32” 4K Surgical Display REF 0240-031-050 Instructions for Use Rev 05 Nov 2018 .pdf
Page 1
32” 4K Surgical Display
0240-031-050
Page 3
Table of Contents
Warnings and Cautions...........................................................................................3
Warnings...............................................................................................................................3
Cautions................................................................................................................................3
About Your Device....................................................................................................5
Intended Use and Indications for Use........................................................................5
Contraindications...............................................................................................................5
Package Contents..............................................................................................................6
Device Features..................................................................................................................7
Setup.........................................................................................................................11
Connections...................................................................................................................... 11
Basic Video Setup............................................................................................................ 13
Operation.................................................................................................................14
On-Screen Display (OSD).............................................................................................. 14
OSD Menus........................................................................................................................ 16
Troubleshooting.............................................................................................................. 18
Cleaning and Maintenance...................................................................................19
Cleaning............................................................................................................................. 19
Inspection.......................................................................................................................... 19
Electrical Safety Testing................................................................................................ 19
Storage................................................................................................................................ 19
Expected Service Life..................................................................................................... 20
Disposal.............................................................................................................................. 20
Technical Specifications........................................................................................21
General Description....................................................................................................... 21
Classification and Approvals....................................................................................... 22
Compliance....................................................................................................................... 22
Electromagnetic Compatibility............................................................................23
Symbols and Definitions.......................................................................................27
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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 field.
5. Do not place the device or any other heavy object on the power cord. Damage to the cable
can cause fire 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
configuration in which it will be used.
8. Ensure weight compatibility with mounting apparatus. Do not mount the display on a cart
arm unless it is labeled with a maximum load ≥ 11.9 kg/26.3 lb.
9. Test this device prior to a surgical procedure. This device was fully tested at the factory
before shipment.
10. Do not attempt internal repairs or adjustments not specifically detailed in this manual.
Ensure that readjustments, modifications, and/or repairs are carried out by persons
authorized by Stryker Endoscopy.
11. Do not put any object into the panel. If this occurs, unplug the device and have it checked by
qualified personnel before operating it any further.
12. Use appropriate caution to prevent contact with fluids if the device is being used with a
power supply in patient environments.
13. The use of cables and/or other accessories with this device, other than those specified, may
result in increased emissions or decreased immunity of this device.
Cautions
1.
2.
3.
To achieve grounding reliability, connect the device to an AC adapter that is connected to a
hospital-grade power cord, and ensure the power cord is plugged into a grounded power outlet.
Do not sterilize the device, as the delicate electronics cannot withstand this procedure.
Use only the proprietary power supply for the display. If you use an extension cable,
completely secure the connection to the DC power cord of the power supply.
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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 Specifications” section of this manual.
6. Unplug the device if it is not to be used for an extended period of time. To disconnect the
power cord from the display, unscrew the plug first, 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 32” 4K Surgical Display (0240-031-050) 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 difficult 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 modifications 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 off
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 different from that to which the other
device(s) are connected.
• Consult the manufacturer or field service technician for help.
The warranty is void if any of these warnings or cautions is disregarded.
This product contains electrical waste or electronic equipment. It must not be disposed of as
unsorted municipal waste and must be collected separately.
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About Your Device
The 32” 4K Surgical Display is a wide screen LED surgical display that can support a maximum
resolution of 4K (4096 x 2160). The display supports the following video inputs: digital RGB (DVI),
HDMI 1.4 and HDMI 2.0. It supports serial communication via the RS232 port and SDC port. It also
has two USB ports that each supply power (5 V, 1 A) for accessories and peripherals (not used for
data transfer).
Intended Use and Indications for Use
The 32” 4K Surgical Display is 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 field. The display
is intended for use by qualified physicians and qualified operating room personnel having
complete knowledge of the surgical procedures being used.
Contraindications
There are no known contraindications for this device.
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Package Contents
1
2
5
6
3
4
Reference
Part Number
Package Contents
1
0240-031-050
32” 4K Surgical Display
2
–
Cable Cover
3
–
(4) M4 x 16 mm VESA screws
4
0240-031-004
Medical Power Supply
Model : BPM150S24F11 (Bridgepower)
5
–
Hospital-grade AC power cord
Reference
Optional Accessories
0240-031-004
Medical Power Supply
Model: BPM150S24F11 (Bridgepower)
0240-031-051
32” 4K Surgical Display Cover
0240-030-951
15-ft. (5 pin) DC extension cable
Model: 1501047***(Bridgepower) ***: blank or 001~999
0240-030-952
75-ft. (5 pin) DC extension cable
Model: 1501047***(Bridgepower) ***: blank or 001~999
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Device Features
Front panel
1
2
3
4
1.
SDC recording status
2.
3.
4.
Display Screen
Power switch (soft)
Power LED*
5.
6.
7.
8.
9.
10.
PIP
Bright
Specialty
Input
Rotary control
Logo Light
10
5
6
7
8
9
LED shines red when SDC is in record mode (requires
SDC compatibility; contact a Stryker representative for
conditions).
Shows video image
Powers the display ON and OFF.
Indicates current status:
Green - Display is powered on or is in screen saver mode
Blinking Green - Display is in sleep mode
Accesses the Picture in Picture adjustment menu.
Accesses the Brightness adjustment menu.
Accesses the Specialty selection menu.
Accesses the Input selection menu.
Accesses the on-screen and navigates through its function.
Indicates current status:
No illumination - Off
Continuous white illumination - On
Slowly fading white illumination - Sleep mode (see Sleep
Timer settings for detail)
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Rear Panel
2
1
9
4
9
5
1
7
3
6
1
4
5
1.
Accessory mount (3)
2.
VESA mounting holes
3.
4.
Power switch (hard)
Handles
5.
6.
7.
8.
9.
Cable cover hinges
Velcro straps
Cable cover
Cable cover clips
Accessory Mount holes
8
8
Provide an access point for mounting optional accessories.
(accepts 1/4 - 20 screws)
Provide access points for mounting the display using provided
screws. (100x100 mm, 200x100 mm, accepts M4 x 16 mm screws)
Turns the input DC power On and OFF.
Aid in display positioning.
Caution: The handles are not intended to bear the entire
weight of the display.
Attach the bottom of the cable cover to the display.
Straps aid in cable management.
Covers and conceals cables.
Attach the top of the cable cover to the display.
Provide access points for mounting optional video accessories.
(accepts M4 x 16 mm screws)
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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.
Removing the Cable Cover
1. Pinch the left and right clips and pull the cable cover towards you.
2. Remove the cable cover from the left and right hinges.
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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 3 mm hex key, loosen the two M4 x 25 mm 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 3 mm hex key, install the two M4 x 25 mm screws to attach the handle.
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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 staff on its operation and
maintenance. To schedule an inservice, contact your local Stryker Endoscopy representative after
your device has arrived.
Connections
Video input and output signals are connected to the rear of the display, as illustrated below:
1
1.
2.
3.
4.
5.
6.
7.
2
3
4
5
6
7
Power Connector (24V)
DVI
HDMI (HDMI 1.4)
HDMI 4K (HDMI 2.0)
RS-232 communication port
SDC device control port
ACC (Accessory) POWER
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Connecting the Power Supply
1.
2.
3.
4.
5.
Connect the power supply to the 24 V input on the display.
Connect the AC power cord to the power supply*.
Connect the AC power, using the supplied hospital-grade power cord.
(Optional, not shown) Connect an extension cord between the power supply and display.
Install cable cover.
* Power supply information: Model Number: BPM150S24F11, Manufacturer: Bridgepower Corp.
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Basic Video Setup
2
Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 USA
Stryker European Rep - RA/QA Manager
ZAC Satolas Green Pusignan
Av. de Satolas Green
69881 MEYZIEU Cedex, France
产品型号:SDC3
产品名称:数字图像刻录装置
AC~100-240V, 50/60Hz; 4-2A
美国史赛克内窥镜
仅适用于非热带气候和海拔2000m以下地区安全使用
1
1.
2.
Route the video output 1 from the camera to the SDC DVI input.
Route the video output 1 from the SDC DVI output to the DVI input on the display.
Note: Stryker recommends a backup connection directly from the camera to the display.
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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
2
3
4
To use the four front-panel buttons:
1. PIP: Press to activate Picture Mode (Picture in Picture, Picture by Picture, Picture on Picture)
2. Bright: Press to activate the Brightness adjustment menu.
3. Specialty: Press to activate the Specialty adjustment menu.
4. Input: Press to activate the Input selection menu.
Note: Press and hold any of the four front-panel buttons to exit the OSD 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.
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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 different 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).
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OSD Menus
Specialty
Menu Item
Description
Range
Color
Choose between color profiles for Standard,
Arthro A, Arthro B, Lap A, Lap B, ENV, ENT,
PACS, Norm or GYN.
Color temperature RGB and gamma
adjustment are available on each profile
except PACS and Norm.
—
Red
Red balance
-128 – 127
Green
Green balance
-128 – 127
Blue
Blue balance
-128 – 127
Gamma
Gamma value
1.0 – 2.5, S0, S1, S2
Enhancement
Color adjustment to enhance sharpness
Off, Low, Mid, High
Menu Item
Description
Range
Brightness
Increase or decrease the brightness.
0 – 100
Contrast
Increase or decrease the contrast.
0 – 100
Image
Sharpness
Set image sharpness.
1 – 10
Brightness Settings
Image Effect
Menu Item
Description
Scale Mode
Choose scale mode between Fill All, Fill To Aspect, Fill All to Aspect, One To
One, V-Fill or H-Fill.
Freeze Frame
Enable or disable the freeze frame.
Mirror
Enable or disable the mirror function.
PIP
Enable PIP (picture in picture) function.
POP
Enable POP (picture on picture) function.
PBP
Enable PBP (picture by picture) function.
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Advanced Settings
Menu Item
Description
Key Lock
Key lock on: Disables all key functions
(except Specialty and Inputs selection)
Press and hold the rotary knob to turn off 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.
Off : The display will not enter sleep mode.
Timer: Set the time until the display enters sleep mode:
30 or 60 minutes
OSD Control
Controls OSD (On Screen Display) Menu Position, Background,
and Timeout
Restore Factory Settings
Sets to factory default
Com Port
Selects which port to use for communications.
Select SDC for SDC device control; select RS-232 for SPI router
control.
Converter power
ON: Enables power to converter through HDMI port
OFF: Disables power to converter through HDMI port
Time Table
Enable: Default signal detection and display output
Disable: Recommended for detecting signal in iSuite setups
Information
Menu Item
Description
User Name
Entry
Enter custom name to be displayed in screen saver mode
Serial Number
Display device serial number
Runtime
Display current device total run time
Input
Display current input format
Note: Actual on-screen display values may vary with updated version of the firmware and
user settings.
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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.
Check the power supply functionality.
Power LED off
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
Display is in sleep mode. Connect ACTIVE
sources or change INPUT to wake the display.
Converters not
powering on
Check that the converter power setting is ON
in the OSD menu.
Turn the hard power switch off and on again.
Abnormal picture
OSD Error message
18
Oversized,
undersized or
missing video
Adjust settings in Scale Mode.
Resolution not
supported
Ensure the video source has a compatible
output resolution.
Wait a few seconds after initial sync of video
signals, or power cycle the display.
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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
Note: 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.
To clean the display or the power supply:
1. If the display cover is in place, remove the cover prior to cleaning.
2. Apply standard disinfectant or mild detergent to a dry sterile cloth.
3. Wipe the display or power supply.
4. Visually inspect the external surface of the device for cleanliness, focusing on hard-to-reach
areas. If visible soil remains, repeat steps 1 – 3.
Inspection
Inspect the device on a continual basis for unacceptable deterioration such as (but not limited
to) corrosion, discoloration, pitting, cracked seals, or abnormal noises. If a problem is observed or
suspected, the device should be returned for service.
Electrical Safety Testing
Testing of ground protective earthing from the display is not necessary. Protective earthing is
assured by the certified external power supply.
Storage
Never store the device in a non-ventilated, humid environment. This can damage the delicate
electronics in the device.
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Expected Service Life
The expected service life of the device is four years.
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.
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Technical Specifications
General Description
Relative Humidity Item
Description
LCD Panel
Description
31.1” (812 mm) Diagonal
Native
Resolution
4096 (H) dots x 2160 (V) lines
Display colors
1,073,741,824 colors
Pixel Pitch
0.1704 mm x 0.1704 mm
Response Time
(typical)
Rise time: 11 ms
Fall time: 9 ms
Viewing Angle
horizontal/vertical: 178°
Brightness
525 cd/m2
Contrast
1500 : 1
Brightness
and Contrast
Input / Output
Temperature
Input
Output
1 x DVI
1 x HDMI (HDMI 1.4)
1 x HDMI 4K (HDMI 2.0)
1 x RS-232 (SPI router
control)
1 x SDC device control
interface (USB)
2 x USB (5 V, 1 A power
only; not used for data
transfer)
Operating
50° – 104°F (10° – 40°C)
Transport and
Storage
0° – 140°F (-18° – 60°C)
Relative
Humidity
Operating
25 – 75%
Transport and
Storage
15 – 90%
Electrical
Power Adapter
Input: 100 – 240 VAC; 50 – 60 Hz; 2.5 A
Output: 24 V DC; 6.25 A (150 W Max)
Model Number: BPM150S24F11
Power
Consumption
20 – 120 Watts
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Relative Humidity Item
Description
Current/
Voltage Rating
110V +/- 10V
power outlets
Select a power supply cord that is UL Listed and C.S.A
Certified, type SJT or SVT, 3 – conductor, 18 AWG,
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 220 V +/- 20 V, 10 A
with a PVC insulated jacket. The cord must have a
molded on plug cap rated 220 V +/-20 V, 10 A. The cord
and plug cap must be suitable for medical use.
Weight with Cable Cover
(approximate)
23.1 lb (10.5 kg)
Unit Dimensions (W x H x D)
756.7 x 453 x 77.2 mm
29.7 x 17.8 x 3 in
VESA Mounting Interface
Dimensions
VESA 100 x 100 mm
Accessory Mounting Interface
Dimensions
75 x 75 mm (x2)
VESA 200 x 100 mm
Classification and Approvals
Class 1 Equipment
Medical equipment with respect to electric shock, fire, and mechanical hazards only in
accordance with ANSI/AAMI ES60601-1 and CAN/CSA C22.2 No. 60601.1.
IP23: Protection against access to hazardous parts from fingers or similar objects,
protection from ingress of spraying water (less than 60° from vertical)
Continuous Operation
Compliance
FCC Regulations: FCC Part 15 Class B
FCC Identifier: QVXAMM320ES
Note: Please contact your local Stryker Endoscopy sales representative for information on
changes and new products.
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Electromagnetic Compatibility
Like other electrical medical equipment, the 32” 4K Surgical Display requires 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
Caution
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.
Portable and mobile RF communications equipment may affect 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 configuration
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 32” 4K Surgical Display is intended for use in the electromagnetic environment specified 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 display 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
Harmonic emissions IEC 61000-3-2
Class A
Voltage Fluctuations/ flicker
emissions IEC 61000-3-3
Complies
The display 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.
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Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The 32” 4K Surgical Display is intended for use in the electromagnetic environment specified 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)
IEC 61000-4-2
± 8 kV contact
± 8 kV contact
± 15 kV air
± 15 kV air
Floors should be wood, concrete,
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV (input a.c. power
port)
± 2 kV (input a.c. power
port)
± 1 kV (signal ports)
± 1 kV (signal ports)
Surge
IEC 61000-4-5
(± 0.5, ± 1, ± 2) kV; line
to earth
(± 0.5, ± 1) kV; line to line
(± 0.5, ± 1, ± 2) kV; line
to earth
(± 0.5, ± 1) kV; line to line
Mains power quality should be that
of a typical commercial or hospital
environment
Voltage dips and
interruptions
•
•
•
•
•
•
•
•
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.
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
0% UT 0.5 cycle
0% UT 1 cycle
70% UT 25 cycles
0% UT 5 Sec
0% UT 0.5 cycle
0% UT 1 cycle
70% UT 25 cycles
0% UT 5 Sec
Supplementary
information:
If the Rated voltage range
<25% of the lowest rated
input voltage, one rated
input voltage. Otherwise,
minimum and maximum
rated voltage. EUT powered
at one of the Nominal input
frequencies.
ME EQUIPMENT and ME
SYSTEMS with power
input voltage selection by
transformer taps shall be
tested at only one tap
setting.
Supplementary
information:
If the Rated voltage range
<25% of the lowest rated
input voltage, one rated
input voltage. Otherwise,
minimum and maximum
rated voltage. EUT powered
at one of the Nominal input
frequencies.
ME EQUIPMENT and ME
SYSTEMS with power
input voltage selection by
transformer taps shall be
tested at only one tap
setting.
30 A/m
30 A/m
Note: UT is the AC mains voltage prior to application of the test level.
24
Mains power quality should be that
of a typical commercial or hospital
environment.
Power-frequency magnetic
fields should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment.
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Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The 32” 4K Surgical Display is intended for use in the electromagnetic environment specified 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 display, including their cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended Separation Distance:
d = 2√P 80 MHz to 2.7 GHz
Conducted RF
IEC 61000-4-6
3 Vrms
Radiated RF
IEC 61000-4-3
10 V/m
80MHz to 2.7 GHz
3 Vrms
10 V/m
80MHz to 2.7 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 than the compliance level in each
frequency range(b).
Interference may occur in the vicinity of
equipment marked
with the following symbol:
(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 32” 4K 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 display.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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