LOCalizer Surgical Probe Instructions for Use Rev 05

HOW SUPPLIED

DESCRIPTION

The LOCalizer Surgical Probe is provided sterile and is intended for single patient use only. The Surgical Probe is not made with natural rubber latex.

RFID Localization System

COMPLIANCE WITH STANDARDS

The Tag Applicator, LOCalizer™ Reader and LOCalizer Surgical Probe are components of the RFID Localization System. The Tag is intended to be placed in breast tissue, within 6 cm of the breast surface, using the Tag Applicator. The Tags, when used in conjunction with the LOCalizer Reader and LOCalizer Surgical Probe, can be used as a guide for the surgeon to follow in the excision of tissue.

When used with the LOCalizer Reader, the Surgical Probe complies with IEC60601-1 requirements for type B applied part and meets electromagnetic compatibility requirements of IEC60601-2.

INTERFERENCE This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: 1 This device may not cause harmful interference, and 2 This device must accept any interference received, including interference that may cause undesired operation. The user is responsible to maintain FCC compliance. Any changes or modifications not expressly approved by Health Beacons Inc. could void the user’s authority to operate the equipment. Use the LOCalizer Surgical probe only with a LOCalizer Reader and Tag. The LOCalizer Reader is MR Unsafe. Keep away from magnetic resonance imaging (MRI) equipment.

RFID Localization System (RFLS) components are listed below: System Component

Description

Part Number

LOCalizer Reader

RFID Reader

HB100

LOCalizer Surgical Probe

Attachment probe for use with LOCalizer RFID reader

HB110

Tag Applicator

Needle applicator with preloaded RFID Tag

HB200-XX* HB300-XX*

* XX indicates the length of the applicator needle in cm. Contact distributor for available sizes in your area. The LOCalizer Instrument Drape (HB120) is provided separately for use with the LOCalizer Reader in a sterile environment.

SYMBOLS Symbol

Description Use by Date

YYYY-MM-DD

Expiration date is represented by the following: YYYY represents the year MM represents the month DD represents the day

LOCalizer Surgical Probe The LOCalizer Surgical Probe is a sterile, single patient use hand-held attachment that, when used with the LOCalizer Reader, can locate and read embedded Tags up to a depth of 3 cm within a surgical incision. The Surgical Probe is approximately 175 mm long and 8 mm in diameter (Figure 1).

Manufacture Date Caution Follow instructions for use www.hologic.com/package-inserts Do NOT use if package is damaged

A

Probe Connector

B

Cable

C

Probe Handpiece

Do NOT resterilize Single use only U.S. Federal law restricts this device to sale by or on the order of a physician Sterilized using irradiation

Figure 1. LOCalizer Surgical Probe

Manufacturer Catalog Number Batch Code Type B Equipment

4

MR

The LOCalizer Reader is MR Unsafe. Keep away from magnetic resonance imaging (MRI) equipment.

QTY

Quantity

INDICATIONS FOR USE The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal. 1

CONTRAINDICATIONS

STORAGE

The RFID Localization System is not intended for use under conditions where breast lesion localization is contraindicated.

Store at ambient temperature 15˚ to 30˚C (59˚ to 86˚F)

The RFID Localization System is not intended for use in the heart, eyes, brain or spinal cord. The Tag should not be placed in a tissue site with clinical evidence of infection. The Tag should not be placed in muscle tissue.

DIRECTIONS FOR USE NOTE: These instructions are NOT meant to define or suggest any medical or surgical technique. The individual physician is responsible for the proper procedure and techniques to be used with this product. 1 Prepare the LOCalizer Reader for use (see details in Reader / System Manual).

WARNINGS The Surgical Probe is designed only for use with the LOCalizer Reader and Tags. If any resistance is felt during advancement of the Surgical Probe, carefully correct the orientation but never apply strong forces in order to overcome the obstacle. When using the Surgical Probe intraoperatively, avoid touching or moving the Tag with the Surgical Probe. The Surgical Probe has been designed for SINGLE USE only. Reusing this medical device bears the risk of cross-patient contamination. The residue of biologic material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.

2 Inspect the packaging of the Surgical Probe to ensure that package integrity has not been compromised. The product is sterile unless the seal is broken or the expiration date has passed. 3 Using standard aseptic technique, open the package and remove the Surgical Probe (Figure 1, A). 4 Uncoil the cable. Align the Probe Connector with the LOCalizer Reader receptacle (Figure 1, B) through the sterile Instrument Cover and insert the connector firmly. NOTE: The Probe Icon (Figure 2) will illuminate on the LOCalizer Reader screen to verify proper connection.

DO NOT RESTERILIZE. After sterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or re-sterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.

A

Surgical Probe

B

Probe Connector

C

LOCalizer Reader

Do NOT use if the package is open or damaged. Use the Surgical Probe prior to the expiration date shown on the product label. The LOCalizer Reader is a non-sterile device. Drape with the sterile LOCalizer Instrument Cover (Product HB120) when using in a sterile environment. Do NOT sterilize the LOCalizer Reader as sterility cannot be guaranteed. Cleaning, reprocessing and sterilization of this LOCalizer Reader could cause the LOCalizer Reader to malfunction due to adverse effects on components.

Figure 1. LOCalizer Reader with connected Surgical Probe (Instrument Cover not shown)

PRECAUTIONS This product should only be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of using a system for lesion localization that employs a marker at the site of the lesion and a reader for marker retrieval. Do NOT use the Surgical Probe if it is damaged.

122

Handle the Surgical Probe in a manner that will prevent accidental contamination. After use, the Surgical Probe is a biohazard. Dispose in accordance with your facility's biohazardous waste procedures. Do NOT immerse the Surgical Probe in liquid.

ADVERSE EVENTS The potential risks associated with implantable breast lesion localization tags, such as the RFLS include but are not limited to: bleeding upon placement, infection, and MRI interference. These adverse events do not include all adverse events that could occur with breast surgery in general but are important considerations for breast lesion localizers when used for percutaneous placement in the breast to mark a lesion intended for surgical removal.

2

Figure 2. Active Probe Icon

5 Follow the LOCalizer Reader steps in initiation and allow the Surgical Probe to complete a self-test. If the self-test is successful, the Surgical Probe is ready for use. 6 Use the Surgical Probe intraoperatively as frequently as needed to determine the location of and distance from the implanted Tag. The Probe produces an audio tone that increases in pitch and volume as it gets closer to the Tag while the distance is displayed on the Reader in millimeters. Refer to LOCalizer Reader instructions for additional device operation. 3