Kinetik WELLBEING BG-710 Blood Glucose Monitoring System Instruction Manual

Instruction Manual Blood Glucose Monitoring System
REF BG – 710

Introduction

• Peel off the insulation film from battery compartment before first use.
  Thank you for purchasing the Kinetik Wellbeing BG-710 Blood Glucose Monitoring System.
  Before you start testing, carefully read this Instruction Manual.
  Intended Use
  The Kinetik Wellbeing BS-602 Test Strips are used with the Kinetik Wellbeing BG-710 Blood Glucose Meter to measure blood glucose with fresh capillary whole blood for self-testing. The blood glucose concentration of venous blood or neonatal blood is to be measured by healthcare professionals. The fresh capillary whole blood should be collected from your fingertip and neonatal blood collected from the heel. The system is intended for in vitro diagnostic home-use or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. This system is not for use in the diagnosis of diabetes mellitus.
  Test Principle
  The strip measures glucose by using amperometric technology employing a glucose dehydrogenase reaction. When whole blood or control solution is drawn into the tip of the test strip, glucose in the sample reacts with chemicals and produces an electrical current.
  The meter measures electrical current and calculates amount of glucose. The glucose result is displayed as a calculated plasma value.
  Venous whole blood and neonatal blood sample collection and preparation should be obtained by healthcare professionals.
  Important Safety information
  Warning
  

  • During normal testing, any blood glucose 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 disinfection.

  • The meter and lancing device should never be used by more than one person. Do not share the meter and lancing device with anyone, including family members, due to the risk of infection from blood-borne pathogens.

  • Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all, blood-borne pathogens.

  • If 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 to handles 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 and disinfected.
    Clean and disinfect the lancing device once per week to remove visible dirt or other material for safe handling and/or prior to disinfecting.
    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 included. Keep away from children.

  • Strong electromagnetic fields may interfere with the proper operation of the meter. Do not use this meter close to sources of strong electromagnetic radiation.

  • To avoid electrostatic discharge, do not use the meter in a very dry environment, especially one in which synthetic materials are present.

  • Patients undergoing oxygen therapy may receive inaccurate results.

  • Some people with diabetes do not experience symptoms of low blood sugar (hypoglycemia). Others, such as children or people who are unconscious or have certain disabilities, may not be able to communicate their symptoms to caregivers. For these reasons, do not change any treatment without first talking to your doctor

  • Runa control test when you open a new box of test strips or if you think that your test result is incorrect. Running a control testlets 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 blood glucose result doesn’ t match how you feel and you have followed the instructions in this manual, follow your doctor’s instructions, or call your doctor.

  • Children should be taught how to use the meter and any other medical products appropriately.

  • Being severely dehydrated or losing a lot of water may give you false (low) test results. If you think you’re suffering from dehydration, call your doctor right away.

  • If you have followed all the instructions in this booklet and still have symptoms that don’t seem to match your test results — or if you have questions — talk to your doctor.

  • The system is designed for use with fresh caillary whole blood and or venous blood and or neonatal blood.

  • Inaccurate test results may be obtained at high altitude more than about 3048 meters above sea level.

  • BS-602 blood glucose test strip: more than 70% of the hematocrit ratio will affect the measurement results. Please contact your doctor to determine your hematocrit ratio.

  • Some substances may cause false results with enzymatic tests.

Limitations
The interference listed below have been tested and shown no apparent influence on results at the normal or higher therapy levels.

Other interfering substances in EN ISO 15197 : 2015 Annex A are not verified, it may also affect the test results.
Alternative Site Testing (AST)
Alternative Site Testing (AST) means you can use parts of the body other than your fingertips to check your blood glucose levels. The system allows you to test from the palm, forearm, calf, or thigh.
WARNING

• Ask your health care professional if Alternative Site Testing(AST) is right for you.
• Do not calibrate a continuous glucose monitoring device from an AST result.
• Do not calculate an insulin dose based on an AST result.

Your meter can be used for fingertip or AST testing.
Do not use AST under the following conditions:

• If you think your blood sugar is low.
• When blood sugar is changing rapidly, such as after a meal, after an insulin dose,or during or after exercise.
• If you are unable to feel symptoms of low blood sugar(hypoglycemic unawareness).
• If you get alternative site blood sugar results that do not agree with how you feel.
• During illness or times of stress.
• If you will be driving a car or operating machinery.

Alternative site results may be different from fingertip results when glucose levels are changing rapidly (e.g.,after a meal, after taking insulin, or during or after exercise). Additionally, glucose levels may not rise as high or fall as low as levels in the fingertip. As such, fingertip results may identify hypoglycemic levels sooner than alternative site results. Alternative Site Testing is recommended only when itis more than 2 hours after a meal, diabetes medication, or exercise.
Minors who cannot complete blood collection on their own need to do it with the help of a guardian or professional.

Getting to know your system

INCLUDED IN YOUR KIT
a. Meter (2 x AAA Batteries included)
b. Test Strips
c. Lancing Device
d. Sterile Lancet
e. Control Solution
f. USB data cable
** Manufacturer of Lancing Device and Sterile LancetShandong Lianfa
Medical Plastic Products Co.. Ltd.No.1
Shuangshan Sanjian Road, 250200, Zhangqiu City, Jinan, Shandong,
PEOPLE’SREPUBLIC OF CHINA
Shanghailnternational Holding Corp. GmbH (Europe)EC| REPEiffestrasse 80, 20537 Hamburg Germany
CE:for lancing device; 0123 for sterile lancet
** Beijing Ruicheng Medical Suplies Co., Ltd.
No. 558 Zhangzikou, Yangsong Town, Huairou District, 10400 Bejing, China Lotus NLB.V.
EC REPKoningin Julinaplein 10, le Verd,2595AA, The Hague, Netherlands.
CE:for lancing device; 0197 for sterile lancet
WARNING: Keep the meter and testing supplies away from children.
Small items such as the battery cover, batteries, test strips, lancets, protective covers of the lancets, and control solution vial cap are choking hazards.
In-door glucose measurement is recommended.
a. MeterContact Bar: Insert it into strip port. Push it all the way until it goes no further.
Top Edge: Apply blood sample here
Confirmation Window: Sample checking area
Important: the meter should only be used with BS-602 test strips.
Using other Test strips with this meter can produce inaccurate results.
Important Test Strip Information

• The system has an operating range of 5’C~45°C (41 ~113F).
• Store the test strip package in a cool, dry place between 1’C~30°C (33.81 ~86 TF).
• 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, immediately close the vial cap tightly.
• With clean, dry hands, you may touch the test strip anywhere when removing it from the vial or inserting it into the meter.
• Do not use test strips beyond the expiration date. This may cause inaccurate results.
• Do not bend, cut, or alter test strips.

Warning: The cap or vial contains drying agents that may be harmful if inhaled or swallowed and may cause skin or eye irritation.

Setting up your meter

When using the meter for the first time, please set the parameters of the meter. With the meter off, press and hold the side DOWN button to enter setting mode.

1. Set the year
   Press and release the side UP button or side DOWN button to cycle forward or backwards through the years.
   After the year is confirmed, press the “M* button to set. The month figure will begin to flash.

2. Set the month
   Press and release the side UP button or side DOWN button to cycle forward or backwards by one month until the correct month appears. After the month is confirmed, press the “M” button to set. The day figure will begin to flash.

3. Set the day
   Press and release the side UP button or side DOWN button to cycle forward or backwards by one day until the correct day appears. After the day is confirmed, press the “M” button to set. The hour figure will begin to flash.

4. Set the hour
   Press and release the side UP button or side DOWN button to forward or backward one hour until the correct hour appears.
   After the hour is set, press button “M’, the minute figure is flashing automatically.

5. Set the minute
   Press and release the side UP button or side DOWN button to forward or backward one minute until the correct minute appears. After the minute is set, press button “M’, the time format figure will appear.

6. Set the time format
   The meter can display the time in either an AM/PM (12-hour) or a 24:00 (24-hour) format. Press and release side UP button or side DOWN button to select the format.
   With the preferred time format on the display, press button “M” to enter the low blood glucose alarm function setting.

7. Setlow blood glucose alarm function
   Press and release the side UP button or side DOWN button to select the low blood glucose alarm function. If select “On”, press “M” button to enter low blood glucose value setting. If select “OFF”,press “M” button to go on to high blood glucose alarm function setting.

8. Set low blood glucose alarm threshold
   Press and release the side UP button or side DOWN button to select one value. Press until the correct value appears.Press “M” button to enter high blood glucose alarm function setting.

9. Set high blood glucose alarm function
   Press and release the side UP button or side DOWN button to select the high blood glucose alarm function, if select “On”,press “M” button to enter high blood glucose alarm concentration value setting. If select “OFF”, press “M” button to go on to “Alarm clock” function setting.

10. Set high blood glucose alarm threshold
    Press and release the side UP button or side DOWN button to select one value. Press until the correct value appears. Press “M” button to enter “Alarm clock” function setting.

11. Set the alarm clock
    The meter can set 6 alarms. These alarms can be used to remind you to take a glucose measurement. Press the side UP button or the side DOWN button to select which alarm to set, press the “M” button to confirm the alarm you selected, press the side UP button or the side DOWN button to turn on/off the alarm clock. If itis on, press the M button to  witch to the alarm clock. For time setting, refer to steps 4 and 5. After setting, press “M” button to enter the next alarm setting until all alarm settings are completed. lf the alarm is off, skip the current alarm setting.
    Finally, press the “M’ key to exit the setting mode. In any setting stage of the setting mode, press and hold the “M” key for three seconds to directly shut down. If not, the device will automatically shut down after 3 minutes without use.

Computer connection

You can measure your blood glucose and then save and send measurement data to a laptop or computer.

1. Install GlucoJoy software. You can find this software on kinetikwellbeing.com/blood-glucose-monitors/blood-glucose-monitoring-system
2. Download the GlucoJoy User Guide
3. Open GlucoJoy and follow instructions to import data from glucose meter.
4. Open GlucoJoy and follow GlucoJoy User Guide to import data from glucose meter.
   Note: Measurement data does not clear from meter once data has been imported onto laptop/desktop.

Testing your blood glucose

Preparing the lancing device
Warning

• During normal testing, any blood glucose 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 disinfection’?
• The meter and lancing device should never be used by more than one person. Do not share the meter and lancing device with anyone, including family members, due to the risk of infection from blood-borne pathogens.
• Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all, blood-borne pathogens.
• If 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 and disinfected. 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.
• You must not insert the lancet cap into the lancing device and simultaneously press the release button or hold the lancing device with the release button resting on a surface such as on the table. This could release the lancet and inadvertently cause injury.

Preparing the lancing device

1. Screw 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 off the lancet.

4. Put on the lancing device cap.
   Avoid touching the trigger button.

5. Adjust the depth setting a The indication marks 5 levels of skin penetration. Switch the lancing device cap  to the desired setting.
   Note: To select the best depth:
   1-2 for soft or thin skin
   3 for average skin
   4-5 for thick or calloused skin

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. Release sliding barrel to return it to its original position.

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 tip against the side of the finger. Press the trigger button, and then lift the lancing device away from the finger after the puncture is complete. Place the lancing device aside and wait a few seconds for a blood drop to form.

3. Gently squeeze your finger until you get a round drop of blood. Discard the first drop.
   Do not use, if the blood is smeared or running.
   Wipe the area and gently squeeze another drop of blood or puncture a new site.

Blood Sampling
IMPORTANT:

• Use only Test Strip BS-602.

• Make sure your meter and test strips are about the same temperature before you test.

• Testing must be done within the operating temperature range 5°C~45°C (41°F ~113°F).
  For the most accurate results, test at room temperature 20°C~25°C (68°F ~77°F ).

• Tightly close the cap on the vial immediately 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 applied to it.
  Test strips are for single use only.

• Write the date that the vial was opened on the vial label when you first open it. Discard the vial 6 months after first opening.

Testing

1. With meter off, insert a test strip to enter into testing mode. The meter will automatically switch to testing mode after inserting a test strip, even if you are in setting mode or memory 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.
   Important: The meter should only be used with BS-602 test strips.

2. System check screen
   The screen will briefly display all content to confirm that the display is working properly. Note:
   • lf appears, it indicates that the operating temperature is out of range. Place the system in room temperature for half hour. Then test again.
   • lf appears, it indicates that the battery is almost empty. Replace the battery now.

3. Pre/post meal marker settings
   Pre/post meal markers provide more details on the test results of your blood glucose before and after meals.
   Press and release the “M” button to select the meal marker fuction. Default is no marker.

4. When the blood drop symbol that you need flashes on the display screen. Your meter is now ready to apply blood sample.

5. 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.
   • 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.

6. 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 blood. Now you can move the test strip away from the blood drop and wait for the meter to count down from 5 to 1 with 1 beep-sound indicating the end of test.

7. Read your result on the meter
   After the measurement Is over, the meter will display the blood glucose level along with the unit of measure, the date and time of the test. Also the test results will show a smiling face within the range or a crying face outside the range. Blood glucose results are automatically stored in the meter’s memory .

8. Colorful indicator bar
   The colorful indicator bar displays a color representing your result value. Red/Green/Yellow bar represent Low/Normal/ High value.

9. Turn your meter off
   Push the eject button gently to automatically eject the test strip from the meter, or remove the test strip by hand, the meter will automatically shut down. Please handle the used test strip carefully.

Interpreting unexpected test results
The meter can accurately measure blood glucose concentrations between 0.5 to 33.3mmol/L (9 to 600mg/dL)
Expected Blood Glucose Level [ 1,2, 3]:

Source:

1. Clin Chem 51,2005:1573-1576;
2. Stedmans Medical Dictionary,27/th Edition,2000:2802;
3. American Diabetes Association: Standard of Medical Care in Diabetes 2019, Vol.39.

Refer to the following cautions whenever your test results are lower or
higher than what you expect.

1. Low glucose results
   • If your test result is lower than 0.5mmol/L(9mg/dL),
   • Lo will appear on the meter display screen. Interpreting unexpected test results

2. High glucose results
   If your test is above 33.3mmol/L(600mg/dL ), HI Wg 08:08 will appear on the display screen.
   • HI Reading with Symptoms
   If you feel symptoms such as fatigue, thirst, excess urination, or blurry vision, then follow your doctor’s recommendation to treat hyperglycemia.
   • HI Reading without Symptoms
   If you get a HI reading, but have no symptoms of high blood glucose, then retest with a new test strip. If you still get a HI reading, follow your doctor’s recommendation to treat hyperglycemia.

3. Unusual hematocrit
   • Too high (above 70%) hematocrit can cause inaccurate results.
   Please contact your doctor to determine your hematocrit ratio.

Comparing Your Meter result to a Laboratory result

Comparing your meter’s results with laboratory results periodically.
The results of the Kinetik Wellbeing BG-710 meter are plasma equivalent.
This method will help you and your healthcare professional compare your meter results with laboratory test results. The Kinetik Wellbeing BG-710 meter’s test result and laboratory test results both are expressed in plasma- equivalent units. However, your blood glucose meter result may differ from your laboratory result due to normal variation. Your blood glucose meter results can be affected by factors and conditions that do not affect laboratory results in the same way ¢ If your blood glucose is below 5.55mmol/L (100mg/dL), your results generally should fall within +0.83mmol/L (+15mg/dL) of the laboratory result.

• If your blood glucose is equal to or over 5.55mmol/L (100mg/dL), your results generally should fall within +15% of the laboratory result.
  To maximize your chances of an accurate comparison between meter and laboratory results, please follow a few basic guidelines:

Before going to the lab

• Perform a control solution test to make sure the meter is working properly.

• Do Not eat for at least eight hours before you test your blood glucose.
  While at the lab

• Perform your meter test within 15 minutes from the lab test.

• Use fresh capillary blood obtained from the fingertip, venous blood, neonatal blood.

• Follow all instructions in this Instruction Manual to perform a blood glucose test by your meter.

Memory and averages

Storing Blood glucose Test results
The meter automatically stores up to 1000 blood glucose 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. Setting the correct time and date helps ensure appropriate interpretation of stored blood glucose results.

1. Enter Memory Mode
   Start with the meter off (no test strip inserted). Press and release the “M” button to enter memory mode.

2. View previous memory in order
   Short press the side UP button or side DOWN button to scroll forward or backward to all results. Your most recent result will display first.
   Note: If there is no test result stored, the meter will display “ ” for a few seconds then automatically turn off.

3. View 7-, 14-, 28-day average
   The meter will average your results every 7 days. You will be shown your latest 7 day, 14 day and 28 day result average. Press and hold the side UP button for 3 second to enter the average value display.
   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 if you are viewing your 7, 14 or 28 day average.

4. Exit
   In memory mode, press and hold the “M” button for few seconds until the meter turns off.

Control solution testing

When to perform a control test
Control Solution contains a specific amount of glucose and is used to check that the meter and the test strips are working properly.
Do acontrol solution test:

• Whenever you open a new vial of test strips.

• Whenever you want to check if you are testing correctly.

• If you suspect the meter and test strips are not working properly.

• If you have had repeated unexpected blood glucose results.

• If you drop or damage the meter.

• If you left the test strip container open or you think the test strips have been damaged.

• If the test strips were stored in extreme temperatures and/or humidity

• Your test result does not match how you feel.
  NOTE:

• Only use the Kinetik Wellbeing 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 after the first open date or the expire date on the vial label, whichever comes first.

• Do not use control solution that exceeds the expired date or discard date.

• Refer to the control solution label for control solution storage conditions.

• The control solution can stain fabric.
  Remove stains by washing with soap and water.

CAUTION: Do Not swallow control solution. It is not for human consumption. Do Not apply control solution to the skin or eyes as it may cause irritation.
Performing a control test

1. Insert a test strip to turn the meter on

2. System check screen
   The screen will briefly display all content to confirm that the display is working properly.

3. The blood drop symbol flashes on the display screen.
   Your meter is now ready to apply blood sample.

4. 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.

5. Touch and hold the hanging drop of contro 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.

6. Read the result on the meter
   When the confirmation window is full, the meter will count down from 5 to 1. After the measurement is over, the meter will display the blood glucose level along with the unit of measurement, the date and time of the test. Understanding out-of-range control test results
   Compare the result displayed on the meter to the control solution range printed on the test strip vial. Each control solution have a different control solution range. Out-of-range results may be due to:
   • not following the instructions detailed in steps 1–6
   • expired or contaminated control solution
   • expired or damaged test strip
   • use of a test strip or control solution that passed its discard date
   • a problem with the meter.
   CAUTION: The control solution range printed on the test strip vial is for Kinetik Wellbeing Control Solution only. It is not a recommended range for your blood glucose 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. Contact the vendor.

7. Turn your meter off
   Push the eject button gently to automatically eject the test strip from the meter, or remove the test strip by hand, the meter will automatically shut down. Please handle the used test strip carefully.

Maintenance

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

1. With the meter off, open the battery cover.
2. Remove the old batteries and insert new, non-rechargeable batteries.
3. Put the battery cover back into position until it locks into place.
4. 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.

Please dispose of the waste batteries according to the local regulations
Meter maintenance
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. Store each item in a cool, dry place.
Test strips and control solution should be stored between 1 °C~30°C (33.8°F ~86°F ). Meter and other items should be stored between -20°C~ 55°C (-4°F~131°F).
Do Not refrigerate. Keep all items away from direct sunlight and heat.Tightly close the cap on the test strip vial and/or control solution vial immediately after use to avoid contamination or damage. Store test strips only in their original 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.
Cleaning and disinfection
Cleaning and disinfection are different, both should be performed.
Cleaning is a part of normal care and maintenance that should be performed prior to disinfection, but cleaning does not kill germs.
Disinfection is a important way to reduce your exposure to disease.
Even though you are the only person using it,
We recommend to disinfect periodically. When you assist others to make blood glucose testing with 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 damped with water and mild detergent. Do not use alcohol or another solvent. Do not get any liquids, dirt, dust, blood, or control solution inside the meter through the strip port. Never spray cleaning solution on the meter or immerse it in any liquid. Do not immerse the lancing device in any liquid.
Disinfecting your meter and lancing device
The meter and lancing device should be disinfected periodically.
Clean your meter and lancing device prior to disinfecting.
To disinfect, prepare a solution of 1 part household bleach and 9 parts water. Hold the meter with the strip port down. Use a soft cloth damped with this solution to wipe the outside of the meter and lancing device. Be sure to squeeze out any excess liquid first.
After wiping, cover the surface you are disinfecting with the soft cloth damped with the bleach solution for 1 minute. Then wipe with a clean soft cloth and wait until it dries.
Wash hands thoroughly with soap and water after handling the meter and lancing device.

seconds.
If it still doesn’t work, please contact the vendor.
| The test strip may be used or damaged.| Make sure that the strip model is correct and retest with a new strip.
| The sample was applied before the meter was ready.| Repeat with a new strip.
Applying blood after the symbol flashes on the screen.
| The test strip may be moved during testing
or insufficient blood volume used.| Retest with a new strip. Make sure that the method of
applying symbol is correct, and test strip can not be moved during testing.
| The strip check has problem| Make sure that the strip model is correct and retest with a new strip.
| Battery power is low.| Replace the battery soon
| The meter is out of operating temperature
range.| Place the system in a appropriate operating environment for 30 minutes before retesting.

Troubleshooting

Meter does not enter the test mode after inserting a test strip.

Probable Cause| What to Do
Battery power is low.| Replace the battery (and reset the date and time, if necessary. )
The battery is installed incorrectly or there is no battery in the meter.| Check that the battery is installed correctly.
Test strip inserted upside down, or incompletely inserted
into the meter.| Check that the test strip is inserted correctly.
Defective meter or test strips.| Contact Kinetik Wellbeing.
Blood or foreign objects put into the test strip port.| Contact Kinetik Wellbeing.
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.| Remove the test strip, and repeat the test using a new test strip. Wait until you see the blood and test strip symbols on the display screen before you apply the blood sample.
Defective meter or test strips.| Contact Kinetik Wellbeing

Tecnical Information

Specification

10-90% RH (non-condensing)
Meter storage environment| -20°C∼55°C (4°F∼131°F)
10∼95% RH (non-condensing)
Strip storage environment| 1°C∼30°C (33.8°F∼86°F)
Altitude| Up to 10,000 feet (3,048 meters)
above sea level
Hematocrit| 0%∼70%
Shelf life| Three years

Electromagnetic Compatibility
This meter meets the electromagnetic immunity requirements as standard
EN ISO 15197 : 2015. The chosen basis for electrostatic discharge immunity testing was basic standard EN 61326 : 2013. It meets the electromagnetic emissions requirements as standard EN 61326. Its electromagnetic emission is thus low. Interference from the meter to other electrically-driven equipment is not anticipated.

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 blood glucose meter may come in contact with blood.
• Lancing devices may also be considered sharps. For disposal of sharps, refer to local regulations.

Refer to any laws or ordinances relating to the disposal of sharps and/or contaminated products. Contact your local health department 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 that the meter is potentially hazardous electronics scrap (e-scrap) and should be disposed of accordingly. The batteries are potentially hazardous also and should be disposed of accordingly.

• Disinfect the meter before recycling or disposing.

• 29 CFR 1910.1030 – Blood-borne pathogens

• Directive 2002/96/EC — Directive on waste electrical and electronic equipment (WEEE)

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. Battery is not included in the warranty.
Traceability
The traceability of the control solution is referenced to the YSI2500 Biochemistry Analyser. The YSI2500 Biochemistry Analyser is the reference method used to assess the accuracy with which glucose results are obtained using the system. The value of the glucose is traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 917c (D-Glucose).
Concentration: 200 mg/dL

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 0.5mmol/L to 33.3 mmol/L (9mg/dL to 600 mg/dL). “HI” and “Lo” messages indicate results outside of this range.
Accuracy: The accuracy of the system was assessed by comparing blood glucose results from fresh capillary whole blood obtained by patients with those obtained using a YSI Glucose Analyser, a laboratory instrument.
Table1. System accuracy results for glucose concentration <5.55 mmol/L (100 mg/dL)

Within ±0.28mmol/L
(Within ±5mg/dL)| Within ±0.56mmol/L
(Within -±10mg/dL)| Within ±0.83mmoI/L
(Within -±15mg/dL)
---|---|---
128/174 (73.6%)| 174/174 (100.0%)| 174/174 (100,0%)

When the blood glucose is below 5.55mmol/L(100mg/dL), 100% of measured glucose results should fall within +0.83mmol/L (+15 mg/dL) of the laboratory result.
Table2. System accuracy results for glucose concentration 25.55mmol/L (100 mg/dL)

When the blood glucose is equal to or above 5.55mmol/L(100mg/dL), 100% of measured glucose results should fall within +15 % of the laboratory result.
Table3. System accuracy results for glucose between 0.5 mmol/L (9 mg/dL) and 33.3 mmol/L (600 mg/dL)
Within +0.83mmol/L or +15%
(Within t15mg/dL or +15%)
600/600(100%)
This study shows that the system compares well with a laboratory method and meets the minimum acceptable performance criteria defined in EN ISO 15197 : 2015.
Precision:
The repeatability evaluation performed with venous whole blood and the intermediate precision evaluation performed with control materials.

Intermediate Precision| Control Solution av 2.4mmol/L SD=0.13mmol/L
Control Solution av 7.5mmol/L CV=3.1%
Control Solution av 20.8mmol/L CV=2.5%
---|---
Repeatability| Blood av 2.4mmol/L SD=0.13mmol/L
Blood av 5.0mmol/L SD=0.18mmol/L
Blood av 7.5mmol/L CV=3.3%
Blood av 12.2mmol/L CV=2.4%
Blood av 20.8mmol/L CV=2.4%

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.

• Do Not eat for at least eight hours before you test your blood.

• Take your meter with you to the lab.
  While at the lab

• Conduct your meter test within 15 minutes of the lab test.

• Use fresh capillary blood obtained from the fingertip, venous blood, neonatal blood.

• Follow all instructions in this Owners Booklet for performing a blood glucose test with your meter.

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
| Storage humidity limitation
| The Product conforms to the requirements of the EC
Directive IVDD (98/97/EC) on in vitro diagnostic medical devices “xxxx” is the identification number of notify body
---|---
| Keep dry
| Please dispose of the waste according to the local regulations
| Direct Current
| European Authorized Representative

Appendix

1. Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Blood-borne Pathogens: Initial Communication, (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
   Accessed June 8, 2011

2. CDC Clinical Reminder: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood-borne Pathogens, (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
   Accessed June 8,2011

3. Healthcare Infection Control Pratices Advisory Committee (HICPAC), William A. Rutala, Ph.D.,M.P.H., and David J. Weber,M.D.,M.P.H.
   Centers for Disease Control and Prevention, 2008. “Guideline for Disinfection and Sterilization in Healthcare Facilities, Atlanta.”

Our manual should provide you with all the information you need to set up and use this product.
If you have a question, have a look at our Product Support page.
Here you will find how-to-use videos, quick start guides, user manuals, troubleshooting & FAQs.
For further assistance, why not contact our Customer Care team directly? We’re here to help!
Our Customer Care team are available from 9am-5pm, Monday to Friday (excluding bank holidays).
We promise to respond to all queries and will ensure to resolve any issue you may be having.
You can reach us by…
Live Chat:
Simply visit www.kinetikwellbeing.com and send us a message.
Email: [email protected]
Post: Kinetik Medical Devices Limited
Unit 11, Perrywood Business Park, Honeycrock Lane, Salfords, Redhill. RH1 5JQ

Document No.: DBG-1404-009
Article No.: 001
Version: B
Date of Issue: 2022.08.02
Hangzhou Sejoy Electronics & Instruments Co., Ltd.
Area C, Building 2, No.365, Wuzhou Road, Yuhang Economic
Development Zone, Hangzhou City, 311100 Zhejiang P.R. China
Shanghai International Holding Corp.Gmbh (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany

References

• Blood Glucose Monitoring System | Kinetik Wellbeing
• ltd.no

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