Points Of Contact With The Patient - Mectron Piezosurgery Plus Gebrauchs- Und Wartungsanleitung

i) ME EQUIPMENT and ME SYSTEMS with RATED input
current greater than 16 A / phase shall be interrupted
once for 250/300 cycles at any angle and at all phases
at the same time (if applicable). PIEZOSURGERY plus
with battery backup shall resume line power operation
after the test. For ME EQUIPMENT and ME SYSTEMS with
RATED input current not exceeding 16 A, all phases shall
be interrupted simultaneously.
j) ME EQUIPMENT and ME SYSTEMS that does not have
a surge protection device in the primary power circuit
may be tested only at ± 2 kV line(s) to earth and ± 1 kV
line(s) to line(s).
k) Not applicable to CLASS II PIEZOSURGERY plus.
l) Direct coupling shall be used.
m) r.m.s. , before modulation is applied.
n) The ISM (industrial, scientific and medical) bands
between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795
MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283
MHz; and 40,66 MHz to 40,70 MHz. The amateur radio
bands between 0,15 MHz and 80 MHz are 1,8 MHz to
2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7
MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to
14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4
MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz
and 50,0 MHz to 54,0 MHz.
7.4.2 Points of Contact with the Patient
PIEZOSURGERY plus, with relative accessories, is designed to operate in the electromagnetic
environment specified below.
The customer or the user of PIEZOSURGERY plus should ensure that it is used in such
environment.
Basic EMC
Phenomenon standard or test
Electrostatic
discharges IEC 61000-4-2
(ESD)
c)
Conducted
disturbances
IEC 61000-4-6
induced by RF
fields
a)
a) The following apply:
• All PATIENT-COUPLED cables shall be tested, either
individually or bundled
40
Immunity test levels
method
±8 kV on contact
±2 kV, ±4 kV, ±8 kV,
±15 kV in air
3 V
b)
0.15 MHz - 80 MHz
6 V in ISM bands
b)
between 0.15 MHz and
80 MHz
80% AM at 1 KHz
o) Applicable to ME EQUIPMENT and ME SYSTEMS with
RATED input current less than or equal to 16 A / phase
and ME EQUIPMENT and ME SYSTEMS with RATED input
current greater than 16 A / phase.
p) Applicable to ME EQUIPMENT and ME SYSTEMS with
RATED input current less than or equal to 16 A / phase.
q) At some phase angles, applying this test to ME
EQUIPMENT with transformer mains power input
might cause an overcurrent protection device to open.
This can occur due to magnetic flux saturation of the
transformer core after the voltage dip. If this occurs, the
ME EQUIPMENT shall provide BASIC SAFETY during and
after the test.
r) For ME E QUIPMENT and ME SYSTEMS that have
multiple voltage settings or auto ranging voltage
capability, the test shall be performed at the power
input voltage specified in Table 1 - "Power input
voltages and frequencies during the tests" of the IEC
60601-1-2:2014/AMD1:2020.
Electromagnetic
Environment Guidance
The floor must be made of
wood, concrete or ceramic
tiles. If the floor is covered
with synthetic material, the
relative humidity should be at
least equal to 30%.
Portable and mobile RF
communication devices
should not be used near any
part of the product, including
cables, except when they
respect the recommended
distances, calculated from the
equation applicable at the
frequency of the transmitter.
• PATIENT-COUPLED cables shall be tested using a
current clamp unless a current clamp is not suitable.
In cases were a current clamp is not suitable, an EM
clamp shall be used.