Multi-Lancet™ Device 2: Instructions for Use and Safety

Please read these instructions carefully before use. Retain this instruction leaflet for future reference. Use this product only under the direction of your physician or qualified medical personnel.

Intended Use

The Multi-Lancet™ Device 2 is a reusable lancing device intended for use with sterile, single-use compatible lancet blades to obtain a capillary blood sample from the fingertip or alternate sites for blood glucose testing or other tests requiring small amounts of blood. The Multi-Lancet™ Device 2 is intended for single-person use only.

For Your Safety

CAUTION

• If the lancing device is being operated by a second person providing assistance, it should be decontaminated prior to use by the second person.
• The lancing device is for use by a single person only. It must not be used to collect blood from more than one person, as this poses an infection risk.
• Do not share the lancing device with anyone, including family members.
• Users should wash hands thoroughly with soap and water before and after handling the lancing device.
• All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after cleaning and disinfection.
• Persons younger than 18 years old should be supervised by adults when using the device, or adults should perform the procedure on them.
• Risk of injury: If the penetration depth is too deep, the puncture can injure children. Before using the lancing device for the first time on children, consult your healthcare professional. Start with the lowest penetration depth.

WARNING

• For use only on a single person. Disinfect reusable components according to manufacturer's instructions between each use.
• Used lancet blades must be safely discarded after a single use.
• Do not use on more than one person. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple people 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 person.
• Do not draw more blood than necessary for testing.
• Do not use this lancing device for tests which require large volumes of blood.

NOTE

Use the Multi Lancet Device 2 at a temperature between 50°F and 104°F (10°C and 40°C). Store it at a temperature between 32°F and 122°F (0°C and 50°C) in a dust-free location.

Features and Device Configuration

The Multi-Lancet™ Device 2 can draw blood from a finger and an appropriate amount of blood from other sites.

Device Components: The device includes a Lancet, Head Cap, Fingerstick Cap (white), AST Cap (clear), Puncture Button, Reset Lever, Pinch Points, Protective Cap, Eject Lever, and Adjustment Dial.

Head Caps

• There are two head caps: one for fingerstick and one for alternate site testing (AST).
• Change the cap to match the blood collection method.
• To remove the head cap, push while holding the pinch points.

Adjusting Lancing Depth

The Multi-Lancet™ Device 2 allows adjustment of the lancing depth to 7 levels. For first-time use, select level 3 for finger samples and level 7 for palm and forearm samples. For soft finger skin, start with level 2 and adjust as needed.

• If blood sample is excessive, turn the dial to a lower setting.
• If blood sample is insufficient, turn the dial to a higher setting.

A lancing depth of 0-3mm is possible with this device when used with compatible single-use lancet blades. The device has been tested with lancets of the following sizes: Needle thickness: 25G, 26G, 28G, 30G, and 33G. Needle length: 2.9mm - 3.6mm. Total lancet length: 25.7mm - 26.6mm.

CAUTION: Do not turn the dial beyond level 1 or 7, as this may damage the device.

Resetting the Internal Trigger

If the puncture button is inadvertently pressed before lancing a site, pull the reset lever in the direction of the arrow until a click is heard. This locks the internal trigger. Then release the reset lever.

CAUTION: Do NOT pull the reset lever while touching the puncture button or the eject lever.

How to Use

Step 1: Remove the head cap

Remove the head cap by pinching and pulling the cap off the lancing device.

Step 2: Insert the lancet

Insert the lancet by pushing down firmly until the lancet is fully seated.

NOTE: Do not use if the protective cap has been removed. The lancing device cannot puncture at the selected depth if the lancet is not fully inserted.

Step 3: Remove the protective cap

Twist the protective cap off the lancet.

Step 4: Attach the head cap

Attach the head cap by pushing it onto the lancing device.

Step 5: Adjust puncture setting

Adjust the puncture setting for the preferred puncture depth level (adjustable depths).

Step 6: Obtain blood sample

Wash the area of skin intended for lancing with warm soapy water and dry thoroughly to prepare for testing. If an alcohol wipe is used, wait for the area to dry before lancing.

NOTE: Consult your blood glucose meter user manual for instructions on how to obtain a blood sample.

Step 7: Attach the protective cap

After obtaining your blood glucose results, remove the head cap, then stab the protective cap with the lancet.

Step 8: Dispose of the lancet

Used lancet blades must be safely discarded in a biomedical sharps container after a single use. Eject the used lancet using the eject lever and dispose of it in a safe manner to avoid accidental lancet stick injuries.

Step 9: Storage

Safely store the reusable lancing device and unused lancets in a dedicated storage case or sealed container between uses to minimize contamination or damage.

Cleaning and Disinfecting Lancing Device

Clean and disinfect the Multi-Lancet™ Device 2 with Clorox® Germicidal Wipes, EPA Registration number 67619-12. Other brand wipes with EPA Registration number 67619-12 may also be used.

Purchase Information for Clorox Healthcare® Bleach Germicidal Wipes

Clorox® wipes can be ordered from these national distributors and on the websites listed below.

• Medline: 800.633.5463
• DNR Supplies: 763.420.7825
• www.amazon.com
• www.walmart.com

If you need assistance or have questions about cleaning and disinfecting, please contact customer service at 800.566.8558.

Cleaning and Disinfection Procedure

NOTE: Only Clorox® wipes or EPA 67619-12 should be used to clean and disinfect the lancing device. Keep Clorox® wipes out of reach of children.

1. Inspect the lancing device for blood, debris, dust, or lint.
2. To clean the lancing device and head cap, blood/body fluids must be thoroughly cleaned from the surfaces before disinfecting. Dispense the wipe (Clorox®) from its package. CLEAN by gently wiping the outside of the device. Dry thoroughly with a dry cloth. Inspect the lancing device again. If residual blood, debris, dust, or lint remain, repeat the cleaning step. Do not use the lancing device if it is not visually clean after several repetitions.
3. DISINFECT by gently wiping the outside of the device. Allow the device to remain wet with the disinfectant solution for 1 minute. Dry the device with a dry cloth.
4. Wash hands with soap and water.

Cleaning and disinfection frequency: ARKRAY has validated the cleaning and disinfection procedure with the disinfectant product listed above. For use only on a single person. Disinfect reusable components according to manufacturer's instructions between each use.

Warranty

Your lancing device is warranted for 3 years.

Contact and Distribution

DISTRIBUTED BY:
ARKRAY USA
5182 West 76th Street
Minneapolis, MN 55439 U.S.A.
800.566.8558
www.arkrayusa.com

For questions/comments, contact Customer Service at 800.566.8558, 24 hours a day, 7 days a week.

Made in Philippines

P/N 5174-04 Rev. 10/22