orfit HP PRO 25000/33, HP Pro 25000/26 Instruction 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 3­points 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
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