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Stryker Endoscopy

5900 Optical Court, San Jose, CA 95138

APPROVALS DATE TITLE
DRAWN BY:
SDC Ultra - Manual Quality Inspection Procedure
Mary Ann Mondala 10/11/07
ORIGINATOR
Mary Ann Mondala 10/11/07
SIZE REV DOCUMENT NO. SHEET OF
A C MAP0575.QIP 1 25
REVISIONS REVISIONS
LTR ECN NO. DATE APPROVED LTR ECN NO. DATE APPROVED
A ECO106857 8/10/07 S/ M. Voskerician
B ECO107398 8/31/07 S/ P. Brar
C ECO108060 10/11/07 S/ M. Mondala

MAP0575.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 1 of 25

Equipment List
Part Description Part Number Qty. Required
SK 18 System SDC Ultra 105-206-688 1 per station
SV2 Flat Panel Monitor and/or 105-203-723 or 2 per station
SVE Flat Panel Monitor 105-206-853
DVI-I Cables 105-198-707 4 per station
S-Video Cables 105-150-908 2 per station
1188HD CCU 105-206-600 2 per station
1188HD Camera Head 105-206-515 2 per station
1188HD Coupler 105-206-366 2 per station
Arthroscope, 4mm 30degree or Equivalent 105-187-696 1 per station
X7000 Lightsource or Equivalent 105-199-580 1 per station
SIDNE HD 105-204-375 1 per station
Switchpoint Infinity Routing System 1 per station
R1, R2 Remote Cable 105-170-599 2 per station
Media, DVD-R 105-203-210 1 per station
Hospital Power Cord 105-033-001 6 per station
External USB Hard Drive 105-204-470 1 per station
HP D7160 Printer 105-208-440 1 per station
Stereo Cable N/A 1 per station
SDC Ultra Remote Control 105-208-352 1 per station
Label, Warranty Violation 1000-201-096 1 per station
License, Windows XPE 1000-301-239 1 per station
Label, Vitec SDC Ultra License 1000-207-315 1 per station

MAP0575.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 2 of 25

MAP0575. The chassis cover and bottom tray should fit snug with no gaps. Cosmetic Inspection 9 Circle Pass or Fail on the DHR Step 30 – Hipot Test ! Always check the hi-pot tester for proper functionality prior to use by hitting the test button and touching the leads. 2. LCD hinges not too loose or tight Patent b. 9 Circle Pass or Fail on the DHR 3. 4. The hi-pot tester should emit the “fail” sound ! Always do this test before the Electrical Safety Test. The rejection must also be documented in the rejection box on the DHR Step 20 – Labeling and Cosmetic Inspection Stryker Serial Number Vitec Serial Number 1. Plug the test fixture into the back of the unit. 2. Verify the SDC patent label is on the back of the unit. Eject remote control twice and replace Label 6.DHR) following completion of each test. 2. Energize the Hi-Pot tester and adjust the voltage by turning the adjusting knob until the meter reads 1. Mechanical Calibration Check SDC a. Hold the SDC Ultra upside-down and shake lightly left to right and up and down to verify that there are no loose components inside. Non-conforming Product (if product needs to be rejected) 9 All non-conforming values are to be recorded on the DHR and noted as having been rejected.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 3 of 25 . Verify the Stryker Serial Number and Vitec Serial Number on the unit is in accordance with the DHR. ! Do not test the unit for more than 1 second or internal damage can occur.8KV.Step 10 – Device History Record and General Requirements 1. All data must be recorded on the Device History Record (MAP0575. 5. 1.

After the test is completed. Staple the printout from the Bio-Tek to the DHR. press “Next” to continue. Press the “Start Test” softkey to start the test. Reference QIP-0054 protocol. 4. 9 Document results of Bio-Tek Electrical Safety Test by circling Pass or Fail on the DHR accordingly MAP0575. 3. press “Next” twice to start the printout. After the protective earth resistance measurement is taken. Press the “Auto” softkey for auto mode sequence. document the Serial Number of the unit on the printout from the Bio-Tek Safety Analyzer. attaching the power cord from the analyzer to the plug and the red clip to the ground post. 9 Verify that the hi-pot does not emit the “Fail” sound and circle Pass or Fail on the DHR Step 40 – Electrical Safety Test 1. Test the unit by running the program number 2. c. Connect the Bio-Tek Safety Analyzer to the unit. b. f. 2. 3. press “enter”. Enter control number “2” and then. Type B in accordance to the following steps: a.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 4 of 25 . 4. e. Touch the positive (red) probe to the hi-pot test fixture and press “Test” on the Hi-Pot tester for 1 second. d. Upon completion of testing. Press the “Automodes” softkey to display the next menu. Connect the Bio-Tek to a 240v transformer for this test. Connect an alligator clip to the ground post of the unit. 5.

13.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 5 of 25 . 8. Connect a power cord to the SDC Ultra. 11. Connect a DVI-I cable from a DVI input on the Infinity router to the SDC Ultra Channel 1 DVI output. Connect an SVHS cable from the second 1188HD Camera to the SDC Ultra SVHS input. Connect a DVI-I cable from the Channel 2 Stryker Vision monitor to the SDC Ultra Channel 2 DVI output. Connect an external USB hard drive to the USB port on the front of the SDC Ultra. Connect a remote cable from the first 1188HD Camera R1 output to the SDC Ultra Channel 1 R1 input. 3. Connect an SVHS cable from the Channel 2 SV2 Monitor to the SDC Ultra SVHS output. and finally to the SV2 Channel 1 monitor. Connect a USB cable from the SIDNE HD device control to a USB port on the rear panel of the SDC Ultra. Infinity route detailed in step 15 2. 6. Connect a DVI-I cable from the output of the second 1188HD Camera to the SDC Ultra Channel 2 DVI input. 7. 10. Connect a DVI-I cable from an output of the Infinity Note: If no Infinity Present. then through the SDC Ultra Channel 1. 12. 15. Connect a stereo cable from the SIDNE HD to the SDC Ultra Line In. 5. Connect a remote cable from the first 1188HD Camera R2 output to the SDC Ultra Channel 1 R2 input. Use the Infinity to route the first 1188HD Camera DVI output through the SIDNE HD first. MAP0575. Turn on all support test equipment. Connect the HP printer USB cable to a USB port on the rear panel of the SDC Ultra. 14. 9.Step 50 – Equipment Setup 1. ensure that the direct DVI route corresponds to the router to the SDC Ultra Channel 1 DVI input. 4.

Turn on the unit. If applicable. MAP0575.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 6 of 25 . verify that the unit serial number has been properly registered on SMS by visiting the device management system @ mystryker.com.Step 60 – Dual Channel Independent Mode Settings 1. agree to create a new case by pressing the check button to enter the capture screen. 3. press the “New Case” button to enter the capture screen. From the home screen. While the unit is booting up. 9 Mark Pass or Fail on the DHR 2.

9 Verify proper live video output on the Channel 1 and Channel 2 DVI monitors MAP0575. 5. Press the Channel 2 button . 6. From the Camera drop down menu. Switch to dual channel mode by selecting the dual camera head button . Set the Record Format to “MPEG 1” 10. Press the “Left Arrow” button to return to the capture screen.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 7 of 25 . 7. Press the “Video Setting” button to enter the video configuration screen. From the drop down menu select DVI 8. 4. ensure that the camera type is set to “1188” 9.

9 Verify “REC STOPPED” OSD displays properly on each DVI output. 5. press both capture buttons twice to capture two images from EACH channel.Step 70 – Capturing and Viewing Dual Channel Images and Videos (DVI MPEG 2 HD and DVI MPEG 1) Using Touch Screen 1. 3. Repeat the following statement into the microphone “Testing 1 2 3”.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 8 of 25 . During the recording. 8. 9 Verify that both preview windows display the proper live video 2. Insert a DVD –R disc. Press the “Save” tab on the screen top right. Press the stop button for both primary and secondary channels to stop the recording on both channels when the recording reaches approximately 10 sec. 4. Press the DVD button to close the DVD tray. Press the dual channel independent mode button to enter independent mode. Press the record button for both primary and secondary channels. 9 Verify that the images flash in the flip screen on the left side of each monitor. Begin recording a 10 sec video using the touch screen. 7. 9 Verify that the images flash on the capture screen. MAP0575. Press the DVD button on the front panel to open the DVD tray. 6. 9 Verify “Recording” shows up in the information bar and the “REC1” and “REC2” OSD displays properly on each DVI output.

the DVD tray will open. 9 Verify voice message: “ Digital Capture Saving Data” 10. Press the “Home” tab on the screen top left.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 9 of 25 . 12. Press the “Save to CD/DVD” button to save the case to the DVD media. Press the “Archive” button to enter the Archive screen. Upon successful completion of saving. Close the DVD tray by pressing the DVD tray open/close button . 11. MAP0575. 9.

14. ! Prior to the next step ensure that the DVD tray has been closed as required by step 10. 18. 13. Select (highlight) the current case from the list. 9 Verify that the image shows up on the center thumbnail (Note: there is a certain timing associated with this function. double-tapping will only de-select and re-select the image) 17. Select the “Image/Video Album” tab . ! It may take a while for the SDC Ultra to access the case data from the DVD. Double tap an image from the bottom panel. Double tap the image at the center panel. Press the “Video Album” button . MAP0575. if the timing is not proper. double-tapping will only de-select and re-select the image) 9 Scroll through all 4 images and review the quality of all captured images. if the timing is not proper. 9 Verify that the full image flashes on the Channel 1 Monitor (Note: there is a certain timing associated with this function.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 10 of 25 . 16. 15. Select the “CD/DVD” button to see the content of the DVD media. be patient.

19. Press the DVD button on the front panel to close the DVD tray. 9 Review the video for proper quality 23. 9 Verify the video plays back properly on the Channel 1 DVI monitor. Select the second video using the scroll button . 26.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 11 of 25 . Press the “Play” button to review the quality of the second video. Press the “Channel Select” button to select Channel 2 for playback. 21. Press the “Current Case” button to enter the capture screen. Remove the DVD. Press the “Home” tab on the screen top left. 22. 9 Verify the video plays back properly on the Channel 2 DVI monitor. 24. 25. 9 Review the video for proper quality 9 Verify the audio “Testing 1 2 3” can be properly heard 20. Press the “Play” button to review the quality of the first video. Press the DVD button on the front panel to open the DVD tray. 9 Verify thumbnails are present for both videos recorded. MAP0575.

2. Press the “Video Setting” button to enter the video configuration screen. 3. 4. Set the Record Format to “MPEG 2” MAP0575. Press “PIP Mode” button to enter into PIP mode. Press the Channel 1 button .Step 80 – Dual Channel PIP Mode Settings 1.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 12 of 25 .

9 Verify that the Channel 2 monitor properly displays the live S-Video output. From the Camera drop down menu. 10. ensure that the camera type is set to “1188” 8. Press the “Left Arrow” button to return to the capture screen. 9 Verify that the Channel 1 DVI monitor properly displays the Channel 1 DVI output as the background and the SVHS input as the PIP in the bottom right corner 12. 9. 6. MAP0575. Switch the Channel 2 monitor to S-Video input mode. Press the Channel 2 button . Verify the Record Format is set to “MPEG 2” and grayed out. 11. Press the “OSD PIP Enable” button to enable the PIP on the Channel 1 DVI monitor. 9 Verify that the preview and the Channel 1 DVI monitor properly contain the Channel 1 DVI input as the background and the SVHS input as the PIP in the bottom right corner. Press the “OSD PIP Disable” button to disable the PIP on the Channel 1 DVI monitor.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 13 of 25 . From the drop down menu select s-video 7. 5. 9 Verify that the Channel 1 DVI monitor only displays the Channel 1 DVI output and not the PIP image.

Step 90 – Capturing and Viewing Dual Channel Images and Videos (DVI MPEG 2 and S-Video MPEG 2) Using Remote Control and Camera Head 1. 5. Press the “Image/Video Album” tab to enter the Image Album screen. 9 Verify “Recording” shows up in the information bar and the “REC” OSD displays properly on the Channel 1 DVI monitor. 9 Verify the “PAUSE” OSD displays properly on the Channel 1 DVI monitor. Begin recording a 10 sec video using the SDC Ultra remote control by pressing the ‘Record’ button. Press the ‘Stop‘ button on the remote control to stop the recording. MAP0575. During the recording. 9 Verify that the flashed images properly contain the background and PIP images.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 14 of 25 . 4. 9 Verify that the images flash on the capture screen. 3. 2. Verify the printer properly prints the images. 9 Scroll through PIP images and review the quality of all captured images. 9 Verify the auto print job is sent to the printer. 9 Verify “REC STOPPED” OSD displays properly on the Channel 1 DVI monitor. capture two images by pressing the ‘Capture’ button on the remote control. 9 Verify that the images flash in the flip screen on the Channel 1 DVI monitor. Press and hold the Camera Head ‘P’ button to pause the recording when the recording reaches approximately 10 seconds.

Press the “Play” button to review the quality of the PIP video. MAP0575. 11. 8. Select the PIP video using the scroll button . 9. 9 Review the video for proper quality. Press the “Video Album” button to enter the Video Album screen. 7. ensuring both the background and PIP videos are present 10. 6. 9 Verify the video plays back properly on the Channel 2 DVI monitor. Press the “Save” tab on the screen top right. Press the “Save Settings” button to enter the save settings screen. Switch the Channel 2 monitor to DVI input mode.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 15 of 25 .

14. 13. 12. Press the “USB Save” button to save the current case to the external USB hard drive. MAP0575. Press the “Home” tab on the screen top left. 15. Verify the “USB Write Videos” check box is checked to ensure that recorded videos are written to the USB hard drive. Press the “Left Arrow” button to return to the save screen.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 16 of 25 .

19. 17. Select the “USB” button to see the content of the USB hard drive. 16. Select the “Image/Video Album” tab . MAP0575.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 17 of 25 . Press the “Archive” button to enter the Archive screen. 18. Select (highlight) the current case from the list.

QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 18 of 25 . MAP0575. The third video thumbnail should have a PIP image 21. Press the “Video Album” button . Press the “Home” tab on the screen top left. The last two image thumbnails should have a PIP image. 9 Verify the presence of six image thumbnails. 20. 9 Verify the presence of three video thumbnails.

22. 23.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 19 of 25 . Press the “Video Setting” button to enter the video configuration screen. MAP0575. Press the “Current Case” button to enter the capture screen.

QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 20 of 25 . Press the Channel 1 button . 9 Verify proper live video output on the Channel 1 DVI monitor MAP0575. Press the “Left Arrow” button to return to the capture screen. Step 100 – Single Channel Mode Settings 1. Switch to single channel mode by pressing the single camera head button . 24. Set the Record Format to “MPEG 2 HD” 26. 25.

Step 110 – Capturing and Viewing Single Channel Images and Videos (DVI MPEG 2 HD) Using Sidne Voice and Camera Head 1. Press the “Video Album” button to enter the Video Album screen. STOP” 4. Press and release the Camera Head ‘P’ button immediately. DIGITAL CAPTURE. 9 Verify that the images flash on the capture screen. “SIDNE. RECORD” 9 Verify “Recording” shows up in the information bar and the “REC1” OSD displays properly on the Channel 1 DVI monitor. 9 Verify that the images flash in the flip screen on the monitor. MAP0575. DIGITAL CAPTURE. 9 Scroll through and review the quality of the latest captured images 5. Stop the recording when the recording reaches approximately 10 sec by using the SIDNE voice command. capture two images using the Camera Head. During the recording. “SIDNE. 3.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 21 of 25 . Press the “Image/Video Album” tab to enter the Image Album screen. Begin recording a 10 sec video using the SIDNE voice command. 2.

MAP0575. Press the “Play” button to review the quality of the last video recorded. Press the “Channel Select” button to select Channel 1 for playback. 8. Select the last video recorded using the scroll button . Press the “New Case” button to create a new case. Press the “Home” tab on the screen top left.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 22 of 25 . Press the “Check” button to agree to create a new case. 9 Verify the video plays back properly on the Channel 1 DVI monitor. 2. 9 Review the video for proper quality Step 120 – Securing the SDC Ultra 1. 3. 4. 7. 6. Press the “Home” tab on the screen top left.

Press the “Archive” button to enter the Archive screen. 5. 6. MAP0575.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 23 of 25 . Press the “Delete All Prior Cases” button to delete all prior cases from the archive.

QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 24 of 25 . 7. 9 Verify all cases are properly cleared from the archive 8. 9. Disconnect all cables from the SDC Ultra MAP0575. Press the “Check” button to agree to delete all prior cases. Press the power button on the front panel to shut down the unit.

Label.Step 130 – Final Labeling 1. Label. Attach the following labels to the unit (see picture to the SDC Ultra License right): a.QIP Rev C – SDC Ultra Manual Quality Inspection Procedure Page 25 of 25 . Vitec SDC Ultra License (1000-207-315) 9 Circle Pass or Fail on the DHR to document completion of the final labeling License. License. Vitec 2. Warranty Violation (1000-201-096) b. Label. Windows XPE MAP0575. Warranty Violation Label. Windows XPE (1000-301-239) c. Turn the unit over.