Eizo CuratOR SP1-24 User manual

Instructions for Use
Digital image and video viewing system
Important
Please read the safety information and all information delivered
with the product carefully to familiarize yourself with safe and
effective usage.

EIZO GmbH
Carl-Benz-Straße 3
76761 Rülzheim
Germany
1086062-001
11/2022 Technical data subject to change.
Copyright © EIZO GmbH 2022.
All rights reserved.
Legal information
Warning notice system
This manual contains notices you have to observe in order to ensure your personal safety, as well as to
prevent damage to property. The notices referring to your personal safety are highlighted in the manual
by a safety alert symbol, notices referring only to property damage have no safety alert symbol. These
notices shown below are graded according to the degree of danger.
DANGER
indicates that death or severe personal injury will result if proper precautions are not taken.
WARNING
indicates that death or severe personal injury may result if proper precautions are not taken.
CAUTION
indicates that minor personal injury can result if proper precautions are not taken.
NOTICE
indicates that material damage can result if proper precautions are not taken.
If more than one degree of danger is present, the warning notice representing the highest degree of
danger will be used. A notice warning of injury to persons with a safety alert symbol may also include a
warning relating to property damage.
Qualified personnel
The product/system described in this documentation may be operated only by personnel qualified for
the specific task in accordance with the relevant documentation, in particular its warning notices and
safety instructions. Qualified personnel are those who, based on their training and experience, are ca-
pable of identifying risks and avoiding potential hazards when working with these products/systems.
Use of EIZO products
WARNING
EIZO products may only be used for the applications described in the catalog and in the relevant tech-
nical documentation. If products and components from other manufacturers are used, these must be
recommended or approved by EIZO. Proper transport, storage, installation, assembly, commissioning,
operation and maintenance are required to ensure that the products operate safely and without any
problems. The permissible ambient conditions must be complied with. The information in the relevant
documentation must be observed.
Trademarks
All names identified by ® are registered trademarks of their respective owners. Please refer to the
trademarks listed in the appendix. The remaining trademarks in this publication may be trademarks
whose use by third parties for their own purposes could violate the rights of the owner.
Disclaimer of liability
We have reviewed the contents of this publication to ensure consistency with the hardware and soft-
ware described. Since variance cannot be precluded entirely, we cannot guarantee full consistency.
However, the information in this publication is reviewed regularly and any necessary corrections are
included in subsequent editions.

Table of contents
CuratOR Surgical Panel
Instructions for Use, 11/2022 3
Table of contents
Legal information ............................................................................................................. 2
1 Introduction....................................................................................................................... 4
1.1 Contents of this document ........................................................................................4
1.2 Intended use .............................................................................................................4
1.3 User groups ..............................................................................................................4
2 Safety information ............................................................................................................ 5
2.1 General safety instructions .......................................................................................5
3 Description........................................................................................................................ 7
3.1 General information ..................................................................................................7
3.2 Design.......................................................................................................................8
4 Installation and start-up................................................................................................. 10
5 Operation......................................................................................................................... 11
5.1 Switching on and off ...............................................................................................11
5.1.1 Switch on .................................................................................................. 11
5.1.2 Shutdown .................................................................................................. 12
5.2 Avoiding image sticking ..........................................................................................12
5.3 Check for pixel defects ...........................................................................................13
5.4 Interfaces ................................................................................................................13
5.5 Switching the LUT...................................................................................................13
5.6 Switching video sources .........................................................................................14
5.7 VMbasic video management (optional) ..................................................................14
6 Cleaning and Maintenance ............................................................................................ 15
6.1 Cleaning..................................................................................................................15
6.2 Maintenance ...........................................................................................................16
7 Technical specifications ................................................................................................ 17
7.1 Power supply ..........................................................................................................17
7.2 Mechanical design ..................................................................................................17
7.3 Climatic conditions..................................................................................................17
7.4 Safety regulations ...................................................................................................17
8 Appendix ......................................................................................................................... 18
8.1 Information on electromagnetic compatibility (EMC) ..............................................18
8.2 Markings and symbols ............................................................................................23
8.3 Environmental protection ........................................................................................24
8.4 Additional devices...................................................................................................24
8.5 Contact ...................................................................................................................24
8.6 Trademarks.............................................................................................................25

Introduction
1.1 Contents of this document
4
CuratOR Surgical Panel
Instructions for Use, 11/2022
1 Introduction
1.1 Contents of this document
This document explains the functions and proper use of the CuratOR Surgical Panel, which
is available in a number of project-specific and standard versions:
All information provided herein applies to standard conditions, and may differ depending on
the operating room and device configuration.
You are additionally advised that the contents of this document are neither part of a previ-
ous or existing agreement, commitment, or legal relationship, nor does it modify such.
Note
• The current electronic version of instructions for use can be found on the EIZO GmbH
home page www.eizo-or.com.
• Information regarding installation and start-up of the CuratOR Surgical Panel will be
provided to you by your EIZO contact.
1.2 Intended use
CuratOR Surgical Panel are digital image and video viewing systems and are intended for
use in the OR or other medical environments.
CuratOR Surgical Panel are merely intended for displaying patient-related data, images and
videos.
CuratOR Surgical Panel serve as central control platforms for video distribution, recording
and buffer storage of patient-specific data, images and videos.
CuratOR Surgical Panel serve as the physical interface between the operating room and the
IT infrastructure of a hospital.
1.3 User groups
User
In the following, healthcare personnel such as surgeons or medical technicians are referred
to as the "user".
Service / service personnel
"Service" or "Service personnel" identifies authorized personnel with knowledge of medical
imaging technology, local standards for image quality requirements, and safety of medical
products, for example a hospital technician or manufacturer of medical devices.
Cleaning staff
"Cleaning staff" refers to personnel responsible for cleaning medical devices.

Safety information
2.1 General safety instructions
CuratOR Surgical Panel
Instructions for Use, 11/2022 5
2 Safety information
2.1 General safety instructions
Careful operation is a prerequisite for correct and safe operation of the CuratOR Surgical
Panel.
The devices may only be used for applications for which they are commonly used.
For safety reasons, the following precautions must be observed:
DANGER
Please observe all warning information present on the device and in the instructions for use
There is a danger to life if warnings are not obeyed. Severe personal injury or damage to property
may occur.
Observe the safety requirements of EN 60601-1 (IEC 60601-1)
To prevent injury to patients and users, connect the electrical system in accordance with the safety
requirements of EN60601‑1 (IEC60601‑1) for “Safety requirements for medical electrical systems”.
Connecting the protective ground conductor
If the device is connected to the line power, the device must be connected to a protective ground
conductor. This is the only way to ensure that the touch leakage current in a first fault event does not
exceed 500 µA.
The interruption of the device's protective conductor is considered a first fault event in accordance
with EN 60601-1.
Use the following measures to ensure that the leakage currents remain below the specified limits:
• Separators for signal input unit or signal output unit.
• Use of a safety isolating transformer.
• Use of the additional protective ground terminal.
DANGER
No unauthorized opening of the device / no unauthorized service or maintenance work
The device may only be opened by service personnel. Likewise, service or maintenance work may
only be carried out by service personnel. There is a risk of electric shock.
No liability is accepted for death and injury to persons or damage to property resulting from work car-
ried out by non-qualified personnel.
Do not touch components in the device
If the device is connected to the line power, components in the device are subjected to high voltages.
Touching the components may be fatal.
No contact between device and patients
The device is not suitable for direct contact with a patient. The device and patient must never be
touched simultaneously. Otherwise there is a danger to life and limb.
Do not insert any objects into the housing
Objects inserted into the housing may result in an electric shock or damage to the device.
Avoid penetration of liquid
Liquids seeping into the device may result in electric shock or device failure.

Safety information
2.1 General safety instructions
6
CuratOR Surgical Panel
Instructions for Use, 11/2022
CAUTION
Care of device / cleaning agents
• Remove water drops immediately.
• Only clean the surfaces using the cleaning agents referred to in the Instructions for Use.
What to do if the device is faulty
If the following conditions exist, the device must be disconnected from line power and checked by
qualified personnel:
• Damage to the device.
• After liquid seeps into the device.
• If the device does not function or if a fault cannot be eliminated using the Instructions for Use.
• If the device smells of burning or makes peculiar noises.
Be aware of the monitors aging
Note that monitors can fail as a result of aging, and that image properties such as brightness, con-
trast, and color value can change.

Description
3.1 General information
CuratOR Surgical Panel
Instructions for Use, 11/2022 7
3 Description
3.1 General information
Each CuratOR Surgical Panel is adapted to the specific requirements of the operating room
(OR). Consequently, the housing is available in a wide variety of sizes and colors, with the
inner workings protected by an anti-reflective single-layer safety glass pane (ESG). The
front can be fully disinfected and should be incorporated into the cleaning plan for the OR.
See also Cleaning [}15].
The inner workings of the Surgical Panel, comprising a monitor system and IT and video
management components.
By default, the Surgical Panel comes with a Microsoft Windows operating system. Follow
the information in the corresponding documentation.
If you are using EIZO Caliop software, please follow the information in the software docu-
mentation.
Input devices include a medical silicone keypad with or without touch pad, which is fit into a
purpose-built holder, and a medical silicone mouse. The tilt of the keypad holder and special
mouse pad ensure ergonomic working conditions.
Various video and USB inputs as well as suitable accessories can be connected on the front
in addition to the main switch and system switch. An additional standard button on the front
is used to switch the LUT.
VMBasic, available as an option, offers additional video management functions that can be
operated using buttons on the front of the Surgical Panel.

Description
3.2 Design
8
CuratOR Surgical Panel
Instructions for Use, 11/2022
Standard versions of the CuratOR Surgical Panel
Standard version Description
SP1-24
SP1-24T
Nurse Station with 24" FHD panel.
Nurse Station with 24" FHD Touchscreen.
SP1-324K
SP1-324KT
Viewing Station with 32" 4K Panel.
Viewing Station with 32" 4K Touchscreen.
SP1-434K
SP1-434KT
Viewing Station with 43" 4K Panel.
Viewing Station with 43" 4K Touchscreen.
SP1-494K
SP1-494KT
Viewing Station with 49" 4K Panel.
Viewing Station with 49" 4K Touchscreen.
SP1-554K
SP1-554KT
Viewing Station with 55" 4K Panel.
Viewing Station with 55" 4K Touchscreen.
SP1-654K
SP1-654KT
Viewing Station with 65" 4K Panel.
Viewing Station with 65" 4K Touchscreen.
SP2-24-24
SP2-24T-24
SP2-24-24T
SP2-24T-24T
HIS/PACS Station with two 24" FHD Panels.
KIS/PACS Station with 24" FHD Touchscreen and 24" FHD Panel.
KIS/PACS-Station with 24" FHD Panel and 24" FHD Touchscreen.
KIS/PACS-Station with two 24" FHD touchscreens.
SP2-24-494K
SP2-24T-494K
SP2-24-494KT
SP2-24T-494KT
KIS/PACS Station with 24" FHD a 49" 4K Panel.
KIS/PACS Station with 24" FHD Touchscreen and 49" 4K Panel.
KIS/PACS Station with 24" FHD Panel and 49" 4K Touchscreen.
KIS/PACS Station with 24" FHD Touchscreen and 49" 4K Touchscreen.
SP2-24-554K
SP2-24T-554K
SP2-24-554KT
SP2-24T-554KT
HIS/PACS - Station with 24" FHD and 55" 4K Panel.
HIS/PACS - Station with 24" FHD Touchscreen and 55" 4K Panel.
HIS/PACS - Station with 24" FHD Panel and 55" 4K Touchscreen.
HIS/PACS - Station with 24" FHD Touchscreen and 55" 4K Touchscreen.
3.2 Design
The CuratOR Surgical Panel has the following components as standard:
• Monitor panel
• PC module
• Keyboard holder with or without mouse pad and palm rest
• Silicone keyboard and silicone mouse
• USB ports
• Main switch and system switch
• Input and output interfaces
• Button for switching the LUT

Description
3.2 Design
CuratOR Surgical Panel
Instructions for Use, 11/2022 9
The following components can also be included as options:
• Button for switching the connected video signals (VMbasic)
• Input and output interfaces
• Blanking plate for upgrade of interfaces
Examples
Fig.: CuratOR Surgical Panel SP2-24-494K / SP2-24T-494K
Fig.: CuratOR Surgical Panel SP1-494K

Installation and start-up
3.2 Design
10
CuratOR Surgical Panel
Instructions for Use, 11/2022
4 Installation and start-up
The CuratOR Surgical Panel is suited to surface-mounted or flush-mounted installation
depending on the individual design.
In addition to mounting on the wall or in a niche, installation includes connection to power
and the IT network.
Start-up includes the first intended use of the CuratOR Surgical Panel.
CAUTION
Installation and start-up
• The CuratOR Surgical Panel may only be installed and put into operation by EIZO em-
ployees or by service personnel.
• The CuratOR Surgical Panel must be installed and operated in accordance with all
applicable national directives and regulations currently in effect.
Note
Information regarding installation and start-up of the CuratOR Surgical Panel will be
provided to you by your EIZO contact.

Operation
5.1 Switching on and off
CuratOR Surgical Panel
Instructions for Use, 11/2022 11
5 Operation
5.1 Switching on and off
5.1.1 Switch on
1. Use the switch labeled “Power Switch” to turn on the system.
ðOperating voltage is turned on.
2. Wait until the border of the switch labeled “PC on/off” illuminates green.
ðThe system is ready for operation after approx. 5 seconds.
3. Press the green-bordered switch labeled “PC on/off”.
ðThe IT system boots.
4. Wait until the IT system has fully booted.
ðThe system is fully operational after approx. 10 seconds.

Operation
5.2 Avoiding image sticking
12
CuratOR Surgical Panel
Instructions for Use, 11/2022
5.1.2 Shutdown
NOTICE
Note the sequence during shutdown
The blue-bordered switch labeled “Power Switch” may not be turned off until the border of
the switch labeled “PC on/off” is off.
Of necessity, any other sequence will cause the IT components to be abruptly discon-
nected from the power supply, which can result in hardware damage such as hard drive
failure.
Prerequisite
All work in progress with the system is ended, so that it can be shut down and, for example,
important data is not lost.
Procedure
1. To shut down the IT system press the green-bordered switch labeled “PC on/off”.
2. Wait until the green border of the switch labeled “PC on/off” goes off.
ðMake sure the system has shut down properly.
3. Use the blue-bordered switch labeled “Power Switch” to turn off the system.
4. All components are disconnected from the operating voltage.
5.2 Avoiding image sticking
Image sticking may occur with LCD monitors. Image sticking is an effect whereby a faint im-
age of the previous screen contents can be seen after the display contents have changed.
The following measures can reduce or prevent image sticking:
• Use a screen saver with regularly changing images
• Switch off the device when it is no longer needed.

Operation
5.3 Check for pixel defects
CuratOR Surgical Panel
Instructions for Use, 11/2022 13
5.3 Check for pixel defects
Pixel defects (small bright or dark dots) can occur in LCD monitors. During the manufactur-
ing process, all monitors are checked for the permitted number of defective pixels.
Defective pixels cannot be corrected.
5.4 Interfaces
USB
Two USB ports are integrated in the front of the CuratOR Surgical Panel as standard. They
are intended for connecting a mouse and a USB data medium.
Note
Data medium
Use trusted data media only. Observe the facility's applicable security guidelines.
Interface extension (video)
The front can be equipped with optional interfaces. The configuration must be coordinated
with EIZO on a project-by-project basis.
NOTICE
Connecting devices
• During connection of devices, make sure the socket will not be damaged when inserting
the connector.
• All devices connected to the Surgical Panel have to meet the respective national safety
standards.
5.5 Switching the LUT
The Surgical Panel is equipped with LUT switching as standard. This allows the display of
medical images and videos to be optimized.
Pressing the button selects one of the predefined LUT.
Fig.: Button for switching the LUT

Operation
5.6 Switching video sources
14
CuratOR Surgical Panel
Instructions for Use, 11/2022
5.6 Switching video sources
The Surgical Panel is equipped with video source switching as standard.
The video signals connected internally or to the front can be switched through for display by
pressing a button.
Fig.: Button for switching the video sources
5.7 VMbasic video management (optional)
The modular design of the Surgical Panel enables project-specific configuration. As a result,
eachSurgical Panel can be equipped with the optional VMbasic video management function.
VMbasic offers additional video management functions that can be operated via buttons on
the front of the Surgical Panel. VMbasic can be used to switch layouts and activate the win-
dows within the selected layout.
Fig.: Button for switching the layouts
Fig.: Button for switching the active window within the selected layout

Cleaning and Maintenance
6.1 Cleaning
CuratOR Surgical Panel
Instructions for Use, 11/2022 15
6 Cleaning and Maintenance
6.1 Cleaning
External cleaning of the protective front pane and housing should be incorporated into the
OR cleaning plan.
NOTICE
Cleaning / Disinfection
• Clean/disinfect the surfaces of the device with a soft cloth and, if necessary, with a rec-
ommended cleaning agent/disinfectant.
• Damp cleaning/disinfection may only be performed by wiping with a damp cloth. When
doing so, make sure that no moisture enters the device at the operating elements or at
any other point.
Recommended cleaning agents and disinfectants
Agent class Tested cleaning agents and disinfectants
Alkylamines Incidin® PLUS, 8 vol.%
Quarternary compounds Incidur®-Spray, undiluted
Pyridine derivatives Octenisept®
Guanidine derivatives Lysoformin® 2 Vol.%
Biguanid® Fläche N undiluted
Chlorine derivatives Terralin® 0.5 Vol.%
Natriumhypochlorit (bleach) 10%
Peroxide compounds Hydrogen peroxide 3%
Organic acids Citric acid 1% (pH 2.3)
Phenol derivatives Helipur®, undiluted
Alcohols Isopropyl alcohol 70 %
Benzine Petroleum benzine boiling range 100-120°C
Common household dishwashing liquids -
detergent substances
Commercial detergent 1 vol.%
Aldehyde Melsitt®, 10 vol. %
Desinfecting agents Morning Mist (1:64)
SURFANIOS® Premium, 0.25%
Taski® Sprint DS 5001 0.5%
0.5% Chlorhexidine in 70% isopropyl alcohol
Water Tap water
Distilled water
Cleaning agent Ammonium solution 1,65 vol. %
Alkaline solution Limewash, saturated Ca(OH)2-solution

Cleaning and Maintenance
6.2 Maintenance
16
CuratOR Surgical Panel
Instructions for Use, 11/2022
Prohibited cleaning agents and disinfectants
The following cleaning agents and disinfectants can bleach the paint after a longer period of
application:
Agent class Tested cleaning agents and disinfectants
Light gasoline Petroleum spirit
Petroleum ether
6.2 Maintenance
WARNING
Maintenance
• Maintenance may only be performed by EIZO or service personnel.
• Maintenance may not take place during device use or ongoing treatment.
Note
• Perform maintenance and inspection at least once per year, including the protective
conductor test.
• Perform a visual inspection every four weeks, for example for paint chips.
• Individual service and maintenance contracts can be negotiated. For detailed informa-
tion, please contact your EIZO partner.
www.eizo-or.com/de/eizo-gmbh/kontakt/

Technical specifications
7.1 Power supply
CuratOR Surgical Panel
Instructions for Use, 11/2022 17
7 Technical specifications
Note
Technical specifications / product information
• Specifications regarding the CuratOR Surgical Panel such as data on the housing,
panel, as well as dimensions of the standard versions can be found on our website.
• The product brochures with additional information can also be found on our website
www.eizo-or.com.
7.1 Power supply
Line voltage 100 V to 240 V
Line frequency 50 Hz to 60 Hz
Current consumption 4 A to 2 A
7.2 Mechanical design
Housing components Powder coated metal housing and protective glass pane
Ventilation openings No fan, thermal output through housing
7.3 Climatic conditions
In operation
Temperature range +5 °C to +35 °C ambient temperature
Temperature gradient Max. 10 K/h, no condensation
Humidity 10 to 85 %, non-condensing, at 25°C
Air pressure 700 to 1060 hPa
During transport and storage (in original packaging)
Temperature range -20 °C to +60 °C ambient temperature
Temperature gradient Max. 20 K/h, no condensation
Humidity 10 to 85 %, non-condensing, at 25 °C
Air pressure 200 to 1060 hPa
7.4 Safety regulations
Safety regulations
Safety standards EN IEC 62368-1
EN IEC 60601-1
Protection class Protection class I

Appendix
8.1 Information on electromagnetic compatibility (EMC)
18
CuratOR Surgical Panel
Instructions for Use, 11/2022
8 Appendix
8.1 Information on electromagnetic compatibility (EMC)
CuratOR Surgical Panel is a digital image and video viewing system and is intended for use
in the OR or other medical environments.
NOTICE
Special EMC provisions are required for use of the CuratOR Surgical Panel. Installation,
assembly, and operation must take place in compliance with the following instructions:
• Do not position any portable or mobile RF communication devices in the immediate
vicinity of the CuratOR Surgical Panel. Otherwise, problem-free function of the device
cannot be guaranteed.
• The CuratOR Surgical Panel should not be positioned or operated in the immediate
vicinity of other devices. If devices have to be operated in the immediate vicinity of one
another, the Surgical Panel must be monitored to ensure proper operation for the de-
fined configuration.
• Operators connecting additional devices to the signal input or output in order to config-
ure a medical system are responsible for ensuring that applicable national laws are
complied with.
Electromagnetic radiation
The CuratOR Surgical Panel is intended for use in the electromagnetic environments noted below.
Operators and users of the CuratOR Surgical Panel have to ensure that the device is used in such
an environment.
Radiation test Conformity Information regarding the electromagnetic environment
RF radiation
CISPR11/EN 55011
Group 1 The CuratOR Surgical Panel uses RF radiation for internal
operation only. For this reason, the RF radiation is very low
and is therefore unlikely that the device will cause interfer-
ence in electronic devices in the immediate vicinity.
RF radiation
CISPR11/EN 55011
GB9254
Class B The CuratOR Surgical Panel is approved for use in a number
of environments. This includes residential areas and areas
connected directly to the public low-voltage grid, such as pri-
vate homes.
Harmonic currents
IEC/EN 61000-3-2
GB17625.1
Class D
Voltage fluctuations /
flicker
IEC/EN 61000-3-3
fulfilled

Appendix
8.1 Information on electromagnetic compatibility (EMC)
CuratOR Surgical Panel
Instructions for Use, 11/2022 19
Electromagnetic interference immunity
The CuratOR Surgical Panel was tested with the following compliance levels in accordance with the
test requirements for professional healthcare facilities, as established in IEC/EN 60601-1-2.
Operators and users of the device have to ensure that the device is used in such an environment.
Interference
immunity test
Measurement
level
Compliance
level
Information regarding the electromagnetic
environment
Electrostatic
discharge
(ESD)
IEC/EN
61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
As described in the CuratOR Surgical Panel ser-
vice manual, the device is suited to surface
mounting or flush mounting depending on the in-
dividual version.
In addition to mounting on the wall or in a niche,
installation includes connection to power and the
IT network inside of the device.
Fast transient
electric distur-
bances (bursts)
IEC/EN
61000-4-4
±2 kV power
lines
±1 kV input /
output lines
±3 kV power
lines
±2 kV input /
output lines
The power supply quality has to correspond to
that of typical industrial environments or hospi-
tals.
Surge voltage
IEC/EN
61000-4-5
±1 kV line
against line
±2 kV line
against ground
±2 kV line
against line
±4 kV line
against ground
The power supply quality has to correspond to
that of typical industrial environments or hospi-
tals.
Voltage dips,
brief interrup-
tions, and fluc-
tuations of
power supply
lines
IEC/EN
61000-4-11
0% VT for
0.5periods
and 1 period
70% VT for
25 / 30 periods
at 50 / 60Hz
0 % VT for
250 / 300 peri-
ods at 50 /
60Hz
0% VT for
0.5periods and
1 period
70% VT for 25
periods at
50Hz
0 % VT for 250
periods at
50Hz
The power supply quality has to correspond to
that of typical industrial environments or hospi-
tals.
If the device has to continue operation even if
the power supply is interrupted, it is recom-
mended to connect the device to an uninterrupt-
ible power supply or battery.
Magnetic fields
with energy
technology fre-
quencies
IEC/EN
61000-4-8
30 A/m
(50 / 60 Hz)
30 A/m
(50 Hz)
The magnetic fields with energy technology fre-
quencies must be in an area that is representa-
tive of a typical location in a typical industrial en-
vironment or hospitals.
This product should be used at least 15 cm
away from the source of magnetic fields with en-
ergy technology frequencies.
Note: VT is the alternating current voltage before application of the measurement level.

Appendix
8.1 Information on electromagnetic compatibility (EMC)
20
CuratOR Surgical Panel
Instructions for Use, 11/2022
Electromagnetic interference immunity
The CuratOR Surgical Panel was tested with the following compliance levels in accordance with the
test requirements for professional healthcare facilities, as established in IEC/EN 60601-1-2.
Operators and users of the device have to ensure that the device is used in such an environment.
Interference
immunity test
Measure-
ment level
Compliance
level
Information regarding the electromagnetic envi-
ronment
Line-based dis-
turbances
caused by RF
fields
IEC/EN
61000-4-6
3 Vrms
150 kHz to
80 MHz
6 Vrms Portable and mobile RF communications devices
may only be operated in the vicinity of the device
and its components (including cables) when in com-
pliance with the recommended minimum distance. It
is determined using the formula for calculating the
frequency of the transmitter.
Recommended minimum distance
d = 0.6 √P, 150 kHz to 80 MHz
d = 2 √P, ISM bands between 150 kHz and 80 MHz
d = 0.35 √P, 80 MHz to 800 MHz
d = 0.7 √P, 800 MHz to 2.7 GHz
In this case, "P" stands for the measured maximum
nominal output power in watts (W) of the transmitter
recommended by the transmitter manufacturer, and
"d" for the recommended minimum distance in me-
ters (m).
The field strengths of fixed transmitters according to
electromagnetic location measurementa) have to be
less than the compliance level in each individual fre-
quency range.
Interference can occur when used in the vicinity of
devices identified with the following symbol.
6 Vrms
ISM bands
between
150kHz and
80MHz
6 Vrms
Electromagnetic
RF fields
IEC/EN
61000-4-3
3 V/m
80 MHz to
2.7 GHz
10 V/m
Note: The higher frequency range applies at 80 MHz and 800 MHz.
Note: Guidelines with respect to line-based interference due to RF fields or electromagnetic RF
fields may not apply in all situations. Absorption and reflection by structures, objects, and people im-
pact the propagation of electromagnetic waves. .
a) The field strengths of fixed transmitters, for example the base station for cordless and mobile tele-
phones, radio, land mobile radio, ham radio, and television cannot be determined precisely in ad-
vance. To evaluate the electromagnetic environment using fixed transmitters, an electromagnetic lo-
cation measurement should be included. If the measured field strength in the environment where the
device is used exceeds the applicable RF compliance level, observe the device to ensure its proper
operation. If improper operation is observed, in some circumstances additional measures may be
necessary, such as reorienting or repositioning the device.