Forward; General Information; Standards Compliance - Inogen Rove 6 Bedienungsanleitung

1. FORWARD

Please refer to this manual for detailed instructions
on warnings, cautions, specifications and additional
information.
Important:
• Users should read this entire manual before oper-
ating the Inogen Rove 6 Portable Oxygen Con-
centrator. Failure to do so could result in personal
injury and/or death. If you have questions about
the information in this user manual or about the
safe operation of this system, contact your equip-
ment provider.
• If, in relation to the use of this product, a death or
serious deterioration of health has occurred, this
should be reported to Inogen, Inc. and the compe-
tent authority of your country.

1.1 GENERAL INFORMATION

This user manual provides information for users of the
Inogen Inogen Rove 6 Portable Oxygen Concentra-
tor. For the sake of brevity, the terms "concentrator,"
"POC", "unit," or "device" are sometimes used in
this document to refer to the Inogen Rove 6 Portable
Oxygen Concentrator. "Patient" and "User" are used
interchangeably.

1.2 STANDARDS COMPLIANCE

This device is listed with an internationally recognized
testing laboratory and classified with respect to elec-
tric shock, fire and mechanical hazards in accordance
with the following standards:
• IEC 60601-1:2005+AMD1:2012, Medical electrical
equipment – Part 1: General requirements for basic
safety and essential performance
• IEC 60601-1-2:2014+AMD1:2020, Medical electrical
equipment – Part 1-2: General safety requirements
– Collateral Standard: Electromagnetic
disturbances - Requirements and tests
• IEC 60601-1-8:2006+AMD1:2012, Medical electrical
equipment – Part 1-8: Medical electrical equipment
– Part 1-8: General requirements for basic safety
and essential performance — Collateral standard:
General requirements, tests and guidance for
alarm systems in medical electrical equipment and
medical electrical systems
• IEC 60601-1-11:2015, Medical electrical equipment –
Part 1-11: General requirements for basic safety
©2022 Inogen, Inc. All rights reserved.
and essential performance – Collateral standard:
Requirements for medical electrical equipment
and medical electrical systems used in the home
healthcare environment
• IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability
• ISO 80601-2-69:2014, Medical electrical equipment
-- Part 2-69: Particular requirements for basic safety
and essential performance of oxygen concentrator
equipment
• ISO 80601-2-67:2014, Medical electrical equipment
-- Part 2-67: Particular requirements for basic safety
and essential performance of oxygen-conserving
equipment
• ISO 80601-2-69:2020, Medical electrical equipment –
Part 2-69: Requirements for the basic safety and
essential performance of oxygen concentrator
equipment
• ISO 80601-2-67:2020, Medical electrical equipment –
Part 2-67: Requirements for the basic safety and
essential performance of oxygen-conserving
equipment
• RTCA DO-160G, Environmental Conditions and Test
Procedures for Airborne Equipment
• ISO 18562-1:2017, Biocompatibility evaluation of
breathing gas pathways in healthcare applications –
Part 1: Evaluation and testing within a risk
management process
• ISO 18562-2:2017, Biocompatibility evaluation of
breathing gas pathways in healthcare applications –
Part 2: Tests for emissions of particulate matter
• ISO 18562-3:2017, Biocompatibility evaluation of
breathing gas pathways in healthcare applications –
Part 3: Tests for emissions of volatile organic
compounds (VOCs)
• IEEE/ANSI C63.27-2017, American National
Standard for Evaluation of Wireless Coexistence
• Bluetooth Core Specification Version 4.2
• RED 2014/53/EU
• CAN/CSA C22.2 NO. 60601-1:14 (R2018)Ð Medical
Electrical Equipment - Part 1: General Requirements
for Basic Safety and Essential Performance
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