Bard EnCor Ultra Instrucciones De Uso página 4

Table 1: LED Status and Troubleshooting
LED Status
DENSE light is OFF
Environmental Conditions
Ingress of Water
Flammability
Dimensions
System Power Ratings
Electrical Conformity
Table 3: Nominal Ratings - Standby
Nominal Ratings
Voltage/Frequency
Current
Watts
Power Factor
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:
equipment.
All ME Equipment and ME Systems
The E C U
®
N OR LTRA
is used in such an environment.
Emissions Test
RF Emissions
CISPR 11
Harmonics
IEC 61000-3-2
Flicker
IEC 61000-3-3
System Status and Troubleshooting
Ready to Calibrate Probe. Install Probe and press SAMPLE on the Driver or press the Foot Pedal to continue.
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 E C U Breast Biopsy System may only use E
®
N OR LTRA
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: The E C U ® Breast Biopsy System may only use E
N OR LTRA
There is a system or Driver error. Restart the system. If the problem persists, remove and connect a different Driver.
Transport and store in a cool dry place between -20ºC to +60ºC, 10% to 90% relative humidity, and 500hPa to 1060hPa atmospheric pressure.
Not protected against the ingress of water. IPX0.
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
60601-1, CAN/CSA C22.2 No 601-1.
Class I, Type BF equipment
Standby
115 VAC ~ 50/60 Hz
230 VAC ~ 50/60 Hz
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600
450
0.75
Compliance
Complies
The E C
N OR
and are not likely to cause any interference in nearby electronic equipment.
Class A
Class A - Complies
The E C
N OR
those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Complies
C Biopsy Probes and is not compatible with E
®
N OR
C U
N OR LTRA
Table 4: Nominal Ratings - Operating
Nominal Ratings
Voltage/Frequency
Current
Watts
Power Factor
U
®
Breast Biopsy System uses RF energy only for its internal function. Therefore, its RF emissions are very low
LTRA
U ®
LTRA Breast Biopsy System is suitable for use in all establishments, other than domestic establishments and
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E C ®
N OR Driver Instructions for Use.
C
N
®
Vacuum Canisters and Vacuum Tubing.
DENSE button.
DENSE button.
Operating
115 VAC ~ 50/60 Hz
230 VAC ~ 50/60 Hz
600
450
0.75
E C U
®
N OR LTRA Breast Biopsy System should ensure that it
®
MRI Probes.
OR
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