Stryker sdc classic User Manual

SDC Classic™
User Guide
240-050-989
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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.
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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.
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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.
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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
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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
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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
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