orfit HP PRO 25000/33 User manual

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INSTRUCTIONS FOR USE
HP PRO® SOLUTION
OVERLAY BASE PLATE –
PAEDIATRIC 8-16 YEARS
Article No. : 25000/33
A. GENERAL PRODUCT INFORMATION
The product referred to in these instructions is a
medical device used for patient positioning and
immobilisation in radiation therapy. This low
density plate can be used during both the
simulation and treatment stage.
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 BASE PLATE is the basic element
of the ORFIT PAEDIATRIC HP PRO SOLUTION. It is
used in combination with special 3 and 5 point HP
PRO paediatric masks, a cranial stop and a
personalised head rest to form a reproducible
patient positioning and immobilisation device.
The PAEDIATRIC HP PRO BASE PLATE has a narrow
shoulder part specifically designed to immobilise
children from 8 –16 years old in a comfortable and
reproducible way.
C. PRECAUTIONS BEFORE USE
This is a fragile product, please handle with
care. Always place the base plate on a flat
surface. Clear the treatment table of any
debris before positioning the base plate.
Always fix the base plate securely to the
treatment couch before positioning a patient.
More information on how to fix this base plate
to the couch top can be found on our website:
www.orfit.com/en/fixation-devices.
When a robotic arm is used to transfer the
table onto a stretcher with the base plate
attached to it, the base plate should be fully
supported at all times. For safety reasons the
base plate cannot hang over the table past the
‘maximum overhang line’ at the level of the
shoulders. Always verify that the base plate is
attached safely to the table before performing
the transfer.
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.
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.
The maximum patient weight is 135 kg/297Ibs.
Make sure the patient is never mounting on
the base plate by sitting on his or her knees.
This might damage the base plate.
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.
Store the base plate between +10°C (50°F) and
30°C (86°F).
E. PROPERTIES
E.1. Physical Properties
Dimensions (± 0,2 mm):
L 1210 mm x W 540 mm x H 49,4 mm
L 47.64”x W 21.26”x H 1.94”
Weight (± 0,05 kg): 2.37 kg / 5.22 Ibs
The thin head shell is made from carbon fibre with
epoxy. Starting from the neck, the thickness
gradually increases to 30 mm using a foam core

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covered with carbon fibre and epoxy. Edges are
epoxy resin. Other inserts are made from
hardwood/epoxy.
E.2. Mechanical Properties
Max. allowed load at point A (lowest point of head
shell): 35 kg / 77 Ibs
Always take into account the maximum weight
loads!
Sag with 10 kg (point A) is 1,6 mm (± 0,2 mm)
Creep with 10 kg is 0,06 mm/h (± 0,02 mm)
Sag with 20 kg (point A) is 3,16 mm
Creep with 20 kg is 0,12 mm/h (± 0,02 mm)
(tested under laboratory conditions of 21°C)
E.3. Dosimetric Properties
The attenuation and skin build-up depend on the
location on the base plate. The values given below
are for photon therapy.
Location
Attenuation
at 6 MV
(± 0.15 %)
mm H2O
equivalence
(± 0.1 mm)
1
0.98 %
2.2 mm
2 (with profile)
1.52 %
3.3 mm
3
0.81 %
2.9 mm
4
0.45 %
2.9 mm
5
1.07 %
3.5 mm
The water equivalence measured with protons is
the following:
Location
mm H2O equivalence
(± 0.1 mm)
1
2.64 mm
3
4.10 mm
5
3.01 mm
The attenuation factor for high energy proton
beams will be negligible. It is so small that it cannot
be measured.
The Base Plate has areas where higher density
(± 1.4 g/mm³) materials have been used. The
following image shows these areas inside the red
lines. Attenuation factors at 6 MV of the non-metal
inserts range from 8 to 10 %.
Note: Use these numbers as a guidance only.
Perform the measurements again in your
department to verify these results.
F. ACCESSORIES FOR THE BASE PLATE
Various accessories can be used in combination
with the HP PRO base plate, such as:
25000/6: Cranial Back Stop
25000/7: Head Support Indexing Plate
25000/17/A and 25000/17/B: Hand Holds
Information on these accessories can be found in
the respective ‘instructions for use’and on
www.orfit.com.
G. HP PRO THERMOPLASTIC MASKS
Various thermoplastic masks are available in a 3-
points and 5-points version to immobilise head and
neck patients.
To attach the lateral head profiles to the base plate
you have to work in a few steps. First slide the
caudal side of the profile over the indexing pin and
secondly swivel the profile inwards until it clicks
over the base plate.
25000/33
High density
areas
A
Max. overhang 383,5 mm from cranial end
(shown on base plate)
1
3
4
5
2

Note:
The instructions were written in accordance with the European Directive 93/42/EEC for Medical Devices. It is prohibited to make alterations to this text without prior approval from Orfit Industries.
EFFICAST® and HP PRO® are registered trademarks of Orfit Industries
www.orfit.com
Ref. No. 50182
VERSION 2
LAST UPDATE: 31/01/2019
REVISION DATE: 31/01/2021
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Attaching a lateral profile to the base plate:
Removing a lateral profile from the base plate:
The cranial head profile and the shoulder profiles
simply click onto the base plate.
If the patient has medium to long hair it is helpful
to add a hair cover. This will automatically clear the
areas where the mask profiles must be attached. It
provides more time to mould the mask and
prevents hair getting stuck in between the mask
profile connection.
Different shapes and sizes are available both in
Efficast and Nanor. The profiles are made from
Polycarbonate (PC).
H. MAINTENANCE AND WASTE MANAGEMENT
This product can be cleaned and disinfected by
means of soapy water or an isopropanol based
disinfectant, applied with a soft cloth. If unsure
about the cleaning fluid, do not use. Never use
aerosol sprays, corrosive cleaning agents, solvents
or abrasive detergents.
Periodic checks of the product should be done to
insure the parts are not worn and require repair or
replacement. Do not attempt to make repairs
yourself. Contact your distributor if there are any
questions or concerns.
The product can be disposed of with household
waste.
Periodic checks of the following parts is extremely
important in order to safeguard a good fixation of
the mask to the base plate:
The holes where the mask profiles click into.
The guidance ribs to position the mask profiles.
The pin to attach the inferior part of the profile
to the base plate.
The profile of the mask.
I. ADDITIONAL INFORMATION
For additional information such as distributor
contact information, product brochures, Safety
Data Sheets and regulatory information, please
visit our website www.orfit.com.
Step 1: pull handle
Step 1: Slide
Step 2: Turn
CLICK
Step 2: Turn & slide