Foreword; General Information; Classification; Typographical Conventions - GCE Zen-O RS-00500 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™ 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.

1.1. General Information

This user manual provides information for users of the Zen-O™ Portable Oxygen Concentrator.
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 60601-1-2:2007, 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.
• Medical Device Directive 93/42/EEC.
This equipment is classified as:
• Class II
• Class IIa according to the MDD 93/42/EEC
• Type BF
• IP22 with the carry bag

1.3. Typographical Conventions

This user manual contains warnings, cautions, and notes to help call attention to the most im-
portant safety and operational aspects of the device. To help identify these items when they
occur in the text, they are shown using the following typographical conventions:
WARNING: Statements that describe serious adverse reactions and potential safety hazards.
CAUTION: Statements that call attention to information regarding any special care to be exer-
cised by the practitioner and/ or patient for the safe and effective use of the device.
IMPORTANT: Statements calling attention to additional significant information about the device or
a procedure.
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EN
Part 1-6: General