Intended Use/Indications; Application Instructions - DJO DONJOY Immo AT4 Everest Manual Del Usuario

ENGLISH
BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING INSTRUCTIONS COMPLETELY AND CAREFULLY. CORRECT APPLICATION IS VITAL TO THE
PROPER FUNCTIONING OF THE DEVICE.
INTENDED USER PROFILE
The intended user should be a licensed medical professional, the patient, the patient's caretaker, or a family member providing assistance. The user should be
able to:
• Read, understand and be physically capable to perform all the directions, warnings and cautions provided in the information for use.

INTENDED USE/INDICATIONS

• Immobilisation of the knee in defined position
• Impairment of Bone / Joint capsule / Ligament-structure
(following mostly after trauma and/or surgery)
• Temporary stabilization of the knee in a defined position
• All indications which need an immobilization in a defined position, e.g.:
- Pre-operative
- Post-operative
- Post-traumatic
• Providing immobilization or controlled movement of the limb or body
segment.
OPTIONAL COLD THERAPY INDICATIONS:
• Localized external application of cold therapy and compression after
surgery or injury, to help minimize inflammation, swelling, and pain.
CONTRAINDICATIONS
Do not use if you are allergic to any of the materials contained in
this product. We recommend that the first application be made by
a professional.
WARNINGS AND PRECAUTIONS
• If pain, swelling,changes in sensation or other unusual reactions occur
while using this product, you should contact your doctor immediately.
• Do not use over open wounds.
• Do not use this device if it was damaged and/or package has been
opened.
NOTE: Contact manufacturer and competent authority in case of a
serious incident arising due to usage of this device.
• CAUTION: This brace is intended to be used for immobilization of a
patient's lower limb following injury or surgery. It is NOT intended to
support the full body weight of a patient while standing or walking.

APPLICATION INSTRUCTIONS

Attach the 3 Panels in a way that the two lateral stabilizers are
positioned right and left in the middle of the leg (Fig. 1).
1) With the patient lying down, open-up the brace and place it under
the patient's extended leg. Adjust the internal anti-slip strap, under the
patella (Fig. 2).
2) Wrap the brace over the leg, taking care to place the front opening
right in the middle of the knee (Fig. 3).
3) Close the immobilizer and tighten the closure straps according to the
circumference of the thigh and calf. Once fitted, the immobilizer can be
easily put into place and removed by using the buckles (Fig. 4).
The Immobilizer is delivered with a 0° degree immobilization angle, but
it can be adapted to 20° by exchanging the lateral stays and by bending
the posterior stay to the desired angle. Therefore open the contact
closure tab on top of the casings and remove the stays, exchange and/
or bend them and reinsert them into their casings (Fig. 5).
CARE
Wash in lukewarm water (30°C) with a mild detergent. Do not
bleach.Rinse thoroughly. Air dry. Do not machine dry. Do not dry
clean. Do not iron.
CARE - Cold Pack
Gel inserts may be cleaned with water, moist towel or sponge.
LATEX
NOT MADE WITH NATURAL RUBBER LATEX.
WARRANTY DJO, LLC will repair or replace all or part of the unit and its accessories for material or workmanship defects for a period of six months from the date
of sale.
NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN STATE-OF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM COMPATIBILITY OF FUNCTION,
STRENGTH, DURABILITY AND COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE PREVENTED THROUGH THE USE OF THIS PRODUCT.
COLD THERAPY & COMPRESSION (OPTIONAL)
For optional application combining Cold therapy and
Compression, the Knee Cuff contains 1 Inflatable Pad, 1 Hand
Pump and 2 Cold Packs (Fig. 6a & 6b).
INTENDED USE/INDICATIONS
• Localized external application of cold therapy and compression
aftersurgery or injury, to help minimize inflammation, swelling,
and pain.
CONTRAINDICATIONS - COLD COMPRESSION
DO NOT use this device on patients with:
Raynaud's or other vasospastic diseases; diabetics; sickle-cell
anemia,arteriosclerosis, cryoglobulinemia, hypercoagulable
clotting disordersor other peripheral vascular diseases causing
ischemia or poor localcirculation; compromised local circulation;
local tissue infection; cold allergy, cold hypersensitivity, previous
cold injury.
APPLICATION INSTRUCTIONS - COLD COMPRESSION
1) Prior to use place the cold pack in freezer for 4 hours minimum.
(Domestic deep freeze temperature between -12°C & -20°C). An
hygineic bag is supplied for this purpose.
2) With the brace settled on the knee, open the 2 middle straps
(Fig. 7).
3) Cover the Cold-Pack with the cover provided and attach the
cold-Pack onto the knee Cuff (Fig. 8a & 8b). Feel Cold Pack and
ensure temperature is adequate before use.
4) Place Knee Cuff with Cold-Pack on the middle of the knee and
attach it with the lateral hook straps to the brace (Fig. 9).
5) Close the 2 middle straps of the brace (Fig. 10).
6) Overlaying straps can be cut.
• CAUTION: It needs to be applied with Inflatable Pad and Cold
Pack before cutting the straps (Fig. 11a & 11b)!
7) For compression: Screw the pump to the Knee Cuff, turn the
valve to 'ON' position. Inflate the Air Cell to the desired level of
compression (Fig. 12a). Once the desired inflation level has been
reached turn the valve to 'OFF' and remove the pump. (Fig. 12b)
8) To deflate, screw the pump to the Knee Cuff, position the valve
on ON and press the button at the base of the pump to release
the air (Fig. 13).
• With the two removable straps provided the Inflatable Pad and
Cold Pack can still be used once the immobilizing brace is no
longer needed (Fig. 14).
• WARNING! Be sure to place a barrier/cloth between your skin
and the cold pack (See WARNING & PRECAUTIONS).
• It is critical that your Skin and soft-tissue temperature is not
lower than 5°C, so make sure to wear the cover between the
Cold Pad and skin!
• WARNING! Do not inflate and tighten the air liner excessively.
Ensure level of compression is not too tight so as not too tight
so as not to restrict blood or fluid flow (see WARNINGS &
PRECAUTIONS).
• WARNING! Upon instruction of a Health Care Professional:
Apply the Cold Pack into the knee for time recommended by a
Health Care Professional. Do not exceed 20-30 minutes period of
application. Alternate with adequate rest periods. If needed, renew
application. Replace the Cold Pack in freezer until needed. Do not
sleep with the Cold Pack applied.
WARNINGS AND PRECAUTIONS - COLD COMPRESSION
• WARNING! THIS DEVICE CAN BE COLD ENOUGH TO CAUSE
SERIOUS INJURY. SERIOUS ADVERSE REACTIONS AND SAFETY
HAZARDS MAY OCCUR WHEN USING THIS DEVICE.
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