GlideScope RANGER SINGLE USE Operations and Maintenance Manual Dec 2018

GLIDESCOPE SYSTEM

RANGER SINGLE USE Operations & Maintenance Manual Effective: December 7, 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. 800.331.2313 (US and Canada only) Tel: 425.867.1348 Fax: 425.883.2896 verathon.com

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

Copyright © 2018 by Verathon Inc. All rights reserved. GlideScope, the GlideScope symbol, GlideRite, GVL, 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 Description...1 Statement of Intended Use...1 Essential Performance...1 Statement of Prescription...1 Notice to All Users...1 Precautions & Warnings...2 INTRODUCTION...7 Single‑Use System...7 System Parts & Accessories...8 Monitor Controls & Connections ...9 Video Laryngoscope Components...9 SETTING UP...10 Procedure 1.

Perform Initial Inspection... 10

Procedure 2.

Charge the Monitor... 11

Procedure 3.

Connect a Video Baton... 13

Procedure 4. Perform a Functional Check... 14 USING THE DEVICE... 15 Procedure 1.

Connect a Video Baton... 16

Procedure 2.

Insert the Video Baton into the Stat... 17

Procedure 3.

Prepare the System... 18

Procedure 4. Intubate Using a Video Baton and Stat... 19

i Operations & Maintenance Manual: Table of Contents

CLEANING & DISINFECTING...20 General Information...20 Procedure 1.

Clean the Video Monitor...22

Procedure 2.

Clean the Video Baton Cradle...22

Procedure 3.

Clean the Storage Case...22

Video Baton...22 Procedure 1.

Remove the Stat...22

Procedure 2.

Clean & Disinfect the Video Baton...23

Procedure 3.

Inspect the Video Baton...25

MAINTENANCE & SAFETY...26 Periodic Inspections...26 System Software...26 GlideScope Ranger Battery...26 Device Repair...27 Device Disposal...27 WARRANTY...28 PRODUCT SPECIFICATIONS...30 System Specifications...30 Component Specifications... 31 Electromagnetic Compatibility...36 GLOSSARY...40

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IMPORTANT INFORMATION PRODUCT DESCRIPTION GlideScope Ranger is a portable, compact video laryngoscope that provides a clear, real‑time view of a patient’s airway, enabling quick intubation. The Ranger system is designed for field (military and pre‑hospital) use. Designed for “1st Pass Success” in military and emergency settings, the Ranger system features rugged, high‑impact construction, patented blade angulation, a patented anti‑fogging mechanism, and a non‑glare monitor that is easily visible in bright light. The device is dependable in an array of field conditions, making it ideal for pre‑hospital and critical care situations. The GlideScope Ranger video laryngoscope has been granted Airworthiness Certification from the United States Army. The Ranger is operational in seconds. It is compact for easy carrying and storage. The integrated, rechargeable lithium battery provides a minimum 90‑minute continuous‑use autonomy and allows for approximately 20 intubations per battery cycle (depending on usage).

STATEMENT OF INTENDED USE GlideScope Ranger video laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the 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 Ranger 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, 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

1 Operations & Maintenance Manual: Important Information

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 36. To maintain electromagnetic interference (EMI) within certified limits, the system must be used with the cables, components, and accessories specified or supplied by Verathon®. For additional information, see the System Parts & Accessories and Component 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.

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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 components will cause permanent device damage and void the warranty. For a list of approved cleaning procedures and products, refer to the Cleaning & Disinfecting chapter.

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 The GlideScope Ranger video monitor is manufactured to be IP68 compliant. If the monitor is disassembled during a service procedure, after reassembly, the monitor will not be IP68 compliant.

3 Operations & Maintenance Manual: Important Information

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

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WARNING Availability of cleaning, disinfection, and sterlilization 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.

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

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

WARNING This instrument and related devices may contain 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 27. Dispose of used, single‑use components as infectious waste.

WARNING Several areas of the video laryngoscope 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.

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, such as to the tonsils or soft palate.

5 Operations & Maintenance Manual: Important Information

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 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.

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.

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INTRODUCTION SINGLE‑USE SYSTEM The GlideScope Ranger system is available in a single‑use configuration. It features a video monitor, a reusable video baton, the cables and adapters to power the device, and any optional system components that may facilitate intubations or provide convenience. The laryngoscope is a reusable video baton that is inserted into a single‑use, disposable Stat. The video baton connects to the video monitor and contains the camera and electronics that process the video data captured by the baton. Stats are available in a wide range of sizes, and each size corresponds to one of two video baton sizes. Figure 1.

Ranger Single‑Use System

7 Operations & Maintenance Manual: Introduction

SYSTEM PARTS & ACCESSORIES Table 1.

Required System Components REQUIRED PARTS & ACCESSORIES

Video monitor

Power supply

Video baton 1‑2

GVL Stat 0

Table 2.

GVL Stat 1

Power cable

Video baton 3‑4

GVL Stat 2

GVL Stat 2.5

GVL Stat 3

GVL Stat 4

Optional System Components OPTIONAL PARTS & ACCESSORIES

GlideRite Rigid Stylet ®

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Ranger Transport Bag

Video Baton Cradle & Case

MONITOR CONTROLS & CONNECTIONS The digital, full‑color video monitor displays the images transmitted from the camera in the video baton. The monitor includes the screen and controls you use to operate the system. It contains a lithium battery that provides power to the system. The system must be operated exclusively on battery power, without a connection to an AC power source. Figure 2.

Ranger Video Monitor

Video cable connector (inside cradle)

DC power socket

Power switch

Battery charge status LED

VIDEO LARYNGOSCOPE COMPONENTS Figure 3.

Single‑Use Video Laryngoscope Components Single‑use Stat

Video baton

Video cable

Camera and light

9 Operations & Maintenance Manual: Introduction

SETTING UP 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: • Procedure 1: Perform Initial Inspection • Procedure 2: Charge the Monitor • Procedure 3: Connect a Video Baton • Procedure 4: Perform a Functional Check

Procedure 1.

PERFORM INITIAL INSPECTION

When you receive the system, Verathon recommends that an operator familiar with the instrument perform a full visual inspection of the system 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/support.

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Procedure 2.

CHARGE THE MONITOR

WARNING In order to maintain electrical safety, use only the provided, medical‑approved power supply. The video monitor includes an internal lithium battery. You must charge the battery fully prior to first use. The system must be operated exclusively on battery power, without a connection to an AC power source. Under normal operating conditions, a fully charged battery lasts approximately 90 minutes. For optimal battery life, ensure that the battery is fully charged before you use the monitor. Note: The system will not operate while charging. If you switch the instrument on during charging, the charging light flashes. Figure 4.

Battery Charge Level Icons

Steady green-The battery is fully charged. Flashing green-Battery power is low. The LED flashes for approximately 5 minutes before the system turns off. No LED-The battery is completely depleted and needs to be recharged. Steady orange-The monitor is connected to an AC power source and the battery is charging. Flashing orange-There is an issue with the battery. If you observe the flashing orange light, ensure the monitor power switch is in the off position, check the cable connections, and then disconnect and reconnect the charging cable to the monitor. If this does not resolve the issue, contact Verathon® Customer Care. 1. Ensure that the power switch is in the OFF position.

2. Connect the video monitor 12V DC power supply to the power cord.

11 Operations & Maintenance Manual: Setting Up

3. On the front of the monitor, unscrew the power socket cap, and then connect the charging cable to the power socket.

4. Plug the power cord into an AC power outlet. Note: Plug varies by region.

5. Allow the battery to charge. Fully charging the battery may take up to 5 hours. • While the battery is charging, the LED is orange. • When the battery has completed charging, the LED turns green.

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Procedure 3.

CONNECT A VIDEO BATON

The video baton attaches directly to the video monitor, supplying power to the video baton and transmitting video data from the camera to the monitor. When you are ready to intubate the patient, ensure that you also complete the procedure Insert the Video Baton into the Stat on page 17. It is recommended that you leave the single‑use Stat in the packaging while inserting the video baton and that you do not remove the Stat from the packaging until you are ready to perform an intubation procedure. This helps ensure that the equipment remains as clean as possible. 1. Ensure that the power switch is in the OFF position.

2. Align the dot on the video cable connector and the arrow on the video cable port.

3. Insert the video cable connector into the port. You will hear a click when the cable is successfully connected.

4. To disconnect the video cable from the monitor, rotate the connector ring in the direction of the release arrow, and then remove the connector from the port.

5. Continue to the procedure Perform a Functional Check on page 14.

13 Operations & Maintenance Manual: Setting Up

Procedure 4.

PERFORM A FUNCTIONAL CHECK

Before you use the device for the first time, perform the following functional check to ensure that the system is working properly. Please contact Customer Care if your system does not function as described below. 1. Ensure that you have fully charged the battery according to the instructions in Charge the Monitor on page 11. 2. Ensure that you have attached the video baton to the monitor, according to the instructions in Connect a Video Baton on page 13. 3. On the video monitor, turn the power switch to the ON position.

4. Look at the monitor screen, and verify that the image displayed is being received from the video baton.

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USING THE DEVICE Prior to using the device, set up the device according to the instructions in the previous chapter, and verify the setup by completing the procedure Perform a Functional Check. WARNING GlideScope systems are delivered nonsterile and require cleaning or disinfection prior to initial use.

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. Ranger video batons are equipped with the an anti‑fog feature, which reduces camera fogging during the intubation procedure. To fully optimize the feature, you must allow the video laryngoscope to warm up for 30–120 seconds prior to use, depending on the ambient temperature and humidity of the clinical environment. Full optimization of the anti‑fog feature is not necessary to use the device; if desired, you may begin the intubation procedure immediately. Note: If the video laryngoscope is stored in cold conditions, additional warming time may be required for optimal performance of the anti‑fog feature. Using the system consists of the following procedures: • Procedure 1: Connect a Video Baton • Procedure 2: Insert the Video Baton into the Stat • Procedure 3: Prepare the System • Procedure 4: Intubate Using a Video Baton and Stat

15 Operations & Maintenance Manual: Using the Device