ED01_REV02-2021 IFU CTS-EN
5- 12
Part of application in
the human body
Entire body of the patient
Type of patients
Children and infants up to 15 kg
Time of application on
the same patient
Short-term use (maximum 30 days of consecutive use)
Information
on use
•
CTS Boscarol can be used on all types of children and infants (up to a maximum weight of 15 kg)
•
Can be used in conjunction with cervical collar and other related medical devices
•
The immobilisation and transport of a patient should always be carried out by professional
rescuers who are trained and knowledgeable about specific patient immobilisation and transport
technologies.
•
It is recommended to use the CTS with at least two trained rescuers
2.
WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION
Read carefully
These operating instructions have been prepared using simple, easy-to-understand language. If
you have difficulty in interpreting what is written, contact the manufacturer for further
clarification.
Phone +39 0471 93 28 93
info@boscarol.it
LATEX
Boscarol CTSs are manufactured without the use of latex. The materials used are latex-free,
however, it cannot be excluded that during the entire production chain they may have come into
contact with latex.
DEVICE
CONTAMINATE
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
or by c39 0471 932893
3.
IMPORTANT INFORMATION TO KNOW BEFORE USE
The Boscarol CTS has been designed and tested to comply with the requirements imposed by the European Medical
Device Regulation 745/2017. The Boscarol CTS is a medical device of risk class I
If the user or patient becomes aware of a danger in use, a side effect, an accident caused
by the device or a critical issue (operational and design) not covered in these instructions
for use, he must immediately report this to the manufacturer at the following e-mail
address:
PERIODIC
SAFETY
INSPECTION
Preventive maintenance and periodic safety inspection:
The Boscarol CTS device must be checked periodically (a full functional check at least once a
week is recommended), especially on the removable parts and the fixing straps. In the event
of a malfunction, contact the manufacturer or replace the device.
LIFETIME
The Boscarol CTS has a lifetime of
5 years
from the date of purchase if stored and used in
accordance with these instructions.
