Stryker WiSe 26 inch HDTV User Manual

WiSe 26˝ HDTV
Surgical Display
User Guide
REF
Display 0240030970
Transmitter 0240030971
Contents
Warnings and Cautions .................................................... 3
Symbol Definitions .............................................................. 6
Product Description ........................................................... 7
Intended Use ...........................................................................7
Indications/Contraindications .................................................8
Package Contents ...................................................................8
Setup and Interconnection .......................................... 11
Connection Ports ..................................................................11
Connecting AC Power ...........................................................12
Basic Video Setup .................................................................13
Operating the Display ..................................................... 14
Accessing the On-Screen Display ........................................14
Using the On-Screen Display ................................................15
On-Screen Display Menus ....................................................16
Using the Optional Fiber Optic Module ................ 18
Installing and Activating the Fiber Optic Module ..................18
Using the Optional WiSe™ HDTV Transmitter .. 19
Device Features ....................................................................19
Connecting AC power ...........................................................20
Setting Up the Optional WiSe™ HDTV Transmitter ..............21
Linking the Transmitter to an Auxiliary Display .....................22
Cleaning and Maintenance .......................................... 24
Maintenance ..........................................................................25
Disposal ................................................................................26
Troubleshooting .................................................................. 27
Technical Specifications ............................................... 28
Electromagnetic Compatibility .................................. 31
Warranty and Return Policy ....................................... 36
3
Warnings and Cautions
Please read this manual and follow its instructions carefully. e words warning, caution, and note carry special meaning and should be carefully reviewed:
Warning Indicates risks to the safety of the patient or user. Failure
to follow warnings may result in injury to the patient or user.
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.
An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance instructions in the manual.
A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage. Refer all service to authorized personnel.
Warnings
To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following warnings:
1. Read the operating manual thoroughly and be familiar with its contents prior to using this unit.
2. Carefully unpack the unit and check if any damage occurred during shipment.
3. Test this unit prior to a surgical procedure. is display was fully tested at the factory before shipment.
4. Do not place the display or any other heavy object on the power cord. Damage to the cable can cause re or electric shock.
5. is unit is not suitable for use in the presence of a ammable anesthetic mixture with air, or with oxygen or nitrous oxide.
6. Do not put any liquid or solid object into the panel. If this occurs, unplug the unit and have it checked by qualied personnel before operating it any further.
7. Disconnect the transmitter from the electrical outlet when inspecting the fuses.
8. To avoid electric shock, avoid removing the control unit covers.
4
9. Ensure that the electrical installation of the relevant operating room complies with NEC and CEC guidelines.
10. Do not attempt internal repairs or adjustments not specically detailed in this operating manual. Ensure that readjustments, modications, and/ or repairs are carried out by persons authorized by Stryker Endoscopy.
11. Use appropriate caution to prevent contact with uids if the unit is being used with a power supply in patient environments.
12. Federal law (United States of America) restricts this unit to sale by, or on the order of, a physician.
Cautions
1. Plug the AC adapter into a grounded power outlet.
2. Use only the proprietary surgical display power supply for the display. Completely secure the connection between the DC power cord and the extension cord.
3. Connect the unit to a hospital grade receptacle to achieve grounding reliability.
4. To connect to an international power supply, use an attachment plug appropriate for the power outlet.
5. Power o the unit when it is not in use.
6. Remove the power module and connection when transporting the unit.
7. Unplug the unit 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.
8. Handle the display with care. Do not strike or scratch the screen.
9. Never operate the unit immediately aer transportation from a cold location to a warm location.
10. Pay close attention to the care and cleaning instructions in this manual. A deviation may cause damage.
11. Do not expose the display to moisture or apply liquid cleaners directly to the screen. Spray the cleaning solution into a so cloth and clean gently.
12. Do not sterilize the display or transmitter console, as the delicate electronics cannot withstand this procedure.
13. Allow adequate air circulation to prevent internal heat buildup. Do not place the unit on surfaces (rugs, blankets, etc.) or near materials (curtains, draperies) that may block the ventilation slots. e display is cooled by natural convection and has no fan.
14. Do not install the unit near sunlight, excessive dust, mechanical vibration, or shock.
5
15. Do not operate with the glass display screen facing downward.
16. Keep the unit away from equipment that uses strong magnets (i.e., large loudspeakers).
17. 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.
18. Changes or modications not expressly approved by the party responsible for compliance could void the user’s authority to operate the unit.
Note is unit has been tested and found to comply with the limit
for a Class B digital device, pursuant to Part 15 of the FCC Rules. ese limits are designed to provide reasonable protection against harmful interference in a residential installation. is unit 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. ere is no guarantee that interference will not occur in a particular installation, which can be determined by turning the unit o and on. e user is encouraged to try to correct the interference by one or more of the following measures:
 •Reorientorrelocatethereceivingunit.
 •Increasetheseparationdistancebetweentheunits.
 •Connecttheunittoanoutletonacircuitdierentfromthat
to which the other unit(s) are connected.
 •Consultthemanufactureroreldservicetechnicianforhelp.
19. To ensure electromagnetic compatibility, refer to the “Electromagnetic Compatibility” section of this manual. e WiSe 26" HDTV Surgical Display (model 0240030970) must be installed and operated according to the EMC information provided in this manual.
e WiSe™ 26" HDTV Surgical Display (model 0240030970 has been tested under the UL 60601-1 standard and is UL listed for medical application.
e warranty is void if any of these warnings or cautions are disregarded.
6
Symbol Definitions
e following symbols appear on the product, its labeling, or the product packaging. Each symbol carries a special denition, as dened below:
Dangerous High Voltage For indoor use only
Direct Current DC power control switch
Protective Earth Ground is Side Up
Wireless Transmission Fragile
Equipotentiality Do not get wet
Operating Pressure Ratings
3
Maximum Stacking
Operating Humidity Ratings
Medical Equipment is in accordance with UL 60601-1 and CAN/CSA C22.2 No. 601.1 in regards to electric shock, re hazards, and mechanical hazards
Operating Temperature Ratings
Tested to comply with FCC Class B standards
Fuse Rating
IPX1
Degrees of protection against the ingress of water
Denotes compliance to CAN/ CSA C22.2 No 601.1-M90 UL60601-1.
is symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment.
7
Product Description
e WiSe™ 26" HDTV Surgical Display is a high-denition, wide screen LCD surgical display with a maximum resolution of WUXGA (1920 × 1200 at 60 Hz). e display supports various video inputs, including digital RGB, analog RGB, serial digital interface (SDI), component video (YPbPr/RGB), S-video, and C-video.
e display features an optional optical module accessory, which allows it to receive a high-denition video signal over ber optic cables. It also features an optional WiSe™ HDTV Transmitter, which allows it to receive a high-denition video signal over a radio-frequency link.
Intended Use
e display is intended to display video images during the following types of surgical procedures:
arthroscopy (orthopedic surgery)• laparoscopy (general and gynecological surgery)• thoracoscopy• endoscopy (general, gastroenterological, and ENT surgery)•
general surgery• e display is a non-sterile, reusable device not intended for use in the sterile eld.
8
Indications/Contraindications
during general surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, sinusocopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
Package Contents
(1) WiSe™ 26" HDTV
Surgical Display
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(1) User guide
(1) AC adapter
(1) Hospital-grade AC power
cord
(4) M4 × 10 mm VESA screws
(2) Cable-management clamps
Optional Accessories (not shown) Stryker Part Number
WiSe™ HDTV Transmitter 0240030971
0240030951
0240030952
2 – 5 pin DC convertor adapter 0240030953
Fiber optic module 0240030962
(Manufacturer: Bridgepower, Model No: JMW1150KA2400F07
or Manufacturer:FSP Group, Model No:PMP150-14)
9
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.
2
1
3
6
4
5
1. Power LED Shines green if the display is powered on; blinks
amber if the display is in standby mode.
2. Power switch (so) Powers the display ON and OFF.
3. Token slot Token insertion site used to establish a wireless
connection with the transmitter.
4. Token LED Provides feedback when linking monitor and
transmitter.
5. Rotary control Accesses the on-screen display and navigates
through its functions.
6. Display Screen Shows video image.
10
Rear panel
1
2
3
4
5
1. VESA mounting holes (100mm)
Provide access points for mounting the monitor.
2. Power switch (hard) Powers the input DC power ON and OFF.
3. Power connector Connects to the 24V DC power converter.
4. Cable-management clamps
Organizes cables.
5. Connector tags Indicate the types of video connectors.
11
Setup and Interconnection
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 equipment and instruct you and your sta on its operation and maintenance. To schedule an inservice, contact your local Stryker Endoscopy representative aer your equipment has arrived.
Connection Ports
Video input signals are connected to the rear of the display, as illustrated below:
1 6 7 85432 131211109 1514
1. Power switch (hard) 9. G/Y
2. Power 24V 10. B/Pb
3. Optical (optional) 11. H-sync
4. DVI 12. V-sync
5. VGA 13. HD/SD SDI IN
6. S-Video 14. HD/SD SDI OUT
7. C-Video SOG 15. RS232
8. R/Pr
12
Connecting AC Power
3
1
2
1. Connect the power supply to the 24V input on the display.
2. Connect the 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 the display.
Optional Extension Cord Connection
Hospital-grade power cord
Power Supply Manufacturer: Bridgepower Model : JMW1150KA2400F07 or Manufacturer: FSP Group Model: PMP150-14
Extension cord Manufacturer: Bridgepower Model : 1501047 (15Ft) or 1501047001 (75Ft) or 1501047002 (6Ft)
Converter cord Manufacturer: Bridgepower Model : 1501055
Converter cord Manufacturer: Bridgepower Model : 1501055001
Connect to cart chasis
Manufacturer: Nortra Cables Model : 240-030-722 (15Ft) or 240-030-932 (75Ft)
or
WiSe™ 26" HDTV Surgical Display
Model 0240030970
13
Basic Video Setup
1
2
3
4
IN OUT
WiSe™ HDTV Surgical Display
VCR or Printer
SDC or SIDNE
Camera
1. Route the video output 1 from the camera to the SDC or SIDNE.
2. Route the video output 1 from SDC or SIDNE to input on the DVI input on the display.
3. Connect the C-video input on the display to the C-video output on a VCR or printer.
4. Connect the C-video input on the VCR or printer to the C-video output on the camera.
14
Operating the Display
Accessing the On-Screen Display
Operate the display using the rotary control located on the front panel. A list of the display controls and their functions is provided below.
3 4
2
1
5
1. Power LED Indicates menu current status. Displays
green if display is powered on; blinks amber if display is in Standby mode.
2. Power Switch (So) Turns the power ON or OFF.
3. Token Slot Insertion site for token to enable wireless
connection.
4. Token LED Provides feedback when linking monitor
and transmitter.
5. Rotary Control a. Turn Right/Le — With the on-screen
display menu activated, increases/decreases the value of the selected parameter. With the on-screen display deactivated, activates the video source selection menu.
b. Push — Accesses/selects on-screen display menu.
c. Push and Hold — Exits on-screen display menu.
15
Using the On-Screen Display
e device on-screen display helps navigate through various device menus.
1. Press the Rotary Control to activate the on-screen display (OSD) menu.
2. Rotate the Rotary Control to move up or down through the menu. e parameter will be 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.
6. While the OSD menu is deactivated, rotate the Rotary Control to activate the input signal selection menu. e current input signal will be indicated by a dot. Rotate the Rotary Control to select the preferred input signal.
Stryker Camera Preset Modes
Camera
Resolution
(H × V)
Horizontal
Frequency
(KHz)
Vertical
Frequency
(Hz)
988 1024 × 768 49.09 59.90
988i 1024 × 768 41.25 50.00
1088/SDC Pro2 1024 × 768 50.03 60.00
1088i/SDC Pro2 1024 × 768 41.10 50.00
1088/1188/SDC HD 1280 × 1024 64.02 60.10
1088i/1188i/SDC HD 1280 × 1024 59.99 50.00
1188w720 1280 × 720 45.00 60.00
1188iw720 1280 × 720 37.50 50.00
16
On-Screen Display Menus
Item Function Description Range
Specialty
Color Temperature * Chooses between color temperatures for Standard,
Arth, Lap, PACS, or Norm
Red Red balance -128 – 128
Green Green balance -128 – 128
Blue Blue balance -128 – 128
Gamma Gamma value 0.1 – 2.5, S0,
S1, S2
Setting
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
Image Eect
Scale Mode Chooses scale mode between Fill All, V-Fill, H-Fill,
One-One or Fill-Aspect
Freeze Frame Enables or disables freeze frame
Zoom/Pan Enables zoom-in and pan function
PIP Enables PIP (picture in picture) function
POP Enables POP (picture on picture) function
PBP Enables PBP (picture by picture) function
Advanced
OSD Control Controls OSD Menu Position, Background, and
Time out
Screen Control*** Controls and adjusts Horizontal, Vertical, Frequency,
and Phase
DPMS Chooses DPMS (display power
management signaling)
60min, 90min, 120min
17
Item Function Description Range
Auto Source Select Adjusts Auto Source Select between on and o
Restore Factory Settings
Sets to factory default
Key Lock Sets to key lock mode
Wireless
Mac ID Unique machine ID of WiSe™ HDTV Transmitter
Status Status message:
Receiver:
RX MAC: XXXXXXXX
RX SW: vXX.XX.XX
Transmitter:
TX MAC: XXXXXXXX
TX SW: vXX.XX.XX
SIGNAL: Excellent, Good, Poor
REGION: US, Europe, Japan
CHANNEL XXXX MHz
Information
User Name Entry Enters custom user name display for boot-up display
Serial Number Displays device serial number
Runtime Displays current device run time
Input Format Displays current input format
Actual on-screen display values may vary with updated versions of the rmware and user setting.
* Color Temperature RGB adjustment is available only for Standard, Arth,
and Lap settings. PACS and Norm selection only available under SOG input.
** Only available under SDI-, S-, or C-video input.
*** Only available under VGA input.
18
Using the Optional Fiber Optic Module
e display features an optional optical module accessory (0240030962), which allows it to receive a high-denition video signal over ber optic cables.
Installing and Activating the Fiber Optic Module
Caution Excessive force or misalignment during insertion might damage
the module connector.
1. Power o the display using the hard power switch.
2. Unscrew the two screws from the cover plate, then remove the cover plate.
1 32
1. Power Switch (hard)
2. Power 24V
3. Optical Module Slot with Cover Plate
3. Insert the Fiber Optic Module into the Fiber Optic Module slot and screw into place.
4. Power on the display using the hard power switch.
5. Power o the display using the so power switch.
6. Press and hold the so power switch on the display for 10 seconds to activate the Fiber-Optic input from the Input Selection menu.
Input Selection List
Digital RGB HD/SD-SDI C-Video
Wireless RGB Component (Y/Pb/Pr) SOG
Analog RGB RGBS Exit
Digital Optical* S-Video
*Greyed out if module is not installed
19
Using the Optional WiSe™ HDTV Transmitter
e display can be used with the optional WiSe™ HDTV Transmitter (0240030971), which allows it to receive a high-denition video signal over a radio-frequency link. is link is established by means of the token, which is included with the transmitter.
Device Features
Front Panel
2
3
1
4
1. Token Slot Site of insertion for the token to establish a wireless
connection.
2. Power switch (hard) Powers transmitter ON and OFF.
3. Token LED Provides feedback when linking monitor and
transmitter.
4. Token Initializes the wireless connection aer insertion
into the transmitter and display.
20
Rear Panel
3 4
21
5 6
1. DVI Input Connects to camera signal.
2. DVI Output Connects to primary display.
3. RS232 Port Maintenance port (not for
customer use).
4. Equipotential Ground Plug
5. AC Power Inlet Connects to separable power
cord that can be used for mains isolation.
6. Fuse Panel Contains two 0.63A fuses.
Connecting AC power
Warning Always use the hospital-grade power cord supplied with the
transmitter.
21
Setting Up the Optional WiSe™ HDTV Transmitter
Warning When the transmitter is used with other equipment,
leakage currents may be additive. Ensure that all systems are installed according to the requirements of IEC 60601-1-1.
Always set up the transmitter in a location that allows adequate ventilation. Insucient ventilation may cause the transmitter to overheat and shut down.
IN OUT
1
2
3
4
6
5
WiSe™ HDTV
Primary Display
SDC or SIDNE
VCR or Printer
Camera
WiSe™ HDTV Transmitter
WiSe™ HDTV Auxiliary Display
22
1. Route the video output 1 from the camera to the input on the SDC or SIDNE.
2. Route the video output 1 from the SDC or SIDNE to the input on the transmitter.
3. Connect the DVI output from the transmitter to the primary display.
4. Connect the C-video input on the display to the C-video output on a VCR or printer.
5. Connect the C-video input on the VCR or printer to the C-video output on the camera.
6. Link an auxiliary display to the transmitter. (Link the display and transmitter each time the display is powered on.)
Linking the Transmitter to an Auxiliary Display
Caution Equipment that employs RF communications may aect
the normal function of the transmitter. When choosing a location for the transmitter, consult the “Electromagnetic Compatibility” section of this manual to ensure proper function.
In accordance with patient privacy laws, do not transmit personal patient information, such as EKG, EEG, patient name, or patient ID, over the wireless signal.
e transmitter functions on one of eight wireless 20 MHz channels in the
4.9 – 5.9 GHz spectrum. As necessary, remove other wireless devices from the environment, such as cordless phones and 802.11a/n routers to make channels available for the transmitter and display.
To link the display to the transmitter and thereby enable wireless communication, any WiSe™ HDTV Transmitter token will suce.
23
1. Power on the transmitter and auxiliary display.
2. Insert the token into the token slot on the transmitter. e token LED shines amber as it writes the data.
3. When the token LED turns green, remove the token from the transmitter.
4. Within 2 minutes, insert the token into the token slot on the auxiliary display. An audible tone will sound from the transmitter and the token LED will shine green when the display and transmitter have been linked.
7. Remove the token from the token slot on the auxiliary display.
8. Store the token in the transmitter token slot when not in use.
Note If multiple transmitters are within 100 feet of each other, link each transmitter to its respective display one at a time. Wait 15 seconds before linking the next transmitter/display pair.
24
Cleaning and Maintenance
Caution Do not expose the display to moisture or apply liquid
cleaners directly to the screen. Spray the cleaning solution into a so cloth and clean the screen gently.
No specic liquid or chemical is necessary for cleaning the display. Use only non-abrasive cloths and cleaning solutions to clean similar equipment used in hospitals. Disconnect the display and transmitter from the AC power before cleaning.
1. Clean the plastic areas of the display with a dry, so cloth, or a so cloth lightly moistened with mild detergent solution. Do not use any type of solvent, such as alcohol or benzine, which might damage the nish. Acceptable cleaning agents for bezel cleaning include:
• Cidex(2.4%glutaraldehydesolution)
• 0.5%Chlorhexidinein70%isopropylalcohol
2. Apply alcohol to glass surfaces with a so cotton applicator to aid in cleaning and drying without leaving spots or streaks.
3. Clean the display lter with a dry, so cloth, or so cloth lightly moistened with warm water. Other acceptable cleaning agents are listed below:
• 70%isopropylalcohol
• Cidex(2.4%glutaraldehydesolution)
• 0.5%Chlorhexidinein70%isopropylalcohol
4. Dry thoroughly with a so towel or gauze surgical sponge.
25
Maintenance
Replacing the Fuses
Warning To avoid the risk of re, use only fuses of the value specied on
the fuse label located on the rear panel of the transmitter.
1. Unplug the power cord from the wall outlet and remove the cord from the transmitter console.
2. Unlatch the fuse holder above the AC inlet and remove it. (You may need to press the tab on the fuse holder with a slender screwdriver to release the latch.)
3. Replace the fuse with the same value and rating.
4. Reinstall the fuse holder until the tab snaps in place.
Periodic Maintenance Schedule
Warning To ensure safe operation of the transmitter you should
periodically perform the following procedure:
Every 12 months, check the earth leakage current to <500µA (<300µA in U.S.A.), ground protective earth impedance to <0.1 ohms, and power consumption less than or equal to rated power. Use a true RMS digital multimeter and safety analyzer to perform this test.
Note Refer calibration and operating diculties not detailed in this
manual to your Stryker Endoscopy sales representative.
26
Disposal
is 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.
27
Troubleshooting
Before returning your display for service, consult the troubleshooting list below:
Problem Current Status Remedy
No picture Power LED on Using the OSD, 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 back of the display are set to ON.
Check if the AC power cord is properly connected to the AC adapter and outlet.
Power LED blinking
Check if the video signal cable is properly connected at the back of the display.
Check if power of the video signal source system is ON.
Abnormal picture Oversized,
undersized, or missing display; or center shi.
Using the Screen Menu, adjust the Phase, Frequency, Horizontal, and Vertical settings with non-standard video signal timing.
Wait a few seconds aer initial sync of video signals, or power cycle the display.
OSD error message
“Video format not supported”
Ensure that an acceptable video source is connected. Refer to technical specications for a list of acceptable video formats.
28
Technical Specifications
Display
LCD Display Panel 64.9 cm (a-Si TFT active matrix LCD) Synchronization 2.5 – 5.0 Vpp separated sync Pixel Pitch 0.2865(W) × 0.2865(H) Response Time <25ms Typ View Angle ±89° (L/R) × ±89° (U/D) Display Colors 16 million colors Native Resolution 1920 dots × 1200 dots Input Signal 1 DVI 1 VGA 1 HD/SD-SDI 1 C-Video/SOG 1 S-Video 1 Component (Y/G, Pb/B, Pr/R, H/CS, VS) 1 Optical (optional) 1 Wireless (optional) Maximum Pixel Clock 170MHz
Electrical
Power Adapter 100 – 240 VAC; 24 VDC Power Consumption 150 W (max) Current Direct
Dimensions
Dimensions (W × H × D) 616.4 × 428.8 × 121.2mm Weight 8.9kg VESA Mounting Interface VESA 100 × 100mm
Operating Conditions
Operating Temperature 41 – 90°F (5 – 32.°C)
RelativeHumidity 10–60%
Atmospheric Pressure Range 500 – 1060 hPa Electrical Input Rating 24V DC 6.25A
Transport & Storage Conditions
Storage -4 – 140°F (-20 – 60°C)
RelativeHumidityRange 10–85%
Atmospheric Pressure Range 500 – 1060 hPa
29
Classication and Approvals
Class I 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. IPX1 Water Ingress Protection Continuous operation
Optional WiSe™ HDTV Transmitter
Video Input
Digital: One Digital Video Interface (DVI) Connector: 29-pin DVI-I
Video Output
Digital: One Digital Video Interface (DVI) Connector: 29-pin DVI-I
Video Formats:
1920 × 1080 @ 60 Hz 1920 × 1080 @ 50 Hz 1280 × 1024 @ 60 Hz 1280 × 1024 @ 50 Hz 1280 × 720 @ 60 Hz 1280 × 720 @ 50 Hz
Operating Conditions
Temperature: 10 – 40°C
RelativeHumidity: 30–75%
Transport and Storage Conditions
Temperature: -20 – 60°C
RelativeHumidity: 10–75%
Atmospheric Pressure: 700 – 1060 hPa
Input Electrical Ratings
100–240VAC±10%(0.6A)@47–63Hz
Total Shipping Weight
6.0 kg
30
Dimensions
Transmitter Console: 31.8 cm w × 8.4 cm h × 38.7 cm d
Wireless
Frequency 4.9 GHz – 5.9 GHz Channel Bandwidth 20 MHz Channel Allocation Automatic frequency selection with prescan Protocol Orthogonal Frequency Division Multiplexing (OFDM) with Multiple Input Multiple Output (MIMO)
Classication
Class II Equipment Water Ingress Protection, IPX0 — Ordinary Equipment Continuous Operation
Complies with Medical Safety Standards
IEC 60601-1:1988 + A1:1991 + A2:1995 CAN/CSA C22.2 No 601.1-M90 UL 60601-1:2003 AS/NZS 3200.1.0:1998 CSA 22.2.601.1.1:2002
Complies with Medical EMC Standard
IEC 60601-1-2:2001 + A1:2004
Complies with FCC Regulations
FCC 15B 2008 (Class B)
FCC Identier: VQSAMN11100R44
Please contact your local Stryker Endoscopy sales representative for information on changes and new products.
Products referenced with ™ designation are trademarks of Stryker.
Products referenced with ® designation are registered trademarks of Stryker.
31
Electromagnetic Compatibility
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 and transmitter, 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 and transmitter 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 and transmitter.
Like other electrical medical equipment, the WiSe™ 26 " HDTV Surgical Display and WiSe™ HDTV Transmitter requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), the display and transmitter must be installed and operated according to the EMC information provided in this manual. e display and transmitter have been designed and tested to comply with IEC 60601-1-2:2001 requirements for EMC with other devices.
32
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The WiSe™ 26" HDTV Surgical Display and WiSe™ HDTV Transmitter is intended for use in the
electromagnetic environment specied below. The customer or the user of the WiSe™ 26" HDTV
Surgical Display and WiSe™ HDTV Transmitter should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment - guidance
RF emissions CISPR 11 Group 1
The WiSe™ 26" HDTV Surgical Display and WiSe™ HDTV Transmitter uses RF energy only for its internal function; therefore, its RF
emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B
The WiSe™ 26" HDTV Surgical Display
and WiSe™ HDTV Transmitter is 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
33
Guidance and Manufacturer’s Declaration — Electromagnetic Immunity
The WiSe™ 26" HDTV Surgical Display and WiSe™ HDTV Transmitter is intended for use in the
electromagnetic environment specied below. The customer or the user of the WiSe™ 26" HDTV
Surgical Display and WiSe™ HDTV Transmitter 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%.
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 differential
mode
2kV common mode
1kV differential
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% 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.
<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
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the Wireless
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: Ut is the AC mains voltage prior to application of the test level.
34
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The WiSe™ 26" HDTV Surgical Display and WiSe™ HDTV Transmitter is intended for use
in the electromagnetic environment specied below.
The customer or the user of the WiSe™ 26" HDTV Surgical
Display and WiSe™ HDTV Transmitter 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 WiSe™ HDTV Transmitter
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
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 affected 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 WiSe™ 26" HDTV Surgical Display is 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 WiSe™ 26" HDTV Surgical Display. (b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
35
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment
and the WiSe™ 26" HDTV Surgical Display
The WiSe™ 26" HDTV Surgical Display is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The user of the WiSe™ 26" HDTV Surgical Display
can help prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the WiSe™ 26" HDTV Surgical Display
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 affected by absorption and reection from structures, objects, and people.
36
Warranty and Return Policy
Product Warranty
Stryker Endoscopy warrants all products, subject to the exceptions provided herein, to be free from defects in design, materials, and workmanship and to substantially conform to the product specications contained in the documentation provided by Stryker Endoscopy with the products for a period of one year from the date of purchase (the “Warranty Period”). is warranty shall apply only to the original end-user purchaser of products directly from Stryker Endoscopy or a Stryker Endoscopy authorized distributor. is warranty may not be transferred or assigned without the express written consent of Stryker Endoscopy.
If a valid warranty claim is received within the Warranty Period, Stryker will, in its sole discretion: (1) repair the product at no charge, (2) replace the product at no charge with a product that is at least functionally equivalent to the original product, or (3) refund the purchase price of the product. In any event, Stryker’s liability for breach of warranty shall be limited to the replacement value of the defective or non-conforming part or component.
is warranty does not apply to: (1) products that have been misused, neglected, modied, altered, adjusted, tampered with, improperly installed or refurbished; (2) products that have been repaired by any person other than Stryker Endoscopy personnel without the prior written consent of Stryker Endoscopy; (3) products that have been subjected to unusual stress or have not been maintained in accordance with the instructions in the user manual or as demonstrated by a Stryker Endoscopy representative; (4) products on which any original serial numbers or other identication marks have been removed or destroyed; or (5) products that have been repaired with any unauthorized or non-Stryker components, including replacement lamps.
If Stryker determines in its reasonable discretion that the claimed defect or non­conformance in the product is excluded from warranty coverage as described hereunder, it will notify the customer of such determination and will provide an estimate of the cost of repair of the product. In such an event, any repair would be performed at Stryker’s standard rates.
Products and product components repaired or replaced under this warranty continue to be warranted as described herein during the initial Warranty Period or, if the initial Warranty Period has expired by the time the product is repaired or replaced, for thirty (30) days aer delivery of the repaired or replaced product. When a product or component is replaced, the item provided in replacement will be the customer’s property and the replaced item will be Stryker’s property. If a refund is provided by Stryker, the product for which the refund is provided must be returned to Stryker and will become Stryker’s property.
e inspection, testing, acceptance, or use of the products and services furnished
37
hereunder shall not aect Stryker’s obligation under this warranty, and such warranty shall survive inspection, test, acceptance, and use.
Notwithstanding the above, the following products are warranted for a period of ninety (90) days from the date of purchase: Scopes, Associated Scope Hardware, Fiber Optic Cables, Laparoscopic Instruments, VCRs, Monitors, and Printers; replacement light bulbs are warranted for a period of sixty (60) days from the date of purchase.
TO THE FULLEST EXTENT PERMITTED BY LAW, THE EXPRESS WARRANTY SET FORTH HEREIN IS THE ONLY WARRANTY APPLICABLE TO THE PRODUCTS AND IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTY BY STRYKER, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. EXCEPT AS SPECIFICALLY PROVIDED IN THIS WARRANTY AND TO THE EXTENT PERMITTED BY LAW, STRYKER IS NOT RESPONSIBLE FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF WARRANTY OR UNDER ANY OTHER LEGAL THEORY.
Return Policy
Stryker Endoscopy values customer relationships and strives for satisfaction in purchases made by our customers. erefore, we oer a return policy for most products. Under this policy, customers may return purchased products to Stryker Endoscopy, within 90 days of customer’s receipt of the product, for a credit or a refund of the purchase price paid, less shipping and handling and applicable restocking fees. Products that fail aer the rst 90 days may be covered by and are subject to the terms of applicable product warranty. Sterile products may not be returned for credit or refund unless they are in their original, unopened packaging or unless they are in breach of the applicable warranty.
Restocking Fees: Unless the product is defective or the return is the direct result
ofaStrykerEndoscopyerror,arestockingfeeof10%maybechargedonall
returned products.
A Returned Merchandise Authorization (RMA) number must be obtained from Stryker Endoscopy before returning product. To obtain an RMA number, please contact Stryker Endoscopy Customer Service at 1.800.624.4422.
Please send any returned products to:
Stryker Endoscopy Attn: Returns 5900 Optical Court San Jose, CA 95138
38
With the return, please include the following:
1. RMA number
2. Purchase order number
3. Original invoice number
4. Name, address, and account number (of the organization returning the product)
5. Itemized list of the items being returned
6. Reason for the return
7. Product Experience Report/Complaint number, if applicable
Please carefully package the product being returned. Credit will not be given for items that are damaged in return shipment due to inadequate packaging.
Stryker Endoscopy does not accept any COD returns. Return shipping costs are borne by the customer unless Stryker Endoscopy specically agrees otherwise.
Please clean and sterilize all potentially contaminated products prior to returning them to Stryker Endoscopy. It is unlawful to transport bio-contaminated products through interstate commerce, unless they are properly packaged and labeled as such. Stryker Endoscopy reserves the right to destroy contaminated product at the customer’s expense and charge the customer for a replacement unit.
If a return does not comply with these terms, Stryker Endoscopy reserves the right to destroy the product at the customer’s expense. Any replacement would be at the customer’s expense.
Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-408-754-2000, 1-800-624-4422 www.stryker.com
European Representative: Regulatory Manager, Stryker France ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex, France
1000401089 B
2008/11
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