Typographical Conventions; Important; Intended Use - GCE Zen-O RS-00500 Manual De Usuario

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
EN
occur in the text, they are shown using the following typographical conventions:
WARNING: Statements that describe serious adverse reactions and potential safety haz-
ards.
CAUTION: Statements that call attention to information regarding any special care to be ex-
ercised 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.
2 .

Intended Use

Zen-O™ portable oxygen concentrator is intended to provide supplemental oxygen to pa-
tients with chronic pulmonary diseases and any patient requiring supplemental oxygen.
The device is portable, enabling patients who need an oxygen device to be treated at home
according to a clinician's prescription or direction.
Zen-O™ is not intended for use in life supporting or life sustaining situations, and is provided
non-sterile. It is a prescription only device, and designed for indoor and outdoor use. For cor-
rect operational conditions see Chapter 15 - Technical Description.
Zen-O™ Portable Oxygen Concentrator is not intended to be used:
• in life-supporting or life-sustaining situations
• in an operating or surgical environment
• with a non-adult population
• in conjunction with flammable anaesthetic or flammable materials
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