GLIDESCOPE PORTABLE GVL SYSTEM

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GLIDESCOPE PORTABLE

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GLIDESCOPE PORTABLE

GVL SYSTEM

Operations & Maintenance Manual

This manual is not intended for use in Canada. If you are in Canada, visit verathon.com or contact

Verathon®_{Customer Care in order to access the appropriate}_{GlideScope Portable GVL System Operations} & Maintenance Manual (version 0900-4532). For contact information, visit verathon.com/contact-us.

IMPORTANT

Effective: October 3, 2014

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

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CONTACT INFORMATION

To obtain additional information regarding your GlideScope system, please contact Verathon®_{Customer Care or visit}_{verathon.com/contact-us}_:

Corporate Headquarters: 20001 North Creek Parkway

Bothell, WA 98011 U.S.A. 800.331.2313 (US and Canada only)

425.867.1348 Fax: 425.883.2896

verathon.com

Verathon® Medical (Canada) ULC

2227 Douglas Road Burnaby, BC V5C 5A9

Canada 604.439.3009 Fax: 604.439.3039

GlideScope, the GlideScope symbol, GlideRite, GVL, Verathon, and the Verathon Torch symbol are trademarks of Verathon Inc. All other brand and product names are trademarks or registered trademarks of their respective owners.

Information in this manual may change at any time without notice. For the most up-to-date information, see the online manuals at

verathon.com.

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

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Operations & Maintenance Manual: Table of Contents

INTRODUCTION ...7

SINGLE-USE AND REUSABLE SYSTEMS ...7

SYSTEM PARTS & ACCESSORIES...8

BUTTONS, ICONS, & CONNECTIONS ...10

Connectors & Ports ...10

Buttons ... 11

Battery Indicator and Charge Status ...12

SETTING UP ...13

Procedure 1. Perform Initial Inspection ...14

Procedure 2. Attach Cleaning Caps (Reusable Only) ...15

Procedure 3. Mount the Video Monitor (Optional) ...16

Procedure 4. Attach the Cradle (Optional) ...20

Procedure 5. Charge the Monitor Battery ...21

Procedure 6. Connect the Video Laryngoscope ...22

Procedure 7. Insert the Video Baton into a Stat (Single-Use Only) ...23

Procedure 8. Connect to an External Monitor (Optional) ...24

Procedure 9. Configure User Settings ...25

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USING THE SYSTEM ...27

Procedure 1. Prepare the GlideScope System...28

Procedure 2. Intubate Using the GlideScope 4-Step Technique ...29

TIPS ...30

Using the GlideScope System ...30

Working with Endotracheal Tubes ...30

CLEANING & DISINFECTING ...31

GENERAL INFORMATION ...31

Procedure 1. Clean the Video Monitor ...33

Procedure 2. Clean the Cradle ...34

Procedure 3. Clean & Sterilize the GlideRite Rigid Stylet ...34

REUSABLE SYSTEM ...35

Procedure 1. Clean & Disinfect the Reusable Blade ...35

Procedure 2. Inspect the Reusable Blade ...38

Procedure 3. Clean & Disinfect the Video Cable ...39

SINGLE-USE SYSTEM ...41

Procedure 1. Remove the Stat ...41

Procedure 2. Clean & Disinfect the Video Baton ...41

Procedure 3. Inspect the Video Baton ...43

MAINTENANCE & SAFETY ...44

INSPECTIONS ...44

DEVICE REPAIR ...44

Video Monitor Battery ...44

Protective Cap Repair ...45

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Operations & Maintenance Manual: Table of Contents

WARRANTY ...47

Original First Year Total Customer Care Warranty ...47

Premium Customer Care Warranty ...48

Disclaimer of Additional Warranties ...48

PRODUCT SPECIFICATIONS ...49 SYSTEM SPECIFICATIONS ...49 COMPONENT SPECIFICATIONS ...50 General Components ...50 Single-Use System ...51 Reusable System ...55 ELECTROMAGNETIC COMPATIBILITY ...57 Electromagnetic Emissions...57 Electromagnetic Immunity ...58

Recommended Separation Distances ...60

Accessory Conformance to Standards ...60

SYMBOL DIRECTORY ...61

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Operations & Maintenance Manual: Important Information

IMPORTANT INFORMATION

PRODUCT DESCRIPTION

The Portable GlideScope®_{Video Laryngoscope (PGVL) system is designed for “1st pass success.” This}

system provides a consistently clear view of a patient’s airway, enabling quick intubation. GlideScope video laryngoscopes are clinically proven to achieve a Cormack-Lehane Grade I or II view 99% of the time.1

The single-use and reusable GlideScope video laryngoscopes include an integrated camera, LED light source, and a patented anti-fog mechanism. The video laryngoscope blade or video baton connects to a color video monitor for real-time viewing and video output. The GlideScope PGVL system features a comprehensive range

of configurations and sizes, allowing clinicians to meet the requirements of patients ranging in size from preterm

infants to morbidly obese adults.

The PGVL system is designed for physicians and other healthcare professionals who need to effectively

manage standard to difficult airways. It is easy to use, learn, and teach. It is ideal for acute care settings and

emergency environments. It also integrates easily into standard emergency department (ED), operating room (OR), intensive care unit (ICU), and NICU applications.

STATEMENT OF INTENDED USE

GlideScope video laryngoscopes are intended for use by qualified medical professionals to obtain a clear,

unobstructed view of the vocal cords for medical procedures.

ESSENTIAL PERFORMANCE

Essential performance is the system performance necessary to achieve freedom from unacceptable risk. The essential performance of the GlideScope PGVL system is to provide a clear view of the vocal cords.

STATEMENT OF PRESCRIPTION

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

This system should be used only by individuals who have been trained and authorized by a physician or used by healthcare providers who have been trained and authorized by the institution providing patient care.

NOTICE TO ALL USERS

Verathon®_{recommends that all users read this manual before using the system. Failure to do so may result in}

injury to the patient, compromise the performance of the system, and may void the system warranty. Verathon recommends that new GlideScope users:

• Obtain instruction from a qualified individual

• Practice using the system on a mannequin before clinical use • Acquire clinical experience on patients without airway abnormalities

1 Cooper RM. Cardiothoracic Anesthesia, Respiration and Airway; Early clinical experience with a new video laryngoscope (GlideScope) in 728 patients. Canadian Journal of Anesthesia. 2005; 52: 2: 191-198.

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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

Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and must be installed and operated according to the instructions in this manual. For more information, see the Electromagnetic Compatibility section on page 57.

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

For additional information, see the System Parts & Accessories and Product Specifications

sections. The use of accessories or cables other than those specified or supplied may result in

increased emissions or decreased immunity of the system.

The GlideScope PGVL system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the system should be observed to verify normal operation in

the configuration in which it will be used.

This device can radiate radio frequency energy and is very unlikely to cause harmful interference with other devices in the vicinity. There is no guarantee that interference will not occur in a particular installation. Evidence of interference may include degradation of performance in this device or other devices when operated simultaneously. If this occurs, try to correct the interference by using the following measures:

• Turn devices on and off in the vicinity to determine the source of interference • Reorient or relocate this device or other devices

• Increase the separation between devices

• Connect the device to an outlet on a circuit different than the other device(s) • Eliminate or reduce EMI with technical solutions (such as shielding)

• Purchase medical devices that comply with IEC 60601-1-2 EMC Standards

Be aware that portable and mobile radio frequency communications equipment (cellular phones, etc.) may affect medical electrical equipment; take appropriate precautions during operation.

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Risk of permanent equipment damage. This product is sensitive to heat, which will cause damage to the electronics. Do not expose the system to temperatures above 60°C (140°F), and

do not use autoclaves, ultrasonic cleaners, or pasteurizers. Use of such methods to disinfect the

system will cause permanent device damage and void the warranty. For a list of approved cleaning procedures and products, see the Cleaning & Disinfecting chapter.

CAUTION

The video batons and video laryngoscopes contain electronics that could be damaged by ultrasonic and automated washing equipment. Do not use an ultrasonic device or automated washing

equipment to clean this product.

CAUTION

When cleaning reusable video laryngoscopes and video batons, do not use metal brushes, abrasive brushes, scrub pads, or rigid tools. They will scratch the surface of the unit or the window protecting the camera and light, which may permanently damage the device.

CAUTION

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

CAUTION

Ensure that you do not use any abrasive substances, brushes, pads, or tools when cleaning the video monitor screen. The screen can be scratched, permanently damaging the device.

CAUTION

Ensure that the video monitor is turned off prior to connecting or disconnecting any component.

CAUTION

On the rear of the monitor, the battery switch must be in the OFF position during shipping and storage.

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WARNINGS

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

• The first area is the light-emitting area surrounding the camera where the anti-fog feature is

located. When used as indicated, continuous contact with this area is unlikely because, if tissue were to contact this area, the view would be lost and devices would need to be adjusted to regain the airway view.

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

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

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

WARNING

When you are guiding the endotracheal tube to the distal tip of the video laryngoscope, ensure that you are looking in the patient’s mouth, not at the video monitor screen. Failure to do so may result in injury to the tonsils or soft palate.

WARNING

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

To ensure patient safety, routinely inspect the GlideScope video laryngoscope blade before and after every use to ensure the blade is free of rough surfaces, sharp edges, cracks, protrusions, shell separation, surface delamination, or any other indication of wear. If found, do not use the damaged or worn blade, otherwise blade breakage may occur and could cause patient injury or death. Always ensure that alternative airway management methods and equipment are readily available.

Report any suspected blade defects to Verathon®_{Customer Care at:}

Phone: 800.331.2313 (U.S. and Canada)

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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

Ensure that you follow the manufacturer’s instructions for handling and disposing of the cleaning and disinfection solutions provided in this manual.

WARNING

Availability of cleaning, disinfection, and sterilization products varies by country, and Verathon®

is unable to test products in every market. For more information, please contact Verathon Customer Care at 1.800.331.2313 or your local representative. For contact information, visit

verathon.com/contact-us.

WARNING

This product may only be cleaned, disinfected, or sterilized by using the low-temperature processes

provided in this manual.

WARNING

The reusable video laryngoscope is considered a semi-critical device intended to contact the airway. It must be thoroughly cleaned and undergo high-level disinfection after each use.

WARNING

Cleaning is critical to ensuring the component is ready for disinfection. Failure to properly clean the device could result in a contaminated instrument after completing the disinfection procedure.

When cleaning, ensure all foreign matter is removed from the surface of the device. This allows the active ingredients of the chosen disinfection method to reach all the surfaces.

WARNING

Do not place the GlideScope video baton or reusable video laryngoscope in the cradle if any of the components are contaminated.

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To reduce the risk of electrical shock, use only the accessories and peripherals recommended by Verathon®_.

WARNING

Electric shock hazard. Do not attempt to open the system components. This may cause serious injury to the operator or damage to the instrument and will void the warranty. Contact Verathon Customer Care for all servicing needs.

WARNING

No modification of this equipment is allowed.

WARNING

The video monitor contains a lithium-ion battery. To avoid the risk of explosion or fire, observe the

following:

• Do not use, charge, or store the video monitor near fire or heat.

• Do not dispose of the video monitor or battery in fire or heat. For more information, see Device Disposal on page 46.

• Prior to shipping or transport, on the rear of the video monitor, ensure the battery switch is in the OFF position.

• Do not use the video monitor if the battery is leaking. Avoid contact with a leaking battery, immediately wash any skin that touches a leaking battery, and then contact Verathon Customer Care.

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Operations & Maintenance Manual: Introduction

INTRODUCTION

SINGLE-USE AND REUSABLE SYSTEMS

The GlideScope PGVL system is available in single-use and reusable configurations. Both configurations

feature the same video monitor, power cable, and any optional system components that may facilitate

intubations or provide convenience. The primary difference between the reusable and single-use systems is the video laryngoscope that connects to the monitor.

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

The single-use system features a reusable video baton and sterile Stats that must be disposed of after one use. The video baton contains the camera, LED light source, and anti-fogging mechanism, and it sends a

real-time video feed to the monitor. The Stat slips over the flexible portion of the video baton and clicks into

place, shielding the video baton from contact with mucous membranes and non-intact skin. Single-use stats are

available in a variety of sizes, enabling you to treat patients ranging from preterm to morbidly obese.

The reusable system features a reusable plastic video laryngoscope that must be cleaned and high-level disinfected between uses. The blade is connected to the video monitor via a reusable video cable. The video electronics—such as the camera, LED light, and anti-fogging mechanism—are located within the reusable laryngoscope.

You may use either the single-use or reusable system configurations, or your facility may elect to provide both configurations. This manual details both single-use and reusable system information and notes where the

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SYSTEM PARTS & ACCESSORIES

The GlideScope PGVL systems consist of the following components. Table 1. System Components

PARTS & ACCESSORIES

Required Components

Video monitor Video cable

(for reusable system only) (for single-use system only)Video batons

3–4 1–2

Power cable GVL®_{Stat sizes 0, 1, 2, 2.5, 3, and 4 (for single-use system only)}

PGVL video laryngoscopes (for reusable system only)

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PARTS & ACCESSORIES

Optional Components

Mobile stand GlideRite®_{Rigid Stylet} _{Universal accessory basket}

Cradle for reusable blade Cradle for video baton

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BUTTONS, ICONS, & CONNECTIONS

CONNECTORS & PORTS

The main component of the GlideScope PGVL system is the full-color monitor. The front of the monitor includes the screen, the buttons you use to operate the system, and the port for connecting the video cable.

Figure 3. Front Panel of Video Monitor

Screen

Keypad Video cable port

The back panel of the monitor includes the power socket, battery switch, and connector for the video output cable. The back of the video monitor also features a mounting point that allows you to attach the monitor to a mobile stand or IV pole.

Figure 4. Rear Panel of Video Monitor

Power socket

Video output port

Mounting point Battery switch

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BUTTONS

The GlideScope video monitor front panel (Figure 3) features the keypad. This keypad contains two battery status LEDs and four buttons: MENU, UP, DOWN, and ON/OFF. The function of each button is described in the following table. For more information about the battery status LEDs, see Battery Indicator and Charge Status on page 12.

Figure 5. Monitor Keypad

Table 2. Monitor Buttons

BUTTON NAME FUNCTION

ON/OFF Turns the monitor on and off

UP Increases the value of a setting

DOWN Decreases the value of a setting

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BATTERY INDICATOR AND CHARGE STATUS

On the front of the video monitor, there are two LEDs that indicate battery level and the charging state (see

Figure 5). The battery indicator LED illuminates when the monitor is operating on battery power and indicates the charge level. The charge status LED indicates whether the battery is currently charging.

Table 3. Battery Indicator LED

STATUS DESCRIPTION FUNCTION

LED turned off The monitor is off, or the battery level is completely depleted and _{needs to be recharged.}

Solid green The monitor is on, and the battery level is normal.

Flashing green

The battery charge is low. Please note the following:

• If the monitor is not beeping, approximately five minutes remain

before the system turns off due to low battery.

• If the monitor is beeping, approximately one minute remains before the system turns off due to low battery.

Table 4. Charge Status LED

STATUS DESCRIPTION FUNCTION

LED turned off The video monitor is not directly connected to power.

Flashing orange

The battery is not charging. Please note the following:

• If the monitor is connected to power, the battery switch may be in the OFF position. In this case the monitor will still function, but the battery will not charge.

• If the monitor is not connected to power, the battery may be malfunctioning. Please contact your Verathon®_{Customer Care}

representative. Solid orange The battery is charging.

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Operations & Maintenance Manual: Setting Up

SETTING UP

To reduce the risk of electrical shock, use only the accessories and peripherals recommended by Verathon®_.

WARNING

Before you can use the GlideScope PGVL system for the first time, you must inspect the components, set up

the system, and perform a functional test as recommended by Verathon®_{. Complete the following procedures:}

1. Perform Initial Inspection—Inspect the system for any obvious physical damage that may have occurred during shipment.

2. Attach Cleaning Caps (Reusable Only)—Attach protective caps to the video cable used with reusable blades. These caps prevent damage to the instrument during the cleaning and disinfection process.

3. Mount the Video Monitor (Optional)—If desired, set up the video monitor on a mobile stand or on an IV pole. 4. Attach the Cradle (Optional)—If desired for convenience, attach a blade or a video baton cradle to the

mobile stand or IV pole.

5. Charge the Monitor Battery— By using the power cord included in the system, you can use the system while the battery is charging.

6. Connect the Video Laryngoscope—Attach the reusable video laryngoscope or video baton to the video monitor.

7. Insert the Video Baton into a Stat (Single-Use Only)—When you are ready to perform an intubation, insert the video baton into a single-use Stat.

8. Connect to an External Monitor (Optional)—Connect the monitor to an external display source, such as a larger monitor screen, by using the video output cable.

9. Configure User Settings—According to preference and your environment, configure the monitor settings.

10. Perform a Functional Check—Before you use the device for the first time, perform a functional check to

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PROCEDURE 1. PERFORM INITIAL INSPECTION

When you receive the GlideScope PGVL system, Verathon recommends that an operator familiar with the instrument perform a full visual inspection of the system for any obvious physical damage that may have occurred during shipment.

1. Verify that you have received the appropriate components for your system by referring to the packing list included with the system.

2. Inspect the components for damage.

3. If any of the components are missing or damaged, notify the carrier and Verathon Customer Care or your local representative:

800.331.2313 (Canada and US) 425.867.1348 (International) +31 (0) 20 210 30 91 (Europe)

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PROCEDURE 2. ATTACH CLEANING CAPS (REUSABLE ONLY)

On both ends of the video cable for the PGVL reusable system, there are two connectors. In order to protect these connectors during the cleaning and disinfection process, it is necessary that you attach two protective cleaning caps to the video cable. In this procedure, you tether the caps to the video cable.

Because the single-use video baton is already outfitted with a protective cleaning cap, it is not necessary that

you complete this procedure if you have a single-use system. 1. On the tether, slide the adjustable sleeve towards the caps.

2. Thread the video cable through the loop in the tether.

3. Slide the adjustable sleeve towards the video cable. This tightens the tether around the video cable.

4. Ensure that the loop is suffiently tightened so that the tether will not slide off the ends of the video cable.

5. Using pliers or an equivalent tool, crimp the adjustable sleeve. This secures the tether and prevents removal of the cleaning caps.

For more information about how to use the protective caps, see the chapter Cleaning & Disinfecting on page 31.

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PROCEDURE 3. MOUNT THE VIDEO MONITOR (OPTIONAL)

If you choose to mount the system, you may use either of the following configurations:

• Option 1: Mobile Stand—Mount the video monitor on a mobile stand (Figure 6) that makes it easy for you to move the system from one location to another.

• Option 2: IV Pole—Mount the video monitor on an IV pole (Figure 7).

Figure 6. Video Monitor on Mobile Stand

Video monitor

Mobile stand

Figure 7. Video Monitor on IV Pole

Video monitor

IV pole IV pole mount

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OPTION 1. MOBILE STAND

ASSEMBLE THE MOBILE STAND

1. Remove the hex bolt and washers from the bottom of the base pole.

2. Insert the bottom end of the base pole into the top of the base. Note: You may remove or reattach wheels on the base by using moderate force in order to pull them out or push them in.

3. Screw the bolt and washers back into place, and then tighten the bolt securely. This attaches the base pole to the base and ensures stability.

4. Insert the spacer pole into the top end of the base pole, and then insert the mounting pole into the top end of the base pole.

5. Turn the height adjustment knob counterclockwise.

6. Place your hands where they cannot be pinched by moving parts, and then raise or lower the pole to the desired height.

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ATTACH THE MONITOR TO THE MOBILE STAND

8. Hold the video monitor against the screw on the tilt head fastener, and then turn the tilt head fastener clockwise until the video monitor is securely attached to the mount.

Tilt head fastener

ADJUST THE MONITOR ANGLE

Before you start using the video monitor, adjust the angle of the monitor for optimal viewing. The ideal angle

minimizes glare and maximizes visibility.

9. Turn the angle adjustment knob counterclockwise.

Angle adjustment knob

10. Tilt the monitor to the desired angle.

11. Turn the angle adjustment knob clockwise. This secures the monitor at the desired angle. 12. To attach a blade cradle or a video baton cradle, see the procedure Attach the Cradle (Optional).

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OPTION 2. IV POLE

ATTACH THE MONITOR TO AN IV POLE

1. 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

2. Hold the video monitor against the screw on the tilt head fastener, and then turn the tilt head fastener clockwise until the video monitor is securely attached to the IV pole mount.

Tilt head fastener

ADJUST THE MONITOR ANGLE

Before you start using the video monitor, adjust the angle of the monitor for optimal viewing. The ideal angle

minimizes glare and maximizes visibility.

3. Turn the angle adjustment knob counterclockwise.

Angle adjustment knob

4. Tilt the monitor to the desired angle.

5. Turn the angle adjustment knob clockwise. This secures the monitor at the desired angle. 6. To attach a blade cradle or a video baton cradle, see the procedure Attach the Cradle (Optional).

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PROCEDURE 4. ATTACH THE CRADLE (OPTIONAL)

You may elect to attach a blade cradle or a video baton cradle to the mobile stand or IV pole mount. The video baton cradle may be attached directly the pole or attached to the interior of the blade cradle. If you would like to attach a blade cradle to the mobile stand or IV pole, complete Option 1. If you would like to attach the video baton cradle directly to the mobile stand or IV pole, complete Option 2.

OPTION 1. ATTACH THE BLADE CRADLE TO THE POLE

This option provides instructions for attaching the blade cradle to the mobile stand or IV pole, and it also provides instructions for optionally attaching the video baton cradle to the blade cradle.

1. Open the cradle latch and position the pole on the back of the cradle.

2. Close the cradle latch and tighten in place by turning the cradle adjustment knob clockwise.

Cradle Adjustment Knob

3. If you would like to attach the video baton cradle to

the blade cradle, hook it into place. Video Baton Cradle (Optional)

OPTION 2. ATTACH THE VIDEO BATON CRADLE TO THE POLE

1. Screw the center pole clamp to the video baton cradle.

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PROCEDURE 5. CHARGE THE MONITOR BATTERY

The battery must be fully charged prior to first use in battery mode. This helps ensure optimal battery life.

IMPORTANT

The system can operate on alternating current (AC) power or battery power. The monitor contains an internal lithium-ion battery that powers itself and the video laryngoscope. Under normal operating conditions, a fully charged battery lasts approximately 90 minutes before it needs to be recharged. You should charge the battery according to the information in Charging Conditions on page 49.

The battery indicator LED on the front of the monitor indicates the current battery charge level, and the charge status LED indicates whether the battery is currently charging. For more information, see Battery Indicator and Charge Status on page 12.

1. Ensure that the AC power cord is disconnected, and on the back of the video monitor, ensure the battery switch is in the OFF position.

2. Slide the battery switch to the ON position, and then insert the power cord into the power socket.

Battery switch Power socket

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

The charge status LED turns solid orange, indicating that the charging cycle has begun. For more information about the charge status LED, see Table 4 on page 12.

4. Allow the battery to charge.

When the battery is fully charged, the charge status LED turns solid green. Fully charging the battery may take approximately 6 hours.

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PROCEDURE 6. CONNECT THE VIDEO LARYNGOSCOPE

The GlideScope PGVL system is available in two configurations:

• Single-use—The video baton connects directly to the video monitor, and a single-use, disposable Stat is attached to the video baton.

• Reusable—The video cable attaches the video laryngoscope to the video monitor, supplying power to the blade and transmitting video data from the blade's camera to the monitor.

This procedure documents how to attach a video laryngoscope for single-use and reusable systems. For baton,

Stat, and blade sizing information, see Table 5 on page 28. 1. Ensure that the video monitor is turned off.

2. Hold the video cable or video baton by the gray connector.

3. On the monitor, align the arrows on the video cable connector with the arrows on the video cable port, and then insert the connector fully into the port.

4. If you are using a reusable system, align the arrows on the video cable connector with the seam on the top of the blade, and then insert the video cable connector into the blade port.

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PROCEDURE 7. INSERT THE VIDEO BATON INTO A STAT (SINGLE-USE ONLY)

It is recommended that you leave the single-use Stat in the packaging while connecting the Stat and that you do not remove it until you are ready to perform an intubation procedure. This helps ensure that the Stat remains as clean as possible.

1. Open the GVL®_{Stat pouch, but do not remove the Stat from the packaging.}

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

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

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

Correct Incorrect

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

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PROCEDURE 8. CONNECT TO AN EXTERNAL MONITOR (OPTIONAL)

The external monitor must be safety-approved medical equipment.

WARNING

By using a video output cable, the PGVL video monitor may be connected to an NTSC-compatible external monitor that is approved for medical use. For more information, please contact your Verathon®_{Customer Care}

representative.

Note: Image quality on the external monitor may vary according to the resolution of the external monitor.

Note: To maintain electromagnetic interference (EMI) within certified limits, the GlideScope PGVL system must be used with the cables, components, and accessories specified or supplied by Verathon. For additional information, see the System Parts & Accessories and Component Specifications sections. The use of

accessories or cables other than those specified or supplied may result in increased emissions or decreased

immunity of the system.

1. Ensure that the video monitor is turned off.

2. On the back of the video monitor, insert the video output cable into the video output port.

Video output port

3. Connect the other end of the cable to the external monitor.

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PROCEDURE 9. CONFIGURE USER SETTINGS

1. Ensure that the video monitor is directly connected to power, or ensure that the battery has been fully charged according to the procedure Charge the Monitor Battery on page 21.

2. Ensure that a video laryngoscope has been attached to the video monitor according to the procedure

Connect the Video Laryngoscope on page 22.

Note: If you are using a single-use system, it is not necessary for you to insert the video baton into a Stat in

order to complete this procedure.

3. Press the ON/OFF button. The monitor turns on. 4. Press the MENU button. The settings screen appears.

BRIGHTNESS

CONTRAST

COLOR

MIRROR

RESET

EXIT

NORMAL NTSC AV1

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5. Using the MENU button to scroll through settings, customize the following settings:

• BRIGHTNESS—Controls the luminosity of the image on the video monitor. Use the UP or DOWN buttons to increase or decrease this value; a value of 18–20 is recommended. Ensure that you set the brightness setting to proper levels for your clinical environment.

• CONTRAST—Controls the contrast of the image on the video monitor. Use the UP or DOWN buttons to increase or decrease this value; a value of 16–20 is recommended.

• COLOR—Controls the color saturation of the image on the video monitor. Use the UP or DOWN buttons to increase or decrease this value; a value of 50 is recommended.

• MIRROR—Determines whether the image on the video monitor is reversed. Use the UP button to mirror the view, or use the DOWN button to return to the original view.

• RESET—Restores all settings to their factory default. Use the UP or DOWN button to restore all default settings.

Notes:

• Depending on the software version, Volume and Mute settings may be available on some video monitors.

These settings are currently inactive.

• The Normal, NTSC, AV1 setting controls the format and channel of the signal being received from the video baton or blade. Because GlideScope PGVL components use NTSC format, this setting does not

change.

6. When you are finished configuring settings, press the MENU button until EXIT is highlighted, and then press either the UP or DOWN button. Your settings are saved, and the setting screen closes. 7. Press the ON/OFF button. The monitor turns off.

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PROCEDURE 10. PERFORM A FUNCTIONAL CHECK

Before you use the system for the first time, perform the following functional check to ensure that it is working

properly. Please contact your Verathon®_{Customer Care representative if your system does not function as}

described below.

1. Ensure that the battery has been fully charged according to the procedure Charge the Monitor Battery on page 21.

2. Ensure that a video laryngoscope has been attached to the video monitor according to the procedure

Connect the Video Laryngoscope on page 22.

Note: If you are using a single-use system, it is not necessary for you to insert the video baton into a Stat in

order to complete this procedure.

3. On the back of the video monitor, slide the battery switch to the ON position.

4. Press the ON/OFF button. The monitor turns on and is running on battery power.

5. Look at the monitor screen, and verify that the image displayed is being received from the video baton or the reusable blade.

Note: There may be a slight blade intrusion in the upper corners of the monitor, and a thin line may appear

along the top. These blade edges are captured in the view because of the wide-angle camera lens used in the video laryngoscope. This image acts as a frame of reference during the intubation process and ensures that the orientation of the image is correct in the monitor.

Potential blade intrusion

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27

Operations & Maintenance Manual: Using the System

USING THE SYSTEM

Prior to using the device, set up the system according to the instructions in the previous chapter, and verify the setup by completing the procedure Perform a Functional Check on page 26.

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

WARNING

To ensure patient safety, routinely inspect the GlideScope video laryngoscope blade before and after every use to ensure the blade is free of rough surfaces, sharp edges, cracks, protrusions, shell separation, surface delamination, or any other indication of wear. If found, do not use the damaged or worn blade, otherwise blade breakage may occur and could cause patient injury or death. Always ensure that alternative airway management methods and equipment are readily available.

Report any suspected blade defects to Verathon®_{Customer Care at:}

Phone: 800.331.2313 (U.S. and Canada) 425.867.1348 (International) Email: [email protected]

WARNING

PGVL reusable and single-use video laryngoscopes are equipped with an anti-fog feature that reduces camera

fogging during the intubation procedure. To fully optimize the feature, you must allow the video laryngoscope

to warm up for 30-120 seconds prior to use, depending on the ambient temperature and humidity of the clinical

environment. Full optimization of the anti-fog feature is not necessary in order to use the device; if desired, you

may begin the intubation procedure immediately.

Note: If the video laryngoscope is stored in cold conditions, additional warming time may be required for optimal

performance of the anti-fog feature.

Using the PGVL system consists of the following procedures: 1. Prepare the GlideScope System

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PROCEDURE 1. PREPARE THE GLIDESCOPE SYSTEM

Table 5. Video Laryngoscope Sizes

SINGLE USE SIZES

Stat Video Baton Recommended Patient Weight/Size*

GVL®_{0 Stat} _{Video baton 1-2} _{Patients less than 1.5 kg (3.3 lbs)}

GVL 1 Stat Video baton 1-2 Patients between 1.5–3.8 kg (3.3–8.4 lbs)

GVL 2 Stat Video baton 1-2 Patients between 1.8–10 kg (4–22 lbs)

GVL 2.5 Stat Video baton 1-2 Patients between 10–28 kg (22–61.7 lbs)

GVL 3 Stat Video baton 3-4 Patients between 10 kg–adult (22 lbs–adult)

GVL 4 Stat Video baton 3-4 Patients between 40 kg–morbidly obese (88 lbs–morbidly obese)

REUSABLE BLADE SIZES

GlideScope PGVL Blade Recommended Patient Weight/Size*

GVL 3 blade Patients between 10 kg–adult

GVL 4 and GVL 5 blades Patients between 40 kg–morbidly obese

* Weight ranges are approximate; a medical professional must evaluate on a patient-by-patient basis. 1. Ensure that each GlideScope system component has been properly cleaned, disinfected, or sterilized

according to the guidance provided in Table 6 on page 32.

2. Using the information in Table 5, in combination with a clinical assessment of the patient and the experience and judgment of the clinician, select the reusable blade or single-use video baton/Stat combination that is appropriate for the patient.

3. Ensure that the video monitor is turned off.

4. Attach the video laryngoscope to the monitor, according to the instructions in Connect the Video Laryngoscope on page 22.

5. If you are using a single-use system, insert the video baton into a Stat, as described in the procedure Insert the Video Baton into a Stat (Single-Use Only) on page 23.

Note: It is recommended that you leave the Stat in its packaging until you are ready to begin the intubation. 6. Press the Power button . The video monitor turns on.

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

8. On the monitor screen, verify that the image displayed is from the video laryngoscope camera. On the monitor, a small portion of the blade may be visible on the top or upper corners.

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29

Operations & Maintenance Manual: Using the System

PROCEDURE 2. INTUBATE USING THE GLIDESCOPE 4-STEP TECHNIQUE

When you are guiding the endotracheal tube to the distal tip of the video laryngoscope, ensure that you are looking in the patient’s mouth, not at the video monitor screen. Failure to do so may result in injury to the tonsils or soft palate.

WARNING

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

• The first area is the light-emitting area surrounding the camera where the anti-fog feature is

located. When used as indicated, continuous contact with this area is unlikely because, if tissue were to contact this area, the view would be lost and devices would need to be adjusted to regain the airway view.

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

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

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

WARNING

To perform an intubation, Verathon®_{recommends using the GlideScope 4-Step Technique as outlined in}

this procedure. Each step begins with where you should be looking in order to complete that action. Prior to beginning this procedure, verify that the monitor is receiving an accurate image from the video laryngoscope. 1. Look in the mouth —With the video laryngoscope in the left hand, introduce it into the midline of the oral pharynx. 2. Look at the screen—Identify the epiglottis, and then manipulate the blade in order to obtain the best glottic view.

Figure 8. Ideal Glottic View

3. Look in the mouth—Carefully guide the distal tip of the tube into position near the tip of the laryngoscope. 4. Look at the screen—Complete the intubation, gently rotating or angling the tube in order to redirect it as needed.

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TIPS

USING THE GLIDESCOPE SYSTEM

• The GlideScope video laryngoscope is designed to be inserted down the midline of the tongue to the epiglottis.

• The GlideScope video laryngoscope may be used to produce a Macintosh-style lift of the epiglottis, or to produce a Miller lift.

• Intubations using the GlideScope video laryngoscope only require approximately 0.5–1.5 kg (1–3.5 lbs) of lifting force.

• The use of an endotracheal tube stylet is recommended. The GlideRite®_{Rigid Stylet has been designed}

to complement the angle of the GlideScope video laryngoscope to facilitate intubation, and it should be used with endotracheal tubes 6.0 mm and larger. A malleable stylet with a 60-90° angle may be used.

• To aid the passage of the endotracheal tube when at the vocal cords, gradually withdraw the stylet

approximately 5 cm (2 in). A 1-cm (0.5 in) withdrawal of the laryngoscope may be beneficial to reduce the

viewing angle and allow the glottis to drop.

WORKING WITH ENDOTRACHEAL TUBES

• Insert the endotracheal tube (ETT) behind or immediately adjacent to the GlideScope video laryngoscope. • Do not insert the stylet into the larynx during intubation.

• Carefully introduce the distal end of the ETT between the vocal folds.

• When introducing the video laryngoscope or the endotracheal tube, look directly into the mouth to avoid damaging the endotracheal tube cuff, the patient’s teeth, or soft tissues such as the soft palate or tonsils. • Advance the ETT while simultaneously withdrawing the stylet with the thumb. The stylet should be

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31

Operations & Maintenance Manual: Cleaning & Disinfecting

CLEANING & DISINFECTING

GENERAL INFORMATION

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

Ensure that you follow the manufacturer’s instructions for handling and disposing of the cleaning and disinfection solutions provided in this manual.

WARNING

Availability of cleaning, disinfection, and sterilization products varies by country, and Verathon®

is unable to test products in every market. For more information, please contact Verathon Customer Care at 1.800.331.2313 or your local representative. For contact information, visit

verathon.com/contact-us.

WARNING

This product may only be cleaned, disinfected, or sterilized by using the low-temperature processes

provided in this manual.

WARNING

The reusable video laryngoscope is considered a semi-critical device intended to contact the airway. It must be thoroughly cleaned and undergo high-level disinfection after each use.

WARNING

Cleaning is critical to ensuring the component is ready for disinfection. Failure to properly clean the device could result in a contaminated instrument after completing the disinfection procedure.

When cleaning, ensure all foreign matter is removed from the surface of the device. This allows the active ingredients of the chosen disinfection method to reach all the surfaces.

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Do not place the GlideScope video baton or reusable video laryngoscope in the cradle if any of the components are contaminated.

WARNING

Cleaning and disinfecting the GlideScope PGVL system is an important part of using and maintaining the system. Prior to each use, ensure that each system component has been cleaned and disinfected according to the guidance provided in Table 6. You should also examine the system periodically to make sure it is operating correctly. For more information, see the Maintenance & Safety chapter on page 44.

This chapter is divided into the following sections:

• General Information—Contains an overview of system information and provides the cleaning and disinfection procedures for components that are common to both the reusable and single-use systems • Reusable System—Contains the cleaning and disinfection procedures for the reusable blade and video

cable

• Single-Use System—Contains the cleaning and disinfection procedures for the video baton

Note: It is understood that all items in the following table will be used as intended, and the level of disinfection or

sterilization required may vary according to local regulations. Table 6. Risk Assessment for PGVL Systems

DEVICE STERILE USE SPAULDING’S/CDC CLASSIFICATION DISINFECTION LEVEL STERILIZATION

Low Int. High

Monitor* Nonsterile Reusable Noncritical

Cradle* Nonsterile Reusable Noncritical

GVL®_Stat† _Sterile _{Single Use} _{Semi-critical}

Video baton‡ Nonsterile Reusable Noncritical X

Video cable Nonsterile Reusable Noncritical X

PGVL reusable

blade Nonsterile Reusable Semi-critical X

GlideRite®

Rigid Stylet Nonsterile Reusable Semi-critical X

* Clean the video monitor and cradle when they are visibly soiled and on a regular basis, as per a schedule established by the medical care

facility or provider.

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

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

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33

Do not let any contaminant(s) dry on the device. Bodily contaminants tend to become securely attached to

solid surfaces when dried, making removal more difficult.

Prior to cleaning or disinfecting, ensure the protective cap is properly fitted on the video cable, video baton,

and blade connectors and ports.

IMPORTANT

PROCEDURE 1. CLEAN THE VIDEO MONITOR

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.

IMPORTANT

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 video monitor, and then unplug the device.

2. Using 70% isopropyl alcohol, bleach (100 ppm), or a mild detergent with water, wipe the exterior of the video monitor.

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PROCEDURE 2. CLEAN THE CRADLE

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

1. Wipe the cradle with a standard hospital-grade, surface-cleaning product.

PROCEDURE 3. CLEAN & STERILIZE THE GLIDERITE RIGID STYLET

The GlideRite®_{Rigid Stylet is a nonsterile, reusable device that requires cleaning and sterilization.} Table 7. Cleaning & Sterilization Methods for the GlideRite Rigid Stylet

METHOD LEVEL CONDITIONS

Enzymatic debridement

agent/detergent Cleaner As per chemical manufacturer’s instructions

Hydrogen Peroxide Gas

Plasma Sterilization System* Sterilization

STERRAD®_{100S (in U.S.),}

STERRAD®_{100S short cycle (outside U.S.),}

STERRAD®_{NX standard cycle, or}

STERRAD®_{100NX standard cycle}

STERIS®_Vaprox®_HC* _{Sterilization} Non-lumen cycle in any STERIS® Amsco® V-PRO®

low-temperature sterilization system.

Autoclave†

(steam cycle) Sterilization Minimum 4-minute, 132°C (269°F) pre-vacuum steam sterilization cycle

* Tested for 500 compatibility cycles.

† Tested for 300 compatibility cycles at 18 minutes and 134°C (273°F).

1. Clean using a low-level disinfection wipe method or rinse/brush method.

2. Using a brush, apply general, hospital-grade detergent or an enzymatic debridement agent.

3. Rinse under clean, running water.

4. Sterilize the stylet, as instructed in Table 7.

5. Visually inspect the stylet and ensure that there are no signs of damage or cracking. If the stylet is damaged, do not use it; contact Verathon®_{Customer Care to order a new stylet.}

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35

REUSABLE SYSTEM

PROCEDURE 1. CLEAN & DISINFECT THE REUSABLE BLADE

The GlideScope PGVL reusable video laryngoscope requires high-level disinfection prior to use. For more information about the risk assessment of PGVL system components, see Table 6 on page 32.

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

Table 8. Cleaning & Disinfection Methods for the GlideScope PGVL Reusable Blade

CHEMICAL DISINFECTION LEVEL CONDITIONS

agent/detergent Cleaner As per chemical manufacturer’s instructions

Metrex®_EmPower™† Cleaner

Water temperature: 19–29°C (66–84°F)

Exposure: Prepare solution at 1 ounce/gallon. 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.

ASP®_Cidex®_OPA† High

Conditioning: 20–40°C (68-104°F)

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 Metrex®_MetriCide®

Plus 30 † High

Conditioning: 20 ± 2°C (68 ± 4°F)

Rinse: (3) 1-minute immersions with agitation in pure water STERIS®_{Revital-Ox™} Resert®_{XL HLD}† Revital-Ox™ Resert® HLD/Chemosterilant† Resert®_{XL HLD}† High Conditioning: 20–60°C (68–140°F) Water Temperature: 20–60°C (68–140°F)

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

STERIS® S40™

or S20™‡

High/

Sterilization

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.)

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CHEMICAL DISINFECTION LEVEL CONDITIONS

STERIS®_Vaprox®_HC_* _{Sterilization} Non-lumen cycle in any STERIS® Amsco® V-PRO® low-temperature

sterilization system.

ASP®_Hydrogen

Peroxide Gas Plasma* Sterilization

* Compatible with ≤ 250 cycles. Exceeding 250 cycles may affect the potential life of the product.

† Compatible with ≤ 2000 cycles.

‡ Compatible with ≤ 500 cycles. Exceeding 500 cycles may affect the potential life of the product.

Do not use metal or abrasive brushes, scrub pads, or rigid tools to clean the blade. 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 and void the device warranty.

IMPORTANT

CLEAN THE GLIDESCOPE PGVL REUSABLE BLADE 1. Ensure the video monitor is turned off.

2. Disconnect the blade from the video cable by gripping the gray connector and then pulling the connector from the blade port.

Note: Clean and disinfect the video cable as described in the procedure Clean & Disinfect the Video Cable on page 39.

3. On the blade, place the protective cleaning cap over the connector.

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37

5. Using a hospital-grade equipment detergent or an enzymatic debridement agent or detergent, wash the

blade manually to remove all foreign material from the surface of the device. 6. Rinse the blade in clean, running water.

7. Visually inspect the blade for contamination. If there is any sign of contamination, restart this procedure. 8. Using a clean, lint-free cloth, hospital-grade clean air, or a low-temperature dryer, dry the blade.

The component should now be clean. Handle the product carefully to avoid recontamination. Before each use, reusable video laryngoscopes must be high-level disinfected. Continue with this procedure in order to high-level disinfect the reusable blade.

DISINFECT OR STERILIZE THE GLIDESCOPE PGVL REUSABLE BLADE 9. Ensure the protective caps on the connectors are secure, according to Step 3.

10. Ensure the video laryngoscope has been properly cleaned, according to Step 4 through Step 8.

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

12. Disinfect the blade according to the conditions stated in Table 8. The exposure process and times vary depending on the solution.

13. Rinse the blade according to the water temperature (if applicable) and the rinsing instructions stated in

Table 8. The rinsing process and times vary depending on the solution.

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

15. Inspect the reusable blade according to the instructions in the following procedure, and then store the component in a clean environment.

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PROCEDURE 2. INSPECT THE REUSABLE BLADE

To ensure patient safety, routinely inspect the GlideScope video laryngoscope blade before and after every use to ensure the blade is free of rough surfaces, sharp edges, cracks, protrusions, shell separation, surface delamination, or any other indication of wear. If found, do not use the damaged or worn blade, otherwise blade breakage may occur and could cause patient injury or death. Always ensure that alternative airway management methods and equipment are readily available. Report any suspected blade defects to Verathon®_{Customer Care at:}

WARNING

1. Visually inspect the video laryngoscope for signs of damage. Damage and wear that may affect safety are shown inside the red circles and are the result of accelerated cycle-to-failure testing to simulate worst-case usage (end-of-life).

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39

PROCEDURE 3. CLEAN & DISINFECT THE VIDEO CABLE

Low-level disinfection is recommended for the video cable after every patient use. High-level disinfection is required for the video cable when it is visibly soiled. For more information about the risk assessment of PGVL system components, see Table 6 on page 32.

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

IMPORTANT

Table 9. Cleaning & Disinfection Methods for the GlideScope PGVL Video Cable

CHEMICAL STRENGTH DISINFECTION LEVEL NOTES

agent/detergent Hospital grade Cleaner Surface cleaning only in preparation for disinfectant

Bleach 500 ppm Low Solution can be corrosive for connector and _{stainless steel ring}

Isopropyl alcohol solution 70% Low —

Hydrogen peroxide ≥ 7.5% High —

Glutaraldehyde ≥ 3.4% High —

Ortho-phthalaldehyde 0.55% High —

Peracetic acid 0.2% _{Sterilization}High/ Classified as a chemical sterilant

Vaporized hydrogen peroxide 90% Sterilization —

CLEAN THE VIDEO CABLE

1. Ensure the video monitor is turned off.

2. Disconnect the video cable from the monitor by gripping the gray connector and then pulling the connector from the video cable port.

3. If a blade is attached to the video cable, disconnect the components by gripping the gray connector and then pulling the connector from the blade port.

Note: Clean and disinfect the blade as described in the procedure Clean & Disinfect the Reusable Blade on page 35.

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4. Place the protective cleaning caps over both gray connectors.

5. Rinse the video cable in clean tap water and scrub with a soft-bristled brush until all visible contamination has been removed.

6. Using a hospital-grade equipment detergent or an enzymatic debridement agent or detergent, wash the

video cable manually to remove all foreign material from the surface of the device. 7. Rinse the video cable in clean, running water.

8. Visually inspect the video cable for contamination. If there is any sign of contamination, restart this procedure.

9. Using a clean, lint-free cloth, hospital-grade clean air, or a low-temperature dryer, dry the video cable. The video cable should now be clean. Handle the product carefully to avoid recontamination. Before each use, low-level disinfection is recommended, but high-level disinfection is required if the cable is visibly soiled. Continue with this procedure in order to disinfect the video cable.

DISINFECT OR STERILIZE THE VIDEO CABLE

10. Ensure the equipment is clean according to the previous steps. 11. Ensure the protective caps on the connectors are secure.

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

13. Disinfect the video cable according to solution manufacturer's instructions. The exposure process and times vary depending on the solution.

14. If applicable, rinse the video cable according to the solution manufacturer’s instructions.

15. Dry the video cable by using a sterile cloth, hospital-grade clean air, or a low-temperature dryer.

16. Examine the component for any signs of damage. If damage is present, do not use the component, and contact Verathon®_{Customer Care.}

17. Handle the product carefully to avoid recontamination, and then store the disinfected video cable in a clean environment.

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41

SINGLE-USE SYSTEM

For more information about the risk assessment of PGVL system components, see Table 6 on page 32.

PROCEDURE 1. REMOVE THE STAT

The GVL®_{Stat is a 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.

PROCEDURE 2. CLEAN & DISINFECT THE VIDEO BATON

When used as intended, the PGVL video baton is a nonsterile, reusable device that is protected from contact with mucous membranes and non-intact skin by the single-use Stat. 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.

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

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

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Table 10. Cleaning & Disinfection Methods for the GlideScope PGVL Video Baton

CHEMICAL DISINFECTION LEVEL CONDITIONS

Enzymatic debridement agent/detergent Cleaner As per chemical manufacturer’s instructions

Bleach (500 ppm) Low As per chemical manufacturer’s instructions

Isopropyl alcohol solution (70%) Low As per chemical manufacturer’s instructions

Metrex®_MetriCide®_{Plus 30} _High _{As per chemical manufacturer’s instructions}

ASP®_Cidex®_OPA _High _{As per chemical manufacturer’s instructions}

Sultan®_{Healthcare Sporox}®_II _High _{As per chemical manufacturer’s instructions}

STERIS®_S20™ High/

Sterilization

Standard cycles in the following processors: STERIS®_{SYSTEM 1}®

SYSTEM 1 EXPRESS SYSTEM 1 PLUS

ASP®_{Hydrogen Peroxide Gas Plasma} _{Sterilization}

CLEAN THE GLIDESCOPE PGVL VIDEO BATON 1. Ensure the video monitor is turned off.

2. Disconnect the video baton from the monitor by gripping the gray connector and then pulling the connector from the video cable port.

3. Place the protective cleaning cap over the connector.

4. Rinse the video baton in clean tap water and scrub with a soft-bristled brush until all visible contamination has been removed. To prevent damage, use a cotton swab in order to clean around the camera window.

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43

8. Using a clean, lint-free cloth, hospital-grade clean air, or a low-temperature dryer, dry the video baton. The video baton should now be clean. Handle the product carefully to avoid recontamination. Before each use, low-level disinfection is recommended, but high-level disinfection is required if the baton is visibly soiled. Continue with this procedure in order to disinfect the video baton.

DISINFECT OR STERILIZE THE GLIDESCOPE PGVL VIDEO BATON 9. Ensure the equipment is clean according to the previous steps. 10. Ensure the protective cap on the connector is secure.

11. Prepare and condition the disinfection solution according to the solution manufacturer’s instructions and the conditions stated in Table 10.

12. Disinfect the video baton according to the conditions stated in Table 10. The exposure process and times vary depending on the solution.

13. If applicable, rinse the video baton according to the solution manufacturer’s instructions.

14. Dry the video baton by using a sterile cloth, hospital-grade clean air, or a low-temperature dryer. 15. Inspect the video baton according to the instructions in the following procedure, and then store the

disinfected video baton in a clean environment.

PROCEDURE 3. INSPECT THE VIDEO BATON

Always ensure that alternative airway management methods and equipment are readily available. Report any suspected defects to Verathon®_{Customer Care at:}

WARNING

1. Visually inspect the video baton for signs of damage. Perform a routine inspection of the video baton before and after every use to ensure that all endoscopic components are free of unintended rough surfaces, sharp edges, protrusions, or cracks.

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MAINTENANCE & SAFETY

INSPECTIONS

In addition to the user perfor

GLIDESCOPE PORTABLE GVL SYSTEM