Stryker SYSTEM G Manual Del Usuario página 12

7308-001-700 Rev-A
The STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) is intended for use in the electromagnetic environment specified below. The customer or the
user of the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions and
voltage variations on power supply
input lines
IEC 61000-4-11
Power frequency (50/
60 Hz) magnetic field
IEC 61000-4-8
NOTE: U is the alternating current mains voltage prior to application of the test level.
T
The STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) is intended for use in the electromagnetic environment specified below. The customer or the
user of the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) should assure that it is used in such an environment.
IEC 60601 test
Immunity test
level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to
80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 80 MHz to
2.5 GHz
NOTE 1: At 80 MHz and 800MHz 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 STRYKER SYSTEM G Sagittal Saw (REF
7308-001-000) is used exceeds the applicable RF compliance level above, the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the STRYKER
SYSTEM G Sagittal Saw (REF 7308-001-000).
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
www.stryker.com
Guidance and manufacturer's declaration - electromagnetic immunity
IEC 60601 test level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5% U (>95% dip in U )
T T
for 0,5 cycle
40% U (60% dip in U )
T T
for 5 cycles
70% U (30% dip in U )
T T
for 25 cycles
<5% U (>95% dip in U )
T T
for 5 seconds
3 A/m
Guidance and manufacturer's declaration - electromagnetic immunity
Compliance level
Portable and mobile RF communications equipment should be used no closer to any
part of the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000), including cables,
than the recommended separation distance calculated from the equation applicable to
N/A
[E ] = 3 V/m
1
according to the transmitter manufacturer and d is the recommended separation
distance in meters (m). Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey,
frequency range.
Compliance level
±6 kV contact
±8 kV air
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
3 A/m
Electromagnetic environment - guidance
the frequency of the transmitter.
Recommended separation distance:
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W)
a should be less than the compliance level in each
b Interference may occur in the vicinity of equipment marked with the
following symbol:
(Non-ionizing electromagnetic radiation)
Electromagnetic environment -
guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
N/A
N/A
N/A
Power frequency magnetic fields
should be at levels characteristics
of a typical location in a typical
commercial or hospital environment.
EN
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