User's Manual

Regulatory Information
KONICA MINOLTA,
INC..……………..…………………………………………………………………………………………………
……………….………..
81
009/(R)2012+A2:2010/(R)2012 MOD)
CAN/CSA-C22.2
No.60601-1:14
Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
ISO 15223-1:2016/ EN ISO
15223-1:2016
Medical devices—Symbols to be used with medical device
labels, labeling and information to be supplied—Part 1:
General requirements
5.2. The compliance for each EMISSIONS and IMMUNITY standard or
test specified b y IEC60601‐1‐2standard
EMI Compliance Table
Emission
Phenomenon Compliance Electromagnetic environment
RF emissions
CISPR 11
Group 1, Class B
Professional healthcare facility
environment
Harmonic distortion
IEC 61000-3-2
Class A
Professional healthcare facility
environment
Voltage fluctuations and flicker
IEC 61000-3-3
Compliance
Professional healthcare facility
environment
EMS Compliance Table
Enclosure Port
Phenomenon
Basic EMC
standard
Immunity test levels
Professional healthcare facility
environment
Electrostatic Discharge IEC 61000-4-2
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
Radiated RF EM field IEC 61000-4-3
3V/m
80MHz-2.7GHz
80% AM at 1kHz
Proximity fields from
RF wireless
communications
equipment
IEC 61000-4-3
Refer to table “Proximity fields from RF
wireless communications equipment”
Rated power frequency
magnetic fields
IEC 61000-4-8
30A/m
50Hz or 60Hz
Proximity fields from RF wireless communications equipment
Test frequency
(MHz)
Band
(MHz)
Immunity test levels
Professional healthcare facility environment
385 380-390 Pulse modulation 18Hz, 27V/m