Inogen One G3 Technical Manual Rev F

This Manual applies to the following Inogen, Inc. products: 

Inogen One G3 Oxygen Concentrator, model # IO-300



Inogen One AC Power supply, model # BA-301



Battery, model # BA-300



Battery, model # BA-316

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TABLE OF CONTENTS 1.

INFORMATION FOR PROVIDERS OF THE INOGEN ONE G3 ... 4 CAUTION AND WARNING STATEMENTS ... 4

1.1. 2.

SETTING UP A PATIENT ON INOGEN ONE G3 ... 6 2.1.

RECOMMENDATIONS FOR USE ... 6

2.2. SYSTEM COMPONENTS ... 6 2.3.

USING THE INOGEN ONE G3 ... 7

2.4. SELECTING THE PROPER FLOW SETTING... 7 3.

SERVICING THE INOGEN ONE G3 ... 9 3.1.

MAINTENANCE BY THE PROVIDER... 9

3.2.

MAINTENANCE BY THE PATIENT ... 13

3.3.

EXPECTED SERVICE REQUIREMENTS ... 16

4.

INOGEN ONE G3 SYSTEM SPECIFICATIONS... 16

5.

INOGEN ONE G3 ERROR CODE TABLE ... 18

6.

ERROR RECALL ... 19

7.

CONTACTS FOR MORE INFORMATION ... 19

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1. INFORMATION FOR PROVIDERS OF THE INOGEN ONE G3 Thank you for choosing to provide your patients with the Inogen One G3 oxygen concentrator. We are pleased to offer you and your patients one solution for your many oxygen needs. This Technical Manual will familiarize you with provider-specific information regarding the Inogen One G3 Oxygen Concentrator and its accessories. Before reading this Technical Manual,

please read and review the Inogen One G3 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 One G3 and its accessories. Proper One G3, 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 One G3 Oxygen Concentrator, you must observe them carefully. A WARNING indicates that the personal SAFETY of the Patient may be involved. WARNING

Disregarding a WARNING could result in a significant injury. Be sure that patients understand all WARNING statements. A CAUTION indicates that a precaution or a service procedure must be followed.

CAUTION

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

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NOTE

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 Inogen

DESIGN

One G3 and/or accessories. This information is included in this manual to provide

NOTE

you with a greater working understanding of the device. This information is not required to operate or maintain the Inogen One G3.

In many cases, warnings and cautions have been included in the Inogen One G3 User Manual.

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2. SETTING UP A PATIENT ON INOGEN ONE G3 2.1. Indications for Use The Inogen One G3 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 concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicle and various mobile environments. Availability of an alternate source of oxygen is recommended in case of power NOTE

outage. Several certifying bodies for Home Health Care Providers require that back-up oxygen be available to the patient. Supplemental oxygen cylinders or extra Inogen One G3 Batteries may satisfy these requirements.

Oxygen demand of some patients, particularly those with high breathing rates CAUTION

and high flow settings, may exceed the capabilities of the Inogen One G3. Inogen suggests that each patient be titrated to assure that the Inogen One G3 is an appropriate solution for their needs.

2.2. System Components The following are standard components of the Inogen One system: o Inogen One G3 Oxygen Concentrator o 8 Single Battery, BA-300 o AC to DC Power Supply, BA-301 o DC Power Cord o Carry Bag o Cannula Patient Set-Up. To properly set up a patient on the Inogen One G3 System, you may need to provide: o Pulse Oximeter (for titration, not included) o Extra cannulas (not included) CONFIDENTIAL and PROPRIETARY

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2.3. Using the Inogen One G3 To quickly configure the Inogen One G3 for patient use: 1. Slide the battery onto the bottom of the system until the latch clicks into place. 2. Connect AC power cord to the power supply. 3. Connect the power supply to the Inogen One G3. 4. Plug into closest AC outlet 5. Turn on the Inogen One G3 by pressing the on/off button. 6. Set the Inogen One G3 to correct flow setting prescribed by the physician or clinician by pressing the + (increase flow) or (decrease flow) button. 7. Attach cannula to the metal hose barb located next to the handle of the Inogen One G3. For further information regarding the use of the Inogen One G3, please consult the User Manual. 2.4. Selecting the Proper Flow Setting 2.4.1. Bolus Volumes Specification All oxygen conserving devices

function differently, and therefore it is prudent

to titrate patients for any new conserving device. Delivery timing, bolus volume, and FiO2), saturation. As an oxygen concentrator, the Inogen One G3 does not contain a finite stored volume of oxygen, such as with compressed gas or liquid cryogenic systems. The Inogen One G3 can provide oxygen to the patient as long as a source of electricity is available. However, because the oxygen is being produced as it is used, supply of oxygen is rate-

limited. The Inogen One G3 delivers up to 1050 ml/min of 90% oxygen (earlier models deliver up to 840 ml/min of 90% oxygen). At each flow setting, the Inogen One generates a specific amount of oxygen (210ml per setting), and the on-board OCD attempts to deliver all of this product to the patient. This is equivalent to a conserving ratio of 4.76 at all flow settings and breathing rates. CONFIDENTIAL and PROPRIETARY

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Slower breathing patients will receive larger boluses, and faster breathing patients will receive smaller boluses. This method of bolus volume determination is similar to what is experienced by a

DESIGN

patient using a continuous flow concentrator actual alveolar oxygen inspiration

NOTE

is more closely linked to flow setting than to breathing rate.

In general, the Inogen One G3 delivers 14ml per bolus per flow setting at 15 breaths per minute (210ml/min per flow setting). The following table summarizes the bolus volumes delivered by the Inogen One OCD at 20C and Sea Level: Flow setting 1.0 2.0 3.0 4.0 5.0

Flow Rate (ml +/- 10%) 180 210 420 630 840 1050

10 BPM (+/- 3ml or +/- 10%) min nominal max 18.9 21.0 23.1 37.8 42.0 46.2 56.7 63.0 69.3 75.6 84.0 92.4 94.5 105.0 115.5

20 BPM (+/- 3ml or +/- 10%) min nominal max 9.5 10.5 13.6 18.9 21.0 27.2 28.4 31.5 40.8 37.8 42.0 54.4 47.3 52.5 67.9

25 BPM (+/- 3ml or +/- 10%) min nominal max 7.6 8.4 9.2 15.1 16.8 18.5 22.7 25.2 27.7 30.2 33.6 37.0 37.8 42.0 46.2

Bolus Volume is tuned to provide the correct bolus volume when delivered DESIGN

through a nasal cannula such as the Salter Labs 1600Q. If bolus volumes are

NOTE

measured without a cannula or with a different type of nasal cannula, bolus volumes will vary from values stated in the table above.

2.4.2. Trigger sensitivity The conserver will trigger when the negative pressure at the internal sensor reaches 0.12 cm H20 (+/- 20%). This low trigger sensitivity allows for breath detection of very shallow breathing, but may also result in the occasional trigger due to motion of the cannula or motion of the concentrator. The trigger sensitivity may vary 2.4.3. Flow Setting Selection Relative to Physician Prescription Inogen has labeled each of the four settings to provide a guideline for matching the setting of the device to the continuous flow prescription issued by the physician. CONFIDENTIAL and PROPRIETARY

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volume, and other physiologic factors. Inogen suggests that each patient be titrated (a) while sedentary, (b) while active or ambulatory. 2.4.4. Use with the Inogen Satellite Conserver The Inogen One G3 is not compatible with the Inogen One Satellite Conserver 3. SERVICING THE INOGEN ONE G3 3.1. Maintenance by the Provider 3.1.1.

Authorized Repair Centers

The Inogen One G3 is only intended to be repaired by authorized repair centers. 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 lists and the necessary repair equipment. 3.1.2. Checking Life Clock, Serial #, and SW version To check usage, press and hold the Alarm Bell Button for 5 seconds. The display will show the hour meter installed on the device. Do not disassemble the Inogen One G3 or any of the accessories or attempt any maintenance other than tasks described in this Technical Manual unless you have NOTE

completed a training course through Inogen. Disassembly of the Inogen One G3 or any of the accessories without proper training certification will void the product warranties. Contact Inogen for information about receiving proper training and certification for service of the Inogen One G3 and accessories.

3.1.3. Suggested Materials for Regular Maintenance To perform regular field maintenance (by a technician) on the Inogen One G3 System, you may need:

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o Replacement cannulas (RP-128) o Replacement intake screens (RP-300 and RP-301) o Replacement Inogen One G3 Batteries (BA-300 or BA-316) o Cannula barb removal tool (Spanner Wrench, RP-102) o Replacement product filters (RP-101) o USB storage drive for data log transfers (such as PNY PN# P-FD2GBATT2-SF) o External Oxygen Analyzer (such as Salter Labs PrO2 Check) During a normal field maintenance visit, the technician may elect to turn off the concentrator for approximately 30 minutes. If the patient requires oxygen during

NOTE

this period, Inogen recommends making arrangements to bring an extra oxygen supply (such as a supplemental Inogen One G3 Concentrator).

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, 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 service. 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 CAUTION

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 safety of the device, arrange for equipment servicing.

3.1.5. Product Filter This filter is intended to protect the user from small particles in the product gas flow. The Inogen One G3 includes a product filter, conveniently located behind the removable cannula nozzle fitting. Inogen suggests that this filter be replaced between patients. CONFIDENTIAL and PROPRIETARY

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To replace the Product Filter: 1. Use the Cannula Barb Tool (available from Inogen as RP-102) 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 One G2. 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 new 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. Failure to inspect and replace the product filter may result in the filter becoming WARNING

clogged or obstructed over time, and in reduced delivery of oxygen to the patient.

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. Data Logging Operating data from your Inogen One G3 concentrator are periodically recorded to flash memory located within the device. Data is stored for a period of approximately 6-12 months; new data replaces the oldest data as it is collected. Additionally, the device records errors and system information at the time of the error which is useful in diagnostics.

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3.1.7.1. The following information is a list of recorded parameters that can be used to evaluate the device and its usage: 

Real Time Clock



Life Clock



Flow Setting



Breaths per Minute



Low, Medium, and High Priority Errors



Ambient Pressure



System Temperature



Battery Status



Charging Status

3.1.8. Data Download To download data from the Inogen One G3, you will need a USB mass storage device. If one of the following drives cannot be obtained, the drive must be less than 2GB in capacity and have a native file format of FAT32. The capacity of the drive and the file system alone do not ensure compatibility with the Inogen One G3. Compatible USB drives include: 

PNY Attache 2GB PN: P-FD2GBATT2-SF



SanDisk Cruzer Micro 2GB PN:SDCZ6-2048RB



Kingston Data Traveler G3 2GB PN:DTIG3/2GBZ



Kingston DataTraveler 102 2GB PN:DT102/2GB



Kingston DataTraveler DT101 2GB PN: DT101G2/2GB



Dane-Elec DNL 2GB PN:DNLDAZMP02GCAW



Transcend JetFlash V30 2GB PN:TS2GJFV30



Patriot Signature 2GB PN: PSF2GUSB

To collect data: a) With the Inogen One G3 off, insert the USB mass storage device into the USB port behind the blue rubber cover b) Plug in external power to the concentrator CONFIDENTIAL and PROPRIETARY

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c) Press

bell

d) The admin e)

bell

f) g)

type of USB mass storage device

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 four to 25 feet in length must be used. Inogen has certified its performance data with the Salter Laboratories 1600Q cannula.

CAUTION

Do not use total cannula tubing length exceeding 25 feet with the Inogen One G3 unless proper saturation has been verified by a clinician.

3.2.2. Intake Filter Cleaning At the front of the Inogen One G3, ambient air passes through two gross particle screens that removes dust fragments. This particle screen must be cleaned on a weekly basis to ensure adequate air flow through the device. If the particle screen is not cleaned frequently, the life expectancy of the concentrator will be shortened due to higher internal operating temperatures. Particle screens should be cleaned using a mild detergent (e.g., dishwashing solution, such as DawnTM) and water solution; be sure the filter is rinsed in water and allowed to air dry before reuse. Additional replacement filters may be obtained from Inogen (RP300 or RP-301). There are other types of filters inside the Inogen One G3 that provide additional filtration. Maintenance of these filters is not required under normal operating conditions.

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3.2.3. Surface Cleaning The outside case should be cleaned using a cloth dampened with a solution of mild detergent (e.g., dishwashing detergent, such as DawnTM) and water. Avoid getting water in or around the battery connectors, power jack, or vents. 3.2.4. Battery Care and Maintenance The Inogen One G3 Lithium Ion Battery requires special care to ensure proper performance and long life. Use only Inogen One G3 Batteries with the Inogen One G3 Oxygen Concentrator.

The Inogen One G3 Oxygen Concentrator adjusts its oxygen production rate to match the oxygen demand specified by the user flow setting. When the device DESIGN

is used at lower settings, its battery life is extended. Additionally, at lower

NOTE

flow settings, the concentrator does not generate as much heat and noise, draw as much electric current from external power supplies, and many system components do not wear as quickly. Initial Battery State The Inogen One G3 batteries are shipped 40% to 100% charged. The battery can be used immediately; however, we recommend the battery be charged upon receipt to ensure adequate run time. Normal Charging The battery is operating properly when a battery icon is displayed on the LCD screen. The Inogen One G3 packs. The Inogen One G3 batteries can be partially charged and discharged without damaging the battery packs. Effect of Temperature on Battery Performance The Inogen One G3 battery powers the Inogen One G3 Oxygen Concentrator from

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2 to 4.5 hours using the standard 8 cell pack (BA-300) under most environmental conditions. To maintain maximum run-time of the battery, users should avoid running in temperatures less than 40oF (4oC) or higher than 95oF (35oC) 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 batteries not be charged at room temperatures exceeding 75oF (24oC). DESIGN

The BA-300 and BA-316 will typically achieve 500 charge/discharge cycles while

NOTE

retaining 80% of their original capacity if proper battery care is taken. Battery Time Remaining Clock The Inogen One G3 continuously displays battery time remaining. It may be necessary to inform the user that this displayed time is only an estimate, and the actual time remaining may vary from this value. To avoid running out of battery power unexpectedly, users should regularly monitor the displayed battery time remaining and/or carry a back-up power supply (extra charged battery or AC Power Supply). Storage Instruct patients to remove the battery from the Inogen One G3 when it is not in use to avoid inadvertent discharge. Leaving a battery attached to an idle Inogen One G3 for prolonged periods will result in battery damage that will severely shorten the expected life of the battery.

DESIGN NOTE

CAUTION

When the concentrator is off but the battery installed, the battery will continue to power draw will empty a full battery in approximately 2-3 weeks. Leaving a Battery in the Inogen One G3 while the device is unused will irreversibly damage the battery. After such storage, the battery may not be able to recharge

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or its life cycle and/or capacity will be greatly diminished. A full battery can be damaged in as little as 20 days if left in the concentrator while not plugged in. Instruct users to avoid storing the Inogen One G3 battery in extreme temperatures, below -4oF (-20oC) or above 140oF (60oC), for any amount of time. They should avoid leaving batteries in automobiles, where these temperatures can be regularly exceeded. Storage of the Inogen One G3 battery in a cool, dry location will help to maximize the longevity of the battery. 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. Service Item Battery

Estimated Service Requirement Frequency 500 full charge/discharge cycles (to approximately 80% capacity)

Compressor

Function of flow setting and time 20,000 run hours @ flow setting 4 25,000 run hours @ flow setting 2

Oxygen Sensor

No Service Requirement

Molecular Sieve

18 to 36 months depending on usage

Valves

25,000 run hours

Intake Filter

20,000 run hours (without smoke or other abnormal contaminants)

Cooling Fan

25,000 run hours

4. INOGEN ONE G3 SYSTEM SPECIFICATIONS

INOGEN ONE G3 CONCENTRATOR Dimensions: CONFIDENTIAL and PROPRIETARY

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INOGEN ONE G3 OXYGEN CONCENTRATOR TECHNICAL MANUAL

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Cm 22.2 22.2

In 8.75 8.75

Cm 7.6 7.6

Weight:

No battery 8 cell battery 22.2 8.75 7.6 16 cell battery 4.8 pounds (includes 8 cell battery)

Noise:

<42 dB (G3) or 39 db (G3HF) on flow setting 2

Warm-Up Time:

Approximately 2 minutes

Oxygen

In 3.0 3.0

Cm 18.4 21.0

In 7.25 8.25

3.0

23.5

9.25

90 + 6/-3%

Concentration: Flow Control Settings:

1,2,3,4,and 5 (G3HF only) AC Power Supply Input:100 to 240 VAC, 50 to 60 Hz, 1.0A to 0.5A Output 19 VDC, 85 W

Power:

DC Input: 13.5 to 19 VDC, 10A Rechargeable Battery: Voltage12.0 to 16.8 VDC, Battery Duration:

Approximately 2 to 4 hours for 8 cell battery Approximately 4 to 8 hours for 16 cell battery

Battery Charging

Approximately 2.25 to 4.25 hours for 8 cell battery

Time:

Approximately 4.25 to 8.00 hours for 16 cell battery

Environmental Ranges

Temperature: 40 - 104oF (4 - 40oC)

Intended for Use:

Humidity: 0% to 95%, non-condensing

Classifications Mode of Operation:

Continuous Duty

Type of Protection Against Electrical Shock:

Class II

Degree of Protection Against Electrical

Type BF

Shock:

Not intended for cardiac application

Degree of Protection Against Ingress of

Concentrator: IP 20

Water:

w/carry bag:

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Degree of Safety for Application in

Not suitable for such applications

Presence of Anesthetic Gases:

5. INOGEN ONE G3 ERROR CODE TABLE Error Code

Explanation

Possible Causes & Troubleshooting

Number 001

Instructions Low voltage on power supply

Replace the power supply or remove the battery to see if the concentrator was running on battery power

004

Pressure Error

The concentrator was shut down due to a pressure error. Check that the sieve beds are installed properly.

016

System electric current out of

There may be a fault with the motor.

specifications

If the error is persistent, return the concentrator for service

128

Signal or reading out of spec.

A sensor has given an out of range

Applies to signals from user

reading and might need to be serviced

interface and other internal

if the error persists after restarting

connections.

the concentrator.

System Hot

Temperature out of

Remove the concentrator from the

System Cold

specifications

carry bag and restart the concentrator after 10 minutes to cool down. If the error persists, the fan may have failed. If the System Cold message appears, allow the concentrator to warm up for 15 minutes in a room temperature environment and then restart the concentrator.

Battery Hot

Battery over temperature during

The concentrator might need to be

Warning

discharge

moved to a cooler location with

Battery Hot Oxygen Low

improved ventilation The Oxygen purity is < 82% for 30 The sieve beds may require servicing minutes

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Oxygen Error

The Oxygen purity is < 50% for 10

The concentrator has a malfunction

minutes

such as a leak or a failed valve

The oxygen sensor is returning

If the problem persists, return the

false readings

concentrator for service

Battery Error/

The system is not properly

Remove and reinsert the battery to

Check Battery

communicating with the battery

clear the error. If the error persists,

Sensor Fail

replace the battery Service

The compressor has reached

The compressor is at its end of life or

Needed/

maximum speed

there is a leak in the concentrator

The input voltage is less than 17V

Remove power to the concentrator

Service Soon External Power Low

and remove and reinsert the battery. Try another external power source such as DC power

O2 Delivery

A Breath is detected but oxygen

Check for kinked tubing and listen for

Error

is not being delivered

proper exhaust noises. If problem persists, return the concentrator for service

O2 Service

The adsorbent beds are near the

Within approximately 30 days, replace

Soon/

end of their useful life

the adsorbent beds

Replace Columns 6. ERROR RECALL Certain errors can be recalled so that the device displays the last error that occurred. The last error stored in memory may be accessed by holding the Plus button for 5 seconds while the unit is in standby mode. All errors will be stored except when the unit is operating in special admin mode, no breath detect, battery low, and Error 1.

7. CONTACTS FOR MORE INFORMATION Inogen Website:

Patient Issues: http://www.inogenone.com Corporate:

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Inogen :

326 Bollay Dr Goleta, CA 93117 1-866-765-2800 [email protected]

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