Foreword; General Information; Classification - GCE Zen-O RS-00500 Manual De 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™ Portable Oxygen
Concentrator. 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
distributor.
EN

1.1. General Information

This user manual provides information for users of the Zen-O™ 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 Zen-O™ 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 –
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.
• 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.
• ISO 7637-2:2011 Road Vehicles - Electrical disturbances from conduction and coupling-
Part 2: Electrical transient conduction along supply lines only.
• Medical Device Directive 93/42/EEC.
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Part 1-6: General