Stryker visionpro 0240-031-020, visionpro synk 0240-031-000, 240-031-050 User Manual

VisionPro 26" LED Display
VisionPro 26" LED Display: 0240-031-020
VisionPro SYNK 26" Wireless LED Display: 0240-031-000
Table of Contents
Warnings and Cautions ............................................................................................1
About Your Device .....................................................................................................3
Intended Use and Indications for Use �������������������������������������������������������������������������4 Contraindications ����������������������������������������������������������������������������������������������������������������4 Package Contents ���������������������������������������������������������������������������������������������������������������5 Device Features��������������������������������������������������������������������������������������������������������������������6
Setup ......................................................................................................................... 11
Connections ����������������������������������������������������������������������������������������������������������������������� 11 Basic Video Setup ������������������������������������������������������������������������������������������������������������� 13
Operation ................................................................................................................. 14
On-Screen Display (OSD) ����������������������������������������������������������������������������������������������� 14 OSD Menus �������������������������������������������������������������������������������������������������������������������������16 Troubleshooting ��������������������������������������������������������������������������������������������������������������� 18
Cleaning and Maintenance ................................................................................... 19
Technical Specications ........................................................................................ 20
Electromagnetic Compatibility ............................................................................ 22
Symbols and Denitions ....................................................................................... 25
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: Indicates measures to avoid potential serious injury to the user and the patient� Caution: Indicates risks to the equipment� Failure to follow cautions may result in product damage� Note: Provides special information to clarify instructions or present additional useful information�
Warnings
To avoid potential serious injury to the user and the patient, please note the following warnings: 1� Read this manual thoroughly and be familiar with its contents prior to using this device� 2� Federal law (United States of America) restricts this device to sale by, or on the order of, a
physician� 3� Carefully unpack the device and check if any damage occurred during shipment� 4� This device is non-sterile and therefore should not be placed in the sterile eld� 5� Do not place the device or any other heavy object on the power cord� Damage to the cable
can cause re or electric shock� 6� To avoid electric shock, avoid removing the bezel� 7� This device should not be used adjacent to or stacked with other devices� If adjacent or
stacked use is necessary, the device should be observed to verify normal operation in the
conguration in which it will be used� 8� Test this device prior to a surgical procedure� This device was fully tested at the factory
before shipment� 9� Do not attempt internal repairs or adjustments not specically detailed in this manual�
Ensure that readjustments, modications, and/or repairs are carried out by persons
authorized by Stryker Endoscopy� 10� Do not put any object into the panel� If this occurs, unplug the device and have it checked by
qualied personnel before operating it any further� 11� Use appropriate caution to prevent contact with uids if the device is being used with a
power supply in patient environments� 12� The use of cables and/or other accessories with this device, other than those specied, may
result in increased emissions or decreased immunity of this device�
Cautions
1� Connect the device to an AC adapter connected to a hospital grade power cord ensuring the
power cord is plugged into a grounded power outlet to achieve grounding reliability� 2� Do not sterilize the device, as the delicate electronics cannot withstand this procedure� 3� Use only the proprietary surgical display power supply for the display� Completely secure the
connection between the DC power cord and the extension cord� 4� Never operate the device immediately after transportation from a cold location to a warm
location�
5� To connect to an international power supply, use an attachment plug appropriate for the
power outlet, as outlined in the "Technical Specications" section of this manual� 6� Unplug the device if it is not to be used for an extended period of time� To disconnect the
cord, unscrew the plug rst, then pull the cord out by the plug� Never pull the cord itself� 7� Do not expose the device to moisture or apply liquid cleaners directly to the screen� Spray
the cleaning solution onto a soft cloth and clean gently� For further detail, refer to the
"Cleaning and Maintenance" section of this manual� 8� Allow adequate air circulation to prevent internal heat buildup� Do not place the device
on surfaces (rugs, blankets, etc�) or near materials (curtains, draperies) that may block the
ventilation slots� The device is cooled by natural convection and has no fan� 9� Do not touch the patient with signal input or output connectors� Equipment with SIP/
SOP connectors should either comply with IEC60601-1 and/or IEC 60601-1-1 harmonized
national standards or the combination should be evaluated for safety� 10� To ensure electromagnetic compatibility, refer to the “Electromagnetic Compatibility” section
of this manual� TheVisionPro26” LED Display (0240-031-020) and the VisionPro SYNK 26”
Wireless LED Display (0240-031-000) must be installed and operated according tothe EMC
information provided in this manual� 11� Pay close attention to the cleaning instructions in this manual� A deviation may cause
damage� 12� Do not install the device near sunlight, excessive dust, mechanical vibration, or shock� 13� Do not position the device so that it is dicult to disconnect the power cord from the supply
mains� 14� Do not operate with the glass device screen facing downward� 15� Handle the device with care� Do not strike or scratch the screen� 16� Changes or modications not expressly approved by the party responsible for compliance
could void the user’s authority to operate the device� 17� Note: This device has been tested and found to comply with the limit for a Class B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
device generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio
communications. There is no guarantee that interference will not occur in a particular
installation, which can be determined by turning the device o and on. The user is
encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving device.
Increase the separation distance between the device.
Connect the device to an outlet on a circuit dierent from that to which the other
device(s) are connected.
Consult the manufacturer or eld service technician for help.
The warranty is void if any of these warnings or cautions are disregarded�
This product contains electrical waste or electronic equipment� It must not be disposed of as unsorted municipal waste and must be collected separately�
About Your Device
VisionPro 26” LED Display
REF: 0240-031-020
The VisionPro 26” LED Display is a wide screen LED surgical display that can support a maximum resolution of WUXGA (1920x1200)� The display supports the following video inputs: digital RGB, analog RGB, serial digital interface (SDI), component video (YPbPr/RGBS), S-video, and C-video/ SOG� It also supports serial communication via the RS232 port�
VisionPro SYNK 26” Wireless LED Display
REF: 0240-031-000
The VisionPro SYNK 26” Wireless LED Display can be used with the optional SYNK Transmitter (0240-031-010), which allows it to receive a high-denition video signal over a radio-frequency link� The display supports the following video inputs: DVI, S-Video, and C-Video/SOG� Once the wireless functionality is enabled, the display supports a wireless digital RGB video input� The display also supports a USB port and serial communication via the RS232 port�
Note: The wireless functionality of the VisionPro SYNK 26” Wireless LED Display can only be
enabled via the SYNK Transmitter.
For details and instructions on using the SYNK Wireless Transmitter and the wireless functionality of the VisionPro SYNK 26” Wireless LED Display, refer to the SYNK Wireless System manual (P21693)�
Intended Use and Indications for Use
The VisionPro SYNK 26” Wireless LED Display and the VisionPro 26” LED Display are intended for video display during surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thoracoscopy, endoscopy (general, gastroenterological, and ENT surgery) and general surgery� The display is a non-sterile reusable device not intended for use in the sterile eld� The display is intended for use by qualied physicians having complete knowledge of these surgical procedures�
Contraindications
There are no known contraindications for this device�
Package Contents
1
2
3
4
5
Reference Part Number Package Contents
1 0240-031-020
0240-031-000
VisionPro 26” LED Display or VisionPro SYNK 26” Wireless LED Display
2 (4) M4 × 16 mm VESA screws
3 Hospital-grade AC power cord
4 0240-031-004 Medical Power Supply
5 Cable Cover
Part Number Optional Accessories
0240-031-002 VisionPro 26” Display Cover
0240-031-004 Medical Power Supply
0240-031-010 SYNK Wireless Transmitter
0240-030-951 15-ft� (5 pin) DC extension cable
0240-030-952 75-ft� (5 pin) DC extension cable
Device Features
Front panel
Operate the display using the rotary control located on the front panel� A list of the display controls and their functions is provided below�
1
2
3
7
10
9
8
11
4 5 6
1. Display Screen Shows video image�
2. Power switch (soft) Powers the display ON and OFF�
3. Power LED Indicates current status:
Green - Display is powered on or is in screen saver mode Blinking Red - Display is in sleep mode Blinking Amber - Over or under voltage
4. Token slot (VisionPro
SYNK 26” Wireless LED
Display only)
Token insertion site used to establish a wireless connection with the transmitter�
5. Token LED (VisionPro
SYNK 26” Wireless LED
Display only)
Green - Link is established Amber - Initializing Blinking Amber - Error, contact service representative
6. Auxillary Connection Supports auxilliary device connections�
7. Audio/PIP VisionPro 26” LED Display:
Accesses the Picture in Picture adjustment menu�
VisionPro SYNK 26” Wireless LED Display:
Press twice for Picture in Picture adjustment menu�
Note: Audio functionality is not enabled at this time.
8. Bright Accesses the Brightness adjustment menu
9. Specialty Accesses the Specialty adjustment menu
10. Input Accesses the Input Selection menu
11. Rotary control Accesses the on-screen display and navigates through its
functions�
Rear panel
2
4
5
3
9
6
10
8
1
11
12
7
1
1
1. Accessory mounts (3) Provide an access point for mounting optional
accessories�
2. VESA mounting holes Provide access points for mounting the display�
3. Power switch (hard) Powers the input DC power ON and OFF�
4. Power connector Connects to the 24V DC power supply�
5. Handles Aid in display positioning�
Caution: The handles are not intended to bear the
entire weight of the display
6. Cable cover hinges Attach the bottom of the cable cover to the display�
7. Velcro straps Straps aid in cable management�
8. Cable cover thumbscrews Attach the cable cover to the display, and are
tightened or loosened using ngers�
9. Cable cover Covers and conceals cables�
10. Cable cover clips Attach the top of the cable cover to the display�
11. Cable wrap Provides a location for wrapping cables�
12. Locking feature A locking mechanism or cable may be routed here
for security purposes�
Cable Cover
Installing the Cable Cover
1� Align the left and right hinges of the cable cover onto the bottom rear of the display� 2� Snap on the top section of the cable cover to the aligning clips� 3� With your ngers, turn the thumbscrews clockwise to tighten and lock the cable cover onto
the display�
Removing the Cable Cover
1� With your ngers, turn the thumbscrews counterclockwise to loosen� 2� Once the thumbscrews are completely loosened, pinch the left and right clips and pull the
cable cover towards you� 3� Remove the cable cover from the left and right hinges�
10
Display Handles
Caution: The handles are intended to aid in positioning the display, not for transporting the
display. The handles should not bear the full weight of the display.
Removing the Display Handles
1� Using a 3mm hex key, loosen the two M4 x 30mm screws and gently pull the handle away
from the display�
Installing the Display Handles
1� Align the handle with the screw holes on the rear of the display� 2� Using a 3mm hex key, install the two M4 x 30mm screws to attach the handle�
11
Setup
Stryker Endoscopy considers instructional training, or inservice, an integral part of this device� Your local Stryker Endoscopy sales representative will perform at least one inservice at your convenience to help set up your device and instruct you and your sta on its operation and maintenance� To schedule an inservice, contact your local Stryker Endoscopy representative after your device has arrived�
Connections
VisionPro 26” LED Display Connection Ports
Video input and output signals are connected to the rear of the display, as illustrated below:
1 2 3
4 5 6
66687
6669 66610
66611
66612
1. DVI
2. 3G/HD/SD
SDI-in
3. 3G/HD/SD
SDI-out
4. VGA
5. S-Video
6. C-Video/SOG
7. R/Pr
8. G/Y
9. B/Pb
10. H-sync
11. V-sync
12. RS232
12
VisionPro SYNK 26” Wireless LED Display Connection Ports
1
2 3
6665
6666
4
1. DVI
2. S-Video
3. C-Video/SOG
4. Auxillary Connector
5. USB
6. RS232
Connecting the Power Supply
1� Connect the power supply to the 24V input on the display� 2� Connect the AC power cord to the power supply*� 3� Connect the AC power, using the supplied hospital-grade power cord� 4� (Optional, not shown) Connect an extension cord between the power supply and display� 5� Install cable cover�
* Power supply information: Model Number: BPM150S24F11, Manufacturer: Bridgepower Corp�
13
Basic Video Setup
1
2
1� Route the video output 1 from the camera to the SDC DVI input� 2� Route the video output 1 from the SDC DVI output to the DVI input on the display�
Note: Stryker recommends a backup connection to the camera.
14
Operation
Operate the display using the rotary control and the four buttons located on the front panel� A list of the display controls and their functions is provided below�
On-Screen Display (OSD)
Accessing the On-Screen Display
1 4
3
2
To use the four front-panel buttons:
1� Audio/PIP (VisionPro SYNK 26” Wireless LED Display):
Press twice to activate Picture Mode (Picture in Picture, Picture by Picture, Picture on Picture)
2� PIP (VisionPro 26” LED Display):
Press to activate Picture Mode (Picture in Picture, Picture by Picture, Picture on Picture)
3� Bright: Activates the Brightness adjustment menu� 4� Specialty: Activates the Specialty adjustment menu� 5� Input: Activates the Input selection menu�
Use the Rotary Control to navigate the on-screen menus once they are activated:
Push — Accesses/selects on-screen display menu�
Turn Right/Left — With the on-screen display menu activated, turning increases/decreases the value of the selected parameter�
Push and Hold — Exits on-screen display menu�
15
Operating On-Screen Display
The device OSD helps navigate through various device menus� 1� Press the Rotary Control to activate the OSD menu� 2� Rotate the Rotary Control to move up or down through the menu�
The parameter is highlighted when selected�
3� Press the Rotary Control to enter the next level OSD� 4� Rotate the Rotary Control to increase or decrease the value of the selected parameter, or to
make a selection on dierent options�
5� To exit the OSD menu screen from the second or third level OSD menu, select the Exit
option� To completely exit the OSD, press and hold the Rotary Control� If no keys are pressed, the OSD will automatically exit after the factory-set predetermined time (the time is customizable)�
16
OSD Menus
Speciality
Menu Item Description Range
Color Temperature* Chooses between color temperatures for Lap A, Lap B,
Arthro A, Arthro B, Standard, PACS, NORM, ENT, GYN�
Red Red balance -128–127
Green Green balance -128–127
Blue Blue balance -128–127
Gamma Gamma value 0�1–2�5,
S0, S1, S2
*
Color Temperature RGB adjustment is available only for Standard, Arth, and Lap settings� PACS and Norm adjustments are only avaliable under SOG input�
Audio (Menu not active at this time)
Brightness Settings
Menu Item Description Range
Brightness Increases or decreases the brightness 0–100
Contrast Increases or decreases the contrast 0–100
Phase** Increases or decreases the Phase level 0–100
Chroma** Increases or decreases the Chroma level 0–100
Image Sharpness Sets image sharpness 1–10
Video Sharpness** Increases or decreases the video sharpness 0–100
**
Only available under SDI-, S-, or C-video input�
Image Eect
Menu Item Description
Scale Mode Chooses scale mode between Fill All, V-Fill, H-Fill, One-To-One, or
Fill-Aspect
Freeze Frame Enables or disables freeze frame
PIP Enables PIP (picture in picture) function
POP Enables POP (picture on picture) function
PBP Enables PBP (picture by picture) function
17
Advanced Settings
Menu Item Description
Key Lock Key lock on: Disables all key functions
Press and hold the rotary knob to turn o key lock�
Auto Source Select Scans inputs until an active video source is detected�
Auto Source Select is disabled during PIP/POP/PBP mode�
Sleep Timer On: The display enters sleep mode if no active video source is
detected�
O: The display will not enter sleep mode�
Timer: Set the time until the display enters sleep mode if no active video source is detected�
OSD Control Controls OSD (On Screen Display) Menu Position, Background,
and Timeout
Restore Factory Settings Sets to factory default
Screen Control VGA
Horizontal
Vertical
Phase
Frequency
S-Video, C-Video, SOG, RGBs, Component
Horizontal
Vertical
SYNK (for the VisionPro SYNK 26” Wireless LED Display)
Status Description
RX APP: XX�XX�XX RX MAC: XX�XX�XX�XX
Receiver
TX APP: XX�XX�XX TX MAC: XX�XX�XX�XX
Transmitter
WiFi SW: XXX-X�XX SIGNAL = Excellent, Good, Poor Default Region: XX FREQ: XXXX MHz
Transmitter
Information
Menu Item Description
User Name Entry Enters custom user name display for boot-up display
Serial Number Displays device serial number
Runtime Displays current device total run time
Input Format Displays current input format
Note: Actual on-screen display values may vary with updated versions of the rmware and
user settings.
18
Troubleshooting
Before returning your display for service, consult the troubleshooting list below:
Problem Current Status Remedy
No picture Power LED on Using the OSD Menu, adjust the brightness
and contrast to maximum, or reset them to their default settings�
Power LED o Ensure the power switch at the front and
rear of the display are set to ON�
Check if the AC power cord is properly connected to the AC adapter and outlet�
Check that the power supply is fully connected and functioning properly�
Power LED blinking Red Display is in sleep mode� Press
any key to wake the display�
Amber The power supply may be over or
under voltage�
Abnormal picture Oversized, undersized,
ormissing video; or center shift�
Using the Screen Control Menu, adjust the Phase, Frequency, Horizontal, and Vertical settings in order to correct the display image�
Adjust settings in Scale Mode
For VGA input only: push and hold the rotary control for 1-2 seconds to re-sync the video feed�
Wait a few seconds after initial sync of video signals, or power cycle the display�
OSD error message “Out of Range” Ensure that an acceptable video source is
connected�
Token LED blinking amber
Error Contact service representative�
19
Cleaning and Maintenance
Warning
To avoid electric shock and potentially fatal injury, unplug the display and power supply from the electrical outlet before cleaning�
Caution
Do not spray cleaning liquid directly onto the display or the power supply as product damage may result� Spray on the cloth before wiping the unit�
Do not immerse the display or power supply in any liquid as product damage will result�
Do not use corrosive cleaning solutions to clean the display or power supply as product damage may result�
Do not sterilize the display or power supply as product damage may result�
Cleaning
To clean the display or the power supply: 1� If the display cover is in place, remove the cover prior to cleaning� 2� For the VisionPro SYNK 26” Wireless LED Display: Make sure to place the cover on the
token slot prior to cleaning� 3� Apply standard disinfectant or mild detergent to a dry sterile cloth� 4� Wipe the display or power supply� 5� Take extra care when cleaning the display screen� Excess liquid or drips that enter the
bottom of the screen or the power supply receptacle may result in product damage�
Disposal
This product contains electrical waste or electronic equipment� It must not be disposed of as unsorted municipal waste and must be collected separately in accordance with applicable national or institutional related policies relating to
obsolete electronic equipment� Dispose of any system accessories according to normal institutional practice relating to potentially contaminated items�
20
Technical Specications
Display
LCD Display Panel 26” (661 mm)Diagonal
(a-Si TFT active matrix LCD)
Synchronization 2�5 – 5�0Vppseparated sync
Pixel Pitch 0�300 (H) x 0�300 (V)mm
Response Time <18msTyp
Viewing Angle Right/Left/Up/Down 89 Degrees
Display Colors 1 billioncolors (10 bit)
Native Resolution 1920(H)dots ×1080(V)lines
VisionPro 26” LED Display Signals
DVI,VGA, 3G/HD/SD-SDI (In/Out), C-Video/SOG, S-Video, Component/RGBs (Y/G, Pb/B, Pr/R, HS, VS), RS232
VisionPro SYNK 26” Wireless LED Display Signals
Wireless digital RGB, DVI, S-Video, C-Video/SOG, RS232 and USB
Maximum Pixel Clock 165MHz
Electrical
Power Adapter Input: 100 – 240 VAC; 50 – 60 Hz; 2�5 A (2�5A - 1�5A)
Output: 24V DC; 6�25A (150W Max) Model Number: BPM150S24F11
Power Consumption (approximate)
35 - 65 Watts
Current/Voltage Rating
Please ensure the respective power cord complies with applicable local regulations and standards�
110V +/- 10V power outlets
Select a power supply cord that is UL Listed and C�S�A Certied, type SJT or SVT, 3 – conductor, 18AWG, terminated in a molded on hospital grade plug cap rated 110V+/-10V, 15A, with a minimum length of six feet�
220V +/- 20V power outlets
Select a power supply cord that is internationally harmonized and marked “<HAR>”, 3 – conductor, 0�75 mm^2 minimum wire, rated 220V+/-20V, 10A with a PVC insulated jacket� The cord must have a molded on plug cap rated 220V+/-20V,10A� The cord and plug cap must be suitable for medical use�
Dimensions
Dimensions (W × H × D)
660�4×442×86�4mm 26×17�4×3�4in
Weight (approximate)
8�3kg;18�3lbs�
21
VESA Mounting Interface
VESA100×100mm
Operating Conditions
Temperature Range 50 – 104°F (10 – 40°C)
Relative Humidity Range
25 – 75%
Transport and Storage Conditions
Temperature Range 0 - 140°F (-18 - 60°C)
Relative Humidity Range
15% -90%
Classication and Approvals
Class 1 Equipment Medical equipment with respect to electric shock, re, and mechanical hazards only in accordance with UL 60601-1 and CAN/CSA C22�2 No�601�1� IP23: Protection against access to hazardous parts from ngers or similar objects, protection from ingress of spraying water (less than 60° from vertical) Continuous Operation
Compliance
FCC Regulations VisionPro 26” LED Display:
FCC Part 15 Class B FCC Identier: QVXAMM261WTDS
VisionPro SYNK 26” Wireless LED Display:
FCC Part 15 Class B FCC Identier: QVXAMM261WTDSW
FCC Part 15 Class C FCC Identier: SSH-SYNKRX (Receiver Board) FCC Identier: SSH-SDMAN (Accessory Board)
IC Regulations VisionPro SYNK 26” Wireless LED Display:
IC: 4919C-SYNKRX (Receiver Board) IC: 4919C-SDMAN (Accessory Board)
Note: Please contact your local Stryker Endoscopy sales representative for information on
changes and new products.
22
Electromagnetic Compatibility
Like other electrical medical equipment, the VisionPro 26” LED Display, and the VisionPro SYNK 26” Wireless LED Display require special precautions to ensure electromagnetic compatibility with other electrical medical devices� Toensure electromagnetic compatibility (EMC), the display must be installed and operated according to the EMC information provided in this manual� The display has been designed and tested to comply with IEC 60601-1-2 requirements for EMC with other devices�
Warning
When this device is connected with other electrical equipment, leakage currents may be additive� To minimize total leakage current per patient, ensure that all systems are installed according to the requirements of IEC 60601-1-1�
Caution Portable and mobile RF communications equipment may aect the
normal function of the display� Do not use cables or accessories other than those provided with the display, as this may result in increased electromagnetic emissions or decreased immunity to such emissions� If the display is used adjacent to or stacked with other equipment, observe and verify normal operation of the display in the conguration in which it will be used prior to using it in a surgical procedure� Consult the tables below for guidance in placing the display�
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The VisionPro 26” LED Display, and the VisionPro SYNK 26” Wireless LED Display are intended for use inthe electromagnetic environment specied below� The customer or the user of the display should ensure it is used in such an environment�
Emissions test Compliance Electromagnetic Environment - guidance
RF emissions CISPR 11 Group 1 The displays use RF energy only for their internal function; therefore,
their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment�
RF emissions CISPR 11 Class B
The displays are suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:
Warning: This system is intended for use by health care professionals only� This system may cause radio interference or may disrupt the operation of nearby equipment� It may be necessary to take mitigation measures, such as reorienting or relocating the system or shielding the location�
Harmonic emissions IEC61000-3-2 Class D
Voltage Fluctuations/ icker emissions IEC61000-3-3
Complies
Guidance and Manufacturer’s Declaration — Electromagnetic Immunity
The VisionPro 26” LED Display, and the VisionPro SYNK 26” Wireless LED Display is intended for use in the electromagnetic environment specied below� The customer or the user of the display should ensure that it is used in such an environment�
Immunity Test IEC 60601 Test Level Compliance Level
Electromagnetic Environment-­Guidance
Electrostatic Discharge (ESD)
IEC61000-4-2
± 6kV contact ± 8kV air
± 6kV contact ± 8kV air
Floors should be wood, concrete, or ceramic tile� If oors are covered with synthetic material, the relative humidity should be at least 30%�
23
Electrical fast transient/burst
IEC61000-4-4
± 2kV for power supply lines
± 1kV for input/output lines
± 2kV line to ground
± 1kV line to line
Mains power quality should be that of a typical commercial or hospital environment�
Surge IEC61000-4-5
± 1kV dierential mode ± 2kV common mode
± 1kV dierential mode ± 2kV common mode
Mains power quality should be that of a typical commercial or hospital environment
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC61000-4-11
• <5% U
T
(>95% dip in Ut)
for 0�5 cycle
• 40% U
T
(60% dip in Ut) for
5 cycles
• 70% U
T
(30% dip in Ut) for
25 cycles
• <5% U
T
(>95% dip in Ut)
for 5 sec�
• <5% UT (>95% dip in Ut) for 0�5 cycle
• 40% U
T
(60% dip in Ut) for
5 cycles
• 70% U
T
(30% dip in Ut) for
25 cycles
• <5% U
T
(>95% dip in Ut)
for 5 sec
Mains power quality should be that of a typical commercial or hospital environment� If the user of the transmitter requires continued operation during power mains interruptions, it is recommended that the Wireless Transmitter be powered from an uninterruptible power supply or a battery�
Power frequency (50/60Hz) magnetic eld
IEC 61000-4-8
3�0 A/m 3�0 A/m Power-frequency magnetic
elds should be at levels characteristic of a typical location in a typical commercial or hospital environment�
Note: U
T
is the AC mains voltage prior to application of the test level�
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The VisionPro 26” LED Display and the VisionPro SYNK 26” Wireless LED Display are intended for use in the electromagnetic environment specied below�
The customer or the user of the display should ensure that it is used in such an environment�
Immunity Test IEC 60601 Test level Compliance Level Electromagnetic Environment - Guidance
Portable and mobile RF communications equipment should be used no closer to any part of the displays, including their 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
3 V d = 1�17√P
Radiated RF IEC 61000-4-3
3 V/m 80MHz to 2�5 GHz
3 V/m 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 xed RF transmitters, as determined by an electromagnetic site survey (a), should be less than 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 aected by absorption and reection
from structures, objects, and people�
(a) Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered� If the measured eld strength in the location in which the VisionPro 26” LED Display and the VisionPro SYNK 26” Wireless LED Display are used exceeds the applicable RF compliance level above, the display and transmitter should be observed to verify normal operation� If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the display�
(b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m�
24
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the VisionPro 26” LED Display or VisionPro SYNK 26” Wireless LED Display
The displays are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled� The user of the displays can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the displays as recommended below, according to the maximum output power of the communications equipment�
Rated maximum output power (W) of transmitter
Separation distance (m) according to frequency of transmitter
150 kHz to 80 MHz d = 1�17√P
80 kHz to 800 MHz d = 1�17√P
800 kHz to 2�5 GHz 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 aected by absorption and reection
from structures, objects, and people�
Hereby, Stryker declares that the VisionPro SYNK 26” Wireless LED Display is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC� A copy of the declaration of conformity may be obtained from Stryker Endoscopy, 5900 Optical Court, San Jose, CA, 95138, USA�
25
Symbols and Denitions
The following symbols appear on the product, its labeling, or the product packaging� Each symbol carries a special denition, as dened below:
Consult Instructions for Use
Attention: See Instructions for Use
Serial Number
QTY
Quantity
Temperature range Humidity range
EC REP
Authorized European Representative
Made in
Korea
Country of Origin
Catalog number Direct Current
Date of Manufacture Legal manufacturer
Tested to comply with FCC Class B and C standards
Wireless Transmission
Federal law restricts this device to sale by or on the order of a physician
Complies with the requirements of directive 93/42/EEC
5
Device recycling code (applicable in China)
China Compulsory Certicate Mark
Enclosure provides protection against:
Access to hazardous parts from ngers or similar objects
Spraying water (less than 60° from vertical)
Complies with Australian regulatory requirements
Medical Equipment is in accordance with AAMI ES60601-1 and CSA C22�2 No� 60601-1-08-CAN/CSA in regards to electric shock, re hazards, and mechanical hazards
This product contains electrical waste or electronic equipment� It must not be disposed of as unsorted municipal waste and must be collected separately�
Produced for: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-800-624-4422
U.S. Patents: www.stryker.com/patents
Products referenced with ™ designation are trademarks of Stryker.
Products referenced with ® designation are registered trademarks of Stryker.
2016/05
WCR: None
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