Hologic LOCalizer, User Manual

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STERILIZE
User Manual 13
Standards Description Security Level or Limit Criteria Test Result
EN61000-4-6:2009
Basic test standard Conducted Immunity:
At any one voltage &
frequency (Per table 7)
3V rms, 0.15 - 80 MHz
6V rms, on ISM bands
on SIP/SOP port only per
Annex I Complies
EN61000-4-8:2010
Basic test standard Power Frequency Magnetic
Field Immunity: At any one
voltage at 50 or 60 Hz
(Per table 1)
30A/m @ 50Hz or 60Hz
3 orthogonal orientations per
Annex I Complies
EN61000-4-11:2004
Basic test standard Voltage Dips and Voltage
Interruptions: At min & max
rated input voltage at any
rated power frequency
(Per table 1)
NA EUT is battery operated
only
NA
NA
NA NA NA
SYMBOLS
The following symbols may be found on the product labeling for the RFID Localization System:
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
Manufacture Date
Manufacturer
Follow instructions for use
www.hologic.com/package-inserts
Do NOT use if package
is damaged
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 Ethylene Oxide
(Tag Applicator)
Sterilized using irradiation
(Probe)
DISPOSAL OF EQUIPMENT
After following the cleaning recommendations above, and there are no biohazard risks involved,
dispose of the LOCalizer Reader at the end of the LOCalizer Reader’s useable life per Waste
of Electrical and Electronic Equipment (WEEE) directive [Directive 2002/96/EC]. Dispose of Tag
Applicator, Surgical Probe, and Instrument Cover per the device Instructions for Use.
Symbol Description
Catalog Number
Batch Code
Serial Number
Quantity
Caution
Device is non-sterile
Type B Equipment
Temperature limitation
Humidity limitation
Do NOT dispose of
the LOCalizer Reader
by placing into trash
receptacles.
Keep dry
Self test in process
Call for Service
QTY