Wheelchair, postural support

GENERAL DESCRIPTION
Wheelchair, manual with postural support (variable position wheelchair)

IMPORTANT INFORMATION
Minimum order quantities apply.
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
Wheelchair, manual with postural support (variable position wheelchair)
FUNCTION AND ENVIRONMENT: Either with large rear or small rear wheels. Primarily for assistant-controlled mobility, but large rear wheels will allow for self-propelling. For use in indoor and outdoor urban, peri-urban and rural settings.
POSTURAL SUPPORT: For CHILD and ADULT users with intermediate or advanced posture support needs who require integrated postural support devices with variable tilt and recline, or larger range of tilt/recline than available on manual wheelchairs. Relationship of seat, back-, arm- and foot support dimensions anatomically appropriate for size of wheelchair.
SUPPLIED WITH CUSHION.

TECHNICAL SPECIFICATIONS
Wheelbase and overall length:
Wheelbase similar to/longer than transport wheelchair with large rear wheels
Overall length similar to/longer than transport wheelchair with large rear wheels

Product general features
CHILD sizes: Folding frame
ADULT sizes: Rigid frame
4 wheels
Seat unit:
CHILD sizes: Base frame with integrated seat and backrest
ADULT sizes: Base frame with separate removable seat and backrest
Self-propelling and assistant-controlled OR assistant-propelled depending on model selected
Push handles, non-slip, ergonomic grip

Recline:
Seat-to-back support angle adjustable: at least 90-105 degrees
Quick-release adjustment

Tilt:
Adjustable range: at least 0-20 degrees
Quick-release adjustment

Size and dimensions:
Depending on model selected, either:
CHILD
1 size: 200-350 x 287.5-360 mm x 300-500 mm
OR
1 size: 190-365 x 317-450 mm x 290-560 mm
-Width adjustment through lateral support adjustment
-Seat depth adjustment through seat panel adjustment
-Backrest height adjustment through backrest panel adjustment

ADULT
2 sizes:
360 x 360-470 x 545-655 mm
400 x 360-470 x 545-655 mm
-Width adjustment through lateral support adjustment
-Seat depth adjustment through seat panel adjustment
-Backrest height options

Seat
Seat: rigid
Seat angle with chair in neutral position: 0 degrees

Back support
Back support: rigid adjustable
Separate removable back support padding and cover allow for/accommodate modifications to optimise pelvis and trunk support

Trunk and pelvis side supports
Separate rigied padded trunk and pelvis side supports
Independently height and width adjustable

Head support
Attach to back of back support
Adjustablility: backward and forwards (horizontal), height (vertical) and angle
Able to support the head behind/in-line/in front of the back support.
Can be mounted off-centre
Shaped to support weight of head and sides of head

Knee support
CHILD: Adjustable and removable knee separator pad
ADULT: No knee support

Seat cushion
Removable cushion and can be separately replaced
Firm, non-deforming, pre-contoured base
Can accommodate 25-35 mm of offloading or immersion once seat-bone well customised
Can be adjusted/modified to optimise posture support for:
- height, depth and width of seat-bone well/shelf;
- thigh support;
- and postural deviations of pelvis, hips and thighs

Seat cushion cover
Removable cover
Cover allows contouring with customizing of cushion
Moisture-resistant breathable cover

Cushion weight
Weight of cushion with cover: maximum 1.3 kg

Cushion user weight capacity
User weight capacity: CHILD: minimum 75 kg
User weight capacity: ADULT: 136 kg

Arm supports:
Arm supports: Removable or fixed depending on model selected
Arm support pad: at least 44% of seat depth
Arm support design to protect clothing and cushion from rear wheels, dust, mud, etc.
Height adjustable: at least 130-250 mm

Foot supports:
Seat to lower leg support angle: between 90-130 degrees depending on model selected
Two individual flip-up, swing-away foot supports OR flip up footrests depending on model selected
Height adjustable: CHILD: at least 240-315 mm; ADULT: 370-505 mm

Tray table
CHILD:
Supplied with tray table that extends around the sides of the body to the front of wheelchair back posts and is wide enough to support elbows and forearms with upper arms in neutral alignment next to body
ADULT:
No tray

Pelvis strap
Two-piece, length adjustable, padded over thigh area
Fastener: user-friendly, quick-release, buckle type system
Washable

Ankle / foot strap
CHILD:
Foot strap with toe and heel strap / ankle straps and cuffs depending on model selected
User-friendly, quick-release, buckle type system
ADULT:
None

Rear wheels and parking brakes:
Two rear wheels: diameter x width: 558 x 35 mm / 305 x 50mm
Puncture-proof polyurethane rear tyres
Rear wheels parking brakes, frame mounted, push-pull/ foot activated push to lock /

Front castors:
Two front castors: diameter x width: at least 150 x 28 mm
Puncture-proof: polyurethane / rubber / polyurethane

Wheelchair weight:
Total weight:
CHILD: maximum 20 kg
ADULT: 35 kg

User weight capacity:
User weight capacity: CHILD: at least 50 kg
User weight capacity: ADULT: 150 kg

ASSEMBLY
Depending on model selected: Fully assembled with standard removable parts to be attached (footrests, armrests, rear wheels and anti-tippers) OR partly assembled and need to install back and head support as well as pelvis and ankle straps (time required: 30-60 min, all tools included except drill and drill bit to install the ankle straps, basic technical knowledge to assemble, detailed, illustrated assembly manual)

SUPPLIED WITH
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.
Frame: 3 years
Components: 1 year

MINIMUM ORDER QUANTITIES
Minimum order quantities apply

PACKAGING / LABELLING
Please note: Minimum order quantities apply
One (1) unit per box
Dimensions:
- Unit Weight in Kg (including its packaging): CHILD 24 kg / ADULT 36 and 8 kg
- Unit Volume in m³ (including its packaging): CHILD 0.36 m³ / ADULT 0.36 m³ and 0.14 m³
Labelling: Compliance with EAN 128 bar code requirements

ESTIMATED LEAD TIME
100 days

ENVIRONMENTAL CONDITIONS
Operating conditions: -25 to 50 degrees Celsius; 20 to 60% RH
Storage conditions: 0 to 45 degrees Celsius; 20 to 75% RH

ITEMS REQUIRED, BUT NOT SUPPLIED
N/A

ESTIMATED LIFE SPAN
3-5 years depending on the model selected

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 by trained technical personnel.

RELATED PRODUCTS
S0004012 Cushion,wheelchair, posture, layered
S0004014 Cushion,wheelchair,pressure, mod layered
S0004015 Cushion,wheelchair,pressure,mod no layer
S0004018 Cushion,wheelchair,pressure,deep,section
S0004020, Strap pelvis/hip, wheelchair
S0004021 Strap lower leg/calf, wheelchair
S0004022 Strap ankle/foot, wheelchair

ALTERNATIVE PRODUCTS
None

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
Depending on model selected, either:
Wheelchair:
ISO 7176-8:2014; and

Cushion:
ISO 16840-2:2018 modified loaded contour depth and overload tests; and

Posture support devices:
ISO 16840-3:2014

NOMENCLATURE
GMDN Code:
41630, 41622