obss tru-shape, obss ortho-shape - ottobock · shape is captured with either a vacuum bean bag or...

OBSS Tru-Shape, OBSS Ortho-Shape

Instructions for use ............................................................................................ 5

INFORMATION FOR PROVIDER & DAILY CAREGIVER/USER

We want to help you get the most from your seating system; this user manual will help you become familiar with your custom seating system. Ottobock provides a range of custom made seating systems including: OBSS Tru-Shape (carved foam seats) and OBSS Ortho-Shape (molded seats).

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Product Description 1.

Date of last update: 2017-11-13

Please read this document carefully before using the product. Follow the safety instructions to avoid injuries and damage to the product. Instruct the user or nursing staff in the proper and safe use of the product. Hand these instructions over to the user or nursing staff.

New information regarding product safety and product recalls can be obtained from the

Customer Care Center (CCC) at [email protected] or from the manufacturer's service department (see inside back cover or back page for addresses).

You can request this document as a PDF file from the Customer Care Center (CCC) at [email protected] or from the manufacturer's service department (see inside back cover or back page for addresses). It is possible to increase the display size of the PDF document.

1.1 Function

Custom made seats are contoured to the specific body shape of the user. The user’s body shape is captured with either a vacuum bean bag or plaster process by an appropriately trained professional. The captured shape data is transferred to the fabrication site together with additional design specifications. Shape, size and design features will differ according to the medical and functional requirements of the user. The final decisions regarding fit, function and design features must be made by an appropriately trained professional.

OBSS Tru-Shape (fig. 1 & 2): High quality urethane foam is carved to create an intimate fit with the user (fig. 1). The intimate fit creates optimal surface area and improved pressure redistribution. The custom shape (example: medial thigh support (fig. 2A)) created by the fitting professional during the molding process ensures additional functional support as necessary for the user. The foam is most often sprayed with a water resistant coating in order to protect the foam from fluid ingress and to make cleaning easier. A wood or ABS mounting shell adds additional structural support to the foam and creates a mounting sur-face for the connection of additional positioning products and also attachment to a mobility base. A textile cover (fig. 2B) is the direct interface to the user and, based on the fitting professional’s specifications, can provide stretch for perfect interface with the complex foam shape, breathability, water resistance or easy cleaning.

OBSS Ortho-Shape (fig. 3 & 4): A Plastazote® foam liner (fig. 4A) is molded to create an intimate fit with the end-user. The intimate fit creates optimal surface area and improved pressure redistribution. One or more liners are provided with the product to customer speci-fication. The inner liner can be removed (fig. 4) to compensate for those occasions when

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the user wears thicker clothes, if they have gained weight or otherwise grown in size. The custom shape (example: lateral thigh support (fig.3A)) created by the fitting professional during the molding process ensures additional functional support as necessary for the user. An ABS shell (fig. 3B) adds additional structural support to the foam and creates a mount-ing surface for the connection of additional positioning products and also attachment to a mobility base. A textile cover is the direct interface to the user creates a slight cushioning effect and comfortable upholstered surface for the user. The ABS shell and Plastazote® liners can be reshaped in the field by a qualified technician (following the instructions in this manual, see section 5.2) to accommodate changing positioning needs. As an alternative to a Plastazote® liner, a breathable spacer fabric textile cover can be selected. This includes 1 - 2 layers of a 6 mm thick spacer which add additional cushioning and breathability especial-ly at the torso.

For all products additional positioning accessories may be included with the product or ordered separately to the trained professional’s specifications. Typical selections include a head support, positioning belt and torso positioning device/harness.

Seat Model Component Figure Function

OBSS Tru-Shape

Carved urethane foam 1 Pressure redistribution and custom

support

Vinyl spray foam coating Not shown Prevent liquid ingress into foam, easy

cleaning

Wood or ABS mounting shell Not shown

Foam support, attachment surface (mobility base or positioning accesso-ries)

Removable textile cover 2B

Comfort, breathability, washability depending on customer’s material selection.

OBSS Ortho-Shape

Molded Plas-tazote® foam with textile cover

3 & 4 Pressure redistribution and custom support

Microclimate upholstery

Not shown Interface comfort and breathability for reduced humidity at the user interface.

ABS mounting shell 3B User structural support, attachment

surface for positioning accessories

Wood mobility base mounting surface

3C Attachment surface for mobility base or positioning accessories

Connection hardware 17A/18A/19A Connection of back component to

canes of mobility base

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Application 2.

2.1 Intended Use

Custom made seats are contoured to a specific user’s form and, as such, are intended to be used by a single individual with asymmetric postural and pressure care needs. The seats are suitable for moderate to complex positioning needs and preventing pressure injuries in pa-tients with paraplegia, hemiplegia, neurological deficits and rheumatic nerve and muscle disorders.

The term ‘seat’ encompasses both a support surface under the legs and pelvis and a sup-port surface for the back and torso. Custom seats can be ordered as complete seat-back system or as individual seat or back components.

Please note that the most appropriate wheelchair seating solution for an individual should always be determined by a suitably qualified or experienced person based on a full risk assessment and used in conjunction with a full program of care.

The product in exclusively intended for use in combination with other Ottobock components following the instructions for use of each individual component. Ottobock assumes no liabil-ity for combinations with medical products or accessories from other manufacturers of Ap-plication.

Because the seat is individually fabricated, it can be adapted for a wide range of users. The order form includes options for additional reinforcements for users who are heavier or expe-rience high tone or strong muscle spasms. Heavy duty options are recommended for user over 136 kg (300 lbs).

2.2 Contraindication

Seek professional advice before selecting an appropriate seating support where there is an existing case or history of pressure injuries.

2.2.1 Absolute Contraindications

Not known.

2.2.2 Relative Contraindication

Seat shell cracking due to impact forces Risk of injury or reduced postural support due to failure in the seat shell

Users whom present with rocking behaviors or high tone may not be appropriate for the fully molded OrthoShape seat system. A clinical risk assessment by the attending ther-apist or trained professional should consider this contraindication.

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If redness of the skin or other problems occur during use, consult a doctor or therapist as soon as possible.

2.3 Further Usage Restrictions

The product is designed for use by one person only. Re-use of the product is not permitted due to hygiene considerations.

2.4 Qualification

This product may only be selected and adapted by trained qualified personnel.

Safety 3.

3.1 Explanation of warning symbols

Warning regarding possible serious risks of accident or injury

Warning regarding possible risks of accident or injury

Warning regarding possible technical damage

3.2 General Safety Instructions for both Provider and Client

Incorrect application and use of lap belts, positioning belts and harness systems Choking, suffocation or strangulation due to sliding forward in the product

Qualified personnel are responsible for individual positioning and fitting of the belt and harness positioning systems and for training the carer in the proper use of the device.

Observe the manufacturer’s instructions for proper application and adjustment of the product in use to prevent the user sliding into a hazardous position.

Adjusting the belt system too loosely can cause the user to slide into a dangerous posi-tion. In addition, the fastening snaps could open unintentionally if they slide against hard parts of clothing (e.g. buttons).

Excessively tight adjustment of the belt system may lead to unnecessary pain or illness of the user.

The positioning system must fit closely but not too tightly so the user is not injured. Sliding two fingers comfortably between the positioning system and body should be possible.

When using an upper body positioning harness always use a correctly applied position-ing lap belt to stabilize the pelvis.

Upper body positioning harnesses must be applied/positioned so that the neck and area of the throat remain free at all times.

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Lack of testing prior to long-term use Risk of skin reddening or pressure injury formation due to incorrectly selected seating sys-tem

Any seating system should be tried out by the user under medical supervision for sever-al hours prior to long-term use. The skin should be monitored for redness and/or dam-age during this time.

Careful monitoring is required over the first few weeks to ensure the client adjusts to the new shape.

The length of time will depend on the individual. During this introductory period, gradu-ally increase the time spent in the seat and regularly check the skin for signs of marking or abrasion.

It is not uncommon to find some marking with a new seat as the client may be in contact on an area previously unsupported.

Careful monitoring is required over the first few weeks to ensure the client adjusts to the new shape.

Altered center of gravity resulting from use of the seating system Tipping over or falling due to unstable set-up

When fitting a seat unit to the host mobility product, ensure the user is not seated in it. Once the seat is fitted a pull test should be carried out to ensure the seat is correctly fit-ted and fully secured before the user is seated.

If required, adjust the sitting position or axle position to optimize stability, or alternatively assess the suitability of anti-tip devices.

After installing any seating into a wheelchair, always check that the user’s sitting posi-tion and the wheelchair's center of gravity are appropriate for the intended use and the user’s abilities. Work with the user to find the optimal sitting position.

Do not leave system unattended especially on hills or ramps even when brakes are engaged.

Incorrect assembly or settings Risk of injury

Combinations of the seating systems with options/add-on parts which have not been approved by Ottobock, especially with wheelchairs and seat frames from manufacturers other than Ottobock, have to be tested and fall within the responsibility of the specialist dealer/combiner.

Ensure that all screws of the mounting elements are properly tightened after any ad-justments are completed, and ensure the stability of the wheelchair/mobility base is checked.

Do not over tighten screws to avoid damaging components. Make sure to mount screw connections at a distance from the body to avoid any risk of

injury for the user by protruding screws.

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Therapist/fitting professional does not train carer in proper use and maintenance of device Injuries, malposition, illness of the user due to information errors

The qualified personnel is responsible for making sure that the user and/or attendant/ nursing staff has understood the proper adjustment, use, maintenance and care of the seating system.

In particular, ensure that the user and/or attendant/nursing staff knows how to quickly loosen and open belts and upper body positioning harnesses to avoid delays in case of emergency.

Discuss daily operation and preventative maintenance with daily carer along with all manufacturers’ instructions and safety information.

3.3 Information to be provided to the Patient/Attendant

Incorrect application & use of lap belts, positioning belts and harness systems Choking, suffocation or strangulation due to sliding forward in the product

The positioning belt and harness is an important part of an individual seating solution. Do not modify the installation position and basic settings established by the qualified personnel who provided your system.

Make sure you understand the appropriate use of these systems. Make sure that all carers understand the appropriate use (teachers, parents, grand-parents, etc.).

In case of problems with these adjustments (such as an unsatisfactory sitting position), promptly contact the qualified personnel who fitted the product.

Immediately consult the qualified personnel if you detect signs of discomfort or fear when using the product.

Have the basic settings of the belt system checked regularly. Adjustments may be re-quired due to the growth of the user or because of changes in the course of the dis-ease.

Do not leave the user unsupervised if the cognitive abilities of the user could lead to unintentional opening of the positioning system.

Improper handling of ignition sources Risk of burns due to seat cushions, padding and upholstery catching on fire

The seat cushions, padding and upholstery are not highly flammable, but can catch fire. Therefore the utmost caution must be exercised in the vicinity of an open flame.

Do not expose the wheelchair cushion to excessive heat or open flame. Keep away from all ignition sources, especially lit cigarettes.

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Skin damage Risk of skin reddening during long-term use

Do not use the seating system until it has been adjusted by a suitably qualified or expe-rienced person.

Examine the skin for redness on a regular basis. Skin reddening is a clinical indicator of tissue damage.

If redness of the skin or other problems occur during use, stop using the seating sys-tem immediately. Only start using the seating system again after consulting the pre-scribing doctor or therapist.

Tipping risk of mobility device Falls or injury if device tips during use

If an anti-tipping device has been fitted to the wheelchair, it should be deployed when-ever there is any doubt as to the safety or stability of the unit. This could be particularly important when transferring the client to or from the unit especially if the client is being hoisted into or out of the seat.

Wherever possible try to park on a flat, level surface. Do not hang items such as bags from the push handles. Be aware that the user leaning far out of the system (forward or to the side) can lead to

instability and tipping. Use caution when operating the Tilt in Space mechanism on gradients/slopes. Do not leave system unattended especially on hills or ramps even when brakes are

engaged.

Improper use Risk of damage to the cushion surface due to user error

Do not allow the wheelchair cushion to come into contact with sharp objects. This also applies to animals such as pet cats with sharp claws.

If the wheelchair cushion is expected to come into contact with liquid, such as spilt drinks or episodes of incontinence, always use it in conjunction with a liquid-repellent cover.

When transferring care to a new person always make sure to inform carer of all safety instructions.

Delivery 4.

4.1 Scope of Delivery

The finished product is delivered to customer specifications most often including the follow-ing components. Because the products are custom fabricated, no two configurations of product are identical. The healthcare professional may also request partial or complete

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assembly of the product to meet the needs of a specific client. Example: partial assembly of the product may be requested in order to allow a trial fit before the product is completed.

Seat Model Component Figure

OBSS Tru-Shape

Carved urethane foam 1

Vinyl spray foam coating Not shown

Wood or ABS mounting shell Not shown

Removable textile cover 2B

OBSS Ortho-Shape

Molded Plastazote® foam with textile cover 3 & 4

Microclimate breathable space upholstery (back component option) Not shown

ABS mounting shell 3B

Wood mobility base mounting surface (for full seat) 3C

Connection hardware for back components 17A/18A/19A

ALL Attachment hardware Various positioning accessories

Example: head support shown in figures 2 & 3

Preparation for Use (for healthcare provider) 5.

The procedures described in this section may not be carried out by the user of the

product. These instructions for use must be given to the user along with the seating system.

5.1 Assembly

Incorrect application and use of positioning belts and harness systems Throttling, suffocation or strangulation due to sliding forward in the product

Qualified personnel are responsible for individual positioning and fitting of the belt & harness positioning systems.

Observe the manufacturer’s instructions for proper application and adjustment of the product in the use so that the user cannot slide into a hazardous position.

Adjusting the belt system too loosely can cause the user to slide into a dangerous posi-tion. In addition, the fastening snaps could open unintentionally if they slide against hard parts of clothing (e.g. buttons).

Excessively tight adjustment of the belt system may lead to unnecessary pain or illness of the user.

The positioning system has to fit closely but not too tightly so the user is not injured.

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Sliding two fingers comfortably between the positioning system and body should be possible.

When using an upper body positioning harness always use a correctly applied and adapted positioning lap belt to stabilize the pelvis.

Upper body positioning products harnesses must be applied/positioned so that the neck and area of the throat remain free at all times.

Incorrect final assembly of back or seat components to mobility base Injury due to disconnection of seat or back component from mobility base

Qualified personnel are responsible for individual positioning and assembly of the seat and/or back system to the mobility base.

Follow all manufacturers’ instructions for attachment to mobility base and test before allowing user to use the device.

Exposure to fumes from vinyl spray coating Discomfort, rash or respiratory distress

During shipping residual volatiles can build up in the packaging. It is recommended to remove the product from the packaging and allow it to air in a well-ventilated room for 24 hours before fitting the user in the system.

In rare cases, the user may have a special sensitivity to the residual smell of the vinyl spray coating. When this happens, remove the user from the system and contact the manufacturer for alternative solutions.

Altered center of gravity resulting from use of the seating system Risk of tipping over or falling due to unstable settings



After installing any seating into a wheelchair, always check that the user’s sitting posi-tion and the wheelchair's center of gravity are appropriate for the intended use and the user’s abilities. Work with the user to find the optimal sitting position.

Incorrect assembly or settings Risk of injury

Combinations of the seating systems with options/add-on parts which have not been approved by Ottobock, especially with wheelchairs and seat frames from manufacturers other than Ottobock, have to be tested and fall within the responsibility of the specialist

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dealer/combiner. Ensure that all screws of the mounting elements are properly tightened after any ad-

justments are completed, and ensure the stability of the wheelchair/mobility base is checked.

Do not over tighten screws to avoid damaging components. Make sure to mount screw connections at a distance from the body to avoid any risk of

injury for the user by protruding screws.

Only have modifications carried out by qualified personnel. 1. For Tru-Shape products with incontinence spray coating, allow the finished seating

system to air out in a well-ventilated space for 24 hours before fitting to the client. 2. Ensure that the cover is installed on both seat and back cushions. 3. Install all positioning elements appropriate for the needs of the individual client. Follow

manufacturer’s instructions and warnings for all devices. Provide these user manuals to the client.

4. Check all connections to confirm they are not loose and that there are no protruding edges or points which could come in contact with the user.

5. Connect the seating system to the mobility base following the manufacturers’ instruc-tions.

5.1.1 Assembly of OrthoShape Back Component to wheelchair canes

1. The back comes with hardware pre-positioned appropriately on the shell. Final mounting position can only be determined with user and mobility base together. Additional mount-ing positions have been prepared in the shell in the case an alternative position is neces-sary (fig. 16A).

2. Loosely attach cane side of hardware to wheelchair canes (fig. 14). 3. Hold the back shell in approximate final position near the canes in order to better approx-

imate final position. 4. While holding onto shell, carefully allow user to lean into the sitting position. Continue to

adjust back position to match user’s shape. Note: depending on level of muscle control and tone, this step may be easier with two people.

5. Quick Release Hardware: Follow the instructions in section 1 using the provided cane clamps. After final assembly ensure that the custom back is aligned appropriately with the release hardware to allow smooth release and mounting function before testing with the user.

6. Tighten all bolts using a 3/16” hex key to 7Nm (5 lb-ft).

5.1.2 Assembly of OrthoShape Back Components to common power chair seat frames

1. The adapter comes mounted to the shell utilizing the appropriate key holes for the power chair product you have indicated on the order form. Match these key holes to mating

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stand-offs on the wheelchair seat frame. Use the flat head screws provided to lock the assembly securely in position.

2. Permobile/Quickie: ‘A’ side faces ABS shell 3. Quantum: ‘B’ side faces ABS shell. 4. Hold the back shell in approximate final position in order to better approximate final

height. 5. Once all points are connected, move shell in space to the expected user position. 6. While holding onto shell, carefully allow user to lean into the sitting position. Continue to

adjust the back position to match the user’s shape. Note: depending on level of muscle control and tone, this step may be easier with two people.

7. Tighten all bolts using a 3/16” hex key to 7 Nm (5 lb-ft).

5.2 Modification of Ortho-Shape at Mid-fit or Final Fitting

5.2.1 Modify OBSS Ortho-Shape Contours (Provider)

The Plastazote® liner and/or at the ABS shell component can be modified to change the shape of the device to better fit the user.

1. Add foam to the liner to increase contact area.

a. Alternatively mark the foam to indicate where you would like foam to be added if re-turning to supplier for finishing.

b. Foam added to front surface of liner will be covered by textile during seat finishing and cannot later be further modified.

c. Foam added to the back surface will be accessible later for further modifications.

d. Do not add foam within 1 inch of the liner edge as this will prevent later finishing of the edges.

2. Modify the ABS shell using a heat gun (750 °F – 900 °F).

Too much heating of ABS shell, especially in localized areas near attachments points Risk of shell breakage or disconnection from mounting surface

This modification method should be used cautiously. The heating of the ABS material can change/weaken the structural properties of the material at the localized area.

Do not heat the plastic within 3 inches of the attachment points of the shell.

a. Remove Plastazote® liner or other upholstery before heating.

b. Heat only the inside of the ABS to avoid damage to the carbon fiber graphic on the outside surface (fig. 6).

c. Heat until the material is malleable but not too hot. If you can smell the material, then it is too hot.

d. Heat an area approximately 2 - 3 inches. Larger than what you want to change to al-low for a smooth transition.

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e. With heat protective gloves (fig. 7) push the ABS material into your wished position. You may need to apply pressure for a few minutes until the plastic cools enough to hold its new shape.

f. The material adapts best to gradual changes, avoid creating sharp edges.

g. Your changes take effect when the ABS cools, after just a few minutes.

h. Replace the Plastazote® liner into the shell. It will conform to the new shape after a few uses.

5.2.2 Modify the trim lines of the ABS shell

Modification of shell support area at seat-back transition Risk of injury due to shell cracking

The seat-back transition area can experience high-stress especially with users who have high tone or spasms. Maximize the shell support area in this region.

Avoid mounting buckles, straps or other accessories in this region (fig. 13) The ABS shell may be modified at the final fitting of the seating system or returned to the supplier for finishing after a trial fit.

1. Mark the area to be removed with a water-based or silver colored pen.

2. Avoid cutting the ABS shell back too far especially at the transition zone between the seat and back.

3. When you wish to create a notch for a lap belt, create the notch in the liners, not the ABS shell (fig. 10).

4. Trim the ABS shell with a jigsaw using a large toothed blade. Always use caution and the appropriate protective equipment when using power tools (fig. 8).

5. Smooth the edges using wet-dry sandpaper or a deburring tool (fig. 9).

5.2.3 Modify the liners

The liners may be modified at the final fitting of the seating system or returned to the suppli-er for finishing after a trial fit.

1. Mark liners for trimming using a highly visible marker/pen.

2. For belt notches, notch the liner so the strap will lie across the body and in front of the pelvis. As shown in fig. 5, the angle of the belt should be 60° - 90°.

3. The liners should extend ½ in. longer than the edge of the ABS shell except at the posi-tion of the belt notches (fig. 10A).

4. Use caution when cutting the liners (fig. 11). A utility knife or very sharp scissors are recommended.

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5.2.4 Marking strap, buckle and belt position

The strap, buckle and belt positions are finished at the supplier.

1. Clearly mark buckle and belt position on the ABS shell using a highly visible marker.

a. The belt connection point must be at least 2 in. from the edge of the shell. This is to maintain structural strength at the seat: back transition.

2. Clearly mark the liner adjacent to the buckles to indicate strap position (fig. 12A).

a. The position should be selected to avoid interference with the user especially at the arms.

b. 8 straps are recommended to securely hold the liners in place. This can vary with the size of the seat.

3. The straps will be sewn directly to the liners. The buckles are riveted to the ABS shell (fig. 13).

4. At the belt attachment position, a T-Nut will be inserted (fig. 12B).

5.3 Positioning User in Seating System

Medical Risk Injuries, pressure injuries due to application errors

It is recommended that the client is introduced to their new seating system over a peri-od of time.

The length of time will depend on the individual. During this introductory period, gradually increase the time spent in the seat and regu-

larly check the skin for signs of marking or abrasion. It is not uncommon to find some marking with a new seat as the client may be in contact

on an area previously unsupported. Careful monitoring is required over the first few weeks to ensure the client adjusts to

the new shape. Should skin irritation and/or skin reddening occur, consult the qualified personnel who

adapted and adjusted the product. Do not continue using the product without consulta-tion.

Altered center of gravity resulting from use of the seating system Risk of tipping over or falling due to unstable settings



After installing any seating into a wheelchair, always check that the user’s sitting posi-tion and the wheelchair's center of gravity are appropriate for the intended use and the

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user’s abilities. Work with the user to find the optimal sitting position. 1. Ensure the seat is well attached to the mobility base. 2. Ensure the brakes and anti-tippers are engaged on the mobility base. 3. Transfer the user into the seat with care. 4. Confirm appropriate set up of the positioning belt across the thighs and in front of the

user’s pelvis (fig. 5).

5. Adjust head support following manufacturer’s instructions and to the needs of the indi-

vidual client. 6. Adjust the foot support in line with the client’s needs and to manufacturer’s instructions. 7. Inform care-givers and patient about appropriate use of all elements of the seating sys-

tem mobility base and accessories. 8. Allow client to sit in the new device for about 1 hour, less if they appear anxious or agi-

tated. 9. Plan, together with the caregivers, an appropriate schedule for allowing the user to

adapt to the new device. Start with multiple short periods of use and gradually increase time when no adverse effects are noted.

Use (for carer) 6.

Use of cushion without a cover Risk of user picking at and ingesting foam materials

The product should always be used with a cover to prevent users with ‘picking’ behav-iors from pulling off pieces of the product and eating it.

Be sure to ask your healthcare provider about appropriate use of your individual seating

system. It is important to understand daily use and care of the device. Request the manufacturer’s safety instructions to keep for your records. These can be

helpful when transferring care to a new attendant, teacher or relative.

6.1 Use

6.1.1 General use

Incorrect use of lap belts, positioning belts and harness systems Choking, suffocation or strangulation due to sliding forward in the product

The positioning belt and harness is an important part of an individual seating solution. Do not modify the installation position and basic settings established by the qualified personnel who provided your system.

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Make sure you understand the appropriate use of these systems. Make sure that all carers understand the appropriate use (teachers, parents, grand-parents, etc.).

In case of problems with these adjustments (such as an unsatisfactory sitting position), promptly contact the qualified personnel who fitted the product.

Immediately consult the qualified personnel if you detect signs of discomfort or fear when using the product.

Have the basic settings of the belt system checked regularly. Adjustments may be re-quired due to the growth of the user or because of changes in the course of the dis-ease.

Do not leave the user unsupervised if the cognitive abilities of the user could lead to unintentional opening of the positioning system.

Exposure to fumes from vinyl spray coating Discomfort, rash or respiratory distress

In rare cases, the user may have a special sensitivity to the residual smell of the vinyl spray coating. When this happens, remove the user from the system and contact your healthcare provider.

Improper uses or adjustments Falls, user falling out, malposition, illness of the user due to adjustment changes due to improper use

The lap belt must be put on when getting into the product and used at all times while using the product.

Only open the lap belt when the user is ready to get out of the product.

Medical risk Injuries, pressure injuries due to application errors

Regular measures for pressure redistribution and skin examinations are required. Should skin irritation and/or skin reddening occur, consult the qualified personnel who adapted and adjusted the product. Do not continue using the product without consulta-tion.

1. A variety of user-specific positioning accessories are issued with the seating system.

You should be made aware of the accessories and how to adjust them by your healthcare provider. If you are unsure about any aspect of your seating system please contact your healthcare provider.

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6.1.2 Use - on slopes and inclines

Tipping risk of mobility device Falls or injury if device tips during use

If an anti-tipping device has been fitted to the wheelchair, it should be deployed when-ever there is any doubt as to the safety or stability of the unit. This could be particularly important when transferring the client to or from the unit especially if the client is being hoisted into or out of the seat.

Wherever possible try to park on a flat, level surface. Do not hang items such as bags from the push handles. Be aware that the user leaning far out of the system (forward or to the side) can lead to

instability and tipping. Use caution when operating the Tilt in Space mechanism on gradients/slopes. Do not leave system unattended especially on hills or ramps even when brakes are

engaged. 1. During handover of the wheelchair/mobility wheelbase, the overall stability was as-

sessed by the healthcare provider with the user seated in the unit, thus highlighting po-tential dangers that could cause the chair to become unstable, such as hanging bags from the push handles or allowing the user to drop forward and/or overhang the sides of the wheelchair.

2. Other dangers include negotiating slopes which may be too steep to maintain stability. An indication of an incline being too steep is when the castor wheels become very light or when going down a slope, the rear wheels become light.

3. Should either of these occur, we would recommend you traverse (zigzag) across the slope so as to reduce the risk of the chair becoming unstable. If in any doubt about the safe use or stability of the unit, an alternative safe route should be found.

6.1.3 Removal and refitting the seat to the wheelbase

Improper use or set-up Falls, user falling out, malposition, illness of the user due to adjustment changes due to improper use


1. Some seats or components can be removed and remounted to the mobility base. It is

important that you understand how to remove the seat from the wheelchair / wheelbase and refit it safely. This should have been demonstrated to you by your healthcare provid-er. If you are unsure how to remove the seat please refer back to the healthcare provider.

2. Some wheelchairs have a specific interface. The instructions for this type of interface can be found in the user manual for the wheelchair.

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3. Where there is no specific interface for the chair then drop hooks or location hooks may be fitted to the bottom of the seat. (Fig 6). These are fitted to ensure that the seat is lo-cated securely on the wheelchair, and/or to lower the system to improve stability.

4. We recommend that weekly checks are carried out to ensure the straps are kept at the correct tension not loose, frayed or damaged.

6.1.4 Use – In transport

Use in vehicles for transporting persons with reduced mobility Falls, user falling out due to improper use

Always use transport approved tie-downs and follow chassis instructions for transport. Do not use the lap belts and positioning systems for the upper body as part of a per-

sonal restraint system during transportation in vehicles for transporting persons with re-duced mobility.

These products do not replace the existing passenger restraint system in vehicles for transporting persons with reduced mobility.

Use in vehicles for transporting persons with reduced mobility Falls, user falling out, loose parts cause injury in event of a crash situation

The Ottobock Ortho-Shape Back Support component has not been crash tested. 1. Whenever possible, transfer the user to a seat installed in the motor vehicle and uses the

corresponding vehicle restraint systems. 2. When the user cannot be transferred to the motor vehicle seat, always use the appropri-

ate wheelchair and passenger restraint systems in the motor vehicle during transport. 3. The seating system is only to be used in conjunction with the mobility base(s) it has been

supplied with and should be transported in the forward facing direction. However it may be transported in the rearwards direction when used in conjunction with a suitable de-vice that supplements the seatback and head restraint (Rear Impact Protection system – RIP Seats). Under NO circumstances should the seat unit be used solely as a car seat, seated on a vehicle seat.

4. Information on the correct procedure for the use of the wheelchair tie down system can be found in the manufacturer’s user manual for the wheelchair (when a new wheelchair is issued a copy of the manufacturer’s user manual will be supplied) or from your re-straint system supplier.

5. Care should be taken to ensure that good contact is made between the occupant and the occupant restraint system belt and that the belt is not impeded by the seating unit or any part of the wheelbase.

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6.2 Cleaning

6.2.1 Cover

Improper cleaning of the wheelchair cushion cover Risk of damage to cushion due to user error

Never wash the cover at a temperature higher than the recommended as this may cause it to shrink. This could impede the cushion's ability to redistribute pressure or it could damage the fabric.

Do not use any bleaching agents for cleaning.

Replace the cover when it shows signs of advanced wear. Should it be necessary to disinfect the cover, add a standard hygiene detergent during

washing (e.g. Sagrotan® laundry hygiene detergent). For OBSS Tru-Shape or Ortho-Shape removable covers:

1. Remove the cover for separate washing. 2. The cover can be washed at 60 °C [140 °F] using a mild, environmentally friendly deter-

gent. Recommendation: Wash the cover using the delicate cycle at 40 °C [104 °F] to prevent excessive wear.

3. Allow to air dry. DO NOT tumble dry, use a hair dryer or place near a hot radiator to dry. 4. Ensure the cover is fully dry before replacing on the foam and placing the user in the

system. For OBSS Ortho-Shape non-removable covers:

1. Wash or wipe down with warm water and detergent, air dry at room temperature. 2. Make sure the seating system is fully dry before placing the user in the system.

6.2.2 Belts & Strapping

The belt straps can be cleaned by being gently dabbed with warm soapy water (with

some disinfectant) or carefully wiped with a dry, clean, absorbent cloth. Follow manufacturer’s instructions. Below are general guidelines.

1. Belts with metal buckles are not machine washable, clean the belt straps by gently dabbing them with warm soapy water (with some disinfectant) or carefully wiped with a dry, clean, absorbent cloth.

2. Belt with plastic buckles are Machine washable between 40 °C [104 °F] and 60 °C [140 °F]. Recommendation: Use a laundry bag or net and mild detergent.

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3. Allow the belts to air dry. Ensure that the belts and pads are completely dry before instal-lation.

4. Do not expose the belts to direct heat (e.g. sunshine, stove or radiator). 5. Do not iron or bleach the belts.

6.2.3 Foam components

Improper cleaning of the wheelchair cushion foam components Risk of damage to cushion due to user error

Never dry the foam components or inserts in a dryer. 1. DO NOT immerse foam components in water. This includes components coated with

water repellent. 2. To clean, wipe with a damp cloth and mild detergent or disinfectant, dry naturally.

Maintenance 7.

Damage caused by wear and tear If the padding is worn or damaged, replace it immediately. All worn or damaged components have to be replaced with original components from

the manufacturer as quickly as possible by qualified personnel. If the functionality of the belt system is impaired, further use of the overall product is not recommended.

Should you experience any problems with your wheelchair seating system or mobility

base, please contact your healthcare provider. Only have repairs carried out by qualified personnel.

7.1 Before each use

Unstable connection between cushions and shell and/or shell and mobility base Risk of tipping over or falling due to unstable settings


1. Check the function of the product especially the connection between the cushions, shell

and mobility base.

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7.2 Weekly

1. If you have been prescribed removable seat components, remove the seat from the wheelchair.

2. Visually inspect the seat for damage. Note signs of wear on the seams, pads and straps, and the mounting materials.

3. Clean all aspects of the shell with warm water and detergent, removing liners or cush-ions as necessary.

4. Launder and change the covers on your cushions. 5. Clean the liners in your molded seat insert. 6. Inspect the belt system for wear and damage. The inspection interval should be in-

creased heavy users. 7. Check the operation of the lap belt buckle. 8. Clean the wheelchair. 9. Refit the seating system to the mobility base and ensure that all connections are secure.

7.3 Repair

Should you experience any problems with your wheelchair seating system or mobility

base, please contact your healthcare provider. Only have repairs carried out by qualified personnel. See section 5.2 for further instructions regarding modification or repair of Ortho-Shape seating products.

Legal Information 8.

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

8.1 Liability

The manufacturer will only assume liability if the product is used in accordance with the descriptions and instructions provided in this document. The manufacturer will not assume liability for damage caused by disregard of this document, particularly due to improper use or unauthorized modification of the product.

8.2 Trademarks

All product names mentioned in this document are subject without restriction to the respec-tive applicable trademark laws and are the property of the respective owners. All brands, trade names or company names may be registered trademarks and are the property of the respective owners. Should trademarks used in this document fail to be explicitly identified as

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such, this does not justify the conclusion that the denotation in question is free of third party right.

8.3 Service Life

Expected service life: 2 years. The design, manufacturing and requirements for the intended use of the product are based on the expected service life. These also include the requirements for maintenance, ensuring effectiveness and the safety of the product. Using the product beyond the specified expected service life leads to increased residual risk and should only happen subject to the due diligence and deliberations of qualified person-nel. If the service life is reached, the user or a responsible attendant should contact the qualified personnel who fitted the product or the manufacturer’s service (see inside rear cover or back page for address). Here the user can obtain information about known risks and the current options for refurbishing the product.

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Technical data 9.

Seat Model Component Technical Info

OBSS Tru-Shape

Carved urethane foam Non-latex, 50-75kg/m3, 5.5-9.5kPa

Vinyl spray foam coating Low volatile vinyl based coating

Wood or ABS mounting shell Baltic Birch or ABS sheet

Removable textile cover Dartex®, Neoprene, Lycra, spacer

OBSS Ortho-Shape

Molded Plastazote® foam with textile cover

Polyethylene foam with textile laminated foam surface layer.

ABS mounting shell ABS sheet, carbon aesthetic

Wood mobility base mounting surface Baltic Birch

Microclimate upholstery Nylon spacer textiles

ALL

System height and weight Varies with each individual seating system based on size of user and com-ponent selection.

Connection components Aluminum and steel depending on variation ordered

Your specialist dealer

Otto Bock HealthCare LP 3820 West Great Lakes Drive Salt Lake City, UT 84120 USA T +1 800 328 4058 F +1 800 655 4963

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