Hologic LOCalizer, Руководство пользователя

Страница: 14 / 192

12 User Manual
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 Description Security Level or Limit Criteria Test Result
IEC 60601-1-2:2014
Product Family
Standard Emissions
and Immunity Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements
and tests - Edition 4 The requirements for use in
the Professional healthcare
facility environment were
chosen by the manufacturer.
See called out basic stan-
dards below See
Below Complies
EN55011:2009
+A1:2010, FCC
15.109(a) & ICES-003 Radiated Emissions: At any
one voltage & frequency
(Per table 1)
Class B Group 1.
30MHz - 1 GHz Limit Complies
EN55011:2009
+A1:2010, FCC
15.107(a) & ICES-003 Conducted Emissions: At
any one voltage & frequency
(Per table 1)
NA, NA.
EUT is battery operated only Limit NA
EN61000-3-2:2006
+A1:2009+A2:2009 Power Harmonics: At 230 V,
50Hz or 60 Hz (Per table 1)
NA
EUT is battery operated only Limit NA
EN61000-3-3:2013 Voltage Fluctuation: At 230
V, 50Hz (Per table 1)
NA
EUT is battery operated only Limit NA
EN61000-4-2:2009
Basic test standard
Electrostatic Discharge
Immunity: At any one
voltage & frequency
(Per tables 1 and 7)
±15 kV Air Discharge
±8 kV Contact Discharge,
VCP, HCP per
Annex I Complies
EN61000-4-3:2006 +
A2:2010
Basic test standard
Radiated Electromagnetic
Fields Immunity: At any one
voltage & frequency
(Per tables 1 and 4)
3V/m, 80-2700 MHz at 80%
1kHz AM Modulation per
Annex I Complies
EN61000-4-3:2006 +
A2:2010
Basic test standard
Radiated Electromagnetic
and Proximity Fields
Immunity:
At any one voltage &
frequency (Per tables 4 and 9)
RF wireless communication
fields on Spot Frequencies
from Table 9 at 50%, Square
wave Modulation 9 to 28 V/w per
Annex I Complies
EN61000-4-4:2012
Basic test standard
Electrical Fast Transient/
Burst Immunity:
100kHz at
any one voltage & frequency
(Per table 1)
NA on AC or DC Mains
±1 kV SIP/SOP
EUT is battery operated only per
Annex I Complies
EN61000-4-5:2006
Basic test standard Surge Immunity:
At any one voltage &
frequency (Per table 1)
NA CM Line-Gnd
NA, DM Line-Line
NA SIP/SOP Ports are not
connected directly to
outdoor cables NA NA