ED01_REV03-2021 IFU HEAD IMMOBILIZER-ENG
9 - 12
PVC.
Disinfection
Always comply with the provisions of local and regional provisions about the correct disinfection
operations
Sterilization
Boscarol OB and WIND head immobilizers cannot
be
sterilized
9.
DEVICE STORAGE
Boscarol head immobilizers can be used and stored in the temperature range between -10 and 50° C. With very low
or too high values the material in contact with the patient could become extremely cold or hot causing complications
to the patient (hypothermia and hyperthermia). Always insert a barrier of appropriate thickness and equip all the
necessary measures to contain these effects to reduce any consequently risk.
The head immobilizer must be stored clean and dry. It must be periodically checked to avoid mold, damage due to
bending and leakage on the welds. If stored or in very humid places it must be checked either every month airing it or
to avoid the formation of mold or other substances that could degrade the device.
10.
DEMOLITION OF THE DEVICE
The device may be scrapped in accordance with national and local guidelines for the disposal of substances based on
PVC, foam and polyethylene. The inner cardboard can be disposed of in the appropriate containers for recycling
purposes. All materials comply with REACH and do not contain dangerous substances.
11.
TECHNICAL SERVICE AND SPARE PARTS
In the event of a functional failure or if auxiliary information is required regarding reuse and/or storage and transport
operations, please contact the manufacturer at +39 0471 932893 or by sending an email to
12.
TECHNICAL DATA AND COMPLIANCE FOR BOSCAROL
HEAD IMMOBILIZERS
Classification of medical devices (in accordance with MDR 2017/745)
I
Basic UDI number (in conformity a MDR 2017/745)
805240088IMMGK
Technical specifications
Device produced on design with technical materials
compliant with REACH Regulation
Degree of protection against the ingress of liquids and solids
(
IEC 529):
IP65 in the absence of abrasion or breakage
Risk assessment (technical documentation)
ISO 14971:2019
Lifespan
5 years from the date of manufacture
Dimension
head immobilizer
Fermacapo Boscarol WIND
40x30.5x16 (h) cm (with wings
raised)
Device weight: 1.28 kg
Fermacapo Boscarol OB
42.5x26.5x16 (h)
Device weight: 0.92
kg
Conditions of preservation and use
Temperature range for transport, use and storage
-10
to 50° C (from -33.8 to
122° F)
Humidity range for transport, use and storage
5÷95 % U.R. not condensed
50 C (122° C)
-10° C (-33.8° C)
