8
Table 3: Troubleshooting
BD EleVation™
Breast Biopsy System
Condition
Action Required
ERROR indicator blinks red, PRIME/PIERCE and
SAMPLE buttons are solid red
Error during:
- Calibration
- PRIME/
PIERCE
- Sampling
- Remove the BD EleVation™ Probe
- Place BD EleVation™ Driver on a
flat surface with hand away from
any moving components
- Press SAMPLE button
ERROR indicator blinks red, SMART MODE indicator
blinks red, PRIME/PIERCE and SAMPLE buttons
are solid red
SMART MODE
overloaded
- Remove BD EleVation™ Probe
- Place BD EleVation™ Driver on a
flat surface with hand away from
any moving components
- Press SAMPLE button
ERROR indicator blinks red, BATTERY indicator
blinks red, PRIME/PIERCE and SAMPLE buttons
are solid red
BD EleVation™
Driver Placed
in wireless
charging
stand while
BD EleVation™
Probe is loaded
- Remove BD EleVation™ Driver
from wireless charging stand
- Remove BD EleVation™ Probe
Table 4: Specifications
Environmental
Conditions – Storage
Transport and store in a cool dry place.
Temperature: -18ºC to + 40ºC
Humidity: 10% - 90%
Atmospheric Pressure: 500 hPa - 1060 hPa
Environmental
Conditions – Operation
Operate the device in ambient conditions.
Temperature: 15ºC to 25ºC
Humidity: 30% - 75%
Atmospheric Pressure: 700 hPa - 1060 hPa
Ingress of Water
Not protected against the ingress of water. IPX0.
Flammability
Equipment not suitable for use in the presence of flammable anesthetic.
Dimensions
Approximately 4 cm x 6 cm x 25 cm
Weight
Approximately 0.4 kg
AC Power Accessories
and Ratings
Use only with supplied AC power accessories.
Power Input:
Input Voltage Range: 100~240 Vac
Input Frequency Range: 50~60Hz
Output Voltage: +5Vdc
Output Current Max: 2.4A
Removing the AC adapter from wall power shall serve as isolation mains. Do not
position the AC adapter and charging stand such that it is difficult to remove the AC
adapter from the wall outlet if needed to remove mains power.
Battery Type
Lithium Ion
Applied Part
BD EleVation™ Probe
Electrical Conformity
This medical equipment has passed all required testing for electric shock, fire and
mechanical hazards in accordance with IEC/EN 60601-1, and CAN/CSA C22.2 No
601-1.
Classification
Class II, internally powered Type BF equipment
Mode of Operation
Continuous operation
Electromechanical
Compatibility
Medical Electrical Equipment needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided below.
Portable and Mobile RF Communications Equipment can affect Medical Electrical
Equipment.
Table 5: Guidance and Manufacturer’s Declaration – Emissions
The BD EleVation™ Breast Biopsy System is intended for use in the electromagnetic environment specified below.
The user of the BD EleVation™ Breast Biopsy System should ensure that it is used in such an environment
Emissions Test
Compliance
Electromagnetic Environment – Guidance
RF Emissions
CISPR11
Group 1, Class A
The BD EleVation™ 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.
Harmonic
IEC 61000-3-2
Class A – Complies
The The BD EleVation™ Breast Biopsy
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.
Flicker
IEC 61000-3-3
Complies
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