Arkray Multi-Lancet Device 2 Instrucciones De Uso

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.
Head Cap
Lancet
Fingerstick
Cap (white)
AST Cap
Protective
(clear)
Cap
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.
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
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
Step 5:
Adjust puncture setting
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 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
EPA Registration number 67619-12. Other brand wipes with EPA Registration
number 67619-12 may also be used.
Purchase Information for Clorox Healthcare
Clorox wipes can be ordered from these national distributors and on the websites
®
listed below.
• Medline ...................................................................... 800.633.5463
Reset Lever
• DNR Supplies ............................................................. 763.420.7825
• www.amazon.com
• www.walmart.com
If you need assistance or have questions about cleaning and disinfecting, please
Eject Lever
contact customer service at 800.566.8558.
NOTE
• Only Clorox
disinfect the lancing device.
• Keep Clorox
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
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.
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.
DISTRIBUTED BY:
ARKRAY USA
5182 West 76th Street
Minneapolis, MN 55439 U.S.A.
800.566.8558
www.arkrayusa.com
Step 2:
Insert the lancet
Remove the
head cap by
pinching and
pulling the cap
off the lancing
device.
Step 4:
Attach the head cap
Twist the
protective cap
off the lancet.
Step 6:
Obtain blood sample
Adjust the Wash area of skin intended for
puncture setting lancing with warm soapy water and
for the preferred dry thoroughly to prepare for testing.
puncture depth If an alcohol wipe is used, wait for
level (adjustable the area to dry before lancing.
depths).
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.
wipes or EPA 67619-12 should be used to clean and
®
wipes out of reach of children.
®
) from its package. CLEAN by gently wiping the
®
Insert the
lancet by
pushing
down firmly
until lancet is
fully seated.
Attach the
head cap
by pushing
it onto the
lancing
device.
Germicidal Wipes,
®
Bleach Germicidal Wipes
®
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