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INSERTO SEAT DOMINO
This Technical Sheet is to be intended as an integral section of the Inserto Seat Range Instruction Manual.
Before use, it is essential for the professional operator to explain all procedures for a correct commissioning and
a proper maintenance.
1.
Commissioning
The pelvis positioning system Inserto Seat Domino of Inserto seat Range comes in a form of a kit:
1)
A structural kit composed by a flat base of construction and 17 closed cells polyethylene inserts, modular
and configurable, useful to individually support or correct the posture of the pelvis during the life time use;
2)
A kit of padding (Free Shapes) composed as follows:
- in the posterior part by two overlapped pads: one superior pad made of an open celled foam with low spring
back action to enhance the maximum comfort and the best adaptation as to the body shapes weather to the
structural kit and an inferior pad of anti-decubitus memory foam for the highest protection from decubitus sores.
- in the anterior part by two independent pads (RH side and LH side) made of an open celled foam with low
spring back action to allow a natural position of the thighs.
3)
A cover, air-exchange and incontinent at the same time, made of three layers of different materials, latex
free, not flammable and at a low risk of skin irritation, commonly used in medical devices applications.
The pelvis positioning system Inserto Domino is recommended preferably, but not exhaustively, for users with
limited mobility, affected by severe deformities and having very high necessity of a postural containment, in
particular:
-
Those who have leg length discrepancies, wind-swept, pelvic obliquity, pelvis rotation, anterior and posterior
pelvis tilt,adduction and abduction of the legs, of severe entities;
-
Those who need to stabilise the ischium;
-
Those who need trocantheric coccygeal-sacral suspension;
-
Those having high risk to develop decubitus sores;
-
Those who need to balance and contain legs/pelvis/rachis/ relationship system.
The pelvis positioning system Inserto Domino can be combined, by means of an adhesive gripping tape, to any
supporting base and/or wheelchair, provided that the structure will host the positioning system is solid enough
to safely support the user during the use.
Once the modifications have been completed, such as removals, for the preparation and configuration
as per prescription of the seat individually customised to the perfect reconstruction of the anatomic
shape, the seat itself cannot be used by other users.
PRODUCT TECHNICAL SHEET
www.versainserto.com
PRODUCT TECHNICAL SHEET
Page
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Summary of Contents for versa INSERTO SEAT DOMINO Series

  • Page 1 www.versainserto.com PRODUCT TECHNICAL SHEET INSERTO SEAT DOMINO This Technical Sheet is to be intended as an integral section of the Inserto Seat Range Instruction Manual. Before use, it is essential for the professional operator to explain all procedures for a correct commissioning and a proper maintenance.
  • Page 2 www.versainserto.com PRODUCT TECHNICAL SHEET The Positioning System Inserto Seat Domino, in its design integrit and numerical and dimensional completeness of the supplied components (structural kit, padding kit, cover) can be easily adapted to sizes/morphology/ deformities of the user. This kind of operations make the commissioning referable to a serial manufacturing device.
  • Page 3 www.versainserto.com PRODUCT TECHNICAL SHEET In order to do so: remove the adhesive film and stick the tape firmly on the insert to attach. Therefore, check for the correct placement. If it is correct remove the tape, taking care to heat the adhesive part for few seconds by using an industrial hot hair dryer at temperature of around 100°...
  • Page 4 www.versainserto.com PRODUCT TECHNICAL SHEET suggested to keep the part of material removed, if not damaged, as occasionally, afterwards can be reused to adapt the device to user’s changes. Alternatively it can be suitable a placement of the inserts on the flat base of construction (8) by removing the exceeding inserts;...
  • Page 5 www.versainserto.com PRODUCT TECHNICAL SHEET INDICATIONS FOR THE WIDTH OF THE SEAT It is possible to reach the desired seat width by operating only on the flat base of construction (8) (see point a), or on the flat base of construction and consequently on the inserts of the structural kit (see point b), or on the inserts of the structural kit only (see point c).
  • Page 6 www.versainserto.com PRODUCT TECHNICAL SHEET Cover the structural kit with the padding by adjusting it as shown in Pic. 3. Place the cover back onto the structure. There are elastic sides that can be securely positioned by pulling the drawstring provided. Once the pelvis positioning system has been assembled, have the user to be seated at least for one hour and verify if the new seat is causing pressure redness on the skin.
  • Page 7 Below it is reported the description of the product as it is shown on the CE Label: The complete name of the device is: Seat VERSA INSERTO DOMINO size Xx The name of the product shown on the label is: VERSA INSERTO D. size Xx where D stays for Domino MANUFACTURED BY: COMPANY CERTIFIED WITH QUALITY MANAGEMENT SYSTEM ISO 9001 / EN ISO 13485 BY BUREAU VERITAS S.P.A.
  • Page 8 www.versainserto.com INSTRUCTION MANUAL Via Montagna Z.I. Lotto 41 c.a.p. 72023 Mesagne (BR) - ITALY Tel . (+39) 0831.777840 - Fax . (+39) 0831.730739 Sito web: www.promedicare.it - e mail: sales@promedicare.it...
  • Page 9 www.versainserto.com Index 1 OPERATING INSTRUCTIONS 1.1 Packing and transportation Pag 04 1.2 Placing into service Pag 04 1.3 User instructions Pag 05 1.4 Processing instructions Pag 06 2 GENERAL WARNINGS 2.1 User warnings Pag 07 3 ADVERSE COLLATERAL EFFECTS Pag 09 4 RESTRICTIONS OF USE Pag 09 5 ADAPTATIONS WITH STRUCTURAL CHANGES AND/OR...
  • Page 10 Introduction Thank you for choosing the VERSA pelvis positioning system INSERTO which is a combination of technology and experience in the development of positioning systems for disabled people. “Inserto seats” pelvic positioning system, can simply be adapted to the user as needed.
  • Page 11: Placing Into Service

    www.versainserto.com For an appropriate after-sale monitoring the device, or in the event of an accident during the use, please refer to the instructions stated in the relevant chapter. CLINICAL INFORMATION/DESTINATION OF USE The clinical information of medical device are written in the technical data sheet attached OPERATING INSTRUCTIONS Packaging and trasportation The original package contains the following components :...
  • Page 12: User Instruction

    www.versainserto.com User Instruction “Inserto seat” positioning system, set up and configured by the professional operator under his responsibility, in accordance with the characteristics of design defined by the professional operator for the specific user, is ready for use, after the check of the color of the skin. If an individual custom seat has been prepared and set up as prescribed, it can not be used by other user.
  • Page 13: Processing Instructions

    www.versainserto.com Processing Instructions In order to guarantee safe use and a long lasting performance of the pelvis positioning system, please find below advice for the user and/or caregiver: • carefully follow all instructions reported in this manual and in the technical sheet of the product; •...
  • Page 14: General Warnings

    www.versainserto.com GENERAL WARNINGS All warnings reported in this section describe the conditions and situations which may cause danger to end user. Please read carefully before putting the positioning system into the service. For an appropriate use of the device some operations, such as the starting and the making of adjustments, must be done exclusively by an authorised clinical professional or dealer - normal operations can be performed by the user or by his or her caregiver/attendant The professional operator is, a person who by virtue of his professional qualification is authorised...
  • Page 15 www.versainserto.com ( B ) some environmental conditions may affect the positioning seat system and their functionality and performance, so, please: • avoid exposure to extreme temperatures; • avoid long exposure to direct sunlight. 2) Standard maintenance/cleaning It is recommended to perform a careful cleaning and a standard maintenance every 2 weeks. It is also advisable to check all parts of the positioning system in order to avoid malfunctions.
  • Page 16: Restriction Of Use

    RESTRICTION OF USE The VERSA range of INSERTO seats has been designed and constructed to provide the end user the correct positioning support within the normal activities of daily working life, social relations, school and leisure time. Any other use may jeopardize the system.
  • Page 17: Performance And Durability

    PERFORMANCE AND DURABILITY PRO MEDICARE S.r.l. ensures that its production line “VERSA”, specifically “INSERTO SEAT” was designed and built in compliance with safety regulations as stated in the relevant directive 93/42/CEE. The performances provided by the above-mentioned devices, used individually or in combination, are suitable and responsive to the design destination aimed to the positioning for users with mobility limits.
  • Page 18: Warranty

    www.versainserto.com WARRANTY PRO MEDICARE S.r.l. warrants functionality for a maximum period of 24 months, covering all manufacturing defects from the first use and 12 months on covers and components replaced under special maintenance from the first date of service installation. The warranty is valid provided that the device is used as shown in this instruction manual.
  • Page 19 www.versainserto.com MONITOR OF AFTER-SALE INCIDENTS PRO MEDICARE S.r.l. ensures that their medical device products are produced within strict compliance with the criteria and requirements established by the relevant National EU rules and give adequate security of operation in the conditions required by Directive N° 93/42/EEC and subsequent amendments and additions for after-sale monitoring.
  • Page 20 Annex 1 Clinical Professional / Authorised Dealer:_________________________________________ Address:________________________________City:______________________________ State:_______Post Code#:_____________tel:__________________fax:_______________ Base:_____________________________________ Serial #:_________________________ Versa system:__________________________________ Serial #:_____________________ Order Details: Invoice #_______________________________Date: __________________ Shipping Doc. #:__________________________________ Date: ____________________ Malfunction: ________________________________________________________________ ___________________________________________________________________________ _________________________________________________________________________ Component to replace : ____________________________________Quantity: ___________ Note:_____________________________________________________________________ _________________________________________________________________________ Cause of Intervention: _______________________________________________________...
  • Page 22 Annex 2 - Monitor of any after-sale incidents Clinical Professional / Authorised Dealer:_________________________________________________ Address:________________________________City:______________________________________ State:_______Post Code#:_____________tel:__________________fax:_______________________ Base:_____________________________________ Serial #:________________________________ Versa system:__________________________________ Serial #:____________________________ Order Details: Invoice #_______________________________Date: _________________________ Shipping Doc. #:__________________________________ Date: ____________________________ Date of incident: __________________________________________________ ____ __________ _ __ Description of incident: ______________________________________________________________ __________________________________________________________________________________ Causes (accidental, collision, not correct operation, structural failure, etc.)______________________...
  • Page 23 COMPANY CERTIFIED WITH QUALITY MANAGEMENT SYSTEM ISO 9001 / EN ISO 13485 BY BUREAU VERITAS S.P.A.

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