arkray 5174-04 Multi Lancet Device 2 Lancing Device Instruction Manual

May 15, 2024
arkray

arkray LOGO Multi-Lancet™ Device 2
Lancing Device
Instructions for Use

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 to be used 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 that require 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 who is providing assistance to the user, the lancing device 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 other family members.
  • User 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 you have performed cleaning and disinfection.
  • Persons younger than 18 years old should be supervised by adults when using the subject device, or adults should perform the procedure on persons younger than 18 years old.
  • 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, ask 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.

arkray 5174 04 Multi Lancet Device 2 Lancing Device - Device
Configuration

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 can adjust the lance depth to 7 levels, as needed. When using the Multi-Lancet™ Device 2 for the first time, select level 3 for finger samples and level 7 for palm and forearm samples. If you have soft finger skin, start with level 2 and adjust depth 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.

arkray 5174 04 Multi Lancet Device 2 Lancing Device - Lancing
Depth

A lancing depth of 0 – 3mm is possible with this lancing device, when used with compatible single-use lancet blades.
The lancing 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 1 or 7 as damage to device may occur.

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 take your hand off the reset lever.

CAUTION
Do NOT pull the reset lever while touching the puncture button or the eject lever.
Warranty: Your lancing device is warranted for 3 years.

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 lancet is fully seated.

NOTE
Do not use if protective cap has been removed.

  • The lancing device cannot puncture at the selected depth when the lancet is not inserted fully.

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

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

Cleaning and Disinfecting Lancing Device

  1. Inspect for blood, debris, dust or lint on the lancing device.

  2. To clean the lancing device and head cap, blood/body fluids must be thoroughly cleaned from the surface of the lancing device and head cap 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 of the cleaning step.

  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.

arkray 5174 04 Multi Lancet Device 2 Lancing Device - 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.

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

DISTRIBUTED BY:
ARKRAY USA
5182 West 76th Street
Minneapolis, MN 55439 U.S.A.
800.566.8558
www.arkrayusa.com
Made in Philippines
P/N 5174-04 Rev. 10/22

References

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