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Sejoy UA-105 Owner's Booklet

Uric acid monitoring system
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UA-105
Uric Acid
Monitoring System
Owner's Booklet

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Summary of Contents for Sejoy UA-105

  • Page 1 UA-105 Uric Acid Monitoring System Owner’s Booklet...
  • Page 3 Before you start testing, carefully read this Intended Use The Sejoy US-101 Test Strips are used with the Sejoy UA-105 Uric Acid Meters to quantitative measuring uric acid with fresh capillary whole blood from the finger or venous blood. The test strips can be used for self-testing at home or for professional use.

  • Page 4: Important Safety Information

    Introduction Important Safety information Warning • Venous whole samples collection and preparation should be obtained by healthcare professionals . • During normal testing, any uric acid meter or lancing device may come in contact with blood. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from blood borne pathogens, even after you have performed cleaning and disinfecting.
  • Page 5 – or if you have questions – talk to your doctor. · The sejoy Uric Acid monitoring system UA-105 is designed for using with fresh capillary whole blood from the finger or venous samples. ·...
  • Page 6 Introduction · The concentration of Acetaminophen above 1.0mg/dL and 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. ...

  • Page 7: Getting To Know Your System

    Getting to know your system INCLUDED WITH YOUR KIT a. Meter (battery included) b. Test Strips c. Lancing Device d. Sterile Lancet e. Control Solution Manufacturer of Lancing Device and Sterile Lancet 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.
  • Page 8 Getting to know your system a. Meter Strip Port “M”Button “S” Button Battery Compartment Battery Cover Test Strip Reminder Apply Blood Sample Reminder Memory Temperature is out of range Low Battery Reminder Display Test Result Average Measuring Unit Time Alarm Clock Reminder Voice Date Month...
  • Page 9 Getting to know your system b. Test Strip Top Edge Contact Bars Confirmation Window Contact Bar: Insert it into strip port. Push it all the way until it will go no further. Top Edge: Apply blood sample here Confirmation Window: Sample checking area Important: the meter should only be used with US-101 test strips.
  • Page 10 Getting to know your system c. Lancing Device Protective Cover Trigger Button Sliding Barrel Arrow Adjustable Tip Lancing Device Cover Lancet Carrier Lancet Ejector d. Lancet Protective Cover Lancet Pin...
  • Page 11 Setting up your meter When use the meter for the first time, please set the parameters of the meter. With the meter off, long press button “S” to enter into setting mode. ① Set the month Press and release the button “M” to advance one month until the correct month appears .
  • Page 12 Setting up your meter ④ Set the minute Press and release the button “M” to advance one minute until the correct minute appears. After the minute is set, press button “S”, the Time format figure will appear. ⑤ Set the time format The meter can display the time in either an AM/PM (12-hour) or a 24:00 (24-hour) format.
  • Page 13 Setting up your meter ⑦ 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 alarm clock setting.
  • Page 14 Setting up your meter ⑨ Set up the code Align the 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 RFID CHIP the screen is consistent with the code number marked on the test box.
  • Page 15 Testing your uric acid Preparing the lancing device Warning • During normal testing, any uric acid meter or lancing device may come in contact with blood. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from bloodborne pathogens, even after you have performed cleaning and disinfecting.

  • Page 16: Preparing The Lancing Device

    Testing your uric acid Preparing the lancing device ① Twist off the lancing device cover. ② Insert a new lancet into the lancet carrier firmly. ③ Hold the lancet needle cover and gently twist it until it separates from the lancet. ④...
  • Page 17 Testing your uric acid Preparing the lancing device ⑥ Hold the lancing 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.
  • Page 18 Testing your uric acid Blood Sampling ① Wash your hands and the puncture site with an alcohol swab or soapy water. Rinse and dry thoroughly. ② Position the end of the adjustable comfort tip against the side-tip of the finger. Press the trigger button, and then lift the lancing device away from the finger after the puncture is complete.
  • Page 19 Testing your uric acid Blood Sampling IMPORTANT: • Use only Test Strips US-101. • Make sure your meter and test strips are about the same temperature before you test. • Testing must be done within the operating temperature range 10℃ ~ 40℃ (50 ℉ ~ 104 ℉). For the most accurate results, try to test as close to room temperature 20℃...
  • Page 20 Testing your uric acid Testing ① With meter off or in setting mode and memory mode, insert a test strip to enter into testing mode. Note: If you do not start the test within three minutes, the meter will turn off. To restart your meter, take out the unused test strip and reinsert it into the meter.
  • Page 21 Testing your uric acid Testing ④ Apply the sample Gently touch the channel to the edge of the blood drop. Note: • Discard the first drop of blood. Do Not smear or scrape the drop of blood with the test strip.
  • Page 22 Testing your uric acid ⑦ Delete the memory If you don’t want to keep the test result, press “S”button “M” button to delete it at the same time . After memory cleared, the meter will display “dEL” for aprrox. 3 minutes , and then automatically turn off.
  • Page 23 Testing your uric acid Interpreting unexpected test results The meter can accurately measure uric acid concentrations between 180 to 1190 umol/L (3 to 20 mg/dL). Expected Uric Acid Level: Reference values Recommend 202-416 umol/L（3.4-7.0 mg/dL） Male 142-360 umol/L （2.4-6.0 mg/dL） Female Refer to the following cautions whenever your test results are lower or higher than what you expect.
  • Page 24 Comparing Your Meter result to a Laboratory result Comparing your meter's results with laboratory results periodically. The results of the Sejoy UA-105 meter are plasma equivalent. This method will help you and your healthcare professional compare your meter results w ith laboratory test results. The Sejoy...
  • Page 25 Memory and averages Storing uric acid and Control Test results The meter automatically stores up to 360 uric acid test results with the time and date of the test and any test markers. Results can be reviewed at any time. Test results are stored from the newest to the oldest, so set the time and date correctly in the meter.
  • Page 26 Memory and averages ③ Viewing7-, 14-, 28-day average Press and release “S” button to scroll forward 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 ④...

  • Page 27: Control Solution Testing

    • 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.

  • Page 28: Performing A Control Test

    Control solution testing Performing a control test ① Insert a test strip to turn the meter on ② System check screen Each time the meter powers on, this screen briefly appears so that you can make sure the display is working properly.
  • Page 29 Control solution testing Performing a control test ⑤ Touch and hold the hanging drop of control solution where the narrow channel meets the TOP EDGE of the test strip. Make sure the confirmation window fills completely. Control solution should not be applied to the flat face of the test strip.
  • Page 30 • 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 results that fall outside the range printed on the test strip vial, Do Not use the meter, the test strips, or the control solution.
  • Page 31 Control solution testing ⑦ Delete the memory If you don’t want to keep the test result, press the “S” “M” button to delete it at the same time. After memory cleared, the meter will display “dEL” about 3 minutes, and then automatically turns off. ⑧...

  • Page 32: Maintenance

    Maintenance Replacing the battery Your meter comes with two preinstalled, 1.5 volt, type AAA, alkaline battery. The battery provides enough power for the meter to perform about 1000 tests. If your battery runs low, the battery symbol “ ” appears on every display screen until you change the battery. Important: When this symbol appears, you should replace the battery immediately.

  • Page 33: Caring For Your System

    Maintenance Caring for your system Avoid getting dirt, dust, blood, control solution, water, or any other liquid in the meter’s test strip port. Important: Never immerse the meter in water or any other liquid. This may cause inaccurate reading or meter malfunction. Storing your system Store your meter, test strips, control solution and other items in your carrying case after each use.
  • Page 34 Maintenance we recommend to disinfect periodically.When you assist others to make uric acid testing, If you take the meter,please disinfect it or wear gloves to protect yourself. Cleaning your meter and lancing device To clean your meter and lancing device, wipe the outside with a soft cloth dampened with water and mild detergent.

  • Page 35: Troubleshooting

    Troubleshooting Message Possible Cause What to do Remove the battery and The system check reinsert it after 30 seconds. may be failed If it still doesn’t work, please contact the vendor. The test strip may be Retest with a new strip. used or damaged.
  • Page 36 Troubleshooting Battery power is low. Replace the battery soon Place the system in The meter is out of appropriate operating operating temperature environment for 30 range. minutes before retesting.
  • Page 37 Troubleshooting Meter does not enter the test mode after inserting a test strip. Probable Cause What to Do Replace the battery (and reset the date and Battery power is low. time,if necessary.) The battery is installed incorrectly or there is no Check that the battery is installed correctly.

  • Page 38: Technical Information

    Technical information Specifications Product description UA-105 Uric Acid Monitoring System Assay method Uric acid electrochemical biosensor Measurement range 180-1190 umol/L ( 3~20 mg/dL Sample Fresh capillary whole blood from the finger Sample size ≥1.5ul Response time 20 seconds Coding Coding...

  • Page 39: Specifications

    Technical information Specifications Weight Approximate 68g, battery not included 10℃～40℃(50℉～104℉) Operating environment 10 ~ 90% RH (non-condensing) -20℃~ 55℃ ( -4℉~131℉) Meter storage environment 10 ~ 95% RH (non-condensing) 1℃~ 30℃ (33.8℉~86℉) Strip storage environment Up to 10,000 feet (3,048 meters) Altitude above sea level Hematocrit...
  • Page 40 39 37 36 39 37 38 Disposing of the meter, test strips, lancets and batteries Warning • Any product coming in contact with blood is considered contaminated (potentially infectious). • During normal testing, any uric acid meter may come in contact with blood.

  • Page 41: Limited 2-Year Warranty

    Warranty Limited 2-Year Warranty The meter is guaranteed for 2-year 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.
  • 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...

  • Page 43: Performance Characteristics

    Performance Characteristics The performance of the system has been evaluated both in laboratory and in clinical tests. Range: The display range of the meter is 180umol/L to 1190 umol/L (3mg/dL to 20 mg/dL). "HI" and "Lo" messages indicate results outside of this range. •...
  • Page 44 Performance Characteristics 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 y-intercept 24.087 correlation coefficient( R²) 24.087 To maximize your chances of an accurate comparison between meter and laboratory results, follow a few basic guidelines: Before going to the lab ·Perform a control solution test to make sure the meter is working properly.

  • Page 45: Symbol Index

    Symbol Index Consult instructions for use In vitro diagnostic medical device Serial number Caution Batch code Manufacturer ∑ Contain sufficient for < n > tests Storage temperature limitation Do not reuse Use by...
  • Page 46 Symbol Index 0123 The product conforms to the requirements of the CE mark in vitro diagnostic medical devices 0197 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...
  • Page 47 1.Kim EK, Waddel 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 Document No.: DUA-0104-002 Version:Z Date of Issue: 2019.02.02 Hangzhou Sejoy Electronics & Instruments Co., Ltd. Area C, Building 2, No.365, Wuzhou Road,Yuhang Economic Development Zone, Hangzhou City 311100 Zhejiang China Shanghai International Holding Corp.Gmbh (Europe) Eiffestrasse 80, 20537 Hamburg, Germany...

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