Stryker sdc classic User manual

SDC Classic™
User Guide
240-050-989
OK

Contents
Warnings and Cautions .................................................... 3
Symbols and Definitions.................................................. 5
Product Description/Intended Use ........................... 7
Indications/Contraindications .................................................7
Operator Prole.......................................................................7
Package Contents...................................................................8
Accessories.............................................................................8
System Overview ....................................................................9
Setup and Interconnection .......................................... 13
Connecting a Printer .............................................................15
Operation................................................................................ 17
Powering the System On and Off .........................................17
Starting a New Case .............................................................17
Capturing Images..................................................................17
Recording Video....................................................................17
Saving Images and Videos....................................................17
Printing Images .....................................................................18
Editing Device Settings .........................................................19
Troubleshooting.................................................................. 23
Cleaning and Maintenance .......................................... 25
Cleaning ................................................................................25
Maintenance..........................................................................25
Disposal ................................................................................25
Technical Specifications ............................................... 26
Environmental Specications................................................26
Electromagnetic Compatibility.................................. 29
Warranty.................................................................................. 34
Return Policy.........................................................................35

3
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 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 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 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. e use of
damaged, wet, or incompatible media will void the warranty and may
result in the malfunctioning of this equipment.
9. Unplug the power cord from the mains outlet before making any
connections.

4
10. Ensure that all equipment connected to the SDC Classic™ has proper
isolations.
11. To avoid risk of re, do not use this device in the presence of ammable
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 specically detailed in
this operating manual. Refer any readjustments, modications, and/or
repairs to Stryker Endoscopy or its authorized representatives.
e warranty is void if any of these warnings are disregarded.

5
Symbols and Definitions
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
Device Symbols
Mouse Keyboard
Monitor Network
USB Out
Serial port In
VGA/Monitor
Packaging/Labeling Symbols
Legal manufacturer
Authorized
representative in
Europe
Date of manufacture Atmospheric
pressure range

6
Ambient temperature
range
Relative humidity
range
LOT Lot number
Product number
SN
Serial Number
U
S
C
Denotes compliance
to CSA C22.2 No.
601.1-M90, and UL
2601-1.
Equipotentiality Protective earth
ground
Denotes compliance to
93/42/EEC, Medical
Device Directive
is product contains electrical waste or electronic equipment.
It must not be disposed of as unsorted municipal waste and
must be collected separately.

7
Product Description/Intended Use
e Stryker Digital Capture Classic (SDC Classic™) is a computer-based unit that
records, manages, and archives digital images and videos of surgical procedures.
e SDC Classic simplies le management by recording surgical photos and
videos to compact digital media, such as CDs, DVDs, Compact Flash Cards, USB
Hard Drives, or USB dongles, for later viewing on a personal computer, a DVD
player, or from the SDC Classic itself.
e SDC Classic 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 control panel located on the front
of the unit.
In addition to the control panel, the SDC Classic can be controlled by a hand-
held remote control, buttons located on the surgical camera head, or the SIDNE®
voice-activation system.
Indications/Contraindications
e SDC Classic™ is indicated for use with compatible endoscopic cameras or
other medical devices that output a standard video signal. e SDC Classic
can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy,
sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope
is indicated for use. (A few examples of the more common endoscopic surgeries
are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic
appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically
assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion,
anterior cruciate ligament reconstruction, knee arthroscopy, shoulder
arthroscopy, small joint arthroscopy, decompression xation, wedge resection,
lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal
mammary artery dissection for coronary artery bypass, coronary artery bypass
graing where endoscopic visualization is indicated, and examination of the
evacuated cardiac chamber during performance of valve replacement.
ere are no known contraindications.
Operator Profile
e users of SDC Classic are general surgeons, gynecologists, cardiac surgeons,
thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons,
urologists and operating room nurses.

8
Package Contents
Carefully unpack the SDC Classic and verify that all components have been
received intact. You should receive:
105-033-001 (1) Medical grade power cord
105-198-707 (1) 6-foot DVI-I cable
105-187-988 (1) 6-foot USB cable
105-198-102 (1) Blank DVD+RW
1000-401-087 (1) User guide
Save all packing materials for future storage or transport.
Accessories
e following accessories are available for purchase separately:
240-080-211 HP D5460 Photosmart Printer Kit
240-050-891 Multi-card reader with media
(256MB Compact Flash card, 256MB multi-media card,
256MB Sony memory stick)
240-050-902 USB 2.0 hard drive, 60GB
240-050-893 USB 2.0 hard drive, 512MB
240-050-840 VGA cable kit (6-foot VGA cable and DVI-VGA adapter)
240-050-845 DVI cable kit
105-208-352 SDC Classic remote control

9
System Overview
Front Panel
OK
10 9 8 7
6
54321
1112
13
14
1. LCD status screen - see the “LCD Status Screen” section of this manual.
2. Menu navigation - use the arrow keys to navigate through the menu.
3. Remote control
4. USB Port
5. Write to USB drive
6. Write to DVD drive
7. DVD drive
8. Preview previous four images
9. Print
10. Stop
11. Record/Pause
12. Capture
13. Power
14. New case

10
Rear Panel
Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 USA
Stryker European Rep. -
RA/QA Manager
ZAC Satolas Green Pusignan
Av. De Satolas Green
69881 MEYZIEU Cedex, France
MADE IN USA
S-VID IN S-VID OUT
SIDNE IN OUT
COMP IN COMP OUT
11
2 4
17 10
5
12
98763
20
19
18
16 15
1
1314
1. Remote 2
2. Remote 1
3. Mic in
4. SIDNE® in
5. SIDNE out
6. S-Vid in
7. S-Vid out
8. Comp in
9. Comp out
10. Power
11. Equipotential ground plug
12. DVI out
13. DVI in
14. SIDNE port
15. USB port
16. Monitor
17. VGA/monitor
18. Keyboard (not intended for the user)
19. Mouse (not intended for the user)
20. Serial port

11
Remote Control
OK
2
1
4
1
2
3
5
6
1. Channel 1 video and image: capture, record, stop
2. Channel 2 not available
3. Print images
4. Display previous image on OSD
5. Voice annotation (reserved for future use)
6. Navigation and Select (reserved for future use)

12
LCD Status Screen
e status screen provides information about currently selected options for
capturing and printing images. ese options can be edited in the Printer
Settings menu.
Recording mode Non-recording mode
2
43 5 6
1
32 4 5
1
1. Video timer
2. Size of video
3. Number of images captured
4. Number of videos captured
5. Number of images to print
per page
6. Number of copies to print
1. Signal status
2. Number of images
captured
3. Number of videos captured
4. Number of images to print
per page
5. Number of copies to print

13
Setup and Interconnection
Stryker Endoscopy considers instructional training an integral part of the SDC
Classic™ 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 Classic.
•PlacetheSDCClassic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 Classic to ensure proper ventilation.
2. Connect the AC power cable.
Warning To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth. To isolate
the device from the supply mains, use only hospital-grade
power cords.
3. Connect peripheral devices according to the interconnection diagrams
on the following pages.
Warning e SDC Classic is a non-sterile device intended for use outside
the patient environment. When setting up the device, select a
location that will ensure optimal ease of use while maintaining
separation between the device and the patient.
Do not connect the SDC Classic to extension cords or multiple
portable socket outlets (power strips) other than those built
into the Stryker cart.
Do not connect items to the SDC Classic that are not intended
for use with the system.
RF and other mobile communications equipment may aect
the normal function of the SDC Classic. When placing the SDC
Classic, follow the instructions located in the “Electromagnetic
Compatibility” section of this manual.

14
Warning When the SDC Classic 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.
4. Prior to the surgical procedure, verify proper setup by recording sample
images and video. Consult the “Troubleshooting” section of this manual
as needed.

15
Connecting a Printer
Warning e 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
adapters when connecting the AC power.
Check the power cord assembly periodically for damaged
insulation or connectors.

16
Connecting the 1188 Camera and SIDNE®
Stryker European Rep. -
RA/QA Manager
ZAC Satolas Green Pusignan
Av. De Satolas Green
69881 MEYZIEU Cedex, France
DVI-IN
Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 USA
Stryker European Rep. -
RA/QA Manager
ZAC Satolas Green Pusignan
Av. De Satolas Green
69881 MEYZIEU Cedex, France
MADE IN USA
S-VID IN S-VID OUT
SIDNE IN OUT
COMP IN COMPOUT
SIDNE® - CAMERA
SIDNE® - AUDIO
SIDNE® - CLASSIC
S-VIDEO IN
S-VIDEO OUT
DVI-OUT
COMP IN
COMP OUT
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.

17
Operation
Powering the System On and Off
Press the power button on the console to power the system on or o.
Starting a New Case
1. Press the New Case button.
2. Select Yes or Cancel.
3. Press OK.
Capturing Images
Press the Capture Image button.
Recording Video
1. Press the Record button to begin recording video.
2. Press the Record button again to pause.
3. Press the Stop button to stop recording.
Saving Images and Videos
1. Select the images to be saved.
•PressandholdthePreview Images button to see the image album.
•Todeselectanimage,highlighttheimagenumberandpress OK.
Images with a checkmark next to the number indicates the image will
be saved.
2. Connect a USB device or insert a blank DVD.
3. Press the USB button to save images and video to an external USB
device.
4. Press the DVD button to save images and video to DVD.

18
Printing Images
1. Select the images to be printed.
•PressandholdthePreview Images button to see the image album.
•Todeselectanimage,highlighttheimagenumberandpress OK.
Images with a checkmark next to the number indicates the image will
be printed.
2. Press the Print button.