F&P Airvo 3 Bedienungsanleitung Seite 50

Standards compliance
Designed to conform to the
following standards:
IEC 60601-1:2005+AMD1:2012
IEC 60601-1-2: 2014
Medical — cardio, vascular and pulmonary equipment
as to electrical shock, fi re and mechanical hazards
only in accordance with AAMI ES60601-1 (2005) +
AMD 1 (2012), CSA CAN/CSA-C22.2 NO. 60601-1:14,
IEC 60601-1-6:2010, AMD1:2013, IEC 60601-1-8: 2006
+ Am.1: 2012, ISO 80601-2- 61:2017, COR1:2018, ISO
80601-2-74:2017
ANSI/AAMI ES 60601-1:2005 and
A1:2012 and CAN/CSA-C22.2 NO.60601-1:14
IEC 60601-1-6:2010+AMD1:2013
IEC 60601-1-8:2006+AMD1:2012
ISO 80601-2-61:2017,
ISO 80601-2-74:2017
FCC compliance
Accessory equipment connected to the any port of the Airvo 3 must be certifi ed to IEC 60601-1-1 or IEC 60950-1.
All confi gurations shall comply with the system standard IEC 60601-1-1. Anyone who connects additional equipment to the signal input
part or signal output part confi gures a medical system and is therefore responsible for ensuring that the system complies with the
requirements of the system standard IEC 60601-1-1. If in doubt, consult your technical services department or your local Fisher & Paykel
Healthcare representative.
Certain elements of the software included with product are supplied under the license terms of third parties, including elements of the
software that are subject to certain open source software licenses. Where required by the terms of these licenses, Fisher & Paykel
Healthcare Limited provides notices regarding such software elements on its website. Please visit www.fphcare.com/airvo3/
third-party-licenses to view these notices. Note that the notices that apply may be updated as the software included in the product
is updated. The F&P Airvo 3 is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at
the following internet address: www.fphcare.com/certifi cations.
Device disposal instructions
This device contains electronics and a lithium battery. Please do not discard as regular waste.
Return to Fisher & Paykel Healthcare or dispose according to local guidelines for disposing of electronics.
In the European Union return to Fisher & Paykel Healthcare for disposal.
Disposal of accessories, spare parts and packaging
Dispose of accessories, spare parts and packaging according to local guidelines. Place the breathing tube and water
chamber in a waste bag at the end of use and discard with normal waste. Hospitals should discard according to their
standard method for disposing of contaminated product.
Do not place any part of the device or accessories within 30 cm of any
portable mobile radio frequency communication equipment. The Airvo 3
complies with the electromagnetic compatibility requirements of IEC
60601-1-2. In certain circumstances the Airvo 3 may aff ect or be aff ected by
nearby equipment because of electromagnetic interference. Excessive
electromagnetic interference may aff ect the therapy delivered by the device.
If this should happen, try moving the Airvo 3 or the unit causing interference,
or consult your healthcare provider.
This device 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 device 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 device does cause
harmful interference to radio or television reception, which can be determined
by turning the device off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reposition or relocate the receiving antenna.
• Increase the separation between the device and receiver.
• Connect the device into an outlet on a circuit diff erent from that to
which the receiver is connected.
• Consult your healthcare provider or your Fisher & Paykel Healthcare
representative for help.
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