Stryker_SDC Ultra- User Manual Guide

2007/08 www.stryker.com 1000-401-050 B

SDC Ultra

User Guide

240-050-988

Contents

Warnings and Cautions..................................................... 1

Symbols and Definitions................................................... 3

Product Description/Intended Use............................ 5System.Overview.....................................................................6

Setup.......................................................................................... 10

Operation................................................................................. 15Getting.Started.......................................................................15Loading.the.Patient.List.........................................................16Viewing.Archived.Information................................................17Capturing.Single.Channel.Images.and.Videos......................18Capturing.Dual.Channel.Images.and.Videos.........................21Editing.Video.Settings............................................................24Entering.Patient.Information..................................................29Viewing.and.Annotating.Images............................................31Viewing.and.Playing.Videos...................................................32Viewing.and.Editing.the.Video.Album....................................33Editing.Annotations................................................................34Saving.Information.................................................................35Saving.Settings......................................................................36

Troubleshooting................................................................... 38

Cleaning and Maintenance........................................... 41Cleaning.................................................................................41Maintenance...........................................................................41

Technical Specifications................................................ 42Environmental.Specifications.................................................42

Electromagnetic Compatibility................................... 45

Warranty................................................................................... 51

Services and Claims......................................................... 52

1Warnings and CautionsPlease read this manual and follow its instructions carefully. The words warning, caution, and note carry special meanings and should be carefully reviewed:

Warning Warningsindicateriskstothesafetyofthepatientoruser.Failuretofollowwarningsmayresultininjurytothepatientoruser.

Caution Cautionsindicateriskstotheequipment.Failuretofollowcautionsmayresultinproductdamage.

Note Notes provide special information to clarify instructions or present additional useful information.

Warning Toavoidpotentialseriousinjurytotheuserandthepatientand/ordamagetothisdevice,theusermustobeythefollowingwarnings:

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 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.

7. Install this device in an operating room that complies with all applicable IEC, CEC, and NEC requirements for safety of electrical devices.

8. 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.

9. Make all connections with the power cord unplugged from the mains outlet.

10. Ensure that all equipment connected to the SDC Ultra has proper

2isolations.11. To avoid risk of fire, do not use this device in the presence of flammable

anesthetics.12. Avoid direct exposure to the laser beam of the DVD/CD drive as it is

harmful to the eyes.13. Pay close attention to the care and cleaning instructions in this manual.

Failure to follow these instructions may result in product damage.14. 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.

The warranty is void if any of these warnings are disregarded.

3Symbols and DefinitionsThis 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

Device Symbols

Mouse Keyboard

Monitor Network

USB Speaker

Serial port

Packaging/Labeling Symbols

Legal manufacturerAuthorized representative in Europe

Date of manufacture Atmospheric pressure range

Ambient temperature range

Relative humidity range

4LOT Lot number Product number

SN Serial NumberUSC

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

Equipotentiality Protective Earth Ground

Denotes compliance to 93/42/EEC, Medical Device Directive

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

5Product Description/Intended UseThe 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.

6System Overview

FrontPanel

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1. CD/DVD drive 2. USB port3. Eject button for CD/DVD drive4. Remote control5. Power button6. LCD touch screen

7RearPanel1 2 3 4 5 6 7 8 9

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23 22 2120 19 18 17 16 1514

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1. 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 input4. Audio In Mic Microphone audio input5. Audio Out Speaker output6. AC Power Inlet7. Equipotential Ground Plug8. Secondary R1 Remote connection for capture control on the secondary

channel9. Secondary R2 Remote connection for recording control on the

secondary channel10. Comp In composite video input11. Comp Out composite video output12. S-Vid In S-video input13. S-Vid Out S-video output14. DVI 2 Out Secondary channel DVI output15. DVI 2 In Secondary channel DVI input16. DVI 1 Out Primary channel DVI output17. DVI 1 In Primary channel DVI input18. SIDNE port Connection to SIDNE console for device control19. SFB connectors ports enables Firewire connection with the Stryker

8Firewire devices20. 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

9RemoteControl

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1. Channel 1 video and image: capture, record, stop2. Channel 2 video and image: capture, record, stop3. Print images4. Display previous image on OSD5. Voice annotation (future use)6. Navigation (future use)7. Select (future use)

10

SetupStryker 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 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.

2. Connect peripheral devices according to the interconnection diagram on the following pages.

Warning WhentheSDCUltraisinterconnectedwithotherelectricaldevices,leakagecurrentsmaybeadditive,resultinginelectromagneticemissionsthatcaninterferewiththenormalfunctionofelectronicmedicalequipment.Toproperlycontrolelectromagneticemissionsandavoidpotentialharmtothepatientoruser,ensureallelectricaldevicesareinstalledandinterconnectedaccordingtotherequirementsofIEC60601-1-1.

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Warning 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.

Note See the Technical Specifications for approved printers and transformers.

3. 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.

12

SettinguptheSDCUltrawiththe1188CameraandSIDNE

Caution Theotherportsnotlistedinthissectionareintendedforusebyservicetechniciansorforfuturedeviceupgrades.Donotconnectanydevicestotheseportsasunexpectedresultsmayoccur.

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SDCUltraNetworkingProtocol Used: FTP (File Transfer Protocol)Setup Requirements

1. A TCP/IP network with DHCP service. SDC Ultra is basically a Win Embedded XP machine. It sends out a DHCP query to request an IP address.

2. An FTP service running with anonymous login enabled.3. A Secure FTP server needs to be installed and configured in the same

way as the other FTP server.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 20 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.

Note SDC Ultra creates a folder which contains the first five characters of the patients last name. All the images and videos (if selected) are then transferred to this folder.

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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.

1. Create a folder under the root folder of the FTP server folder.3. 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

box and enter the password.Directory Structure:

\SDC\Username\?????MMDDYYYY_HHMMSSwhere, ?????: First 13 characters of the Patients Name / ID enteredUsername: Doctors 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.

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

Getting Started

HomeScreen421 3

Select from the following options:1. Press NewCaseto begin a new patient case.2. Press CurrentCase 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 LoadPatientList 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 LoadPatientList button on the Home screen.

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1. Press the Home button to return to the home screen.2. Enter the patient information.

Enter the patients name Enter the patient ID Enter the birth date Enter the sex

3. Select the Surgeon from the drop-down menu. To add or delete an item on the list, press add or delete.

4. Select the procedure from the drop-down menu. 5. Navigational buttons

Press the down arrow to access the secondary screen. 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 PatientList to see a list of all patients that have been

preloaded into the system.6. 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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1. Press Album to view the album of the selected archived case.2. Press Save to save the selected archived case to media. 3. Navigational buttons

Press HardDrive 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.

4. Press the Check-mark icon to select a patient record. 5. Press the Up/Down arrows to scroll through the list of patients. 6. Press Deleteall to delete all patient information stored on the hard

drive.7. Press Delete to delete the selected patients case.

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Capturing Single Channel Images and Videos

Images can be captured from a single or a dual source/channel.To display the Capture screen, press the NewCase or CurrentCase button on the home screen.

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1. Press Home to return to the home screen.2. Select a Patient ID from the drop-down menu.3. Video recording time. 4. Press PatientInformation to enter patient information.5. Press Capture to display the capture screen.6. Press Album to edit or view images or videos.7. Press Save to display the save screen.8. Video size.9. Navigational buttons

Press SingleChannel/DualChannel to toggle between single and double channel mode.

Press VideoSettings to change video options. Press PrinterSettings to change printer options.

10. The number of videos captured.11. The number of images captured. 12. The number of copies to be printed. 13. The number of images to be printed per page. 14 Operational buttons.

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Press Print to print images that have not previously been printed.

Press Stop to stop recording. Press the Record/Pause button to toggle between recording

and pausing the video mode. Press the Capturebutton to begin capturing images.

15 Press the left/right arrow buttons to scroll through images.

RecordingPress the Record button on the Capture screen to record video.

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1. Press the Pause button to pause recording.2. Press the Stop button to stop recording.

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PausingPress the Pause button on the Recording screen to pause video.

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1. Press the Resume button to continue recording.2. Press the Stop button to stop recording.

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Capturing Dual Channel Images and Videos

To capture dual channel images and video, press the DualCapture button on the Capture screen

PIPCaptureModeTo capture images and videos in PIP mode, press the PIP (picture-in-picture) button on the Dual Capture screen.

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1. Press OSD (on screen display) PIP to toggle between turning on or off the PIP on the monitor.

2. Press SingleChannel/DualChannel to toggle between single and double channel mode.

3. Press Print to print images that have not previously been printed.4. Press Stop to stop recording. 5. Press the Record/Pause button to toggle between recording and pausing

the recording mode. 6. Press the Capture button to begin capturing images with PIP.7. Press DualCapture to view and individually control the primary and

secondary sources. 8. Press Synchronize capture to view and simultaneously capture and

record primary and secondary sources.9. Press the PIP button to display the PIP mode.

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SynchronizeCaptureModeTo capture images and video in synchronize mode, press the Synchronize button on the Dual Capture screen.

31 2

1. Press the Capture button to capture images on both channels simultaneously.

2. Press theRecord button to record video on both channels simultaneously.

3. Press the Stop button to stop recording on both channels simultaneously.

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IndividualCaptureModeTo capture images and video in the individual mode, press the Individual button on the Dual Capture screen.

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1. Press Capture to capture images on channel 1.2. Press Record to record video on channel 1.3. Press Stop to stop recording on channel 1.4. Press Capture to capture images on channel 2.5. Press Record to record video on channel 2.6. Press Stop to stop recording on channel 2.

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Editing Video Settings

EditingChannel1VideoSettingsTo edit channel 1 video settings, press the VideoSettings button on the Capture screen.

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1. Select the Record Format from the drop-down menu.2. Select the Camera from the drop-down menu.3. Select the Signal from the drop-down menu. 4. Press the left arrow button to return to the previous screen.

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EditingChannel2VideoSettingsTo edit channel 2 video settings, press the VideoSettings button on the Capture screen and then press the Channel2VideoSettings button.

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1. Select the Record Format from the drop-down menu.2. Select the Camera from the drop-down menu.3. Select the Signal from the drop-down menu.

EditingPIPSettingsTo edit PIP settings, press the VideoSettings button on the Capture screen and then press the PIPsettings button.

1

1. Press the corresponding quadrant to display the location of the picture in picture.

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EditingAdvancedVideoSettingsTo edit advanced video settings, press the VideoSettings button on the Capture screen and then press the MoreSettings button.

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1. Press FlipScreen to choose the image orientation on the OSD.2. Press Mute to toggle between On and Off.3. Press RECDisplay to toggle between On, display live video on the OSD,

and Off. 4. Press LiveVideoTime out to display the amount of time the image is

displayed on the OSD before reverting back to live video.5. Press Remote2Controlto toggle between Pause recording and Stop.6. Press AutoCutOff to toggle between DVD, CD, and None. DVD will

stop recording when it reaches 4 GB, CD when it reaches 600MB, and None keeps recording until the user stops the recording or case size limit of 20GB is reached.

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EditingPrintSettingsTo edit print settings, press the PrintSettings button on the Album screen.

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1. Press the minus or plus sign to indicate the number of copies to print.2. Press the minus or plus sign to indicate the number of images to print

per page.3. Press AdvancedPrinterSettings to edit options. 4. Press PrintsPending to cancel the number of jobs pending to print.5. Press AutoPrint to toggle between On, automatically prints the selected

Images Per Page, and Off.

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EditingAdvancedPrintSettingsTo edit advance print settings, press the PrintSettings button on the Capture screen and then press the MoreSettings button.

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1. Press the corresponding minus or plus buttons to edit the brightness, contrast, phase, chroma, or sharpness of channel 1 or channel 2 images.

2. Press the DefaultSettings to reset the image options to the factory default settings.

3. Press Print to print the selected images.

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Entering Patient Information

To enter patient information, press the PatientInformation button on the Home screen.

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1. Patient information. Enter the last name. Enter the birth date. Enter the sex. Enter the patients ID. Enter the first name.

2. Press the down arrow to display the second data-entry screen. See the Entering Patient Information - Second Data-entry Screen.

3. Select a procedure from the drop-down menu. To add or delete an item to or from the list, press add or delete.

4. Select a surgeon from the drop-down menu. To add or delete an item to or from the list, press add or delete.

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EnteringPatientInformation-SecondData-entryScreen.To enter patient information on the secondary data-entry screen, press the down arrow on the Patient Information screen to display the second data-entry screen.

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1. Enter the facility.2. Enter the accession number.3. Press the up arrow to return to the primary data-entry screen.4. Select a station from the drop-down menu. To add or delete an item on

the list, press add or delete.5. Enter the details.6. Enter the referred, the doctor who referred the patient for surgery. To

add or delete an item on list, press add or delete.

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Viewing and Annotating Images

To view images, press the Album button on the Capture screen and then press the Imagealbum button.

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1. Press the arrow buttons to scroll through the images.2. Press DICOM Album for viewing PACS image information.3. Press ImageAlbum to display the editing screen for the album.4. Press VideoAlbum to annotate video and playback video. 5. Press the arrow buttons to scroll through the images. 6. Press Select/DeselectAll to select or deselect images for printing.7. Press the image twice to display the image in the center.8. Press EditAnnotations to edit or add annotations to images and video. 9. Press Printer to print the images selected.10. Press the image twice to display on the OSD.

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Viewing and Playing Videos

To view and play videos, press the Album button then press the VideoAlbum button.

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1. Press the arrow buttons to scroll through the images.2. Press the Select/DeselectAll button to select or deselect images for

printing and saving.3. Press the Stop button to stop playing the video. 4. Press the small right arrow button to play the video on the OSD.5. Press the Channel button to select which channel to play video.6. Press the Annotate button to go to the annotation screen.

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Viewing and Editing the Video Album

To view and edit the album, press the Annotation button on the video album screen.

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1. Press the Annotations button to bring up the editing annotations screen.

2. Press PlaybackVideo to display the playback mode screen.

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Editing Annotations

To edit annotations, press the ImageAlbum button on the Capture screen and then press the AnnotationVideo button.

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1. Select the specialty from the drop-down menu. To add or delete an item on the list, press add or delete.

2. Select the procedure from the drop-down menu. To add or delete an item on the list, press add or delete.

3. Select the annotation from the drop-down menu. To add or delete an item on the list, press add or delete.

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Saving Information

To save information, press the New or CurrentCase buttons on the Home screen.

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1. Press CD/DVD to save the selected case to a CD or DVD.2. Press Eject to eject the CD or DVD.3. Press USB to save images or video to the USB.4. PressSavetoNetwork to save images or video on the PACS or FTP

network.5. Press SaveSettings to edit the save options.6. Press the network drop-down menu to select a network address.

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Saving Settings

To save settings, press the Save button on the Saving Information screen.

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1. Press ImageFormat to toggle between BMP, JPEG, JPEG2000, TGA, TIFF, and PNG.

2. Press Encryption to toggle between On and Off.3. Press MoreSettings to display more save settings. (See the More Save

Settings section of this manual) 4. Select the destination for writing videos when saving a case to the USB

and the Network.5. To select the Network Type, press the corresponding box.

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MoreSaveSettingsTo adjust more save settings, press the MoreSettings button on the Save screen.

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1. Press the corresponding minus or plus buttons to edit the brightness, contrast, phase, chroma, or sharpness of channel 1 or channel 2 images.

2. Press the DefaultSettings to reset the image options to the factory default settings.

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TroubleshootingThe table below shows the most common errors and possible solutions to each.

Problem SolutionLogin failure Ensure that the correct user name

and password are used to log into the system.

New Case Error Delete archived cases to create free space.

Video limit reached Begin a new case to capture more videos.

Image limit reached Begin a new case to capture more images.

List limit reached The maximum number of cases permitted to be entered has been reached. Delete older entries in the list.

SIDNE Comm Error Ensure that SIDNE is connected properly. Reboot the SDC Ultra and SIDNE.

Error printing. No image captured/selected

Capture images and then select them to print.

Error saving settings To restore previous settings, reboot the system.

FTP connection error Ensure that the FTP server is up and the network cable is plugged in.

Error: Media unavailable Please insert/connect a valid media to the SDC Ultra.

USB space insufficient Ensure that there is free space available on the media.

Error: Disk corrupt. Please try again... The media is corrupt. Insert a new disc to continue.

Error: Disc drive busy Ensure that the disc drive is not being currently used. Reboot the machine if the error persists.

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Error: locating logo.bmp Ensure that the USB cable is connected properly. Ensure that the logo file is present on the USB drive and it is called logo.bmp.

Error: upgrading software Insert the upgrade dongle in the save screen.

Application has encountered a critical error and is shutting down.

Please reboot the system.

No live video on preview Ensure that the camera is on and check the cable connections.

Ensure that the proper video source is selected.

If the video is routed through SIDNE, ensure that SIDNE is powered on.

No live video on the monitor Check the cable connections Ensure that the camera is powered

on. Ensure that the proper video source

is selected. If the video is routed through

SIDNE, ensure that SIDNE is powered on.

No live video in PIP on preview Check the cable connections Ensure that the camera is powered

on. Ensure that the proper video source

is selected. If the video is routed through

SIDNE, ensure that SIDNE is powered on.

Ensure that you are in PIP mode.No live video PIP on monitor Check the cable connections.

Ensure that the camera is powered on.

Ensure that the proper video source is selected.

If the video is routed through SIDNE, ensure that SIDNE is powered on.

Ensure that the monitor OSD PIP is enabled via the application.

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Print errors Ensure there arent any paper jams. Ensure the printer has enough ink.. Ensure the printer door is closed. Ensure the printer has paper. Ensure the printer is powered on. Ensure the printer cable is

connected..Error saving more than 4GB files to the USB

Ensure that the USB is formatted as NTFS. FAT 32 will not support any file size bigger than 4GB.

Error reading archived cases from DVD/CD

Reboot the system if you have just written the case. Check the disc on a different system.

No videos written to the USB Ensure write videos to USB in the save settings is selected.

No videos written to the network Ensure write videos to Network in the save settings is selected.

Selecting the security feature Ensure that the user names and passwords for the system have been setup before you select the security feature

Annotation list is blank Ensure that a procedure is selected in the Patient information screen in order to enable the annotation list.

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Cleaning and Maintenance

Cleaning

Should the unit need cleaning, wipe it down with a sterile cloth.

Warning Toavoidelectricshockandpotentiallyfatalinjury,unplugtheSDCUltrafromtheelectricaloutletbeforecleaning.

Caution Donotimmersetheconsoleinanyliquidasproductdamagewillresult.

Caution Donotusealcohol,solvents,orcleaningsolutionsthatcontainammoniatocleantheunit,asproductdamagemayresult.

Caution Donotsterilizetheunitasproductdamagemayresult.

Maintenance

SDC Ultra requires no preventative or periodic maintenance. However, Stryker recommends you reboot the system daily for best performance.

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Technical Specifications

Environmental Specifications

Operating temperature: 10 40COperating humidity: 30 75% RHShipping temperature: -20 60CShipping humidity: 10 85% RH

System Type

MPEG -1 or -2 compression engine with full IBP encoding

Video Inputs

1 S-Video, 1 Composite2 DVI and 2 RGBHV (via DVI-I connectors)

Video Outputs

1 S-Video, 1 Composite2 DVI and 2 RGBHV (via DVI-I connectors)

Audio

Stereo Line and Microphone input2 speaker outputs

Image Resolution

Progressive scan image capture: 1280 1024

Disc Capacity

100 images and 99 video files, with auto cutoff for CD (600MB), DVD (4.0 GB), or none (20 GB, maximum case size permitted)

File Format

Images: Bitmap (BMP), JPEG, JPEG2K, Tagged Image File Format (TIFF), Truevision Targa (TGA), and Portable Network Graphics (PNG) Videos: MPEG-1 and MPEG-2

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Disc Recording Formats

CD-R, DVD-R, DVD+R (single session), DVD+RW

USB

NTFS format supportedMAC users will only have read capabilities

Remote Control

Wireless infrared, camera head triggering

Power Consumption

100 240VAC~ 50/60Hz, 4A maximum

Safety and EMC Compliance

IEC 60601-1:1988 + A1:1991 + A2:1995CAN/CSA C22.2 No.601.1-M90 UL 60601-1:2003AS/NZS 3200.1.0:1998IEC 60601-1-1:2000IEC 60601-1-2:2001 + A1:2004IEC 60601-1-4:1996 + A1:1999

Equipment Classification

Class I equipmentNo applied partWater ingress protection, IPX0Continuous Operation

Size (control unit)

12.5" W 16.2" D 7.0" H

Network

10/100 Mbps ethernet

Auto Printing

1, 2, 4, 6, 8, 12, or18 images per page

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Printers Supported

HP 8250HP D7160

Isolation Transformer

Stryker 240-099-050 (2KVA transformer)Stryker 240-050-705 (180VA transformer)

Display

8" TFT LCD, with digital touch screen

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Electromagnetic CompatibilityLike other electrical medical equipment, SDC Ultra requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), SDC Ultra must be installed and operated according to the EMC information provided in this manual.The SDC Ultra has been designed and tested to comply with IEC 60601-1-2:2001 requirements for EMC with other devices.

Caution PortableandmobileRFcommunicationsequipmentmayaffectthenormalfunctionoftheSDCUltra.

Caution DonotusecablesoraccessoriesotherthanthoseprovidedwiththeSDCUltra,asthismayresultinincreasedelectromagneticemissionsordecreasedimmunitytosuchemissions.

Caution IftheSDCUltraisusedadjacenttoorstackedwithotherequipment,observeandverifynormaloperationoftheSDCUltraintheconfigurationinwhichitwillbeusedpriortousingitinasurgicalprocedure.ConsultthetablesbelowforguidanceinplacingtheSDCUltra

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Guidance and Manufacturers Declaration: Electromagnetic Emissions

SDC Ultra is intended for use in the electromagnetic environment specified below. The customer or the user of SDC Ultra should ensure that it is used in such an environment.

Emissions test Compliance Electromagnetic Environment - guidance

RF emissions CISPR 11 Group 1

SDC Ultra uses RF energy only for its internal function; therefore, its RF emissions are very low and are not likely to cause any

interference in nearby electronic equipment.

RF emissions CISPR 11 Class ASDC Ultra is suitable for use in all

establishments, including domestic establishments and those directly connected

to the public low-voltage power supply network that supplies buildings used for

domestic purposes, provided the following warning is heeded:

Warning: This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigating measures such as reorienting or relocating the system or shielding the location.

Harmonic emissions IEC61000-3-2 Class A

Voltage Fluctuations/ flicker emissions IEC61000-3-3 Complies

47

Guidance and Manufacturers Declaration--Electromagnetic Immunity

The SDC Ultra system is intended for use in the electromagnetic environment specified below. The user of the SDC Ultra system should ensure that it is used in such an environment.

Immunity Test IEC 60601 Test LevelCompliance

LevelElectromagnetic Environment--

Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the SDC Ultra system,

including its cables, than the recommended separation distance calculated from the

equation applicable to the frequency of the transmitter.

Recommended Separation Distance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz 3 V d = 1.17P

Radiated RFIEC 61000-4-3

3 V/m80 MHz to 2.5 GHz

3 V/md = 1.17P 80 MHz to 800 MHzd = 2.33P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (a), should be less that the compliance level in each frequency range (b).Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SDC Ultra system is used exceeds the applicable RF compliance level above, the SDC Ultra system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SDC Ultra unit.

(b) Over the frequency range 150 kHz to 80 Mhz, field strengths should be less than 3 V/m.

48

Guidance and Manufacturers Declaration: Electromagnetic Immunity


Immunity Test IEC 60601 test level Compliance LevelElectromagnetic

Environment - guidance

Electrostatic Discharge (ESD) IEC61000-4-2

6kV contact 8kV air 2,4,6kV contact 2,4,8kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with

synthetic material, the relative humidity should

be at least 30%.

Electrical fast transient/burst IEC61000-4-4

2kV for power supply

lines2kV for power supply lines Mains power quality

should be that of a typical commercial or hospital environment

1kV for input/output

lines1kV for input/output lines

Surge IEC61000-4-5

1kV differential

mode0.5, 1kV differential mode Mains power quality

should be that of a typical commercial or hospital environment

2kV common

mode0.5,1, 2kV common mode

Voltage dips, short interruptions and voltage variations on power supply

input lines IEC61000-4-11

95% dip

in Ut) for 0.5 cycle

95% dip in Ut) for 0.5 cycle

Mains power quality should be that of a

typical commercial or hospital environment.

If the user of SDC Ultra requires continued

operation during power mains interruptions, it is recommended that SDC Ultra be powered from

an uninterruptible power supply or a battery.

40% Ut (60% dip in Ut) for

5 cycles

40% Ut (60% dip in Ut) for 5 cycles

70% Ut (30% dip in Ut) for

25 cycles

70% Ut (30% dip in Ut) for 25 cycles

95% dip in Ut) for 5 sec

95% dip in Ut) for 5 sec

Power frequency (50/60Hz) magnetic field IEC 61000-4-8

3 A/m 3 A/m Not Applicable

NOTE Ut is the a.c. mains voltage prior to application of the test level.

49

Guidance and Manufacturers Declaration: Electromagnetic Immunity


(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) tele-phones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast, can-not be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SDC Ultra system is used exceeds the applicable RF compliance level above, the SDC Ultra system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SDC Ultra unit.(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

50

Recommended Separation Distances Between Portable and Mobile RF CommunicationsEquipment and the SDC Ultra System

The SDC Ultra system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the SDC Ultra system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications

equipment (transmitters) and the SDC Ultra system as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power (W) of transmitter

Separation distance (m) according to frequency of transmitter

150 kHz to 80 MHzd = 1.17P

80 kHz to 800 MHz d = 1.17P

800 kHz to 2.5 GHz d = 1.17P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

51

WarrantyThe warranty set forth herein is exclusive and in lieu of all other warranties, remedies, obligations, and liabilities of Stryker Endoscopy, expressed or implied, including the implied warranties of merchantability and fitness for use and of consequential damages. This product is being sold only for the purpose described herein. In no event shall Stryker Endoscopy be liable for any breach of warranty in any amount exceeding the purchase price of the product.Stryker Endoscopy warrants this product against defects in both materials and workmanship to the registered owner at the time of purchase. This warranty is valid only to the original purchaser of Stryker Endoscopy products directly from a Stryker Endoscopy authorized agent. The warranty cannot be transferred or assigned by the original purchaser.The purchaser is responsible for returning defective equipment to the factory at his or her own expense. Stryker Endoscopy or its representative will service the equipment, repair or replace any defective parts thereof, and return it to the purchaser.This warranty does not apply to any product that has been subject to misuse, neglect, or improper installation, or has been altered, adjusted, or tampered with by any person other than Stryker Endoscopy authorized personnel. If, upon examination by authorized service personnel, it is determined that the malfunction is due to misuse or abuse, warranty provisions will not apply. An estimate of the cost of repair work will be given to the purchaser prior to servicing and repairing the product.Products repaired under Stryker Endoscopys standard repair program will be issued a thirty-day warranty against defects in both materials and workmanship, provided the original warranty period has passed. Products submitted due to defects in materials and workmanship during the warranty period will be repaired at no charge to the purchaser.No agent, employee, or representative of Stryker Endoscopy has the authority to bind the Company to any other warranty, affirmation, or representation concerning this product.All components are covered by warranty for one year as described above. This warranty applies to customers in the United States only. Outside of the USA, contact your Stryker sales representative or your local Stryker subsidiary.

Note The device described in this manual is continually being reviewed, and improvements may be made without notice.

52

Services and ClaimsIf service is needed either during or after the warranty period:

1. Contact Stryker Endoscopy at 1-800-642-4422 or phone your local Stryker Endoscopy sales representative.

2. When returning equipment for service, package all the components carefully in the original shipping container, if possible.

3. Ship the unit, prepaid and insured, to your local Stryker Endoscopy distributor or to:

Stryker Endoscopy Customer Service Attention: Repair Department 5900 Optical Court San Jose, CA 95138, USAStryker is a registered trademark of Stryker Corporation

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-408-754-2000, 1-800-624-4422 www.stryker.com

European Representative: Regulatory Manager, Stryker France ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex, France

2007/08 www.stryker.com 1000-401-050 B

Documents

Stryker_SDC Ultra- User Manual Guide