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Tru-Shape Operation Manual

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Important Safety Information - General

WARNINGS:

-  DO NOT REUSE. This product is designed to be 

uniquely shaped to its user. DO NOT use this 

product for another individual. 

-  DO NOT use the components of this product 

separately. Assemble and use this product only as 

instructed in this manual. 

-  Altering the seating system or using any hardware 

or components other than those supplied by 

The Comfort Company / Permobil may result in 

product damage and may void the warranty.

-  Follow all instructions and safety information 

provided with the seating system and provided 

by the manufacturer of the wheelchair or other 

accessories. 

-  Skin/soft tissue breakdown can occur due to a 

number of factors, which vary by individual. Check 

skin frequently, at least once a day. Redness, 

bruising, or darker areas (when compared to 

normal skin) may indicate superficial or deep 

tissue injury and should be addressed. If there 

is any discoloration to skin/soft tissue, STOP 

USE immediately. If the discoloration does 

not disappear within 30 minutes after disuse, 

immediately consult a healthcare professional. 

-  If skin irritation and/or skin reddening occur, 

consult the qualified personnel who adapted and 

adjusted the product. Do not continue using the 

product without consultation.

-  Leaning too far forward or to the side may lead to 

instability and tipping.

WARNINGS, continued:

-  DO NOT expose the product to high heat, open flames 

or hot ashes. Testing or certification claims, including 

flammability, may no longer apply to this device once it 

is combined with other products and materials. Check 

testing and certification claims for all products used in 

combination with this device. 

-  If you are unable to perform any tasks described in 

this manual, seek assistance by contacting a clinician, 

equipment provider, distributor, or Customer Support.

WARNINGS - MOTOR VEHICLE TRANSPORTATION:

-  Failure to pay attention to these warnings could result 

in severe injury to the individual in the wheelchair or to 

others.

-  The Permobil Tru-Shape has not been tested for use in a 

motor vehicle.

-  Transfer out of the wheelchair installed with the custom 

seating system and into a manufacturer-installed 

vehicle seat, and use the vehicle’s crash-tested occupant 

restraint system.

-  If the seating system has been involved in an accident 

during transport, see the “Maintenance” section in this 

manual.

CAUTIONS: 

-  Periodically, check the cover and components for 

damage and wear, and replace if necessary.

-  Keep the seating system away from sharp objects.

Intended Use

The Tru-Shape is a custom-made seating system that is made specifically for a wheelchair and designed to meet 

the needs of a specific user.
The Tru-Shape is high-quality urethane foam carved to create an intimate fit with the user for optimal contact 

surface area and improved pressure redistribution. Tru-Shape can be designed as a complete seat and back 

system or as separate seat or back components. 

A clinician who is experienced in seating and positioning, along with a full risk assessment and program of care, should 

determine whether the product is appropriate for the individual’s particular seating needs. The product’s intended use 

statement alone should not be relied upon to make that determination.
The medical products featured in this document are intended to be only one part of an overall care regimen that 

includes all seating and mobility equipment and therapeutic interventions. A clinician who is experienced in seating 

and positioning should identify this care regimen after evaluating the individual’s physical needs and overall medical 

condition.
A clinician should also evaluate for visual, reading, and cognitive impairment to determine the need for caregiver 

assistance or the need for other assistive technology, such as large-print instructions, to ensure proper product use.

Summary of Contents for Tru-Shape

Page 1: ...Tru Shape OPERATION MANUAL ...

Page 2: ......

Page 3: ... CAUTION Indicates not following the specified procedure could lead to potentially hazardous conditions resulting in minor to moderate injury or damage to the equipment or other property Incident Reporting In the event of a serious incident or injury contact Customer Support Symbols Glossary Manufacturer Date of manufacture Consult instructions for use Please Note Supplier These instructions must ...

Page 4: ... or Customer Support WARNINGS MOTOR VEHICLE TRANSPORTATION Failure to pay attention to these warnings could result in severe injury to the individual in the wheelchair or to others The Permobil Tru Shape has not been tested for use in a motor vehicle Transfer out of the wheelchair installed with the custom seating system and into a manufacturer installed vehicle seat and use the vehicle s crash te...

Page 5: ...vers Compatible with Tru Shape Not available in all markets Contact Customer Support COMFORT TEK Cover STRETCH AIR Cover Neoprene Cover Spacer Fabric Cover Breathe 4 Cover Product expected lifetime 5 Years Before Use The custom seating system featured in this document is intended to be only one part of an overall care regimen that includes all seating and mobility equipment and therapeutic interve...

Page 6: ... adjusted properly Check all hardware for wear breakage and tightness Re tighten loose screws bolts DO NOT continue to use the seating system if any part is broken cannot be tightened or is not functioning properly Make sure that all screws of the mounting elements are properly tightened until snug one quarter turn after any adjustments are completed and ensure stability of the wheelchair is check...

Page 7: ...ntact the healthcare provider Make sure that the seating system is securely mounted to the wheelchair and is adjusted properly each time it is in use Check all hardware for wear breakage and tightness weekly Re tighten any screws of mounting elements until snug one quarter turn Weekly check the seating system and components for damage and replace if necessary DO NOT continue to use the seating sys...

Page 8: ...t Specifications in this manual placement of any items between the individual and the air insert 1 may reduce or eliminate the benefits of the product increasing the risk to skin or to other soft tissue and 2 may cause the individual to become unstable and vulnerable to falling WARNINGS continued If the air insert does not appear to be holding air or if you are not able to inflate or deflate the a...

Page 9: ...e user is both immersed in the air cells and supported by the air cells a Slide your hand between the air cells and the user and feel for the user s lowest bony prominences b Refer to the Hand Check Guide below to adjust the air insert Suggestion To help locate the bony prominences while performing a hand check lift and lower the leg The recommended distance between the lowest bony prominence and ...

Page 10: ...d bleach using 1 part household liquid bleach per 8 parts warm 40 C 104 F water Rinse thoroughly with clean water and line dry Let dry completely before use Or Machine wash hot using common laundry detergent and tumble dry low 60C OR Foam Components WITHOUT Vinyl Coating WARNING Disinfectants are NOT effective on porous surfaces such as foam that is NOT coated with a water repellent vinyl DO NOT u...

Page 11: ...foam base Close the inflation valve and place in a large sink Hand wash using mild liquid hand soap hand dish washing liquid laundry detergent or a multipurpose detergent follow product label instructions Gently scrub all surfaces using a soft plastic bristle brush a sponge or a cloth Rinse thoroughly with clean water Let dry completely before use Disinfecting Follow the hand wash instructions usi...

Page 12: ...placed in the foam base Confirm that the air insert is positioned correctly in the foam base After checking all of the above allow the individual at least one hour to adjust to the air insert The air insert slides in the foam base Make sure the hook and loop fastener strips are lined up correctly For correct orientation use the directional labels on the air insert A component is damaged Contact Cu...

Page 13: ...atisfactory Permobil will work to modify and adjust the product to remedy the deficiency If these modifications and adjustments are unsuccessful the customer will be contacted for advisement by Permobil who will determine whether a remake is appropriate and if so will initiate the Remake Request Process A Remake Request Form completed by the ordering ATP is required to begin the remake process Any...

Page 14: ...SE EN GARDE Indique que le non respect de la procédure spécifiée peut conduire à des conditions potentiellement dangereuses entraînant des blessures légères à modérées ou des dommages à l équipement ou à d autres biens Signalement des incidents En cas d incident grave ou de blessure communiquer avec le service à la clientèle Glossaire des symboles Fabricant Date de fabrication Consulter le mode d ...

Page 15: ... clinicien un fournisseur d équipement un distributeur ou le service à la clientèle AVERTISSEMENTS TRANSPORT EN VÉHICULE MOTORISÉ Le fait de ne pas prêter attention à ces avertissements peut entraîner des blessures graves pour la personne dans le fauteuil roulant ou les autres Tru Shape de Permobil n a pas été testé pour une utilisation dans un véhicule motorisé Sortez l utilisateur du fauteuil ro...

Page 16: ...tériaux varieront Housses compatibles avec Tru Shape Non offertes sur tous les marchés Communiquez avec le service à la clientèle Housse COMFORT TEK Housse STRETCH AIR Housse en néoprène Housse en tissu Spacer Housse Breathe 4 Durée de vie prévue du produit 5 ans Avant l utilisation Le système d assise sur mesure présenté dans ce document a pour but d être seulement une partie d un régime de soins...

Page 17: ...l est correctement réglé Vérifiez l usure la rupture et le serrage de la quincaillerie Resserrez les vis ou boulons desserrés Ne continuez PAS d utiliser le système d assise si une pièce est cassée ne peut être serrée ou ne fonctionne pas correctement Après avoir effectué tous les réglages et vérifié la stabilité du fauteuil roulant veillez à ce que toutes les vis des éléments de fixation soient b...

Page 18: ...ystème d assise est fixé de façon sécuritaire sur le fauteuil roulant et qu il est réglé correctement chaque fois qu il est utilisé Vérifiez chaque semaine l usure la cassure et le serrage de la quincaillerie Resserrez les vis des éléments d installation jusqu à ce qu elles soient bien serrées avec un quart de tour supplémentaire Vérifiez chaque semaine que le système d assise et ses composants ne...

Page 19: ...ent de tout article entre la personne et l insert à air 1 peut réduire ou éliminer les avantages du produit augmentant ainsi le risque pour la peau ou d autres tissus mous et 2 la personne peut perdre sa stabilité et tomber AVERTISSEMENTS suite Si l insert à air ne semble pas retenir l air ou si vous ne pouvez pas le gonfler ou le dégonfler consultez la section Dépannage Si le problème persiste ve...

Page 20: ...lisateur est à la fois immergé dans les cellules d air et soutenu par elles a Glissez la main entre les cellules d air et l utilisateur et trouvez les proéminences osseuses les plus basses de l utilisateur b Reportez vous au guide de vérification manuelle ci dessous pour régler l insert à air Suggestion Pour aider à localiser les proéminences osseuses lors d une vérification manuelle soulevez et a...

Page 21: ...umes d eau chaude à 40 C 104 F Rincez abondamment à l eau propre et séchez à l air libre Laissez sécher complètement avant de l utiliser Ou Lavez à la machine à l eau chaude en utilisant un détergent courant et séchez par culbutage à basse température 60C OU Composants en mousse SANS revêtement en vinyle AVERTISSEMENT Les désinfectants NE sont PAS efficaces sur les surfaces poreuses telles que la ...

Page 22: ...ains du détergent liquide pour vaisselle à la main du détergent à lessive ou du détergent à usage multiple suivez les instructions sur l étiquette du produit Frottez doucement toutes les surfaces à l aide d une brosse à poils souples en plastique d une éponge ou d un chiffon Rincez abondamment à l eau propre Laissez sécher complètement avant de l utiliser Désinfection Suivez les instructions de la...

Page 23: ... mousse Vérifiez que l insert à air est correctement positionné dans la base en mousse Après avoir vérifié tout ce qui précède donnez l occasion à la personne de s adapter au moins une heure à l insert à air L insert à air glisse dans la base en mousse Assurez vous que les bandes de fixation autogrippantes sont correctement alignées Pour une orientation correcte utilisez les étiquettes directionne...

Page 24: ...ande le système d assise n est pas satisfaisant Permobil veillera à modifier et à ajuster le produit pour remédier à la défaillance Si ces modifications et ajustements n aboutissent pas le client sera contacté pour avis par Permobil qui déterminera si la refabrication est appropriée et le cas échéant lancera le processus de demande de refabrication Un formulaire de demande de refabrication rempli ...

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Page 28: ...OM TRU SHAPE AMR 2021 06 18 1960 South Calhoun Rd New Berlin WI 53151 USA permobil com ...

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