GlideScope TITANIUM SYSTEM Operations and Maintenance Manual

GLIDESCOPE SYSTEM

TITANIUM Operations & Maintenance Manual Effective: September 26, 2014

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

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

CONTACT INFORMATION To obtain additional information regarding your GlideScope Titanium 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. Linnaeusweg 11 3401 MS IJsselstein The Netherlands +31.30.68.70.570 Fax: +31.30.68.70.512 verathon.eu

Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby, BC V5C 5A9 Canada 604.439.3009 Fax: 604.439.3039

Copyright© 2014 by Verathon Inc. All rights reserved. No part of this manual may be copied or transmitted by any method without the express written consent of Verathon Inc. GlideRite, GlideScope, the GlideScope symbol, Reveal, Verathon, and the Verathon Torch symbol are trademarks of Verathon Inc. All other brand and product names are trademarks or registered trademarks of their respective owners. The GlideScope technology is covered under US Patents (6,655,377) (6,543,447) (6,142,144) as well as European Patent 1307131. Additional patents pending. Information in this manual may change at any time without notice. For the most up-to-date information, see the online manuals on verathon.com.

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TABLE OF CONTENTS IMPORTANT INFORMATION...1 Product Information...1 Product Description...1 Statement of Intended Use...1 Essential Performance...1 Statement of Prescription...1 Notice to All Users...1 Precautions & Warnings...2 INTRODUCTION...7 Single-Use & Reusable Systems...7 Language Settings...7 System Parts & Accessories...8 Video Laryngoscope Components...10 Video Monitor Buttons, Icons, & Connections... 11 SETTING UP...14 Procedure 1.

Perform Initial Inspection...14

Procedure 2.

Mount the System (Optional)...15

Procedure 3.

Charge the Monitor Battery...18

Procedure 4. Attach the Video Cable & Blade...19 Procedure 5.

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

Procedure 6. Configure User Settings...22 Procedure 7.

Perform a Functional Check...23

USING THE DEVICE...25 Procedure 1.

Prepare the GlideScope System...26

Procedure 2.

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

Procedure 3.

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

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

i Operations & Maintenance Manual: Table of Contents

CLEANING & DISINFECTING...32 Procedure 1.

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

Procedure 2.

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

Procedure 3.

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

Procedure 4. Clean the GlideScope Video Monitor...43 Procedure 5.

Clean & Sterilize the GlideRite Rigid Stylet...43

MAINTENANCE & SAFETY... 44 Periodic Inspections... 44 GlideScope Video Monitor Battery... 44 System Software... 44 Device Repair...45 Device Disposal...45 WARRANTY... 46 PRODUCT SPECIFICATIONS... 48 System Specifications, Standards, & Approvals... 48 Component Specifications...49 Battery Specifications... 54 Electromagnetic Compatibility...55 SYMBOL DIRECTORY...59 GLOSSARY...62

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

PRODUCT DESCRIPTION The new GlideScope Titanium reusable and single-use video laryngoscopes are the most advanced GlideScope instruments ever, designed to deliver clear airway views and enable rapid intubation. New low-profile designs and innovative construction make these blades streamlined and lightweight, offering improved maneuverability and working space for routine and difficult airways. With more VL options, including new Mac-style blades, clinicians can choose their preferred airway tool for a wide range of patients and clinical settings. And whether it’s reusable or single use, the new GlideScope Titanium system features a high-resolution, full-color digital camera and monitor for real-time viewing and recording. GlideScope Titanium video laryngoscopes are designed to work with the GlideScope Video Monitor version 0570-0338.

STATEMENT OF INTENDED USE The GlideScope Titanium system is intended for use by qualified professionals to obtain a clear, unobstructed view of the airway and vocal cords for medical procedures.

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

STATEMENT OF PRESCRIPTION Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. GlideScope Titanium video laryngoscopes should be used only by individuals who have been trained and authorized by a physician or used by healthcare providers who have been trained and authorized by the institution providing patient care.

NOTICE TO ALL USERS Verathon® recommends that all users read this manual before using the GlideScope Titanium system. Failure to do so may result in injury to the patient, may compromise the performance of the system, and may void the system warranty. Verathon recommends that new users: • Obtain instruction from a qualified individual • Practice using the video laryngoscope on a mannequin before clinical use • Acquire clinical training experience on patients without airway abnormalities

1 Operations & Maintenance Manual: Important Information

PRECAUTIONS & WARNINGS Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of the device. Cautions indicate that use or misuse of the device may cause a problem, such as a malfunction, failure, or damage to the product. Throughout the manual, pay attention to sections labeled Important, as these contain reminders or summaries of the following cautions as they apply to a specific component or use situation. To ensure safe and reliable operation for the user and patient, please heed the following warnings and cautions.

PRECAUTIONS CAUTION Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and must be installed and operated according to the instructions in this manual. See the Electromagnetic Compatibility section for additional information. To maintain electromagnetic interference (EMI) within certified limits, the GlideScope Titanium system must be used with the cables, components, and accessories specified or supplied by Verathon®. 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. The GlideScope Titanium system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the GlideScope Titanium system should be observed to verify normal operation in the configuration in which it will be used. This device can radiate radio frequency energy and is very unlikely to cause harmful interference with other devices in the vicinity. There is no guarantee that interference will not occur in a particular installation. Evidence of interference may include degradation of performance in this device or other devices when operated simultaneously. If this occurs, try to correct the interference by using the following measures: • Turn devices on and off in the vicinity to determine the source of interference • Reorient or relocate this device or other devices • Increase the separation between devices • Connect the device to an outlet on a circuit different than the other device(s) • Eliminate or reduce EMI with technical solutions (such as shielding) • Purchase medical devices that comply with IEC 60601-1-2 EMC standards Be aware that portable and mobile radio frequency communications equipment (cellular phones, etc.) may affect medical electrical equipment; take appropriate precautions during operation.

CAUTION The video cables and video laryngoscopes contain electronics that could be damaged by ultrasonic and automated washing equipment. Do not use an ultrasonic device or automated washing equipment to clean this product.

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

CAUTION Caution. Risk of permanent equipment damage. This product is sensitive to heat, which will cause damage to the electronics. Do not expose the video cables or reusable Titanium video laryngoscopes to temperatures above 60°C (140°F). Do not use autoclaves or pasteurizers for video cables or reusable Titanium video laryngoscopes. Use of such methods to clean, disinfect, or sterilize the components will cause permanent device damage and void the warranty. Refer to the Cleaning & Disinfecting chapter for a list of approved cleaning procedures and products.

WARNINGS WARNING Before every use, ensure the instrument is operating correctly and has no sign of damage. Do not use this product if the device appears damaged. Refer servicing to qualified personnel. To ensure patient safety, routinely inspect the reusable video laryngoscope before and after every use in order to ensure the blade is free of rough surfaces, sharp edges, cracks, protrusions, or any other indication of wear. If found, do not use the damaged or worn blade. Always ensure that alternative airway management methods and equipment are readily available. Report any suspected blade defects to Verathon® Customer Care at: Phone: 800.331.2313 (U.S. and Canada) +1.425.867.1348 (International) Email: [email protected]

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

3 Operations & Maintenance Manual: Important 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 Cleaning is critical to ensuring the component is ready for disinfection. Failure to properly clean the device could result in a contaminated instrument after completing the disinfection procedure. When cleaning, ensure all foreign matter is removed from the surface of the device. This allows the active ingredients of the chosen disinfection method to reach all the surfaces.

WARNING This product may only be cleaned, disinfected, or sterilized by using the approved processes provided in this manual. Cleaning, disinfection, and sterilization methods listed are recommended by Verathon® based on efficacy or compatibility with component materials.

WARNING Availability of cleaning, disinfection, and sterilization products varies by country, and Verathon is unable to test products in every market. For more information, please contact Verathon Customer Care at 1.800.331.2313 or your local representative. For additional contact information, visit verathon.com/contact-us.

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

WARNING Do not reuse, reprocess or resterilize single-use components. Reuse, reprocessing or resterilization may create a risk of contamination of the device, cause patient infection or cross-infection.

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WARNING This instrument and related devices may contain mineral oils, batteries, and other environmentally hazardous materials. When the instrument or accessories have reached the end of their useful service life, see the section Device Disposal on page 45. Dispose of used, single-use components as infectious waste.

WARNING Several areas of the video laryngoscope that contact the patient can exceed 41°C (106°F) as part of normal operation: • The first area is the light-emitting area surrounding the camera. When used as indicated, continuous contact with this area is unlikely because, if tissue were to contact this area, the view would be lost and devices would need to be adjusted to regain the airway view. • The second area is the area surrounding the camera, out of view of the camera. Continuous contact with this area is unlikely because the product is typically not held stationary for an extended period of time exceeding 1 minute. If continuous contact is maintained for longer than 1 minute, it is possible to cause thermal damage such as a burn to the mucosal tissue. Note: Typical intubations are less than 1 minute in duration.

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

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

WARNING The external monitor must be safety-approved medical equipment.

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

5 Operations & Maintenance Manual: Important Information

WARNING In order to maintain electrical safety, use only the provided, medical-approved power supply.

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

WARNING No modification of this equipment is allowed.

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

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INTRODUCTION SINGLE-USE & REUSABLE SYSTEMS The GlideScope Titanium system is available in single-use and reusable configurations. Both configurations feature the same video monitor, the cables and adapters to power the device, and any optional system components that may facilitate intubations or provide convenience to the user. The primary differences between the reusable and single-use systems are the video laryngoscopes and the cables that connect the laryngoscope to the video monitor. Figure 1.

Titanium Single-Use System

Figure 2.

Titanium Reusable System

The single-use system features durable, plastic blades that must be disposed of after one use. It also features the GlideScope Smart Cable-a reusable video cable that connects the single-use blade to the video monitor and contains the electronics that process the video data captured by the blade. Single-use video laryngoscopes are identified by an S in the blade name, such as LoPro S4. The reusable system features a titanium video laryngoscope that must be cleaned and high-level disinfected between uses. The blade is connected to the video monitor via a reusable video cable. Unlike the single-use system, the reusable system video electronics are located within the laryngoscope. Due to their titanium construction, reusable video laryngoscopes contain a T in the blade name, such as LoPro T4. You may use either the single-use or reusable system configurations, or your facility may elect to provide both configurations. This manual details both single-use and reusable system information and notes where the systems differ. In this document, unless otherwise noted, the term video cable describes both the GlideScope Smart Cable for the single-use system and the video cable for the reusable system.

LANGUAGE SETTINGS The GlideScope Titanium video monitor software is available in a variety of languages. To change the language used on your system, you must install a new software version via a USB flash drive. For more information, contact Verathon® Customer Care or your local representative. For contact information, see verathon.com/contact-us.

7 Operations & Maintenance Manual: Introduction

SYSTEM PARTS & ACCESSORIES Table 1.

Required System Components REQUIRED PARTS & ACCESSORIES

GlideScope Video Monitor

Video cable (for reusable system)

GlideScope Smart Cable (for single-use system)

Note: Cable shortened for illustration purposes.

Note: Cable shortened for illustration purposes.

One or more of the following reusable or single-use video laryngoscopes: LoPro T3

LoPro T4

MAC T3

MAC T4

LoPro S3

LoPro S4

MAC S3

MAC S4

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

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Power cable

Table 2.

Optional System Components OPTIONAL PARTS & ACCESSORIES

Mobile stand

HDMI-to-DVI cable

IV pole mounting kit

Universal accessory basket

GlideRite® Rigid Stylet

Note: Representative stand

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

TRAINING & INFORMATION PACK The GlideScope Titanium Training and Information Pack contains recommended accessories for the system and reference materials that provide instructions for use. The following items are included in the pack: • (2) GlideRite Rigid Stylet-A stylet that facilitates quick placement of an endotracheal tube and is recommended for use with GlideScope systems. • (1) Quick Reference Card Ring Assembly-Quick reference information that may be attached to the system, for your convenience and ease of use. • (1) In-Service USB Flash Drive-A white, 2 GB USB flash drive that contains reference documentation in multiple languages. See Figure 3. • (1) Media Storage USB Flash Drive-A blue, 2 GB USB flash drive that can be connected to the video monitor and used for recording video or taking snapshots. See Figure 4. Figure 3.

In-Service USB Flash Drive

Figure 4.

Media Storage USB Flash Drive

9 Operations & Maintenance Manual: Introduction

VIDEO LARYNGOSCOPE COMPONENTS The main components of the GlideScope Titanium system are the LoPro or MAC video laryngoscopes in either single-use (S) or reusable (T) configurations. The LoPro S3 and S4 single-use blades feature the signature GlideScope curve in an easy-to-use, disposable format. The LoPro T3 and T4 reusable blades combine the performance of a GlideScope blade with the strength of titanium, and the MAC blades incorporate the look and feel of traditional Macintosh blades. Figure 5.

Video Laryngoscope Components

2

1

2

1 4

4

3

3

5

5

1

2

2 6

4 3

Table 3.

4 3

Video Laryngoscope Components

FIGURE KEY

10

1

COMPONENT

NOTES

1

Connector

-

2

Handle

-

3

Blade

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

4

Distal tip/lifter

-

5

Camera and light

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

6

Product number and serial number

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

VIDEO MONITOR BUTTONS, ICONS, & CONNECTIONS The digital, full-color GlideScope Video Monitor clearly displays the images transmitted from the camera in the video laryngoscope. The front of the monitor includes the screen and a keypad with the buttons you use to operate the system. The back panel of the monitor includes the sockets and ports for connecting the power cord, the video cable, an HDMI-to-DVI cable for external video display, and a USB flash drive. When a socket or port is not in use, it is recommended that the rubber cap is inserted into the opening. This protects the exposed connectors from dust and other contamination. The back of the video monitor also features a mounting plate fitting that allows you to attach the monitor to a mobile stand or IV pole. Figure 6.

GlideScope Video Monitor Keypad Record button

Power button

Table 4.

External video button

Snapshot button

Battery indicator

Tutorial button

Keypad Buttons

BUTTON

FUNCTION

Power: Press and release to turn on the monitor. Press and hold for three seconds to turn it off. Note: If the monitor freezes at any time during use, press and hold the Power button for 10 seconds to reset the system. Record: Press to start and stop recording directly to a USB flash drive that has been inserted in the USB port. When you are recording, the red LED indicator to the right of the button will be lit, and the Recording icon will be shown on the screen. Note: To record video, a USB flash drive must be inserted into the monitor USB port. Snapshot: Press this button to save a snapshot of the live display to the USB flash drive. You may take a snapshot while video recording or independent of recording. Note: To take a snapshot, a USB flash drive must be inserted into the monitor USB port. External Video: Press to display video on an external monitor. The yellow LED to the right of the button will light up to indicate that the key has been activated. Press the key again to deactivate the external video. Note: An HDMI-to-DVI cable is required in order to display video on an external monitor. Tutorial: If a USB flash drive is not inserted into the monitor, press and hold for three seconds to access the video tutorial. If a USB flash drive is inserted into the monitor, press and hold for three seconds to access the Playback menu. Battery Indicator: LED is: Green: Unit fully charged Red: Unit charging Flashing Red: Indicates a problem with the battery. Charge for 6 hours, and if still flashing, contact Verathon® Customer Care.

11 Operations & Maintenance Manual: Introduction

Table 5.

On-Screen Icons ICON

FUNCTION

Battery Status: The approximate battery capacity is indicated. If the icon is red, the battery should be charged as soon as possible. (See also Charge the Monitor Battery.) While the battery is being charged, a lightning bolt will be displayed alongside the Battery Status icon. Progress Confirmation: While the user is pressing a button, the operation is loading. If the button is released before the loading process is completed, the operation is canceled. Power-Down Countdown: The unit is about to turn off. If this is due to the Auto Power Off feature that saves battery life, pressing any button stops the power-down sequence. Note: The Auto Power Off feature can be adjusted or disabled on the User Settings screen. For more info, see Configure User Settings on page 22. USB Flash Drive: A USB flash drive is detected. While recording, a number next to the icon indicates approximately what percentage of the USB flash drive has been used. When the USB flash drive is full, recording stops. Incompatible USB Drive: The USB flash drive that is plugged into the monitor is not suitable for recording videos. (This normally occurs when using an encrypted USB flash drive or when using an older, inexpensive model that is not capable of the speed necessary to save video in real time.) USB Flash Drive Not Found: A USB flash drive needs to be inserted into the monitor USB port.

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

Recording: The system is recording video to the USB flash drive. Note: Do not remove the USB flash drive while recording is in progress, or the recording will be lost. Saving Snapshot: The system is saving a snapshot to the USB flash drive. Note: Do not remove the USB flash drive while saving a snapshot, or the snapshot will be lost. Saving File: The system is saving a recorded file to the USB flash drive. Note: Do not remove the USB flash drive while this icon is displayed, or the recording will be lost. External Monitor: The HDMI-to-DVI connection for external video is enabled, and video is being displayed on an external monitor.

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ICON

FUNCTION

Hourglass: Please wait while the system prepares for the next action. Audio Recording is Active: Audio is being recorded on the video. Note: The default for audio recording is OFF, so audio recording on the video occurs only if the setting has been changed to ON in user settings. Back Arrow: Exit to previous screen. Up Arrow: Select previous file for playback. Down Arrow: Select next file for playback. Play: Play the selected file or continue playing a paused video file. Pause: Pause the video playback. Snapshot: On the Playback menu, this icon indicates that a file is a snapshot.

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

Figure 7.

GlideScope Video Monitor Back Panel

Video-out port: Connect the HDMI-to-DVI cable from the external monitor Video cable port: Attach the video cable or GlideScope Smart Cable USB port: Connect a USB flash drive to record video or take a snapshot

Power socket: Connect the barrel plug from the 12V power adapter

Product identification: Includes product serial number

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

13 Operations & Maintenance Manual: Introduction

SETTING UP Before you can use the GlideScope Titanium system for the first time, you must inspect the components, set up the system, and perform a functional test as recommended by Verathon®. Complete the following procedures: 1. Perform Initial Inspection-Inspect the system for any obvious physical damage that may have occurred during shipment. 2. Mount the System (Optional)-Set up the GlideScope Video Monitor on a mobile stand or IV pole. 3. Charge the Monitor Battery-Note that you can use the system while the battery is charging. Note: The monitor will operate without charging the battery by using the GlideScope Video Monitor 12V DC power adapter that shipped with the unit. 4. Attach the Video Cable & Blade-Connect the video cable or GlideScope Smart Cable to the monitor, and then connect the video laryngoscope to the video cable or Smart Cable. 5. Connect to an External Monitor (Optional)-Connect the monitor to an external display source, such as a larger monitor screen, by using the HDMI-to-DVI cable. 6. Configure User Settings-Enter data customized to your clinic, and configure settings such as the date and time. 7. Perform a Functional Check-Before you use the device for the first time, perform a functional check to ensure that the system is working properly.

Procedure 1.

PERFORM INITIAL INSPECTION

When you receive the GlideScope Titanium system, Verathon recommends that an operator familiar with the instrument perform a full visual inspection of the system for any obvious physical damage that may have occurred during shipment. Note: Due to the hand-polishing method used to create the titanium exterior of the reusable blades, slight variations or irregularities may occur in the finish. These variations do not affect the cleaning process or system efficacy. 1. Verify that you have received the appropriate components for your system by referring to the packing list included with the system. 2. Inspect the components for damage. 3. If any of the components are missing or damaged, notify the carrier and Verathon Customer Care or your local representative: 800.331.2313 (Canada and US) +1.425.867.1348 (International) +31.30.68.70.570 (Europe) For additional contact information, see Contact Information.

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Procedure 2.

MOUNT THE SYSTEM (OPTIONAL)

If you choose to mount the system, you may use either of the following configurations: • Mount it on a mobile stand (Figure 8). The mobile stand makes it easy for you to move the system from one location to another. • Mount it on an IV pole (Figure 9). Figure 8. Video Monitor on Mobile Stand

Figure 9. Video Monitor on IV Pole

Video monitor Video monitor IV pole mount IV pole

Mobile stand

Representative stand

ATTACH THE MONITOR TO THE MOBILE STAND OR IV POLE 1. If you are using an IV pole mount, place the mounting bracket on the IV pole, and then tighten the bracket attachment knob until the IV pole mount is secure.

Bracket attachment knob

2. On the mobile stand mount or the IV pole mount, ensure that the locking pin and quick-release lever are in the unlocked (horizontal) position.

Quick-release lever in unlocked position

Locking pin in unlocked position

15 Operations & Maintenance Manual: Setting Up