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Glossary of Symbols Glossary of Symbols Camera Selected item Create Text Annotation Share Patient Data PDF S (Secure Report) Pen tool Erase Content Draw a filled or empty circle or rectangle Redo Play Screen shot Forward Delete Worklist Active

Worklist Error

Video Capture (Start/Stop) Record Audio Annotation Create Image Annotation E-mail Save to Camera Roll PDF F (Full Report) Draw a line Integration Broker Undo USB Pause Rewind Full Screen Pull Worklist - Patient(s) data

Worklist Idle

Auto Print Idle Auto Print Active Create Patient(s) from Worklist

Choose color

Clear fields on Image Annotation

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Navigation Bar Symbols Navigation Bar Symbols Symbols on Navigation Bar CCU connect status - Orange indicates that the App is connected to the LENS Integrated System. Gray indicates that there is no connection. Patient List - Displays a list of created patient files. Patient File - Indicates the current patient file you are viewing. Create Patient - Tap to create a new patient file. Worklist - Displays the patient data pulled from the hospital’s archiving system via Integration Broker. The icon is grayed out when not active, and turns orange when connected to the LENS Integrated System, Integration Broker, or a network drive. CCU settings - Turns orange when connected to the LENS Integrated System. The icon is grayed out when not active. CCU keyboard - Used to control the control unit functions. The icon is grayed out when not connected to the LENS Integrated System. Settings - Provides access to various user functions, for the purpose of user customization. Tool Tips- Displays the name of a icon. Help - Contains Frequently Asked Questions (FAQ’s), Contacts - App version and the Technical Support number, and access to Tutorials. Logout of App - Logs the user out of the App.

Term Help

Definition The question mark symbol is visible on any screen within the App. Refer to the Tutorials section in the Application Help- Advanced Topics section for more information.

Navigation Bar

The navigation bar is located to the left of the patient file list and contains several icons. The icons displayed on the navigation bar are presented in the Navigation Bar Symbols Table.

Camera Setup(s)

A Camera Setup consists of a group of control unit settings that are easily customized and applied to the LENS Integrated System. Refer to the Camera Setup section in this document.

Offline

Offline refers to not connected to the LENS CCU Wi-Fi to perform actions on the mobile device locally.

Online

Online refers to connecting to the LENS Integrated System via Wi-Fi to exchange information with the mobile device.

Integration Broker

Refers to (REF 1061567) Integration Broker System Admin software v3.4, which a facility may utilize on a networked system. Some facilities reference the Integration Broker as IB or Broker. In the LENS App v3.0 document the reference used will be Integration Broker.

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Preface Preface This manual contains general information, together with operation instructions for the Smith & Nephew LENS Application (App). It is essential that all materials in this manual be read and understood before any attempt is made to operate the App. These Instructions for Use contains three main sections: • Process: The sections in this document provide work flow examples that will assist you in utilizing the different functions of the App. • Advanced Topics: This section provides maintenance areas such as Forgot Passwords, User Management, Patient File Management, and Tutorials to assist with these areas as needed. • Troubleshooting and System Specifications: The information in the Troubleshooting section provides data to assist you with App issues. The System specification contains content, which is essential in assisting you with storage management. The Admin Considerations section contains information that should be considered when installing LENS with the Integration Broker.

Typographical Conventions Typographical

Highlighting

Commands

The command will be bold. Note: A command initiates an action and becomes a default when users tab to it.

Placeholder

The placeholder text will be italic. Note: Referred to as dummy text, or filler text.

Text that the user enters

The font the user needs to enter will be Courier New.

Section Reference

References to another Section in the document will use initial capitals, i.e. System Specifications.

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Table of Contents Table of Contents Glossary of Symbols... 3 Navigation Bar Symbols... 4 Preface... 5 Typographical Conventions... 5 Table of Contents... 6 Device Description... 7 Intended Use... 7 Indications for Use... 7 Contraindications... 7 Precautions... 7 Hardware Infrastructure Setup... 7 For Korean Users Only... 7 Process... 8 Installation... 8 New Installation... 8 Connect your mobile device to the Internet enabled Wi-Fi Network... 8 Download and Install the App (One-time Setup)... 8 Complete Request Product Key Form ... 8 Send App Product Key Request ... 9 Activate the App... 9 New User Setup ... 9 Create a personal user account... 9 Configure Integration Broker ... 10 Integration Broker - One-Time Set-up... 10 Configure the Settings for Integration Broker... 10 Verify the Connection to Integration Broker... 11 Scheduling for a Pull ... 11 Scheduling a Push... 11 Report Settings ... 12 Cover Page PDF Settings... 13 Patient List... 14 Wireless Network Name Identifier... 14 User Customization - Settings ... 14 User Settings... 14 Change an Existing Password... 14 Change Security Question... 14 History ... 15 Camera Setup(s)... 15 Select Default Camera Setup Setting . . 15

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Default Camera Setup... 15 Create a new local Camera Setup (offline) ... 15 Create a new Default Camera Setup(s)... 16 Manage Shortcuts... 16 Create Shortcuts... 16 Change an Existing Shortcut...16 Append an Existing Shortcut...17 General Settings... 17 Sort Files By... 17 Set E-mail Attachment Size... 17 File Storage Alerts... 18 Switch Tool Tips... 18 Switch File Name Under Media Objects...18 Printer Settings... 18 Manual Print Configuration... 18 Auto Print... 18 Configuring Auto Printing...18 Paper Orientation... 19 Paper Size of Report... 19 Enable the iOS mobile Guided Access... 19 On Demand Pull ... 19 Pre-Operative (Offline) - Create a Patient... 20 Personal Info... 20 Procedural Info ... 20 Notes... 20 Create Patient(s) from the Worklist...21 Create Individual or Multiple Patient files ... 21 View Option... 21 Operative (Online)... 21 Adjust Control Unit Settings ... 21 LENS Integrated System (Remote Camera Setup(s))... 21 Change Button Mapping Functions Associated with a Profile (Offline)... 22 Going Online...22 Capture Data... 23 Intra operative Auto Print... 23 Camera ... 23 Video ... 23

LENS Application  Instructions for Use

Exit a patient file... 23 Lock Patient ... 24 Postoperative - (Annotation)... 24 Create Audio Annotation... 24 Create Text Annotation ... 25 Create Image Annotation ... 25 Image Tool Bar... 25 Generate a PDF File... 25 Cover Page PDF Settings . ... 25 Customizing the Cover Page PDF...26 Share a PDF Report From within a Patient File...27 Share Patient Data (Media) ... 27 Archive Patient Data... 28 On Demand Push... 28 Application Help - Advanced Topics... 28 Recover Login Information (Forgot Password)... 29 User Management... 29 Delete an Existing User... 29 Delete A Local Camera Setup(s) ... 29 Delete Existing Shortcuts... 29 Patient File Management... 30 Delete Objects (Media files)... 30 Delete Existing Patient File... 30 Tutorials... 30 How to Access the Tutorials ... 30 From Any Screen... 30 Troubleshooting... 31-33 System Error Messages... 34 System Specifications... 35 Admin Considerations... 36 IP Address ... 36 Integration Broker Service Repeat Interval . . . 36 LENS Compatibility with the Worklist... 36 Special Considerations ... 36 Warranty... Back Cover For Further Information... Back Cover

Device Description Device Description

• Read these instructions completely prior to use.

The LENS Application (App), is a mobile application that when used in conjunction with the LENS Integrated System allows for patient management, intraoperative image and video capture, media object annotation, and media object sharing.

• Each time you choose a file to delete, the App will alert you. The file will be immediately deleted from the mobile device storage and is non-recoverable.

The App runs on iOS 11.X and is used in conjunction with two systems:

• Once the file is locked it cannot be modified. Please ensure that you have completed all annotation prior to locking the file.

• LENS Integrated System, (REF 10601034) for information regarding the control unit RF considerations. • Integration Broker System Admin, v3.4 (REF 1061567). Refer to the System Specifications section listed in this document for more information.

Intended Use The LENS Integrated System and LENS Camera Head are intended to provide illumination, visualization and capture of still and motion pictures of surgical sites. In addition, the LENS Application is intended to capture still and motion pictures, and provide patient file management and limited redundant control of camera features.

Indications for Use The LENS Integrated system and LENS Camera Head are used in diagnostic and operative procedures for arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of surgical sites within articular cavities, body cavities, hollow organs, and canals. Additionally, the LENS Integrated System and Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope. The LENS Application, when used in conjunction with the LENS Integrated System WiFi version, is indicated for capture of still and motion pictures, patient file management, and limited redundant control of the LENS camera control unit within articular cavities, body cavities, hollow organs, canals, and the thoracic cavity.

Contraindications None known.

Precautions

• Once a patient file is locked, it cannot be unlocked.

For System Networked with Integration Broker Only: • For v3.4 to ensure videos reach PACS and Integration Broker, complete the Configure Integration Broker section in this document. • When configuring Scheduling a Push selecting the data delete will delete all content from the tablet, after a successful Push is complete. Alternatively, the user may select to manually delete content after a push, refer to section Patient File Management in this document. If Delete Data is enabled via a Scheduled Push, it will result in permanent loss of all videos from the tablet. • All service repeat intervals within the Broker administration interface must be set to 30 minutes. Refer to the Admin Considerations listed in this document.

Hardware Infrastructure Setup A mobile device is meant to be used with the LENS Integrated System. Refer to the System Specifications section of this document for the recommended mobile device specifications. Refer to the LENS Integrated System (REF 10601034) for more information about the LENS Integrated System.

For Korean Users Only • Archival of Mobile picture and communication system software are ancillary equipment to assist with diagnosis. • Consideration of ambient light conditions is required for interpretation of Medical images displayed on the Mobile picture archival and communication system software. • The device can be used unless it is against the Medical treatment law.

U.S. Federal law restricts this device to sale by or on the order of a physician. • To ensure maximum performance, safe operation, and full warranty protection of the App, read and follow these precautions.

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Process Process The Instructions for Use document is divided into seven sections:

4. Enter the username and security password for the network, if any.

–– Prior Installation

Note: The network password only needs to be entered the first time a device is connected to the network. The mobile device will automatically remember the network password.

–– New Installation

Contact the network administrator for your location.

• Installation

• New User Setup • Configure Integration Broker (if used)

Download and Install the App - (One-time Setup)

• User Customization - Settings

Note: Ensure that the mobile device is connected to the Internet (Wi-Fi).

• Pre-Operative (Offline) - Create a Patient

1. From the mobile device desktop, access the Apple Store®.

• Operative (Online)

2. Search the Apple Store for LENS.

• Post-Operative (Annotation)

Installation

3. Tap the LENS icon to install the App. If prompted, enter the Apple Store Identifier. The LENS icon (Figure 1) will appear on the mobile device once the App is fully installed.

Prior Installation All prior installations of the App must be removed from the mobile device.

4. Tap the LENS icon to launch and display the Request Product Key screen.

1. Prior to removing the app, each user must back up any data. Refer to Archive Patient Data section in this document.

5. Ensure an email service is enabled on the tablet to permit email messages to be sent.

2. Locate the previously installed App to delete.

Complete Request Product Key Form

3. Push down lightly on the LENS icon (Figure 1) until it starts to dance.

1. Fill in the email address and other fields on the Request Product Key form (Figure 2). Note: The email address is a required field.

Figure 1.  LENS icon

4. Tap the small x icon that appears on the top left. 5. Tap Remove.

New Installation Before using the App, refer to and complete the one-time Download (install), Product Key, and Activate the App (authorization) sections in this document.

Prep: Contact your network administrator for the following information. • Name of your facility’s Wi-Fi access. • The username and security password, if required.

Connect your mobile device to the Internet enabled Wi-Fi Network

Figure 2.  Request Product Key

1. From your iOS mobile device desktop, tap the Settings icon.

2. Tap Submit Request to send form.

2. Tap the Wi-Fi tab. 3. Tap the Wi-Fi network associated with your facility’s Wi-Fi network to connect to the Internet.

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Process Send App Product Key Request

Create a personal user account

1. Your email will open with the example email message in (Figure 3).

1. From the mobile device desktop, locate the LENS icon (Figure 1) and tap it to launch the App. The Log in screen (Figure 5) appears.

Figure 3.  LENS Product Key Request

2. Tap Send. Note: The email will be sent to Smith & Nephew’s Technical Support department for processing. The Technical Support department will send the activation code to your email address.

Activate the App

Figure 5.  Log in Screen

2. From the Log in screen (Figure 5) tap on the Create New User tab. The App displays the Create New User screen (Figure 6).

The App must be activated prior to the first use. Activation is a one-time procedure and does not need to be repeated prior to subsequent log-ins, or upon future updates. Note: If the App is uninstalled and then reinstalled, the App will need to be reactivated. Note: Have your site’s information available. 1. Tap the LENS icon (Figure 1) to start the App. 2. Open your email with the Product Key information. 3. Enter the Product Key code (case sensitive), (Figure 4), and tap Activate.

Figure 6.  Create User screen

Note: The requested information is used to customize the user’s experience. 3. Enter your First Name and Last Name. 4. Enter your Username.

Example: First initial and last name, (sjones), etc.

Figure 4.  Activate Product Key

Note: Once the App is active, the New User Setup screen displays. Refer to this section in the document and create a new user account.

New User Setup

–– Once the user account is created your username will display in the drop down list. –– When you log in, your username will display in the upper left corner of the screen. 5. Enter your password.

The App supports multiple users up to 32. Each user must create a personal user account.

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Process 6. Confirm the password by re-entering your password.

Note: When creating a new user account, select and answer a security question. The security question and answer is part of the authentication process. A warning will appear if you do not select a security question.

7. Tap Select Security Question and choose a security question to answer. 8. Enter your security answer.

9. Tap and read Terms & Conditions. 10. Tap the check box to agree. 11. Tap Submit to create your account and return to the Log in screen (Figure 5).

Integration Broker-One-Time Setup Integration Broker is a separate software application that converts images and videos provided by the App to a DICOM compatible format for export to the hospital PACS system. In addition, Integration Broker will interface to the hospital PACS and acquire the Patient Query Worklist, at which point, the LENS system will pull the worklist data the current day, providing the user with error free patient creation. The connection to the Broker server must be configured within the App in order to access this functionality.

Prep Contact your network administrator for the following information.

Note: When the Log in screen (Figure 5) appears you have successfully created a New User Setup.

• The IP Address and Share Name for your facility’s Integration Broker, which are required.

Log into the App. It is recommended that you refer to and complete the User Customization - Settings section before moving to the Pre-Operative (Offline) - Create a Patient sections in this document.

• The Username and Password.

Configure Integration Broker Refer to section Admin Considerations listed in this document, if: • Installing the App with an existing Integration Broker 3.4, or • Installing a new App with Integration Broker. Note: To proceed, your facility must utilize the Smith & Nephew Integration Broker, version 3.4. CAUTION: If Delete Data is enabled via a Scheduled Push, it will result in permanent loss of all videos from the tablet. For version 3.4 to ensure videos reach PACS and Broker, complete section Configure the Settings for Integration Broker in this document to implement. During the networking of Integration Broker, with the App, a USB to Ethernet adapter is required. To achieve the connection, between Integration Broker, the facilities Internet, and the PACS system, the user must use an USB to Ethernet adapter and connect to the CCU (Figure 7). Then ensure the facilities internal Internet is connected to the adapter. The adapter model referenced in the System Specification section in this document is for Model USB2-E-1000, by Plugable, or equivalent.

• Connection with the LENS CCU be networked to the App via a USB CAT 5 connector. • Refer to Integration Broker System Admin v3.4 (REF 1061567).

Configure the Settings for Integration Broker Note: If the tablet is not connected to the CCU Wi-Fi, complete step 1 and then continue. 1. From your iOS mobile device desktop, tap the Settings icon. 2. From the Navigation Bar, tap on the Settings icon. 3. Tap the Broker Settings. 4. Enter the IP Address and the Share Name for the Integration Broker* (Figure 8). Note: The Share Name is strictly the name of the Share folder without the domain notification. Refer to Integration Broker System Admin v3.4 (REF 1061567), section Acquisition Devices: PACS.

Figure 8.  Broker Settings

5. Enter the Username, and Password for Integration Broker. Note: The Username and Password are optional.

Figure 7.  Connection Diagram 10   10601295 Rev. H

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Process Verify the Connection to Integration Broker

Scheduling a Push

1. Turn on the CCU system.

Note: To ensure the tablet does not go into sleep mode during a Scheduled Push, place the tablet in the iOS mobile Guided Access mode. Refer to the Enable the iOS mobile Guided Access mode section in this document.

2. Connect to the CCU; if the Integration Broker settings have been configured the App will try to establish a connection to Integration Broker. Note: The system will perform a connection test. If the worklist icon turns orange, the connection is good. If the worklist icon turns red, please check your information, and retry. Further information regarding an On Demand Pull, Scheduling a Push or Pull; refer to the desired section(s) in this document.

A Push refers to the ability of the LENS system to transfer patient data to the appropriate Integration Broker network location via the CCU for further processing and interfacing with a hospital archive system. The Push process consists of two types of pushes; Scheduled and manual On Demand. Refer to the On Demand Push section in this document.

Scheduling for a Pull

Note: Ensure the CCU network is on prior to a Scheduled Push.

A Pull refers to the ability of the LENS system to transfer the patient worklist information from the appropriate Integration Broker network location. The App will then allow the user to view information from the worklist or facilitate the creation of patients from the data within the worklist.

A Scheduled Push is conducted by setting the frequency, date, and time within the Integration Broker settings view.

Note: Ensure the CCU network is on prior to a Scheduled Pull. A Scheduled Pull is conducted by setting the frequency, date, and time. Frequency is then determined via a popup with the following entries: once, daily, weekly, monthly recurrence entries for selection.

Frequency is then determined via a popup with the following entries: once, daily, weekly, monthly recurrence entries for selection. Note: Ensure the Connection Status icon is enabled. 1. Slide the Push Schedule button On. 2. Tap Intervals to select the frequency, Once, Daily, Weekly, or Monthly (Figure 10).

Note: Ensure the Connection Status icon is enabled. 1. Slide the Pull Schedule button On. 2. Tap Intervals to select the frequency, Once, Daily, Weekly, or Monthly (Figure 9).

Figure 10.  Scheduling for Push Figure 9.  Scheduling for Pull

3. Tap and select the appropriate date, then tap Done. 4. Tap and select the appropriate time to pull the data, then tap Done. Notes: • Do not turn off the CCU to ensure data is available for the scheduled Pull. • Ensure the tablet has adequate memory to support storage. When the iPad®’s internal storage reaches 80% capacity, the user receives an alert. A failure by the user to delete old data will result in new data not being pulled until old data is removed. Refer to System Specifications section in this document.

3. Tap and select the appropriate date, then tap Done. 4. Tap and select the appropriate time to push the data, then tap Done. 5. Slide the Delete Data button On or Off. –– When On the local data will only be delete after a Successful Push. –– When Off the data remains on the tablet. Note: Do not turn off the CCU to ensure data is available for the scheduled Push. CAUTION: Selecting the data delete will delete all content from the tablet, after a successful Push is complete. Alternatively, the user may select to manually delete content after a push, refer to the Patient File Management section in this document. Note: Once the Scheduled Push or Scheduled Pull is complete, it is recommended moving to the User Customization section in this document.

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Process Report Settings The Report Settings consists of Secure Report and Full Report Settings template(s). The Report Settings is an optional configuration, per user. Each user can customize a report. Tap the Preview button and quickly verify the changes as the user creates the Report, (Secure Name or Full report). A sample of the Full Report Settings template is shown in (Table 1). A description of the label settings and the location of the assets are provided in the table with respect to the final Report.

Label

Description

Secure or Full Report Settings

Secure Report - Is anonymous, does not contain patient information. It does contain the logo or image, and number of images per page. Full Report - Contains patient’s information via one of 7 selectable fields. A logo or image and a number of images per page.

Select Report Line (1-7) Note: Applies to a Full Report

Each report line provides customization of the information contained within the report. The user can select from 10 report elements.

Header Logo Applies to both Report Types

A graphical logo or symbol representing an organization or individual(s). Ensure the Logo is saved to the tablet prior to being selected from the Camera Roll. The default is the Smith & Nephew logo.

Image(s) Per Page Applies to both Report Types

The user can select from 1 to 12 different images to appear on the report.

Include Text Annotation Content

When selected ON, the Full Report will contain text annotations. No text annotations will appear on the Secure Report.

Preview Applies to both Report Types

Tap Preview to see how the report will look when generated.

Table 1.  Report Settings

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Sample Report (Full)

Process Cover Page PDF Settings The Cover Page PDF is a one-time optional configuration, per user. Each user can customize a greetings Cover Page. A description of the settings and the location of the assets are provided in (Table 2) with respect to how the PDF report will display. Refer to Cover Page Settings and Customizing the Cover Page PDF sections in this document on how to create.

Label

Description

Use this template for Patient Report Generation

Toggles OFF/ON. When ON will generate a customized report that is attached to the PDF sent via email to the patient. The default is OFF.

Report Logo

A graphical logo or symbol representing an organization or individual(s). Ensure the Logo is saved to the tablet prior to being selected from the Camera Roll. The default is the Smith & Nephew logo.

Top Section Text

The name of the organization, the address, phone/fax, and website link. The default is text blank.

Greetings Text and Surgery Information

A general message from the Doctor regarding the a general discharge summary of the patients’ procedure, and any follow-up.

Bottom Image Header #1

Name of Physician Assistant.

Image #1

Ensure the picture is saved to the tablet prior to selecting from the Camera Roll.

Bottom Image Caption #1

Name of Physician.

Bottom Image Header #2

Name of Physician Assistant.

Image #2

Picture of Physician Assistant. Ensure the picture is saved to the tablet prior to selecting from the Camera Roll.

Bottom Image Caption #2

Name of Physician.

Sample Cover Page PDF

Table 2.  Customize Cover Page PDF Settings

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Process Patient List

User Settings

Once you log into the App, the navigation bar, (Figure 11) is on the left side of the screen. The patient list is on the right side of the screen.

• Change the Existing Password

The User Setting screen (Figure 12) allows a user to change three options: • Change Security Question and answer • Change Camera Setup - assigned when creating a patient file

Figure 11.  Navigation Bar with patient list

Wireless Network Name Identifier When you log into the App, the name of the Wireless Network to which you are currently connected will display in the upper left corner of the screen.

Change an Existing Password

User Customization - Settings

Note: The username of the last user to log in will appear in the username field.

The App provides customization of different settings per user account to enhance the user’s experience, and provides timesaving process steps. If no customization exists, the App will use the default settings. The individual user can, if desired, modify the settings during the Operative phase. User Customization - Settings provides eight areas to customize the individual user experience. Areas include: • User Settings

Figure 12.  User Settings

1. Tap the Settings icon on the navigation bar. 2. Tap User Settings. 3. Tap the Existing Password field, and enter your Existing Password.

4. Tap the New Password field, and enter your New Password. 5. Tap the Confirm Password field, and re-enter your New Password.

• History

6. Tap Save Changes to save the new password.

• Camera Setup(s)

Change Security Question

• Default Camera Setup

1. Tap the Settings icon on the navigation bar.

• Manage Shortcuts

2. Tap User Settings.

• Report Settings

3. Tap the Select New Question field and select a new Security Question.

• Cover Page PDF Setting • General Settings Customizing any of the areas can be completed prior to the Operative (Online) scenario and is based on your user preferences.

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4. Tap the Enter Security Question Answer field, and enter your New Answer. 5. Tap Save Changes to save the new Security Question Answer.

Process History

Default Camera Setup

The History provides the user access to the operation logs captured by the software. The user can view the logs, create a PDF of the log file(s), and email the PDF for support.

A Default Camera Setup refers to a set of defined custom settings for a particular procedure. The default Camera Setup is assigned to a patient and is used during the patient’s surgery.

Note: To assist with HIPPA compliance you can export the History logs for incident tracking.

The default Camera Setup is applied when connected to the LENS Integrated System and the user taps on the patient name in the Patient List.

Camera Setup(s) The user selects which Camera Setup to assign to a patient and use during the patient’s surgery. There are two types of Camera Setup(s): • Local – created on or offline, located, and accessed via the App per the user account. • Remote - located and accessed via the Control Unit when connected via Wi-Fi. A Camera Setup consists of a group of control unit settings that are easily customized and applied to the LENS Integrated System. The control unit settings configure the Brightness, Zoom, and Enhancement settings for a specific profile.

Select Default Camera Setup Setting Select a Default Camera Setup Setting to use for a patient’s surgery. Refer to section Default Camera Setup section in this document. 1. Tap the Settings icon on the navigation bar. 2. Tap User Settings. 3. Tap the Select Default Setting and then select the new local Default Camera Setup (Figure 13).

The App contains two built-in Camera Setup(s): • Built-In Camera Setup #1 - cannot be changed • Built-In Camera Setup #2 - cannot be changed Note: The user cannot delete the two default camera setups. The App will provide the user with access to the saved Remote LENS Camera Setups when the App is connected via Wi-Fi to the control unit. To access, from the Navigation bar, tap Settings and then Camera Setups. The Remote Camera Setups will display. Refer to the LENS Integrated System (Remote Camera Setup(s))section listed in this document.

Create New local Camera Setup (offline) It is a recommendation that the creation of a new local Camera Setup be complete prior to an OR date. Creating a new Camera Setup, the user selects one of the Built-in Camera Setup(s) 1 or 2. Then applies the defined custom settings of a specific Camera Setup and saves the New Camera Setup via the App. 1. Tap the Settings icon on the navigation bar. 2. Tap Camera Setups. 3. To create a new local Camera Setup, tap the orange Create New Camera Setup and adjust the control unit settings to the individual user preference. 4. Tap Settings. Refer to section Adjust Control Unit Settings in this document. Adjust the Zoom, Brightness, and or the Enhancement settings to the user’s preference.

Figure 13.  Select Default Setting

4. To create a new Default Camera Setup, refer to section Create New Camera Setup (offline) in this document. 5. Tap Save Changes.

5. Tap Button Mapping, and refer to Change Button Mapping Functions associated with a Camera Setup (Offline) in this document. 6. Tap Save. 7. Enter the name of the New Camera Setup and tap OK.

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Process Create a new Default Camera Setup(s)

5. Tap inside the box (Figure 16).

The defined custom settings of a specific profile can be applied to a new default Camera Setup. 1. Tap the Settings icon on the navigation bar. 2. Tap Camera Setup(s). 3. Tap one of the Built-In Camera Setup and adjust the control unit settings to the individual user preference. Refer to section Adjust Control Unit Settings in this document. 4. Tap Save As. 5. Enter the name of the New Camera Setup (Figure 14), and tap OK.

Figure 16.  Adding a Shortcut

6. Enter the Shortcut information. 7. Tap Save. Figure 14.  Name of new Camera Setup

Manage Shortcuts A shortcut is a predefined text field that can be inserted into any media object’s text annotation.

Note: As you create shortcuts, the list of Manage Shortcuts will display in the Manage Shortcuts list view. Once the shortcut is saved, the annotation appears in the patient file.

Change an Existing Shortcut

Example: A standard patient note or hyperlink.

1. Tap the Settings icon on the navigation bar.

Shortcuts reduce text entry for commonly used annotations.

2. Tap Manage Shortcuts.

Note: You may create, save, and append shortcut(s) in advance to reduce the amount of manual typing required. Shortcuts can be applied to a patient’s file during surgery. There is a limit of 64 shortcuts per each user.

3. From the Shortcut list (Figure 17) tap the Shortcut to be changed.

Create Shortcuts 1. Tap the Settings icon on the navigation bar. 2. Tap Manage Shortcuts. 3. Tap Add Shortcut to bring up the Add Shortcut box and keyboard (Figure 15).

Figure 17.  Existing Shortcut list

4. Tap inside the box and make any change(s) to the Shortcut and tap Save. 5. To save the Shortcut with a different name, enter a unique Shortcut Name. 6. Tap Save to return to the Shortcut list.

Figure 15.  Create a Shortcut

4. Enter a unique Shortcut Name.

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Process Append an Existing Shortcut

Sort Files By

The user can append a different shortcut to an existing shortcut.

The App provides you with four different options for sorting the 1. From the Shortcut list (Figure 18) tap the Shortcut to be changed. patient files. The four options include Sorting Files By: • Patient Name 2. Tap the down arrow next to Shortcuts and select the Shortcut with the (+) to append (Figure 18) and tap Save.

• MRN#

• Procedure Type • Procedure Date All options can be sorted in Ascending or Descending order, as preferred (Figure 19).

Figure 18.  Append Shortcut

3. To save the Shortcut with a different name, enter a unique Shortcut Name.

Figure 19.  Sort File by Methods - Name - Ascending

4. Tap Save to return to the Manage Shortcut list.

1. Tap the Settings icon on the navigation bar.

General Settings

2. Tap General Settings

In this section you may customize how to: • Sort File By • Set E-mail attachment size • File Storage Alerts • Switch Tool tips - Off/On • Switch Filenames under media objects - Off/On • Printer Settings –– Configuration of a Manual Printer –– Auto Printing –– Configuring Auto Printing –– Paper Orientation

3. Tap the drop down arrow in the Sort File By field to view the list of available sorting methods.

Set E-mail Attachment Size Commercial e-mail servers do not permit any e-mail file size larger than 25MB. The user can set the desired maximum e-mail size to between 5MB and 25MB. To set the maximum e-mail attachment size: 1. Tap the Settings icon on the navigation bar. 2. Tap General Settings. 3. Tap the drop down arrow in the Max E-mail Attachment Size. 4. Tap the maximum e-mail attachment size (MB).

–– Paper Size of a Report

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Process File Storage Alerts

Auto Print

You may customize when you receive alerts that the total remaining storage on the device has dropped the set percentage (%) level.

Involves a number of settings on the tablet to be configured. The settings include:

1. Tap the Settings icon on the navigation bar. 2. Tap General Settings.

• General Settings – allows the user to configure a default Print printer. Refer to section Configuring Auto Printing in this document.

3. To receive File Storage Alerts, swipe with your finger to switch On.

• PDF Settings - allows the user to select the Report Settings and configure the number of copies.

Note: Complete step four if File Storage Alerts is switched on.

The app saves the default auto print settings per user to ensure that the user does not need to configure the desired auto printer each time.

4. Tap the down arrow to select the level 10, 20, 30 percent.

Switch Tool Tips 1. Tap the Settings icon on the navigation bar. 2. Tap General Settings. 3. Swipe with your finger to switch Off or On the Tools Tips in the field.

• If an auto printer is not configured, then the app displays a popup for selection of a printer. • If the auto printer is offline at the time of the print, the app displays a popup and notifies the user that the print failed. Tap Select Printer and then choose a printer. Tap Print.

File Name under media objects can be switched Off and On. This is useful for quick look up of user-created annotations and images.

The PDF settings define which PDF setting report to use, as well as the number of images per page. The auto print default is the PDF Settings selected during the configuration of Auto Printing, (Secure Report or Full Report Settings).

1. Tap the Settings icon on the navigation bar.

Refer to section Configuring Auto Printing in this document.

Switch File Name Under Media Objects

2. Tap General Settings. 3. Swipe with your finger to switch Off or On in File name under media object field. Note: Switch File Name is helpful when annotating as it displays the File Name under the media objects.

Printer Settings There are two Printer modes to choose; Manual Print and Auto Printing. • Manual Print – connects a compatible Wi-Fi Printer the user selects during the Manual Print Configuration. To change printers, the user must go to the General Settings and reconfigure. To print the user taps manual printing while in the App. • Auto Print - the user configures the Auto Print mode once, per user. This involves selecting the PDF settings, the number of copies (a limit of 4) to Auto Print per page.

Manual Print Configuration 1. Tap the Settings icon on the navigation bar. 2. Tap General Settings. 3. Tap the down arrow and select the desired Printer compatible printer.

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Configuring Auto Printing 1. Tap the Settings icon on the navigation bar. 2. Tap General Settings. 3. Swipe with your finger to slide the button either ON or OFF to enable. 4. Tap on the down arrow and select the PDF Settings, either Secure Report Settings, or Full Report Settings (Figure 20).

Figure 20.  PDF Report Type

5. Select the number of copies (from 1-4) per page to display. The maximum is four copies per page (Figure 21).

Figure 21.  Copies per Report

Notes: • The page count of a report when printed will be based on the number of pages, (i.e. 1,2,3,4 etc.) • When viewing the report within the App, the page count will be 1 of x, based on the total number of pages.

Process Paper Orientation

On Demand Pull

Select the page orientation to display in the PDF view; either portrait Note: Prior to transferring data, ensure to enable the iOS mobile or landscape. Guided Access. • Portrait = vertical - (taller) icon which is The On Demand Pull contains a Pull Worklist • Landscape = horizontal - (wider) utilized from the Worklist View (Figure 22). The default is Portrait.

Paper Size of Report Select the paper size of how the report will print; 8 ½ x 11, or Paper Print A4. The default is 8 ½ x 11.

Enable the iOS mobile Guided Access

Figure 22.  Worklist View

The iOS mobile Guided Access allows the App to remain in a connected state, and does not allow the App to go into a sleep mode.

Note: The Worklist icon on the navigation bar becomes orange when connected.

Note: Prior to transferring data, it is important to enable the iOS mobile guided access.

1. From the Navigation Bar, tap on the Worklist icon

1. From your iOS mobile device desktop, tap the Settings icon. 2. Tap on General. 3. Tap on Accessibility. 4. Under the Learning section, tap on Guided Access.

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2. Tap on the Pull Worklist icon and the available patients appear in the Worklist view. Note: A successful pull (either schedule or on demand) displays the relevant information in the worklist view. 3. From the Worklist view the user can select:

5. Tap the switch to turn on Guided Access.

•

An individual, tap the circle or swipe left on a patient.

6. Tap on Passcode Settings.

•

Multiple patients, (clicking individually on each circle), or

Note: Setting a passcode prevents from leaving an active session.

•

Tap on the circle in the top row to Select All .

7. Tap Set Guided Access Passcode and set a passcode. 8. Log into the App. 9. Triple-click the Home button.

Note: The Select All circle toggles from selecting all patients in the Worklist to Deselect All. Refer to section Create Patient(s) from the Worklist in this document.

10. Adjust the settings for the session, and then tap Start. For more information, please see the iOS process on how to enable: https://support.apple.com/en-us/HT202612

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Process Pre-Operative (Offline) - Create a Patient To reduce O.R. setup time, it is recommended that a patient file be created before each procedure while offline. This section contains the segments to complete when creating a patient file. Note: Each user can create up to 64 patient files.

Personal Info 1. From the Log in screen (Figure 5), tap the drop down arrow and select your username. 2. Enter your password in the Password field. 3. Tap the Log in button. The App verifies your information and the Navigation, Patient List screen (Figure 11) appears. 4. From the Navigation, Patient List screen, tap the Create Patient icon. The Create Patient screen (Figure 23) appears.

Procedure Info 1. Tap in the MRN# field and enter the patient’s MRN number. Note: The MRN# is alphanumeric.

2. To choose a Camera Setup for the patient, tap the drop down arrow to view and select an available Camera Setup(s). Note: To change a Camera Setup, go to the Default Camera Setup section of this document. 3. Tap in the Procedure # and enter the procedure number for the patient. Note: The Procedure number is alphanumeric, and is mandatory. 4. Tap the down arrow and select the Procedure Type. Note: The user may create and name a New Procedure Type. 5. If a New Procedure Type is preferred, select Create New Procedure Type. 6. Enter the name for the New Procedure Type, and tap OK.

Note: A Procedure Type name cannot be repeated. If a Procedure Type name exists, the user will receive the message “Procedure type with the same name already exists”. The user will need to enter a different name.

7. Tap Date and enter the date of the patient’s surgery.

Note: Use your finger to scroll up or down to select the Date (month/day/year), and then Tap Done.

8. Tap Time and enter the time of the patient’s surgery.

Note: Use your finger to scroll up/down to select the Time in hours and minutes, and then Tap Done.

Notes 1. Tap in the Notes box to enter any notes regarding the patient. Example: Left knee, Right hip, etc. 2. Tap the Submit button. Figure 23.  Create Patient Screen

5. Tap in the First Name field and enter the patient’s First name.

6. Tap in the Last Name field and enter the patient’s Last Name. Use only alpha-numeric characters.

7. Tap the (date of birth, recommended) DOB field and select the patient’s DOB and then tap Done. Note: Use your finger to scroll up or down to select the Date, (month/day/year).

8. Choose if the patient is Male or Female. Note: When creating a patient, the App requires the following two fields to be completed; MRN #, and Procedure ID#. All other fields are optional.

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3. Review patient information. 4. Once the patient information is complete, tap the keyboard and then tap Submit. Note: The user will then preview the patient information. If changes are needed, click on the (<) back arrow and made adjustments. Note: Once Confirm is selected, no additional changes can be made.

Process Create Patient(s) from the Worklist Once a patient(s) are selected, the user can automatically create the selected patient(s) from the information contained within the worklist. The downloaded patient information displays in the Patient List View.

Create Individual or Multiple Patient files 1. Swipe left on a patient and select Create to create an individual patient file (Figure 24).

Operative (Online) During surgery, the App connects to the LENS Integrated System to capture patient data (images, video, and pictures). Note: The Wi-Fi icon notifies the user the that the iPad is communicating or not communicating with the control unit. If the Wi-Fi connection between the App and the control unit is lost, the Wi-Fi icon on both the OSD status bar and the iPad will change from orange to gray. The APP will automatically connect when the signal is available again. Should the connection be lost or interrupted during surgery, all control unit control features can be accessed either from the front panel of the control unit or the camera head buttons.

Adjust Control Unit Settings Figure 24.  Create patient file(s)

2. To create multiple patient files: •

Tap the circle on the top row, or

•

Tap each individual circle

3. Tap the Create Patient icon

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View Option The View Option when selected will display a pop-up with the information downloaded from the worklist (Figure 25).

The control unit settings are used to create a new local Camera Setup or to adjust a Built-In Camera Setup. In the operative state, the App can be used to temporarily change settings remotely. The adjustable settings involved in the Camera Setup are: • Brightness: To adjust Brightness, use your finger to drag and release the white circle to adjust the Brightness to the desired level. • Zoom: To adjust Zoom, use your finger to drag and release the white circle to adjust the Zoom to the desired level. • Enhancement: To adjust Enhancement, use your finger to drag and release the white circle to adjust the Enhancement to the desired level.

LENS Integrated System (Remote Camera Setup(s))

Figure 25.  View

Note: Not all entries will be available; as the content is a function from the hospital’s archiving system specifics. 1. Swipe left on a patient file and select View. •

The worklist icon on the navigation bar will reflect either an On Demand or Scheduling Pull failure.

•

If a failure occurs the:

Remote Camera Setup(s) are those Camera Setup(s) which are stored on the LENS Integrated System rather than the iPad. These Camera Setup(s) are listed as remote Camera Setup(s) on the App, when the App is connected to the control unit via Wi-Fi. The titles of the Remote Camera Setup(s) are High Definition, Custom 1 through Custom 8, Moiré 1 and 2. The Camera Setup(s) stored on the App are referred to as Local Camera Setup(s). When the App is connected to the LENS Integrated System control unit and you select Camera Setups, both the Local and Remote Camera Setup(s) display on the App. A remote Camera Setup may be selected, the settings adjusted, and then the Camera Setup saved on the mobile device as a new Local Camera Setup.

–– Worklist icon changes to Red. –– History log provides the type of On Demand Pull failure. Note: The error state of the icon will clear on the next attempt of either an On Demand or Scheduled Pull.

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