GlideScope Titanium Operation & Maintenance Manual

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GLIDESCOPE SYSTEM

TITANIUM

Operations & Maintenance Manual

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0900-4391-09-60

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GLIDESCOPE SYSTEM

TITANIUM

Operations & Maintenance Manual

Effective: May 29, 2015

Caution: Federal (United States) law restricts this

device to sale by or on the order of a physician.

For customers with Titanium Systems utilizing the GlideScope Video Monitor (Version 0570-0338).

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CONTACT INFORMATION

To obtain additional information regarding your GlideScope Titanium system,

please contact Verathon® Customer Care or visit verathon.com/contact-us.

Verathon Inc.

20001 North Creek Parkway

Bothell, WA 98011 U.S.A.

Tel: 800.331.2313 (US and Canada only)

Tel: 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 Medical (Canada) ULC

2227 Douglas Road

Burnaby, BC V5C 5A9

Canada

Tel: 604.439.3009

Fax: 604.439.3039

GlideRite, GlideScope, the GlideScope symbol, Reveal, 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.

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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

Precautions & Warnings ............................................................................................................................................2

INTRODUCTION ..........................................................................................................................................................7

Single-Use & Reusable Systems .................................................................................................................................7

Language Settings ....................................................................................................................................................7

System Parts & Accessories .......................................................................................................................................8

Video Laryngoscope Components ...........................................................................................................................10

Video Monitor Buttons, Icons, & Connections ......................................................................................................... 11

SETTING UP ............................................................................................................................................................... 14

Procedure 1. Perform Initial Inspection ...........................................................................................................14

Procedure 2. Mount the System (Optional) ..................................................................................................... 15

Procedure 3. Charge the Monitor Battery .......................................................................................................18

Procedure 4. Attach the Video Cable & Blade .................................................................................................19

Procedure 5. Connect to an External Monitor (Optional) ................................................................................. 21

Procedure 6. Conﬁgure User Settings .............................................................................................................22

Procedure 7. Perform a Functional Check .......................................................................................................23

USING THE DEVICE ...................................................................................................................................................25

Procedure 1. Prepare the GlideScope System ..................................................................................................26

Procedure 2. Intubate Using the GlideScope 4-Step Technique ........................................................................27

Procedure 3. Use the Record & Snapshot Features (Optional) ..........................................................................29

Procedure 4. Use the Playback Feature (Optional) ...........................................................................................31

Operations & Maintenance Manual: Table of Contents

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CLEANING & DISINFECTING .....................................................................................................................................32

Procedure 1. Clean a Blade, Video Cable, or Smart Cable ...............................................................................34

Procedure 2. Disinfect a Blade, Video Cable, or Smart Cable ...........................................................................39

Procedure 3. Sterilize a Blade, Video Cable, or Smart Cable (Optional) ............................................................42

Procedure 4. Clean & Disinfect the GlideRite Rigid Stylet .................................................................................43

Procedure 5. Clean the GlideScope Video Monitor ..........................................................................................46

Procedure 6. Clean the GlideScope Premium Cart ...........................................................................................46

MAINTENANCE & SAFETY ........................................................................................................................................47

Periodic Inspections ................................................................................................................................................47

Elution Compatibility ............................................................................................................................................... 47

GlideScope Video Monitor Battery ..........................................................................................................................47

System Software .................................................................................................................................................... 48

Device Repair ......................................................................................................................................................... 48

Device Disposal ...................................................................................................................................................... 48

WARRANTY...............................................................................................................................................................49

PRODUCT SPECIFICATIONS ....................................................................................................................................... 51

System Speciﬁcations, Standards, & Approvals .........................................................................................................51

Component Speciﬁcations ......................................................................................................................................52

Battery Speciﬁcations ..............................................................................................................................................58

Electromagnetic Compatibility ................................................................................................................................. 59

SYMBOL DIRECTORY ................................................................................................................................................63

GLOSSARY ................................................................................................................................................................ 66

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IMPORTANT INFORMATION

PRODUCT INFORMATION

GlideScope® Titanium video laryngoscopes combine innovative blade options, angles, and construction in order to enable rapid intubations for more patients in more settings. The GlideScope Titanium system is designed with low proﬁle blades, and the slimmer design allows for more working space in the airway and accommodates smaller mouth openings.

PRODUCT DESCRIPTION

The new GlideScope Titanium reusable and single-use video laryngoscopes are the most advanced GlideScope instruments ever, designed to deliver clear airway views and enable rapid intubation. New low-proﬁle designs and innovative construction make these blades streamlined and lightweight, offering improved maneuverability and working space for routine and difﬁcult airways. With more VL options, including new Mac-style blades, clinicians can choose their preferred airway tool for a wide range of patients and clinical settings. And whether it’s reusable or single use, the new GlideScope Titanium system features a high-resolution, full-color digital camera and monitor for real-time viewing and recording.

GlideScope Titanium video laryngoscopes are designed to work with the GlideScope Video Monitor version0570-0338.

STATEMENT OF INTENDED USE

The GlideScope Titanium system is intended for use by qualiﬁed professionals to obtain a clear, unobstructed view of the airway and 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 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.

GlideScope Titanium 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 Titanium system. Failure to do so may result in injury to the patient, may compromise the performance of the system, and may void the system warranty. Verathon recommends that new users:

• Obtain instruction from a qualiﬁed individual

• Practice using the video laryngoscope on a mannequin before clinical use

• Acquire clinical training experience on patients without airway abnormalities

Operations & Maintenance Manual: Important Information

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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. See the

Electromagnetic Compatibility section for additional information.

To maintain electromagnetic interference (EMI) within certiﬁed limits, the GlideScope Titanium system must be used with the cables, components, and accessories speciﬁed or supplied by Verathon

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 Titanium system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the GlideScope Titanium system should be observed to verify normal operation in the conﬁguration in which it will be used.

. For additional information, see the System Parts & Accessories and Component

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.

CAUTION

The video cables 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.

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WARNINGS

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

Caution. Risk of permanent equipment damage.

This product is sensitive to heat, which will cause damage to the electronics. Do not expose the video cables or reusable Titanium video laryngoscopes to temperatures above 60°C (140°F).

Do not use autoclaves or pasteurizers for video cables or reusable Titanium video laryngoscopes. Use of such methods to clean, disinfect, or sterilize the components will cause permanent device damage and void the warranty. Refer to the Cleaning & Disinfecting chapter for a list of approved cleaning procedures and products.

WARNING

Before every use, ensure the instrument is operating correctly and has no sign of damage. Do not use this product if the device appears damaged. Refer servicing to qualiﬁed personnel.

To ensure patient safety, routinely inspect the reusable video laryngoscope before and after every use in order to ensure the blade is free of rough surfaces, sharp edges, cracks, protrusions, or any other indication of wear. 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 blade defects to Verathon

Customer Care at:

Phone: 800.331.2313 (U.S. and Canada) +1.425.867.1348 (International)

Email: [email protected]

WARNING

Reusable Titanium video laryngoscopes are delivered nonsterile and require cleaning and high-level disinfection prior to initial use.

Operations & Maintenance Manual: Important Information

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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 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

This product may only be cleaned, disinfected, or sterilized by using the approved processes provided in this manual. Cleaning, disinfection, and sterilization methods listed are recommended by Verathon

based on efﬁcacy or compatibility with component materials.

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 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.

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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 48. Dispose of used, single-use components as infectious waste.

WARNING

Several areas of the video laryngoscope that contact the patient can exceed 41°C (106°F) as part of normal operation:

• The ﬁrst area is the light-emitting area surrounding the camera. When used as indicated, continuous contact with this area is unlikely because, if tissue were to contact this area, the view would be lost and devices would need to be adjusted to regain the airway view.

• The second area is the area surrounding the camera, out of view of the camera. Continuous contact with this area is unlikely because the product is typically not held stationary for an extended period of time exceeding 1minute.

If continuous contact is maintained for longer than 1minute, it is possible to cause thermal damage such as a burn to the mucosal tissue.

Note: Typical intubations are less than 1minute in duration.

WARNING

The reusable Titanium 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

The external monitor must be safety-approved medical equipment.

WARNING

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

Operations & Maintenance Manual: Important Information

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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 Titanium 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 differences between the reusable and single-use systems are the video laryngoscopes and the cables that connect the laryngoscope to the video monitor.

Figure 1. Titanium Single-Use System Figure 2. Titanium Reusable System

The single-use system features durable, plastic blades that must be disposed of after one use. It also features the GlideScope Smart Cable—a reusable video cable that connects the single-use blade to the video monitor and contains the electronics that process the video data captured by the blade. Single-use video laryngoscopes are identiﬁed by an S in the blade name, such as LoPro S4.

The reusable system features a titanium 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. Unlike the single-use system, the reusable system video electronics are located within the laryngoscope. Due to their titanium construction, reusable video laryngoscopes contain a T in the blade name, such as LoP ro T4.

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. In this document, unless otherwise noted, the term video cable describes both the GlideScope Smart Cable for the single-use system and the video cable for the reusable system.

LANGUAGE SETTINGS

The GlideScope Titanium 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/contact-us.

Operations & Maintenance Manual: Introduction

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SYSTEM PARTS & ACCESSORIES

Table 1. Required System Components

REQUIRED PARTS & ACCESSORIES

GlideScope Video Monitor Video cable

(for reusable system)

Note: Cable shortened for

illustration purposes.

One or more of the following reusable or single-use video laryngoscopes:

LoPro T3 LoPro T4 MAC T3 MAC T4

GlideScope Smart Cable

(for single-use system)

Note: Cable shortened for

illustration purposes.

LoPro S3 LoPro S4 MAC S3 MAC S4

Video monitor 12V DC poweradapter (0400-0105)

Power cable

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Table 2. Optional System Components

Premium cart AVL portable stand HDMI-to-DVI cable IV pole mounting kit

OPTIONAL PARTS & ACCESSORIES

The monitor is also compatible with GlideScope AVL system blades. For more information, contact Verathon® Customer Care or see the GlideScope AVL System Operations & Maintenance Manual.

TRAINING & INFORMATION PACK

The GlideScope Titanium Training and Information Pack contains recommended accessories for the system and reference materials that provide instructions for use. The following items are included in the pack:

• (2) GlideRite Rigid Stylet—A stylet that facilitates quick placement of an endotracheal tube and is recommended for use with GlideScope systems.

• (1) Quick Reference Card Ring Assembly—Quick reference information that may be attached to the system, for your convenience and ease of use.

• (1) In-Service USB Flash Drive—A white, 2 GB USB ﬂash drive that contains reference documentation in multiple languages. See Figure 3.

• (1) Media Storage USB Flash Drive—A blue, 2 GB USB ﬂash drive that can be connected to the video monitor and used for recording video or taking snapshots. See Figure 4.

Universal accessory basket

Note: For use with AVL

portablestand

GlideRite® Rigid Stylet

Figure 3. In-Service USB Flash Drive Figure 4. Media Storage USB Flash Drive

Operations & Maintenance Manual: Introduction

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VIDEO LARYNGOSCOPE COMPONENTS

The main components of the GlideScope Titanium system are the LoPro or MAC video laryngoscopes in either single-use (S) or reusable (T) conﬁgurations. The LoPro S3 and S4 single-use blades feature the signature GlideScope curve in an easy-to-use, disposable format. The LoPro T3 and T4 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.

Figure 5. Video Laryngoscope Components

1 1

Table 3. Video Laryngoscope Components

FIGURE KEY COMPONENT NOTES

1 Connector — 2 Handle —

3 Blade

4 Distal tip/lifter —

5 Camera and light

6 Product number and serial number

The low-proﬁle, thinner blade design allows for more working room in the airway and mouth

High-resolution, full-color camera with integrated LED light source

On the left side of the handle of reusable LoPro and MAC blades. (Not available on single-use blades.)

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VIDEO MONITOR BUTTONS, ICONS, & CONNECTIONS

The digital, full-color GlideScope Video Monitor clearly displays the images transmitted from the camera in the video laryngoscope. The front of the monitor includes the screen and a keypad with the buttons you use to operate the system.

The back panel of the monitor includes the sockets and ports for connecting the power cord, the video cable, an HDMI-to-DVI cable for external video display, and a USB ﬂash drive. When a socket or port is not in use, it is recommended that the rubber cap is inserted into the opening. This protects the exposed connectors from dust and other contamination. The back of the video monitor also features a mounting plate ﬁtting that allows you to attach the monitor to a mobile stand or IV pole.

Figure 6. GlideScope Video Monitor Keypad

Record button External video button

Power button Snapshot button

Tutorial button

Table 4. Keypad Buttons

BUTTON FUNCTION

Power: Press and release to turn on the monitor. Press and hold to turn it off.

Note: If the monitor freezes at any time during use, press and hold the Power button for 10 seconds to reset the system.

Record: Press to start and stop recording directly to a USB ﬂash drive that has been inserted in the USB port. When you are recording, the red LED indicator to the right of the button will be lit, and the Recording icon will be shown on the screen.

Note: To record video, a USB ﬂash drive must be inserted into the monitor USB port.

Snapshot: Press this button to save a snapshot of the live display to the USB ﬂash drive. You may take a snapshot while video recording or independent of recording.

Battery indicator

Note: To take a snapshot, a USB ﬂash drive must be inserted into the monitor USB port.

External Video: Press to display video on an external monitor. The yellow LED to the right of the button will light up to indicate that the key has been activated. Press the key again to deactivate the external video.

Note: An HDMI-to-DVI cable is required in order to display video on an external monitor.

Tutorial: If a USB ﬂash drive is not inserted into the monitor, press and hold to access the video tutorial. 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

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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 Status icon.

Progress Conﬁrmation: While the user is pressing a button, the operation is loading. If the button is released before the loading process is completed, the operation is canceled.

Power-Down Countdown: The unit is about to turn off. If this is due to the Auto Power Off feature that saves battery life, pressing any button stops the power-down sequence.

Note: The Auto Power Off feature can be adjusted or disabled on the User Settings screen. For more info, see Conﬁgure User Settings on page 22.

USB Flash Drive: A USB ﬂash drive is detected.

While recording, a number next to the icon indicates approximately what percentage of the USB ﬂash drive has been used. When the USB ﬂash drive is full, recording stops.

Incompatible USB Drive: The USB ﬂash drive that is plugged into the monitor is not suitable for recording videos. (This normally occurs when using an encrypted USB ﬂash drive or when using an older, inexpensive model that is not capable of the speed necessary to save video in real time.)

USB Flash Drive Not Found: A USB ﬂash drive needs to be inserted into the monitor USB port.

Attach Video Cable: The video cable is not attached to themonitor.

Recording: The system is recording video to the USB ﬂash drive.

Note: Do not remove the USB ﬂash drive while recording is in progress, or the recording will be lost.

Saving Snapshot: The system is saving a snapshot to the USB ﬂash drive.

Note: Do not remove the USB ﬂash drive while saving a snapshot, or the snapshot will be lost.

Saving File: The system is saving a recorded ﬁle to the USB ﬂash drive.

Note: Do not remove the USB ﬂash drive while this icon is displayed, or the recording will be lost.

External Monitor: The HDMI-to-DVI connection for external video is enabled, and videois being displayed on an external monitor.

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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, so audio recording on the video occurs only if the setting has been changed to ON in user settings.

Back Arrow: Exit to previous screen.

Up Arrow: Select previous ﬁle for playback.

Down Arrow: Select next ﬁle for playback.

Play: Play the selected ﬁle or continue playing a paused video ﬁle.

Pause: Pause the video playback.

Snapshot: On the Playback menu, this icon indicates that a ﬁle is a snapshot.

Video: On the Playback menu, this icon indicates that a ﬁle is a video.

Figure 7. GlideScope Video Monitor Back Panel

Video-out port:

Connect the HDMI-to-DVI cable from the external monitor

USB port:

Connect a USB ﬂash drive to record video or take a snapshot

Power socket:

Connect the barrel plug from the 12V power adapter

Video cable port: Attach the video cable or GlideScope Smart Cable

Product identiﬁcation: Includes product serial number

Mounting plate ﬁtting: Connect the monitor to a mobile stand or IV pole

Operations & Maintenance Manual: Introduction

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SETTING UP

Before you can use the GlideScope Titanium 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. Mount the System (Optional)—Set up the GlideScope Video Monitor on a mobile stand or IV pole.

3. Charge the Monitor Battery—Note that you can use the system while the battery is charging.

Note: The monitor will operate without charging the battery by using the GlideScope Video Monitor 12V DC power adapter that shipped with the unit.

4. Attach the Video Cable & Blade—Connect the video cable or GlideScope Smart Cable to the monitor, and then connect the video laryngoscope to the video cable or Smart Cable.

5. Connect to an External Monitor (Optional)—Connect the monitor to an external display source, such as a larger monitor screen, by using the HDMI-to-DVI cable.

6. Conﬁgure User Settings—Enter data customized to your clinic, and conﬁgure settings such as the date and time.

7. 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.

PROCEDURE 1. PERFORM INITIAL INSPECTION

When you receive the GlideScope Titanium 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.

Note: Due to the hand-polishing method used to create the titanium exterior of the reusable blades, slight variations or irregularities may occur in the ﬁnish. These variations do not affect the cleaning process or system efﬁcacy.

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. 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 AVL portable stand (Figure 8 or Figure 9). These solutions

make it easy for you to move the system from one location to another.

• Mount it on an IV pole (Figure 10).

Figure 8. GlideScope Premium Cart Figure 9. AVL Portable Stand Figure 10. IV Pole Mount

IV pole mount

ATTACH THE MONITOR TO THE CART OR IV POLE

1. If you are using the GlideScope premium cart or AVL portable stand, assemble it according to the instructions included with the component.

2. If you are using an IV pole mount, place the mounting bracket on the IV pole, and then tighten the bracket attachment knob until the IV pole mount is secure.

Bracket attachment knob

Operations & Maintenance Manual: Setting Up

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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.

Quick-release locking plate

5. Seat the locking plate of the monitor on the quick-release mount. When properly situated, the monitor sits securely on the mount, and the quick-release lever automatically snaps into the locked (down) position.

6. Ensure that the quick-release lever is fully in the locked (down) position. This secures the monitor in place.

Quick-release lever in locked position

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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.

8. Turn the angle adjustment knob counterclockwise.

Angle

adjustment

knob

9. Tilt the monitor to the desired angle.

10. Turn the angle adjustment knob clockwise. This secures the monitor at the desired angle.

Operations & Maintenance Manual: Setting Up

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PROCEDURE 3. 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.

Under normal operating conditions, a fully charged battery lasts approximately 90minutes before it needs to be recharged. For optimal battery life, ensure that the battery is fully charged before you try to use the monitor in battery mode. You should charge the battery at temperatures between 0–35°C (32–95°F).

The percentage above the Battery Status icon indicates the remaining battery charge.

Figure 11. Battery Status Icons

Battery must be charged

Approximately ⅓ battery life remaining

Approximately ⅔ battery life remaining

Battery is ⅔ to fully charged. The lightning bolt indicates that the battery is charging.

1. Connect the video monitor 12V DC poweradapter to the power cable.

2. On the back panel of the monitor, remove the power socket cap, and then connect the 12V DC power adapter to the power socket.

3. Plug the power supply into a hospital-grade power outlet.

4. Allow the battery to charge. Fully charging the battery may take up to 6hours.

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PROCEDURE 4. ATTACH THE VIDEO CABLE & BLADE

The video cable attaches the video laryngoscope to the GlideScope Video Monitor, supplying power to the blade and transmitting video data from the camera to the monitor. This procedure provides options for single-use and reusable systems—complete the option appropriate for your conﬁguration.

Ensure that the video monitor is turned off prior to connecting or disconnecting a video cable or blade.

The GlideScope Video Monitor is also compatible with GlideScope AVL system blades. For more information, contact Verathon® Customer Care or see the GlideScope AVL System Operations & Maintenance Manual.

OptiOn 1. REUSABLE SYStEM

1. Align the arrow on the video cable and the arrow on the video cable port.

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

3. Align the arrow on the video cable with the dot on the reusable blade, and then insert the video cable into the blade port. You will hear a click when the cable is successfully connected.

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

Connector ring

Operations & Maintenance Manual: Setting Up

Page 26

OptiOn 2. 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.

1. Align the arrow on the GlideScope Smart Cable and the arrow on the video cable port.

2. Insert the Smart Cable connector into the port. You will hear a click when the cable is successfully connected.

3. Align the arrow on the Smart Cable with the dot on the single-use blade port, and then insert the connector fully into the port.

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

Connector ring

5. To disconnect a single-use blade from the GlideScope Smart Cable, hold the cable connector in one hand and the blade handle in the other, and then pull. The blade disconnects from the cable.

Page 27

PROCEDURE 5. CONNECT TO AN EXTERNAL MONITOR (OPTIONAL)

WARNING

The external monitor must be safety-approved medical equipment.

By using an HDMI-to-DVI cable, you can connect the GlideScope Video Monitor to an 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 Titanium 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 monitor, remove the HDMI cap from the video-out port.

3. Connect the HDMI end of the cable to the video-out port.

Video-out port

4. Connect the other end of the cable to the DVI port on an external monitor that is approved for medical use.

5. Press the Power button. The monitor turns on.

6. Press the External Video button. The indicator LED to the right of the button illuminates when the connection is successful, and the video displays on the external monitor.

7. To stop sending video to an external monitor, press the External Video button again.

8. Prior to disconnecting the HDMI-to-DVI cable, ensure the video monitor is turned off.

Operations & Maintenance Manual: Setting Up

Page 28

PROCEDURE 6. CONFIGURE USER SETTINGS

Mode Exit

GlideScope User Settings

Change Date, Time & Settings

01-15-2014 20:35:51 US

UBL Version: 1.4 Core Version: 3.4 Tutorial Version: 1.3 Baton Version:

Key Click Sound: OFF Audio Recording: ON Auto External Video: OFF Clinic Name: CLINIC NAME

Auto Power Off: OFF Auto Recording: OFF

NOTE: PLUG IN POWER ADAPTER TO ENABLE SOFTWARE UPGRADING

UBoot Version: 2.1 Filesystem Version: 3.5 App Version: 3.5

Scope

Power Cycle: 19

Running Time: 0 d 11 h 30 m

Back

GlideScope User Settings

Monitor

Power Cycle: 3

Running Time: 0 d 0 h 30 m

Battery Level: 94%

No USB Drive Detected.

Monitor Download

Scope Download

You may conﬁgure the following settings directly on the unit:

• Date and Time

• Date and Time Format

• Key Click Sound

• Auto Power Off

• Audio Recording

• Auto Recording

• Auto External Video

• Clinic Name

The second page of user settings, as seen in Figure 13, displays system-use information, and it does not contain any conﬁgurable settings.

Figure 12. User Settings Screen Page 1

Figure 13. User Settings Screen Page 2

1. If a USB ﬂash drive is inserted into the monitor, remove it.

2. Press the Power button. The monitor turns on.

3. Hold the Tutorial button , and then press the Snapshot button . The User Settings screen appears on the monitor. The conﬁgurable user settings are displayed in yellow, and the selected setting is highlighted in red.

4. Customize your user settings by using the following buttons:

• Press the Record button to select the parameter you want to set.

• Press the Snapshot button to decrease the parameter value.

• Press the External Video button to increase the parameter value.

• When inputting the Clinic Name, the Tutorial button moves the selection to the next letter. Press the

Record button twice to return the selection back to the Date/Time setting.

• To view the second page of user settings, press the Record button until Next Page is highlighted in

5. When you are ﬁnished customizing the settings, press the Record button until the option Exit is

red, and then press the Tutorial button . To exit the second page of user settings, press the Tutorial button again.

available in the gray bar, and then press the Tutorial button . This saves the parameters, and the User Settings screen closes.

Page 29

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 GlideScope

Titanium system does not function as described below.

1. Fully charge the monitor battery (this takes approximately 6hours).

2. Attach the video cable and video laryngoscope to the monitor, according to the instructions in Attach the

Video Cable & Blade.

3. Press the Power button. The monitor turns on.

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

Note: There may be a slight blade intrusion in the upper-left corner 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.

5. On the back of the monitor, remove the USB port cap, and then insert a USB ﬂash drive into the port.

USB port

6. Ensure that the USB ﬂash drive is detected by checking if the USB Flash Drive icon on the bottom of the screen is displayed.

7. Press the Record button . Recording starts.

8. To stop recording, press the Record button again.

Operations & Maintenance Manual: Setting Up

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® operating system (OS), use an application such as Windows Media Player®.

If you are viewing the recorded video ﬁle on Mac OS®, use an application such as one of the following:

• MPlayerX (free in the App StoreSM)

• VLC® (free at http://www.videolan.org/vlc/index.html)

If you are viewing the recorded video ﬁle on iOS®, use an application such as one of the following:

• VLC® for iOS® (free in the App StoreSM)

• 8player lite (free in the App StoreSM)

• Media Player - PlayerXtreme™ HD (free in the App StoreSM)

Page 31

USING THE DEVICE

Prior to using the device, set up the device according to the instructions in the previous chapter, and verify the setup by completing the procedure Perform a Functional Check.

WARNING

Reusable Titanium 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. Refer servicing to qualiﬁed personnel.

Always ensure that alternative airway management methods and equipment are readily available.

Report any suspected blade defects to Verathon

Phone: 800.331.2313 (U.S. and Canada) +1.425.867.1348 (International)

Email: [email protected]

WARNING

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

Reusable Titanium video laryngoscopes are equipped with the Reveal™ anti-fog feature, which reduces camera fogging during the intubation procedure. To fully optimize the feature, you must allow the reusable video laryngoscope to warm up for 30-120 seconds prior to use, depending on the ambient temperature and humidity of the clinical environment. Full optimization of the Reveal™ anti-fog feature is not necessary to use the device; if desired, you may begin the intubation procedure immediately.

Using the Titanium system consists of the following:

1. Prepare the GlideScope System—Select and attach the correct video laryngoscope for the patient, turn the system on, and verify that it is working properly.

2. Intubate Using the GlideScope 4-Step Technique—Perform the intubation.

Customer Care at:

3. Use the Record & Snapshot Features (Optional)—Record the intubation and take snapshots during theprocedure.

4. Use the Playback Feature (Optional)—View recorded videos or snapshots on the video monitor.

Operations & Maintenance Manual: Using the Device

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.

Ensure that the video monitor is turned off prior to connecting or disconnecting a video cable, GlideScope Smart Cable, or video laryngoscope.

The monitor is also compatible with GlideScope AVL system blades. For more information, contact Verathon® Customer Care or see the GlideScope AVL System Operations & Maintenance Manual.

Table 6. Video Laryngoscope Sizes

GLIDESCOPE TITANIUM BLADE RECOMMENDED PATIENT WEIGHT/SIZE

LoPro T3 or LoPro S3 10 kg to adult LoPro T4 or LoPro S4 40 kg to morbidly obese

MAC T3 or MAC S3 Medium adult MAC T4 or MAC S4 Large adult

1. Ensure that each GlideScope system component has been properly cleaned, disinfected, or sterilized according to the guidance provided in Table 7 on page 33.

2. Using the information in Table 6, in combination with a clinical assessment of the patient and the experience and judgment of the clinician, select the GlideScope video laryngoscope that is appropriate for the patient.

3. Attach the video cable and video laryngoscope to the monitor, according to the instructions in Attach the

Video Cable & Blade.

4. Press the Power button . The video monitor turns on.

Note: If the GlideScope Video Monitor locks up or becomes unresponsive for any reason, press and hold the Power button for 10seconds to reboot the system.

5. Ensure that the battery is sufﬁciently charged. If necessary, connect the monitor directly to power.

6. On the monitor screen, verify that the image displayed is from the video laryngoscope camera. A small portion of the blade may be visible on the upper-left corner or top of the monitor screen.

7. If you are using a reusable blade and if needed, allow the GlideScope Reveal™ anti-fog feature to warm up for 30–120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 of the anti-fog feature.

8. If desired to provide additional anti-fog beneﬁts, you may apply Dexide™ Fred™ Lite to the camera window on the reusable blade.1 Use the solution according to the manufacturer’s instructions.

1 Compatibility has been demonstrated for up to 100 cycles on reusable blades.

Page 33

PROCEDURE 2. INTUBATE USING THE GLIDESCOPE 4-STEP TECHNIQUE

WARNING

Several areas of the video laryngoscope that contact the patient can exceed 41°C (106°F) as part of normal operation:

• The ﬁrst area is the light-emitting area surrounding the camera 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.

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 the user should be looking to complete that action. Prior to beginning this procedure, verify that the monitor is receiving an accurate image from the video laryngoscope.

Operations & Maintenance Manual: Using the Device

Page 34

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 14. 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.

Page 35

PROCEDURE 3. 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 GlideScope Titanium system is equipped with video and audio recording features and the ability to save a snapshot of the live display on the monitor. The GlideScope Titanium system saves this data to a USB ﬂash drive, and you can view the recordings or snapshots on the video monitor or a computer.

By default, audio recording is disabled on the GlideScope Titanium system. If you would like the system to record audio in addition to video, complete the procedure Conﬁgure User Settings to enter the User Settings screen, and then change the Audio Recording setting to On.

While recording, a number next to the icon indicates approximately what percentage of the USB ﬂash drive has been used. When the USB ﬂash drive is full, recording stops.

1. On the back of the monitor, remove the USB port cap, and then insert a USB ﬂash drive into the port.

Note: If you do not insert a USB ﬂash drive, the video recording, audio recording, and snapshot features will not be available.

USB port

2. Ensure that the USB ﬂash drive is detected by checking if the USB Flash Drive icon on the bottom of the screen is displayed.

3. If you want to record the intubation, press the Record button . Video recording starts and is saved to the USB ﬂash drive.

If audio recording is enabled in the User Settings display, the Audio Recording is Active icon will appear on the screen, and audio will be recorded with the video.

4. When you are ﬁnished recording, press the Record button again, and then wait for the Saving File icon

to disappear.

Note: If you remove the USB ﬂash drive before the Saving File icon disappears, the recording will be lost.

Operations & Maintenance Manual: Using the Device

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.

6. If you would like to review the recorded ﬁles on the video monitor, complete the following procedure, Use

the Playback Feature (Optional).

If you would like to review the recorded ﬁles on a computer, insert the USB ﬂash drive into the PC, and then view the .avi or .jpg ﬁles.

Note:

If you are viewing the recorded ﬁle on a Windows® operating system (OS), use an application such as Windows Media Player®.

If you are viewing the recorded video ﬁle on Mac OS®, use an application such as one of the following:

• MPlayerX (free in the App StoreSM)

• VLC® (free at http://www.videolan.org/vlc/index.html)

If you are viewing the recorded video ﬁle on iOS®, use an application such as one of the following:

• VLC® for iOS® (free in the App StoreSM)

• 8player lite (free in the App StoreSM)

• Media Player - PlayerXtreme™ HD (free in the App StoreSM)

Page 37

PROCEDURE 4. USE THE PLAYBACK FEATURE (OPTIONAL)

20140114_205213.jpg

20131101_132217.jpg

Tutorial

20140114_203419.avi

20140110_203355.avi

20130411_143605.avi

20131101_132115.avi

20130411_213043.avi

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. Ensure that the USB ﬂash drive is detected by checking if the USB Flash Drive icon on the bottom of the screen is displayed.

3. Press and hold the Tutorial button 3 seconds or longer. The playback menu is displayed.

Figure 15. Playback Menu

4. Navigate the menu as follows:

5. When you have selected the item that you want to play, press the Tutorial button . Playback starts.

6. When the ﬁle is being played back and is displayed on the screen, press the Snapshot button to playback

7. If the ﬁle being played back is a video, pause and resume playback by pressing the Tutorial button .

8. Press the Record button to return to the playback menu.

9. Press the Record button again to close the playback menu.

• Press the Snapshot button to move up the list of playback ﬁles.

• Press the External Video button to move down the list of playback ﬁles.

the next ﬁle above the one currently displayed. Press the External Video button to play the next ﬁle below the one currently displayed.

Operations & Maintenance Manual: Using the Device

Page 38

CLEANING & DISINFECTING

IMPORTANT

In this chapter, the term video cable refers to the cable for the reusable system, and the term Smart Cable refers to the cable for the single-use system.

WARNING

www.osha.gov.

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 1.800.331.2313 or your local representative. For contact information, visit

verathon.com/contact-us.

WARNING

The reusable Titanium 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

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.

Page 39

Cleaning and disinfecting the GlideScope Titanium system is an important part of using and maintaining the system. Prior to each use, ensure that each system component has been cleaned, disinfected, or sterilized according to the guidance provided in Table 7.

The availability and regulatory compliance of the cleaning, disinfection, and sterilization products provided in this manual vary by region; ensure that you select products in accordance with your local laws and regulations.

Titanium single-use blades arrive sterilized by ethylene oxide, and they do not require cleaning, disinfection, or sterilization prior to use. Dispose of single-use blades once they have been used. Do not attempt to disinfect and reuse single-use video laryngoscopes.

The following table describes the risk assessment for each system component, including the Spaulding’s/CDC classiﬁcation for the minimum required disinfection level.

Table 7. Titanium System Risk Assessment

DEVICE PACKAGED USE

SPAULDING’S/CDC

CLASSIFICATION

DISINFECTION LEVEL

STERILIZE

Low High

GlideRite® Rigid Stylet Nonsterile Reusable Semi-critical X

Blade Nonsterile Reusable Semi-critical X Video cable Nonsterile Reusable Noncritical X* GlideScope

Smart Cable

Cart

†

Monitor

Single-use blades

* The low-level disinfection solutions in this manual are not available in all geographic regions. If they are not available in your region, such as

the United States, use a high-level disinfection method only.

† Clean the video monitor or cart when visibly soiled and on a regular basis, as per a schedule established by the medical care facility or provider.

‡ Single-use blades may not be cleaned, disinfected, or sterilized. Dispose of single-use blades after use.

X Checked boxes show minimum disinfection level requirement.

Shaded areas indicate that the disinfection/sterilization level is not required/not compatible with the device materials.

Unshaded areas show permissible levels of disinfection or sterilization based on compatibility with the device materials.

Nonsterile Reusable Noncritical X*

Nonsterile Reusable Noncritical Nonsterile Reusable Noncritical

‡

Sterile Single-use —

After reviewing Table 7, complete the following procedures to clean, disinfect, or sterilize the GlideScope Titanium system components:

• Clean a Blade, Video Cable, or Smart Cable

• Disinfect a Blade, Video Cable, or Smart Cable

• Sterilize a Blade, Video Cable, or Smart Cable (Optional)

• Clean & Disinfect the GlideRite Rigid Stylet

• Clean the GlideScope Video Monitor

• Clean the GlideScope Premium Cart

Operations & Maintenance Manual: Cleaning & Disinfecting

Page 40

PROCEDURE 1. CLEAN A BLADE, VIDEO CABLE, OR SMART CABLE

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 of the device.

Use this procedure in order to clean the GlideScope 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.

To signiﬁcantly reduce the amount of effort needed to clean the system, do not let contaminant(s) dry on any system component. Bodily contaminants tend to become securely attached to solid surfaces when dried, making removal more difﬁcult.

The reusable GlideScope Titanium blades and reusable system video cable are IPX8 compliant and can be completely immersed in the recommended cleaning solutions. The GlideScope Smart Cable is IPX7 compliant and may also be completely immersed in the solutions.

IMPORTANT

Do not use metal or abrasive brushes, scrub pads, or rigid tools when cleaning the reusable video laryngoscope. The window that protects the camera and light can be scratched, permanently damaging the device.

This product is heat-sensitive, and exposing the components to temperatures in excess of 60°C (140°F) will cause damage to the electronics.

Page 41

Table 8. Cleaning Methods for Video Cables, Smart Cables, and Reusable VideoLaryngoscopes

CHEMICAL LEVEL COMPONENT CYCLES* CONDITIONS

Water temperature: 33– 40 °C (91–104°F)

Exposure: Spray all surfaces until drenched. Allow to remain wet

Blade 3000

for 3 minutes. Brush all surfaces.

Rinse: Rinse for 5 minutes under running water. While rinsing, use a soft-bristled brush and a syringe to ﬂush and brush any hard-to-reach areas.

Water temperature: 33– 40 °C (91–104°F)

Exposure: Spray all surfaces until drenched. Allow to remain wet

for 5 minutes. Brush all surfaces. Rinse under running water for 3 minutes. Spray all surfaces until drenched. Allow to remain wet for 10 minutes.

Video Cable 3000

Rinse: Rinse under running water for 5 minutes. Fully immerse in water and agitate for 2 minutes. Before removing from water,

Metrex®

CaviCide

Cleaner

brush the cable with a soft-bristled brush. Remove from water and ﬂush the connectors with running water and a syringe. Fully immerse in fresh water and agitate for 2 minutes. Rinse under running water for 1 minute.

Water temperature: 33– 40 °C (91–104°F)

Getinge®

Tec Wash III

Metrex®

EmPower

Exposure: Spray all surfaces until drenched. Allow to remain wet for 10 minutes. Brush all surfaces. Rinse under running water for 5 minutes. Spray all surfaces until drenched. Allow to remain wet for 10 minutes.

Smart Cable 1500

Rinse: Rinse under running water for 5 minutes. Fully immerse in water and agitate for 3 minutes. Before removing from water, brush the cable with a soft-bristled brush. Remove from water and ﬂush the connectors with running water and a syringe. Fully immerse in fresh water and agitate for 3 minutes. Rinse under running water for 2 minutes.

Water temperature: 20–40°C (68 –104°F)

Exposure: Soak for 3 minutes. Brush all surfaces.

Rinse: Rinse for 3 minutes under running water.

Water temperature: 19–29°C (66–84°F)

†

Blade 3000

Cleaner

Video Cable 3000

Blade 3000

Exposure: Prepare solution at 1ounce/gallon (7.81 mL/L). Soak

Cleaner

™

Video Cable 3000

component for 3 minutes. Before removing from solution, brush all surfaces and pay special attention to hard-to-reach areas.

Smart Cable 1500

Rinse: Rinse for 3 minutes under running water.

Operations & Maintenance Manual: Cleaning & Disinfecting

Page 42

CHEMICAL 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).

STERIS®

eSSENTIALS

Concentrates

Cleaner Blade 750

™

Soak component for 5 minutes. Before removing from solution, brush all surfaces and pay special attention to hard-to-reach areas. Use a syringe to ﬂush the connector.

Rinse: Rinse for 3 minutes under running water. Flush the connector with running water and a syringe.

Pro-Line

Solutions

EcoZyme

Metrex®

Cavi Wip es™

Wip’Anios

Premium

Clinell®

Universal

Sanitizing

Wipes

Sani Cloth®

Active Wipes

Cleaner

Blade 3000

Video Cable 3000

Smart Cable 1500

Video Cable 1500

Smart Cable 150 0

Video Cable 1500

Smart Cable 150 0

Video Cable 1500

Smart Cable 150 0

Video Cable 1500

Smart Cable 150 0

Water temperature: 19–29°C (66–84°F)

Exposure: Prepare solution at 1ounce/gallon (7.81 mL/L) in

30–40°C (86–104°F) water. Soak component for 5 minutes. Before removing from solution, brush all surfaces and pay special attention to hard-to-reach areas. Using a syringe, ﬂush the connectors.

Rinse: Rinse for 5 minutes under running water. Using a syringe, ﬂush the connectors.

Water temperature: N/A

Exposure: Use towelette(s) to remove all visible contamination

from the component. Using fresh towelette(s), wet all surfaces and allow to remain wet for 3 minutes.

Rinse: N/A. Allow the component to thoroughly air dry.

Water temperature: N/A

Exposure: Use towelette(s) to remove all visible contamination

from the component. Using fresh towelette(s), wet all surfaces and allow to remain wet for 5 minutes.

Rinse: N/A. Allow the component to thoroughly air dry. Water temperature: N/A

Exposure: Use towelette(s) to remove all visible contamination

from the component. Using fresh towelette(s), wet all surfaces and allow to remain wet for 5 minutes.

Rinse: N/A. Allow the component to thoroughly air dry. Water temperature: N/A

Exposure: Use towelette(s) to remove all visible contamination

from the component. Using fresh towelette(s), wet all surfaces and allow to remain wet for 5 minutes.

Rinse: N/A. Allow the component to thoroughly air dry.

* Value indicates number of compatibility cycles tested on the component. Exceeding the recommended number of cycles may affect the potential life of

the product.

† Do not use this solution to clean a GlideScope Smart Cable.

Page 43

1. Ensure the video monitor has been turned off.

2. Detach the video cable from the monitor by turning the connector ring in the direction of the release arrow.

Connector ring

3. If you are cleaning a reusable system, detach the cable from the blade by rotating the connector ring in the direction of the release arrow, and then pulling gently in order to disconnect the components.

If you are cleaning a single-use system, detach the cable from the blade by holding the GlideScope Smart Cable connector in one hand and the blade handle in the other, and then pulling. Dispose of the single-use blade.

4. If you are using a wipe method to clean the component, skip to Step 9.

5. Using the water temperature speciﬁed in Table 8, rinse the component in clean tap water and scrub with a soft-bristled brush until all visible contamination has been removed.

If you are cleaning a reusable video laryngoscope, to prevent damage, use a cotton swab in order to clean around the camera window. Pay extra attention to cleaning the areas highlighted in the following ﬁgures: around the tip, inner corners, and camera.

LoPro T3 or T4 Blade LoPro T3 or T4 Blade MAC T3 or T4 Blade

6. Examine all connectors for contamination.

LoPro T3 or T4 Connector MAC T3 or T4 Connector Smart Cable ConnectorVideo Cable Connector

Operations & Maintenance Manual: Cleaning & Disinfecting

Page 44

7. If there is any visible sign of contamination in the connectors, use a long, soft-bristled brush or cotton swab to remove it.

8. Prepare one of the approved cleaning solutions in Table 8 according to the solution manufacturer’s instructions.

9. Expose the components to the cleaning solution according to the instructions in Table 8. The exposure process and times vary depending on the solution and the component.

Note:

• If you are using Metrex® CaviCide®, spray additional solution as needed in order to ensure that the

component remains visibly wet for the duration of the exposure period(s).

• If you are using a wipe method, rewipe the component as needed in order to ensure that it remains visibly

wet for the duration of the exposure period. You may use multiple wipes as necessary.

10. If applicable for the cleaning solution, rinse the components according to the instructions in Table 8. The rinsing process and times vary depending on the solution and the component.

WARNING

To reduce the risk of cytotoxic residual when cleaning with Metrex® CaviCide®, thoroughly rinse the component as instructed in this manual.

11. Visually inspect the component for contamination. If there is any sign of contamination, restart the procedure.

12. Using hospital-grade clean air, which is free from oils and residuals found in common compressed air, blow out the connectors. This dries the connectors and removes any remaining residuals.

13. Using a clean, lint-free cloth, hospital-grade clean air, or a low-temperature dryer, dry the component.

Note: If you are using a wipe method, allow the component to thoroughly air dry.

14. 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® Customer Care.

The component should now be clean and free of contamination. Handle the product carefully to avoid recontamination.

Note: Before each use, reusable video laryngoscopes must be high-level disinfected, and video cables and Smart Cables must be low-level disinfected.

Page 45

PROCEDURE 2. DISINFECT A BLADE, VIDEO CABLE, OR SMART CABLE

Before each use, reusable video laryngoscopes must be high-level disinfected, and video cables and Smart Cables must be low-level disinfected. Use the following instructions to disinfect the GlideScope Smart Cable, video cable, or reusable Titanium video laryngoscope. Not all chemical solutions listed in Table 9 are compatible with each component. Ensure that you select a chemical that is compatible with the component you are disinfecting.

In this procedure, the term pure water refers to water that is suitable for disinfection according to local regulations and your medical facility.

IMPORTANT

Do not use metal or abrasive brushes, scrub pads, or rigid tools when disinfecting the reusable video laryngoscope. The window that protects the camera and light can be scratched, permanently damaging the device.

This product is heat-sensitive, and exposing the components to temperatures in excess of 60°C (140°F) will cause damage to the electronics.

When high-level disinfecting a blade, video cable, or Smart Cable, you may use a Medivators® CER Optima1&2AER, DSD-201AER, or SSD-102AER system, provided you do the following:

• Use an approved high-level disinfectant from Table 9.

• Use a disinfectant that is compatible with the Medivators® system. For more information about chemical

compatibility, contact Medivators.

• Use the conditions provided in Table 9, such as temperature, exposure, and concentration.

• Do not expose the component to temperatures exceeding 60°C (140°F) on any cycle.

Table 9. Disinfection Methods for Video Cables, Smart Cables, and Reusable VideoLaryngoscopes

CHEMICAL

DISINFECTION

LEVEL

COMPONENT CYCLES* CONDITIONS

Conditioning: N/A

Clinell® Universal Sanitizing Wipes

Video Cable 1500

†

Low

Smart Cable 150 0

Water temperature: N/A

Exposure: Using fresh towelette(s), wet all surfaces and

allow to remain wet for 6 minutes.

Rinse: N/A. Allow the component to thoroughly air dry. Conditioning: N/A

Clorox® Bleach

Germicidal Wipes

Video Cable 3000

Low

Smart Cable 150 0

Water temperature: N/A

Exposure: Using fresh towelette(s), wet all surfaces and

allow to remain wet for 3 minutes.

Rinse: N/A. Allow the component to thoroughly air dry.

STERIS®

Revital-Ox™

Resert® XLHLD

Revital-Ox™ Resert® HLD/

Chemosterilant

Resert® XL HLD

Blade 3000

‡

High

‡

Video Cable 3000

Smart Cable 150 0

Conditioning: 20°C (68°F) or higher

Water Temperature: 20°C (68°F) or higher

Exposure: Soak for 8 minutes, ensuring that all air bubbles

are removed from the surface of the component.

Rinse: (1) 1-minute immersion with agitation in pure water. Ensure the connector is properly rinsed.

Operations & Maintenance Manual: Cleaning & Disinfecting

Page 46

CHEMICAL

STERIS® S40™

or S20™

DISINFECTION

LEVEL

High

COMPONENT CYCLES* CONDITIONS

Blade 675

Standard cycles in the following processors: STERIS® SYSTEM 1® (outside U.S.)

Video Cable 600

Smart Cable 750

SYSTEM 1E® (in U.S.) SYSTEM 1 EXPRESS (outside U.S.) SYSTEM 1 PLUS (outside U.S.)

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.

ASP®

Cidex® OPA

Metrex®

MetriCide® OPA

Plus

High

Video Cable 3000

Smart Cable 150 0

Blade 3000

Video Cable 3000

Smart Cable 150 0

Rinse: (3) 1-minute immersions with agitation in pure water. Conditioning: 20°C (68°F) or higher

Water Temperature: 20°C (68°F) or higher

Exposure: Soak for 10 minutes, ensuring that all air

bubbles are removed from the surface of the cable.

Rinse: (3) 1-minute immersions with agitation in pure water. Conditioning: 20°C (68°F) or higher

Water Temperature: 20°C (68°F) or higher

Exposure: Soak for 12 minutes, ensuring that all air

bubbles are removed from the surface of the blade.

Rinse: (3) 1-minute immersions with agitation in pure water.

Conditioning: 20°C (68°F) or higher

Water Temperature: 20°C (68°F) or higher

Exposure: Soak for 10 minutes, ensuring that all air

bubbles are removed from the surface of the cable.

Rinse: (3) 1-minute immersions with agitation in pure water.

Conditioning: 25 ± 2°C (77 ± 4°F)

Water temperature: 33– 40 °C (91–104°F)

Metrex®

MetriCide® 28

High

Video Cable 3000

Blade 3000

Exposure: Soak for 20 minutes, ensuring that all air bubbles are removed from the surface of the blade.

Rinse: (3) 3-minute immersions in pure water, while agitating, ﬂushing, and brushing with a sterile, soft-bristled brush.

Conditioning: 25 ± 2°C (77 ± 4°F)

Water temperature: 33– 40 °C (91–104°F)

Exposure: Soak for 20 minutes, ensuring that all air

bubbles are removed from the surface of the cable.

Rinse: (3) 1-minute immersions in pure water, while agitating, ﬂushing, and brushing with a sterile, soft-bristled brush.

Page 47

CHEMICAL

DISINFECTION

LEVEL

COMPONENT CYCLES* CONDITIONS

Conditioning: 20 ± 2°C (68 ± 4°F)

Water Temperature: 33– 40°C (91–104°F)

Sultan®

Healthcare

Sporox® II

High Video Cable 3000

Exposure: Soak for 30 minutes, ensuring that all air bubbles are removed from the surface of the cable. Following soak, brush and ﬂush. Repeat 30-minute soak.

Rinse: (3) 3-minute immersions with brushing and ﬂushing in pure water.

Blade 100

Concentration: 850 ± 100 parts per million

Conditioning: 28–32°C (82–90°F)

Medivators®

Rapicide® PA

30°C

High

Video Cable 100

Smart Cable 100

Exposure: 5 minutes in a Medivators® Advantage Plus AER reprocessing system with the following conﬁguration:

• Hookup: 2-8-002HAN Rev. B

• Parameter: 1-24-010 C DISF

* Value indicates number of compatibility cycles tested on the component. Exceeding the recommended number of cycles may affect the potential life of

the product.

† Clinell® Universal Sanitizing Wipes are not available in all geographic regions, such as the United States.

‡ This chemical may cause discoloration of metal components, but the discoloration does not affect system efﬁcacy or functionality.

§ Do not use this solution to disinfect a GlideScope Smart Cable.

1. Ensure the video laryngoscope, video cable, or Smart Cable has been properly cleaned, according to the procedure Clean a Blade, Video Cable, or Smart Cable.

2. Prepare and condition the disinfection solution according to the solution manufacturer’s instructions and the conditions stated in Table 9.

3. Disinfect the component according to the conditions stated in Table 9. The exposure process and times vary depending on the solution and the component.

Note: If you are using a wipe method, rewipe the component as needed in order to ensure that it remains visibly wet for the duration of the exposure period. You may use multiple wipes as necessary.

4. Rinse the component according to the conditions stated in Table 9. The rinsing process and times vary depending on the solution and the component.

5. Dry the component by using a sterile cloth, hospital-grade clean air, or a low-temperature dryer.

Note: If you are using a wipe method, allow the component to thoroughly air dry.

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® Customer Care.

7. Store the component in a clean environment.

Operations & Maintenance Manual: Cleaning & Disinfecting

Page 48

PROCEDURE 3. STERILIZE A BLADE, VIDEO CABLE, OR SMART CABLE (OPTIONAL)

Reusable Titanium video laryngoscopes are considered to be semi-critical devices; therefore, sterilization of the blade, video cable, or GlideScope Smart Cable is optional. Your medical care facility or provider may require sterilization of these components prior to use. These components use an identical sterilization process, so you may use the following instructions to sterilize any component.

IMPORTANT

This product is heat-sensitive, and exposing the components to temperatures in excess of 60°C (140°F) will cause damage to the electronics.

Table 10. Sterilization Methods for Video Cables, Smart Cables, and Reusable VideoLaryngoscopes

CHEMICAL

STERIS® S40™

or S20™

DISINFECTION

LEVEL

High/

Sterilization

COMPONENT CYCLES

Blade 675

Video Cable 600

Smart Cable 750

CONDITIONS

Standard cycles in the following processors: STERIS® SYSTEM 1® (outside U.S.) SYSTEM 1E® (in U.S.) SYSTEM 1 EXPRESS (outside U.S.) SYSTEM 1 PLUS (outside U.S.)

Blade 125

STERIS® Vaprox® HC Sterilization

Video Cable 125

Non-lumen cycle in any STERIS® Amsco® V-PRO® low-temperature sterilization system.

Smart Cable 100

Blade 125

STERRAD® 100S (in U.S.) STERRAD® 100S short cycle (outside U.S.)

ASP® Hydrogen

Peroxide Gas Plasma

Sterilization

Video Cable 125

Smart Cable 100

STERRAD® NX standard cycle STERRAD® 100NX standard cycle STERRAD® 50 STERRAD® 200 short cycle

* Value indicates number of compatibility cycles tested on the component. Exceeding the recommended number of cycles may affect the

potential life of the product.

1. Ensure that the component has been properly cleaned according to the procedure Clean a Blade, Video

Cable, or Smart Cable.

2. Package the component according to the instructions provided by the manufacturer of the sterilization system (Example: trays, pouches, or wraps).

3. Sterilize the component according to the manufacturer’s instructions or according to the conditions stated in

Table 10.

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® Customer Care.

5. Store the component in a clean environment that is appropriate for sterile equipment.

Page 49

PROCEDURE 4. CLEAN & DISINFECT THE GLIDERITE RIGID STYLET

The GlideRite® Rigid Stylet is a reusable device that requires cleaning and either high-level disinfection or sterilization prior to use.

In this procedure, the term pure water refers to water that is suitable for disinfection according to local regulations and your medical facility.

Table 11. Cleaning and Disinfection Methods for the GlideRite Rigid Stylet

METHOD LEVEL CYCLES* CONDITIONS

Water temperature: 33– 40 °C (91–104°F)

Exposure: Spray all surfaces until drenched. Allow to

Metrex® CaviCide

Cleaner 3000

remain wet for 3 minutes. Brush all surfaces.

Rinse: Rinse for 5minutes under running water. While rinsing, use a soft-bristled brush and a syringe to ﬂush and brush any hard-to-reach areas.

Water temperature: 20–40°C (68 –104°F)

Getinge® Tec Wash III Cleaner 3000

Metrex® EmPower

Pro-Line Solutions

EcoZyme

Metrex®

MetriCide®28

™

Cleaner 3000

High 3000

Exposure: Soak for 3 minutes. Brush all surfaces.

Rinse: Rinse for 3 minutes under running water. Water temperature: 19–29°C (66–84°F)

Exposure: Prepare solution at 1ounce/gallon (7.81 mL/L).

Soak component for 3minutes. Before removing from solution, brush all surfaces and pay special attention to hard-to-reach areas.

Rinse: Rinse for 3 minutes under running water. Water temperature: 19–29°C (66–84°F)

Exposure: Prepare solution at 1ounce/gallon (7.81 mL/L) in

30–40°C (86–104°F) water. Soak component for 5minutes. Before removing from solution, brush all surfaces and pay special attention to hard-to-reach areas. Using a syringe, ﬂush the connectors.

Rinse: Rinse for 5minutes under running water. Conditioning: 23–27°C (73–81°F)

Water temperature: 33– 40 °C (91–104°F)

Exposure: Soak for 20 minutes, ensuring that all air bubbles

are removed from the surface of the component.

STERIS® Revital-Ox™

Resert® XLHLD

Revital-Ox™ Resert®

HLD/Chemosterilant

Resert® XL HLD

†

High 3000

†

Operations & Maintenance Manual: Cleaning & Disinfecting

Rinse: (3) 3-minute immersions in pure water, while agitating, ﬂushing, and brushing with a sterile, soft-bristled brush.

Conditioning: 20°C (68°F) or higher

Water Temperature: 20°C (68°F) or higher

Exposure: Soak for 8 minutes, ensuring that all air bubbles

are removed from the surface of the component.

Rinse: (1) 1-minute immersion with agitation in pure water.

Page 50

METHOD LEVEL CYCLES* CONDITIONS

Conditioning: 20°C (68°F) or higher

ASP®

Cidex® OPA

Metrex®

MetriCide® OPA Plus

Medivators

Rapicide®

PA 30°C

STERIS® S40™

or S20™

ASP® Hydrogen

Peroxide Gas Plasma

High 3000

High 100

High 675

Sterilization 500

Water Temperature: 20°C (68°F) or higher

Exposure: Soak for 12 minutes, ensuring that all air bubbles

are removed from the surface of the component.

Rinse: (3) 1-minute immersions with agitation in pure water. Conditioning: 20°C (68°F) or higher

Water Temperature: 20°C (68°F) or higher

Exposure: Soak for 12 minutes, ensuring that all air bubbles

are removed from the surface of the component.

Rinse: (3) 1-minute immersions with agitation in pure water. Concentration: 750–950 parts per million

Conditioning: 28–32°C (82–90°F)

Exposure: 5 minutes in a Medivators® Advantage Plus AER

reprocessing system with the following conﬁguration:

• Hookup: 2-8-002HAN Rev. B

• Parameter: 1-24-010 C DISF Standard cycles in the following processors:

STERIS® SYSTEM 1® (outside U.S.) SYSTEM 1E® (in U.S.) SYSTEM 1 EXPRESS (outside U.S.) SYSTEM 1 PLUS (outside U.S.)

STERRAD® 100S (in U.S.) STERRAD® 100S short cycle (outside U.S.) STERRAD® NX standard cycle STERRAD® 100NX standard cycle STERRAD® 50 STERRAD® 200 short cycle

STERIS® Vaprox®HC Sterilization 500

Autoclave

(steam cycle)

* Value indicates number of compatibility cycles tested. Exceeding the recommended number of cycles may affect the potential life of the

product.

† This chemical may discolor metal, but the discoloration does not affect efﬁcacy or functionality.

Sterilization 300

Non-lumen cycle in any STERIS® Amsco® V-PRO® low-temperature sterilization system.

Temperature: 132–137° C (270 –279 °F) Exposure: 4–18 minutes

Page 51

CLEAN THE STYLET

1. Using the water temperature speciﬁed in Table 11, rinse the stylet in clean tap water and scrub it with a soft-bristled brush until all visible contamination has been removed.

2. Prepare one of the approved cleaning solutions in Table 11 according to the solution manufacturer’s instructions.

3. Expose the components to the cleaning solution according to the instructions in Table 11.

Note: If you are using Metrex® CaviCide®, spray additional solution as needed in order to ensure that the stylet remains visibly wet for the duration of the exposure period(s).

4. Rinse the stylet according to the instructions in Table 11.

WARNING

To reduce the risk of cytotoxic residual when cleaning with Metrex® CaviCide®, thoroughly rinse the component as instructed in this manual.

5. Visually inspect the stylet for contamination. If there is any sign of contamination, restart the procedure.

6. Using a clean, lint-free cloth, hospital-grade clean air, or a low-temperature dryer, dry the stylet.

The component should now be clean and free of contamination. Handle the product carefully to avoid recontamination.

DISINFECT OR STERILIZE THE STYLET

7. Ensure the stylet has been properly cleaned according to the previous steps.

8. Prepare and condition the disinfection or sterilization solution according to the solution manufacturer’s instructions and the conditions stated in Table 11.

9. Disinfect or sterilize the stylet according to the conditions stated in Table 11.

10. Rinse the stylet according to the conditions stated in Table 11.

11. Dry the stylet by using a sterile cloth, hospital-grade clean air, or a low-temperature dryer.

12. Visually inspect the stylet and ensure that there are no signs of damage or cracking. If the stylet is damaged, discard it and contact Verathon® Customer Care to order a new stylet.

13. Store the stylet in a clean environment.

Operations & Maintenance Manual: Cleaning & Disinfecting

Page 52

PROCEDURE 5. CLEAN THE GLIDESCOPE VIDEO MONITOR

IMPORTANT

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.

Clean the video monitor when it is visibly soiled and on a regular basis, as per a schedule established by the medical care facility or provider.

1. Turn off the GlideScope Video Monitor, and then unplug the device.

2. Using 70% isopropyl alcohol (IPA),* Metrex® CaviWipes™,* AHP® Oxivir®,* or PDI® Chlorascrub™,* wipe the exterior of the video monitor.

* Tested for 100 compatibility cycles. Exceeding the recommended number of cycles may affect the potential life of the product.

PROCEDURE 6. 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 INGREDIENT

†

BRAND NAME CONCENTRATION

Sodium hypochlorite Clorox® Bleach 0.16% (1600ppm)

Virox® Technologies Accel® TB Wipes

Hydrogen peroxide

0.5%

Diversey® Oxivir® TB Wipes

Isopropyl alcohol — 70%

Quaternary ammonium

compound (alcohol-based)

* All solutions have been tested for 100 compatibility cycles. Exceeding the recommended number of cycles may affect the potential life of the

product.

† See solution manufacturer’s label for additional active and inactive ingredients.

PDI® Super Sani-Cloth® Germicidal Disposable Wipes 0.5% Metrex® Cavi Wip es™ 0.28%

1. If you are using bleach, prepare the solution to the concentration indicated in Table 12.

Note: If you are using a product containing 5% bleach, dilute 120mL (4ounces) of bleach in 3.8L (1 gallon) of water.

2. Using one of the solutions in Table 12, expose the cart to the cleaning solution according to the solution manufacturer’s instructions.

Page 53

MAINTENANCE & SAFETY

PERIODIC INSPECTIONS

Periodic inspections should be performed to ensure safe and effective operation, in addition to performing routine inspection by the user before and after every use. It is recommended that an operator familiar with the instrument perform a full visual inspection of all components at least every three months. The inspector should check the system for the following:

• External damage to the equipment

• Damage to the power supply or adapter

• Damage to the connectors or cable insulation

Report any suspected defects to Verathon® Customer Care at:

Phone: 800.331.2313 (U.S. and Canada) +1.425.867.1348 (International)

Email: [email protected]

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. The protein sample solution is then examined as a veriﬁcation of the hospital cleaning process.

The testing concluded that 1% SDS solution with pH 11.0 is chemically compatible with the reusable blades and gives no adverse results when performing repeated 30-minute soaking for 100cycles.

GLIDESCOPE VIDEO MONITOR BATTERY

Under normal operating conditions, the monitor battery will last 2–3 years, or approximately 500charge and discharge cycles. For more information about the battery, see Battery Speciﬁcations.

The battery is not user-replaceable. In case of battery malfunction, do not attempt to replace the monitor battery. Any attempts to replace the battery by unauthorized service technicians may cause serious harm to the user and will void the warranty. Please contact your Verathon Customer Care representative for more information on battery replacement.

Operations & Maintenance Manual: Maintenance & Safety

Page 54

SYSTEM SOFTWARE

Verathon® may release software upgrades for the GlideScope Video Monitor. Software upgrades are supplied directly by Verathon or an authorized representative, and installation instructions are provided with the upgrade.

Do not perform any software upgrades from third-party vendors or attempt to modify the existing software. Doing so may damage the monitor and void the warranty.

For information about software language options, see Language Settings on page 7.

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.

If you have any questions, contact your local Verathon representative or Verathon Customer Care.

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.

DEVICE DISPOSAL

The GlideScope Titanium instrument and related devices may contain batteries and other environmentally hazardous materials. When the instrument has reached the end of its useful service life, it must be disposed of in accordance with WEEE requirements. Coordinate disposal through your Verathon Service Center, or alternatively, follow your local protocols for hazardous waste disposal.

Page 55

WARRANTY

Verathon® includes a one-year warranty when you buy a GlideScope Titanium system. You may also purchase a Premium Customer CareSM warranty that extends your warranty from the date of purchase.

ORIGINAL FIRST YEAR TOTAL CUSTOMER CARE WARRANTY

Verathon warrants the GlideScope Titanium system against defects in material and workmanship. This warranty applies for one (1) year from the date of shipment from Verathon. This warranty applies only to the original purchaser of the GlideScope system.

Verathon is ﬁrmly committed to providing our customers with best-in-class, reliable products through authorized dealers. Our policy is to honor product warranties and to perform services only on products purchased from an authorized Verathon dealer. If you purchase a Verathon product or system components from an unauthorized dealer or if the original factory serial number has been removed, defaced or altered, your Verathon warranty will not be valid. Purchasing Verathon products from unauthorized entities could result in receipt of product that is counterfeit, used, defective, or not intended for use in your region.

If a customer’s system requires service or repair, Verathon will, at its discretion, either repair or replace the customer’s unit and provide a loaner unit within one (1) business day from the date of customer service notiﬁcation. The customer agrees to send the defective unit to Verathon (cleaned and disinfected as appropriate) upon receipt of the loaner unit, and the customer agrees to return the loaner unit within two (2) business days of receipt of the repaired unit.

• This warranty provides coverage for damage from accidental drops or mishandling. It does not cover

damage due to deliberate mishandling.

• This warranty does not apply if the product has been damaged due to, or as the result of, service or

modiﬁcation by anyone other than an authorized Verathon Service Center.

• This warranty does not apply if there is evidence of the equipment being exposed to temperatures in

excess of 60°C (140°F).

• All exchanged parts become property of Verathon.

The product shall be used in accordance with the instructions contained in this manual. Consumable items (e.g., single-use blades) shall be used in conformance with Verathon product speciﬁcations. Consumable items are not covered under this warranty.

WHAT IS COVERED?

Warranty coverage applies to the GlideScope Titanium system:

• GlideScope Video Monitor

• GlideScope Smart Cable (single-use system only)

• Reusable video cable (reusable system only)

• Reusable GlideScope Titanium video laryngoscope (reusable system only)

Additional reusable video laryngoscopes, video monitors, or video cables purchased either singularly or as a part of a system are warranted separately.

Operations & Maintenance Manual: Warranty

Page 56

PREMIUM CUSTOMER CARE WARRANTY

The Premium Customer CareSM warranty from Verathon® may be extended from the date of purchase.

DISCLAIMER OF ADDITIONAL WARRANTIES

There are no understandings, agreements, representations of warranties expressed or implied (including warranties of merchantability or ﬁtness for a particular purpose) other than those set forth in this chapter. The contents of this manual do not constitute a warranty.

Some states disallow certain limitations on applied warranties. The purchaser should consult state law if there is a question regarding this disclaimer. The information, descriptions, recommendations, and safety notations in this manual are based upon Verathon experience and judgment with GlideScope systems. The contents of this manual should not be considered to be all-inclusive or to cover all contingencies.

Page 57

PRODUCT SPECIFICATIONS

SYSTEM SPECIFICATIONS, STANDARDS, & APPROVALS

Table 13. Titanium System Speciﬁcations

GENERAL SPECIFICATIONS

Classiﬁcation: Electrical Class II, Applied Part BF Line voltage: Range: 100–240 VAC, 50 and 60 Hz. Connect to a medical-grade power supply DC power supply: 12V DC, 2.5A max Fuse: Internal 2.5A hold / 5A trip, 15V max

Video monitor IP54

Ingress protection against water:

Expected product life:

Temperature: 10 to 35°C (50 to 95°F) Relative humidity: 0 to 95% Atmospheric pressure: 540 –1060 hPa

Temperature: -20 to 40°C (-4 to 104°F) Relative humidity: 0 to 95% Atmospheric pressure: 440–1060 hPa

Single-use blade IPX4 GlideScope Smart Cable IPX7 Reusable blade and video cable IPX8 Single-use blade 1 use or 3-year shelf life Reusable blade 3 years or 3000 cycles

OPERATING & STORAGE SPECIFICATIONS

Operating Conditions

Shipping & Storage Conditions

Operations & Maintenance Manual: Product Speciﬁcations

Page 58

COMPONENT SPECIFICATIONS

Table 14. System Component Speciﬁcations

GLIDESCOPE VIDEO MONITOR

TFT Color, VGA 640 x 480 px

Monitor: 6.4 in

Height: 174 mm

Width: 223 mm

Depth: 80 mm

Weight: 1.0 kg

VIDEO CABLE (REUSABLE SYSTEM)

Cable length: 2190 ± 55mm

Diameter: 5.4 mm

2190±55 (cable length)

Length: 1540 ± 50mm

Diameter: 5.4 mm

Handle Length: 82 mm

Handle Width: 16 mm

Stylet Rod Length: 266 mm

Distal Tip Diameter: 5 mm

5.4 (diameter)

GLIDESCOPE SMART CABLE (SINGLE-USE SYSTEM)

1540 ± 50 (cable length)

5.4 (diameter)

GLIDERITE® RIGID STYLET

Page 59

Wheelbase: 53.3 cm

Min. height: 101.6cm

Max. height: 132.1 cm

Weight: 8.0–8.4kg

GLIDESCOPE PREMIUM CART

AVL PORTABLE CART

Wheelbase diameter: 61 cm

Min. height: 76cm

Max. height: 122 cm

Operations & Maintenance Manual: Product Speciﬁcations

Page 60

Height at handle: 10.8mm

Height at camera: 10.5mm

Blade tip to handle: 72mm

Width at camera: 20mm

LOPRO T3 (REUSABLE SYSTEM)

72 (blade tip to handle)

10.8 (height at handle)

10.5 (height at camera)

20 (width at camera)

LOPRO T4 (REUSABLE SYSTEM)

91 (blade tip to handle)

Height at handle: 11.0mm

Height at camera: 10.0 mm

Blade tip to handle: 91 mm

Width at camera: 25 mm

10.0 (height at camera)11.0 (height at handle)

25 (width at camera)

Page 61

Height at handle: 14.5mm

Height at camera: 9.6 mm

Blade tip to handle: 107 mm

MAC T3 (REUSABLE SYSTEM)

107 (blade tip to handle)

Width at camera: 22 mm

Height at handle: 13.4mm

Height at camera: 9.6 mm

Blade tip to handle: 128 mm

Width at camera: 22 mm

14.5 (height at handle)

MAC T4 (REUSABLE SYSTEM)

128 (blade tip to handle)

13.4 (height at handle)

9.6 (height at camera)

22 (width at camera)

9.6 (height at camera)

Operations & Maintenance Manual: Product Speciﬁcations

22 (width at camera)

Page 62

Height at handle: 11.0mm

Height at camera: 11.0mm

Blade tip to handle: 74mm

Width at camera: 20mm

LOPRO S3 (SINGLE-USE SYSTEM)

74 (blade tip to handle)

Height at handle: 12.0mm

Height at camera: 11.3 mm

Blade tip to handle: 91 mm

Width at camera: 25 mm

11.0 (height at handle)

LOPRO S4 (SINGLE-USE SYSTEM)

91 (blade tip to handle)

12.0 (height at handle)

11.0 (height at camera)

20 (width at camera)

11.3 (height at camera)

25 (width at camera)

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Height at handle: 14.3mm

Height at camera: 11.2 mm

Blade tip to handle: 107 mm

Width at camera: 22 mm

MAC S3 (SINGLE-USE SYSTEM)

107 (blade tip to handle)

11.2 (height at camera)14.3 (height at handle)

22 (width at camera)

MAC S4 (SINGLE-USE SYSTEM)

127 (blade tip to handle)

Height at handle: 13.4mm

Height at camera: 11.0 mm

Blade tip to handle: 127 mm

Width at camera: 22 mm

13.4 (height at handle)

11.0 (height at camera)

22 (width at camera)

Operations & Maintenance Manual: Product Speciﬁcations

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BATTERY SPECIFICATIONS

Table 15. Battery Speciﬁcations

CONDITION DESCRIPTION

Battery type Lithium-ion

Battery life

Charging time

Rated capacity 2150mAh Nominal voltage 7.2V Max charging voltage 8.4V Nominal weight 90g Width 0.9in (23mm) Length 5.4in (391mm) Thickness 0.9in (23mm)

Under normal operating conditions, a fully charged battery lasts approximately 90minutes

Charging time off line will take no more than 6hours from an empty battery to a full charge

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ELECTROMAGNETIC COMPATIBILITY

GlideScope Titanium 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.

The GlideScope Titanium system complies with the applicable essential performance requirements speciﬁed in IEC 60601-1 and IEC 60601-2-18. Results of immunity testing show that the essential performance of the system is not affected under the test conditions described in the following tables. For more information about the essential performance of the GlideScope Titanium system, see Essential Performance on page 1.

ELECTROMAGNETIC EMISSIONS

Table 16. Guidance and Manufacturer’s Declaration—Electromagnetic Emissions

The GlideScope Titanium system is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the GlideScope Titanium system should assure that it is used in such an environment.

EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT – GUIDANCE

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage ﬂuctuations/ ﬂicker emissions IEC 61000-3-3

Group 1

Class A

Complies

The GlideScope Titanium system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The GlideScope Titanium system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Operations & Maintenance Manual: Product Speciﬁcations

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ELECTROMAGNETIC IMMUNITY

Table 17. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity

IMMUNITY TESTS IEC 60601 TEST LEVEL

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical fast transient/ burst

IEC 61000-4-4

Surge

IEC 61000-4-5

± 6 kV contact

± 8 kV air

± 2 kV for power supply lines

± 1 kV for input/output lines

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

<5% Ut (>95% dip in Ut)

for 0.5 cycle Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

40% Ut (60% dip in Ut)

for 5 cycles

70% Ut (30% dip in Ut)

for 25 cycles

<5% Ut (>95% dip in Ut)

for 5 s

Power frequency (50/60 Hz) magnetic ﬁeld

3 A/m In compliance

IEC 61000-4-8

Conducted RF IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

COMPLIANCE

LEVEL

In compliance

3 V

ELECTROMAGNETIC ENVIRONMENT

– GUIDANCE

Floors should be wood, concrete, or ceramic tile. If ﬂoors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the GlideScope Titanium system requires continued operation during power mains interruptions, it is recommended that the GlideScope Titanium system be powered from an uninterruptible power supply or a battery.

Power frequency magnetic ﬁelds should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Portable and mobile RF communications equipment should be used no closer to any part of the GlideScope Titanium system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance d (m)

d=1.2 √P

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Table 17. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity

IMMUNITY TESTS IEC 60601 TEST LEVEL

Radiated RF IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

COMPLIANCE

LEVEL

3 V/m

ELECTROMAGNETIC ENVIRONMENT

– GUIDANCE

d=1.2 √P 80 MHz to 800 MHz

d=2.3 √P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from ﬁxed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

Note: Ut is the AC mains voltage prior to application of the test level.

At 80 MHz and 800 MHz, the higher frequency range applies.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reﬂection from structures, objects and people.

a. Field strengths from ﬁxed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,

AM and FM radio broadcast and T V broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to ﬁxed RF transmitters, an electromagnetic site survey should be considered. If the measured ﬁeld strength in the location in which the GlideScope Titanium system is used exceeds the applicable RF compliance level above, the GlideScope Titanium system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the GlideScope Titanium system.

b. Over the frequency range 150 kHz to 80 MHz, ﬁeld strengths should be less than 3 V/m.

Operations & Maintenance Manual: Product Speciﬁcations

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RECOMMENDED SEPARATION DISTANCES

Table 18 . Recommended Separation Distances between Portable and Mobile RF Communications Equipment

and the GlideScope Titanium System

The GlideScope Titanium system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the GlideScope Titanium system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the GlideScope Titanium system as recommended below, according to the maximum output power of the communications equipment.

RATED MAXIMUM

OUTPUT POWER OF

TRANSMITTER (W)

SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER (m)

150 kHz to 80 MHz

d=1.2 √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73 1 1.2 1. 2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reﬂection from structures, objects and people.

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

& 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.

80 MHz to 800 MHz

d=1.2 √P

800 MHz to 2.5 GHz

d=2.3 √P

Table 19. EMC Standards for Accessories

ACCESSORY MAX LENGTH

AC power cord 4.5 m (15 ft) DC medical power adapter — HDMI-to-DVI cable 6 m (20 ft) Video cable (reusable system) 2.2 m (7.2 ft) Smart Cable (single-use system) 1.6 m (5.2 ft)

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SYMBOL DIRECTORY

The following table explains the symbols used with the system in order to indicate safety information, instructions for use, and compliance with standards and regulations.

Table 20. Directory of Symbols

SYMBOL MEANING

Warnings & Cautions

Warning or Caution—Consult accompanying documents. Read instructions before connecting or operating.

Risk of electric shock

Flammable material

Non-ionizing, electromagnetic radiation

Product Use & Speciﬁcations

Refer to the operations & maintenance manual

Manufacturer

Use-by date

Catalogue (part) number

Serial number

Batch code

Upper temperature limit

Temperature limitation

Operations & Maintenance Manual: Symbol Directory

Page 70

SYMBOL MEANING

Humidity limitation

Atmospheric pressure limitation

USB

Statement of prescription

USB ﬂash drive for media storage

Sterilized using ethylene oxide

Non sterile

Reuse is not allowed

Shipping

Fragile item, handle carefully

Keep dry

Handle with care

This way up

Quantity per box

Stacking limit by number—Indicates that the items are not to be vertically stacked higher than the speciﬁed number of items

Shipping box is made of corrugated cardboard and should be recycled accordingly

Page 71

SYMBOL MEANING

Electrical & Power

Class II equipment

Type BF applied part

Energy Efﬁciency Level IV

Connector polarity mark

Direct current

Alternating current

Standards & Certiﬁcations

CE—Marked in accordance with the Medical Device Directive (MDD)

CSA—Canadian Standards Association mark of certiﬁcation to applicable standards for electromedical equipment

EC REP—Authorized Representative in the European Community

TUV—Safety approval mark for components or subassemblies

UL—Underwriters Laboratories Recognized Component certiﬁcation mark in Canada and the United States

WEEE—Subject to waste electrical and electronic equipment regulations

Operations & Maintenance Manual: Symbol Directory

Page 72

GLOSSARY

TERM DEFINITION

A Ampere AC Alternating current AER Automated endoscope reprocessor C Celsius CFR Code of Federal Regulations (U.S.) CISPR International Special Committee on Radio Interference cm Centimeter CSA Canadian Standards Association DL Direct laryngoscopy EMI Electromagnetic interference ESD Electrostatic discharge Essential performance The system performance necessary to achieve freedom from unacceptable risk F Fahrenheit g Gram GHz Gigahertz HDMI High-deﬁnition multimedia interface hPa Hectopascal Hz Hertz IEC International Electrotechnical Commission in Inch IPA Isopropyl alcohol ISM Industrial, scientiﬁc, and medical kHz Kilohertz kV Kilovolt L Liter m Meter mAh Milliampere-hour MDD Medical Device Directive MHz Megahertz mL Milliliter mm Millimeter MSDS Material Safety Data Sheet OSHA Occupational Safety and Health Administration (federal agency in U.S.) psia Pounds per square inch absolute

Pure water

Water that is suitable for high-level disinfection according to local regulations and your medical facility

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TERM DEFINITION

RF Radio frequency RH Relative humidity

RoHS

Restriction of the Use of Certain Hazardous Substances in Electrical and

Electronic Equipment SDS Sodium dodecyl sulphate V Volt Vrms Voltage root mean squared W Watt WEEE Waste electrical and electronic equipment

Operations & Maintenance Manual: Glossary

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