SDC Ultra Ref0240050988 Instructions for Use Rev K Feb 2016

Contents Warnings and Cautions... 1 Symbols and Definitions... 3 Product Description/Intended Use... 5 System Overview...6

Setup... 10 Operation... 15 Loading the Patient List...17 Viewing Archived Information...18 Studio3 Media Transfer Queue - Pending Cases...20 Studio3 Media Transfer Queue - Completed Cases...21 Entering Patient Information...22 Capturing Single Channel Images and Videos...25 Capturing Dual Channel Images and Videos...28 Editing Video Settings...31 Viewing and Annotating Images...36 Viewing and Playing Videos...37 Viewing and Editing the Video Album...40 Editing Annotations...41 Saving Information...42 Saving Settings...43

Troubleshooting... 57 Cleaning and Maintenance... 60 Technical Specifications... 61

Warnings and Cautions Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meanings and should be carefully reviewed: Warning: To avoid potential serious injury to the user and the patient and/or damage to this device, the user must obey the following warnings: 1. Federal law (United States of America) restricts this device to use by, or on order of, a physician. 2. Read this operating manual thoroughly and be familiar with its contents prior to setting up or using this equipment. 3. Carefully unpack the unit and check for any damage that may have occurred during shipment. If damage is detected, refer to the “Service and Claims” section in this manual. 4. Use of this device is restricted to qualified health care professionals who have a complete knowledge of the use of this equipment and the devices to which it can be connected. 5. Test this equipment prior to using it in a surgical procedure. This unit was fully tested at the factory before shipment; however, it must be tested for proper function in the environment and setup configuration in which it will be used. 6. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 7. To avoid risk of electric shock, use only a hospital-grade power cord furnished with the unit. Disconnect the unit from the power supply to make connections or to inspect the equipment. 8. Install this device in an operating room that complies with all applicable IEC, CEC, and NEC requirements for safety of electrical devices. 9. Do not position the console so that it is difficult to disconnect the power cord from the supply mains. 10. Use only clean, dry, undamaged Stryker brand media. The use of damaged, wet, or incompatible media will void the warranty and may result in the malfunctioning of this equipment. 11. Make all connections with the power cord unplugged from the mains outlet. 12. Ensure that all equipment connected to the SDC Ultra™ has proper isolations. 13. To avoid risk of fire, do not use this device in the presence of flammable anesthetics. 14. Avoid direct exposure to the laser beam of the DVD/CD drive as it is 1

harmful to the eyes. 15. Pay close attention to the care and cleaning instructions in this manual. Failure to follow these instructions may result in product damage. 16. Attempt no internal repairs or adjustments not specifically detailed in this operating manual. Refer any readjustments, modifications, and/or repairs to Stryker Endoscopy or its authorized representatives. 17. Do not modify this equipment without authorization of the manufacturer. The Stryker Standard Warranty and Return Policy (1000401175) is void if any of these warnings or cautions are disregarded.

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Symbols and Definitions This device and its labeling contain symbols that provide important information for the safe and proper use of the device. These symbols are defined below.

Warning Symbols Warning/Caution: See Instructions for Use

Hazardous voltage present

Consult Instructions for Use.

Device Symbols Mouse

Keyboard

Monitor

Network

USB

Speaker

Serial port

Packaging/Labeling Symbols Legal manufacturer

Authorized representative in Europe

Date of manufacture

Atmospheric pressure range 3

SN

Ambient temperature range

Relative humidity range

Serial Number

Denotes compliance to CSA C22.2 No. 601.1-M90, and UL 2601-1.

C

US

Equipotentiality

Protective Earth Ground

Product number

Made in USA

Complies with the requirements of directive 93/42/EEC.

This product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately.

Federal law (USA) restricts this device to sale by or on the order of a physician.

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Product Description/Intended Use The Stryker Digital Capture System Ultra (SDC Ultra™) is a computer-based unit that records, manages, and archives digital images and videos of surgical procedures. The SDC Ultra™ simplifies file management by recording surgical photos and videos to compact digital media, such as CDs, DVDs, Compact Flash Cards, USB Hard Drive, or USB dongles, which can then be viewed from a personal computer, a DVD player, or from the SDC Ultra™ itself. The SDC Ultra™ records images on a built-in hard drive, where they can be easily accessed after the surgical procedure. The images stored on the hard drive can be named and burned to a CD or DVD through a touch-screen control panel located on the front of the unit. In addition to the touch-screen control panel, the SDC Ultra™ can be controlled by a hand-held remote control, buttons located on the surgical camera head, or the SIDNE® voice-activation system.

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System Overview Front Panel 1

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CD/DVD drive USB port Eject button for CD/DVD drive Remote control (optional accessory) Power button LCD touch screen

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Rear Panel 1

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REP

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Primary R2– Remote connection for recording control on the primary channel 2. Primary R1 – Remote connection for capturing control on the primary channel 3. Audio In SIDNE® –Line audio input 4. Audio In Mic –Microphone audio input 5. Audio Out – Speaker output 6. AC Power Inlet 7. Equipotential Ground Plug 8. Secondary R1– Remote connection for capture control on the secondary channel 9. Secondary R2– Remote connection for recording control on the secondary channel 10. Comp In – composite video input 11. Comp Out – composite video output 12. S-Vid In – S-video input 13. S-Vid Out –S-video output 14. DVI 2 Out –Secondary channel DVI output 15. DVI 2 In –Secondary channel DVI input 16. DVI 1 Out –Primary channel DVI output 17. DVI 1 In –Primary channel DVI input 18. SIDNE port – Connection to SIDNE console for device control 19. SFB connectors ports – enables Firewire connection with the Stryker 7

Firewire devices 20. Speaker port (development use only) 21. USB ports (2) 22. Monitor (development use only) 23. Keyboard (development use only) 24. Mouse (development use only) 25. Serial port (development use only) 26. Network port

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Remote Control (optional accessory) 1 2 3 4 5

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Channel 1 video and image: capture, record, stop Channel 2 video and image: capture, record, stop Print images Display previous image on OSD Voice annotation (future use) Navigation (future use) Select (future use)

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Setup Stryker Endoscopy considers instructional training an integral part of the SDC Ultra™ system. Your Stryker Endoscopy sales representative will perform at least one in-service at your convenience to help you set up your equipment and instruct you and your staff on its operation and maintenance. Please contact your local Stryker Endoscopy representative to schedule an in-service after your equipment has arrived. 1.

Choose a location for the SDC Ultra™. • Place the SDC Ultra™ on a Stryker cart or other sturdy platform. • Provide at least four to six inches of space around the sides and top of the SDC Ultra™ to ensure proper ventilation.

Warning

2.

RF and other mobile communications equipment may affect the normal function of the SDC Ultra™. When placing the SDC Ultra™, follow the instructions located in the “Electromagnetic Compatibility” section of this manual. Connect peripheral devices according to the interconnection diagram on the following pages.

Warning

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When the SDC Ultra™ is interconnected with other electrical devices, leakage currents may be additive, resulting in electromagnetic emissions that can interfere with the normal function of electronic medical equipment. To properly control electromagnetic emissions and avoid potential harm to the patient or user, ensure all electrical devices are installed and interconnected according to the requirements of IEC 60601-1-1.

Warning

Note

3.

When used inside the patient environment (represented by an area 1.5 m from the patient in all directions), the printer must be properly connected to the isolation transformer prior to use. Failure to do so may result in a higher leakage current for the printer. See the “Technical Specifications” for approved printers and transformers.

Connect the AC power. • Connect the provided power cord to the AC inlet on the rear console panel. • Connect the other end to a hospital-grade power outlet.

Warning

Do not use extension cords or three-prong to two-prong adapters when connecting the AC power.

Warning

Check the power cord assembly periodically for damaged insulation or connectors.

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Setting up the SDC Ultra™ with the 1188 Camera and SIDNE®

Caution

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The other ports not listed in this section are intended for use by service technicians or for future device upgrades. Do not connect any devices to these ports as unexpected results may occur.

SDC Ultra™ Networking Protocol Used: FTP (File Transfer Protocol) Setup Requirements 1. A TCP/IP network. 2.

A secure FTP (FTP over SSH) server may be installed and configured, if needed. Ultra does not support FTP over SSL. Instructions 1. Enter the IP address of the FTP server (and not the SDC Ultra™) into the SDC Ultra™ Network tab in the Config menu. 2. Create a folder named SDC in the default path of the FTP Server. In this folder, create a folder for the username. For example, if you have anonymous FTP service running on a server with an IP address of 10.2.101.26, and you have a folder called JOHND in the SDC folder in the default path of the anonymous login, then you should enter 10.2.101.26 in the network tab as the FTP address and JOHND as the username. 3. Press Add so that SDC Ultra™ will remember the username and the FTP address in the list. SDC Ultra™ can remember up to 500 usernames and FTP addresses. 4. Select the Write Videos check box on the Network tab if you want to write videos to the network. 5. To save the images and videos, press the Save to Network button from the Save menu. A confirmation screen will display. Check the Anonymous Login checkbox. Note

The SDC Ultra™ checks the server for a response. If it gets a valid response, it performs an anonymous FTP login. It then changes directory to the directory corresponding to the current username (JOHND, in current example). It does not create a new directory based on the username. This avoids creation of multiple directories if someone accidentally enters a wrong/invalid username. Therefore, you have to enter a username for the FTP to work.

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For Login with Username and Password: Note

The FTP server should be setup for the users who have access. Passwords should be all caps.

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Create a folder under the root folder of the FTP server folder. Create another folder under the SDC folder with the same name as the username. 4. Follow steps 3 - 5 above, except in step 5 uncheck the Anonymous Login checkbox and enter the password. Directory Structure: <Default FTP path>SDCUsername?????MMDDYYYY_HHMMSS where, ?????: First 13 characters of the Patient’s Name / ID entered Username: Doctor’s Username which can be the same as his/her Notematic ID MMDDYYYY_HHMMSS: Date/Time stamp to guarantee uniqueness Note

If there are any problems writing the data, check if the read/write permissions of the FTP server are set. Also make sure that the firewall settings on the server do not block the FTP port.

Protocol Used: Studio3 Media Server Setup Requirements 1. A TCP/IP network. 2. A Stryker Studio3 Media Server installed and configured. . Instructions 1. Enter the IP address of the Studio3 Media Server into the SDC Ultra Studio 3 tab in the Config menu. 2. Select the Studio 3 checkbox in the Save Settings screen to enable the Studio 3 Save button. 3. To save the images and videos, press the Studio3 Save button from the Save menu. A confirmation message will appear to indicate that the case has been added to the Studio3 transfer queue. 4. To view the pending/completed transfer queue, press the Studio3 tab in the Archive menu.

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Operation SDC Ultra™ provides an interface for entering patient information, capturing images and videos, and archiving photos and video.

Getting Started Login Screen

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If the application password is on, enter the user name and password. This security feature will be turned off by default for quicker access to the Home Screen.

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Home Screen 1

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Select from the following options: 1. Press New Case to begin a new patient case. 2. Press Current Case to load the current patient information, images, and videos. 3. Press Archive to view cases that were saved to the hard drive, a USB dongle, or a disc. 4. Press Load Patient List to preload patient information before surgery.

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Loading the Patient List Patient information can be added prior to surgery to save time. To load patient information, press the Load Patient List button on the Home screen.

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Press the Home button to return to the home screen. Enter the patient information. • Enter the patient’s name • Enter the patient ID • Enter the birth date • Enter the sex Select the Surgeon from the drop-down menu. To add or delete an item on the list, press add or delete. Select the referrer from the drop-down menu. Navigational buttons • Press the up and down arrows to access the second- and third-tier screens. See the section in this manual called “Entering Patient Information.” • Press the Add button to add the patient information. • Press the MWL button to display the modality work list. • Press Patient List to see a list of all patients that have been preloaded into the system. Keyboard

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Viewing Archived Information To archive information and to access the archive, press the Archive button on the Home screen.

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A checkmark under the SC (DICOM Storage Commit) column indicates that the case has been saved on the PACS server and acknowledgement for the same has been received from the server. 2. A check on the USB column indicates that the case has been successfully saved to the USB. 3. A check under CD/DVD column indiicates that case has been saved successfully to the CD/DVD. 4. A check under the network column indicates case has been saved to either FTP server or PACS server. 5. Press Album to view the album of the selected archived case. 6. Press Save to save the selected archived case to media. 7. Navigational buttons • Press Hard Drive to view cases stored on the hard drive. • Press USB to view cases stored on the USB. • Press Disc to view cases stored on a CD or DVD. • Press Studio3 to view cases pending storage/stored on the Studio3 server 8. Press the Check-mark icon to select a patient record. 9. Number of pages remaining for the SDP1000 printer. 10. Press the Up/Down arrows to scroll through the list of patients. 11. Move all cases from the Hard Drive to the USB Drive.