Abiomed Automated Impella Controller Manual De Usuario página 22

Table 3. (Table 203) Guidance and Manufacturer's Declaration – Emissions Equipment and Systems that are Life-Supporting
The Automated Impella Controller is intended for use in the electromagnetic environment specified below.
The customer or user of the Automated Impella Controller should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test Level
Conducted RF 10 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 10 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz
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.
(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 Automated Impella Controller is used exceeds the applicable RF compliance level above, the Automated
Impella Controller should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
Automated Impella Controller.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Table 4. (Table 205) Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the
AIC, Equipment and Systems that are Life-Supporting
The Automated Impella Controller is intended for use in the
electromagnetic environment in which radiated disturbances are
controlled. The customer or user of the Automated Impella Controller
can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
and the Automated Impella Controller as recommended below, according
to the maximum output power of the communications equipment.
Rated Recommended Separation Distances
Maximum for the Automated Impella Controller (m)
Output
150 KHz to
Output Power 80 MHz
of Transmitter d = 0.35
(Watts)
0.01 0.04
0.1 0.11
1 0.35
10 1.11
100 3.5
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.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from
structures, objects, and people.
22
Compliance Level
10 Vrms
20 V/m
80 MHz to 800 MHz to
800 MHz 2.5 GHz
√ √ √
P d = 0.6 P d = 1.2
0.06 0.12
0.19 0.38
0.6 1.2
1.9 3.8
6.0 12
Electromagnetic Environment – Guidance
Portable and mobile RF communications equipment should be separated from
the Automated Impella Controller by no less than the recommended separation
distances calculated/listed below:
d = 0.35√P
d = 0.6√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
Where P is the maximum power rating in watts and d is the recommended
separation distance in meters.
Field strengths from fixed transmitters, as determined by an electromagnetic site
survey (a) , should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following
symbol:
Immunity Test
Avionics: RTCA DO-160G
Conducted RF: Section 20.4
Radiated RF: Section 20.5
(c) the AIC will not maintain its essential performance when subjected to
Category R Levels (radiated RF at a field strength of 150 V/m).
Immunity Test
RFID
P
AIM 7351731:2017
RFID Specification
ISO 14223
ISO/IEC 14443-3 (Type A)
ISO/IEC 14443-4 (Type B)
ISO/IEC 15693 (ISO 18000-3
Mode 1)
ISO/IEC 18000-7
ISO/IEC 18000-63 Type Ca
ISO/IEC 18000-4 Mode 1
RFID Transmitter / Receiver Specifications
Frequency
Receiver bandwidth
Effective radiated power
Modulation
(b)
Compliance Level
Category R: 10 MHz - 400MHz
Category T (c): 100 MHz - 8 GHz
Frequency Test Level (RMS)
134.2 kHz 65 A/m
13.56 MHz 7.5 A/m
13.56 MHz 7.5 A/m
13.56 MHz 12 A/m
433 MHz 3 V/m
860-960 MHz 54 V/m
2.45 GHz 54 V/m
13.56 MHz
14 kHz
30 nW
ASK
User Manual