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Intended Use, Contraindications  
and General Precautions

Intended Use, Contraindications and General Precautions   Chapter 1

Intended Use

The Inogen One® G4 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® G4 may be used in home, institution, vehicle and various mobile environments.

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 
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.

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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English

Содержание InogenOne G4

Страница 1: ...1 1 USER MANUAL ...

Страница 2: ...2 ...

Страница 3: ...itional Operating Instructions 19 Battery Operating Instructions 20 Battery Care and Maintenance Chapter 4 21 Inogen One G4 Oxygen Concentrator Audible and Visible Signals including Alerts Chapter 5 29 Troubleshooting Chapter 6 31 Cleaning Care and Maintenance 31 Cannula Replacement 31 Case Cleaning 31 Filter Cleaning and Replacement 33 Inogen One G4 Column Change Procedure 36 Other Service and Ma...

Страница 4: ...4 ...

Страница 5: ...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 type of back up system recommended CAUTION It is the responsibility of the patient to make back up arra...

Страница 6: ... 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 General Precautions WARNING The device produces enriched oxygen gas which accelerates combustion Do NOT ALLOW SMOKING OR OPEN FLAMES within 10 feet o...

Страница 7: ...ortant Parts of the Inogen One G4 Oxygen Concentrator On Off Button Breath Detection Light Display Audible Alert Button Alert Alert Light Flow Control Description of the Inogen One G4 Oxygen Concentrator Chapter 2 English Description of the Inogen One G4 Oxygen Concentrator Chapter 2 Actual display appearance may vary ...

Страница 8: ...e 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...

Страница 9: ...atus 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 ...

Страница 10: ...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 Batter...

Страница 11: ... Aircraft Power Output Plug Plug into Concentrator 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 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...

Страница 12: ...d to ensure proper breath detection and oxygen delivery WARNING To avoid danger of choking and strangulation hazard keep tubing away from 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 Inogen One G4 Carry Strap CA 401 The carr...

Страница 13: ...he intake vent should be visible through the mesh on the side of the bag just below the cannula barb There is a slim pocket to allow for minimal storage of items such as ID cards and currency 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 p...

Страница 14: ...he 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 10 ...

Страница 15: ...he Inogen One G4 in presence of flammable 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 column...

Страница 16: ...r 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...

Страница 17: ...onnected 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...

Страница 18: ...rn 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 WARNING If you begin to feel ill or are experiencing discomfort while using this device consult your physician immediately CAUTION The Inogen One G...

Страница 19: ...gen 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 ...

Страница 20: ...ting 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...

Страница 21: ...pter 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 ...

Страница 22: ... 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 alt...

Страница 23: ...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 ...

Страница 24: ...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 Ma...

Страница 25: ... examples of those shown in the display s window when the Inogen One G4 is operating on battery power Inogen One G4 Oxygen Concentrator Audible and Visible Signals Audible and Visible Signals Chapter 4 Meaning Battery is empty Battery has less than 10 charge remaining This icon flashes Battery has approximately 40 to 50 charge remaining Battery is full Icon 4 English ...

Страница 26: ...ly 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 Icon Mode Icons These are the mode icons shown in the display s window Display Text NOTE When two conditions occur simultaneously the condition with the higher priority will be displayed Meaning The br...

Страница 27: ...harge e g 86 Default display when the battery is not charging or when the time remaining is not available from the battery 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 Messag...

Страница 28: ... 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 mi...

Страница 29: ...ll 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 The co...

Страница 30: ... A breath has been recognized but proper oxygen delivery has not been detected 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 Message Display Text No Breath Detect Check Cannula Oxygen Error O2...

Страница 31: ...t your equipment provider 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 Message Display Text Battery Empty Attach Plug Battery HOT System HOT High Priority Alerts CAUTION If you are not near t...

Страница 32: ...llow the unit to warm up before starting it If condition persists switch to a backup source of oxygen and contact your equipment provider Concentrator has stopped producing oxygen and is shutting down You should 1 Switch to backup oxygen source 2 Contact your equipment provider Message Display Text System COLD System Error High Priority Alerts continued ...

Страница 33: ...ider Battery is discharged or no battery is present AC Power supply is not connected properly DC Cable is not connected properly Malfunction Concentrator does not power on when On Off button is pressed Recommended Solution Refer to Chapter 4 Possible Cause Refer to Chapter 4 Problem Any problem accompanied by information on concentrator display indicator lights and or audible signals Solutions to ...

Страница 34: ...centrator Check cannula and its connection to concentrator nozzle Concentrator is not powered on Cannula is not connected properly or is kinked or obstructed No oxygen Recommended Solution Possible Cause Problem Troubleshooting continued ...

Страница 35: ...gen One G4 or its accessories in water or allow water to enter into the case this may lead to electrical shock 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 based cleaners on the cases or on the particle filter Filter Cleaning and Replacement The particle filter must be cleaned wee...

Страница 36: ... 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 Lig...

Страница 37: ...ed for practice purpose 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 as sembly can be seen on one side of the device F...

Страница 38: ...he 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 Open and unlocked ...

Страница 39: ...tion 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 ...

Страница 40: ...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 Other Service and Maintenance WARNING Do not disassemble the Inogen One G4 or any of the accessories or attempt any maintenance other than tasks describ...

Страница 41: ...rvice procedure must be followed Disregarding a caution could lead to a minor injury or damage to equipment 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 ...

Страница 42: ...provider for servicing by authorized personnel Do Not Dispose of In Unsorted Municipal Waste Type BF Applied Part Not Intended for Cardiac Application Class II Device Electrical Safety Agency Certification Logo Symbol User Interface Label Meaning ON OFF Button Increase Flow Setting Decrease Flow Setting Audible Alert Button Symbol ...

Страница 43: ...0 to 60 Hz Auto Sensing 1 0A DC Input 13 5 15 5VDC 10A Max Voltage 12 0 to 16 8VDC 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 ...

Страница 44: ...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 Tested by Independent Laboratory Safety IEC 60601 1 CAN CSA C22 2 No 60601 1 Electromagnetic Compat...

Страница 45: ...rs 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 Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst EC 61000 4 4 Surge IEC 61000 4 5 6 kV contact 8 kV air 6 kV contact 8 kV air ...

Страница 46: ...mum output power of the communi cations equipment 150 kHz to 80 MHz d 1 2 P 0 12 0 38 1 2 3 8 12 0 12 0 38 1 2 3 8 12 0 23 0 73 2 3 7 3 23 0 01 0 1 1 10 100 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P Separation Distance According to Frequency of Transmitter M Rated Maximum Power Output of Transmitter W For transmitters rated at a maximum output power not listed above the recommended sepa...

Страница 47: ......

Страница 48: ...PN 96 06728 00 01 B Inogen Inc 326 Bollay Drive Goleta CA 93117 Toll Free 877 466 4362 1 805 562 0515 Outside the USA E mail info inogen net www inogen com 2016 Inogen All rights Reserved ...

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