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Zimmer Biomet TRICERA SYSTEM Instrucciones De Uso página 16

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III.
Output Power vs. Setting
APPENDIX G
EMC TABLES
The following tables provide information on the electromagnetic environment in which the Tricera System is capable of operating safely. Use of accessories and cables other than those specified may result in
increased emissions or decreased immunity of the system. To ensure proper grounding reliability, a Hospital Grade Power Cord must be used with a receptacle marked "Hospital Grade".
List of Tricera Controller Accessories:
Tricera Fluid Management Accessories
Tricera Footswitch
10 ft. Hospital Grade Power Cord
The Tricera System is intended for use in the electromagnetic environment specified below. The customer or the user of the Tricera System should assure that it is used in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3
The Tricera System is intended for use in the electromagnetic environment specified below. The customer or the user of the Tricera System should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Electrostatic
 6 kV contact
discharge (ESD)
 8 kV air
IEC 61000-4-2
Electrical fast
 2 kV for power
transient/burst
supply lines
IEC 61000-4-4
 1 kV for input/output lines
Surge
 1 kV line(s) to
IEC 61000-4-5
line(s)
 2 kV line(s) to earth
Voltage dips, short
<5% UT
interruptions and
(>95% dip in UT)
voltage variations
for 0.5 cycle
on power supply
40% UT
input lines
(60% dip in UT)
IEC 61000-4-11
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 s
NOTE UT is the AC mains voltage prior to application of the test level.
Power frequency
3 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
DCO-1394
Effective Date: 12-JAN-2022
Maximum RF Voltage Output
Mode
Cut
Coag
Setting
1
2
3
4
5
6
7
8
9
10
COAG 1
COAG 2
COAG 3
Table 1: Electromagnetic Emissions Statement
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
Compliance
Group 1
Class A
Class A
Complies
Table 2: Electromagnetic Immunity Statement
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
Compliance 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% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 s
3 A/m
Maximum Voltage
450 V
200 V
Power (W)
195
215
235
255
275
300
320
345
370
400
55
75
95
Electromagnetic Environment – Guidance
The Tricera System 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.
The Tricera System 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.
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 %.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. If the
user of the Tricera System requires continued operation during power mains interruptions, it
is recommended that the Tricera System be powered from an uninterruptible power supply
or a battery.
Power frequency magnetic fields should be at levels characteristic of a typical location in a
typical commercial or hospital environment.
Portable and mobile RF communications equipment should be used no closer to any part of
the Tricera System, including cables, than the recommended separation distance. The
separation distance is calculated from the equation applicable to the frequency of the
transmitter.
LBL 6028 Rev. K
Page 16 of 306

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