Inogen Rove 6 User Manual

©2022 Inogen, Inc. Id-drittijiet kollha riżervati. Paġna 305 minn 356 96-12100-01-01-A
Maltese
1. KELMTEJN QABEL
Jekk jogħġbok irreferi għal dan il-manwal għal struzzjonijiet
dettaljati dwar twissijiet, sejħiet għall-attenzjoni,
speċikazzjonijiet u informazzjoni addizzjonali.
Importanti:
• L-utenti għandhom jaqraw dan il-manwal kollu qabel ma
joperaw il-Konċentratur Portabbli tal-ossiġnu Inogen Rove
6. In-nuqqas ta’ dan jista’ jirriżulta f’korriment personali u/
jew mewt. Jekk għandek mistoqsijiet dwar l-informazzjoni
f’dan il-manwal tal-utent jew dwar it-tħaddim sikur ta’ din
is-sistema, ikkuntattja lill-fornitur tat-tagħmir tiegħek.
• Jekk, r-rigward tal-użu ta’ dan il-prodott, tkun seħħet
mewt jew deterjorament serju tas-saħħa, dan għandu jiġi
rrappurtat lil Inogen, Inc. u lill-awtorità kompetenti ta’
pajjiżek.
1.1 INFORMAZZJONI ĠENERALI
Dan il-manwal għall-utent jipprovdi informazzjoni għall-utenti
tal-Konċentratur Portabbli tal-ossiġnu Inogen Rove 6. Għall-
qosor, it-termini “konċentratur,” “POC”, “unità,” jew “apparat”
huma xi kultant użati f’dan id-dokument biex jirreferu għall-
Konċentratur Portabbli tal-ossiġnu Inogen Rove 6. “Pazjent” u
“Utent” huma użati b’mod interskjambjabbli.
1.2 ILKONFORMITÀ MALISTANDARDS
Dan l-apparat huwa elenkat ma’ laboratorju tal-ittestjar
rikonoxxut internazzjonalment u kklassikat r-rigward tax-
xokk elettriku, in-nar u perikli mekkaniċi f’konformità mal-
istandards li ġejjin:
• 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 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: Użabilità
• 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 Specication 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 (Adopted

Inogen Rove 6 Specifications

General

Oxygen Concentration	90% (+6% / -3%)
Flow Settings	1-6
Power Options	AC, DC, and battery
Battery Duration	Up to 6.5 hours
Noise Level	38 dBA