JAY 126052 Balance Cryo Fluid User Manual

AIR INSERT
Owner’s Manual Supplement

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.

GENERAL WARNINGS

WARNING
Check inflation at least once a day!

• Under-inflation: Do not use an under-inflated cushion. Using a cushion that is under-inflated reduces or eliminates the cushion’s benefits, increasing the risk to the skin and other soft tissue. If your cushion appears under-inflated or does not appear to be  holding air, check to make sure that all valve(s) are closed by turning the inflation valve(s) clockwise. If your cushion is still not holding air, contact your clinical caregiver, supplier immediately.
• Over-inflation: Do not use an over-inflated cushion. Using an over-inflated cushion will not allow you to sink into the cushion and will reduce or eliminate the cushion’s benefits increasing risk to skin and other soft tissue.Cushion and cover orientation: Product must be used with the air cells facing up.
• Pressure: Changes in altitude may require adjustment to your cushion. Check your cushion when changing altitude of 1,000 feet (300 meters) or greater.
• Puncture: Keep your cushion away from sharp objects which may puncture the air cells and cause it to deflate.
• Heat/flame: Do not expose your cushion to high heat, open flames or hot ashes.
• Climate: If a cushion has been in temperatures less than 32°F / 0°C and experiences unusual stiffness, allow the cushion to warm to room temperature, then open air valve. Roll up the pad and then unroll it until the neoprene is soft and pliable again. Then repeat proper adjustment instructions before using.
• Do not use on top or in conjunction with another cushioning product other than the Balance Cushion with which it was supplied.
• Obstructions: Do not place any obstructions between the user and the cushion, as it will reduce product effectiveness.
• Handling: Do not use any valve as a handle for carrying or pulling the cushion.
• Product use: Do not use your cushion as a water flotation device (e.g., a Life Preserver).

CAUTION

• Solutions: Do not allow oil-based lotions or lanolin to come in contact with your cushion, as they may degrade the material.
• Ozone generators: The US Environmental Protection Agency, Health Canada and other government agencies have issued warnings regarding the use of ozone generators. Prolonged exposure to ozone will degrade rubber, fabrics and other materials used in the manufacture of the product and may affect the performance of the product and may void the product warranty.
• Do not use a pump or repair kit other than those provided by Sunrise Medical. Doing so may void your product’s warranty.

NOTE: Please make sure that you have read und understood the JAY Balance Cushion owner’s manual before setting up and adjusting the cushion. The following instructions pertain to the installation and adjustment of the Air Insert only (air bladder).

if the advice is
not followed
WARNING!| Advice to the user of a risk of injury if the advice is not followed
CAUTION!| Advice to user that potential damage to equipment may occur if the advice
is not followed
NOTE:| General advice or best practice
****| Reference To Additional Documentation

AREA OF APPLICATION
The JAY Balance air cushion has been designed to help reduce the incidence of skin break down. Through pressure distribution, pressure on affected areas of skin, or those areas which are at risk is decreased and these can regenerate if necessary. The extent to which this may be possible depends on the thickness and size of the damage and must be assessed by the attending doctor.
However, no cushion can completely eliminate sitting pressure or prevent pressure sores. JAY seat cushions are not a substitute for good skin care, which also covers:- appropriate diet, cleanliness, and regular weight shifting. Before use please consult the attending doctor, as to whether you can/should use the cushion and if so, for how long.
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 to the back of the wheelchair with the material identification tags and the air bladder toward the rear. When fit correctly, your hips should be to the back of the chair. Your ischial (seat bones) should be centered on the insert 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. 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.
Contraindications: The user should have the cognitive ability to adjust the air pressure in the JAY Balance Air cushion and to check this at least once a day.
If necessary, this can also be carried out by a carer.

INSTALLATION

INSTALLATION OF THE INFLATION TUBE(S)
Some configurations of the Balance Cushion with the Air insert come with the inflation tube(s) un-installed. If this is the case, you will have received the following parts:

• Air insert.
• 1 or 2 lengths of tube with one end terminated by an inflation valve, the other end open. A second tube will be included if the Air insert was a dual chamber insert. A coupling connector has already been installed in the truncated inflation tubes.

Fig. 1 shows a Dual chambered Air insert ready to have the tube length attached by following the steps below.

To install the inflation tube(s):

1. Install the Air insert into the Balance foam base with inner cover, as outlined in the instructions below.
2. Measure the length of inflation tube required for your specific cushion size, (Fig. 2). Do this by threading the tube through the loops on the inner cover with the front edge. Measure about 1/2” (13.0 mm) from the front edge of the cushion, and run it the distance (L) until the open end matches up with the tube valve coming out of the Insert.
3. Cut the length of inflation tube as measured using scissors.
4. Insert the coupling connector into the cut length of each inflation tube.

INSTALLATION OF AIR INSERT INTO CUSHION

1. With the outer cover removed from the Balance foam base, install the Air insert into the Well. Ensure that the Air insert is aligned with the well and that the inflation tubes are to the rear of the cushion, (Fig. 3).
   Ensure that the Velcro attached to the Air insert is aligned with the matching Velcro adhered to the inner cover.

2. With the Air insert installed, the inflation tube(s) need to be secured to the inner cover. Your Air insert may have one or two inflation tubes depending if it is a single chamber insert or a dual chamber insert. Use the fabric loops on either side of the inner cover, to route the inflation tube(s). (Fig. 4 and 5)

3. Thread the inflation tube through the loops starting at the rear of the inner cover and inserting the tube through each loop, working your way around to the front of the product.

4. If the Air insert is dual chambered, do the same for the second inflation tube on the opposite side.

5. Re-install the outer cover by sliding it over the base and inner cover assembly. It is best to secure the inflation valve in place with your hand as you slide the cover over the assembly with your other hand.

6. Insert the valve through the slot in the outer cover behind the Jay logo. The valve is intended to protrude through the slot and be secured by the side band on the Balance cover. (Fig. 6)

ADJUSTMENTS

ADJUSTMENT

1. Open the air valve by twisting it anticlockwise. If your cushion comes with two valves, open both valves using the same technique. (Fig. 7)
2. Attach the rubber hose on the pump to the end of the valve. Inflate the cushion insert with the pump until just before the cushion begins to arch. (Fig. 8)
3. Remove the pump hose from the valve and close it by twisting it clockwise. (Fig. 9)
4. Sit on the Balance Cushion, with the Air insert installed, in your normal sitting position with armrests and footrests properly positioned.
5. Slide your hand beneath your buttocks to locate your lowest bony prominence, usually the ischial tuberosites. If necessary, your clinician or caregiver should assist you. (Fig.10)
6. Leaving one hand in place beneath the lowest bony prominence, use the other hand to open the valve. As air is released from the cushion insert, you will begin to sink into it. When your fingertips touch its base, close the valve. Approximately 1/2” (13.0 mm) of  air should be between your lowest bony prominence and the base of the cushion.
(Fig. 11) IMPORTANT ADJUSTMENT NOTES

• Your Balance Cushion with Air insert may have been ordered with two valves, one on each side of the cushion. If you have two valves, steps 1-6 above should be repeated for each valve. Two valves indicate that your cushion insert is divided in the middle. You, your clinician or caregiver should locate the lowest bony prominence on the same side as the air valve used to adjust the cushion.
• You, your clinicians or caregivers should check the cushion insert daily to ensure that you have not bottomed out (ie. lost air and are now sitting on the base of the cushion). If you have bottomed out, the protective value of the cushion insert is lost. You should also check to be sure the cushion insert is not over-filled with air. The cushion insert will work best with approximately 1/2” (13.0 mm) of air between you and its base.
• The Air insert may be affected by changes in altitude. You may have to repeat steps 1- 6 above as you change altitudes.

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

CLEANING & MAINTENANCE

CLEANING AND DISINFECTING YOUR AIR INSERT
Cleaning and disinfecting are two separate processes. Cleaning must precede disinfection.
CLEANING THE AIR INSERT
To clean the Air insert, gently pull it out of the recess in the foam base, taking care to gently pull the valve through the foam. Deflate the cushion, close the valve(s) and place in a large sink. Gently scrub the air cells and the spaces between them with a soft plastic bristle brush, sponge or washcloth.
Liquid dishwashing or laundry detergent or other general-purpose cleaning product is suggested.
Spray and wipe disinfection is also possible for the Air element and the positioning elements.
For institutional cleaning, a general housekeeping disinfectant cleaner may be used.
DISINFECTING THE AIR INSERT
To disinfect the Air Insert, use a germicidal product that meets infection control needs. A disinfectant with tuberculocidal properties is recommended. Follow the manufacturer’s dilution directions. For home disinfection, use solutions of approximately 1/2 cup liquid household bleach per quart of water (125 ml bleach to 1 liter of water). Keep the clean cushion wet with bleach solution for 10 minutes. Rinse thoroughly and dry.
WARNING
Disinfectants are not effective on porous surfaces, such as foam, if the cushion becomes soiled or contaminated. DO NOT use with multiple users.
CAUTION
Do not use oil-based lotions or lanolin on your cushion as they may compromise the integrity of the neoprene rubber.

• If 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 may be 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.

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. It is essential that the cushion is properly cleaned before re-use (see section “Cleaning and disinfecting of your insert”).
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 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.

REPAIRS
Each Balance Cushion with an air insert is shipped complete with a repair kit and instructions for minor repairs. The following information can be used if repair instructions have been lost or misplaced.
If a leak occurs

1. Place your cushion cells down and over-inflate until all four corners touch.
2. Immerse the over-inflated cushion in water to locate the leak.
3. Once the leak has been located, mark the leak by inserting a toothpick into the hole
4. Allow the cushion to dry thoroughly.
5. Remove the toothpick, and clean the area around the hole with the alcohol wipe provided. Let the surface dry.
6. Peel the backing from the patch provided and, centering the patch, place it over the hole.
7. Press the patch down firmly until a good seal is achieved.
8. The cushion is now ready for use. Adjust the cushion for proper inflation following the instructions in this manual.

Although patches do not change the performance of the cushion, they should be monitored periodically to ensure effectiveness in addressing the leak. If the patch is not successful in addressing the problem, or if more extensive damage is present, please contact your supplier immediately.
CAUTION
Do not remove an inflation valve by holding the cushion and pulling the valve, doing so may tear the cushion.
Replacing Valves:

1. Firmly grip the rubber valve stem and remove the old inflation valve by using pliers.
2. Moisten the ribbed end of the replacement valve and insert it into the valve stem until the rubber is snug to the body of the valve.

WARRANTY

JAY BALANCE CUSHION WARRANTY
Every Jay air cushion has been researched and tested, in order to ensure peak performance. Under normal use, we provide a 24-month guarantee on every Jay air cushion from the date of purchase, to confirm that it is free from material and manufacturing  defects. If, within 24 months from the original date of purchase, a material or manufacturing defect should occur, 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.
Claims and repairs should be processed through the nearest approved supplier. Except for express warranties listed herein, all other warranties, including implied warranties of merchantability and warranties of fitness for a particular purpose are excluded.
There are not 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.

SPECIFICATIONS

TECHNICAL DATA FOR THE JAY BALANCE AIR

ADMPEU, ADSEU, ADSPEU, ADIEU, ADIPEU.
Cover Material| Polyester and nylon.
Foam Material| Polyurethane and polyethylene.
Density| 1.1 – 1.6 kg
Colour| Natural, grey and black.
Air Bladder Material| Neoprene, filled with 02.
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 / 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 NEOPRENE AIR BLADDER, 1021-1: 2-76382-0-C, 1021-2: 2-76445-1
Intended Lifetime| The intended lifetime of this product is 5 years.

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 follows[R7-R14] :

• Spinal Cord Injury
• MS
• Neurological disease pattern (hemiplegia, M. Parkinson)
• Extremity defect deformity
• Amputation
• Joint contracture
• 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 S.r.l.
Via Riva, 20 – Montale
29122 Piacenza
Italia
Tel.: +39 0523 573111
Fax: +39 0523 570060
www.SunriseMedical.it| Sunrise Medical GmbH
Kahlbachring 2-4
69254 Malesich/Heidelberg
Deutschland
Tel.: +49 (0) 7253/980-0
Fax: +49 (0) 7253/980-222
www.SunriseMedical.de
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Sunrise Medical AG
Erlenauweg 17
CH-3110 Meiningen
Schweiz/Suisse/Svitzer
Fon +41 (0)31 958 3838
Fax +41 (0)31 958 3848
www.SunriseMedical.ch| 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 AS
Delitoppen 3
1540 Vestry
Norge
Telefon: +47 66 96 38 00
post@sunrisemedical.no
www.SunriseMedical.no| Sunrise Medical S.L.
Poligono Braciola, 41
48498 Arrankudiaga – Vizcaya
España
Tel.: +34 (0) 902142434
Fax: +34 (0) 946481575
www.SunriseMedical.es
Sunrise Medical AB
Neonatal 5
431 53 Mandal
Sweden
Tel.: +46 (0)31 748 37 00
post@sunrisemedical.se
www.SunriseMedical.se| Sunrise Medical Poland
Sp. z oxo.
ul. Electronica 6,
94-103 Lodz
Polska
Telefon: + 48 42 275 83 38
Fax: + 48 42 209 35 23
E-mail: pl@sunrisemedical.de
www.Sunrise-Medical.pl
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 B.V.
Groningen haven 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 Aps
Mårkærvej 5-9
2630 Kastrup
Denmark
+45 70 22 43 49
info@sunrisemedical.dk
www.Sunrisemedical.dk| 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 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 S.A.S
ZAC de la Vrillonnerie
17 Rue Mickaël Faraday
37170 Chambray-Lès-Tours
Tel : + 33 (0) 2 47 55 44 00
Email: info@sunrisemedical.fr
www.sunrisemedical.fr

126052_OMBalance Air Insert EU ML Rev G

References

• C.A. Leschbrandt. Leverer år etter år.
• Wózki manualne, elektryczne i dzieciÄ™ce. | Sunrise Medical
• Wheelchairs, Seating & Mobility Scooters | Sunrise Medical
• Sillas de ruedas, grúas y scooters eléctricos | Sunrise Medical
• Wheelchairs, Mobility Scooters, Rollators | Sunrise Medical
• Hjem | Sunrise Medical
• Oficiální stránky společnosti Medicco s.r.o. | Sunrise Medical
• RKI - Homepage
• Wózki manualne, elektryczne i dzieciÄ™ce. | Sunrise Medical
• Rollstühle, Elektromobile und Sitzsysteme | 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
• Sillas de ruedas, grúas y scooters eléctricos | Sunrise Medical
• Wheelchairs, Mobility Scooters, Rollators | Sunrise Medical
• Fauteuils roulants, scooters & positionnement | Sunrise Medical
• Carrozzine, postura e ausili per la mobilità | Sunrise Medical
• Rolstoelen | Zitkussens | Scootmobielen | Sunrise Medical
• Hjem | Sunrise Medical
• Cadeiras de rodas, gruas e scooters eléctricas | Sunrise Medical
• Rullstolar, sittande & scooter | Sunrise Medical

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