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SDC Ultra™

240-050-988

User Guide

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


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

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

Product Description/Intended Use............................ 5


System Overview.....................................................................6

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

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

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

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


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

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

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

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

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


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

Warning Warnings indicate risks to the safety of the patient or user. Failure
to follow warnings may result in injury to the patient or user.

Caution Cautions indicate risks to the equipment. Failure to follow


cautions may result in product damage.

Note Notes provide special information to clarify instructions or present


additional useful information.

Warning To avoid potential serious injury to the user and the patient
and/or damage to this device, the user must obey the following
warnings:
1. Federal law (United States of America) restricts this device to use by, or
on order of, a physician.
2. Read this operating manual thoroughly and be familiar with its contents
prior to setting up or using this equipment.
3. Carefully unpack the unit and check for any damage that may have
occurred during shipment. If damage is detected, refer to the “Service
and Claims” section in this manual.
4. Use of this device is restricted to qualified health care professionals who
have a complete knowledge of the use of this equipment and the devices
to which it can be connected.
5. Test this equipment prior to using it in a surgical procedure. This unit
was fully tested at the factory before shipment; however, it must be
tested for proper function in the environment and setup configuration
in which it will be used.
6. To avoid 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

isolations.
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.


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

Warning Symbols

Warning/Caution: See Hazardous voltage


Instructions for Use present

Device Symbols

Mouse Keyboard

Monitor Network

USB Speaker

Serial port

Packaging/Labeling Symbols

Authorized
Legal manufacturer representative in
Europe

Atmospheric
Date of manufacture
pressure range

Ambient temperature Relative humidity


range range


LOT
Lot number Product number

Denotes compliance
to CSA C22.2 No.
SN Serial Number
C US 601.1-M90, and UL
2601-1.

Protective Earth
Equipotentiality
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.


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


System Overview

Front Panel

1
2

5 4 3
1. CD/DVD drive
2. USB port
3. Eject button for CD/DVD drive
4. Remote control
5. Power button
6. LCD touch screen


Rear Panel
1 2 3 4 5 6 7 8 9

10
26 11

25 12
24 13

14
23 22 2120 19 18 17 16 15
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 input
4. Audio In Mic –Microphone audio input
5. Audio Out – Speaker output
6. AC Power Inlet
7. Equipotential Ground Plug
8. Secondary R1– Remote connection for capture control on the secondary
channel
9. Secondary R2– Remote connection for recording control on the
secondary channel
10. Comp In – composite video input
11. Comp Out – composite video output
12. S-Vid In – S-video input
13. S-Vid Out –S-video output
14. DVI 2 Out –Secondary channel DVI output
15. DVI 2 In –Secondary channel DVI input
16. DVI 1 Out –Primary channel DVI output
17. DVI 1 In –Primary channel DVI input
18. SIDNE port – Connection to SIDNE console for device control
19. SFB connectors ports – enables Firewire connection with the Stryker

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


Remote Control

3
4
5

7
1. Channel 1 video and image: capture, record, stop
2. Channel 2 video and image: capture, record, stop
3. Print images
4. Display previous image on OSD
5. Voice annotation (future use)
6. Navigation (future use)
7. Select (future use)


Setup
Stryker Endoscopy considers instructional training an integral part of the SDC
Ultra™ system. Your Stryker Endoscopy sales representative will perform at
least one in-service at your convenience to help you set up your equipment and
instruct you and your staff on its operation and maintenance. Please contact
your local Stryker Endoscopy representative to schedule an in-service after your
equipment has arrived.
1. Choose a location for the SDC Ultra.
• Place the SDC Ultra on a Stryker cart or other sturdy
platform.
• Provide at least four to six inches of space around the sides
and top of the SDC Ultra to ensure proper ventilation.
Warning 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 When the SDC Ultra is interconnected with other electrical
devices, leakage currents may be additive, resulting in
electromagnetic emissions that can interfere with the normal
function of electronic medical equipment. To properly control
electromagnetic emissions and avoid potential harm to the
patient or user, ensure all electrical devices are installed and
interconnected according to the requirements of IEC 60601-1-
1.

10
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.

11
Setting up the SDC Ultra™ with the 1188 Camera and SIDNE®

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

12
SDC Ultra Networking
Protocol 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 patient’s last name. All the images and videos (if selected) are then
transferred to this folder.

13
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:
<Default FTP path>\SDC\Username\?????MMDDYYYY_HHMMSS
where, ?????: First 13 characters of the Patient’s Name / ID entered
Username: Doctor’s Username which can be the same as his/her Notematic
ID MMDDYYYY_HHMMSS: Date/Time stamp to guarantee uniqueness

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

14
Operation
SDC Ultra™ provides an interface for entering patient information, capturing
images and videos, and archiving photos and video.

Getting Started

Home Screen
1 2 3 4

Select from the following options:


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

15
Loading the Patient List

Patient information can be added prior to surgery to save time.


To load patient information, press the Load Patient List button on the Home
screen.
1 2 3 4

6
1. Press the Home button to return to the home screen.
2. Enter the patient information.
• Enter the patient’s 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 Patient List to see a list of all patients that have been
preloaded into the system.
6. Keyboard

16
Viewing Archived Information

To archive information and to access the archive, press the Archive button on the
Home screen.
1 2

7 6 5 4
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 Hard Drive to view cases stored on the hard drive.
• Press USB to view cases stored on the USB.
• Press Disc to view cases stored on a CD or DVD.
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 Delete all to delete all patient information stored on the hard
drive.
7. Press Delete to delete the selected patient’s case.

17
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 New Case or Current Case button on
the home screen.
1 2 3 4 5 6 7

15 14 13 12 11 10
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 Patient Information 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 Single Channel/Dual Channel to toggle between single
and double channel mode.
• Press Video Settings to change video options.
• Press Printer Settings 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.
18
• 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 Capture button to begin capturing images.
15 Press the left/right arrow buttons to scroll through images.

Recording
Press the Record button on the Capture screen to record video.

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

19
Pausing
Press the Pause button on the Recording screen to pause video.

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

20
Capturing Dual Channel Images and Videos

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

PIP Capture Mode


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

1
9
2
8

6 5 4 3
1. Press OSD (on screen display) PIP to toggle between turning on or off
the PIP on the monitor.
2. Press Single Channel/Dual Channel 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 Dual Capture 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.

21
Synchronize Capture Mode
To capture images and video in synchronize mode, press the Synchronize button
on the Dual Capture screen.

1 2 3
1. Press the Capture button to capture images on both channels
simultaneously.
2. Press the Record button to record video on both channels
simultaneously.
3. Press the Stop button to stop recording on both channels
simultaneously.

22
Individual Capture Mode
To capture images and video in the individual mode, press the Individual button
on the Dual Capture screen.

1 2 3 4 5 6
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.

23
Editing Video Settings

Editing Channel 1 Video Settings


To edit channel 1 video settings, press the Video Settings button on the Capture
screen.

1
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.

24
Editing Channel 2 Video Settings
To edit channel 2 video settings, press the Video Settings button on the Capture
screen and then press the Channel 2 Video Settings button.

2 1
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.

Editing PIP Settings


To edit PIP settings, press the Video Settings button on the Capture screen and
then press the PIP settings button.

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


in picture.

25
Editing Advanced Video Settings
To edit advanced video settings, press the Video Settings button on the Capture
screen and then press the More Settings button.
1 2

4 3
1. Press Flip Screen to choose the image orientation on the OSD.
2. Press Mute to toggle between On and Off.
3. Press REC Display to toggle between On, display live video on the OSD,
and Off.
4. Press Live Video Time out to display the amount of time the image is
displayed on the OSD before reverting back to live video.
5. Press Remote 2 Control to toggle between Pause recording and Stop.
6. Press Auto Cut Off 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.

26
Editing Print Settings
To edit print settings, press the Print Settings button on the Album screen.
1 2

5 4 3
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 Advanced Printer Settings to edit options.
4. Press Prints Pending to cancel the number of jobs pending to print.
5. Press Auto Print to toggle between On, automatically prints the selected
Images Per Page, and Off.

27
Editing Advanced Print Settings
To edit advance print settings, press the Print Settings button on the Capture
screen and then press the More Settings button.
1

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 Default Settings 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 Patient Information button on the Home
screen.
1

2
4 3

1. Patient information.
• Enter the last name.
• Enter the birth date.
• Enter the sex.
• Enter the patient’s 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.

29
Entering Patient Information - Second Data-entry Screen.
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.
1 2

6
5 3
4

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.

30
Viewing and Annotating Images

To view images, press the Album button on the Capture screen and then press
the Image album button.
1

10 3
9
4

8 7 6 5
1. Press the arrow buttons to scroll through the images.
2. Press DICOM Album for viewing PACS image information.
3. Press Image Album to display the editing screen for the album.
4. Press Video Album to annotate video and playback video.
5. Press the arrow buttons to scroll through the images.
6. Press Select/Deselect All to select or deselect images for printing.
7. Press the image twice to display the image in the center.
8. Press Edit Annotations 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.

31
Viewing and Playing Videos

To view and play videos, press the Album button then press the Video Album
button.
1

6 2

5 4 3
1. Press the arrow buttons to scroll through the images.
2. Press the Select/Deselect All 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.

32
Viewing and Editing the Video Album

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

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


screen.
2. Press Playback Video to display the playback mode screen.

33
Editing Annotations

To edit annotations, press the Image Album button on the Capture screen and
then press the Annotation Video button.
1 2 3

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.

34
Saving Information

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

1 2 3 4 5
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. Press Save to Network to save images or video on the PACS or FTP
network.
5. Press Save Settings to edit the save options.
6. Press the network drop-down menu to select a network address.

35
Saving Settings

To save settings, press the Save button on the Saving Information screen.
1 2

4 3
1. Press Image Format to toggle between BMP, JPEG, JPEG2000, TGA,
TIFF, and PNG.
2. Press Encryption to toggle between On and Off.
3. Press More Settings 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.

36
More Save Settings
To adjust more save settings, press the More Settings button on the Save screen.
1

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 Default Settings to reset the image options to the factory
default settings.

37
Troubleshooting
The table below shows the most common errors and possible solutions to each.
Problem Solution
Login 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/ Capture images and then select them
selected 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.

38
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 Please reboot the system.
error and is shutting down.
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.
39
Print errors • Ensure there aren’t 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 Ensure that the USB is formatted as
the USB NTFS. FAT 32 will not support any
file size bigger than 4GB.
Error reading archived cases from Reboot the system if you have just
DVD/CD 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.

40
Cleaning and Maintenance

Cleaning

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

Warning To avoid electric shock and potentially fatal injury, unplug the
SDC Ultra™ from the electrical outlet before cleaning.

Caution Do not immerse the console in any liquid as product damage will
result.

Caution Do not use alcohol, solvents, or cleaning solutions that contain


ammonia to clean the unit, as product damage may result.

Caution Do not sterilize the unit as product damage may result.

Maintenance

SDC Ultra requires no preventative or periodic maintenance. However, Stryker


recommends you reboot the system daily for best performance.

41
Technical Specifications

Environmental Specifications

Operating temperature: 10 – 40°C


Operating humidity: 30 – 75% RH
Shipping temperature: -20° – 60°C
Shipping humidity: 10 – 85% RH

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

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

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

Audio
Stereo Line and Microphone input
2 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

42
Disc Recording Formats
CD-R, DVD-R, DVD+R (single session), DVD+RW

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

Equipment Classification
Class I equipment
No applied part
Water ingress protection, IPX0
Continuous 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

43
Printers Supported
HP 8250
HP D7160

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

Display
8" TFT LCD, with digital touch screen

44
Electromagnetic Compatibility
Like 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 Portable and mobile RF communications equipment may affect


the normal function of the SDC Ultra.

Caution Do not use cables or accessories other than those provided with
the SDC Ultra, as this may result in increased electromagnetic
emissions or decreased immunity to such emissions.

Caution If the SDC Ultra is used adjacent to or stacked with other


equipment, observe and verify normal operation of the SDC Ultra
in the configuration in which it will be used prior to using it in
a surgical procedure. Consult the tables below for guidance in
placing the SDC Ultra™

45
Guidance and Manufacturer’s 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

SDC Ultra uses RF energy only for its internal


function; therefore, its RF emissions are
RF emissions CISPR 11 Group 1
very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions CISPR 11 Class A


SDC Ultra is suitable for use in all
establishments, including domestic
establishments and those directly connected
Harmonic emissions to the public low-voltage power supply
Class A
IEC61000-3-2 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
Voltage Fluctuations/ flicker nearby equipment. It may be
Complies necessary to take mitigating
emissions IEC61000-3-3
measures such as reorienting
or relocating the system or
shielding the location.

46
Guidance and Manufacturer’s 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.
IEC 60601 Test Compliance Electromagnetic Environment--
Immunity Test
Level Level 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 3 Vrms
3V d = 1.17√P
IEC 61000-4-6 150 kHz to 80 MHz

Radiated RF 3 V/m 3 V/m


IEC 61000-4-3 80 MHz to 2.5 GHz d = 1.17√P 80 MHz to 800 MHz
d = 2.33√P 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.

47
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

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.

IEC 60601 Electromagnetic


Immunity Test Compliance Level
test level Environment - guidance

Floors should be wood,


concrete or ceramic tile.
Electrostatic Discharge ±6kV contact If floors are covered with
±2,4,6kV contact ±2,4,8kV air
(ESD) IEC61000-4-2 ±8kV air synthetic material, the
relative humidity should
be at least 30%.

±2kV for
power supply ±2kV for power supply lines Mains power quality
Electrical fast lines should be that of a
transient/burst
±1kV for typical commercial or
IEC61000-4-4
input/output ±1kV for input/output lines hospital environment
lines
±1kV
differential ±0.5, 1kV differential mode Mains power quality
Surge mode should be that of a
IEC61000-4-5 ±2kV typical commercial or
common ±0.5,1, 2kV common mode hospital environment
mode
<5% Ut
(>95% dip <5% Ut (>95% dip in Ut) for
in Ut) for 0.5 0.5 cycle
cycle Mains power quality
should be that of a
40% Ut (60% typical commercial or
40% Ut (60% dip in Ut) for 5
Voltage dips, short dip in Ut) for hospital environment.
cycles
interruptions and 5 cycles If the user of SDC Ultra
voltage variations requires continued
on power supply operation during power
70% Ut (30%
input lines 70% Ut (30% dip in Ut) for 25 mains interruptions, it is
dip in Ut) for
IEC61000-4-11 cycles recommended that SDC
25 cycles
Ultra be powered from
an uninterruptible power
supply or a battery.
<5% Ut
<5% Ut (>95% dip in Ut) for
(>95% dip in
5 sec
Ut) for 5 sec

Power frequency
(50/60Hz) magnetic 3 A/m 3 A/m Not Applicable
field IEC 61000-4-8

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

48
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

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.

(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.

49
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment 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.

Separation distance (m) according to frequency of transmitter


Rated maximum output 150 kHz to 80 MHz 80 kHz to 800 MHz 800 kHz to 2.5 GHz
power (W) of transmitter d = 1.17√P d = 1.17√P d = 1.17√P
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.

50
Warranty
The 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 Endoscopy’s 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.

51
Services and Claims
If 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, USA
Stryker is a registered trademark of Stryker Corporation

52
53
54
Stryker Endoscopy European Representative:
5900 Optical Court Regulatory Manager, Stryker France
San Jose, CA 95138 USA ZAC Satolas Green Pusignan
1-408-754-2000, 1-800-624-4422 Av. De Satolas Green
www.stryker.com 69881 MEYZIEU Cedex, France

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

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