4
1 INTRODUCTION
1.1
Relevance of this Manual
The present MANUAL is the user’s guide for the medical device named EmoLED employed as an
adjuvant
to
the healing of wounds in its version 1 including its embedded software called SanaLight, version 2.1.
In the present document “EmoLED” or “Device” will be referring to the medical device EmoLED used as an
adjuvant for the healing of wounds.
The Device is made of two parts: the upper part, from where the
luminous radiation
is coming from, it is
defined as “Head” of the Device or “Optical Head” and the lower handling part identified as Device’s “Body”.
The correct performances and duration in time of the Device are depending on its correct use and the respect
of the following instructions.
This Manual is an integral part of the Device and mast be kept for the entire useful life of the Device according
to its definition here after.
It is recommended the careful reading of the Manual before using the Device.
1.2
Manual conservation
Use the manual doing attention to not damage its content.
Do not remove, cut or modify any part of the Manual for any reason.
Keep the Manual in an environment protected from humidity and heat.
This document is exclusive property of EMOLED Srl. It is forbidden any copy or reproduction, even partial, of
its contents.
1.3
Warnings
ATTENTION:
THE INAPPROPRIATE USE OR NEGLIGENCE IN THE MAINTENANCE OF THIS DEVICE
MAY RESULT IN INJURIES TO THE USER, TO THE PATIENT AND TO THIRD PARTIES. TO AVOID ANY
RISK, IT IS RECOMMENDED TO FOLLOW CAREFULLY THE INSTRUCTIONS HERE CONTAINED.
DANGER: DEVICE EMITTES UV RAYS
The Device has LED sources in Risk Class III. Do not aim directly to the eyes and avoid skin
exposure outside the medical treatment. It is suggested for people present in patient’s area to
use glasses with UV protection.
ATTENTION: EMISSION OF POTENTIALLY HARMFUL OPTICAL RADIATION
Do not look directly into the emitted light. Blue light may be harmful to the eyes.
IN CASE OF NON UNIFORM LIGHT EMISSION
Do not use the Device and contact assistance: www.myemoled.com/contatti.
DO NOT USE UNATHORIZED PERSONNEL FOR MAINTENANCE
For
any
type
of
intervention
or
problem
contact
the
Manufacturer:
www.myemoled.com/contacts.
DO NOT USE DEVICE BEFORE DISINFECTION
Before use disinfect the Device with sterilized gauze soaked with ethylic alcohol at 50%. DO
NOT INSERT THE DEVICE IN AUTOCLAVE AND DO NOT USE DISINFECTION METHODS
DIFFERENT FROM THESE HERE SPECIFICATED.