Boscarol CTS User manual
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BOSCAROL IMMOBILISATION DEVICES
CTS
CHILDREN TRANSPORT
SYSTEM
OPERATING INSTRUCTIONS
Medical devices compliant with European
Medical Device Regulation 745/2017
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PRODUCED BY:
OSCAR BOSCAROL SRL
Via Enzo Ferrari 29
39100 Bolzano
ITALY
Tel. +39 0471 932893
Fax: +39 02 57760140
www.boscarol.it
Information on the manufacturer and the medical device:
•Oscar Boscarol applies a quality management system in accordance with international standards
ISO 13485 and ISO 9001.
•Medical devices in the "Immobilization" category (in all their configurations) comply with European
Regulation MDR 2017/745 and bear the CE marking in accordance with risk class I (see Annex VIII of
the Regulation).
•The medical device meets the safety and performance requirements (GSPR) described in Annex I of
European Regulation 2017/745
Information on these operating instructions:
•This document contains important information for the safe, effective and compliant use of the
medical device.
•Use the information reported to train users and confirm their training
•This manual may not be modified (even partially). Only the manufacturer of the device may make
changes
•These instructions should always accompany the device. We recommend using the electronic
version and making it available on operators' PDAs, tablets and mobile phones.
These operating instructions apply to the following devices:
IMM120050
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EC INDEX
0. MEANING OF SYMBOLS AND PICTOGRAMS ..................................................................................................... 4
0.1. Symbols used in these operating instructions to call the reader's attention.................................................... 4
0.2. Symbols used on the device.............................................................................................................................. 4
1. INTENDED USE ................................................................................................................................................. 4
2. 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. CTS BOSCAROL................................................................................................................................................. 6
7. COMPOSITION OF THE DEVICE......................................................................................................................... 7
8. REUSE OF CTS BOSCAROL................................................................................................................................. 8
9. STORAGE OF THE DEVICE ................................................................................................................................. 9
10. DEMOLITION OF THE DEVICE ........................................................................................................................... 9
11. TECHNICAL SERVICE AND SPARE PARTS ........................................................................................................... 9
12. TECHNICAL DATA AND CONFORMITY FORBOSCAROL CTS................................................................................ 9
13. WARRANTY.....................................................................................................................................................10
Note: From now on the word CTS will be used to indicate and refer to the medical device.
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0. MEANING OF SYMBOLS AND PICTOGRAMS
0.1. Symbols used in these operating instructions to call the reader's attention
Danger: important safety information on the correct use of the CTS to prevent injury to the operator or
patient and/or damage to the device itself
Warnings: information requiring special attention
Notes or information for proper use and to prevent damage to the device or others. Activate the correct
prevention measures
1. List of actions to be performed: follow them step by step
These operating instructions
Required maintenance service (contact the manufacturer and/or its authorised service centres)
0.2. Symbols used on the device
Use the CTS only within the specified temperature range. Using the CTS outside of this range may reduce
its functional performance and damage it.
Limits of use in relation to humidity
Read these operating instructions carefully and completely
Indicates the need for the user to consult these operating instructions for information such as warnings
and precautions that cannot be displayed on the medical device in question
CE mark in accordance with European Regulation MDR 2017/745 for medical devices in class I
Manufacturer
Order number (device code)
Please read the operating instructions in other languages available on the indicated website
Indicates that the CTS is a medical device
Example of medical device UDI-DI and UDI-PI code:
(01) Identification of manufacturer and associated device
(11) Date of production
(20) Product variant
(10) Lot number
1. INTENDED USE
Device name CTS - Children Transport System Boscarol
Primary use A medical device intended to immobilise an infant or young child for the purpose of lifting
and carrying him or her safely on other transport equipment
Other uses Can also be used on healthy patients for the sole purpose of protecting them
Medical purpose Immobilisation and safe transport of the immobilised patient. The device allows the
immobilisation of a patient wearing a cervical collar.
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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
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: raq@boscarol.it
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.
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