Bauerfeind AirLoc - Intended Purpose and Indications; Product Purpose; Indications for Use; Product Safety and Precautions

05
2021-07
Dear customer,
thank you for choosing a Bauerfeind product.
We work to improve the medical eectiveness of our products every day – because your health
is very important to us. Please read through these instructions for use carefully. If you have any
questions, please contact your doctor or medical retailer.
Intended purpose
AirLoc is a medical device. It is an orthosis
1
for
the stabilization of the ankle with movement
limitation in pronation and supination,
including unilaterally adjustable air cushioning.
The AirLoc must be individually adjusted for
the patient by a trained specialist
2
. This is
the only way to guarantee the full eect and
ideal wearing comfort of the orthosis.
Indications
• Treatment of (acute) injuries to the capsular
ligament complex
• Early functional / non-surgical treatment, e. g.
after ankle sprains and ruptured ligaments
• Post-operative rehabilitation / protection,e. g.
after suture repair / ligament reconstruction
• Chronic ligament insuciency / instability
• Recurrence prevention
• Weber A fracture (not dislocated)
Risks of using this product
Important Information
2
• AirLoc is a prescribed product that should be
applied under medical supervision. AirLoc
should be applied in accordance with these
directions for use and only for the specified
indications.
• No liability is accepted for improper use of
the product.
• The product must be worn in combination
with firm footwear (e.g. sports shoes or
outdoor shoes).
• No improper modifications may be made
to the product. In case of non compliance,
the performance of the product can be
compromised. In addition, any product
change will have a negative impact on
questions of liability and could potentially
lead to loss of liability.
• Patients with sensitive skin, known contact
allergies or who are sensitive to pressure
should wear a cotton sock or stocking under
the AirLoc.
• Should you notice any unusual changes
(e. g. increased symptoms), please contact
your medical provider without delay.
• A combination with other products (e. g.
compression stockings) must be discussed
beforehand with your medical provider.
• Avoid the use of ointments, lotions or any
substances including grease or acids.
• Contact sports present a higher risk of injury.
Bauerfeind does not guarantee that AirLoc
will prevent injuries during these activities.
• Side eects involving the body as a whole
have not been reported to date. Correct fitting
is assumed. Any supports and orthoses
applied externally to the body can, if tight
-
ened excessively, lead to local pressure signs
or, rarely, constrict the underlying blood
vessels or nerves.
Note: Never expose the AirLoc to direct heat
(e. g. heater, sunlight, in your car, etc.)! This
could damage the material. This can impair
the eectiveness of the AirLoc.
Contra-indications
Hypersensitive reactions harmful to health
have not been reported to date. In the following
conditions such aids should only be fitted and
applied after consultation with your medical
provider:
• Skin disorders / injuries in the relevant part
of the body, particularly if inflammation is
present. Likewise, any raised scans with
swelling, redness and excessive heat build-
up.
• Severe varicose veins.
• Impaired sensation and circulatory disorders
of the legs, e. g. Diabetes mellitus.
• Impaired lymph drainage – including soft
tissue swellings of uncertain origin located
remotely from the fitted aid.
Application instructions
Putting on and taking o the AirLoc
Putting on the AirLoc
• Undo both straps and loosely refasten the
ends of the straps.
• Open the cover of the valve on the outside of
the orthosis and press the button below in
order to release the air from the air cushion
1
.
• Ensure there is no air left in the air cushions.
• Position the orthosis in such a way that the
shell with the air cushion and the pump are
on the outside of the aected leg
2
.
• The shells are positioned on the side of the
leg in such a way that the front edges of
the orthosis are parallel to the edge of the
shin
3
.
• To fasten the orthosis, it is equipped with two
straps on the shell.
• When putting the orthosis on the right leg,
first the top strap is closed around the front
and then the bottom strap is closed around
the back
4a
.
• When putting the orthosis on the left leg, first
the top strap is closed around the back and
then the bottom strap is closed around the
front
4b
.
• The Velcro ends are fastened to the middle of
the relevant strap’s fleece. The correct strap
alignment is indicated by the contours on the
shell at the fastening for the strap
4b
.
• When the orthosis is positioned correctly, the
upper strap and then the lower strap must be
re-tightened.
• Now put your shoe on.
• Pump up the air bladders using the
integrated pump mechanism on the
outside of the shell
5
. The correct level of
stabilization is usually achieved after 5 – 10
pump strokes. Please make sure you don’t
fill the air cushion with more than 20 pump
strokes, otherwise it may be destroyed.
• The pressure can be individually adjusted
via the pump and the release valve
5
+
6
.
• To let out air, open the cover of the valve and
press the button below into the shell in order
to release the air
6
.
Taking o the AirLoc
• Before taking o the shoe, open the valve
cover on the orthosis. Empty the air bladders
by pressing the button below
6
.
• Now take o the shoe.
• To take o the orthosis, both straps must be
opened.
• First open the top strap, then the bottom
strap, and take o the orthosis.
• Before you put on the AirLoc again, please
make sure the air bladder is empty.
Cleaning instructions
To prevent damage to the product, the
AirLoc should only be washed by hand and
maintained with a gentle cleaning agent / soap.
Before washing, please fasten both Velcro
straps to ensure their adhesive property is not
aected.
Part of the body this product is used for
In accordance with the indications (ankle joint).
Assembly and fitting
AirLoc is supplied ready for use and does not
need to be adjusted. It can be used on the left
or right leg.
Maintenance instructions
If handled and cared for correctly, the product
is practically maintenance-free.
Technical parameters
AirLoc is an ankle orthosis with an inflatable
air bladder and two adjustable Velcro straps.
Notes on reuse
This product is intended to be fitted to one
patient only.
Warranty
The statutory regulations of the country
of purchase apply. Please first contact the
retailer from whom you obtained the product
directly in the event of a potential claim under
the warranty. The product must be cleaned
before submitting it in case of warranty claims.
Warranty may be limited or excluded if the
instructions on how to handle and care for the
AirLoc have not been observed.
Warranty is excluded if:
• The product was not used according to the
indication
• The instructions given by the specialist were
not observed
• The product was modified arbitrarily.
Duty to report
Due to regional legal regulations, you are
obliged to immediately report any serious inci
-
dent involving the use of this medical product
to both the manufacturer and the responsible
authority. Our contact details can be found on
the back of this brochure.
Disposal
Once you have finished using the product,
please dispose of it according to local speci
-
fications.
Material content
Polypropylene (PP), Polyurethane (PUR),
Polyamide (PA), Thermoplastic elastomer (TPE),
Thermoplastic polyurethane (TPU),
Polyethylene terephthalate (PET),
Polyester (PES), Copper (Cu), Tin (Sn)
– Medical Device
– DataMatrix Unique Device Identifier UDI
1
Orthosis = orthopedic aid used to stabilize, relieve, immobilize, control, or correct the limbs or
the torso
2
A specialist is any person who is authorized according to the state regulations for fitting and
instruction in the use of orthoses which are relevant to you.
 Note on the risk of personal injury (risk of injury, harm to health, and accidents) or damage to
property (damage to the product)
EN