Stryker Endoscopy

5900 Optical Court, San Jose, CA 95138

APPROVALS DATE TITLE

DRAWN BY:
SDC Ultra - Functional Test Procedure
Paramjit Brar 8/17/07
ORIGINATOR
Paramjit Brar 8/17/07
SIZE REV DOCUMENT NO. SHEET OF
A B MAP0575 1 15
REVISIONS REVISIONS
LTR ECN NO. DATE APPROVED LTR ECN NO. DATE APPROVED
A ECO107125 8/17/07 s/ E. McCarthy
B ECO107396 8/31/07 s/ E. McCarthy
 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
1188HD CCU 105-206-600 1 per station
1188HD Camera Head 105-206-515 1 per station
1188HD Coupler 105-206-366 1 per station
X7000 Lightsource or Equivalent 105-199-580 1 per station
(Optional)
Arthroscope, 4mm 30degree or Equivalent 105-187-696 1 per station
(Optional)
Fake Knee N/A 1 per station
DVD Player N/A 1 per station
Speaker N/A 1 per station
PS/2 Keyboard N/A 1 per station
PS/2 Mouse N/A 1 per station
DVI-I Cable 105-198-707 4 per station
DVI-I Splitter Cable, DVI-I to N/A 2 per station
VGA & DVI-D
S-Video Cable 105-150-908 2 per station
Composite BNC Cable 103-166-002 2 per station
Adapter, RCA male to BNC female N/A 1 per station
Stereo Cable N/A 1 per station
SDC Ultra 2-Channel Remote Test Fixture N/A 1 per station
USB Keys (2GB) N/A 2 per station
USB Key w/ test software (2GB) N/A 1 per station
Com Port Loop back N/A 1 Per Station
SDC Ultra Remote Control or 105-208-352 or 1 per station
SDC HD Remote Control 105-201-415
Hospital Power Cord 105-033-001 1 per station
Scanner N/A 1 per station
FireWire HDD N/A 3 per station

MAP0575 Rev B – SDC Ultra Functional Test Procedure Page 2 of 15

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 – Restore DVD (if required)

1. If the SDC Ultra must be programmed with a restore DVD,

complete the following:
1.1. Turn on the SDC Ultra, open the DVD drive tray, insert
the restore DVD, close the tray and turn off the unit.
1.2. Turn on the SDC Ultra and allow the restore process to
complete.
1.3. When the process is complete, the DVD drive tray will
open. Remove the restore DVD, close the tray and turn
off the unit.
1.4. Turn on the SDC Ultra and wait until the initial start
screen (New Case, Current Case, etc.) appears.
1.5. The system will reboot automatically.
9 Mark Pass or Fail on the DHR to document the completion of
the restore process
Step 30 – Test bench set-up

1. Video and audio connections

1.1. Ensure that the Camera head is connected to the CCU.
The use of a lightsource, scope, and fake knee is
optional.
1.2. Using a DVI-I cable, connect the 1188HD CCU DVI 1
output to the SDC Ultra DVI 1 input.
1.3. Using a DVI-I cable, connect the 1188HD CCU DVI 2
output to the SDC Ultra DVI 2 input.
1.4. Using a DVI-I splitter cable, connect the SDC Ultra DVI
1 output to the #1 Stryker Vision DVI and VGA inputs.
1.5. Using a DVI-I splitter cable, connect the SDC Ultra DVI
2 output to the #2 Stryker Vision DVI and VGA inputs.
1.6. Using an S-VHS cable, connect the output of the DVD

MAP0575 Rev B – SDC Ultra Functional Test Procedure Page 3 of 15

 player to the SDC Ultra S-VHS input.
1.7. Using an S-VHS cable, connect the SDC Ultra S-VHS
output to the #1 Stryker Vision S-VHS input.
1.8. Using a Composite BNC cable and an RCA/BNC
adapter, connect the DVD player Composite output to
the SDC Ultra Composite input.
1.9. Using a Composite BNC cable, connect the SDC Ultra
Composite output to the #2 Stryker Vision Composite
input.
1.10. Connect the SDC Ultra audio output to the speaker.
2. Other Connections
2.1. Using an Ethernet cable, connect the SDC Ultra
Network connection to the Stryker network.
2.2. Connect the keyboard to the SDC Ultra PS/2 keyboard
connector.
2.3. Connect the mouse to the SDC Ultra PS/2 mouse
connector.
2.4. Connect the Com Port Loop Back to the motherboard
com port.
2.5. Connect the remote cables from the Remote Test Fixture
to the appropriate R1/R2 inputs for both channels.
2.6. Connect the power supplies to each of the three FireWire
HDDs.
2.7. Connect a stereo cable from the DVD player audio out to
the SDC Ultra Audio In SIDNE
! Don’t connect to SDC Ultra Audio In Mic
Step 40 – 1st Test Phase: FAIL SAFE Mode

1. Turn on the 1188HD CCU, the DVD player and both Stryker
Vision monitors. Ensure the SDC Ultra remains off.
2. Switch both Stryker Vision monitors to VGA input. Verify
that there is an image from the CCU.
3. Switch the #1 Stryker Vision monitor to S-VHS input. Verify
that video from the DVD player is present.
4. Switch the #2 Stryker Vision monitor to Composite input.
Verify that video from the DVD player is present.
5. Verify that audio from the DVD player can be heard on the
speaker.

MAP0575 Rev B – SDC Ultra Functional Test Procedure Page 4 of 15

Step 50 – 2nd Test Phase: Test of Ports and Software Version

1. Turn on the SDC Ultra.

9 Record the software version (displayed on the bottom right of
the touchscreen during startup) on the DHR

2. Enter Username and Password then press

User : ADMIN
Password: TESTULTRA
! This step only needs to be completed if the software was
not restored at Stryker.

3. Select Configuration Button

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4. Enter Password
Password: M

5. Select

6. Select Setting Button

7. Uncheck Enable Security Button.

8. Select Home Button.

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9. Select New Case.

10. Press the Capture button to capture a still image.

11. Press the Save tab to enter the Save Menu.

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12. Insert the USB key with the test software in the SDC Ultra
front panel USB port.
13. Stryker Software will close and Functional Test will launch.
14. After the test launches automatically, a message will appear
in a DOS window requesting that the Firewire drives and the
USB keys are connected.
15. If a Windows message appears asking if the system should be
restarted, select No.
16. Using FireWire cables, connect the three FireWire HDDs to
the three SDC Ultra SFB ports.
17. When the FireWire HDDs are connected, a message
regarding driver update will appear (this message will appear
3 times). Select Cancel each time.
18. Insert the two remaining USB keys in the SDC Ultra rear
panel USB ports.
19. Press any key to continue.

20. A window will open, the ports and software versions listed
below will be tested automatically, and the results will be
displayed (as shown to the right).
21. If all results are « PASS », press any key to continue the tests.
If one or more of the results are « FAIL », stop the test by
pressing Ctrl & C simultaneously.

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Step 60 – 3rd Test Phase: TouchScreen Calibration

1. The VITEC test application will start automatically and the

screen to the right will be displayed.
2. Press « Start Calibration » and calibrate the screen by
pressing on the cross with stylet.
3. Once all 12 crosses have been calibrated, press « calibration »
and then « Save & Exit » to return to the screen to the right.
Press « Pass » or « Fail » then « Next » to continue.

Step 70 – 3rd Test Phase: Serial Number Scan

1. Scan the Vitec Serial Number Label on the SDC Ultra rear
panel.
2. After the serial number becomes visible (on the screen to the
right) press « NEXT » to move to the next stage of the test.
Note: if a message requesting to quit the test appears
select No

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Step 80 – 3rd Test Phase: LCD TEST

1. After the screen to the right appears, select « Display Pattern

1 », and check that the color is uniform and that all pixels are
of the same color.
2. Touch the screen to return to the screen to the right and select
« PASS » or « FAIL ».
3. Repeat the same procedure for « Display Pattern 2 » and
« Display Pattern 3 ».
4. Select « NEXT » to continue after all 3 patterns have been
checked.

Step 90 – 3rd Test Phase: 1st Video Test (DVI-A + Composite)

1. After the screen to the right appears, check of the presence

and quality of the « preview » in the windows, including the
audio bar. Select « PASS » or « FAIL » then « NEXT » to
continue.
NOTE : The « Device » status indicated by the red box
does not yet function for the video test and should be
ignored.
2. Switch the #1 Stryker Vision monitor to VGA input and the
#2 Stryker Vision monitor to Composite input.
3. Check the presence and quality of the image on both
monitors. Select « PASS » or « FAIL » then « NEXT » to
continue.
4. Check the presence of the logo on the video on both
monitors. Select « PASS » or « FAIL » then « NEXT » to
continue.

MAP0575 Rev B – SDC Ultra Functional Test Procedure Page 10 of 15

5. Check the presence and quality of the still images displayed
on both monitors. Select « PASS » or « FAIL » then
« NEXT » to continue.
6. During encoding of MPEG files, check that the HDD counter
decreases. Select « PASS » or « FAIL » then « NEXT » to
continue.
7. Check the quality of the image and audio during playback of
the « Channel 1 » MPEG file. Select « PASS » or « FAIL »
then « NEXT » to continue.
8. Check the quality of the image and audio during playback of
the « Channel 2 » MPEG file. Select « PASS » or « FAIL »
then « NEXT » to continue.
Step 100 – 3rd Test Phase: Remote and IR Test

1. After the screen to the right appears, press the R1-R4 buttons
(Channel 1 Capture, Channel 1 Record, Channel 2 Capture,
Channel 2 Record) on the remote fixture one after another
and check that proper message is displayed in the window.
2. Then press a button on the SDC remote control and check for
a proper message. Select « PASS » or « FAIL » then
« NEXT » to continue.

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Step 110 – 3rd Test Phase: 2nd Video Test (DVI-D + DVI-D)

1. After the screen to the right appears, check of the presence

and quality of the « preview » in the windows, including the
audio bar. Select « PASS » or « FAIL » then « NEXT » to
continue.
NOTE : The « Device » status indicated by the red box
does not yet function for the video test and should be
ignored.
2. Switch the #1 Stryker Vision monitor to DVI input and the #2
Stryker Vision monitor to DVI input.
3. Check the presence and quality of the image on both
monitors. Select « PASS » or « FAIL » then « NEXT » to
continue.
4. Check the presence of the logo on the video on both
monitors. Select « PASS » or « FAIL » then « NEXT » to
continue.
NOTE : The OSD logo and still images are opaque when
displayed on the Stryker Vision monitors.
5. Check the presence and quality of the still images displayed
on both monitors. Select « PASS » or « FAIL » then
« NEXT » to continue.
6. During encoding of MPEG files, check that the HDD counter
decreases. Select « PASS » or « FAIL » then « NEXT » to
continue.
7. Check the quality of the image and audio during playback of
the « Channel 1 » MPEG file. Select « PASS » or « FAIL »
then « NEXT » to continue.
8. Check the quality of the image and audio during playback of
the « Channel 2 » MPEG file. Select « PASS » or « FAIL »
then « NEXT » to continue.

MAP0575 Rev B – SDC Ultra Functional Test Procedure Page 12 of 15

Step 120 – 3rd Test Phase: 3rd Video Test (S-VHS + DVI3)

1. After the screen to the right appears, check of the presence

and quality of the « preview » in the windows, including the
audio bar. Select « PASS » or « FAIL » then « NEXT » to
continue.
NOTE : The « Device » status indicated by the red box
does not yet function for the video test and should be
ignored.
2. Switch the #1 Stryker Vision monitor to S-VHS input and the
#2 Stryker Vision monitor to DVI input.
3. Check the presence and quality of the image on both
monitors. Select « PASS » or « FAIL » then « NEXT » to
continue.
4. Check the presence of the logo on the video on both
monitors. Select « PASS » or « FAIL » then « NEXT » to
continue.
NOTE : The OSD logo and still images are opaque when
displayed on the Stryker Vision monitors.
5. Check the presence and quality of the still images displayed
on both monitors. Select « PASS » or « FAIL » then
« NEXT » to continue.
6. During encoding of MPEG files, check that the HDD counter
decreases. Select « PASS » or « FAIL » then « NEXT » to
continue.
7. Check the quality of the image and audio during playback of
the « Channel 1 » MPEG file. Select « PASS » or « FAIL »
then « NEXT » to continue.
8. Check the quality of the image and audio during playback of
the « Channel 2 » MPEG file. Select « PASS » or « FAIL »
then « NEXT » to continue.

MAP0575 Rev B – SDC Ultra Functional Test Procedure Page 13 of 15

Step 130 – End of Test

1. At the end of the test the results will be displayed « PASS »

or « FAIL ».
9 Mark Pass or Fail on the DHR to document the completion of
the functional test
2. Turn off the unit.
3. Disconnect all cables from the SDC Ultra except the power
cord, the keyboard, and the network Ethernet cable.
Step 140 – SMS Registration

1. Ensure that the nothing is connected to the SDC Ultra

except the power cord, the keyboard, and the network
Ethernet cable.
2. Turn on the unit.
3. Press the Advanced Configuration button at the top left of the
initial screen.

4. Press the ‘M’ keyboard button and the green checkmark

button to enter the Advanced Configuration screen.

5. Press the More Settings button at the top right of the

Advanced Configuration screen.

MAP0575 Rev B – SDC Ultra Functional Test Procedure Page 14 of 15

6. Press the SMS button at the bottom right of the More Settings
screen.

7. When in the SMS screen, press the F12 key on the keyboard
to launch the SMS application.

8. After the SMS application starts, enter the SDC Ultra Serial
Number and the Work Order Number.
9. Press the ‘Send’ button on the screen.
10. Verify a successful registration from the status bar on the
screen.
11. Turn off the SDC Ultra and disconnect all cables.
9 Mark Pass or Fail on the DHR to document the completion of
SMS registration

MAP0575 Rev B – SDC Ultra Functional Test Procedure Page 15 of 15