Inogen One G3 Manual de usuario

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TECHNICAL MANUAL Page 1 of 16

INOGEN ONE G3 OXYGEN CONCENTRATOR

TECHNICAL MANUAL

96-03996-00-01

Revision H

GUIDANCE TO AUTHORIZED SERVICE AND REPAIR CENTERS

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.....................................3

1.1. CAUTION AND WARNING STATEMENTS.............................................................................3

2. SETTING UP A PATIENT ON INOGEN ONE G3...........................................................4

2.1. RECOMMENDATIONS FOR USE.........................................................................................4

2.2. SYSTEM COMPONENTS...................................................................................................4

2.3. USING THE INOGEN ONE G3...........................................................................................4

2.4. SELECTING THE PROPER FLOW SETTING .........................................................................5

3. SERVICING THE INOGEN ONE G3...............................................................................6

3.1. MAINTENANCE BY THE PROVIDER ....................................................................................6

3.2. MAINTENANCE BY THE PATIENT.....................................................................................11

3.3. EXPECTED SERVICE REQUIREMENTS.............................................................................13

4. INOGEN ONE G3 SYSTEM SPECIFICATIONS...........................................................14

5. INOGEN ONE G3 ERROR CODE TABLE ...................................................................15

6. ERROR RECALL..........................................................................................................16

7. CONTACTS FOR MORE INFORMATION....................................................................16

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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 care in relaying this information will not only enhance the user’s experience with the

Inogen 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.

WARNING

A WARNING indicates that the personal SAFETY of the Patient may be

involved. Disregarding a WARNING could result in a significant injury. Be

sure that patients understand all WARNING statements.

CAUTION

A CAUTION indicates that a precaution or a service procedure must be

followed. Disregarding a caution could lead to a minor injury or damage to

the equipment. Be sure that patients understand all CAUTION statements.

NOTE

A NOTE indicates specific information to improve ease of use or

maintenance of the equipment.

DESIGN

NOTE

A DESIGN NOTE indicates specific information regarding the design of the

Inogen One G3 and/or accessories. This information is included in this

manual to provide you with a greater working understanding of the device.

This information is not required to operate or maintain the Inogen One 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.

NOTE

Availability of an alternate source of oxygen is recommended in case of

power 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.

CAUTION

Oxygen demand of some patients, particularly those with high breathing

rates 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:

oInogen One G3 Oxygen Concentrator

o8 Single Battery, BA-300

oAC to DC Power Supply, BA-301

oDC Power Cord

oCarry Bag

oCannula

Patient Set-Up. To properly set up a patient on the Inogen One G3 System, you may

need to provide:

oPulse Oximeter (for titration, not included)

oExtra cannulas (not included)

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.

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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 (OCD’s) function differently, and therefore it is prudent

to titrate patients for any new conserving device. Delivery timing, bolus volume, and

oxygen concentration all contribute to a patient’s fraction of inspired oxygen (FiO2),

and therefore to the OCD’s efficacy at maintaining the patient’s blood oxygen

saturation.

As an oxygen concentrator, the Inogen One 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. Slower breathing patients will receive larger boluses, and faster

breathing patients will receive smaller boluses.

DESIGN

NOTE

This method of bolus volume determination is similar to what is

experienced by a patient using a continuous flow concentrator – actual

alveolar oxygen inspiration 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

Flow Rate

(ml +/- 10%)

180 min nominal max min nominal max min nominal max

1.0 210 18.9 21.0 23.1 9.5 10.5 13.6 7.6 8.4 9.2

2.0 420 37.8 42.0 46.2 18.9 21.0 27.2 15.1 16.8 18.5

3.0 630 56.7 63.0 69.3 28.4 31.5 40.8 22.7 25.2 27.7

4.0 840 75.6 84.0 92.4 37.8 42.0 54.4 30.2 33.6 37.0

5.0 1050 94.5 105.0 115.5 47.3 52.5 67.9 37.8 42.0 46.2

10 BPM

(+/- 3ml or +/- 10%)

20 BPM

(+/- 3ml or +/- 10%)

25 BPM

(+/- 3ml or +/- 10%)

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DESIGN

NOTE

Bolus Volume is tuned to provide the correct bolus volume when

delivered through a nasal cannula such as the Salter Labs 1600Q. If

bolus volumes are 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.

Actual correlation is dependent upon the patient’s breathing rates, inspiratory tidal

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. 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:

oNitrile Gloves or equivalent

oSafety Glasses

oDisinfecting wipes or Spray designed to kill bacteria and viruses

oCompressed Air (30 psi / 207 kPa, for blowing off parts)

oParticulate Respirator (N95 rated)

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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.

3. Avoid touching your face during and after cleaning the concentrator to

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

The use of Nocolyse (OxyPharm) surface disinfectant system

has been approved for use in Europe. Not approved in United

States.

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 debris.

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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.

3.1.3. Checking Life Clock, Serial #, and SW version

To check usage, press and hold the Alarm Bell Button for 5 seconds. The

concentrator’s display will show the hour meter, the unit’s serial number, and the

software version installed on the device.

NOTE

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 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.

3.1.4. Suggested Materials for Regular Maintenance

To perform regular field maintenance (by a technician) on the Inogen One G3

System, you may need:

oReplacement cannulas (RP-128)

oReplacement intake screens (RP-300 and RP-301)

oReplacement Inogen One G3 Batteries (BA-300 or BA-316)

oCannula barb removal tool (Spanner Wrench, RP-102)

oReplacement product filters (RP-101)

oUSB storage drive for data log transfers (such as PNY PN# P-FD2GBATT2-

SF)

oExternal Oxygen Analyzer (such as Salter Labs PrO2 Check)

NOTE

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 this period, Inogen recommends making arrangements

to bring an extra oxygen supply (such as a supplemental Inogen One

G3 Concentrator).

3.1.5. System Inspection

At the start of any maintenance visit:

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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.

CAUTION

Discovery of cracks or other types of external damage may be

indicative of other internal damage that may not be visible. If such

external damage is discovered, be certain to inquire as to how it

occurred, and whether any changes in the device have been noticeable

since its occurrence. If you have any concern over the safety of the

device, arrange for equipment servicing.

3.1.6. 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.

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.

WARNING

Failure to inspect and replace the product filter may result in the filter

becoming clogged or obstructed over time, and in reduced delivery of

oxygen to the patient.

3.1.7. 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.

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3.1.8. 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.

3.1.8.1. 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

3.1.9. 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

c) Press the “alarm bell” and the “light” buttons for 5 seconds

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