orfit AIO 3.0-SBRT User manual

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INSTRUCTIONS FOR USE
AIO 3.0 - SBRT
PRESSURE SYSTEM BRIDGE LOW
–HEXAPOD™COMPATIBLE
Article Nos. : 38240
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 product
can be used during both the simulation and the
treatment stage, including MRI simulation.
To attain an optimal result, it is recommended to
use this product in combination with Orfit
immobilisation products.
B. PRODUCT DESCRIPTION
This arch is used as a compression device for the
abdomen. It clamps onto the AIO 3.0 SBRT
compatible and HexaPOD™compatible base plates
ref. 38019, 38020 & 38021. The compression plate
is screwed downwards to reach the desired
pressure on the abdomen and as such immobilise
the abdomen. Information on these other parts
(and instructions on how to make the masks) can be
found in the respective ‘instructions for use’ and on
www.orfit.com.
C. PRECAUTIONS FOR USE
•This is a fragile product, please handle with
care.
•Make sure the device is securely locked
onto the AIO 3.0 SBRT compatible
HexaPOD™compatible base plates ref.
38019, 38020 & 38021 on both sides.
•The pressure system bridge can only be
used with the AIO 3.0 SBRT compatible and
HexaPOD™compatible base plates ref.
38019, 38020 &38021. This bridge is not
compatible with the other AIO 3.0 SBRT
base plates.
D. INSTALLATION
1. Position the arch in the highest position by
opening the locks (A) on both sides and moving
the arch vertically upwards to position 5. Close
the locks again. (Figure 1)
Figure 1
2. Position the screw in the highest position by
opening the locking system, pulling the screw
upwards and closing the locking system again.
(Figure 2)
Figure 2
3. Place the pressure plate (32317/2/12) in the
correct position on the abdomen of the patient.
Be aware that the plate does not exercise
pressure on the xiphoid process or ribs to
prevent fractures. (Figure 3)
Figure 3

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4. Position the arch on the baseplate so the screw
will touch the pressure plate once you screw it
down. Attach the arch to the base plate by
opening the clamps (B) on both sides. The arch
indexes onto the round holes on top of the
base plate and clamps underneath the thin
edge. For repositioning purposes write down
the location of the arch. The different locations
are numbered on the base plate E1 to E26.
(Figure 4)
Figure 4
5. !! Note that the arch can be positioned with the
screw facing the caudal end of the base plate
and also the other way around with the screw
facing the cranial end of the baseplate. Choose
the correct position so the arch is located
outside of the treatment field.
6. Move the arch vertically downwards until the
screw touches the pressure plate by opening
the locks (A) on both sides. When you have
reached the correct position, close the locks
again.
When releasing the lock handles make sure to
hold the frame to prevent it from sliding down
on the patient.
Figure 5
7. Fasten the screw until you have reached the
desired pressure or height on the abdomen. If
the standard screw doesn’t reach deep enough,
switch to the longer screw.
Figure 6
8. The height of the screw can be read from the
ruler (Figure 7) or measured for future
reference.
Figure 7
9. Make sure to note all indexing positions of the
arch prior to release.
In case of an emergency, pressure can be released
quickly:
1. by opening the vertical screw locking handle
and pulling the screw upwards.
Figure 8
2. by releasing the arch to base plate handles and
pulling the arch backwards.
B
A
B

Note:
It is prohibited to make alterations to this text without prior approval from Orfit Industries.
RAYCAST®and EFFICAST®are registered trademarks of ORFIT Industries. HexaPOD™is a trademark of the Elekta Group.
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www.orfit.com
Ref. No. 50295
VERSION 1
LAST UPDATE: 30/11/2023
REVISION DATE: 30/11/2025
Figure 9
Minimum and maximum height (with standard
screw):
Figure 10
E. STORAGE
Always store the product in a safe place to prevent
it from getting damaged.
Store the arch between +10°C (50°F) and 40°C
(122°F).
F. PROPERTIES
F.1. Physical Properties 38240
Dimensions: W 195mm x H 380mm x
L 630 mm
Weight: 2.35 kg
Materials: HPL, POM, PEEK, PA
Average density: 1,4 gr/cm³
The arch is made entirely of electrically non-
conductive, non-metallic and non-magnetic
materials and is MRI safe.
F.2. Mechanical Properties
Figure 11
Component failure can occur when max load is
exceeded typically because the patient excerpts
high forces on the device (panic, coughing, vomiting,
etc.). Component failure is not harmful for the
patient.
G. MAINTENANCE AND WASTE MANAGEMENT
This product can be cleaned and disinfected by
means of 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. Do not use the product when damaged.
Contact your distributor if there are any questions
or concerns.
The product can be disposed of with household
waste.
H. 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.
Max load: 30 kg