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2 Normal use
2.1 Intended use
Flexible intubation endoscopes
Flexible intubation endoscopes without working channel (CMOS) are used for both
endotracheal and nasal intubation. Flexible intubation endoscopes without working channel
(CMOS) are used for endoscopic visualization and image transmission for diagnosis of the
upper and lower respiratory tract. Flexible intubation endoscopes without working channel
(CMOS) are designed for transient use in invasive procedures through a body orifice.
Flexible intubation endoscopes with working channel
Flexible intubation endoscopes with working channel (CMOS) are designed for both
endotracheal and nasal intubation. Flexible intubation endoscopes with working channel
(CMOS) are designed for endoscopic visualization and image transmission as well as for
creating an access to introduce additional instruments for diagnosis and treatment of the
upper and lower airways. Flexible intubation endoscopes with working channel (CMOS) are
intended for temporary use in interventions performed through natural orifices.
Suction valve
Unsterile single-use suction valves are used for interrupting the suction in conjunction with
flexible endoscopes. Suction valves are non-invasive and are designed for transient or short-
term use in invasive procedures through a body orifice or surgically invasive procedures.
Reusable suction valves are used for interrupting the suction in conjunction with flexible
endoscopes. Suction valves are non-invasive and are designed for transient or short-term use
in invasive procedures through a body orifice or surgically invasive procedures.
Tube adapter
Tube adaptors are used for fastening the ETT on the intubation endoscope. Tube adaptors are
non-invasive and are designed for transient or short-term use in invasive procedures through a
body orifice or surgically invasive procedures.
Irrigation adapter
A cleaning adaptor is used for connecting the existing interfaces of a medical device during
reprocessing. Cleaning adaptors have no contact with the human body.
2.2 Indications
The use of intubation endoscopes is indicated if, in the opinion of the responsible physician, a
fiberoptic endotracheal intubation or inspection of the oropharyngeal, supraglottic, or
subglottic region is indicated or a percutaneous dilatational tracheostomy (PCT) is performed.
This includes, but is not limited to:
–
Endotracheal intubation with a difficult respiratory tract
–
Endoscopic inspection and monitoring of the mouth, nose, and throat region
–
Monitoring of percutaneous tracheostomy
–
Anesthesiological bronchoscopy
–
Bronchial lavage
Instructions for use • Flexible intubation videoendoscopes • BMF168_EN_V1.0_02-2021_IFU_CE-MDR
Normal use
7
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