Explanation Of Symbols - 3M 9661L Bedienungsanleitung

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 Compliance level
test level
3 Vrms
c
3 Vrms
Conducted RF 150 kHz to
10 V/m from
IEC 61000-4-6 80 MHz
c
30MHz to 1GHz,
10 V/m for
Radiated RF IEC 10 V/m
1GHz to 2.7 GHz;
61000-4-3 80 MHz to
(1000 Hz. 80%
2.7 GHz
Modulated Test Signal)
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
a
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.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
6 V RMS was applied in the ISM and amateur radio bands, (see note 2 on subsequent page).
c
Electromagnetic environment - guidance
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 Interference may occur in the vicinity of
b
equipment marked with the following symbol:
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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.
Separation Distance According to Frequency of Transmitter (m)
Rated Max. Output Power of **150 kHz to 80 MHz
Transmitter (W) d = 1.17 √P
(V1=3)
0.01 0.12
0.1 0.37
1 1.17
10 3.70
100 11.70
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
To indicate disconnection from the mains, at least for main switches, or their positions, and all
"OFF" (power)
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
"ON" (power)
Atmospheric pressure Indicates the range of atmospheric pressure to which the medical device can be safely
limitation
Authorized
Representative in Indicates the authorized representative in the European Community. ISO 15223, 5.1.2
European Community
Indicates the manufacturer's catalogue number so that the medical device can be
Catalogue number
Indicates the need for the user to consult the instructions for use for important cautionary
Caution 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.
To identify equipment meeting the safety requirements for Class II equipment per IEC 61140.
Class II equipment
80 MHz to 800 MHz 800 MHz to 2.7 GHz
d =1.17 √P d = 2.33 √P
(E1=10) (E1=10)
0.04 0.07
0.11 0.22
0.35 0.70
1.11 2.21
3.50 7.00
Description and Reference
cases where safety is involved. Source: IEC 60417, 5007
exposed. ISO 15223, 5.3.9
identified. ISO 15223, 5.1.6
Source: IEC/TR 60878
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