Bard EnCor Ultra Instructions For Use Manual

Bard EnCor Ultra Instructions For Use Manual Manual pdf 1 page image

1Breast Biopsy SystemINSTRUCTIONS FOR USECAUTION: Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.Device DescriptionThe ENCOR U LTRA® Breast Biopsy System provides control operations for specialized biopsyinstruments intended to acquire tissue samples of suspected breast abnormalities.The EN C OR ULTRA® Breast Biopsy System may be used with the EN C OR® Breast Biopsy Driver,E N C OR® Foot Pedal, and EN C OR® Breast Biopsy Probes. Reference Figures 1, 2 and 3. E N C OR®Breast Biopsy Probes and E N C OR ULTRA® Vacuum Tubing and Canisters are available separately.Figure 3 – ENCOR® Foot PedalIndications For UseThe ENCOR ULTRA® Breast Biopsy System is indicated to provide breast tissue samples fordiagnostic sampling of breast abnormalities.• It is intended to provide breast tissue for histologic examination with partial or completeremoval of the imaged abnormality.• It is intended to provide breast tissue for histologic examination with partial removal of apalpable abnormality.The extent of a histologic abnormality cannot always be readily determined from palpation orimaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of anabnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy.When the sampled abnormality is not histologically benign, it is essential that the tissue margins beexamined for completeness of removal using standard surgical procedures.,QLQVWDQFHVZKHQDSDWLHQWSUHVHQWVZLWKDSDOSDEOHDEQRUPDOLW\WKDWKDVEHHQFODVVL¿HGDVEHQLJQWKURXJKFOLQLFDODQGRUUDGLRORJLFDOFULWHULD HJ¿EURDGHQRPD¿EURF\VWLFOHVLRQ WKH(N C OR ULTRA®Breast Biopsy System may also be used to partially remove such palpable lesions. Wheneverbreast tissue is removed, histological evaluation of the tissue is the standard of care. When thesampled abnormality is not histologically benign, it is essential that the tissue margins be examinedfor completeness of removal using standard surgical procedures.Contraindications1. This device is not intended for use except as indicated.2. The ENCOR ULTRA® Breast Biopsy System is contraindicated for those patients where,in the physician’s judgment, there is an increased risk of complications associated withpercutaneous removal of tissue samples.Warnings1. The ENCOR ULTRA® Breast Biopsy System must be properly grounded to ensure patientsafety. The system is supplied with a medical grade Power Cord with AC plug. Donot connect the included Power Cord to extension cords or three-prong to two-prongadapters. To avoid the risk of electric shock, this equipment must only be connectedto supply mains with protective earth.2. To minimize interference with other equipment, cables should be positioned in such amanner to prevent contact with other cables.3. Use of accessories not compatible with the ENCOR ULTRA® Breast Biopsy System maycreate potentially hazardous conditions.4. Only use EN C OR® Breast Biopsy Drivers with script version 1.23 or greater, with theENCOR ULTRA® Breast Biopsy System. The system is not compatible with earlier driverscripts.5. The ENCOR ULTRA® Breast Biopsy System console may not be placed in an MRI suite. 1RPRGL¿FDWLRQRIWKLVHTXLSPHQWLVDOORZHG'RQRWUHPRYHWKH(NCOR ULTRA® BreastBiopsy System housing. Removal of the housing may cause electrical shock. ContactBard for service.7. The ENCOR ULTRA®%UHDVW%LRSV\6\VWHPLVQRWFODVVL¿HGDVDQ$3RU$3*FODVVL¿HGGHYLFH7KHV\VWHPLVQRWVXLWDEOHIRUXVHLQWKHSUHVHQFHRIÀDPPDEOHDQHVWKHWLF8. After use, this product may be a potential biohazard. Handle and dispose of inaccordance with acceptable medical practice and applicable local, state, and federallaws and regulations.9. Do not use in the presence of infection.Precautions1. This device should only be used by physicians trained in percutaneous biopsy procedures.2. Carefully inspect the device prior to use to verify that device has not been damaged. Do notuse if product damage is evident and/or needle is bent.3. Locate the ENCOR ULTRA® Breast Biopsy System as far as possible (no closer than 30 cm orLQFKHV IURPRWKHUHOHFWURQLFHTXLSPHQWRUFDEOHVWRPLQLPL]HLQWHUIHUHQFHRUGHJUDGDWLRQof performance of the E NC OR ULTRA® Breast Biopsy System.4. 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 electricalshock to the patient or to the operator.5. Inspect tubing connections to the Vacuum Canister and the Vacuum Tubing to ensure propervacuum levels are achieved and maintained during use.6. Inspect the Vacuum Canister to ensure the lid is secure and that no damage has occurredduring shipping or installation. A heavily scratched canister can break during use.7. Do not leave the ENCOR ULTRA® Breast Biopsy System powered on overnight. Damage mayoccur to the Vacuum Tubing.8. Connect the Power Cord to a hospital grade wall outlet having the correct voltage or productdamage may result.9. Patients who may have a bleeding disorder or who are receiving anticoagulant therapy maybe at increased risk of complications.10. As with any biopsy instrument, there is a potential for infection. $OOEUHDVWELRSVLHVVKRXOGEHSHUIRUPHGXQGHULPDJLQJJXLGDQFHWRFRQ¿UPWKH3UREHposition relative to the target region to be sampled and to help mitigate the occurrence of afalse negative biopsy.12. When performing a biopsy with ENCOR® Breast Biopsy Probes, the orientation of the sampleQRWFKLVGLFWDWHGE\WKHLPDJHJXLGDQFHVHOHFWHG3ULRUWRLQLWLDWLQJWKHSURFHGXUHFRQ¿UPthat the sample notch orientation is correct for the image guidance being used.13. Ensure that the ENCOR ULTRA® Breast Biopsy System is positioned in such a way that thePower Cord and retainer are accessible. In the event that the system Power Switch isinoperable, release retainer and remove cord to shut off system power.Potential ComplicationsPotential complications may include, but are not limited to hematoma, hemorrhage, infection,adjacent tissue injury, pain, allergic reaction, and tissue adherence to the biopsy probe duringremoval from the breast (as per routine biopsy procedures, it may be necessary to cut tissueDGKHULQJWRWKHVW\OHWRUFRD[LDOZKLOHUHPRYLQJLWIURPWKHEUHDVW Equipment RequiredThe following equipment is required for a biopsy procedure:• Appropriate imaging modality and accessories• EN C OR® Breast Biopsy Driver• ENCOR® Breast Biopsy Probe• ENCOR ULTRA® Vacuum Tubing and Canister 7LVVXH0DUNHU RSWLRQDO• Surgical gloves and drapes• Local anesthetic• Scalpel• Other equipment as necessaryDirections For UseUnpacking InstructionsCarefully remove the ENC OR ULTRA® Breast Biopsy System from the packaging. Thoroughly inspectthe packaging materials and the system for any signs of transit damage. Do not use the unit if itappears to have any damage. Contact Bard Customer Service for instructions on how to reportshipping damage.(1*/,6+Figure 4 – E NC OR ULTRA® Systemwith HandleFigure 5 – E N C OR ULTRA® Systemwith Optional TrayFigure 1 – ENCOR® Breast Biopsy Probes Figure 2 – ENCOR® Breast Biopsy Driverand ENCOR® Breast Biopsy Probe