Stryker Flyte 0408-600-000, Instructions For Use Manual

Page: 9 / 120

0408-600-705 Rev-AB EN
www.stryker.com 9
Specifications
Guidance and manufacturer's declaration - electromagnetic emissions
Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 are intended for use in the electromagnetic environment specified below. The customer or the
user of Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 use RF energy only for
its internal function. Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment
(for which CISPR 11 class B is normally required), this equipment might not offer adequate
protection to radio frequency communication services. The user might need to take
mitigation measures, such as relocating or reorienting the equipment.
Harmonic emissions
IEC 61000-3-2
Not Applicable Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 are suitable for use in all
establishments other than domestic, and may be used in domestic establishments and those
directly connected to the public low-voltage power supply network that supplies buildings
used for domestic purposes, provided the following warning is heeded:
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Not Applicable WARNING: This equipment/system is intended for use by healthcare professionals
only. This equipment/system may cause radio interference or may disrupt the
operation of nearby equipment. Mitigation measures may be necessary, such as
reorienting or relocating the Flyte Helmet REF 0408-600-000, 0408-635-000 and
0408-645-000 or shielding the location.
Guidance and manufacturer's declaration - electromagnetic immunity
Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 are intended for use in the electromagnetic environment specified below. The customer or the
user of Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 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
3 V 0.15 MHz – 80 MHz
6 V in ISM bands between
0.15 MHz and 80 MHz
80% AM at 1 kHz
b 3 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz
27 V/m
385 MHz, pulse modulation 18
Hz, Maximum power = 1.8 W
28 V/m
450 MHz, FM ± 5 kHz
deviation, 1 kHz sine,
Maximum power = 2 W
9 V/m
710, 745, 780, 5240, 5500,
5785 MHz, pulse modulation
217 Hz, Maximum power =
0.2 W
28 V/m
810, 870, 930 MHz, pulse
modulation 18 Hz, Maximum
power = 2 W
28 V/m
1720, 1845, 1970, 2450 MHz,
pulse modulation 217 Hz,
Maximum power = 2 W
3 V 0.15 MHz – 80 MHz
6 V in ISM bands between
0.15 MHz and 80 MHz
80% AM at 1 kHz
b 3 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz
27 V/m
385 MHz, pulse modulation 18
Hz, Maximum power = 1.8 W
28 V/m
450 MHz, FM ± 5 kHz
deviation, 1 kHz sine,
Maximum power = 2 W
9 V/m
710, 745, 780, 5240, 5500,
5785 MHz, pulse modulation
217 Hz, Maximum power =
0.2 W
28 V/m
810, 870, 930 MHz, pulse
modulation 18 Hz, Maximum
power = 2 W
28 V/m
1720, 1845, 1970, 2450 MHz,
pulse modulation 217 Hz,
Maximum power = 2 W
IEC 60601-1-2 3rd Edition:
Portable and mobile RF equipment should be used no closer to
any part of the Flyte Helmet REF 0408-600-000, 0408-635-000
and 0408-645-000, including cables, than the recommended
separation distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d =1.2√ P
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).
IEC 60601-1-2 4th Edition:
WARNING: Portable RF equipment (including peripherals
such as antenna cables and external antennas) should
be used no closer than 30 cm (12 inches) to any part
of the Flyte Helmet REF 0408-600-000, 0408-635-
000, or 0408-645-000, including cables specified
by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
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:
(Non-ionizing electromagnetic radiation)
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 Flyte Helmet REF 0408-600-000, 0408-635-000, and 0408-645-000 are used exceeds the applicable RF compliance level above, the
Flyte Helmet REF 0408-600-000, 0408-635-000, and 0408-645-000 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Flyte Helmet REF 0408-600-000, 0408-635-000, and 0408-645-000.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.