JAY 126042 Balance Cushion Instruction Manual

: August 12, 2024
: JaY

Table of Contents

JAY 126042 Balance Cushion
Important Consumer Information
GENERAL WARNINGS
AREA OF APPLICATION
FITTING & ADJUSTING
MAINTENANCE & CLEANING
CLEANING CHART
SPECIFICATIONS & BOTTOMING OUT
WARRANTY
References
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JAY 126042 Balance 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 it for future reference.

NOTE

Check all parts for shipping damage. In case of damage DO NOT use. Contact Carrier/Sunrise Medical for further instructions.
Sunrise Medical recommends that a clinician such as a doctor or therapist experienced in seating and positioning be consulted to determine if a JAY Balance Cushion is appropriate.
Cushions should only be installed by an authorized Sunrise Medical supplier.

GENERAL WARNINGS

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.
Installing a cushion on a wheelchair may affect the center of gravity of the wheelchair and may cause the wheelchair to tip backward, potentially resulting in injury. Always assess for the potential need for anti-tippers or amputee axle adapter brackets to be added to the wheelchair to help increase stability.
Before 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 JAY Balance Cushion is designed to help reduce pressure. However, no cushion can eliminate sitting pressure or prevent pressure sores.
The JAY Balance Cushion is not a substitute for good skin care including; proper diet, cleanliness, and regular pressure relief.
Do not leave the fluid 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 (above 108OF / 42OC) 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: The product must be used with the cushion cover facing up. If the cover is not used correctly it may reduce or eliminate the cushion’s benefits and could increase risk to the skin and soft tissue.
AIR INSERT: please see the relevant warnings in the AIR INSERT Supplement.

AREA OF APPLICATION

The JAY Balance Cushion is designed for clinicians to use with clients who need superior pressure distribution and stability. The JAY Balance Cushion offers a complete solution to meet a large range of skin protection and positioning needs. The JAY®Flow Fluid Pad, the JAY® Fluid with Cryo ® Technology Pad, and the Air Insert Pad are all interchangeable pelvic loading area (PLA) options for the Balance Cushion. The intended lifetime of this product is 5 years.

Maximum occupant mass: Fluid and air cushions

340 mm to 500 mm width = 150 kg
560 mm to 600 mm width = 225 kg

Before use please consult the attending doctor, as to whether you can/should use the cushion and if so, for how long.

FITTING & ADJUSTING

FITTING A PRESSURE REDISTRIBUTING CUSHION
Select a cushion to match your hip width when in the seated position.

The cushion length should extend to within 25 mm – 50 mm, (1” – 2”), from the back of the knees.
Place the cushion on the back of the wheelchair with the material identification tags and the fluid pad toward the rear. When fit correctly, your hips should be to the back of the chair and the seat bones should be central to the seat well of the JAY®Flow Fluid Pad and JAY®Fluid Pad with Cryo®Technology.
Proper footrest adjustment may enhance sitting comfort and help lower peak sitting pressures.
Adjust the footrests so that your legs rest firmly but comfortably on the cushion.
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.
Avoid very tightly stretched backrest upholstery.
Stretched back upholstery does not provide adequate support for the body and improper positioning may result. Replace the stretched back upholstery, or buy a suitable backrest from Sunrise Medical.

Contact an authorized supplier for a free demonstration of these products.

Contraindications: none known.

JAY BALANCE COMPONENTS

A. Microclimatic/Stretch/Incontinent Outer cover.
B. Fluid Insert add with or without Cryo® Technology
C. Moisture Resistant Inner Cover*
D. Dual Layer Foam base.
E. Air Bladder.
- special inner covers are available to accommodate positioning elements and also different types of inserts (fluid or air).

CUSHION ADJUSTABILITY

Fluid and Air Adjustability
The JAY Balance Cushion offers volume adjustability to accommodate for users’ s through the determination of the correct amount of fluid made by your clinician during evaluation. The determination of Air Single or Air Dual Models is also made by your clinician during evaluation. The inserts should only be changed at the direction of your clinician. Adjusting through the AIR Insert The AIR INSERT version of the JAY Balance Cushion can be adjusted at any time through the use of the hand pump (provided) and release valve on the AIR INSERT.

ADJUSTING THROUGH POSITIONING COMPONENTS
The JAY Balance Cushion can be ordered with positioning components to offer excellent positioning possibilities (Fig. 2.0). When the client has any kind of postural deformity, he /she might require a custom configuration of his/her cushion such as stability supports and additional positioning elements. Sunrise Medical recommends that a clinician such as a doctor or therapist experienced in seating and positioning be consulted to determine if a JAY Balance Cushion with positioning components is appropriate. The following components can be ordered optionally, according to individual positioning needs:

Lateral Thigh Supports: Stop the legs from gradually moving apart.
Medial Thigh Support: Separate thighs for improving hip alignment and stabilizing sitting posture.
Lateral Pelvic Supports: maintain the pelvis in the center of the seat.
Obliquity Pads: Accomodate flexible or fixed pelvic obliquities.

Solid base : provides more postural stability

MAINTENANCE & CLEANING

JAY® FLUID WITH CRYO® TECHNOLOGY
JAY® Fluid with Cryo® Technology is designed for users at high risk for skin breakdown by actively lowering the seated skin surface temperature for up to 8 hours. Peak performance for this technology occurs at room temperature and extreme high and low temperatures may affect the performance of the fluid. Recharging the JAY®Fluid Pad with Cryo®Technology After 8 hours of continued use, the JAY® Fluid with Cryo® Technology Pad requires a recharge period of 12 hours at room temperature (75°F / 24°C) to reach peak performance. Recharge time is dependent on ambient temperature and may be accelerated with a lower temperature. Sustained temperatures above 82°F/ 28°C will not recharge the pad. If the fluid pad remains in use after 8 hours or the pad remains in a sustained ambient temperature above 82°F/ 28°C during recharge, the JAY ® Fluid with Cryo® Technology provides the same pressure distributing and skin protection benefit of the standard JAY® Fluid without the active cooling benefit.

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 local authorized supplier.

To clean cover

Remove the cover from the foam base and turn inside out.
Machine wash in warm water (70°C) and drip or tumble dry on low heat.
No ironing is required.

CAUTION!

Do not dry clean covers or use industrial washers and dryers to clean covers. 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.

CAUTION!
For cover sterilization, Sunrise Medical does not recommend high-temperature sterilization procedures.

NOTE

If a local protocol requires sterilization, please consult the instruction table at the end of this manual to learn more about recommended sterilization methods.
The cushion cover may be washed at 80°C for 10 minutes and maybe tumble dried, but we recommend cleaning the cover by using the shortest time and the lowest temperature allowed by local protocol to sterilize the cover.
If utilized 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-designed 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
Remove the cover, fluid pad, and inner cover from the foam base.

CAUTION!
Avoid submersion of the foam base in water.

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.
Reinstall the cover over foam base.
Ensure the back of the cover matches up to the back of the foam base.

Fig.3.0 To clean fluid pad:
Remove the cover from the foam base. Remove fluid pad from the inner cover 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.

If at any time, the outer cover, inner cover, foam base, fluid insert or any other component appears to be wearing or you notice a degradation in the texture, contact your supplier/Sunrise for evaluation and further instructions.

NOTE: To clean the AIR INSERT (if applicable), reference the AIR INSERT Owner’s Manual Supplement for proper cleaning 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 alcoholbased 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 micro-bacterial 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.

REASSEMBLING THE JAY BALANCE CUSHION AFTER CLEANING

Reassemble as follows:

WARNING!

Place the JAY Fluid or AIR INSERT on the inner cover 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 / inner cover assembly into the outer cover. Ensure that the zipper is at the rear of the foam base where the pelvic loading area is located.

RE-USE
This JAY cushion is designed to be re-used. The frequency of re-use depends largely on the way the cushion has been used previously. The cushion must be properly cleaned before re-use (see section “Easy Maintenance & Cleaning”).

CLEANING CHART

Recommended Disinfectants

All disinfectants which are listed and recommended by the Robert Koch Institute: http://www.rki.de/EN/Home/homepage_node.html

SPECIFICATIONS & BOTTOMING OUT

TECHNICAL DATA FOR THE JAY BALANCE FLUID

Cushion weight at maximum fill pressure: 1.6 kg (JAY Flow®Fluid); 2.6 kg (JAY® Fluid with Cryo) Minimum weight tolerance: 11.3 kg, (25lb).
Maximum fill pressure is: 0.24 bar (3.5 PSI).

Cushion| JAY Balance Fluid, JAY Balance Cryo Fluid, JAY Balance Deep Contour Fluid, JAY Balance Deep Contour Cryo Fluid
---|---
Model| JBALC / JBALCDC: FLMEU, FLMPEU, FLSEU J, FLSPEU, FLIEU, FLIPEU and CFLMEU, CFLMPEU, CFLSEU, CFLSPEU, CFLIEU, CFLIPEU
Cover Material| Polyester and nylon
Foam Material| Polyurethane and polyethylene
Density| 1.1 – 1.6 kg
Colour| Natural, grey and black
Fluid Insert Material| Urethane ﬁlm, ﬁlled with JF35 (ﬂuid with a vegetable oil base) and Cryo® Fluid (mixture of graphite and vegetable oil).
Permitted Patient Weight| Minimum 11.3 kg, Maximum 150 kg (SW 340-500 mm) 225 kg (SW 560-600 mm)
Spatial dimensions in ready-to-use state| Seat widths 340 to 600 mm, Seat depths 340 to 600 mm, Height: approx. 75 and 100 mm JAY®Fluid with Cryo® Technology: Seat width (JAY® with Cryo® Technology) 360 to 600 mm, Seat depth 360 to 600 mm, Height: approx. 75 / 100 mm
Weight in ready-to-use state| From 1.5 kg
Test report project number| ISO 1021-1:101098525MID-002 ISO 1021-2:101098525MID-003

WHAT IS BOTTOMING OUT?
Bottoming out may occur on a JAY Balance Cushion if you displace the fluid or air 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, or people who slouch when sitting.

WARNING!

When bottoming out occurs, increased pressure is placed onto the ischials and coccyx increasing the risk for skin breakdown.
Immediately discontinue use of the pad.
See your healthcare professional.

HOW TO CHECK FOR BOTTOMING OUT (FIG. 5.0)
JAY® Flow Fluid Pad or JAY® Fluid with Cryo® Technology Pad To check for bottoming out:

Sit on the cushion, with the cover on and the zipper opened, for seven to ten 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 lest 1/2” (13 mm) of fluid before you feel the firm cushion base below. If the cushion is properly positioned, the footrests are properly adjusted, and there is not at least the minimum 1/2” (13 mm) 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. Call your local authorized supplier to see if this is appropriate for you.

AIR INSERT
Reference the AIR INSERT Owner’s Manual Supplement for instructions on preventing and checking for bottoming out.

WHEN TO CHECK
With JAY® Flow Fluid and JAY® Fluid with Cryo® Technology pad, check every month when you clean it. With AIR INSERT, check daily.

Fluid Pad.
Foam Base.
Minimum 13.0 mm Fluid Depth.

WARRANTY

JAY BALANCE CUSHION WARRANTY
Each JAY cushion is carefully inspected and tested to provide peak performance. Every JAY 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 is no implied warranty beyond what is contained herein. 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.

ADDENDUM TO WARRANTY USE AND CARE GUIDE
JAY® Flow Fluid and JAY® Fluid with Cryo Technology Pad Consult your healthcare 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 the cushion.
Once a month, 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 kneed it back to its original consistency.
If bottoming out occurs discontinue use of this cushion and contact your healthcare professional.

If further assistance is necessary, contact Sunrise Medical Customer Service at:

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

AIR INSERT
Reference the AIR INSERT Owner’s Manual Supplement for additional use and care guidelines.

The management system of SUNRISE MEDICAL is certiﬁ ed to EN ISO 13485 and ISO 14001. We at SUNRISE MEDICAL have been awarded the ISO-13485 certiﬁ cate, which aﬃ rms the quality of our products at every stage, from R & D to pro- duction. 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 ﬁ tting variants, as well as the diﬀ erent positioning components to deliver higher positioning and skin protection beneﬁ ts according to each user requirement and indication, mean that it can be used by a range of users with diﬀ erent 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 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, 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.