GCE Zen-O'lite RS-00600 Mode D'emploi page 7

• 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.
This equipment is classifi ed as:
• Class II FDA classifi cation
• Class IIa according to the MDD 93/42/EEC
• Type BF in accordance with IEC 60601
• IP22 in accordance with IEC 60509
EN
1.3. TYPOGRAPHICAL CONVENTIONS
This user manual contains warnings, cautions, and notes to help call attention to the most
important 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
exercised by the practitioner and/ or patient for the safe and eff ective use of the device.
IMPORTANT: Statements calling attention to additional signifi cant information about the
device or a procedure.
2. INTENDED USE
Zen-O lite™ portable oxygen concentrator is intended to provide supplemental oxygen
to patients with chronic pulmonary diseases and any patient requiring supplemental oxy-
gen.
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 lite™ 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 correct operational conditions see Chapter 15. Technical Description.
Zen-O lite™ 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 fl ammable anaesthetic or fl ammable materials
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