iHealth PO3M Guide De Présentation page 6

IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)/EN 60601-1:2006 /AC:2010（
Medical electrical equipment-Part1: General requirements for basic safety and essential
performance）
IEC60601-1-2:2007/EN 60601-1-2:2007 /AC:2010 (Medical electrical equipment -- Part
1-2: General requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and tests)
IEC 60601-1-11 (First Edition): 2010（Medical electrical equipment-Part 1-11: General
requirements for basic safety and essential performance – Collateral Standard:
Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment）
ISO 80601-2-61:2011 (Medical electrical equipment-Particular requirements for the
basic safety and essential performance of pulse oximeter equipment for medical use).
CONTRAINDICATIONS
The PO3M Wireless Pulse Oximeter cannot be used on infant babies.
WARNINGS
1.This device is for use on adults only.
2.Certain activities may pose a risk of injury, including strangulation, if the lanyard
should become wrapped around your neck. Use the lanyard with caution.
3.Do not use the device in a magnetic resonance (MR) environment.
Notice
1.Do not use the device as the only basis for making medical decisions. It is intended
only to be used as additional information that you can give to your licensed health
care professional.
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