300-002547-00 rev7 11
Disposable Accessories
The system features sterilized single-use accessories necessary to perform
bronchoscopic procedures. These accessories are:
Bronchoscope Patient Introducer: A tube that guides the Bronchoscope
System through the Bronchoscope Swivel Adapter and into the endotracheal
tube.
Bronchoscope Swivel Adapter: Standard bronchoscope accessory that
attaches to the endotracheal tube to allow passage of a bronchoscope while
maintaining ventilation pressure. It is packaged with the Bronchoscope
Patient Introducer.
Bronchoscope Fluidics Tubing: Separate tubing lines for saline irrigation and
vacuum aspiration which converge at a valve that attaches to the
bronchoscope working channel. Saline irrigation and aspiration lines connect
to the tower. A valve is connected to the end of the Bronchoscope Fluidics
Tubing and provides a means of introducing working channel instruments,
irrigation, and aspiration into the working channel.
Bronchoscope Sheath Valve: Attaches to the proximal hub of the sheath and
provides a seal around the bronchoscope to reduce ventilation leakage.
Navigation Patient Patches: Single-use disposable adhesive patches that are
used to attach the Monarch Navigation Patient Sensors to the patient’s chest.
The patches are not provided sterile.
Non-Disposable Accessories
The following non-disposable accessories are included and stored with the tower.
Bronchoscope Patient Introducer Mount: Adjustable mount that attaches to a
bed rail and holds the Bronchoscope Patient Introducer.
Monarch Navigation Patient Sensors: Attaches to the patient to provide an
estimate of patient positioning for alignment of the Monarch Navigation Field
Generator.
Monarch Navigation Field Generator: Provides an electromagnetic field to be
sensed by scope and patient sensors to provide locational information. The
Monarch Navigation Field Generator plugs into the Monarch Tower.
Monarch Navigation Field Generator Mount: Adjustable mounts that attaches
to a bed rail and holds the Monarch Navigation Field Generator.
Classifications
According to Directive 2017/745, this product is a Class IIa Medical Device.
According to CISPR 11 (a publication of the IEC committee on radio
interference), this product is Group 1, Class A ISM Equipment.
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