Verathon GLIDESCOPE BFLEX Manual

GLIDESCOPE BFLEX
SINGLE‑USE BRONCHOSCOPES
WITH GLIDESCOPE VIDEO MONITOR
Operations & Maintenance Manual

0900‑4868 REV‑08

GLIDESCOPE BFLEX
SINGLE‑USE BRONCHOSCOPES
WITH GLIDESCOPE VIDEO MONITOR
Operations & Maintenance Manual
Effective: April 8, 2022
Caution: Federal (United States) law restricts this
device to sale by or on the order of a physician.

CONTACT INFORMATION
To obtain additional information regarding your GlideScope system,
please contact Verathon Customer Care or visit verathon.com/global‑support.
Verathon Inc.
20001 North Creek Parkway
Bothell, WA 98011 U.S.A.
Tel: [phone] (US and Canada only)
Tel: [phone]
Fax: [phone]
verathon.com
Verathon Medical (Europe) B.V.
Willem Fenengastraat 13
1096 BL Amsterdam
The Netherlands
Tel: [phone]
Fax : [phone]
Verathon Medical (Canada) ULC
2227 Douglas Road
Burnaby, BC V5C 5A9
Canada
Tel: [phone]
Fax: [phone]
Verathon Medical (Australia) Pty Limited
Unit 9, 39 Herbert Street
St Leonards NSW 2065
Australia
Within Australia: 1800 613 603 Tel / 1800 657 970 Fax
International: [phone] Tel / [phone] Fax
0123
Copyright © 2022 by Verathon Inc. All rights reserved. No part of this manual may be copied or transmitted by any method without the
express written consent of Verathon Inc.
GlideScope, BFlex, Verathon, and the associated symbols are trademarks of Verathon Inc. All other brand and product names are
trademarks or registered trademarks of their respective owners.
Not all Verathon Inc. products shown or described in this manual are available for commercial sale in all countries.
Note: The BFlex 2.8 is not CE marked for sale in the following geographies: EU
Information in this manual may change at any time without notice. For the most up‑to‑date information, see the documentation
available at verathon.com/product‑documentation.

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Operations & Maintenance Manual: Table of Contents 0900‑4868 REV‑08
TABLE OF CONTENTS
IMPORTANT INFORMATION.................................................................................................................................1
Product Description ............................................................................................................................................1
Statement of Intended Use..................................................................................................................................1
Intended Patient Population ................................................................................................................................1
Intended Use Environment and User Population ..................................................................................................1
Contraindications................................................................................................................................................1
Essential Performance .........................................................................................................................................1
Environments of Intended Use.............................................................................................................................2
Statement of Prescription ....................................................................................................................................2
Notice to All Users ..............................................................................................................................................2
Warnings & Cautions ..........................................................................................................................................2
INTRODUCTION ....................................................................................................................................................9
System Parts & Accessories ...............................................................................................................................10
Language Settings ............................................................................................................................................ 13
Bronchoscope Components .............................................................................................................................. 14
Video Monitor Buttons, Icons, & Connections ...................................................................................................15
SETTING UP .........................................................................................................................................................18
Perform Initial Inspection ............................................................................................................................ 18
Mount the System (Optional) ...................................................................................................................... 19
Charge the Monitor Battery ........................................................................................................................22
Attach the Cable & Bronchoscope...............................................................................................................23
Connect to an External Monitor (Optional)..................................................................................................25
Configure User Settings ..............................................................................................................................26
Perform a Functional Check ........................................................................................................................ 27

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0900‑4868 REV‑08
USING THE DEVICE .............................................................................................................................................29
Procedure 1. Prepare the GlideScope System............................................................................................30
Procedure 2. Position the Handle and Controls ......................................................................................... 31
Procedure 3. Insert Through a Tube or Catheter (Optional) .......................................................................32
Procedure 4. Insert and Flex the Bronchoscope.........................................................................................33
Procedure 5. Introduce Liquids or Accessories (Optional)...........................................................................34
Procedure 6. Use the Record & Snapshot Features (Optional) ....................................................................36
Procedure 7. Remove the Bronchoscope...................................................................................................37
Procedure 8. Use the Playback Feature (Optional) .....................................................................................38
REPROCESSING....................................................................................................................................................39
MAINTENANCE & SAFETY..................................................................................................................................40
Periodic Inspections ..........................................................................................................................................40
GlideScope Video Monitor Battery ....................................................................................................................40
System Software...............................................................................................................................................40
Device Repair.................................................................................................................................................... 41
Device Disposal................................................................................................................................................. 41
WARRANTY.........................................................................................................................................................42
PRODUCT SPECIFICATIONS.................................................................................................................................44
Component Specifications ................................................................................................................................44
Battery Specifications........................................................................................................................................ 51
Electromagnetic Compatibility...........................................................................................................................52
GLOSSARY ...........................................................................................................................................................55

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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.

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ENVIRONMENTS OF INTENDED USE
The GlideScope BFlex Single‑Use Bronchoscope system is intended to be used in professional healthcare
environments such as hospitals.
STATEMENT OF PRESCRIPTION
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
NOTICE TO ALL USERS
Verathon recommends that all users do the following:
• Read the manual before using the equipment.
• Obtain instruction from a qualified individual.
• Practice using the bronchoscope on a mannequin before clinical use.
• Acquire clinical training experience on patients without airway abnormalities.
WARNINGS & CAUTIONS
Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of
the device. Cautions indicate that use or misuse of the device may cause a problem, such as a malfunction,
failure, or damage to the product.
WARNINGS: USE
Before every use, ensure that the instrument is operating correctly and has no sign of damage.
Do not use this product if the device appears damaged. Refer servicing to qualified personnel.
Always ensure that alternative airway management methods and equipment are readily
available.
Report any suspected defects to Verathon Customer Care. For contact information, visit
verathon.com/global‑support.
WARNING
The video signals produced and used by this system are intended for device positioning only. Do
not use the system as the sole diagnostic method of any pathology.
WARNING
Verathon has conducted no analysis to establish the compatibility of the system with
environments where magnetic resonance imaging (MRI) equipment is installed. Because of this,
the owner of the system must exclude it from any magnetic resonance (MR) environment.
WARNING

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Operations & Maintenance Manual: Important Information 0900‑4868 REV‑08
Do not use this system during defibrillation.
WARNING
Do not use the power adapter in the presence of flammable anesthetics.
WARNING
Do not use this system to deliver highly flammable anaesthetic gases to the patient. Such use
may result in patient injury.
WARNING
Do not use excessive force when inserting, positioning, or removing the single‑use
bronchoscope or accessories. Using excessive force against resistance could result in product
damage, including damage to or detachment of the distal tip.
WARNING
When using suction, limit the vacuum level to 85 kPa (638 mmHg) or less. Higher vacuum levels
may make it difficult to cut off suction if required.
WARNING
Do not use active endoscopic components such as laser probes or electrosurgical devices with
this system. Such use may result in injury to the patient or damage to the system.
WARNING
Do not introduce accessories that exceed the maximum accessory width shown in the Product
Specifications section or on the package label of the bronchoscope.
WARNING
Do not advance the bronchoscope while endoscopic accessories extend out of the opening in
the distal tip. The resulting accessory movements may result in patient injury.
WARNING

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0900‑4868 REV‑08
Use caution when withdrawing endoscopic accessories from the patient.
WARNING
Before withdrawing the bronchoscope, place the distal tip into a straight, neutral position. While
withdrawing, do not touch the control lever. Any bend in the distal tip may result in patient
injury.
WARNING
If a malfunction should occur during use, do not continue the procedure. Place the distal tip into
a straight, neutral position, and then slowly withdraw the bronchoscope without touching the
control lever.
WARNING
Always watch the video display carefully while advancing or withdrawing the bronchoscope,
flexing the distal tip, or applying suction. Failure to do so may result in injury to the patient.
WARNING
Before discarding a bronchoscope, ensure that no parts of the camera, distal tip, or insertion
tube are missing.
WARNING
WARNINGS: CLEANING
Do not reuse, reprocess, or resterilize single‑use components. Reuse, reprocessing, or
resterilization may create a risk of contamination of thedevice.
WARNING
QuickConnect Cable, Monitor, and Cart Only: Availability of cleaning products varies by country,
and Verathon is unable to test products in every market. For more information, please contact
Verathon Customer Care. For contact information, visit verathon.com/global‑support.
WARNING

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Operations & Maintenance Manual: Important Information 0900‑4868 REV‑08
QuickConnect Cable, Monitor, and Cart Only: This product may only be cleaned or disinfected
by using the approved processes provided in the GlideScope and GlideRite Products
Reprocessing Manual (part number 0900‑5032). Cleaning and disinfection methods listed are
recommended by Verathon based on efficacy or compatibility with component materials.
WARNING
QuickConnect Cable, Monitor, and Cart Only: For information on the handling and disposing of
recommended reprocessing solutions, please refer to the solution manufacturer’s instructions.
WARNING
Power Adapter Only: Electric shock hazard. Do not immerse the power adapter in water. When
cleaning the power adapter, use a cloth dampened with isopropyl alcohol on the outside of the
enclosure.
WARNING
WARNINGS: PRODUCT SAFETY
This instrument and related devices may contain batteries or other environmentally hazardous
materials. When the instrument or accessories have reached the end of their useful service life,
see the section Device Disposal. Dispose of used, single‑use components as infectious waste.
WARNING
Two areas of the bronchoscope tip that contact the patient can exceed 41°C (106°F) as part of
normal operation:
The first area is the light‑emitting area surrounding the camera in the tip. When used as
indicated, continuous contact with this area is unlikely because, if tissue were to contact this
area, a usable view would be lost. Devices would then need to be adjusted to regain the
working distance needed for a usable view.
The second area is the area of the tip that surrounds the camera, but is out of its field of view.
Continuous contact with this area is unlikely because the product is typically not held stationary
for an extended period of time, and because there is normally a small clearance between the
area and the adjacent tissue.
To prevent thermal damage, such as a burn to the mucosal tissue, avoid prolonged, continuous
contact with these areas of the bronchoscope tip.
WARNING

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0900‑4868 REV‑08
No modification of this equipment is allowed.
WARNING
Electric shock hazard. Do not attempt to open the system components. This may cause serious
injury to the operator or damage to the instrument and voids the warranty. Contact Verathon
Customer Care for all servicing needs.
WARNING
To maintain electrical safety, use only the provided power supply. Connect the power cord and
power adapter to a properly grounded plug, and ensure that the disconnect is easily accessible.
Use only the accessories and peripherals recommended by Verathon.
WARNING
Monitor Only: Use only a passive‑type USB flash drive. Do not use USB drives powered by
another externalsource.
WARNING
Monitor Only: The external monitor must be safety‑approved medical equipment.
WARNING
Use of accessories and cables other than those specified or provided by Verathon may cause this
system to experience electromagnetic malfunctions, including increased emissions or decreased
immunity. This may cause improper operation, procedure delays, or both.
WARNING
Portable radio frequency communications equipment (including peripherals such as antenna
cables and external antennas) may not be used within 30 cm (12 inches) of any part of the
GlideScope BFlex Single‑Use Bronchoscope system, including cables that Verathon specifies or
provides for use with the system. If this distance is not maintained, performance of the system
may be degraded and image display may be compromised.
WARNING

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Operations & Maintenance Manual: Important Information 0900‑4868 REV‑08
CAUTIONS
Medical electrical equipment requires special precautions regarding electromagnetic
compatibility (EMC) and must be installed and operated according to the instructions in this
manual. For more information, see the Electromagnetic Compatibility section.
Avoid using the GlideScope system adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, observe the system to verify normal operation in the configuration in
which it will be used.
This device can radiate radio frequency energy and is highly unlikely to cause harmful
interference with other devices in the vicinity. There is no guarantee that interference will
not occur in a particular installation. Evidence of interference may include degradation of
performance in this device or other devices when operated simultaneously. If this occurs, try to
correct the interference and restore optimal image quality by using the following measures:
•Turn devices on and off in the vicinity to determine the source of interference
•Reorient or relocate this device or other devices
•Increase the separation between devices
•Power off and on the monitor if the image quality is not optimal after removal of the
interference
•Connect the device to an outlet on a circuit different than the other device(s)
•Eliminate or reduce EMI with technical solutions (such as shielding)
•Purchase medical devices that comply with IEC60601‑1‑2 EMC standards
Be aware that portable and mobile radio frequency communications equipment (cellular phones,
etc.) may affect medical electrical equipment; take appropriate precautions during operation.
CAUTION
Monitor Only: The system contains electronics that may be damaged by ultrasonic and
automated washing equipment. Do not use an ultrasonic device or automated washing
equipment to clean this product.
CAUTION
Risk of permanent equipment damage. This product is sensitive to heat, which causes damage
to the electronics. Do not expose the system to temperatures above 45°C (113°F), and do not
use autoclaves or pasteurizers. Use of such methods to clean or disinfect the system causes
permanent device damage and voids the warranty. For a list of approved cleaning procedures
and products, see the GlideScope Products Reprocessing Manual (part number 0900‑5032).
CAUTION

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0900‑4868 REV‑08
Do not use a knife or other sharp instrument to open the packaging containing the
bronchoscope, and do not use the bronchoscope if its packaging is damaged.
CAUTION
Before using an endoscopic accessory, ensure it is compatible with the working channel of the
bronchoscope.
CAUTION
Do not use the system if it is not functioning properly or if it is damaged in any way.
CAUTION
Do not store BFlex pouches in direct sunlight.
CAUTION
European Union only: If any serious incident occurs during use of this product, you must
immediately notify both Verathon and the Competent Authority of the Member State where the
incident occurred.
CAUTION

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Operations & Maintenance Manual: Introduction 0900‑4868 REV‑08
INTRODUCTION
The GlideScope BFlex Single‑Use Bronchoscope system incorporates the following central components:
• GlideScope BFlex bronchoscope (single‑use)
• GlideScope Video Monitor QuickConnect Cable (reusable)
• GlideScope Video Monitor (reusable)
The system also includes the cables and adapters to power the monitor, and it may include optional system
components that simplify use or provide convenience to the user.
Figure 1. GlideScope BFlex Single‑Use System

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SYSTEM PARTS & ACCESSORIES
Table 1. Required System Components
REQUIRED PARTS & ACCESSORIES
GlideScope Video Monitor

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Operations & Maintenance Manual: Introduction 0900‑4868 REV‑08
REQUIRED PARTS & ACCESSORIES
GlideScope BFlex 2.8 Single‑Use bronchoscope
GlideScope BFlex 3.8 Single‑Use bronchoscope
GlideScope BFlex 5.0 Single‑Use bronchoscope
GlideScope BFlex 5.8 Single‑Use bronchoscope
GlideScope Video Monitor QuickConnect Cable

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REQUIRED PARTS & ACCESSORIES
Introducer Video monitor 12V DC poweradapter
Power cable In‑service USB flash drive
Note: Contains instructions for use.

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Operations & Maintenance Manual: Introduction 0900‑4868 REV‑08
Table 2. Optional System Components
OPTIONAL PARTS & ACCESSORIES
Premium cart Mobile stand Media storage USB flash drive
Universal accessory basket
Note: For use with mobilestand
HDMI‑to‑DVI cable IV pole mounting kit
LANGUAGE SETTINGS
The video monitor software is available in a variety of languages. To change the language used on your
system, you must install a new software version via a USB flash drive. For more information, contact Verathon
Customer Care or your local representative. For contact information, see verathon.com/global‑support.

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0900‑4868 REV‑08
BRONCHOSCOPE COMPONENTS
The GlideScope BFlex bronchoscope is a single‑use device that can be inserted either directly or through an
endotracheal (ET) tube. The main components of the bronchoscope are shown in the following figure.
Figure 2. Bronchoscope Components
12
11 13
2
153
6 7 9
8
10
4
Table 3. Bronchoscope Component Descriptions
FIGURE KEY COMPONENT NOTES
1Cable connector Includes magnetic quick release
2Handle —
3Insertion tube —
4Positioning marks Includes marks at 50 mm intervals to assist in scope placement
within the airway
5Articulating distal tip —
6Suction port*Accommodates tubing with an inside diameter between 6.0 and
7.0mm, inclusively.
7Suction button*—
8Control lever Positions articulating distal tip
9Accessory port*Enables introduction of accessories or liquids.
10 Tube retainer Enables mounting of endotracheal (ET) tubes with standard ISO
connectors.
11 Camera and light High‑resolution, full‑color camera with integrated LED light source
and anti‑fog protection
12 Working channel*—
13 Introducer*Connects Luer syringes securely to the accessory port
* Does not apply to BFlex 2.8.