TRIVIDIA HEALTH TRUEdraw Lancing Device Instruction Manual

TRIVIDIA HEALTH TRUEdraw Lancing Device

Product Information: Lancing Device

The Lancing Device is designed for the hygienic collection of capillary blood for testing purposes. It is used with sterile, single-use lancets for blood collection from the side of a fingertip and alternative sites like the forearm. The device is intended for use by one patient only and is not suitable for healthcare or care workers.

The Lancing Device comes with a Twist Top / Pull Top Lancet, a Clear End Cap for forearm testing, an End Cap for finger testing, an Arrow Holder, a Trigger Button, a Depth Dial, a Lancet Top, and an Arming Barrel. The Clear End Cap can be obtained by calling Trividia Health, Inc. at 1-800-803-6025, Monday – Friday, 8AM- 8PM EST.

Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. Therefore, DO NOT use on more than one patient. Used lancet blades must be safely discarded after a single use. All parts of the Lancing Device are considered biohazardous and can potentially transmit infectious diseases, even after cleaning and disinfection.

Product Usage Instructions: Lancing Device

1. Select the area to be lanced and wash with soap and warm water. Rinse and dry thoroughly.

2. Disinfect the clean skin with an antiseptic (e.g., 70% alcohol).

3. Pull off the End Cap and push the Lancet firmly into the Holder. Remove the Lancet Top and save it for safe disposal of used Lancet. Replace the End Cap.

4. Note: Use Clear End Cap for lancing forearm. To obtain a Clear End Cap, call Trividia Health, Inc. at 1-800-803-6025, Monday – Friday, 8AM-8PM EST.

5. For Finger Testing: Turn Depth Dial to the desired lancing depth. Use Clear End Cap in place of regular Depth Dial End Cap. If Clear End Cap is not available, select #5 on Depth Dial.

6. Hold End Cap in one hand and Arming Barrel in the other. Gently pull Arming Barrel until you hear a click.

7. Rub the area vigorously or apply a warm compress to stimulate blood flow.

8. Lower your hand to waist level and gently massage the finger to get blood flowing.

9. Place the Tip firmly against the finger.
   Note: For best results, lance on either side of the finger (see shaded areas).

10. Press the Trigger Button. Remove the lancing SIDE device after the finger is lanced.

11. Gently massage the finger from palm to fingertip to form a blood drop.

12. For Forearm Testing: Place the Tip firmly against the forearm. Note: For best results, lance in shaded area SIDE.

13. Press the Trigger Button.

14. Apply firm pressure on the lancing device until an adequate blood drop is formed. Remove the lancing device after the forearm is lanced.

15. Disinfect reusable components according to manufacturer’s instructions between each use.

16. Wash hands thoroughly with soap and water before and after handling the Lancing Device to prevent the transfer of blood-borne viruses or infectious agents.

For use with sterile, single-use lancets for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

For use only on a single patient. Disinfect reusable components according to manufacturer’s instructions between each use. Used lancet blades must be safely discarded after a single use.

WARNING! DO NOT use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.

WARNING! DO NOT share your Lancing Device with others, including family members. DO NOT use on multiple patients. ALL parts of the Lancing Device are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.

CAUTION! Do not use lancet if lancet top has been previously removed. Wash hands thoroughly with soap and water before and after handling the Lancing Device to prevent the transfer of blood-borne viruses or infectious agents.
Note : Lancing Device and Clear End Cap are for self-testing and intended for use by one patient only. Not suitable for use by healthcare or care workers.

Universal, polygon-symmetrical lancet with body diameter 0.248” ± 0.004” (6.30 mm ± 0.10 mm), length 0.900” ± 0.010” (22.86 mm ± 0.25 mm), and exposed needle length 0.126” ± 0.008” (3.20 mm ± 0.20 mm).

READY

1. Select area to be lanced. Wash with soap and warm water, rinse and dry thoroughly. Disinfect the clean skin with an antiseptic (e.g., 70% alcohol).
2. Pull off End Cap. Push Lancet firmly into Holder.
3. Remove Lancet Top. Save Lancet Top for safe disposal of used Lancet.
4. Replace End Cap.
   Note : Use Clear End Cap for lancing forearm. To obtain a Clear End Cap, call Trividia Health, Inc. at 1-800-803-6025, Monday – Friday, 8AM- 8PM EST.

SET

For Finger Testing:

1. Turn Depth Dial to desired lancing depth.
   Note : Finer adjustments can be made by setting Arrow between numbers.
   Lancing Depth Guide:

   • 1-2 for soft / thin skin
   • 3-4 for average skin
   • 4-5 for thick / calloused skin

2. Hold End Cap in one hand and Arming Barrel in other. Gently pull Arming Barrel until you hear a click.

3. Lower hand to waist level. Gently massage finger to get blood flowing.

For Forearm Testing:

1. Use Clear End Cap in place of regular Depth Dial End Cap, but if Clear End Cap is not available, select #5 on Depth Dial.
2. Rub area vigorously or apply a warm compress to stimulate blood flow.
3. Hold End Cap in one hand and Arming Barrel in other. Gently pull Arming Barrel until you hear a click.

LANCE

1. Place Tip firmly against finger.
   Note : For best results, lance on either side of finger (see shaded areas).

2. Press Trigger Button. Remove lancing device after finger is lanced.

3. Gently massage finger from palm to fingertip to form blood drop.

LANCE

1. Place Tip firmly against forearm.
   Note : For best results, lance in shaded area

2. Press Trigger Button.

3. Apply firm pressure on the lancing device until an adequate blood drop is formed. Remove lancing device after forearm is lanced.

Removing Used Lancet

1. Pull off End Cap.
2. Place the saved Lancet Top flat on a firm surface and push the exposed lancet tip into the Lancet Top.
3. Remove the lancet from the Holder and discard the used lancet into a sharps disposal or other container for sharp objects according to your state/local regulations.

Lancing Device Cleaning and Disinfecting

Cleaning and disinfecting the lancing device is a two-step process. The first step is Cleaning. Cleaning removes any blood, liquids, dust or dirt. The second step is

Disinfecting. Disinfecting removes most, but not all possible infectious agents (bacteria or viruses), including blood-borne pathogens. Cleaning must be done before Disinfecting.
Caution! Clean and disinfect the lancing device at least once a week. Lancing device may be cleaned and disinfected once a day for up to 3 years. If blood gets on the lancing device, clean and disinfect it before anyone else touches it. If someone is helping you test your blood or performs a test on you, do the cleaning and disinfecting before allowing anyone else to handle it.

1. Wash hands thoroughly with soap and water or wear disposable gloves.

2. To Clean: Using ONLY Super Sani-Cloth (EPA* Reg. No. 9480-4), thoroughly wipe the entire outside surface of the lancing device with one cloth by wiping in circles 3 times. Discard the used cloth.

3. Repeat step 2 if the lancing device is not visually clean, or safely dispose of it according to your state/local regulations.

4. To Disinfect: Remove a fresh Super Sani-Cloth and thoroughly wipe the entire outside surface of the lancing device by wiping in circles 3 times. Make sure that you go over the entire lancing device.

5. Using fresh cloths, if needed, make sure that all outside surfaces of the lancing device stay wet for 2 minutes by patting with the cloth. Discard used cloth. Let lancing device air dry completely before using.

6. Gently pull back Arming Barrel and press the Trigger Button. You will hear a click if the lancing device is working properly.

7. Wash hands thoroughly again.
   Caution! Other disinfectants have not been tested. The effect of other disinfectants used interchangeably has not been tested with the lancing device. Use of disinfectants other than Super Sani-Cloth may damage lancing device. Do not use lancing device and call Customer Care for assistance at 1-800-803-6025, Monday – Friday, 8AM – 8PM EST, if:

   • Markings on lancing device are coming off,
   • Trigger Button is hard to push,
   • End Cap does not go back on,
   • Arming Barrel does not click when gently pulled back.

Super Sani-Cloth may be purchased at: Amazon.com, Officedepot.com (or your local Office Depot store), Walmart.com Super Sani-Cloth has been tested on the lancing device for a total of 1,095 cleaning and disinfecting cycles, which is equal to cleaning and disinfecting the lancing device once a day for a 3-year period. Lancing device may be cleaned and disinfected up to 7 cycles per week for 3 years.

Storing Lancing Device
Protect the lancing device from liquids, dust, and dirt. Store at room temperature. Store without a lancet inserted.

Important Notes Regarding Forearm Blood Samples
If your test system indicates capillary blood from the forearm can be used for testing:

• Check with your Doctor or Healthcare Professional to see if forearm testing is right for you.
• Check your test system user manual for information about forearm testing and results from forearm blood samples as results from the forearm may not always be the same as results from the fingertip.

References

1. FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication.
   Available at https://wayback.archive-it.org/7993/20170111013014/ http:/www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm

2. Infection Prevention during Blood Glucose Monitoring and Insulin Administration. Available at http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html © 05/2022 Trividia Health, Inc. The Trividia Health logo is a trademark of Trividia Health, Inc. Made in China • M2TVH06 Rev. 43

2400 N.W. 55th Court
Fort Lauderdale, FL 33309 USA
www.trividiahealth.com
1-800-803-6025

References

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