Foreword; General Information; Classification - GCE Zen-O RS-00500 Manual Del Usuario

1 . FOREWORD

Please refer to this manual for detailed instructions on warnings, cautions, specifica-
tions, and additional 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 Con-
centrator. 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 fol-
lowing standards:
• 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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