Documentos de Académico
Documentos de Profesional
Documentos de Cultura
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
Caution
Note
Warning
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.
Warning Symbols
Warning/Caution: See
Instructions for Use
Hazardous voltage
present
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
Ambient temperature
range
Relative humidity
range
LOT
SN
Lot number
Product number
Serial Number
Denotes compliance
to CSA C22.2 No.
601.1-M90, and UL
2601-1.
Equipotentiality
US
Protective Earth
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.
System Overview
Front Panel
1
5
1.
2.
3.
4.
5.
6.
CD/DVD drive
USB port
Eject button for CD/DVD drive
Remote control
Power button
LCD touch screen
Rear Panel
1 2
9
10
26
11
25
12
24
13
14
23 22 2120 19 18 17
16
15
20.
21.
22.
23.
24.
25.
26.
Firewire devices
Speaker port (development use only)
USB ports (2)
Monitor (development use only)
Keyboard (development use only)
Mouse (development use only)
Serial port (development use only)
Network port
Remote Control
1
2
3
4
5
7
1.
2.
3.
4.
5.
6.
7.
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
10
Warning
Note
Warning
11
Setting up the SDC Ultra with the 1188 Camera and SIDNE
Caution
12
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.
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 patients last name. All the images and videos (if selected) are then
transferred to this folder.
13
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 Patients Name / ID entered
Username: Doctors Username which can be the same as his/her Notematic
ID MMDDYYYY_HHMMSS: Date/Time stamp to guarantee uniqueness
Note
14
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.
Operation
SDC Ultra provides an interface for entering patient information, capturing
images and videos, and archiving photos and video.
Getting Started
Home Screen
1
15
6
1. Press the Home button to return to the home screen.
2. Enter the patient information.
Enter the patients 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
17
15
14
13 12 11
10
18
11.
12.
13.
14
Recording
Press the Record button on the Capture screen to record video.
19
Pausing
Press the Pause button on the Recording screen to pause video.
20
8
7
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
22
1
1.
2.
3.
4.
5.
6.
23
3
2
1
1.
2.
3.
4.
24
25
6
5
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
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
3
2
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.
28
2
4
1. Patient information.
Enter the last name.
Enter the birth date.
Enter the sex.
Enter the patients 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
1 2
6
5
3
4
1.
2.
3.
4.
30
2
10
8
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
31
32
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.
35
Saving Settings
To save settings, press the Save button on the Saving Information screen.
36
2
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
38
Print errors
40
Caution
Caution
Caution
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:
Operating humidity:
Shipping temperature:
Shipping humidity:
10 40C
30 75% RH
-20 60C
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
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
Equipment Classification
Class I equipment
No applied part
Water ingress protection, IPX0
Continuous Operation
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
Caution
Caution
45
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class A
Harmonic emissions
IEC61000-3-2
Class A
Warning:
46
Complies
Compliance
Level
Electromagnetic Environment-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
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3V
3 V/m
d = 1.17P
d = 1.17P 80 MHz to 800 MHz
d = 2.33P 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
Electrostatic Discharge
(ESD) IEC61000-4-2
Electrical fast
transient/burst
IEC61000-4-4
Surge
IEC61000-4-5
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8
IEC 60601
test level
Compliance Level
Electromagnetic
Environment - guidance
6kV contact
8kV air
2kV for
power supply
lines
1kV for
input/output
lines
1kV
differential
mode
2kV
common
mode
<5% Ut
(>95% dip
in Ut) for 0.5
cycle
40% Ut (60%
dip in Ut) for
5 cycles
70% Ut (30%
dip in Ut) for
25 cycles
<5% Ut
(>95% dip in
Ut) for 5 sec
3 A/m
3 A/m
Not Applicable
NOTE Ut is the a.c. mains voltage prior to application of the test level.
48
49
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
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 Endoscopys 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
51
52
53
54
Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 USA
1-408-754-2000, 1-800-624-4422
www.stryker.com
2007/08
European Representative:
Regulatory Manager, Stryker France
ZAC Satolas Green Pusignan
Av. De Satolas Green
69881 MEYZIEU Cedex, France
www.stryker.com
1000-401-050 B