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The LOCalizer Reader is compliant to applicable emissions and immunity standards listed below.
Standards
Description
IEC 60601-1-2:2014
Medical electrical equipment - Part
Product Family Standard
1-2: General requirements for
basic safety and essential
Emissions and Immunity
performance - Collateral standard:
Electromagnetic compatibility -
Requirements and tests - Edition 4
Radiated Emissions: At any one
EN55011:2009
+A1:2010, FCC
voltage & frequency (Per table 1)
15.109(a) & ICES-003
Conducted Emissions: At any one
EN55011:2009
voltage & frequency (Per table 1)
+A1:2010, FCC
15.107(a) & ICES-003
Power Harmonics: At 230 V, 50Hz
EN61000-3-2:2006
or 60 Hz (Per table 1)
+A1:2009+A2:2009
Voltage Fluctuation: At 230 V,
EN61000-3-3:2013
50Hz (Per table 1)
Electrostatic Discharge Immunity:
EN61000-4-2:2009
At any one voltage & frequency
Basic test standard
(Per tables 1 and 7)
EN61000-4-3:2006 +
Radiated Electromagnetic Fields
Immunity: At any one voltage &
A2:2010
frequency (Per tables 1 and 4)
Basic test standard
Radiated Electromagnetic and
EN61000-4-3:2006 +
Proximity Fields Immunity:
A2:2010
At any one voltage & frequency
Basic test standard
(Per tables 4 and 9)
Electrical Fast Transient/Burst
EN61000-4-4:2012
Immunity: 100kHz at any one
Basic test standard
voltage & frequency (Per table 1)
Surge Immunity: At any one
EN61000-4-5:2006
voltage & frequency (Per table 1)
Basic test standard
Conducted Immunity: At any one
EN61000-4-6:2009
voltage & frequency (Per table 7)
Basic test standard
Power Frequency Magnetic Field
EN61000-4-8:2010
Immunity: At any one voltage at 50
Basic test standard
or 60 Hz (Per table 1)
Voltage Dips and Voltage
EN61000-4-11:2004
Interruptions: At min & max rated
Basic test standard
input voltage at any rated power
frequency (Per table 1)
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Security Level or Limit
Criteria
Test Result
The requirements for use in the
See
Complies
Professional healthcare facility
Below
environment were chosen by the
manufacturer.
See called out basic standards below
Class B Group 1.
Limit
Complies
30MHz - 1 GHz
NA, NA.
Limit
NA
EUT is battery operated only
NA EUT is battery operated only
Limit
NA
NA EUT is battery operated only
Limit
NA
±15 kV Air Discharge
per Annex I
Complies
±8 kV Contact Discharge, VCP , HCP
3V/m, 80-2700 MHz at
per Annex I
Complies
80% 1kHz AM Modulation
RF wireless communication elds on
per Annex I
Complies
Spot Frequencies from Table 9 at
50%, Square wave Modulation 9
to 28 V/w
NA on AC or DC Mains
per Annex I
Complies
±1 kV SIP/SOP
EUT is battery operated only
NA CM Line-Gnd
NA
NA
NA, DM Line-Line
NA SIP/SOP Ports are not connected
directly to outdoor cables
3V rms, 0.15 - 80 MHz
per Annex I
Complies
6V rms, on ISM bands
on SIP/SOP port only
30A/m @ 50Hz or 60Hz
per Annex I
Complies
3 orthogonal orientations
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
Expiration date is represented by the
YYYY-MM-DD
following:
YYYY represents the year
MM represents the month
DD represents the day
Manufacture Date
Manufacturer
Follow instructions for use
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
Caution
Device is non-sterile
Type B Equipment
Temperature limitation
Humidity limitation
LOC
Do NOT dispose of the
alizer Reader
by placing into trash receptacles.
Keep dry
Self test in process
Call for Service
The LOCalizer Reader is MR Unsafe.
MR
Keep away from magnetic resonance
imaging (MRI) equipment.
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