Adverse Reactions; How Supplied - Hologic LOCalizer Manual Del Usuario

LOCalizer Reader
The LOCalizer Reader is designed to locate the low frequency 134 kHz Health Beacons Tags.
Do NOT use the LOCalizer Reader with RFID markers other than the Health Beacons Tags. Other
markers may give some response but the detection range and accuracy may be affected. Most
markers at other frequencies will not be readable.
Metal Items, such as surgical tools, that block the path between the implanted Tag and LOCalizer
Probe may alter the LOCalizer Reader readings. Ensure these items are not in the path of the Tag
being read.
Ensure the LOCalizer Reader battery is fully charged prior to use. A back-up LOCalizer Reader is
recommended in the case of instrument malfunction or battery depletion.
Do NOT immerse LOCalizerReader in liquid.
The LOCalizer Reader is sensitive to electromagnetic interference during the operation of HF Surgical
Equipment such as Electrosurgery cutting tools and instruments, and should be used
non-concurrently with such equipment.
The LOCalizer Reader is a sensitive radio receiver operating at 134 kHz. Its operation may be affected
by other devices operating near this frequency.
The LOCalizer Reader is intended for use only in a hospital, except near active HF Surgical Equipment
and other RFID equipment or wireless battery chargers.
The LOCalizer transmits RF energy at 134 kHz and is sensitive to a receive bandwidth of 120kHz
to 150khz.
The LOCalizerReader transmits a weak unmodulated magnetic field at 134 kHz (<200 microwatts
ERP) to sense the presence of the Tag. Modulation of the field by the Tag is detected by the LOCalizer
Reader. Other devices that generate electromagnetic fields in this frequency region may interfere with
the ability of the LOCalizer to sense the location of the Tag. Interference may occur for example from
other RFID readers, inductive chargers commonly used for cell phones or other devices, or magnetic
induction proximity detectors. Sensitive devices such as other Low Frequency RFID readers may
likewise be affected by the operation of the LOCalizer Reader in the same vicinity.

ADVERSE REACTIONS

None known.

HOW SUPPLIED

The LOCalizer Reader with its integrated Loop Probe is provided nonsterile and is intended for reuse.
The Tag Applicator and LOCalizer Surgical Probe are provided sterile and are intended for single
use only. The Tag is non-pyrogenic. The RFLS is not made with natural rubber latex.
User Manual 5