BFlex Single-Use Bronchoscopes with GlideScope Monitor Operations and Maintenance Manual Rev -09 Aug 2022

0900‑4868 REV-09

BFlex

Single‑Use Bronchoscopes with GlideScope Video Monitor

Operations & Maintenance Manual Effective: August 1, 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/service-and-support. Verathon Inc. 20001 North Creek Parkway Bothell, WA 98011 U.S.A. Tel: +1 800 331 2313 (US and Canada only) Tel: +1 425 867 1348 Fax: +1 425 883 2896 verathon.com Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby, BC V5C 5A9 Canada Tel: +1 604 439 3009 Fax: +1 604 439 3039 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: +61 2 9431 2000 Tel / +61 2 9475 1201 Fax

Verathon Medical (Europe) B.V. Willem Fenengastraat 13 1096 BL Amsterdam The Netherlands Tel: +31 (0) 20 210 30 91 Fax : +31 (0) 20 210 30 92

EU

MDSS CH GmbH Laurenzenvorstadt 61 5000 Aarau Switzerland

  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/service-and-support.

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...2 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... 11 Bronchoscope Components...12 Video Monitor Buttons, Icons, & Connections...13 SETTING UP...17 Perform Initial Inspection...17 Mount the System (Optional)...18 Charge the Monitor Battery...21 Attach the Cable & Bronchoscope...21 Connect to an External Monitor (Optional)...24 Configure User Settings...25 Perform a Functional Check...26

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USING THE DEVICE...28 Procedure 1. Prepare the GlideScope System...29 Procedure 2. Position the Handle and Controls...30 Procedure 3. Insert Through a Tube or Catheter (Optional)...31 Procedure 4. Insert and Flex the Bronchoscope...32 Procedure 5. Introduce Liquids or Accessories (Optional)...33 Procedure 6. Use the Record & Snapshot Features (Optional)...35 Procedure 7. Remove the Bronchoscope...36 Procedure 8. Use the Playback Feature (Optional)...37 REPROCESSING...38 MAINTENANCE & SAFETY...39 Periodic Inspections...39 GlideScope Video Monitor Battery...39 System Software...39 Device Repair...40 Device Disposal...40 WARRANTY...41 PRODUCT SPECIFICATIONS...43 Component Specifications...43 Battery Specifications...50 Electromagnetic Compatibility...51 GLOSSARY...54

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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.

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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.

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 WARNING 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.

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WARNING Monitor Only: Use only a passive‑type USB flash drive. Do not use USB drives powered by another external source. WARNING No modification of this equipment is allowed.

WARNING Do not use the power adapter in the presence of flammable anesthetics.

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 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 Do not use this system during defibrillation.

WARNING Monitor Only: The external monitor must be safety-approved medical equipment.

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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 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.

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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 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.

Warnings: Reprocessing WARNING Do not reuse, reprocess, or resterilize single‑use components. Reuse, reprocessing, or resterilization may create a risk of contamination of the device.

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Warnings: Electrical 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 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 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 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.

Warnings: Disposal WARNING 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.

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Cautions: Use CAUTION 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 either Verathon (or its authorized representative), the Competent Authority of the Member State where the incident occurred, or both. CAUTION The GlideScope BFlex 3.8 Single-Use Bronchoscope should not be used with 35Fr Shiley Endobronchial Tubes. Damage or tear to BFlex tip sheath may occur.

Cautions: Reprocessing 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.

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CAUTION 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. 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).

Cautions: Electrical CAUTION 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.

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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

Video monitor 12V DC power adapter

Power cable

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

Introducer

In‑service USB flash drive Note: Contains instructions for use.

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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/service-and-support.

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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. 8

1

6

Bronchoscope Components 3

2

9

7

4

5

10

13

11

12

Table 3. FIGURE KEY

Bronchoscope Component Descriptions COMPONENT

NOTES

1

Cable connector

Includes magnetic quick release

2

Handle

-

3

Insertion tube

-

4

Positioning marks

Includes marks at 50 mm intervals to assist in scope placement within the airway

5

Articulating distal tip

-

6

Suction port*

Accommodates tubing with an inside diameter between 6.0 and 7.0 mm, inclusively.

7

Suction button*

-

8

Control lever

Positions articulating distal tip

9

Accessory 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.

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*

Video Monitor Buttons, Icons, & Connections The digital, full‑color GlideScope Video Monitor clearly displays the images transmitted from the camera in the bronchoscope. The front of the monitor includes the screen and a keypad with the buttons you use to operate the system. The back panel of the monitor includes the sockets and ports for connecting the power cord, the GlideScope Video Monitor QuickConnect Cable, an HDMI‑to‑DVI cable for external video display, and a USB flash drive. When a socket or port is not in use, it is recommended that the rubber cap be inserted into the opening. This protects the exposed connectors from dust and contamination. The back of the video monitor also features a mounting plate fitting that allows you to attach the monitor to a mobile stand or IV pole. Figure 3.

GlideScope Video Monitor Keypad Record button

Power button

Table 4.

External video button

Snapshot button

Battery indicator

Tutorial button

Keypad Buttons

BUTTON

FUNCTION

Power: Press and release to turn on the monitor. Press and hold to turn it off. Note: If the monitor freezes at any time during use, press and hold the Power button for 10 seconds to reset the system. Record: Press to start and stop recording directly to a USB flash drive that has been inserted in the USB port. When you are recording, the red LED indicator to the right of the button will be lit, and the Recording icon will be shown on the screen. The playback menu is not available during recording. Note: To record video, a USB flash drive must be inserted into the monitor USB port. Snapshot: Press this button to save a snapshot of the live display to the USB flash drive. You may take a snapshot while video recording or independent of recording. Note: To take a snapshot, a USB flash drive must be inserted into the monitor USB port. External Video: Press to display video on an external monitor. The yellow LED to the right of the button will light up to indicate that the key has been activated. Press the key again to deactivate the external video. Note: An HDMI‑to‑DVI cable is required in order to display video on an external monitor. Tutorial: If no USB flash drive is connected, hold for 3 seconds to view the video tutorial. If a USB flash drive is connected, hold for 3 seconds to enter the playback menu. During the 3‑second delay, press the Snapshot button to enter the User Settings screens.

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BUTTON

FUNCTION

Battery Indicator: LED is: Green: Unit fully charged Red: Unit charging Flashing Red: Indicates a problem with the battery. Charge for 6 hours, and if still flashing, contact Verathon Customer Care. Table 5.

On‑Screen Icons ICON

FUNCTION

Battery Status: The remaining battery power is indicated by the Battery Status icon and the percentage above the icon. If the icon is red, the battery should be charged as soon as possible. (See Charge the Monitor Battery on page 21.) While the battery is being charged, a lightning bolt will be displayed alongside the Battery Status icon. Progress Confirmation: While the user is pressing a button, the operation is loading. If the button is released before the loading process is completed, the operation is canceled. Power‑Down Countdown: The unit is about to turn off. If this is due to the Auto Power Off feature that saves battery life, pressing any button stops the power‑down sequence. Note: The Auto Power Off feature can be adjusted or disabled on the User Settings screen. For more info, see Configure User Settings on page 25. USB Flash Drive: A USB flash drive is detected. While recording, a number next to the icon indicates approximately what percentage of the USB flash drive has been used. When the USB flash drive is full, recording stops. Incompatible USB Drive: The USB flash drive that is plugged into the monitor is not suitable for recording videos. (This normally occurs when using an encrypted USB flash drive or when using an older, inexpensive model that is not capable of the speed necessary to save video in real time.) USB Flash Drive Not Found: A USB flash drive needs to be inserted into the monitor USB port.

Attach GlideScope Video Monitor QuickConnect Cable: The GlideScope Video Monitor QuickConnect Cable is not properly attached to the monitor.

Recording: The system is recording video to the USB flash drive. Note: Do not remove the USB flash drive while recording is in progress, or the recording will be lost. Saving Snapshot: The system is saving a snapshot to the USB flash drive. Note: Do not remove the USB flash drive while saving a snapshot, or the snapshot will be lost.

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