Strap ankle/foot, wheelchair

GENERAL DESCRIPTION
Ankle straps for wheelchair

IMPORTANT INFORMATION
Inappropriate prescription and fitting of wheelchairs, cushions and accessories may harm the user’s health and/or function. Therefore, this product should only be purchased after consultation with the Medical Devices Unit in Supply Division.

INTENDED USE
Ankle/foot straps:
FUNCTION AND POSTURE SUPPORT: For CHILD and ADULT wheelchair users to secure the feet to the foot support to prevent movement and/or sliding off the foot support/s. Durable, adjustable straps with universal design to be fitted to a range of wheelchairs.
ENVIRONMENT: For indoor and outdoor use.

TECHNICAL SPECIFICATIONS
Padded ankle cuff which wraps around the ankle (one pair)
Cuff fastener: user-friendly, quick-release, buckle type system
Cuff adjustable in length
Cuff is length adjustable to optimise fit after fastened
Skin protection through:
- Padding which contours to the body
- Design to prevent curling of edges, bunching, wrinkling, deforming or fraying and/or localised pressure points
Attachment straps of cuff length adjustable/can be mounted at different lengths to accommodate difference types of shoes and shape of feet with/without orthothics
Mounting system to attach cuff to foot support

Size and dimensions:
Desirable range: 3 sizes to fit snugly around lower leg above ankle joint and cover the range of CHILD to ADULT sizes.

ASSEMBLY:
Fully assembled

SUPPLIED WITH:
Standard components to attach to wheelchair
Detailed illustrated instructions to mount/attach to wheelchair
Detailed illustrated instructions for safe use

WARRANTY
Limited warranty to cover defects in material and workmanship only. Warranty excludes normal wear or damage following inappropriate use or lack of maintenance.
2 years

PACKAGING, LABELLING, INSTRUCTIONS:
One (1) pair per box
Dimensions:
- Unit Weight in Kg (including its packaging): 0.4 kg
- Unit Volume in M3 (including its packaging): 0.04 m³
Labelling: Compliance with EAN 128 bar code requirements

ESTIMATED LEAD TIME
30 days

ENVIRONMENTAL CONDITIONS
Operating conditions: 0 to 50 degrees Celsius; 10 to 85% RH
Storage conditions: 0 to 50 degrees Celsius; 10 to 85% RH

ESTIMATED LIFE SPAN
5 years

USER FITTING AND TRAINING REQUIREMENTS
Users to be fitted and trained by trained wheelchair service personnel.

MAINTENANCE REQUIREMENTS
Product maintenance as per manufacturer’s instructions

RELATED PRODUCTS
S0004004 Wheelchair, assistnt controlld,transport
S0004005 Wheelchair,active urban,fold,more support
S0004006 Wheelchair, active urban, folding
S0004007 Wheelchair, active urban, rigid
S0004008 Wheelchair, active dual terrain, folding
S0004009 Wheelchair, active dual terrain, rigid
S0004010 Wheelchair, active rough terrain
S0004011 Wheelchair, postural support
S0004012 Cushion,wheelchair, posture, layered
S0004014 Cushion,wheelchair,pressure, mod layered
S0004015 Cushion,wheelchair,pressure,mod no layer
S0004018 Cushion,wheelchair,pressure,deep,section

ALTERNATIVE PRODUCTS
S0004020, Strap pelvis/hip, wheelchair
S0004021 Strap lower leg/calf, wheelchair

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier is certified for ISO 9001 Quality management systems – Requirements.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDR 2017/745 as Class I device.

NOMENCLATURE
GMDN Code:
13356