not have enough power to test any more strips.Turn the power off and replace the batteries.
A test strip is not present, is dry, or is not positioned properly (upside down, not touching the end of the test table, or not laying flat in the middle trough); the wrong table is inserted for the strip being used; or the test being used cannot be identified by the software.Discard the strip, then press CONT and retest using a new test strip and the correct table;be sure the name of the strip you are using is shown on the display.
The test table is not in its correct position.The instrument or table may have been moved or bumped during testing, or the bottom of the table may be dirty. Discard the strip. Remove and clean the table, then reinsert. Press CONT and retest with a new test strip.
Error 3:The table is not present or is not pushed in far enough to allow movement.Push the table in about halfway.
All other Errors: Discard the strip. Turn the instrument off, wait several seconds, then turn it back on. If the error occurs again, contact Customer Service (see page 25).
Possible Cause and Remedy
REPLACE BATTERIES
STRIP PROBLEM-RETEST HELP CONT
TABLE PROBLEM-RETEST HELP CONT
INSTRUMENT ERROR X HELP CONT
24
Serial Number __ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Installation Date __________________________
YES NO
1. Have you reviewed the error messages on page 23?

2. Does the test table move out to the “load”position when the Analyzer is first turned on?

3. If Step 2 is NO —
Is the power cord plugged into a live electrical outlet, into the
transformer, and then into the Analyzer?

If using the battery pack, are the batteries fully charged and correctly placed in the pack and the cord plugged into the Analyzer?

4. Does the display show the expected messages? (If the display is blank, see page 22 for possible causes.)

5. Does the test table move into the Analyzer shortly after the key is pressed?

6. Does a test strip dipped into a negative control provide correct results?

Has a second test strip been tried? 
7. Is the name of the Bayer Reagent Strip shown on the display the same as the product being used? (If using any of the MULTISTIX PRO
®
Reagent Strips, is the family name of the product shown on
the display?)

8. Does the display or printout show the correct test names and reasonable results?

9. Is the test table or the white bar dirty, scratched, or damaged? 
10. Does the test table operate correctly?  If not, describe:
———————————————————————————
——————————————————————————————————
11. Please record any error messages that have been displayed:
—————————————————————————————————— ——————————————————————————————————
If you need additional help, our Technical Care Center 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 ne xt page.
CLINITEK®50 Problem Checklist
25
Where to Call
for Ser vice
If you are located in the United States, contact the Technical
Care Center of Bayer Corporation by calling toll free:
1-877-229-3711
The office is open from 8:00 AM to 8:00 PM Eastern Time (weekend and holiday schedule may vary).
If you are located in a country other than the United States,
call the Bayer office that is nearest you:
Canada
Bayer Inc.Healthcare Division 77 Belfield Road Toronto, Ontario M9W 1G6 Telephone: 416-248-0771
1-888-406-2222
U.K.
Bayer Plc, Bayer Diagnostics Bayer House Strawberry Hill Newbury RG14 1JA Telephone: 01635 566211
Australia
Bayer Diagnostics 2 Keith Campbell Court Scoresby VIC 3179 Telephone (toll free):
Telephon 1800 034 490
East Asia, Pakistan, Sri Lanka, Bangladesh
Bayer (Singapore) Pte, Ltd. Regional Headquarters BG-DS 9 Benoi Sector Singapore 629844 Telephone: 65 261-3389 Fax:65 266-3376
26
Product
No. Description
6511 Battery Pack and Batteries
5773 Thermal Printer Paper (5 rolls)
1364 CHEK-STIX
®
Combo Pak Control Strips
(1 bottle each — Positive and Negative Control Strips)
1360 CHEK-STIX
®
Positive Control Strips for Urinalysis
(1 bottle of 25 strips)
6517 Computer Cable/Connector Kit
6521 Software Update Kit (Cable and software disk
can also be ordered separately)
Ordering Accessories
Where to Order:
In the United States, you can
order these accessory items directly from your authorized CLINITEK distributor.
In countries other than the United States, you can order
these accessory items through your nearest Bayer office.You can find the address and phone number on page 25.
27
Part
No. Description
95001874 Test Strip Table — Long (labeled “L”)
(for use with Bayer Reagent Strips with five or more
tests and with CLINITEK®Microalbumin Strips)
95001875 Test Strip Table — Short (labeled “S”)
(for use with Bayer Reagent Strips with four or fewer
tests except for CLINITEK Microalbumin Strips)
50062316 Printer Cover
Ordering Replacement Parts
Where to Order:
In the United States, you can
order these replacement parts directly from:
Instrument Service Bayer Corporation P.O. Box 2004 Mishawaka, IN 46546
or by calling toll free:
1-800-348-8100
In countries other than the United States, you can order
these replacement parts through your nearest Bayer office.You can find the address and phone number on page 25.
28
Specifications
Power Required:
Power T r ansformer:
Input: 100-250 V~, 50/60 Hz,
0.5-0.3 A, grounded
Output: +9 V , 2.78 A
Optional Battery Pack —
Holds 6 “AA”standard alkaline or rechargeable NiCad batteries
Up to 200 tests can be run when using new alkaline batteries, fewer with rechargeable batteries.
Instrument Fuse:
4A, 63V, Quick-Acting
(
not replaceable by the user)
Line Leakage Current:
<0.5 milliamperes in normal
condition
<3.5 milliamperes in single
fault condition
(
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.)
Computer Interface:
Customized RJ11 Cable
(
For use in connecting to a
computer only)
Dimensions:
Depth — 23.5 cm (9.2 in.) Width — 15.2 cm (6.0 in.) Height — 15.5 cm (6.1 in.)
Weight:
Instrument only — 1.25 kg (2.8 lbs.) Instrument with Battery Pack —
1.42 kg (3.1 lbs.)
Ambient Operating Temperature Range:
18°C to 30°C (64°F to 86°F)
Optimum Operating Temperature Range:
22°C to 26°C (72°F to 79°F)
Ambient Operating Humidity Range:
20% to 85% Relative Humidity
Safety Standards:
The CLINITEK
®
50 Urine Chemistry Analyzer (Models 6510 and 6510A) conforms to the Low Voltage Safety Directive 73/23/EEC.The instrument is listed by the Underwriters’ Laboratories, Inc.(UL) and the Canadian Standards Association (CSA) as certified and complies with the safety standards specified in UL 3101 and CSA-C22.2, No.1010.1.
Model 6510A conforms to EMC Directive 89/336 Amendment 92/31/EEC.
Warning:
This instrument must be used in the manner specified in this User’s Guide in order to provide the safety and performance standards specified.
Symbols:
Refer to User’s Guide for complete information on using this instrument.
DC V oltage Power Input
Computer Interface
CLIA Status:
The CLINITEK 50 Analyzer is “Waived” per CLIA ’88.
29
Table 1
Traditional Bayer Reagent Strips
ENGLISH — CONV.
Units — Conventional
Abbre-
Printed/Displayed Results
Test
viation
Units
Normal System + / – System
YELLOW GREEN
Color* ORANGE BLUE No Difference
RED BROWN
NEGATIVE 500 NEGATIVE 2+
Glucose GLU mg/dL 100 > = 1000 TRACE 3+
250 1+
Bilirubin BIL
NEGATIVE MODERATE NEGATIVE 2+ SMALL LARGE 1+ 3+
NEGATIVE 40 NEGATIVE 2+
Ketone KET mg/dL TRACE > = 80 TRACE 3+
15 1+
Specific
< = 1.005 1.020
Gravity
SG 1.010 1.025 No Difference
1.015 > = 1.030
Occult
NEGATIVE SMALL NEGATIVE 1+
Blood
BLO TRACE-LYSED MODERATE TRACE-LYSED 2+
TRACE-INTACT LARGE TRACE-INTACT 3+
5.0 6.5 8.0
pH pH 5.5 7.0 8.5 No Difference
6.0 7.5 > = 9.0 NEGATIVE 100 NEGATIVE 2+
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
NEGATIVE MODERATE NEGATIVE 2+
Leukocytes LEU TRACE LARGE TRACE 3+
SMALL 1+
*Color may be preceded with “LT.”or “DK.” Shaded areas = abnormal results
Traditional Bayer Reagent Strips
30
Abbre-
Printed/Displayed Results
Test
viation
Units
Normal System + / – System
YELLOW GREEN
Color* ORANGE BLUE No Difference
RED BROWN NEGATIVE 28 NEGATIVE 2+
Glucose GLU mmol/L 5.5 > = 55 TRACE 3+
14 1+
Bilirubin BIL
NEGATIVE MODERATE NEGATIVE 2+ SMALL LARGE 1+ 3+
NEGATIVE 3.9 NEGATIVE 2+
Ketone KET mmol/L TRACE > = 7.8 TRACE 3+
1.5 1+
Specific
< = 1.005 1.020
Gravity
SG 1.010 1.025 No Difference
1.015 > = 1.030
Occult
NEGATIVE Ca 25 NEGATIVE 1+
Blood
BLD Ery/µL TRACE-LYSED Ca 80 TRACE-LYSED 2+
TRACE-INTACT Ca 200 TRACE-INTACT 3+
5.0 6.5 8.0
pH pH 5.5 7.0 8.5 No Difference
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 µmol/L 16 > = 131 No Difference
33
Nitrite NIT NEGATIVE POSITIVE No Difference
NEGATIVE Ca 125 NEGATIVE 2+
Leukocytes LEU Leu/µL Ca 15 Ca 500 TRACE 3+
Ca 70 1+
*Color may be preceded with “LT.”or “DK.” Shaded areas = abnormal results
Table 2
Traditional Bayer Reagent Strips
ENGLISH — S.I.
Units — International (S.I.)
Traditional Bayer Reagent Strips
31
Abbre-
Printed/Displayed Results
Test
viation
Units
Normal System + / – System
YELLOW GREEN
Color* ORANGE BLUE No Difference
RED BROWN NEGATIVE 3+ NEGATIVE 2+
Glucose GLU 1+ 4+ TRACE 3+
2+ 1+
Bilirubin BIL
NEGATIVE 2+ 1+ 3+
No Difference
NEGATIVE 3+ NEGATIVE 2+
Ketone KET 1+ 4+ TRACE 3+
2+ 1+
Specific
< = 1.005 1.020
Gravity
SG 1.010 1.025 No Difference
1.015 > = 1.030
Occult
NEGATIVE 1+
Blood
BLD + / – 2+ No Difference
+ / – INTACT 3+
5.0 6.5 8.0
pH pH 5.5 7.0 8.5 No Difference
6.0 7.5 > = 9.0 NEGATIVE 2+ NEGATIVE 2+
Protein PRO + / – 3+ TRACE 3+
1+ 1+
3.2 66
Urobilinogen URO µmol/L 16 > = 131 No Difference
33
Nitrite NIT NEGATIVE POSITIVE No Difference
NEGATIVE 3+ NEGATIVE 2+
Leukocytes LEU 1+ 4+ TRACE 3+
2+ 1+
*Color may be preceded with “LT.”or “DK.” Shaded areas = abnormal results
Table 3
Traditional Bayer Reagent Strips
ENGLISH — NORDIC
Units — Nordic Plus System
Traditional Bayer Reagent Strips
32
Table 4
MULTISTIX PRO Reagent Strips
ENGLISH — CONV.
Units — Conventional
MULTISTIX PRO Reagent Strips
Abbre-
Printed/Displayed Results
Test
viation
Units
Normal System + / – System
YELLOW GREEN
Color* ORANGE BLUE No Difference
RED BROWN NEGATIVE 500 NEGATIVE 2+
Glucose GLU mg/dL 100 > = 1000 TRACE 3+
250 1+
Bilirubin BIL
NEGATIVE MODERATE NEGATIVE 2+ SMALL LARGE 1+ 3+
NEGATIVE 40 NEGATIVE 2+
Ketone KET mg/dL TRACE > = 80 TRACE 3+
15 1+
Specific
< = 1.005 1.020
Gravity
SG 1.010 1.025 No Difference
1.015 > = 1.030
Occult
NEGATIVE SMALL NEGATIVE 1+
Blood
BLO TRACE-LYSED MODERATE TRACE-LYSED 2+
TRACE-INTACT LARGE TRACE-INTACT 3+
5.0 6.5 8.0
pH pH 5.5 7.0 8.5 No Difference
6.0 7.5 > = 9.0
0.2 4.0
Urobilinogen URO E.U./dL 1.0 > = 8.0 No Difference
2.0
Nitrite NIT NEGATIVE POSITIVE No Difference
NEGATIVE MODERATE NEGATIVE 2+
Leukocytes LEU TRACE LARGE TRACE 3+
SMALL 1+ NEGATIVE 100 NEGATIVE 2+
Protein PRO mg/dL 15 300 LOW 3+
30 1+ 10 200
Creatinine CRE mg/dL 50 300 No Difference
100
NORMAL DILUTE
Protein-to- NORMAL Creatinine P:C mg/g 150 ABNORMAL No Difference Ratio 300 ABNORMAL
> 500 ABNORMAL
*Color may be preceded with “LT.”or “DK.” Shaded areas = abnormal results
Specimen is too dilute to accurately determine ratio result. Repeat test on new specimen.
33
Table 5
MULTISTIX PRO Reagent Strips
ENGLISH — S.I.
Units — International (S.I.)
MULTISTIX PRO Reagent Strips
Abbre-
Printed/Displayed Results
Test
viation
Units
Normal System + / – System
YELLOW GREEN
Color* ORANGE BLUE No Difference
RED BROWN NEGATIVE 28 NEGATIVE 2+
Glucose GLU mmol/L 5.5 > = 55 TRACE 3+
14 1+
Bilirubin BIL
NEGATIVE MODERATE NEGATIVE 2+ SMALL LARGE 1+ 3+
NEGATIVE 3.9 NEGATIVE 2+
Ketone KET mmol/L TRACE > = 7.8 TRACE 3+
1.5 1+
Specific
< = 1.005 1.020
Gravity
SG 1.010 1.025 No Difference
1.015 > = 1.030
Occult
NEGATIVE Ca 25 NEGATIVE 1+
Blood
BLD Ery/µL TRACE-LYSED Ca 80 TRACE-LYSED 2+
TRACE-INTACT Ca 200 TRACE-INTACT 3+
5.0 6.5 8.0
pH pH 5.5 7.0 8.5 No Difference
6.0 7.5 > = 9.0
3.2 66
Urobilinogen UBG µmol/L 16 > = 131 No Difference
33
Nitrite NIT NEGATIVE POSITIVE No Difference
NEGATIVE Ca 125 NEGATIVE 2+
Leukocytes LEU Leu/µL Ca 15 Ca 500 TRACE 3+
Ca 70 1+ NEGATIVE 1.0 NEGATIVE 2+
Protein PRO g/L 0.15 3.0 LOW 3+
0.3 1+
0.9 17.7
Creatinine CRE mmol/L 4.4 26.5 No Difference
8.8 NORMAL DILUTE
Protein-to- NORMAL Creatinine P:C mg/mmol 17.0 ABNORMAL No Difference Ratio 33.9 ABNORMAL
> 56.6 ABNORMAL
*Color may be preceded with “LT.”or “DK.” Shaded areas = abnormal results
Specimen is too dilute to accurately determine ratio result. Repeat test on new specimen.
34
Table 6
MULTISTIX PRO Reagent Strips
ENGLISH — NORDIC
Units — Nordic Plus System
Abbre-
Printed/Displayed Results
Test
viation
Units
Normal System + / – System
YELLOW GREEN
Color* ORANGE BLUE No Difference
RED BROWN NEGATIVE 3+ NEGATIVE 2+
Glucose GLU 1+ 4+ TRACE 3+
2+ 1+
Bilirubin BIL
NEGATIVE 2+ 1+ 3+
No Difference
NEGATIVE 3+ NEGATIVE 2+
Ketone KET 1+ 4+ TRACE 3+
2+ 1+
Specific
< = 1.005 1.020
Gravity
SG 1.010 1.025 No Difference
1.015 > = 1.030
Occult
NEGATIVE 1+
Blood
BLD +/– 2+ No Difference
+/– INTACT 3+
5.0 6.5 8.0
pH pH 5.5 7.0 8.5 No Difference
6.0 7.5 > = 9.0
3.2 66
Urobilinogen URO µmol/L 16 > = 131 No Difference
33
Nitrite NIT NEGATIVE POSITIVE No Difference
NEGATIVE 3+ NEGATIVE 2+
Leukocytes LEU 1+ 4+ TRACE 3+
2+ 1+ NEGATIVE 2+
Protein PRO LOW 3+ No Difference
1+
0.9 17.7
Creatinine CRE mmol/L 4.4 26.5 No Difference
8.8 NORMAL DILUTE
Protein-to- NORMAL Creatinine P:C mg/mmol 17.0 ABNORMAL No Difference Ratio 33.9 ABNORMAL
> 56.6 ABNORMAL
*Color may be preceded with “LT.”or “DK.” Shaded areas = abnormal results
Specimen is too dilute to accurately determine ratio result. Repeat test on new specimen.
MULTISTIX PRO Reagent Strips
Be kind to the environment.
Please recycle the User’s
Guides you do not use.
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