Verathon GlideScope Go Operation & Maintenance Manual

Operations & Maintenance Manual EN

Manuel d'utilisation et de maintenance

Bedienungs‑ und Wartungshandbuch

Manual de funcionamiento y mantenimiento

Manuale di funzionamento e manutenzione

Manual de Manutenção e Operações

Betjenings‑ og vedligeholdelsesvejledning DA

Bedienings‑ en onderhoudshandleiding NL

Drifts‑ og vedlikeholdshåndbok

Drift‑ och underhållshandbok

0900‑4788‑05‑60

ENGLISH ..................................................................................................................... 1

Important Information ................................................................................................. 1

Introduction................................................................................................................. 4

Setting Up the System ................................................................................................. 6

Using the Device ........................................................................................................ 10

Cleaning & Disinfecting ............................................................................................. 13

Maintenance & Safety ................................................................................................ 19

Warranty ................................................................................................................... 20

Product Speciﬁcations ............................................................................................... 20

FRANÇAIS ................................................................................................................ 25

Informations importantes .......................................................................................... 25

Introduction............................................................................................................... 28

Conﬁguration du système .......................................................................................... 29

Utilisation du dispositif .............................................................................................. 31

Nettoyage et désinfection .......................................................................................... 33

Maintenance et sécurité ............................................................................................. 36

Garantie .................................................................................................................... 38

Caractéristiques du produit ........................................................................................ 38

DEUTSCH .................................................................................................................. 44

Wichtige Informationen .............................................................................................44

Einführung ................................................................................................................. 47

Einrichten des Systems ............................................................................................... 48

Verwenden des Geräts .............................................................................................. 51

Reinigung und Desinfektion ....................................................................................... 53

Wartung und Sicherheit ............................................................................................. 56

Garantie .................................................................................................................... 57

Technische Produktdaten ........................................................................................... 57

ESPAÑOL .................................................................................................................. 63

Información importante ............................................................................................. 63

Introducción .............................................................................................................. 66

Conﬁguración del sistema .......................................................................................... 67

Uso del dispositivo ..................................................................................................... 69

Limpieza y desinfección ............................................................................................. 71

Mantenimiento y seguridad ....................................................................................... 75

Garantía .................................................................................................................... 76

Especiﬁcaciones del producto .................................................................................... 76

ITALIANO .................................................................................................................81

Informazioni importanti ............................................................................................. 81

Introduzione .............................................................................................................. 84

Conﬁgurazione del sistema ........................................................................................ 85

Utilizzo del dispositivo ............................................................................................... 87

Pulizia e disinfezione .................................................................................................. 89

Manutenzione e sicurezza ......................................................................................... 92

Garanzia .................................................................................................................... 93

Speciﬁche di prodotto ............................................................................................... 93

PORTUGUÊS ............................................................................................................. 99

Informações importantes ........................................................................................... 99

Introdução ............................................................................................................... 102

Conﬁguração do sistema ......................................................................................... 103

Utilizar o dispositivo ................................................................................................. 105

Limpeza e desinfeção .............................................................................................. 107

Manutenção e segurança .........................................................................................11 0

Garantia ...................................................................................................................112

Especiﬁcações do produto ........................................................................................112

DANSK .....................................................................................................................117

Vigtig information ....................................................................................................117

Indledning ............................................................................................................... 120

Indstilling af systemet ...............................................................................................121

Brug af enheden ...................................................................................................... 123

Rengøring og desinfektion....................................................................................... 125

Vedligeholdelse og sikkerhed ....................................................................................127

Garanti .................................................................................................................... 129

Produktspeciﬁkationer ............................................................................................. 129

NEDERLANDS ......................................................................................................... 134

Belangrijke informatie .............................................................................................. 13 4

Inleiding................................................................................................................... 137

Het systeem opstellen .............................................................................................. 13 8

Het apparaat gebruiken ............................................................................................141

Reinigen en desinfecteren ........................................................................................ 143

Onderhoud en veiligheid ......................................................................................... 146

Garantie .................................................................................................................. 147

Productspeciﬁcaties ................................................................................................. 14 8

NORSK .................................................................................................................... 154

Viktig informasjon ................................................................................................... 154

Innledning ............................................................................................................... 157

Oppsett av systemet ................................................................................................ 15 8

Bruke enheten ......................................................................................................... 160

Rengjøring og desinfeksjon...................................................................................... 162

Vedlikehold og sikkerhet .......................................................................................... 164

Garanti .................................................................................................................... 166

Produktspesiﬁkasjoner ............................................................................................. 166

SVENSKA ................................................................................................................ 171

Viktig information.....................................................................................................171

Inledning ..................................................................................................................174

Installera systemet ................................................................................................... 175

Använda enheten .................................................................................................... 17 7

Rengöring och desinﬁcering .................................................................................... 179

Underhåll och säkerhet ............................................................................................ 182

Garanti .................................................................................................................... 183

Produktspeciﬁkationer ............................................................................................. 183

iii

ENGLISH

IMPORTANT INFORMATION

CONTACT INFORMATION

To obtain additional information regarding your system, please contact Verathon® Customer Care or visit verathon.com/support.

Headquarters European Rep Manufacturer

Verathon Inc. 20001 Nor th Creek Parkway Bothell, WA 98011 U.S.A. Tel: +1 800 331 2313 (US/Canada) Tel: +1 425 867 1348 Fax: +1 425 883 2896

ABOUT THIS MANUAL

Information in this manual may change at any time without notice. For the most up‑to‑date information, see the documentation available at verathon.com/product‑documentation.

Copyright © 2018 by Verathon Inc. All rights reserved. No part of this manual may be copied or transmitted by any method without the express written consent of Verathon Inc. Ambient Light Reduction, DirectView, Dynamic Light Control, GlideRite, GlideScope, GlideScope Go, the GlideScope symbol, Spectrum, Verathon, and the Verathon Torch symbol are trademarks or registered trademarks of Verathon Inc. All other brand and product names are trademarks or registered trademarks of their respective owners.

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: +1 604 439 3009 Fax: +1 604 439 3039

PRODUCT DESCRIPTION

GlideScope Go is a handheld video laryngoscope system designed to deliver clear airway views, both directly and indirectly, facilitating rapid intubation. The reusable 3.5‑inch tilting color monitor and rechargeable battery can be fully submerged for cleaning. Available user settings include auto‑record, auto‑shutdown, and content display, supporting a more customized user experience. This system integrates with the Spectrum™ product portfolio offering fully disposable blades that can be swapped without powering down the monitor. It also integrates with the GlideScope Video Baton 2.0, which reduces electronic waste through the use of disposable Stats. GlideScope Go is ideal for working under rugged conditions, for routine and difﬁcult airways, and in a wide range of patients and clinical settings.

STATEMENT OF INTENDED USE

The GlideScope Go System is intended for use by qualiﬁed medical professionals to obtain a clear, unobstructed view of the airway and vocal cords for medical procedures.

STATEMENT OF PRESCRIPTION

Federal (United States) law restricts this device to sale by, or on the order of, a physician.

NOTICE TO ALL USERS

The system should be used only by individuals who have been trained and authorized by a physician, or by health care providers who have been trained and authorized by the institution providing patient care. Verathon® recommends that all users do the following:

• Read the manual before using the instrument

• 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

CAUTIONS & WARNINGS

Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of the device. Cautions indicate that use or misuse of the device may cause a problem, such as a malfunction, failure, or damage to the product. Throughout the manual, pay attention to sections labeled Important, as these contain reminders or summaries of the following cautions as they apply to a speciﬁc component or usesituation. Please heed the following warnings and cautions.

CAUTION

regarding electromagnetic compatibility (EMC) and must be installed and operated according to the instructions in this manual. For more information, see the Electromagnetic

Compatibility section on page22.

CAUTION

video recording. Removing the USB ﬂash drive before a recording has fully saved may corrupt the video ﬁle.

CAUTION

using the approved low‑temperature processes recommended by Verathon.

CAUTION

a power adapter or charging cradle.

CAUTION

or disinfecting the monitor. The screen can be scratched, permanently damaging the device.

CAUTION

WARNING

electromagnetic compatibility, use only the accessories and components recommended by Verathon, including the provided, medical‑approved powersupply.

Medical electrical equipment requires special precautions

Disconnect the blade or turn off the monitor in order to save a

This product may only be cleaned, disinfected, or sterilized by

Ensure the monitor's micro‑USB port is dry before connecting

Ensure that you do not use any abrasive tools when cleaning

Do not submerge the charging cradle in a liquid solution.

The monitor must be cleaned before initial use.

To reduce the risk of electrical shock and maintain

WARNING

of the video laryngoscope, ensure that you are looking in the patient’s mouth, not at the screen. Failure to do so may result in injury, such as to the tonsils or soft palate.

When you are guiding the endotracheal tube to the distal tip

WARNING

handling and disposing of cleaning, disinfection, or sterilization solutions.

Ensure that you follow the manufacturer’s instructions for

WARNING

Reuse, reprocessing, or resterilization may create a risk of contamination of thedevice.

WARNING

cause serious injury to the operator or damage to the instrument and will void the warranty. Contact Verathon® Customer Care for all servicing needs.

WARNING

can contact the patient and can exceed 41°C (106°F) as part of normal operation. Patient contact with this area of the blade during intubation is unlikely, as it would cause an obstruction of the camera view. Do not maintain continuous contact with this area of the blade for longer than 1minute; it is possible to cause thermal damage such as a burn to the mucosal tissue.

WARNING

are not compatible with this system:

• 0574‑0176 (Spectrum™ LoPro S3) • 0574‑0178 (Spectrum MAC S3)

• 0574‑0177 (Spectrum LoPro S4) • 0574‑0179 (Spectrum MAC S4)

Refer to part numbers when assessing whether a blade is compatible with the system. For more information about compatible components and accessories, see page5.

WARNING

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.

Do not reuse, reprocess, or resterilize single‑use components.

No modiﬁcation of this equipment is allowed.

Do not attempt to open the system components. This may

The area surrounding the camera in the video laryngoscope

GlideScope blades labeled with the following part numbers

Because the product may be contaminated with human blood

WARNING

and has no sign of damage. Do not use this product if the device appears damaged. Ensure that alternative airway management methods and equipment are available.

WARNING

placing it in the charging cradle.

WARNING

GlideScope Go monitor.

Before every use, ensure the instrument is operating correctly

Ensure the monitor is clean and free of contamination before

The charging cradle should be used only for charging the

SYMBOLS

For a full list of caution, warning, and informational symbols used on this and other Verathon products, please refer to the Verathon Symbol Directory at verathon.com/symbols.

INTRODUCTION

SYSTEM OVERVIEW

The GlideScope Go system features a small handheld monitor that can use either GlideScope Spectrum video laryngoscopes or GlideScope GVL® Stats.

GlideScope Spectrum video laryngoscopes are durable, single‑use plastic blades that must be disposed of after one use. Single‑use blades are identiﬁed by an S in their name, such as LoPro S4. These blades incorporate the following technologies:

• Dynamic Light Control™—Optimizes image brightness and clarity.

• Ambient Light Reduction™— Diminishes excess reﬂected light to further improve image quality.

GVL Stats are durable, transparent, single‑use laryngoscope shells that ﬁt over a ﬂexible, reusable stalk called a video baton. The Stats contain no active components, so waste is kept to a minimum. Although they are single‑use devices, they do not have an S in their names.

Figure 1. GlideScope Go Monitor

Indicator LED

Micro‑USB and charging port

Power button

Connector arm

Blade/baton connector

LCD screen

SYSTEM PARTS & ACCESSORIES

REQUIRED SYSTEM COMPONENTS

The following components are required for the system to function:

• GlideScope Go monitor

• Power adapter

INTERCHANGEABLE COMPONENTS

The system also must have one video laryngoscope connected to function. The laryngoscope can be either a Spectrum™ blade or a video baton with a Stat, as shown in the following list:

• Spectrum LoPro S1 (0574‑0165)

• Spectrum LoPro S2 (0574‑0166)

• Spectrum LoPro S3 (0574‑0194)

• Spectrum LoPro S4 (0574‑0195)

• Spectrum DirectView™ MAC S3 (0574‑0187)

• Spectrum DirectView MAC S4 (0574‑0188)

• GlideScope Video Baton 2.0, Large (size 3‑4, part number 0570‑0382) with one of the following:

GVL® 3 Stat (0270‑ 0626) GVL® 4 Stat (0270‑ 0628)

ADDITIONAL ACCESSORIES

The following accessories are optional and may be used with the system:

• Charging cradle

• Small carrying case

• Large carrying case

• GlideRite® Rigid Stylet (For ET tubes 6.0 mm or larger)

• GlideRite Single‑Use Stylet – Small (For ET tubes 3.0–4.0 mm)

• Micro‑to‑standard hybrid USB ﬂash drive, for conﬁguring settings and recording video

SETTING UP THE SYSTEM

PROCEDURE 1. PERFORM INITIAL INSPECTION

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.

PROCEDURE 2. CHARGE THE BATTERY

WARNING

electromagnetic compatibility, use only the accessories and components recommended by Verathon, including the provided, medical‑approved powersupply.

WARNING

placing in the charging cradle.

For more about the battery and charging conditions, see Battery Speciﬁcations on page21.

1. Connect the power adapter to a hospital‑grade power outlet.

2. Ensure the micro‑USB port on the monitor is dry.

3. If charging directly from the power adapter, connect it to the micro‑USB port on the monitor.

If charging with the charging cradle, connect the power adapter to the micro‑USB port on the cradle, and then place the monitor in the cradle.

See the following table for a list of indicator LED status descriptions.

Table 1. Indicator LED Status Descriptions

LED Status Description

Solid green Battery is fully charged.

Solid orange Battery is charging with an approved or equivalent power adapter.

Solid red Battery is charging with an unapproved power adapter.

Blinking red Error. There is a problem with the battery or charging circuit.

Off Not charging.

* Using an unapproved power adapter may not charge the battery correctly. Please replace the unapproved

power adapter with the power adapter provided with the system.

To reduce the risk of electrical shock and maintain

Ensure the monitor is clean and free of contamination before

4. Allow the battery to charge until the indicator LED is solid green.

5. Remove the monitor from the cradle, and then press the Power button on the monitor.

Note: Do not attach a blade or baton at this time.

6. In the upper right corner of the monitor screen, verify that the installed software version is 1.3 or higher. If not, contact Verathon® Customer Care for a software update.

PROCEDURE 3. CONFIGURE USER SETTINGS

The User Settings Tool is a Java‑based tool and is available on the USB ﬂash drive.

1. Connect the USB ﬂash drive to a USB port on a computer.

2. Navigate to the USB ﬂash drive, and then open the User Settings Tool.

3. Conﬁgure the settings as needed, and then click Save.

4. In the Save As dialog box, navigate to the USB ﬂash drive, and then click Save.

5. Ensure the monitor is powered off, and then insert the USB ﬂash drive into the micro‑USB port on the monitor.

6. On the monitor, press the Power button. The monitor powers on and the settings automatically update. The settings ﬁle is then automatically deleted to help prevent accidentally overwriting the date and time settings.

PROCEDURE 4. INSERT THE VIDEO BATON INTO THE STAT (OPTIONAL)

If you are using a video baton and a GVL® Stat, attach the Stat to the baton before you connect the baton to the monitor.

1. Open the GVL Stat pouch, but do not remove the Stat from the packaging.

2. Ensure that the logo on the side of the baton and the logo on the side of the Stat are aligned.

3. Slide the video baton into the GVL Stat until it clicks into place. Do not remove the Stat from the pouch until you are ready to begin the intubation. This ensures that the Stat remains as clean as possible.

Note: Ensure that you do not insert the video baton backwards.

Correct Incorrect

4. When you remove the GVL® Stat from the packaging, visually inspect the Stat to ensure that all exterior surfaces are free of unintended rough areas, sharp edges, protrusions, or cracks.

5. If desired to provide additional anti‑fog beneﬁts, you may apply Dexide™ Fred™ Lite to the camera window on the Stat.* Use the solution according to the manufacturer’s instructions.

PROCEDURE 5. ATTACH THE BLADE OR BATON

The blade or video baton attaches to the monitor’s connector arm. The monitor rotates on the connector arm, allowing you to set a starting angle to begin the intubation.

It is recommended that you leave the sterile, single‑use blade in the packaging while connecting the blade and until you are ready to perform an intubation procedure.

1. Align the arrow on the monitor with the arrow on the baton or single‑use blade, and then insert the blade/baton connector fully into the connector port on the blade or baton.

Alignment marks

* Compatibility has been demonstrated for up to one hour of continuous exposure on video batons and Stats.

PROCEDURE 6. PERFORM A FUNCTIONAL CHECK

Before you use the device for the ﬁrst time, ensure the system is working properly.

1. Fully charge the monitor battery.

2. Attach the video laryngoscope to the monitor, according to the prior procedure.

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

4. Look at the screen, and verify that video is being received from the laryngoscope.

Note: The edges of the blade or Stat may be captured in the camera view. 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.

USING THE DEVICE

Prior to using the device, complete the instructions in the chapter Setting Up the System.

PROCEDURE 1. PREPARE THE SYSTEM

WARNING

are not compatible with this system:

• 0574‑0176 (Spectrum™ LoPro S3) • 0574‑0178 (Spectrum MAC S3)

• 0574‑0177 (Spectrum LoPro S4) • 0574‑0179 (Spectrum MAC S4)

Refer to part numbers when assessing whether a blade is compatible with the system. For more information about compatible components and accessories, see page5.

WARNING

and has no sign of damage. Do not use this product if the device appears damaged. Ensure that alternative airway management methods and equipment are available.

Table 2. Video Laryngoscope Sizes

GlideScope Blade Part Number Recommended Patient Weight/Size

Spectrum™ LoPro S1 0574‑ 0165 1.5–3.8kg (3.3–8.4lbs)

Spectrum LoPro S2 0574‑016 6 1.8–10kg (4–22lbs) Spectrum LoPro S3 0574‑019 4 10kg (22lbs) to medium adult Spectrum LoPro S4 0574‑ 0195 40kg (88lbs) to large adult

GVL® 3 Stat 0270‑ 0626 Medium adult GVL® 4 Stat 0270‑0628 Large adult

Spectrum DirectView™ MAC S3 0574 ‑ 0187 Medium adult

Spectrum DirectView MAC S4 0574‑ 0188 Large adult

1. Ensure that each GlideScope system component has been properly cleaned or disinfected according to the guidance provided in Tabl e 3 on page13.

2. Using the information in Table 2, 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 laryngoscope to the monitor per Attach the Blade or Baton on page8.

GlideScope blades labeled with the following part numbers

Before every use, ensure the instrument is operating correctly

* Weight ranges are approximate; a medical professional must evaluate on a patient‑by‑ patient basis.

PROCEDURE 2. PERFORM AN INTUBATION

WARNING

of the video laryngoscope, ensure that you are looking in the patient’s mouth, not at the screen. Failure to do so may result in injury, such as to the tonsils or soft palate.

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.

1. Look in the Mouth: With the video laryngoscope in your left hand, introduce it along the midline of the oropharynx.

2. Look at the Screen: Identify the epiglottis, and then manipulate the blade in order to obtain the best glottic view.

3. Look in the Mouth: Carefully guide the distal tip of the tube into position towards the tip of the laryngoscope.

4. Look at the Screen: Complete the intubation, gently rotating or angling the tube as needed to redirectit.

The area surrounding the camera in the video laryngoscope

When you are guiding the endotracheal tube to the distal tip

PROCEDURE 3. RECORD THE INTUBATION

CAUTION

video recording. Removing the USB ﬂash drive before a recording has fully saved may corrupt the video ﬁle.

1. Start the recording by ensuring the following conditions are met:

• A blade or video baton is connected to the monitor.

• A USB ﬂash drive is connected to the micro‑USB port on the monitor.

• The monitor is powered on.

• The record feature is turned on in the user settings. Once these conditions are met, the recording starts automatically.

2. Stop the recording by pressing and holding the power button until the monitor has fully powered off. The recording also stops when the video laryngoscope is disconnected, the media capacity on the USB ﬂash drive drops too low, or the monitor’s remaining battery charge provides less than 1minute of power.

3. If you would like to review the recording, connect the USB ﬂash drive to a computer, and then view the .avi ﬁle. Files are automatically named with the system date and time.

Disconnect the blade or turn off the monitor in order to save a

PROCEDURE 4. DISCONNECT THE BATON (VIDEO BATONS ONLY)

The GVL® Stat is a sterile, single‑use device. After each use, it is a biohazard, and it should be removed from the video baton and disposed of in a manner consistent with local protocols.

1. Hold the Stat in one hand.

2. To reduce the force required to remove the video baton from the Stat, use your thumb and ﬁnger to gently press the collar of the Stat.

3. With the other hand, grasp the handle of the video baton and pull ﬁrmly.

CLEANING & DISINFECTING

CAUTION

Ensure that you do not use any abrasive tools when cleaning

or disinfecting the monitor. The screen can be scratched, permanently damaging the device.

CAUTION

This product may only be cleaned, disinfected, or sterilized by

using the approved low‑temperature processes recommended by Verathon®.

WARNING

Because the product may be contaminated with human blood or body ﬂuids capable of transmitting pathogens, all cleaning facilities must be in compliance with (U.S.) OSHA Standard 29 CFR1910.1030 “Bloodborne Pathogens” or an equivalent standard. For more information, visit www.osha.gov.

WARNING

Ensure that you follow the manufacturer’s instructions for handling and disposing of cleaning, disinfection, or sterilization solutions.

WARNING

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

WARNING

The monitor must be cleaned before initial use.

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.

Table 3 describes the risk assessment for each system component, including the Spaulding

classiﬁcation for the minimum required disinfection level. Prior to each use, ensure that each system component has been cleaned, disinfected, or sterilized according to the guidance provided in this table.

Table 3. System Risk Classiﬁcation

Device Use

Monitor Reusable Non‑critical X

Charging cradle

Single‑use blades

Video Baton 2.0

GVL® Stats

GlideRite® RigidStylet

GlideRite Single‑Use Stylet§Single‑use —

* Clean the charging cradle whe n visibly soiled and on a regular b asis.

† For instr uctions, see the GlideRite Rigid Stylet Operations and Maintenance Manual.

§ Single‑use blades and stylets may not be reused. Dispose of single‑ use items after use.

|| Video batons require low‑level disinfection between uses, but may be high ‑level disinfected if desired.

X Checked boxes show minimum disinfection level requirement.

Shaded ar eas indicate that the disinfection or sterilization level is not required or not compatible with the device.

Unshaded areas show permissible levels of disinfe ction or sterilization based on compatibilit y with the device materials.

Reusable Non‑critical

Single‑use —

Reusable Non‑critical X

Single‑use —

†

Reusable Semi‑critical X

Spaulding

Classiﬁcation

Clean

Disinfect

Low High

Sterile

COMPATIBILITY & AVAILABILITY

Availability of cleaning, disinfection, and sterilization products varies by country, and Verathon® is unable to test products in every market. Ensure that you select products in accordance with your local laws and regulations. For information about additional solutions that may be available, please contact Verathon Customer Care.

The following solutions have demonstrated material compatibility with the charging cradle and monitor, and cleaning or disinfection efﬁcacy with the monitor:

Solution Cycles

ASP® CIDEZYME® Enzymatic Detergent 15 0 0 ASP® CIDEX® OPA Disinfectant 150 0 PDI® Sani‑Cloth® AF3 Germicidal Disposable Wipe

The following solutions have demonstrated material compatibility only with the monitor through the number of use cycles shown, but have not been tested for cleaning or disinfection efﬁcacy. Refer to the solution manufacturers' instructions for information about how to use them.

Solution Cycles

Clinell® Universal Wipes 150 0 Metrex® CaviW i pes™ 150 0 Metrex® CaviWip e s1™ 150 0 Tristel Trio® Wipes System 150 0 Wip'Anios Excel Wipes 1500

150 0

PROCEDURE 1. CLEAN THE MONITOR

Clean the monitor after each use, adhering to the instructions below. Verathon has validated the solutions and method below for compatibility and efﬁcacy. For information about additional solutions that may be available, please contact Verathon Customer Care.

Table 4. Cleaning Solutions for GlideScope Go

Solution Conditions

Up to 1500 cycles as per the following instructions:

Exposure: Prepare working solution at a concentration of 8–16 mL

ASP® CIDEZYME® Enzymatic Detergent

PDI® Sani‑Cloth® AF3 Germicidal Disposable Wipe

per L (1–2 U.S. ﬂuid ounces per U.S. gallon). Soak component for 1–3 minutes. Use a lint‑free cloth or cotton‑tip swab to clean the component while still immersed, paying special attention to the areas around the button, hinge, all surface contours, and edges.

Rinse: Rinse for 3 minutes under running water. Ensure the HDMI connector and micro USB connector are properly rinsed.

Up to 1500 cycles as per the following instructions:

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 a minimum of 3 minutes. Paying special attention to hard‑to‑reach surface contours and edges.

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

1. Ensure the monitor is turned off, and the power adapter or USB ﬂash drive is disconnected.

2. Detach the single‑use blade from the monitor, and then dispose of the blade.

3. Prepare a solution from Tabl e 4 according to the manufacturer’s instructions.

4. Expose the monitor to the solution according to the conditions provided in Tab le 4.

5. Using a towelette or a cotton swab moistened with the solution, clean the power button, micro‑USB port, the groove around the LCD window, and the groove where the connector arm attaches to the monitor.

6. Rinse the monitor according to the conditions provided in Table 4.

7. Inspect the monitor for contamination. If any is present, repeat steps 4‑6.

8. Using a clean cloth, dry the monitor.

9. Inspect the monitor for damage. If any is present, do not use it, and contact Verathon® Customer Care.

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

PROCEDURE 2. DISINFECT THE MONITOR

Disinfection of the monitor is optional. Your medical care facility or provider may require disinfection prior to use. Verathon has validated the solutions and method below for compatibility and efﬁcacy. For information about additional solutions that may be available, please contact Verathon Customer Care.

Table 5. Disinfection Solutions for GlideScope Go

Solution Level Conditions

Up to 1500 cycles as per the following instructions:

Conditioning: N/A Water temperature: Room temperature

ASP® CIDEX® OPA High

PDI® Sani‑Cloth® AF3 Germicidal Disposable Wipe

Exposure: Soak the component in CIDEX® OPA for 12 minutes, ensuring that all air bubbles are removed from the surface.

Rinse: (3) 1‑minute immersions with agitation in pure water. Ensure the HDMI connector and micro USB connector are properly rinsed.

Up to 1500 cycles as per the following instructions:

Conditioning: N/A Water temperature: N/A

Low

Exposure: Using fresh towelette(s), wet all surfaces and allow them to remain wet for 3minutes, paying special attention to the area around the hinge, all surface contours, and edges.

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

1. Ensure the monitor has been cleaned, according to the prior procedure.

2. Prepare a solution from Table 5 according to the manufacturer’s instructions.

3. Expose the monitor to the solution according to the conditions provided in Tab le 5. Ensure that the monitor is exposed for the full duration of the exposure period.

4. Rinse the monitor according to the conditions stated in Table 5.

5. Allow the monitor to air dry.

6. Store the monitor in a clean environment.

PROCEDURE 3. CLEAN THE VIDEO BATON

Clean and disinfect the video baton after each use.

IMPORTANT

to clean the video baton. The window that protects the camera and light can be scratched, permanently damaging the device.

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

Bleach may be used on the video baton, but pay special attention to the stainless steel on the component, as bleach can corrode stainless steel..

Table 6. Cleaning Solutions for the Video Baton 2.0 Large

Product Conditions

Enzymatic

debridement

agent/detergent

STERIS Prolystica 2x Concentrate

Enzymatic

Presoak and Cleaner

SaniCloth® AF3

Germicidal

Wipes

As per chemical manufacturer’s instructions

Up to 2000 cycles as per the following instructions:

Exposure: Prepare solution in warm water at ⅛ to ½ ﬂ. oz. per gallon

(1–4 mL/L). Soak component for at least 3 minutes. Before removing from solution, brush all surfaces using a soft‑bristled brush, paying special attention to hard‑to‑reach areas. Use a cotton swab for the camera window to avoid damaging the window.

Rinse: Rinse for 3 minutes under warm running water. If component is soaked for longer than 3 minutes, increase rinse time in proportion to soak time.

Up to 2000 cycles as per chemical manufacturer’s instructions

Do not use metal or abrasive brushes, scrub pads, or rigid tools

1. Wash the video baton manually using a hospital‑grade equipment detergent or an enzymatic debridement agent/detergent to remove all foreign material (e.g., soil and organic material) from the surface of the device. For more information, see

Table 6 .

2. Rinse the video baton in clean, running water.

The video baton can now be disinfected.

PROCEDURE 4. DISINFECT THE VIDEO BATON

When used as intended, the video baton is a nonsterile, reusable device, which is protected from contact with mucous membranes and non‑intact skin by the Stat (sterile, single‑use). Low‑level disinfection is recommended for the video baton after every patient use. High‑level disinfection is required for the video baton when it is visibly soiled.

Table 7. Disinfection and Sterilization Solutions for the VideoBaton 2.0 Large

Disinfection

Level

Low As per chemical manufacturer’s instructions

Up to 1100 cycles as per chemical manufacturer’s instructions

Low

High As per chemical manufacturer’s instructions

High

High As per chemical manufacturer’s instructions

Up to 750 cycles as per chemical manufacturer’s instructions

Exposure: Using fresh wipe(s), wet all surfaces and allow to remain wet for 3 minutes.

Rinse: Not applicable. Allow the component to thoroughly air dry.

100 cycles in a Medivators Advantage® Plus automated endoscope reprocessor (AER) disinfection routine meeting the following requirements:

• Concentration of disinfectant – 750‑950 parts per million

• Temperature – 28°C–32°C (82.4°F – 89.6°F)

• Exposure time – 5 minutes

• AER conﬁguration – Hookup 2‑8‑002HAN rev A

• AER parameter set – 1‑35‑101 C DISF

Conditions

Product

Bleach (500

ppm)

Isopropyl alcohol

solution (70%)

Oxivir® Tb Wipes Low

Sani‑Cloth®

Bleach Wipes

SaniCloth® AF3

Germicidal

Wipes

ASP®

CIDEXPLUS®

28Day Solution

ASP® CIDEX®

OPA

Metrex®

MetriCide®

Plus30

Medivators®

Rapicide

Sultan®

Healthcare

Sporox® II

Product

STERIS® S40™

or S20™

STERIS® V‑PRO®

low temperature

sterilization

systems

ASP® Hydrogen

PeroxideGas

Plasma

1. Ensure the equipment is clean according to the previous steps.

2. Prepare and condition the disinfection solution according to the solution manufacturer’s instructions and the conditions stated in Tabl e 7.

3. Disinfect the video baton according to the conditions stated in Tabl e 7. 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. If applicable, rinse the video baton according to the solution manufacturer’s instructions.

5. Dry the video baton 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. Inspect the video baton according to the instructions in the following procedure, and then store the disinfected video baton in a clean environment.

Disinfection

Level

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

Sterilization

Sterilization Up to 200 cycles as per manufacturer’s instructions

Sterilization

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, or STERRAD® 100NX standard cycle

Conditions

PROCEDURE 5. CLEAN THE CHARGING CRADLE

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

CAUTION

1. Ensure the monitor is not in the charging cradle, and then unplug the device.

2. Using a solution from Compatibility & Availability on page14, wipe the exterior until all visible contamination has been removed.

Do not submerge the charging cradle in a liquid solution.

MAINTENANCE & SAFETY

WARNING

cause serious injury to the operator or damage to the instrument and will void the warranty. Contact Verathon® Customer Care for all servicing needs.

WARNING

Do not attempt to open the system components. This may

No modiﬁcation of this equipment is allowed.

PERIODIC INSPECTIONS

In addition to the user performing routine inspections before and after every use, periodic inspections should be performed to ensure safe and effective operation. It is recommended that you 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 adapter

• Damage to the connectors

Report any suspected defects to Verathon Customer Care or your local representative.

BATTERY

After 300 charge and discharge cycles, the battery capacity is approximately 80% of the initial capacity. Under normal operating conditions, this may happen at around 3 years. For more information about the battery, see Battery Speciﬁcations on page21.

The battery is not user‑replaceable. Do not attempt to replace the battery. Any attempts to replace the battery by unauthorized service technicians may cause serious harm to the user and will void the warranty. For more information, contact Verathon Customer Care or your local representative.

SYSTEM SOFTWARE

This manual documents the most current version of the software. If your monitor does not function as described in this manual, or to determine if your software should be updated, contact Verathon Customer Care. 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.

DEVICE REPAIR

The 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 Verathon® Customer Care or your local Verathon representative.

DEVICE DISPOSAL

The system and related accessories 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.

WARRANTY

Verathon products and software are warranted against defects in material and workmanship according to the Terms and Conditions of Sale. This limited warranty applies for the speciﬁed term from the date of shipment from Verathon and applies only to the original purchaser of the system. Warranty coverage applies to the following system components:

Component Warranty Term

Monitor 2 years Charging cradle 1 year Video Baton 2.0 1 year

Additional reusable components purchased either singularly or as a part of a system are warranted separately. Consumable items are not covered under this warranty.

For more information about your warranty or to purchase a Premium Total Customer CareSM warranty that extends the limited warranty on your system, please contact Verathon Customer Care or your local representative.

PRODUCT SPECIFICATIONS

SYSTEM SPECIFICATIONS

Table 8. System Speciﬁcations

General Speciﬁcations

Classiﬁcation: Electrical Class II / Internally Powered, Applied Part BF

Monitor IP67

Ingress protection against water:

Single‑use blade IPX4 Video baton IPX8 Single‑use Stat N/A

Table 8. System Speciﬁcations

General Speciﬁcations

Monitor 1500 uses or 3 years Spectrum™ LoPro Single‑Use blade 1use or 3‑year shelf life Spectrum DirectView™ MAC

Expected product life:

Monitor:

Operating temperature: 10 to 40°C (50 to 104°F) Charging temperature: 10 to 35°C (50 to 95°F) Relative humidity: 0 to 95% (non‑condensing) Atmospheric pressure: 700–1060hPa

Temperature: ‑20 to 40°C (‑4 to 104°F) Relative humidity: 0 to 95% (non‑condensing) Atmospheric pressure: 700–1060hPa

Single‑Use blade GlideScope video baton 2.0 Large

(3‑4) GVL® Single‑use Stat 1 use or 3‑year shelf life

Monitor Component Speciﬁcations

Height 86mm (3.39in) Width 98mm (3.86in) Depth 47mm (1.85in) Weight (approximate) 0.25kg (8.82oz) LCD: 320 x 240 px, 8.9 cm (3.5 in) Frames per second (displayed and recorded): 30

Operating & Storage Speciﬁcations

Operating Conditions

Shipping & Storage Conditions

1use or 1‑year shelf life

2 years or 2000 cycles

BATTERY SPECIFICATIONS

Table 9. Battery Speciﬁcations

Condition Description

Battery type: Lithium‑ion

Battery life:

Charging time:

Rated capacity: 1200mAh or higher Nominal voltage: 3.7V Max charging voltage: 4.2V

Under normal operating conditions, a fully charged, new battery lasts approximately 100minutes, (5) intubations without recording.

Charging time off line will take no more than 3hours from an empty battery to a full charge.

ELECTROMAGNETIC COMPATIBILITY

The system is designed to be in compliance with IEC60601‑1‑2:2007, which contains electromagnetic compatibility (EMC) requirements for medical electrical equipment. The limits for emissions and immunity speciﬁed in this standard are designed to provide reasonable protection against harmful interference in a typical medical installation.

The 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.

ELECTROMAGNETIC IMMUNITY

Table 10. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity

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

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

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

IEC61000‑4‑11

Power frequency (50/60Hz) magnetic ﬁeld

IEC61000‑4‑8

Conducted RF

IEC61000‑4‑6

± 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

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

3A/m In compliance

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 system requires continued operation during power mains interruptions, it is recommended that the 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 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

Table 10. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity

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

Immunity Tests IEC60601 Test Level

Compliance

Level

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).

Radiated RF

IEC61000‑4‑3

3V/m 80MHz to 2.5GHz

3V/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: U t 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 elec tromagnetic environment due to ﬁxed RF transmitters, an electromagnetic site survey should be considered. If the measured ﬁeld strength in the location in which the system is used exceeds the applicable RF compliance level above, the 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 system.

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

ELECTROMAGNETIC EMISSIONS

Table 11. Guidance and Manufacturer’s Declaration— Electromagnetic Emissions

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

Emissions Test Compliance Electromagnetic Environment – Guidance

RF emissions CI S P R 11

Harmonic emissions IEC61000‑3‑2

Voltage ﬂuctuations/ﬂicker emissions IEC6100 0‑3‑3

Group 1

Class A

Complies

The 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 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.

RECOMMENDED SEPARATION DISTANCES

Table 12. Recommended Separation Distances between Portable and Mobile RF Communications

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

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.

Equipment and the System

Rated maximum output power of

transmitter (W)

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

Separation distance according to frequency of transmitter (m)

150kHz to 80MHz

d=1.2 √P

80MHz to 800MHz

d=1.2 √P

800MHz to 2.5GHz

d=2.3 √P

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 System Parts & Accessories. The use of accessories or cables other than those speciﬁed or supplied may result in increased emissions or decreased immunity of the system.

Table 13. EMC Standards for Accessories

Accessory Max Cable Length

Monitor power adapter 1.5m (4.9ft) Charging cradle power adapter 1.5m (4.9ft)

+ 166 hidden pages

Verathon GlideScope Go Operation & Maintenance Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

IMPORTANT INFORMATION

INTRODUCTION

SETTING UP THE SYSTEM

USING THE DEVICE

CLEANING & DISINFECTING

MAINTENANCE & SAFETY

WARRANTY

PRODUCT SPECIFICATIONS