GlideScope AVL SYSTEM Operations and Maintenance Manual August 2014

GLIDESCOPE

AVL SYSTEM

Operations & Maintenance Manual IMPORTANT This manual is intended for use in Canada only. If you are outside of Canada, visit verathon.com or contact Verathon® Customer Care in order to access the appropriate GlideScope AVL System Operations & Maintenance Manual (version 0900-4200). For contact information, visit verathon.com/contact-us.

Effective: August 18, 2014

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

For customers with GlideScope systems utilizing the GlideScope Video Monitor (version 0570‑0338).

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

Verathon Medical (Europe) B.V. Linnaeusweg 11 3401 MS IJsselstein The Netherlands +31.30.68.70.570 Fax: +31.30.68.70.512 verathon.eu

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

Copyright© 2013, 2014 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 online manuals at verathon.com. GlideScope video laryngoscope systems are CE marked in accordance with the Medical Device Directive, and the Verathon Inc. quality system is Quality System Certified to ISO 13485:2012 standards.

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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 GlideScope Video Monitor... 7 Single Use System... 8 Reusable System... 9 GlideScope Direct Intubation Trainer...10 INTRODUCTION... 11 SYSTEM PARTS & ACCESSORIES... 11 LANGUAGE SETTINGS...12 VIDEO LARYNGOSCOPE COMPONENTS...13 BUTTONS, ICONS, & CONNECTIONS ...14 SETTING UP...17 Procedure 1. Perform Initial Inspection...17 Procedure 2. Mount the GlideScope Video Monitor (Optional)... 18 Procedure 3. Attach the Cradle (Optional)...22 Procedure 4. Charge the Monitor Battery...24 Procedure 5. Connect the Video Cable...25 Procedure 6. Connect to an External Monitor (Optional)... 26 Procedure 7. Configure User Settings...27 Procedure 8. Perform a Functional Check...28

Operations & Maintenance Manual: Table of Contents

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USING THE DEVICE...30 Procedure 1. Connect the Video Cable to the Monitor... 31 Procedure 4. Insert the Video Baton into the Stat (Single Use Only)... 32 Procedure 2. Prepare the GlideScope System...33 Procedure 3. Intubate Using the GlideScope 4‑Step Technique... 33 Procedure 5. Intubate Using the GlideScope Direct... 35 Procedure 6. Use the Record & Snapshot Features (Optional)... 36 Procedure 7. Use the Playback Feature (Optional)...38 TIPS FOR USING THE GLIDESCOPE AVL SYSTEM...39 TIPS FOR WORKING WITH ENDOTRACHEAL TUBES...39 CLEANING & DISINFECTING...40 GENERAL INFORMATION...40 Procedure 1. Clean the GlideScope Video Monitor...42 Procedure 2. Clean the Cradle...43 Procedure 3. Clean & Sterilize the GlideRite Rigid Stylet... 43 REUSABLE SYSTEM...44 Procedure 1. Clean & Disinfect the Reusable Blade...44 Procedure 2. Inspect the Reusable Blade...46 SINGLE USE SYSTEM...47 Procedure 1. Remove the Stat...47 Procedure 2. Clean & Disinfect the Video Baton...48 Procedure 3. Inspect the Video Baton...50 DIRECT INTUBATION TRAINER...51 Procedure 1. Clean & Disinfect the GlideScope Direct... 51 MAINTENANCE & SAFETY...53 INSPECTIONS...53 GLIDESCOPE VIDEO MONITOR BATTERY...53 SYSTEM SOFTWARE...53 DEVICE REPAIR...54 DEVICE DISPOSAL...54

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WARRANTY...55 Original First Year Total Customer Care Warranty...55 Premium Customer Care Warranty...56 Disclaimer of Additional Warranties...56 PRODUCT SPECIFICATIONS...57 SYSTEM SPECIFICATIONS...57 COMPONENT SPECIFICATIONS...58 General Components...58 Single Use System...60 Reusable System...64 Direct Intubation Trainer...66 ELECTROMAGNETIC COMPATIBILITY...67 Electromagnetic Emissions...67 Electromagnetic Immunity...68 Recommended Separation Distances...70 Accessory Conformance to Standards...70 SYMBOL DIRECTORY...71 GLOSSARY...74

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IMPORTANT INFORMATION PRODUCT INFORMATION The GlideScope® AVL Reusable and Single Use video laryngoscope systems are designed for “1st Pass Success.” They provide 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.1

STATEMENT OF INTENDED USE The GlideScope AVL system is intended for use by qualified professionals to obtain a clear, unobstructed view of the airway and vocal cords for medical procedures.

ESSENTIAL PERFORMANCE

STATEMENT OF PRESCRIPTION Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. The GlideScope AVL 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 GlideScope AVL 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

1 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.

Operations & Maintenance Manual: Important Information

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REUSABLE & SINGLE USE

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.

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. To ensure safe and reliable operation for the user and patient, 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 67.

REUSABLE & SINGLE USE

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 AVL 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 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 disinfect 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.

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CAUTION The video batons and video laryngoscopes contain 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. CAUTION When cleaning reusable video laryngoscopes and video batons, 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.

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. WARNINGS WARNING Several areas of the video laryngoscope or 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 where the anti-fog feature is located. 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. Note: Typical intubations are less than 1 minute in duration.

Operations & Maintenance Manual: Important Information

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REUSABLE & SINGLE USE

CAUTION

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 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.

REUSABLE & SINGLE USE

To ensure patient safety, routinely inspect the GlideScope video laryngoscope blade before and after every use to ensure the blade is free of rough surfaces, sharp edges, cracks, protrusions, shell separation, surface delamination, or any other indication of wear. If found, do not use the damaged or worn blade, otherwise blade breakage may occur and could cause patient injury or death. Always ensure that alternative airway management methods and equipment are readily available. Report any suspected blade defects to Verathon® Customer Care at: Phone: 800.331.2313 (U.S. and Canada) 425.867.1348 (International) Email: [email protected] WARNING AVL Reusable video laryngoscopes and the GlideScope Direct intubation trainer are delivered nonsterile and require cleaning and high-level disinfection prior to initial use. WARNING Because the product will likely 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.

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WARNING Ensure that you follow the manufacturer’s instructions for handling and disposing of the cleaning and disinfection 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 at 1.800.331.2313 or your local representative. For contact information, visit verathon.com/contact-us. 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.

The reusable 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 Cleaning is critical to ensuring the component is ready for disinfection. Failure to properly clean the device could result in a contaminated instrument after completing the disinfection 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 GlideScope AVL video baton or reusable video laryngoscope 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.

Operations & Maintenance Manual: Important Information

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REUSABLE & SINGLE USE

WARNING

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.

WARNING REUSABLE & SINGLE USE

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.

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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 GlideScope 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 or blades 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.

GLIDESCOPE VIDEO MONITOR

Verathon occasionally makes software updates available for the GlideScope video monitor. This manual documents the most current version of the GlideScope Video 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.

GlideScope Video Monitor

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REUSABLE & SINGLE USE

The monitor can record video and photos directly to a USB flash drive for archiving and further review. The monitor 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 AVL by connecting it to the medical-grade power supply provided by Verathon or by using the internal, rechargeable lithium-ion battery.

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: • GlideScope Video Monitor • AVL Video Baton 1-2 (for neonatal patients and small children) ○○ GVL 0 Stat (patients less than 1.5 kg)* ○○ GVL 1 Stat (patients between 1.5–3.8 kg)* ○○ GVL 2 Stat (patients between 1.8–10 kg)* ○○ GVL 2.5 Stat (patients between 10–28 kg)* • AVL Video Baton 3-4 (for use on children and adults) ○○ GVL 3 Stat (patients between 10 kg–adult)* ○○ GVL 4 Stat (patients between 40 kg–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.

SINGLE USE

Figure 2.

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GlideScope AVL Single Use System

REUSABLE SYSTEM AVL Reusable video laryngoscopes are designed to work with the GlideScope Video Monitor. The scopes incorporate a high-resolution digital camera and LED lighting to provide views of anterior airways. The system is recommended for use with an endotracheal tube stylet, particularly the GlideRite® Rigid Stylet. The system may include the following components: • GlideScope Video Monitor • AVL reusable video laryngoscopes ○○ GVL® 2 (patients between 4–20 kg)* ○○ GVL 3 (patients between 10 kg–adult)* ○○ GVL 4 (patients between 40 kg–morbidly obese)* ○○ GVL 5 (patients between 40 kg–morbidly obese)* • GlideRite Rigid Stylet (recommended) * Weight ranges are approximate; a medical professional must evaluate on a patient-by-patient basis. Figure 3.

GlideScope AVL Reusable System

REUSABLE

Operations & Maintenance Manual: Important Information

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GLIDESCOPE DIRECT INTUBATION TRAINER The GlideScope Direct intubation trainer is designed to work with the GlideScope Video 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 AVL 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 a GlideScope AVL reusable blade or to a single-use video baton and GVL® Stat for an optimal view.

INTUBATION TRAINER

Figure 4.

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GlideScope Direct Intubation Trainer

INTRODUCTION SYSTEM PARTS & ACCESSORIES The GlideScope AVL systems consist of the following components. Table 1.

System Components PARTS & ACCESSORIES

Required Components GlideScope Video Monitor

Video batons (for Single Use system only)

REUSABLE & SINGLE USE

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

AVL video laryngoscopes (for Reusable system only) GVL 2

GVL 3

Video monitor 12V DC power adapter

Operations & Maintenance Manual: Introduction

GVL 4

GVL 5

Power cable

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PARTS & ACCESSORIES

Optional Components

REUSABLE & SINGLE USE

Mobile stand

GlideScope Direct

GlideRite® Rigid Stylet

Universal accessory basket

Cradle for reusable blade

Cradle for video baton

IV pole mounting kit

HDMI‑to‑DVI cable

LANGUAGE SETTINGS The GlideScope 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/contact-us.

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VIDEO LARYNGOSCOPE COMPONENTS Figure 5.

AVL Reusable Video Laryngoscope Components

Camera and light

Video cable

Distal tip/lifter Handle Blade

Product number and serial number (On the right side of the handle-not pictured)

Figure 6.

AVL Single Use Video Laryngoscope Components Video baton

Single-use Stat

Video cable

Blade Camera and light

REUSABLE & SINGLE USE

Figure 7.

GlideScope Direct Intubation Trainer

Video cable (Shortened for illustration)

Handle

Connector (Attaches to the monitor) Lifter blade

Cleaning cap Camera and light

Operations & Maintenance Manual: Introduction

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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 AVL system. The back panel of the monitor includes the sockets and ports for connecting the power cord, 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 mobile stand or IV pole. Figure 8.

GlideScope Video Monitor Keypad Record button

Power button

REUSABLE & SINGLE USE

Table 2.

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 for three seconds 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. 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 feature has been activated. Press the button again to deactivate the external video. Tutorial: If a USB flash drive is not inserted into the monitor, press and hold for three seconds to access the video tutorial. If a USB flash drive is inserted into the monitor, press and hold for three seconds to access the Playback menu. Note: The Playback menu is only accessible if the GlideScope Video Monitor is operating software version 3.4 or higher and if a USB flash drive is inserted in the monitor. 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®.

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