Regulatory Information; Safety Classification; Safety - Power Supply; Adapter - Whale PE-12-025 User Manual

Portable ultrasound diagnostic scanner
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Chapter 2 - Safety
structions contained in this manual. It is advisable to maintain a list of autho-
rized operators.
Should the system fail to operate correctly, or if the unit does not respond to
the commands described in this manual, the operator should contact the
nearest Whale Service Office.
2.4

Regulatory Information

AAMI/ANSI ES60601-1:2005/A2:2010/CAN/CSA-C22.2 No. 60601-1:
2008
EN60601-1:2006/AC: 2010
IEC 60601-1-2:2007
IEC 60601-2-37:2007/ EN 60601-2-37:2008
NEMA UD 2-2004 (R2009)
IEC 62359:2010
AAMI / ANSI / ISO 10993-5:2009/(R) 2014
AAMI / ANSI / ISO 10993-5:2009/(R) 2014
2.5

Safety Classification

Type of protection against electric shock
Class I Equipment
Degree of protection against electric shock
Continuous Operation
2.6

Safety - Power Supply

2.6.1

Adapter

Input Rated: 100-240V~, 50/60 Hz, 1.8 A
Output: 19V DC 7.89A
18
Probes: BF applied parts
ECG: BF applied parts
System in Ordinary Equipment (IPX0)
Probe (IPX7)
Portable Ultrasound Diagnostic Scanner User Manual
Regulatory Information

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