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Table 1: LED Status and Troubleshooting
LED Status
System Status and Troubleshooting
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Ready to Calibrate Probe. Install Probe and press
SAMPLE
on the Driver or press the Foot Pedal to continue.
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Driver Instructions for Use.
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There is a Probe error. Remove the Probe to continue. After the system has reset, re-install the Probe and press
SAMPLE
on the Driver or
press the Foot Pedal to continue.
NOTE:
The
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Breast Biopsy System may only use
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Biopsy Probes and is not compatible with
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MRI Probes.
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There is a vacuum error. Check and secure the Tubing and Canister connections. Check for pinched tubing. Ensure the Vacuum Tubing is loaded
properly. Press the
RESET VACUUM
button to continue. If the problem persists, replace the disposable components.
NOTE:
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Breast Biopsy System may only use
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Vacuum Canisters and Vacuum Tubing.
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There is a system or Driver error. Restart the system. If the problem persists, remove and connect a different Driver.
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DENSE
button.
DENSE light is OFF
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DENSE
button.
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Environmental Conditions
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Transport and store in a cool dry place between -20ºC to +60ºC, 10% to 90% relative humidity, and 500hPa to 1060hPa atmospheric pressure.
Ingress of Water
Not protected against the ingress of water. IPX0.
Flammability
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Dimensions
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System Power Ratings
Maximum:
100-120 VAC, 600VA, 50/60 Hz, 3-wire, grounded with removable Power Cord
220-240 VAC, 600VA, 50/60 Hz, 3-wire, grounded with removable Power Cord
Electrical Conformity
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Class I, Type BF equipment
Table 3: Nominal Ratings - Standby
Table 4: Nominal Ratings - Operating
Nominal Ratings
Standby
Nominal Ratings
Operating
Voltage/Frequency
115 VAC ~ 50/60 Hz
230 VAC ~ 50/60 Hz
Voltage/Frequency
115 VAC ~ 50/60 Hz
230 VAC ~ 50/60 Hz
Current
4
Current
4
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600
9$&DOFXODWHG
600
Watts
450
Watts
450
Power Factor
0.75
Power Factor
0.75
Electromagnetic Emissions and Immunity
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below. This device is suitable for
environments using ultrasound equipment. It is not suitable for MRI environments.
NOTE:
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equipment.
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All ME Equipment and ME Systems
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The
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Breast Biopsy System should ensure that it
is used in such an environment.
Emissions Test
Compliance
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RF Emissions
CISPR 11
Complies
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Class A
The
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Breast Biopsy 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.
Harmonics
IEC 61000-3-2
Class A - Complies
The
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Breast Biopsy System is suitable for use in all establishments, other than domestic establishments and
those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Flicker
IEC 61000-3-3
Complies
