10A01 DJ Orthopedics Aircast Ankle Cryo Cuff with Cooler Tube User Guide

: June 6, 2024
: AIRCAST

Table of Contents

INTENDED USER PROFILE:
APPLICATION INFORMATION:
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PEDIATRIC ANKLE
CRYO/CUFF

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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 use 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 and understand the directions, warnings, and cautions.

OPERATING PRINCIPLE: The Pediatric AirCast Cryo/Cuff provides cold therapy and compression.
INTENDED USE/INDICATIONS: The Aircast Cryo/Cuff combines focal compression with cold to minimize swelling, edema, hematoma, hemarthrosis, 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 the individual patient’s needs.
Do NOT use this device if a prescription has not been provided to you or if you do not understand the prescription as this may result in injury. 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 another 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.

WARNINGS AND CAUTIONS:

A Pediatric Ankle Cryo/Cuff with an AutoChill system should only be used in a the medical facility or clinical environment with direct healthcare provider supervision.
When using the Pediatric Ankle Cryo/Cuff with the AutoChill system, always apply a heavy cotton sock or bandaging to prevent skin temperature from falling below 50°F (10°C).
Do not use an elastic wrap in conjunction with the Cryo/Cuff.
Dressings used under the Cryo/Cuff should be applied lightly.
The patient’s skin should be observed frequently due to individual sensitivity and susceptibility to cold.
It is recommended that at least 20 minutes of cessation should be encouraged between 2 hour-long cryotherapy sessions.
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 the use of the device and contact your physician.
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:

PREPARE COOLER: Connect blue tube to cooler. Add water to line inside cooler, then add ice. For 6 to 8 hour treatment, add ice to the top of the cooler. Lay the insulation disk on top of the ice. Attach cooler lid snugly. Allow 5 minutes with occasional shaking to chill water.
APPLY THE EMPTY CUFF: Close bottom flaps underfoot. Place foot in the cuff, position heel against the back of the cuff. If necessary, adjust cuff width by repositioning bottom flaps. Wrap foot cover around the foot and secure the bottom strap (Fig. 1). Wrap ankle cover around the ankle and secure top strap (Fig. 1).
FILL CUFF: Connect blue tube to cuff. 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 the cooler lid. If not using an Aircast AutoChill System, the cooler can now be disconnected from the cuff by pressing the metal tab on the quick disconnect while the cooler is raised.
RECHILL WATER: At first, rechill the water in the cuff after 15 or 30 minutes, then once an hour or as needed. Reconnect the blue tube to the cuff, lower the cooler below the 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 the cuff, tube, and cooler. (To drain tube, elevate tube while pressing the tip of quick-disconnect.) Store cooler with the 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.
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. To the extent the terms of this warranty are inconsistent with local regulations, the provisions of such local regulations will apply.

RX ONLY.
INTENDED FOR SINGLE PATIENT USE.
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 UNCTION, STRENGTH, DURABILITY, AND COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE PREVENTED THROUGH THE USE OF THIS PRODUCT.

MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
**©2021 DJO, LLC

DJO, LLC
1430 Decision Street
Vista, CA 92081-8553
U.S.A.**
10P100 REV P – 2021-01-21