Boscarol IMM121628 Operating Instructions Manual Download Page 11 | Manualshive

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ED01_REV03-2021 IFU HEAD IMMOBILIZER-ENG

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Summary of Contents for IMM121628

Page 1: ...MMOBILIZER ENG 1 12 BOSCAROL IMMOBILIZATION DEVICES WIND AND OB HEAD IMMOBILIZER OPERATING INSTRUCTIONS WIND HEAD IMMOBILIZER OB HEAD IMMOBILIZER Medical devices compliant with the European Regulation on Medical Devices 745 2017 ...

Page 2: ... VIII of the Regulation The medical device meets the safety and performance requirements GSPR described in Annex I to the European Regulation 2017 745 About these operating instructions This document contains information that is important for safe effective and compliant use of your medical device Use the information below to train users and confirm their training It is not allowed to modify even ...

Page 3: ...WARNINGS PRECAUTIONS AND IMPORTANT INFORMATION 5 3 IMPORTANT INFORMATION TO KNOW BEFORE USE 5 4 CONTRAINDICATIONS DO NOT USE FOR 6 5 SIDE EFFECTS POSSIBLE DURING USE 6 6 FERMACAPO BOSCAROL 6 7 COMPOSITION OF DEVICES 7 8 REUSE OF BOSCAROL HEAD IMMOBILIZER 8 9 DEVICE STORAGE 9 10 DEMOLITION OF THE DEVICE 9 11 TECHNICAL SERVICE AND SPARE PARTS 9 12 TECHNICAL DATA AND COMPLIANCE FOR BOSCAROL HEAD IMMO...

Page 4: ...ge limits Read these operating instructions carefully and completely Indicates the user s need to consult these operating instructions for the presence of information such as warnings and precautions that cannot be displayed on the medical device CE mark in accordance with the European MDR Regulation 2017 745 for medical devices in class I of risk Manufacturer of the medical device Order number de...

Page 5: ...g the entire production chain they may have come into contact with substances or traces of latex Contaminated device Warning in case of contamination of the device immobilization of the patient s head on the head immobilizer may be a source of contamination For this reason after each use the device must be cleaned and disinfected to eliminate any residual risk Follow the instructions in this user ...

Page 6: ...ovisions on safety at work use of PPE Rescuers not properly trained to use the head immobilizer can create wounds and damage to the patient as well as to themselves The application of the device always provides for 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 It is mandatory to...

Page 7: ...ickness coated with a thin layer of foam that guarantees structural rigidity The two chin guards are identical and are used to ensure that the forehead and chin are good fastened to the device OB HEAD IMMOILIZER Boscarol head immobilizer type OB available in two versions that differ only in color yellow or black while maintaining the functional characteristics of the WIND model it is realized with...

Page 8: ... hospital or nearby rescue center The photo on the side illustrates the correct use of the immobilizer WIND applied to a patient already equipped with a cervical collar 8 REUSE OF BOSCAROL HEAD IMMOBILIZER After each use it is necessary to proceed with the cleaning and disinfection of the medical device These operations are of greater importance if the patient s pathological condition is not known...

Page 9: ...foam and polyethylene The inner cardboard can be disposed of in the appropriate containers for recycling purposes All materials comply with REACH and do not contain dangerous substances 11 TECHNICAL SERVICE AND SPARE PARTS In the event of a functional failure or if auxiliary information is required regarding reuse and or storage and transport operations please contact the manufacturer at 39 0471 9...

Page 10: ...form in the product documentation must be completed and returned by post fax or e mail at the following address OSCAR BOSCAROL SRL V E Ferrari 29 39100 BOLZANO ITALY Fax 39 0257760142 Email info boscarol it To validate the warranty process the customer must provide evidence of the following documentation 1 copy of the invoice and or purchase receipt containing the lot number of the device and the ...

Page 11: ...ED01_REV03 2021 IFU HEAD IMMOBILIZER ENG 11 12 ...

Page 12: ...ED01_REV03 2021 IFU HEAD IMMOBILIZER ENG 12 12 Printed in Italy by Oscar Boscarol Srl Ltd ED01_REV03 2021 IFU HEAD IMMOBILIZER ENG Language of editing English https www boscarol it ita eifu php ...

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