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 ED01_REV02-2021 IFU CTS-EN

 

 

10- 12 

13.

 

WARRANTY  

Oscar Boscarol warrants the CTS (all models) for a period of 1 year from the date of purchase from the original distributor 

or manufacturer. The company guarantees that the device is  free from defective materials and/or defects due to 

manufacturing processes.  

The warranty does not cover: normal wear and tear of the device, discolouration and any other cosmetic irregularities 

that do not affect the operation of the unit. 

If, during the entire warranty period of 1 year, the product is found to be defective it must be sent to Oscar Boscarol 

S.r.l. (Ltd) with a note describing the defect. Oscar Boscarol S.r.l. (Ltd) will repair or replace at its discretion the defective 

parts and/or the whole unit. All shipping costs are the responsibility of the customer. 

Warranty conditions: 

To benefit from the guarantee, the registration form in the product documentation must be completed and returned 

by post, fax or e-mail to the following address: 

 

OSCAR BOSCAROL SRL 

V. E. Ferrari, 29 - 39100 BOLZANO, ITALY   

Fax: +39 0257760142 - E-mail: 

[email protected] 

 

To validate the guarantee process, the customer must provide evidence of the following documentation: 
1.

 

a copy of the invoice and/or purchase receipt containing the batch  number of the device and the date of 

purchase 

2.

 

confirmation by the manufacturer or a person representing the manufacturer that it is indeed a fault due to 

the production process or defective components since their procurement 

3.

 

absence of tampering, modifications and/or anything not conforming to the original product 

 

In terms of safety, reliability and functionality of the CTS, Oscar Boscarol S.r.l. can only be held liable if: 
1.

 

all technical operations, repairs, modifications and inspections  were carried out by Oscar Boscarol S.r.l.  or an 

authorised service centre 

2.

 

the  device  has  been and is being used  correctly, strictly following the instructions given in these operating 

instructions 

With reference to what is described in these warranty conditions, Oscar Boscarol S.r.l. cannot be held responsible for 

accidental direct or indirect damages, if modifications, repairs, unauthorized technical interventions have been made 

on the device or any of its parts have been damaged by accident or improper use. There are no other express or limited 

warranties of merchantability, fitness or any other kind on the CTS other than those described in this user manual.

 

 

 

 

 

 

Summary of Contents for CTS

Page 1: ...ED01_REV02 2021 IFU CTS EN 1 12 BOSCAROL IMMOBILISATION DEVICES CTS CHILDREN TRANSPORT SYSTEM OPERATING INSTRUCTIONS Medical devices compliant with European Medical Device Regulation 745 2017 ...

Page 2: ...ass I see Annex VIII of the Regulation The medical device meets the safety and performance requirements GSPR described in Annex I of European Regulation 2017 745 Information on these operating instructions This document contains important information for the safe effective and compliant use of the medical device Use the information reported to train users and confirm their training This manual may...

Page 3: ...FORMATION 5 3 IMPORTANT INFORMATION TO KNOW BEFORE USE 5 4 CONTRAINDICATIONS DO NOT USE FOR 6 5 SIDE EFFECTS POSSIBLE DURING USE 6 6 CTS BOSCAROL 6 7 COMPOSITION OF THE DEVICE 7 8 REUSE OF CTS BOSCAROL 8 9 STORAGE OF THE DEVICE 9 10 DEMOLITION OF THE DEVICE 9 11 TECHNICAL SERVICE AND SPARE PARTS 9 12 TECHNICAL DATA AND CONFORMITY FORBOSCAROL CTS 9 13 WARRANTY 10 Note From now on the word CTS will ...

Page 4: ...efully and completely Indicates the need for the user to consult these operating instructions for information such as warnings and precautions that cannot be displayed on the medical device in question CE mark in accordance with European Regulation MDR 2017 745 for medical devices in class I Manufacturer Order number device code Please read the operating instructions in other languages available o...

Page 5: ...Warning about device contamination Immobilization of a child infant on the CTS may be a source of contamination For this reason the device must be cleaned and disinfected after each use to eliminate any residual risk Follow the instructions in this user manual If you have any doubts before sending a device in for repair please contact Boscarol s technical service department by sending an email to ...

Page 6: ...scuers who are not properly trained in the use of CTS can create injury and damage to the patient as well as themselves The application of the device always requires maximum cooperation within the rescue team 4 CONTRAINDICATIONS DO NOT USE FOR CONTRAINDICATIONS Direct contact of the patient s skin injured or intact with the device A sterile drape must always be placed in between to ensure isolatio...

Page 7: ...e which has two specific functions to isolate the baby infant from the synthetic fabric of which the device is made and to retain any organic liquid leaks from the patient thus avoiding contaminating the device and making it difficult to reuse In the case of small or very small people immobilisation of the head or limbs can be carried out before or after laying the patient on the CTS see cervical ...

Page 8: ...g machines as they may damage the surface layers of the CTS and damage the Velcro and polyethylene webbing Attention Do not cut or modify the structure and shape of Boscarol CTS to avoid irreparable damage Washing machines Do not spin the device if machine washed Do not exceed 40 C water temperature Aggressive detergents may alter the colours of the device and damage it Safely remove the drape bet...

Page 9: ...ontact the manufacturer by phone at 39 0471 932893 or by sending an email to info boscarol it 12 TECHNICAL DATA AND CONFORMITY FOR BOSCAROL CTS Classification of the medical device in accordance with MDR 2017 745 I Basic UDI number in conformity with MDR 2017 745 805240088IMMGK Technical specifications Device manufactured to design with technical materials in compliance with REACH Regulation Degre...

Page 10: ...rocess the customer must provide evidence of the following documentation 1 a copy of the invoice and or purchase receipt containing the batch number of the device and the date of purchase 2 confirmation by the manufacturer or a person representing the manufacturer that it is indeed a fault due to the production process or defective components since their procurement 3 absence of tampering modifica...

Page 11: ...ED01_REV02 2021 IFU CTS EN 11 12 NOTES BY THE USER TRAINING ON USE AND REUSE by the user ...

Page 12: ...ED01_REV02 2021 IFU CTS EN 12 12 Printed in Italy by Oscar Boscarol Srl Ltd ED01_REV02 2021 IFU CTS EN Language of editing Italian https www boscarol it ita eifu php ...

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