GCE HEALTHCARE Zen-O RS-00500 Manuel De L'utilisateur page 6

1. FOREWORD
Please refer to this manual for detailed instructions on warnings, cautions, specifi ca-
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 classifi ed
with respect to electric shock, fi re, 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.
4/370