Operator`s Manual

Operator’s Manual
Manufactured for & Distributed by
www.InovaLabs.com
Copyright © 2015 Inova Labs, Inc. All rights reserved.
No part of this document may be reproduced or
transmitted in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise,
without prior written permission from Inova Labs Inc.
Inova Labs Inc.
3500 Comsouth Drive
Suite 100
Austin, TX 78744 USA
Phone: 1.512.617.1700
Toll-Free: 1.800.220.0977
www.InovaLabs.com
0459
Represented in Europe by:
QNET BV
Hommerterweg 286
6436 AM Amstenrade
The Netherlands
TABLE OF CONTENTS
Introduction2
Application/Indications For Use
2
Symbol Descriptions
3
Warnings4
Contraindications4
Adverse Events/Hazards
5
System Overview
6
Compatibility Interoperability
6
Standard Package Contents
7
User Controls
8
Part Names
10
Operating Instructions
12
Light Indicators/Alarms
15
Routine Maintenance
18
Specifications20
Oxygen Concentration Over Altitude and Flow Rate
21
Accessories21
Technical Support
22
Disposal22
Service Life
22
Service Life Record
23
Warranty 25
EMC Information 29
Provider Instructions
32
INTRODUCTION
The Activox DUO2® System is a fully-integrated oxygen concentrator
system for stationary and portable use. It consists of the Activox
DUO2 Stationary Base and the LifeChoice® Activox® Portable
Oxygen Concentrator (POC).
This operator’s manual will provide familiarity with the stationary
base and its accessories when used in conjunction with the POC.
It is important that all of the enclosed information, as well as that
pertaining to the LifeChoice Activox Portable Oxygen Concentrator
Operator’s Manual is read in its entirety.
The Activox DUO2 Stationary Base is an externally powered,
Class II, Type B device. The essential function of the device 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 oxygen concentration and create
an alarm is also considered a part of its essential function.
APPLICATION/INDICATIONS FOR USE
This manual applies to the Activox DUO2 Stationary Base Model
130-001.
INDICATIONS FOR USE: The Activox DUO2 Oxygen Concentrator
is used on a prescriptive basis by adult patients who are diagnosed
as requiring supplemental oxygen. The 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 or institutional/hospital setting.
2
SYMBOL DESCRIPTIONS
Symbol
Description
Symbol
Description
Symbol
Description
Caution
Consult Instructions
for Use
Portable Oxygen
Concentrator
Connection
No Smoking
No Oil or Grease
No Open Flame
Do Not Disassemble
Keep Dry
This Side Up
Fragile, Handle
with Care
Compliant with
WEEE
Class II Equipment
Temperature Limit
Humidity Limitation
Radio Frequency
Gas Flow
Rechargeable
Battery
IPX0
Not Protected Against
Water Ingress
U.S. Federal Law
Restricts This Device
to Sale By or On The
Order of A Physician
Catalogue Number
Manufacturer
Serial Number
Date of Manufacture
Type B Applied Part
Device that has no
conductive contact with
the patient
CE Marking
of Conformity
Representative
Authorized
Representative in the
European Community
3
WARNINGS
1. U.S. Federal law restricts this device to sale by or on the order of a
physician.
2.It is the responsibility of the patient and/or provider to make
back-up arrangements for an alternative oxygen supply.
3. Availability of an alternate source of oxygen is required in case of
power outage or mechanical failure.
4. The device should be located as to avoid pollutants or flames.
5.Portable and mobile RF communications equipment can affect
medical devices. It is not recommended to operate the device near
or adjacent to other equipment other than the LifeChoice Activox
POC. If adjacent use is necessary, the Activox DUO2 Stationary
Concentrator should be observed to verify normal operation in the
configuration in which it will be used.
6. When storing or transporting the device, always keep it upright.
7.Inova Labs Inc. assumes no liability for persons choosing not to
adhere to manufacturer recommendations.
CONTRAINDICATIONS
1. The device is not intended to be life-supporting nor life-sustaining.
2. In certain circumstances, oxygen therapy can be hazardous. Please
seek medical advice before using this device.
3.The system is designed to provide a flow of high purity oxygen
up to 5 LPM continuous on the stationary base and up to 3 LPMeq
pulse on the POC. This system should only be used by patients
prescribed oxygen therapy within this range.
4.As the device will alarm through audio and visual indicators,
patients who are unable to communicate discomfort, hear, see and/
or understand the alarms may require additional monitoring.
4
ADVERSE EVENTS/HAZARDS
Failure to adhere to the statements below may impair performance of
the device and may void all warranties.
1.DO NOT use oil, grease or petroleum-based products on or near
the device.
2. DO NOT use power supplies or air filters other than those that came
with the system.
3.DO NOT allow smoking or open flames within 10 ft. (3 m) of the
device as the device produces enriched oxygen gas which
accelerates combustion.
4.DO NOT obstruct the air flow to the inlet and exhaust vents on
the oxygen concentrator. The device should be located in a well
ventilated area. 5. DO NOT submerge the device in liquid. The device should not be
exposed to water or precipitation as it may damage the electronic
components of the device and will void all warranties.
6.DO NOT operate or expose the device to temperatures and
humidity levels outside of the specified operational environment
conditions outlined in the Specifications section on pg. 20.
Excessive temperatures and humidity levels may damage the
device.
7.DO NOT plug the device into the same electrical outlet as major
appliances. Doing so may cause an electrical overload.
8. Humidifiers should not be used with pulse dose delivery
concentrators as they may affect the device’s performance in
triggering a pulse.
9. Use of certain humidifiers not specified for use with this oxygen
concentrator may impair performance.
10. DO NOT dismantle, open or shred secondary cells or batteries.
11. DO NOT expose cells or batteries to heat or fire and avoid storage in
direct sunlight.
NOTE: Refer to the LifeChoice Activox Portable Oxygen Concentrator
Operator’s Manual for additional Warnings, Contraindications and
Adverse Events/Hazards related to the POC.
5
SYSTEM OVERVIEW
The Activox DUO2 System is a fully-integrated oxygen concentrator
system for stationary and portable use. It consists of the Activox
DUO2 Stationary Base and the LifeChoice Activox POC.
It is important to keep the POC connected to the stationary base when
not in use. The POC offers additional control functions (mute) for the
stationary unit as well as monitors overall system operation (runtime)
and records service-related events (alarms). When connected to a
power source, the stationary base will charge both the internal and,
if purchased, external batteries for the POC.
COMPATIBILITY INTEROPERABILITY
Designed as a fully-integrated system, the stationary base will only
work with a compatible POC. In the event that the POC requires
service, the stationary base will operate independently.
Stationary base settings will not transfer to the POC when it is
disconnected for use. When disconnected from the stationary base,
the POC will power on at the last Pulse Setting used.
6
STANDARD PACKAGE CONTENTS
1
2
3
8
4
7
5
6
1
Activox DUO2 Stationary Base*
5
Replacement Air Filter
2
LifeChoice Activox POC*
6
LifeChoice Activox External Battery
(Sold Separately)
3
AC Power Cord
(On back of unit)
7
External Battery Crate
4
Maintenance Tool
8
Tool Holder
*Model identified on unit and packaging labels.
7
USER CONTROLS
Activox DUO2 Stationary Base Control Panel
Reset
Button
Power
Indicator
External Battery
Charge Indicator
Power
Switch
Alarm
Indicator
Flow Setting
Control Dial
Flow Setting
Meter
Power Switch: Turns the stationary base on or off.
Reset Button: If the internal circuit breaker has been tripped, the
Reset Button will extend, an audible alarm will sound continuously
for approximately 2 seconds, the unit will shut down and the POC will
function as though it were not connected to the stationary base. To
reset the internal circuit breaker, press the Reset Button.
Power Indicator: This LED will indicate if the stationary base is on
or off.
External Battery Charge Indicator: This LED will indicate if an
External Battery connected to the stationary base is charging. The LED
will flash if the External Battery is charging and will remain solid if it
is fully charged.
Alarm Indicator: This LED will indicate an alarm. Alarms may
consist of an audible and/or visual signal. Please reference the Alarm
Indicator diagram on pg. 16 to determine the cause of the alarm.
Flow Setting Control Dial: This dial is used to adjust the oxygen
flow within a range of 0 and 5 liters per minute (LPM).
Flow Setting Meter: This meter will indicate the oxygen flow
settings in LPM.
Audible Signals: An audible signal (beep) will indicate either a
change in operating status, or a condition that may need response
(alarm). Audio response will vary among users depending upon
hearing abilities.
8
CAUTION: Using unauthorized accessories may impair performance
and may void all warranties.
LifeChoice Activox POC Control Panel
When a LifeChoice Activox POC and Activox DUO2 Stationary Base
are connected, the POC’s Control Panel will provide additional control
functions for the stationary base. For instructions on using the POC
separately, please refer to the LifeChoice Activox Portable Oxygen
Concentrator Operator’s Manual that came as a part of the system.
For a quick reference on the POC’s Control Panel, refer to the diagram
below.
Activox Pro & Sport Control Panel
Pulse Setting
Indicators
Alarm
Indicator
Power Indicator
Power Button
Mute Button
Internal Battery
Charging Indicator
External Battery
Charging Indicator
Battery
Check
Button
Battery
Charge
Indicator
Hour Meter
(For use by trained
personnel only)
9
PART NAMES
Retractable Handle
POC Connection
Cable
Lifting Handles
(on both sides)
LifeChoice
Activox POC
Cradle
Cannula Nozzle
Fitting
Locking Front
Wheels
POC Connection Cable: The Connection Cable plugs into the port on
the left side of the POC.
Lifting Handles: The handles are used when manually lifting the
stationary base.
Locking Front Wheels: The wheels swivel to enhance mobility during
relocation and lock to prevent unwanted movement when stationary.
Retractable Handle: The handle raises to enable the stationary base
to be moved easily.
LifeChoice Activox POC Cradle: The cradle holds the POC while it is
connected to the stationary base.
Cannula Nozzle Fitting: The nasal cannula connects to the metal
oxygen output nozzle on the front of the stationary base. Always
connect the cannula to this nozzle as it serves as a safety mechanism in
case of fire.
10
PART NAMES
continued
Air Filter
Access Door
Fan Inlet Vent
External Battery
Charging Port
External Battery
Crate
AC Power Cord
Strap
AC Power Cord
Rear Wheels
Fan Outlet Vent (bottom)
Air Filter Access Door: The door is used to access the Air Filter for
replacement.
Fan Inlet Vent: Cooling air is drawn in through this opening.
(See Routine Maintenance section for cleaning instructions.)
Rear Wheels: The wheels support the entire weight of the stationary
base when it is tilted and rolled.
External Battery Charging Port: The port charges the POC’s External
Battery.
External Battery Crate: The crate stores the External Battery while
it is being charged.
AC Power Cord Strap: The strap secures the AC Power Cord when not
in use.
AC Power Cord: The cord is a NEMA 1-15P cord for a standard US nongrounded AC power plug.
Fan Outlet Vent: Processed air is exhausted through this opening.
11
OPERATING INSTRUCTIONS
The Activox DUO2 Stationary Base is designed to be used with a
compatible LifeChoice Activox POC. It is important to keep the POC
connected to the stationary base when not in use. The POC offers
additional control functions for the stationary unit, as well as monitors
overall system operation and records service-related incidents.
When connected to a power source, the stationary base will charge
both the internal and, if purchased, external batteries for the POC.
For specific instructions on how to operate the LifeChoice Activox
POC separately, please refer to the LifeChoice Activox Portable
Oxygen Concentrator Operator’s Manual.
SETTING UP YOUR SYSTEM:
1.Plug the stationary base into the
nearest wall outlet. 2. Connect the nasal cannula to the
Cannula Nozzle Fitting.
3. Place the POC in the cradle located on
top of the stationary base and secure it
into place using the straps.
12
OPERATING
INSTRUCTIONS
continued
3. Plug the POC Connection Cable into
the port on the left side of the POC. All
three pulse setting LEDs will illuminate
on the Activox POC.
NOTE: Ensure that the POC has at
least a partial internal battery charge
before connecting it to stationary base
that is powered on.
4. If an External Battery was purchased:
A.To attach the External Battery
Crate: (1) Insert the mounting
tabs on the External Battery Crate
into the holes on the backside of the
stationary base and (2) Slide the
External Battery Crate down until it
locks into place.
1
2
B. Place the External Battery in the
External Battery Crate. C.Connect the External Battery to
the External Battery Port located
above the External Battery Crate.
The flat end of the cable should
be facing up. Verify the Battery
Charge LED on the front of the
unit is flashing.* It should take
approximately eight hours to fully
charge the External Battery.
CAUTION: Only use external batteries approved by Inova Labs.
NOTE: The External Battery will begin charging after the Internal Battery
in the POC has reached a 100% charge. The External Battery will also
charge when the POC is not connected to the DUO2.
*
13
OPERATING
INSTRUCTIONS
continued
OPERATING YOUR SYSTEM:
1.Flip the Power Switch to the “On”
position. A one second audible
beep will sound, the Power LED will
illuminate green and the system will
begin running. It takes approximately
two minutes to reach full oxygen
concentration.
2.Use the Flow Setting Control Dial to
set the oxygen flow to the prescribed
LPM setting.
NOTE: If a 5 LPM setting is utilized,
adjust the dial so that the flow
indicator ball does not rise above the
“5” mark as it may cause the device
to alarm.
3.Position the nasal cannula or
breathing accessory onto your face
securely and begin breathing.
CAUTION: (1) Use the stationary base only at the LPM setting and for
the length of time prescribed by your physician. (2) Maintain at least
1 ft. (30 cm) between the wall and the unit. (3) Do not set the indicator
ball above the red line.
14
LIGHT INDICATORS/ALARMS
NORMAL OPERATION INDICATORS
Normal
Operation
Light Indication
Stationary
base is
plugged into a
power source.
Audible
Alarm
Action
Brief
audible
tone from
unit.
None. Stationary
base is functioning
normally.
None
Allow for a warm-up
period of approximately
2 minutes before using.
None
None. Stationary
base is functioning
normally.
None
None. Stationary
concentrator
is functioning normally.
Brief
audible
tone from
POC.
None. POC is properly
connected to the stationary
base.
All LEDs flash briefly.
Stationary
base is in the
“On” position
and running.
Stationary
base is
charging
the External
Battery.
Stationary
base has fully
charged the
External
Battery.
When POC is
first connected
to the
stationary
base.
Power LED illuminates solid
green. Battery Charge LED
may illuminate or flash if
External Battery is connected.
The Battery Charge LED
flashes green faster as the
External Battery approaches a
full charge.
The Battery Charge LED
illuminates solid green.
All LEDs flash once and
Pulse Setting LEDs remain
illuminated. The INT LED will
illuminate until the internal
battery is fully charged.
15
ALARM/LIGHT
INDICATORS
continued
NORMAL OPERATION INDICATORS
Normal
Operation
Stationary
base is on and
connected to
the POC.*
Light Indication
Audible
Alarm
None
Power LED illuminates solid
green. Battery Charge LED
may illuminate or flash if
External Battery is connected.
Action
None. The stationary base
is properly connected to
the POC.
*If the POC being connected to the stationary base has a completely depleted internal battery, the LEDs
on the stationary base will briefly turn off and an approximate two second audible tone will sound before
the normal operation indicators initiate.
ALARM INDICATORS
Problem
No oxygen
flow or low
oxygen
detected by
the system.*
High
pressure
detected by
the system.
16
Light Indication
Power LED is illuminated and
the Alarm LED illuminates
solid red.
The red Alarm LED light
flashes on and off every
.5 seconds
Audible
Alarm
5 second
audible
tone every
minute.
Audible
tone
alternating
on for
2 seconds
and then
off for 2
seconds.
Action
Remove the nasal cannula
hose from the Cannula Nozzle
Fitting:
• If the alarm stops, you
have a “no oxygen flow”
alarm. Check the hose for
kinks or blockage. If found,
remove the kink or blockage
and re-connect the cannula
hose. If the alarm does not
return, continue use. If no
kink or blockage is found,
switch to the POC or another
source of oxygen and contact
your equipment provider.
• If the alarm remains, you
have a “low oxygen purity”
alarm. Turn the system off.
Switch to the POC or another
source of oxygen and contact
your equipment provider.
Turn the system off.
Switch to the POC or another
source of oxygen and contact
your equipment provider.
ALARM/LIGHT
INDICATORS
continued
ALARM INDICATORS
Problem
Low
pressure
detected by
the system.
High
Temperature
detected by
the system.
Light Indication
Audible
Alarm
Action
The red Alarm LED light
flashes on and off every .5
seconds
Audible
tone
alternating
on for
2 seconds
and then
off for 5
seconds.
The red Alarm LED light
flashes on and off every .5
seconds
Audible
tone
alternating
on for
2 seconds
and then
off for 1
second.
Turn the system off.
Switch to the POC or another
source of oxygen. Check the
air vents. If there is blockage,
remove it and restart the
system after 15 minutes. If
there is no blockage, contact
your equipment provider.
Approx.
2 second
audible
tone.
Switch to the POC or another
source of oxygen. Check the
power supply. If there is a
power supply issue, solve
as appropriate. If there is no
power supply issue, contact
your equipment provider.
Approx.
2 second
audible
tone.
Reset the internal circuit
breaker, by pressing the
Reset Button. If there is a
power supply issue, solve
as appropriate. If there is no
power supply issue, contact
your equipment provider.
AC power
interruption
detected by
the unit.
All LEDs off.
Circuit
Breaker
tripped
All LEDs off.
Turn the system off.
Switch to the POC or another
source of oxygen and contact
your equipment provider.
MUTE BUTTON
When the POC is connected to the Stationary Base, the POC mute button can be
pressed to mute the audible tones from the Stationary Base.
NOTE: The unit will not alarm for low oxygen purity during the first five minutes of
Activox DUO2 operation to allow the unit to reach full oxygen production.
*
17
ROUTINE MAINTENANCE
The Activox DUO2 System was designed to minimize the amount of
routine maintenance that is required. The device includes no enduser repairable parts. Aside from the preventative maintenance
outlined below, all other required maintenance must be performed
by qualified personnel.
INSTALLING A NEW AIR FILTER:
It is recommended that the Air Filter be changed yearly. However,
if the Activox DUO2 Stationary Base is used in dusty environments,
filter replacement may be required more frequently. The system
comes equipped with one factory-installed air filter and one
replacement filter. Contact your equipment provider for additional
replacement filters.
1.Flip the Power Switch to the “Off”
position.
2. Unplug the stationary base from the
electrical outlet.
3. Remove the Air Filter Access Door.
4. Remove the used Air Filter.
A.Wedge the pointed end of the
Maintenance Tool under the Air
Filter.
B. Raise the Air Filter up until it
dislodges from its position. C.Pull the Air Filter out of its housing.
18
ROUTINE
MAINTENANCE
continued
5. Replace with a new Air Filter.
A.Put the new Air Filter into its
housing.
B
A
B. Firmly push down on the Air Filter
until it pops securely into place.
6. Replace the Air Filter Access Door.
7. Plug the stationary base into an
electrical outlet.
8. Flip the Power Switch to the “On”
position.
CAUTION: DO NOT operate the stationary base without an approved
Inova Labs Air Filter installed. Operating the system without a filter
may cause damage.
FAN INLET VENT CLEANING:
There is one fan inlet vent located on the back of the stationary base,
just above the serial number label. It is recommended that you
check this vent frequently to ensure there is no buildup of lint, hair
or other materials that could obstruct the flow of air into the vent.
Should the vent become obstructed, remove the material buildup
using a soft brush or a dry cloth. Never use alcohol, solvents or
petroleum distillates for cleaning any part of the stationary unit.
NASAL CANNULA INSPECTION:
At least once a week, visually inspect the nasal cannula. Make sure
there are no kinks or obstructions in the nasal cannula. Replace as
needed. DO NOT use a nasal cannula greater than 57 ft. (17 m).
19
SPECIFICATIONS
These specifications apply to the Activox DUO2 Stationary Base. For
LifeChoice Activox POC specifications, refer to the LifeChoice Activox
Portable Oxygen Concentrator Operator’s Manual.
Device Electrical Classification: Class II, Type B
Stationary Base Weight: 37.5 lbs. (17 kg)
Dimensions: 14.2” w x 24.8” h x 14.6” d (36 cm w x 63 cm h x 37cm d)
Mode of Operation: Continuous
Flow Setting Control*: 0 to 5 LPM
Oxygen Concentration†: 93% ± 3% (0-5 LPM)
Oxygen Concentration Sensor Alarm: 82% or less
Maximum Outlet Pressure: 8 psi (55 kPa)
Average Sound Level: 45 dB(A) at 10 ft. (3 m)
Power Supply: 230 (±10%) VAC, 50 Hz (Model 130-002)
Nasal Cannula: 57 ft. (17.3 m) maximum
Environmental Conditions for Use, Storage and Transport
Operational Temperature Range: 50°F to 95°F (10°C to 35°C)
Operational Humidity Range: Up to 95%, Non-condensing
Storage Temperature Range: 32°F to 140°F (0°C to 60°C)
Storage Humidity Range: Up to 95%, Non-condensing
Oxygen Sensor: 41°F to 113°F (5°C to 45°C), 0 to 13,123 ft. (0 to 4000 m), .
101kPA to 60kPA
*The variation of the flow does not exceed the greater 10% of the set value or .2
LPM when a back pressure of 7 kPa (1 psig) is applied to the device output.
†Degradation may occur for settings less than 1 LPM.
TECHNICAL DESCRIPTION
20
The Activox DUO2 System is a transportable*, prescription-use only
device that provides a high concentration of supplemental oxygen
to the end user. The system’s operation is based on the principle of
pressure swing adsorption (PSA). During PSA, nitrogen is removed
from incoming ambient air by bonding onto a molecular sieve material.
The remaining atmospheric gases, primarily concentrated oxygen, is
supplied to the end user through a nasal cannula. The system produces
a reliable and consistent source of physiologically appropriate levels
of oxygen within a concentration range of 90-96% across a continuous
flow rate range of 0 to 5 LPM. The stationary base unit and POC user
interfaces enable user control and notification of stationary base unit
events via LED and audible alerts. F1, F2 Fuse: 5A, 250V T-LAG, NANO2
SMD, RoHS Compliant
*Per IEC 60601-1
OXYGEN CONCENTRATION OVER ALTITUDE AND FLOW RATE
Oxygen Concentration Over Altitude Range 0-4000 m
100%
99%
Oxygen
98%
97%
96%
95%
1LPM
2LPM
3LPM
4LPM
5LPM
Flow Rate
NOTE: Stated accuracy of multi-function oxygen concentrator indicator
is +/- 2%.
ACCESSORIES (ADDITIONAL/REPLACEMENT/SPARE)
The accessories listed below are for the Activox DUO2 Stationary
Base. Please refer to the LifeChoice Activox Portable Oxygen
Concentrator Operator’s Manual for a list of accessories applicable to
that unit.
Air Filter
Removes dust particles from the air entering the Stationary Base.
Included with purchase of the Activox DUO2 Standard Package.
Product Number: 131-007
External Battery Crate
Stores the External Battery while it is being charged by the stationary
base. Included with purchase of Activox DUO2 Standard Package.
Product Number: 131-004
Maintenance Tool
Used to remove the air filter during routine maintenance. Included
with purchase of Activox DUO2 Standard Package. Product Number:
131-005
Tool Holder
Attach to your DUO unit to store the Maintenance Tool. Included with
purchase of Activox DUO2 Standard Package. Product Number: 133160.
21
TECHNICAL SUPPORT
Please contact the local medical equipment company that provided
or sold you the Activox DUO2 system for any technical or emergency
support.
If any additional information is needed, please contact Inova Labs’
Customer Care Team Monday-Friday, 7:00AM-7:00PM CST at
1.512.617.1744.
DISPOSAL
Inova Labs expects end users to dispose of the Activox DUO2 system in
an environmentally friendly way. Electrical and electronic equipment
is labeled with a crossed-out wheeled bin symbol indicating that the
equipment should be disposed of by the end user separate from
other types of waste. The end users should contact Inova Labs or
their local distributor for disposal, collection and recycling options
and terms and conditions for their country. In 2002, the European
Union introduced the Directive on Waste Electrical and Electronic
Equipment (WEEE). The aim of the Directive is to ensure that WEEE is
collected and treated separately. WEEE items may contain hazardous
substances that should not end up in the human environment and can
have adverse affects on it if they do.
SERVICE LIFE
This section outlines the defined service life of the Activox DUO2
components. The Service Life of these components is dependent on
operating and environmental conditions. Should your device indicate
an alarm that requires you to contact your equipment provider, the
provider may determine that the Activox DUO2 unit must be sent
in for service. The corresponding alarm triggered by an internal
component at the end of its service life is listed below.
22
Component
Alarm Triggered
Sieve Bed
Low Oxygen
Compressor
Low Oxygen or Low Pressure
Solenoid Valve
Low Oxygen or Low Pressure
SERVICE LIFE RECORD
In the event that a component of the Activox DUO2 System is
returned for service or repair, use this section to track the date
and details of service.
Date
Serviced
Unit Serviced
(Stationary or POC)
Components Serviced
Date
(Sieve Bed,
Returned
Compressor, etc.)
23
Date
Serviced
24
Unit Serviced
(Stationary or POC)
Components Serviced
Date
(Sieve Bed,
Returned
Compressor, etc.)
WARRANTY
LIMITED WARRANTY AND DISCLAIMER
(“Limited Warranty”)
NOTE: This Limited Warranty provides specific legal rights. Purchaser may
also have other rights which vary from state to state or country to country and
in some cases, due to applicable laws, certain limitations or exclusions of this
Limited Warranty may not apply.
Inova Labs, Inc. (“Inova Labs”) warrants solely to the first purchaser from Inova
Labs (“Purchaser”) that each new portable or stationary oxygen concentrator
unit (or any combination thereof) excluding the Sieve Bed, Accessories, and
Batteries (such new units excluding the Sieve Bed, Accessories, and Batteries
hereinafter referred to as “Product”) shall be free from defects of design,
materials, and workmanship under normal use, operation and service for
three (3) years from the date of purchase (meaning the date of purchase as
evidenced by the sales receipt from Inova Labs or its authorized distributor,
hereafter referred to as the “Date of Purchase”). The Sieve Bed is warranted
to Purchaser to be free of defects of design, materials, and workmanship
under normal use, operation and service, for one (1) year from the Date of
Purchase. Accessories and Batteries are warranted to Purchaser solely to be
free of defects, for one (1) year from the Date of Purchase for Accessories and
Batteries. Refer to the table below for a detailed description of the relevant
timeframes under this Limited Warranty. Product components (which include
the Outer Shell, Control Panel, Compressors, Computer Controller & Power
Boards, and PSA Lung Assembly), Sieve Beds, Accessories, and Batteries are
collectively referred to as “Items.”
ITEM
LENGTH OF COVERAGE
Outer Shell (POC Housing)
3 Years (POC & Stationary)
Control Panel (POC Keypad)
3 Years (POC & Stationary)
Computer Controller & Power Boards
3 Years (POC & Stationary)
Compressors
3 Years (POC & Stationary)
PSA Lung Assembly
3 Years (POC & Stationary)
Sieve Bed
1 Year (POC); 3 years (Stationary)
Battery – Internal
1 Year (POC)
Battery – External/Supplemental
1 Year (POC)
Accessories
1 Year (POC & Stationary)
25
WARRANTY
continued
The Limited Warranty extends only to the Purchaser and is not transferable
unless otherwise expressly agreed to in writing by Inova Labs.
Inova Labs’ oxygen concentrators produce enriched oxygen gas which
accelerates combustion. DO NOT ALLOW SMOKING OR OPEN FLAMES
within ten (10) feet (three (3) meters) of these devices while in use. A user’s
SMOKING of any kind (including cigarette, cigar, and pipe) while using
Product, and evidence that a user has smoked while using the Product, will
void all warranties with respect to that Product and related Items.
An extended warranty on the Product is available at a maximum of two (2)
additional years and must be purchased at the time of the original Date of
Purchase. An extended warranty on the Product covers components included
in the Standard Package (POC, Sieve Bed, Accessories and Internal Battery).
Extended warranties are offered to Purchaser only and are non-transferrable
unless otherwise expressly agreed to in writing by Inova Labs.
The Limited Warranty excludes from coverage any damage, failure, or
malfunction caused by or related to:
a. Abuse, misuse, negligence or accident;
b. Failure to comply with instructions contained in the Operator’s Manual;
c. Alteration, tampering, or modification by someone other than an
authorized Inova Labs representative;
d. Unauthorized repairs or alterations;
e. Environmental conditions (including but not limited to water, flame,
chemicals, fumes in the atmosphere, extreme heat or cold, food or
liquid, sand, dirt or the like);
f. Lack of regular, preventive maintenance and cleaning;
g. Damage in shipment to Inova Labs;
h. Other acts beyond the reasonable control of Inova Labs; and
i. Any damage caused by improper packaging when returning Items to
Inova Labs.
Warranty Service and Coverage
PURCHASER’S EXCLUSIVE REMEDY AND INOVA LABS’S SOLE OBLIGATION
HEREUNDER SHALL BE LIMITED TO REPAIR OR REPLACEMENT OF THE
DEFECTIVE ITEM OR REFUND OF THE APPLICABLE PURCHASE PRICE, AT
INOVA LABS’ OPTION.
26
Inova Lab’s warranty obligations hereunder are conditioned upon Purchaser’s
compliance with the warranty procedures set forth herein. If an Item fails
to conform to the Limited Warranty set forth herein, Purchaser must give
prompt written notice to Inova Labs (with such notice in no event beyond
the applicable warranty period), at which time Inova Labs or its authorized
distributor will issue a Return Material Authorization (“RMA”) number. All
Items claimed to be defective within the warranty period shall be properly
packaged and shipped on a prepaid basis to Inova Labs (USA sales) or
its authorized service center at Purchaser’s expense. The exterior of the
WARRANTY
continued
shipping container must clearly display the RMA number which properly
identifies returned Items and the Item must be packaged together with proof
of Date of Purchase. Items returned without a proper RMA number shall be
refused and returned to Purchaser at Purchaser’s expense. All returned Items
are subject to warranty confirmation by Inova Labs. Inova Labs shall pay
for standard shipment back to Purchaser for repair or replacement of Items
properly covered under this Limited Warranty.
When repairing or replacing the Item, Inova Labs may use functionally
equivalent Products or parts that are new, equivalent to new or refurbished.
All parts removed in the replacement of any Item shall become the property
of Inova Labs.
To the full extent permitted under applicable law, the warranty coverage
will not be extended or renewed or otherwise affected due to Inova Labs’s
authorized repair or replacement. However, part(s) repaired or replacement
Items will be warranted for the unexpired portion of the original Limited
Warranty.
Disclaimer of Warranties.
NO REPRESENTATIVE OF INOVA LABS HAS AUTHORITY TO MAKE
ANY REPRESENTATIONS OR PROMISES EXCEPT AS EXPRESSLY
STATED HEREIN. NO AGREEMENT VARYING OR EXTENDING THIS
LIMITED WARRANTY SHALL BE BINDING UPON INOVA LABS UNLESS
IN WRITING, SIGNED BY A DULY AUTHORIZED REPRESENTATIVE OF
INOVA LABS. THIS LIMITED WARRANTY IS EXCLUSIVE AND GIVEN
AND ACCEPTED IN LIEU OF ANY AND ALL OTHER WARRANTIES,
AND TO THE FULLEST EXTENT PERMITTED UNDER APPLICABLE
LAW INOVA LABS EXPRESSLY DISCLAIMS ANY AND ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.
Limitation of Liability.
TO THE FULLEST EXTENT PERMITTED UNDER APPLICABLE LAW,
IN NO EVENT SHALL INOVA LABS HAVE ANY LIABILITY FOR ANY
CONSEQUENTIAL, SPECIAL, INCIDENTAL, INDIRECT, EXEMPLARY
OR PUNITIVE DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST
PROFITS, LOSS OF USE AND LOST REVENUE, REGARDLESS OF THE
FORM OF THE CLAIM, WHETHER IN CONTRACT, TORT, NEGLIGENCE,
STRICT LIABILITY OR OTHERWISE, ARISING OUT OF OR RELATING
TO INOVA LABS’ ITEMS, MATERIALS AND/OR SERVICES, AND EVEN
IF INOVA LABS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE
LAW, INOVA LABS’ LIABILITY HEREUNDER OR RELATING HERETO
SHALL NOT EXCEED THE PURCHASE PRICE PAID FOR THE ITEMS,
REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY
ACTION OR CLAIM IS BASED ON CONTRACT, TORT, NEGLIGENCE,
27
WARRANTY
continued
STRICT LIABILITY OR OTHERWISE. PURCHASER AGREES AND
ACKNOWLEDGES THAT THE ITEMS ARE OF A SIZE, DESIGN AND
CAPACITY SELECTED BY ITS MEDICAL PROVIDER.
Basis of Bargain
PURCHASER ACCEPTS THESE DISCLAIMERS OF WARRANTIES AND
LIMITATIONS OF LIABILITY CONTAINED HEREIN AS PART OF A
BARGAIN WITH RESPECT TO THE PRICING OF THE ITEMS AND
UNDERSTANDS THAT THE PRICING WOULD LIKELY BE HIGHER IF
INOVA LABS WERE REQUIRED TO BEAR LIABILITY IN EXCESS OF
THAT STATED HEREIN. ALL OF THE LIMITATIONS AND DISCLAIMERS
SET FORTH HEREIN SHALL APPLY NOTWITHSTANDING THE FAILURE
OF THE ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.
Governing Law and Jurisdiction
The rights and obligations of the parties pursuant to this Limited Warranty
and any dispute arising hereunder shall be governed by and interpreted in
accordance with the internal (but not the conflicts) laws of the State of Texas,
USA. The 1980 U.N. Convention on Contracts for the International Sale of
Goods shall not apply. If any provision of this Limited Warranty is inconsistent
with applicable laws relating to Purchaser, Purchaser agrees to waive any and
all rights and remedies it may have under such laws to the extent it may waive
such rights and remedies. This Limited Warranty is offered as an additional
benefit to Purchaser’s statutory rights and it does not affect such statutory
rights in any way. The parties agree and consent that the state or federal
courts in Texas shall have exclusive jurisdiction with respect to any dispute
arising out of or relating to this Limited Warranty. If any provision of this
Limited Warranty is held to be illegal or unenforceable, that provision will
be limited or eliminated to the minimum extent necessary so that this Limited
Warranty will otherwise remain in full force and effect and enforceable.
EACH PARTY EXPRESSLY WAIVES ALL RIGHTS TO A TRIAL BY JURY.
Technical Support
Inova Labs’ Customer Care Team can be reached Monday-Friday, 7:00AM7:00PM CST at 1.512.617.1744.
28
EMC INFORMATION
Medical electrical equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information
provided in the accompanying tables.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity and
Emissions
The Activox DUO2™ Stationary Base is intended for use in the electromagnetic
environment specified below. The customer or end user of the model
130001 should assure that it is used in such an environment.
Immunity Test
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Electrical Fast
Transient/Burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Power Frequency
(50/60Hz)
Magnetic Field
IEC 61000-4-8
IEC 60601
Test Level
Compliance
Level
+/- 2, 4, 8 kV
+/- 2, 4, 8 kV
Air Direct
Air Direct
+/- 2, 4, 8 kV
+/- 2, 4, 8 kV
Contact Direct
Contact Direct
+/- 2, 4, 8 kV
+/- 2, 4, 8 kV
Contact Indirect Contact Indirect
+/-2 kV for
power
supply lines
+/-2 kV for
power
supply lines
± 0.5 kV, ± 1
kV differential ± 0.5 kV, ± 1 kV
differential mode
mode
± 0.5 kV, ± 1 kV, ± 0.5 kV, ± 1 kV,
± 2 kV common ± 2 kV common
mode
mode
Electromagnetic
Environment - Guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Mains power quality
should be that of a typical
commercial or hospital
environment.
Mains power quality
should be that of a typical
commercial or hospital
environment.
< 5% UT
< 5% UT
(>95% dip in UT) (>95% dip in UT)
for 0.5 cycle
for 0.5 cycle
Mains power quality
should be that of a typical
commercial or hospital
40% UT
40% UT
environment. If the user of the
(60% dip in UT) (60% dip in UT) model REF 130-002 requires
for 5 cycles
for 5 cycles
continued operation during
power mains interruptions,
70% UT
70% UT
it is recommended that
(30% dip in UT) (30% dip in UT)
the
oxygen concentrator
for 25 cycles
for 25 cycles
be powered from an
uninterrupted power supply
< 5% UT
< 5% UT
or battery.
(>95% dip in UT) (>95% dip in UT)
for 5 seconds
for 5 seconds
Power frequency magnetic
fields should be at levels
3 A/m
3 A/m
characteristic of a typical
commercial or hospital
environment.
29
EMC
INFORMATION
continued
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment - Guidance
Portable and mobile RF
communications equipment
should be used no closer to
any part of the model REF
130-002, including cables,
than the recommended
separation distance
calculated from the equation
applicable to the frequency
of the transmitter.
d=[
d=[
3.5
V1
7
E1
]√P 80 MHz to
800 MHz
] √P 800 MHz to
2.5 GHz
Where ‘P’ is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and ‘d’ is the
recommended separation
distance in meters (m).
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150kHz- 80MHz
3 V/m
80MHz- 2.5GHz
3V
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic
site survey,a should be less
than the compliance level in
each frequency range.b
3 V/m
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1: UT is the a.c. mains voltage prior to application of the test level.
NOTE 2: At 80MHz and 800MHz, the higher frequency range applies.
NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast
and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in
which the model
130-001 is to be used exceeds the applicable RF compliance
level above, the model
130-001 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the model
130-001.
30
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
EMC
INFORMATION
continued
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions, CISPR 11
Group 1
The model
130-001 use RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference to nearby electronic equipment.
RF Emissions, CISPR 11
Class B
Harmonic Emissions,
IEC 61000-3-2
N/A
Voltage Fluctuations/Flicker
Emissions, IEC 61000-3-3
N/A
The model
130-001 are suitable for use
in all establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and The Activox DUO2 Stationary Base Model
130-001.
The model
130-001 is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user
of the model
130-001 can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the model
130-001
as recommended below, according to the maximum output power of the
communications equipment.
Separation Distance According to the Frequency of Transmitter (m)
Rated Maximum
Output Power of
Transmitter (W)
150kHz to 80MHz
3.5
d=[ ]
√P
V1
80MHz to 800MHz 800MHz to 2.5GHz
3.5
7
d=[ ]
√P
d=[ ]
√P
E1
E1
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.74
1
1.2
1.2
2.3
10
3.8
3.8
7.4
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance (d) in meters (m) can be estimated using the equation applicable
to the frequency of the transmitter, where p is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
31
PROVIDER INSTRUCTIONS
BATTERY CHARGING
Connection of the Activox POC to the DUO2 Stationary Base (No
External Battery)
When the POC is connected to the stationary base, it will generate a
short audible beep tone. The three LEDs for LPM 1, 2, and 3 will remain
on. The green LED for INT will remain on until the internal battery
is fully charged when it turns off. The “Battery Charge” LED of the
stationary base will not turn on.
Connection of the Activox POC and External Battery to the DUO2
Stationary Base
The external battery will begin charging AFTER the internal battery of
the POC is completely charged. The “Battery Charge” green LED on
the stationary base will flash until the external battery is completely
charged when it stops flashing and remains solid green . The POC EXT
LED will not illuminate.
Connection of the External Battery to the DUO2 Stationary Base
The “Battery Charge” green LED on the stationary base will flash until
the external battery is completely charged when it stops flashing and
remains solid green .
CHECK HOURS
When the Activox POC is connected to the DUO2 Stationary Base,
the Activox POC will provide the hours of operation for the DUO2
Stationary Base. When disconnected, the Activox POC will provide
the hours of operation of the Activox POC.
Make sure the three LEDs for LPM 1, 2, and 3 are on, indicating the
POC is connected to the stationary base. To determine the run time
hours of the stationary base, follow the directions of the POC provider
document titled “Hour Meter Instructions for all Models”.
MUTE BUTTON
When connected to the DUO2 Stationary Base, the Activox POC
“Mute” button can be pressed to mute the audible tone of the
stationary base alarm
When the Stationary DUO2 produces an alarm, depress the POC
“Mute” button and the audible tone will be muted. The RED “Alarm”
LED on the stationary base will remain on. The amber LED next to the
“Mute” button will turn on. To “un-mute” press the POC “Mute” button
again.
32
33
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© 2015 Inova Labs Inc. All rights reserved.
13M-001 Rev G March 2015