Device Description; Indications For Use; Contraindications - Bard EnCor ENSPIRE Mode D'emploi

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E C E Breast Biopsy System
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Instructions for Use
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
A. DEVICE DESCRIPTION
The E C E Breast Biopsy System provides control operations for specialized biopsy instruments intended to acquire tissue samples of suspected
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breast abnormalities. The E C
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The E C E Breast Biopsy System may be used with E
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Probes, Tubing Cassettes, Canisters, adapters and needle guides are available separately. Reference Figure 1 – Figure 4 for photographs of the above
mentioned accessories.
Figure 1 – E C ® and E C ® 360 Biopsy
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Probes
B. INDICATIONS FOR USE
The E C E Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities.
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C. CONTRAINDICATIONS
2. The E C E Breast Biopsy System is contraindicated for those patients where, in the physician's judgment, there is an increased risk of
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complications associated with percutaneous removal of tissue samples.
D. WARNINGS
1. The E C E Breast Biopsy System must be properly grounded to ensure patient safety. The system is supplied with a medical grade power cord
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equipment must only be connected to supply mains with protective earth.
2. To minimize interference with other equipment, cables should be positioned in such a manner to prevent contact with other cables.
3. Use of accessories not compatible with the E
4. Only use E C and E C
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system initialization.
5. The E C E Breast Biopsy System console may not be placed in an MRI suite. Place the console outside of the MRI suite and use the appropriate
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E C MRI accessories when performing a biopsy under MRI guidance.
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electrical shock. Contact Bard for service.
7. The E C E
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E. PRECAUTIONS
1. This equipment should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.
2. Locate the E C E TM
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3. Inspect accessories and cords for breaks, cracks, nicks, or other damage before every use. If damaged, do not use. Failure to observe this precaution may
result in injury or electrical shock to the patient or to the operator.
4. Inspect tubing connections to the vacuum canister and the vacuum tubing cassette to ensure proper vacuum levels are achieved and maintained
during use.
5. Inspect the vacuum canister to ensure the lid is secure and that no damage has occurred during shipping or installation. A heavily scratched canister can
break during use.
6. Do not leave the E C E
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7. Connect the power cord to a hospital grade wall outlet having the correct voltage or product damage may result.
8. Patients who may have a bleeding disorder or who are receiving anticoagulant therapy may be at increased risk of complications.
9. As with any biopsy instrument, there is a potential for infection.
mitigate the occurrence of a false negative biopsy.
12. Ensure that the E C E
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system power switch is inoperable, release retainer and remove cord to shut off system power.
E TM Biopsy System is designed to recognize individual biopsy drivers and provide a user interface and to accept
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Figure 2 – E C ® 360 Driver and Probe
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E
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C E
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MRI drivers with script version 1.19 or greater, or E
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Breast Biopsy System as far as possible from other electronic equipment to minimize interference.
Breast Biopsy System powered on overnight. Damage may occur to the vacuum or vacuum and rinse tubing cassette.
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C and E C MRI probes, the orientation of the sample notch is dictated by the image guidance selected. Prior to
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Breast Biopsy System is positioned in such a way that the power cord and retainer are accessible. In the event that the
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C , E C MRI and E C
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Figure 3 – E
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Breast Biopsy System may create potentially hazardous conditions.
C 360 drivers with script version 1.05 or greater with the E
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C E Breast Biopsy System housing. Removal of the housing may cause
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360 drivers, foot pedals and probes. E
C ® Driver and Probe
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C Biopsy
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Figure 4 – E C ® Foot Pedal
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