Activox LifeChoice XYC105B Manuale dell'operatore - Pagina 3

Sfoglia online o scarica il pdf Manuale dell'operatore per Apparecchiature mediche Activox LifeChoice XYC105B. Activox LifeChoice XYC105B 16. Lifechoice activox portable oxygen concentrator

INTRODUCTION

The Operator's Manual will provide familiarity with the LifeChoice
Activox Portable Oxygen Concentrator (POC) and its accessories. Be
sure to read all of the enclosed information in its entirety before using
the LifeChoice Activox POC. The LifeChoice Activox POC is an
internally powered, Type BF device when powered by the internal
battery and a Class II, Type BF device when connected to the external
AC Adapter/Charger, DC Adapter/Charger or rechargeable external
battery. The essential performance of the LifeChoice Activox POC is
to provide oxygen at a volume that remains within tolerance (the
tolerance was defined based on technical judgment from within the
manufacturer's expertise in this specific medical application). In
addition, the device's ability to detect certain error conditions (such
as low concentration or no breath) and create an alarm is also considered
a part of essential performance.

APPLICATION

This manual applies to the LifeChoice Activox POC
INDICATIONS FOR USE: The LifeChoice Activox Oxygen Concentrator
is used on a prescriptive basis by patients who are diagnosed as
requiring supplemental oxygen. This oxygen concentrator will provide
supplemental, high concentration oxygen to these patients. It is not life-
supporting nor life-sustaining. It may be used continuously in a home,
institution or travel environment. The LifeChoice Activox is also portable.
The LifeChoice Activox POC is FAA-approved for air travel. The
required FAA label location is on the bottom of the LifeChoice Activox
POC. The FAA-approved POC list shows Inova Labs LifeChoice Activox.
Every airline has specific information required for traveling with
oxygen. Before traveling, review your airline's specific requirements.
The Inova Labs website contains additional inf ormation at
www.InovaLabs.com/resources.
2
REF
XYC100B.

SYMBOL DESCRIPTIONS

Symbol
Description
Symbol
Temperature
Manufacturer
Humidity
Limitation
Waste Disposal
Class II Equipment
REF
General Warning,
!
Catalogue Number
Risk of Danger
Keep Dry
No Smoking
External
or Open Flame
Rechargeable
Battery
!

WARNINGS

1. This device is not intended to be life-sustaining or life-supporting.
2. This device should be used only when prescribed by a physician.
3. In certain circumstances, oxygen therapy can be hazardous. Please
seek medical advice before using the LifeChoice Activox POC.
4. U.S. Federal law restricts this device to sale by or on the order of a
physician.
5. The LifeChoice Activox POC is designed to provide a flow of high
purity oxygen. Patients with a fast breathing rate or requiring high
oxygen flow may require more oxygen than the LifeChoice Activox
POC can produce and, therefore, may not be suitable candidates.
6. This device is not suitable for patients who are unable to hear or
see alarms or communicate discomfort. If the patient shows any
signs of discomfort, a physician should be consulted immediately.
7. It is the responsibility of the patient and/or provider to make back-up
arrangements for an alternative oxygen supply when traveling;
Inova Labs Inc. assumes no liability for persons choosing not to
adhere to manufacturer recommendations.
8. Availability of an alternate source of oxygen is required in case of
power outage or mechanical failure. Consult your physician or medical
equipment supplier for the type of back-up system required.
9. The LifeChoice Activox POC is designed to be used in the provided/
approved carry case.
Description
Symbol
Description
Radio
Limitation
Frequency
Type BF
DC Power
Applied Part
Device that has
conductive contact
with patient
CE Marking
Caution,
of Conformity
EU Authorized
Danger,
Representative
Gas
Flow
3