Electromagnetic Emissions And Immunity - Hologic LOCalizer Manual Del Usuario

Electromagnetic Emissions and Immunity

This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses, and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Consult the dealer or an experienced radio/TV technician for help.
The LOCalizer Reader is compliant to applicable emissions and immunity standards listed below.
Standards
IEC 60601-1-2:2014
Product Family
Standard Emissions
and Immunity
EN55011:2009
+A1:2010, FCC
15.109(a) & ICES-003
EN55011:2009
+A1:2010, FCC
15.107(a) & ICES-003
EN61000-3-2:2006
+A1:2009+A2:2009
EN61000-3-3:2013
EN61000-4-2:2009
Basic test standard
EN61000-4-3:2006 +
A2:2010
Basic test standard
EN61000-4-3:2006 +
A2:2010
Basic test standard
EN61000-4-4:2012
Basic test standard
EN61000-4-5:2006
Basic test standard
12 User Manual
Description
Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements
and tests - Edition 4
Radiated Emissions: At any
one voltage & frequency
(Per table 1)
Conducted Emissions: At
any one voltage & frequency
(Per table 1)
Power Harmonics: At 230 V,
50Hz or 60 Hz (Per table 1)
Voltage Fluctuation: At 230
V, 50Hz (Per table 1)
Electrostatic Discharge
Immunity: At any one
voltage & frequency
(Per tables 1 and 7)
Radiated Electromagnetic
Fields Immunity: At any one
voltage & frequency
(Per tables 1 and 4)
Radiated Electromagnetic
and Proximity Fields
Immunity:
At any one voltage &
frequency (Per tables 4 and 9)
Electrical Fast Transient/
Burst Immunity: 100kHz at
any one voltage & frequency
(Per table 1)
Surge Immunity:
At any one voltage &
frequency (Per table 1)
Security Level or Limit
The requirements for use in
the Professional healthcare
facility environment were
chosen by the manufacturer.
See called out basic stan-
dards below
Class B Group 1.
30MHz - 1 GHz
NA, NA.
EUT is battery operated only
NA
EUT is battery operated only
NA
EUT is battery operated only
±15 kV Air Discharge
±8 kV Contact Discharge,
VCP, HCP
3V/m, 80-2700 MHz at 80%
1kHz AM Modulation
RF wireless communication
fields on Spot Frequencies
from Table 9 at 50%, Square
wave Modulation 9 to 28 V/w
NA on AC or DC Mains
±1 kV SIP/SOP
EUT is battery operated only
NA CM Line-Gnd
NA, DM Line-Line
NA SIP/SOP Ports are not
connected directly to
outdoor cables
Criteria Test Result
See Complies
Below
Limit Complies
Limit NA
Limit NA
Limit NA
per Complies
Annex I
per Complies
Annex I
per Complies
Annex I
per Complies
Annex I
NA NA