Jedmed EF-N, Instructions For Use Manual, Page: 11 / 29

11
Ergo-Flex
Operating / Service Manual
DEVICE OPERATION - List of Warnings
WARNING - !
Endoscope tip may become hot depending on the particular fiberoptic light source used.
ALWAYS test tip temperature and heat emitted from scope tip before use. ALWAYS ensure
either condition does not cause an unacceptable risk to the patient or user.
WARNING - !
High-intensity, radiated light may be transmitted from the light emission window at the front of
the scope. To minimize potential heat-related issues, ALWAYS observe the following:
WARNING -
!
In the event of a scope malfunction (example: loss of light or angulation function) ALWAYS terminate
examination as soon as possible and carefully remove scope from patient so as to minimize any risk
or harm to the patient.
• Turn off or minimize light source intensity when scope is not in use.
• Before use, always test temperature of light emitted from scope tip
to determine adequacy.
• Do not allow light emitted from scope tip near sensitive tissue or
near flammable objects.
• Do not use more light than required to complete the task at hand.
• Do not leave light source operating while unattended.
WARNING -
!
ALWAYS verify any fiberoptic light source used contains the manufacturer’s specified lamp and any
associated optical filters.
WARNING - !
This endoscope is intended to be “floating” or electrically isolated from any other equipment it is attached
to. In order to achieve this, any fiberoptic light sources, video cameras or other equipment attached
to the scope MUST be medical-grade and type BF (floating or electrically isolated connections). In
addition, ALWAYS use an isolated fiberoptic cable (never use a fiberoptic cable which contains an
internal, metal monocoil sheath or other means to electrically connect the two ends of the cable).
WARNING -
!
Before each use, ALWAYS inspect outer surface of scope to ensure there are no unintended rough
surfaces, sharp edges or protrusions which could cause harm.
WARNING - !
When using a video camera on this endoscope, ALWAYS verify a live video image is being observed (as
opposed to a stored image in memory) before beginning an examination. Likewise, after storing a video
image in memory, always verify a live video image is being observed before continuing examination.
WARNING -
!
NEVER use this endoscope (or any high-frequency cautery or endotherapy device) in the presence
of flammable or explosive concentrations of medical gases or anesthetics.
WARNING -
!
All electrical equipment connected to this equipment will produce patient leakage currents which are
additive.
WARNING - !
In the case where this endoscope is used along with LASER equipment, ALWAYS observe all pertinent
safety precautions governing laser devices including, but not limited to:
• User should wear suitable, laser-filtering, eye protection.
• Never shine a laser beam directly into any person’s eye(s)
WARNING -
!
Before using with accessories or other endoscopic devices, check compatibility of this scope with the
criteria for safe use as defined in the equipment’s instructions for use.