Accu-Chek Softclix Manual

Lancing device
07575050003
Rotatable Window for
Cap Lancet Penetration Depth Setting
Protective Cap
Notch
Comfort Dial with
Depth Selection
(11 depth settings) Lancet Holder Ejector
Instructions for Use
attention to the lancet so that you do not injure
yourself on it. Always eject the lancet and
discard it.
Intended Use
The lancing device is intended for the hygienic
Features
collection of capillary blood for testing purposes from
The Accu-Chek Softclix lancing device is a device for
the side of a fingertip and from other sites, such as the
virtually pain-free collection of capillary blood from the
palm, the upper arm, and the forearm, which is
fingertips. The lancing device has 11 different
referred to as non-fingertip testing or alternate site
penetration depths so that you can adjust the
testing. The lancing device is for use only on a single
penetration depth to the texture of your skin. You insert
patient.
a lancet into the lancing device. With the priming
button, you prime the lancing device. With the release
For use only on a single patient. Disinfect
button, you trigger a lancet. When a lancet is triggered,
re usable components according to
it penetrates the skin. Afterwards, the lancet retracts
manufacturer's instructions between each use.
automatically into the lancing device. This helps
Each lancet may only be used once to obtain prevent accidental fingersticks.
blood. Used lancets must be safely discarded
Before Using the Lancing Device
after a single use.
WARNING
Wash your hands with warm water and soap
X
X
Do not use on more than one patient. Improper
(see 1 ).
use of blood lancets can increase the risk
Inserting a Lancet
of inadvertent transmission of bloodborne
pathogens, particularly in settings where
You have to insert a lancet to be able to obtain blood
multiple patients are tested. The cleaning and
with the lancing device.
disinfection instructions for this device are
Remove the cap from the lancing device (see
intended only to reduce the risk of local use site X
X
infection; they cannot render this device safe
Insert a new lancet into the lancet holder as far as it
X
X
for use for more than one patient.
will go (see
place.
WARNING
Twist the protective cap off of the lancet (see
X X
If the lancing device is being operated by a
z z
Place the cap back on again, lining up the notch on
X
X
second person who is providing testing
the cap with the notch on the lancing device
assistance to the user, the lancing device should
(see 5 ). The cap must audibly click into place.
be cleaned and disinfected prior to use by the
second person. The second person must wear Setting the Penetration Depth
protective gloves for all the steps when providing
You can set 11 penetration depths (0.5 to 5.5). The
testing assistance.
penetration depth set is shown in the window. The
Keep the lancing device with all its components
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larger the number, the greater the penetration depth.
away from children under the age of 3 years.
If you have no experience with this lancing device, we
There is a risk of suffocation if small parts (e.g.
recommend setting a low penetration depth, such as
caps or similar objects) are swallowed.
penetration depth 2.
Only insert Accu-Chek Softclix lancets into the
z z
Accu-Chek Softclix lancing device. Other lancets
Rotate the comfort dial until the desired penetration
X X
may impair the operation of the lancing device or
depth is set (see
damage it permanently.
Priming the Lancing Device
If the lancing device falls with a lancet inserted,
z z
the lancet may become loose in the lancet holder.
In order to be able to obtain blood, you must prime the
You cannot use it anymore to obtain blood. In
lancing device.
rare cases, the lancet could protrude from the
Press the priming button all the way down (see
opening in the cap and you could injure yourself X
X
Do not press the release button simultaneously.
on it. Therefore, do not touch the front of the cap.
If the lancing device falls, pick it up with care. The lancing device is primed when the center of the
Remove the cap from the lancing device. Pay release button is yellow (see
Colored cap
Notch
for obtaining blood from
the fingertip
Release Button Priming Button
WARNING
Only prime the lancing device just before obtaining
blood.
Obtaining a Blood Drop
In general, blood can be obtained from any finger.
Certain fingers can be unsuitable if, for example, a skin
or fingernail infection is present. We recommend
obtaining capillary blood from the sides of the fingertips
as these areas are the least sensitive to pain.
WARNING
Always use a new lancet when you obtain blood.
z z
In doing this, you reduce the risk of infection,
and obtaining blood remains less painful.
Only use the lancing device when the cap is
z z
attached. Without the cap, the lancet penetrates
too deeply and may cause discomfort.
Wash your hands with warm water and soap before
X X
obtaining blood (see
reduces contamination of the puncture site and
stimulates blood flow.
Disinfect the selected puncture site. The puncture
X X
site must dry completely afterwards.
2 ).
Press the lancing device firmly against the selected
X X
puncture site (see 9 ).
3 ). The lancet must audibly click into Press the release button (see
X X
The lancet is released and it penetrates the skin.
4 ).
Massage the finger in the direction of the fingertip to
X
X
encourage a blood drop to form.
The amount of blood that emerges depends on the
penetration depth and the pressure used to hold the
lancing device against the skin.
If not enough blood emerges, apply more pressure on
the lancing device when you next obtain blood. If that
is not sufficient, increase the penetration depth
progressively in addition.
If too much blood emerges, decrease the penetration
depth.
Test your blood glucose immediately after you
X X
obtained blood, according to the instructions for use
6 ). for your blood glucose meter.
We recommend protecting the puncture site from
contamination afterwards.
Ejecting the Used Lancet
Remove the cap from the lancing device (see
X
7 ). X
Slide the ejector forward (see
X
X
The used lancet is ejected.
8 ). Place the cap back on again.
X X
Clear AST cap
for obtaining blood from
non-fingertip testing sites
Dispose of used lancets according to local
X
X
regulations.
WARNING
Dispose of used lancets in such a way as to prevent
injury from the needles.
After Using the Lancing Device
Wash your hands with warm water and soap
X X
(see 1 ).
Storing and Using the Lancing Device
Protect the lancing device from excessive humidity,
sunlight and heat. Store and use at room temperature.
WARNING
Store the lancing device only without a lancet
inserted.
Cleaning and Disinfecting the Lancing
Device and Cap
The lancing device can spread infection if it becomes
1 ). Dry your hands well. This
soiled with blood. During normal testing any lancing
1,2
device may come in contact with blood. For this
reason, it is important to keep the lancing device clean
and disinfected.
To clean and disinfect without damaging the lancing
device, follow these procedures carefully.
What is the difference between cleaning and
0 ).
disinfecting?
Cleaning is the removal of dirt from the lancing
z z
device.
3
Disinfecting is the removal of most, but not all,
z z
disease-causing and other types of micro organisms
(bloodborne pathogens) from the lancing device.
Approved Cleaning and Disinfecting Product
The following product has been approved for cleaning
and disinfecting the lancing device:
Super Sani-Cloth (EPA* reg. no. 9480-4)
* Environmental Protection Agency
Super Sani-Cloth can be purchased from Amazon.com,
Officedepot.com, and Walmart.com.
Do not use any other cleaning or disinfecting
z z
solutions. Using solutions other than the Super Sani-
Cloth could result in damage to the lancing device.
The effect of using more than one product
z z
interchangeably to clean and disinfect the lancing
device has not been tested. Always use Super Sani-
Cloth to clean and disinfect the lancing device.
2 ).
Roche has demonstrated that the product is good for
z z
q ).
5-year use, after testing in a total of 260 disinfection
cycles (equal to cleaning and disinfecting once per
week for 5 years).
NOTE
For technical assistance or questions on cleaning and
disinfecting, visit our website at www.accu-chek.com/
support or call the Accu-Chek Customer Care Service
Center at 1-800-858-8072.
When to Clean and Disinfect the Lancing
Device
Clean the lancing device to remove visible dirt or
z z
other material prior to disinfecting.
Clean and disinfect the lancing device at least once
z z
per week to remove visible dirt or other material for
safe handling.
Clean and disinfect the lancing device before
z z
allowing anyone else to handle the lancing device,
for instance, if you have someone assisting you. Do
not allow anyone else to use the lancing device.
NOTE
Do not throw away the cap after each use.
z z
Always remove the lancet before cleaning and
z z
disinfecting the lancing device.
Using cleaning and disinfecting products could result
z z
in damage to the lancing device. If you notice any of
the following signs of deterioration after cleaning
and disinfecting your lancing device, stop using
your lancing device and visit our website at www.
accu-chek.com/support or call the Accu-Chek
Customer Care Service Center at 1-800-858-8072:
residue around buttons, difficulty in priming the
lancing device, difficulty in inserting the lancet.
You might observe a slight discoloration of the
z z
lancing device after multiple cleaning and
3
disinfecting cycles. This does not affect the
functionality of the device.
What to Clean and Disinfect
The following parts of the lancing device should be
cleaned and disinfected:
The entire lancing device surface
z z
The cap
z z
How to Clean and Disinfect the Lancing
Device
WARNING
Failure to follow these instructions may damage
the lancing device and stop it from working
properly.
Do not get any moisture into openings.
z z
Always use the same product for both cleaning
z z
and disinfecting.
A separate Super Sani-Cloth should be used for
cleaning and disinfection.
1. Wash hands thoroughly with soap and water.
2. Wipe the entire lancing device surface and the
inside of the cap with a Super Sani-Cloth (see
w
and e ).
3. For disinfecting the lancing device, use a new cloth.
Repeat step 2 making sure that the surface stays
wet for 2 minutes.
4. Wash hands thoroughly with soap and water.
Discarding the Lancet and Lancing Device
Any product coming in contact with blood is considered
contaminated (potentially infectious).* During obtaining
a blood drop, any lancet and lancing device may come
in contact with blood. Lancets and lancing devices
may also be considered sharps. Disposal of sharps is
regulated by law in many jurisdictions.
Roche is committed to recycling and sustainability.
Comply with any laws or ordinances relating to the
disposal of sharps and/or contaminated products.
Contact your local health department or other
appropriate authorities for proper handling and
disposal of used lancets and used lancing devices.
Remove the lancet before discarding the lancing
device.
*29 CFR 1910.1030 – Bloodborne pathogens
We Are Here to Help
If you have any questions about your lancing device
or any procedure in these instructions, visit our website
at www.accu-chek.com/support or call the Accu-Chek
Customer Care Service Center.
1-800-858-8072 phone
1-800-858-8074 TDD/TTY
(for hearing impaired)
DE 07575050001(03) – US 07575050003