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LOCalizer Reader
Do NOT use if the package or LOCalizer Reader is damaged.
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.
Use of the LOCalizer Reader adjacent to or stacked with other equipment should be avoided
because it could result in improper functioning. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified or provided by Health Beacons
could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
The LOCalizer Reader may suffer erroneous signal detection or degraded distance accuracy of an
RFID Tag due to electromagnetic interference from HF Surgical Equipment, other RFID readers, or
wireless charging devices.
Portable RF communications equipment such as cell phones or tablets should be used no closer than
30 cm (12 inches) to any part of the LOCalizer Reader to avoid degradation of the performance of this
equipment.
With the exception of battery replacement, no modification or repair of this equipment by the user is
allowed. If the LOCalizer Reader stops working or is damaged it should be replaced.
The user is responsible to maintain FCC compliance. Any changes, modifications, or use of non-
Health Beacons probes could void the user's authority to operate the equipment.
PRECAUTIONS
General
Failure to thoroughly review and adhere to the information contained in this User Manual may pose a
potential hazard to the patient and/or user and may void the warranty.
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.
Handle all components in a manner that will prevent accidental contamination.
Tag Applicator and Surgical Probe
Do NOT use the Tag Applicator if needle is bent and/or tip is damaged.
Do NOT use the Surgical Probe if it is damaged.
Do NOT remove Safety Lock from applicator until needle has been advanced to desired location for
Tag deployment.
Do NOT implant Tag greater than 6 cm deep from the breast surface to accommodate the LOCalizer
Reader detection range.
Ensure the Tag is completely deployed in the breast tissue by depressing the plunger until it contacts
the Applicator barrel.
After use, the Tag Applicator, Tag, and Surgical Probe are biohazards. Dispose in accordance with
your facility's biohazardous waste procedures.
Do NOT immerse the Surgical Probe in liquid.
4 User Manual
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