12
ENGLISH
• This appliance must be used on individuals (patients) suitable for undergoing a procedure of
endoscopy;
• The light source is intended for professional use in a consulting room / operating theatre.
• Ensure sucient ventilation in order to avoid overheating inside the device: at least 15cm
at all sides of the device. Do not cover the device and ensure that the feet of the device are
always visible.
• Never place the device near a heat source or in a location where it is exposed to vibration
and/or shock.
• A multisocket or extension cable must not be connected to the EM system.
• Never use corrosive or abrasive products to clean the device, but only the disinfectant
agents as recommended in chapter 8.
• This device is not suitable for use in an ionizing environment.
• Do not expose the device to laser radiation.
• The device is not sterile.
• Before every use, check the device for rough surfaces, sharp edges or protruding elements
which could present a safety risk.
• The surface temperature of the light cable ends can exceed 41°C (aer a few minutes of
use). Therefore, avoid holding area in contact with the patient.
• When removing the fibre from its light guide aer use of the lamp the temperature of the
metal coupler is very high and injuries may occur when touching.
• The luminous power at the outlet of the cable can cause damage to the eye. Be careful when
handling the light cable when the lamp is operating at full power.
• Aer use, be sure to remove the light cable carefully without touching the distal tip which
can be very hot and cause burns.
• Never touch the patient or other flammable material (bed sheets, dressings, surgical drapes)
directly with the end of the light cable or the endoscope as it can become very hot: risk of
burning.
• The devices that connect to the inputs/outputs must comply with IEC 60950-1
• Placed the light source in order to facilitate the disconnection of the power supply
• According to connection requirements the electro medical devices in contact with the body
of patient have to be compatible with endoscopies devices of type BF or CF
Class Laser : risk group 2
According to the standard IEC 62471. Do not look directly at the light to avoid any risk of eye
damage.
Caution : Possibly hazardous optical radiation emitted from this product. Do not stare at
operating lamp. may be harmful to the eyes.
Not suitable for use in the presence of inflammable anaesthetic gas mixture with air, oxygen or
nitrous oxide.
It is advisable to have a second light source available in the operating room to use if an
absence or degradation of performance is observed.
3 Safety instructions
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