GlideScope Operations and Maintenance Manual Rev 12

0900-4940 REV-12

GLIDESCOPE

Video Laryngoscopes Operations & Maintenance Manual Effective: November 11, 2022

Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.

0900-4940 REV-12

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: +1 800 331 2313 (US and Canada only) Tel: +1 425 867 1348 Fax: +1 425 883 2896 verathon.com

EU

Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby, BC V5C 5A9 Canada Tel: +1 604 439 3009 Fax: +1 604 439 3039

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

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

MDSS CH GmbH Laurenzenvorstadt 61 5000 Aarau Switzerland

Anandic Medical Systems AG Stadtweg 24 8245 Feuerthalen Switzerland

CH

MDSS-UK RP Ltd. 6 Wilmslow Road, Rusholme Manchester M14 5TP United Kingdom Tel: +44 (0)7898 375115

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, the GlideScope symbol, GVL, Core, Spectrum, Reveal, Verathon, and the Verathon Torch symbol 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. 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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TABLE OF CONTENTS IMPORTANT INFORMATION...1 Product Information...1 Statement of Intended Use...1 Essential Performance...1 Environments of Intended Use...1 Statement of Prescription...1 Notice to All Users...1 Warnings & Cautions...2 BLADES, BATONS, & CABLES...8 Video laryngoscopes...8 Video Cables... 11 Compatibility... 11 COMPONENTS... 13 Video laryngoscopes... 13 Batons... 14 Video Cables... 14 SETTING UP... 15 Procedure 1.

Perform Initial Inspection... 15

Procedure 2.

Attach the Video Cable to the Monitor... 16

Procedure 3.

Attach the Scope to the Video Cable... 17

Procedure 4. Perform a Functional Check... 18 USING THE DEVICE... 19 Procedure 1.

Prepare the Scope... 19

Procedure 2.

Intubate the Patient... 21

Procedure 3.

Prepare a Component for Cleaning...22

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IMPORTANT INFORMATION This manual details how to use video laryngoscopes that are compatible with the GlideScope Video Monitor (GVM) and GlideScope Core monitor.

PRODUCT INFORMATION GlideScope video laryngoscopes combine innovative designs in reusable and single‑use options to enable intubations across a wide range of patient types, weights, and clinical settings. GlideScope video laryngoscopes are designed to deliver high‑resolution airway views when used with compatible GlideScope video monitors. For manuals specific to your video monitor, please visit verathon.com/product‑documentation, or contact Verathon Customer Care. For information on monitor, cable, and scope compatibility, see Compatibility on page 11.

STATEMENT OF INTENDED USE These components are intended for use by qualified professionals to obtain a clear, unobstructed view of the airway and vocal cords for medical procedures.

ESSENTIAL PERFORMANCE Essential performance is the system performance necessary to achieve freedom from unacceptable risk. When connected with an appropriate monitor, the essential performance of these components is to provide a clear view of the vocal cords.

ENVIRONMENTS OF INTENDED USE GlideScope systems are 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. These components should be used only by individuals who have been trained and authorized by a physician or used by healthcare providers who have been trained and authorized by the institution providing patient care.

NOTICE TO ALL USERS Verathon recommends that all users read this manual before using these components. Failure to do so may result in injury to the patient, may compromise the performance of the system, and may void the system warranty. Verathon recommends that new GlideScope users: • Obtain instruction from a qualified individual • Practice using the system on a mannequin before clinical use • Acquire clinical experience on patients without airway abnormalities

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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. Throughout the manual, pay attention to sections labeled Important, as these contain reminders or summaries of the following cautions as they apply to a specific component or use situation. Please heed the following warnings and cautions.

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.

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 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 When you are guiding the endotracheal tube to the distal tip of the video laryngoscope, ensure that you are looking in the patient’s mouth, not at the screen. Failure to do so may result in injury, such as to the tonsils or soft palate.

WARNING Do not place the video baton in the cradle if any of the components are contaminated.

WARNING The area surrounding the camera in the video laryngoscope can contact the patient and can exceed 41°C (106°F) as part of normal operation. Patient contact with this area of the blade during intubation is unlikely, as it would cause an obstruction of the camera view. Do not maintain continuous contact with this area of the blade for longer than 1 minute; it is possible to cause thermal damage such as a burn to the mucosal tissue.

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WARNINGS: REPROCESSING WARNING Reusable video laryngoscopes and video cables are delivered nonsterile and require cleaning and disinfection prior to initial use.

WARNING Cleaning is critical to ensuring a component is ready for disinfection or sterilization. Failure to properly clean the device may result in a contaminated instrument after completing the disinfection or sterilization procedure. When cleaning, ensure all foreign matter is removed from the surface of the device. This allows the active ingredients of the chosen disinfection method to reach all the surfaces.

WARNING This product may only be cleaned, disinfected, or sterilized by using the approved processes provided in the GlideScope and GlideRite Products Reprocessing Manual (part number 09005032). Cleaning, disinfection, and sterilization methods listed are recommended by Verathon based on efficacy or compatibility with component materials.

WARNING Availability of cleaning, disinfection, and sterilization 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 The reusable Titanium video laryngoscope is considered a semi‑critical device intended to contact the airway. It must be thoroughly cleaned and undergo high‑level disinfection after each use.

WARNING Because the product may be contaminated with human blood or body fluids capable of transmitting pathogens, all cleaning facilities must be in compliance with (U.S.) OSHA Standard 29 CFR 1910.1030 “Bloodborne Pathogens” or an equivalent standard.

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WARNING Do not reuse, reprocess, or resterilize single‑use components. Reuse, reprocessing, or resterilization can contaminate the component or the GlideScope system.

WARNING For information on the handling and disposing of recommended reprocessing solutions, please refer to the solution manufacturer’s instructions.

WARNING Make sure each component is completely clean before you disinfect or sterilize it. If it is not, the disinfection or sterilization procedure may not remove all contamination. This increases the risk of infection.

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

WARNINGS: PRODUCT SAFETY WARNING To reduce the risk of electrical shock, 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 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.

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WARNING No modification of this equipment is allowed.

CAUTIONS CAUTION The system contains electronics that may be damaged by ultrasonic and automated washing equipment. Do not use an ultrasonic device or automated washing equipment, other than Verathon-approved systems, to clean this product.

CAUTION When cleaning video laryngoscopes, do not use metal brushes, abrasive brushes, scrub pads, or rigid tools. They will scratch the surface of the unit or the window protecting the camera and light, which may permanently damage the device.

CAUTION Bleach may be used on the video batons, but pay special attention to stainless steel components, as bleach can corrode stainless steel.

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 60°C (140°F), and do not use autoclaves or pasteurizers. Use of such methods to clean, disinfect, or sterilize the system causes permanent device damage and voids the warranty. For a list of approved cleaning procedures and products, see the GlideScope and GlideRite Products Reprocessing Manual (part number 0900-5032).

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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 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 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.

CAUTIONS: REPROCESSING CAUTION Do not return GlideScope system components to their storage locations until they have been thoroughly cleaned, and disinfected or sterilized if appropriate. Returning contaminated components to these locations increases the risk of infection. CAUTION For recommendations on the handling and disposal of a reprocessing agent, refer to the manufacturer’s instructions for the reprocessing agent.

CAUTION The reusable components of GlideScope systems are not shipped in sterile condition. Clean them, and disinfect or sterilize them if appropriate, before their first use. Failure to do so increases the risk of infection.

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CAUTION Do not use abrasive brushes, pads, or tools when cleaning cameras or screens. These items can scratch transparent plastic parts and permanently damage the device.

CAUTION Do not use an ultrasonic device or automated washing equipment to clean a Verathon product, except when using Verathon-approved systems to clean products compatible with those systems. Using ultrasonic or automated washing equipment to clean any other Verathon product, or using automated cleaning systems not listed as compatible, could damage the 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 60°C (140°F), and do not use autoclaves or pasteurizers. Use of such methods to clean, disinfect, or sterilize the system causes permanent device damage and voids the warranty. For a list of approved cleaning procedures and products, see the GlideScope and GlideRite Products Reprocessing Manual (part number 0900-5032).

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BLADES, BATONS, & CABLES GlideScope video laryngoscopes are available in the following formats: • GlideScope Titanium Reusable video laryngoscopes • GlideScope Spectrum Single‑Use video laryngoscopes • GlideScope AVL Video Batons for use with Single‑Use GVL Stats (blades) • GlideScope Video Baton 2.0 for use with Single‑Use GVL Stats (blades) Note: For information on approximate weight ranges for reusable video laryngoscopes, single‑use video laryngoscopes, and GVL Stats, see the procedure Prepare the Scope on page 19.

VIDEO LARYNGOSCOPES TITANIUM REUSABLE VIDEO LARYNGOSCOPES GlideScope Titanium reusable video laryngoscopes are made from durable/lightweight titanium, which enable low‑profile blade designs for optimized maneuverability and working space. The video laryngoscope is connected to the video monitor via a reusable video cable. Titanium reusable video laryngoscopes are available in a uniquely angulated LoPro style, and in Mac style as well. Figure 1.

GlideScope Titanium Reusable Video Laryngoscopes

LoPro T2

LoPro T3

MAC T3

MAC T4

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LoPro T4

SPECTRUM SINGLE‑USE VIDEO LARYNGOSCOPES The Spectrum single‑use video laryngoscopes are fully disposable video laryngoscopes that integrate the latest advancements in lighting technology to optimize image brightness and clarity throughout the intubation process. Spectrum single‑use video laryngoscopes are connected to cart‑based video monitors via a Smart Cable and are available in a uniquely angulated LoPro style, and in Miller and Mac styles as well. IMPORTANT White, single‑use video laryngoscopes are not part of the Spectrum Single‑Use system. For more information, contact Verathon Customer Care. For contact information, visit verathon.com/global‑support. Figure 2.

Spectrum Single‑Use video laryngoscopes

LoPro S1

LoPro S2

Miller S0

Miller S1

DirectView MAC S3

LoPro S2.5

LoPro S3

LoPro S4

DirectView MAC S4

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VIDEO BATONS & STATS Reusable video batons combine a high‑resolution, full‑color digital camera with an integrated LED light source and Reveal anti‑fog feature. Video batons are connected to cart‑based video monitors via a permanently‑integrated video cable (AVL Video Batons), or a separate Smart Cable (Video Baton 2.0). Video batons are available with a choice of two sizes and are designed to be used with single‑use GVL Stats. GVL Stats are offered in a comprehensive range of sizes, allowing clinicians to meet the particular requirements of a wide range of patients. Figure 3.

Figure 4.

Video Batons

AVL Video Baton 1‑2

AVL Video Baton 3‑4

Video Baton 2.0 Large (3‑4)

GlideScope Video Baton QC Large

Single‑Use Stats

GVL Stat size 0

GVL Stat size 1

GVL Stat size 3

GVL Stat size 4

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GVL Stat size 2

GVL Stat size 2.5

VIDEO CABLES The video laryngoscopes in this manual require a video cable to connect to cart‑based monitors. In this document, unless otherwise noted, the term video cable describes both Smart Cables and video cables. For information on compatibility between video laryngoscopes, batons, cables, and monitors, see Compatibility on page 11. Figure 5.

GlideScope Cables*

Spectrum Smart Cable

GlideScope Core Video Cable

Titanium Video Cable

GlideScope Core Smart Cable GlideScope Core QuickConnect Cable

COMPATIBILITY GlideScope components may be compatible with other GlideScope product lines. The following tables show the component compatibility between monitors, video cables, and scopes. For information specific to your monitor, see verathon.com/product‑documentation, or contact Verathon Customer Care. Table 1.

GlideScope Core Compatibility MONITOR

GlideScope Core

VIDEO CABLE

SCOPE

To Monitor To Scope GlideScope Core Video Cable

Titanium reusable blades

To Monitor To Scope GlideScope Core Smart Cable

Video Baton 2.0 Large (3‑4)

Spectrum Single‑Use blades

To Monitor To Scope GlideScope Core QuickConnect cable

GlideScope Video Baton QC Large

* Cables have been shortened for illustrative purposes. For cable dimensions, see Component Specifications on page 27

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Table 2.

GlideScope Video Monitor (GVM) Compatibility MONITOR

VIDEO CABLE

To Monitor

SCOPE

To Scope

Titanium Video Cable

To Monitor

To Scope

Spectrum Smart Cable

GlideScope Video Monitor

Titanium Reusable

Video Baton 2.0 Large (3‑4)

Spectrum Single‑Use blades

Video Baton 3‑4

Video Baton 1‑2

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COMPONENTS VIDEO LARYNGOSCOPES Figure 6.

Titanium & Spectrum Video Laryngoscope Components

2

1

1 2 4

4

3

3

5

5

1

1

2

2 6

4

4 3

Table 3.

3

Video Laryngoscope Components

FIGURE KEY

COMPONENT

NOTES

1

Connector

-

2

Handle

-

3

Blade

Various styles, sizes, and construction.

4

Distal tip

-

5

Camera and light

High‑resolution, full‑color camera with integrated LED light source

6

Product number and serial number

On the left side of the handle of reusable video laryngoscopes.

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BATONS Figure 7.

Video Baton Components

7

1

3

6 2

5

8

4

4

Table 4.

Video Baton Components

FIGURE KEY

COMPONENT

NOTES

1

Connector

-

2

Handle

-

3

Baton

Reusable camera compatible with Single‑Use GVL Stats.

4

Distal tip

-

5

Camera and light

High‑resolution, full‑color camera with integrated LED light source.

6

Label

Product number and serial number. Located the right side of the video baton handle.

7

Video cable

-

8

Single‑Use GVL Stat

-

VIDEO CABLES Figure 8.

Video Cable Components

2

1

Table 5.

3

Video Cable Components

FIGURE KEY

COMPONENT

NOTES

1

Connector

Cables are available with several connector configurations. For more information, see Compatibility on page 11.

2

Cable*

-

3

Electronics

Smart cables only.

* Cable have been shortened for illustrative purposes.

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SETTING UP Please read the Warnings & Cautions section before performing the following tasks. This chapter contains information on connecting a video monitor, video cable, and scope. The video cable attaches the scope to the monitor, supplying power to the component and transmitting video data from the scope’s camera to the monitor. Before you can use the system for the first time, you must inspect the components, set up the system, and perform a functional test as recommended by Verathon. Complete the following procedures: 1. Perform Initial Inspection-Inspect components for any obvious physical damage that may have occurred during shipment. 2. Attach the Video Cable to the Monitor-Attach the video cable that provides power to the scope, and transmits the video signal to the monitor. 3. Attach the Scope to the Video Cable-Attach the scope that houses the camera and light. 4. Perform a Functional Check-Before you use the device for the first time, perform a functional check to ensure that the system is working properly.

Procedure 1.

PERFORM INITIAL INSPECTION

When you receive a component, Verathon recommends that an operator familiar with it perform a full visual inspection for any obvious physical damage that may have occurred during shipment. 1. Verify that you have received the appropriate components for your system by referring to the packing list included with the system. 2. Inspect the components for damage. 3. If any of the components are missing or damaged, notify the carrier and Verathon Customer Care or your local representative. For contact information, visit verathon.com/global‑support.

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