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 ED01_REV03-2021 IFU HEAD IMMOBILIZER-ENG

 

 

5 - 12 

Application part in the 

human body 

Patient's head 

Type of patients 

Children and adults of both genders starting from 25 Kg 

Application time on 

the same patient 

"Short-term" use (maximum 30 days of consecutive use) 

 

 

Usage 

information 

 

Boscarol head immobilizer (OB model and WIND model) can be used on all types of patients, 
excluding those under 25 kg in weight due to head size which may be too small 

 

It can be used simultaneously with the cervical collar and other immobilization and transport 
systems such as the scoop stretcher or spinal stretcher 

 

Immobilization of a patient's head with injuries of various kinds must be carried out by 
professional rescuers, trained and aware of the specific technologies of immobilization and 
transport of patients 

 

It is recommended to use the head immobilizer with at least two trained rescuers 

2.

 

WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION 

 

Read carefully 

These operating instructions were prepared using simple and easy-to-understand language. If you 
have difficulty interpreting  these instructions, please contact the manufacturer for further 
clarification.

 

 
Phone +39 0471 93 28 93 

[email protected]

 

 

 

 

LATEX 

Boscarol head immobilizers are made without the use of latex. The materials used are latex-free, 
but it is not excluded that along 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 
manual. 
If you have any concerns or before sending a device for repair, contact Boscarol Technical Service 

by emailing [email protected]

 or c39 0471 932893 

3.

 

IMPORTANT INFORMATION TO KNOW BEFORE USE 

Boscarol head immobilizer has been designed or tested to comply with the requirements imposed by the European 
Medical Devices Regulation 745/2017. WIND and OB head immobilizers are medical devices in class of risk I 

 

If the user or patient becomes aware of a user hazard, a side effect, an accident caused by 
the device or a criticality (operational and constructive) not dealt with in these instructions 
for use, he must immediately report it to the manufacturer at the email address: 

[email protected]

 

 

PERIODIC 

SAFETY 

INSPECTION 

Preventive maintenance and

 

periodic safety inspection: 

Boscarol  head immobilizer  must  be  checked  periodically (full functional verification is 
recommended at  least once a week) especially on removable parts  and on Velcro 
attachments that allow the fixing of the side wedges, the chin guards and fastening straps. 
In the event of a failure, you must contact the manufacturer or replace them asap 

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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