Contraindications; Warnings; Notice - iHealth Air Manual De Funcionamento

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).
Hereby, [Andon Health CO.,LTD], declares that this [PO3M] is in compliance with the
essential requirements and other relevant provisions of Directive 1999/5/EC. Directive
1999/5/EC declaration of conformity can be downloaded on the following link :
https://www.ihealthlabs.eu/support/certifications

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

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