orfit HP PRO 25000/28 Instructions For Use

HP PRO® EXTENSION WITH
CLAMP INTERFACE –
PAEDIATRIC 0-7 YEARS - TYPE 2
Article No. : 25000/28
A. GENERAL PRODUCT INFORMATION
The product referred to in these instructions is a
medical device, used for paediatric patient
positioning and immobilisation in radiation
therapy. This low density base plate is suitable
for proton as well as photon treatments.
This product may only be used in combination
with immobilisation masks produced by Orfit.
Orfit prohibits the use of unauthorised third-
party products in conjunction with its own
products.
B. PRODUCT DESCRIPTION
This carbon fibre extension BASE PLATE is the
basic element of the ORFIT® PAEDIATRIC HP
PRO® SOLUTION and can be used for children
between 0 and 7 years old. It is used in
combination with special 3 and 5 points
PAEDIATRIC HP PRO masks, a cranial stop and a
personalised head rest to form a reproducible
patient positioning and immobilisation device.
Information on these other parts can be found in
the respective 'instructions for use' and on
www.orfit.com.
The PAEDIATRIC HP PRO® BASE PLATE has a
narrow shoulder part and is shorter in the neck
area. This allows to properly immobilise children
from 0-7 years old in a comfortable and
reproducible way.
C. PRECAUTIONS BEFORE USE
•
This is a fragile product, please handle with
care.
•
Use this base plate as an extension only.
•
Always fix the extension securely to the couch
before positioning a patient or additional
equipment. More information on how to fix
this extension to the couch top can be found
in this document.
•
Have the patient sit on the pedestal area first
and then slide towards the extension. Make
INSTRUCTIONS FOR USE
sure the patient is never mounting on the
base plate by sitting on his or her knees. This
might damage the base plate.
•
Take into account the maximum weight loads.
•
The carbon fibre base plate is constructed to
be light in weight. When handled roughly, it
may get damaged and fibres may come off.
When this happens, stop using the base plate
to prevent fibres from getting in contact with
the patient's or user's skin. Contact your
distributor.
•
Do not use the extension after it had a severe
collision with the ground, wall/door or other
device in the room. A collision might
compromise the strength of the internal
structure and could result in failure.
•
The article number and lot number can be
found on the back of the base plate. They are
mentioned on the bottom side of the plate in
between 2 indexing holes at the edge.
•
In case there are any uncertainties about the
safe use of this extension, contact your
distributor.
D. STORAGE
Always store the product in a safe place to
prevent it from getting damaged. Take care not to
damage the edges of the plate when storing it in
an upright position. Prevent hard objects from
falling onto the plate. Do not place any items on
top of the extension while in storage.
Store the base plate between +10°C (50°F) and
40°C (104°F).
E. PROPERTIES
Physical Properties
E.1
Outer dimensions : L 1107 x W 530 x H 58 mm
Weight
Page 1 of 4
: L 43.58" x W20.86" x H 2.28"
: 7,76 kg / 17.11 Ibs