Touch Glass Image Management System Instruction Manual Rev H

Proprietary Information This manual contains information deemed proprietary to CONMED Corporation. The information contained herein, including all the designs and related materials, is the sole property of CONMED and/or its licensors. CONMED and/or its licensors reserve all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction. This document, and any related materials, is confidential and is protected by copyright laws and shall not be duplicated, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form or by any means, electronic, mechanical, magnetic, manual or otherwise, or disclosed to third parties, in whole or in part, without the prior express written consent of CONMED. CONMED reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law. Linvatec, Hall, Smart OR and Smart are trademarks or registered trademarks of CONMED Corporation.

Contents 1.0

INTRODUCTION

1.1 1.2 1.3 1.4 1.5 1.6

Operating Principle  Device Description Warnings and Precautions  1.3.1 Warnings  1.3.2 Precautions  Environmental Directives  Product Photographs and Drawings  Symbol Definitions 1.6.1 Product Warnings and Information Symbols 

1 1 1 2 2 3 3

2.0

SYSTEM INSTALLATION AND OPERATION

2.1 2.2

Set-Up and Installation  Operation  2.2.1 Graphical User Interface 

4 7 7

3.0

MAINTENANCE  3.1 Cleaning Information  3.1.1 Warnings, Precautions and Notes  3.1.2 Console Cleaning Instructions  3.1.3 Recommended Cleaning Instructions  3.2 Sterilization Information  3.2.1 Warnings, Precautions and Notes  3.2.2 Sterilization Instructions  3.3 Troubleshooting  3.4 Life Expectancy  3.5 Leakage Test 

32 32 32 33 33 33 33 33 33 34 34

4.0

TECHNICAL SPECIFICATIONS  4.1 Product Technical Specifications  4.1.1 Technical Specifications  4.1.2 Power Cord Requirements  4.2 Product Environmental Requirements  4.2.1 Environmental Technical Specifications  4.2.2 Electromagnetic Requirements  4.3 Accessories/Compatible Equipment 

35 35 35 35 35 35 36 39

5.0

CUSTOMER SERVICE  5.1 Assistance and Repair  5.2 Warranty 

40 40 40

I

1.0

INTRODUCTION

It is recommended that personnel review this manual before attempting to operate or clean this or associated equipment. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product, and included in this manual. This equipment is designed for use by medical professionals completely familiar with the required techniques and Instructions for Use of the equipment. Service intervals, as listed in section “3.0 Maintenance”, are required to keep the equipment at its optimum operating performance.

1.1

Operating Principle

The Touch Glass Image Management System is a 15.6” diagonal display designed for medical recording and documentation that can capture high definition video and images from multiple sources and store the captured media with patient information. It can duplicate captured videos and images to portable media, network storage, iOS and android devices, and PACS (Picture Archiving and Communication systems) for documentation, storage, and presentation. Its ruggedized design, compact size and touch-screen interface makes it suitable for system control applications. The software is built upon H.264 technology; utilizing the best compression and the highest quality video capture available and is released with Windows Embedded OS.

1.2

Device Description

The Touch Glass Image Management System is designed to be used by medical professionals in surgical theaters to record and playback video and still images of medical procedures for documentation purposes.

1.3

Warnings and Precautions

Do not bypass this section. It contains warnings and precautions that must be thoroughly understood before operating any of the equipment. Lack of understanding or adherence to these warnings and precautions may result in injury or even death to the patient. The words WARNING, PRECAUTION, and NOTE carry special meanings and they must be read carefully. WARNING: A warning contains critical information regarding serious adverse reactions and potential safety hazards that can occur in proper use or misuse of the equipment. Failure to observe the information or procedures presented in a Warning may result in injury, death or other serious adverse reactions to the patient and/or surgical staff. PRECAUTION: A precaution contains instructions for any special care to be exercised by the practitioner for the safe and effective use of the equipment. Failure to observe the information or procedures presented in a Precaution may result in damage to the equipment. NOTE: A note is added to provide additional focused information. This information has no critical effect on the patient or equipment.

1.3.1

Warnings

1. Equipment grounding is vital for safe operation. Plug power cord into a properly earthed mains supply outlet whose voltage and frequency characteristics are compatible with those listed on the unit or in this manual. 2. Do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering. 3. To avoid the risk of electric shock, this equipment must be connected to a supply main with protective earth. Do not use plug adapters or extension cords; such devices may defeat the safety ground and could result in injury. 4. Do not excessively bend or kink the power cord or accessory cord. Always inspect cords for signs of excessive wear or damage. If wear or damage is found, discontinue use and replace immediately. Using a damaged power cord could possibly cause injury. 5. To completely remove power from the device, unplug the device from the wall or power source. 6. Do not connect known damaged equipment or equipment that is corroded or wet. Failure to comply may cause injury or result in damage to equipment. 1

7. Do not simultaneously contact the console and patient. This may contaminate the sterile field and create an unsafe electrical condition. 8. This equipment should not share an electrical outlet or grounding with life supporting or life sustaining equipment. 9. This system may cause radio interference or may disrupt the operation of nearby equipment. Avoid stacking equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the console or shielding the location. 10. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Touch Glass System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 11. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 12. No modification of this equipment is allowed. 13. Restoring a backup will erase any settings and surgical cases that are presently stored on the machine that is receiving the restore. Backup surgical cases prior to restoring a backup to prevent loss. 14. Back up videos and images to external storage periodically; This system is not a long-term storage device. 15. Initiating factory reset will erase any settings and surgical cases that are presently stored on the machine that is receiving the restore. Backup surgical cases prior to initiating factory reset to prevent loss. 16. Do not use equipment in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking. 17. Clean all equipment and associated accessories according to Instructions for Use. Refer to section “3.1 Cleaning Information”. The console is not intended to be sterilized. 18. Place the Visualization Cart casters in locked positions prior to the installation of video equipment. 19. Refrain from suspending the CMS/SIC over the sterile field.

1.3.2

Precautions

CAUTION: United States Federal law restricts sale of this equipment to or on the order of a physician. 1. Handle all equipment carefully. If any equipment is dropped or damaged in any way, return it immediately for service. 2. Use only CONMED approved equipment, attachments and accessories. They have been tested and certified to specific medical standards. Using unapproved accessories may result in improper operation, may negatively affect EMC performance, and may result in non-compliance to medical standards. 3. Do not attempt to open or service the Touch Glass as this may void your warranty. There are no userserviceable parts inside. Removing the cover may introduce an electric shock hazard by exposing you to dangerous high voltages or other risks. No modification of this equipment is allowed. 4. Do not place the equipment on an unstable surface. Additionally, the equipment must remain in an upright position. 5. Only connect IEC 60601 series compliant devices to signal input or output ports. 6. Ensure power cord placement does not interfere with installing the device. Additionally, do not position the device so it is difficult to remove the power cord from the device.

1.4

Environmental Directives

WEEE Directive [2002/96/EC] on Waste Electrical and Electronic Equipment. This statement only applies to European countries with regard to the Waste Electrical and Electric Equipment (WEEE) European Directive. The WEEE symbol on the product or its packaging indicates that this product must not be disposedof with other waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment. The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your medical equipment at the end of its useful life for recycling, please contact CONMED. RoHS Directive 2011/65/EC on the restriction of certain hazardous substances in electrical and electronic equipment. According to what declared by our component’s suppliers, this product is RoHS compliant. WARNING: The Touch Glass System console contains a lithium coin battery. The battery must be disposed of properly. 2

NOTE: Lithium batteries contain perchlorate material and special handling may apply. Please recycle according to local laws and practices.

1.5

Product Photographs and Drawings

The pictures in this manual are for reference only. Items shown may not represent the actual product. However, procedural steps are identical, unless otherwise specified. When necessary, the actual pictures will be represented.

1.6

Symbol Definitions

1.6.1

Product Warnings and Information Symbols Power (ON/OFF)

UDI

Network

UDI Symbol

IP20

Ingress Protection from solid foreign objects (12 mm)

Indicates the device is approved according to the KC regulations

Indicates compliance with Part 15 of the FCC rules (Class A or Class B)

Trademark of Intertek Testing Services NA, Inc., a nationally Recognized Testing Laboratory, listing compliance as Medical Electrical Equipment to standard UL 60601 and CAN/CSA C 22.2 No. 601.1

CE Mark of Conformity

Manufacturer

Date of Manufacture

Authorized Representative in the European Community

SN

Serial Number

Catalog Number

Consult the operating instructions

Prescription Only: Federal Law restricts this device to sale by or on the order of a physician

Waste Electrical and Electronic Equipment (WEEE) Symbol. Regarding European Union end-of-life of product, indicating separate collection for electrical and electronic equipment

Refer to Instruction Manual/Booklet (for critical safety instruction).

Input

Output

Display In

Display Out

Input / Output

DC Voltage

Indicates the USB connectors on the device

3

Non Sterile

Equipotentiality

Quantity

90%

Humidity Limitation

QTY 10%

+60° C

Temperature Limitation

-20° C

110 kPa

Atmospheric Pressure Limitation

70 kPa

This Side Up

Fragile

Do not stack n number high ISO 7000 2403

Keep Dry

n RECORD

Record

CAPTURE

Capture

Warning: Electrical Hazard/High Voltage

Do Not Immerse

Do Not Use if Package is Damaged

Non-Ionizing Electromagnetic Radiation (RF Symbol)

Caution

No User Service Recommended. Refer servicing to qualified CONMED service personnel

2.0

SYSTEM INSTALLATION AND OPERATION

2.1

Set-Up and Installation

a. Connecting System to Power The system comes with one (1) hospital grade power cord which is indicated by a green dot on the male end of the cord for connecting the system to the electrical outlet. In order to achieve proper grounding of the system, use the provided hospital grade power cord or equivalent. b. Startup Procedure The Touch Glass System is configured to power on and boot when main power is applied. No user interaction is required during a typical boot up process. Once in the operating system, the recording software will automatically load. If the software fails to load, see Troubleshooting Section 3.3. c. Shutdown Procedure The Touch Glass System should always be powered off properly by pressing and quick releasing the power button, then waiting for the power LED to turn off. Provisions are taken in an attempt to prevent software corruption and data loss; however, data integrity cannot be guaranteed with improper shutdown. d. Connection to Looking Glass To connect the Touch Glass System to a Looking Glass System there are five necessary connections. In the image of the bottom panel below, ports 2 and 11 must be wired to the Looking Glass to share video signals between the two devices. Ports 13 and 15 must be connected to allow for recording and capturing of desired media. Finally, the GPIO cable, coming from port 12, must be connected to the Cable Connector Interface.

4

NOTE: Installation of a ferrite core is required to assure proper device operation. The ferrite core must be installed onto the HDMI cable connecting the Touch Glass HD Video Out (port 2) to the Looking Glass REC input. To install, position the ferrite core onto the HDMI cable end closest to the Touch Glass port 2 connection, then clamp (close) the ferrite in place.

e. Connections The Touch Glass System’s bottom panel can be seen below. Touch Glass Bottom Panel

Connection Descriptions : 1. DC Input 2. HD Video Out 3. Equipotential Ground 4. Network/Ethernet 5. Network/Ethernet 6. USB 3.0 (x2) 7. COM 8. USB 3.0 (x2) 9. Audio Output / Audio Input 10. Remote 11. HD Video In 1 12. GPIO Out 13. Record 14. HD Video In 2 15. Capture 16. USB 2.0 (x2)

5

2.1.1

Installation Instructions

The AV41SIC (Touch Glass) is intended to mount on the AV8571 (Secondary Arm) with the VESA mounting holes on the back of the display. The included M4 x 22mm screws, spring lock washers, and flat washers (quantity four of each) are needed for this installation. Install 2 screws onto Touch Glass without washers and do not fully tighten. Leave space between screw head and Touch Glass. Lift up the Touch Glass and align screw heads with holes on the secondary arm and slide into place. While holding the Touch Glass unit, install 2 screws with spring lock washer and flat washer. Remove the 2 screws without washers and re-install with spring lock washer and flat washer. Tighten the 4 screws.

2.1.2

Installing the AV41CMS Wi-Fi Hardware (Optional)

The AV41CMS Content Management System is a device that provides the ability to wirelessly connect and exchange information with a local wireless network. The Wi-Fi hardware provides the ability to connect the Touch Glass to a wireless network from any location within the hospital. The Wi-Fi hardware is intended to mount between the AV41SIC (Touch Glass) and AV8571 (Secondary Arm). The assembly can be used on the AV8500, AV8501, VP8500, and VP8501 Visualization Carts that are used outside the sterile field.

Installation Instructions: 1. Carefully remove the Touch Glass from the Secondary Arm, if already mounted, by removing the 4 screws (with washers) from the back of the Touch Glass. 2. Place the Wi-Fi bracket assembly on the back of the Touch Glass, aligning the screw holes. Install 2 screws without washers and do not fully tighten. Leave space between screw head and Wi-Fi bracket. 3. Lift up the Touch Glass and WiFi assembly and align screw heads with holes on the secondary arm and slide into place. While holding the Touch Glass unit, install 2 screws with spring lock washer and flat washer. Remove the 2 screws without washers and re-install with spring lock washer and flat washer. Tighten the 4 screws. 4. Connect the USB cable to either USB ports at location 6 or 8 on the Touch Glass as shown above. USB 2.0 ports at location 16 are not recommended for this application. 6

2.2

Operation

2.2.1

Graphical User Interface

2.2.1.1 Standard Software Included with Standard Image Capture Work List Page The work list page is the starting point (by default) to which a user will go to begin a surgical case. The user may enter Patient Information to create and begin a case, schedule future cases, organize the Work List using various filter buttons, or receive and display pending cases from a Work List server. Work List modes can be chosen on the Setup Page > Work List Tab. A user may choose to enter no Patient Information and begin a case, or to enter as much Patient Information as desired. Local Work List (Default) All cases are created and maintained on the system locally. There is no required Patient Information to create and begin or to schedule a future case. None Navigation to the Work List Page is not available and the software displays the Record Page upon launch. Required Fields Patient Data Fields can optionally be set as Required and will appear in red in the Patient Information section indicating that this field must have an entry before any case can begin. Work List Page Controls Clear Filters Button – removes all filters that have been applied to the Work List on the Work List Page. Today’s Work List Button – displays only cases on the Work List that are scheduled by the Case Date for the present day. Delete from Work List Button – delete the case that is presently selected in the local Work List. Search Work List Button – search for scheduled patients to be added to the local Work List from the configured DICOM Modality Work List. Cases may also be started from the Search Work List Screen. Start Case – begins the case that is presently entered the Patient Information or selected in the Work List. Save – saves the case that is presently entered the Patient Information or selected in the Work List. New – clears all information entered into Patient Information, restores all preset default values to Patient Information Filter Box – enter text and numbers to filter the Work List by a keyword. Patient Field Button – sorts the Work List by the filter text entered Deactivate Filter Button – removes the filter from the Work List Scroll Bars – adjusts the view of the Patient Information Fields to enable the user to see all of the cases and data in the Work List and in the Patient Information sections of the Work List Page. Scroll Bar Arrow Buttons – moves the Scroll Bar in small increments On Screen Keyboard (OSK) – enters Patient Information Patient Information Text Boxes – create a collection of patient demographics that are associated with a case to be created. Archiving Indicator – displays the present status of media to be automatically copied to external storage (only visible when Application Status Bar is enabled in Setup Page > General > System Tab). Printing Indicator – displays when a print job is being sent to the printer (only visible when Application Status Bar is enabled in Setup Page > General > System Tab). On Screen Keyboard Button – displays the on-screen keyboard when clicked. PATIENT INFORMATION Patient demographic information is entered here to create a case (Figure 1). Patient Fields may be re-sorted or disabled and hidden depending on user preference and the present Work List Mode. The Performing Physician field can be populated with freehand text and contains a drop-down menu in which performing physicians will be stored. This field is automatically populated with the username of the user who is logged in unless a default value is configured in the Patient Fields Setup. Performing Physician are added to the drop-down menu when a surgical case is added to the local work list or started. When surgical cases originate on a Modality Work List, the performing physician is added to the list when the case is started. Stored physicians will be listed in alphabetical order. This list will be narrowed down when typed characters match a physician in the list. Unwanted physicians can be removed from the list by using the “X” next to the name. 7

Figure 1 CREATING A CASE ON THE WORK LIST PAGE The user may create a case on the Work List page at any time. A scheduled or unscheduled case may be created and begun in any of the Work List modes. To create a case: 1. Click the “New” Button on the upper left side of the page. 2. Enter data into appropriate Patient Information Fields. Pressing the “Enter” key on the keyboard moves the cursor down to the next Patient Information Field. (Figure 2-1)

Figure 2-1 3. After entering all desired patient information, click the “Start Case” Button on the upper left side of the page to begin the case or optionally in Work List mode; click the “Save” Button to add the case to the Work List for future use. (Figure 3) 4. When the case is started, the Record Page will display, and the System will be ready to capture videos and images for the case created.

8

Figure 2-2 NOTE: There is no limit to how many cases can be created and saved to the local Work List; this allows cases to be created and scheduled in advance. The software populates the Case Data field with the present date and time each time a new patient entry is started. The Case Date can be edited and changed to a future date if desired. If the Case Date or time are incorrect, they can be adjusted on the Setup Page > General Tab > Regional Sub Tab > Date/Time text box. STARTING A CASE FROM THE WORK LIST PAGE Selecting and starting a case from the Work List Page is the same process for each of the Work List Modes. (Figure 3) 1. Browse the cases listed in the middle of the Work List Page and click on the desired case to select. The case will highlight to show that it is selected. 2. The Patient Information section will populate with the information from the selected case. 3. Click the “Start Case” Button to begin the case. When a case is selected and started, the case will be removed from the Local Work List Page. After a case has been started and/or completed, it will appear to the Review Page. From the Review Page, the user can review, copy, and print media. If the user wishes to alter the Patient Information or add media to a case that was previously created with the software, the Review Page offers this function. Patient Information in cases that were started from MWL may be edited but it is not recommended.

Figure 3 DELETING A CASE FORM THE WORK LIST PAGE The user can delete scheduled cases from the Work List in the event of a cancellation. Deleting a case from the Work List Page only removes it from the local system. MWL cases which have been removed from the local Work List will still exist on the server. (Figure 4) 9

1. Browse the cases listed in the middle of the Work List page and click on the desired case to select. The case will highlight to show it has been selected. 2. The Patient Information section will populate with the information from the selected case. 3. Click the “Delete from Work List” Button to delete the selected case form the local Work List.

Figure 4 FILTER WORK LIST The Work List Page provides the user the ability to sort the cases in the Work List by any native Patient Information Field, by date range, and by cases scheduled for the present date (default). After applying filters, click the Today’s Work List Button to revert to viewing only the cases scheduled for the present date or click the Clear Filters button to remove all filters. (Figure 5)

Figure 5 CREATING A CASE ON THE RECORD PAGE If desired, the Work List page can be disabled, and the Record Page can be the first page by choosing “None” under the Work List Setting on the Setup Page. Users may begin a case on the Record Page at any time. Patient Information can be entered prior to the start of a case or at any time before the case is closed. To create a case with Patient Information: 1. Click the “New Case” button on the lower left side of the page and the Edit window will appear. (Figure 6-1) 2. Enter data into the appropriate Patient Information Fields. Pressing the ‘Enter’ key on the keyboard moves the cursor down to the next Patient Information Field. 3. After entering all desired Patient Information, click the ‘Save’ button on the lower left side of the Edit Window to begin the case. 4. Use the Information Tab ‘Edit” button to add or edit Patient Information any time when a case is in progress. (Figure 6-2) 5. Clicking the “Close Case” button will save all entered data on the Review Page. 10

Figure 6-1

Figure 6-2 To begin a case without Patient Information: 1. Use touchscreen controls, endoscope triggers or foot pedal commands to capture media. 2. Use the Information Tab “Edit” button to add or edit the Patient Information any time when the case is in progress. 3. Clicking the “Close Case” button will save all entered data on the Review Page. RECORD PAGE CONTROLS Status Tab – displays the current segment of time and overall recording time of each video capture source while video capture is still in progress, the storage space that has been filled, and the total number of video segments that have been captured in the present surgical case. NOTE: Recorded videos less than 3 seconds long are not saved. Archiving Tab – displays status of media items to be sent to Archiving Location(s) set on the Setup Page > My Settings Tab > Media Sub Tab. Archive status indicators and their meanings:

Images Tab – view thumbnails of previously captured images and their timestamps without having to leave the Record Page. Information Tab – displays the Patient Information for the case in progress. Click the “Edit” button to alter the Patient Information for the case in progress. 11

Annotation Button – used to assign an annotation to the last still image captured. The user may type, select from a list, or use an attached microphone to input an annotation from the list. When selecting annotations from the list, users can search the list to find annotations faster. Delete Button – delete the captured image shown on the upper right of the Record Page. Users must provide confirmation to delete the image. New/Close Case Button – signal the start (Work List set to NONE) and completion of a surgical case and concludes of all automated background functions like automatic printing and automatic send to DICOM. Capture Button – capture a still image from the Primary Camera. A counter displays the total number of still images captured in the current case. If Multi Capture is enabled, a still image from all connected sources will be captured. Record/Pause Button – initiates and ends a video segment. A red dot appears to indicate video capture is in progress. CAPTURING VIDEO The Record Page captures HD video from the Primary Camera and optionally from the Primary and Secondary Cameras simultaneously. Videos are limited to 5-minute Segment Length by default. (Figure 7)

Figure 7 CAPTURING STILL IMAGES The Record Page captures still images from the Primary Camera. Images are captured in JPEG format by default and can optionally be changed to capture BMP or PNG image files. (Figure 8)

Figure 8 REVIEW PAGE A user can use the Review Page to review and expedite media workflow for cases that have been captured on the Record Page. Recorded cases can be viewed, annotated, deleted, copied to external media or network folders, burned into an optical disc using an external disc burner (not included), printed, and sent to a DICOM Storage server while a surgical case is in progress or after a surgical case is completed. 12

Users may only review cases captured with the current logged-in user, Administrators can view all cases captured by all users. The Review Page has two views that will display based on the preference of an open surgical case or no surgical case in progress. When a case is open, the Review Page will show only media for the case in progress. When a case is not in progress, the Review Page will default to List View and display all the user’s cases stored on the system. REVIEW PAGE VIEWS List View – displays all the closed surgical cases for the user. To select a case, click the Checkbox on the left side of the page next to the desired case. Case View – displays a list of thumbnails foe each still image and video captured. To select an image or video click in the middle of the thumbnail and a check icon will appear on the thumbnail. Playback View – displays a large screen view of the media item. To select an image or video click the Media Item Checkbox on the upper right of the page. REVIEW PAGE CONTROLS List View Controls: Clear Filter Button – removes all filters that have been applied to a case list on the review page. Filter Box – enter text and numbers to filter the Work List by a keyword. Activate Filter Button – sorts the Work List by the filter text entered. Deactivate Filter Button – removes the filter from the case list sorting. Scroll Bars – adjusts the view of the Patient Information Fields to enable the user to see all of the cases and data in the case list. Scroll Bar Arrow Buttons – move the scroll bars in small increments Sessions – displays the start time, stop time, and length of the corresponding case session. The sessions screen also allows for review and printing of the case checklist. Appending to a closed case creates additional sessions. Top Checkbox – selects and deselects all cases. Checkbox – selects and deselects the individual case or multiple cases to copy, burn, or delete. View Button – changes the page to Case View and for the corresponding surgical cases. Edit Button – opens pop-up window that allows the user to edit Patient Information of the corresponding surgical case. Append Button – allows the user to reopen the corresponding surgical case to add additional media. When clicked, a warning dialog pop-up window will appear to confirm that the user wishes to navigate to the Record Page with the corresponding surgical case loaded to append media to the case. If Case checklist is enabled, the user will be required to complete the checklist before appending the case. Copy Button – navigates to the Copy page to duplicate case media to external media or network folders or MedXStream app (iOS connected by sync cable). Delete Button – allows users to delete a selected case. A warning dialog pop-up window will appear to confirm that the user wishes to delete. Playback View Controls: Back Button – navigates to case view. Media Item Checkbox – selects the displayed media for copy, burn, or delete when the user navigates back to Case View. Controls Specific to Video Playback: Mute Button – activates and deactivates audio playback of the video displayed. Speaker Button – allows a user to mute or unmute playback of the video Volume Slider – adjusts the volume of the audio playback of the video displayed Play/Pause Button – starts and paused the playback of the video displayed .25x Button – slows video playback to 25% of full speed. .50x Button – slows video playback to 50% of full speed. Normal Button – returns video playback to full speed. Loop Button – when activated, the selected video repeats playback until stopped. Looped playback is activated by default. Seek Bar – click and drag the dot on the seek bar to navigate to a desired place in the video displayed. FILTER BY PATIENT FIELD CRITERIA When in List View, the Review Page can be filtered in the same manner as the filters in the Work List Page and persist over reboots of the system. (Figure 9)

13

Figure 9 PRINT PAGE The Print Page is accessed form the Review Page and offers full featured printing options. (Figure 10) The user can send a print job to an available printer in the list or create a PDF file to print later, select a page layout, crop HD images to a 4:3 ration to save black ink with scope images, add a personalized heading and logo to the top of the printed page, make adjustments to the images prior to printing, and include dates, annotations, and add up to 6 Patient Fields to the printed page. Any adjustments made to the print layout on the Print Page will not be saved after the page is closed, it is recommended that the user set the preferred default print settings on the Setup Page > My Settings Tab > Printing Sub Tab during the initial setup.

Figure 10 PRINT PAGE CONTROLS Print Preview Navigation Buttons – used to display each page of a multiple page print job. Print Preview Window – displays the print job with all the set options as it will look when printed. Selected Printer – used to select an installed printer to send the present job to. Page Layout Dropdown – used to select 1, 2, 4, 6, 8, or 15 images per printed page. 4:3 Crop Checkbox – activate this checkbox to crop a 16:9 image to a 4:3 image. This is useful with scope images. Include Annotations Checkbox – when activated the print job will include assigned annotations under each image. Header Text Box – add text here to add a header or a title for all the pages in the present print job. Logo Checkbox – when activated the print job will include a preselected logo at the top of the pages. Logo Dropdown – used to select a custom logo JPEG file. This file will be saved into the software and able to be reused at any time. Footer Fields Dropdown – used to select Patient Fields to be added to the present job. Footer 1-6 – used to set the specified Patient Field to respective position of the numbered footer. Include Image Date Checkbox – when activated the print job will include the date of the image capture under the images. 14

Enhancements Enabled – when activated, the Enhancements Dropdown will become available. It is recommended to configure color correction setting in the printer before using these enhancements. Enhancements Dropdown – used to access digital Gamma, Brightness, Saturation, Sharpen, and Contrast adjustments for the images in the present job. Enhancements Checkbox – when activated the enhancement sliders will become available and a print job will include adjustments to image color, brightness, contrast, and sharpen adjustments. This does not alter the original image. Enhancement Sliders – used to adjust the selected enhancement. The result of the adjustment will be seen in the Print Preview Window as it is made. Copies – adjusts the number of copies for the present print job. Print Button – sends the printing job to the specified printer with all the preset printing options. Save as PDF Button – saves the print job to a PDF file with all the preset printing options. Exit Button – closes the Print Page without sending the present print job. COPY PAGE The Copy Page is accessed from the Review Page and used to copy surgical cases to external devices and network folders. The Copy Page displays the file size of the media to be transferred and the percentage of completion of the present copy job. To copy a case to an external device or network folder, select the desired media then click the “Copy” Button on the Review Page to display the Copy Page. (Figure 11). All USB Drives installed into the Touch Glass system will be encrypted. Decryption will require a private password.

Figure 11 COPY PAGE CONTROLS Copy Location Button – choose a location to copy selected items. The copy locations defaults to the first available USB device. Media items can be copied to external USB drives, shared network folders and iOS devices with the MedXStream app installed. Eject Button – used to safely eject a removeable USB device after a copy job has completed. Abort – used to cancel a copy job in progress. Any items already copied will not be removed. Exit – closes the copy page. LOCATION PAGE This feature is accessed from the Copy Page when the “Copy Location” Button is clicked and is used to select a location to copy surgical cases. (Figure 12)

15

Figure 12 LOCATION PAGE CONTROLS An arrow will appear to the left of the dropdown when a copy location becomes available. Click the folder name to select the Copy Location SETUP PAGE The Setup Page is divided into Tabs on the left side of the page and Sub Tabs near the top of the page. Each Tab and Sub Tab contains several controls that relate to its title. The Setup Page allows for configuration of system wide settings and individualized settings for the user. Admins can configure system wide security settings, manage usernames and passwords, camera settings, network settings, Work List modes, configure Work List and DICOM server settings, manage patient fields, checklist questions, manage the trash bin and user activity for all users, procedures and annotations lists as well as their own personalized annotation, patient field, procedure, media, and printing preferences and view the user manual. The setup page also allows logged in users without admin privileges to manage their own trash bin, customize settings. A non-admin user may also view software version information, network settings, the user manual, and their own user activity. GENERAL TAB The General Tab contains Sub Tabs for System, Camera, Network, and Regional settings. The General Tab is displayed by first when the user navigates to the Setup Page. SYSTEM SUB TAB (Figure 13) Version Numbers – displays the software GUI and Firmware version numbers. Please have this information available when troubleshooting with CONMED support. MedXStream Display Name – allows user to create a custom display name for the Touch Glass which is useful when scanning for recorders in the MedXStream mobile app. The recorders serial number is used by default. If the display name is erased and saved, it will revert back to the serial number or hostname configured in windows. Router Password – allows a user with administrative privileges to create a unique password for the network created by the CMS mini-router. For conformance with cybersecurity best practices, it is highly recommended that the default password be replaced with a unique hardened password. The new password must contain the following: - At least eight characters - At least one capital letter - At least one special character - At least one number

16

Figure 13 Reset System Settings Button – reset system settings to factory default. This button does not erase Work List entries, cases, regional or security/user management settings. Software Update Button – used in conjunction with a USB flash drive to update the software. Instructions for update will be provided by CONMED. Delete Cases – move cases for all users to the trash bin. Choose all cases or cases older than 7, 14, 30, 60, 90, or 120 days. Work List items are considered cases and will be moved to the trash bin with this feature. Auto Delete Cases – set the system to automatically delete cases older than 7, 14, 30, 60, 90, or 120 days starting when the control is set and continuing until the control is deactivated. Auto delete will remove cases and media items from the system permanently, bypassing the trash bin. Purge Local Work List – removes all cases in the local work list without removing completed cases. Mute System Audio Checkbox – deactivates the audible feedback when a still image is captured and when a video is started or stopped. Enable OSK – enable or disable the automatic popup of the on-screen keyboard. This control is enabled by default. With this setting disabled, users may still activate the OSK with the icon on the application status bar. Popup on screen keyboards contain an “X” to dismiss the keyboard and a keyboard language selector to quickly change languages if necessary. Enable Application Status Bar – displays or hides the top bar on the software window that displays the time and date, Printing Indicator, Archiving Indicator, OSK button, and window management buttons. Disable USB Mass Storage – prevent the use of USB storage devices. This option is only available to software admin users and must be logged into Windows with administrative privileges. Non-admin users will be able to see the status of this feature but will not be able to alter it. Session Timeout – enabled and set to 30 minutes by default. Blurs out the user interface when the specified period of inactivity is reached to prevent unauthorized viewing of ePHI. The password for the user currently logged in is required to unlock the user interface after a session timeout. Capturing still images and video recording by an attached foot pedal or endoscopic camera head is possible during a session timeout. The video preview is viewable during a session timeout. CAMERA SUB TAB The Camera Sub Tab contains controls for the camera inputs. Inputs may be disabled, renamed, or set as the default. (Figure 14)

17