Indications For Use; Contraindications; Prescription Statement; Patient Population - Invacare Platinum P5NXG1 User Manual

Invacare® Platinum® 5NXG Oxygen Concentrator
WARNING!
Risk of Injury or Damage
Use of this product outside of the intended
use and specifications has not been tested
and may lead to product damage, loss of
product function, or personal injury.
-DO NOT use this product in any way other
than described in the Specifications and
Intended Use sections of this manual.
DANGER!
Risk of Injury or Death
While Invacare strives to produce the best
oxygen concentrator in the market today, this
oxygen concentrator can fail to produce
oxygen due to power failure or device
malfunction.
-ALWAYS have a backup source of oxygen
readily available.
-In the event the concentrator fails to
produce oxygen, the concentrator will briefly
alarm signaling the patient to switch to their
backup source of oxygen. Refer to
Troubleshooting for more detail.

1.4 Indications For Use

The Invacare® Platinum® 5NXG oxygen concentrator is
indicated for patients with respiratory disorders
requiring supplemental oxygen at flow rates of 1 to 5
liters per minute. For flow rates below 1 liter per
minute use with Invacare Pediatric Flowmeter
accessory. It is not intended to sustain or support life.

1.5 Contraindications

There are no known contraindications.

1.6 Prescription Statement

Per 21 CFR 801.109(b)(1) the device is labeled for
prescription use only.
CAUTION!
Federal (statutory) law restricts this device
sale to or on the order of a medical
practitioner licensed by a governmental
agency where he/she practices.
-ONLY a licensed medical practitioner may
order the purchase or use of this device.

1.7 Patient Population

5
Patients requiring supplemental oxygen at flow rates
of 1 to 5 liters per minute.

1.8 Description

The Invacare Platinum® 5NXG concentrator is used by
patients with respiratory disorders who require
supplemental oxygen. The device is not intended to
sustain or support life.
The oxygen concentration level of the output gas
ranges from 87% to 96%. The oxygen is delivered to
the patient through the use of a nasal cannula.
The Invacare Platinum® 5NXG concentrator uses a
molecular sieve and pressure swing adsorption
separation methodology to produce the oxygen gas
output. Ambient air enters the device, is filtered and
then compressed. This compressed air is then directed
toward one of two nitrogen adsorbing sieve beds.
Concentrated oxygen exits the opposite end of the
active sieve bed and is directed into an oxygen
reservoir where it is delivered to the patient.
The Invacare Platinum® 5NXG oxygen concentrator is
capable of operation by the patient in a home
environment or in an institutional environment. Device
operates at a nominal 120 VAC/60 Hertz supply.
The power supply cord is replaceable by qualified
personnel only.
Service information will be available upon request to
qualified technical personnel only.

1.9 Limited Warranty

Terms and conditions of the warranty are part of the
general terms and conditions particular to the
individual countries in which this product is sold.
Contact information for your local Invacare office is
located on or inside the back cover of this manual.
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