PUREVUE Operators Manual Rev B May 2021

149995 Rev. B

en

Contents

HD Camera Control System with Integrated Light Source

PREFACE

4

CHAPTER 1 OVERVIEW 5 1.1 About These Instructions for Use ...5 1.2 Intended User and Patient Target Group...5 1.3 Indications and Intended Use ...5 1.4 Contraindications...5 1.5 Contents of Device Packaging ...5 1.6 Compatible Devices... 6 CHAPTER 2 OPERATING PRECAUTIONS AND GENERAL SAFETY 7 2.1 Warnings...7 2.1.1 Electrical Safety...7 2.1.2 Operating Warnings...7 2.2 Precautions...8 2.3 Adverse Effects...8 2.4 Expected Clinical Benefit...8 CHAPTER 3 OPERATOR CONTROLS, DISPLAYS AND ALERTS 9 3.1 Front Panel Controls and Displays ...9 3.2 Back Panel ...10 CHAPTER 4 UNPACKING, INSTALLATION AND SYSTEM CHECK 13 4.1 Overview...13 4.2 Unpacking...13 4.3 Installation...13 4.4 Setting up the Camera Control System...14 4.5 HD Camera Head Button Settings... 16 4.6 Video Specialty Setup...16 4.7 Pre-Use Check ...16

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CHAPTER 5 OPERATING INSTRUCTIONS 17 5.1 First Time Startup...17 5.2 The Login Screen ...18 5.3 The Home Screen ...19 5.4 Creating Surgeon Profiles...20 5.5 Creating a Case... 22 5.6 Starting a Case...23 5.7 Live Surgery Screen ...24 5.8 Ending a Case...25 5.9 Completed Cases (Printing, Annotating & Resuming Case)...25 5.10 Creating Users...29 5.11 Setting Screen...30 5.12 Settings ...31 5.13 Quick Start...32 5.14 Onscreen Keyboard...33 5.15 Light Source...34 5.16 White Balance ...34 5.17 Take Video...35 5.18 Take Photo...35 5.19 Printing...35 5.20 Sending the CCS out for Service & Repair ...36 5.21 Mobile Application ...36 CHAPTER 6 TROUBLESHOOTING 37 6.1 Pre-Use Troubleshooting...37 6.2 Troubleshooting During Use...38 6.3 Error Codes...40 6.4 Further Troubleshooting ...41 CHAPTER 7 POST-USE INSTRUCTIONS 42 7.1 After Use...42 7.2 Re-Use ...42 7.2.1 Cleaning Instructions...42 7.3 Maintenance ...42 7.3.1 Physical Inspection...43 7.3.2 Replacing the Fuse...43 7.3.3 Other Service... 44 7.4 Device Lifetime ...44 7.5 Disposal of Device...45 7.6 Reporting of Serious Incidents ...45 CHAPTER 8 TECHNICAL DESCRIPTION 46 8.1 Electrical Specifications...46 8.2 Video Specifications ...46 8.3 Physical Specifications ...46 8.4 Classifications...46

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8.5 8.6 8.7 8.8 8.9

Operating Conditions...47 Transportation and Storage Conditions...47 Installation Requirements ...47 Isolation Requirements...47 Applied Parts...47

APPENDIX A EMC INFORMATION

48

APPENDIX B WARRANTY, SERVICE AND REPAIRS

52

FIGURES Figure 1. Camera Control System Front Panel...9 Figure 2. Camera Control System Back Panel ...10 Figure 3. Installation... 13 Figure 4. Connecting the Light Cable and Camera Head ...15 Figure 5. Camera Head Buttons and Button Presets... 16 Figure 6. First screen of initial startup screens ...17 Figure 7. Login screen...18 Figure 8. Home screen ...19 Figure 9. Surgeon Profiles screen...20 Figure 10. Case List screen...22 Figure 11. Live Surgery screen...24 Figure 12. Completed Cases screen / list level ...26 Figure 13. Completed Cases screen / case level...26 Figure 14. Settings screen...30 Figure 15. On-screen keyboard...33 Figure 16. Fuse Cap Location...43 Figure 17. Battery Location within HD Camera Control System ...45 TABLES Table 1. Front Panel Controls...9 Table 2. Back Panel Connectors ...10 Table 3. Back Panel Symbol Descriptions... 11 Table 4. Packaging Label Descriptions ...12 Table 5. System Connection Steps ...14 Table 6. Supply Mains Icons...14 Table 7. User Access Comparison...29 Table 8. Settings...31

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Preface Some products may not be licensed in all jurisdictions.

Caution: Federal law restricts this device to sale by order of a physician. © DePuy Synthes 2021. All rights reserved. This manual describes the DePuy Synthes Mitek Sports Medicine HD Camera Control System and provides instructions for its use. It is important to review this manual thoroughly before installing and operating the Unit. Additional information, training, and product servicing are available from Mitek Sports Medicine. When using HD Camera Control System accessories, please refer to the appropriate Instructions for Use (IFUs). Read all instructions carefully. Refer to this manual when operating the Mitek Sports Medicine HD Camera Control System. The information contained in this manual is based upon the most current information available at the time of implementation. Figures are representative. The entire content of this manual is the property of Mitek Sports Medicine and is protected by all relevant copyright laws. Do not reproduce any portion of this manual, in any form, without express written approval of Mitek Sports Medicine. Mitek Sports Medicine declares that this product meets the provisions of the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. All supporting documentation is retained under the premises of the manufacturer. Intertek Semko evaluated the HD Camera Control System and its accessories for Electromagnetic Compatibility, to regulations IEC 60601-1 edition 3.1: 2012 and IEC 60601-1-2 4th edition: 2014. The unit and accessories were found to be compliant. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This Class A digital apparatus complies with Canadian ICES-003. This digital device Class A complies with Canadian NMB-003.

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Chapter 1

Overview 1.1 About These Instructions for Use These Instructions for Use are intended to aid the user in safe and proper installation, setup, and operation of the HD Camera Control System. Throughout this manual, "Camera Control System" or "CCS" refers to the HD Camera Control System. "Camera Head" refers to the HD Camera Head.

1.2 Intended User and Patient Target Group The HD Camera Control System is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices. Use of HD Camera Control System is not associated with a specific patient population.

1.3 Indications and Intended Use The HD Camera Control System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs, or joint spaces.

1.4 Contraindications There are no known contraindications. It is the responsibility of the physician in charge to determine whether the application of the Camera Control System is acceptable based on the patient’s condition. WARNING!

For critical applications, maintain a replacement Camera Control System in case of device failures.

WARNING!

For critical applications, make sure a spare F 5A L 250V fuse is available.

1.5 Contents of Device Packaging Quantity 1 (one) 1 (one) 1 (one) 4 (four) 1 (one) 1 (one) 1 (one)

Item Power Cable USB Flash Drive FAT 32 Format DisplayPort to DVI Video Cable, 3 m 3G-SDI Cable, 3.7 m DisplayPort to DisplayPort Video Cable 3 m Wireless Router IFU (Instructions for Use)*

* In regions where e-IFU is accepted, printed IFU will not be included in device packaging. Contact your sales representative for information about additional verified compatible devices and accessories.

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1.6 Compatible Devices NOTE: Refer to the appropriate Instructions for Use when using these compatible devices. • HD Camera Head (IFU-115835)* • C-Mount Coupler (Refer to manufacturer instructions) • Display - HD Quality or better (Refer to manufacturer instructions) • DisplayPort to DisplayPort Video Cable (N/A) • DisplayPort to DVI Cable (NA) • 3G-SDI to 3G-SDI Video Cable (N/A) • Hospital Grade Power Cable (N/A) • MedXChange® EvolutionHD ("Evo") Video Recorder (Refer to manufacturer instructions)* • MedXChange® Evolution4K Video Recorder (Refer to manufacturer instructions)* • Light Cable or Light Guide with Olympus light source end tip, and Light Adaptors (Refer to manufacturer instructions) • Remote Cable (Refer to manufacturer instructions) • SONY® UP-DR80MD Printer (Refer to manufacturer instructions)* • Regional USB Keyboards (IFU-146027)* • USB Flash Drive (FAT 32 format not recommended for use above 4GB) • GL.iNet GL-MT300N-V2 (Refer to manufacturer instructions)* • ITD Mobile Cart (IFU-115831)* Use of devices not verified as compatible by Mitek Sports Medicine is not WARNING! recommended and may result in unsafe conditions. The enclosed USB flash drive is a portable, data-storage device that can WARNING! be used for the storage, data back-up, and transfer of electronic files. This device is unencrypted; therefore, it is not a secure way to store, transfer, or back up electronic files containing, protected health information, sensitive information, individually identifiable health information, or patient data. It is strongly recommended to encrypt the USB flash drive to protect data at rest. Should you choose to use this unencrypted USB flash drive for the storage, transfer, or back-up of electronic files containing protected health information, sensitive information, individually identifiable health information, or patient data; you are responsible for the contents stored on this device and liable for any data loss or data breach resulting from the use of this device with protected health information, sensitive information, individually identifiable health information, or patient data. Prior to using this USB flash drive, you should consult with your institution’s Privacy designee and policies regarding protecting patient information and the use of portable data storage devices. * Validated as compatible by Mitek Sports Medicine.

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Chapter 2

Operating Precautions and General Safety Read and understand this manual before using the system. The following list of warnings and precautions applies to the general operation of the System.

2.1 Warnings It is important to read this document completely prior to installation, setup, use, or post-use activities. Throughout this document, the words "NOTE," "CAUTION," and "WARNING" have special meaning. NOTE:

Tips for optimal operation and other useful information.

CAUTION!

This symbol and the word, “CAUTION,” is used as a caution note or indicates failure to observe can result in damage to the device.

WARNING!

This symbol and the word, “WARNING,” is used as a warning note or indicates failure to observe can result in damage to the device.

2.1.1 Electrical Safety • Electrical safety testing should be performed by a biomedical engineer or other qualified person. • Risk of electrical shock. Do not remove the housing. Refer servicing to an authorized Repair Service Center. • Do not connect the device to a power source that is not properly earthed (grounded). If the power source is not grounded, use the equipotential connector. • Disconnect the device from the main power source when cleaning, servicing, or inspecting. • Inspect all equipment and cables periodically for wear. If damage is noted, replace or return to Repair Service Center. • Avoid fluid contact on the system and its electrical connectors. • To avoid risk of fire, replace fuses with same type and rating. • Do not restrict access to the power switch. Ensure that the Camera Control System is positioned so that access to power main is not obstructed. To remove all mains power from the unit, disconnect the power cord from the appliance inlet. • The power supply detachable cord serves as the means of isolation between the power supply and the power main. Ensure that the placement of the equipment does not interfere with access to the power supply cord. • Type BF. Conforms to standard IEC 60601-1.

2.1.2 Operating Warnings • Unpack and inspect this device for damage prior to installation, setup, or use. Do not use this device if it is damaged. Do not use this device if it malfunctions. • This device is for use by personnel trained in endoscopic procedures. • Do not use this device in the presence of explosive gases.

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• Factory settings should only be used as guidelines. The surgeon is responsible for settings pertaining to the surgical procedure. • Failure to follow all applicable instructions may result in serious surgical consequences to the patient. • Any modifications to the system must be authorized by Mitek Sports Medicine. Modifying the device in a manner other than specified by Mitek Sports Medicine may result in injury. Contact Customer Service at +1 (800) 382-4682 for service requests.Outside the United States, contact your local affiliate. • If it is believed that the device has been compromised from a security incident, please report your issue to Customer Service at +1 (800) 382-4682. Outside the United States, contact your local affiliate. • The Camera Control System is equipped with a terminal for the connection of a Potential Equalization Connector as required by Electrical Safety Standard IEC 60601-1. The Potential Equalization Connector is provided to prevent electric shock hazards by maintaining a constant potential (voltage) to all exposed metal parts, so a person cannot simultaneously make contact with two different potentials. Use of the potential equalization connector should be determined by the facility where it is installed based on the design of the electrical distribution system. • If using the Camera Control System without the ITD cart, connect one end of the Potential Equalization Connector to the terminal on the back of the Camera Control System (Figure 2, Item 11). Attach the other end to the bus bar of the electrical installation. • If using the Camera Control System with the ITD cart, connect one end of the Potential Equalization Connector to the terminal on the back of the Camera Control System (Figure 2, Item 11). Attach the other end to the ITD cart (Refer to IFU-115831). Connect the cart’s equalization connector to the bus bar of the electrical installation. • Accessories labeled “REUSABLE” must be processed only according to the recommended procedures. Refer to the applicable Instructions for Use. • The use of accessories, transducers, and cables other than those specified with the exception of transducers and cables sold by the Manufacturer of the ME Equipment or ME System; may result in increased emissions or decreased immunity of the ME Equipment or ME System. • No part of the system can be serviced or maintained while the unit is in use. • Do not look directly into the light source. The intense light may cause eye injury.

2.2 Precautions • Read the instructions, cautions, and warnings provided with all System accessories before use. Your sales representative can advise which accessories are used with the System. • Test this equipment prior to installation or setup. Perform pre-use checks prior to each use.

2.3 Adverse Effects The following list of adverse effects may be associated with the use of this device: • Soft Tissue Damage. • Injury to patient (caused by burn from contacting light guide). • Injury to User (due to electrical and/or mechanical hazards).

2.4 Expected Clinical Benefit Intended to facilitate endoscopic procedures.

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Chapter 3

Operator Controls, Displays and Alerts This chapter describes operator controls, displays, and alerts on the System. Operating instructions for system accessories are described in separate instructions for use (refer to “1.6, Compatible Devices”). Figure 1 shows the front of the Camera Control System.

3.1 Front Panel Controls and Displays

Figure 1. Camera Control System Front Panel Table 1. Front Panel Controls No.

Description

1

Power Button

2

Olympus Light Cable Female Port

3

LCD Touch Screen

4

Two (2) USB-A 3.0 Female Ports

5

Camera Head LED Indicator

6

Camera Head Connector

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3.2 Back Panel 1

2

3

1

4

2

5

6

7

8

9

10

REMOTES 1 2

1

3

2

4

11

12

13

Figure 2. Camera Control System Back Panel Table 2. Back Panel Connectors No.

Description

1

HDMI Video Port Input

2

Four (4) 3G-SDI Video Ports Output

3

DisplayPort Video Port Output (2)

4

Three (3) USB-A 2.0 Female Ports

5

Three (3) USB-A 2.0 Female Ports

6

USB-A 3.0 Female Port

7

Service Port. For future use. The service port has no functions available to the user.

8

Network Port

9

Two (2) Remote Ports - Remote 1 (Image Capture Remote) and Remote 2 (Video Capture Remote)

10

Equipotentiality Plug

11

Power Cord Receptacle

12

Fuse Cap

13

Supply Mains Power Switch

NOTE: Only approved electronic equipment (IEC60950-1, IEC60601-1) can be connected to the four rear panel communications connectors (Figure 2).

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Table 3. Back Panel Symbol Descriptions Symbol

Description Refer to instruction manual/booklet

Caution Consult Instructions for Use Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Intertek Semko evaluated the HD Camera Control System and its accessories for Electromagnetic Compatibility, to regulations IEC 60601-1 edition 3.1: 2012 and IEC 60601-1-2 4th edition: 2014. The unit and accessories were found to be compliant. Mitek Sports Medicine declares that this product meets the provisions of the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5  April 2017 on medical devices. All supporting documentation is retained under the premises of the manufacturer. Type BF applied part The Equipotential terminal provides a connection between the unit and the potential equalization bus bar of the electrical installation. Replace the fuse with a 5A Time Delay Fuse rated for 250 VAC Manufacturer Serial Number Catalogue Number

GTIN

Global Trade Item Number Medical Device Electrical and electronic equipment. Return waste to a collection system or treatment and recycling facilities. Applicable in the EU. Follow decontamination instructions before returning waste.

ASSEMBLED IN

Assembled In HDMI Video Port

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Symbol

Description DisplayPort USB-A 2.0 Port USB-A 3.0 Port Service Port Network Port

Table 4. Packaging Label Descriptions Symbol

Description Keep dry This way up Keep away from heat

Maximum stack height: 4

Caution Atmospheric pressure limitation Humidity limitation

Temperature limit Fragile, handle with care NONSTERILE

Nonsterile Packaging Unit

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Chapter 4

Unpacking, Installation and System Check 4.1 Overview This section describes how to unpack the Camera Control System and connect the accessories. After unpacking and assembly, follow the Pre-Use Check Procedure (Section 4.7) to ensure that the Camera Control System is working properly.

4.2 Unpacking 1. Place hands in the open areas between the two pieces of packaging material on both sides of the console until you can securely grasp the underside of the unit. 2. Carefully remove the unit from the box and place it on a level and sturdy surface. 3. Verify that all items on the packing list match the products you have received. 4. Report damage immediately to a Mitek Sports Medicine Sales Representative or call Mitek Sports Medicine Customer Service in the USA at +1 (800) 382-4682. Save all packing materials to use in the event you must return product(s) to Mitek Sports Medicine. Outside the United States, contact your local affiliate. 5. Recycle all PUREVUE packaging material, including cardboards, foam inserts, and antistatic bag. CAUTION! Do not drop the device. Damage may result.

4.3 Installation Install the Camera Control System outside of the sterile field and in a location where there is enough space to access the controls. Position the unit so that access to power main is not obstructed. The System may be installed on the video cart (Ref. 242283, 242287) or on a level surface outside of the sterile field. Refer to Figure 3 and Table 5. Normal Installation RADIANCE ULTRA 4K UHD CONNECTOR PANEL

CCS BACK PANEL

Figure 3. Installation 2021-05-10 14:34:12

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Table 5. System Connection Steps Step

What to Connect

1.

Power cable

2.

CCS to 4K Display CCS to 4K Display (Secondary)

3.

How to Connect Female end of the power cable to the male connector on the Camera Control System CCS Display Port 2 to 4K Display Port CCS SDI Out (1-4) to 4K Display SDI In (1-4)

CCS USB to WR Power CCS NIC to WR LAN CCS to Printer CCS USB to Printer USB Once everything is connected turn on the Supply Main power switch on the back of the device (13)

4.

CCS to Wireless Router

5. 6.

TERMS: CCS – Camera Control System IMS – Image Management System WR – Wireless Router NOTES: If a native 4K resolution pass through from the IMS to the display is desired, four SDI cables must be connected between the IMS and the 4K display. Be sure the IMS SDI Out # and display SDI In # are the same (e.g. connect IMS SDI Out 2 to display SDI In 2). If a native 4K resolution pass through from the CCS to the IMS is desired, be sure to set the CCS video resolution to 4K (50 Hz). To avoid the risk of electric shock, this device must be connected only to a Supply Main with protective earth.

WARNING!

Table 6. Supply Mains Icons Icon

Description Supply Mains Connected Supply Mains Disconnected

4.4 Setting up the Camera Control System 1. Ensure the CCS is on. Power indicator light should be lit blue. Icon

Description Power on

If a camera head and light cable are connected, live video appears. If no camera head and light cable are connected, the Display shows color bars. 2. Connect the male Camera Head Connector on the Camera Head cable to the female Camera Head Connector on the Camera Control System (Figure 4A). 2021-05-10 14:34:12

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3. Align the arrow on the male connector with the arrow on the female connector and insert. If the device is turned on, a blue LED illuminates above the Camera Head Connector demonstrating that the Camera Head Connector is properly connected (Figure 4A). Icon

Description Camera Head

4. Push the male Light Cable connector into the female connector on the Camera Control System until the cable seats into place (Figure 4B). Icon

Description Connect Light Cable

A

B

Figure 4. Connecting the Light Cable and Camera Head 5. Attach the coupler, endoscope, and distal end of the Light Cable as described in their Instructions for Use. 6. Turn on the Light Source as indicated on the display by pressing any of the Camera Head buttons or by pressing the Light Source button on the LCD Touch Screen. The light source illuminates. Icon

Description Light Source

7. Adjust camera’s White Balance before use. As indicated on the display, press any Camera Head button to initiate a White Balance before the case begins. The White Balance appears on the On Screen Display screen (see Section 5.7). Icon

Description Start White Balance. Setting White Balance adjusts the camera to the current lighting conditions. White Balance Directions icon. Follow instructions to set White Balance.

NOTE: Improper White Balance or lack of White Balance prior to use may cause poor video quality. Refer to Section “5.16, Adjusting White Balance” for more information. 2021-05-10 14:34:12

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4.5 HD Camera Head Button Settings The Camera Control System is preset with button assignments for the Camera Head. To adjust the button settings, go to camera screen within advanced settings (Section 5.12). Each Camera Control System is preset to provide the following six button functions for the Camera Head buttons:

Short Press Long Press

Left Arrow Button (◄)

Circle Button (○)

Right Arrow Button (►)

No Action

Capture Image

No Action

No Action

Start / Stop Video

No Action

Camera Head Buttons Figure 5. Camera Head Buttons and Button Presets

4.6 Video Specialty Setup The Camera Control System is preset with a selection of Video Specialties. Each Video Specialty is preset to settings determined to be favorable for each surgical specialty. Video settings on all Video Specialties can be completely customized per surgeon. Refer to “5.4, Creating Surgeon Profiles.”

4.7 Pre-Use Check To ensure that the Camera Control System and other required video-system components are properly connected and functioning: 1. Power on the Camera Control System and connected display after setting up the device and attaching the Camera Head. Video appears on the display only if the entire video system is properly connected. 2. Ensure that the Light Source activates by touching the Light Source Control button on the Home Screen. 3. If there is no video, review the setup instructions in the Instructions for Use included with each device to ensure all devices are properly installed, and consult "6.1, Pre-Use Troubleshooting". If the problem persists, call Customer Service at +1 (800) 382-4682 in the United States or contact your Mitek Sports Medicine representative. Outside the United States, contact your local representative. For Camera Control System software support, call Med X Change, Inc. Customer Service at +1 (888) 982-4469. NOTE: Complete the pre-use checks before each use of the camera to ensure the device is functioning properly prior to surgery. WARNING!

Do not use the device if it is improperly installed or if it is not functioning properly after setup.

WARNING!

Do not look directly into the light source. The intense light may cause eye injury.

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Chapter 5

Operating Instructions NOTE: Figures shown in Chapter 5 are Illustrative only. User interface may vary based on software version.

5.1 First Time Startup When the Camera Control System is powered on, an initial startup screen appears, followed by the Select a Language Screen (Figure 6). Follow prompts to continue through the following screens:

Figure 6. First screen of initial startup screens NOTE: All selections made in First Time Startup workflow can be adjusted within the system settings (Section 5.12).

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5.2 The Login Screen Once First Time Startup is complete, you will be directed to the Login Screen (Figure 7) (or Home Screen if you selected no user login. See NOTE below).

Figure 7. Login screen NOTE: If login credentials are forgotten, you can either press Forgot Password Button or the Quick Start Button (Section 5.13) to begin a case without the ability of editing case data and profiles. WARNING!

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If no user login option is selected, you will be able to access the CCS without authentication. Facility security policies and procedures should be considered before opting not to select user login options. Facility will be out of Health Insurance Portability and Accountability Act, HIPAA compliance if no user login options are selected. User must logout in less than 24 hours.

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5.3 The Home Screen Once authenticated (not auto-login), you will be directed to the Home Screen (Figure 8). Once at the Home Screen, you will have the options of navigating to the following areas:

Figure 8. Home screen 1. Mirror Press Mirror to project what is on the screen to the surgical display (action may be disabled if display isn’t hooked up to CCS). 2. Start Case Press Start Case to view your case list and to add, edit, delete or start a case (Section 5.6). 3. Settings Press settings to access users, system information, CCS settings and to logout (Section 5.11). 4. Completed Cases Press Completed Cases to see your finished cases and stored media. (Section 5.9). 5. Surgeon Profiles Press Surgeon Profiles to create a new surgeon profile or edit an existing one (Section 5.4).

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