GlideScope GVL and Cobalt Users Manual and Quick Reference Guide

GlideScope® GVL and Cobalt Quick Reference Guide

Corporate Headquarters: Verathon Inc. 20001 North Creek Parkway, Bothell, WA 98011 USA 800.331.2313 (Canada and US) 425.867.1348 Fax: 425.883.2896 verathon.com

Verathon Medical (Europe) B.V. Linnaeusweg 11 3401 MS, IJsselstein The Netherlands +31.30.68.70.570 Fax: +31.30.68.70.512 verathon.eu

Verathon Medical (Canada) ULC 4224 Manor Street Burnaby, BC V5G 1B2 Canada 604.439.3009 Fax: 604.439.3039

For additional contact information please visit our corporate website: verathon.com. GlideScope, GVL, GlideRite, and Verathon are trademarks of Verathon Inc. All other brand and product names are trademarks of their respective owners. ®

The GlideScope technology is covered under US Patents (6,655,377) (6,543,447) as well as European Patent 1307131. Additional patents pending. Information in this User’s Manual and Quick Reference Guide may change at any time without notice. For the most up-to-date information, see the online manuals on www.verathon.com. ®

GlideScope Video Laryngoscope systems are CE marked in accordance with the Medical Device Directive, and the Verathon Inc. quality is Quality System Certified to ISO 13485:2003 standards. © 2009, 2010 Verathon Inc. No part of this manual may be copied or transmitted by any method without the express written consent of Verathon Inc.

PN 0900-2100-01-20

GlideScope® System Quick Start The monitor may be used immediately by plugging it into an AC power source, or by fully charging the battery prior to first use. To ensure proper charging, follow these steps in order: •

Make sure the AC power cord is disconnected and the power switch is in the OFF position.

•

Slide the power switch at the back of the monitor to the ON position.

•

Plug the Monitor into an AC power source:

◦ Insert the female end of the power cord into the port on the back of the Monitor.

•

The charge status LED will turn orange, indicating that the recharging cycle has begun.

•

When charging is complete, the status LED will turn green. At this point the unit is fully functional on battery power.

If the AC power cord is inserted before the power switch is in the ON position, the charge status LED will flash orange. Connect the Video Laryngoscope to the monitor. •

If using the GVL®: Connect either end of the video cable to the GVL® connector. Connect the video cable to the monitor connector.

GlideScope® System Quick Start •

If using the Cobalt system:

STAT

Video Baton

Connect the video baton to the monitor as shown for the GVL® above. Then slide a single-use GVL® Stat over the video baton.

To detach a GVL® Stat from a Cobalt Video Baton, grasp the base of the video baton and pull firmly. IMPORTANT! A used GVL® Stat is a biohazard and should be disposed of in compliance with local protocols. LED State

Meaning

Steady green

The battery is fully charged and ready for use.

CHARGE STATUS

Flashing orange CHARGE STATUS

Flashing orange can indicate two states: •

•

Steady orange

If the AC power is connected and the power switch is off ("O" - to the left), the CHARGE STATUS LED will flash orange. The monitor will still function but the battery will not charge. If the AC power is NOT connected and the CHARGE STATUS LED flashes orange, the battery is malfunctioning.

Charging in progress

CHARGE STATUS Corporate Headquarters: Verathon Inc. 20001 North Creek Parkway Bothell, WA 98011, USA Tel: 800.331.2313 (US and Canada only) Tel: 425.867.1348 Fax: 425.883.2896

Manufacturer: Verathon Medical (Canada) ULC 4224 Manor Street Burnaby, British Columbia Canada, V5G 1B2

EC Representative: Verathon Medical (Europe) B.V. Linnaeusweg 11 3401 MS IJsselstein Netherlands Tel: +31.30.68.70.570 Fax: +31.30.68.70.512t

www.verathon.com

GlideScope®, GVL®, Verathon® and Verathon Medical® are registered trademarks of Verathon Inc. in the United States and/or other countries. All rights reserved. Copyright © 2008 by Verathon Inc. GlideScope® video laryngoscope systems are CE marked in accordance with the Medical 0900-2077-01-60 Device Directive, and the Verathon Inc. quality system is Quality System Certified to ISO 13485:2003 standards.

Cleaning and Disinfecting the GlideScope® GVL and Cobalt Video Baton • DO NOT expose to temperatures above 60oC (140oF). Do not disinfect using devices such as autoclaves, ultrasonic cleaners or pasteurizers. • The GlideScope® GVL is a non sterile, reusable device. It is recommended that the GlideScope® GVL is cleaned and disinfected after every patient use using a High Level Disinfectant method. High Level Disinfection is required for the GlideScope® GVL when it is visibly soiled. • The GlideScope Cobalt Video Baton is a non sterile, reusable device. When used as intended, it is protected from direct contact with the patient by the sterile, single-use GVL® Stat. Low Level Disinfection is recommended for the video baton after every patient use. High Level Disinfection is required for the GlideScope® Cobalt Video Baton when it is visibly soiled. Disconnect the GVL® or video baton from the monitor. Place the cleaning cap over the connector as shown. • During cleaning, the protective cap must be inserted as shown to protect the cable connector. Cobalt Video Baton

GVL®

GlideScope® Cobalt Cleaning Cap

Correct Cleaning Position

Video Baton Cleaning Cap

Wash the GVL® or video baton manually to remove all foreign material from the surface of the device. • Chemical compatibility and disinfection methods are detailed in the User’s Manual. • To clean the exterior of the monitor and the video cables, wipe with IPA (70% isopropyl alcohol) bleach (100ppm) or a mild detergent and water. • Wipe the cradle with a standard hospital-grade surface cleaning product. For more detailed cleaning instructions see the GlideScope® System User’s Manual.

Attaching/Detaching the GlideScope® GVL or Cobalt Video Baton Insert the GVL® or Cobalt Video Baton cable into the port located on the face of the monitor so that the arrows on the cable and the monitor line up.

For GVL® only: Attach the opposite end of the video cable to the port located on the GVL®. Note: When connecting and disconnecting the cable, grasp the connector by the gray sleeve.

Attaching/Detaching the GlideScope® Cobalt Video Baton and Stat Insert the Cobalt Video Baton into the sterile, single-use GVL® Stat until it clicks into place. Ensure proper insertion by matching the GlideScope® logo on the side of the video baton and the GVL® Stat.

STAT

video baton

Detach the video baton from the GVL® Stat by grasping the base of the video baton and pulling firmly.

IMPORTANT! A used GVL® Stat is a biohazard and should be disposed of in a manner consistent with local directives in the user’s jurisdiction. Corporate Headquarters: Verathon Inc. 20001 North Creek Parkway Bothell, WA 98011, USA Tel: 800.331.2313 (US and Canada only) Tel: 425.867.1348 Fax: 425.883.2896

Manufacturer: Verathon Medical (Canada) ULC 4224 Manor Street Burnaby, British Columbia Canada, V5G 1B2

EC Representative: Verathon Medical (Europe) B.V. Linnaeusweg 11 3401 MS IJsselstein Netherlands Tel: +31.30.68.70.570 Fax: +31.30.68.70.512t

verathon.com

GlideScope, GVL, and Verathon are trademarks of Verathon Inc. © 2008, 2009 Verathon Inc. GlideScope® video laryngoscope systems are CE marked in accordance with the Medical Device Directive, and the Verathon Inc. quality system is Quality System Certified to ISO 13485:2003 standards.

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The GlideScope® 4-Step Technique Looking directly into the patient’s mouth and with the GlideScope® in the left hand, introduce the video laryngoscope into the midline of the oral pharynx. With the laryngoscope inserted, look to the monitor to identify the epiglottis, then manipulate the scope to obtain the best glottic view. Looking directly into the patient’s mouth, not at the screen, carefully guide the distal tip of the tube into position near the tip of the laryngoscope. It is important to look into the mouth at this step to avoid injuring the tonsils or soft palate.

Look to the monitor to complete the intubation; gently rotate or angle the tube to redirect as needed.

GlideScope® video laryngoscope systems are CE marked in accordance with the Medical Device Directive, and the Verathon Inc. quality system is Quality System Certified to ISO 13485:2003 standards. © 2009 Verathon Inc.

Tips for GlideScope® Video Laryngoscope Insertion • Verathon® recommends inserting the GlideScope® Video Laryngoscope down the midline of the tongue to the epiglottis. • The GlideScope® video laryngoscope may be used to produce a MacIntosh indirect lift of the epiglottis or a Miller lift. • Intubations using GlideScope® Video Laryngoscopes require approximately 0.5kg-1.5kg of lifting force. • 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. A malleable stylet may be used with a 60°-   90° angle. • To aid the passage of the endotracheal tube, withdraw the stylet (approx. 5 cm) while gently advancing the ETT. A 1 cm adjustment (withdrawal) of the laryngoscope also may be beneficial to reduce the viewing angle and allow the glottis to drop.

Corporate Headquarters: Verathon Inc. 20001 North Creek Parkway Bothell, WA 98011, USA Tel: 800.331.2313 (US and Canada only) Tel: 425.867.1348 Fax: 425.883.2896

Verathon Medical (Canada) ULC 4224 Manor Street Burnaby, British Columbia Canada, V5G 1B2

Verathon Medical (Europe) B.V. Linnaeusweg 11 3401 MS IJsselstein Netherlands Tel: +31.30.68.70.570 Fax: +31.30.68.70.512

GlideScope, GVL, GlideRite, and Verathon are trademarks of Verathon Inc. © 2009 Verathon Inc. All rights reserved.

verathon.com

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GlideScope® Products and Systems REUSABLE

SINGLE USE STATS

GVL® Size

GVL® 2

GVL® 3

GVL® 4

GVL® 5

GVL® 1

GVL® 2

GVL® 3

GVL® 4

Patient Weight

1.8 - 10 kg

10 kg Adult

40 kg Morbidly Obese

40 kg Morbidly Obese

< 3.6 kg

1.8 - 10 kg

10 kg - Adult

40 kg Morbidly Obese

Cobalt AVL

Video Baton 1-2 Video Baton 3-4

GlideScope® GVL Ranger Ranger Single Use

Video Baton 1-2 Video Baton 3-4

GlideRite® Rigid Stylet *

FPO Cobalt AVL System (single use)

GVL® System (reusable)

FPO Ranger System (reusable)

Note: System configurations vary. The Cobalt AVL and Ranger Single Use Video Batons are reusable. *For use with endotracheal tubes 6.0 mm and larger.

FPO Ranger Single Use System

GlideScope® Product Specifications System MONITORS

REUSABLE SYSTEM COMPONENTS

SINGLE USE SYSTEM COMPONENTS

Cobalt AVL Monitor

Cobalt AVL Video Baton 1-2

Cobalt AVL Video Baton 3-4

GVL® 2

GVL® 3

Color, 6.4in (diagonal), VGA 640 x 480 Height: 190 mm Width: 225 mm Depth: 80 mm Weight: 1.0 kg

Length: Camera tip to SS ring to handle: 66mm Height of camera: 6 mm Width of camera: 7 mm Cable length: 194.5 cm Weight: 170 g

Length: Camera tip to SS ring: 100 mm Height of camera: 11 mm Width of camera: 11 mm Cable length: 193 cm Weight: 230 g

Blade length (tip to handle): 47 mm Thickness (height) at camera: 14.5 mm Width at camera: 18 mm

Blade length (tip to handle): 82 mm Thickness (height) at camera: 14.5 mm Width at camera: 20mm

GVL® Monitor

Ranger Video Baton 1-2

Ranger Video Baton 3-4

GVL® 4

GVL® 5*

Color, 6.4in (diagonal), 440 x 234 Height: 167 mm Width: 207 mm Depth: 83 mm Weight: 1.4 kg

Length: Camera tip to handle: 40 mm Height of camera: 6 mm Width of camera: 7 mm Cable length: 86.4 cm Weight: 95 g

Length: Camera tip to SS ring: 104.1 mm Height of camera: 10.7 mm Width of camera: 10.9 mm Cable length: 86.4 cm Weight: 141 g

Blade length (tip to handle): 102 mm Thickness (height) at camera: 14 mm Width at camera: 27 mm

Blade length (tip to handle): 102 mm Thickness (height) at camera: 14 mm Width at camera: 27 mm

Ranger Monitor

GVL® 1 and 2

GVL® 3 and 4

Ranger GVL® 3

Ranger GVL® 4

Color, 3.4in (diagonal), 480 x 234 Height: 168 mm Width: 173 mm Depth: 49 mm Weight: 0.56 kg

STAT length (tip to handle): 38 mm/51 mm Thickness (height) at camera: 8.7 mm/8.7 mm Width at camera: 9.9 mm/10.9 mm

STAT length (tip to handle): 80 mm/95 mm Thickness (height) at camera: 16 mm/16 mm Width at camera: 16 mm/20 mm

Blade length (tip to handle): 78mm Thickness (height) at camera: 14.5 mm Width at camera: 14 mm

Blade length (tip to handle): 89 mm Thickness (height) at camera: 14.5 mm Width at camera: 19 mm

Note: The Cobalt AVL and Ranger Single Use Video Batons are reusable. 20001 North Creek Parkway, Bothell, WA 98011

www.verathon.com

*The GVL® 5 is designed to accommodate anatomical anomalies sometimes associated with bariatric patients.

1.800.331.2313 (U.S. & Canada Only) 425.867.1348

The GlideScope video laryngoscopy systems are CE marked in accordance with the Medical Device Directive, and the Verathon Inc. quality system is Quality System Certified to ISO 13485:2003 standards. US Patent No. 6,655,377; 6,543,447; Other patents pending. GlideScope, GVL and Verathon are trademarks of Verathon Inc. © 2009 Verathon Inc.

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GlideScope® System

Important Information Statement of Prescription Federal (USA) law restricts this device for sale by or on the order of a physician. ®

The GlideScope Video Laryngoscope 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.

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.

Warnings and Cautions Caution. Risk of permanent equipment damage. ® Do not expose GlideScope Video Laryngoscopes or Cobalt Video Baton to temperatures above 140° F (60° C). Do not ® disinfect GlideScope Video Laryngoscopes or Cobalt Video Batons using devices such as autoclaves, ultrasonic cleaners, or pasteurizers. Use of such methods will cause permanent device damage and void the warranty. Equipment Caution: Electrical shock hazard. Refer servicing to qualified personnel. This equipment has been tested and found to comply with the standards listed in the Approvals section of this manual. These limits are designed to provide reasonable protection against harmful interference in typical medical installations. CAUTION: Risk of equipment damage.

Failure to cover the cable connector port with the protective cap prior to cleaning may result in water ingress and potential device failure. Bleach can be used on the baton but with special attention to the connector. Bleach may corrode the stainless steel inserts and damage the connector pins. CAUTION: Potential interference with other devices. ®

GlideScope Video Laryngoscopes must be used with the supplied cables to maintain electromagnetic interference (EMI) within certified limits. Quick Reference Guide

1

GlideScope® System

®

GlideScope GVL and Cobalt Systems GlideScope® GVL System ®

GlideScope non-glare color Video Monitor Video cable

Reusable ® GVL (4 sizes)

®

GlideRite Rigid Stylet

GlideScope® Cobalt System ®

GlideScope non-glare color Video Monitor Reusable Cobalt Video Batons (2 sizes)

Single-use ® GVL Stats (4 sizes) ®

GlideRite Rigid Stylet

Quick Reference Guide

2

GlideScope® System

GlideScope® Video Monitor Rear Panel NTSC Video Out Connector (external monitor)

Power cord connector

Mounting point for mobile stand, IV pole, or hard shell case

Power switch ON/OFF

GlideScope® Video Monitor Front Panel GREEN: Monitor is operating on battery power

FLASHING GREEN: Battery is

Press to turn the ® GlideScope System On/Off

low Press MENU to view display setting options

Video cable connector

Press UP/DOWN to move between menu options or to increase/decrease setting values

Quick Reference Guide

GREEN: Battery is fully charged ORANGE: Battery is charging FLASHING ORANGE: Monitor is plugged in but battery is not charging

3

GlideScope® System

GlideScope® System Configurations ®

The GlideScope System may be configured in one of three ways to best meet the needs of individual practices. Please refer to the User’s Manual for complete assembly and setup information.

Mobile Stand

Hard Shell Case

Mounted on an IV Pole

Preparing for First Use ®

Prior to using the GlideScope system for the first time, perform the following steps: 1. Charge the monitor battery. ®

2. Set up the GlideScope system in your preferred configuration. 3. Attach a video laryngoscope or video baton to the monitor. 4. Connect the monitor to an external source such as a TV screen (optional). 5. Perform a functional check. ®

a. Connect a GlideScope Video Laryngoscope to the ® ® monitor (GVL or Cobalt Video Baton + GVL Stat. b. Turn the system on by pressing the ON/OFF button located on the face of the monitor. c.

Observe the monitor screen to verify that an image ® is being received from the GlideScope .

Quick Reference Guide

4

GlideScope® System ®

If the GlideScope GVL, Video Baton, or Stat are stored in cold conditions, additional warming time may be required for optimal performance of the anti-fog feature.

Cleaning, Disinfecting, and Maintenance To ensure patient safety, users should perform a routine ® inspection of the GlideScope Video Laryngoscope before every use to ensure that all endoscopic components are free of unintended rough surfaces, sharp edges, protrusions or cracks. If inspection reveals any faults in the components, contact ® Verathon Medical Customer Care or your local GlideScope representative. All repairs must be performed by an authorized Verathon Medical Service Center. CAUTION: Risk of permanent device damage! ®

Do not expose GlideScope Video Laryngoscopes or Cobalt Video Batons to temperatures above 140° F (60°C). The temperature indicator turns black ® when the GVL is exposed to temperatures above 140° F (60° C)

Quick Reference Guide

5

GlideScope® System

General Cleaning and Disinfection Information Table 1: Risk Assessment Disinfection

Device

Sterile

Use

Spaulding’s CDC Classification

GVL®

Nonsterile

Reusable

Semicritical

GVL® Stat

Sterile

Single use

Semicritical

Cobalt Video Baton*

Nonsterile

Reusable

Noncritical

X

Video Cables

Nonsterile

Reusable

Noncritical

X

Stylet

Nonsterile

Reusable

Semicritical

Monitor#

Nonsterile

Reusable

Noncritical

X

Cradle#

Nonsterile

Reusable

Noncritical

X

Low Level

Int. Level

High Level

Sterilization

X

X

It is understood that all items in this chart will be used as intended

Quick Reference Guide

6

GlideScope® System

Key: *

The Cobalt 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 Cobalt Video Baton after every patient use. High Level Disinfection is required for the Video Baton when it is visibly soiled.

#

Disinfect 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.

–

Shaded areas - not required/not compatible with device materials.

–

Checked boxes (x) show minimum requirement.

–

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

Warning: Disinfectants and cleaning methods listed are recommended by Verathon based on compatibility with product materials. Refer to the label instructions for guidance on disinfection efficacy and appropriate clinical uses. Caution: Meticulous cleaning must precede any disinfection process, to ensure all foreign matter is removed from the surface of the device. This allows the active ingredients of the chosen process to reach all the surfaces of the device. Availability of cleaning products varies by country, and we are unable to test products in every market. Please use the list of recommended chemicals in this manual to compare with products available locally.

Quick Reference Guide

7

GlideScope® System

Note: When using any of the chemicals listed below, read and comply with product use instructions in all applications.

Table 2: Chemical Compatibility and Disinfection Methods for GVL®, Cobalt Video Batons and Video Cables Active Ingredient

Compatibility

Conditions

Enzymatic debridement agent/ detergent

General hospital grade

Isopropyl Alcohol Solution

Glutaraldehyde

OrthoPhthalaldehyde

Peracetic Acid

Bleach (Sodium Hypochlorite)

Disinfection Level

Caution/ Comments

As per instructions

N/A

Surface cleaning only in preparation for disinfectant

70%

70% used to wipe down with minimum 1 minute exposure

Low

Up to 3.4%

2.0% – exposure for minimum 20 minutes at 20°C or as per manufacturer’s instructions

High

0.55%

0.55% – exposure for 12 minutes at 20°C or as per manufacturer’s instructions

High

0.2%

0.2% - exposure for minimum 12 minutes at 50 to 56°C or as per manufacturer’s instructions

See comments on right

Classified as a chemical sterilant

5000ppm – exposure for 10 minutes at 20°C

High

Corrosive for connector pins and SS ring

500ppm – used to wipe down with minimum 1 minute exposure

Low

Noncorrosive at ≤ 500ppm

Up to 8000ppm

Quick Reference Guide

8

GlideScope® System

Table 3: Chemical Compatibility and Disinfection Methods for GlideRite® Rigid Stylet Active Ingredient

Compatibility

Conditions

Disinfection Level

Glutaraldehyde

Up to 3.4%

2.0% – exposure for minimum 20 minutes at 20°C or as per manufacturer’s instructions

High

OrthoPhthalaldehyde

0.55%

0.55% – exposure for 12 minutes at 20°C or as per manufacturer’s instructions

High

Peracetic Acid

0.2%

0.2% - exposure for minimum 12 minutes at 50 to 56°C or as per manufacturer’s instructions

See comments on right

Isopropyl Alcohol Solution

70%

70% - exposure for 10 minutes at 20°C

Intermediate

70% used to wipe down with minimum 1 minute exposure

Low

Caution/ Comments

Classified as a chemical sterilant

500ppm – used to wipe down with minimum 1 minute exposure

Low

General hospital grade

As per instructions

N/A

Surface cleaning only in preparation for disinfectant

Tested in autoclave (steam cycle)

Minimum 4 minute 132°C pre-vacuum steam sterilization cycle

See comments on right

Based on requests from users, an autoclave cycle has been established for the Stylet for ease of use

Bleach (Sodium Hypochlorite)

≤ 500ppm

Enzymatic debridement agent/ detergent N/A

Quick Reference Guide

Noncorrosive at ≤ 500ppm

9