Foreword; This Manual; Product Liability; Intended Use - Enraf Nonius Endolaser 422 Mode D'emploi

1 Foreword

1.1

This manual

This manual has been written for the owners and operators of the Endolaser 422. It contains general
instructions on operation, precautionary practices, maintenance and parts information. In order to
maximize the use, efficiency and lifespan of your unit, please read this manual thoroughly and become
familiar with the controls as well as the accessories before operating the unit.
Specifications put forth in this manual were in effect at the time of publication. However, owing to Enraf-
Nonius BV's policy of continual improvement, changes to these specifications may be made at any time
without obligation on the part of Enraf-Nonius BV.
1.2

Product liability

A law on Product Liability has become effective in many countries. This Product Liability law implies,
amongst other things, that once a period of 10 years has elapsed after a product has been brought into
circulation, the manufacturer can no longer be held responsible for possible shortcomings of the product.
To the maximum extent permitted by applicable law, in no event will Enraf-Nonius or its suppliers or
resellers be liable for any indirect, special, incidental or consequential damages arising from the use of or
inability to use the product, including, without limitation, damages for loss of goodwill, work and
productivity, computer failure or malfunction, or any and all other commercial damages or losses, even if
advised of the possibility thereof, and regardless of the legal or equitable theory (contract, tort or
otherwise) upon which the claim is based. In any case, Enraf-Nonius's entire liability under any provision
of this agreement shall not exceed in the aggregate the sum of the fees paid for this product and fees for
support of the product received by Enraf-Nonius under a separate support agreement (if any), with the
exception of death or personal injury caused by the negligence of Enraf-Nonius to the extent applicable
law prohibits the limitation of damages in such cases.
CAUTION:
No modification of this device is allowed.

2 Intended Use

The Endolaser 422 is a Low Level Laser therapy unit. The light source treatment that generates light of a
single wavelength. LLLT emits no heat, sound, or vibration.
The light energy absorbed into the patient's tissue, triggers biological changes at a cellular level.
Lasertherapy devices are non-invasive therapeutic active devices, used mainly by physiatrists,
physiotherapists, and pain therapists.
The use of these equipments is reserved, under the supervision and responsibility of an expert in the
problems of the laser radiation, for operators that, by their training, provide assurance of proper use and
safe for the patient.
In fact, the operator must be appropriately qualified and he carefully studied the contents of the user
manual in order to use the device; or, he must operate under the supervision of a health professional
adequately qualified to use the machine, able to understand the benefits and the limits of therapy and to
work in conditions of safety for the person undergoing treatment.
Such equipment can be used in hospital environment outpatient, nevertheless, it is important to know that
the user follow the medical instructions to use the equipment or that he follow the indications present in
the user's manual.
WARNINGS:
•
CLASS A device (EN 61000-3-2) suitable for use in all establishments other than domestic and
those directly connected to the public low-voltage power supply network that supplies buildings
used for domestic purposes.
•
The device or system must not be used near other equipment and, if it is necessary to use it near
other equipment, the medical electrical equipment must be observed to check normal operation in
the configuration in which it is used.
•
If the electro-medical device, interacting with another device, causes or receives detectable
interferences, the user is invited to limit the interference by adopting one or more of the following
measures:
EN
1