Introduction; Indications And Intended Use - Inogen Rove 6 User Manual

2. INTRODUCTION

Please refer to this manual for detailed instructions on warnings, cautions, specifications and
additional information.
Important
Users should read this entire manual before operating the Inogen Rove 6 Portable Oxygen
Concentrator. Failure to do so could result in personal injury. If you have questions about the
information in this user manual or about the safe operation of this system, contact
your equipment provider.
This user manual provides information for users of the Inogen Rove 6 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 Inogen Rove 6 Portable Oxygen Concentrator.
"Patient" and "User" are used interchangeably.

3. INDICATIONS AND INTENDED USE

3.1 INTENDED USE
The Inogen Rove 6 Portable Oxygen Concentrator provides a high concentration of supplemental
oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home,
institution, vehicle, and other transport modalities.
This device is to be used as an oxygen supplement and is not intended to be life sustaining or life
supporting.
3.2 INDICATIONS FOR USE AND CLINICAL BENEFIT
The Inogen Rove 6 is used on a prescriptive basis by patients requiring supplemental oxygen to
increase blood oxygen saturation.
3.3 CONTRAINDICATIONS
This device is to be used as an oxygen supplement and is NOT INTENDED to be life sustaining or
life supporting. ONLY use this product if the patient is capable of spontaneous breath and is able to
inhale and exhale without the use of a machine.
DO NOT use in conjunction with flammable anesthetic or flammable materials.
DO NOT use this device in tracheotomized patients.
DO NOT use this device in persons whose breathing during normal resting is unable to trigger the
device.
CAUTION!
Risk of minor injury or discomfort
DO NOT use this device in conjunction with a humidifier, nebulizer, or CPAP, or in parallel or
series with other oxygen concentrators or oxygen therapy devices. Doing so may impair the
performance and could damage the equipment.
3.4 PATIENT POPULATION
Patients requiring supplemental oxygen. Prescription Required.
3.5 SERVICE LIFE
The expected service life of the device is 8 years, except for the sieve beds (columns) which
have an expected life of 1 year and the batteries, which have an expected life of 500 full
charge/discharge cycles.
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