Covidien Kangaroo - Page 30

Kangaroo™ Connect Enteral Feeding Pump | 30
Table of Contents
Section 15 — Electromagnetic Conformity Declaration
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Kangaroo Connect pump, WCH and WiFi module are intended for use in the electromagnetic environment specified below. The
customer or the user of the Kangaroo Connect pump, WCH and WiFi module 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
6 Vrms
150 kHz to 80 MHz
6 Vrms
Portable and mobile RF communications
equipment should be used no closer to any
part of the Kangaroo Connect pump, WCH
and WiFi module, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Not applicable
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 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,
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:
Radiated RF
(EN 61000-4-3
per EN 60601-1-
2: 2007)
Band Frequency Modulation
380-390 MHz 385 MHz PM, 18 Hz, 50% 27 V/m
430-470 MHz 450 MHz PM, 18 Hz, 50% 28 V/m
704-787 MHz 710 MHz PM, 217 Hz, 50% 9 V/m
745 MHz
780 MHz
800-900 MHz 810 MHz PM, 18 Hz, 50% 28 V/m
870 MHz
930 MHz
1700-1990 MHz 1720 MHz PM, 217 Hz, 50% 28 V/m
1845 MHz
1970 MHz
2400-2570 MHz 2450 MHz PM, 217 Hz, 50% 28 V/m
5100-5800 MHz 5240 MHz PM, 217 Hz, 50% 9 V/m
5500 MHz
5785 MHz
27 V/m
28 V/m
9 V/m
28 V/m
28 V/m
28 V/m
9 V/m
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 Kangaroo Connect enteral feeding pump is used
exceeds the applicable RF compliance level above, the Kangaroo Connect pump, WCH and WiFi module should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Kangaroo Connect enteral feeding pump.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.