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

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 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

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Step 10 – Device History Record and General Requirements

1. All data must be recorded on the Device History Record

(MAP0575.DHR) following completion of each test.
2. 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. 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. Verify the Stryker Serial Number and Vitec Serial
Number on the unit is in accordance with the DHR.
2. Verify the SDC patent label is on the back of the unit.
9 Circle Pass or Fail on the DHR
3. The chassis cover and bottom tray should fit snug with no
gaps.
4. 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.
5. Mechanical Calibration Check SDC
a. LCD hinges not too loose or tight Patent
b. Eject remote control twice and replace Label
6. 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. The hi-pot tester should emit the “fail” sound
! Always do this test before the Electrical Safety Test.
! Do not test the unit for more than 1 second or internal
damage can occur.
1. Energize the Hi-Pot tester and adjust the voltage by
turning the adjusting knob until the meter reads 1.8KV.
2. Plug the test fixture into the back of the unit.

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 3. Connect an alligator clip to the ground post of the unit.
4. Touch the positive (red) probe to the hi-pot test fixture
and press “Test” on the Hi-Pot tester for 1 second.
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. Connect the Bio-Tek Safety Analyzer to the unit,

attaching the power cord from the analyzer to the plug
and the red clip to the ground post. Connect the Bio-Tek
to a 240v transformer for this test.
2. Reference QIP-0054 protocol.
3. Test the unit by running the program number 2, Type B
in accordance to the following steps:
a. Press the “Automodes” softkey to display the
next menu.
b. Press the “Auto” softkey for auto mode sequence.
c. Enter control number “2” and then, press “enter”.
d. Press the “Start Test” softkey to start the test.
e. After the protective earth resistance measurement
is taken, press “Next” to continue.
f. After the test is completed, press “Next” twice to
start the printout.
4. Upon completion of testing, document the Serial Number
of the unit on the printout from the Bio-Tek Safety
Analyzer.
5. Staple the printout from the Bio-Tek to the DHR.
9 Document results of Bio-Tek Electrical Safety Test by
circling Pass or Fail on the DHR accordingly

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Step 50 – Equipment Setup

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

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Step 60 – Dual Channel Independent Mode Settings

1. Turn on the unit. While the unit is booting up, verify that
the unit serial number has been properly registered on
SMS by visiting the device management system @
mystryker.com.
9 Mark Pass or Fail on the DHR
2. From the home screen, press the “New Case” button

to enter the capture screen.

3. If applicable, agree to create a new case by pressing the

check button to enter the capture screen.

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 4. Switch to dual channel mode by selecting the dual

camera head button .

5. Press the “Video Setting” button to enter the

video configuration screen.

6. Press the Channel 2 button .

7. From the drop down menu select DVI
8. From the Camera drop down menu, ensure that the

camera type is set to “1188”

9. Set the Record Format to “MPEG 1”

10. Press the “Left Arrow” button to return to the

capture screen.
9 Verify proper live video output on the Channel 1 and
Channel 2 DVI monitors

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Step 70 – Capturing and Viewing Dual Channel Images and
Videos (DVI MPEG 2 HD and DVI MPEG 1) Using Touch
Screen

1. Press the dual channel independent mode button to

enter independent mode.
9 Verify that both preview windows display the proper live
video
2. Begin recording a 10 sec video using the touch screen.

Press the record button for both primary and

secondary channels.
9 Verify “Recording” shows up in the information bar and
the “REC1” and “REC2” OSD displays properly on each
DVI output.

3. During the recording, press both capture buttons

twice to capture two images from EACH channel.
9 Verify that the images flash in the flip screen on the left
side of each monitor.
9 Verify that the images flash on the capture screen.
4. Repeat the following statement into the microphone
“Testing 1 2 3”.

5. Press the stop button for both primary and

secondary channels to stop the recording on both
channels when the recording reaches approximately 10
sec.
9 Verify “REC STOPPED” OSD displays properly on each
DVI output.
6. Press the DVD button on the front panel to open the
DVD tray.
7. Insert a DVD –R disc. Press the DVD button to close the
DVD tray.

8. Press the “Save” tab on the screen top right.

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 9. Press the “Save to CD/DVD” button to save the
case to the DVD media.
9 Verify voice message: “ Digital Capture Saving Data”
10. Upon successful completion of saving, the DVD tray will
open. Close the DVD tray by pressing the DVD tray

open/close button .

11. Press the “Home” tab on the screen top left.

12. Press the “Archive” button to enter the Archive

screen.

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 ! Prior to the next step ensure that the DVD tray has been
closed as required by step 10.

13. Select the “CD/DVD” button to see the content of

the DVD media.

! It may take a while for the SDC Ultra to access the case
data from the DVD; be patient.

14. Select (highlight) the current case from the list.

15. Select the “Image/Video Album” tab .

16. Double tap an image from the bottom panel.

9 Verify that the image shows up on the center thumbnail
(Note: there is a certain timing associated with this
function; if the timing is not proper, double-tapping will
only de-select and re-select the image)
17. Double tap the image at the center panel.
9 Verify that the full image flashes on the Channel 1
Monitor (Note: there is a certain timing associated with
this function; 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.

18. Press the “Video Album” button .

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 9 Verify thumbnails are present for both videos recorded.

19. Press the “Play” button to review the quality of the

first video.
9 Verify the video plays back properly on the Channel 1
DVI monitor.
9 Review the video for proper quality
9 Verify the audio “Testing 1 2 3” can be properly heard

20. Select the second video using the scroll button .

21. Press the “Channel Select” button to

select Channel 2 for playback.

22. Press the “Play” button to review the quality of

the second video.
9 Verify the video plays back properly on the Channel 2
DVI monitor.
9 Review the video for proper quality

23. Press the “Home” tab on the screen top left.

24. Press the “Current Case” button to enter the

capture screen.
25. Press the DVD button on the front panel to open the
DVD tray.
26. Remove the DVD. Press the DVD button on the front
panel to close the DVD tray.

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Step 80 – Dual Channel PIP Mode Settings

1. Press “PIP Mode” button to enter into PIP mode.

2. Press the “Video Setting” button to enter the

video configuration screen.

3. Press the Channel 1 button .

4. Set the Record Format to “MPEG 2”

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 5. Press the Channel 2 button .
6. From the drop down menu select s-video
7. From the Camera drop down menu, ensure that the

camera type is set to “1188”

8. Verify the Record Format is set to “MPEG 2” and grayed
out.

9. Press the “Left Arrow” button to return to the

capture screen.

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.

10. Press the “OSD PIP Disable” button to disable the

PIP on the Channel 1 DVI monitor.
9 Verify that the Channel 1 DVI monitor only displays the
Channel 1 DVI output and not the PIP image.

11. Press the “OSD PIP Enable” button to enable the

PIP on the Channel 1 DVI monitor.
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. Switch the Channel 2 monitor to S-Video input mode.
9 Verify that the Channel 2 monitor properly displays the
live S-Video output.

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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. Begin recording a 10 sec video using the SDC Ultra

remote control by pressing the ‘Record’ button.
9 Verify “Recording” shows up in the information bar and
the “REC” OSD displays properly on the Channel 1 DVI
monitor.
2. During the recording, 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.
9 Verify that the images flash on the capture screen.
9 Verify that the flashed images properly contain the
background and PIP images.
9 Verify the auto print job is sent to the printer. Verify the
printer properly prints the images.
3. Press and hold the Camera Head ‘P’ button to pause the
recording when the recording reaches approximately 10
seconds.
9 Verify the “PAUSE” OSD displays properly on the
Channel 1 DVI monitor.
4. Press the ‘Stop‘ button on the remote control to stop the
recording.
9 Verify “REC STOPPED” OSD displays properly on the
Channel 1 DVI monitor.

5. Press the “Image/Video Album” tab to enter

the Image Album screen.
9 Scroll through PIP images and review the quality of all
captured images.

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 6. Press the “Video Album” button to enter the
Video Album screen.

7. Select the PIP video using the scroll button .

8. Switch the Channel 2 monitor to DVI input mode.

9. Press the “Play” button to review the quality of

the PIP video.
9 Verify the video plays back properly on the Channel 2
DVI monitor.
9 Review the video for proper quality, ensuring both the
background and PIP videos are present

10. Press the “Save” tab on the screen top right.

11. Press the “Save Settings” button to enter the save

settings screen.

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 12. Verify the “USB Write Videos” check box
is checked to ensure that recorded videos are written to
the USB hard drive.

13. Press the “Left Arrow” button to return to the

save screen.

14. Press the “USB Save” button to save the current

case to the external USB hard drive.

15. Press the “Home” tab on the screen top left.

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 16. Press the “Archive” button to enter the Archive
screen.

17. Select the “USB” button to see the content of the

USB hard drive.
18. Select (highlight) the current case from the list.

19. Select the “Image/Video Album” tab .

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 9 Verify the presence of six image thumbnails. The last
two image thumbnails should have a PIP image.

20. Press the “Video Album” button .

9 Verify the presence of three video thumbnails. The third

video thumbnail should have a PIP image

21. Press the “Home” tab on the screen top left.

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 22. Press the “Current Case” button to enter the
capture screen.

23. Press the “Video Setting” button to enter the

video configuration screen.

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 24. Press the Channel 1 button .

25. Set the Record Format to “MPEG 2 HD”

26. 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 .

9 Verify proper live video output on the Channel 1 DVI
monitor

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Step 110 – Capturing and Viewing Single Channel Images
and Videos (DVI MPEG 2 HD) Using Sidne Voice and
Camera Head

1. Begin recording a 10 sec video using the SIDNE voice

command. “SIDNE; DIGITAL CAPTURE; RECORD”
9 Verify “Recording” shows up in the information bar and
the “REC1” OSD displays properly on the Channel 1
DVI monitor.
2. During the recording, capture two images using the
Camera Head. Press and release the Camera Head ‘P’
button immediately.
9 Verify that the images flash in the flip screen on the
monitor.
9 Verify that the images flash on the capture screen.
3. Stop the recording when the recording reaches
approximately 10 sec by using the SIDNE voice
command. “SIDNE; DIGITAL CAPTURE; STOP”

4. Press the “Image/Video Album” tab to enter the

Image Album screen.

9 Scroll through and review the quality of the latest

captured images

5. Press the “Video Album” button to enter the

Video Album screen.

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 6. Select the last video recorded using the scroll button

7. Press the “Channel Select” button to select

Channel 1 for playback.

8. Press the “Play” button to review the quality of

the last video recorded.
9 Verify the video plays back properly on the Channel 1
DVI monitor.
9 Review the video for proper quality

Step 120 – Securing the SDC Ultra

1. Press the “Home” tab on the screen top left.

2. Press the “New Case” button to create a new

case.

3. Press the “Check” button to agree to create a new

case.

4. Press the “Home” tab on the screen top left.

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 5. Press the “Archive” button to enter the Archive
screen.

6. Press the “Delete All Prior Cases” button to

delete all prior cases from the archive.

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 7. Press the “Check” button to agree to delete all prior
cases.

9 Verify all cases are properly cleared from the archive

8. Press the power button on the front panel to shut down

the unit.
9. Disconnect all cables from the SDC Ultra

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Step 130 – Final Labeling

1. Turn the unit over. Label, Warranty Violation Label, Vitec

2. Attach the following labels to the unit (see picture to the SDC Ultra License
right):
a. Label, Warranty Violation (1000-201-096)
b. License, Windows XPE (1000-301-239)
c. Label, Vitec SDC Ultra License (1000-207-315)
9 Circle Pass or Fail on the DHR to document completion
of the final labeling License, Windows XPE

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