Esaote 350009500, Getting Started, Page: 111 / 114

MyLab
- G E T T I N G S T A R T E D
12 - 7
GETTI
NG STARTED
Optional Footswitch(140001000)

3 programable pedal switches

Cable: 2.8m long, USB connector (type A)

Electrical Characteristics: 5V DC 50mA

Waterproof IPX8
Standards
Standard Title
IEC 60601-1:2005 and its
amendments AMD1:2012
/COR1:2014
EN 60601-1:2006 and its
amendments A1:2013/
C1:2014 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-2:2007
EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General
requirements for safety - Collateral Standard:
Electromagnetic compatibility - Requirements and tests
IEC 60601-1-6
EN 60601-1-6 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance
– Collateral standard: Usability
IEC 60601-2-37
EN 60601-2-37 Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment
IEC 61157
EN 61157 Standard means for the reporting of the acoustic output
of medical diagnostic ultrasonic equipment
IEC 62366
EN 62366 Application of Usability Engineering to Medical
Devices
IEC 62304
EN 62304 Medical device software - Software life cycle processes
ISO 14971 Medical equipment - Application of risk management
to medical devices.
ISO 15223-1 Medical devices - Symbols to be used with medical
device labels, labeling and information to be supplied -
Part 1: General Requirements
ISO 10993-1 Biological evaluation of medical devices - Evaluation
and testing