GlideScope Core Operations and Maintenance Manual Dec 2016

GLIDESCOPE

CORE

Operations & Maintenance Manual Effective: December 21, 2018

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/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 (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: +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

Copyright © 2018 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, Core, GVL, GlideRite, Reveal, Verathon, and the Verathon Torch symbol are trademarks or registered 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 Product Description...1 Statement of Intended Use...1 Essential Performance...1 Environments of Intended Use...1 Statement of Prescription...1 HIPAA Privacy...1 Notice to All Users...2 Cautions & Warnings...2 INTRODUCTION...6 GlideScope Core...6 System Parts & Accessories...7 Buttons, Icons, & Connections...8 SYSTEM FEATURES... 14 Home Screen... 14 Gallery... 15 SETTING UP...16 Procedure 1.

Perform Initial Inspection... 16

Procedure 2.

Mount the System (Optional)... 17

Procedure 3.

Charge the Monitor Battery...20

Procedure 4. Complete the Setup Wizard (Optional)... 21 Procedure 5.

Configure User Settings (Optional)... 24

Procedure 6. Attach the Video Cable and Scope... 27 Procedure 7.

Attach the USB Device (Optional)...29

Procedure 8. Connect to an External Monitor (Optional)...30 Procedure 9.

Perform a Functional Check... 31

i Operations & Maintenance Manual: Table of Contents

USING THE DEVICE...32 Procedure 1.

Prepare the System...32

Procedure 2.

Use a USB Pulse Oximeter...33

Procedure 3.

Adjust Picture-in-Picture...34

Procedure 4. Rotate the Display...35 Procedure 5.

Record Video or Take a Snapshot...35

Procedure 6. Use the Gallery...36 CLEANING & DISINFECTING... 41 Procedure 1.

Clean the Video Monitor...43

Procedure 2.

Clean the Workstation and Power Adapter...43

Procedure 3.

Clean a Video Cable...43

MAINTENANCE & SAFETY...45 Periodic Inspections...45 GlideScope Core Battery...45 System Software...45 Device Repair...46 Device Disposal...46 LIMITED WARRANTY...47 PRODUCT SPECIFICATIONS...49 System Specifications, Standards, & Approvals...49 Component Specifications...49 Battery Specifications... 51 Electromagnetic Compatibility... 51 GLOSSARY...55

ii

IMPORTANT INFORMATION PRODUCT INFORMATION The GlideScope Core monitor provides the ability to attach a wide range of accessories, allowing for innovative system configurations. With two input connections, the system allows users to switch between different scopes without needing to disconnect and reconnect, or to have two different instruments connected for use simultaneously with picture-in-picture options.

PRODUCT DESCRIPTION The GlideScope Core monitor, in conjunction with reusable and Spectrum single‑use video laryngoscopes, is designed to deliver clear airway views and enable rapid intubation. Low‑profile designs and innovative construction make these blades streamlined and lightweight, offering improved maneuverability and working space for routine and difficult airways. With more scope options, including Mac‑style laryngoscopes, clinicians can choose their preferred tools for a wide range of patients and clinical settings. And whether it’s reusable or single‑use, the system features a high‑resolution, full‑color digital camera and monitor for real‑time viewing and recording. For more information on compatible scopes, please see the GlideScope Video Laryngoscopes Operations and Maintenance Manual available at verathon.com/product‑documentation.

STATEMENT OF INTENDED USE The monitor and workstation are intended to work with video laryngoscopes, in conjunction with other ancillary equipment, for laryngoscopy within the airway.

ESSENTIAL PERFORMANCE When connected to compatible camera components (such as a video laryngoscope), the essential performance of the monitor is to support these components in displaying a clear, unobstructed view of the airway for medical procedures.

ENVIRONMENTS OF INTENDED USE The GlideScope Core system is intended to be used in Professional Healthcare Environment.

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

HIPAA PRIVACY The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) regulation require our customers to monitor and limit the ways in which patients’ confidential information is accessed, utilized, stored, transmitted, and disposed. Our customers are ultimately responsible for ensuring all electronic health information contained within the system is protected. In the course of providing the services to customers, Verathon will remove all electronic protected health information from the system if present.

1 Operations & Maintenance Manual: Important Information

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, may compromise the performance of the system, and may void the system warranty. Verathon recommends that new users: • Obtain instruction from a qualified individual • Practice using video laryngoscopes on a mannequin before clinical use • Acquire clinical training experience on patients without airway abnormalities

CAUTIONS & 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 51. 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.

2

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.

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.

WARNINGS 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. 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/support.

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.

WARNING This product may only be cleaned by using the approved processes provided in this manual. Cleaning methods listed are recommended by Verathon based on efficacy or compatibility with component materials.

WARNING Availability of cleaning products varies by country, and Verathon is unable to test products in every market. For more information, please contact Verathon Customer Care. For contact information, visit verathon.com/support.

3 Operations & Maintenance Manual: Important Information

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

WARNING This instrument and related devices may contain mineral oils, batteries, and other environmentally hazardous materials. When the instrument or accessories have reached the end of their useful service life, see the section Device Disposal on page 46. Dispose of used, single‑use components as infectious waste.

WARNING In order to maintain the electrical safety of the system, the external monitors must be certified to IEC 60601-1, IEC 60950-1 or equivalent standards.

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

WARNING In order to maintain electrical safety, use only the provided power supply. Connect the power cord and power adapter to a properly grounded plug, and ensure the disconnect is easily accessible. Use only the accessories and peripherals recommended by Verathon.

WARNING No modification of this equipment is allowed.

WARNING Electric shock hazard. Do not attempt to open the system components. This may cause serious injury to the operator or damage to the instrument and will void the warranty. Contact Verathon Customer Care for all servicing needs.

4

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

WARNING Stored mechanical energy hazard. The premium workstation arm mechanism is under tension. When the monitor is removed, it can move up rapidly on its own. Ensure the arm is at its highest position before removing the monitor.

WARNING To reduce the risk of electrical shock, before cleaning the monitor or workstation, ensure the monitor is powered off and the power supply has been disconnected from both the monitor and AC power.

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 system should be excluded from any magnetic resonance (MR) environment.

WARNING Use of accessories, transducers, and cables other than those specified or provided by Verathon could result in increased electromagnetic emissions or decreased Electromagnetic Immunity of this equipment and could result in improper operation.

WARNING Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the GlideScope Core system including cables specified by Verathon, otherwise degradation of performance of this equipment could result.

5 Operations & Maintenance Manual: Important Information

INTRODUCTION GLIDESCOPE CORE The monitor is compatible with the following single‑use and reusable scopes: • Spectrum Single‑Use blades • Titanium Reusable blades • Video Batons and Stats The monitor uses scopes and connecting cables, along with optional system components to help facilitate intubations, endoscopy, or provide convenience to the user. You may use either single‑use or reusable components, or your facility may elect to provide both. This manual details how to use the monitor and provides limited information on how to connect scopes. For more information on compatible scopes, see the GlideScope Video Laryngoscope Operations & Maintenance Manual available at verathon.com/product‑documentation, or contact Verathon Customer Care. In this document, unless otherwise noted, the term video cable describes all possible cable configurations for reusable blades, single‑use blades, and video batons.

SINGLE‑USE OPTIONS Single-use Spectrum blades and the video baton 2.0 connect to the monitor through the reusable GlideScope Core Smart Cable. Single‑use video laryngoscopes are identified by an S in the blade name, such as LoPro S4. Video batons use single‑use GVL Stats which are offered in a comprehensive range of sizes, allowing clinicians to meet the particular requirements of patients ranging in size from preterm infants to large adults. All single-use components must be disposed of after one use. IMPORTANT

T

Single‑use blades in S3 and S4 sizes may also be available in white. These are not part of the Spectrum Single‑Use system. For more information about the white blades, see the GlideScope Titanium Single‑Use Operations and Maintenance Manual at verathon.com/product‑documentation.

REUSABLE OPTIONS Titanium video laryngoscopes must be cleaned and high‑level disinfected between uses. These connect to the video monitor through the reusable GlideScope Core Video Cable. Due to their titanium construction, reusable video laryngoscopes contain a T in the blade name, such as LoPro T4.

6

SYSTEM PARTS & ACCESSORIES Table 1.

Required System Components REQUIRED PARTS & ACCESSORIES

GlideScope Core Video Monitor

12V DC power adapter

Power cable

Video cable*†

One or more of the following scope styles: Spectrum Single‑Use Blades†

Video Batons and Single‑Use Stats†

Titanium Reusable Blades†

* Cable shortened for illustration purposes. † For a full list of compatible cables and video scopes, please see the GlideScope Video Laryngoscope Operations & Maintenance Manual

7 Operations & Maintenance Manual: Introduction

Table 2.

Optional System Components* OPTIONAL PARTS & ACCESSORIES

Nonin 3231 USB External Pulse Oximeter* Basic workstation

GlideRite Single‑Use Stylet (Small) For ET tubes 3.0–4.0 mm

Premium workstation

GlideRite DLT Stylet

GlideRite Rigid Stylet

For ET tubes 6.0 mm or larger

For ET tubes 6.0 mm or larger

Media storage USB

Operations and Maintenance Manual USB

BUTTONS, ICONS, & CONNECTIONS The digital, full‑color GlideScope Core Video Monitor clearly displays the images transmitted from the camera in the scope. The front of the monitor includes the button for power and the touchscreen. The back panel of the monitor includes sockets and ports for connecting the power cord, video cables, USB flash drives, and an HDMI cable for an external video display. When the USB and HDMI ports are not in use, it is recommended that the rubber cover be used to protect the openings from dust and other contamination. The back of the monitor also features VESA mounting holes that allow you to attach the monitor to a GlideScope workstation. The following tables provide general information regarding the buttons and icons on the monitor. Table 3.

Monitor Buttons

BUTTON GROUP

Front panel

* Not available in all markets.

8

BUTTON

FUNCTION

Power: This is a physical button located on the bottom left corner of the display. Press and release to turn on the monitor. Press and hold to turn it off. Note: If the monitor locks up or becomes unresponsive for any reason, press and hold the Power button for 7 seconds to turn off the system.

BUTTON GROUP

BUTTON

FUNCTION

Favorites filter: Toggles the favorites filter. When the filter is turned on, the star and toggle will change from gray to gold.

Status bar

Sort by date (Gallery): Select the up arrow down arrow for descending order.

for ascending order or

Record (toggle): Records all visible video feeds. While recording, and depending on the recording status and mode, the record button’s icon will change to one of the following: Video is recording. Press to end recording. Video is recording with audio. Press to end recording. Video recording error. Home screen (left side)-media buttons and main menu

Video with audio recording error. Snapshot button: Takes a photo of the video feed(s). If there is an error, the icon changes to include an Attention symbol:

Note editor button: Launches Note Editor. If there is an error, the icon changes to include an Attention symbol:

Main Menu: Reveals the Main Menu flyout containing the Gallery and Settings buttons, and when enabled the Video Rotation. Gallery: Launches Gallery page. If there is an error, the icon changes to include an Attention symbol:

Main Menu Flyout Settings: Launches Settings page. 180

Video Rotation: Pressing this button rotates video feed(s) 180‑degrees. Can be enables or disabled in the Feature Settings Tab. Features: Displays the Feature Settings page

Settings menu

Regional Settings: Displays the Regional Settings page Administrative Settings: Displays the Admin Settings page

9 Operations & Maintenance Manual: Introduction

BUTTON GROUP

BUTTON

FUNCTION

Switch in the off position. Switch in the on position.

Toggle switches

Note: If the toggle switch modifies a critical option, the switch will turn gold instead of blue when turned on. AB B A A

Home screen (right side)-picture-inpicture options

B

Picture-in-Picture Configurations: Opens the input and picture‑in‑picture menu, or if the menu is already open, select the picture-in-picture configuration for the A and B video feeds.

Video Input Selection: Opens the input and picture‑in‑picture menu, or if the menu is already open, selects either the A or B video feed.

Left Dock: Docks Picture-in-Picture window to left side. Right Dock: Docks Picture-in-Picture window to right side. Close: Closes Picture-in-Picture window, dialog, or editor. Save: Saves editor changes. Note editor Close: Closes editor. Export: Exports selected file. Star: Adds or removes ‘favorite’ status to selected file. Delete: Deletes selected file. Gallery

Back: Returns to previous screen. Select All: When viewing files in the Gallery, check this box to select all files in the row. Note Thumbnail: Indicates the file is a patient note. Tap to open the patient note viewer. Video Thumbnail: Indicates the file is a video. Select to open the video player.

10

BUTTON GROUP

BUTTON

FUNCTION

Copy: After tapping the Export button, select this option to copy the selected files to the USB drive. This leaves a copy in the internal memory. Media Export

Move: After pressing the Export button, select this option to move the selected files to the USB drive. This removes the copy from the internal memory unless the file is marked as favorite. Restart: Rewinds selected video to beginning. Rewind: Rewinds selected video by 20% of the video’s duration. Play Video: Plays selected video. Changes to pause button while video is playing. Pause Video: Pauses the playing video. Changes to play button while video is paused. Fast Forward: Skips selected video by 20% of the video’s duration.

Gallery-video player Volume (toggle): Toggles volume buttons and meter. Volume Up: Turns the volume up. Volume Down: Turns the volume down. Mute: Mutes the volume. When muted, also un-mutes the volume Playhead: Shows the current location in the video. Can be dragged horizontally to jump to a specific location in the video. Table 4.

On‑Screen Icons ICON

FUNCTION

Battery Status: Indicates the remaining battery power and, when available, the estimated time remaining. See Charge the Monitor Battery on page 20 for more information. Favorite: Displays above Gallery files that have been selected as favorites. Power‑Down Countdown: The unit is about to turn off. If this is due to the Auto Shutdown feature, touch the screen to cancel the shutdown. Note: The Auto Shutdown feature can be adjusted or disabled on the Feature Settings screen. For more information, see Complete the Setup Wizard (Optional) on page 21.

11 Operations & Maintenance Manual: Introduction

ICON

FUNCTION

Internal Memory: Displays available internal memory. USB Drive: Displays available USB memory. Shows when a USB drive is attached. Attention: Indicates important text. USB Flash Drive: A USB flash drive is detected.. Hourglass: Advises the operator to wait while the system shuts down. Patient name field: Indicates the patient name text entry field. Device Name: Indicates the device name text entry field. Recording options: Indicates settings for video and audio recording. Video Rotate options: Indicates settings for video rotation. System Sounds: Indicates settings for system sounds. Time zone and daylight savings: Indicates settings for the time zone and daylight savings time. Security Code options: Indicates settings for system security code. Video Timestamps: Indicates settings for video timestamps. Date options: Indicates settings for the system date. Icon for the time editor. Charging indicator: Appears when the monitor is connected to the power adapter. Auto-Shutdown: Indicates settings for Auto-Shutdown. Pulse rate: Appears when an external pulse oximeter is connected to the monitor and receiving readings from the patient. Note Field options: Indicates settings for note fields. Reset Settings: Indicates option to reset system settings to factory default.

12

Figure 1.

GlideScope Core Monitor Front Panel Battery indicator LED: Displays power and battery charge state

Power button: Powers the monitor on or off

Figure 2.

LCD touch screen: Displays images from video accessories and recorded videos and images

GlideScope Core Monitor Back Panel

Video cable ports: Attach video cables or Smart Cables

Connector panel cover: Protects USB, HDMI ports, and power socket from debris

USB ports: Connect USB flash drives to transfer recorded videos or snapshots Product identification: Includes product serial number

Mounting plate area: Connect the monitor to workstation

Video‑out port: Connect an HDMI cable from the external monitor

Power socket: Connect the barrel plug from the 12 V power adapter

13 Operations & Maintenance Manual: Introduction

SYSTEM FEATURES HOME SCREEN The Home screen displays system information and provides access to several options and menus. Date and time

Warning messages

10:55 2018-10-14

USB device connected

Verathon Medical

95 min

A

% SpO2

Pulse Oximeter readings

Device name

98

A

Input A

B

Input B

AB

Picture-in-picture menu

78

Patient notes

Battery level indicator

B

Only shown when two cameras are connected to monitor

Video snapshot Record video Main menu Video Feed B

Video Feed A

STATUS BAR The Status Bar runs along the top of the display. It is shown at all times and can provide the following information depending on the current screen: • Date and Time

• USB connection status

• Warning messages

• Battery status

• Device name

• Organization controls (Gallery)

• System or task status

• Favorites filter (Gallery)

LEFT COLUMN The left column provides access to the Main Menu, Note, and Snapshot buttons, and also the Record Video button when it is enabled in the settings menu. The monitor can also relay SpO2 and pulse-rate readings when a Nonin 3231 USB External Pulse Oximeter is attached. The readings are displayed near the top of the column. Note: If a pulse oximeter is attached to the monitor and is not receiving information from a patient, two dashes (--) are shown instead of a reading.

14

IMPORTANT The SpO2 values displayed on the monitor can be used as a convenient secondary display. These are not intended for patient diagnosis. For direction on using the USB pulse oximeter, please refer to the Nonin instructions for use. RIGHT COLUMN The right column displays an icon for connected scopes. When more than one scope is attached, the picture‑in‑picture settings menu is shown. For more information on the picture-in-picture feature, see Adjust Picture-in-Picture on page 34. VIDEO FEED The main feature of the Home screen is the video feed. This displays the video transmitted from the scopes, or when two scopes are attached, shows both feeds in “picture-in-picture” format. This area can also be mirrored to an external monitor through an HDMI connection.

GALLERY The Gallery allows you to view videos and snapshots that have been recorded and stored on the monitor. From the Gallery you can view patient notes, create favorites, and export files to a USB flash drive to use as a backup or to view on a computer. For information on using the Gallery, see Use the Gallery on page 36. Figure 3.

Main Gallery Screen Favorites filter

Sort by date

Internal storage

10:55 2018-10-14

Video file icon

Verathon Medical 2018-01-06

95 min

11:16

15%

USB available storage

Snapshot file icon

0:27

Internal Storage

60% USBUSB Drive

Patient note icon

2018-03-15

13:44

2018-05-22

10:29

Export Favorite

6:13

Delete 2018-06-01

8:10 0:48

15 Operations & Maintenance Manual: System Features