JAY Fit 2U Wheelchair Back Instruction Manual

June 12, 2024
JaY

FIT 2U ® BACK
Owner’s Manual

Fit 2U Wheelchair Back

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.
FOR ANSWERS TO YOUR QUESTIONS
Your Sunrise Medical authorized dealer knows your product bestand can answer most of your questions about product safety, use, and maintenance.
For future reference, please fi ll in the following:
Dealer: __
Address: __
Telephone:

Serial #: ___
Date/Purchased: _

ADDITIONAL INFORMATION YOU SHOULD KNOW
No component of this product was made with Natural Rubber Latex.
DISPOSAL AND RECYCLING INFORMATION
When this product reaches the end of its life, please take it to an approved collection or recycling point designated by your local or state government. This product is manufactured using a variety of materials. Your product should not be disposed of as ordinary household waste. You should dispose of your product properly, according to local laws and regulations. Most materials that are used in the construction of this product are fully recyclable. The separate collection and recycling of your product at the time of disposal will help conserve natural resources and ensure that it is disposed in a manner that protects the environment.
Ensure you are the legal owner of the product prior to arranging for the product disposal in accordance with the above recommendations.
DO NOT USE BACK TO LIFT WHEELCHAIR
MODEL#:…………….
SERIAL#:…………….
Please refer to the Owner’s Manual for detailed installation and fitting instructions.
For serial number, find this product label located on the front in the middle of the JAY Back Shell.

GENERAL WARNINGS

The word “WARNING” refers to a hazard or unsafe practice that may cause severe injury or death to you or to other persons.
Throughout this owner’s manual and on the product you will see the icons listed below to identify warnings and potential hazards.
A. Check all parts
WARNING
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 health care provider experienced in seating and positioning be consulted to determine if a JAY FIT 2U Back is appropriate.
Backs should only be set up by a Sunrise Medical authorized dealer.
B. Read and understand this manual
WARNING
DO NOT set up this equipment without fi rst reading and understanding the manual. If you are unable to understand the Warnings, Cautions, and Instructions, contact a Sunrise Medical authorized dealer – otherwise injury or damage may occur.
C. Center of gravity
WARNING
Placing a back support on a wheelchair may aff ect 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 anti-tips or amputee axle adapter brackets to be added to the wheelchair to help increase stability.
D. Anti-tips
WARNING
Anti-Tips: Anti-tip tubes can help keep your chair from tipping over backward in normal conditions.

  1. Sunrise recommends the use of anti-tip tubes.
  2. Always assess the need for anti-tips or amputee axle adapter brackets that could be added to the wheelchair to help increase the stability of the wheelchair and seating system.

If you fail to heed these warnings damage to your chair, a fall, tip over, or loss of control may occur and cause severe injury to the rider or others.
E. Pushing or lifting
WARNING
Pushing or Lifting: do not use the JAY FIT 2U back to move or push the wheelchair.

  1. Do not use the JAY FIT 2U Back handle to lift the wheelchair. It is intended only for back removal.
  2. Improper use of the back by pushing or pulling may cause the back to unexpectedly detach from the wheelchair.

If you fail to heed these warnings damage to your chair, a fall, tip over, or loss of control may occur and cause severe injury to the rider or others.
F. Compatibility
WARNING

The JAY FIT 2U back is designed to be compatible with most wheelchairs with the following exception:

  1. Wheelchairs that are angle adjustable with recline or tilt, and result in a back angle greater than 60° from the vertical.

JAY FIT 2U back use with these types of wheelchairs may cause the back to accidentally disconnect from the wheelchair. This could result in a fall or potential injury of the rider and/or caregiver.
If you fail to heed these warnings damage to your chair, a fall, tip over, or loss of control may occur and cause severe injury to the rider or others.
G. Transit safety 1, 2
WARNING
The JAY FIT 2U Back has been dynamically tested for use in a motor vehicle. This system conforms to ANSI-RESNA WC-20. If the JAY FIT 2U Back is to be used in a transit situation, it must be mounted to a wheelchair that conforms to the performance requirements of ANSI/ RESNA WC-19 or ISO Standard 7176-19. For rider safety, please follow all installation, use, and maintenance instructions within this manual and the wheelchair manufacturer’s manual as well as the transit instructions listed below.

  1. If possible and feasible, the rider should transfer to the Original Equipment Manufacturer vehicle seat and use the vehicle restraints.
  2. The wheelchair must be labeled as appropriate for use as a seat in a motor vehicle, dynamically tested and installed, used, and maintained according to the manufacturer’s instructions.
  3. If the original wheelchair seat was replaced, the new seat must be approved for wheelchair transit, installed and used as indicated in the manufacturer’s instructions.
  4. The Wheelchair Tie down and Occupant Restraint System (WTORS) should be compatible with the specifi c wheelchair, used as indicated in the manufacturer’s instructions, and should comply with the performance requirements of ISO Standard 10542.
  5. The Wheelchair must be forward facing during transport.
  6. In order to reduce the potential of injury to vehicle occupant’s wheelchair-mounted accessories, such as trays and respiratory equipment, should be removed and secured separately.
  7. Postural support devices such as pelvic positioning belts, anterior trunk supports, or postural supports such as lateral trunk supports should not be relied on for occupant restraint in a moving vehicle unless they are labeled as conforming to ISO Standard 16840-4.
  8. Alterations or substitutions should not be made to the structure of the chair or seating system, parts, and/or components, without consulting the manufacturer.
  9. Back shell mounting bracket must be attached in the correct position for transit use (see below.) Refer to the appropriate section for correct back hardware mounting instructions. (Fig. 1)

If you fail to heed these warnings damage to your chair, a fall, tip-over, or loss of control may occur and cause severe injury to the rider or others.

JAY Fit 2U Wheelchair Back - Transit safety

INTRODUCTION

Sunrise Medical recommends that a clinician such as a doctor or therapist experienced in seating and positioning be consulted to determine if a JAY FIT 2U Back is appropriate. Backs should only be set up by a Sunrise Medical authorized dealer.
JAY FIT 2U
The JAY FIT 2U Back is designed to provide the important benefi ts of a proper back support for a wide variety of users.
Maximum user weight:
– 165 lbs (75 kg) for widths 14-in and below
– 300 lbs (136 kg) for widths 16-in and above
A. Fitting the back to the Wheelchair
WARNING
The owner of this equipment is responsible for ensuring that it has been set up and adjusted by a Sunrise Medical authorized dealer under the advice of a health care provider. The back and hardware may require periodic safety and function checks. Adjustments should be performed by your Sunrise Medical authorized dealer. Always use parts and/or accessories that have been recommended or approved by Sunrise Medical.
The JAY FIT 2U Back is designed to be compatible with most wheelchairs with the following exception: Wheelchairs that are angle adjustable with recline or tilt that result in a back angle greater than 60° from the vertical should not be used with the JAY FIT 2U back system.
B. Wheelchair Dimensions 3, 4
Prior to placement, determine if the wheelchair used has compatible back canes by measuring the width between the back canes (as shown in Fig 3). The JAY FIT 2U Back off ers up to 2-in (5 cm) of back cane width adjustment.
Next, check that the back canes are a compatible diameter. The JAY FIT 2U back hardware can be mounted on wheelchair back canes ranging from 3/4-in to 1 1/8-in (1.9 cm to 2.86 cm) . Measure your back cane diameter (Fig 4) and refer to Table 2 to ensure your back canes are compatible. If you cannot determine that the back canes are compatible, please contact your Sunrise Medical authorized dealer or Sunrise Medical Customer Service.

TABLE 1
JAY FIT 2U
Back Width*| Width of back canes from outside to outside of the tubes (A)
---|---
Minimum width| Maximum width
inch| cm| inch| cm
10-in| 9.7| 24.6| 12.3| 31.2
12-in| 11.7| 29.7| 14.3| 36.3
14-in| 13.7| 34.9| 16.3| 41.3
16-in| 15.7| 40.0| 18.3| 46.4
18-in| 17.7| 45.1| 20.3| 54.5
20-in| 19.7| 50.1| 22.3| 56.5
Cane Diameter (B)

TABLE 2 nimum width| Maximum width
inch| cm| inch| cm
3/4| 1.9| 1 1/8| 2.85

  • Back Width is identifi ed in your back part number. Example: part number JFIT2UB1618HD is a 16-in wide back.
    JAY FIT 2U COMPONENTS

JAY Fit 2U Wheelchair Back - COMPONENTS

INSTALLATION, USE, AND ADJUSTMENTS

B. JAY FIT 2U FP (Four Point) Hardware 5 6 7 8 9 10
Please read the following instructions before beginning. To mount the JAY FIT 2U Back with FP (Four Point) hardware, it is best to begin without a user in the wheelchair. Once the back has been mounted and minor adjustments are needed, the user can be seated back in the wheelchair. This is supplied as standard hardware.
Tools required (included with the JAY FIT 2U Back)

  1. 4mm Hex Key
  2. 10mm Box End Wrench
  3. 5/8-in Box End Wrench

Back Hardware Mounting

  1. Remove existing back components
    a. Remove the existing wheelchair back according to the wheelchair manufacturer’s instructions.
    b. Remove any pre-existing back hardware or components.

  2. Locating the hardware receivers
    a. The back shell should come with mounting brackets (A) attached.
    b. Visually determine the optimum clamp receiver (B) location on the back canes. The mounting hardware should be at approximately equal heights on each back post (D) and parallel to the seat frame. (Fig. 10)
    NOTE – A higher location on the back canes is generally better.

  3. Attaching the hardware receivers
    a. Using the 4mm hex key, loosen the clamp screws (C).
    NOTE: For large tube diameters, the clamp screws may have to be removed completely.
    b. Attach and align the receiver to the wheelchair back canes (D).
    c. Hand tighten the clamp screws (C).
    d. Using a 10mm wrench, loosen the bracket nuts (E) and the mounting pin bolts (K) until you can move the hardware easily in all directions for adjustment.
    e. The receivers may require additional lateral adjustments to ensure proper alignment.

  4. Attaching and aligning with the upper hardware receivers
    a. Attach the JAY FIT 2U Back to the hardware receivers by inserting left and right mounting pins (F) in the left and right receivers (H).
    b. Locate the back to the approximate location, relative to both the chair and the user.
    c. Tighten bolts (I) on the inside of the mounting pin (F) to a torque of 11.3-12.4 Nm [100-110 in-lbs].
    d. Tighten the bracket nuts (E). Torque to 8.5-9.6 Nm [75-85 in-lbs].
    e. Test the back release by pressing the release levers (G) forward and removing the back off of the chair. Proper alignment of the mounting hardware and back is correct when it is possible to have a smooth attachment and release of the back assembly. If proper alignment has not been achieved, adjust the components until properly aligned.
    f. Once properly aligned, tighten the hardware receiver clamp screws (C). Torque to 8.5-9.6 Nm [75-85 in-lbs].
    g. Finish by inserting the locking pin (J) into the receiver.

  5. Attaching and aligning the lower hardware receivers
    NOTE: Ensure the upper and lower brackets are aligned and parallel to the seat frame.
    a. Test the back release for the upper mounting hardware by pressing the release levers (G) forward and removing the back from the chair. Proper alignment of the mounting hardware and back can be determined by the smooth attachment and release of the back assembly. If needed, continue small adjustments until the back can be attached and/or removed smoothly.
    b. Loosen screws (L) to mount lower receivers on back canes (M).
    c. Using a 5/8-in wrench, loosen the nut (N) that secures the lower mounting pin (O) so that it slides foreward and rearward.
    d. Slide lower receiver (P) up until it surrounds the lower mounting pin (O).
    NOTE – Leave 1/8-in to 1/4-in of space between the bottom of the lower mounting pin (Q) and the bottom of the lower receiver channel (R).
    e. Once properly aligned, tighten the hardware receiver clamp screws (L). The recommended torque is 8.5-9.6 Nm [75-85 in-lbs]. Then tighten the lower mounting pin nut (N) and torque to 11.3-12.4 Nm [100-110 in-lbs].
    f. Finish by inserting the locking pin (S) into the receiver. Function check, and complete micro adjustments to height, depth, and angle.

  6. Attaching the back to the hardware receivers
    Attach the JAY FIT 2U Back to the top and bottom mounting hardware receivers and push down until the assembly is locked. There should be a “click” when locked properly. If needed, continue small adjustments until the back can be attached and/or removed smoothly, and locks correctly into the mounts. To make micro adjustments, loosen bolts (T) and (U). This will allow for minor changes in height, depth, and angle. Retighten all bolts to required specs and test back function and quick-release. Or, to make macro adjustments, loosen, but do not remove, bolts (C), (E), (I) and (L), and nut (N). Position backrest to desired height, depth, and angle. Retighten all bolts to required specs and test back function and quick-release.

JAY Fit 2U Wheelchair Back - Hardware

B. JAY FIT 2U HD (Two Point) Hardware 11, 12, 13, 14, 15
Please read the following instructions before beginning. To mount the JAY FIT 2U back, with 2-point hardware, it is best to begin without a user in the wheelchair. Once the back has been mounted the user can be seated back in the wheelchair for minor adjustments. This is only available as a spare part.
Tools required (included with the JAY FIT 2U Back)

  1. 4mm Hex Key
  2. 10mm Box End Wrench

Back Hardware Mounting

  1. Remove existing back components
    a. Remove the existing wheelchair back according to the wheelchair manufacturer’s instructions.
    b. Remove any pre-existing back hardware or components.

  2. Locating the hardware receivers
    a. The back shell should come with mounting brackets (A) attached.
    b. Visually determine the optimum clamp receiver location (B) on the back canes. The mounting hardware should be at approximately equal heights on each back post (C), and parallel to the seat frame (Fig. 6).
    NOTE: A higher location on the back canes is generally better.

  3. Attaching the hardware receivers
    a. Using the 4mm hex key, loosen the clamp screws (D).
    NOTE: For large tube diameters, the clamp screws may have to be removed completely.
    b. Attach and align the receiver to the wheelchair back canes (E).
    c. Hand tighten the clamp screws (D).
    d. The receivers may require additional lateral adjustments to ensure proper alignment.

  4. Attaching and aligning the JAY FIT 2U Back shell
    a. Using a 10mm wrench, loosen the bracket nuts (F) and mounting pin bolts (J) until the hardware can move easily in all directions.
    b. Attach the JAY FIT 2U Back to the hardware receivers by inserting left and right mounting pins (G) in the left and right receivers (H).
    c. Locate the back to the approximate location, relative to both the chair and the user.
    d. Tighten bolts (L) on the inside of the mounting pin (G). The recommended torque specifi cation is 11.3-12.4 Nm [100-110 in-lbs].
    e. Once all components have been properly aligned, tighten the clamp screws (D) to approximately 8.5-9.6 Nm [75-85 in-lbs].
    f. Test the back release by pressing the release levers (I) forward and removing the back off of the chair. Proper alignment of the mounting hardware and back is correct when it is possible to have a smooth attachment and release of the back assembly. If proper alignment has not been achieved, adjust the components until properly aligned.
    f. Finish by inserting the locking pin (K) into the receiver.

NOTE – Back depth and angle may require additional adjustment to ensure proper fit to the user.

JAY Fit 2U Wheelchair Back - Hardware 2

C. Adjusting Height, Depth, and Angle 16, 17, 18, 19, 20, 21
Once the initial installation is complete, adjustments can be made with the user seated in the chair for a personalized fi t. Ensure that the user does not apply their full weight to the back until the hardware has been fully tightened to the specifi ed torque requirements.

  1. Height adjustment
    a. With the user seated in the chair, identify the correct height for the back.
    b. Have the user slide forward slightly. Using a 10mm wrench loosen the nuts (A-Fig. 18 for HD, D-Fig. 19 for FP).
    c. Move back to the correct height, and tighten the nuts to 8.5-9.6 Nm [75-85 in-lbs].

  2. Depth and angle adjustment
    Depth adjustment varies with the type of hardware ordered. HD and FP hardware have approximately 2 inches of depth adjustment.
    a. Using a 10mm wrench, loosen the left and right hardware on the bracket slots. For HD loosen hex screws B-Fig. 18. For FP loosen hex screws E-Fig. 19 and nuts G-Fig. 19.
    b. Adjust the depth and/or angle settings and securely tighten the screws to lock in the adjustment. Recommended torque specifi cation is 11.3-12.4 Nm [100-110 in-lbs].
    c. If additional depth is needed, remove the JAY FIT 2U Back from the receivers. Remove the screws (Fig. 16 for HD, Fig. 17 for FP) from the receiver using a 4mm hex key and reposition the hardware to the desired depth. After adjusting to the correct depth, tighten the screws to 2.8-4 Nm [25-35 in-lbs].

  3. Check Out
    WARNING
    Ensure that all hardware has been properly tightened according to suggested specifi cations.
    1. Ensure the Back Support is locked, and the locking pin (C-Fig. 18 for HD, F-Fig. 19 for FP) is inserted into the receiver.
    2. Check that the Back Support can be attached smoothly and securely, by attaching and removing the assembly several times.
    3. Double check fi t and comfort for the user before putting the Back Support into use.
    4. Failure to follow this check out procedure could result in injury and/or damage to your Back Support and/or components.

  4. Adjusting the Side Wings
    Each wing is held in place by three bolts (H) located on the back of the back shell. The wings can be adjusted independently depending on the positioning needs. Adjustment should only be performed by a health care provider experienced in seating and positioning.
    a. Loosen the three bolts located on the back of the shell using a 5mm hex key.
    b. Slide the adjustment wing to the desired width.
    c. Retighten the three bolts (H) to 8.5-9.6 Nm [75-85 in-lbs].
    d. Repeat as needed for each side.

  5. Adjusting the Height Panel
    a. Loosen the two bolts (I) located on the bottom of the back of the shell using a 5mm hex key.
    b. Slide the height extension to the desired height.
    c. Retighten the two bolts to 8.5-9.6 Nm [75-85 in-lbs].

  6. Positioning Insert Adjustment
    The JAY FIT 2U Back ships with positioning inserts already placed inside inner cover. Adjustment of the positioning inserts should be performed by a health care provider experienced in seating and positioning.
    a. Remove 6 button snaps and bottom Velcro © of the outer cover from the center shell and side wings and set aside.
    b. Unzip the double zipper of the center section of inner cover to reveal positioning inserts.
    c. Remove the stack of positioning inserts by inserting fi ngers in side cutouts and remove from the Velcro© backing.
    d. Slide the inserts apart, then restack to the desired height. Each insert must have a base and top cap installed. If needed, a positioning insert can be completely removed.
    e. Utilize the positioning inserts to create the desired contour.

Note: Additional positioning inserts are included with the JAY FIT 2U back and can be utilized if greater contour is desired. We recommend a maximum of 5 total pieces per positioning insert.

JAY Fit 2U Wheelchair Back - Hardware 3JAY Fit 2U
Wheelchair Back - Hardware 4

MAINTENANCE AND CLEANING

WARNING
The owner of this equipment is responsible for ensuring that it has been set up and adjusted by a Sunrise Medical authorized dealer under the advice of a health care provider. It may require periodic safety and function checks or certain in-use adjustments that can be performed by the owner, caregiver, or a Sunrise Medical authorized dealer if desired. Proper maintenance and cleaning may help extend the life of your JAY back. Clean your JAY back regularly. During cleaning, component inspection is recommended.
Check the cover for tears and excessive wear and replace if ripped, torn, or otherwise not fully functional. If at any time, the outer cover or any other component appears to be wearing or you notice a degradation in the texture, contact your Sunrise Medical authorized dealer or Sunrise Medical for evaluation and further instructions.
A. To clean the outer cover

  1. Remove the outer cover from the back shell by detaching the Velcro© and snaps.

  2. Unzip the zippers at the bottom and remove all foam components.
    Then turn the cover inside out.

  3. Machine wash in warm water 50° C (122° F) and drip or tumble dry on low heat.

  4. Ensure all foam is placed back in the proper confi guration before using the back again.

Note: 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.

(Cushion Cover) Laundry Care Symbols

| Machine wash in warm water (50° C)
| Only non-chlorine bleach, when needed
| Drip dry
| Do not iron
| Do not dry clean

B. To clean the back shell

  1. The back shell should be wiped clean with soap and water on a regular basis.
  2. Inspect the back shell for any loose, worn, bent, or damaged parts.
    If discovered, loose, worn, or damaged parts should be replaced before using the back support.

C. To clean the inner cover

  1. The inner cover should be wiped clean with soap and water on a regular basis.
  2. Check the inner cover for tears and excessive wear and replace if ripped, torn, or otherwise not fully functional.
  3. Removal and adjustment of the positioning inserts should be performed by a health care provider experienced in seating and positioning.

D. Critical safety checks

  1. Fasteners: Sunrise Medical recommends that all fasteners be checked for wear, such as loose bolts or broken components, every 6 months. Loose fasteners should be retightened according to the set-up instructions. j
  2. Replacing components: contact your Sunrise Medical authorized dealer immediately to replace any components. Do not continue to use the system after identifying worn, loose, or broken components.

E. Removal and replacement
After mounting and/or adjustment, the back can be easily removed from the wheelchair if necessary.

  1. Removal
    a. Remove the locking pin from the mounting hardware.
    b. Push both the release levers forward to unlock the hardware.
    c. Once both levers are in the forward position, lift the back straight up, using the handle located on the top of the back.

  2. Re-Attachment
    a. To re-attach the back and hardware receivers, line up the pins to the receivers. Push the back into place on the receivers. If properly inserted, the pins will “click” into a locked position.
    b. Insert the locking pins (A) into the mounting receiver (B). The locking pins provide a safety feature which prevents the back from being released unintentionally from the wheelchair.

WARNING
If you are uncertain that you have heard the locking “click”, pull up on the back using the handle to test and ensure it has been securely locked.
If you fail to heed these warnings damage to your equipment, a fall, or loss of control may occur and cause severe injury to the rider or others.
F. Accessories
The JAY FIT 2U Back is compatible with our full line of Whitmyer head supports and select JAY thoracic laterals. Refer to the individual products Owner’s Manual and Instruction sheets for mounting, maintenance, and cleaning instructions. Accessories should only be placed by a Sunrise Medical authorized dealer.

SUNRISE LIMITED WARRANTY

JAY FIT 2U BACK WARRANTY
Each JAY FIT 2U Back is carefully inspected and tested to provide peak performance. Every JAY FIT 2U Back 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 back’s removable cover.
The removable outer 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 Sunrise Medical authorized dealer. Except for express warranties made herein, all other warranties, including implied warranties of merchantability and warranties of fi tness 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.
ADDITIONAL WARRANTY INFORMATION
For goods provided by Sunrise Medical Pty Ltd in Australia, our goods come with a guarantee by Sunrise that cannot be excluded under the Australian Consumer Law. You are entitled to a replacement or refund for a major failure and for compensation for any other reasonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure. The benefi ts to you given by this warranty are in addition to your other rights and remedies under a law in relation to the goods to which the warranty relates.

① Type:| Product Name| XXX kg| Max user weight| | This symbol means Medical Device| JAY Fit 2U Wheelchair Back - ICON 9
---|---|---|---|---|---|---
② Date:| LOT: defined by Julian Date|
| CE Mark| | Manufacturer
| Seat width|
XXXX-XX-XX| Date of Manufacture| ****| European Authorised Representative
| Seat depth| Part Code| Assembly Part Number| |

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 production. This product meets the requirements in accordance with EU regulations. Options or accessories shown are available at extra cost.
The varieties of backrest fi tting variants, as well as the diff erent positioning components to deliver postural support, pressure distribution, increase seating tolerance are benefits according to each user requirement and indication, mean that it can be used by a range of users with diff erent positioning needs and indications as follows:

  • Spinal Cord Injury
  • MS
  • Neurological disease pattern (hemiplegia, M. Parkinson)
  • Amputation
  • Tetraplegia
  • Muscle Dystrophy
  • Joint contracture
  • Cerebral Palsy
  • Extremity defect deformity

No contraindications are known or available.
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**.

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 Malsch/Heidelberg
Deutschland
Tel.: +49 (0) 7253/980-0
Fax: +49 (0) 7253/980-222
www.SunriseMedical.de
---|---
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 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 Vestby
Norge
Telefon: +47 66 96 38 00
post@sunrisemedical.no
www.SunriseMedical.no| Sunrise Medical S.L.
Polígono Bakiola, 41
48498 Arrankudiaga – Vizcaya
España
Tel.: +34 (0) 902142434
Fax: +34 (0) 946481575
www.SunriseMedical.es
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Neongatan 5
431 53 Mölndal
Sweden
Tel.: +46 (0)31 748 37 00
post@sunrisemedical.se
www.SunriseMedical.se| 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
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 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 Aps
Mårkærvej 5-9
2630 Taastrup
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) 247554400
Fax : +33 (0) 247554403
www.sunrisemedical.fr
Sunrise Medical (US) LLC
North American Headquarters
2842 Business Park Avenue
Fresno, CA, 93727, USA
800-333-4000
800-300-7502
www.SunriseMedical.com|

** OM_Jay Fit 2U Back_EU_ML_Rev.A_2021-11-16
255813 Rev. A**

References

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