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Operations & Maintenance Manual: Important Information
0900‑4868 REV‑08
IMPORTANT INFORMATION
PRODUCT DESCRIPTION
The GlideScope BFlex device is a bronchoscope system consisting of a single‑use bronchoscope, a reusable
video monitor, and a reusable cable. This device is intended to provide real time viewing and recording for a
wide range of airway procedures.
STATEMENT OF INTENDED USE
GlideScope BFlex Single‑Use bronchoscopes are intended to work with a video monitor, in conjunction with
non‑powered endoscopic accessories and other ancillary equipment, for endoscopy within the airways and
tracheobronchial tree.
INTENDED PATIENT POPULATION
The GlideScope BFlex Single‑Use system is for use in a hospital environment. The GlideScope BFlex
bronchoscope is a single‑use device designed for use in adults, with the BFlex 2.8 also designed for pediatric
use (6 months to 6 years). It has been verified and validated for the following endotracheal tube (ETT) and
endoscope accessory (EA) sizes:
MODEL
MINIMUM ETT INSIDE DIAMETER
EA MINIMUM WORKING CHANNEL WIDTH
BFlex 2.8
4.0 mm
—
BFlex 3.8
5.0 mm
1.2 mm
BFlex 5.0
6.0 mm
2.1 mm
BFlex 5.8
7.0 mm
3.0 mm
Note: There is no guarantee that instruments selected solely using these instrument dimensions will be
compatible in combination.
INTENDED USE ENVIRONMENT AND USER POPULATION
The GlideScope BFlex Single‑Use bronchoscope is intended for in‑hospital use by physicians trained in the use
of endoscopic equipment.
CONTRAINDICATIONS
The GlideScope BFlex 2.8 Single‑Use Bronchoscope does not have a working channel and therefore cannot
be used for therapeutic purposes.
ESSENTIAL PERFORMANCE
The essential performance of the GlideScope BFlex Single‑Use bronchoscope is visualization of the airway
and tracheobronchial tree as well as certain procedures such as suction and use of endoscopic accessories
sized to work with the dimensions of the bronchoscope.
