Programming Manual

Algovita Spinal Cord Stimulation System
Clinician Programming Manual 59
Guidance and manufacturer’s declaration – electromagnetic emissions
e Bridge Communicator is intended for use in the electromagnetic environment specied below. e customer or the user of the Bridge
Communicator 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
Proximity Fields
from RF wireless
communication
equipment
IEC 61000-4-3
3 Vrms
150 kHz to
80 MHz
10 V/m
80 MHz to
2.7 GHz
Per table 9
of §8.10
9 to 28 V/m
385 MHz to
5785 MHz
3 Vrms
150kHz to 80
MHz
10 V/m
80 MHz to
2.7 GHz
9 to 28 V/m
385 MHz to
5785 MHz
Portable and mobile RF communications equipment should be used no closer to any part of the
Bridge Communicator, including cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d=1.2
d=1.2 80 MHz to 800 MHz
d= 2.3
800 MHz to 2.7 GHz
where P is the maximum output 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 xed RF transmitters, as determined by an electromagnetic site survey,
a
should be less than the compliance level in each frequency range.
b
Recommended separation distane E=6/d*sqrt(P)
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: ese guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures,
objects, and people.
a
Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the Bridge
Communicator is used exceeds the applicable RF compliance level above, the Bridge Communicator should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Bridge Communicator.
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3V/m.
Recommended separation distances between portable and mobile RF communications equipment and the Bridge
Communicator
e Bridge Communicator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. e customer
or the user of the Bridge Communicator can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Bridge Communicator as recommended below, according to the maximum output
power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d=1.2
80 MHz to 800 MHz
d=1.2
800 MHz to 2.7 GHz
d=2.3
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
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.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: ese guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures,
objects, and people.
0300-000176-001 Rev.2 SCS CP_Mobile.indb 59 7/12/19 9:20 AM