Cushion,wheelchair,pressure,deep,section

GENERAL DESCRIPTION
Wheelchair seat cushion: Pressure-redistribution cushion with deep/full offloading or immersion/envelopment features: Cushion with multiple sections without dedicated structural base.

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
Pressure-redistribution cushion with deep/full offloading or immersion/envelopment features: Cushion with multiple sections without dedicated structural base.
For CHILD or ADULT wheelchair users who are at risk of, or have existing or previous pressure injuries, and who need good support to maintain stability and an aligned posture. Cushion and cover function to reduce heat and moisture generated when the user is sitting on the cushion.

TECHNICAL SPECIFICATIONS
Characteristics:
No dedicated structural base
Cushion consists of multiple sections with sealed air-filled cells
Placement of sections and manipulation of volume by removing/adding cells create pelvis well area for offloading and full or deep imersion and envelopment
Volume can be manipulated in different sections to accommodate minor fixed pelvis and hip postural deviations
Thigh area: level

Height and offloading OR immersion
Overall cushion height 100 mm
Allows deep/full offloading OR immersion and envelopment of at least 40 mm or deeper

Design of bottom of base:
Bottom of base: flat: moulds to wheelchair seat

Size and dimensions:
Seat width range: 4 sizes between 350 and 500 mm in 50 mm increments
Seat depth: Adjustable and/or different seat depth options

Cushion cover
Removable cover
Cover allows contouring with user weight and compression of cushion without restricting/changing posture support and pressure redistribution properties and function
Moisture-resistant breathable cover

Cushion weight
Weight of cushion with cover: 0.72-0.99 kg depending on size

Desirable user weight capacity
User weight capacity: CHILD: N/A
User weight capacity: ADULT: 250 kg

Use and orientation:
The cushion is 'ready to use', and requires no specific setup or assembly prior to use (excluding customizations)
Bottom, front and back of cushion clearly marked
Cover front and back clearly marked if specific front/back

WARRANTY
Limited warranty to cover defects in material and workmanship only. Warranty excludes normal wear or damage following inappropriate use or lack of maintenance.
Cushion: 2 years
SmartCells: lifelong
Cover: 1 year

SUPPLIED WITH
Cushion cover
Detailed illustrated instructions for safe use

PACKAGING / LABELLING
One (1) unit per box
Dimensions:
- Unit Weight in Kg (including its packaging): 2 kg
- Unit Volume in M3 (including its packaging): 0.04 m³
Labelling: Compliance with EAN 128 bar code requirements

ESTIMATED LEAD TIME
14 days

ITEMS REQUIRED, BUT NOT SUPPLIED
N/A

ESTIMATED LIFE SPAN
5 years

ENVIRONMENTAL CONDITIONS
Storage conditions: -20 to 55 degrees Celsius; 0 to 100% RH
Operating conditions: -20 to 55 degrees Celsius; 0 to 100% RH

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
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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
S0004020, Strap pelviship, wheelchair
S0004021, Strap lower legcalf, wheelchair
S0004022, Strap anklefoot, wheelchair

ALTERNATIVE PRODUCTS
S0002012 Cushion,wheelchair, posture, layered
S0002014 Cushion,wheelchair,pressure, mod layered
S0002015 Cushion,wheelchair,pressure,mod no layer

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.

SAFETY AND PRODUCT STANDARDS
ISO 16840-2:2018 (modified loaded contour depth and overload tests)
BSEN 1021-1 and 2 of 2014

NOMENCLATURE
GMDN Code:
11100