User's Manual

CARESONO PadScan HD 5 Plus User’s Manual

System Storage

 System should be unpacked when storage time exceeds six months. Power it on for four hours, and

then re-pack it. Do not place any objects on the package, and do not place it against floors, walls, or

roof.

 Keep it in a well-ventilated area away from sunlight or caustic gases.

Declaration of Electromagnetic Compatibility

PadScan HD 5 Plus in use will not interfere with other wired, wireless equipment and/or other electrical

equipment.

Promulgation of Heat Index and Mechanical Index

Heat index: TI﹤0.1;

Mechanical index: MI﹤0.5.

Standards

This device is designed and manufactured in strict accordance with:

 EN 60601-1-1:2006+A1:2013/IEC 60601-1-1:2005+A1:2012 “Medical electrical equipment - Part 1: Ge

neral requirements for basic safety and essential performance”

 EN 60601-1-2:2015/IEC 60601-1-2:2014 “ Medical electrical equipment-Part 1-2:General

requirements for basic safety and essential performance-Collateral Standard ： Electromagnetic

disturbances-Requirements and tests”

 IEC 60601-2-37:2007+A1:2005 “Medical electrical equipment-Part 2-37:Particular requirements for

the basic safety and essential performance of ultrasonic medical diagnostic and monitoring

equipment”

 Type B, Class II protection to the risk of electric shock

 Degree of protection against ingress of water: IPX7(probe), IPX0 (main unit)

Warning: Users replacing the equipment without prior permission from CARESONO may cause

unintended electromagnetic compatibility problems. Only CARESONO-trained technicians can service

the system

Warning: Shared power supplies may produce distorted images. Eliminate the interference of

electromagnetic coupling by means of test and verify.

Warning: Use of the PadScan HD 5 Plus under strong electromagnetic environments, close to

generators, X-ray devices, broadcasting stations, or buried cables, etc... may introduce interference

signals in the image. It is recommended to correct this by repositioning the PadScan HD 5 Plus, or

increasing the separation between the PadScan HD 5 Plus and the interfering equipment.