SpineGuard PediGuard Manual Del Usuario página 6

Symbols found on the product are described below:
See instructions for use
"BF" (body floating) type insulation
Guidance and manufacturer's declaration – electromagnetic emissions
The PediGuard is intended for use in the electromagnetic environment specified below. The customer or the user of the PediGuard should
assure that it is used in such an environment.
Emissions test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Guidance and manufacturer's declaration – electromagnetic immunity
The PediGuard is suitable for use in the electromagnetic environment specified below. The customer or the user of the PediGuard should assure
that it is used in such an electromagnetic environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Radiated RF
IEC 61000-4-3
Radiated RF
IEC 61000-4-3
Proximity fields from RF wireless
communications equipment
Power frequency magnetic field
(50/60Hz)
IEC 61000-4-8
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 re-orienting the equipment.
Information and manufacturer's declaration concerning electromagnetic compatibility (EMC)
Compliance
Group 1
Class A
Test level
± 8 kV contact
± 15 kV air
3 V/m
from 80 MHz to 2,5 GHz
380 - 390 MHz
27 V/m; PM 50%; 18 Hz
430 - 470 MHz
28 V/m; (FM ±5 kHz, 1
kHz sine) PM; 18 Hz
704 - 787 MHz
9 V/m; PM 50%; 217 Hz
800 - 960 MHz
28 V/m; PM 50%; 18 Hz
1700 - 1990 MHz
28 V/m; PM 50%; 217 Hz
2400 - 2570 MHz
28 V/m; PM 50%; 217 Hz
5100 - 5800 MHz
9 V/m; PM 50%; 217 Hz
30 A/m
Manufacturer
Expiration date
Electromagnetic environment – guidance
PediGuard uses 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.
PediGuard is suitable for use in all establishments other than domestic and
those directly connected to the public low-voltage power supply network that
supplies
buildings used for domestic purposes.
Compliance level Electromagnetic environment – guidance
± 8 kV contact Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
± 15 kV air humidity should be at least 30 %.
PediGuard is suitable for use in all establishments
other than domestic and those directly connected
3 V/m
to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
27 V/m
28 V/m
9 V/m
Portable RF communications equipment (including
peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12
28 V/m
inches) to any part of the PediGuard, including cables
specified by the manufacturer.
28 V/m
28 V/m
9 V/m
30 V/m
Single use only
Sterilized using
ethylene oxide
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