Stryker SDC Ultra User manual

EC REP
SDC Ultra™
0240050988

Contents
Warnings and Cautions .................................................... 1
Symbols and Definitions.................................................. 3
Product Description/Intended Use ........................... 5
System Overview ....................................................................6
Setup......................................................................................... 10
Operation................................................................................ 15
Loading the Patient List ........................................................17
Viewing Archived Information ...............................................18
Studio3 Media Transfer Queue - Pending Cases..................20
Studio3 Media Transfer Queue - Completed Cases .............21
Entering Patient Information .................................................22
Capturing Single Channel Images and Videos......................25
Capturing Dual Channel Images and Videos ........................28
Editing Video Settings...........................................................31
Viewing and Annotating Images............................................36
Viewing and Playing Videos ..................................................37
Viewing and Editing the Video Album ...................................40
Editing Annotations...............................................................41
Saving Information ................................................................42
Saving Settings .....................................................................43
Troubleshooting.................................................................. 57
Cleaning and Maintenance .......................................... 60
Technical Specifications ............................................... 61

1
Warnings and Cautions
Please read this manual and follow its instructions carefully. e words warning,
caution, and note carry special meanings and should be carefully reviewed:
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 qualied 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. is unit
was fully tested at the factory before shipment; however, it must be
tested for proper function in the environment and setup conguration
in which it will be used.
6. To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
7. 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.
8. Install this device in an operating room that complies with all applicable
IEC, CEC, and NEC requirements for safety of electrical devices.
9. Do not position the console so that it is dicult to disconnect the power
cord from the supply mains.
10. Use only clean, dry, undamaged Stryker brand media. e use of
damaged, wet, or incompatible media will void the warranty and may
result in the malfunctioning of this equipment.
11. Make all connections with the power cord unplugged from the mains
outlet.
12. Ensure that all equipment connected to the SDC Ultra™ has proper
isolations.
13. To avoid risk of re, do not use this device in the presence of ammable
anesthetics.
14. Avoid direct exposure to the laser beam of the DVD/CD drive as it is

2
harmful to the eyes.
15. Pay close attention to the care and cleaning instructions in this manual.
Failure to follow these instructions may result in product damage.
16. Attempt no internal repairs or adjustments not specically detailed in
this operating manual. Refer any readjustments, modications, and/or
repairs to Stryker Endoscopy or its authorized representatives.
17. Do not modify this equipment without authorization of the
manufacturer.
e Stryker Standard Warranty and Return Policy (1000401175) is void if any of
these warnings or cautions are disregarded.

3
Symbols and Denitions
is device and its labeling contain symbols that provide important information
for the safe and proper use of the device. ese symbols are dened below.
Warning Symbols
Warning/Caution: See
Instructions for Use
Hazardous voltage
present
Consult Instructions for
Use.
Device Symbols
Mouse Keyboard
Monitor Network
USB Speaker
Serial port
Packaging/Labeling Symbols
Legal manufacturer
Authorized
representative in
Europe
Date of manufacture Atmospheric
pressure range

4
Ambient temperature
range
Relative humidity
range
SN
Serial Number
U
S
C
Denotes compliance
to CSA C22.2 No.
601.1-M90, and UL
2601-1.
Equipotentiality Protective Earth
Ground
Product number Made in USA
Complies with the requirements of directive 93/42/EEC.
is product contains electrical waste or electronic equipment.
It must not be disposed of as unsorted municipal waste and
must be collected separately.
Federal law (USA) restricts this device to sale by or on the order
of a physician.

5
Product Description/Intended Use
e Stryker Digital Capture System Ultra (SDC Ultra™) is a computer-based
unit that records, manages, and archives digital images and videos of surgical
procedures. e SDC Ultra™ simplies le 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.
e SDC Ultra™ records images on a built-in hard drive, where they can be easily
accessed aer the surgical procedure. e 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.

6
System Overview
Front Panel
EC REP
1
3
2
45
6
1. CD/DVD drive
2. USB port
3. Eject button for CD/DVD drive
4. Remote control (optional accessory)
5. Power button
6. LCD touch screen

7
Rear Panel
1
EC REP
2 3 4 5 6 7 8 9
10
11
12
26
25
24
23 22 21 20 19 18 17 16 15
14
13
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

8
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

9
Remote Control (optional accessory)
4
1
2
3
5
6
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)

10
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 sta on its operation and maintenance. Please contact
your local Stryker Endoscopy representative to schedule an in-service aer 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 aect
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.

11
Warning When used inside the patient environment (represented by an
area 1.5 m from the patient in all directions), 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 Specications” 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 adapt-
ers when connecting the AC power.
Warning Check the power cord assembly periodically for damaged insu-
lation or connectors.

12
Setting up the SDC Ultra™ with the 1188 Camera and SIDNE®
Caution e 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.

13
SDC Ultra™ Networking
Protocol Used: FTP (File Transfer Protocol)
Setup Requirements
1. A TCP/IP network.
2. A secure FTP (FTP over SSH) server may be installed and congured, if
needed. Ultra does not support FTP over SSL.
Instructions
1. Enter the IP address of the FTP server (and not the SDC Ultra™) into the
SDC Ultra™ Network tab in the Cong 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 500 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 conrmation screen will display. Check the
Anonymous Login checkbox.
Note e 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. is avoids creation of multiple directories
if someone accidentally enters a wrong/invalid username. erefore,
you have to enter a username for the FTP to work.

14
For Login with Username and Password:
Note e 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 checkbox 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 rewall
settings on the server do not block the FTP port.
Protocol Used: Studio3 Media Server
Setup Requirements
1. A TCP/IP network.
2. A Stryker Studio3 Media Server installed and congured. .
Instructions
1. Enter the IP address of the Studio3 Media Server into the SDC Ultra
Studio 3 tab in the Cong menu.
2. Select the Studio 3 checkbox in the Save Settings screen to enable the
Studio 3 Save button.
3. To save the images and videos, press the Studio3 Save button from the
Save menu. A conrmation message will appear to indicate that the case
has been added to the Studio3 transfer queue.
4. To view the pending/completed transfer queue, press the Studio3 tab in
the Archive menu.

15
Operation
SDC Ultra™ provides an interface for entering patient information, capturing
images and videos, and archiving photos and video.
Getting Started
Login Screen
1. If the application password is on, enter the user name and password.
is security feature will be turned o by default for quicker access to
the Home Screen.

16
Home Screen
421 3
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.