Foreword; General Information; Classification - GCE Zen-Olite RS - 00600 Manual Del Usuario

Foreword

1 .
Please refer to this manual for detailed instructions on warnings, cautions, specifications, and ad-
ditional information.
Important: Users should read this entire manual before operating the Zen-O lite™ Portable Oxy-
gen Concentrator. Failure to do so could result in personal injury and/or death. If you have ques-
tions about the information in this user manual or about the safe operation of this system, contact
your distributor.
EN

1.1. General Information

This user manual provides information for users of the Zen-O lite™ Portable Oxygen Concen-
trator. For the sake of brevity, the terms "concentrator, " "POC", "unit, " or "device" are sometimes
used in this document to refer to the Zen-O lite™ Portable Oxygen Concentrator. "Patient"
and "User" are used interchangeably.

1.2. Classification

This device is listed with an internationally recognised testing laboratory and classified with
respect to electric shock, fire, and mechanical hazards in accordance with the following stand-
ards:
• IEC/EN 60601-1:2012, Medical Electrical Equipment – Part 1: General Requirements for Basic
Safety and Essential Performance.
• IEC/EN 60601-1-2:2014, Part 1-2: General Requirements for Safety – Collateral Standard:
Electromagnetic Compatibility – Requirements and Tests.
• IEC/EN 60601-1-6:2010+A1:2013 Medical Electrical Equipment – Part 1-6: General
Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability.
• IEC/60601-1-8:2006 Medical Electrical Equipment – Part 1-8: General Requirements for
Safety – Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems
in Medical Electrical Equipment and Medical Electrical Systems.
• IEC/60601-1-11:2011 Medical Electrical Equipment - Part 1-11: General Requirements for
Safety - Collateral Standard: Requirements for Medical Electrical Equipment and Medical
Electrical Systems Used in the Home Healthcare Environment.
• ISO 80601-2-67:2014, Medical Electrical Equipment - Part 2-67: Particular Requirements for
Basic Safety and Essential Performance of Oxygen Conserving Equipment.
• ISO 80601-2-69:2014, Medical Electrical Equipment - Part 2-69: Particular Requirements for
Basic Safety and Essential Performance of Oxygen Concentrator Equipment.
• CAN/CSA C22.2 No. 60601-1:14, Canadian Standard, Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance.
• RTCA DO-160G:12/8/2010 Environmental Conditions and Test Procedures for Airborne
Equipment.
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