7
6
Table 4 Guidance and Manufacturer’s Declaration
Guidance and manufacturer’s declaration - electromagnetic emissions
The
Model 9661L
is intended for use in the electromagnetic environment specified below. The customer or the user of the
Model 9661L
should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF IEC
61000-4-3
3 Vrms
150 kHz to
80 MHz
c
10 V/m
80 MHz to
2.7 GHz
3 Vrms
c
10 V/m from
30MHz to 1GHz,
10 V/m for
1GHz to 2.7 GHz;
(1000 Hz. 80%
Modulated Test Signal)
Portable and mobile RF communications equipment should be used
no closer to any part of the
Model 9661L
, including cables, than the
recommended separation distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
D = 1.17
√
P
D = 1.17
√
P (80 MHz to 800 MHz)
D = 2.33
√
P (800 MHz to 2.7 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 strengths from fixed RF transmitters, as determined by an
electromagnetic site survey
a
should be less than the compliance level
in each frequency range
b
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.
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 Model 9661L is used exceeds the applicable RF compliance level above, the Model 9661L should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the Model 9661L.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c
6 V RMS was applied in the ISM and amateur radio bands, (see note 2 on subsequent page).
Table 6 Guidance and Manufacturer’s Declaration
Recommended separation distance between Portable and mobile RF communications equipment and the Model 9661L
The
Model 9661L
is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer
or the user of the
Model 9661L
can help prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the
Model 9661L
as recommended below, according to the maximum
output power of the communications equipment.
Rated Max. Output Power of
Transmitter (W)
Separation Distance According to Frequency of Transmitter (m)
**150 kHz to 80 MHz
d
= 1.17
√
P
(V1=3)
80 MHz to 800 MHz
d
=1.17
√
P
(E1=10)
800 MHz to 2.7 GHz
d
= 2.33
√
P
(E1=10)
0.01
0.12
0.04
0.07
0.1
0.37
0.11
0.22
1
1.17
0.35
0.70
10
3.70
1.11
2.21
100
11.70
3.50
7.00
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d
in metres (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.
**See Note 2, (below): 6 V RMS was applied in the ISM and amateur radio bands.
NOTE 1
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 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
NOTE 3
An additional factor of 10/3 has been incorporated into the formulae 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.
NOTE 4
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
Please report a serious incident occurring in relation to the device to 3M and the local competent authority (EU) or local
regulatory authority.
Explanation of Symbols:
Symbol Title
Symbol
Description and Reference
“OFF” (power)
“ON” (power)
To indicate disconnection from the mains, at least for main switches, or their positions, and all
those cases where safety is involved. Source: IEC 60417, 5008
To indicate connection to the mains, at least for mains switches, or their positions, and all those
cases where safety is involved. Source: IEC 60417, 5007
Atmospheric pressure
limitation
Indicates the range of atmospheric pressure to which the medical device can be safely
exposed. ISO 15223, 5.3.9
Authorized
Representative in
European Community
Indicates the authorized representative in the European Community. ISO 15223, 5.1.2
Catalogue number
Indicates the manufacturer's catalogue number so that the medical device can be
identified. ISO 15223, 5.1.6
Caution
Indicates the need for the user to consult the instructions for use for important cautionary
information such as warnings and precautions that cannot, for a variety of reasons, be
presented on the medical device itself. Source: ISO 15223, 5.4.4
CE Mark
Indicates conformity to European Union Medical Device Regulation or Directive.
Class II equipment
To identify equipment meeting the safety requirements for Class II equipment per IEC 61140.
Source: IEC/TR 60878
