Indications For Use; Contraindications, Cautions, And Warnings - Nice NICE1 User Manual

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INDICATIONS FOR USE

NICE1 combines cold and compression therapies. It is intended to treat
post-surgical and acute injuries to reduce edema, swelling, and pain where
cold and compression are indicated. It is intended to be used by or on the
order of a healthcare professional in hospitals, outpatient clinics, athletic
training settings, or home settings.
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CONTRAINDICATIONS, CAUTIONS, AND WARNINGS

PRECAUTIONS
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Basic safety precautions should always be followed when using NICE1 to reduce the risk of
fire, electric shock, and personal injury.
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Please read the entire User Manual carefully before operating the unit.
MEDICAL
CONTRADICTIONS FOR COLD THERAPY
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NICE1 or any cold therapy device should not be used by patients that:
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have significant vascular impairment in the affected region (e.g., from prior frostbite,
diabetes, arteriosclerosis, or ischemia).
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have acute paroxysmal cold hemoglobinuria or cryoglobulinemia.
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have Raynaud's disease or cold hypersensitivity (cold urticarial).
WARNINGS
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Do not use over sensitive skin areas or in the presence of poor circulation.
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Therapy wraps are non-sterile and should never be directly applied to an open wound or
breached skin.
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Dressings used under the therapy wrap should be applied lightly. Do not use pins to secure
the therapy wraps or hoses.
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Do not apply the therapy wrap so tightly as to restrict blood or fluid flow.
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Follow the prescribed instructions of your physician for area, frequency, and duration of
treatment.
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If unusual swelling, skin discoloration or discomfort occurs, immediately discontinue use of
NICE1 and consult a healthcare professional.
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Immediately stop compression therapy if you experience any sense of discomfort, numbness
or tingling of the limb.
POTENTIAL HARM FROM MISUSE
WARNINGS
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Use of this device may also cause frostbite or tissue damage if used incorrectly.
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Use carefully. May cause serious burns.
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The unattended use of NICE1 by children or incapacitated persons may be dangerous.
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Do not drink or ingest the coolant or water that has been circulating in the system.
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Observe all warning and caution labels. Never remove the caution/warning labels.
POWER SUPPLY AND ACCESSORIES
CAUTION
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Only use the supplied power supply and power cord.
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Do not operate the unit with a damaged or frayed power cord.
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A multiple socket outlet (power strip) or extension cord will not be used to power the
NICE1 unit.
WARNINGS
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Connect only items that have been specified as part of the ME equipment for NICE1
including the specified external Medical Grade AC/DC power supply.
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Use only NICE1 approved therapy wraps.
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ENVIRONMENT AND OPERATING CONDITIONS CAUTION
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WARNINGS
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POTENTIAL DAMAGE TO UNIT FROM MISUSE CAUTION
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WARNINGS
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WRAPS WARNINGS
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DISPOSAL
CAUTION
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Do not operate the unit if it has any noticeable or physical damage or is leaking fluid.
Do not smoke while using therapy wraps or use wraps by an open flame.
Do not use near equipment that generates electromagnetic or other interference, as this may be
harmful to the therapy unit.
The therapy unit is not intended to be used in a wet environment.
The NICE1 has an IPx1 rating and can tolerate light rain during movement or storage. If the
unit gets wet, unplug the unit from the wall and allow the unit to dry before use.
The NICE1 has an IP2x rating and can tolerate and prevent foreign object intrusion such as a
finger. Do not stick foreign objects into the reservoir, fan protective covers, or power
connectors
Never push objects of any kind into the therapy unit through the frame.
Do not simultaneously touch parts of other electrical equipment when using the NICE1 unit.
Slots and openings in the cabinet are provided for ventilation to protect the unit from
overheating. These openings must not be blocked or covered at any time except by the
supplied air filter.
Do not allow the therapy wrap or hoses to contact sharp objects that could puncture it.
Monitor all hose and cord placement when in use to avoid tripping and strangulation hazards for
children and pets. Store hoses and cords when not in use to avoid hazardous situations.
Keep the system, including hoses and cords, away from children and pets. No parts of the
system are to be used as toys.
Keep the system away from pest. If your home has problems with insects, please keep the unit
away from problem areas and off the floor.
All compression therapies must be turned OFF when the unit is not in use, the wrap is
removed from the patient for prolonged periods, or for repositioning of the wrap.
Do not overfill the water reservoir.
Never spill liquid of any kind on the therapy unit.
Do not drop the therapy unit or cause impact to the unit.
Do not pull or otherwise put undue stress on the hoses.
Do not spray the unit with any water solvents or cleaners.
Do not service or perform maintenance while the equipment is in use.
Do not attempt to sterilize this device by any means.
No modification of this equipment is allowed.
The NICE1 contains multiple sensors that monitor device performance and issues error
messages. If the wrap does not become cold, makes unusual noises, or becomes unresponsive,
please turn the device off and contact your NICE representative.
Disposable therapy wraps are designed for single patient use only and may only be used on the
same patient for the length of the treatment.
The therapy wrap should be periodically cleaned if it is used on the same patient for an
extended period.
The NICE1 and accompanying Power Supply must not be disposed of with your household
waste. To learn where to drop off your electrical and electronic waste, please contact your
local city/municipal waste disposal service office or contact Nice Recovery Systems for
assistance.
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