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DJO ORMED ARTROCARE PRO3 クイック・スタート・マニュアル

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 or the patient's caregiver. 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: The Ormed ArtroCare Pro3 Knee Brace is designed to

support the knee and provide protected range of motion following ligament injuries or

instabilities, collateral ligament deficiencies, severe knee joint instability and meniscal

injuries. Soft-good/semi-rigid designed to restrict motion through elastic or semi-rigid

construction. Providing mild protection of a limb or body segment for acute and

prophylactic care.

CONTRAINDICATIONS: Do not use if you are allergic to any of the materials contained

within this product.

WARNINGS AND PRECAUTIONS: • Loss of circulation, patient discomfort and patient

re-injury are potential effects caused by device failure. • ROM settings should not be

changed without supervision of a medical professional. • This product must be prescribed

and fitted by a healthcare professional. • The frequency, duration of use and directions

for use should be determined by your healthcare professional. • If pain, swelling, changes

in sensation or other unusual reactions occur while using this product, you should

contact your doctor immediately. • Consult your medical professional immediately if

you experience leg pain, tenderness, swelling or redness of the skin as these may be

symptoms of a venous thromboembolism • The support should be snug but not impair

circulation. • Do not use over open wounds. • Do not use the device if it is damaged

and/or the packaging has been opened. NOTE: Contact manufacturer and competent

authority in case of a serious incident arising due to usage of this device.

INSTRUCTIONS FOR APPLICATION: • Applying orthosis. Sit on the edge of a chair and

loosen all Velcro straps. Bend the knee at a 45° angle and place the orthosis as shown

in Figure A by aligning the joint with the top edge of the kneecap and slightly offset

backwards from the center line of the leg. Make sure that the orthosis is not twisted

on the leg. • Closing the belt. Pull the straps through the opposite straps and close the

Velcro fasteners in the given order:

0. Wide anti-migration band below the joint (Fig. B)

1. Calf strap near to the knee (Fig. C)

2. Calf strap away from the knee (Fig. D)

3. Thigh strap near to the knee (Fig. E)

4. Thigh strap away from the knee (Fig. F)

5. Tibia belt (Fig. G)

• Check the correct seat. When all straps are fastened, the center of the joint should

be directly above the top end of the kneecap and slightly offset backwards from the

center line of the leg. It is recommended to bend the knee a few times or walk for a few

minutes to ensure that the orthosis does not shift when moving. Then tighten the straps

again according to steps 1-5 to ensure a safe and comfortable fit. • Adjust the knee

width. The knee width can be adjusted by means of enclosed condyle pads of different

thicknesses. • Set the extension and flexion limit (according to medical specifications

only by specialist personnel). Remove the condylene pads. Insert the respective limiting

wedges and fix them with the enclosed screws (Fig. H). Make the same settings on both

joints.

USE AND CARE: • If the orthosis needs to be adjusted after use, tighten all belts according

to the application instructions. • All straps and pads can be tailored to the patient's limb

circumference. • The orthosis can be used in both salt and fresh water. After use, rinse

with clean tap water and let it dry in the air. • Wash the belt and pad material by hand

in a mild, warm (30°C) soap solution. Air-drying. • Check screws regularly for a tight fit

and retighten if necessary. • Lubricate joints regularly with dry lubricant or Teflon™spray.

To lubricate the inner joint mechanism, bring the orthosis in a flexion position and spray

lubricant into the joint gap. • The orthosis should be used only with the accessories

intended for this product. • Always consult the doctor before changing the settings on

the orthosis.

MATERIAL USED

Frame

Aluminum

Joints

Aluminum, Stainless steel

Velcro straps

Nylon fabric

Pad material

Velours, EVA 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. 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.

LATEX

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.