SUNRISE MEDICAL JAY Xtreme Active Wheelchair Cushion Owner’s Manual

XTREME ACTIVE CUSHION
Owner’s Manual

Xtreme Active™ Cushion

Important Consumer Information
NOTE: This manual contains important instructions that must be passed on to the user of this product. Please do not remove this manual before delivery to the end user.
SUPPLIER: This manual must be given to the user of this product.
USER: Before using this product, read this entire manual and save for future reference.
WARRANTY REGISTRATION : To validate the warranty on this product, please complete and return the postcard attached to the enclosed instruction and warranty booklet.

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WARNINGS

NOTE: Check all parts are free from shipping damage. In case of damage DO NOT use. Contact Sunrise Medical or your supplier for further instructions. Sunrise Medical recommends that a clinician such as a doctor, therapist or rehab engineer experienced in seating and positioning be consulted to determine if a Jay Xtreme Active Cushion is appropriate. Cushions should only be installed by:

• an authorized Sunrise Medical supplier
• a qualified healthcare professional who has undergone appropriate training by either Sunrise Medical or their approved supplier.

GENERAL WARNING

• DO NOT install this equipment without first reading and understanding this manual. If you are unable to understand the Warnings, Cautions and Instructions, contact a qualified clinician or supplier – otherwise injury or damage may occur.
• Hook and loop Velcro® should not come into prolonged contact with moisture as this may degrade the adhesive and lead to a failure of the Velcro®.

INTRODUCTION
The Xtreme Active Cushion is designed with the benefits of skin protection in a light-weight, comfortable and low maintenance design. The Xtreme Active incorporates a Jay Flow Fluid pad, a soft foam base, with an incontinent inner cover, optional lateral and medial thigh supports and an outer cover. For active and regular users , the Xtreme Active helps to provide pressure and shear reduction which may help reduce the incidence of skin breakdown. It is comfortable and facilitates movement, allowing the user to change positions on the cushion. The Jay Xtreme Active cushion is designed to help reduce the incidence of pressure ulcers. However, no cushion can completely eliminate sitting pressure or prevent pressure ulcers. The Jay Xtreme Active cushion is not a substitute for good skin care including proper diet, cleanliness and regular pressure relieving.

The intended lifetime of this product is 5 years.
Maximum User Weight:

• 150 kg for all sizes.

WARNING

• Installing a cushion on a wheelchair may affect the centre of gravity of the wheelchair and may cause the wheelchair to tip backwards, potentially resulting in injury. Always assess the potential need for anti-tippers or amputee axle adapter brackets to be added to the wheelchair to help increase stability.
• Prior to prolonged sitting, any cushion should be tried for a few hours at a time while a clinician inspects your skin to ensure that red pressure spots are not developing. You should regularly check for skin redness. The clinical indicator for tissue breakdown is skin redness. If your skin develops redness, discontinue the use of the cushion immediately and see your doctor or therapist.
• The Xtreme Active cushion is designed to help reduce the incidence of pressure ulcers. However, no cushion can completely eliminate sitting pressure or prevent pressure ulcers.

WARNING

• Do not leave the cushion outside overnight at temperatures below 40° F (5° C). Allow the cushion to warm to room temperature before using. Sitting on extremely cold or hot surfaces can cause skin damage.
• Avoid sharp objects or exposure to excessive heat or open flame.
• PROPER FLUID LEVEL: The amount of fluid contained in the insert is determined by the clinician during a seating evaluation. This should not be adjusted without a clinician directive as it can alter the pressure relieving properties and lead to injury or damage.
• OBSTRUCTIONS: DO NOT: place any obstructions between the user and the cushion because it will reduce product effectiveness.
• CUSHION AND COVER ORIENTATION: Product must be used with the fluid insert facing up. If the cover is not used correctly or if the cover is the wrong size, it may reduce or eliminate the cushion’s benefits and could increase risk to the skin and soft tissue.
• CUSHION BASE AND FLUID PAD: this product has two different fluid pads that match two different bases. The bases are not interchangeable. Using a fluid pad
  with the incorrect base will reduce or eliminate the cushion’s benefits, increasing risk to the skin and soft tissue

INSTALLATION

FITTING THE GS CUSHION

Place the Cushion on the seat of the wheelchair, (A solid base of support, like the Jay Adjustable Solid Seat or Solid Seat Insert is recommended). If using an adjustable depth back on the wheelchair, like the JAY 3 GS Back, position the back of the Cushion even with the front of the upright back posts.
If using a fixed depth back, like a JAY® J2 Back or Jay Care Active™ Back, notch the rear corners of the base to establish seat depth to within 1” (2.5 cm) from the back of the knees, (see score lines on base).
This will allow the back of the Cushion to go between the posts.
Place the individual on the Cushion allowing the buttocks to sit in the rear, carved-out portion and the legs to rest comfortably on the raised front portion. To achieve the lowest average sitting pressures possible, utilize the GS Pressure Relief Pad. Additionally, the footrests should be adjusted low enough to allow the legs to rest firmly on the front of the Cushion. The Cushion should come within 0 1” (0-2.5 cm) of the back of the knee.

Assess the client:

• Are the hips level?
• Are the legs in good position?
• Is the client comfortable?

If the answer to any of these questions is “no,” see the Accessories section in this Owner’s Manual.

HOW THE JAY JAY GS CUSHION GROWS
The Jay JAY GS Cushion grows by maintaining the positional relationship between the user and the cushion.
The Jay JAY GS Cushion shown with other components of the Growth and Positioning System.
As the client grows, the area under the buttocks remains roughly the same, while the area under the legs grows backward. Using the Pre-ischial Shelf Extender (see diagram on bottom of previous page) will increase leg support and position the anti-thrust shelf where needed.

USE WITH A SOLID SEAT AND A SOLID BACKREST
Avoid using the cushion on overly stretched seat upholstery. Stretched upholstery does not provide adequate support for the cushion and improper positioning may result. Replace stretched upholstery or purchase the Jay Adjustable Solid Seat or the Jay Solid Seat insert that is appropriate for the cushion.
Avoid using overly stretched back rest upholstery.
Stretched back upholstery does not provide adequate support for the body and improper positioning may result.
Replace stretched back rest upholstery or purchase a back support product from Sunrise that is appropriate for you. Contact an authorized supplier for a free demonstration of these products.

WARNING

• When you install a seat cushion in a wheelchair, this affects the centre of gravity and could increase the risk of the wheel¬chair tipping over backwards!
• Always have the anti-tip tubes fitted to the wheelchair! For better posture and to give greater relief from back pain, we recommend the JAY J3 backrest. Your Sunrise Medical dealer will be pleased to demonstrate these backrests for you.

SETTING THE LEG POSITION
In order to achieve the lowest seated pressure and maximise the leg support, lower the footrests, raise the seat and/or use a longer cushion. The leg wedges in the cushion base cover stop the legs from gradually moving apart. You can make the wheelchair sling tighter or consider using a solid seat insert. If the legs are still too far
apart, consider a JAY J2, Jay Balance or JAY J3 cushion.
XTREME ACTIVE CUSHION ACCESSORY PARTS
Each Xtreme Active can accommodate leg support wedges (2 lateral thigh supports, 1 medial thigh support).
These supports can be ordered as a kit and fitted through Velcro®’s on the inner cover.
When positioned on the inner cover, the supports enhance the top surface contour of the cushion providing lateral thigh support without compromising softness.
This increases the contact with the legs to help control abduction (separation of legs) and adduction (if medial thigh support is used).

MAINTENANCE/CLEANING

EASY MAINTENANCE & CLEANING

• Monthly cleaning and regular maintenance may help extend the life of your cushion. During cleaning, component inspection is recommended.
• Check the cover for tears and excessive wear and replace if ripped, torn or otherwise not fully functional. Inspect the fluid pad for punctures or any other abnormalities.
• Check the foam insert to ensure foam consistency. While checking the fluid pad if you ever feel the fluid is firmer in one area, simply knead the fluid back to its original consistency and/or call your supplier.

TO CLEAN INNER COVER

• Remove the cover from the foam insert and turn inside out.
• Machine wash in warm water (40°), Or spray/wipe disinfect and air dry.
• No ironing required.

TO CLEAN OUTER COVER

• Remove the cover from the foam insert and turn inside out.
• Machine wash in warm water (maximum recommended temperature is 70° for microclimatic and stretch covers, 60°C for incontinent covers) and air dry.
• No ironing required.

CAUTION

• Do not dry clean covers or use industrial washers and dryers to clean cover.
• Do not steam autoclave.
• Do not bleach.
• To refit cover after washing, reinstall the cover on the foam insert. Ensure the back of the cover matches up to the back of the foam insert.
• If used in an institutional setting, write the resident’s name with a permanent marker on the content label of the covers. This will help to ensure the return of the covers after washing.
• Use only Jay covers on Jay cushions. The cover is an important part of allowing the immersion into the fluid insert which redistributes the pressure. Changing the cover will alter this design and its efficacy.

CLEANING THE FOAM BASE / LEG SUPPORT WEDGES
Remove the covers and fluid pad from the foam base.
Wipe lightly with a damp cloth. Do not use soap. Do not submerge in water. Wipe off with a clean cloth. Let it completely air-dry before reassembly.
The leg support covers can be machine washed in warm water (40°C) or spray/wipe disinfected and air dried. The leg support wedges can be wiped with a damp cloth (do not use soap and do not submerge in water) and then wiped off with a clean cloth. Let it completely air-dry before reintroducing them into the covers.
CAUTION
Avoid submersion of the foam base and leg supports in water.

CLEANING THE FLUID PAD
Remove the outer cover from the cushion. Remove fluid pad from the inner cover and wipe it with warm water and soap. Rinse with a clean, damp cloth, then wipe dry with a clean cloth.

CAUTION

• Never submerge the fluid pad in any liquid.
• Avoid harsh cleaning or rough handling as this may lead to a degradation of the fluid insert and lead to a leakage.

Should there be evidence of wear and tear on the cover, foam insert, fluid insert or other parts or if you notice that the consistency has deteriorated, please contact your dealer or Sunrise Medical for an assessment and further instructions.
HYGIENE MEASURES WHEN BEING RE-USED
Prior to the wheelchair being re-used, it must be carefully prepared. All surfaces which come into contact with the user must be treated with a disinfection spray. To do this, you must use a disinfectant as authorised/recommended in your country, for rapid alcohol-based disinfection for medical products and medical devices, which must be disinfected quickly. Please be aware of the manufacturer’s instructions for the disinfectant you are using. In general, a complete disinfection cannot be guaranteed on seams. We therefore recommend that you dispose of seat and back slings to avoid microbacterial contamination with active agents according to your local infection protection law.

CONDITIONS FOR SAFE STORAGE

• Products should be stored in a dry place: at 20 – 75% Relative Humidity.
• Protect from direct sunlight and dust for long periods.
• Away from direct heat and at a temperature between 5°C (40°F) to 40°C (104°F)
• Position and stack the packaged products according to the “this side up” arrows on the packaging.
• If a package is high and narrow and therefore potentially unstable, ensure it is well secured on the pallet or in the racking, to prevent it from falling down.
• Do not stack anything on top of the packaged products when the “do not stack” mark on the packaging is shown.
• Product should never be stored outside and subject to the elements.

LAUNDRY CARE SYMBOLS

| Machine wash in warm water (70° C)
| Only non-chlorine bleach, when needed
| Drip dry
| Do not iron
| Do not dry clean

CLEANING CHART

1. 70°C is the maximum recommended temperature.
2. 60°C is the maximum recommended temperature.
3. The Xtreme Active and Balance inner covers can be washed at 60°C as well as spray and wipe disinfected. Possible discoloration if washed at 60°C but the functional aspect of the covers is not diminished.
4. An autoclave is a self locking machine that sterilizes with steam under pressure.
5. At low temperature (< 30°C)

The product warranty shall not apply to products damaged due to the failure to follow these cleaning instructions or the use of inappropriate cleaning compounds.
Recommended Disinfectants
All disinfectants which are listed and recommended by the Robert Koch Institute: http://www.rki.de/EN/Home/homepage_node.html

REASSEMBLING

REASSEMBLING THE XTREME ACTIVE CUSHION AFTER CLEANING

Follow cleaning and maintenance instructions as described in “Easy maintenance, cleaning and re-use” then reassemble as follows.
Insert the foam base into the water resistance inner cover.
Ensure that the zipper is at the rear of the foam base where the seat well is located, and the Velcro® is on top in the seat well. Attach the fluid pad to the inner cover at the seat well matching all Velcro® strip locations, according to the colour codes.
If your cushion contains leg thigh supports, place them on the inner cover according to your positioning needs.
The Xtreme Active components are labelled with front and rear to help match components for easy assembly.

WARNING

• Insert the Jay Fluid pad on the inner cover making sure that all Velcro® strip locations are aligned according to the Velcro® loop and hook colours . A misalignment could cause an unwanted pressure point which could lead to injury.

WHEN TO CHECK
Check your cushion and fluid pad every month when you clean it.

WARRANTY

JAY XTREME ACTIVE CUSHION WARRANTY

Each Jay fluid cushion is carefully inspected and tested to provide peak performance. Every Jay fluid cushion is guaranteed to be free from defects in materials and workmanship for a period of 24 months from the date of purchase, provided normal use. Should a defect in materials or workmanship occur within 24 months from the original date of purchase, Sunrise Medical will, at its option, repair or replace it without charge. This warranty does not apply to punctures, tears or burns, nor to the cushion’s removable cover.
The removable cover is guaranteed to be free from defects in materials and workmanship for a period of six (6) months from the date of purchase, provided normal use.
Should a defect in materials or workmanship occur within  six (6) months from the original date of purchase, Sunrise Medical will, at its option, repair or replace it without charge.
Claims and repairs should be processed through the nearest authorized supplier. Except for express warranties made herein, all other warranties, including implied warranties of merchantability and warranties of fitness for a particular purpose are excluded.

ADDENDUM TO WARRANTY USE AND CARE GUIDE
Consult your health care professional for proper fitting and use, and read the following statements carefully:

• The fluid in this cushion may lose volume over time.
• Volume loss in this cushion may result in bottoming-out of the cushion.
• Monthly, during routine cleaning and inspection, check the cushion for bottoming-out (see instructions under “checking for bottoming-out” in the warranty use and care guide) and any fluid inconsistencies. If the fluid is firmer in one area simply knead it back to its original consistency.
• If bottoming-out occurs discontinue use of this cushion and contact your health care professional. If further assistance is necessary, contact Sunrise Medical Customer Services.

Sunrise Medical Limited Thorns Road, Brierley Hill West Midlands, DY5 2LD UNITED KINGDOM

The management system of SUNRISE MEDICAL is certified to EN ISO 13485 and ISO 14001.
We at SUNRISE MEDICAL have been awarded the ISO-13485 certificate, which affirms the quality of our products at every stage, from R & D to production.
This product meets the requirements in accordance with EU and UK regulations. Options or accessories shown are available at extra cost.
The varieties of cushions fitting variants, as well as the different positioning components to deliver higher positioning and skin protection benefits according to each user requirement and indication, mean that it can be used by a range of users with different positioning and skin protection needs and indications as folows[R7-R14] :

– Spinal Cord Injury
– MS
– Neurological disease pattern (hemiplegia, M.Parkinson)
– Extremity defect deformity
– Joint contracture
– Amputation
– Tetraplegia
The cushion for a wheelchair shall not be used in case of [R3, R4]:
– Redness developed in the skin contact area
– Bottoming out present in the JAY Fluid Insert
– Decubitus
NOTE: General user advice. Not following these instructions may result in physical injury, damage to the product or damage to the environment!
Notice to the user and/or patient: any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
As the manufacturer, SUNRISE MEDICAL, declares that this product conforms to the Medical Device Regulation (2017/745).
As the manufacturer, SUNRISE MEDICAL, declares that the product conforms to the UK Medical Devices Regulation 2002 No. 618.
B4Me special adaptations
Sunrise Medical strongly recommends that in order to ensure that your B4Me product operates, and performs as intended by the manufacturer; all the user information supplied with your B4Me product is read and understood, before the product is first used. Sunrise Medical also recommends that the user information is not discarded after reading it, but it is kept safely stored for future reference.
Medical Device Combinations
It may be possible to combine this Medical device with one or more other Medical Device or other product. Information on which combinations are possible can be found at www.Sunrisemedical.co.uk. All combinations listed have been validated to meet the General Safety and Performance Requirements, section 14.1 of the Medical Device Regulation 2017/745.Guidance on the combination, such as mounting, can be found at www.SunriseMedical.co.uk.

Sunrise Medical Ltd.
Thorns Road
Brierley Hill
West Midlands
DY5 2LD
England
Phone: 0845 605 66 88
Fax: 0845 605 66 89
www.SunriseMedical.co.uk
Sunrise Medical S.L.
Polígono Bakiola, 41
48498 Arrankudiaga – Vizcaya
España
Tel.: +34 (0) 902142434
Fax: +34 (0) 946481575
www.SunriseMedical.es
Sunrise Medical Poland
Sp. z o.o.
ul. Elektronowa 6,
94-103 Łódź
Polska
Telefon: + 48 42 275 83 38
Fax: + 48 42 209 35 23
E-mail: pl@sunrisemedical.de
www.Sunrise-Medical.pl
127348_OM_JAY Xtreme Active_EU_ML_RevH

References

• Wózki manualne, elektryczne i dzieciÄ™ce. | Sunrise Medical
• Wheelchairs, Seating & Mobility Scooters | Sunrise Medical
• Wheelchairs, Mobility Scooters, Rollators | Sunrise Medical
• Hjem | Sunrise Medical
• Oficiální stránky společnosti Medicco s.r.o. | Sunrise Medical
• Wózki manualne, elektryczne i dzieciÄ™ce. | Sunrise Medical
• Wheelchairs, Seating & Mobility Scooters | Sunrise Medical
• Wheelchairs, Mobility Scooters & Custom Seating | Sunrise Medical
• Rollstühle, Rollstuhlzubehör & Elektromobile | Sunrise Medical
• Kørestole, rollatorer, siddesystemer | Sunrise Medical
• Wheelchairs, Mobility Scooters, Rollators | Sunrise Medical
• Carrozzine, postura e ausili per la mobilità | Sunrise Medical
• Rolstoelen | Zitkussens | Scootmobielen | Sunrise Medical
• Hjem | Sunrise Medical
• Rullstolar, sittande & scooter | Sunrise Medical

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