GlideScope RANGER SYSTEM Operations & Maintenance Manual 6-xx-60

GLIDESCOPE

RANGER SYSTEM Operations & Maintenance Manual Effective: April 8, 2015

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/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. Willem Fenengastraat 13 1096 BL Amsterdam The Netherlands Tel: +31 (0) 20 210 30 91 Fax : +31 (0) 20 210 30 92 verathon.com

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

0413 Copyright© 2009, 2015 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, contact Verathon Customer Care or your local representative.

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 & REUSABLE SYSTEMS... 7 SYSTEM PARTS & ACCESSORIES... 8 MONITOR CONTROLS & CONNECTIONS ... 9 VIDEO LARYNGOSCOPE COMPONENTS...10 SETTING UP... 11 Procedure 1. Perform Initial Inspection... 11 Procedure 2. Charge the Ranger Monitor...12 Procedure 3. Connect a Blade or Video Baton...14 Procedure 4. Perform a Functional Check...15 USING THE DEVICE...16 Procedure 1. Connect the Blade or Video Baton...17 Procedure 2. Insert the Video Baton into the Stat (Single-Use Only)... 18 Procedure 3. Prepare the GlideScope System...19 Procedure 4. Intubate Using the GlideScope 4-Step Technique... 20

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CLEANING & DISINFECTING...21 GENERAL INFORMATION...21 Procedure 1. Clean & Disinfect the GlideRite Rigid Stylet... 23 Procedure 2. Clean the Video Monitor...26 Procedure 3. Clean the Video Baton Cradle...26 Procedure 4. Clean the Storage Case...26 REUSABLE SYSTEM...27 Procedure 1. Clean & Disinfect the Reusable Blade...27 Procedure 2. Inspect the Reusable Blade...29 SINGLE-USE SYSTEM...30 Procedure 1. Remove the Stat...30 Procedure 2. Clean & Disinfect the Video Baton...31 Procedure 3. Inspect the Video Baton...33 MAINTENANCE & SAFETY...34 PERIODIC INSPECTIONS...34 SYSTEM SOFTWARE...34 GLIDESCOPE RANGER BATTERY...34 DEVICE REPAIR...35 DEVICE DISPOSAL...35 WARRANTY...36

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PRODUCT SPECIFICATIONS...38 SYSTEM SPECIFICATIONS...38 COMPONENT SPECIFICATIONS...39 Video Monitor & Accessories...39 Battery Specifications...39 Video Laryngoscopes...40 Video Batons & Stats...41 ELECTROMAGNETIC COMPATIBILITY...45 Electromagnetic Emissions...45 Electromagnetic Immunity...46 Recommended Separation Distances...48 Accessory Conformance to Standards...48 SYMBOL DIRECTORY...49 GLOSSARY...51

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. GlideScope Ranger video laryngoscopes 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 Ranger 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

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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. 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 45. To maintain electromagnetic interference (EMI) within certified limits, the GlideScope Ranger 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 and/or cables other than those specified or supplied may result in increased emissions and/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 Caution. Risk of permanent equipment damage. This product is sensitive to heat, which will cause damage to the electronics. Do not expose the Ranger video laryngoscopes or Ranger video batons to temperatures above 60°C (140°F). Do not use autoclaves or pasteurizers for these components. 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 When cleaning reusable 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 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 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.

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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. 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 GlideScope Ranger reusable video laryngoscopes and video batons are delivered nonsterile and require cleaning and 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. 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 and disinfected by using the approved low-temperature processes provided in this manual.

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WARNING Availability of cleaning and disinfection 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 additional contact information, visit verathon.com/contact-us. 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, cause patient infection or cross-infection. WARNING To reduce the risk of cytotoxic residual when cleaning with Metrex® CaviCide®, thoroughly rinse the component as instructed in this manual. 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 35. Dispose of used, single-use components as infectious waste. 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. 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.

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WARNING 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 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 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.

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INTRODUCTION SINGLE-USE & REUSABLE SYSTEMS The GlideScope Ranger system is available in single-use and reusable configurations. Both configurations feature the same video monitor, the cables and adapters to power the device, and any optional system components that may facilitate intubations or provide convenience to the user. The primary difference between the reusable and single-use systems is the type of video laryngoscope that attaches to the monitor. Figure 1.

Ranger Single-Use System

Figure 2.

Ranger Reusable System

The single-use system features a reusable video baton that is inserted into a single-use, disposable Stat. The reusable video baton that connects to the video monitor and contains the camera and electronics that process the video data captured by the blade. Stats are available in a wide range of sizes, and each size corresponds to one of two video baton sizes. The reusable system features a reusable video laryngoscope that must be cleaned and high-level disinfected between uses. The blade is connects to the video monitor via an integrated cable, and the blade is comprised of a reusable, medical-grade plastic shell that houses a camera, an LED light source, and an innovative antifogging mechanism. The reusable video laryngoscope is available in two sizes. You may use either the single-use or reusable system configurations, or your facility may elect to provide both configurations. This manual details both single-use and reusable system information and notes where the systems differ.

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

Required System Components REQUIRED PARTS & ACCESSORIES

GlideScope Ranger video monitor

GVL® 3 video laryngoscope (for reusable system only)

Video baton 1-2 (for single-use system only)

GVL 4 video laryngoscope (for reusable system only)

Video baton 3-4 (for single-use system only)

GVL Stats (for single-use system only) GVL Stat 0

GVL Stat 1

Power supply

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GVL Stat 2

GVL Stat 2.5

GVL Stat 3

Power cable

GVL Stat 4

Table 2.

Optional System Components OPTIONAL PARTS & ACCESSORIES

GlideRite Rigid Stylet

Ranger Transport Bag

®

Video Baton Cradle & Case (for single-use system only)

MONITOR CONTROLS & CONNECTIONS The digital, full-color Ranger video monitor clearly displays the images transmitted from the camera in the video laryngoscope. The monitor includes the screen and controls you use to operate the system. The monitor contains a lithium battery that provides power to the Ranger system. The system must be operated exclusively on battery power, without a connection to an AC power source. Figure 3.

Ranger Video Monitor

Video cable connector (inside cradle)

DC power socket

Power switch

Battery charge status LED

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VIDEO LARYNGOSCOPE COMPONENTS Figure 4.

Ranger Reusable Video Laryngoscope Components Protective cap

Video cable Product number and serial number

Handle

Distal tip/lifter Blade

Camera and light

Figure 5.

Ranger Single-Use Video Laryngoscope Components Video baton

Single-use Stat Blade Camera and light

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Video cable

SETTING UP Before you can use the GlideScope Ranger 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 Ranger Monitor • Procedure 3: Connect a Blade or Video Baton • Procedure 4: Perform a Functional Check

Procedure 1. PERFORM INITIAL INSPECTION When you receive the GlideScope Ranger 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: 800.331.2313 (Canada and US) +1.425.867.1348 (International) +31 (0) 20 210 30 91 (Europe) For additional contact information, see Contact Information.

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Procedure 2. CHARGE THE RANGER MONITOR WARNING To maintain electrical safety, use only the provided, medical-approved power supply. The GlideScope Ranger 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 GlideScope Ranger system will not operate while charging. If you switch the instrument on during charging, the charging light flashes. Figure 6.

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.

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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 BLADE OR VIDEO BATON Complete this procedure if you are using a reusable or single-use system. The video baton or video laryngoscope attaches directly to the Ranger video monitor, supplying power to the blade or baton and transmitting video data from the camera to the monitor. If you are using a single-use system, when you are ready to intubate the patient, ensure that you also complete the procedure Insert the Video Baton into the Stat (Single-Use Only) on page 18. 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 15.

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