Guidelines And Manufacturer's Declaration - Electromagnetic Resistance To Jamming - KaVo INTRAsurg 300 Instructions For Use Manual

Surgical implant rotary system non optic unit
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Instructions for use INTRAsurg 300 / INTRAsurg 300 plus
9 Details on electromagnetic compatibility | 9.3 Guidelines and manufacturer's declaration - electromagnetic
resistance to jamming
Immunity tests
Electrostatic discharge
(ESD) according to IEC
61000-4-2
Fast transient electrical
disturbances/ Bursts ac‐
cording to IEC 61000-4-4
Surges according to IEC
61000-4-5
Voltage interruptions,
short-term interruptions
and fluctuations of the
supply voltage according
to IEC 61000-4-11
Magnetic field with a sup‐
ply frequency (50/60 Hz)
according to IEC
61000-4-8
IEC 60601 test level
± 6 kV contact discharge
± 8 kV atmospheric dis‐
charge
± 2 kV for power lines
± 1 kV for input and output
lines
± 1 kV Push-pull voltage
(symmetrical)
± 2 kV common mode volt‐
age
(unsymmetrical)
< 5% U
T
for 1/2 period
(>95% interruption)
40 % U
T
for 5 periods
(60% interruption)
70 % U
T
for 25 periods
(30 % interruption)
< 5% U
T
for 5 s
(>95% interruption)
3 A/m
NOTE: V
is the alternating mains voltage before the test level is used.
T
9.3 Guidelines and manufacturer's declaration - electromagnetic re‐
sistance to jamming
The IS 300 is for use in an environment like the one cited below. The IS 300 customer
or user should ensure that use takes place in such an environment.
Conformance level
± 6 kV contact discharge
± 8 kV atmospheric dis‐
charge
± 2 kV for power lines
± 1 kV for input and output
lines
± 1 kV Push-pull voltage
(symmetrical)
± 2 kV common mode volt‐
age
(unsymmetrical)
< 5% U
T
for 1/2 period
(>95% interruption)
40 % U
T
for 5 periods
(60% interruption)
70 % U
T
for 25 periods
(30 % interruption)
< 5% U
T
for 5 s
(>95% interruption)
3 A/m
64/66
Electromagnetic environ‐
ment - guidelines
Floors should be made of
wood or concrete or have
ceramic tiles. When the
floor is made of synthetic
material, the relative hu‐
midity must be at least
30%.
The quality of the supply
voltage should correspond
to that of a typical business
or hospital environment.
The quality of the supply
voltage should correspond
to that of a typical business
or hospital environment.
The quality of the supply
voltage should correspond
to that of a typical business
or hospital environment.
When the user of the IS
300 needs continued
operation even when the
power supply is interrup‐
ted, it is recommended to
supply the IS 300 from an
uninterrupted power sup‐
ply or a battery.
Magnetic fields at the
mains frequency should
correspond to typical val‐
ues in a business and
hospital environment.

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Intrasurg 300 plus

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