GlideScope Cobalt AVL Single Use System Operations and Maintenance Manual Rev Jan 2021

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GLIDESCOPE SYSTEM

COBALT AVL SINGLE‑USE

Operations & Maintenance Manual Effective: January 15, 2021

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

For customers with GlideScope systems using the GlideScope Cobalt AVL Video Monitor (version 0570‑0304).

CONTACT INFORMATION To obtain additional information regarding your GlideScope system, please contact Verathon® Customer Care or visit verathon.com/support. Verathon Inc. 20001 North Creek Parkway Bothell, WA 98011 U.S.A. Tel: 800.331.2313 (US and Canada only) Tel: 425.867.1348 Fax: 425.883.2896 verathon.com

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 (Canada) ULC 2227 Douglas Road Burnaby, BC V5C 5A9 Canada Tel: 604.439.3009 Fax: 604.439.3039

Copyright © 2021 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. GlideRite, GlideScope, the GlideScope symbol, GVL, 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. 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.

TABLE OF CONTENTS IMPORTANT INFORMATION...1 Product Information...1 Statement of Intended Use...1 Essential Performance...1 Statement of Prescription...1 Notice to All Users...1 Precautions & Warnings...2 Product Description...7 INTRODUCTION...10 System Parts & Accessories... 10 Video Laryngoscope Components... 12 Buttons, Icons, & Connections ... 13 SETTING UP...16 Procedure 1.

Perform Initial Inspection... 16

Procedure 2.

Mount the Cobalt AVL Monitor (Optional)... 17

Procedure 3.

Attach the Video Baton Cradle (Optional)... 19

Procedure 4. Charge the Monitor Battery...20 Procedure 5.

Connect the Video Cable... 21

Procedure 6. Connect to an External Monitor (Optional)...22 Procedure 7.

Configure User Settings...23

Procedure 8. Perform a Functional Check...25

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USING THE DEVICE...26 Procedure 1.

Connect the Video Cable to the Monitor... 27

Procedure 2.

Insert the Video Baton into the Stat (Single‑Use Only)...28

Procedure 3.

Prepare the GlideScope System...28

Procedure 4. Intubate Using the GlideScope 4‑Step Technique...29 Procedure 5.

Intubate Using the GlideScope Direct...30

Procedure 6. Use the Recording Feature (Optional)... 31 CLEANING & DISINFECTING...34 General Information...34 MAINTENANCE & SAFETY...36 Inspections...36 Cobalt AVL Monitor Battery...36 System Software...36 Device Repair...37 Device Disposal...37 WARRANTY...38 PRODUCT SPECIFICATIONS...40 System Specifications...40 Component Specifications...40 Battery Specifications...46 Electromagnetic Compatibility...47 GLOSSARY... 51

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IMPORTANT INFORMATION PRODUCT INFORMATION The GlideScope® Cobalt AVL Single‑Use video laryngoscope system is designed for “1st Pass Success.” It provides a consistently clear view of a patient’s airway, enabling quick intubations. The AVL design is based on the GlideScope GVL®, which is clinically proven to achieve a Cormack‑Lehane Grade I or II view 99 percent of the time.*

STATEMENT OF INTENDED USE The GlideScope Cobalt AVL Single‑Use system is intended for use by qualified medical 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. The essential performance of the GlideScope AVL system is to provide a clear view of the vocal cords.

STATEMENT OF PRESCRIPTION Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. This system 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 the system. Failure to do so may result in injury to the patient, 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

* Cooper RM, Pacey JA, Bishop MJ, McCluskey SA. Early clinical experience with a new videolaryngoscope (GlideScope) in 728 patients. Can J Anaesth. 2005;52(2):191‑198.

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PRECAUTIONS & WARNINGS 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. PRECAUTIONS 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 on page 47. To maintain electromagnetic interference (EMI) within certified limits, the GlideScope AVL system must be used with the cables, components, and accessories specified or supplied by Verathon®. For additional information, see the System Parts & Accessories and Product Specifications sections. The use of accessories or cables other than those specified or supplied may result in increased emissions or decreased immunity of the system. The GlideScope system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it will be used. This device can radiate radio frequency energy and is very 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.

CAUTION The system contains electronics that could 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 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 Ensure that you do not use any abrasive substances, brushes, pads, or tools when cleaning the video monitor screen. The screen can be scratched, permanently damaging the device.

CAUTION Risk of permanent equipment damage. This product is sensitive to heat, which will cause 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 will cause permanent device damage and void the warranty. For a list of approved cleaning procedures and products, see the Cleaning & Disinfecting chapter. WARNINGS WARNING Several areas of the Stat 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. When used as indicated, continuous contact with this area is unlikely because, if tissue were to contact this area, the view would be lost and devices would need to be adjusted to regain the airway view. • The second area is the area surrounding the camera, out of view of the camera. Continuous contact with this area is unlikely because the product is typically not held stationary for an extended period of time exceeding 1 minute. If continuous contact is maintained for longer than 1 minute, it is possible to cause thermal damage such as a burn to the mucosal tissue.

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WARNING If the GlideScope Direct is powered on for an extended period of time, it is possible for the surface temperature to exceed 41°C (106°F) at the tip of the blade, where the lighting and camera are located.

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 video monitor screen. Failure to do so may result in injury to the tonsils or soft palate.

WARNING Before every use, ensure the instrument is operating correctly and has no sign of damage. Do not use this product if the device appears damaged. 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/support.

WARNING GlideScope systems are delivered nonsterile and require cleaning or disinfection prior to initial 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. For more information, visit www.osha.gov.

WARNING Ensure that you follow the manufacturer’s instructions for handling and disposing of the cleaning, disinfection, or sterilization solutions provided in this manual.

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/support.

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WARNING This product may only be cleaned, disinfected, or sterilized by using the approved low‑temperature processes provided in this manual. Cleaning, disinfection, and sterilization methods listed are recommended by Verathon® based on efficacy or compatibility with component materials.

WARNING Cleaning is critical to ensuring a component is ready for disinfection or sterilization. Failure to properly clean the device could 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 Do not place the video baton in the cradle if any of the components are contaminated.

WARNING In order to maintain electrical safety, use only the provided, medical‑approved power supply.

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 will void the warranty. Contact Verathon Customer Care for all servicing needs.

WARNING No modification of this equipment is allowed.

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WARNING The external monitor must be safety‑approved medical equipment.

WARNING Use only a passive‑type USB flash drive. Do not use USB drives powered by another external source.

WARNING When cleaning the power adapter, use a cloth dampened with isopropyl alcohol on the outside of the enclosure. Do not immerse the power adapter in water.

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

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

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PRODUCT DESCRIPTION The GlideScope AVL system is an ideal tool for physicians and other healthcare professionals who need to effectively manage routine to difficult airways. It is useful for the intubation of normal airways, anterior airways, neonatal patients, obese patients, and patients with limited neck extension. Additionally, it is useful for teaching purposes, verification of endotracheal tube (ETT) placement, nasal intubation, and ETT exchange. The AVL is easy to learn, use, and teach. It is ideal for acute care settings and emergency environments. It also integrates into standard ED, OR, ICU, and NICU applications. The AVL system combines a high‑resolution, full‑color digital camera with an integrated LED light source and Reveal™ anti‑fog feature. The AVL video batons and GlideScope Direct blade connect directly to a full‑color, digital video monitor for real‑time viewing. The AVL system is recommended for use with an endotracheal tube stylet, particularly the GlideRite® Rigid Stylet, which complements the AVL blade angle. For more information about the stylet, see the GlideRite Rigid Stylet Operations and Maintenance Manual.

COBALT AVL MONITOR The monitor can store up to one hour of video (approximately 40 typical intubations), which you can download to a USB flash drive for archiving and further review. The monitor also has a DVI video output through an HDMI connector. It is recommended that you use the HDMI‑to‑DVI cable provided by Verathon® to connect to an external monitor that is approved for medical use. You can operate the monitor by connecting it to the medical‑grade power supply provided by Verathon or by using the internal, rechargeable lithium‑ion battery. Verathon creates software updates for the Cobalt AVL Monitor as needed. This manual documents the most current version of the Cobalt AVL Monitor software. If your monitor does not function as described in this manual, or to determine if your software should be updated, contact Verathon Customer Care. Figure 1.

Cobalt AVL Monitor

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SINGLE‑USE SYSTEM The AVL single‑use system can be used with a choice of two video batons and multiple GVL® Stats. Single‑use GVL Stats are offered in a comprehensive range of sizes, allowing clinicians to meet the particular requirements of patients ranging in size from preterm infants to morbidly obese adults. The system may include the following components:­­ • Cobalt AVL Monitor • AVL Video Baton 1‑2 (for neonatal patients and small children) ○ GVL 0 Stat, for patients less than 1.5 kg (3.3 lbs)* ○ GVL 1 Stat, for patients between 1.5–3.8 kg (3.3–8.4 lbs)* ○ GVL 2 Stat, for patients between 1.8–10 kg (4–22 lbs)* ○ GVL 2.5 Stat, for patients between 10–28 kg (22–61.7 lbs)* • AVL Video Baton 3‑4 (for use on children and adults) ○ GVL 3 Stat, for patients between 10 kg–adult (22 lbs–adult)* ○ GVL 4 Stat, for patients between 40 kg–morbidly obese (88.2 lbs–morbidly obese)* • GlideRite® Rigid Stylet (recommended for use with the AVL Video Baton 3‑4) * Weight ranges are approximate; a medical professional must evaluate on a patient‑by‑patient basis. Figure 2.

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GlideScope AVL Single‑Use System

GLIDESCOPE DIRECT INTUBATION TRAINER The GlideScope Direct intubation trainer is designed to work with the Cobalt AVL Monitor. The GlideScope Direct resembles a traditional Macintosh direct laryngoscope with the addition of a video camera near the end of the blade, permitting both direct laryngoscopy and a video display of the airway. This provides the user with a laryngeal view, permits mentoring by an instructor, and combined with the system monitor allows the image to be captured for documentation, quality control, and teaching. The GlideScope Direct intubation trainer does not provide the same benefits of GlideScope video laryngoscopes in settings when a line of sight cannot be achieved. Typically, these occur in patients with difficult (Cormack‑Lehane grade 3 or 4) airways. It will, however, facilitate the instruction of direct laryngoscopy. Should the GlideScope Direct fail to provide an adequate laryngeal view, the airway manager can easily convert to an AVL single‑use video baton and GVL® Stat for an optimal view. Figure 3.

GlideScope Direct Intubation Trainer

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INTRODUCTION SYSTEM PARTS & ACCESSORIES The GlideScope AVL system consists of the following components. Table 1.

System Components PARTS & ACCESSORIES

Required Components Cobalt AVL Monitor

Video batons (for Single‑Use system only)

GVL® Stat sizes 0, 1, 2, 2.5, 3, and 4 (for Single‑Use system only)

Video monitor 12 V DC power adapter

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Power cord

PARTS & ACCESSORIES

Optional Components GlideScope Premium Cart

Mobile stand

Universal accessory basket Note: For use with AVL portable stand

Cradle for video baton

GlideScope Direct Intubation Trainer

IV pole mounting kit

HDMI‑to‑DVI cable

GlideRite® Rigid Stylet

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VIDEO LARYNGOSCOPE COMPONENTS Figure 4.

AVL Single‑Use Video Laryngoscope Components Single‑use Stat

Video baton

Video cable

Camera and light

Figure 5.

GlideScope Direct Intubation Trainer

Video cable (Shortened for illustration)

Handle

Connector (Attaches to the monitor) Lifter blade

Cleaning cap Camera and light

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BUTTONS, ICONS, & CONNECTIONS The main component of the GlideScope AVL system is the digital, full‑color monitor. The front of the monitor includes the screen and the buttons you use to operate the system. The back panel of the monitor includes the sockets and ports for connecting the 12 V DC power adapter, the video 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 is inserted into the opening. This protects the exposed connectors from dust and other contamination. The back of the video monitor also features a mounting plate fitting that allows you to attach the monitor to a premium cart, mobile stand, or IV pole. Figure 6.

Cobalt AVL Monitor Keypad Record button

Power button

Table 2.

External Video button

Download Video 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. Record: Press to start and stop recording video. 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. Download Video: Press to download video clips from the device to a USB flash drive. 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 feature has been activated. Press the button again to deactivate the external video. Note: An HDMI‑to‑DVI cable is required in order to display video on an external monitor. Tutorial: Press and hold for three seconds to play a video tutorial about the GlideScope 4‑Step Technique. Battery Indicator: LED is: Green: Unit fully charged Red: Unit charging Flashing Red: Indicates a problem with the battery. Charge for 12 hours, and if the LED is still flashing, contact Verathon® Customer Care.

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Table 3.

On‑Screen Icons ICON

FUNCTION

Battery Status: The remaining battery power is indicated by the Battery Status icon. If the icon is red, the battery should be charged as soon as possible. (See Charge the Monitor Battery.) Cancel Operation: Indicates the button that cancels the current operation, moves to the previous screen, or returns to the main menu. 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. Download New: Indicates the button that downloads the video clips that have not previously been downloaded. Download All: Indicates the button that downloads all stored video clips, whether they have previously been downloaded or not. Cancel Download: Indicates the button that cancels the video download currently in progress.

USB Flash Drive Not Found: A flash drive needs to be inserted into the USB port.

Attach Video Cable: The video baton or video laryngoscope is not attached to the monitor.

Recording: The system is recording video. Saving File: The system is saving a video clip to its internal memory.

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