CARELINK ENCORE™ 29901
Programmer
Electromagnetic Compatibility Declaration
Caution: Federal law (USA) restricts this device to sale by or on
the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United States and
possibly in other countries. All other trademarks are the property of their respective owners.
CareLink, CareLink Encore, Medtronic
Electromagnetic compatibility declaration
The following list of cables and accessories were included in the system demonstrating compliance with the
requirements of IEC 60601-1-2 2007 subclause 36.201 and 36.202:
Accessory Maximum length
26901 programming head 4 m
Medtronic ECG cable & electrodes 3 m
Medtronic stylus 1 m
Video cable N/A
Ethernet cable N/A
USB cable N/A
Use of accessories and cables other than those that are specifically listed may result in increased emissions or
decreased immunity of the programmer.
Warning: The CareLink Encore Model 29901 programmer (hereafter referred to as the “programmer”) should not
be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the programmer
should be observed to verify normal operation in the configuration in which it will be used.
The programming system contains RF transmission and receiving capabilities. Consequently, it is possible that
other equipment may interfere with the programming system even if that other equipment complies with CISPR
emission requirements. The following is a technical summary of the RF communication properties:
Transmitting and receiving at 175 kHz:
●
Receiving bandwidth of programming system: NA
●
Modulation characteristics: 18K0M1D or 74K4F1D
●
Field strength: 30 dBµA/m @ 10 m
1
2
Guidance and manufacturer’s declaration—electromagnetic emissions
The programmer is intended for use in the electromagnetic environment specified below. The customer or the
user of the programmer should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment—guidance
RF emissions Group 1 The programmer uses RF energy primarily for its internal
CISPR 11
function. Therefore, its RF emissions are very low and are
not likely to cause interference in nearby electronic equipment.
1
Receiver detects switching magnetic fields and thus has the capability to respond to any frequency in the LF
(low frequency) area as long as the incidence angle is correct.
2
Effective radiated power is expressed as field strength given that it is the regulated parameter measured for
this frequency.
3
Guidance and manufacturer’s declaration—electromagnetic emissions
RF emissions Class B The programmer is suitable for use in all establishments
CISPR 22
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/flicker
Complies
other than domestic and those directly connected to the
public, low-voltage power supply network. It is a communications device that is used in areas where RF emissions
can be high, such as in certain areas of clinics and hospitals.
emissions
IEC 61000-3-3
Guidance and manufacturer’s declaration—electromagnetic immunity
The programmer is intended for use in the electromagnetic environment specified below. The customer or the
user of the programmer should assure that it is used in such an environment.
Immunity test IEC 60601 Test
level
Electrostatic discharge
±6 kV contact ±6 kV contact Floors should be wood, concrete,
Compliance
level
(ESD)
IEC 61000-4-2 ±8 kV air ±8 kV air
Electrical fast transient/burst ±2 kV for power
supply lines
IEC 61000-4-4 ±1 kV for input/
output lines
Surge ±1 kV differential
mode
IEC 61000-4-5 ±2 kV common
mode
Voltage dips, short interruptions, and voltage variations
on power supply input lines
IEC 61000-4-11
<5% U
T
(>95% dip in UT)
for 0.5 cycle
40% U
T
(60% dip in UT)
for 5 cycles
70% U
T
(30% dip in UT)
for 25 cycles
<5% U
T
(>95% dip in UT)
for 5 s
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV differential
mode
±2 kV common
mode
<5% U
T
(>95% dip in UT)
for 0.5 cycle
40% U
T
(60% dip in UT)
for 5 cycles
70% U
T
(30% dip in UT)
for 25 cycles
<5% U
T
(>95% dip in UT)
for 5 s
Electromagnetic environment—
guidance
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the programmer requires continuous
operation during power mains
interruptions, it is recommended
that the programmer be powered
from an uninterruptible power supply or a battery.
Note:UT is the AC mains voltage
prior to application of the test level.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical commercial or hospital environment.
4
Guidance and manufacturer’s declaration—electromagnetic immunity
The programmer is intended for use in the electromagnetic environment specified below. The customer or the
user of the programmer should assure that it is used in such an environment.
Immunity test IEC 60601 Test
level
Compliance
level
Electromagnetic environment—
guidance
Portable and mobile RF communications equipment should be used
no closer to any part of the programmer, including cables, than
the recommended separation distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF 3 V
RMS
(volts
3 V
RMS
d = 1.2 √P
root-meansquare)
IEC 61000-4-6 150 kHz to
80 MHz
Radiated RF 3 V/m 3 V/m d = 1.2 √P
IEC 61000-4-3 80 MHz to
2.5 GHz
d = 2.3 √P
where P is the maximum output
power rating of the transmitter in
watts (W) according to the trans-
mitter manufacturer and d is the
recommended separation distance
in meters (m). Field strengths from
fixed RF transmitters, as deter-
mined 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:
5
Guidance and manufacturer’s declaration—electromagnetic immunity
Note 1: At 80 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, consider an
electromagnetic site survey. If the measured field strength in the location in which the programmer is used
exceeds the applicable RF compliance level above, observe the programmer to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
the programmer.
b
Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment
and the programmer
The programmer is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the programmer can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the programmer as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output
power of transmitter
Separation distance according to frequency of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 √P d = 1.2 √P d = 2.3 √P
0.01 W 0.12 m 0.12 m 0.23 m
0.1 W 0.38 m 0.38 m 0.73 m
1 W 1.2 m 1.2 m 2.3 m
10 W 3.8 m 3.8 m 7.3 m
100 W 12 m 12 m 23 m
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 separation distance for 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
6
Medtronic, Inc.
*M954722A001*
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
Tel. +1 763 514 4000
Fax +1 763 514 4879
Medtronic USA, Inc.
Toll-free in the USA (24-hour technical
consultation for physicians and medical
professionals)
Bradycardia: +1 800 505 4636
Tachycardia: +1 800 723 4636
Europe/Africa/Middle East
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
Tel. +41 21 802 7000
Fax +41 21 802 7900
Technical manuals:
www.medtronic.com/manuals
© Medtronic, Inc. 2013
M954722A001A
2013-04-30
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