orfit AIO SOLUTION AC-LS User manual

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INSTRUCTIONS FOR USE
THE AIO SOLUTION®BELLYBOARD & PELVIC SOLUTION
LEG SEPARATOR
AIO SOLUTION® code: AC-LS
Article No. : 32037
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 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 LEG SEPARATOR is a part of the "AIO SOLUTION
BELLYBOARD PACKAGE”. It is used in combination with THE AIO
2.0 and 3.0 SOLUTION BASE PLATES, the AIO 2.0 and 3.0
BELLYBOARD CUSHIONS and the EFFICAST PRE-CUTS to form a
reproducible patient positioning and immobilisation system. It
can also be used on the base plates of the PELVICASTTM product
range. 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.
Note: This device can be used securely on a 1st generation AIO
base plate but it cannot be locked.
C. PRECAUTIONS FOR USE
Always use this LEG SEPARATOR on an AIO SOLUTION base
plate or on a PELVICASTTM base plate and where applicable in
combination with the other AIO SOLUTION BELLYBOARD
components.
This device is placed between the patient’s legs in the holes in
the base plate. It is locked into the base plate by means of the
locking mechanism on top of the device.
There are two possibilities for the placement: a cranial and a
caudal one. The position can be changed by turning the device
180°. Always verify that the LEG SEPARATOR is positioned
correctly on the base plate.
There are two slots on top of the device that are used when
making EFFICAST6-point pelvic masks.
D. STORAGE
Always store the product in a safe place to prevent it from
getting damaged. Store the product in such a way that it cannot
fall or bump against anything. Never place the device under
load or pressure.
Store the device between + 10°C (50°F) and 40°C (122°F).
E. PROPERTIES
E.1. Basic Physical Properties
The following physical properties apply to the LEG SEPARATOR:
Dimensions: L 225 mm x W 91 mm x H 163 mm
Weight: 3,34 kg
E.2. Mechanical Properties
The LEG SEPARATOR is made of POM, covered with “a high
grade” coated PE foam. This combination makes sure that it will
keep its dimensions overtime and under conditions of frequent
use.
This product is made entirely of electrically non-conductive,
non-metallic and non-magnetic materials and is MR safe.

Note:
It is prohibited to make alterations to this text without prior approval from Orfit Industries.
THE AIO SOLUTION® and EFFICAST® are registered trademarks of ORFIT INDUSTRIES N.V.
www.orfit.com
Ref. No. 31911
VERSION 8
LAST UPDATE: 08/07/2021
REVISION DATE: 08/07/2023
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F. MAINTENANCE AND WASTE MANAGEMENT
This product can be cleaned and disinfected by means of an
ethanol 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.
Further cleaning instructions can be found in the Orfit Cleaning
Guidelines.
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.