Inogen GS-100, RP-109 TECHNICAL MANUAL

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INOGEN AT HOME OXYGEN
INOGEN AT HOME STATIONARY OXYGEN CONCENTRATOR
TECHNICAL MANUAL
96-05070-00-01
Revision D
GUIDANCE TO AUTHORIZED SERVICE AND REP AIR CENTERS
This Manual applies to the following Inogen, Inc. products:
Inogen At Home Oxygen Concentrator, model #GS-100
Inogen At Home AC Power Cord, model #RP-109
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TABLE OF CONTENTS
1. INFORMATION FOR PROVIDERS OF THE INOGEN AT HOME .................................. 3
1.1. CAUTION AND WARNING STATEMENTS ......................................................................... 3
2. SETTING UP A PATIENT ON INOGEN AT HOME ........................................................ 4
2.1. RECOMMENDATIONS FOR USE ..................................................................................... 4
2.2. SYSTEM COMPONENTS ............................................................................................... 4
2.3. USING THE INOGEN AT HOME ...................................................................................... 4
2.4. SELECTING THE PROPER FLOW SETTING ...................................................................... 4
3. SERVICING THE INOGEN AT HOME ............................................................................ 5
3.1. MAINTENANCE BY THE PROVIDER ................................................................................. 5
3.2. MAINTENANCE BY THE PATIENT ................................................................................... 9
3.3. EXPECTED SERVICE REQUIREMENTS ......................................................................... 10
4. INOGEN AT HOME SYSTEM SPECIFICATIONS ........................................................ 10
4.1. CLASSIFICATIONS ..................................................................................................... 11
5. INOGEN AT HOME ERROR ALARMS ........................................................................ 11
5.1. NOTES ..................................................................... ERROR! BOOKMARK NOT DEFINED.
5.2. LOW PRIORITY ALARMS ............................................ ERROR! BOOKMARK NOT DEFINED.
5.3. MEDIUM PRIORITY ALARMS ....................................... ERROR! BOOKMARK NOT DEFINED.
5.4. HIGH PRIORITY ALARMS ............................................ ERROR! BOOKMARK NOT DEFINED.
5.5. ERROR CODE TABLE ................................................ ERROR! BOOKMARK NOT DEFINED.
CONTACTS FOR MORE INFORMATION ........................................................................... 15
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1. INFORMATION FOR PROVIDERS OF THE INOGEN AT HOME

A WARNING indicates that the personal SAFETY of the Patient may be sure that patients understand all warning statements.
A CAUTION indicates that a precaution or service procedure must be the equipment. Be sure that patients understand all caution statements.
A NOTE indicates specific information to improve ease of use or maintenance of the equipment.
A DESIGN NOTE indicates specific information regarding the design of the
This information is not required to operate or maintain the Inogen At Home.
Thank you for choosing to provide your patients with the Inogen At Home stationary oxygen concentrator. We are pleased to offer you and your patient s a comprehensive solution for your stationary oxygen needs.
This Technical Manual will familiarize you with provider-specific information regarding the Inogen At Home Oxygen Concentrator and its accessories. Before r eading this Technical Manual, please read and review the Inogen At Home Patient Manual for description and indications for use of the device.
Be sure to thoroughly read all of the information in this manual in its entirety. 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 help assure that patients are given proper guidance in the use and function of the Inogen At Home and its accessories. Proper care in relaying this information will not only enhance the user’s experience with the Inogen At Home, but will also protect the patient, prolong the life of the device, and help you avoid unnecessary service calls and complaints from users.

1.1. Caution and Warning Statements

You will see Warnings and Cautions throughout this Technical Manual. To ensure effective Oxygen Therapy and proper operation of the Inogen At Home Oxygen Concentrator , you must observe them carefully.
involved. Disregarding a warning could result in a significant injury. Be
WARNING
CAUTION
followed. Disregarding a caution could lead to a minor injury or damage to
NOTE
DESIGN
NOTE
Inogen At Home and/or accessories. This information is included in this manual to provide you with a greater working understanding of the device.
In many cases, warnings and cautions have been included in the Inogen At Home User Manual.
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Availability of an alternate source of oxygen is recommended in case of
patient.

2. SETTING UP A PATIENT ON INOGEN AT HOME

2.1. Indications for Use

The Inogen At Home Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is use d with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen At Home Oxygen Concentrator may be used in a home or institution.
CAUTION
power outage or mechanical failure. Several certifying bodies for Home Health Care Providers require that back-up oxygen be available to the

2.2. System Components

The following are standard components of the Inogen system:
o Inogen At Home Oxygen Concentrator o AC Power Cord o Humidifier Bottle (not included) o Cannula (not included)
Patient Set-Up. To properly set up a patient on the Inogen At Home System, you may need to provide:
o Extra cannulas (not included) o Extra output filters (not included)

2.3. Using the Inogen At Home

To quickly configure the Inogen At Home for patient use:
1. Place the concentrator in a well-ventilated location; air intake and exhaus t vents must have clear access.
2. Attach the cannula to the nozzle fitting on the top of the concentrator or to the humidifier bottle, if using.
3. Connect the power cord to the Inogen At Home.
4. Plug into closest AC outlet.
5. Turn on the Inogen At Home by pressing the on/off button.
6. Use the + (increase flow) or – (decrease flow) buttons to adjust the Inogen At Home to the flow setting prescribed by the physician or clinician.
For further information regarding the use of the Inogen At Home, please consult the User Manual.

2.4. Selecting the Proper Flow Setting

The Inogen At Home can provide oxygen to the patient as long as a source of electricity is available. Because the oxygen is being pr oduced as it is used, supply of
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oxygen is rate-limited. The Inogen At Home delivers up to 5 L/min of 90% (+6%/-3%)
1
1.0 2 2.0 3 3.0 4 4.0
5
5.0
oxygen.
At each flow setting, the Inogen One generates a specific amount of oxygen (1 L/min per setting), which is delivered continuously to the patient. The device will deliver the same volume of oxygen regardless of the patient’s breath rate.
Flow Setting Flow Rate (L/min)

3. SERVICING THE INOGEN AT HOME

3.1. Maintenance by the Provider

3.1.1. Authorized Repair Centers

The Inogen At Home is only intended to be repaired by authorized repair cent er s . If a repair is required, please contact Inogen to locate your nearest authorized repair center. If you would like to become an authorized repair center, please contact Inogen for access to certification training, service instructions, component part list s and the necessary repair equipment.

3.1.2. Cleaning and Processing for Reuse

Reprocessing between patient use is required. Refer to the following guidance on the process to clean and disinfect for reuse.
The following supplies are recommended:
o Nitrile Gloves or equivalent o Safety Glasses o Disinfecting wipes or Spray designed to kill bacteria and viruses o Compressed Air (30 psi / 207 kPa, for blowing off parts) o Particulate Respirator (N95 rated)
The following safety precautions should be followed when cleaning and processing a concentrator for reuse:
1. The cleaning process should be performed in a well-ventilated area.
2. Wear nitrile gloves, safety glasses, and a particulate respirator when cleaning and disinfecting the concentrator.
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3. Avoid touching your face during and after cleaning the concentrator to
The use of Nocolyse (OxyPharm) surface disinfectant system States.
prevent transfer of contaminants.
4. Immediately after cleaning remove gloves and wash hands.
The following steps should be performed to clean and disinfect the concentrator:
1. Put on personal protective equipment (PPE).
2. Disinfect by wiping down exterior surfaces with disinfecting wipes or spray. Avoid getting moisture in or around the battery connectors, power jack, or vents. Follow manufacturer’s instructions for application and surface dwell times.
NOTE
has been approved for use in Europe. Not approved in United
3. Cleaning. If visibly soiled, clean exterior surfaces using a soft cloth dampened with a mild liquid detergent (such as Dawn™ in US) and water. Then gently wipe dry. Avoid getting moisture in or around the battery connectors, power jack, or vents. If items have scuff marks or other such surface discoloration, use multi-surface sponge cleaner may be used.
4. Hard-Surfaces: (concentrator shell, batteries, power supplies, carts, pulse oximeter, etc.): Disinfect and clean entire outer surface as necessary per above.
5. Cords: Uncoil or untie cord(s). Disinfect entire length of cord(s) and connectors at each end. Clean as necessary per above.
6. Disposables: If the disposable item has been opened or is dirty it is to be discarded; otherwise, it does not need to be disinfected. Clean as necessary per above.
7. Carry Bags: Disinfect entire outer and inner surfaces of carry bag. If the carry bag is dirty and/or emits excessive odor, it is to be discarded. Clean as necessary per above.
8. Literature: Literature does not need to be disinfected; if dirty, discard.
9. Packaging Materials: Packaging materials do not need to be disinfected; if dirty, discard.
10. Once cleaned and disinfected, remove Particle Filters and blow off accessible internal areas with compressed air to remove any visible debris.
11. Blow off Particle Filters with compressed air to remove any visible debr is.
12. Disinfect any accessible area behind the Particle Filters with disinfecting towels. Avoid getting moisture on the electronics (USB port and motherboard). Replace the Particle Filters as necessary.
13. Disinfect batteries and power supplies by wiping down the exterior of them with disinfecting towels or spray.
14. Remove and replace Output Filter per section 3.1.6 below.
15. Unit is now ready for reuse.
16. Remove PPE and wash hands with soap and water for a minimum of 20 seconds.
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Do not disassemble the Inogen At Home or any of the accessories or
for service of the Inogen At Home and accessories.
During a normal field maintenance visit, the technician may elect to turn
to bring an extra oxygen supply.
Discovery of cracks or other types of external damage may be
safety of the device, arrange for equipment servicing.
attempt any maintenance other than tasks described in this Technical Manual unless you have completed a training course through Inogen.
NOTE
Disassembly of the Inogen At Home or any of the accessories without proper training certification will void the product warranties. Contact Inogen for information about receiving proper training and certificat ion

3.1.3. Suggested Materials for Regular Maintenance

To perform regular field maintenance (by a technician) on the Inogen At Home System, you may need:
o Inogen At Home Particle Filter (RP-400) o Inogen At Home Output Filter Replacement Kit (RP-107)
Includes spanner wrench and two output filters
o Inogen At Home Air Inlet Filter (RP-401) o Inogen At Home Column Pair (RP-402) o Humidifier Connector Tube (Salter Labs #S0-676) o Humidifier Bottle (Salter Labs #7600) o Nasal Cannula (Salter Labs 16SOFT) o External Oxygen Analyzer (such as Salter Labs PrO2 Check)
NOTE
off the concentrator for approximately 30 minutes. If the patient requires oxygen during this period, Inogen recommends making arrangements

3.1.4. System Inspection

At the start of any maintenance visit:
1. Be sure to ask the patient if they have experienced any difficulties in operating the equipment.
2. Be sure to ask the patient if they have observed any malfunctions or changes in characteristics of the equipment.
3. Visually inspect the device 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 service.
indicative of other internal damage that may not be visible. If such
CAUTION
external damage is discovered, be certain to inquire as to how it occurred, and whether any changes in the device have been noticeable since its occurrence. If you have any concern over the
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3.1.5. Output Filter Replacement

Failure to inspect and replace the product filter may result in the filter oxygen to the patient.
This filter is intended to protect the user from small particles in the product gas flow. The Inogen At Home includes an output filter conveniently located behind the removable cannula nozzle fitting. Inogen suggests that this filter be replaced between patients.
Use the Output Filter Replacement Kit (RP-107) to replace the Output Filter:
1. Use the Cannula Barb Tool (included in RP-107) to access the product filter. The tool has two prongs which mate with two indentations located on the surface of the metal cannula barb fitting on the Inogen At Home.
2. Carefully remove the cannula fitting by unscrewing it in the counter-clockwise direction.
3. The filter, a hard plastic disk with a silicone 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.
5. Install a replacement filter.
6. Carefully screw the cannula barb fitting back into the recess (clockwise) until it bottoms out on the filter gasket. Take care to squarely screw the nozzle fitting into the threads, and not to over tighten.
CAUTION
becoming clogged or obstructed over time, and in reduced delivery of

3.1.6. Oxygen Purity Check

The oxygen concentration can be checked using the Salter Labs PrO2 Check ultrasonic oxygen analyzer. The concentrator should be run for 10 minutes before measuring the oxygen concentration. If the concentrator has not been used for more than 2 weeks, the concentrator should be run for a minimum of 30 minutes to allow for adjustments to the operating parameters prior to measuring the oxygen concentration.

3.1.7. Air Inlet Filter Replacement

The inlet filter on the top of the concentrator (behind the handle) should be replaced when visually necessary (i.e. filter appears dirty) using the Air Inlet Filter Replacement Kit.

3.1.8. Column Change Procedure

There are two columns in the concentrator located behind the particle filter. These two columns should be removed and replaced when column service is required. Ensure adequate time is allotted to complete all steps without disruption when performing this maintenance.
1. Turn off the concentrator by pressing the power button.
2. Unplug the concentrator from the electrical outlet.
3. Lay the concentrator down on its side.
4. Press the two latch buttons on the sides of the device to remove the cover from the bottom of the concentrator in order to access the two columns.
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5. Press the column latch button with thumb or finger and pull the column out
Do not use total cannula tubing length exceeding 100 feet with the Inogen At Home unless proper saturation has been verified by a clinician.
Do not leave the column exposed after the dust caps are removed; it
lifespan.
Column change instructions are only to be used when maintenance is procedure.
of the concentrator using the pull ring attached to the column cap.
6. Remove the column completely from the concentrator.
7. Repeat steps 5-6 to remove the other column.
Installation of the new columns:
8. Remove the upper and lower dust caps from each column. There should be a total of two dust caps removed from each column. Make sure there is no dust or debris where the dust caps were located.
9. Insert the new column into the concentrator.
CAUTION
should be inserted into the concentrator as soon as the dust caps have been removed to minimize environmental exposure and maximize
10. The column should click into place and the spring loaded latch button
should fully return to the closed position when the column is completely inserted.
11. Repeat steps 9-10 to install the other column.
12. Replace the lower cover and return the concentrator to its upright position.
13. Connect the power supply cord from the concentrator and plug into an
electrical outlet. Do not power on the concentrator.
14. Press and hold the plus (+) button for ten seconds. Flow indicators 1, 3 & 5
will be illuminated and columns will be reset. Release the plus button.
15. Press the power button to turn on the concentrator and use normally.
NOTE
required. Column should only be removed during this maintenance

3.2. Maintenance by the Patient

3.2.1. Cannula Replacement

The nasal cannula should be replaced on a regular basis. A single lumen cannula of 4 to 100 feet in le ngth must be used. I nogen has certified its perf ormance data with the Salter Laboratories 16SOFT cannula.
CAUTION

3.2.2. Particle Filter Cleaning and Replacement

On the side of the Inogen At Home, ambient air passes through a particle filter that removes dust fragments. This particle filter must be cleaned on a weekly basis to
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ensure adequate air flow through the device. If the particle screen is not cleaned
Service Item
Estimated Service Requirement Frequency
Compressor
20,000 run hours
Columns
18 to 24 months
Valves
25,000 run hours
Particle Filter
20,000 run hours with regular cleaning by user
Cooling Fan
25,000 run hours
Dimensions:
16.5”H (41.25 cm) x 13”W (15 cm) x 7”D (31 cm)
Weight:
18 lbs (8.2 kg.)
Noise:
<50 dBa
Warm-Up Time:
<5 minutes
Oxygen Concentration:
90 + 6/-3%
Flow Control Settings:
5 settings; 1-5 liters per minute
Power:
AC Power Supply 100-240 V, 50-60 Hz, 275 W Max
frequently, the life expectancy of the concentrator will be shortened due to higher internal operating temperatures.
Particle filters should be cleaned using a mi ld liquid detergent (such as DawnTM) and water solution; be sure the filter is rinsed in water and allowed to air dry befor e reuse. Additional replacement filters may be obtained from Inogen (RP-400). There are other types of filters inside the Inogen At Home that provide additional filtration. Maintenance of these filters is not required under normal operating conditions.

3.2.3. Humidifier Bottle Refill

The humidifier bottle should be routinely refilled according to the manufacturer’s instructions.

3.2.4. Surface Cleaning

The outside case should be cleaned using a clot h dampened with a solution of mild liquid detergent (such as DawnTM) and water. Avoid getting water in or around the power jack or vents.

3.3. Expected Service Requirements

The following table is provided as an estimate only and assumes typical environmental conditions for temperature, humidity, and air pollution. Any smoking around the device will severely shorten its life expectancy. Please refer to product warranty coverage terms.

4. INOGEN AT HOME SYSTEM SPECIFICATIONS

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Environmental Ranges
Temperature: 41 - 104oF (5 - 40oC) Altitude: 0 - 10,000 ft. (0 - 3048 m)
Mode of Operation:
Continuous
Type of Protection Against Electrical Shock:
Class II
Type BF Not intended for cardiac application
Degree of Protection Against Ingress of Water:
Concentrator: IP 21
Degree of Safety for Application in Presence of Anesthetic Gases:
Intended for Use:
Humidity: 15% to 95%, non-condensing

4.1. Classifications

Degree of Protection Against Electrical Shock:

5. INOGEN AT HOME ERROR ALARMS

5.1. DEFINITIONS

5.1.1. Alarm LED: The alarm LED is positioned above a warning symbol () o n the user interface
panel and is used to indicate when an alarm is occurrin g.
Not suitable for such applications
5.1.2. Warning LED: The warning LED is positioned above the Alarm LED and is us ed to indicate when column maintenance is required. Depending on the concentrator version, there may or may not be a triangle symbol positioned below the Warning LED. Please note that the
visuals used below do not include the triangle symbol but actual appearance may vary.
5.1.3. Flow LED Indicator: In addition to the Alarm and Warning LEDs, the flow indi cator LEDs are
used to indicate the reason for which the concentrator is malfunctioning. Unlike in normal operation when the flow indicator LEDs incrementally turn on, only one flow indicator LED turns on with the alarm or warning LED to signify the reason for which the concentrator has errored.

5.1.4. Hour meter Error Code: Unique Error Codes exist for each error which can occur. This code will be displayed on the Hour meter Screen on the backside of the concentrator when the unit is experiencing the error.

5.1.5. Error Recall: The most recent err or can be recalled on the Hour meter screen by pressing and holding the minus (-) button for 5 seconds while the unit is in standby. The unique error code will then be displayed on the Hour meter Screen for 30 seconds after which the Screen will revert back to displaying the life clock.
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5.2. WARNINGS

Indicator Condition Action/Explanation Continuous beep Power Error -
Power was lost during operation.
Flow indicator LED flashing
System Startup – The oxygen concentration and/or flow are not yet in spec.
Solid blue LED Double beep
O2 Service Soon ­One or both of the columns attached to the concentrator need to be replaced.
Try unplugging the power cord and plugging it back in. Try using a different AC outlet or a different power cord. If the alarm is not reset, hold the power button down f or 2 seconds. If error persists, return the concentrat or for service.
As long as the yellow alarm LED is not illuminated, there is no error and no action is required. Once the output stabilizes, the green flow indicator LED will remain solid.
Column maintenance is required within 30 days. Follow the procedure included with the replacement columns to change the columns. Press and hold the plus (+) button for 5 seconds to clear the alarm for 72 hours.

5.3. LOW PRIORITY ALARMS

The following low priority alarm messages are accom panied by a double beep and a solid yellow light.
Indicator Condition
Low Oxygen ­Oxygen < 82% for 10 minutes.
Service Needed ­The concentrator’s compressor has reached its maximum speed.
Hour
Action/Explanation meter Error Code
-25- The concentrator has been producing
oxygen at a slightly decreased level
for over 5 minutes. Column
maintenance may be required or there
may be a leak in the concentrator.
Return the concentrator for service if
the low oxygen error was not
preceded by an O2 service soon error.
-27- The compressor is at its end of life or
there is a leak in the concentrator.
Return the concentrator for service.
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Sensor Fail ­One of the concentrator’s sensors has malfunctioned.
-24- Remove power and restart the
concentrator. If error persists, return
the concentrator for service.
Low Flow - Flow <10% of specified flow setting for 5 minutes.

5.4. MEDIUM PRIORITY ALARMS

The following medium priority alarm messages are accompanied by a triple beep and a flashing yellow light.
Indicator Condition
Oxygen Error ­Oxygen <50% for 10 minutes.
-26-
The concentrator is producing oxygen
at a slightly decreased rate. Ensure air
intake vents have clear access and
particle filters are clean. Check for
kinked tubing and listed for proper
exhaust noise. If problem persists,
return the concentrator for service.
Hourmeter
Action/Explanation
Error Code
-22- The concentrator has a malfunction such as a leak or a failed valve. Return the concentrator for service.
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Flow Error ­Oxygen is <50% of specified flow setting for 1 minute.
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-23-
Proper oxygen delivery is not being detected. Check for kinked tubing and listen for proper exhaust noises. If problem persists, return the concentrator for service.
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5.5. HIGH PRIORITY ALARMS

The following high priority alarm messages are acc ompanied by a five beep pattern and a flashing yellow light.
Indicator Condition
Fire Hazard ­Internal smoke detector has been activated.
System Hot ­Concentrator is too hot and is shutting down.
System Cold ­Concentrator is too cold and is shutting down.
Hourmeter
Action/Explanation
Error Code
- 9- Smoke has been detected inside the device. Allow the concentrator to air out in a smoke-free environment. Restart the concentrator. If the smoke detection error occurs frequently when no smoke is deemed present, return the concentrator for service.
-13-
Ensure air intake and outlet vents have clear access and particle filters are clean. Allow the concentrator to cool for 10 minutes and restart. If problem persists, the cooling fan is not functioning. Return concentrator for service.
-12- Allow the concentrator to warm up in a room temperature environment for 10 minutes and restart. If error persists, return concentrator for service.
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System Error ­System has encountered an error and is shutting down.
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Take note of the error code displayed on the small screen on the backside of the device. See Error Code table below.
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5.6. ERROR CODE TABLE

The following error codes are displayed on the small screen on the backside of the concentrator during System Error.
Error Code Number Condition Action/Explanation
- 2- Software Error. Unplug the external power to clear the e rro r and then restart the concentrator. If error persists, switch to a backup source of oxygen and contact your equipment provider.
- 6- Pressure Error. Check that the sieve beds are installed properly. I f error persists, switch to a backup source of oxygen and contact your equipment provider.
-10- Low Current.
-11- High Current.
-14-
-15-
-18-
Sensor Error. Signal or reading out of spec. Applies to signals from user interface and other internal connections.
Restart concentrator. If error persists, switch to a ba ckup source of oxygen and contact your equipment provider.
There may be a fault with the motor. If error persists, switch to a backup source of oxygen and contact your equipment provider.
A sensor has given an out of range reading and might need to be serviced if the error persists after resta rt ing the concentrator.

5.7. CONTACTS for MORE INFORMATION

Inogen, Inc.
301Coromar Drive
Goleta, CA 93117 1-866-765-2800
http://www.inogenone.com
http://www.inogen.net
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