JAY J3 Fluid Cushion Instructions

JAY J3 Fluid Cushion

IMPORTANT CONSUMER INFORMATION

NOTICE: 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.

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 J3 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 JAY J3 Cushion is designed for clinicians to use with clients who are at extremely high risk of skin breakdown. Designed for superior pressure distribution and stability, the J3 Cushion offers a high end cushion to meet a large range of skin protection and positioning needs. The J3 Cushion has the benefit of skin protection in a comfortable and low maintenance design. The J3 incorporates a JAY Flow Fluid Pad, optional Fluid Inserts, optional PLA (pelvic loading area) reducer ring, foam base and one of two cover materials.

Maximum User Weight:

• 150 kg on Pelvic Loading Area ring sizes A and B
• 227 kg on Pelvic Loading Area size C

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 J3 cushion is designed to help reduce the incidenc of pressure ulcers. However, no cushion can completely eliminate sitting pressure or prevent pressure ulcers.

• The J3 cushion is not a substitute for good skin care including proper diet, cleanliness and regular pressure relieving.

• 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 obstruction 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 Adjustability
The size of the PLA (pelvic loading area) is adjustable.
Your clinician will determine if a PLA reducer is needed in your cushion at the time of your evaluation.

Fluid Adjustability
The J3 Cushion offers fluid volume adjustability to accommodate user’s needs through two models the “Factory Filled” or the “Field Variable Volume” model.
The determination of factory filled or field variable filled is made by your clinician during evaluation. The insert should only be changed at the direction of your clinician.
The field variable volume insert has the ability to adjust to the user’s need over time. Your supplier will be involved in the adjustment once it is determined to be needed for better clinical efficacy.

Adjusting the “Factory Filled” J3 Cushion
If at any time the volume needs to be modified, Sunrise Medical or its approved supplier can at no additional product cost modify the volume to meet current medical needs. This method of fluid adjustment prevents unqualified fluid adjustments. This allows the appropriate fluid amount to be controlled by the appropriate healthcare provider and prevents the fluid volume from being manipulated by a patient or caregiver that might place the patient at a higher risk for skin breakdown.
To modify the fluid volume of the Factory Filled Fluid Pad, simply contact Customer Services of JAY supplier, or Sunrise Medical.

Adjusting the “Field Variable Volume” J3 Cushion
The Field Variable Volume version of the J3 Cushion allows the appropriate healthcare provider to apply a specified amount of fluid at the time of prescription and to modify the amount of fluid if needs change through the use of discreet Fluid Supplement Pads. This method of adjustment is useful where there is no concern of unqualified fluid adjustments occurring after prescription.

WARNING
The Field Variable Volume Fluid Pad comes with two Fluid Supplement Pads as standard and has a blue urethane cover to differentiate it versus the standard grey urethane on the Factory Filled Fluid Pad. This colour difference identifies that the blue fluid pad comes underfilled in comparison to the grey Factory Filled pad, and has four Velcro attachment points to attach the standard Fluid Supplement pads for obliquities, and overfills. To determine how to use the Fluid Supplement pads, please reference the “Fitting a Pressure Distributing Cushion” section.

Fitting A Pressure Distributing Cushion

Using Fluid Supplements Pads.
Fluid Supplement pads are to be only used with the Field Variable Fluid pad. To determine if you have a Field Variable Fluid pad, unzip the cushion cover and look at the pad in the pelvic loading area. If the pad has a blue outer cover, it is a Field Variable Fluid pad and designed to work with Fluid Supplement pads.
Clinicians or therapists should use Fluid Supplement pads by attaching or removing to the Fluid pad Velcro attachment points located between the folds on the upper Fluid Pad surface to increase or decrease the amount of fluid needed.

Fitting The Cushion.
Select a cushion to match your hip width when in the seated position. The cushion length should extend to within 1” – 2” (2.5cm – 5cm) from the back of the knees.
Place the cushion to the back of the wheelchair with the material identification tags and fluid pad toward the rear.
When fitted correctly, your hips should be to the back of the chair. Your ischials (seat bones) should be centered on the JAY Fluid pad in the pelvic loading area of the cushion.
Proper footrest adjustment may enhance sitting comfort and help lower peak sitting pressures. Adjust the footrests so your legs rest firmly but comfortably on the cushion.
Use the cushion indexing notches located in the rear of the foam base to ensure proper alignment of the cushion to the backrest. This will ensure that the pelvic loading area and fluid insert are in the right position for the user.
Misalignment of the fluid insert and pelvic loading area could lead to injury and skin breakdown.
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.

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 base 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 Cover

• Remove the cover from the foam base and turn inside out.
• Machine wash in warm water and drip or tumble dry on low heat.
• 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 base. Ensure the back of the cover matches up to the back of the foam base.
• 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.

To Clean Foam Base, Pla Reducer Ring And Positioning Components.

• Remove the cover, fluid pad and PLA reducer ring (if applicable) 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 airdry before reassembly.
• Avoid submersion of the foam base in water.
• Re-install the cover over foam base. Ensure the back of the cover matches up to the back of the foam base.

To clean fluid pad and fluid inserts (if applicable)
Remove the cover from the foam base. Remove fluid pad from its foam base and wipe with warm water and soap.
Rinse with a clean, damp cloth, then wipe dry with a clean cloth.

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 base. Ensure the back of the cover matches up to the back of the foam base.
• 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.

To Clean Foam Base, Pla Reducer Ring And Positioning Components.

• Remove the cover, fluid pad and PLA reducer ring (if applicable) 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 airdry before reassembly.
• Avoid submersion of the foam base in water.
• Re-install the cover over foam base. Ensure the back of the cover matches up to the back of the foam base.

To clean fluid pad and fluid inserts (if applicable)
Remove the cover from the foam base. Remove fluid pad from its foam base and wipe 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.
• If at any time the cover, Pelvic Loading Ring, foam base, fluid insert or any other component appears to be wearing or you notice a degradation in the texture, contact your supplier/Sunrise Medical for evaluation and further instructions.

LAUNDRY CARE SYMBOLS

| Machine wash in warm water (60° C)
---|---
| Only non-chlorine bleach, when needed
| Drip dry
| Do not iron
| Do not dry clean

Re-Assembling The JAY J3 Cushion After Cleaning

Follow cleaning and maintenance instructions as described in “Easy maintenance and cleaning” then re-assemble as follows.

WARNING

• Insert the JAY Fluid pad on the foam base making sure that all Velcro® strip locations are aligned.
• A mis-alignment or creation of an edge could cause an unwanted pressure point which could lead to injury.
• Insert the foam base into the outer cover.
• Ensure that the zipper is at the rear of the foam base (the part number tag should be to the rear of the foam base) where the pelvic loading area is located.
  

What Is Bottoming-Out?

Bottoming-out may occur on a J3 Cushion if you displace the fluid underneath your pelvic bones or buttocks, which would leave you sitting on the foam base. It sometimes occurs on very thin individuals, people using recliner wheelchairs, people who have lost weight or have other changes in body size or shape, people who slouch when sitting or a person using a PLA (pelvic loading area) inappropriately sized for their pelvis.

WARNING
When bottoming-out occurs, increased pressure is placed onto the is chials and coccyx increasing the risk of skin breakdown. Immediately discontinue use of the pad. See your health care professional.

How To Check For Bottoming-Out

To check for bottoming-out, sit on the cushion with the cover on and the zipper opened for at least two minutes.
Transfer up and off the cushion (or have someone help you transfer), trying not to disturb the fluid underneath you.
Fold the back portion of the cover forward over the front, exposing the fluid pad. Push down in the depressions on the pad where your ischials (seat bones) and coccyx (tailbone) were. You should have to push through at least 1/2” (1.3 cm) of fluid before you feel the firm cushion base below.

1/2” (1.3 cm) is approximately this deep.

WARNING

If the cushion is properly positioned, the footrests are properly adjusted and there is not at least the minimum 1/2” (1.3 cm) of fluid, the cushion is bottoming-out and should not be used.
If you are bottoming-out, discontinue use of the cushion and see your clinician. Usually bottoming-out is easily solved by ordering additional fluid in the form of an Overfill on the Factory Filled model. On the Field Variable version you can use the Fluid Supplement pads to add additional fluid. Call your local supplier to see if this is appropriate for you.

When To Check
Check your cushion and fluid pad every month when you clean it.

JAY J3 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.

There are no warranties which extend beyond the description on the face hereof. Remedies for breach of express warranties herein are limited to repair or replacement of the goods.

In no event shall damages for breach of any warranty include any consequential damages or exceed the cost of non-conforming goods sold.
This does not affect your statutory rights.

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 i 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.
  

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 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 follows [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!
A notice to the user and/or patient that 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).

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.

Approved Cleaning Procedures for JAY Cushions

Product| JAY Lite| JAY J3| J2 GS| JAY Easy Visco| JAY Soft Combi P| JAY Xtreme Active| JAY Basic| JAY Easy| JAY Balance
---|---|---|---|---|---|---|---|---|---
Outer Cover (Microclimatic and Stretch)
(1). Wet Wash 70°C | | | | | | | | |
Outer Cover (Incontinent)
(2). Wet Wash 60°C | | | | | | | | |
Inner Cover
(3). Spray and Wipe disinfection or Wet Wash 60°C| NA| NA| NA| NA| NA| | NA| NA|
Cushion core (foam base)
(4). Steam autoclave up to 105 °C (1)| | | | | | | | |
Spray and wipe disinfection | | | | | | | | |
(5). Immersion disinfection| | | | | | | | |
Cushion elements
Roho Air element| NA| | | NA| NA| NA| NA| NA|
Positioning elements| NA| | | NA| NA| | NA| NA|
Fluid pad| NA| | | NA| NA| | NA| |
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

CUSTOMER SERVICE

Sunrise Medical S.r.l.
Via Riva, 20 – Montale
29122 Piacenza
Italia
Tel.: +39 0523 573111
Fax: +39 0523 570060
www.SunriseMedical.it

Sunrise Medical AG
Erlenauweg 17
CH-3110 Münsingen
Schweiz/Suisse/Svizzera
Fon +41 (0)31 958 3838
Fax +41 (0)31 958 3848
www.SunriseMedical.ch

Sunrise Medical AS
Delitoppen 3
1540 Vestby
Norge
Telefon: +47 66 96 38 00
post@sunrisemedical.no
www.SunriseMedical.no

Sunrise Medical AB
Neongatan 5
431 53 Mölndal
Sweden
Tel.: +46 (0)31 748 37 00
post@sunrisemedical.se
www.SunriseMedical.se

MEDICCO s.r.o.
H – Park, Heršpická 1013/11d,
639 00 Brno
Czech Republic
Tel.: (+420) 547 250 955
Fax: (+420) 547 250 956
www.medicco.cz
info@medicco.cz

Bezplatná linka 800 900 809
Sunrise Medical Aps
Mårkærvej 5-9
2630 Taastrup
Denmark
+45 70 22 43 49
info@sunrisemedical.dk
www.Sunrisemedical.dk

Sunrise Medical Australia
11 Daniel Street
Wetherill Park NSW 2164
Australia
Ph: +61 2 9678 6600
Email: enquiries@sunrisemedical.com.au
www.SunriseMedical.com.au

Sunrise Medical (US) LLC
North American Headquarters
2842 N. Business Park Avenue
Fresno, CA, 93727, USA
800-333-4000
800-300-7502
www.SunriseMedical.com

Sunrise Medical GmbH
Kahlbachring 2-4
69254 Malsch/Heidelberg
Deutschland
Tel.: +49 (0) 7253/980-0
Fax: +49 (0) 7253/980-222
www.SunriseMedical.de

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

Sunrise Medical B.V.
Groningenhaven 18-20
3433 PE NIEUWEGEIN
The Netherlands
T: +31 (0)30 – 60 82 100
F: +31 (0)30 – 60 55 880
E: info@sunrisemedical.nl
www.SunriseMedical.nl

Sunrise Medical HCM B.V.
Vossenbeemd 104
5705 CL Helmond
The Netherlands
T: +31 (0)492 593 888
E: customerservice@sunrisemedical.nl
www.SunriseMedical.nl
www.SunriseMedical.eu
(International)

Sunrise Medical S.A.S
ZAC de la Vrillonnerie
17 Rue Mickaël Faraday
37170 Chambray-Lès-Tours
Tel : + 33 (0) 247554400
Fax : +33 (0) 247554403
www.sunrisemedical.fr

The management system of SUNRISE
MEDICAL is certified to ISO 9001,
ISO 13485 and ISO 14001.

References

• Wheelchairs, Mobility Scooters, Rollators | Sunrise Medical
• Fauteuils roulants, scooters & positionnement | Sunrise Medical
• Haltija
• 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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