Gima TOBI Mode D'emploi page 12

The surgical aspirator TOBI is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator TOBI should assure that it's used in such an environment.
Immunity Test
Conducted Immunity
IEC / EN 61000-4-6
Radiated Immunity
IEC / EN 61000-4-3
Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied
Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the absorption and by
reflection from buildings, objects and people.
a) The field intensity for fixed transmitters such as the base stations for radiotelephones (mobile and cordless) and terrestrial mobile radio,
amateur radio devices, radio AM and FM transmitters and TV transmitters can not be theoretically and accurately foreseen.
To establish an electro-magnetic environment generated by fixed RF transmitters, an electro-magnetic study of the site should be considered.
If the field intensity measured in the place where the device will be used surpasses the above mentioned applicable level of conformity, the
normal functioning of the device should be monitored. If abnormal performance arises, additional measures such as changing the device's
direction or positioning may be necessary.
b) The field intensity on an interval frequency of 150 kHz to 80 MHz should be less than 3 V/m.
Recommended separation distance between portable and mobile radio-communication devices and the monitor
The TOBI surgical aspirator is intended to operate in an electro-magnetic environment where RF irradiated interferences are under control. The
client or operator of the TOBI device can help prevent electro-magnetic interference by keeping a minimum distance between the portable and
mobile RF communication devices (transmitters) and the TOBI device, as recommended below, in relation to the radio-communication
maximum output power.
Maximum nominal output
power of the
Transmitter W
0,01
0,1
1
10
100
For transmitters with a maximum nominal output power not shown above, the recommended separation distance in metres (m) can be
calculated using the equation applicable to the transmitter frequency, where P is the maximum nominal output power of the transmitter in Watt
(W) depending on the transmitter's manufacturer.
Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied
Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the absorption and by the
reflection from buildings, objects and people.
Guidance and manufacturer's declaration – Immunity Emissions
Level indicated by Compliance level
the IEC 60601-1-2
3Vrms 150kHz to V
80Mhz
(for non life-
supporting devices)
3V/m 80MHz to E
2.5GHz
(for non life-
supporting devices)
150 kHz to 80 MHz
d = [3.5 / V ]
1
0,12
0,38
1,2
3,8
12
= 3 V rms The portable and mobile RF communication devices,
1
including cables, must not be used closer to the TOBI device,
than the separation distance calculated by the equation
applicable to the transmitter frequency. Recommended
separation distance
= 3 V / m
1
d = [3.5 / V
d = [12 / E
d = [23 / E
Where P is the maximum nominal output voltage of the
transmitter in Watt (W) depending on the manufacturer of the
transmitter and the recommended separation distance in
metres (m). The intensity of the field from the fixed RF
transmitters, as determined by an electro-magnetic study of
a)
the site , could be lower than the level of conformity of each
frequency interval
It is possible to check for interference in proximity to devices
identified by the following symbol:
Separation distance from the frequency transmitter (m)
80 MHz to 800 MHz
P
d = [12/E
0,12
0,38
1,2
3,8
12
12
Electromagnetic environments - guidance
P
]
1
P
] from 80 MHz to 800MHz
1
P
] from 800 MHz to 2.5 GHz
1
b)
.
800 MHz to 2.5 GHz
P
] d = [23/E
1
P
]
1
0,23
0,73
2,3
7,3
23