AIRCAST FS12691 Calf Cryo Cuff with Cooler User Guide

AIRCAST FS12691 Calf Cryo Cuff with Cooler

BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING INSTRUCTIONS COMPLETELY AND CAREFULLY. CORRECT APPLICATION IS VITAL TO THE PROPER FUNCTIONING OF THE DEVICE.

IF YOU ARE USING THE CRYO/CUFF WITH THE AIRCAST CRYO/CUFF IC UNIT BE SURE YOU READ AND UNDERSTAND ALL INSTRUCTIONS LOCATED IN THE AIRCAST CRYO/ CUFF IC INSTRUCTIONS FOR USE.

INTENDED USER PROFILE
The intended user should be a licensed medical professional, the patient, the patient’s caretaker, or a family member providing assistance. 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.

OPERATING PRINCIPLE
The AirCast Cryo/Cuff provides cold therapy and compression.

INTENDED USE/INDICATIONS
The Aircast Cryo/Cuff combines focal compression with cold to minimize swelling and pain.

FREQUENCY OF USE
The length of use and frequency of use of the Cryo/Cuff are determined by the healthcare professional depending on individual patient’s needs. This device can be cold enough to cause serious injury be sure to check skin frequently.

CONTRAINDICATIONS
Cryotherapy should not be used on persons with Raynaud’s or other vasospastic disease, cold hypersensitivity, decreased skin sensitivity, compromised local circulation, diabetics, sickle-cell anemia, arteriosclerosis, cryoglobulinemia, hypercoagulable clotting disorders or other peripheral vascular diseases causing ischemia or poor local circulation, local tissue infection, cold allergy, cold hypersensitivity, previous cold injury and
paroxysmal cold hemoglobinuria.
Do not use if you are allergic to any of the materials contained within this product.

WARNINGS AND CAUTIONS

• This device can be cold enough to cause serious injury, including tissue necrosis. You must be able to check your skin condition under the Cuff (DO NOT use if you cannot check your skin condition frequently). People are sensitive to cold in diverse ways and may react differently to cold treatment.
• Check for increased pain, burning, numbness, tingling, increased redness, discoloration, itching, increased swelling, blisters, welts, irritation or other changes in skin condition under the Cuff or around the treatment area. If you experience any of these conditions, immediately discontinue use of the device and contact your physician.
• Patient skin condition checks must occur every 1~2 hours on a routine basis. Caution must be taken by routinely monitoring the patient during use on children, elderly, incapacitated patients, severe cardiovascular diseases, those with decreased skin sensitivity or circulation due to poor nutrition, medications (e.g. beta blocker or epinephrine, narcotics), tobacco and alcohol use. If such monitoring is to occur outside the presence of the licensed healthcare professional, he or she must ensure that the patient or patient caretaker understands how such monitoring is to be conducted.
• It is recommended that at least 20 minutes of cessation should be encouraged between 2 hour long cryotherapy sessions.
• When applying the device wrap to the skin, apply a barrier (e.g. cloth or bandage) between the wrap and your skin, and do not wrap it around the area tightly. No part of the wrap should touch the skin for any period of time.
• Check for moisture. If moisture is present on the Cuff, immediately discontinue use of the device.
• Do not use an elastic wrap in conjunction with the Cryo/Cuff.
• Dressings used under the Cryo/Cuff should be applied lightly.
• When filling the Cryo/Cuff, do not raise the cooler higher than 15 inches (38 cm) above the cuff to avoid excessive pressure.
• Reduce pressure with any sense of discomfort, numbness or tingling of the limb.
• The Cryo/Cuff is designed for single patient use only and may be used on the same patient for the length of treatment.
• The device should be cleaned if it is used on the same patient for an extended period of time (see “Cleaning Instructions” for cleaning information).
• Keep small parts and packaging materials away from small children and animals. These items pose a risk for suffocation or strangulation
• It could be unsafe to use accessories, detachable parts and materials, or interconnect to other equipment not described in these instructions, or otherwise modified equipment.

APPLICATION INFORMATION

1. PREPARE COOLER – Connect blue tube to cooler. Add water to line inside cooler, then add ice to top of cooler. Lay the insulation disk on top of ice. Attach cooler lid snugly. Allow 5 minutes with occasional shaking to chill water.
2.  APPLY THE EMPTY CUFF – Position cuff on calf with quick-disconnect pointing down (cuff can be positioned on front or back of calf). Thread straps through white rings and secure snugly (Fig. 1).
3.  FILL CUFF – Connect blue tube to the cuff, listen for a click/snap. When using the Gravity Cryo/Cuff (non-motorized), open air vent on cooler lid and raise cooler no more than 15 inches (38 cm) above the cuff (Fig 2). (If the cooler is raised more than 15 inches (38 cm), the cuff will increase in volume and weight.) Hold raised cooler for about 30 seconds while cuff fills. Close air vent on cooler lid. The cooler can now be disconnected from cuff by pressing the metal tab on the quick-disconnect while cooler is raised.
4. RECHILL WATER – Reconnect the blue tube to cuff, lower the cooler below cuff, and the warmed water will drain from the cuff into the cooler. Allow a minute or two for the water to mix with the ice and rechill, then raise the cooler and repeat the filling process (see step 3).

CLEANING INSTRUCTIONS

After use, completely drain water from cuff, tube, and cooler. (To drain tube, elevate tube while pressing tip of quick-disconnect.) Store cooler with top off to allow drying. Periodically clean cuff, tube, and cooler using a few ounces of liquid soap added to hot water in cooler. Recycle soap/water mixture between cooler and cuff a few times, then repeat with warm water only. Rinse completely.

MATERIAL CONTENTS
Polyurethane Nylon, Nylon, Polyether foam.

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.

Warnings
FOR SINGLE PATIENT USE ONLY. NOT MADE WITH NATURAL RUBBER LATEX.

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.

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