User manual
24 Pages
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URYXXON® 200 for Medi-Test Combi 11
USER'S MANUAL
Version 1.0
Table of Contents
Page 1. Description and Principles of Operation... 2 2. Installation ... 3 • Unpacking ... 3 Contents... 3 • Setup... 3 Location ... 3 Power... 3 Self-Test... 3 Initial Setup ... 3 3. Functions... 4 • Keypad... 4 • Measurement Module ... 5 4. Instrument Settings ... 6 • Time/Date/Format ... 7 • Test Code ... 10 • Result Type... 10 • Language ... 11 • Result Layout ... 11 5. Operation ... 12 • Patient Testing ... 12 • Quality Control Testing... 13 6. Warning, Precaution, Limitations ... 14 7. Service and Maintenance ... 15 • Paper roll... 15 • Battery replacement ... 16 § Cleaning... 17 • Technical support... 17 • Return procedure ... 17 8. Trouble Shooting ... 18 9. Table of Results ... 19 • Test Code 10 Convenience Mode - Conventional System... 19 • Test Code 11 High Throughput Mode - Conventional System ... 20 • Test Code 21 High Throughput Mode - Standard International System... 21 10. Specification ... 22 11. Warranty ... 23
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1.
Description and Principles of Operation
This manual contains the directions for the operation and maintenance of the URYXXON® 200. For the testing procedure refer to the product inserts for the specific urine strips and follow the operating instructions. There is no special training needed to use this instrument. The URYXXON® 200 is a portable desk-top instrument for reading reagent strips for urinalysis. In general urine strips of different manufacturers with various parameters can be used on condition of being adapted to the instrument. In this instrument the Medi-Test Combi 11 from Macherey-Nagel is implemented. It can be used in a central laboratory or in a point-of-care setting. The URYXXON® 200 uses four LEDs (2x 522nm green, 2x 624nm orange) as a light source, the reflected light is detected with a photodiode and according to the calibration converted to the concentration of the analyte on the test pad. The test specific information of the reagent strip is loaded in the instrument. Therefore it is necessary to use the stipulated urinalysis reagent strips. After the application of the sample the strip placed on a strip adapter is inserted into the instrument, where the strips is read. After measurement depending on the user’s selection: either in the internal incubation mode/”convenience” (according to the specified incubation times (25s/55s) or in the external incubation mode/”high throughput”, and calculation the results are printed automatically. The URYXXON® 200 accepts strip adapters specifically designed for the instruments and the strips.
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2. •
Installation Unpacking
After opening the shipping box of the URYXXON® 200 and accessories, compare the contents with the list below. In case of damages or anything is missing contact your retailer. Contents 1. URYXXON® 200 2. User’s Manual 3. Batteries 4. 4 Rolls of Paper 5. 3 Strip Adapters 6. Optional: AC Adapter •
Setup Location
The URYXXON® 200 should be placed on a dry, clean, flat and horizontal surface. Power The instruments requires 6 V DC supplied by the 4 AA batteries or optional by the external AC adapter. The external AC adapter must comply with the requirements for SELV electric circuits and the requirements for electric circuits with limitation.
Self-Test The instrument performs a self-test to check if it is operating within normal parameters. The self-test is performed: 1. each time the meter is turned on 2. during each time a test is run and checks the following meter functions: 1. Electronic, mechanical, optical integrity 2. Memory failure 3. Battery power available
Initial Setup Remove the URYXXON® 200 carefully from the box and either install the batteries or connect it to the AC adapter (See service and maintenance). 3
3. •
Functions Keypad ON/OFF
Power on/off Green LED on in stand-by mode Green LED flushes in all wait screens The instrument has an automatic switch off mode that is activated if 30 minutes elapse from the last operation or display of results. As a safety measure the instrument will also shut down if the voltage drops below 3.6 V.
START
Measurement mode: Start reading Instrument settings mode: accept/confirm selection
STOP
Going to instrument settings by pressing 3 times
EJECT
Measurement mode: Interrupt reading Instrument settings mode: decline/cancel selection
Measurement mode: Print last record Instrument settings mode: printout of the actual setting screen
Paper feed
One line paper feed
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•
Measurement Module
The measurement module (optics, mechanics for the transport of the strip adapter) is protected by a cover. Do not open the covering in the normal process of running tests and controls. In case of problems follow the advise of the technical service representative.
Cover
Strip adapter
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4.
Instrument Settings
For the selection of the settings in the instrument settings mode following functions from the keypad are required.
START
Accept/confirm selection, Store actual setting and activate next
STOP
Going to instrument settings by pressing 3 times
EJECT
Instrument settings mode: decline/cancel selection Return to measurement mode
Printout of the actual setting screen
To change from the measurement mode to the instrument settings mode: Press the Stop button 3 times
With a beep a printout with a list of possible setting parameters will appear: The instrument settings function allows a selection within the following settings.
INSTRUMENT
SETTINGS
TIME/DATE/FORMAT
1*
TEST CODE
2*
LANGUAGE
3*
RESULT LAYOUT
4*
1* = 1 beep/flash 2* = 2 beep/flash 3* = 3 beep/flash 4* = 4 beep/flash In the printout of the specific setting menu the actual settings are shown inverse.
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•
Time/Date/Format
-
To set Time/Date/Format press START (to confirm the selection) after the 1 beep/flash signal.
TIME/DATE/FORMAT FORMAT:
EUR
TIME:
11:53
DATE:
03-31-99
AM
FORMAT
1*
TIME
2*
DATE
3*
Format for Time and Date -
Press START after the 1 beep/flash signal
TIME/DATE FORMAT
-
-
-
-
1*
US
2*
EUR
3*
JP
Press START after the 1 beep/flash signal US format (MM DD YY / 0-12 AM, PM): Press START after 1beep/flash signal EUR format (DD MM YY / 00:00-23:59) Press START after 2 beep/flash signal JP format (YY MM DD / 00:00-23:59) Press START after 3 beep/flash signal
Set Time TIME/DATE/FORMAT FORMAT:
EUR
TIME:
11:53
DATE:
03-31-99
AM
FORMAT
1*
TIME
2*
DATE
3*
The internal clock / date moves as long there is either a connection to the mains power supply or the instrument is battery run.
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-
Press START after the 2 beep/flash signal SET TIME TIME:
11:53
Allowed values in EUR format / JP format for time are (positions from left to right): Pos 1: 0-2 // Pos 2: 0-9 // Pos:3: 0-5 // Pos 4: 0-9
-
-
The numbers will be changed from first left position of the time to last right position. Press STOP to count up Press START to store the selection and to activate the next position With pressing PRINT the actual screen will be printed
Example: To change from 11:53 to 04:10 Pos1: 1 to 0 Pos2: 1 to 4 Pos3: 5 to 1 Pos4: 3 to 0
2 times STOP / START to store / activate next position 3 times STOP / START to store / activate next position 2 times STOP / START to store / activate next position 7 times STOP / START to store / activate next position
SET TIME TIME:
11:53
AM/PM
AM
Allowed values in US format for time are (positions from left to right): Pos1: 0,1 // Pos2: 0-9 // Pos3: 0-5 // Pos4: 0-9 After the time has been stored and the AM/PM is activated: Press STOP to scroll to the next allowed value (AM or PM) The instrument performs a plausibility check of the settings after all positions of time have been set and stored with the START button. In case of not allowed values (e.g. EUR 24:65) an error message - wrong range – will be printed. For the correction the first left position is activated and printed out. The procedure can be restarted. 8
Set Date
SET DATE DATE:
03-31-99
Allowed values in EUR format (DD MM YY) for date are (positions from left to right): Pos1: 0-3 // Pos2: 0-9 // Pos3: 0-1 // Pos4: 0-9 // Pos5: 0-9 // Pos 6: 0-9
-
-
The numbers will be changed from first left position of the date to last right position. Press STOP to count up Press START to store the selection and to activate the next position With pressing PRINT the actual screen will be printed
Example: To change from 02.01.97 to 30.12.00 Pos1: 0 to 3 Pos2: 2 to 0 Pos3: 0 to 1 Pos4: 1 to 2 Pos5: 9 to 0 Pos6: 7 to 0
3 times STOP / START to store / activate next position 7 times STOP / START to store / activate next position 1 time STOP / START to store / activate next position 1 time STOP / START to store / activate next position 1 time STOP / START to store / activate next position 3 times STOP / START to store / activate next position
Allowed values in US format (MM DD YY) for date are (positions from left to right): Pos1: 0,1 // Pos2: 0-9 // Pos3: 0-3 // Pos4: 0-9 // Pos5: 0-0 // Pos6: 0-9 Allowed values in JP format (YY MM DD) for date are (positions from left to right): Pos1: 0-9 // Pos2: 0-9 // Pos3: 0,1 // Pos4: 0-9 // Pos5: 0-3 // Pos6: 0-9 The instrument performs a plausibility check of the settings after all positions of date have been set and stored with the START button. In case of not allowed values (e.g. EUR 31.02.1999) an error message - wrong range – will be printed. For the correction the first left position is activated and printed out. The procedure can be restarted.
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Test Code
INSTRUMENT
-
SETTINGS
TIME/DATE/FORMAT
1*
TEST CODE
2*
LANGUAGE
3*
RESULT LAYOUT
4*
Press START after 2 beep/flash signal
TEST CODES
-
1*
LOT NO.1002
2*
LOT NO.1005
Press START after the beep/flash signal according to the urine reagent strips
The Test Code contains all data of the strip definition including calibration data and Result Layout. For Medi-Test Combi 11 this means: -
-
-
•
Code 10 corresponds to - Convenience mode with internal incubation (25s/55s) and conventional units. Code 11 corresponds to - High throughput mode with external incubation and conventional units. Code 21 corresponds to - High throughput mode with external incubation and SI units. Result Type
A table for the possible selections is shown in chapter 9.
RESULT TYPE TYPE 1
1*
TYPE 2
2*
TYPE 3
3* T
-
Press START after the beep/flash signal according to the result type.
Type 1: +/- System Type 2: Semi-quantitative Type 3: Combination of Type 1+2
(Optional with reflection values) (Optional with reflection values) (without reflection values) 10
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Language
-
Press START after the 3 beep/flash signal LANGUAGES 1*
ENGLISH
2*
DEUTSCH
3*
ESPAGNOL
4*
FRANCAIS
5*
POLSKI
6*
ITALIANO
7*
CESKO
8*
SLOVENSKO
-
Press START after the beep/flash signal according to language.
•
Result Layout INSTRUMENT
-
SETTINGS
TIME/DATE/FORMAT
1*
TEST CODE
2*
LANGUAGE
3*
RESULT LAYOUT
4*
Press START after the 4 beep/flash signal. RESULT LAYOUT WITHOUT REM 1* WITH REM 2*
-
Press START after the beep/flash signal according to the Result Layout
With Result Type 1 (+/- ) / Result Type 2 (semi-quantitative) it is possible to get additional information about the values in % reflection: -
Without rem: With rem:
without values in % reflection with values in % reflection
To leave the instrument settings menu, to return to the measurement menu : Press EJECT
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5.
Operation
Refer to the specification of the distributor with which type of strips the instrument is running. The actual information of the strip is necessary to get accurate results. •
Patient Testing
1. Switch the URYXXON® 200 ON using 2. Wait until the self-test is performed. 3. Dip and blot the reagent strip according to the instructions of the urine strip package insert. 4. Place the test strip with the pads facing up into the middle trough of the strip adapter. Make sure that the top of the strip is contacting the upper edge of the strip adapter. 5. Insert the strip adapter to the insertion slot until the device catches on pin. An audible click indicates that the device is seated properly.
6. Press START 7. The strip adapter is automatically pulled into the instrument. The test pads are read according to the specific reaction time. The completion of the test is indicated by a beep and the start of the printout. 8. Remove the strip adapter and discard the used reagent strip. Do not remove the strip adapter from the instrument before it is released. This could cause a damage of optics and mechanics. Wait for the signal: beep and start of printout.
9. The test results are printed automatically. Press the Print key to reprint the last result. 10. Clean the strip adapter if necessary. 11. Turn the instrument off to save power, if you are using the battery pack.
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Quality Control Testing
Positive and negative control solutions should be tested on a regular basis to provide a check to ensure that the reagent strips are reacting properly and the instrument is reading the strips properly. Prepare the control solutions as instructed in the package insert and test the control solutions using the same procedure when testing patient samples. Record the control results. In case of results which are out of the expected range inform the lab supervisor or the physician. Running controls is recommended: Ø Ø Ø Ø
at the start of the day if a new bottle of reagent strips is opened whenever results are in doubt when training instrument operators
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6. § § § § §
Warning, Precaution, Limitations Do not bring the URYXXON® 200 into water. Do not drop or throw the URYXXON® 200 Operate the URYXXON® 200 on a level, dry surface. Do not move the URYXXON® 200 while a test is in process. Use only the AC/DC adapter provided with the URYXXON® 200.
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7.
Service and Maintenance
There is no maintenance other than paper roll replacement, battery replacement and cleaning required of the user. •
Paper roll
1. 2.
Tear off any exceeding paper. Raise the printer cover by pulling up the cover as indicated by the arrow on the cover.
3. 4.
Pull out the remaining paper and remove the empty core. Feed the paper manually under the printer roller with the inside face of the paper upward. Press the -paper feed- button until the paper comes through the paper opening of the top of the meter.
5.
6. 7.
Place the roll into the printer compartment. Replace the printer cover. 15
•
Battery replacement
1.
Depress the snaps of the battery compartment one after another, follow the direction of the arrows and draw the battery compartment table out.
2. 3.
Remove the batteries Insert 4 AA 1,5 V batteries (+ and – signs on the batteries corresponding to the signs in the compartment.
4.
Replace the compartment to the instrument.
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§
Cleaning
The strip adapter must be kept clean to obtain accurate test results and to provide correct operating. Strip adapter Remove, clean and dry the strip adapter. It is advisable to clean the strip adapter by using a wet cotton-tipped stick with distilled water. For a disinfecting cleaning the strip adapter can be cleaned disinfectant on alcoholic basis or alcohol (70% to 85%). In case of heavy buildup a household bleach0.1N Sodiumhydroxide (NaOH) can also be used. Afterwards the strip adapter has to be rinsed thoroughly with distilled water and dried with a soft cloth or tissue.
Instrument For an occasional cleaning of the instrument make sure that the instrument is switched off. Use a mild soap and water solution, wipe the instrument with a soft cloth or sponge, and dry the meter with a soft cloth or tissue. Do not allow water to sweep into the meter (printer, measurement module).
•
Technical support
If there is any technical support required contact the authorized service representative of your retailer.
•
Return procedure
Should the URYXXON® 200 meter malfunction, call your retailer. In some cases it will be determined that the URYXXON® 200 meter should be returned to your retailer who will provide the detailed information about the return procedure.
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8.
Trouble Shooting
Meter Messages
Probable Cause
Battery low
Batteries have to be replaced Turn the power off and replace 4AA batteries or use the AC power adapter Internal standard is out of Return to retailer specification Problems with motor or drive Power meter off and on electronics Several times to test the Function Objects lodged on path belt Listen/look for loose objects
Optic failure Motor failure
Corrective Action
If the problem persists, call technical service / distributor No test code loaded Measurement failed
Wrong range
No tests implemented Meter error
Call retailer Power meter off and on Several times to test the Function. If the problem persists, call Retailer Not allowed values for setting Check the settings and time or date restart the setting procedure
Meter Symptoms
Probable Cause
Corrective Action
Meter will not power on
Batteries absent or non functional Batteries are not placed correctly Problem with mains power supply Device did not catch pin
Replace 4 AA batteries
Device not drawn into meter
Pin may be broken No printout appears on Paper Printer jam
Paper may be installed backwards Paper may have not been fed properly
Electrical smell or smoke
Wrong AC power may have been used
Software Codes E-LO or E-HI
Probable Cause Values out of defined ranges No strip inserted
E-HI
Replace batteries according to the polarity mark Source not plugged in meter/power source Insert the device to lock position Return the meter to Retailer Replace paper in reverse position Pull out paper of printer re-feed paper into the printer Power meter off and on to check if the electrical system is damaged Use an AC adapter According specification Return the meter to Retailer
Corrective Action Retest and compare with the tube color chart Insert a strip and restart 18
9. Table of Results •
Test Code 10 Convenience Mode - Conventional System Result Type 1 Conventional +/Result Type 2 Conventional Semi-quantitative Result Type 3 is a combination of Result Type 1 and Type 2
Test
Abbre- Units viation
Output
Blood
BLD
Ery/µl
Urobilinogen
UBG
mg/dl
Bilirubin
BIL
Protein
PRO
Nitrite
NIT
Ketones
KET
Ascorbic Acid
ASC
Glucose
GLU
pH
pH
Density
SG
Leukocytes
LEU
Negative 10 50 250 Negative 1+ 2+ 3+ Normal 2 4 8 12 Normal 1+ 2+ 3+ 4+ Negative 1+ 2+ 3+ No difference Negative 30 100 500 Negative 1+ 2+ 3+ Negative Positive No difference Negative 1+ 2+ 3+ No difference Negative 1+ 2+ No difference Negative Normal 50 150 >500 Negative Normal 1+ 2+ 3+ 5 6 7 8 9 No difference 1.000 1.005 1.010 1.015 1.020 1.025 1.030 No difference Negative 25 75 500 Negative 1+ 2+ 3+
mg/dl
mg/dl
Leu/µl
Result Type 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1
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