ApexBio AUSure II Link User Manual

Blood uric acid monitoring system

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UASure II Link Manual Cover

SIZE: W15 x H10 cm

P/N 65070000684

Rev.8/23

Distributed by

UASure USA

1679 E Orangethorpe Ave #602

Atwood, CA 92811 USA

Tel: (877) 682-7873

(Monday - Friday from 8am to 5pm PT)

Manufactured in Taiwan

Email: info@UASure-USA.com

Manufactured by

APEX BIOTECHNOLOGY CORP.

No. 7, Li Hsin Rd. V,

Hsinchu Science Park Hsinchu, Taiwan

Tel: 886-3-5641952

Fax: 886-3-5678302

E-mail: info@apexbio.com

Website: www.apexbio.com

15cm

Lancing Device

Lancets (Do not re-use. Sterilized using irradiation.)

Manufactured by

SteriLance Medical (Suzhou) Inc.

No. 168, PuTuoShan Road, New District

215153 Suzhou, Jiangsu, P.R.China

Suitable for self-testing

For In Vitro Diagnostic Use

P/N 65070000684 Rev.8/23

30cm

UASure II Link Blood Uric Acid Monitoring System

User's Guide

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Summary of Contents for ApexBio AUSure II Link

Page 1 Manufactured in Taiwan Email: info@UASure-USA.com Manufactured by APEX BIOTECHNOLOGY CORP. No. 7, Li Hsin Rd. V, Hsinchu Science Park Hsinchu, Taiwan Tel: 886-3-5641952 Fax: 886-3-5678302 E-mail: info@apexbio.com Website: www.apexbio.com Suitable for self-testing For In Vitro Diagnostic Use P/N 65070000684 Rev.8/23...
Page 2 Link UASure II Link Blood Uric Acid Monitoring System User's Guide...
Page 3 Manufactured in Taiwan Email: info@UASure-USA.com Manufactured by APEX BIOTECHNOLOGY CORP. No. 7, Li Hsin Rd. V, Hsinchu Science Park Hsinchu, Taiwan Tel: 886-3-5641952 Fax: 886-3-5678302 E-mail: info@apexbio.com Website: www.apexbio.com Suitable for self-testing For In Vitro Diagnostic Use P/N 65070000684 Rev.8/23...
Page 4 Dear UASure II Link Owner Thank you for choosing the UASure II Link Blood Uric Acid Monitoring System to help you easily monitoring your blood uric acid level. All of the information you need to use and maintain your new UASure II Link Blood Uric Acid Monitoring System is included in this manual and does not require any special training.
Page 5 Intended Use The UASure II Link Blood Uric Acid Monitoring System is intended for quantitative measurement of uric acid level in fresh capillary whole blood drawn from fingertips. Testing is done outside the body (in vitro diagnostic use). It is indicated for self-testing by individuals at home, as an aid in monitoring blood uric acid level.
Page 6: Table Of Contents
Table of Contents Understanding Your UASure II Link Blood Uric Acid Monitoring System . . . . . . . . . 5 The UASure II Link Blood Uric Acid Meter ........7 The UASure II Link Blood Uric Acid Meter Display Screen .
Page 7 Understanding Your Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Understanding Your Blood Uric Acid Test Results .
Page 8: Understanding Your Uasure Ii Link Blood Uric Acid Monitoring System
Understanding Your UASure II Link Blood Uric Acid Monitoring System Each UASure II Link system may include the following items: UASure II Link Lancets Lancing Device User Guide meter...
Page 9 Test strip/ code card/ control solutions The Uric Acid Test Strip Uric Acid Code Card Uric Acid Control Solution (vial or foil-wrapped) (Level 1, Level 2) NOTE: • Contents may change without notice. • Lancets and Lancing Device are optional components. •...
Page 10: The Uasure Ii Link Blood Uric Acid Meter
The UASure II Link Blood Uric Acid Meter Meter Display Shows your test results, memory values, average, and other messages. Enter ( ) and ▲▼buttons Press ( ) and hold to turn ON/OFF the meter, entering the Memory Mode or the Setup Menu. Press ▲...
Page 11 Micro USB Port Connect to a PC by a dedicated Micro USB cable. Code Card Port Insertion site for the uric acid code card. Battery Holder Houses CR2032 3V lithium coin cell batteries.
Page 12: The Uasure Ii Link Blood Uric Acid Meter Display Screen
The UASure II Link Blood Uric Acid Meter Display Screen CLOCK BATTERY BEEPER HAPPY FACE BLUETOOTH CODE MAIN DISPLAY AREA CONTROL SOLUTION MODE (CTL) UNIT TEMPERATURE HOUR/MINUTES BLOOD DROP TEST STRIP...
Page 13 HAPPY Face ....Indicates whether the meter electronic circuit works properly BATTERY ......Appears when the battery is low and needs to be replaced (see page 12) CLOCK ......Appears when setting date and time of the meter (see page BEEPER ......Indicates the beeper is on (see page 18) BLUETOOTH ....Indicate Bluetooth is turn on MEM ........Indicates the number in the display area is a stored test value (see page 42)
Page 14: The Uasure Ii Blood Uric Acid Test Strips
The UASure II Blood Uric Acid Test Strips Sampling End Contact Points Apply blood or control solution Insert this end to the test here strip port on the meter The UASure II Blood Uric Acid Test Strips is uric acid specific, biosensor based test strip that can test uric acid in capillary whole blood in 10 seconds and requires about only 1.5 μL of blood sample.
Page 15: Setting Up Your New System
Setting Up Your New System Inserting (or Changing) the Battery The batteries need to be inserted before using your UASure II Link Blood Uric Acid Monitoring Meter for the first time or when the “ ” icon appears on the meter display screen. Material you will need: •...
Page 16 NOTE: • After replacing the battery, the meter will automatically prompt you to check the time and date of the meter when using a test strip to turn on the meter. If setting is correct, press “ ” again to exit, or if the time and date are not correct, turn to page 15 for Setting the Clock .
Page 17: Meter Setup
Meter Setup Step 1. Make sure the meter is OFF. To turn OFF the meter, press “ ” and hold until the screen switches OFF. Step 2. Press “ ” and hold until SET appears to enter the setup menu. Step 3.
Page 18: Setting The Clock
Setting the Clock Material you will need: • Your UASure II Link Blood Uric Acid Meter Begin Set Up Step 1. Press and hold “ ” for 4 seconds to enter the setup menu. Step 2. Press ▲ or ▼ until meter display screen shows ” ”. Press ” ” to enter clock setting.
Page 19 Set Month Step 4. The current month will flash. Use ▲ or ▼ to select the correct month. Press “ ” to confirm your choice and advance to set the day. Set Day Step 5. The current day will flash. Use ▲ or ▼ to select the correct day. Press “...
Page 20 Set Minutes Step 8. The current minute will flash. Use ▲ or ▼ to select the correct minute. Press “ ” to confirm your choice and return to the setting menus. NOTE: • Anytime during setup, you may insert a test strip to begin testing. The changes you have done so far will be memorized by the meter.
Page 21: Beeper Setup
Beeper setup Step 1. Press and hold “ ” for 4 seconds to enter the setup menu. Step 2. Press ▲ or ▼ until meter display screen shows ” ”. Press ” ” to enter beeper setting. Step 3. Use ▲ or ▼ to turn on/off the tone sound. Press ” ” to confirm and return to the setting menus.
Page 22: Coding The Meter
Coding the Meter You must code the meter before you begin uric acid testing on your UASure II Link Blood Uric Acid Meter. Coding is a process of programming the meter to the new of uric acid test strips and to ensure accurate test results. A new code card is packaged along with each box of UASure II Blood Uric Acid Test Strips.
Page 23 Step 2. Verify that the code number on the code card matches the code number on the test strip package. TAS3858 Code 2021-12-30 Exp. Step 3. Insert the code card into the code card port located on the top of the meter.
Page 24 Step 4. Insert a UASure II Blood Uric Acid Test Strip with the blood sample reaction zone facing up to turn ON the meter automatically. Make sure the test strip contact point is fully inserted into the meter. Close the test strip vial immediately after you've taken out a test strip.
Page 25: Control Solution Testing
Control Solution Testing (Optional) Performing a Uric Acid Control Solution Test The purpose of the uric acid control solution testing is to validate the performance of the UASure II Link Blood Uric Acid Monitoring System using the testing solution with a known range of uric acid.
Page 26 Materials you will need: • UASure II Uric Acid Control Solution(Level 1 and Level 2) • Your UASure II Link Blood Uric Acid Meter • A new UASure II Blood Uric Acid Test Strips • A uric acid code card IMPORTANT: •...
Page 27 IMPORTANT: • Do not use a test strip that has expired. Check the expiration date which is printed on the test strip bottle (for vial test strip) or box (for foil-wrapped test strip). • Use each test strip immediately after removing it from its package. •...
Page 28 Step 2. Insert a UASure II Blood Uric Acid Test Strip with the blood sample reaction zone facing up to turn ON the meter automatically. Make sure the test strip contact point is fully inserted into the meter. Close the test strip vial immediately after you've taken out a test strip. Step 3.
Page 29 Step 5. Squeeze a drop of uric acid control solution (Level 1 or Level 2) onto a clean, dry, non-absorbent surface. Do not apply control solution to the test strip directly from the bottle. Replace the bottle cap on the control solution bottle immediately after use.
Page 30 Step 9.-uploading data When the meter is paired with a portable device the test results are uploaded to the device. The test results are uploaded to the device and the Bluetooth symbol flashes. After the transfer is complete, the Bluetooth symbol disappears. (BLE Transmission completed) mg /dL...
Page 31 Step 10. The meter will automatically turn off by pressing the eject switch or by pulling the test strip out by hand. Throw the used strip into the appropriate waste basket. The meter will also automatically turn off after 1 minute of inactivity. IMPORTANT: •...
Page 32: Control Solution Test Trouble Shooting
Control Solution Test Trouble Shooting If your control solution testing is out of range (too high or too low), it may be caused by the following: Possible Causes What you can do … Wrong brand of control Make sure you are using UASure II Uric Acid solution being used Control Solution(Level 1 &...
Page 33 Possible Causes What you can do … Check the expiration and opened date on bottles Expired or contaminated of both control solution and test strips. Repeat the control solution or damaged test using a new test strip. If the result is still out test strips of range, use a new bottle of control solution and retest.
Page 34: Testing Your Blood Uric Acid
Testing Your Blood Uric Acid Materials you will need: • Your UASure II Link Blood Uric Acid Monitoring Meter • A new UASure II Blood Uric Acid Test Strips • A uric acid code card • Lancing device with a sterile, unused lancet Before you begin, make sure: •...
Page 35: Preparing Your Lancing Device
Preparing Your Lancing Device CAUTION: • The lancets are for single use only. • DO NOT share your lancing device or lancets with other people. Sharing or reusing lancets can lead to disease transmission. • Discard used lancet according to your local regulations. Used lancets are biohazard materials and can transmit blood-borne diseases.
Page 36 Step 3. Hold the lancing device (puncture) or lancet against the puncture site and lance it. Follow manufacturer’s instruction for how the lancing device (puncture) or lancet should be used. TIP: • To avoid soreness, select a site on the side of your fingertips. To avoid calluses, choose a different site each time for obtaining the blood sample.
Page 37: Performing A Blood Uric Acid Test
Performing a Blood Uric Acid Test Step 1. You must code the meter before performing a blood uric acid test, see Coding the Meter on page 19. TAS3858 Code 2021-12-30 Exp. Step 2. Insert a UASure II Blood Uric Acid Test Strip with the blood sample reaction zone facing up to turn ON the meter automatically.
Page 38 • Do not use wet or damaged test strips. • Keep away from direct sunlight and heat. Store the test strip bottle in a dry, cool place. • For vial test strip, record the “date opened” on the bottle label. Discard the bottle and any remaining test strips three months after the date of opening.
Page 39 Step 5. Gently bring the test strip and touch the drop of blood at a slight angle. The test strip acts like a straw to pull the blood in. Keep the test strip in the blood drop until the meter beeps to indicate the test strip has enough blood to test.
Page 40 Step 7. -uploading data Bluetooth is always on. When the meter is paired with a portable device and the app is open, the test results are uploaded to the device. The test results are uploaded to the device and the Bluetooth symbol flashes. After the transfer is complete, the Bluetooth symbol disappears.
Page 41 Step 9. Remove the used lancet from your lancing device according to instructions and discard it into a proper wastebasket. IMPORTANT: • Used lancets and strips are biohazard materials and can transmit blood-borne diseases. Please follow your local healthcare provider's recommendation regarding proper disposal of used lancets and strips.
Page 42: Understanding Your Test Results
Understanding Your Test Results Understanding Your Blood Uric Acid Test Results Uric acid in your body may fluctuate over time. Your test results may also vary because of several factors. Some of these factors include but are not limited to the following: •...
Page 43 Food High in Purines Very high: Hearts, herring, mussels, yeast, smelt, sardines, sweetbreads Moderately high: Anchovies, grouse, mutton, veal, bacon, liver, salmon, turkey, kidneys, partridge, trout, goose, haddock, pheasant, scallops Normal Blood Uric Acid Readings Target blood uric acid levels are as follows: Male: 4.0~8.5 mg/dL Female: 2.7~7.3 mg/dL High Blood Uric Acid Readings...
Page 44 Low Blood Uric Acid Readings No significant symptoms or diseases are found related to low blood uric acid. Contact your physician for more information if you get low uric acid reading. Frequency of Testing How often you need to test your blood uric acid will vary according to your age, your diet, the medication you are taking, and your physical and emotional health.
Page 45: Viewing Stored Readings From Memory
Viewing Stored Readings from Memory Uric Acid Test Results from Memory Your UASure II Link Blood Uric Acid Meter can store up to 200 uric acid test and control results with date and time. You will need to set your meter’s date and time before using the memory, see Setting Up Your New System on page 15.
Page 46 Step 4. Press and hold “ ” to switch the meter off or OFF. NOTE: • Control testing results will be flagged by a “ctl” icon when viewing stored readings. • When the memory is full, perform a new test will deleted the oldest test result.
Page 47: Upload Data
Upload Data Test results stored in the UASure II Link Blood Uric Acid Meter’s memory can be transmitted to your personal computer or mobile devices. Material you will need: • Your UASure II Link Blood Uric Acid Meter • A dedicated micro USB cable Step 1.
Page 48: Caring For The Meter
Caring for the Meter Caring your UASure II Link Blood Uric Acid Meter is easy. Follow these simple guidelines to keep your UASure II Link Blood Uric Acid Meter working properly. Cleaning the Meter • If the meter gets dirty, wipe the surface of the meter using a moist (NOT WET) lint- free cloth dampened with a mild detergent.
Page 49: Storage And Precautions
Storage and Precautions • Handle the meter with care; severe shock, such as dropping the meter, could damage the electronics. • The meter and the test strips are designed to be used within the environment between 10°C~38°C(50°F~100°F) and 20%~85% RH. •...
Page 50: Solving Problems
Solving Problems This section details the significant display screen messages and error codes you may encounter when using your UASure II Link Blood Uric Acid Monitoring Meter with UASure II Blood Uric Acid Test Strips. Message What It Means What You Should Do •...
Page 51 Message What It Means What You Should Do • Repeat the test with a new test strip. Not enough sample on Testing Your Blood Uric Acid on page the test strip to start Test strip removed during • Turn off the meter and repeat the test countdown with a new test strip.
Page 52 Message What It Means What You Should Do • Make sure the clock is set correctly. To reset the date & time, please remove the battery from the meter for at least 1 minute. Reinsert the battery, press and hold or insert an unused test strip to turn ON the meter, and set Code card shows the date the clock starting with the year.
Page 53 Message What It Means What You Should Do Data transmission is • When the Bluetooth function is turned interrupted by inserting on again, untransmitted data is the test strip transferred to the portable device. Data transmission is • When the Bluetooth function is turned interrupted by the portable on again, untransmitted data is device...
Page 54 Message What It Means What You Should Do • Move the meter into an area that is between 10˚C~38°C (50°F~100°F) Temperature out of range and 20~85% RH for uric acid test, and allow 10 to 15 minutes for it to reach the new temperature •...
Page 55 Message What It Means What You Should Do • Check if the date and time on your meter is set up. See Setting Up Your New System on page 12. • Start testing your blood uric acid, see No memorized uric acid Testing Your Blood Uric Acid on page test results in the meter •...
Page 56: Product Warranty
Product Warranty UASure USA warrants the UASure II Link Blood Uric Acid Monitoring Meter to be free of defects in workmanship and materials under normal use for a period of five (5) years from the date of purchase to the consumer. The liability of Apex Biotechnology Corporation is limited to repair or replacement and in no event shall UASure USA be liable for any collateral or consequential damages or loss.
Page 57: Specifications
Specifications Product: UASure II Link Blood Uric Acid Monitoring System Tested items: Blood uric acid level; Test strip coding: Coding required Sample Fresh capillary whole blood from fingertips Test range: 3~20 mg/dL Hematocrit Range: 20~60 % Sample size: Minimum 1.5 μL Test time: 10 seconds Batteries:...
Page 58 Automatic turn off: • After 90 seconds of inactivity before the test (sensor strip inserted into the meter, drop icon flashing) • After 60 seconds of inactivity after testing and setup Electromagnetic Compatibility: The UASure II Link meter complies with the electromagnetic requirements specified in IEC 60601-1-2 Edition 4.0 including selected electrostatic discharge immunity testing based on the basic standard IEC 61000-4-2.
Page 59 Wireless Technology : Bluetooth 5, with the operating characteristics as following: • Radio Frequency Band: 2.4 GHz–2.483 GHz • Maximum Radio Transmitter Power: 4 dBm • Security Encryption: 128-bit AES (Advanced Encryption Standard) CCM, ECB,AAR • The transmitted distance between the meter and the mobile device : within a range of 10 meters.
Page 60: Supplies
Supplies S95048 UASure II Link Blood Uric Acid Monitoring System (Complete Kit) S95049 UASure II Link Blood Uric Acid Monitoring System (Basic Kit) S5640993 UASure II Blood Uric Acid Test Strip (25s, Vial) S5640994 UASure II Blood Uric Acid Test Strip (50s, Vial) S5640995 UASure II Blood Uric Acid Test Strip (5s, Foil Packets) S5640996 UASure II Blood Uric Acid Test Strip (10s, Foil Packets) S5640997 UASure II Blood Uric Acid Test Strip (25s, Foil Packets)
Page 61: Uasure Ii Link Blood Uric Acid Contents
UASure II Link Blood Uric Acid Contents Confirm that the system contains the following items: Lancing Control Product Ref. Meter Lancet Strip Device Solution Complete Kit S95048 Basic Kit S95049...
Page 62: Federal Communications Commission Interference Statement
Federal Communications Commission Interference Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Page 63 RF exposure warning The equipment complies with FCC RF exposure limits set forth for an uncontrolled environment. The equipment must not be co-located or operating in conjunction with any other antenna or transmitter. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

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