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
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
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:
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