orfit AIO SOLUTION AC-LS-L Instruction Manual

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INSTRUCTIONS FOR USE

THE AIO SOLUTION® BELLYBOARD & PELVIC SOLUTION
LEG SEPARATOR LOW

AIO SOLUTION® code:
AC-LS-L

Article No. : 32008

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 LEG SEPARATOR LOW is a part of the "AIO SOLUTION®
BELLYBOARD PACKAGE”. It is used in combination with THE AIO
SOLUTION® BASE PLATES, the 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 range. Information on these other
parts 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 LOW 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.
Always verify that the LEG SEPARATOR LOW is positioned
correctly on the base plate.
There are two slots on top of the device that are used when
making EFFICAST® 6-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. HOW TO USE

Before mounting the device to a base plate, make sure that the

locking mechanism is ‘open’ by turning the locking handle until

it is perpendicular to the centreline of the base plate.

Then place the leg separator into the insert on the base plate
until flat on the surface. You can select a caudal or a more
cranial position of the device by using the appropriate holes in
the base plates. When done, lock the leg separator by turning
the handle until it is aligned with the centreline of the base
plate.

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.
THE AIO SOLUTION® is a registered trademark of Orfit Industries.

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www.orfit.com

Ref. No. 31960
VERSION 3
LAST UPDATE: 12/06/2018
REVISION DATE: 12/06/2020

An immobilization mask is then fixed in the two slots using the
HP system EVA handles.

F. PROPERTIES

E.1. Basic Physical Properties

The following physical properties apply to the LEG SEPARATOR
LOW:

Dimensions: L 225 mm x W 91 mm x H 63 mm
Weight: +/- 0,4 kg

E.2. Mechanical Properties

The LEG SEPARATOR LOW is made of POM. This material makes
sure that it will keep its dimensions overtime and under
conditions of frequent use.

G. 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.

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.