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 ED01_REV03-2021 IFU HEAD IMMOBILIZER-ENG

 

 

8 - 12 

have no experience, skill and expertise. Normally the number of rescuers for these operations is two. Below are the 
operations necessary for the immobilization of the head: 

1.

 

Always warn a conscious patient about what we are doing and calm them down as much as possible 

2.

 

One rescuer manually stabilizes the patient's head and neck (to which the cervical collar had previously been 
applied  correctly). These instructions do not deal with the application of the collar that refers to other 
manufacturers and user manuals 

3.

 

The second rescuer applies a sterile sheet on the head immobilizer (both models) that will serve to isolate the 
head and the skin from the device itself and avoid any allergies or irritations. Then apply the device by slightly 
raising the patient's head and insert the head immobilizer (applies to both the WIND and OB version) 

4.

 

Make sure the base is centered relative to the patient's head 

5.

 

Now if you are using the WIND head immobilizer it is enough to raise the two wings and apply the two chin 
guards respectively to fix the chin and forehead. In the OB head immobilizer, it is enough instead to apply the 
two wedges on the Velcro of the base, taking care not to tighten the head excessively (the wedges must be 
adherent)  

 
 
 
 
 

 

 

BIOCOMPATIBILITY 

Sterile sheet placed between the head immobilizer and the patient's head is necessary to 
prevent skin irritation and reactivity due to the patient's direct contact with PVC (WIND) or 
vinyl paint applied to the surface of the device (OB). It also establishes a thermal barrier in 
case the temperature of the device is very high or very low 

 

6.

 

Always check the patient’s condition  during all immobilization operations and during 
transport to the 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 and direct contamination maybe present.   
The user must always take protective measures and means to protect his or her safety. 
OB and WIND head immobilizers must be washed with water not exceeding 40°C of temperature. Never use metal or 
very hard abrasive brushes that could ruin the fabric and coating of PVC. 

  

 

Pressure washer 

Do not use high pressure washers that could damage the surface layers of the head immobilizer 
and damage Velcro and polyethylene flaps 

 

Attention 

Do not cut or change the structure and shape of Boscarol head immobilizer so as not to damage 
it irreparably

 

 

Remove the sheet that was placed between the patient's head and the device and discard it. After separated the 
wedges (by removing from the Velcro strap), the chin guards and the fasten belts of the OB head immobilizer (the 
WIND head immobilizer is composed of a single piece) clean and remove with the use of water all the substances 
present. If necessary, use a non-abrasive sponge to remove any fouling. Before proceeding with disinfection remove 
any traces of blood and/or organic  left from  the  patient. Disinfect the head immobilizer (the  entire  surface)  with 
substances suitable for that purpose (do a test on one side of the device to check does not damage). Do not use bleach 
and iron brushes, steel wool and blades of any kind to eliminate fouling. Colored disinfectants could irreparably stain 
the surfaces of the device itself. Before storing the device, make sure it is completely dry to avoid mold forming on the 

Sterile sheet

 

Head immobilizer

 

Head of the patient 

 

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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