DJO Global Donjoy Support Everest Ice Mode D'emploi page 5

SUPPORT EVEREST ICE
For treatment combining Cold therapy and Compression, the Knee Brace is
delivered with a KNEE CUFF containing 1 Inflatable Pad, 1 Hand Pump and 2
Cold Packs.
INTENDED USE/INDICATIONS
• To be used ONLY in conjunction with SUPPORT EVEREST Knee Brace.
• Localized external application of cold therapy and compression after surgery
or injury, to help minimize inflammation, swelling, and pain.
CONTRAINDICATIONS
DO NOT use this device on patients with:
Raynaud's or other vasospastic diseases; diabetics; sickle-cell anemia,
arteriosclerosis, cryoglobulinemia, hypercoagulable clotting disorders or
other peripheral vascular diseases causing ischemia or poor local circulation;
compromised local circulation; local tissue infection; cold allergy, cold
hypersensitivity, previous cold injury.
APPLICATION INSTRUCTIONS
Prior to use, detach Cold Pack from Knee Cuff and place in freezer for 4 hours
minimum. (Domestic deep freeze temperature between -12°C & -20°C).
A - Once Cold Pack is cold / frozen, attach the Cold Pack onto the Knee Cuff,
using the hook and loop.
Feel Cold Pack and ensure temperature is adequate before use.
• WARNING! Be sure to place a barrier/cloth between your skin and the Cold
Pack. (See "WARNING & PRECAUTIONS" ). Cold Pack temperature should not
be lower than 5C.
B - Place the Knee Cuff around the knee, with the patella opening centred on
the knee cap.
Secure the Knee Cuff by attaching the Thigh Strap and the Calf Strap using the
hook and loop closures.
C - Position the SUPPORT EVEREST KNEE BRACE above the Knee Cuff. (See
"APPLICATION INSTRUCTIONS" 1 to 3).
D - Screw the pump to the Knee Cuff, turn the valve to 'ON' position. Inflate
the Air Cell to the desired level of compression.
Once the desired inflation level has been reached turn the valve to 'OFF' and
remove the pump.
• WARNING! Do not inflate and tighten the Knee Cuff excessively. Ensure
level of compression is not too tight so as not to restrict blood or fluid flow.
(See "WARNING & PRECAUTIONS" ).
• WARNING! Upon instruction of a Health Care Professional: Apply the Knee
Cuff to injured area 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 using second Cold Pack. Replace first Cold Pack in
freezer until needed. Do not sleep with the Knee Cuff on.
E - 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.
HINGED KNEE BRACE WITH COLD COMPRESSION
WARNING & PRECAUTIONS
WARNING! THIS DEVICE CAN BE COLD ENOUGH TO CAUSE SERIOUS
INJURY. SERIOUS ADVERSE REACTIONS AND SAFETY HAZARDS MAY
OCCUR WHEN USING THIS DEVICE.
USE OF KNEE CUFF WITH INFLATABLE PAD & COLD PACK :
• A health care practitioner must state how long and how often the
device should be used and the length of breaks between uses.
• Extreme care must be taken when using any cold therapy system.
Any cold products may cause injuries, e.g. burns, blisters, frostbite,
swelling, discoloration and skin or tissue necrosis if improperly used or
monitored.
• WARNING! DO NOT inflate and tighten the Knee Cuff excessively.
Ensure level of compression is not too tight so as not to restrict blood
or fluid flow.
• WARNING! This device can be cold enough to cause serious injury,
including tissue necrosis. You must be able to check your skin condition
under the Cold Pack frequently (at least every hour). DO NOT use this
device if you cannot check your skin condition frequently (at least every
hour). Check for increased pain, burning, numbness, tingling, increased
redness, discoloration, itching, increased swelling, blisters, irritation
or other changes in skin condition under the Cold Pack or around the
treatment area. If you experience any of these conditions, immediately
discontinue use of this device and contact your physician.
• WARNING! Application of the Cold Packs directly on the skin may result
in serious injury, including tissue necrosis. DO NOT let any part of the
Cold Pack touch your skin. ALWAYS use with a barrier/cloth between
your skin and the Cold Pack.
• Keep the product away from children.
• All Cold Pack ingredients are non-toxic. They are, however, not intended
for ingestion.
• Do not heat the Cold Packs (microwave, oven, hot water, etc...)
• Do not use on open wound(s) and/or sensitive skin.
• Do not use this product if it is damaged or defective.
• Do not use this product in any way that may damage its integrity.
• Do not sit or lay over the Cold Pack or fall asleep with the Cold Pack
on the skin.
• If contents get in contact with eye or skin, rinse with water
immediately.
LIMITATIONS ON SPECIAL PATIENT POPULATIONS
Limit the use of this device with patients who are unresponsive,
incapacitated, have altered mental status or altered pain perception.
Post-surgical patients under sedation or on analgesics or anesthetics, as
well as patients taking hypnotics, anxiolytics, or antidepressants, must be
monitored frequently during use of this device. These patients may not be
able to perceive pain, burning, numbness, tingling or decreased sensation
and may be susceptible to injury. Discontinue cold therapy immediately
at the first sign of cold injury.
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