EMC HAMILTON-T1 User Manual

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HAMILTON-T1
EMC Declarations
2020-09-04
627049/01
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EMC declarations IEC 60601-1-2:2007, 3rd edition
EMC declarations IEC 60601-1-2:2007, 3rd edition
HAMILTON-T1 EMC Declara­tions
This guide provides information about EMC declarations. It is designed for use together with your ventilator Operator’s
The HAMILTON-T1 ventilator is intended for use in the electromagnetic environ­ment specified in Tables 1, 2, and 3. The HAMILTON-T1 ventilator user should ensure that it is used in such an environ-
ment. Manual, and refers to information pro­vided there.
Table 1 Guidance and manufacturer's declaration – electromagnetic emissions
(IEC 60601-1-2)
Emissions test Compliance Electromagnetic environment guid-
ance
RF emissions CISPR 11
RF emissions CISPR 11, conducted
RF emissions CISPR 11, radiated
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/flicker emissions IEC 61000-3-3
Group 1 The HAMILTON-T1 ventilator 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.
Class B The HAMILTON-T1 ventilator is suitable
for use in all establishments other than
Class B
Class A
Complies
domestic and those directly connected to the public low-voltage power supply network that supplies buildings for domestic purposes.
• UT is the AC mains voltage prior to application of the test level.
• At 80 MHz and 800 MHz, the higher frequency range applies.
• 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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Table 2 Guidance and manufacturer's declaration – electromagnetic immunity
(IEC 60601-1-2)
Immunity test IEC 60601 test
level
Electrostatic discharge (ESD)
±6 kV contact
±8 kV air
IEC 61000-4-2
Electrical fast tran­sient/burst IEC 61000-4-4
±2 kV for power supply lines ±1 kV for input/ output lines
Surge IEC 61000-4-5
±1 kV line(s) to line(s) ±2 kV line(s) to earth
Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11
Power frequency
< 5% U dip in U
0.5 cycle 40% U
in U 70% U
in <5% U
in U
3 A/m 30 A/m The power frequency magnetic
1
(>95%
T
) for
T
(60% dip
T
) for 5 cycles
T
(30% dip
T
U
) for 25 cycles
T
(>95% dip
T
) for 5 s
T
(50/60 Hz) mag­netic field IEC 61000-4-8
Compliance level Electromagnetic
environment guidance
±8 kV contact
±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 5%.
±2 kV for power supply lines ±1 kV for input/
Mains power quality should be that of a typical commercial or hospital environment.
output lines
±1 kV line(s) to line(s) ±2 kV (line(s) to
Mains power quality should be that of a typical commercial or hospital environment.
earth
<5% U in U
) for 0.5 cycle
T
40% U in U
) for 5 cycles
T
70% U in U
) for 25 cycles
T
<5% U
) for 5 s
in U
T
(>95% dip
T
(60% dip
T
(30% dip
T
(>95% dip
T
Mains power quality should be that of a typical commercial or hospital environment.
If the user of the HAMILTON­T1 ventilator requires contin­ued operation during power mains interruptions, it is rec­ommended that the HAMIL­TON-T1 ventilator be powered from an uninterruptible power supply or battery.
field should be at levels charac­teristic of a typical location in a typical commercial or hospi­tal environment.
Hamilton Medical | HAMILTON-T1 EMC Declarations 3
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EMC declarations IEC 60601-1-2:2007, 3rd edition
d 0.35 P=
d 1.2 P=
Table 2 Guidance and manufacturer's declaration – electromagnetic immunity
(IEC 60601-1-2)
(cont.)
Immunity test IEC 60601 test
level
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
outside ISM bands
10 Vrms 150 kHz to 80 MHz
in ISM bands
5
Compliance level Electromagnetic
environment guidance
Portable and mobile RF com­munications equipment should be used no closer to any part of the HAMILTON-T1 ventila­tor, including cables, than the recommended separation dis­tance calculated from the equation applicable to the fre­quency of the transmitter.
Recommended separation dis­tance:
10 Vrms
2
10 Vrms
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Table 2 Guidance and manufacturer's declaration – electromagnetic immunity
d 0.40 P=
d 0.77 P=
(IEC 60601-1-2)
(cont.)
Immunity test IEC 60601 test
level
Radiated RF IEC 61000-4-3
10 V/m 80 MHz to 2.5 GHz
Compliance level Electromagnetic
environment guidance
30 V/m
80 MHz to 800 MHz
80 MHz to 2.5 GHz
800 MHz to 2.5 GHz
where
P is the maximum out-
put power rating of the trans­mitter in watts (W) according to the transmitter manufac­turer and d is the recom­mended separation distance in meters (m).
3
Field strengths from fixed RF transmitters, as determined by an electromagnetic site
4
survey
, should be less than
the compliance level in each frequency range
ence may occur in the vicinity of equipment marked with the
symbol
5
. Interfer-
1. UT is the AC mains voltage prior to application for the test level.
2. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
3. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to
2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interfer­ence if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formulas used in calculating the recommended separation distance for transmitters in these frequency ranges.
4. 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 HAMILTON-T1 ventilator is used exceeds the applicable RF compliance level above, the HAMILTON-T1 ventilator should be observed to verify normal operation. If abnormal per­formance is observed, additional measures may be necessary, such as re-orienting or relocating the HAMILTON-T1 venti­lator.
5. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Hamilton Medical | HAMILTON-T1 EMC Declarations 5
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EMC declarations IEC 60601-1-2:2007, 3rd edition
d0.35P=
d1.2P=
d0.40P=
d0.77P=
Table 3 FDA additional tests
FDA Excerpts Related to EMI FDA Excerpts Related to EMI
test level
FDA Excerpts Related to EMI compliance level
Slow Sags and Surges 150/120/90 Vrms 500 ms 150/120/90 Vrms 500 ms
Quasi-static electric fields 2000 V/m; 0.5 Hz 2000 V/m; 0.5 Hz
Steady-state voltage 95 V / 60 Hz
132 V / 60 Hz
The HAMILTON-T1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ventilator can help prevent electromagnetic interfer-
between portable and mobile RF commu­nications equipment (transmitters) and the ventilator as recommended in Table 4, according to the maximum output power of the communications equipment.
95 V / 60 Hz 132 V / 60 Hz
ence by maintaining a minimum distance
Table 4 Recommended separation distances between portable and mobile RF communica-
tions equipment and the HAMILTON-T1 ventilator
Rated maximum output power of transmitter (W)
0.01 0.035 0.12 0.040 0.077
0.1 0.11 0.38 0.13 0.24
1 0.35 1.2 0.40 0.77
10 1.1 3.8 1.3 2.4
100 3.5 12 4.0 7.7
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz outside ISM bands
150 kHz to 80 MHz in ISM bands
80 MHz to 800 MHz
800 MHz to 2.5 GHz
output power rating of the transmitter in watts (W) according to the transmitter
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
• For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum
manufacturer.
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to
40.70 MHz.
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• An additional factor of 10/3 has been incorporated into the formulas used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.
Table 5 Guidance and manufacturer’s
declaration electromagnetic emissions (RTCA/DO-160F)
Description Standard Criteria
Maximum level of con­ducted RF interference ­Power line
Maximum level of radi­ated RF inter­ference
RTCA/DO-160F Section 21
RTCA/DO-160F Section 21
Category M
Category M
Table 6 Guidance and manufacturer’s
declaration electromagnetic im­munity (RTCA/DO-160F)
Description Standard Criteria
Electrostatic discharge
Magnetic fields induced into equipment
Radio Fre­quency Sus­ceptibility Radiated Standard
RTCA/DO-160F Section 25
RTCA/DO-160F
19.3.1
RTCA/DO-160F Section 20.5
Category A
Category BC
Category R 28 V DC
Table 6 Guidance and manufacturer’s
declaration electromagnetic im­munity (RTCA/DO-160F)
Description Standard Criteria
Radio Fre­quency Sus­ceptibility Conducted, BCI
RTCA/DO-160F Section 20.4
Category R 28 V DC
Table 7 Guidance and manufacturer’s
declaration electromagnetic im­munity (RTCA/DO-160F)
Description Standard Criteria
Normal surge voltage (DC
Abnormal operating conditions (DC) -> Volt­age steady stat
Low voltage conditions (DC)
Abnormal surge volt­age (DC)
Voltage spike RTCA/DO-160F
DC input power leads
RTCA/DO-160F Section 16.6.1.4
RTCA/DO-160F Section 16.6.2.1
RTCA/DO-160F Section 16.6.2.2
RTCA/DO-160F Section 16.6.2.4
Section 17
RTCA/DO-160F Section 18.3.1
Category A 28 V DC
Category A 28 V DC
Category A 28 V DC
Category A 28 V DC
Category A 28 V DC
Category B
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EMC declarations IEC 60601-1-2:2007, 3rd edition
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HAMILTON-T1 EMC
EMC declarations IEC 60601-1-2:2014, 4th edition
Declarations
This guide provides information about EMC declarations. It is designed for use together with your ventilator Operator’s Manual, and refers to information provided there.
Functioning of the device may be impaired by the operation of high-frequency surgical equipment, microwaves, shortwaves, or strong magnetic fields in close proximity.
The HAMILTON-T1 ventilator is intended for use in the electromagnetic environ­ment specified in Tables 5, 6, and 12; essential performance is not affected.
The customer or the user of the HAMILTON-T1 ventilator should ensure that it is used in such an environment.
• To prevent interrupted operation of the ventilator due to electromagnetic inter­ference, avoid using it adjacent to or stacking other devices on it. If adjacent or stacked use is necessary, verify the ventilator’s normal operation in the con­figuration in which it will be used.
• To prevent increased emissions, decreased immunity, or interrupted operation of the ventilator or any acces­sories, use only accessories or cables that are expressly stated in this manual.
• Use of accessories, transducers, and cables other than those specified or pro­vided by the manufacturer of this equip­ment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equip­ment and result in improper operation.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the HAMILTON-T1 ventilator, including cables specified by the manu­facturer. Otherwise, degradation of the performance of this equipment could result.
Hamilton Medical | HAMILTON-T1 EMC Declarations 9
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EMC declarations IEC 60601-1-2:2014, 4th edition
Table 5 Guidance and manufacturer's declaration – electromagnetic emissions
(IEC 60601-1-2:2014)
Emissions test Compliance Electromagnetic environment
guidance
RF emissions CISPR 11
Group 1 The HAMILTON-T1 ventilator 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, conducted
RF emissions CISPR 11, radiated
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/flicker emissions IEC 61000-3-3
Class B The emissions characteristics of this
equipment make it suitable for use in
Class B
Class A
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential envi­ronment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to
Complies
radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
frequency range applies.
• These guidelines may not apply in all
• UT is the AC mains voltage prior to application of the test level.
• At 80 MHz and 800 MHz, the higher
situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
Table 6 Guidance and manufacturer's declaration – electromagnetic immunity
(IEC 60601-1-2:2014)
Immunity test IEC 60601-1-2:2014
Test level
For electromagnetic environment guidance, see Table 8
Electrostatic discharge (ESD) IEC 61000-4-2
Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5:
±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air
±2 kV for power supply lines ±1 kV for input/output lines
±1 kV line(s) to line(s) ±2 kV line(s) to earth
IEC 60601-1-2:2014 Compliance level
±2 kV, ±4 kV, ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air
±2 kV for power supply lines ±1 kV for input/output lines
±1 kV line(s) to line(s) ±2 kV (line(s) to earth
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Table 6 Guidance and manufacturer's declaration – electromagnetic immunity
(IEC 60601-1-2:2014)
(cont.)
Immunity test IEC 60601-1-2:2014
For electromagnetic environment guidance, see Table 8
Voltage dips, short interrup­tions, and voltage variations on power supply input lines IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
Conducted RF IEC 61000-4-6:
Test level
Cycle 0.5
U
=0%
T
Phase=0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°.
Cycle 1
U
=0%
T
Phase=0°
Cycle 25 (50Hz) Cycle 30 (60Hz)
U
= 70%
T
Phase=0°
Cycle 250 (50Hz) Cycle 300 (60Hz)
U
=0%
T
Phase=0°
30 A/m 30 A/m
3Vrms 150 kHz to 80 MHz outside ISM bands
IEC 60601-1-2:2014 Compliance level
Cycle 0.5
U
=0%
T
Phase=0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°.
Cycle 1
U
=0%
T
Phase=0°
Cycle 25 (50Hz) Cycle 30 (60Hz)
U
= 70%
T
Phase=0°
Cycle 250 (50Hz) Cycle 300 (60Hz)
U
=0%
T
Phase=0°
6 Vrms 150 kHz to 80 MHz outside ISM bands
6Vrms 150 kHz to 80 MHz in ISM bands
Radiated RF IEC 61000-4-3
3 V/m 80 MHz - 2.7 GHz 80 % AM at 1 kHz
Immunity to proximity fields IEC 61000-4-3
Hamilton Medical | HAMILTON-T1 EMC Declarations 11
See Table 7 See Table 7
6 Vrms 150 kHz to 80 MHz in ISM bands
10 V/m 80 MHz - 3 GHz 80 % AM at 1 kHz
Page 12
EMC declarations IEC 60601-1-2:2014, 4th edition
Table 7 Compliance and test levels, Radiated RF IEC 61000-4-3
Te st frequency
Band (MHz)
Service Modulation Maximum
(MHz)
385 380-390 TETRA 400 Pulse
450 430-470 GMRS 460, FRS
710 704-787 LTE Band 13, 17 Pulse
745
780
810 800-960 GSM 800/900,
870
930
1720 1700-1990 GSM 1800,
1845
1970
2450 2400-2570 Bluetooth,
5240 5100-5800 WLAN 802.11
5500
5785
460
TETRA 800, iDEN 820, CDMA 850, LTE Band 5
CDMA 1900, GSM 1900, DECT, LTE Band 1, 3, 4, 25, UMTS
WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7
a/n
modulation 18 Hz
FM ± 5 kHz deviation 1kHz sine
modulation 217 Hz
Pulse modulation 18 Hz
Pulse modulation 217 Hz
Pulse modulation 217 Hz
Pulse modulation 217 Hz
Distance
power
(m)
(W)
1.8 0.3 27
20.328
0.2 0.3 9
20.328
20.328
20.328
0.2 0.3 9
Immunity test level (V/m)
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Table 8 Recommended separation distances between portable and mobile RF communica-
d
6 E
--- P=
d
6 E
--- P=
d
6 E
--- P=
d
6 E
--- P=
tions equipment and the HAMILTON-T1 ventilator
Rated maximum output power of transmitter P(W)
0.01 27 0.3 0.01 28 0.3
0.1 27 0.3 0.1 28 0.3
1270.3 1 280.3
10 27 0.7 10 28 0.68
100 27 2.22 100 28 2.14
Electric field strength E(V/m) at frequency band
380 to 390
MHz
Minimum separation distance (m)
or 0.3, whichever is greater
Rated maximum output power of transmitter P(W)
Electric field strength E(V/m) at frequency band
430 to 470
MHz
Minimum separation distance (m)
or 0.3, whichever is greater
Rated maximum output power of transmitter P(W)
Electric field strength E(V/m) at frequency band
704 to 787
MHz
Minimum separation distance (m)
or 0.3, whichever is greater
Rated maximum output power of transmitter P(W)
Electric field strength E(V/m) at frequency band
800 to 960
MHz
0.01 9 0.3 0.01 28 0.3
0.1 9 0.3 0.1 28 0.3
1 9 0.67 1 28 0.3
10 9 2.11 10 28 0.68
100 9 6.67 100 28 2.14
Minimum separation distance (m)
or 0.3, whichever is greater
Hamilton Medical | HAMILTON-T1 EMC Declarations 13
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EMC declarations IEC 60601-1-2:2014, 4th edition
d
6 E
--- P=
d
6 E
--- P=
d
6 E
--- P=
d
6 E
--- P=
Rated maximum output power of transmitter P(W)
Electric field strength E(V/m) at frequency band
1700 to 1990
MHz
Minimum separation distance (m)
or 0.3, whichever is greater
Rated maximum output power of transmitter P(W)
Electric field strength E(V/m) at frequency band
2400 to 2570
MHz
Minimum separation distance (m)
or 0.3, whichever is greater
0.01 28 0.3 0.01 28 0.3
0.1 28 0.3 0.1 28 0.3
1280.3 1280.3
10 28 0.68 10 28 0.68
100 28 2.14 100 28 2.14
Rated maximum output power of transmitter P(W)
Electric field strength E(V/m) at frequency band
80 MHz to
2.7 GHz
Minimum separation distance (m)
or 0.3, whichever is greater
Rated maximum output power of transmitter P(W)
Electric field strength E(V/m) at frequency band
5.1 to 5.8 GHz
Minimum separation distance (m)
or 0.3, whichever is greater
0.01 10 0.3 0.01 9 0.3
0.1 10 0.3 0.1 9 0.3
1100.6 1 90.67
10 10 1.9 10 9 2.11
100 10 6 100 9 6.67
The HAMILTON-T1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ventilator can help prevent electromagnetic interfer­ence by maintaining a minimum distance between portable and mobile RF commu­nications equipment (transmitters) and the ventilator, according to the maximum out­put power of the communications equip­ment.
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Table 9 Guidance and manufacturer’s
declaration electromagnetic emissions (RTCA/DO-160F)
Table 11 Guidance and manufacturer’s
declaration electromagnetic im­munity (RTCA/DO-160F)
Description Standard Criteria
Maximum level of con­ducted RF interference ­Power line
Maximum level of radi­ated RF inter­ference
RTCA/DO-160F Section 21
RTCA/DO-160F Section 21
Category M
Category M
Table 10 Guidance and manufacturer’s
declaration electromagnetic im­munity (RTCA/DO-160F)
Description Standard Criteria
Electrostatic discharge
Magnetic fields induced into equipment
Radio Fre­quency Sus­ceptibility Radiated Standard
Radio Fre­quency Sus­ceptibility Conducted, BCI
RTCA/DO-160F Section 25
RTCA/DO-160F
19.3.1
RTCA/DO-160F Section 20.5
RTCA/DO-160F Section 20.4
Category A
Category BC
Category R 28 V DC
Category R 28 V DC
Description Standard Criteria
Normal surge voltage (DC
Abnormal operating conditions (DC) -> Volt­age steady stat
Low voltage conditions (DC)
Abnormal surge volt­age (DC)
Voltage spike RTCA/DO-160F
DC input power leads
RTCA/DO-160F Section 16.6.1.4
RTCA/DO-160F Section 16.6.2.1
RTCA/DO-160F Section 16.6.2.2
RTCA/DO-160F Section 16.6.2.4
Section 17
RTCA/DO-160F Section 18.3.1
Category A 28 V DC
Category A 28 V DC
Category A 28 V DC
Category A 28 V DC
Category A 28 V DC
Category B
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EMC declarations IEC 60601-1-2:2014, 4th edition
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
• For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined 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.
Table 12 FDA additional tests
FDA Excerpts Related to EMI FDA Excerpts Related to EMI
test level
FDA Excerpts Related to EMI compliance level
Slow Sags and Surges 150/120/90 Vrms 500 ms 150/120/90 Vrms 500 ms
Quasi-static electric fields 2000 V/m; 0.5 Hz 2000 V/m; 0.5 Hz
Steady-state voltage 95 V / 60 Hz
132 V / 60 Hz
95 V / 60 Hz 132 V / 60 Hz
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Hamilton Medical | HAMILTON-T1 EMC Declarations 17
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EMC declarations IEC 60601-1-2:2014, 4th edition
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HAMILTON-T1 EMC
EMC RFID declarations, AIM Standard Rev. 1.00 2016-08-22
Declarations
This guide provides information about EMC RFID declarations. It is designed for use together with your ventilator Operator’s Manual, and refers to information provided there.
Table 13 Guidance and manufacturer's declaration – RFID immunity (IEC 61000-4-3)
Immunity test Test frequency Test level Compliance level
Immunity to RFID fields (Proximity cards) ISO/IEC 14443-3 (Type A)
Immunity to RFID fields (Proximity cards) ISO/IEC 14443-4 (Type B)
Immunity to RFID fields (Vicinity cards) ISO/IEC 15693 (ISO 18000-3, Mode 1)
Immunity to RFID fields (Item management) ISO/IEC 18000-7
Immunity to RAIN fields (Item management) ISO/IEC 18000-63, Type C
Immunity to 2.45 GHz RFID fields (Item management) ISO/IEC 18000-4, Mode 1
13.56 MHz
13.56 MHz 5 A/m 5 A/m
13.56 MHz 5 A/m 5 A/m
433.92 MHz 3 V/m 3 V/m
860 - 960 MHz 54 V/m 54 V/m
2.45 GHz 54 V/m 54 V/m
5 A/m 5 A/m
Hamilton Medical | HAMILTON-T1 EMC Declarations 19
Page 20
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+41 58 610 10 20
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