Boscarol CTS Operating Instructions Manual Download | Manualshive

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ED01_REV02-2021 IFU CTS-EN

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BOSCAROL IMMOBILISATION DEVICES

CTS

CHILDREN TRANSPORT

SYSTEM

OPERATING INSTRUCTIONS

Medical devices compliant with European
Medical Device Regulation 745/2017

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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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