Warnings And Cautions; Warnings; Cautions; Notes - Sunoptic Surgical SSL-LX2 Manuel D'utilisation

2. WARNINGS AND CAUTIONS

Use of this equipment may present hazards to the user and/or patient. Before operating this device, please
read this operating manual thoroughly and follow all warnings, cautions, and instructions for use. The words
warning, caution, and note carry special meaning and should be carefully reviewed:
WARNING: Indicates risks to the safety of the patient or user. Failure to follow warnings may result in injury
to the patient or user.
CAUTION: Indicates risks of improper use and/or damage to the equipment. Failure to follow cautions may
result in loss of function or product damage.
NOTE: Indicates special information to clarify instructions or present additional useful information.
The appropriate "WARNING", "CAUTION" or "NOTE" symbol in this manual is intended to alert the user to
the presence of important operating and maintenance instructions in the manual.

2.1. Warnings

•
The headlight produces highly concentrated light. Avoid looking directly into the light source.
•
Qualified personnel must determine a safe distance between the headlight module and patient
for each application.
•
User is responsible for determining if interruption of light output will create an unacceptable risk.
Having a backup headlight or other illuminator is advised.
•
User is responsible for providing backup lighting systems for your application when using this
device.
•
Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen or
nitrous oxide.
•
To prevent fire and/or electric shock, do not open or expose the headlight system to liquids.
•
The headlight system should only be used with manufacturer-approved battery packs.
•
This device meets CISPR 11 Class A limits and is suitable for use in a hospital environment.
Performance of this device may be affected in proximity of another device and/or equipment
capable of producing high levels of RF emissions. In the event performance of this device is
affected due to high levels of RF emissions, relocation of the suspected device and/or
equipment producing high levels of RF emissions or the headlight system may reduce or
eliminate the problem.
•
Any serious incident that has occurred in relation to this device should be reported to the
manufacturer and the competent authority of the Member State and/or Country in which the user
and/or patient is established.

2.2. Cautions

•
Before each procedure, carefully check the battery state-of-charge and charge battery as
necessary to ensure the headlight has enough duration for the procedure.
•
All servicing and repair must be performed by the manufacturer or qualified service technicians.
•
Ensure that the air vents located on the headlight module are not obstructed to allow the
headlight to receive the necessary cooling to prevent an overheating.

2.3. Notes

•
Battery packs supplied from the manufacturer and approved vendors are distributed in
a discharged state. Please fully charge the battery packs before using the headlight for
the first time.
•
The headlight produces some heat in addition to light, which causes the module and/or holster
to become warm. This is normal operation.
•
This device may interfere with other electrical equipment if used outside a hospital setting.
•
The LED headlight is not provided sterile, nor is sterilizable.
LIT-246
Sunoptic Surgical
Rev. E
®
Page 4 of 80
(English)