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Nonin Onyx 9500 Instructions For Use page 5

Finger pulse oximeter

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Table 3: Guidance and Manufacturer's Declaration—Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used
in such an environment.
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables,
than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
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
device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal per-
formance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
NOTES:
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.
Table 4: Recommended Separation Distances
The following table details the recommended separation distances between portable and mobile RF communications equipment and this device.
This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Users of this device can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters)
and the device as recommended below, according to maximum output power of the communications equipment.
Rated Maximum Output Power of Transmitter
W
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated 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.
NOTES:
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.
®
NONIN
Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441-5443 USA
Compliance
Level
Recommended Separation Distance
N/A
d
=
1.17 P
[3] V/m
80 MHz to 800 MHz
800 MHz to 2.5 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
Interference may occur in the vicinity of equipment marked with the following symbol:
Separation Distance According to Frequency of Transmitter
150 kHz to 80 MHz
d
=
1.17 P
0.12
0.37
1.2
3.7
12
+1 (763) 553-9968
800-356-8874 (US & Canada)
Fax +1 (763) 553-7807
E-mail: mail@nonin.com
www.nonin.com
Electromagnetic Environment—Guidance
d
=
1.17 P
d
=
2.33 P
a
, should be less than the compliance level in each frequency range.
80 MHz to 800 MHz
d
=
1.17 P
0.12
0.37
1.2
3.7
12
EC
REP
Authorized EC Representative:
MPS, Medical Product Service
GmbH
Borngasse 20
b
800 MHz to 2.5 GHz
d
=
2.33 P
0.23
0.74
2.3
7.4
23
0123
© 2006
4821-001-06

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