Natus Medical Incorporated
Additional Safety and Accessory Reference Information
Natus Electromagnetic Compatibility Reference Guide Rev 05 Sept 2012
Reference Guide
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Natus Brand Products
Electromagnetic Compatibility Reference Guide September 27, 2012
269-596201 Rev 05 © 2012 Natus® Medical Incorporation or one of its subsidiaries. All rights reserved. All product names appearing on this document are trademarks or registered trademarks owned, licensed to, promoted or distributed by Natus Medical Incorporation, its subsidiaries or affiliates.
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual, SEE ELECTROMAGNETIC COMPATIBLY (EMC) INFORMATION section for your specific product. Portable and mobile RF communications equipment can affect the Equipment. Install and operate the Equipment according to the EMC information presented in this user’s manual. List all cables and the maximum lengths of cables, transducers, and other accessories that claim to meet compliance with requirements. Note: Accessories that do not affect compliance need not be listed, they may be specified either generically (e.g. shielded cable) or specifically (e.g. mfg model or part number).
The use of accessories, transducers and cables other than those specified , with the exception of servicing parts sold by Natus Medical Incorporation as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device. Equipment should not be used adjacent to or stacked with other equipment, if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used. Portable and mobile RF communications equipment can affect your product. Install and operate your product according to the EMC information presented on this page and the next three pages. Your product has been tested for EMC emissions and immunity as a stand-alone instrument. Do not use the system adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in that configuration.
EMC Information Electromagnetic Compatibility (EMC) Information ... i
NeuroCare Products Nicolet BMSI 6000 - Electromagnetic Compatibility (EMC) Information ...1-3 Nicolet Endeavor CR - Electromagnetic Compatibility (EMC) Information ...1-8 Nicolet cEEG - Electromagnetic Compatibility (EMC) Information...1-13 Nicolet nEEG and LTM - Electromagnetic Compatibility (EMC) Information ...1-18 Nicolet vEEG - Electromagnetic Compatibility (EMC) Information ...1-23 Pressure Transducer Airflow Sensor - Electromagnetic Compatibility (EMC) Information 1-28 Nicolet VikingQuest - Electromagnetic Compatibility (EMC) Information...1-33 Nicolet VikingSelect - Electromagnetic Compatibility (EMC) Information ...1-38 Nicolet EDX - Electromagnetic Compatibility (EMC) Information...1-43 2 Channel Impedance Meter - Electromagnetic Compatibility (EMC) Information ...1-48 150VA Isolation Transformer - Electromagnetic Compatibility (EMC) Information...1-53 2015 Visual Stimulator - Electromagnetic Compatibility (EMC) Information...1-58 Nicolet Ambulatory EEG - Electromagnetic Compatibility (EMC) Information ...1-63 Nicolet EEG Diagnostic System with the V44 Amplifier...1-68
Vascular Products Nicolet StethoDop - Electromagnetic Compatibility (EMC) Information ...2-3
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EMC Information
Electromagnetic Compatibility (EMC) Information This information is applicable to all systems described in this guide unless otherwise noted in the specific product’s User guide. The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by Natus Medical Incorporation as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device. Equipment should not be used adjacent to or stacked with other equipment, if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used. Your Natus system has been tested for EMC emissions and immunity as a stand-alone instrument. Do not use the system adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in that configuration. EMI by nature can be a possible source of disturbance to electronic equipment. This device should be used in an environment free* of other equipment that could be affected by interference. *Environment free described in IEC 1000-2-3, Part 2, First Edition. Observe the EN/IEC 60601-1-1 and EN/IEC 60601-1-2 standards in case of connection with other instruments. The connection of the equipment with other devices is allowed only when the safety requirements for the patient, the user and the environment are not compromised. If the Manual does not contain adequate information about the possibility of interconnection with other devices, the user should contact the manufacturer or the nearest authorized servicing center to obtain information about the effects that coupling devices may have on the patient, the user and the environment.t the effects that coupling devices may have on the patient, the user and the environment.
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EMC Information - NeuroCare Radio transmitting equipment, cellular phones, etc., shall not be used in the close proximity of the device since this could influence the performance of the device. Be careful using the equipment in locations disturbed by strong magnetic fields. The equipment is compliant with the EMC requirements (Electromagnetic Compatibility) according to what specified by the EN 60601-1-2 standard. It is recommended that the equipment be kept away from disturbance sources and induced electromagnetic fields surpassing the values prescribed by the standard in order to avoid any possible instabilities and malfunctioning of the equipment. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. Portable and mobile RF communications equipment can affect the Equipment. Install and operate the Equipment according to the EMC information presented in this manual. Pins of USB connectors identified with the ESD warning symbol should not be touched and that connections should not be made to these connectors unless ESD precautionary procedures are used. Pins of USB connectors identified with the ESD warning symbol should not be touched and that connections should not be made to these connectors unless ESD precautionary procedures are used. Precautionary procedures include: • Methods to prevent build-up of electrostatic charge (e.g., air conditioning, humidification, conductive floor coverings, non-synthetic clothing); • Discharging one’s body to the frame of the EQUIPMENT or SYSTEM or to earth or a large metal object; • Bonding oneself by means of a wrist strap to the EQUIPMENT or SYSTEM or to earth.
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EMC Information Staff that could touch USP connectors identified with the ESD warning symbol should receive this explanation and training. This includes clinical/biomedical engineering and health care staff. ESD training should include an introduction to the physics of electrostatic charge, the voltage levels that can occur in normal practice and the damage that can be done to electronic components if they are touched by an OPERATOR who is electrostatically charged. Further, an explanation should be given of methods to prevent build-up of electrostatic charge, and how and why to discharge one’s body to earth or to the frame of the EQUIPMENT or SYSTEM, or bond oneself by means of a wrist strap to the EQUIPMENT or SYSTEM or to earth prior to making a connection.
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NeuroCare Products
Introduction This chapter contains information concerning Electromagnetic compatibility (EMC) for NeuroCare products.
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EMC Information
Nicolet BMSI 6000 - Electromagnetic Compatibility (EMC) Information Portable and mobile RF communications equipment can affect the Nicolet BMSI 6000. Install and operate the Nicolet BMSI 6000 according to the EMC information presented on this page and the next 4 pages. The Nicolet BMSI 6000 has been tested for EMC emissions and immunity as a standalone instrument. Do not use the Nicolet BMSI 6000 adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration.
Guidance and manufacturer’s declaration - electromagnetic emissions The BMSI 6000 is intended for use in the electomagnetic environment specified below. The customer or the user of the BMSI 6000 should assure that it is used in such an environment. Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The Nicolet BMSI 6000 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 A
Harmonic emissions
Class A
The Nicolet BMSI 6000 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
IEC 61000-3-2 Voltage fluctuations / flicker emissions
Complies
IEC 61000-3-3
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EMC Information - NeuroCare
Nicolet BMSI 6000 Recommended separation distances between portable and mobile RF communications equipment and the Nicolet BMSI 6000
The Nicolet BMSI 6000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Nicolet BMSI 6000 can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Nicolet BMSI 6000 as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum output
Separation distance according to frequency of transmitter
power of transmitter W
m 150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.17
d = 1.17
d = 2.23
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 higher frequency range applies. Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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EMC Information
Nicolet BMSI 6000 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Nicolet BMSI 6000 is intended for use in the electromagnetic environment specified below. The customer or the user of the Nicolet BMSI 6000 should assure that it is used in such an environment. Immunity Test IEC 60601 Test level Compliance Level Electrostatic Discharge (ESD)
+6 kV contact
+6 kV contact
IEC 61000-4-2
+8 kV air
+8 kV air
Electrical fast transient/burst
+2 kV for power supply lines
+2 kV for power supply lines
IEC61000-4-4
+1 kV for input/output lines
+1 kV for input/output lines
Surge
+1 kV differential mode
+1 kV differential mode
IEC 61000-4-5
+2 kV common mode
+2 kV common mode
Voltage dips, short interruptions and voltage variations on power supply lines
< 5% UT
< 5% UT
(>95% dip in UT) for 0.5 cycle 40% UT
(>95% dip in UT) for 0.5 cycle
(60% dip in UT) for 5 cycles
40% UT
70% UT
(60% dip in UT) for 5 cycles
(30% dip in UT) for 25 cycles
70% UT
<5% UT
(30% dip in UT) for 25 cycles
(>95% dip in UT) for 5 sec
<5% UT
IEC 61000-4-11
(>95% dip in UT) for 5 sec Power Frequency (50/60 Hz)
3 A/m
3 A/m
IEC 61000-4-8
Electromagnetic Environment-Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be less than 30%. Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the Nicolet BMSI 6000 requires continued operation during power mains interruptions, it is recommended that the Nicolet BMSI 6000 be powered from an Uninterruptable power supply or its battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
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EMC Information - NeuroCare
Nicolet BMSI 6000 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Nicolet BMSI 6000 is intended for use in the electromagnetic environment specified below. The customer or the user of the Nicolet BMSI 6000 should assure 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 Nicolet BMSI 6000, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
d = 1.17
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz
3V
3 V/m 80 MHz to 2.5 GHz
3 V/m
d = 1.17
80 MHz to 800 MHz
d = 2.23
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 Strengthens from fixed RF transmitters, as determined by an electromagnetic site survey, (a* on the next page) should be less than the compliance level in each frequency range. (b* on the next page) Interference may occur in the vicinity of equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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EMC Information
Nicolet BMSI 6000 (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 Nicolet BMSI 6000 is used exceeds the applicable RF compliance level above, the Nicolet BMSI 6000 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Nicolet BMSI 6000. (b*) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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EMC Information - NeuroCare
Nicolet Endeavor CR - Electromagnetic Compatibility (EMC) Information Guidance and manufacturer’s declaration - electromagnetic emissions The Nicolet Endeavor CR is intended for use in the electomagnetic environment specified below. The customer or the user of the Nicolet Endeavor CR should assure that it is used in such an environment. Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The Nicolet Endeavor CR 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 A
Harmonic emissions
Class A
The Nicolet Endeavor CR is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.
IEC 61000-3-2 Voltage fluctuations / flicker emissions
Complies
IEC 61000-3-3
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EMC Information
Nicolet Endeavor CR
Recommended separation distances between portable and mobile RF communications equipment and the Nicolet Endeavor CR
The Nicolet Endeavor CR is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Nicolet Endeavor CR can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Nicolet Endeavor CR as recommended below, according to the maximum output power of the communications equipment. Rated Maximum output
Separation distance according to frequency of transmitter
power of transmitter W
m 150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.17
d = 1.17
d = 2.23
0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 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 higher frequency range applies. Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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EMC Information - NeuroCare
Nicolet Endeavor CR
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Nicolet Endeavor CR is intended for use in the electromagnetic environment specified below. The customer or the user of the Nicolet Endeavor CR should assure that it is used in such an environment. Immunity Test IEC 60601 Test level Compliance Level Electrostatic Discharge (ESD)
+6 kV contact
+6 kV contact
IEC 61000-4-2
+8 kV air
+8 kV air
Electrical fast transient/burst
+2 kV for power supply lines
+2 kV for power supply lines
IEC61000-4-4
+1 kV for input/output lines
+1 kV for input/output lines
Surge
+1 kV differential mode
+1 kV differential mode
IEC 61000-4-5
+2 kV common mode
+2 kV common mode
Voltage dips, short interruptions and voltage variations on power supply lines
< 5% UT
< 5% UT
(>95% dip in UT) for 0.5 cycle 40% UT
(>95% dip in UT) for 0.5 cycle
(60% dip in UT) for 5 cycles
40% UT
70% UT
(60% dip in UT) for 5 cycles
(30% dip in UT) for 25 cycles
70% UT
<5% UT
(30% dip in UT) for 25 cycles
(>95% dip in UT) for 5 sec
<5% UT
IEC 61000-4-11
(>95% dip in UT) for 5 sec Power Frequency (50/60 Hz)
3 A/m
NA
IEC 61000-4-8
Electromagnetic Environment-Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, less than 30%.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the Nicolet Endeavor CR requires continued operation during power mains interruptions, it is recommended that the Nicolet Endeavor CR be powered from an Uninterruptable power supply or its battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
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EMC Information
Nicolet Endeavor CR
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Nicolet Endeavor CR is intended for use in the electromagnetic environment specified below. The customer or the user of the Nicolet Endeavor CR should assure 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 Nicolet Endeavor CR, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
d = 1.17
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz
3V
3 V/m 80 MHz to 2.5 GHz
3 V/m
d = 1.17
80 MHz to 800 MHz
d = 2.23
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 Strengthens from fixed RF transmitters, as determined by an electromagnetic site survey, (a* on the next page) should be less than the compliance level in each frequency range. (b* on the next page) Interference may occur in the vicinity of equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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EMC Information - NeuroCare
Nicolet Endeavor CR (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 Nicolet Endeavor CR is used exceeds the applicable RF compliance level above, the Nicolet Endeavor CR should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Nicolet Endeavor CR. (b*) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1} V/m.
Notes Maximum constant current, as listed in the product specifications, will not be achievable with load impedances greater than 4K. Maximum constant voltage, as listed in the product specifications, will not be achievable with load impedances less than 4K.
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