orfit AIO SOLUTION P-LD-PED User manual

INSTRUCTIONS FOR USE
THE AIO SOLUTION®
PEDIATRIC BASE PLATE
IN CARBON FIBRE LAMINATE
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AIO SOLUTION®code:
P-LD-PED
Article No. : 32301-PED
A. GENERAL PRODUCT INFORMATION
The products referred to in these instructions are medical
devices, used for patient positioning and immobilisation in
radiation therapy.
B. PRODUCT DESCRIPTION
This carbon fibre laminate BASE PLATE, used for the
treatment of both children and adults, is the basic element
of "THE TOTAL AIO SOLUTION®TREATMENT
PACKAGE”. It is used in combination with THE AIO
SOLUTION®CUSHIONS, the RAYCAST®HIGH
PRECISION HEAD SUPPORTS and BLOCKS &
WEDGES, and with the EFFICAST® PRE-CUTS to form a
reproducible patient positioning and immobilisation device.
Information on these other parts can be found in the
respective ‘instructions for use’.
C. PRECAUTIONS FOR USE
This is a fragile product, please handle with care. Always
place the base plate on a flat surface.
Always fix the base plate securely to the treatment couch
before positioning a patient. More information on how to fix
this base plate to a couch top can be found on our website
http://www.orfit.com/en/fixation-devices/.
If the base plate is used in overhang over the couch a
Table Fix (art. no. 35744/6) or iBeam couch fixation (art. no.
32813) needs to be used at the caudal end to secure the
base plate to the couch top. This prevents the base plate
from falling off the table when the patient moves.
The CFL 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.
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 40°C
(122°F).
E. PROPERTIES
E.1. Physical Properties
Dimensions: L 1350 mm x W 544 mm x H 30 mm
Weight : 3,630 kg
E.2. Mechanical Properties
Bending:
The bending (sag) Δ Lw of the AIO base plate (measured
between the two positioning holes of the head support, at
323 mm from the ‘maximum overhang line) can be
calculated using the next equation:
Δ Lw = 0,07695W + 0,04889, where
Δ Lw is the displacement of the plate (mm)
W is the vertical force (weight), exerted at the measuring
point (kg)
SD: ± 0,017 mm

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E.3. Dosimetric Properties
Attenuation factor (± 0,15 %)
6 MV
1.4%
10 MV
1.2%
H2O equivalence
4 mm
Note: Use these numbers as a guidance only. Perform the
measurements again in your department to verify these
results.
F. 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.
G. 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.
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.
THE AIO SOLUTION®is a registered trademark of ORFIT Industries
Ref. No. 31954 - 32301-PED AIO.doc
VERSION 3 - LAST UPDATE: 01/12/2014 - REVISION DATE: 01/12/2016
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