Bard ENCOR ECMRINTLOC Instructions For Use Manual

Bard ENCOR ECMRINTLOC Instructions For Use Manual Manual pdf 1 page image

1EN C OR® Introducer SetENGLISHECMRINTLOCECMRINTLOC7GFor use with E N C OR® MRI Breast Biopsy ProbesINSTRUCTIONS FOR USECAUTION: Federal (U.S.A.) law restricts this device to sale by or on the orderof a physician.Device DescriptionThe EN C OR® Introducer Set consists of the following:• Trocar• V ISIL OC™ Obturator• Cannula• Needle Guide BlockThe Trocar, V ISIL OC™ Obturator, and E N C OR® MRI Breast Biopsy Probe can be usedco-axially with the Cannula. When inserted in the Cannula, the tip of the VISIL OC™Obturator approximates the center of the sample aperture of the EN C OR® MRI BreastBiopsy Probe.Reference markings on the Cannula indicate the distance to the center of the E N C OR®MRI Breast Biopsy Probe sample aperture. When the half-sample option is selected,the tip of the V ISIL OC™ Obturator will represent the proximal edge of the half-sample.7KH&DQQXOD¿WVWKURXJKWKH1HHGOH*XLGH%ORFNDQGLVORFNHGLQWRSODFHZLWKDclockwise rotation (if present).Needle Guide Blocks:• The 10G Needle Guide Block has 4 holes which allow targeting from 13 positions,based on rotation of the Needle Guide Block within the grid.• The 7G Needle Guide Block has 4 holes which allow targeting from 5 positions,based on rotation of the Needle Guide Block within the grid.• The Needle Guide Block has a locking feature that helps to stabilize the NeedleGuide Block within the grid after installation.The EN C OR® Introducer Set is also compatible with the Aurora™ 1 Dedicated BreastMRI System using the Aurora™ Needle Guide Insert (supplied separately).The EN C OR® Introducer Set is compatible with pillar/post localization systems as well.Indications for UseThe EN C OR® Introducer Set is indicated for use to penetrate the breast under imageguidance and provide a passageway through which a diagnostic biopsy of the breastmay be performed.ContraindicationsThis device is not intended for use except as indicated.Warnings• This device is not recommended for use in patients with breast implants.• Do not use in the presence of infection.• This device has been designed for single use only. Reusing this medicaldevice bears the risk of cross-patient contamination as medicaldevices – particularly those with long and small lumina, joints, and/orFUHYLFHVEHWZHHQFRPSRQHQWV±DUHGLI¿FXOWRULPSRVVLEOHWRFOHDQRQFHERG\ÀXLGVRUWLVVXHVZLWKSRWHQWLDOS\URJHQLFRUPLFURELDOFRQWDPLQDWLRQhave had contact with the medical device for an indeterminable period oftime. The residue of biological material can promote the contaminationof the device with pyrogens or microorganisms which may lead to infectiouscomplications.• Do not resterilize. After resterilization, the sterility of the product is notguaranteed because of an indeterminable degree of potential pyrogenicor microbial contamination which may lead to infectious complications.Cleaning, reprocessing and/or resterilization of the present medical deviceincreases the probability that the device will malfunction due to potentialDGYHUVHHIIHFWVRQFRPSRQHQWVWKDWDUHLQÀXHQFHGE\WKHUPDODQGRUmechanical changes.• After use, this product may be a potential biohazard. Handle and dispose ofin accordance with acceptable medical practice and applicable local, state,and federal laws and regulations.Precautions• This device should only be used by physicians trained in percutaneousbiopsy procedures.• Do not use if the product sterile barrier system or its packaging is compromised.• Carefully inspect the device prior to use to verify that device has not beendamaged. Do not use if product damage is evident and/or needle is bent.• Exercise caution in proximity to the magnet by maintaining control of the Trocarand E N C OR® MRI Breast Biopsy Probe, which may accelerate in a strongPDJQHWLF¿HOG• Verify that the Cannula does not move when inserting or removing the Trocar/VISIL OC™ Obturator.Potential ComplicationsPotential complications may include, but are not limited to hematoma, hemorrhage,infection, adjacent tissue injury, pain, allergic reaction, and tissue adherence to theEN C OR® MRI Breast Biopsy Probe during removal from the breast (as per routinebiopsy procedures, it may be necessary to cut tissue adhering to the stylet or coaxialwhile removing it from the breast).Equipment RequiredThe following equipment is required for a biopsy procedure:• Appropriate imaging modality and accessories• Appropriate biopsy probe and system• Breast Tissue Markers (if applicable)• Surgical gloves and drapes• Local anesthetic• Scalpel• Other equipment as necessaryHow Supplied / StoredThis product is provided sterile and is intended for single use only. Do not resterilize.Store at temperatures above 0° C (32° F).Directions For UseRefer to Figures 1, 2, 3, and 4.Trocar (A)VISILOC™Obturator (F)Cannula Stop (D)Trocar TipProtector (E)Cannula (B)Needle GuideBlock (C)Figure 1. E N C OR® Introducer SetUse of the Introducer with a Grid Localization Method:1. Inspect the package to ensure that the package integrity has not beencompromised. Do not use the product if the sterility has been compromised.2. Using standard aseptic technique, remove the Trocar (A) from the package,remove the Trocar Tip Protector (E), and inspect the Trocar (A) tip for signsof damage.3. Remove the Cannula (B) from the package. Insert the Trocar (A) intothe Cannula (B).4. Identify the target lesion or site in the breast.5. The Needle Guide Block (C) is used with grid localization systems. Insert theNeedle Guide Block (C) into the grid and lock by rotating the lever clockwiseapproximately 90°. Refer to Figure 2.6. Anesthetize the area and make a skin nick.7. Using the 0.5cm depth reference markings, position the Cannula Stop (D) on theCannula (B) to the desired depth.Note: The leading (distal) edge of the depth stop indicates the desired depth.8. Insert the Trocar (A) and Cannula (B) assembly through the targeted hole in theNeedle Guide Block (C) into the breast, advancing the Trocar (A) tip to thetarget site.Unlocked Locked10G7GFigure 2. Needle Guide Block9. Orient the small tab (located on the leading edge of the Cannula Stop (D)) towardany adjacent hole of the Needle Guide Block (C) and rotate clockwise to stabilizethe Cannula (B) within the Needle Guide Block (C).10. Support the Cannula (B) while replacing the Trocar (A) with the VISIL OC™Obturator (F). Re-image the breast to verify placement of the VISIL OC™ Obturator(F) tip at the target site. Modify position, if needed.