Jedmed EF-N, Инструкция по эксплуатации, Страница: 10 / 29

Ergo-Flex
Operating / Service Manual
10
DEVICE OPERATION - Light Source Risks
Background
High-intensity light sources used for endoscope
illumination may pose multiple risks to the patient
and/or user. Primary risks include patient burns, fire
and electrical shock. It is important to understand
and limit these risks in all cases.
Many types and manufacture of fiberoptic light
sources are readily available. Common types include:
halogen (incandescent), light-emitting diode (LED),
metal-halide, and xenon-arc. In general, all light
sources and cables must be medical-grade to ensure
patient safety.
Heat / Burn Hazards
Each light source emits different amounts of heat
associated with the light, depending on the nature
of the light and type of construction. LED sources
typically emit the least heat, while xenon-arc sources
generally emit the most.
Emitted light may cause the tip of the scope to heat,
at times, significantly. Additionally, the emitted light
may be absorbed by tissue or material upon which it
is shining, also causing significant heating. Broken
or missing heat filters, incorrect lamps in sources
and fiberoptic cable diameter can also affect heat at
the distal tip.
Before use, be sure to test any light source with the
scope to determine that the tip temperature remains
as cool as possible (ideally under 41º C/106 ºF) and
that the emitted light does not cause excessive
heating of tissue. Tip temperatures exceeding
41º C/106 ºF may be allowable, in some instances,
depending on location of viewing, type of tissue
contact and duration of use, among others.
In all cases, it is imperative to assure that tip heat
and/or emitted light does not cause an unacceptable
risk to the patient or user.
Due to the extreme nature of arc-lamps, JEDMED
does not recommend using xenon-arc sources with
this endoscope.
Fire Hazards
Along with patient burns, extreme light output at the
tips of endoscopes can also be a fire hazard. Always
keep scope tip away from flammable materials and
turn off light source when not in use.
Never leave light operating while unattended.
Electrical Shock Hazard
Leakage current is always present on some level
in mains (ac) powered equipment. In some cases,
leakage current can be felt by the patient as a tingling
sensation on sensitive tissue such as mucus-lined
nasal passages. To minimize any possibility of
macro or micro shock from fiberoptic light sources, all
sources and fiberoptic cables used must be Type BF
and medical-grade. BF indicates that each device is
“floating” and not electrically connected to the patient
in any fashion.
Explosion Hazard - Do NOT use in the presence of
flammable anesthetics!
WARNING !