Technical Manual

PN 96-00447-00-04 B 
This manual applies to the following Inogen, Inc. products:

• Inogen One Oxygen Concentrator, model # IO-100

• Inogen One AC Power Supply, model # BA-101
• Inogen One Lithium Ion Battery, model # BA-100
• Inogen One Satellite Conserver, model # SC-100
• Inogen One Mobile Power Charger, model # BA-106
• Inogen One External Battery Charger with Power Supply, model # BA-103

This manual will be updated periodically. The latest version may be found
at: http://www.inogen.net/providerlogin
 Contents

Chapter 1 Information For Providers Of The Inogen One

Caution And Warning Statements

Chapter 2 Inogen One System Specifications

Chapter 3 Setting Up a Patient On The Inogen One

Recommendations For Use
Using The Inogen One
Selecting The Proper Flow Setting

Chapter 4 Servicing the Inogen One

Maintenance By The Patient
Maintenance By The Provider
Expected Service Requirements

Chapter 5 Inogen One Error Code Table

Chapter 6 Limited Warranty

Chapter 7 Contacts for More Information

Inogen One Device Service Record Template

Notes
 Information for
Providers of the
Inogen One
1

Thank you for choosing to provide

your patients with the Inogen One.
We are pleased to offer you and
your patients one solution for your
many oxygen needs.

This Technical Manual will famil-

iarize you with provider-specific
information regarding the Inogen
One Oxygen Concentrator and
accessories. Before reading this
Technical Manual, please read and
review the Inogen One Patient
Manual for directions and indica-
tions for use of the device.

Be sure to thoroughly read all of the information in this manual in its en-
tirety. If you have any additional questions, please see the list of contacts at
the end of this Technical Manual.

Instructions included in this Technical Manual are intended to ensure that

Providers instruct patients on the proper use and function of the Inogen
One and its accessories. Proper care in relaying this information will not
only enhance your patients’ experience with the Inogen One, but will also
protect the patients, prolong the life of the device, and help you avoid un-
necessary service calls and complaints.

Information for Providers of the Inogen One Chapter 1 1-1

 1
Caution and Warning Statements
You will see Warnings and Cautions throughout this Technical Manual and
the Patient Manual. To ensure effective oxygen therapy and proper opera-
tion of the Inogen One Oxygen Concentrator, you should observe them care-
fully.

WARNING A WARNING indicates that the personal SAFETY of the Patient

may be involved. Disregarding a WARNING could result in a sig-
nificant injury. Be sure that patients understand all WARNING
statements.

CAUTION A CAUTION indicates that a precaution or a service procedure

must be followed. Disregarding a caution could lead to a minor
injury or to damage to the equipment. Be sure that patients
understand all CAUTION statements.

NOTE A NOTE indicates specific information to improve ease of use

or maintenance of the equipment.

DESIGN
NOTE A DESIGN NOTE indicates specific information regarding the
design of the Inogen One and/or accessories. This information
is included in this manual to provide you with a greater
working understanding of the device. This information is not
required to operate or maintain the Inogen One.

In many cases, Warnings and Cautions have been included in the Inogen
One Patient Manual.

Information for Providers of the Inogen One Chapter 1 1-2

 Inogen One System
Specifications
2

Inogen One Concentrator

Dimensions: L / W / H : 11.62 in. / 6.00 in. / 10.74 in. (no handle)

11.62 in. / 6.00 in. / 12.39 in. (w/ handle)
Weight: Approximately 9.8 pounds (includes battery)
Noise: Less than 40dBA (as packaged)
Warm-Up Time: Less than 30 minutes
Oxygen Concentration: 90 ± 3% at all settings
Flow Control Settings: 5 settings: 1 to 5 and one setting of “Satellite”
OCD Trigger Sensitivity: 0.12 cm water (12Pa)
Power: Inogen One: 46W (max setting, not charging)
Up to 86W when charging
AC Power Supply: Input: 100 to 240 VAC
50 to 60 Hz
Output: 18 VDC, up to 90 W
Mobile Power Charger: Input: 10.6-16.0VDC
Output: 18VDC, up to 90W
Rechargeable Battery: Voltage: 12.0 to 16.8 VDC
Battery Duration: Approximately 2 to 3 hours;
Duration varies with user flow setting on battery power.
Battery Charging Time: Approximately 3 hours
Environmental Ranges Temperature: 41 to 104˚F (5 to 40˚C)
Intended for Use: Humidity: 0% to 95%, non-condensing
Environmental Ranges Temperature: -4 to 140˚F (-20 to 60˚C)
Intended for Storage: Humidity: 0% to 95%, non-condensing
Store in a dry environment
Transportation Keep Dry, Handle With Care
Tested by Independent Safety: UL 60601-1
Laboratory: CAN/CSA C22.2 No. 601.1-M-90 with
supplement and amendment
IEC 601-1:1988 with amendments
Electromagnetic Compatibility:
EN 60601-1:2002, RTCA DO 160D

Inogen One System Specifications Chapter 2 2-1

 2
Classifications
Mode of Operation: Continuous Duty
Type of Protection Class II
Against Electrical
Shock:
Degree of Type BF
Protection Against Not intended for cardiac application
Electrical Shock:
Degree of IPXO
Protection Against
Ingress of Water:
Degree of Safety Not suitable for such application
for Application in
Presence of
Anesthetic Gases:

Satellite Conserver
Dimensions: 5.5” high x 2.9” wide x 1.3” thick
Weight: 9.0 oz. (0.56 lbs, 254g) (including battery)
Flow Control 5 settings from 1 to 5
Settings:
Power: One “C” alkaline battery
Battery Life: Up to 4 weeks at 8 hours usage per day

External Battery Charger

Power: AC Power Supply Input: 100 to 240 VAC, 50 to 60 Hz
AC Power Supply Output: 18 VDC, 50 W
Battery Charging Approximately 3 hours
Time:

NOTE Technical drawings and internal parts lists are available only to
Inogen One Certified Service Providers. Contact Inogen about
how to become an Inogen One Certified Service Provider.

Inogen One System Specifications Chapter 2 2-2

 Setting Up a Patient 3
On the Inogen One

Indications for Use

The Inogen One Oxygen Concentrator is used on a prescriptive basis by
patients requiring supplemental oxygen. It supplies a high concentration of
oxygen and is used with a nasal cannula to channel oxygen from the con-
centrator to the patient. The Inogen One Oxygen Concentrator may be used
in a home, institution, vehicles and various mobile environments.

WARNING It is the responsibility of the Home Healthcare Provider,

licensed Respiratory Therapist, or Physician supplying the
Inogen One to the patient to ensure that the device is used in
a safe and effective manner in keeping with the physician’s
prescription for supplemental oxygen use. While this Technical
Manual and the Patient Manual are intended to support this
goal, ultimate determination of the patient’s safety resides
with the patient’s care giver.

WARNING Availability of an alternate source of oxygen is required in

case of power outage or mechanical failure. Several certifying
bodies for Home Healthcare Providers require back-up oxygen
be available to the patient. Supplemental oxygen cylinders
may satisfy these requirements.

CAUTION Oxygen demand of some patients, particularly those with high

breathing rates and high flow settings, may exceed the design
specifications of the Inogen One.

NOTE Inogen suggests you consider titrating the flow setting of each
patient upon the initial delivery / setup to assure that the
Inogen One is an appropriate oxygen delivery solution for their
individual needs.

Setting Up a Patient on the Inogen One Chapter 3 3-1

 3
Inogen One Oxygen Delivery
The Inogen One incorporates an electronic oxygen conserving device (OCD),
which delivers a predetermined bolus of oxygen in response to a patient’s
inspiratory trigger/demand. The unit has five oxygen delivery settings, rang-
ing from 1 to 5. The Inogen One promotes a unique OCD technology that
offers breath sensing sensitivity of - 0.12cm H2O.

The Inogen One OCD has been calibrated and validated for use with a single
lumen cannula. Inogen has tested its performance data with the Salter Labs
1600Q cannula, which is an adult cannula. Higher flow cannulas (e.g., those
rated for 8 LPM or greater) are preferred as they offer less flow restriction.
Low flow and small diameter cannulas may offer greater resistance to flow.
Such flow resistance may impact the accuracy of the oxygen bolus volume
and flow delivered by the Inogen One.

Comments Regarding Use in Pediatric Oxygen Applications

The Inogen One is cleared for use by all patients meeting the above noted
“indications for use.” The term “pediatric use” is broad and may define a di-
verse population of patients ranging from very small and low weight infants
to larger adolescents. Respiratory rates, tidal volumes and inspiratory flow
demand can vary greatly depending on the age, size and medical condition
of the patient. Use of low flow and/or small diameter pediatric/infant can-
nulas may also impact bolus volume flow delivered by the Inogen One.

All oxygen patients, including pediatric patients, using the Inogen One must
be capable of tolerating and receiving oxygen as delivered by the Inogen
One oxygen conserver. The device setting, type of cannula used and the
patient’s respiratory rate will affect the fraction of inspired oxygen (FiO2);
therefore it is prudent to evaluate and titrate all patients for use and toler-
ance of any oxygen conserving device, including the Inogen One.

We strongly recommend as a good standard of clinical practice that provid-

ers ensure all patients are appropriately evaluated and titrated to determine
individual tolerance and the best clinical effect.

Setting Up a Patient on the Inogen One Chapter 3 3-2

 3
Comments Regarding Transtracheal Catheter Applications
The use of the Inogen One in conjunction with any oxygen delivery other
than a nasal cannula has not been validated. Transtracheal oxygen (TTO)
catheters are single lumen, very small diameter tubes (typically 9-13 cm in
length and 9 french in diameter) that are surgically placed directly into the
airway via stoma. The catheter tip resides inside the patient’s upper airway,
normally resting a few centimeters above the carina.

Inogen currently has no clinical or technical data supporting the use of the
Inogen One with TTO catheters.

Using the Inogen One

Patient Set-Up. To properly set up a patient on the Inogen One System, you
may need to provide:
• Extra cannulas (not included)
• Satellite Tubing – up to 100 ft. (not included)

For quick start instructions on how to configure the Inogen One System for
first use, please reference the Patient Manual.

Under some conditions, particularly upon start-up of the unit and upon
return to flow settings 1 through 5 from operating in satellite mode, the Ino-
gen One may require 30-45 seconds to reset internal electronics. During this
period, the conserver will not function and “Please Wait” will appear on the
display. The Inogen One may require up to 30 minutes for oxygen concentra-
tion to reach full specification. The device will otherwise function normally
during this period.

For further information regarding the use of the Inogen One, please consult
the Patient Manual.

DESIGN
NOTE It is recommended that the Inogen One be used in an upright
position whenever possible. The Inogen One employs an inter-
nal vibration isolation system which is most effective when the
device is upright. This system helps to protect internal compo-
nents from wear while reducing the noise and external vibra-
tion of the device. Operating the device in another orientation
may lead to increased vibration which, if sustained for long
periods of time, may reduce life expectancy of the Inogen One.

Setting Up a Patient on the Inogen One Chapter 3 3-3

 3
Selecting the Proper Flow Setting
Bolus Volume Specification
All oxygen conserving devices (OCD’s) function differently, and therefore it is
prudent to titrate patients for any new conserving device. Delivery timing,
bolus volume, and oxygen concentration all contribute to a patient’s fraction
of inspired oxygen (FiO2), and therefore to the OCD’s efficacy at maintaining
the patient’s blood oxygen saturation.

As an oxygen concentrator, the Inogen One does not contain a finite stored
volume of oxygen, such as with compressed gas or liquid cryogenic systems.
The Inogen One provides oxygen to the patient as long as a power source
is available. However, because the oxygen is being produced as it is used,
supply of oxygen is rate-limited. That is, delivery rate of oxygen has an upper
limit, while total volume to be delivered over time is constrained only by
availability of electric power. The Inogen One delivers up to 750 ml/min of
90% oxygen.

At each flow setting, the Inogen One generates a specific amount of oxygen
(150ml per setting), and the on-board OCD delivers this entire product flow
to the patient. The Inogen One is designed to deliver the total amount of
oxygen per setting, regardless of the patient’s respiratory rate. To accom-
plish this, slower breathing patients will receive larger boluses, and faster
breathing patients will receive smaller boluses, with the net result yielding
the same total volume of oxygen delivered per setting per minute.

NOTE The audible breath detection alarm is turned off by default at

each startup. Note that all other audible and visual notifica-
tions and alarms remain active at all times. Patients may elect
to remove their cannula for a short period of time while leaving
the concentrator running and may not want to hear the breath
detection alarm during these periods. You may elect to instruct
patients how to enable and disable the breath detection alarm.

DESIGN
NOTE Breath detection sensitivity is particularly important to
patients who exert low inspiratory effort and may have dif-
ficulty using conserving devices. This is often exacerbated
when these patients are inactive, when breathing efforts may
be weaker. It may also be exacerbated when patients mouth
breathe or have difficulty with nose-only inhalation. The
Inogen One is equipped with a conserver technology designed
to respond to very low inspiratory signals.

Setting Up a Patient on the Inogen One Chapter 3 3-4

 3
DESIGN
NOTE Breath detection sensitivity is also important to the speed at
which the conserver is able to recognize and respond to an in-
halation. Many presently used breathing models indicate
that only the first half of a patient’s inspiratory volume reaches
the lungs’ alveoli, where oxygen is exchanged. These models
suggest that when an oxygen bolus (or a portion of a bolus) is
delivered too late in the inspiratory effort, the blood oxygen-
ation efficacy may be reduced. Inogen’s breath detection tech-
nology allows for high sensitivity and fast response.

DESIGN
NOTE Because the Inogen One employs a single lumen cannula, the
same tubing that transmits the inspiratory signal to the OCD
delivers the oxygen to the patient. The OCD employs a very
brief “Blind Time” following each bolus delivery. During the
Blind Time, the OCD’s breath sensing is disabled while the
system resets in preparation for the next breath. Patients who
are “huffing” or who breathe in quick succession (faster than
30 breaths per minute or less than 2 seconds between breaths)
may not receive a bolus on every breath. The Inogen One Satel-
lite Conserver has a similar function.

In general, the Inogen One delivers 10ml per bolus per flow setting at 15
breaths per minute (150ml/min per flow setting). The following table sum-
marizes the bolus volumes delivered by the Inogen One OCD:

Inogen One OCD Bolus Volumes (ml)

Production Rate Breathing Rate (BPM)
Flow Setting (ml/min) 10 15 20 25
1 150 15.0 10.0 7.5 6.0
2 300 30.0 20.0 15.0 12.0
3 450 45.0 30.0 22.5 18.0
4 600 60.0 40.0 30.0 24.0
5 750 75.0 50.0 37.5 30.0
Satellite 750

Setting Up a Patient on the Inogen One Chapter 3 3-5

 3
Flow Setting Selection Relative to Physician Prescription
Inogen has labeled each of the five settings (1-5) to provide a guideline for
matching the setting of the device to the continuous flow oxygen prescrip-
tion issued by the physician. Actual correlation is dependent upon the
patient’s breathing rates, inspiratory tidal volume, and other physiologic fac-
tors. Inogen suggests that prior to patient use, you consider titrating each
patient.

NOTE If you do not know or you are uncertain how to perform

titration on a patient, please consult a licensed Respiratory
Therapist or a Physician.

Use with the Inogen Satellite Conserver

When shipped, the Inogen One is not set up for use with the Satellite Con-
server. If the patient receives a Satellite Conserver, please call Inogen Cus-
tomer Care at 1-877-4-Inogen (1-877-446-6436) to configure the Inogen One
for use with the satellite conserver. The Inogen Satellite Conserver receives
pressurized oxygen from the concentrator and is similar in function to the
Inogen One OCD, sensing breaths and delivering boluses. In general, the
Satellite Conserver is best employed when a user is not highly ambulatory
– when the Inogen One concentrator can be left in one place for a period of
time, plugged into an external source of electricity.

The concentrator, when used in this mode, generates its maximum amount
of oxygen, 750ml/min. The Satellite Conserver delivers a fixed volume of
8.75ml of oxygen per breath per flow setting. For higher flow settings, and
higher breathing rates, the Satellite Conserver may deliver more volume
per minute than the concentrator can produce, resulting in slightly lower
oxygen concentrations. In these cases, the device will continue to function
normally; an alert will appear on the concentrator’s display informing the
user that the demand is exceeding production (“Maximum Flow Exceeded”).
In this state, the oxygen concentration of the device may be reduced, but the
concentrator is operating normally and may continue to be used. For many
patients, the device will still meet their supplemental oxygen supply needs,
but Inogen suggests you consider titrating each patient under a variety of
conditions for assurance.

Setting Up a Patient on the Inogen One Chapter 3 3-6

 3
The following table summarizes the bolus delivery of the Inogen Satellite
Conserver:

Satellite OCD Bolus Volumes (ml)

Flow Setting Production Breathing Rate (BPM)
Rate (ml/min) 10 15 20 25
1 750 8.8 8.8 8.8 8.8
2 750 17.5 17.5 17.5 17.5
3 750 26.3 26.3 26.3 26.3
4 750 35.0 35.0 35.0 35.0
5 750 43.8 43.8 43.8 43.8

Shaded boxes indicate combinations of settings and breathing rates at which the Satellite Conserver’s delivery may
exceed the production of the Inogen One. In these conditions, the oxygen concentration may be below specification.

Some patients may be sensitive to the sound of the concentrator when at

home and when background noise is very low. Use of the Satellite Conserver
on a long hose (25 to 100 feet) while the concentrator is placed in another
room may alleviate some of this sensitivity.

NOTE It is recommended that the Inogen One be physically located

in such a manner that the audible alarms can effectively alert
the user and/or a caregiver.

Selecting the Proper Breath Detect Alarm Mode

Pressing and releasing the Mode Button will toggle between enabling and
disabling the breath detect alarms. A bell is shown on the display when the
breath detect alarm is enabled. When the Inogen One is powered up, the
breath detect alarm is disabled.

Setting Up a Patient on the Inogen One Chapter 3 3-7

 Servicing the 4
Inogen One

Patient Maintenance
Instruct your patient on proper maintenance of the Inogen One.

Cannula Replacement
The nasal cannula should be replaced on a regular basis. A single lumen
cannula can be used. Inogen has tested its performance data with the Salter
Laboratories 1600Q cannula. Higher flow cannulas (e.g., those rated for
8LPM or greater) are preferred as they offer less flow restriction.

Providers should advise patients as to the proper cleaning and replacement

of cannulas.

CAUTION Do not use cannula tubing length exceeding 7 feet total with
the Inogen One or the Satellite Conserver. The breath detection
system may not function properly.

Intake Filter Cleaning

Under the front (intake) vent of the Inogen One, ambient air passes through
a particle filter that removes dust fragments. The intake particle filter must
be cleaned at least weekly to ensure ease of air flow. This filter should be
disposed of and replaced periodically. No particle filter is used at the exhaust
vent, which is located above the ratings label.

Patients should understand how to properly clean the particle filter using
a mild detergent (e.g., dishwashing solution, such as Dawn™) and water
solution; they should be sure to rinse the filter in water and allow to air dry
before reuse. Spare filters are provided with the Inogen One to enable use
of the device while the filter is drying. Additional replacement filters may be
obtained from Inogen. There are other types of filters inside the Inogen One
that provide additional filtration. Maintenance of these filters is performed
during internal servicing.

Servicing the Inogen One Chapter 4 4-1

 4
NOTE When setting up a patient on the Inogen One, it is recommend-
ed that you observe the operating environment and instruct
the patient about the negative effects of dirt and dust on
device function. It may be necessary to instruct patients to
clean the intake particle filter more often in dusty environ-
ments or in homes with shedding animals. In some cases, you
may elect to contact or visit the patient more frequently to as-
sure that they are properly caring for their equipment.

DESIGN
NOTE Care has been taken in the design of the Inogen One to protect
the functional components from dust, particulates, and other
contaminants that may enter the device. The Inogen
One contains 15 filters in total. Only the intake particle filter
and the product filter require field maintenance.

Surface Cleaning
Patients should understand how to clean the outside case using a cloth
dampened with a solution of mild detergent (e.g., dishwashing detergent)
and water.

Battery Care and Maintenance

The Inogen One Lithium Ion Battery requires special care to ensure proper
performance and long life. Use only Inogen One Batteries with the Inogen
One Concentrator.

DESIGN
NOTE The Inogen One Lithium Ion Battery employs smart battery
technology to communicate its status and protect the battery
and concentrator from potential hazards. This battery chemis-
try and technology is similar to that used in laptop computer
and cell phone batteries.

DESIGN
NOTE The Inogen One Oxygen Concentrator adjusts its oxygen pro-
duction rate to match the oxygen demand specified by the
user flow setting. When the device is used in lower settings,
its battery run time is extended. Additionally, at lower flow
settings, the concentrator does not generate as much heat and
noise, draw as much electric current from external power sup-
plies, and many system components do not wear as quickly.

Servicing the Inogen One Chapter 4 4-2

 4
Initial Charging
The Inogen One battery requires an initial 3 hours of uninterrupted charg-
ing from an empty state using either the Inogen One or the External Bat-
tery Charger in order to condition the battery. Batteries may arrive partially
charged, requiring less time to achieve full charge.

Patients should avoid running the Inogen One on battery power until this
initial charging has been completed.

Normal Charging
The patient should understand how to ensure that the battery is properly
charging. Inspect that the correct AC power adapter is being used and that
the adapter is properly inserted into the power outlet. Observe the display
or lights that indicate charging status. Patients should be made aware that
the Inogen One battery will take longer to charge when the concentrator is
operating, and will take longer when operating at higher flow settings.

Effect of Temperature on Battery Performance

The Inogen One battery powers the Inogen One Concentrator from 2 to 3
hours under most environmental conditions. To maintain maximum run-
time of the battery, users should avoid running on battery in temperatures
less than 40˚F (4˚C) or higher than 95˚F (35˚C) for extended periods of time.

The number of cycles that the battery will last is highly dependent upon the
temperature at which the battery is charged. Inogen recommends that bat-
teries not be charged inside of a running concentrator at ambient tempera-
tures exceeding 85˚F (30˚C).

DESIGN
NOTE The Inogen One Battery has been cycle life tested at its maxi-
mum charge and discharge rates while held at elevated
temperature. In general, the capacity of the battery gradually
decreases as the number of cycles increases. Exposure of the
battery to elevated temperatures may result in fewer cycles,
decreased capacity, or both.

Patients should be aware that attempting to charge their battery in a run-

ning Inogen One concentrator in elevated temperatures, particularly if they
are using higher flow settings, may result in a charging error and termina-
tion of the battery charge. In this case, they may (a) place the concentrator
into a cooler environment, (b) charge the battery while the Inogen One is
turned off and plugged into an AC power outlet, or (c) remove the battery

Servicing the Inogen One Chapter 4 4-3

 4
and charge on the External Battery Charger (optional accessory). Improper
charging may also result in decreased run time on a single battery charge
and in reduced life expectancy of the battery.

DESIGN
NOTE The Inogen One Battery can discharge at higher temperatures
than it can be charged. When the concentrator is used at high
ambient temperatures, it is possible that the battery will need
to cool for a period of time following a deep discharge. In this
case the concentrator may be run from AC power or another
battery. To accelerate cooling, remove the battery from the
concentrator.

Battery Time Remaining Clock

The Inogen One continuously displays battery time remaining. Explain to the
user that this displayed time is only an estimate, and the actual time remain-
ing may vary from this value. In some conditions, the concentrator may display
battery time remaining as a percentage, and not as hours and minutes. In
most cases, the display will revert to time remaining within several minutes.

To avoid running out of battery power unexpectedly, users should regularly

monitor the displayed battery levels and/or carry a back-up power supply
(extra charged battery, AC Power Supply, or Mobile Power Charger).

Conditioning the Battery

Under some conditions, the battery time remaining indicator may indicate
that the battery’s remaining energy is less than it actually is. This can result
in premature low battery level alarms and perceived reduction in battery run
time. To reduce the risk of this:
• Users should fully charge the battery
• Users should then fully discharge the battery by running the concentra-
tor on battery power until the concentrator displays “Battery Low, Attach
Plug”, or automatically shuts down. Do not attempt to charge the bat-
tery early during this discharge cycle. Doing so will negate the correc-
tion algorithm.
• Users should then completely recharge the battery using either the con-
centrator on AC power or the External Battery Charger.

Battery Run Time Management

The Inogen One opens new approaches to ambulatory oxygen management
by putting the patients in control of their supply. In essence, they are never

Servicing the Inogen One Chapter 4 4-4

 4
further from a supplemental supply of oxygen with their Inogen One than
they are from a source of electric power.

In setting up a patient on the Inogen One, you may choose to inform them
about the freedom and independence they can achieve through battery
run time management. By combining the use of the AC Power Supply, the
Mobile Power Charger, and the Inogen One Battery, patients may stay away
from their homes almost indefinitely, when other types of devices require
returning home to replace or refill their oxygen supply.

As an illustration of Battery Run Time Management, imagine a day in the life

of oxygen patient “Mae”:

Time Battery
Period Activity Power Source Level *
6:00-8:30 am Wake Up / Breakfast AC Power Supply 100%
8:30-8:50 am Drive to store Mobile Power Charger 100%
8:50-9:30 am Shopping Battery Power 65%
9:30-9:50 am Drive to friend’s home Mobile Power Charger 70%
9:50-12:00 pm Visit with friend AC Power Supply 100%
12:00-12:15 pm Drive to lunch date Mobile Power Charger 100%
12:15-1:30 pm Leisurely lunch Battery Power** 40%
1:30-4:00 pm Drive to visit family Mobile Power Charger 80%
4:00-5:00 pm Play with grandson Battery Power 30%
5:00-7:00 pm Dinner with family AC Power Supply 75%
7:00-9:00 pm Visit with family AC Power Supply 100%
9:00 pm - 6:00 am Sleep at family’s house AC Power Supply 100%
6:00-8:30 am Wake Up / Breakfast AC Power Supply 100%
8:30-8:50 am Drive to church Mobile Power Charger 100%
8:50-10:30 am Church service Battery Power 15%
10:30-1:00 pm Drive back home Mobile Power Charger 55%
1:00-5:00 pm Bridge game & lunch with friends AC Power Supply 100%
5:00-5:30 pm Get mail & chat with neighbor Battery Power 75%
outside
5:30-6:30 pm Spontaneous dinner at neighbor’s Battery Power 25%
home
6:30 pm - Read & watch TV before going AC Power Supply 100%
to bed
* Assumes high power usage rate (setting 4); conservative battery level at end of time period
** Many restaurants may make AC power accessible upon request

Servicing the Inogen One Chapter 4 4-5

 4
As can be seen from the illustration above, proper battery management
can, in many cases, allow users to remain away from home for entire days or
longer without stress or concern of running out of oxygen. Patients who use
lower flow settings or who carry a second charged battery may experience
even greater flexibility than seen in the above example.

Storage
Patients should remove the battery from the Inogen One when it is not in
use to avoid inadvertent discharge. Leaving a battery in an unused Inogen
One for prolonged periods will result in battery discharge. Additionally, leav-
ing a warm fully charged battery in an Inogen One may result in reduced
battery capacity.

DESIGN
NOTE When the concentrator is off but the battery is installed, the
battery will continue to provide a small amount of power to
the concentrator’s microprocessor. This power draw will
empty a full battery in approximately 20 days.

If an external power supply is plugged into the power port on

the concentrator but not plugged into an outlet or other power
source, the turned-off concentrator will maintain activity in a
much larger portion of its electronics while battery power is
available. Under these conditions, the battery may go from full
to empty in less than 5 days.

Patients should avoid storing the Inogen One battery in extreme tempera-
tures, below -4˚F (-20˚C) or above 140˚F (60˚C), for any amount of time. They
should avoid leaving batteries in automobiles, where these temperatures
can be regularly exceeded. Storage of the Inogen One battery in a cool, dry
location will help to assure the longevity of the battery.

Battery Disposal
Lithium ion batteries, like all rechargeable batteries, are recyclable and
should never be incinerated. Contact your local Hazardous Waste disposal
center for information on proper disposal and recycling.

Maintenance by the Provider

Expected Maintenance Intervals
It is suggested that the Inogen One Oxygen Concentrator be field-serviced
at least annually by a trained technician. At the time of service, it is recom-
mended that the amount of usage be checked. To do so, press and hold the

Servicing the Inogen One Chapter 4 4-6

 4
Mode Button for 5 seconds. The concentrator’s display will show the non-
resettable hour meter, the unit’s serial number, and the software version
installed on the device. It is suggested that you maintain a service log for
the Inogen One and accessories (see the sample Service Record template
included at the end of this Technical Manual).

CAUTION Do not disassemble the Inogen One or any of the accessories

or attempt any maintenance other than tasks described in this
Technical Manual.

DISASSEMBLY OF THE INOGEN ONE OR ANY OF THE ACCES-

SORIES WITHOUT PROPER TRAINING CERTIFICATION WILL
VOID THE PRODUCT WARRANTIES.

Contact your distributor for information about receiving

proper training and certification for service of the Inogen One
and accessories.

NOTE While Inogen recommends field service of the Inogen One on

an annual basis, it may be advisable to visit the patient more
frequently to monitor the patient’s proper maintenance and
usage of the device.

DESIGN
NOTE For the ease of providers, the device has been designed with
maintenance and service requirements in mind. The concen-
trator requires periodic field maintenance which requires very
little training, and can be done without opening the outer case.
Service, which typically involves opening the device and is more
equipment intensive, is intended to be performed by Inogen
Certified Service Centers. For information about becoming cer-
tified in servicing the device, please contact your distributor.

Suggested Materials for Regular Maintenance

To perform regular field maintenance (by a technician) on the Inogen One
System, you may need:
• Replacement Inogen One Batteries (model # BA-100)
• Replacement intake particle filters (model # RP-100)
• Replacement output filters (model # RP-101)
• Spanner Wrench for Output Filter (model # RP-102)
• Replacement “C” batteries for Satellite Conserver
• Replacement cannulas
• Personal Data Assistant (PDA, Palm OS) for collection of usage data

Servicing the Inogen One Chapter 4 4-7

 4
• Equipment service log
• Extra oxygen supply (for temporary use by the patient while concentra-
tor is being serviced)

NOTE During a normal field maintenance visit, the technician may

elect to turn off the concentrator for approximately 30 mi-
nutes. If the patient requires oxygen during this period, Inogen
recommends making arrangements to bring an extra oxygen
supply (such as a supplemental Inogen One Concentrator).

System Inspection
At the start of each maintenance visit:
1. Ask the patient if they have experienced any difficulties in operating the
equipment.
2. Ask the patient if they have observed any malfunctions or changes in
characteristics of the equipment.
3. Visually inspect the device, batteries, and accessories for cracks or other
damage.
4. Feel the sides of the device for vibration and listen for unusual noises,
rattles, or other signs that the device requires more attention or exten-
sive service.

CAUTION Discovery of cracks or other types of external damage may be

indicative of other internal damage that may not be visible. If
such external damage is discovered, be certain to inquire as to
how it occurred, and whether any changes in the device have
been noticed since its occurrence. If you have any concern over
the safety of the device, repair it (if possible) or arrange for
equipment servicing.

To arrange for more extensive equipment servicing, please contact your cus-
tomer care representative (evo Medical Solutions: 800-759-3038). Do not
attempt to ship equipment without an RMA number.

Output Filter
The output filter is intended to protect the user from inhalation of small
particles in the product gas flow. The Inogen One includes an output filter,
conveniently located behind the removable cannula nozzle fitting. Inogen
suggests that this filter be inspected and replaced on an annual basis during
a provider maintenance visit.

Servicing the Inogen One Chapter 4 4-8

 4
To replace the Product Filter:

1. Use the Spanner Wrench for the Output

Filter (available from your distributor)
to access the product filter. The tool has
two prongs which mate with two in-
dentations located on the surface of the
metal nozzle fitting on the Inogen One.
2. Carefully remove the nozzle fitting by
unscrewing it in a counter-clockwise
direction.
3. The filter, a hard plastic disk with a sili-
cone gasket on its outer edge, will be
visible in the recess once the hose barb
is removed.
4. Remove the filter, and inspect the recess
to make sure it is free of debris. You
may require a pointed object to aid in
removing the filter.
5. Install a replacement filter.
6. Carefully screw the nozzle fitting back
into the recess (clockwise) until it bot-
toms out on the filter gasket. Take care
to squarely screw the nozzle fitting into
the threads. Do not over tighten.

CAUTION Failure to inspect and replace the product filter may result in
the filter becoming clogged or obstructed over time, and in
reduced delivery of oxygen to the patient.

CAUTION Take care not to over tighten the cannula nozzle fitting during
re-installation. Over tightening may cause the concentrator
case to break or crack, or may cause the filter to break. This
may result in hazards to the user.

CAUTION Take care not to cross-thread the cannula nozzle fitting during
re-installation. Cross-threading may result in the development
of leaks, in reduced delivery of oxygen to the patient, or in sys-
tem malfunction.

Servicing the Inogen One Chapter 4 4-9

 4
Administrative Functions and Modes
The Inogen One is equipped with several Administrative Modes and Func-
tions, designed for use by providers and service personnel. These features
facilitate controlled testing of the Inogen One, and monitoring of past sys-
tem performance.

To enter into the administrative modes:

1. Make sure the concentrator is turned off and plugged into an AC Power
Supply connected to a wall outlet.
2. With the unit off, depress and hold the Light and Mode buttons simulta-
neously for 5 seconds.
3. A text message will appear on the display indicating the administrative
mode has been entered.
4. Use the (+) and (-) buttons to cycle through available options until you
see the desired mode displayed.
5. Some modes contain sub-menus. These are indicated by a “>”. To enter
the sub-menu, press Mode. To navigate within the sub-menu, press “-”
or “+”. To navigate back up in the menu structure, press Light.
6. Depress the Mode button to enter the desired administrative function.
7. To cancel this process during selection, or to exit a mode, depress the off
button.

CAUTION Take care not to select a function that is not intended.

Auto Pulse Mode

This mode starts up the Inogen One with all functions normal, except that
boluses are automatically delivered at a regular interval and the breath
detection circuitry is disabled. Several auto pulse options may be available
with different bolus delivery rates. These may be selected by navigating to
this administrative mode and by depressing the Mode button to select the
desired option.

Servicing the Inogen One Chapter 4 4-10

 4
This mode may be used to establish if a concentrator is working properly
(i.e., via a simple bench test) by entering auto pulse mode and allowing the
concentrator to run for at least 40 minutes uninterrupted. Because the de-
vice monitors its own systems actively and reports errors (exception report-
ing), if the device does not show any notifications or alerts after this period,
then the device is operating normally. In summary, if after 40 minutes of un-
interrupted operation in the auto-pulse mode there are no alerts or alarms,
the unit is operating to specification.

Data Logging
Inogen One operating data are periodically recorded to flash memory lo-
cated within the concentrator as an administrative function. Data is stored
for a period of approximately 1-2 months; new data replaces the oldest data
as it is collected.

DESIGN
NOTE This data collection function is designed to provide information
regarding the operation and use of the Inogen One. This data
may be uploaded to the Inogen web site and then used by Inogen
to assist in diagnosing and correcting errors, should they occur.
After uploading data to the Inogen web site, providers may
view records of each upload, including the serial number of
the concentrator, its life clock reading, and the date and time
of the upload.

Data Download
You may collect stored data at your discretion.

To download data from the Inogen One, you will

need a Personal Digital Assistant (PDA) equipped
with an infrared communications port and operat-
ing on Palm OS (operating system 5.0 or higher).
Consult the Inogen web site (http://www.inogen.
net/providerlogin) for more information.

To collect data:
1. Turn the Inogen One off, but leave it plugged
into an external power supply.
2. Turn on the PDA and position it such that its in-
frared port points at the Inogen One’s infrared
port (located in a clear window on the ratings
label on the rear of the device).

Servicing the Inogen One Chapter 4 4-11

 4
3. Simultaneously depress the Light and
Mode buttons for 5 seconds.
4. Using the (+) and (-) buttons, cycle
through the administrative options.
Select the Data Log mode by depressing
the Mode button. Press Mode and
when you see “Transfer”, press Mode
again to initiate transfer.
5. The display will show “Data Transfer
in Process”, and then will show “Data
Transfer Complete”. This process may take up to 10 minutes. The transfer
process may be stopped by pressing the ON/OFF button.
6. If the transfer is interrupted, the display will indicate “Data Transfer
Failure.” In this case, you may elect to re-start the transfer process. If the
problem persists, contact your distributor for assistance.

Data files are saved on the PDA in a .PDB file with a name that is unique to
the concentrator from which the data was retrieved. While files from mul-
tiple concentrators may be held on the PDA without problem, subsequent
downloads of data from a particular concentrator will overwrite older files
on the PDA. It is recommended that you remove files to a computer as soon
as possible following download.

Data Upload
Once a data file has been received by the PDA, this file may be transferred to
a personal computer and uploaded to the password protected Provider area
of the Inogen web site (http://www.inogen.net/providerlogin). From there,
Inogen technical service personnel can view the data and use it to assist
with troubleshooting.

For information about transferring files from the PDA to a PC, and about
uploading the files from the PC to the provider website, please visit the web
address above.

Expected Service Requirements

Inogen One Concentrator

Life expectancy of many parts of the Inogen One Oxygen Concentrator is
affected by patient usage patterns. Devices that are used at higher flow
settings and/or for more hours each day will require more frequent service.
Service of internal components of the Inogen One may only be performed
by certified service centers. Contact Inogen about how to become a certified
service center.

Servicing the Inogen One Chapter 4 4-12

 4
Inogen One Accessories
The Inogen One AC Power Supply, Mobile Power Charger, and External Bat-
tery Charger are not expected to require service. The Satellite Conserver is
not expected to require service beyond periodic battery changes.

NOTE Regular maintenance of the Inogen One and accessories, as

described in this manual, is a key contributor to prolonging
product life. Failure to provide proper maintenance may
adversely affect component and system life expectancy.

DESIGN
NOTE Inogen has submitted the Inogen One to an extensive series of
tests designed to uncover potential design and manufacturing
flaws. These tests included accelerated component life testing,
Highly Accelerated Life Testing (HALT), drop testing, high cycle
life testing, and environmental stress testing.
The Inogen One is safety certified by CSA. To receive this
certification, the products have undergone extensive third-
party electrical safety qualification. Additional product
reliability testing has been performed. Manufacturing
processes have been validated, and are regularly third-party
audited. The Inogen One is manufactured in an ISO 9002 and
IS0 13485 certified system.
Inogen believes that these tests reflect our commitment to
the durability and longevity of the Inogen One. We have at-
tempted to build reasonable safety margins and controls into
our products.

Servicing the Inogen One Chapter 4 4-13

 Inogen One 5
Error Code Table

These codes are supplemental to the text alarm and alerts listed in the
Patient Manual.

Error Code
Number Explanation
1 Low voltage on power supply

2 Software error

4 Accumulator pressure sensor signal out of specification

16 System electric current out of specification

128 Signal or reading out of specification. Applies to signals

from user interface and other internal connections.

Inogen One Error Code Table Chapter 5 5-1

 Limited Warranty
6

Inogen One™ Oxygen Concentrator -

Limited Warranty Statement
Inogen, Inc. 326 Bollay Drive, Goleta, CA 93117

INOGEN Inc. (“INOGEN”) warrants that each new Inogen OneTM Oxygen
Concentrator (“Concentrator”), components for the Concentrator (“Compo-
nents”) and accessories and replacement parts for the Concentrator (“Ac-
cessories and Parts” and, together with the Concentrator and Components,
the “Products”) shall be free from defects in materials and workmanship
under normal use and service and when correctly maintained for the periods
shown from the date of shipment, except as provided below:

Description Period
Concentrator
Inogen One™ Oxygen Concentrator 3 years
Accessories and Parts
Satellite Conserver 2 years
All other accessories and replacement parts 1 year

Purchaser agrees that before this limited warranty shall become effective,
Purchaser shall fully inspect each Product within two (2) days of delivery
and before such Product is put to use. Purchaser also agrees to operate
the Product in accordance with INOGEN’s operating instructions as pro-
vided and that failure to do so shall void this limited warranty. Purchaser
further agrees that any claim for breach of warranty must be made in writ-
ing promptly following the discovery of a purported defect and within the
warranty period. INOGEN will not be responsible for any alleged breach of
warranty, which, as a result of INOGEN’s inspection, INOGEN determines to
have arisen from a cause not covered by this limited warranty.

Limited Warranty Chapter 6 6-1

This limited warranty does not apply to: (A) normal routine service items;
(B) repair or replacement of Products necessitated by misuse, abuse, acci-
dent, or repairs made by persons other than INOGEN or persons expressly
authorized by INOGEN; (C) use of Components or Accessories and Parts with
the Concentrator other than those expressly approved by INOGEN; (D) de-
fects caused by the effects of normal wear and tear; (E) Acts of God, or other
causes not within the control of INOGEN.

If Purchaser believes that a Product does not comply with the limited war-
ranty stated above, Purchaser should contact the distributor, describing the
problem and providing proof of the date of purchase. If directed by the dis-
tributor, Purchaser shall return the Products, freight prepaid, properly pack-
aged in an INOGEN approved shipping container and properly identified by
a Return Material Authorization Number issued by the distributor. Products
returned without a Return Material Authorization Number will be refused
and returned at Purchaser’s expense.

The sole and exclusive remedy for any breach of this limited warranty is
limited to repair or replacement of the defective Product or refund of the
purchase price, at the sole discretion of INOGEN. INOGEN shall pay for ship-
ment back to the Customer for repairs or replacements of Products under
warranty. For Products returned for repair that are not covered under war-
ranty, INOGEN’s standard repair charges shall be applicable in addition to all
shipping expenses.

THIS LIMITED WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WAR-

RANTIES OR REPRESENTATIONS, EXPRESSED, OR IMPLIED, EITHER IN FACT OR
BY OPERATION OF LAW, STATUTORY OR OTHERWISE, INCLUDING BUT NOT
LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE AND NON-INFRINGEMENT. NO REPRESENTATION OR
STATEMENT OF INOGEN MAY CHANGE OR ALTER THIS LIMITED WARRANTY.

INOGEN SHALL HAVE NO FURTHER LIABILITY FOR DAMAGES, LOSSES, COST

OR FEES OF ANY KIND OR NATURE, WHETHER FORESEEABLE OR NOT, IN-
CLUDING BUT NOT LIMITED TO ATTORNEY’S FEES AND CONSEQUENTIAL,
GENERAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES, REGARDLESS OF
THE FORM OF ANY CLAIM, WHETHER IN CONTRACT, TORT OR OTHERWISE,
ARISING OUT OF OR RELATED TO THE USE OF INOGEN PRODUCTS EVEN IF
INOGEN HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, LOSS-
ES, COST OR FEES. INOGEN’S LIABILITY FOR LOSS OR DAMAGES SHALL NOT
EXCEED THE PURCHASE PRICE PAID FOR THE PARTICULAR PRODUCT.

Any claims for breach of this limited warranty shall be governed by Califor-
nia law and must be brought in a state or federal court in California.

Limited Warranty Chapter 6 6-2

 Contacts for 7
More Information

Inogen Websites: http://www.inogenone.com

http://www.inogen.net
http://www.OxygeNation.com

Inogen Customer Care: 326 Bollay Drive

Goleta, CA 93117
805-562-0515
1-877-4-Inogen (Toll-Free Customer Care)
1-877-446-6436 (Toll-Free Customer Care)
E-mail: care@inogen.net

Contacts for More Information Chapter 7 7-1

Device Service Record

7-2
Concentrator S/N: Service Event Date:
Life Clock Hours: Group / Company:
Technician Name:
Service Checklist: Concentrator: Patient Name / ID:
Interview the patient
Inspect for external damage / wear
Service Location:
Operational inspection
Patient’s residence
Replace intake / exhaust filters
Service center / office
Replace product filter
Other:
Inspect Satellite Conserver & tubing
Download operational data file Service Type:
Provide replacement filters Set up equipment
Provide replacement cannulas Scheduled visit
Other: Patient call / complaint
Other:
Accessories:
Check battery on Satellite Conserver
Inspect power supplies & cords
Inspect mobile power adapter
Inspect carry bag and cart
Notes:
Notes