Trividia Health Sidekick Instructions For Use

Sidekick® All-In-One Blood Glucose Testing System - Instructions for Use
Importance of Blood Glucose Monitoring
Your Doctor or Diabetes Healthcare Professional decides your blood
glucose target range and testing frequency. Having most results within
your target range helps slow or stop diabetic complications. Do not change
your treatment plan before discussing with your Doctor or Diabetes
Healthcare Professional.
Important Information
• Sidekick® All-In-One Blood Glucose Testing System is an in vitro
(outside body) quantitative system that is for self-testing and point-of-
care testing of human whole blood glucose.
• Read all instructions before testing.
• Write date first opened on vial and Control Solution bottle labels. To
assure accurate results:
- Use Controls or Strips before date printed next to EXP.
- Use Controls within 3 months after opening.
- Use Strips within 120 days after opening.
• When all Strips are used, or Sidekick® All-In-One Blood Glucose Testing
System has reached expiration date, make sure all results are recorded on
log sheet, then discard entire System. Test Strips cannot be purchased
separately.
• Sidekick® All-In-One Blood Glucose Testing System Test Strips in vial
only work with Meter mounted on vial lid. There is no need to code
Strips.
• Discard vials or bottles that appear cracked or leaking.
• Use only fresh capillary whole blood samples from finger or forearm for
Meter/Vial
Meter
Display
Button
Test Port
LOT
Lot
Vial Cap Lip
EXP
Expiration
(Lift Up
0
to Open)
Control
1
Level Ranges
To assure that you are getting accurate and reliable results, Sidekick® All-In-One Blood Glucose Testing System offers two types of quality control tests. These tests
let you know that your Sidekick® All-In-One Blood Glucose Testing System is working properly so you can have confidence in your test results.
• All meter brands perform differently. Test results from one meter brand to another may vary. This is why test results from your meter
should only be compared to a lab instrument and not to another meter brand. To assure your system is working properly,
manufacturers of all meter brands recommend performing quality control tests.
An automatic self-test is performed each time a Test Strip is inserted correctly into Test Port. If drop symbol appears in Display after
inserting Test Strip, meter is working properly. If "E-4" appears in Display after inserting Test Strip, Meter will not perform test. Call
Customer Care for assistance. Control tests using TRUEcontrol® Control Solutions let you know Test Strips are accurate. Control tests
should be performed when Sidekick® All-In-One Blood Glucose Testing System is first opened; when results do not match how you feel; or
if Sidekick® All-In-One Blood Glucose Testing System may have been damaged.
• Control Solutions are for in vitro (external) use only. Do not inject or drink Controls.
• Do not use Control Level Ranges printed on the Sidekick® All-In-One Blood Glucose Testing System label for your target
blood glucose range. These ranges are for Control test results only.
• Your Sidekick® All-In-One Blood Glucose Testing System includes a Level 1 Control Solution. A Level 0 Control Solution is
also available. If you need a Level 0 Control Solution, please call 1-800-803-6025.
Control Testing
1. Allow Sidekick® All-In-One Blood Glucose Testing System and
Control Solutions to adjust to a temperature between 68°F-77°F
(20°C-25°C) for at least 30 minutes. (If opening for the first time,
write date on labels.)
Note: Only use TRUEcontrol® Control Solution
Aug. 28, 2019
provided with System. Using Controls from
LOT
other systems will give inaccurate results.
EXP
2. Check dates on labels.
0
Caution! Using Controls 3 months past written
1
opened date or past date printed next to EXP
may give inaccurate results. Discard out-of-date product. Test
with new product.
3. Gently swirl contents of Control bottle. Do not shake.
4. Remove cap from Control bottle. Squeeze one drop of Control
onto clean tissue. Wipe tip of Control bottle with tissue.
5. Gently squeeze drop of Control onto piece of unused aluminum
foil or plastic wrap.
Wipe tip of Control bottle with clean
tissue. Tightly recap bottle.
Lift Up
6. Open vial by lifting up Vial Cap to Open
Lip. Remove one Strip. Close vial
immediately by firmly pressing down on Vial Cap Lip.
testing. Use of blood from veins or arteries with Sidekick® All-In-One
Blood Glucose Testing System is not recommended.
• Test results are displayed as Plasma values.
• Sidekick® All-In-One Blood Glucose Testing System is not intended to
diagnose diabetes or for testing newborn blood glucose.
• Use of Sidekick® All-In-One Blood Glucose Testing System
in a manner not specified in these Instructions for Use is not
recommended and may affect your ability to determine your blood
glucose.
• When carrying your Sidekick® All-In-One Blood Glucose Testing
System with you, be sure it is not left someplace (e.g. jacket pocket,
handbag, car, etc.) where the recommended storage temperatures
may be exceeded.
• Sidekick® All-In-One Blood Glucose Testing System is to be used
ONLY with Sidekick® All-In-One Blood Glucose Testing System Test
Strips and TRUEcontrol® Control Solution.
WARNING: Upon opening the carton, examine the product for missing,
damaged or broken parts. Ensure the vial cap is securely closed. If the
product is damaged or the vial cap is not closed, DO NOT use the test
strips for testing; product may give inaccurate results. Contact Trividia
Health Customer Care at 1-800-803-6025 for replacement and assistance.
For assistance or more information on
Sidekick® All-In-One Blood Glucose Testing System,
call: 1-800-803-6025, Monday - Friday, 8AM-8PM EST.
System Components
Test Strip
Contact End -
(insert into Test Port,
color side facing up)
Sample Tip -
(apply blood or
LOT
Control to edge)
EXP
Correct Incorrect
Quality Control Testing
Note: Use Strip quickly after removal from vial. Strips out of vial
too long give error message E-3. See Troubleshooting section.
7. Insert Contact End of Strip
into Test Port. Display turns
on. Drop symbol appears.
8. Press and release Button.
Display shows "C".
EA6942A
9. While holding vial, touch
31DEC19
Sample Tip of Strip to drop of
56 to 85
Control. Do not remove Strip from
150 to 210
Control drop until Display begins countdown.
Note: Do not apply drop to top of Strip.
If Display does not start countdown soon after
touching Strip to drop, discard Strip. Repeat test with new
Strip and new drop. If condition persists, see Troubleshooting.
10. Compare result with Control Level Range printed on vial label.
11. Remove Strip and discard.
WARNING! Do not use Sidekick® All-In-One Blood
Glucose Testing System for blood testing if
Control test results are not within Control Level
Press Down
Ranges. Call Customer Care for assistance.
to Close
1. Allow Sidekick® All-In-One Blood Glucose
Testing System to adjust to room temperature
for 30 minutes. If opening system for first time,
write date on vial label.
2. Check dates on label.
Caution! Using Test Strips 120 days past written opened date or past
Expiration Date may give inaccurate results. Discard out-of-date
product. Test with new product.
3. Wash hands (and forearm for alternate
site testing). Rinse well, dry thoroughly.
4. Open vial by lifting up Vial Cap Lip.
Remove one Strip. Close vial
immediately by firmly pressing down
on Vial Cap Lip.
Note: Use Strip quickly after removal from vial. Strips out of vial too
long give error message E-3. See Troubleshooting section.
WARNING!
• NEVER reuse Test Strips. NEVER wipe Test Strips with water,
alcohol or any cleaner. DO NOT attempt to remove blood or
control sample from Test Strips or clean Test Strips and re-use.
Reuse of Test Strips will cause inaccurate results.
• NEVER add a second drop of sample to Strip. Adding more
samples gives an error message.
5. Insert Contact End of Strip into Test Port.
Control Solution
Display turns on. Drop symbol appears.
6. Lance fingertip or forearm. Allow drop to
Red liquid with
form.
known amount
7. With Test Strip still in Meter, touch edge of
of glucose.
Sample tip to blood drop and allow blood to
Lot
be drawn into strip. Remove Test Strip sample
tip from sample drop immediately after dashes
Expiration
appear across the meter display.
Date
CAUTION! Holding Test Strip Sample Tip to
the blood sample too long after the Meter
begins testing may cause inaccurate results.
Note: Do not apply drop to top of Strip.
If Display does not start countdown soon after touching Strip to
drop, discard Strip. Repeat test with new Strip and new drop. If
condition persists, see Troubleshooting.
8. Record result on log sheet.
9. Remove Strip and discard.
Note: Removing Strip before result
displays cancels test. A result will not
be displayed or stored in Memory.
Warning Messages (WARNING!):
➯ Lo: Result is less than 20 mg/dL
➯ HI: Result is greater than 600 mg/dL
Caution! Always repeat test to confirm "Lo" and
"HI" results. If results still display "Lo" or "HI", call your Doctor
or Diabetes Healthcare Professional immediately!
Important Notes Regarding Forearm Testing
• Check with your Doctor or Diabetes Healthcare Professional to see
if forearm testing is right for you.
• Results from forearm are not always the same as results from
fingertip.
• Use fingertip instead of forearm for more accurate results:
- Within 2 hours of eating
- After taking insulin
- Immediately after exercise
- If you are ill or under stress
- If your forearm test results do not match how you feel
- If your blood sugar may be high or low
- If you don't notice symptoms when blood sugar is high or low
References:
1. U.S. Food and DrugAdministration. Blood Glucose Meters, Getting the Most Out ofYour Meter.
[ElectronicVersion]. Retrieved December 22, 2009 from http://www.fda.gov/MedicalDevices/Safety/
AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109371.htm
2. Hackett, J., Aziz, K., Review Criteria Assessment of Portable Blood Glucose Monitoring in Vitro Diagnostic Devices
Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology; FDA Draft Documnet, p. 6 (1997).
Control Solution Chemical Composition: water,
d-glucose, viscosity enhancing agent, inorganic salts,
amaranth, preservatives.
System Features:
Result Range: 20 - 600 mg/dL
Sample: Minimum 1 microliter (1 µL)
fresh capillary whole blood or Control
Test Time: Less than 10 seconds
Result: Plasma value
Assay Method: Electrochemical
Automatic shut-off: After 2 minutes of non-use
Weight (with Test Strips): 1.6 oz. (45.4 g)
Memory Size: 50 results (blood or Control)
Operating Range:
Relative Humidity: 10-90% (Non-condensing)
Room Temperature: 34°F-86°F (1°C- 30°C)
Hematocrit: 30-55%
Note: Use within specified operating conditions only.
Blood Testing
Memory holds 50 blood or Control test results.
Aug. 28, 2019
Press and release Button to view results in Memory. Last
EA6942A
LOT
test result (blood or Control) is shown first. Press and hold
EXP 31DEC19
Button to scroll through Memory results.
Blood test results are shown as "R 1" followed by test
result, "R 2" followed by test result, etc.
Control test results are shown as "C 1" followed by test
result, "C 2" followed by test result, etc.
Severe dehydration and/or excessive water loss may
cause false low results.
Lift Up Press Down
severe dehydration, contact your Doctor or Diabetes Healthcare
to Open to Close
Professional immediately.
• Low blood glucose (hypoglycemia) symptoms may include
trembling, sweating, intense hunger,
nervousness, weakness, and trouble speaking.
• High blood glucose (hyperglycemia) symptoms may include intense
thirst, a need to urinate often, a dry mouth, vomiting, or headache.
If you have any of these symptoms, check your
blood glucose. If your result does not match the
way you feel, repeat the test. If your results still do
not match the way you feel, call your Doctor or
Healthcare Professional.
WARNING! DO NOT share your Meter with anyone, including
family members. ALL parts of your Blood Glucose Testing System
could carry blood-borne diseases after use, even after cleaning and
disinfection. Cleaning removes blood and soil, disinfecting removes
infectious agents.
• Store Sidekick® All-In-One Blood Glucose Testing System and
Control in a dry place between
36°F-86°F/2°C-30°C. DO NOT REFRIGERATE OR FREEZE.
• When carrying your Sidekick® All-In-One Blood Glucose Testing
System with you, be sure it is not left someplace (e.g. jacket
pocket, handbag, car, etc.) where the recommended storage
temperatures may be exceeded or the System may be crushed.
To Clean the Meter (removing blood or soil):
• For multi-patient use facilities, refer to Customer Care for proper
cleaning and disinfection of the system.
• Wipe Meter with clean, lint free cloth, dampened with one of the
following:
- Mild detergent or mild soap,
- 70% isopropyl alcohol (isopropanol)
• Let Meter air dry thoroughly before using to test.
- Do not use bleach to clean the Meter.
• Store Strips in original vial only. Never store Strips outside of vial.
• Do not reuse Strips.
• Do not bend, cut or change Strips in any way.
1. If Display does not turn on after inserting a Strip:
Remove Strip. Re-insert Strip fully into Test Port.
➯
2. After sample is drawn into the Strip, Display does not begin
countdown:
1
Repeat test with new Strip and a larger sample.
➯
Repeat test with new Strip. Apply drop until
➯
countdown begins.
3. If error message appears in Display:
E-1 ➯ Wait 30 minutes for Sidekick®
➯
E-2 ➯ Retest with new Strip and
➯
E-3 ➯ Repeat with new Strip,
➯
E-4; Lb; db ➯
➯
-E- ➯
➯
Note: For any other ERROR messages please call Customer Care.
Manufactured by:
Trividia Health, Inc.
Fort Lauderdale, FL 33309
Memory
Health Related Information
If you believe you have
2
Care and Storage
Troubleshooting
All-In-One Blood
Glucose Testing System to
reach room temperature
before testing.
larger sample. If you have
symptoms such as fatigue,
excess urination, thirst
or blurry vision, follow your
healthcare professional's
advice for high blood glucose.
making sure that Strip
has not been used or out
of the vial too long.
Call Customer Care at 1-800-803-6025.
Testing capacity has been reached.
Meter will no longer test.
© 07/2018 Trividia Health, Inc. Sidekick is
a trademark of Trividia Health, Inc.
D4TVH04 Rev. 40