ED01_REV02-2021 IFU CTS-EN
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9.
STORAGE OF THE DEVICE
Boscarol CTS can be used and stored in the temperature range -10 to +50 °C. At very low or high temperatures, the
material in contact with the patient may become extremely cold or hot, resulting in patient complications
(hypothermia and hyperthermia). Always insert a sterile drape of appropriate thickness and take all necessary
measures to contain these effects and limit them as much as possible.
The CTS must be stored clean and dry. It should be checked periodically for mould, seam damage and the functionality
of the straps and hinges. If stored in a very humid location it should be checked every month by airing it in order to
avoid the formation of mould or other substances that could degrade the device.
10.
DEMOLITION OF THE DEVICE
The device can be dismantled in accordance with national and local regulations for the disposal of plastic and
polyethylene based substances. All materials are REACH compliant and contain no hazardous substances.
11.
TECHNICAL SERVICE AND SPARE PARTS
In the event of a functional failure or if you need additional information regarding reuse and/or storage and transport,
please contact the manufacturer by phone at +39 0471 932893 or by sending an email to [email protected].
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
Degree of protection against ingress of liquids and solids (IEC 529):
IP65 without abrasion or breakage
Risk assessment (technical documentation)
ISO 14971:2019
Service life
5 years from date of manufacture
Dimensions CTS Boscarol
CTS Boscarol
134x57x5 (h) cm
Device weight: 1,5 Kg ±5 %
Conditions of storage and use
Temperature range for transport, use and storage
-10 to 50° C (-33.8 to 122° F)
Humidity range for transport, use and storage
5÷95 % R.H. n.c.
Keep away from direct sunlight
For further technical information or information on the use and storage of the
device, please contact the manufacturer
On all CTS sizes, the tolerance is ±5 cm (due to fitment). On the remaining sizes it is
5%.
Declaration of conformity
The declaration of conformity is kept by the manufacturer together with all
traceability data applicable to the materials and production processes. You can
request a copy from the manufacturer by sending an email to
50° C (122° F)
-10° C (-33.8° F)
