Verathon GLIDESCOPE TITANIUM Operation & Maintenance Manual
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Verathon GLIDESCOPE TITANIUM Operation & Maintenance Manual

Reusable & spectrum single-use
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GLIDESCOPE TITANIUM
REUSABLE & SPECTRUM SINGLE-USE
Operations & Maintenance Manual

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Summary of Contents for Verathon GLIDESCOPE TITANIUM

  • Page 1 GLIDESCOPE TITANIUM REUSABLE & SPECTRUM SINGLE-USE Operations & Maintenance Manual...
  • Page 2 0900-4712-02-60...
  • Page 3 GLIDESCOPE TITANIUM REUSABLE & SPECTRUM SINGLE-USE Operations & Maintenance Manual Effective: November 24, 2017 Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
  • Page 4 Fax: 604.439.3039 0413 Copyright © 2017 by Verathon Inc. All rights reserved. No part of this manual may be copied or transmitted by any method without the express written consent of Verathon Inc. GlideRite, GlideScope, the GlideScope symbol, DirectView, Reveal, Verathon, and the Verathon Torch symbol are trademarks or registered trademarks of Verathon Inc.

  • Page 5: Table Of Contents

    TABLE OF CONTENTS IMPORTANT INFORMATION ..........................1 Product Information ............................1 Product Description ............................1 Statement of Intended Use ..........................1 Essential Performance ............................1 Statement of Prescription ............................1 Notice to All Users ..............................1 Cautions & Warnings ............................2 INTRODUCTION ..............................7 Reusable & Spectrum Single-Use Systems ......................7 System Parts &...
  • Page 6 USING THE DEVICE .............................25 Procedure 1. Prepare the GlideScope System ....................26 Procedure 2. Intubate Using a LoPro ......................27 Procedure 3. Intubate Using a MAC-Style Blade ..................28 Procedure 4. Use the Record & Snapshot Features (Optional) ..............29 Procedure 5. Use the Playback Feature (Optional) ..................31 CLEANING &...

  • Page 7: Important Information

    ESSENTIAL PERFORMANCE Essential performance is the system performance necessary to achieve freedom from unacceptable risk. The essential performance of the GlideScope Titanium 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.

  • Page 8: Cautions & Warnings

    Electromagnetic Compatibility section on page 61. To maintain electromagnetic interference (EMI) within certified limits, the GlideScope system must be used with the cables, components, and accessories specified or supplied by Verathon ® For additional information, see the System Parts & Accessories Product Specifications...
  • Page 9 If found, do not use the damaged or worn blade. 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.
  • Page 10 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. For contact information, visit verathon.com/support. WARNING Ensure that you follow the manufacturer’s instructions for handling and disposing of the cleaning, disinfection, or sterilization solutions provided in this manual.
  • Page 11 WARNING This instrument and related devices may contain mineral oils, batteries, and other environmentally hazardous materials. When the instrument or accessories have reached the end of their useful service life, see the section Device Disposal on page 49. Dispose of used, single-use components as infectious waste.
  • Page 12 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.

  • Page 13: Introduction

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

  • Page 14: System Parts & Accessories

    SYSTEM PARTS & ACCESSORIES Table 1. Required System Components REQUIRED PARTS & ACCESSORIES GlideScope Video Monitor Video cable Spectrum™ Smart Cable (for reusable system) (for single-use system) Note: Cable shortened for Note: Cable shortened for illustration purposes. illustration purposes. One or more of the following reusable or single-use video laryngoscopes: Spectrum Single-Use Sizes DirectView™...

  • Page 15: Language Settings

    The video monitor software is available in a variety of languages. To change the language used on your system, you must install a new software version via a USB flash drive. For more information, contact Verathon Customer Care or your local representative. For contact information, see verathon.com/support. Operations & Maintenance Manual: Introduction...

  • Page 16: Video Laryngoscope Components

    VIDEO LARYNGOSCOPE COMPONENTS The main components of the system are the LoPro or MAC video laryngoscopes in either single-use (S) or reusable (T) configurations. The LoPro single-use blades feature the signature GlideScope curve in a disposable format. The LoPro reusable blades combine the performance of a GlideScope blade with the strength of titanium, and the MAC blades incorporate the look and feel of traditional Macintosh blades.

  • Page 17: Video Monitor Buttons, Icons, & Connections

    If a USB flash drive is inserted into the monitor, press and hold to access the playback menu. Battery Indicator: LED is: Green: Unit fully charged Red: Unit charging Flashing Red: Indicates a problem with the battery. Charge for 6 hours, and if still flashing, contact Verathon ® Customer Care. Operations & Maintenance Manual: Introduction...
  • Page 18 Table 5. On-Screen Icons ICON FUNCTION Battery Status: The remaining battery power is indicated by the Battery Status icon and the percentage above the icon. If the icon is red, the battery should be charged as soon as possible. (See Charge the Monitor Battery.) While the battery is being charged, a lightning bolt will be displayed alongside the Battery...
  • Page 19 ICON FUNCTION Hourglass: Please wait while the system prepares for the next action. Audio Recording is Active: Audio is being recorded on the video. Note: The default for audio recording is OFF. Audio recording on the video occurs only if the setting has been changed to ON in user settings. Back Arrow: Exit to previous screen.

  • Page 20: Setting Up

    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.

  • Page 21: Procedure 2. Mount The System (Optional)

    PROCEDURE 2. MOUNT THE SYSTEM (OPTIONAL) If you choose to mount the system, you may use either of the following configurations: • Mount it on a GlideScope premium cart or mobile stand (Figure 6 Figure 7). These solutions make it easy for you to move the system from one location to another.
  • Page 22 3. On the cart mount or the IV pole mount, ensure that the locking pin and quick-release lever are in the unlocked (horizontal) position. Quick-release lever in unlocked position Locking pin in unlocked position 4. Using the orientation shown in the following images, screw the quick-release locking plate to the back panel of the monitor.
  • Page 23 7. Adjust the locking pin to the locked (down) position. This secures the quick-release lever in the locked position. Locking pin in locked position 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.

  • Page 24: Procedure 3. Charge The Monitor Battery

    CHARGE THE MONITOR BATTERY WARNING In order to maintain electrical safety, use only the provided, medical-approved power supply. The GlideScope Video Monitor includes an internal lithium battery. Verathon ® recommends that you charge the battery fully prior to first use.

  • Page 25: Procedure 4. Attach The Video Cable & Blade

    This procedure provides options for single-use and reusable systems—complete the option appropriate for your configuration. The monitor is also compatible with GlideScope AVL system components. For more information, contact Verathon ® Customer Care or see the GlideScope AVL Single-Use Operations and Maintenance Manual.
  • Page 26 OPTION 2. SPECTRUM SINGLE-USE SYSTEM It is recommended that you leave the sterile, single-use blade in the packaging while connecting the blade and that you do not remove the blade until you are ready to perform an intubation procedure. This helps ensure that the blade remains as clean as possible.

  • Page 27: Procedure 5. Connect To An External Monitor (Optional)

    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 system must be used with the cables, components, and accessories specified or supplied by Verathon. For additional information, see System Parts & Accessories Component Specifications...

  • Page 28: Procedure 6. Configure User Settings

    PROCEDURE 6. CONFIGURE USER SETTINGS You may configure the following settings directly on the unit: • Date and Time • Audio Recording • Date and Time Format • Auto Recording • Key Click Sound • Auto External Video • Auto Power Off •...

  • Page 29: Procedure 7. Perform A Functional Check

    PROCEDURE 7. 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 your Verathon ® Customer Care representative if your system does not function as described below.
  • Page 30 9. Wait until the Saving File icon has disappeared from the screen, and then remove the USB flash drive from the monitor. 10. On a computer, verify that the recorded video (.avi) file can be played. Note: If you are viewing the recorded file on a Windows ®...

  • Page 31: Using The Device

    If found, do not use the damaged or worn blade. 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.

  • Page 32: Procedure 1. Prepare The Glidescope System

    In this procedure, you select and attach the appropriate video laryngoscope for the patient, turn the system on, and verify that the system is functioning properly. Table 6. Video Laryngoscope Sizes GLIDESCOPE TITANIUM BLADE RECOMMENDED PATIENT WEIGHT/SIZE Spectrum™ LoPro S1 1.5–3.8 kg (3.3–8.4 lbs) Spectrum LoPro S2 1.8–10 kg (4–22 lbs)

  • Page 33: Procedure 2. Intubate Using A Lopro

    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. To perform an intubation, Verathon ® recommends using the technique outlined in this procedure. Prior to beginning this procedure, verify that the monitor is receiving an accurate image from the video laryngoscope.

  • Page 34: Procedure 3. Intubate Using A Mac-Style Blade

    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. To perform an intubation, Verathon ® recommends using the technique outlined in this procedure. Prior to beginning this procedure, verify that the monitor is receiving an accurate image from the video laryngoscope.

  • Page 35: Procedure 4. Use The Record & Snapshot Features (Optional)

    PROCEDURE 4. USE THE RECORD & SNAPSHOT FEATURES (OPTIONAL) WARNING Use only a passive-type USB flash drive. Do not use USB drives powered by another external source. The system is equipped with video and audio recording features and the ability to save a snapshot of the live display on the monitor.
  • Page 36 5. If at any point you would like to save a photo of the live display to the USB flash drive, press the Snapshot button , and then wait for the Saving Snapshot icon to disappear. Note: If you remove the USB flash drive before the Saving Snapshot icon disappears, the photo will be lost.

  • Page 37: Procedure 5. Use The Playback Feature (Optional)

    PROCEDURE 5. USE THE PLAYBACK FEATURE (OPTIONAL) Recorded videos and snapshots on a USB flash drive can be viewed on the GlideScope Video Monitor. 1. On the back of the monitor, remove the USB port cap, and then insert a USB flash drive into the port. 2.

  • Page 38: Cleaning & Disinfecting

    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. For contact information, visit verathon.com/support. WARNING This product may only be cleaned, disinfected, or sterilized by using the approved low-temperature processes provided in this manual.
  • Page 39 Cleaning and disinfecting the system is an important part of using and maintaining it. Prior to each use, ensure that all system components have been cleaned, disinfected, or sterilized according to the guidance provided in Table The availability and regulatory compliance of the cleaning, disinfection, and sterilization products provided in this manual vary by region;...
  • Page 40 Periodic Inspections on page 48. 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 or your local representative. For contact information, visit verathon.com/support.

  • Page 41: Procedure 1. Clean A Blade, Video Cable, Or Smart Cable

    Use this procedure in order to clean the Smart Cable, video cable, or reusable Titanium video laryngoscope. By reducing as many hard-to-access areas as possible, all of the reusable GlideScope Titanium blades have been designed to be easy to clean. It is critical to remove all traces of contamination from the component prior to completing disinfection or sterilization procedures.
  • Page 42 PRODUCT LEVEL COMPONENT CYCLES* CONDITIONS Water temperature: 30–40°C (86–104°F) Exposure: Prepare solution at 0.125–1 ounce/gallon (1–8 mL/L). Soak component for 5 minutes. Before STERIS ® removing from solution, brush all surfaces and pay eSSENTIALS Cleaner Blade 3000 special attention to hard-to-reach areas. Use a syringe to Concentrates ™...
  • Page 43 PRODUCT LEVEL COMPONENT CYCLES* CONDITIONS Water temperature: 19–29°C (66–84°F) Blade 3000 Exposure: Prepare solution at 1 ounce/gallon (7.8 mL/L). ® Metrex Soak component for 3 minutes. Before removing from Video Cable 3000 Cleaner EmPower ™ solution, brush all surfaces and pay special attention to hard-to-reach areas.
  • Page 44 PRODUCT LEVEL COMPONENT CYCLES* CONDITIONS Water temperature: N/A Video Cable 1500 Exposure: Use towelette(s) to remove all visible Sani Cloth ® contamination from the component. Using fresh Cleaner Active Wipes towelette(s), wet all surfaces and allow to remain wet for Smart Cable 1500 5 minutes.
  • Page 45 If damage is ® present, do not use the component, and contact Verathon Customer Care. The component should now be clean and free of contamination. Handle the product carefully to avoid recontamination.

  • Page 46: Procedure 2. Disinfect A Blade, Video Cable, Or Smart Cable

    • Do not expose the component to temperatures exceeding 60°C (140°F) on any cycle. Verathon has validated the products in this procedure for both chemical compatibility and biological efficacy when disinfecting the indicated component(s) as instructed in the Conditions column. Not all product listed in Table 10 are compatible with each component.
  • Page 47 DISINFECTION PRODUCT COMPONENT CYCLES* CONDITIONS LEVEL Exposure: Prepare working solution at a concentration of 7.0–15.6 mL per L, or 0.5–2 U.S. fluid ounces per U.S. gallon. Soak components for 2–5 minutes. After soaking, § brush all surfaces except the camera window with a soft- bristled brush in order to remove any visible contamination.
  • Page 48 DISINFECTION PRODUCT COMPONENT CYCLES* CONDITIONS LEVEL Standard cycles in the following processors: Blade ® ® STERIS SYSTEM 1 (outside U.S.) STERIS ® S40™ ® High Video Cable SYSTEM 1E (in U.S.) or S20™ SYSTEM 1 EXPRESS (outside U.S.) Smart Cable SYSTEM 1 PLUS (outside U.S.) Clean according to the entry “Tristel™...
  • Page 49 DISINFECTION PRODUCT COMPONENT CYCLES* CONDITIONS LEVEL Conditioning: 20°C (68°F) or higher Water Temperature: 20°C (68°F) or higher Blade 3000 Exposure: Soak for 12 minutes, ensuring that all air bubbles are removed from the surface of the blade. ® Metrex Rinse: (3) 1-minute immersions with agitation in pure water. ®...
  • Page 50 6. Examine the component for any signs of damage. Reusable titanium blades should not have any signs of damage other than minor surface scratches or discoloration of the metal as the result of use. If damage is present, do not use the component, and contact Verathon ®...

  • Page 51: Procedure 3. Sterilize A Blade, Video Cable, Or Smart Cable (Optional)

    Verathon has validated the products in this procedure for both chemical compatibility and biological efficacy when sterilizing the indicated component(s) as instructed in the Conditions column. Not all products listed in Table 11 are compatible with each component.

  • Page 52: Procedure 4. Clean The Glidescope Video Monitor

    4. Examine the component for any signs of damage. Reusable titanium blades should not have any signs of damage other than minor surface scratches or discoloration of the metal as the result of use. If damage is present, do not use the component, and contact Verathon ®...

  • Page 53: Procedure 5. Clean The Glidescope Premium Cart

    PROCEDURE 5. CLEAN THE GLIDESCOPE PREMIUM CART Clean the cart when it is visibly soiled and on a regular basis, as per a schedule established by the medical care facility or provider. Table 12. Cleaning Methods for the GlideScope Premium Cart* PRIMARY ACTIVE BRAND NAME CONCENTRATION...

  • Page 54: Maintenance & Safety

    ELUTION COMPATIBILITY For use with GlideScope Titanium reusable blades, Verathon has completed testing of compatibility with a 1% sodium dodecyl sulphate (SDS) solution with pH 11.0. The SDS solution is commonly utilized in Europe as an eluting solution to collect residual protein samples from medical tools or devices that are cleaned after contacting patient tissue.

  • Page 55: System Software

    DEVICE REPAIR The GlideScope Titanium system components are not user-serviceable. Verathon does not make available any type of circuit diagrams, component parts lists, descriptions, or other information that would be required for repairing the device and related accessories. All service must be performed by a qualified technician.

  • Page 56: Warranty

    The limited warranty applies for one (1) year from the date of shipment from Verathon and applies only to the original purchaser of the system. The terms of this warranty are subject to the Terms and Conditions of Sale or any other contractual document between the parties.
  • Page 57 The information, descriptions, recommendations, and safety notations in this manual are based upon Verathon experience and judgment. The contents of this manual should not be considered to be all-inclusive or to cover all contingencies.

  • Page 58: Product Specifications

    PRODUCT SPECIFICATIONS SYSTEM SPECIFICATIONS, STANDARDS, & APPROVALS Table 13. Titanium System Specifications GENERAL SPECIFICATIONS Classification: Electrical Class II, Applied Part BF Range: 100–240 V AC, 50 and 60 Hz. Connect to a medical-grade power supply Line voltage: (If the provided power cord has a third prong, it is used as a functional ground). DC power supply: 12 V DC, 2.5 A max Fuse:...

  • Page 59: Component Specifications

    COMPONENT SPECIFICATIONS Table 14. System Component Specifications GLIDESCOPE VIDEO MONITOR TFT Color, VGA 640 x 480 px 174 mm Monitor: 16.3 cm (6.4 in) Height: 174 mm Width: 223 mm Depth: 80 mm 223 mm Weight: 1.0 kg 80 mm VIDEO CABLE (REUSABLE SYSTEM) 2190 ± 55 mm Cable length: 2190 ±...
  • Page 60 PREMIUM CART Wheelbase diameter: 53.3 cm Min. height: 101.6 cm Max. height: 132.1 cm Weight: 8.0–8.4 kg MOBILE STAND Wheelbase diameter: 61 cm Min. height: 76 cm Max. height: 122 cm IV POLE MOUNT Weight: 0.9 kg Arm length: 27 cm Width: 6.2 cm...
  • Page 61 LOPRO T3 (REUSABLE SYSTEM) 72 mm Height at handle: 10.8 mm Height at camera: 10.5 mm Blade tip to handle: 72 mm Width at camera: 20 mm 10.8 mm 10.5 mm 20 mm LOPRO T4 (REUSABLE SYSTEM) 91 mm Height at handle: 11.0 mm Height at camera: 10.0 mm Blade tip to handle: 91 mm Width at camera: 25 mm 11.0 mm 10.0 mm...
  • Page 62 MAC T3 (REUSABLE SYSTEM) 107 mm Height at handle: 14.5 mm Height at camera: 9.6 mm Blade tip to handle: 107 mm Width at camera: 22 mm 14.5 mm 9.6 mm 22 mm MAC T4 (REUSABLE SYSTEM) 128 mm Height at handle: 13.4 mm Height at camera: 9.6 mm Blade tip to handle: 128 mm Width at camera: 22 mm 9.6 mm...
  • Page 63 SPECTRUM LOPRO S1 (SINGLE-USE SYSTEM) 29 mm Height at handle: 8.7 mm Height at camera: 9.6 mm Blade tip to handle: 29 mm Width at camera: 12.2 mm 8.7 mm 9.6 mm 12.2 mm SPECTRUM LOPRO S2 (SINGLE-USE SYSTEM) 44 mm Height at handle: 8.7 mm Height at camera: 9.6 mm Blade tip to handle: 44 mm Width at camera: 13.0 mm 8.7 mm...
  • Page 64 SPECTRUM LOPRO S3 (SINGLE-USE SYSTEM) 74 mm Height at handle: 11.0 mm Height at camera: 11.0 mm Blade tip to handle: 74 mm Width at camera: 20 mm 11.0 mm 11.0 mm 20 mm SPECTRUM LOPRO S4 (SINGLE-USE SYSTEM) 91 mm Height at handle: 12.0 mm Height at camera: 11.3 mm Blade tip to handle: 91 mm Width at camera: 25 mm 12.0 mm...
  • Page 65 SPECTRUM DIRECTVIEW MAC S3 (SINGLE-USE SYSTEM) 107.5 mm Height at handle: 14.6 mm Height at camera: 11.7 mm Blade tip to handle: 107.5 mm Width at camera: 26.6 mm 14.6 mm 11.7 mm 26.6 mm SPECTRUM DIRECTVIEW MAC S4 (SINGLE-USE SYSTEM) 128 mm Height at handle: 14.3 mm Height at camera: 11.4 mm Blade tip to handle: 128 mm Width at camera: 26.4 mm...

  • Page 66: Battery Specifications

    BATTERY SPECIFICATIONS Table 15. Battery Specifications CONDITION DESCRIPTION Battery type Lithium-ion Under normal operating conditions, a fully charged battery lasts Battery life approximately 90 minutes Charging time off line will take no more than 6 hours from an empty battery Charging time to a full charge Rated capacity 2150 mAh...

  • Page 67: Electromagnetic Compatibility

    ELECTROMAGNETIC COMPATIBILITY The system is designed to be in compliance with IEC 60601-1-2:2007, which contains electromagnetic compatibility (EMC) requirements for medical electrical equipment. The limits for emissions and immunity specified in this standard are designed to provide reasonable protection against harmful interference in a typical medical installation.
  • Page 68 ELECTROMAGNETIC IMMUNITY Table 17. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should ensure that it is used in such an environment. COMPLIANCE ELECTROMAGNETIC ENVIRONMENT IMMUNITY TESTS...
  • Page 69 Table 17. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should ensure that it is used in such an environment. COMPLIANCE ELECTROMAGNETIC ENVIRONMENT IMMUNITY TESTS IEC 60601 TEST LEVEL LEVEL...
  • Page 70 ACCESSORY CONFORMANCE TO STANDARDS 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 &...

  • Page 71: Glossary

    GLOSSARY The following table provides definitions for specialized terms used in this manual or on the product itself. For a full list of caution, warning, and informational symbols used on this and other Verathon ® products, please refer to the Verathon Symbol Glossary at verathon.com/symbols.
  • Page 72 TERM DEFINITION OSHA Occupational Safety and Health Administration (federal agency in U.S.) psia Pounds per square inch absolute Water that is suitable for high-level disinfection according to local regulations Pure water and your medical facility Radio frequency Relative humidity Restriction of the Use of Certain Hazardous Substances in Electrical and RoHS Electronic Equipment Sodium dodecyl sulphate...

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