Aair Medicals 5926 ROM Walker and ROM Air Walker User Manual
- June 11, 2024
- Aair Medicals
Table of Contents
ROM Walker & ROM Air Walker
User Manual
5926 ROM Walker and ROM Air Walker
DESCRIPTION OF SYMBOLS
** Medical Device
Intended Use**
The device is intended for immobilization of the foot and ankle. The device
must be fitted and adjusted by a healthcare professional.
Indication
The following conditions of the foot and ankle can be alleviated by restricting movement or limiting the range of motion:
- Ankle sprain severity level 2 and 3
- Stable fracture
- Achilles’ tendon rupture
- Postoperative or rehabilitation
Washing Instruction
Washing in cold water, gentle cycle, and a mild soap.
- Do not dry clean or tumble dry.
- Do not use bleach.
- Dry in an air current, and do not expose this brace to any heat source.
Warning and Cautions
- Do not remove walker unless instructed by your doctor.
- Because the design and testing of this product is assumed to be used by a single patient, it is not recommended for multiple patients.
- If any inflammation is found on the skin, instruct the patient to consult a healthcare professional immediately.
- Be sure to check the patient’s blood circulation. If you feel that the circulation is not smooth or feel that the walker is too tight, adjust the straps to a comfortable tightness. If discomforts continue, consult your healthcare professional immediately.
- Patients with diabetes, vascular defects, and neurological disorders need special care and consideration.
- Do not remove the insole installed in the walker.
General Safety Instructions
The healthcare professional should inform the patient about everything in this
document that is required for safe use of this device. Any serious incident in
relation to the device must be reported to the manufacturer and relevant
authorities.
Warning: The patient should immediately contact a healthcare
professional:
- If there is a change or loss in device functionality, or if the device shows signs of damage or wear hindering its normal functions.
- If any pain, skin irritation, or unusual reaction occurs with the use of the device.
1.Fitting Instruction
- Place the foot and leg in the foam liner and fix them snugly.
- Optional: If necessary, insert a pad kit between the frame and the softgood.
- Put the foot in the walker frame. Align the center of the shaft of the ankle with the position of the support. Remove the cover of the support and gently press it to fit the foam liner.
- Tighten and secure the straps in the order shown.
2.How to adjust the compression by the air chamber (if using Air version)
-
Inflate by pushing the pump. Repeat until proper compression is obtained.
-
To deflate, turn the valve clockwise.
WARNING: To prevent breakage, do not turn the valve too much.
3.How to set the ROM hinge -
Turn the opening of the cover so that the stop pin can be operated.
-
Adjust the stop pin so that the setting of the operating range becomes appropriate.
-
When finished, turn the cover, and close it.
Disposal
The device and packaging must be disposed of in accordance with respective
local or national environmental regulations.
Liability
Elife does not assume liability, if the device is not maintained as instructed
by the instructions for use, assembled with components from other
manufacturers, or used outside of recommended use condition, application, or
environment.
UK Ltd
Unit No 1
S:Park
Hamilton Road
Stockport SK1 2AE, UK
Tel: +44 (0) 8450 065 065
ossuruk@ossur.com
Legal manufacturing: e-life International CO., LTD.
7F, No.1, Baosheng Rd., Yonghe Dist.
New Taipei City 234 , Taiwan (R.O.C)