GLIDESCOPE PORTABLE GVL SYSTEM

Transcription

1 GLIDESCOPE PORTABLE GVL SYSTEM Operations & Maintenance Manual

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3 GLIDESCOPE PORTABLE GVL SYSTEM Operations & Maintenance Manual IMPORTANT This manual is not intended for use in Canada. If you are in Canada, visit verathon.com or contact Verathon Customer Care in order to access the appropriate GlideScope Portable GVL System Operations & Maintenance Manual (version ). For contact information, visit verathon.com/contact-us. Effective: October 3, 2014 Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.

4 CONTACT INFORMATION To obtain additional information regarding your GlideScope system, please contact Verathon Customer Care or visit verathon.com/contact-us: Corporate Headquarters: North Creek Parkway Bothell, WA U.S.A (US and Canada only) Fax: verathon.com Verathon Medical (Europe) B.V. Willem Fenengastraat BL Amsterdam The Netherlands Tel: +31 (0) Fax : +31 (0) verathon.com Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby, BC V5C 5A9 Canada Fax: Copyright 2009, 2014 by Verathon Inc. All rights reserved. No part of this document may be copied or transmitted by any method without the express written consent of Verathon Inc. 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 online manuals at verathon.com.

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6 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 AND REUSABLE SYSTEMS...7 SYSTEM PARTS & ACCESSORIES...8 BUTTONS, ICONS, & CONNECTIONS...10 Connectors & Ports...10 Buttons Battery Indicator and Charge Status...12 SETTING UP...13 Procedure 1. Perform Initial Inspection...14 Procedure 2. Attach Cleaning Caps (Reusable Only)...15 Procedure 3. Mount the Video Monitor (Optional)...16 Procedure 4. Attach the Cradle (Optional)...20 Procedure 5. Charge the Monitor Battery...21 Procedure 6. Connect the Video Laryngoscope...22 Procedure 7. Insert the Video Baton into a Stat (Single-Use Only)...23 Procedure 8. Connect to an External Monitor (Optional)...24 Procedure 9. Configure User Settings...25 Procedure 10. Perform a Functional Check...26 Operations & Maintenance Manual: Table of Contents i

7 USING THE SYSTEM...27 Procedure 1. Prepare the GlideScope System...28 Procedure 2. Intubate Using the GlideScope 4 Step Technique...29 TIPS...30 Using the GlideScope System...30 Working with Endotracheal Tubes...30 CLEANING & DISINFECTING...31 GENERAL INFORMATION...31 Procedure 1. Clean the Video Monitor...33 Procedure 2. Clean the Cradle...34 Procedure 3. Clean & Sterilize the GlideRite Rigid Stylet...34 REUSABLE SYSTEM...35 Procedure 1. Clean & Disinfect the Reusable Blade...35 Procedure 2. Inspect the Reusable Blade...38 Procedure 3. Clean & Disinfect the Video Cable...39 SINGLE-USE SYSTEM...41 Procedure 1. Remove the Stat...41 Procedure 2. Clean & Disinfect the Video Baton...41 Procedure 3. Inspect the Video Baton...43 MAINTENANCE & SAFETY...44 INSPECTIONS...44 DEVICE REPAIR...44 Video Monitor Battery...44 Protective Cap Repair...45 Other Device Repair...45 TRANSPORTATION...46 DEVICE DISPOSAL...46 ii

8 WARRANTY...47 Original First Year Total Customer Care Warranty...47 Premium Customer Care Warranty...48 Disclaimer of Additional Warranties...48 PRODUCT SPECIFICATIONS...49 SYSTEM SPECIFICATIONS...49 COMPONENT SPECIFICATIONS...50 General Components...50 Single-Use System...51 Reusable System...55 ELECTROMAGNETIC COMPATIBILITY...57 Electromagnetic Emissions...57 Electromagnetic Immunity...58 Recommended Separation Distances...60 Accessory Conformance to Standards...60 SYMBOL DIRECTORY...61 GLOSSARY...63 Operations & Maintenance Manual: Table of Contents iii

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10 IMPORTANT INFORMATION PRODUCT DESCRIPTION The Portable GlideScope Video Laryngoscope (PGVL) system is designed for 1st pass success. This system provides a consistently clear view of a patient s airway, enabling quick intubation. GlideScope video laryngoscopes are clinically proven to achieve a Cormack-Lehane Grade I or II view 99% of the time. 1 The single-use and reusable GlideScope video laryngoscopes include an integrated camera, LED light source, and a patented anti-fog mechanism. The video laryngoscope blade or video baton connects to a color video monitor for real-time viewing and video output. The GlideScope PGVL system features a comprehensive range of configurations and sizes, allowing clinicians to meet the requirements of patients ranging in size from preterm infants to morbidly obese adults. The PGVL system is designed for physicians and other healthcare professionals who need to effectively manage standard to difficult airways. It is easy to use, learn, and teach. It is ideal for acute care settings and emergency environments. It also integrates easily into standard emergency department (ED), operating room (OR), intensive care unit (ICU), and NICU applications. STATEMENT OF INTENDED USE GlideScope 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 PGVL system is to provide a clear view of the vocal cords. STATEMENT OF PRESCRIPTION Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. This system should be used only by individuals who have been trained and authorized by a physician or used by healthcare providers who have been trained and authorized by the institution providing patient care. NOTICE TO ALL USERS Verathon recommends that all users read this manual before using the system. Failure to do so may result in injury to the patient, compromise the performance of the system, and may void the system warranty. Verathon recommends that new GlideScope users: Obtain instruction from a qualified individual Practice using the system on a mannequin before clinical use Acquire clinical experience on patients without airway abnormalities 1 Cooper RM. Cardiothoracic Anesthesia, Respiration and Airway; Early clinical experience with a new video laryngoscope (GlideScope) in 728 patients. Canadian Journal of Anesthesia. 2005; 52: 2: Operations & Maintenance Manual: Important Information 1

11 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 57. To maintain electromagnetic interference (EMI) within certified limits, the GlideScope PGVL 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 PGVL 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 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 Prior to cleaning or disinfecting, ensure the protective cap is properly fitted on the video cable, video baton, and blade connectors and ports. 2

12 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, ultrasonic cleaners, 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. 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. 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 Ensure that the video monitor is turned off prior to connecting or disconnecting any component. CAUTION On the rear of the monitor, the battery switch must be in the OFF position during shipping and storage. Operations & Maintenance Manual: Important Information 3

13 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. 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. 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: (U.S. and Canada) (International) customerservice@verathon.com WARNING PGVL reusable video laryngoscopes are delivered nonsterile and require cleaning and high-level disinfection prior to initial use. 4

14 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 Bloodborne Pathogens or an equivalent standard. For more information, visit 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 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 low-temperature processes provided in this manual. 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 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 video baton or reusable video laryngoscope in the cradle if any of the components are contaminated. Operations & Maintenance Manual: Important Information 5

15 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 The video monitor contains a lithium-ion battery. To avoid the risk of explosion or fire, observe the following: Do not use, charge, or store the video monitor near fire or heat. Do not dispose of the video monitor or battery in fire or heat. For more information, see Device Disposal on page 46. Prior to shipping or transport, on the rear of the video monitor, ensure the battery switch is in the OFF position. Do not use the video monitor if the battery is leaking. Avoid contact with a leaking battery, immediately wash any skin that touches a leaking battery, and then contact Verathon Customer Care. 6

16 INTRODUCTION SINGLE-USE AND REUSABLE SYSTEMS The GlideScope PGVL system is available in single-use and reusable configurations. Both configurations feature the same video monitor, power cable, and any optional system components that may facilitate intubations or provide convenience. The primary difference between the reusable and single-use systems is the video laryngoscope that connects to the monitor. Figure 1. PGVL Single-Use System Figure 2. PGVL Reusable System The single-use system features a reusable video baton and sterile Stats that must be disposed of after one use. The video baton contains the camera, LED light source, and anti-fogging mechanism, and it sends a real-time video feed to the monitor. The Stat slips over the flexible portion of the video baton and clicks into place, shielding the video baton from contact with mucous membranes and non-intact skin. Single-use stats are available in a variety of sizes, enabling you to treat patients ranging from preterm to morbidly obese. The reusable system features a reusable plastic video laryngoscope that must be cleaned and high-level disinfected between uses. The blade is connected to the video monitor via a reusable video cable. The video electronics such as the camera, LED light, and anti-fogging mechanism are located within the reusable laryngoscope. 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. Operations & Maintenance Manual: Introduction 7

17 SYSTEM PARTS & ACCESSORIES The GlideScope PGVL systems consist of the following components. Table 1. System Components Video monitor PARTS & ACCESSORIES Required Components Video cable (for reusable system only) Video batons (for single-use system only) Power cable GVL Stat sizes 0, 1, 2, 2.5, 3, and 4 (for single-use system only) PGVL video laryngoscopes (for reusable system only) GVL 3 GVL 4 GVL 5 8

18 PARTS & ACCESSORIES Optional Components Mobile stand GlideRite Rigid Stylet Universal accessory basket Cradle for reusable blade Cradle for video baton IV pole mounting kit Video output cable Operations & Maintenance Manual: Introduction 9

19 BUTTONS, ICONS, & CONNECTIONS CONNECTORS & PORTS The main component of the GlideScope PGVL system is the full-color monitor. The front of the monitor includes the screen, the buttons you use to operate the system, and the port for connecting the video cable. Figure 3. Front Panel of Video Monitor Screen Keypad Video cable port The back panel of the monitor includes the power socket, battery switch, and connector for the video output cable. The back of the video monitor also features a mounting point that allows you to attach the monitor to a mobile stand or IV pole. Figure 4. Rear Panel of Video Monitor Power socket Video output port Mounting point Battery switch 10

20 BUTTONS The GlideScope video monitor front panel (Figure 3) features the keypad. This keypad contains two battery status LEDs and four buttons: MENU, UP, DOWN, and ON/OFF. The function of each button is described in the following table. For more information about the battery status LEDs, see Battery Indicator and Charge Status on page 12. Figure 5. Monitor Keypad Table 2. Monitor Buttons BUTTON NAME FUNCTION ON/OFF Turns the monitor on and off UP Increases the value of a setting DOWN Decreases the value of a setting MENU Opens the menu and navigates between settings. For more information, see Configure User Settings on page 25. Operations & Maintenance Manual: Introduction 11

21 BATTERY INDICATOR AND CHARGE STATUS On the front of the video monitor, there are two LEDs that indicate battery level and the charging state (see Figure 5). The battery indicator LED illuminates when the monitor is operating on battery power and indicates the charge level. The charge status LED indicates whether the battery is currently charging. Table 3. Battery Indicator LED STATUS DESCRIPTION FUNCTION LED turned off Solid green Flashing green The monitor is off, or the battery level is completely depleted and needs to be recharged. The monitor is on, and the battery level is normal. The battery charge is low. Please note the following: If the monitor is not beeping, approximately five minutes remain before the system turns off due to low battery. If the monitor is beeping, approximately one minute remains before the system turns off due to low battery. Table 4. Charge Status LED STATUS DESCRIPTION FUNCTION LED turned off Flashing orange Solid orange The video monitor is not directly connected to power. The battery is not charging. Please note the following: If the monitor is connected to power, the battery switch may be in the OFF position. In this case the monitor will still function, but the battery will not charge. If the monitor is not connected to power, the battery may be malfunctioning. Please contact your Verathon Customer Care representative. The battery is charging. Solid green The battery is fully charged. 12

22 SETTING UP WARNING To reduce the risk of electrical shock, use only the accessories and peripherals recommended by Verathon. Before you can use the GlideScope PGVL 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: 1. Perform Initial Inspection Inspect the system for any obvious physical damage that may have occurred during shipment. 2. Attach Cleaning Caps (Reusable Only) Attach protective caps to the video cable used with reusable blades. These caps prevent damage to the instrument during the cleaning and disinfection process. 3. Mount the Video Monitor (Optional) If desired, set up the video monitor on a mobile stand or on an IV pole. 4. Attach the Cradle (Optional) If desired for convenience, attach a blade or a video baton cradle to the mobile stand or IV pole. 5. Charge the Monitor Battery By using the power cord included in the system, you can use the system while the battery is charging. 6. Connect the Video Laryngoscope Attach the reusable video laryngoscope or video baton to the video monitor. 7. Insert the Video Baton into a Stat (Single-Use Only) When you are ready to perform an intubation, insert the video baton into a single-use Stat. 8. Connect to an External Monitor (Optional) Connect the monitor to an external display source, such as a larger monitor screen, by using the video output cable. 9. Configure User Settings According to preference and your environment, configure the monitor settings. 10. Perform a Functional Check Before you use the device for the first time, perform a functional check to ensure that the system is working properly. Operations & Maintenance Manual: Setting Up 13

23 Procedure 1. PERFORM INITIAL INSPECTION When you receive the GlideScope PGVL 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: (Canada and US) (International) +31 (0) (Europe) For additional contact information, see Contact Information. 14

24 Procedure 2. ATTACH CLEANING CAPS (REUSABLE ONLY) On both ends of the video cable for the PGVL reusable system, there are two connectors. In order to protect these connectors during the cleaning and disinfection process, it is necessary that you attach two protective cleaning caps to the video cable. In this procedure, you tether the caps to the video cable. Because the single-use video baton is already outfitted with a protective cleaning cap, it is not necessary that you complete this procedure if you have a single-use system. 1. On the tether, slide the adjustable sleeve towards the caps. 2. Thread the video cable through the loop in the tether. 3. Slide the adjustable sleeve towards the video cable. This tightens the tether around the video cable. 4. Ensure that the loop is suffiently tightened so that the tether will not slide off the ends of the video cable. 5. Using pliers or an equivalent tool, crimp the adjustable sleeve. This secures the tether and prevents removal of the cleaning caps. For more information about how to use the protective caps, see the chapter Cleaning & Disinfecting on page 31. Operations & Maintenance Manual: Setting Up 15

25 Procedure 3. MOUNT THE VIDEO MONITOR (OPTIONAL) If you choose to mount the system, you may use either of the following configurations: Option 1: Mobile Stand Mount the video monitor on a mobile stand (Figure 6) that makes it easy for you to move the system from one location to another. Option 2: IV Pole Mount the video monitor on an IV pole (Figure 7). Figure 6. Video Monitor on Mobile Stand Figure 7. Video Monitor on IV Pole Video monitor Video monitor IV pole mount IV pole Mobile stand 16

26 Option 1. MOBILE STAND ASSEMBLE THE MOBILE STAND 1. Remove the hex bolt and washers from the bottom of the base pole. 2. Insert the bottom end of the base pole into the top of the base. Note: You may remove or reattach wheels on the base by using moderate force in order to pull them out or push them in. 3. Screw the bolt and washers back into place, and then tighten the bolt securely. This attaches the base pole to the base and ensures stability. 4. Insert the spacer pole into the top end of the base pole, and then insert the mounting pole into the top end of the base pole. 5. Turn the height adjustment knob counterclockwise. 6. Place your hands where they cannot be pinched by moving parts, and then raise or lower the pole to the desired height. 7. Turn the height adjustment knob clockwise until tight. This secures the pole at the desired height. Operations & Maintenance Manual: Setting Up 17

27 ATTACH THE MONITOR TO THE MOBILE STAND 8. Hold the video monitor against the screw on the tilt head fastener, and then turn the tilt head fastener clockwise until the video monitor is securely attached to the mount. Tilt head fastener ADJUST THE MONITOR ANGLE Before you start using the video monitor, adjust the angle of the monitor for optimal viewing. The ideal angle minimizes glare and maximizes visibility. 9. Turn the angle adjustment knob counterclockwise. Angle adjustment knob 10. Tilt the monitor to the desired angle. 11. Turn the angle adjustment knob clockwise. This secures the monitor at the desired angle. 12. To attach a blade cradle or a video baton cradle, see the procedure Attach the Cradle (Optional). 18

28 Option 2. IV POLE ATTACH THE MONITOR TO AN IV POLE Bracket attachment knob 1. Place the mounting bracket on the IV pole, and then tighten the bracket attachment knob until the IV pole mount is secure. 2. Hold the video monitor against the screw on the tilt head fastener, and then turn the tilt head fastener clockwise until the video monitor is securely attached to the IV pole mount. Tilt head fastener ADJUST THE MONITOR ANGLE Before you start using the video monitor, adjust the angle of the monitor for optimal viewing. The ideal angle minimizes glare and maximizes visibility. 3. Turn the angle adjustment knob counterclockwise. Angle adjustment knob 4. Tilt the monitor to the desired angle. 5. Turn the angle adjustment knob clockwise. This secures the monitor at the desired angle. 6. To attach a blade cradle or a video baton cradle, see the procedure Attach the Cradle (Optional). Operations & Maintenance Manual: Setting Up 19

29 Procedure 4. ATTACH THE CRADLE (OPTIONAL) You may elect to attach a blade cradle or a video baton cradle to the mobile stand or IV pole mount. The video baton cradle may be attached directly the pole or attached to the interior of the blade cradle. If you would like to attach a blade cradle to the mobile stand or IV pole, complete Option 1. If you would like to attach the video baton cradle directly to the mobile stand or IV pole, complete Option 2. Option 1. ATTACH THE BLADE CRADLE TO THE POLE This option provides instructions for attaching the blade cradle to the mobile stand or IV pole, and it also provides instructions for optionally attaching the video baton cradle to the blade cradle. 1. Open the cradle latch and position the pole on the back of the cradle. 2. Close the cradle latch and tighten in place by turning the cradle adjustment knob clockwise. Cradle Adjustment Knob 3. If you would like to attach the video baton cradle to the blade cradle, hook it into place. Video Baton Cradle (Optional) Option 2. ATTACH THE VIDEO BATON CRADLE TO THE POLE 1. Screw the center pole clamp to the video baton cradle. 2. Attach the center pole clamp and video baton cradle to the pole, and then turn the adjustment knob clockwise to tighten. 20

30 Procedure 5. CHARGE THE MONITOR BATTERY IMPORTANT The battery must be fully charged prior to first use in battery mode. This helps ensure optimal battery life. The system can operate on alternating current (AC) power or battery power. The monitor contains an internal lithium-ion battery that powers itself and the video laryngoscope. Under normal operating conditions, a fully charged battery lasts approximately 90 minutes before it needs to be recharged. You should charge the battery according to the information in Charging Conditions on page 49. The battery indicator LED on the front of the monitor indicates the current battery charge level, and the charge status LED indicates whether the battery is currently charging. For more information, see Battery Indicator and Charge Status on page Ensure that the AC power cord is disconnected, and on the back of the video monitor, ensure the battery switch is in the OFF position. 2. Slide the battery switch to the ON position, and then insert the power cord into the power socket. Power socket Battery switch 3. Plug the power supply into a hospital-grade power outlet. The charge status LED turns solid orange, indicating that the charging cycle has begun. For more information about the charge status LED, see Table 4 on page Allow the battery to charge. When the battery is fully charged, the charge status LED turns solid green. Fully charging the battery may take approximately 6 hours. Operations & Maintenance Manual: Setting Up 21

31 Procedure 6. CONNECT THE VIDEO LARYNGOSCOPE The GlideScope PGVL system is available in two configurations: Single-use The video baton connects directly to the video monitor, and a single-use, disposable Stat is attached to the video baton. Reusable The video cable attaches the video laryngoscope to the video monitor, supplying power to the blade and transmitting video data from the blade's camera to the monitor. This procedure documents how to attach a video laryngoscope for single-use and reusable systems. For baton, Stat, and blade sizing information, see Table 5 on page Ensure that the video monitor is turned off. 2. Hold the video cable or video baton by the gray connector. 3. On the monitor, align the arrows on the video cable connector with the arrows on the video cable port, and then insert the connector fully into the port. 4. If you are using a reusable system, align the arrows on the video cable connector with the seam on the top of the blade, and then insert the video cable connector into the blade port If you are using a single-use system, when you are ready to perform an intubation, insert the video baton into a Stat, as described in Insert the Video Baton into a Stat (Single-Use Only) on page When you want to disconnect video cable, video baton, or blade, do the following: Ensure the video monitor is turned off. Grip the gray connector. Pull the connector from the port.

32 Procedure 7. INSERT THE VIDEO BATON INTO A STAT (SINGLE-USE ONLY) It is recommended that you leave the single-use Stat in the packaging while connecting the Stat and that you do not remove it until you are ready to perform an intubation procedure. This helps ensure that the Stat remains as clean as possible. 1. Open the GVL Stat pouch, but do not remove the Stat from the packaging. 2. Ensure that the logo on the side of the baton and the logo on the side of the Stat are aligned. 3. Slide the video baton into the Stat until it clicks into place. Do not remove the Stat from the pouch until you are ready to begin the intubation. This ensures that the Stat remains as clean as possible. Note: Ensure that you do not insert the video baton backwards. Correct Incorrect 4. When you remove the Stat from the packaging, visually inspect the Stat to ensure that all exterior surfaces are free of unintended rough areas, sharp edges, protrusions, or cracks. For instructions about how to detach the video baton and Stat, see Remove the Stat on page 41. Operations & Maintenance Manual: Setting Up 23

33 Procedure 8. CONNECT TO AN EXTERNAL MONITOR (OPTIONAL) WARNING The external monitor must be safety-approved medical equipment. By using a video output cable, the PGVL video monitor may be connected to an NTSC-compatible external monitor that is approved for medical use. For more information, please contact your Verathon Customer Care representative. Note: Image quality on the external monitor may vary according to the resolution of the external monitor. Note: To maintain electromagnetic interference (EMI) within certified limits, the GlideScope PGVL 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. 1. Ensure that the video monitor is turned off. 2. On the back of the video monitor, insert the video output cable into the video output port. Video output port 3. Connect the other end of the cable to the external monitor. 4. Prior to disconnecting the video output cable, ensure the video monitor is turned off. 24

34 Procedure 9. CONFIGURE USER SETTINGS 1. Ensure that the video monitor is directly connected to power, or ensure that the battery has been fully charged according to the procedure Charge the Monitor Battery on page Ensure that a video laryngoscope has been attached to the video monitor according to the procedure Connect the Video Laryngoscope on page 22. Note: If you are using a single-use system, it is not necessary for you to insert the video baton into a Stat in order to complete this procedure. 3. Press the ON/OFF button. The monitor turns on. 4. Press the MENU button. The settings screen appears. BRIGHTNESS CONTRAST COLOR MIRROR RESET EXIT NORMAL NTSC AV Using the MENU button to scroll through settings, customize the following settings: BRIGHTNESS Controls the luminosity of the image on the video monitor. Use the UP or DOWN buttons to increase or decrease this value; a value of is recommended. Ensure that you set the brightness setting to proper levels for your clinical environment. CONTRAST Controls the contrast of the image on the video monitor. Use the UP or DOWN buttons to increase or decrease this value; a value of is recommended. COLOR Controls the color saturation of the image on the video monitor. Use the UP or DOWN buttons to increase or decrease this value; a value of 50 is recommended. MIRROR Determines whether the image on the video monitor is reversed. Use the UP button to mirror the view, or use the DOWN button to return to the original view. RESET Restores all settings to their factory default. Use the UP or DOWN button to restore all default settings. Notes: Depending on the software version, Volume and Mute settings may be available on some video monitors. These settings are currently inactive. The Normal, NTSC, AV1 setting controls the format and channel of the signal being received from the video baton or blade. Because GlideScope PGVL components use NTSC format, this setting does not change. 6. When you are finished configuring settings, press the MENU button until EXIT is highlighted, and then press either the UP or DOWN button. Your settings are saved, and the setting screen closes. 7. Press the ON/OFF button. The monitor turns off. Operations & Maintenance Manual: Setting Up 25

35 Procedure 10. PERFORM A FUNCTIONAL CHECK Before you use the system for the first time, perform the following functional check to ensure that it is working properly. Please contact your Verathon Customer Care representative if your system does not function as described below. 1. Ensure that the battery has been fully charged according to the procedure Charge the Monitor Battery on page Ensure that a video laryngoscope has been attached to the video monitor according to the procedure Connect the Video Laryngoscope on page 22. Note: If you are using a single-use system, it is not necessary for you to insert the video baton into a Stat in order to complete this procedure. 3. On the back of the video monitor, slide the battery switch to the ON position. 4. Press the ON/OFF button. The monitor turns on and is running on battery power. 5. Look at the monitor screen, and verify that the image displayed is being received from the video baton or the reusable blade. Note: There may be a slight blade intrusion in the upper corners of the monitor, and a thin line may appear along the top. These blade edges are captured in the view because of the wide-angle camera lens used in the video laryngoscope. This image acts as a frame of reference during the intubation process and ensures that the orientation of the image is correct in the monitor. Potential blade intrusion 6. Press the ON/OFF button. The video monitor turns off. 26

36 USING THE SYSTEM Prior to using the device, set up the system according to the instructions in the previous chapter, and verify the setup by completing the procedure Perform a Functional Check on page 26. WARNING PGVL reusable video laryngoscopes are delivered nonsterile and require cleaning and high-level 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. 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: (U.S. and Canada) (International) customerservice@verathon.com PGVL reusable and single-use video laryngoscopes are equipped with an anti fog feature that reduces camera fogging during the intubation procedure. To fully optimize the feature, you must allow the video laryngoscope to warm up for 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 in order 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 PGVL system consists of the following procedures: 1. Prepare the GlideScope System 2. Intubate Using the GlideScope 4 Step Technique Operations & Maintenance Manual: Using the System 27

37 Procedure 1. PREPARE THE GLIDESCOPE SYSTEM Table 5. Video Laryngoscope Sizes SINGLE USE SIZES Stat Video Baton Recommended Patient Weight/Size* GVL 0 Stat Video baton 1-2 Patients less than 1.5 kg (3.3 lbs) GVL 1 Stat Video baton 1-2 Patients between kg ( lbs) GVL 2 Stat Video baton 1-2 Patients between kg (4 22 lbs) GVL 2.5 Stat Video baton 1-2 Patients between kg ( lbs) GVL 3 Stat Video baton 3-4 Patients between 10 kg adult (22 lbs adult) GVL 4 Stat Video baton 3-4 Patients between 40 kg morbidly obese (88 lbs morbidly obese) GlideScope PGVL Blade GVL 3 blade GVL 4 and GVL 5 blades REUSABLE BLADE SIZES Recommended Patient Weight/Size* Patients between 10 kg adult Patients between 40 kg morbidly obese * Weight ranges are approximate; a medical professional must evaluate on a patient-by-patient basis. 1. Ensure that each GlideScope system component has been properly cleaned, disinfected, or sterilized according to the guidance provided in Table 6 on page Using the information in Table 5, in combination with a clinical assessment of the patient and the experience and judgment of the clinician, select the reusable blade or single-use video baton/stat combination that is appropriate for the patient. 3. Ensure that the video monitor is turned off. 4. Attach the video laryngoscope to the monitor, according to the instructions in Connect the Video Laryngoscope on page If you are using a single-use system, insert the video baton into a Stat, as described in the procedure Insert the Video Baton into a Stat (Single-Use Only) on page 23. Note: It is recommended that you leave the Stat in its packaging until you are ready to begin the intubation. 6. Press the Power button. The video monitor turns on. 7. Ensure that the battery is sufficiently charged. If necessary, connect the monitor directly to power. 8. On the monitor screen, verify that the image displayed is from the video laryngoscope camera. On the monitor, a small portion of the blade may be visible on the top or upper corners. 9. If needed, allow the anti fog feature to warm up for seconds. Note: The time required for the anti fog feature to be fully optimized varies according to the ambient temperature and humidity where the equipment is being stored or used. If the video laryngoscope is stored in cold conditions, additional warming time may be required for optimal performance. 28

38 Procedure 2. INTUBATE USING THE GLIDESCOPE 4 STEP TECHNIQUE 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 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. To perform an intubation, Verathon recommends using the GlideScope 4 Step Technique as outlined in this procedure. Each step begins with where you should be looking in order to complete that action. Prior to beginning this procedure, verify that the monitor is receiving an accurate image from the video laryngoscope. 1. Look in the mouth With the video laryngoscope in the left hand, introduce it into the midline of the oral pharynx. 2. Look at the screen Identify the epiglottis, and then manipulate the blade in order to obtain the best glottic view. Figure 8. Ideal Glottic View 3. Look in the mouth Carefully guide the distal tip of the tube into position near the tip of the laryngoscope. 4. Look at the screen Complete the intubation, gently rotating or angling the tube in order to redirect it as needed. Operations & Maintenance Manual: Using the System 29

39 TIPS USING THE GLIDESCOPE SYSTEM The GlideScope video laryngoscope is designed to be inserted down the midline of the tongue to the epiglottis. The GlideScope video laryngoscope may be used to produce a Macintosh-style lift of the epiglottis, or to produce a Miller lift. Intubations using the GlideScope video laryngoscope only require approximately kg (1 3.5 lbs) of lifting force. The use of an endotracheal tube stylet is recommended. The GlideRite Rigid Stylet has been designed to complement the angle of the GlideScope video laryngoscope to facilitate intubation, and it should be used with endotracheal tubes 6.0 mm and larger. A malleable stylet with a angle may be used. To aid the passage of the endotracheal tube when at the vocal cords, gradually withdraw the stylet approximately 5 cm (2 in). A 1-cm (0.5 in) withdrawal of the laryngoscope may be beneficial to reduce the viewing angle and allow the glottis to drop. WORKING WITH ENDOTRACHEAL TUBES Insert the endotracheal tube (ETT) behind or immediately adjacent to the GlideScope video laryngoscope. Do not insert the stylet into the larynx during intubation. Carefully introduce the distal end of the ETT between the vocal folds. When introducing the video laryngoscope or the endotracheal tube, look directly into the mouth to avoid damaging the endotracheal tube cuff, the patient s teeth, or soft tissues such as the soft palate or tonsils. Advance the ETT while simultaneously withdrawing the stylet with the thumb. The stylet should be withdrawn approximately 5 cm (2 in). Avoid excessive lifting or pushing of the glottis. Maximum laryngeal exposure may not facilitate intubation; reducing the elevation applied to the laryngoscope may make inserting the ETT easier. 30

40 CLEANING & DISINFECTING GENERAL INFORMATION 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 Bloodborne Pathogens or an equivalent standard. For more information, visit 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 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 low-temperature processes provided in this manual. 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 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. Operations & Maintenance Manual: Cleaning & Disinfecting 31

41 WARNING Do not place the GlideScope video baton or reusable video laryngoscope in the cradle if any of the components are contaminated. Cleaning and disinfecting the GlideScope PGVL system is an important part of using and maintaining the system. Prior to each use, ensure that each system component has been cleaned and disinfected according to the guidance provided in Table 6. You should also examine the system periodically to make sure it is operating correctly. For more information, see the Maintenance & Safety chapter on page 44. This chapter is divided into the following sections: General Information Contains an overview of system information and provides the cleaning and disinfection procedures for components that are common to both the reusable and single-use systems Reusable System Contains the cleaning and disinfection procedures for the reusable blade and video cable Single-Use System Contains the cleaning and disinfection procedures for the video baton Note: It is understood that all items in the following table will be used as intended, and the level of disinfection or sterilization required may vary according to local regulations. Table 6. Risk Assessment for PGVL Systems DEVICE STERILE USE SPAULDING S/CDC DISINFECTION LEVEL CLASSIFICATION Low Int. High STERILIZATION Monitor* Nonsterile Reusable Noncritical Cradle* Nonsterile Reusable Noncritical GVL Stat Sterile Single Use Semi critical Video baton Nonsterile Reusable Noncritical X Video cable Nonsterile Reusable Noncritical X PGVL reusable blade Nonsterile Reusable Semi critical X GlideRite Rigid Stylet Nonsterile Reusable Semi critical X * Clean the video monitor and cradle when they are visibly soiled and on a regular basis, as per a schedule established by the medical care facility or provider. Single-use Stats may not be cleaned, disinfected, or sterilized. Dispose of single-use Stats after use. The PGVL video baton is a nonsterile, reusable device, which is protected from contact with mucous membranes and non-intact skin by the Stat (sterile, single-use) when used as intended. Low-level disinfection is recommended for the video baton after every patient use. High-level disinfection is required for the video baton when it is visibly soiled. X Checked boxes show minimum disinfection level requirement. Shaded areas indicate that the disinfection/sterilization level is not required or not compatible with the device materials. Unshaded areas show permissible levels of disinfection or sterilization based on compatibility with the device materials. 32