Clarity BG1000 Reference guide

PROCEDURE MANUAL
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Lab Name: Procedure #:
Procedure: CLIA Complexity: WAIVED
Prepared By Date Adopted Supersedes Procedure #
Review Date Revision Date Signature
Distributed to # of Copies Distributed to # of Copies
This Procedural Bulletin is intended to provide a ready outline reference for performance of the assay. It is
the obligation of every manufacturer of medical devices labeled FOR IN VITRO DIAGNOSTIC USE to
provide a complete package insert in accordance with FDA labeling regulation (21 CFR 809.10). Prepared
in accordance with the guidelines recommended by the Clinical and Laboratory Standards Institute,
Wayne, PA 19087; CLSI Document GP2-A2.
Clarity Diagnostics provides CLSI procedures for your use. The procedures are required to
include the same information as listed in the package insert. Any modifications to this document
are the sole responsibility of the Laboratory.
CLIA Complexity: WAIVED
Intended Use:
Clarity BG1000 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose
in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare
professionals as an aid in the management of diabetes, and may be used for testing multiple patients in
clinical setting.

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It is intended for use outside the body (in-vitro diagnostic use) and not for the diagnosis of or
screening for diabetes or for neonatal use. The alternative site testing (palm or forearm)
should be done only during steady state times (when glucose is not changing rapidly).
Only auto-disabling, single use lancing devices (safety lancet) should be used with this
system.
Application:
Clarity BG1000 Blood Glucose Test Strips are for in-vitro diagnostic use.
The Clarity BG1000 Blood Glucose Meter is not a substitute for the physician or healthcare
professional. Use the Clarity BG1000 Blood Glucose Meter in conjunction with patients
healthcare program.
Test Principle:
Glucose in the blood sample reacts with glucose oxidase on the test strip and a harmless electrical
current is produced. The strength of these currents change with the amount of glucose in the blood
sample and the Clarity BG1000 Blood Glucose Meter automatically interprets this reaction.
Glucose measurements are reported as plasma equivalents. This system uses a plasma equivalent
method. Results that use a plasma equivalent method are approximately 11% higher than those
obtained with whole-blood equivalent test strips.
Special Features:
Accurate result in 5 seconds using only 0.5µ1 blood sample.
The Clarity BG1000 Blood Glucose Meter identifies the test strip code automatically.
Stores up to 300 test results.

Blood glucose measurement units are pre-set in mg/dl.
Usage and Storage:
Before using your monitoring system, please place it in the environment of the system's normal
operating temperature range of 50-104°F for about twenty (20) minutes.
Do not allow dirt or dust in the test strip port in order to avoid affecting the monitoring
system's accuracy .
Do not attempt to repair or alter your monitoring system.
Handle your monitoring system with care.
Avoid leaving the meter in extremely hot or cold places, such as near a
heat source or in an extremely hot or cold car.
Do not store or use the meter or test strips at high humidity levels, such as in the bathroom or
kitchen .
Always close the cap of the test strip bottle immediately after removing a test strip. Make
sure the cap is tightly closed.
Do not use a corrosive product (e.g. Benzene, Acetone) to clean your monitoring system)

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Important Information:
Before using the Clarity BG1000 Blood Glucose Monitoring System, please read this manual
carefully.
The Clarity BG1000 Blood Glucose Monitoring System is for testing outside of the body (in-vitro
diagnostic use).
This product is not for neonatal use or severely dehydrated individuals or patients.
Use this system only for blood glucose test.
Make sure to use your test strip immediately after retrieving it from the vial,
be sure to keep the test strip vial closed tightly at all times.
For the most accurate results, make sure your hands are clean and dry before removing the
test strips from the vial. Do not touch test strip slit.
Do not use test strips that have expired, using expired test strips may cause inaccurate test
results.
Do not reuse test strips. This test strip is for single use only.
Before the test you must make sure that the code number displayed on the meter matches the code
number on the test strip vial.
Be sure to check the glucose measurement unit on the meter before the test.
- This meter is preset tomg/dl.
- mg/dl is the unit of measurement used in theUS.

Make sure the test strip vial isclosed tightly and stored at 39.2-86°F. Do not
freeze.
Keep test strips away from direct sunlight and heat.
The meter and test strips should be handled at the same temperature.
For accurate test results, keep the Clarity BG1000 Blood Glucose Monitoring System
operating temperature at a range between 50-104°F for more than twenty (20) minutes
before testing.
You may use this system at altitude up to 10,000 feet.
Keep your Clarity BG1000 Blood Glucose Meter, lancing device, and control solutions out of
reach of children.
Clean and disinfect your Clarity BG1000 Blood Glucose Meter before testing each patient.
Dispose of used test strips and lancing device according to local regulations. Inaccurate results may
occur for individuals or patient in shock.
Inaccurate results may occur for individuals experiencing a hyperglycemic- hypersmolar state with
or without ketosis . Critically ill patients should not be tested with this blood glucose meter.
Interferences: Acetaminophen, salicylates, uric acid, ascorbic acid (vitamin C) and other interferent
substances in normal blood or normal therapeutic concentrations do not significantly affect results,
however abnormally high concentrations in blood may cause inaccurate results.
Patients undergoing oxygen therapy may yield false low results.
Lipemic samples (triglycerides) in excess of 1,500 mg/dl may produce elevated results.
Hematocrit is the percentage of red blood cells in the blood. HGT levels of 30-55% do not affect
glucose measurements with this meter.
This test strip is not for use with arterial, venous, neonatal, serum or plasma samples.
Testing outside of HGT level range of (30-55%) and recommended storage conditions may cause
inaccurate results.
Testing under out of the specification range may cause inaccurate results.

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CAUTION: Use only Clarity BG1000 Test Strips with your Clarity BG1000 Blood Glucose Meter.
Healthcare Professional Information:
Healthcare professionals performing blood glucose tests with this system on multiple patients must always
wear gloves and should follow the infection control policies and procedures approved by their facility.
When using the Clarity BG1000 Blood Glucose Monitoring System always follow the recognized
procedures for handling objects that are potentially contaminated with human material. Practice the
health and safety policy of your laboratory or institution.
A drop of blood is required to perform a blood glucose test. Only fresh capillary blood can be used.
The Complete Medisign BG1000 Blood Glucose Monitoring System:
The Clarity BG1000 Blood Glucose Monitoring System includes the Clarity BG1000 Meter,
Carrying Bag, User Manual, Warranty Card and (2) 3.0 Volt CR2032 Lithium Batteries.
Clarity BG1000 Test Strips, Clarity BG1000 Glucose Control Solutions are required but not
included and must be purchased separately.
Auto-disabling single-use lancing device, Clarity BG1000 Test Strips and Clarity BG1000
Glucose Control Solutions (Level 2, LeveI3), Clarity BG1000 Diabetes Management Software
and Clarity BG1000 Data Transfer Cable can be purchased by contacting your distributor, or for
additional information you can contact Clarity Diagnostics Customer Service at 1-877-722-6339.
Clarity BG1000 Blood Glucose Meter:
Serial Port Battery Lid
'M"
p
FRONT BACK
D
Test Strip Slot

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Clarity BG1000 Blood Glucose Test Strip:
Lot number
Expiration Date
Test Strip Slit
Test Strip Vial Clarity BG1000 Blood Glucose Test Strip
- Use Clarity BG1000 Blood Glucose Test Strips with the Clarity BG1000 Blood Glucose Meter.
- Check the expiration date of your test strips before using.
- Write the opening date of the new test strip vial in order to avoid using any expired products.
Explanation of Display:
Testing Your Blood Glucose:
Disinfect Before Testing:
- Before testing, let patients wash hands with soap and water and dry thoroughly.
- Use an alcohol prep pad to wipe the area before testing.

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- Wait until the alcohol dries completely.
Performing a Blood Glucose Test:
1. Insert a test strip to turn on the meter. Make sure it is inserted completely without bending the test
strip.
2. The meter identifies the code number automatically. Compare the code number displayed on the
LCD with the code number shown on the test strip vial. If they do not match try again with an
another test strip. If the problem persists contact Clarity Diagnostics Customer Support at 1-877-
722-6339.
3.
When the bloodsymbol appears,you can proceed withthetest.
4. Choose a sample site on the outer edge of one finger, but try to avoid the index finger or thumb.
Place the sampling device's platform against the finger and take the sample. Always choose a
different finger each time to avoid soreness.
5. Gently squeeze the patients finger to assist the flow of blood. Do not squeeze excessively on the
puncture site.
6. Hold the tip of the test strip to the drop of blood, the test strip will automatically draw the blood
into the test strip. When the test strip has enough blood the meter will beep.
NOTICE:
When the blood sample is not sufficient, the display screen will show the message of 'Er4'. (Please refer
to error message in this manual.)

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CAUTION:
Do not drop the blood directly on the end of the test strip.
The sample channel at the end of the test strip should show full. When you hear a beeping sound, you
have enough blood in the test strip.
Inaccurate results may occur for individuals or patient in shock.
Inaccurate results may occur for individuals experiencing a hyperglycemic-hypersmolar state, with
or without ketosis. Critically ill patients should not be tested with a blood glucose meter.
NOTICE:
If the test result is abnormal, please retest with a new test strip. If the test result also has a
problem, please refer to the Troubleshooting section in this manual.
7. The test result will appear after the meter counts down from five (5) seconds.Do not shake
the meter while the meter is counting down.
8. After five seconds you will hear a second beep and the test result will be displayed. You
can remove the test strip by pushing the test strip ejector on the back of the meter. The
meter will automatically power off.
CAUTION:
- Do not leave the auto-disabling, single use lancing devices after use, be sure to dispose of properly.
- Only an auto-disabling, single use lancing devices should be used.
- Always dispose of the used auto-disabling, single use lancing devices in a biohazard container.
- Keep your Glucose Meter, test strips, control solution and auto-disabling, single use lancing devices
out of reach of pet or children at all times.
- Do not reuse auto-disabling, single use lancing devices. Those are for single use only.
- The user needs to adhere to the Standard Precautions when handling or using this device.
- All parts of the glucose monitoring system should be considered potentially infectious and are
capable of transmitting blood-borne pathogens between patients and healthcare professionals.
- For more information, refer to 'Guildline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings 2007'.
http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html
- The meter should be disinfected after use on each patient. This Blood Glucose Monitoring
System may only be used for testing multiple patients when Standard Precautions and the
manufacturer's disinfection procedures are followed.
- A new pair of clean gloves should be worn by the user before testing each patient.
- Refer to the following practice guidelines:
- BiosafetyinMicrobiologicalandBiomedical Laboratories (BMBL}foundat
http : //www . cdc . gov/biosafety/publications/bm 1 5 b /
- Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Guideline-Third Edition, Clinical and Laboratory Standards Institute (CLSI} M29-A3.

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Flagging Test Results:
Ifyou wantto flag pre-meal, post-meal or control solution readings press the'M' Button after your
test result is displayed. The icon for post-meal will be displayed onyour screen.Pressthe'C'
Button totoggle between pre-meal
, post-meal and control solution . After you have
identified the activity you would like to flag simply remove the test strip.(see explanation of display
on page 13)
Notice:
Control Solution Test results are not included in the 14-day average.
Alternate Site Testing:
Contact a healthcare professional before using any alternative sites to test patients blood glucose.
- 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).
- Use alternative site testing only two hours or more after taking insulin, two hours or more after a
meal, two hours or more after exercise.
- Do not use alternative site testing if patient glucose level is not as stable as usual, or if you think the
patient may have hypoglycemia (low blood glucose) hyperglycemia (high blood glucose), or you think
the patients blood glucose may be rising or falling rapidly.
- Do not use alternative site testing if the patients alternative site testing results do not match the way
they feel.
- AST measurements should never be used to calibrate continuous glucose monitors (CGM).
- AST measurements should never be used in insulin dosing calculations.
Do not rely on test results at an alternative sampling site, but use samples taken from the fingertip, if any
of the following applies:
- You think the patients blood sugar is low.
- You are not aware of symptoms when the patient became hypoglycemic.
- The test results do not agree with the way they feel.
- After a meal.
- After exercise.
- During illness.
- During times of stress.
CAUTION:
Never change any treatment without first consulting the physician or a healthcare professional.
Never ignore symptoms of high or low blood glucose.
If the patients blood glucose does not match how they feel, perform a fingertip test to confirm the result.
If the fingertip test result still does not match how they feel, call their healthcare professional.

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Lancing and Sampling from an Alternate Site:
Sampling from the palm or forearm allows you to use their fingertips less often. You may find
that obtaining a blood sample from an alternative site is less painful than using a fingertip.
Getting a blood sample from the forearm or palm is different than getting a sample from their
fingertips.
Forearm sampling: Choose a fleshy area of the forearm away from the
bone, visible veins and hair. Sometimes there is less blood flow to the
forearm than to the fingertips. To help patients get a large enough
drop of blood, you may gently massage or apply warmth to their site to
increase blood flow.
Palm sampling: Choose a fleshy area on the palm below the thumb
or little finger. Select an area away from veins or deep creases which may
cause the blood sample to smear.
NOTICE:
- You may need to wait a little longer to get a large enough drop of blood from the forearm or
palm. Do not squeeze the siteexcessively.
- If the sample drop of blood runs or spreads due to contact with hair or a
crease in the palm, do notuse that sample. Try puncturing again ina smoother area.
Setting Up Your Meter:
1. Press and hold the 'M' button for roughly three seconds, you will hear a beep
sound and the LCD Screen will display the screen icons of the meter.

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2. Continue to hold the 'M' button and "SET" will appear on the screen.
3. Setting the Month: When the month blinks, press and release the 'C' Button until the correct month
appears, then press the 'M' Button to set the correct month and move to the date setting.
4. Setting the Date: When the date blinks, press and release the 'C' Button until the correct date
appears, then press the 'M' Button to set the correct date and move to the time setting.
5. Setting the Time Format: The meter can be set to show the time in AM/PM 12 hour format or 24
hour "Military Time". With the "12h" blinking press the 'C' Button to move between 12h and 24h, then
press the 'M' Button to set and move to the hour setting.
6. Setting the Hour: When the hour blinks, press and release the 'C' Button until the correct
hour appears, then press the 'M' Button to set the correct hour
and move to the minute setting.
7. Setting the Minute: When the minute blinks, press and release the 'C' Button until the
correct minute appears, then press the 'M' Button to set the correct minute and move to the
year setting.
8. Setting the Year: The year will appear on the screen, press and release the 'C' Button until
the correct year appears, then press the 'M' Button to set the correct year and move to
confirming the Measurement Unit Type mode.