User's Manual

Airofit Breathing Trainer
User Manual
Page 19 of 20
Standards
The Airofit system is designed according to the Medical Device Directive - MDD 2007/47/EC.
The Airofit system complies to medical device Class I.
The Airofit system complies to the EU Directive on personal data security - 2016/680/EU.
The major standards applied are
Standard
Title
Date
IEC 60601-1 (ed. 3.1)
Medical electrical equipment
General requirements for basic safety and essential
performance
2012
IEC 60601-1-2
Medical electrical equipment
Electromagnetic compatibility requirements and tests
2014
ISO 13485
Medical devices
Quality management systems - Requirements for
regulatory purposes
2016
ROHS (2011/65/EU)
Restriction of Hazardous Substances in electrical and
electronic equipment
2011
REACH (EC 1907/2006)
Registration, Evaluation, Authorisation and Restriction
of Chemical substances
2006
Radio equipment compliance
The Airofit system complies with Radio Equipment Directive (RED) - 2014/53/EU.
The device complies with part 15 of the FCC Rules. FCC ID: 2ATQX-AF002
Operation is subject to the following two conditions:
1. This device may not cause harmful interference
2. This device must accept any interference received, including interference that may cause
undesired operation
Note: This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no guarantee that interference
will not occur in a particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
• Consult the dealer or an experienced radio/TV technician for help.