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Sejoy UA-105, Owner'S Booklet

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Sejoy UA-105 Owner'S Booklet Download Page 42

Traceability

The accuracy of UA-105 uric acid system is compared with the results by testing 

fingertip whole blood or venous blood and the results by testing the calibration 

product used Mindray biochemical analyzer. The traceability material of the 

calibration product trace to NIST SRM 913a, and the reference method of 

Mindray biochemical analyzer is NIST definitive method of ID-LC/MS/MS.

 40

Summary of Contents for UA-105

Page 1: ...Owner s Booklet UA 105 Monitoring System Uric Acid ...

Page 2: ......

Page 3: ... testing at home or for professional use It is not used for diagnosis screening nor for testing newborns The product is for in vitro diagnostic use only The Sejoy US 101 Test Strip is a plastic strip containing chemistries and electrodes The strip measures uric acid by using amperometric technology employing an uric acid electrochemical reaction When whole blood from the finger or control solution...

Page 4: ...use by the second person Disinfect the meter and lancing device before allowing anyone else to handle them Do not allow anyone else to test with the meter or lancing device For instructions on how to clean and disinfect the meter and lancing device see Chapter Maintenance Wash hands thoroughly before and after handling the meter lancing device or test strips Choking hazard Small parts Keep away fr...

Page 5: ...test when you open a new box of test strips or if you think that your test result is incorrect Running a control test lets you know that the meter and test strips are working properly DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT THAT DOES NOT MATCH HOW YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT If your uric acid result doesn t match how you feel and you have follo...

Page 6: ...d that of L DOPA above 0 5 mg dL may affect the test results High concentration of Cholesterol up to 500 mg dL and that of Triglycerides up to 300 mg dL will not affect the test results The user is suggested to test uric acid in the morining after fasting for 12 hours ...

Page 7: ...ina Lotus NL B V Koningin Julianaplein 10 le Verd 2595AA The Hague Netherlands CE for lancing device CE0197 for sterile lancet Manufacturer of Lancing Device and Sterile Lancet EC REP Shandong Lianfa Medical Plastic Products Co Ltd No 1 Shuangshan Sanjian Road 250200 Zhangqiu City Jinan Shandong PEOPLE S REPUBLIC OF CHINA Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 20537 Hambur...

Page 8: ...LCD M Button S Button Battery Cover Battery Compartment Display Measuring Unit Test Strip Reminder Apply Blood Sample Reminder Memory Low Battery Reminder Test Result Month Date Voice Time Average Alarm Clock Reminder 6 o Temperature is out of range ...

Page 9: ...of 10 40 50 104 Store the test strip package in a cool dry place between 1 30 33 8 86 Use test strips only within the system operating temperature range Keep away from direct sunlight or heat Store your test strips in their original vial only never transfer them to another vial or any other container Never store individual test strips outside the vial After removing a test strip from the vial imme...

Page 10: ...Getting to know your system d Lancet c Lancing Device Protective Cover Lancet Pin Lancet Ejector Trigger Button Sliding Barrel Lancet Carrier Protective Cover Lancing Device Cover Arrow Adjustable Tip 8 ...

Page 11: ...ct month appears After the month is set press button S the Date figure is flashing automatically Set the date Press and release the button M to advance one day until the correct date appears After the date is set press button S the Hour figure is flashing automatically Set the hour Press and release the button M to advance one hour until the correct hour appears After the hour is set press button ...

Page 12: ...ligrams per decilitre mg dL or micromole per litre umol L Press and release button M to select the preferred format With the preferred measuring unit format on the display press button S to enter the voice setting The meter can display the time in either an AM PM 12 hour or a 24 00 24 hour format Press and release button M to select the format With the preferred time format on the display press bu...

Page 13: ...ase refer to step 3 and 4 for the time setting After the time is set press button S button to exit the setting mode If there is no alarm function requirement press button S to setting enter the code OR Set the voice The meter can set the voice in either an on or an off format Press and release button M to select the format With the preferred voice format on the display press button S to enter the ...

Page 14: ...e label area on the back of the uric acid instrument with the RFID on the cover of the test box And check that the code number displayed on the screen is consistent with the code number marked on the test box Set up the code RFID CHIP ...

Page 15: ... the meter is being operated by a second person who is providing testing assistance to the user the meter and lancing device should be cleaned and disinfected prior to use by the second person Disinfect the meter and lancing device before allowing anyone else to handle them Do not allow anyone else to test with the meter or lancing device It is important to keep the meter and lancing device clean ...

Page 16: ...and gently twist it until it separates from the lancet Replace the lancing device cap Avoid touching the lancet pin Adjust the depth setting The adjustable tip offers 5 levels of skin penetration Twist the lancing device cap until the desired setting appears Note To select the best depth 1 2 for soft or thin skin 3 for average skin 4 5 for thick or calloused skin 14 ...

Page 17: ...ancing device cover in one hand Using the other hand slowly pull the sliding Barrel away from the lancing device cover You will hear a click indicating that the lancet carrier is locked into position Release sliding barrel to return it to its original position 15 ...

Page 18: ...he finger Press the trigger button and then lift the lancing device Gently squeeze your finger until you get a round drop of blood If the blood smears or runs Do Not use that sample Wipe the area and gently squeeze another drop of blood or puncture a new site Approximate size away from the finger after the puncture is complete Place the lancing device aside and wait a few seconds for a blood drop ...

Page 19: ...mmediately after use to avoid contamination and damage Store unused test strips only in their original vial Do Not open the test strip vial until you are ready to remove a test strip and perform a test Use the test strip immediately after removing it from the vial Do Not return the used test strip to the vial after performing a test Do Not re use a test strip that had blood or control solution app...

Page 20: ...en Each time the meter powers on this screen briefly appears so that you can make sure the display is working properly Note If appears it indicates the operating temperature is over range Place the system in operating temperature room for half hour Then test again If appears it indicates the battery is almost out of power Replace the battery now The blood drop symbol flashes on the display screen ...

Page 21: ... drop of blood with the test Do Not apply more blood to the test strip after you have moved the drop of blood away Do Not move the test strip in the meter during a test Wait for the confirmation window to fill completely The blood drop will be drawn into the narrow channel and the confirmation window should fill completely When the confirmation window is full this means you have applied enough blo...

Page 22: ... the test result press S button and to delete it After M button at the same time memory cleared the meter 3 minutes will display dEL for aprrox and then automatically turn off Turn your meter off Simply remove the test strip Carefully dispose the used test strip 20 o ...

Page 23: ...202 416 umol L 3 4 7 0 mg dL 142 360 umol L 2 4 6 0 mg dL Male Female Recommend Refer to the following cautions whenever your test results are lower or higher than what you expect Low uric acid results If your test result is lower than 180 umol L 3 mg dL LO will appear on the meter display screen 21 High results uric acid If your test is above HI 1190 umol L mg dL 20 will appear on the display scr...

Page 24: ...olution test to make sure the meter is working properly While at the lab Conduct your meter test of the lab test within 15 minutes Use only fresh capillary blood obtained from the fingertip Follow all instructions in this Owner s Booklet to performing a uric acid test by your meter will help you and your healthcare professional compare your meter results with laboratory test results The Sejoy mete...

Page 25: ... Note If there is no test result stored the meter will display for a few seconds then automatically turn off The meter automatically stores up to 360 test results uric acid with the and date of the test and any test markers Results can time be reviewed at any time Test results are stored from the newest to the time and date correctly in the meter Having the correct time and date setting helps ensu...

Page 26: ...orward to averages The first memory display screen you see is your 7 day average This average includes all the readings from the last period days n indicates the number of results included in your average Deleting all memory Press and hold S button approximately 3 seconds After memory cleared the meter will display dEL for aprrox 3 minutes and then automatically turns off 24 o ...

Page 27: ...ored in extreme temperatures and or humidity Your test result does not match how you feel NOTE Only use the Sejoy CS 301 control solution Close the control solution bottle tightly after use Write the date you open the control solution bottle on the bottle label The control solution must be discarded 3 months from the date the first open date or the expire date on the vial label whichever comes fir...

Page 28: ...that you can make sure the display is working properly The blood drop symbol flashes on the display screen Your meter is now ready to apply blood sample Shake the control solution vial before each test Remove the cap and squeeze the vial to discard the first drop Then wipe the tip with a clean tissue or cloth Hold the vial upside down and gently squeeze a hanging drop 26 o ...

Page 29: ...pletely Control solution should not be applied to the flat face of the test strip CONFIRMATION WINDOW Read the result on the meter When the confirmation window is full the meter will count down from 20 to 1 uric acid level appears on the display along with the unit of measure the date and time of the test The results are automatically stored in the meter s memory TOP EDGE NARROW CHANNEL Apply Drop...

Page 30: ...uctions detailed in steps 1 6 expired or contaminated control solution expired or damaged test strip use of a test strip or control solution passed its discard date a problem with the meter CAUTION The control solution range printed on the test strip vial is for Sejoy Control Solution only It is not a recommended range for your uric acid level CAUTION If you continue to get control solution test r...

Page 31: ...ep the test result press the S and button to delete it at the same time After M memory cleared the meter will display dEL about 3 minutes and then automatically turns off To turn your meter off simply remove the test strip Carefully dispose of the used test strip 29 o ...

Page 32: ... you should replace the battery immediately With the meter off open the battery cover Remove the old batteries and place the new ones in the battery compartment Put the battery cover back into position until it locks into place Check your meter settings Replacing the battery does not affect your stored results However you may need to re set your meter settings See Setting Up Your Meter section Not...

Page 33: ...ginal vial Checking for expiration or damages to test strips and control solution Expiration dates for test strips and control solutions are printed on their vial labels When you first open a new vial of test strips or control solution record the discard date on the label Refer to the test strip or control solution vial for instructions on determining the discard date 20 55 4 131 Cleaning and disi...

Page 34: ...r to disinfecting To disinfect prepare a solution of 1 part household bleach and 9 parts water Hold the meter with the strip port and pointed down Use a soft cloth dampened with this solution to wipe the outside of the meter and lancing device until the surface is damp Be sure to squeeze out any excess liquid before you wipe the meter After wiping cover the surface you are disinfecting with the so...

Page 35: ...be moved during testing The strip check has problem Repeat with a new strip Remove the battery and reinsert it after 30 seconds If it still doesn t work please contact the vendor Retest with a new strip Make sure that the method of applying sample is correct and test strip can not be moved during testing Applying blood after the screen or sampling data is unstable Retest with a new strip symbol fl...

Page 36: ...Troubleshooting Battery power is low The meter is out of operating temperature range Replace the battery soon Place the system in appropriate operating environment for 30 minutes before retesting 34 ...

Page 37: ...ip with the printed side up Defective meter or test strips Contact the vendor Blood or foreign objects put into the test strip port Test does not start after applying the blood sample Probable Cause What to Do Defective test strip Repeat the test with a new test strip Sample applied after meter times out and turns off Defective meter or test strips Troubleshooting meter and the top of the strip in...

Page 38: ...osensor 180 1190 umol L 3 20 mg dL Fresh capillary whole blood from the finger 20 seconds Coding 2 X AAA alkaline battery replaceable Approximately 1 000 tests umol L or mg dL switchable 360 uric acid results with date and time 106 5 66 5 21 5 mm L W H Sample size Response time Coding Battery Battery life Calibration Plasma equivalent uric acid values 1 5ul 36 LCD size 41 8 41 8 mm L H ...

Page 39: ... Approx 3 minutes after last user action 10 95 RH non condensing Electromagnetic Compatibility The chosen basis for electrostatic discharge immunity testing emissions requirements as standrard EN 61326 Its electromagnetic emission is thus low to other electrically driven equipment Interference from the meter is not anticipated was basic standard EN61326 In addition it meets the electromagnetic 37 ...

Page 40: ...t or other appropriate authorities for proper handling and disposal of used meters used test strips used lancets and used batteries Please consider the following points when disposing of used testing materials Consider recycling of the meters and batteries at an appropriate facility Be aware the meter is potentially hazardous electronics scrap e scrap and should be disposed of accordingly The batt...

Page 41: ...r from the date of purchase If the meter does not function properly due to defective components or poor workmanship we will repair or replace it freely This warranty does not cover damage due to improper handling in any way Battery does not included in the warranty 39 ...

Page 42: ...ngertip whole blood or venous blood and the results by testing the calibration product used Mindray biochemical analyzer The traceability material of the calibration product trace to NIST SRM 913a and the reference method of Mindray biochemical analyzer is NIST definitive method of ID LC MS MS 40 ...

Page 43: ...rument Table1 System accuracy results for uric acid concentration 297umol L Mindray Chemistry Analyzer Table2 System accuracy results for uric acid concentration 297umol L Within 60 umol L 126 126 100 fall within 60umol L 1 mg dL of the laboratory result If the uric acid is below 297umol L 5mg dL the results generally should If the uric acid is equal to or over 297umol L 5mg dL the results general...

Page 44: ... test to make sure the meter is working properly Do Not eat for at least eight hours before you test your blood Take your meter with you to the lab Performance Characteristics y intercept 24 087 correlation coefficient R 24 087 Precision Average concentrarion umol L 272 6 430 6 532 6 709 4 928 9 SD umol L 16 8 20 3 25 4 28 8 37 7 CV 6 2 4 7 4 8 4 1 4 1 Slope 0 9493 42 ...

Page 45: ...ol Index SN Consult instructions for use In vitro diagnostic medical device Serial number Batch code Manufacturer Contain sufficient for n tests Caution Do not reuse Use by Storage temperature limitation 43 ...

Page 46: ... in vitro diagnostic medical devices 44 Biological risks Keep dry This symbol indicates that you should not discard waste electrical or electronic equipment WEEE in the trash For proper disposal contactyour local Direct Current European Authorized Representative EC REP 0197 ...

Page 47: ...del LD Sundedrland MLE et al Obser vations on Diagnostic Kits for the Determination of Uric Acid Clin Biochem 1971 4 279 286 2 Fossati P et al Clin Chem 26 2 227 1980 Thefeld L et al Dtsch Med Wschr 98 380 384 1973 ...

Page 48: ...C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone Hangzhou City 311100 Zhejiang China EC REP Document No DUA 0104 002 Version Z Date of Issue 2019 02 02 Shanghai International Holding Corp Gmbh Europe Eiffestrasse 80 20537 Hamburg Germany ...

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