EnCor Enspire™ Breast Biopsy System
The first smart breast biopsy system features a sleek, streamlined console, palm-sized handpiece, an intuitive touch screen interface, and versatile performance in multiple modalities.
- Overview
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The first smart biopsy system
One look and you'll know the EnCor Enspire™ Breast Biopsy System is different. One touch and you'll know it's smart. A sleek, streamlined console, palm-sized hand piece, and an intuitive touch screen interface combine to create the first smart biopsy system.
Smart system with unique advantages
The EnCor Enspire™ Breast Biopsy System transforms the breast biopsy experience for you, your patient, and your practice.
For You: Increased certainty. In-breast adaptability.
- Simple, intuitive touch screen interface
- Real-time, visual confirmation of needle activity
- Adjustable while in the breast
For Your Patient: Increased comfort and less anxiety.
- Undiluted anesthetic available through the probe, as needed
- Sharp TriConcave™ trocar tip penetrates dense tissue easily, reduces drag
- Pre-programmed sampling option enables time and attention for patient support
For Your Practice: Improved efficiency. Reduced inventory.
- Adjustable console, monitor and tray adapt to room requirements
- Top-load canister enables rapid set-up
- Snap-in tubing cassette eliminates manual threading
- Advanced probe design eliminates need for specialty supplies and simplifies inventory management
The EnCor Enspire™ Breast Biopsy System features a large, intuitive touch screen interface that provides visualization of needle activity and easy access to procedure options.
- In-breast adaptability: Adapt in real time to challenging lesions while in the breast
- Density: Normal and dense tissue modes adjust for tissue density
- Size: Full- and half-sample modes provide flexibility for thin breasts and superficial lesions
- Visualization of needle activity: Real-time, on-screen feedback of needle orientation and activity
- Pre-programmed sampling option: Enables time and attention for patient support
Designed for maximum maneuverability, the EnCor Enspire™ Breast Biopsy System's lightweight, ergonomic driver fits easily and comfortably in the palm of your hand.
Physician Control
- Closed system: Samples collected in chamber are easily accessible
- Headlights: Built-in headlights reduce need to turn room lights on and off
- Probe options: 7G, 10G sizes available
- Excellent sample quality: Large consistent samples facilitate diagnosis
- Marker placement: Breast tissue markers are easily deployed through the back of the probe
Patient Comfort
- Pain management: Undiluted anesthetic available through the probe, as needed
- TriConcave™ trocar tip: Sharp tip reduces tissue drag and discomfort
Practice Efficiencies
- No specialty probes required: Ordering is simplified and inventory is minimized
- Snap-in probes: Probes snap in easily and speed the set up process
The ergonomic design of the EnCor Enspire™ Breast Biopsy System console improves the technologists' efficiency and performance while the compact, maneuverable, and adjustable console adapts readily to procedure and room requirements. It all combines to make the procedure easier and more efficient for the technologists.
Adjustable tray and touch screen: Adapts to room requirements
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Top-load canister: Enables rapid and comfortable setup from an upright position
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Snap-in tubing cassette: Eliminates manual threading and signals technologists as connections lock automatically into place
The EnCor Enspire™ Breast Biopsy System is designed for versatile performance using MRI, stereotactic and ultrasound imaging modalities.
Designed for Enhanced MRI Accuracy
The VisiLoc™ obturator and locking block contribute to excellent accuracy under MRI guidance.
- Consistent visualization throughout the full length of the VisiLoc™ MRI visible obturator
- Easy visualization with standard MRI imaging protocols
- Stable needle with locking block and cannula
- Optimal targeting localization with 13 placement options
Ergonomic Design for Maximum Maneuverability in Ultrasound
- Palm-sized hand piece
- Lightweight driver
- Accessible controls on both hand piece and foot pedal
- Built-in headlights
- Super-sharp, TriConcave™ trocar tip
Designed for Stereotactic Flexibility
- Mechanical fire forward
- Compatibility with both prone and upright systems
- Closed system
Without changing the familiarity of your routine procedure, the EnCor Enspire™ Breast Biopsy System's intelligent design provides real-time, on-screen feedback of needle orientation and activity so you always know where you've been and where you're going. No manual tracking required.
- Easy access to procedure options
- Real-time feedback of needle activity
- Confirmation of procedural steps along with support annotations
With the EnCor Enspire™ Breast Biopsy System you can adapt in real time to challenging lesions while in the breast - avoiding a reinsertion of the probe.
A quick touch switches to half-sample mode, enabling you to handle thin breasts or lesions close to the skin without changing probes or adding sleeves. And you can easily switch to dense tissue mode to sample dense breasts and lesions effectively.
- Adapt to challenges while in the breast - avoiding reinsertion
- Minimizes need for specialized inventory and accessories
- Provides sufficient posterior access
Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions and directions for use.
BD-97442
EnCor Enspire™ Breast Biopsy System
INDICATIONS FOR USE
The EnCor Enspire™ Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. • It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. • It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality 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 be examined for completeness of removal using standard surgical procedures.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the EnCor Enspire™ Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
CONTRAINDICATIONS
- This device is not intended for use except as indicated.
- The EnCor Enspire™ Breast Biopsy System is contraindicated for those patients where, in the physician’s judgment, there is an increased risk of complications associated with percutaneous removal of tissue samples.
WARNINGS
- The EnCor Enspire™ Breast Biopsy System must be properly grounded to ensure patient safety. The system is supplied with a medical grade Power Cord with AC plug. Do not connect the included Power Cord to extension cords or three-prong to two-prong Adapters. To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth.
- To minimize interference with other equipment, cables should be positioned in such a manner to prevent contact with other cables.
- Use of accessories not compatible with the EnCor Enspire™ Breast Biopsy System may create potentially hazardous conditions.
- Only use EnCor™ and EnCor™ MRI Drivers with script version 1.19 or greater with the EnCor Enspire™ Breast Biopsy System. The system is not compatible with earlier driver scripts. The script version is identified on the touch screen display during system initialization.
- EnCor Enspire™ Breast Biopsy System console may not be placed in an MRI suite. Place the console outside of the MRI suite and use the appropriate EnCor™ MRI accessories when performing a biopsy under MRI guidance.
- No modification of this equipment is allowed. Do not remove the EnCor Enspire™ Breast Biopsy System housing. Removal of the housing may cause electrical shock.
- The EnCor Enspire™ Breast Biopsy System is not classified as an AP or APG classified device. The system is not suitable for use in the presence flammable anesthetic.
- Do not use in the presence of infection.
- After use, this product may be a potential biohazard. Handle and dispose of in 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 percutaneous biopsy procedures.
- Carefully inspect the device prior to use to verify that the device has not been damaged. Do not use if product damage is evident and/or needle is bent.
- Locate the EnCor Enspire™ Breast Biopsy System as far as possible from other electronic equipment to minimize interference or degradation of performance of the EnCor Enspire™ Breast Biopsy System.
- 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.
- Inspect tubing connection to the Vacuum Canister and the Vacuum Tubing Cassette to ensure proper vacuum levels are achieved and maintained during use.
- 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.
- Do not leave the EnCor Enspire™ Breast Biopsy System powered on overnight. Damage may occur to the Vacuum or the Vacuum and Rinse Tubing Cassette.
- Connect the Power Cord to a hospital grade wall outlet having the correct voltage or product damage may result.
- Patients who may have a bleeding disorder or who are receiving anticoagulant therapy may be at increased risk of complications.
- As with any biopsy instrument, there is a potential for infection.
- All breast biopsies should be performed under imaging guidance to confirm that Probe position relative to the target region to be sampled and to help mitigate the occurrence of a false negative biopsy.
- When performing a biopsy with the EnCor™ and EnCor™ MRI Probes, the orientation of the sample notch is dictated by the image guidance selected. Prior to initiating the procedure, confirm that the sample notch orientation is correct for the image guidance being used.
- Ensure that the EnCor Enspire™ Breast Biopsy System is positioned in such a way that the Power Cord and retainer are accessible. In the event that the system Power Switch is inoperable, release retainer and remove cord to shut off system power.
POTENTIAL COMPLICATIONS
Potential complications may include, but are limited to hematoma, hemorrhage, infection, adjacent tissue injury, pain, allergic reaction, and tissue adherence to the Biopsy Probe during removal from the breast (as per routine biopsy procedures, it may be necessary to cut tissue adhering to the stylet or coaxial while removing it from the breast).