Xo FLEX, Инструкция по эксплуатации, Страница: 84 / 95

XO FLEX – Instructions for use
Legal
84
Interference immunity
tests IEC 60601-1-2
test level Compliance
level Electromagnetic environment -
guidelines
Conducted RF disturbance
IEC 61000-4-6
3 V
eff
150 kHz to
80 MHz
3 V
eff
Portable and mobile radio devices,
including the wires, should not be used
closer to the unit than the recommended
safe distance, calculated using the
equation for the transmission frequency.
Recommended safe distance:
d = 1.17 √P for 80 MHz to 800 MHz
d = 2.33 √P for 800 MHz to 2.5 GHz
with P as the maximum rated power of the
transmitter in watts according to the
transmitter manufacturer, and d as the
recommended safe distance in meters. The
field strength of stationary radio
transmitters should be less than the
conformance level at all frequencies in an
on-site check. Disturbances are possible
close to devices that have the following
symbol
Radiated RF interference
IEC 61000-4-3 3 V/m 80 MHz -
2500 MHz
11.10
CLASSIFICATION
Classification according to M.D.D. 93/42/EEC: Class IIa
Classification according to EN 60601-1: Class I, TYPE B applied parts.
IP classification of the Foot Control: IP21 (Protected against solid foreign objects of 12,5 mm
and greater, and Protection against vertically falling water drops).
11.11 APPLIED PARTS
In relation to EN 60601-1 the following parts of XO FLEX are applied parts – that the patient can
get in contact with):
•
Instruments
•
Suction system
•
Patient chair
11.12 MARKING PLATE
Please see the black XO FLEX marking plate at the base of the unit stand at 6 o’clock.