Users Guide
35 Pages
Preview
Page 1
USER’S GUIDE
䊚1996 Bayer Corporation All Rights Reserved Printed in the U.S.A.
Bayer Corporation Elkhart, IN 46515 USA Revised 4/99
99D65109
Contents 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
C HA PTE R
2 Selecting your Options... 8 Location of results and number of copies... 8 Listing the tests... 8 Setting the time... 9 Setting the date... 9 Reporting the urine color...10 Setting the sequence number...10 Clearing the memory and marking positives . . .11
3 Testing Controls...12 4 Testing Specimens...13 Testing routine urines...13 Summary of steps...15 Testing with CLINITEK® Tests...15 Getting results...15 If results are printed...15 If results are displayed...15 When you are finished testing...16 Operating notes...16
5
Cleaning the Instrument...17 Daily cleaning...17 Disinfecting the table...18 Removing heavy buildup...19 General cleaning...20 Appendix...21 Solving problems...21 If the display is blank...21 Error messages and remedies...22 Problem checklist...23 Where to call for service...24 Ordering accessories...25 Ordering replacement parts...26 Specifications...27 Tables of results...28
iii
A Brief Description What does this instrument do? Your CLINITEK® 50 Urine Chemistry Analyzer is a portable instrument for reading Bayer Reagent Strips for Urinalysis. No special training is needed to use the instrument. Several different Bayer Reagent Strip products (e.g., MULTISTIX® 10 SG) can be used with the Analyzer; refer to the bottle label for the tests that are included with each product. The Analyzer can also report the color of the urine sample. The CLINITEK® line of tests from Bayer can also be read. 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
iv
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 changes 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.
墌
CAUTIONS should be followed carefully to ensure your instrument operates correctly and is not damaged. Cautions appear in bold type like this.
Unpacking and Setup
1
Unpacking 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
4
3
5
2 6
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 26). (The CLINITEK® line of tests are all 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 26).
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
3 Place the instrument on a level work surface where the temperature and humidity are fairly constant.
墌
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.
4 Locate the following:
1
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 transformer, 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 AC electrical wall outlet.
2
2
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 25 to order). The kit includes all the information you need to connect and use the cable.
3
Installing the Battery Pack 1 If you will be using the optional battery pack, place six AA-size batteries into the battery compartment.
2 Turn the instrument over and snap the battery pack into the opening.
3 Plug the cord into the
power inlet.
4
Loading the Paper Roll
1 Insert the two tabs on the printer cover into the two openings on the instrument. Rest the cover on its back edge.
✏
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.
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.
3 Pulling toward the back, gently pull the end of the paper until the full width of the paper is completely exposed.
墌
Do not pull the paper straight up or toward the front, as this will damage the printer.
5
4 Feed the paper through the printer cover opening and snap the cover into position.
✏
If you have Model Number 6510A, 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.
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.
✏
Refer to pages 28 to 30 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. 6
To prevent damage 墌 to the printer, do not tear the paper without the cover in place.
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. 4 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.”
墌
Do not use any Reagent Strip product other than what is shown on the display. Using the wrong Reagent Strip will give you incorrect results.
✏
CLINITEK ® Tests 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”.
Final Paper Work 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 23. 2 Fill out and mail the Warranty Registration Card and Customer Information Card if these are included with your instrument.
7
2
Selecting Your Options
Location of Results and Number of Copies
✏ One copy of each set of results will be printed if you do not change this option.
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.
2 Press the key under your choice.
3 If you pressed PRINTER, you can choose to have more than one copy of the results. Press the key under your choice.
✏ Listing the Tests 1 Press the key under the word LIST. 2 If you selected PRINTER as
your output, the list is printed. If DISPLAY was selected, press the key to display each test name, then press EXIT.
8
You can print or display a list of the Bayer Reagent Strips and CLINITEK ® Tests that can be read by your instrument through this option. If the CLINITEK Test you want to use is not listed, you must update the software in your Analyzer before using the product. See page 25 to order the Software Update Kit.
Setting the Time
Setting the Date
1 Press the key under the word SET.
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.
2 Press the key under DATE and select a date format: MDY Month-Day-Year DMY Day-Month-Year YMD Year-Month-Day
3 Press the the hour.
key to adjust
✏
If you press and hold the key, the numbers will advance more quickly. 4 Press the ➞ key, then press
to adjust the minutes.
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.
5 Press EXIT. 6 Press EXIT.
9
✏ Reporting the Urine Color 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.
Color will be reported automatically when using Bayer Reagent Strips if this option is set to YES.
✏
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.
✏ Setting the Sequence Number
The sequence 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. 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.
10
✏ 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.
✏ Clearing the Memory and Marking Positives 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.
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.
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 ( * ).
✏ Check whether your software program can accept the asterisk that marks positive results. Press NO if it cannot.
5 Press EXIT as needed.
11
3
Testing Controls
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.
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.
✏ CHEK-STIX® Positive and Negative Control Strips are available for use in your quality control program for routine urine testing (see page 25 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.
12
If the test you are running is not included in the CHEK-STIX insert, you will need to purchase a different control product that includes values for that test. For information about control manufacturers, contact the Bayer Customer Service Dept. at 1-800-348-8100 (U.S.A. only).
✏ Expected values are found in the package insert that comes with the control product.
Testing Specimens
4
Testing Routine Urines
✏
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 17. 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.
Testing can be started only from the READY FOR TEST screen. Be sure the Reagent Strip name agrees with the strip being used.
✏
Replace the cap as soon as you remove each strip from the bottle.
1 Dip a Bayer Reagent Strip into the urine. Be sure all the test pads are wet.
✏ Refer to the direction insert included with your Reagent Strips for complete information on using the strips.
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.
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.
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.
墌
You must place the test strip while the message PLACE TEST 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.
14
6 Remove the used Reagent Strip and discard it in the proper container.
✏
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.
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.
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 Analyzer.
Getting Results 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.
墌
Thermal print will fade with time. Also, do not cover thermally printed results with transparent tape.
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. 15
When You Are Finished Testing
✏ 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 17. 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.
You will be prompted to clean the table after every 50 strips. Press CONT to return to the READY FOR TEST screen.
✏ 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.
Operating Notes
16
䊱 The instrument does not
䊱 If you never erase the memory
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.
or reset the sequence number, the number will continue to increase until 999 is reached. The next number will then be 001.