HEALTH BEACONS HB200-EU Serie Consignes D'utilisation page 2

ENGLISH
DESCRIPTION
RFID Localization System
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.
RFID Localization System (RFLS) components are listed below:
System Component
LOCalizer Reader
LOCalizer Surgical Probe
Tag Applicator
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).
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.
CONTRAINDICATIONS
The RFID Localization System is not intended for use under conditions where breast lesion localization is contraindi-
cated.
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.
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 ob-
stacle.
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.
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.
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.
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.
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 REACTIONS
None known.
HOW SUPPLIED
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.
STORAGE
Store at ambient temperature 15˚ to 30˚C (59˚ to 86˚F)
Description
RFID Reader
Attachment probe for use with
LOCalizer RFID reader
Needle applicator with
preloaded RFID Tag
Part Number
* XX indicates the length of the applicator needle in cm.
Contact distributor for available sizes in your area.
HB100-EU
The LOCalizer Instrument Drape (HB120) is provided
HB110-EU
separately for use with the LOCalizer Reader in a sterile
environment.
HB200-XX-EU*
HB300-XX-EU*
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Figure 1. LOCalizer Surgical Probe
A Probe Connector
B Cable
C Probe Handpiece