glidescope portable

Transcription

glidescope portable

GLIDESCOPE PORTABLE
GVL SYSTEM
Operations & Maintenance Manual
0900-1204-09-60
GLIDESCOPE PORTABLE
GVL SYSTEM
Operations & Maintenance Manual
IMPORTANT
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.
Effective: October 3, 2014
Caution: Federal (United States) law restricts this
device to sale by or on the order of a physician.
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 (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
Verathon® Medical (Canada) ULC
2227 Douglas Road
Burnaby, BC V5C 5A9
Canada
604.439.3009
Fax: 604.439.3039
Copyright© 2009, 2014 by Verathon Inc. All rights reserved. No part of this document may be copied or transmitted by any method
without the express written consent of Verathon Inc.
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.
0413
TABLE OF CONTENTS
IMPORTANT INFORMATION............................................................................................................................................... 1
PRODUCT DESCRIPTION.............................................................................................................................................. 1
STATEMENT OF INTENDED USE.................................................................................................................................. 1
ESSENTIAL PERFORMANCE......................................................................................................................................... 1
STATEMENT OF PRESCRIPTION.................................................................................................................................. 1
NOTICE TO ALL USERS.................................................................................................................................................. 1
PRECAUTIONS & WARNINGS....................................................................................................................................... 2
INTRODUCTION................................................................................................................................................................... 7
SINGLE-USE 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
Procedure 10.Perform a Functional Check.............................................................................................................26
Operations & Maintenance Manual: Table of Contents
i
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
Other Device Repair....................................................................................................................................................45
TRANSPORTATION.......................................................................................................................................................46
DEVICE DISPOSAL........................................................................................................................................................46
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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
GLOSSARY.........................................................................................................................................................................63
Operations & Maintenance Manual: Table of Contents
iii
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.
Operations & Maintenance Manual: Important Information
1
PRECAUTIONS & WARNINGS
Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of the
device. Cautions indicate that use or misuse of the device may cause a problem, such as a malfunction, failure,
or damage to the product. Throughout the manual, pay attention to sections labeled Important, as these contain
reminders or summaries of the following cautions as they apply to a specific component or use situation.
To ensure safe and reliable operation for the user and patient, please heed the following warnings and cautions.
PRECAUTIONS
CAUTION
Medical electrical equipment requires special precautions regarding electromagnetic compatibility
(EMC) and must be installed and operated according to the instructions in this manual. 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.
CAUTION
Prior to cleaning or disinfecting, ensure the protective cap is properly fitted on the video cable,
video baton, and blade connectors and ports.
2
CAUTION
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.
3
WARNINGS
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
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)
425.867.1348 (International)
Email:[email protected]
WARNING
PGVL reusable video laryngoscopes are delivered nonsterile and require cleaning and high-level
disinfection prior to initial use.
4
WARNING
Because the product will likely be contaminated with human blood or body fluids capable of
transmitting pathogens, all cleaning facilities must be in compliance with (U.S.) OSHA Standard
29 CFR 1910.1030 “Bloodborne Pathogens” or an equivalent standard. For more information, visit
www.osha.gov.
WARNING
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.
5
WARNING
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.
6
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
systems differ.
Operations & Maintenance Manual: Introduction
7
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)
Video batons
(for single-use system only)
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)
GVL 3
8
GVL 4
GVL 5
PARTS & ACCESSORIES
Optional Components
Mobile stand
IV pole mounting kit
GlideRite® Rigid Stylet
Universal accessory basket
Cradle for reusable blade
Cradle for video baton
Video output cable
9
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
Video output port
Power socket
Mounting point
Battery switch
10
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
ON/OFF
FUNCTION
Turns the monitor on and off
UP
Increases the value of a setting
DOWN
Decreases the value of a setting
MENU
Opens the menu and navigates between settings. For more
information, see Configure User Settings on page 25.
11
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
LED turned off
Solid green
FUNCTION
The monitor is off, or the battery level is completely depleted and
needs to be recharged.
The monitor is on, and the battery level is normal.
The battery charge is low. Please note the following:
Flashing green
• 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
LED turned off
FUNCTION
The video monitor is not directly connected to power.
The battery is not charging. Please note the following:
Flashing orange
• 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.
12
Solid orange
The battery is charging.
Solid green
The battery is fully charged.
SETTING UP
WARNING
To reduce the risk of electrical shock, use only the accessories and peripherals recommended by
Verathon®.
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
ensure that the system is working properly.
Operations & Maintenance Manual: Setting Up
13
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)
+31 (0) 20 210 30 91 (Europe)
For additional contact information, see Contact Information.
14
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.
15
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
Figure 7. Video Monitor on IV Pole
Video monitor
IV pole mount
IV pole
Mobile stand
16
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.
7. Turn the height adjustment knob clockwise until tight. This secures the pole at the desired height.
17
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).
18
Option 2. IV POLE
ATTACH THE MONITOR TO AN IV POLE
Bracket attachment knob
1. Place the mounting bracket on the
IV pole, and then tighten the bracket
attachment knob until the IV pole mount is
secure.
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).
19
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.
Cradle Adjustment Knob
2. Close the cradle latch and tighten in place by
turning the cradle adjustment knob clockwise.
3. If you would like to attach the video baton cradle to
the blade cradle, hook it into place.
Option 2. ATTACH THE VIDEO BATON CRADLE TO THE POLE
1. Screw the center pole clamp to the video baton
cradle.
2. Attach the center pole clamp and video baton
cradle to the pole, and then turn the adjustment
knob clockwise to tighten.
20
Video Baton
Cradle (Optional)
Procedure 5. CHARGE THE MONITOR BATTERY
IMPORTANT
The battery must be fully charged prior to first use in battery mode. This helps ensure optimal battery life.
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.
Power socket
Battery switch
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.
21
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.
5. If you are using a single-use system, when you are ready to perform an intubation, insert the video baton
into a Stat, as described in Insert the Video Baton into a Stat (Single-Use Only) on page 23.
6. When you want to disconnect video cable, video baton, or blade, do the following:
• Ensure the video monitor is turned off.
• Grip the gray connector.
• Pull the connector from the port.
22
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.
For instructions about how to detach the video baton and Stat, see Remove the Stat on page 41.
23
Procedure 8. CONNECT TO AN EXTERNAL MONITOR (OPTIONAL)
WARNING
The external monitor must be safety-approved medical equipment.
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.
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.
4. Prior to disconnecting the video output cable, ensure the video monitor is turned off.
24
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
4. Press the MENU
button. The monitor turns on.
button. The settings screen appears.
BRIGHTNESS
CONTRAST
COLOR
MIRROR
RESET
EXIT
NORMAL NTSC AV1
50
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
buttons to increase or decrease this value; a value of 16–20 is recommended.
or DOWN
• COLOR—Controls the color saturation of the image on the video monitor. Use the UP
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
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
default settings.
or DOWN
or DOWN
button to
button to restore all
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.
25
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
6. Press the ON/OFF
26
button. The video monitor turns off.
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.
WARNING
PGVL reusable video laryngoscopes are delivered nonsterile and require cleaning and high-level
disinfection prior to initial use.
WARNING
Always ensure that alternative airway management methods and equipment are readily
available.
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
2. Intubate Using the GlideScope 4‑Step Technique
Operations & Maintenance Manual: Using the System
27
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.
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.
9. If needed, allow the anti‑fog feature to warm up for 30–120 seconds.
Note: The time required for the anti‑fog feature to be fully optimized varies according to the ambient
temperature and humidity where the equipment is being stored or used. If the video laryngoscope is stored
in cold conditions, additional warming time may be required for optimal performance.
28
Procedure 2. INTUBATE USING THE GLIDESCOPE 4‑STEP TECHNIQUE
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
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.
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.
Operations & Maintenance Manual: Using the System
29
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
withdrawn approximately 5 cm (2 in).
• Avoid excessive lifting or pushing of the glottis. Maximum laryngeal exposure may not facilitate
intubation; reducing the elevation applied to the laryngoscope may make inserting the ETT easier.
30
CLEANING & DISINFECTING
GENERAL INFORMATION
WARNING
Because the product will likely be contaminated with human blood or body fluids capable of
transmitting pathogens, all cleaning facilities must be in compliance with (U.S.) OSHA Standard
29 CFR 1910.1030 “Bloodborne Pathogens” or an equivalent standard. For more information, visit
www.osha.gov.
WARNING
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.
Operations & Maintenance Manual: Cleaning & Disinfecting
31
WARNING
Do not place the GlideScope video baton or reusable video laryngoscope in the cradle if any of the
components are contaminated.
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
STERILE
USE
SPAULDING’S/CDC
CLASSIFICATION
Monitor*
Nonsterile
Reusable
Noncritical
Nonsterile
Reusable
Noncritical
Sterile
Single Use
Semi‑critical
Video baton
Nonsterile
Reusable
Noncritical
X
Video cable
Nonsterile
Reusable
Noncritical
X
PGVL reusable
blade
Nonsterile
Reusable
Semi‑critical
GlideRite®
Rigid Stylet
Nonsterile
Reusable
Semi‑critical
Cradle*
GVL Stat
®
†
‡
*
DISINFECTION LEVEL
DEVICE
Low
Int.
High
STERILIZATION
X
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
disinfection is required for the video baton when it is visibly soiled.
X Checked boxes show minimum disinfection level requirement.
Shaded areas indicate that the disinfection/sterilization level is not required or not compatible with the device materials.
Unshaded areas show permissible levels of disinfection or sterilization based on compatibility with the device materials.
32
IMPORTANT
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.
Procedure 1. CLEAN THE VIDEO MONITOR
IMPORTANT
Ensure that you do not use any abrasive substances, brushes, pads, or tools when cleaning the video
monitor screen. The screen can be scratched, permanently damaging the device.
Clean the video monitor when it is visibly soiled and on a regular basis, as per a schedule established by the
medical care facility or provider.
1. Turn off the 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.
33
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
Enzymatic debridement
agent/detergent
LEVEL
CONDITIONS
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.
34
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
agent/detergent
Cleaner
CONDITIONS
Water temperature: 19–29°C (66–84°F)
Metrex® EmPower™ †
Cleaner
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.
Conditioning: 20–40°C (68-104°F)
ASP® Cidex® OPA †
High
Exposure: Soak for 12 minutes, ensuring that all air bubbles are
removed from the surface of the blade
Rinse: (3) 1-minute immersions with agitation in pure water
Conditioning: 20 ± 2°C (68 ± 4°F)
Metrex MetriCide
Plus 30 †
®
®
High
Rinse: (3) 1-minute immersions with agitation in pure water
Conditioning: 20–60°C (68–140°F)
STERIS® Revital-Ox™
Resert® XL HLD †
Revital-Ox™ Resert®
HLD/Chemosterilant †
Water Temperature: 20–60°C (68–140°F)
High
Resert® XL HLD †
Rinse: (1) 1-minute immersion with agitation in pure water. Ensure
the connector is properly rinsed.
STERIS® S40™
or S20™ ‡
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.)
High/
Sterilization
35
CHEMICAL
DISINFECTION
LEVEL
STERIS® Vaprox® HC *
Sterilization
Non-lumen cycle in any STERIS® Amsco® V-PRO® low-temperature
sterilization system.
Sterilization
ASP Hydrogen
Peroxide Gas Plasma*
®
*
CONDITIONS
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.
IMPORTANT
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.
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.
4. Rinse the blade 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.
36
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.
37
Procedure 2. INSPECT THE REUSABLE BLADE
WARNING
Always ensure that alternative airway management methods and equipment are readily available.
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).
Surface Degradation
38
Cracking
Camera Window Cracking
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.
IMPORTANT
Bleach may be used on the video cable, but pay special attention to stainless steel components, as bleach
can corrode stainless steel.
Table 9.
Cleaning & Disinfection Methods for the GlideScope PGVL Video Cable
STRENGTH
DISINFECTION
LEVEL
agent/detergent
Hospital
grade
Cleaner
Bleach
500 ppm
Low
Solution can be corrosive for connector and
stainless steel ring
70%
Low
—
Hydrogen peroxide
≥ 7.5%
High
—
Glutaraldehyde
≥ 3.4%
High
—
Ortho-phthalaldehyde
0.55%
High
—
Peracetic acid
0.2%
High/
Sterilization
Classified as a chemical sterilant
Vaporized hydrogen peroxide
90%
Sterilization
—
CHEMICAL
Isopropyl alcohol solution
NOTES
Surface cleaning only in preparation for
disinfectant
CLEAN THE VIDEO CABLE
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.
39
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.
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.
40
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.
IMPORTANT
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.
41
Table 10. Cleaning & Disinfection Methods for the GlideScope PGVL Video Baton
CHEMICAL
Enzymatic debridement agent/detergent
DISINFECTION
LEVEL
CONDITIONS
Cleaner
Bleach (500 ppm)
Low
Isopropyl alcohol solution (70%)
Low
Metrex® MetriCide® Plus 30
High
ASP® Cidex® OPA
High
Sultan® Healthcare Sporox® II
High
High/
Sterilization
Standard cycles in the following processors:
STERIS® SYSTEM 1®
SYSTEM 1 EXPRESS
SYSTEM 1 PLUS
Sterilization
STERIS® S20™
ASP® Hydrogen Peroxide Gas Plasma
CLEAN THE GLIDESCOPE PGVL VIDEO BATON
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.
video baton manually to remove all foreign material from the surface of the device.
6. Rinse the video baton in clean, running water.
7. Visually inspect the component for contamination. If there is any sign of contamination, restart this
procedure.
42
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
WARNING
Always ensure that alternative airway management methods and equipment are readily available.
Report any suspected defects to Verathon® Customer Care at:
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.
43
MAINTENANCE & SAFETY
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 an operator familiar with the
instrument perform a full visual inspection of all components at least every three months. The inspector should
check the system for the following:
• External damage to the equipment
• Damage to the power supply or adapter
• Damage to the connectors or cable insulation
Report any suspected defects to Verathon® Customer Care at:
+1.425.867.1348 (International)
DEVICE REPAIR
WARNING
No modification of this equipment is allowed.
WARNING
Electric shock hazard. Do not attempt to open the system components. This may cause serious
injury to the operator or damage to the instrument and will void the warranty. Contact Verathon
Customer Care for all servicing needs.
VIDEO MONITOR BATTERY
Under normal operating conditions, the monitor battery will last 2–3 years; or approximately 400 charge and
discharge cycles. For more information about the battery, see the Battery Specifications section on page 49.
The battery is not user-replaceable. In case of battery malfunction, do not attempt to replace the monitor battery.
Any attempts to replace the battery by unauthorized service technicians may cause serious harm to the user
and will void the warranty. Please contact your Verathon Customer Care Representative for more information on
battery replacement.
44
PROTECTIVE CAP REPAIR
A protective cap is attached to the top of the reusable video laryngoscope, to the end of the video baton cable,
and to both ends of the video cable. The protective cap contains a rubber O-ring that ensures an effective seal
during cleaning and disinfection procedures. Over time, routine use may wear out the O-ring. Replace the O-ring
immediately if:
• Any nicks or tears are visible
• There is any liquid in the cable connector port after cleaning
To repair the protective cap:
1. Contact Verathon in order to order a replacement O-ring.
2. Remove the protective cap from the connector.
3. On the inside of the protective cap, remove the O-ring from the groove located at the base of the cap.
4. Stretch the replacement O-ring around the base of the cap and insert it into the groove. Ensure that it is
seated correctly in the groove and was not damaged during handling.
OTHER DEVICE REPAIR
With the exception of repairing the protective cap, GlideScope PGVL system components are not
user-serviceable. Verathon® does not make available any type of circuit diagrams, component parts lists,
descriptions, or other information that would be required for repairing the device and related accessories. All
service must be performed by a qualified technician.
If you have any questions, contact your local Verathon representative or Verathon Customer Care.
Operations & Maintenance Manual: Maintenance & Safety
45
TRANSPORTATION
GlideScope PGVL system components may be safely transported or stored under the environmental conditions
specified in Environmental Specifications on page 49. Prior to shipping or storing the video monitor, ensure
that the battery switch is in the OFF position.
Battery switch
DEVICE DISPOSAL
Disposal of this device in accordance with WEEE requirements can be coordinated through your Verathon
Service Center.
46
WARRANTY
Verathon® includes a one-year warranty when you buy a GlideScope PGVL system. You may also purchase a
Premium Customer CareSM warranty that extends your warranty from the date of purchase.
ORIGINAL FIRST YEAR TOTAL CUSTOMER CARE WARRANTY
Verathon warrants the GlideScope PGVL system against defects in material and workmanship. This warranty
applies for one (1) year from the date of shipment from Verathon. This warranty applies only to the original
purchaser of the GlideScope system.
If a customer’s system requires service or repair, Verathon will, at its discretion, either repair or replace the
customer’s unit and provide a loaner unit within one (1) business day from the date of customer service
notification. The customer agrees to send the defective unit to Verathon (cleaned and disinfected as appropriate)
upon receipt of the loaner unit, and the customer agrees to return the loaner unit within two (2) business days of
receipt of the repaired unit.
• This warranty provides coverage for damage from accidental drops or mishandling. It does not cover
damage due to deliberate mishandling.
• This warranty does not apply if the product has been damaged due to, or as the result of, service or
modification by anyone other than an authorized Verathon Service Center.
• This warranty does not apply if there is evidence of the equipment being exposed to temperatures in
excess of 60°C (140°F).
• All exchanged parts become property of Verathon.
The product shall be used in accordance with the instructions contained in this manual. Consumable items
(e.g., Stats) shall be used in conformance with Verathon product specifications. Consumable items are not
covered under this warranty.
WHAT IS COVERED?
Warranty coverage is extended to the GlideScope PGVL system:
• Video Monitor
• GlideScope PGVL video baton
• GlideScope PGVL reusable video laryngoscope
• GlideScope PGVL video cable
Additional reusable video laryngoscopes, video monitors, video cables, or video batons purchased either
singularly or as a part of a system are warranted separately.
Operations & Maintenance Manual: Warranty
47
PREMIUM CUSTOMER CARE WARRANTY
The Premium Customer CareSM warranty from Verathon® may be extended from the date of purchase.
DISCLAIMER OF ADDITIONAL WARRANTIES
There are no understandings, agreements, representations of warranties expressed or implied (including
warranties of merchantability or fitness for a particular purpose) other than those set forth in this chapter. The
contents of this manual do not constitute a warranty.
Some States disallow certain limitations on applied warranties. The purchaser, user, and patient should consult
State law if there is a question regarding this disclaimer. The information, descriptions, recommendations, and
safety notations in this manual are based upon Verathon experience and judgment with GlideScope systems
as of this manual's effective date. The contents of this manual should not be considered to be all-inclusive, or to
cover all contingencies.
48
PRODUCT SPECIFICATIONS
SYSTEM SPECIFICATIONS
GENERAL SPECIFICATIONS
Classification
Electrical Class I, Applied Part BF
Line voltage range:
100–240 VAC, 50 and 60 Hz
Line current:
Max 0.50 A
Line protection:
2A fuse, internal
Ingress protection
against water:
Expected product life:
Video monitor
IPX0
Reusable blade
IPX8
Video baton
IPX8
Reusable blade
2 years or 2000 use cycles
Single-use Stat
1 use
ENVIRONMENTAL SPECIFICATIONS
Operating Conditions
Temperature:
10 to 40°C (50 to 104°F)
Relative humidity:
0 to 95%
Atmospheric pressure:
540–1060 hPa
Shipping & Storage Conditions
Temperature:
-20 to 45°C (-4 to 113°F)
Relative humidity:
0 to 95%
540–1060 hPa
Charging Conditions
Temperature:
0 to 40°C (32 to 104°F)
Relative humidity:
0 to 95%
540–1060 hPa
BATTERY SPECIFICATIONS
Table 11. Battery Specifications
CONDITION
DESCRIPTION
Battery type
Lithium-ion
Battery life
Under normal operating conditions, a fully charged battery lasts approximately
90 minutes
Charging time
Charging time off line will take no more than 6.5 hours from an empty battery to a
full charge
Rated capacity
1150 mAh
Nominal voltage
11.1 V
Max charging voltage
12.9 V
Operations & Maintenance Manual: Product Specifications
49
COMPONENT SPECIFICATIONS
GENERAL COMPONENTS
SPECIFICATIONS
Video Monitor
LCD TFT Panel, 320 x 240
Monitor: 6.4 in
Height: 167.3 mm
Width: 210.0 mm
Depth: 87.6 mm
Weight : 1.4 kg
GlideRite® Rigid Stylet
Handle length: 82 mm
Handle width: 16 mm
Stylet rod length: 266 mm
Distal tip diameter: 5 mm
IV Pole Mount
Weight: 0.9 kg
Arm length: 27 cm
Width: 6.2 cm
Mobile Stand
Base height: 12.5 cm
Base weight: 2.5 kg
Base diameter: 61 cm
Pole height range: 75–119 cm
Pole weight: 0.7 kg
50
COMPONENT
SINGLE-USE SYSTEM
Table 12. Single-Use System Component Specifications
SPECIFICATIONS
COMPONENT
1800 ± 50 mm (video cable length)
PGVL Video Baton 1-2
Length of flexible portion of baton: 66 mm
Height at camera: 6 mm
Width at camera: 7 mm
Video cable length: 1800 ± 50 mm
66 mm (length of flexible baton)
6 mm (height of camera)
7 mm (width of camera)
1800 ± 50 mm (video cable length)
PGVL Video Baton 3-4
Length of flexible portion of baton: 106 mm
Video cable length: 1800 ± 50 mm
11 mm (height of camera)
106 mm (length of flexible baton)
11 mm (width of camera)
51
SPECIFICATIONS
GVL® 0 Stat
COMPONENT
Blade tip to handle: 36.2 mm
11.0 mm (width at camera)
Height at camera: 8.6 mm
11.0 mm (max blade width
in front of camera)
Width at camera: 11.0 mm
Blade length in front of camera: 6.5 mm
Max blade width in front of camera: 11.0 mm
36.2 mm (blade tip to handle)
6.5 mm (blade length
in front of camera)
8.6 mm (height at camera)
GVL 1 Stat
in front of camera)
15.0 mm (blade length in
front of camera)
52
SPECIFICATIONS
COMPONENT
GVL 2 Stat
®
in front of camera)
in front of camera)
GVL 2.5 Stat
in front of camera)
in front of camera)
53
SPECIFICATIONS
COMPONENT
GVL 3 Stat
®
Blade tip to handle: 77 mm
20 mm (max blade width
in front of camera)
16 mm (width at camera)
Blade length in front of camera: 37 mm
Max blade width in front of camera: 20 mm
77 mm (blade tip to handle)
37 mm (blade length in
front of camera)
14 mm (height at camera)
GVL 4 Stat
27 mm (max blade width
in front of camera)
Blade length in front of camera: 52 mm
Max blade width in front of camera: 27 mm
52 mm (blade length in
front of camera)
54
REUSABLE SYSTEM
Table 13. Reusable System Component Specifications
SPECIFICATIONS
COMPONENT
GVL® 3
Max blade width in front of camera: NA
GVL 4
55
SPECIFICATIONS
COMPONENT
GVL® 5
56
ELECTROMAGNETIC COMPATIBILITY
GlideScope PGVL system is designed to be in compliance with IEC 60601-1-2:2007, which contains
electromagnetic compatibility (EMC) requirements for medical electrical equipment. The limits for emissions and
immunity specified in this standard are designed to provide reasonable protection against harmful interference in
a typical medical installation.
The GlideScope PGVL 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
systemis not affected under the test conditions described in the following tables. For more information about the
essential performance of the GlideScope PGVL system, see Essential Performance on page 1.
ELECTROMAGNETIC EMISSIONS
Table 14. Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
The GlideScope PGVL system is intended for use in the electromagnetic environment specified below. The
customer or the user of the GlideScope PGVL system should assure that it is used in such an environment.
EMISSIONS TEST
COMPLIANCE
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
ELECTROMAGNETIC ENVIRONMENT – GUIDANCE
The GlideScope PGVL system uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
The GlideScope PGVL 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.
57
ELECTROMAGNETIC IMMUNITY
Table 15. Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
IMMUNITY TESTS
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient/
burst
IEC 61000-4-4
IEC 60601 TEST LEVEL
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
Surge
± 1 kV line(s) to line(s)
IEC 61000-4-5
± 2 kV line(s) to earth
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
field
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT
– GUIDANCE
In compliance
Floors should be wood, concrete,
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
In compliance
Mains power quality should be that
of a typical commercial or hospital
environment.
In compliance
environment.
In compliance
environment. If the user of the
GlideScope PGVL system requires
continued operation during
power mains interruptions, it is
recommended that the GlideScope
PGVL system be powered from an
uninterruptible power supply or a
battery.
In compliance
Power frequency magnetic
fields should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment.
<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
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3V
Portable and mobile RF
communications equipment
should be used no closer to any
part of the GlideScope PGVL
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
58
Table 15. Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
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.b
Interference may occur in the
vicinity of equipment marked with
the following symbol:
Note: Ut is the AC mains voltage prior to application of the test level.
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
GlideScope PGVL system is used exceeds the applicable RF compliance level above, the GlideScope PGVL system should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
GlideScope PGVL system.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
59
RECOMMENDED SEPARATION DISTANCES
Table 16. Recommended Separation Distances between Portable and Mobile RF Communications
Equipment and the GlideScope PGVL System
The GlideScope PGVL system is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the GlideScope PGVL system can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the GlideScope PGVL system as recommended below,
according to the maximum output power of the communications equipment.
SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER (m)
RATED MAXIMUM OUTPUT
POWER OF TRANSMITTER
(W)
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
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
ACCESSORY CONFORMANCE TO STANDARDS
To maintain electromagnetic interference (EMI) within certified limits, the system must be used with the cables,
components, and accessories specified or supplied by Verathon®. For additional information, see the System
Parts & Accessories and Component Specifications sections. The use of accessories or cables other than those
specified or supplied may result in increased emissions or decreased immunity of the system.
Table 17. EMC Standards for Accessories
ACCESSORY
AC power cord
DC medical power adapter
Video output cable (for connection to NTSC-compatible devices)
Video cable
60
LENGTH
4.5 m (15 ft)
—
0.8 m (2.7 ft)
1.8 m (6 ft)
SYMBOL DIRECTORY
SYMBOL
MEANING
Warnings & Cautions
Warning or Caution—Consult accompanying documents. Read instructions before
connecting or operating.
Non-ionizing, electromagnetic radiation
Product Use & Specifications
Refer to the operations & maintenance manual
Refer to the operations & maintenance manual
Manufacturer
Use-by date
Catalogue (part) number
Serial number
Batch code
Upper temperature limit
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
Statement of prescription
Sterilized through irradiation
Operations & Maintenance Manual: Symbol Directory
61
SYMBOL
MEANING
Non sterile
Reuse is not allowed
Shipping
Fragile item, handle carefully
Keep dry
Handle with care
This way up
Quantity per box
Do not use if package is damaged
Electrical & Power
Type BF applied part
Alternating current
Standards & Certifications
CE—Marked in accordance with the Medical Device Directive (MDD)
CSA—Canadian Standards Association mark of certification to applicable standards for
electromedical equipment
EC REP—Authorized Representative in the European Community
FCC—Tested to Federal Communications Commission requirements
WEEE—Subject to waste electrical and electronic equipment regulations
62
GLOSSARY
TERM
DEFINITION
A
Ampere
AC
Alternating current
C
Celsius
CFR
Code of Federal Regulations (U.S.)
CISPR
International Special Committee on Radio Interference
cm
Centimeter
DC
Direct current
ED
Emergency department
EMI
Electromagnetic interference
ESD
Electrostatic discharge
Essential performance
The system performance necessary to achieve freedom from unacceptable risk
ETT
Endotracheal tube
F
Fahrenheit
GHz
Gigahertz
hPa
Hectopascal
Hz
Hertz
ICU
Intensive care unit
IEC
International Electrotechnical Commission
in
Inch
kHz
Kilohertz
kV
Kilovolt
m
Meter
mAh
Milliampere-hour
MHz
Megahertz
mm
Millimeter
NA
Not available
NICU
Neonatal intensive care unit
NTSC
National Television Standard Committee
mm
Millimeter
OR
Operating room
OSHA
Occupational Safety and Health Administration (federal agency in U.S.)
PGVL
Portable GlideScope Video Laryngoscope
ppm
Parts per million
Pure water
Water that is suitable for high-level disinfection according to local regulations and
your medical facility
RF
Radio frequency
Operations & Maintenance Manual: Glossary
63
TERM
64
DEFINITION
V
Volt
Vrms
Voltage root mean squared
W
Watt
WEEE
Waste electrical and electronic equipment
verathon.com

glidescope portable

Transcription

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