User Manual for JAY models including: 247816-EU_ART, 247816-EU_ART Union Cushion, 247816-EU_ART, Union Cushion, Cushion
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DocumentDocumentUNION CUSHION JAY® UnionTM Cushion EN Owner's Manual 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. 247816 Rev. F N W E S 03 ENGLISH 3 GENERAL WARNINGS 3 JAY UNION CUSHION 4 FITTING A PRESSURE DISTRIBUTING CUSHION 4 JAY UNION COMPONENTS 4 EASY MAINTENANCE & CLEANING 5 REASSEMBLING THE JAY UNION CUSHION AFTER CLEANING 5 JAY UNION CUSHION WARRANTY 5 APPROVED CLEANING PROCEDURES FOR JAY CUSHIONS 6 JAY Union 2 247816 Rev. F ENGLISH NOTE: Check all parts for shipping damage. In case of damage DO NOT use. Contact Carrier/Sunrise 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 Union Cushion is appropriate. Cushions should only be installed by an authorized Sunrise Medical supplier. GENERAL WARNINGS 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. WARNING 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. WARNING Installing a cushion on a wheelchair may affect the center of gravity of the wheelchair and may cause the wheelchair to tip backwards, potentially resulting in injury. Always assess for the potential need for antitippers or amputee axle adapter brackets to be added to the wheelchair to help increase stability. J AY U N I O N WARNING 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 JAY Union cushion is designed to help reduce pressure. However, no cushion can completely eliminate sitting pressure or prevent pressure sores. The JAY Union cushion is not a substitute for good skin care including; proper diet, cleanliness, and regular pressure relief. CAUTION AVOID SHARP OBJECTS OR EXPOSURE TO EXCESSIVE HEAT OR OPEN FLAME. WARNING OBSTRUCTIONS: DO NOT place any obstructions between the user and the cushion because it will reduce product effectiveness. WARNING COVER ORIENTATION: 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. MAXIMUM USER WEIGHT: 380 mm to 520 mm (14" to 21") width = 136 kg (300 lbs.) 540 mm to 600 mm (22" to 24") width = 226 kg (500lbs.) JAY Union 3 247816 Rev. F ENGLISH JAY UNION CUSHION The JAY Union is designed with the benefits of skin protection and positioning in a lightweight, comfortable and low-maintenance design. The JAY Union incorporates a JAY FlowTM fluid pad, a soft foam base and a visco elastic top layer with a moisture-resistant inner cover and microclimatic outer cover. The JAY Union helps to provide pressure and shear reduction which may help reduce the incidence of decubitus ulcers. The cushion is intended to be comfortable and does not restrict movement, allowing the user to change positions on the cushion. The maximum user weight for this product is 136 kg (300 lbs.) for 340 mm to 520 mm (14" to 21") widths and 226 kg (500lbs.) for 540 mm to 600 mm (22" to 24") widths. The intended lifetime of this product is 5 years. FITTING A PRESSURE DISTRIBUTING CUSHION Select a cushion to match your hip width when in the seated position.The cushion length should extend to within 1" - 2" (25mm - 50mm) from the back of the knees. Place the cushion to the back of the wheelchair with the pelvic loading area toward the rear. When fit correctly, your hips should be to the back of the chair. Your ischials (seat bones) should be centered in the rear 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. Avoid using overly stretched backrest upholstery. Stretched back upholstery does not provide adequate support for the body and improper positioning may result. Replace stretched backrest 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. J AY U N I O N JAY UNION COMPONENTS Microclimatic Outer Cover Moistureresistant Inner Cover Dual Layer Foam Base Visco Elastic Foam Modular Pelvic Insert JAY FlowTM Fluid Pad Foam Base JAY Union 4 247816 Rev. F ENGLISH EASY MAINTENANCE & CLEANING Regular cleaning and maintenance may help extend the life of your cushion. During cleaning, component inspection is recommended. Check the cover for tears and excessive wear and or any other abnormalities. Check the foam base to ensure foam consistency. To clean cover 1. Remove the outer cover from the foam base and zip closed. 2. Machine wash in warm water and drip or tumble dry on low heat. No ironing required. NOTE: 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, fit cover back over foam base. Ensure the back of the cover matches up to the back of the foam base. NOTE: 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. To clean foam base Remove the cover 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. NOTE: Avoid submersion of the foam base in water. REASSEMBLING THE JAY UNION CUSHION AFTER CLEANING Follow cleaning and maintenance instructions as described in "Easy maintenance and Cleaning" then reassemble as follows. Insert the foam base into the inner cover with white label down and zipper to rear of cushion. Then insert base plus inner cover into the outer cover. Make sure white inner cover label is down and zipper is to the rear. Ensure that both zippers are at the rear of the foam base (the part number tag should be to the rear of the foam base) where the pelvis is typically located. 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. JAY Union 5 J AY U N I O N 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. JAY UNION CUSHION WARRANTY Every JAY Union cushion base 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 outer and inner covers are 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 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 nonconforming goods sold. 247816 Rev. F ENGLISH CLEANING CHART Approved Cleaning Procedures for JAY Cushions Product JAY Lite JAY J3 J2 GS JAY Easy Visco JAY Soft JAY Xtreme Combi P Active Outer Cover (Microclimatic and Stretch) (1). Wet Wash 70°C JAY Basic JAY Easy JAY Balance Outer Cover (Incontinent) (2). Wet Wash 60°C Inner Cover (3). Spray and Wipe NA NA NA NA NA disinfection or Wet Wash 60°C Cushion core (foam base) (4). Steam autoclave up to 105 °C (1) Spray and wipe disinfection NA NA (5). Immersion disinfection Cushion elements Air element NA 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 JAY Union 6 247816 Rev. F ENGLISH Product Name/ SKU Number LOT: defined by Julian Date Seat width Seat depth Max user weight CE Mark UKCA Mark Consult instructions for use Date of Manufacture Assembly Part Number This symbol means Medical Device Manufacturer's address European Authorised Representative UK Responsible Person Swiss Representative's address Importer's address 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. JAY Union 7 247816 Rev. F 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 CH 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. 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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 Lód 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. Defensiedok 20 3433 NE Nieuwegein The Netherlands T: +31 (0)30 60 82 100 EU 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) 2 47 55 44 00 Email: info@sunrisemedical.fr www.SunriseMedical.fr 247816 Rev. F 2024-05-20