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 ED01_REV02-2021 IFU CTS-EN

 

 

8- 12 

 
 
 
 
 

 

 

BIOCOMPATIBILITY 

The sterile drape placed between the CTS and the patient's body is necessary to prevent 
irritation and skin reactivity due to direct patient contact with synthetic fabrics. In addition, 
it establishes a thermal barrier and limits the release of organic substances.  

 

 
Always check the condition of the patient during all restraint operations and 
during transport to the hospital or nearby rescue centre. The photo opposite 
illustrates the correct use of the device when mounted on a transport 
stretcher equipped with a vacuum mattress. 

 
 

8.

 

REUSE OF CTS BOSCAROL  

The medical device must be cleaned and disinfected after each use. This is particularly important if the patient's 
pathological condition is unknown and direct contamination may be present. The user must always adopt protective 
measures and means to protect his or her own safety. 
The CTS can be washed with water which must not exceed a temperature of 40° C. Never use abrasive metal brushes or 
very hard brushes, which could damage the fabric. If using a washing machine, avoid spinning. 

  

 

Pressure 

washers 

Do not use high-pressure cleaning machines as they may damage the surface layers of the CTS and 
damage the Velcro and polyethylene webbing. 

 

Attention 

Do not cut or modify the structure and shape of Boscarol CTS to avoid irreparable damage. 

 

Washing 

machines 

Do not spin the device if machine washed. Do not exceed 40° C water temperature. 
Aggressive detergents may alter the colours of the device and damage it. 

Safely remove the drape between the CTS and the patient's body.  
Check the condition of the straps, clean the buckles thoroughly. Soak the device in lukewarm water not exceeding 40° 
C with a mild detergent. Clean and remove all substances. If necessary, use a non-abrasive sponge to remove any 
deposits. Remove any traces of blood and/or organic matter left by the patient before disinfecting. Disinfect the CTS 
(entire surface) with products suitable for this purpose (test on one side of the device to ensure no damage). Do not 
use bleach and iron brushes, steel wool or blades of any kind to remove scale. Coloured disinfectants may permanently 
stain the surfaces of the device itself. Before storing the device make sure it is completely dry to prevent mould from 
forming. 

 

Disinfection 

Always comply with local and regional regulations regarding validation of disinfection operations 

 

Sterilisation 

The CTS Boscarol CANNOT be sterilised! 

Sterile towel 

CTS Boscarol 

Patient body 

Summary of Contents for CTS

Page 1: ...ED01_REV02 2021 IFU CTS EN 1 12 BOSCAROL IMMOBILISATION DEVICES CTS CHILDREN TRANSPORT SYSTEM OPERATING INSTRUCTIONS Medical devices compliant with European Medical Device Regulation 745 2017 ...

Page 2: ...ass 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...

Page 3: ...FORMATION 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 ...

Page 4: ...efully 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 o...

Page 5: ...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 ...

Page 6: ...scuers who are not properly trained in the use of CTS can create injury and damage to the patient as well as themselves The application of the device always requires 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 A sterile drape must always be placed in between to ensure isolatio...

Page 7: ...e which has two specific functions to isolate the baby infant from the synthetic fabric of which the device is made and to retain any organic liquid leaks from the patient thus avoiding contaminating the device and making it difficult to reuse In the case of small or very small people immobilisation of the head or limbs can be carried out before or after laying the patient on the CTS see cervical ...

Page 8: ...g machines as they may damage the surface layers of the CTS and damage the Velcro and polyethylene webbing Attention Do not cut or modify the structure and shape of Boscarol CTS to avoid irreparable damage Washing machines Do not spin the device if machine washed Do not exceed 40 C water temperature Aggressive detergents may alter the colours of the device and damage it Safely remove the drape bet...

Page 9: ...ontact the manufacturer by phone at 39 0471 932893 or by sending an email to info boscarol it 12 TECHNICAL DATA AND CONFORMITY FOR BOSCAROL CTS Classification of the medical device in accordance with MDR 2017 745 I Basic UDI number in conformity with MDR 2017 745 805240088IMMGK Technical specifications Device manufactured to design with technical materials in compliance with REACH Regulation Degre...

Page 10: ...rocess the customer must provide evidence of the following documentation 1 a copy of the invoice and or purchase receipt containing the batch number of the device and the date of purchase 2 confirmation by the manufacturer or a person representing the manufacturer that it is indeed a fault due to the production process or defective components since their procurement 3 absence of tampering modifica...

Page 11: ...ED01_REV02 2021 IFU CTS EN 11 12 NOTES BY THE USER TRAINING ON USE AND REUSE by the user ...

Page 12: ...ED01_REV02 2021 IFU CTS EN 12 12 Printed in Italy by Oscar Boscarol Srl Ltd ED01_REV02 2021 IFU CTS EN Language of editing Italian https www boscarol it ita eifu php ...

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