Inogen One G4 System User Manual

English
USER MANUAL
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English
Contents
Chapter 1
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Intended Use, Contraindications and General Precautions
Chapter 2
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Description of the Inogen One® G4 Oxygen Concentrator
Important Parts of the Inogen One® G4 Oxygen Concentrator
User Interfaces
Input / Output Connections
Power Supply Options
Inogen One® G4 Accessories
Chapter 3
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Operating Instructions
General Instructions
Additional Operating Instructions
Battery Operating Instructions
Battery Care and Maintenance
Chapter 4
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Inogen One® G4 Oxygen Concentrator Audible and
Visible Signals (including Alerts)
Chapter 5
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Troubleshooting
Chapter 6
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Cleaning, Care and Maintenance
Cannula Replacement
Case Cleaning
Filter Cleaning and Replacement
Inogen One® G4 Column Change Procedure
Other Service and Maintenance
Disposal of Equipment and Accessories
Chapter 7
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Symbols Used on Concentrator and Accessories
Chapter 8
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Inogen One® G4 System Specifications
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English
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Intended Use, Contraindications
and General Precautions
Intended Use
The Inogen One® G4 Oxygen Concentrator provides a high concentration of
supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It
may be used in the home, institution, vehicle, train, airplane, boats and other transport
modalities.
Indications for use and clinical benefit
The Inogen One® G4 Oxygen Concentrator is used on a prescriptive basis by patients
requiring supplemental oxygen to increase blood oxygen saturation.
Contraindications
This device is to be used as an oxygen supplement and is NOT INTENDED to be
life sustaining or life supporting. ONLY use this product if the patient is capable of
spontaneous breath and is able to inhale and exhale without the use of a machine.
• DO NOT use in conjunction with flammable anesthetic or flammable materials.
• DO NOT use this device in tracheotomized patients.
• DO NOT use this device in persons whose breathing during normal resting is unable
to trigger the device.
Patient Population
Adults only. Prescription Required.
General Precautions
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WARNING The device produces enriched oxygen gas, which accelerates combustion.
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Do NOT ALLOW SMOKING OR OPEN FLAMES within 10 feet of this device
while in use.
Intended Use, Contraindications and General Precautions Chapter 1
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WARNING Do not submerse the Inogen One® G4 or any of the accessories in liquid.
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Do not expose to water or precipitation. Do not operate in exposed rain.
This could lead to electrical shock and/or damage.
CAUTION
Do not use oil, grease, or petroleum-based products on or near the
Inogen One® G4.
CAUTION
Never leave the Inogen One® G4 in an environment which can reach
high temperatures, such as an unoccupied car in high temperature
environments. This could damage the device.
CAUTION
USA Federal law restricts this device to sale by or on the order of a
physician. May also be applicable in other countries.
CAUTION
Nasal cannula should be rated for 3 liters per minute (e.g. Salter Labs
16SOFT) to ensure proper patient usage and oxygen delivery.
WARNING Availability of an alternate source of oxygen is recommended in case of
power outage or mechanical failure. Consult your equipment provider for
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type of back-up system recommended.
CAUTION
It is the responsibility of the patient to make back-up arrangements for
alternative oxygen supply when traveling; Inogen assumes no liability for
persons choosing not to adhere to manufacturer recommendations.
CAUTION
Under certain circumstances, the use of non-prescribed oxygen therapy
can be hazardous. This device should be used only when prescribed
by a physician.
CAUTION
Additional monitoring or attention may be required for patients using
this device who are unable to hear or see alerts or communicate
discomfort. If the patient shows any signs of discomfort, a physician
should be consulted immediately.
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The Inogen One® G4 is not designed or specified to be used in conjunction
with a humidifier, nebulizer or connected with any other equipment. Use
of this device with a humidifier, nebulizer or connected with any other
equipment may impair performance and/or damage the equipment.
Do not modify the Inogen One® G4 Concentrator. Any modifications
performed on the equipment may impair performance or damage
equipment and will void your warranty.
WARNING “To ensure you are receiving the therapeutic amount of oxygen according
to your medical condition, the device must (1) be used only after one or
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more settings have been individually determined or prescribed for you
at your specific activity levels, (2) be used with the specific combination
of parts and accessories that are in line with the specification of the
concentrator manufacturer and that were used while your settings were
determined.”
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WARNING The Inogen One® G4 is MR Unsafe. Do not expose to MRI equipment or
other devices that generate strong magnetic fields (for example, x-ray,
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CT scan, or other types of radiation).
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WARNING Use of this device has not been studied in pediatric populations.
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Consult your physician before using the product for pediatric patients.
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WARNING Use of this product outside of the intended use and specifications has not
been tested and may lead to product damage, loss of product function, or
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personal injury.
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WARNING Do not use this product in any way other than described in the
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specifications and intended use sections of this manual.
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CAUTION
WARNING Patients who exhibit breathing effort below the specified inspiratory
sensitivity value may not be able to consistently trigger the device to
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receive oxygen therapy.
Intended Use, Contraindications and General Precautions Chapter 1
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WARNING The settings of other models or brands of oxygen therapy equipment
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may not correspond with the settings of this device.
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WARNING Oxygen is flammable. Do not leave the nasal cannula on bed coverings or
chair cushions. Turn the oxygen concentrator off when not in use.
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The expected life for the Inogen One® G4 Oxygen System is 5 years, with the exception
of the sieve beds (metal columns) which have an expected life of 1 year and the
batteries, which have an expected life of 500 full charge/discharge cycles.
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Description of the Inogen One® G4
Oxygen Concentrator
Important Parts of the Inogen One® G4 Oxygen Concentrator
*Display
Flow Control
On/Off
Button
Breath
Detection Light
Audible Alert Button
Alert Light
* Actual display appearance may vary.
* Remove the static cling FCC label from the user interface panel
(applicable for all Bluetooth models).
Description of the Inogen One® G4 Oxygen Concentrator Chapter 2
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User Controls
ON / OFF Button
Press once to turn “ON”; Press and hold for one second to turn “OFF”.
Audible Alert Button
Pressing this button will toggle the Inogen One® G4’s breath detection
audible alert on and off.
Breath Detection Alert Mode. The Inogen One® G4 will alert with
audible and visual signals for “no breath detected” when this mode
is enabled and no breath has been detected for 60 seconds.
At 60 seconds, the device will enter into auto pulse mode and once
another breath is detected, the device will exit auto pulse mode and
deliver normally on inspiration. The display’s mode indication area will
show a bell icon, flashing yellow light and display message when the
alert is enabled.
If power is lost, the breath detection audible alert remains set in the
user preferred mode.
Flow Setting Control Buttons
Use the – or + flow setting control buttons to select the setting
as shown on the display. There are three settings, from 1 to 3.
User Interfaces
Display
This screen displays information regarding flow setting, power status,
battery life and errors. If you would like to change the language on the
Inogen LCD Screen contact your Equipment Provider for instructions.
Actual display appearance may vary.
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User Interfaces (continued)
Indicator Lights
A green light indicates breath detection.
A yellow light indicates either a change in operating status or
a condition that may need response (alert). A flashing light is
higher priority than non-flashing.
Audible Signals
An audible signal (beep) indicates either a change in operating
status or a condition that may need response (alert). More
frequent beeps indicate higher priority conditions.
Backlight
A backlight will illuminate the screen for 15 seconds when the
on/off button is briefly pressed.
Input / Output Connections
Particle Filter
The filter must be in place at the intake end of the concentrator
during operation to keep input air clean.
Cannula Nozzle Fitting
The nasal cannula connects to this nozzle for Inogen One® G4
output of oxygenated air.
DC Power In
Connection for external power from the AC power supply or
DC power cable.
USB Port
For service use only.
Description of the Inogen One® G4 Oxygen Concentrator Chapter 2
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Power Supply Options
Single and Double Rechargeable Lithium Ion Batteries
The battery will power the Inogen One® G4 without
connection to an external power source. When fully
charged, a single battery will provide up to 2.7 hours of
operation; a double battery will provide up to 5 hours of
operation. The battery recharges when properly installed
in the Inogen One® G4 and the concentrator is connected
to AC or DC power. Recharging time is up to 3 hours for a single battery and 5 hours for a
double battery. See information in the “Battery Care and Maintenance” section.
Power Supply
Overview
The Inogen One® G4 AC power supply (BA-401) is used to power the Inogen One® G4
concentrator from an AC power source.
Description
The Inogen One® G4 AC power supply is specifically designed for use with the Inogen
One® G4 Oxygen Concentrator (IO-400). The AC power supply provides the precise
current and voltage required to safely power the Inogen One® G4 and is designed to
operate from specified AC power sources. When used with AC power sources, the power
supply automatically adapts to input voltages from 100V to 240V (50-60HZ) permitting
use with most power sources throughout the world.
The AC power supply will charge the Inogen One® G4 Batteries when used with AC input
power. Due to aircraft power limitations, the AC Power Supply cannot be used to charge
the Inogen One® G4 Battery when used on an aircraft.
The AC power supply is used with the following components:
• Power supply with attached power output cable to connect to the Inogen One® G4
• AC power input cable
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The DC power cable (BA-306) is specifically designed for use with the Inogen One®
G4 Oxygen Concentrator (IO-400). The DC power input cable connects directly to
the automobile cigarette lighter or auxiliary DC power supply. Refer to Chapter 3 for
additional operating instructions for use with DC power source.
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Inogen One AC Power Supply Model# BA-401
AC Input
LED Indicator Light*
Power Output Plug (Plug into Concentrator)
AC Power
Plug*
Inogen One G4 DC Power Cable Model# BA-306
DC cigarette lighter
Power Plug for use
in Automobile/RV/
Boat/Aircraft
Power Output Plug
(Plug into Concentrator)
* Actual product appearance may vary.
!
WARNING Do not use power supplies or power cables other than those specified
in this user manual. The use of non-specified power supplies or power
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cables may create a safety hazard and/or impair equipment performance.
Do not wrap cords around power supply for storage. Do not drive, drag
or place objects over cord. Doing so may lead to damaged cords and a
failure to provide power to the concentrator. To avoid danger of choking
or strangulation hazard, keep cords away from children and pets.
Description of the Inogen One® G4 Oxygen Concentrator Chapter 2
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Inogen One® G4 Accessories
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WARNING
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Do not use power supplies/adapters or accessories other than those specified
in this user manual. The use of non-specified accessories may create a safety
hazard and/or impair equipment performance.
Nasal Cannula
A nasal cannula must be used with the Inogen One® G4 to provide
oxygen from the concentrator. A single lumen cannula up to 25 feet
in length is recommended to ensure proper breath detection and
oxygen delivery.
!
WARNING To avoid danger of choking and strangulation hazard, keep tubing away from
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children and pets.
NOTE
Increasing the cannula length may reduce the perceived noise during oxygen
bolus delivery.
NOTE
When using a cannula 25ft. in length with the Inogen One® G4, an increase in
flow setting may be required, consult your physician.
Inogen One G4 Carry Strap (CA-401)
The carry strap is designed to attach directly to the concentrator.
There is a metal slide for ease of length adjustments, a shoulder
pad for comfort and a sewn on velcro tab to wrap up that extra
cannula tubing.
Carry Bag (CA-400)
The Carry Bag provides a protective cover with a handle and shoulder strap to enable you to
carry the Inogen One® G4. The Inogen One® G4 can be operated using battery power during
transport with the Carry Bag.
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Inogen One® G4 Optional Accessories
External Battery Charger (BA-403)
The Inogen One® G4 external battery charger will charge the Inogen One® G4 single and
double batteries.
1. Plug the External Battery Charger AC power supply
cord into an electrical outlet.
2. Plug the External Battery Charger AC power supply
into the battery charger.
3. Slide your charger onto the Inogen One G4 Battery
by clicking and locking into the charger.
4. When the battery is in the correct position, a solid
red light will indicate that the battery is charging.
5. When the green light illuminates, the battery is
fully charged.
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CAUTION
Avoid touching the recessed electrical contacts of the External Battery
Charger; damage to contacts may affect charger operation.
NOTE
These contacts are not powered unless a battery is in place and charging.
NOTE
To completely remove power from the External Battery Charger,
remove the plug.
WARNING Do not repackage concentrator, accessories, or systems for shipment in
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packaging not provided by Inogen.
Description of the Inogen One® G4 Oxygen Concentrator Chapter 2
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Operating Instructions
General Instructions
1. Place the Inogen One® G4 in a well ventilated location.
Air intake and exhaust must have clear access.
Intake
Locate the Inogen One® G4 in such a way that any
auditory alerts may be heard. Always operate the
Inogen One® G4 in an upright position (see image
Exhaust
for proper orientation).
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This side
UP
Exhaust
WARNING Avoid use of the Inogen One® G4 in presence of pollutants, smoke
or fumes. Do not use the Inogen One® G4 in presence of flammable
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anesthetics, cleaning agents or other chemical vapors.
CAUTION
Do not obstruct air intake or exhaust when operating the device.
Blockage of air circulation or proximity to a heat source may lead to
internal heat buildup and shutdown or damage to the concentrator.
CAUTION
The Inogen One® G4 Concentrator is designed for continuous use. For
optimal sieve bed (columns) life, the product should be used frequently.
2. Ensure particle filter is in place.
CAUTION
Do not operate the Inogen One® G4 without the
particle filter in place. Particles drawn into the
system may damage the equipment.
Operating Instructions Chapter 3
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3. Install the battery.
Insert the Inogen One® G4 battery by sliding
battery into place until the latch returns to the
upper position.
CAUTION
The Inogen One® G4 battery acts as a secondary power supply in the event
of a planned or unexpected loss of the AC or DC external power supply. When
operating the Inogen One® G4 from an AC or DC external power supply, a
properly inserted Inogen One® G4 battery should be maintained in the unit.
This procedure will ensure uninterrupted operation and will operate all alerts
and alerts in the event of a loss of the external power supply.
4. Connect the Power Supply.
Connect the AC input plug to the power supply. Connect the AC power
plug to the power source and connect the power output plug to the
Inogen One® G4. The green LED on the power supply will be illuminated
and a beep will sound from the concentrator.
CAUTION
Ensure the power supply is in a well ventilated location as it relies on air circulation for heat dissipation. The power supply may become hot during operation. Make sure the power supply cools down before handling.
CAUTION
The power supply is not water resistant.
CAUTION
Do not disassemble the power supply. This may lead to component failure
and/or safety risk.
CAUTION
Do not place anything in the power supply port other than the supplied wall
cord. Avoid the use of electrical extension cords with the Inogen One® G4.
If an extension cord must be used, use an extension cord that has an
Underwriters Laboratory (UL) Mark and a minimum wire thickness of
18 gauge. Do not connect any other devices to the same extension cord.
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Under certain conditions (see Technical Specifications) the power
supply may shut down. The green LED will blink or will no longer be
illuminated. If this occurs, disconnect the power supply for at least 10
seconds and reconnect.
NOTE
When the power supply is disconnected from the AC outlet,
also disconnect it from the concentrator to avoid unnecessary
battery discharge.
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NOTE
5. Connect the nasal cannula tubing to the nozzle fitting.
Nozzle fitting is located on the top of the Inogen One® G4.
Use of a single lumen cannula up to 25 feet in length is
recommended to ensure proper breath detection and oxygen
delivery. Additional titration may be needed to ensure proper
oxygen delivery when using a particular cannula.
CAUTION
To ensure oxygen flow, ensure that the nasal cannula is properly connected to
the nozzle fitting and that the tubing is not kinked or pinched in any way.
CAUTION
Replace the nasal cannula on a regular basis. Check with your equipment
provider or physician to determine how often the cannula should be replaced.
6. Turn on your Inogen One® G4 by pressing the ON/OFF Button.
A single short beep will sound after the Inogen logo is displayed.
“Please Wait” will appear while the concentrator starts up. The display
will indicate the selected flow setting and power condition. Following a
brief start-up sequence, a warm up period up to 2 minutes will initiate.
During this time period the oxygen concentration is building to but may
not have reached specification. Additional warm up time may be needed
if your Inogen One® G4 has been stored in extremely cold temperatures.
7. Set the Inogen One® G4 Concentrator to the flow rate prescribed by your
physician or clinician.
Use the + or – setting buttons to adjust the Inogen One® G4 to the desired setting.
The current setting can be viewed on the display.
Operating Instructions Chapter 3
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8. Position the nasal cannula on your face and breathe through your nose.
The Inogen One® G4 will sense the onset of inhalation and deliver
a burst of oxygen at a precise time when you inhale. The Inogen
One® G4 will sense each breath and continue to deliver oxygen in
this manner. As your breathing rate changes, the Inogen One® G4
will sense these changes and deliver oxygen only as you need it. At
times, if you inhale very quickly between breaths the Inogen One®
G4 may ignore one of the breaths, giving the appearance of a
missed breath. This may be normal as the Inogen One® G4 senses
and monitors the changes in your breathing pattern. The Inogen
One® G4 will normally sense the next breath and deliver oxygen
accordingly.
A green light will flash each time a breath is detected. Make certain that the nasal
cannula is properly aligned on your face and you are breathing through your nose.
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WARNING If you begin to feel ill or are experiencing discomfort while using
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this device, consult your physician immediately.
CAUTION
The Inogen One® G4 is designed to provide a flow of high purity oxygen. An
advisory alert, “Oxygen Low”, will inform you if oxygen concentration drops.
If alert persists, contact your equipment provider.
General
To remove power, unplug the input cord from its source (i.e., AC wall outlet, DC car
cigarette lighter adapter) and disconnect it from the Inogen One® G4.
CAUTION
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Ensure the power supply is powered from only one power source
(AC or DC) at any given time.
WARNING It is the responsibility of the patient to use only parts and accessories
mentioned in these instructions for use. Parts and accessories used by the
patient not recommended in these instructions for use are at the sole reC
sponsibility for the patient. Inogen assumes no liability for use of parts and
accessories not mentioned in these instructions for use.
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Additional Operating Instructions
For Use In Home with AC Power
For operation of the power supply using an AC power source, follow these instructions:
1. Connect the AC input to the power supply.
2. Connect the AC power plug to the power source and connect the power output plug
to the Inogen One® G4. The green LED will be illuminated, indicating the
power supply has input power.
Traveling with your Inogen One® G4 System
The Inogen One® G4 System makes travel by boat, car or train more convenient
for oxygen users than ever before. Now you get the same quality performance and
convenience while on the go that you’re used to receiving from your Inogen One® G4 at
home. Here are some useful and important instructions for maximizing performance and
convenience when using your Inogen One® G4 while traveling.
You should begin planning for a trip with a checklist of items to remember. This checklist
should include:
✓ AC power supply and DC power cable
✓ Extra Battery(s) if required
✓ Important phone numbers, such as those of your physician and home healthcare
provider, or providers in the area you will be traveling
✓ Plan for backup oxygen in the event of a prolonged power outage or
mechanical failure
For Use In Automobile/RV/Boat/Aircraft
For operation using a DC power source, follow these instructions:
1. Connect the DC power output plug to the Inogen One® G4.
2. Connect the DC power plug (Cigarette Lighter Adapter) to
the power source.
3. The plug should insert into the socket without excessive
force and securely remain in place.
Operating Instructions Chapter 3
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4. Check the device display screen to confirm that an external power supply is connected.
An icon of a battery with a lightning bolt or an AC power plug will be displayed on the
screen, indicating that external power is connected and functioning properly.
!
WARNING Ensure that the automobile power socket is adequately fused for the Inogen
One® G4 power requirements (minimum 15 Amp). If the power socket cannot
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support a 15 Amp load, the fuse may blow or the socket may be damaged.
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WARNING The tip of the Cigarette Adapter Plug becomes HOT when in use. Do not touch
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the tip immediately after removal from an auto cigarette lighter socket.
CAUTION
Ensure the automobile power socket is clean of cigarette ash and the adapter
plug fits properly, otherwise overheating may occur.
CAUTION
Do not use the power supply with a cigarette plug splitter or with an
extension cable. This may cause overheating of the DC power input cable.
CAUTION
Do not jump start the automobile with the DC power cable connected.
This may lead to voltage spikes which could shut down and/or damage the
DC power input cable.
CAUTION
When powering the Inogen One® G4 in an automobile ensure the vehicle’s
engine is running first, before connecting DC cable into cigarette lighter adapter.
Operating the device without the engine running may drain the vehicle’s battery.
CAUTION
A change in altitude (for example, from sea level to mountains) may affect total
oxygen available to the patient. Consult your physician before traveling to
higher or lower altitudes to determine if your flow settings should be changed.
Traveling By Air
The Inogen One® G4 conforms to all applicable FAA requirements for POC use on board an
aircraft.
Planning Your Flight
When flying with the Inogen One® G4, you must inform the airline that you will be using your
Inogen One® G4 on board the aircraft. You should contact the Special Assistance desk of the
airline on which you will be traveling to learn of any paperwork, etc. that might be needed.
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• Some airlines may equip their aircraft with onboard electrical power. You may have an
opportunity to request a seat with a power port which can be used to power your Inogen One®
G4. However, availability varies by airline, type of aircraft and class of service. You should check
with your airlines for availability and always plan on having sufficient battery power for no less
than 150% of the expected duration of the flight. Airlines may have specific requirements for
battery life duration, so check with the airline before traveling.
• Your DC Power Cable is equipped with a commonly used cigarette lighter adapter. However,
aircrafts use different power port configurations and it is difficult to determine which type
of power port compatibility your aircraft may supply. It’s a good idea to purchase an adapter,
found at electronic and travel stores.
Before Your Flight
Here are some things to keep in mind the day your flight departs:
• Ensure your Inogen One® G4 is clean, in good condition and free from damage or other signs
of excessive wear or abuse.
• Bring enough charged batteries with you to power your Inogen One® G4 for no less than
150% of the expected duration of the flight, plus a conservative estimate of unanticipated
delays.
• Regional/Commuter airlines do not offer onboard electrical power. If your travel plans call
for flights on regional airlines, bring enough charged batteries with you to power your
Inogen One® G4 for no less than 150% of the expected duration of the flight, plus a
conservative estimate of unanticipated delays.
• Arrive at the airport early. Airport security screening personnel may require extra time to
inspect your Inogen One® G4.
• While waiting to board your flight, you may be able to conserve battery power by using
the AC Power Supply to power your Inogen One® G4 from an electrical outlet in the airport
terminal if available.
Operating Instructions Chapter 3
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During Your Flight
1. If using airline power port, remove the Battery from the Inogen One® G4 Oxygen
Concentrator. Due to aircraft power limitations, the AC Power Supply cannot
be used to charge the Inogen One® G4 Battery when onboard aircraft.
2. Connect the DC Power Plug for available airline power. Check with airline personnel
to ensure compatibility.
• During taxi, takeoff and landing, stow your Inogen One® G4 under the seat in front of you.
Your Inogen One® G4 will fit upright under most airline seats.
• It is not necessary to turn off your Inogen One® G4 during taxi, takeoff and landing.
CAUTION
A change in altitude (for example, from sea level to mountains) may affect
total oxygen available to the patient. The Inogen One® G4 has been verified
to provide oxygen to specification up to 10,000 ft. (3048 m). Consult your
physician before traveling to higher or lower altitudes to determine if your
flow settings should be changed.
After Your Flight
• Remember to recharge additional batteries you may have used prior to your next flight.
Traveling By Bus, Train or Boat
Contact your carrier to find out about power port availability.
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Battery Operating Instructions
Ensure that the battery is in place and charged. Disconnect the Inogen One® G4 from its
power source. While the Inogen One® G4 is operating on battery power, the battery will
discharge. The display will indicate the estimated remaining percentage (%) or minutes of
use.
When the concentrator detects that the battery life is low, with less than 10 minutes
remaining, a low priority alert will sound. When the battery is empty, the alert will change
to a high priority.
When battery life is low, do one of the following:
• Plug the Inogen One® G4 into an AC or DC power source using the AC power supply or
DC cable.
• Replace the battery with a charged battery after turning off the Inogen One® G4
(by pressing the ON/OFF button). To remove battery press and hold the battery latch
button and slide battery off the concentrator.
• If the battery is drained, charge the battery or remove it from the concentrator.
If the Inogen One® G4 is being powered by the AC power supply or DC power, batteries will
charge during operation. Leaving your Inogen One® G4 plugged in past the full charge time will
not harm the concentrator or the battery.
!
WARNING It is the responsibility of the patient to periodically check the battery and
replace as necessary. Inogen assumes no liability for persons choosing not to
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adhere to manufacturers recommendations.
Normal Battery Charging
To ensure that your battery is properly charging, inspect that the correct AC and DC power
output plug adapter is being used and that the adapter is properly inserted into the power
outlet. Observe the display or lights that indicate charging status.
NOTE
When starting to charge a fully discharged battery, the charging process may start and stop during the first few minutes.
Operating Instructions Chapter 3
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Battery Care and Maintenance
Your Inogen One® G4 Lithium Ion Battery requires special care to ensure proper performance
and long life. Use only Inogen One® G4 Batteries with your Inogen One® G4 Concentrator.
Keep Dry
Always keep liquids away from batteries. If batteries become wet, discontinue use
immediately and dispose of battery properly.
Effect of Temperature on Battery Performance
The Inogen One® G4 single battery powers the Inogen One® G4 Concentrator up to 2.7 hours
under most environmental conditions. To extend the run-time of your battery, avoid running
in temperatures less than 41˚F (5˚C) or higher than 95˚F (35˚C) for extended periods of time.
Battery Time Remaining Clock
The Inogen One® G4 continuously displays battery time remaining. This displayed time is
only an estimate and the actual time remaining may vary from this value.
Please Follow These Important Guidelines to Maximize Battery Performance and Life:
• Store battery in a cool, dry place. Store with a charge of 40-50%.
• If using multiple batteries, make sure that each battery is labeled (1, 2, 3 or A, B, C, etc.)
and rotate on a regular basis. Batteries should not be left dormant for more than
90 days at a time.
Battery Charge Indicator Gauge
When the single or double battery is not attached to the Inogen® One G4 Concentrator, you
can check the battery gauge on the battery to determine the amount of charge available.
Determine the amount of battery charge available by pressing the green battery icon button
and observing how many LEDs illuminate.
4 LEDs Light: 75% to 100% full
3 LEDs Light: 50% to 75% full
2 LEDs Light: 25% to 50% full
1 LED Lights: 10% to 25% full
1 LED Blinks: Battery is less than 10% full and needs to be recharged
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Inogen One® G4 Oxygen
Concentrator Audible
and Visible Signals
Display
The Inogen One® G4 display contains power status icons, mode icons, text with
informational messages and error notifications.
Power Status Icons
These icons are examples of those shown in the display’s window when the
Inogen One® G4 is operating
on battery power.
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!
!
C
Icon
!
!
C
CMeaning
Battery is empty.
Battery has less than 10% charge remaining. This icon flashes.
Battery has approximately 40% to 50% charge remaining.
Battery is full.
Audible and Visible Signals Chapter 4
23
Power
! C Status Icons (continued)
!
C
The mode icons below are examples of those shown when the Inogen One® G4 is
operating from an external power supply and charging the battery. The lightning bolt
indicates that an external power supply is connected.
Icon
! ! CMeaning
C
Battery is charging with charge level between 60% and 70%.
The battery is fully charged and is charging as necessary to
maintain its charge.
Battery is charging with charge level less than 10%.
The Inogen One® G4 is operating from an external power source with
no battery present.
Mode Icons
These are the mode icons shown in the display’s window.
Icon
Meaning
The breath detection audible alert has been enabled.
The breath detection audible alert is disabled. This is the default condition.
24
English
Display Icons
The icons below are examples of those shown when pertaining to Bluetooth
functionality.
Icon
Meaning
Bluetooth turned off.
Bluetooth turned on.
Pairing with Inogen Connect application.
Concentrator unpaired from device.
Display Text
NOTE
When two conditions occur simultaneously, the condition with the
higher priority will be displayed.
Audible and Visible Signals Chapter 4
25
Informational Messages
The following information displays are not accompanied by any audible feedback or any
visual change in the indicator lights.
Message Display & Text
Condition/Action/Explanation
The Inogen logo is displayed at startup.
Setting X
Please Wait
Displayed during warm up. “X” represents the selected flow
setting (eg., Setting 2).
Setting X Battery
HH:MM
Default display when operating on battery power. “X”
represents the selected flow setting (e.g., Setting 2).
“HH:MM” represents the approximate time remaining on
the battery charge (e.g., 1:45).
Setting X Charging xx
(or) Battery Full
Default display when operating on an external power
supply and the battery is charging. “xx%” represents the
percent battery charge (e.g., 86%).
Setting X Battery xx%
Default display when the battery is not charging or when the
time remaining is not available from the battery.
Charging xx% (0r)
Battery Full
Displayed when the concentrator is plugged in and being
used to charge a battery (not being used for oxygen
production). It is normal to see a fully charged battery read
between 95% and 100% when external power is removed.
This feature maximizes the useful life of the battery.
Notifications
!
26
WARNING Audible notifications, ranging from 55dba to 65dba depending on the
users position, are to warn the user of problems. To insure that audible
notifications may be heard, the maximum distance that the user can
C
move away from it must be determined to suit the surrounding noise level.
English
Notifications (continued)
The Inogen One® G4 monitors various parameters during operation and utilizes an
intelligent alert system to indicate a malfunction of the concentrator. Mathematical
algorithms and time delays are used to reduce the probability of false alerts while still
ensuring proper notification of an alert condition.
If multiple alert conditions are detected, the highest priority alert will be displayed.
Note that failure to respond to the cause of an alert condition for low, medium and high
priority alerts potentially will result in discomfort or reversible minor injury only and
develop within a period of time sufficient to switch to a backup source of oxygen.
The following notification messages are accompanied by a single, short beep.
Message Display & Text
Condition/Action/Explanation
Please Wait
Shutting Down
On/Off button has been pressed for two seconds.
Concentrator is performing system shut down.
HH:MM
Vx.x:Serial Number
Audible Alert button has been pressed for five seconds.
Low Priority Alerts
The following low priority alert messages are accompanied by a double beep and a
solid yellow light.
Message Display & Text
Condition/Action/Explanation
Battery Low
Attach Plug
Battery power is low, with less than 10 minutes remaining.
Attach external power supply or power down and insert
a fully charged battery.
Replace
Columns
Column maintenance is required within 30 days. Contact
your equipment provider to arrange for service.
Audible and Visible Signals Chapter 4
27
Low Priority Alerts (continued)
28
Message Display & Text
Condition/Action/Explanation
Check Battery
Battery error has occurred. Check the connection of your
battery and ensure that it is properly attached and latched
on concentrator. If battery error recurs with same battery,
stop using the battery and switch to a new battery or
remove battery and operate concentrator using external
power supply.
Oxygen Low
Concentrator is producing oxygen at a slightly low level
(<82%) for a period of 10 minutes. If condition persists,
contact your equipment provider.
Remove Battery
to Cool
Battery has exceeded its charging temperature and charging
has stopped. The battery will not charge while this alert
is present but will begin to charge when the battery
temperature returns to the normal operating range.
If battery charging is desired sooner, remove the battery
from the concentrator and allow it to cool in an open area for
approximately 10-15 minutes. Then, re-insert the battery into
the Inogen One® G4. If the problem still persists, contact your
equipment provider.
Service Soon
The concentrator requires servicing at the earliest
convenience. The concentrator is operating to specification
and may continue to be used. Contact your equipment
provider to arrange for service.
Sensor Fail
The concentrator’s oxygen sensor has malfunctioned.
You may continue to use the concentrator. If the condition
persists, contact your equipment provider.
English
Medium Priority Alerts
The following medium priority alert messages are accompanied by a triple beep,
repeated every 25 seconds, and a flashing yellow light.
Message Display & Text
Condition/Action/Explanation
No Breath Detect
Check Cannula
Concentrator has not detected a breath for 60 seconds.
Check that cannula is connected to concentrator, there are
no kinks in tubing and cannula is positioned properly in
your nose.
Oxygen Error
Oxygen output concentration has been below 50% for
10 minutes. If condition persists, switch to your backup
oxygen source and contact your equipment provider to
arrange for service.
O2 Delivery Error
A breath has been recognized, but proper oxygen delivery
has not been detected.
Battery HOT
Warning
Battery has exceeded temperature limit while concentrator
is running on battery power. If possible, move concentrator
to a cooler location or power unit with an external power
supply and remove battery. If condition persists, contact
your equipment provider.
System HOT
Warning
Concentrator has exceeded temperature limit. If possible
move concentrator to a cooler location. Ensure air intake
and outlet vents have clear access and particle filters
are clean. If condition persists, contact your equipment
provider.
Audible and Visible Signals Chapter 4
29
High Priority Alerts
CAUTION
If you are not near the Inogen One® G4 you may not be able to hear
or see the high priority alerts. Make sure the Inogen One® G4 is in a
location where the alerts and alerts will be recognized if they occur.
The following high priority alert messages are accompanied by a five beep pattern,
repeated every 10 seconds and a flashing yellow light.
30
Message Display & Text
Condition/Action/Explanation
Battery Empty
Attach Plug
Concentrator has insufficient battery power to produce
oxygen. Attach external power supply or exchange battery,
then restart unit if necessary by pressing On/Off button.
Battery HOT
Battery has exceeded temperature limit while concentrator
is running on battery power. Concentrator has stopped
producing oxygen. If possible, move concentrator to a
cooler location, then turn power off and back on. Ensure
air intake and outlet vents have clear access and particle
filters are clean. If condition persists, switch to a backup
source of oxygen and contact your equipment provider.
System HOT
Concentrator temperature is too high and oxygen
production is shutting down. Ensure air intake and outlet
vents have clear access and particle filters are clean. If
condition persists, switch to a backup source of oxygen and
contact your equipment provider.
System COLD
This may result from the concentrator being stored in a
cold environment (below 0ºC (32ºF)). Move to a warmer
environment to allow the unit to warm up before starting
it. If condition persists, switch to a backup source of
oxygen and contact your equipment provider.
System Error
Concentrator has stopped producing oxygen and is
shutting down. You should:
1. Switch to backup oxygen source
2. Contact your equipment provider
English
5
Troubleshooting
Solutions to some possible issues you may encounter are described in this section.
Inogen One® G4 Oxygen Concentrator
Problem
Possible Cause
Recommended Solution
Any problem
accompanied
by information
on concentrator
display, indicator
lights and/or
audible signals
Refer to Chapter 4
Refer to Chapter 4
Concentrator does
not power on when
On/Off button is
pressed
Battery is discharged or
no battery is present
Use external power supply or
replace battery with one that is
fully charged
AC Power supply is not
connected properly
Check power supply connection and
verify green light is solid
DC Cable is not connected
properly
Check DC Cable connection at
the Concentrator and at cigarette
lighter or auxiliary DC power source
Malfunction
Contact your equipment provider
Troubleshooting Chapter 5
31
Troubleshooting (continued)
32
Problem
Possible Cause
Recommended Solution
No oxygen
Concentrator is not
powered on
Press On/Off button to power
concentrator
Cannula is not
connected properly
or is kinked or obstructed
Check cannula and its connection
to concentrator nozzle
English
6
Cleaning, Care
and Maintenance
Cannula Replacement
Your nasal cannula should be replaced on a regular basis. Consult with your physician
and/or equipment provider and/or cannula manufacturer’s instructions for replacement
information. A single lumen cannula up to 25 feet in length is recommended to ensure
proper breath detection and oxygen delivery.
!
WARNING Oxygen is flammable. Do not leave the nasal cannula on bed coverings or
chair cushions. Turn the oxygen concentrator off when not in use.
C
Case Cleaning
You may clean the outside case using a cloth dampened with a mild liquid detergent
(such as DawnTM) and water.
!
WARNING Do not submerse the Inogen One® G4 or its accessories in water or
allow water to enter into the case; this may lead to electrical shock
C
and/or damage.
!
WARNING Do not use cleaning agents other than those specified in this User Manual.
Do not use alcohol, isopropyl alcohol, ethylene chloride or petroleum
C
based cleaners on the cases or on the particle filter.
Filter Cleaning and Replacement
The particle filter must be cleaned weekly to ensure the ease of
air flow. Remove filters from the front of the device. Clean the
particle filters with a mild liquid detergent (such as DawnTM) and
water; rinse in water and dry before reuse.
Cleaning, Care and Maintenance Chapter 6
33
NOTE
It may be necessary to clean the particle filter more often in dusty
environments.
To purchase additional particle filters contact your equipment provider or Inogen.
Output Filter
The output filter is intended to protect the user from inhalation of small particles in the
product gas flow. The Inogen One® G4 includes an output filter conveniently located
behind the removable cannula nozzle fitting.
The output filter may be replaced by the equipment provider or by the owner using the
Output Filter Replacement Kit (RP-404).
The Inogen One G4 Concentrator must be cleaned and disinfected as per the above
instructions for each new patient. No special maintenance needs to be carried out
by the patient. Your equipment provider performs maintenance operations to assure
continued reliable service from your Inogen One G4. The manufacturer’s instructions for
the preventative maintenance of the devices are defined in the service manual. All work
must be performed by trained technicians certified by the manufacturer.
DC Input Cable Fuse Replacement
The Cigarette Lighter DC power plug contains a fuse. If the DC input cable is being used
with a known good power source and the unit is not receiving power, the fuse may need
to be replaced.
To replace the fuse, follow these instructions and refer to the photograph below.
1. Remove the tip by unscrewing the retainer. Use a tool if necessary.
2. Remove the retainer, tip and fuse.
3. The spring should remain inside the Cigarette Lighter Adapter housing. If the spring
is removed, make sure to replace the spring first before inserting the replacement
fuse.
34
English
4. Install a replacement fuse, Inogen RP#125 (BUSS MDA-12) and reassemble the tip.
Ensure the retainer ring is properly seated and tightened.
Cigarette Adapter Plug
CAUTION
Fuse
Retainer Tip
Retainer
For continued protection against risk of fire, only use fuse specified.
Inogen One® G4 Column Change Procedure
NOTE
!
Column change instructions are only to be used when maintenance is
required and are not intended for practice purpose.
WARNING Do not use any columns other than those specified in this user manual.
The use of non-specified columns may create a safety hazard and/or
C
impair equipment performance and will void your warranty.
1. Turn off the Inogen One® G4 concentrator by pressing the power button to shut
down the device.
2. Remove the Inogen One® G4 concentrator from the carry case, if applicable.
3. Remove the battery from the Inogen One® G4 concentrator.
4. Place the Inogen One® G4 concentrator on its side so
that the underside is visible. The metal column assembly can be seen on one side of the device.
Cleaning, Care and Maintenance Chapter 6
35
Inogen One® G4 Column Change Procedure (continued)
5. Unlock the column assembly by pushing the latch
button away from the columns.
6. While holding the button open, slide the column
assembly out of the device by pulling on the column
pull handle.
7. Remove the columns completely from the Inogen
One® G4. Both columns are removed as one piece.
Column (metal tube) Installation
8. Remove dust caps of new column assembly. Make
sure there is no dust or debris where the dust caps
were located.
36
Open and unlocked
English
Inogen One® G4 Column Change Procedure (continued)
9.
Insert column assembly into the Inogen One® G4
concentrator. Do not leave the column ends
exposed; column assembly should be inserted into
the Inogen One® G4 as soon as the dust caps have
been removed.
10. Push the column assembly into the device such
that the columns are fully seated into the Inogen
One® G4 concentrator. The spring loaded latch
button should fully return to the closed position.
Closed and locked
11. Connect the AC power supply cord to the Inogen One® G4 and plug the power supply AC cord into an
electrical outlet. Do Not Power on the Inogen One®
G4 concentrator.
12. Press and hold the plus (+) and (-) minus button for 5
seconds. The screen will display “sieve reset”
message. Release button once message is displayed
on screen.
13. Press the alert
button once and screen will
display “sieve reset success”.
14. Press the power
button to turn on the Inogen
One® G4, and use normally.
15. If you are using Inogen Connect App, navigate to the Advanced screen,
then to Additional Information screen and click on the Column Reset button.
Cleaning, Care and Maintenance Chapter 6
37
Other Service and Maintenance
WARNING Do not disassemble the Inogen One® G4 or any of the accessories or
attempt any maintenance other than tasks described in this user
manual; disassembly creates a hazard of electrical shock and will
void your warranty. Do not remove the tamper evident label.
C
For events other than those described in this manual, contact
your equipment provider for servicing by authorized personnel.
!
CAUTION
Do not use lubricants on the Inogen One® G4 or its accessories.
Do not perform maintenance on the device while it is in use.
C
! WARNING
Disposal of Equipment and Accessories
Follow your local governing ordinances for disposal and recycling of the Inogen
One® G4 and accessories. If WEEE regulations apply, do not dispose of in unsorted
municipal waste. Within Europe, contact the EU Authorized Representative for disposal
instructions. The battery contains lithium ion cells and should be recycled. The battery
must not be incinerated.
Maintenance Items List
•
•
•
•
•
Inogen One® G4 single battery (model # BA- 400)
Inogen One® G4 double battery (model # BA- 408)
Replacement intake particle filters (model # RP- 405)
Output Filter Replacement Kit (model # RP-404)
Inogen One® G4 columns (model # RP-406)
For assistance, if needed, in setting up, using, maintaining, or to report unexpected
operation or events, contact your equipment provider, or manufacturer.
!
38
WARNING It is the responsibility of the patient to use only parts and accessories
mentioned in these instructions for use. Parts and accessories used by
C
the patient not recommended in these instructions for use are at the sole
responsibility for the patient. Inogen assumes no liability for use of parts
and accessories not mentioned in these instructions for use.
Symbol
Meaning
WARNING
A warning indicates that the personal safety of the patient may be
involved. Disregarding a warning could result in significant injury.
CAUTION
A caution indicates that a precaution or service procedure must be
followed. Disregarding a caution could lead to a minor injury or damage
to equipment.
!
ONLY
ONLY
ONLY
English
7
Symbols Used
On Concentrator
and Accessories
C See User Manual for Instructions.
U.S. Federal Regulation Restricts this Device to Sale by Order of
Physician. May also be applicable in other Countries.
AC Power
DC Power
No Smoking while device is in use.
No Open Flames (Concentrator);
Do not incinerate (Battery).
Refer to instruction manual/booklet.
Manufacturer
Symbols Used on Concentrator and Accessories Chapter 7
39
Symbol
Meaning
Authorized Representative in the European Community
Keep Dry
Indoor or Dry Location Use Only, Do Not Get Wet
Use No Oil or Grease
ONLY
Do Not Disassemble (contact your equipment provider for servicing
by authorized personnel)
ONLY
Do Not Dispose of In Unsorted Municipal Waste
Class II Device
Electrical Safety Agency Certification Logo
Complies With Applicable EU Directives Including Medical Device
0123 Directive
0123
COLOR SUMMARY:
1. Black
UK Declaration of Conformity
Importer
93-01213-00-00 rev1
Medical device
Indicates the range of humidity to which the medical device can be
safely exposed
Date of Manufacture
40
CH REP
English
Symbol
Meaning
CH Authorized Representative
Indicates not for use in MRI environment
Unique Device Identification
Serial Number
Catalog Number
Indicates the maximum and minimum temperature limits at which the
item shall be stored, transported or used.
Atmospheric pressure limitation to which the medical device can be
safely exposed (operating)
Type BF Applied Part
User Interface Label
Symbol
Meaning
ON / OFF Button
Increase Flow Setting
Decrease Flow Setting
Audible Alert Button
Symbols Used on Concentrator and Accessories Chapter 7
41
42
English
8
Inogen One® G4
System Specifications
Inogen One® G4 Concentrator
Dimensions:
With single battery
L / W / H : 5.91 in. (15.01 cm.) / 2.68 in. (6.8 cm.) / 6.5 in. (16.3 cm.)
L / W / H : 5.91 in. (15.01 cm.) / 2.68 in. (6.8 cm.) / 7.2 in. (18.2 cm.)
Weight:
2.8 pounds (1.27 Kg.) (includes single battery)
Noise:
40 dBA (on setting 2)
Warm-Up Time:
2 minutes
Oxygen Concentration:
90% - 3% /+ 6% at all settings
Flow Control Settings:
3 settings: 1 to 3
Power:
AC Power Supply:
AC Input:
DC Power Cable:
Rechargeable Battery:
DC Input:
Voltage:
Battery Duration*:
Up to 2.7 hours with single battery
Up to 5 hours with double battery
Battery Charging Time:
Up to 3 hours for a single battery
Up to 5 hours for a double battery
Environmental Ranges
Intended for Use:
Temperature: 41 to 104˚F (5 to 40˚C)
Humidity: 0% to 95%, non-condensing
Altitude: 0 to 10,000 ft (0 to 3048 meters)
Environmental Ranges
Intended for Shipping and
Storage:
Temperature: -13 to 158˚F (-25 to 70˚C)
Humidity: 0% to 95%, non-condensing
Store in a dry environment
Transportation:
Keep Dry, Handle With Care
Tested by Independent
Laboratory:
Safety: IEC 60601-1
CAN/CSA C22.2 No. 60601-1
Electromagnetic Compatibility: IEC 60601-1-2, RTCA DO 160
100 to 240 VAC
50 to 60 Hz
Auto-Sensing: 1.0A
13.5-15.5VDC,10A Max.
12.0 to 16.8 VDC
*Battery time varies with flow setting and environmental conditions.
Inogen One® G4 System Specifications Chapter 8
43
Contains Transmitter Module IC: 12246A-BM71S2. Contains FCC ID: A8TBM71S2
This device complies with Part 15 of the FCC rules. Operation is subject to the following
two conditions: (1) this device may not cause harmful interference, and (2) this device must
accept any interference received, including interference that may cause undesired operation.
Note: IT-network is a system composed of wireless (Bluetooth) transmission between the
Inogen One® G4 and the Inogen Connect Application.
• Connection of the Inogen One® G4 to an IT-Network could result in previously unidentified
risks to patients, operators or third parties.
• Subsequent changes to the IT-network could introduce new risks and require additional
analysis
• Changes to the IT-network include:
º Changes in the IT-network configuration;
º Connection of additional items to the IT-network
º Disconnecting items from the IT-network
º Updating equipment connected to the IT-network
Classifications
Mode of Operation:
Continuous Duty
Type of Protection Against Electrical
Shock:
Class II
Degree of Protection to Concentrator
Components Against Electrical Shock:
Type BF
Not intended for cardiac application
Degree of Protection to Concentrator
Components Against Ingress of Water:
IP22 - Vertically dripping water shall have no
harmful effect & protect against ingress
of solid objects ≥ 12.5 mm. diameter
when the enclosure is tilted at an angle
up to 15˚ from its normal position*
Degree of Safety for Application in
Presence of Anesthetic Gases:
Not suitable for such application
*Normal position of the Inogen One® G4 is upright with the user interface display facing upward.
44
English
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity:
The Concentrator is intended for use in the electromagnetic environment specified below. The user of the Concentrator
should make sure it is used in such an environment.
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 device, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the
transmitter.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz
to 80 MHz
3V/m
80 MHz
to 2.5 GHz
3 Vrms
3V/m
Recommended separation distance:
d=1.2√P 150 kHz to 80 MHz
d=1.2√P 80 MHz to 800 MHz
d=2.3√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).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey a, should be less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of equipment marked with the following
symbol:
Electrostatic
discharge (ESD)
± 6 kV contact
± 6 kV contact
IEC 61000-4-2
± 8 kV air
± 8 kV air
Electrical fast
transient/burst
± 2 kV for power
supply lines
± 2 kV for power
supply lines
EC 61000-4-4
± 1 kV for input/
output lines
± 1 kV for input/
output lines
Surge
± 1 kV line(s) to
line(s)
± 1 kV line(s) to
line(s)
IEC 61000-4-5
± 2 kV line(s) to
earth
± 2 kV line(s) to
earth
Voltage dips, short <5% UT (>95% dip
interruptions and in UT) for 0.5 cycle
voltage variations
on power supply
40% UT (60% dip in
input lines
UT) for
5 cycles
IEC 61000-4-11
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip
in UT) for 0.5 cycle
<5% UT (>95% dip
in UT) for 5 sec
<5% UT (>95% dip
in UT) for 5 sec
3 A/m
3 A/m
Power frequency
(50/60 Hz)
magnetic
field
IEC 61000-4-8
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.
Mains power quality should be that of a typical commercial or hospital
environment. If the user of the [ME EQUIPMENT or ME SYSTEM] requires
continued operation during power mains interruptions, it is recommended
40% UT (60% dip in that the [ME EQUIPMENT or ME SYSTEM] be powered from
an uninterrupted power supply or a battery.
UT) for
5 cycles
70% UT (30% dip in
UT) for 25 cycles
Power frequency magnetic fields should be at levels characteristic of a typical
location in a typical hospital or home environment.
45
NOTE
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
NOTE
UT is the a.c. main voltage prior to application of the test level.
: Field strength 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
concentrator is used exceeds the applicable RF compliance level above, the concentrator should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
a
: Over the frequency range 150 kHz to 80 MHz, the field strengths should be less than 3V/m.
b
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This
Device:
This concentrator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the
concentrator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this concentrator as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum Power
Output of Transmitter (W)
Separation Distance According to Frequency of Transmitter (M)
150 kHz to 80 MHz
d=1.2√P
80 MHz to 800 MHz
d=1.2√P
800 MHz to 2.5 GHz
d=2.3√P
0.01
0.1
1
10
0.12
0.38
1.2
3.8
0.12
0.38
1.2
3.8
0.23
0.73
2.3
7.3
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
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE
The guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The concentrator is intended for use in the electromagnetic environment specified below. The user of the concentrator should assure that it
is used in such an environment.
46
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1
The concentrator uses RF energy only for its internal function. Therefore its RF emissions are very
low and not likely to cause any interference in nearby equipment.
RF emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage fluctuations
/ flicker emissions
IEC 61000-3-3
Class B
The concentrator is 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.
Class A
Complies
®
©2023 Inogen. All rights Reserved.
UK Responsible Person :
Emergo Consulting (UK) Limited
c/o Cr360 – UL International
Compass House, Vision Park Histon
Cambridge CB24 9BZ
United Kingdom
Inogen, Inc.
859 Ward Drive, Suite 200
Goleta, CA 93111 USA
Independent Living Specialists
Unit 1 / 12 Mars Road
Lane Cove West NSW 2066
Tel: 02 9427 4995
E-mail: [email protected]
www.inogen.com
BOC Limited
10 Julius Avenue, North Ryde,
NSW 2113,
Australia
Tel: 1800 050 999
988 Great South Road,
Penrose Auckland,
New Zealand
Tel: 0800 699 2273
NOVEMBER/2023
Air Liquide Healthcare
Level 4, Suite 3-4 247 Coward Street
Mascot NSW 2020
Tel: 1300 360 202
2797
0086
PN 96-06728-00-03 E
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