Inogen At Home GS-100 User Manual – English
Contents
1. and utilizes an intelligent alarm system to indicate a malfunction of the concentrator Mathematical algorithms and time delays are used to reduce the probability of false alarms while still ensuring proper notification of an alarm condition If multiple alarm conditions are detected the highest priority alarm will be displayed To insure that audible notifications may be heard the operators position must be determined to suit the surrounding noise level Note that failure to respond to the cause of an alarm condition for low medium and high priority alarms potentially will result in discomfort or reversible minor injury only and develop within a period of time sufficient to switch to a backup source of oxygen The following notification messages are accompanied by an audible and or Condition Action Explanation Flow rate on LED Current flow rate of oxygen being displayed at a Display setting from 1 5 liters per minute visual indicator Flow rate indicator Flow status indicator is green Blue Indicator Light Column maintenance is required within 30 days Contact your equipment provider to arrange service Low Priority Alarms The following low priority alarm messages are accompanied by a double beep and a solid yellow light Low Oxygen Service Needed Sensor Fail Flow setting flashing Low Flow LS Qu4s Je3 e Fle2 A e1 Medium Priority Alarms Concentrator is producing oxygen at a slightl2. INOGEN at RE USER MANUAL n gen Contents Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 WN N N Vi U1 R A Glossary of Symbols Warnings Cautions and Contraindications Contraindications Warnings Cautions Indications for Use Indications for Use User Interfaces Controls and Serviceable Items User Interfaces User Controls Serviceable Items Operating Instructions Audible and Visual Indicators Troubleshooting Cleaning Care and Maintenance Cleaning and Care Routine Maintenance Replacement Parts and Recommended Accessories Service Column Change Procedure Storage Specifications 1 Glossary of Symbols Symbol Key WARNING CAUTION DOOQESGDORO bb Awarning indicates that the personal safety of the patient may be involved Disregarding a warning could result in significant injury Romy A caution indicates that a precaution or service procedure must be followed Disregarding a caution could lead toa minor injury or damage to equipment l ps 44 a 4 4 sata 4 45 473 A IP21 On Off Power Flow setting indicator parl C Blue Indicator Light General alarm indicator light Follow instructions for use Type BF Applied Part Ec REP Class Il Equipment No Open Flames No Smoking No Oil or Grease Do Not Disassemble THIS SIDE UP U S Federal Regulation Restricts this device to sale by order
3. cations 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 used 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 4 User Interfaces Controls and Serviceable Items Blue Indicator Light Flow Setting Indicator INOGEN at gt a le5 k l Flow gt le3 Control On Off Button General Caution Indicator User Interfaces 2 General Caution Indicator Light Low Medium Priority Alarm A yellow light indicates either a change in operating status or a condition that may need response A flashing light is higher priority than non flashing Blue Indicator Light Change Column Soon e Column maintenance is required within 30 days Contact your equipment provider to arrange service User Interfaces Audible Indicators An audible alarm beep indicates either a change in operating status or a condition that may need response alarm More C T 1 frequent beeps indicate higher priority conditions y 2 Flow Setting Indicator je 3 A green indicator light indicates the selected flow setting e 2 1 User Controls ON OFF Button Press once to turn ON Press and hold for one second to turn OFF Flow Setting Control Buttons Use the or flow setting control buttons to select the sett
4. eclaration Electromagnetic Emissions The concentrator is intended for use in the electromagnetic environment specified below The user of the concentrator should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions The concentrator uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and not likely to cause any interference in nearby equipment RF emissions Class B The concentrator is suitable for use in all establishments including CISPR 11 domestic establishments and those directly connected to the public Harmonic Emissions Class A low voltage power supply network that supplies buildings used for IEC 61000 3 2 domestic purposes Voltage fluctuations Complies flicker emissions IEC 61000 3 3 15 n gen 2015 Inogen All rights Reserved 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 Ec rer Europe Authorized Representative EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 0 70 345 8570 TGA Australia sponsor 166371 Independent Living Specialists 67 Mars Road Lane Cove NSW 2066 Tel 61 0 2 94274995 PN 96 04564 00 01B
5. entrator so that it is difficult to disconnect the power cord Turn on the concentrator by pressing the ON OFF button See illustration 5 A single short beep will sound and all indicator lights will illuminate for a few seconds Use the or buttons to adjust the device to the prescribed setting There are five flow settings from 1 liter per minute to 5 liters per minute The current setting can be viewed on the display The green LED will illuminate once the set flow rate of oxygen is achieved You may begin breathing from the device the required oxygen concentration is normally reached within five minutes after device is powered on Ensure that the tubing is not kinked or pinched in any way and that oxygen is flowing through the nasal cannula If oxygen is not flowing the green LED will not be illuminated Refer to the troubleshooting guide section of this manual Adjust the nasal cannula so that it is properly aligned on your face or as directed by your healthcare provider Turn off the concentrator by pressing the ON OFF button Turn off the concentrator when not in use Nozzle Fitting INOGEN MAI 4A2 4B2 6 Audible and Visual Indicators Blue pas 7 v Indicator Light ndicator Yellow Indicator Light The concentrator has an audible alarm and three visual indicators green yellow and blue Notifications The concentrator monitors various parameters during operation
6. etic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol t Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8kV air 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 8kV air Electrical fast transient burst EC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 2 kV for power supply lines 1 kV for input output lines 1kV line s to line s 2 kV line s t earth lt 5 U 39526 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment 1 kV for input output lines 1kV line s to Mains power quality should be that of a typical commercial line s or hospital environment 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment If the user of the ME EQUIPMENT or ME SYSTEM requires continued operation during power mains interrupti
7. field strengths should be less than 3V m Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device This concentrator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the concentrator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and this concentrator as recommended below according to the maximum output power of the communications equipment Rated Maximum Power Separation Distance According to Frequency of Transmitter M Output of Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 1 2VP d 2 3VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maxi mum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE The guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Guidance and Manufacturer s D
8. he device 2 Unplug the concentrator from the electrical outlet 3 Lay down the concentrator 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 5 Press the latch button with thumb or finger and pull the column out of the concentrator using the pull ring attached to the bottom of 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 metal tubes 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 Do not leave the column exposed after the dust caps are removed it should be inserted into the concentrator as soon as the dust caps have been removed to minimize environmental exposure 10 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 amp 5
9. ing 2 as shown on the display There are five settings from 1 to 5 Serviceable Items Particle Filter The filter must be in place at the intake end of the concentrator during operation Air Inlet Filter The filter must be in place at the top of the concentrator during operation Nozzle Cannula Nozzle Fitting Fitting The nasal cannula connects to this nozzle for output of oxygen Nasal Cannula Nasal cannulas should be replaced on a regular basis consult with your physician or equipment provider or cannula manufacturer s instructions 5 1 Operating Instructions Place the concentrator in a well ventilated location air intake and exhaust must have clear access Ensure that the concentrator is at least 6 inches 15 cm away from walls furniture and curtains that could impede adequate airflow to the device Ensure particle filter is in place Ensure intake filter is in place Follow instructions A or B below A Ifyou are not using a humidifier bottle connect your nasal cannula tubing to the nozzle fitting Nozzle fitting is located on the top of the concentrator See illustrations 4A1 and 4A2 B If you are using a humidifier bottle follow the manufacturer s instructions Place the humidifier bottle in the designated holder See illustrations 4B1 and 4B2 Attach the power cord to the back of the concentrator and plug the other end into an electrical outlet Do not position the conc
10. n is pressed Malfunction Contact your equipment provider No oxygen Concentrator is not Press On Off button to powered on power concentrator Cannula is not Check cannula and its connected properly oris connection kinked or obstructed The oxygen tubing or Inspect and replace cannula is faulty the items if necessary 8 Cleaning Care and Maintenance Cleaning and Care Periodically you may clean the outside case using a cloth dampened with a mild liquid detergent such as Dawn and water Follow manufacturer s instructions on cleaning and care of concentrator accessories clean or replace these accessories according to your healthcare provider or respective manufacturer s instructions for use 10 Filter Cleaning and Replacement The particle filter must be cleaned weekly to ensure the Particle ease of air flow Remove filter from the side of the device Clean the particle filter with a mild liquid detergent such as Dawn and water rinse in water and dry before reuse Ensure the filter is completely dry before reinstalling into the concentrator Air Inlet Filter Replace when filter is dirty according to visual indicator The airinlet filter may be replaced by the equipment provider or by the user Output Filter The output filter is intended to protect the user from inhalation of small particles in the product gas flow The device includes an output filter conveniently located behind the removable cannula
11. nozzle fitting Inogen requires that this filter be replaced between patients The output filter may be replaced by the equipment provider or by the user Routine Maintenance No special maintenance other than weekly particle filter cleaning needs to be carried out by the user Replacement Parts and Recommended Accessories Contact your home care provider if you have any questions about equipment Use only the following replacement parts and accessories with this device e Inogen At Home Particle Filter RP 400 e Inogen At Home Output Filter Replacement Kit RP 107 e Inogen At Home Air Inlet Filter RP 401 Inogen At Home Column Pair RP 402 e Humidifier Connector Tube Salter Labs S0 676 e Humidifier Bottle Salter Labs 7600 e Nasal Cannula Salter Labs 16SOFT e AC Power Cord RP 109 Service The concentrator is specifically designed to minimize routine preventative maintenance 11 For assistance if needed in setting up using maintaining or reporting unexpected operation or events contact your equipment provider or the manufacturer Column Change Procedure There are two columns metal tubes on the concentrator located behind the particle filter These two columns will be removed and replaced when service is required Ensure adequate time to complete all steps without disruption is allotted when performing this maintenance 1 Turn off the concentrator by pressing the power button to shut down t
12. nt Part 1 General requirements for basic safety and essential performance Classification IEC Class Il Equipment Type BF Applied Part IP21 Enclosure Ingress Protection against solid objects of 12 5mm minimum diameter and vertically falling drops of water Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Continuous Operation 13 Guidance and Manufacturer s Declaration Electromagnetic Immunity The Concentrator is intended for use in the electromagnetic environment specified below The user of the Concentrator should make sure it is used in such an environment Immunity Test Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 IEC 60601 Test Level 3 Vrms 150 kHz to 80 MHz 3V m 80 MHz to 2 5 GHz Compliance Electromagnetic Level Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2VP 150 kHz to 80 MHz d 1 2VP 80 MHz to 800 MHz d 2 3VP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagn
13. of physician May also be applicable in other countries Do not dispose of in unsorted municipal waste AC Power Keep Dry Enclosure Ingress Protection against solid objects of 12 5mm minimum diameter and vertically falling drops of water Manufacturer Complies with applicable EU directives including medical devices directive As Packaged Per Box Authorized representative in the European Community Fragile Humidity Temperature This Side Up 2 Warnings Cautions and Contraindications Contraindications This equipment is to be used as an oxygen supplement and is NOT INTENDED to be life supporting or life sustaining Warnings The device produces concentrated oxygen gas which accelerates combustion DO NOT USE THE DEVICE WHEN SMOKING OR NEAR OPEN FLAME MATCHES PETROLEUM OIL GREASE SOLVENTS RADIANT HEATERS AEROSOLS etc Use only water based lotions or salves that are concentrated oxygen compatible during oxygen therapy Concentrated oxygen makes it easier for a fire to start and spread Do not leave the nasal cannula on upholstery or other fabric such as bedding or personal clothing if the oxygen concentrator is turned on but not in use Concentrated oxygen will make the materials flammable Turn off the oxygen concentrator when not in use Do not use the oxygen concentrator in the presence of pollutants smoke or fumes flammable anesthetics cleaning agents or other chemical vapors This may internall
14. ons it is recommended that the ME EQUIPMENT or ME SYSTEM be powered from an uninterrupted power supply or a battery lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U 39526 dip in U for 5 sec Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital or home environment NOTE At 80 MHz and 800 MHz the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE U is the a c main voltage prior to application of the test level a Field strength from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the concentrator is used exceeds the applicable RF compliance level above the concentrator should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device gt Over the frequency range 150 kHz to 80 MHz the
15. t your equipment provider System Hot Concentrator temperature is too high for operation 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 condition persists switch to a backup source of oxygen and contact your equipment provider System Cold Concentrator temperature is too cold for operation Allow the concentrator to warm up in a room temperature environment for 10 minutes and restart If condition persists switch to a backup source of oxygen and contact your equipment provider System Error Switch to a backup source of oxygen and contact your equipment provider Sound indicator Power Error Concentrator lost power during operation only Try unplugging the power cord and plugging it back in If alarm does not reset press and hold the power button down for 2 seconas If condition persists switch to a backup source of oxygen and contact your equipment provider NOTE When power is lost during operation the buzzer will alarm continuously 7 Troubleshooting Contact your home care provider ifyou need assistance with the device Possible Cause Recommended Solution Any problem accompanied Refer to Chapter 4 Refer to Chapter 4 by information on concentrator display visual and or audible indicators Concentrator does not Power cord is not Check power cord for power on when On Off connected properly proper connection butto
16. te a safety hazard and or impair equipment performance and will void the warranty To avoid danger of choking and strangulation hazard keep tubing away from children and pets If you begin to feel ill or are experiencing discomfort while using the oxygen concentrator consult your health care provider immediately Cautions USA Federal law restricts this device to sale or rental by or on the order of a physician or any other practitioner licensed by the State in which he she practices to use or order the use of this device may also be applicable in other countries Under certain circumstances the use of non prescribed oxygen therapy can be hazardous 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 Additional monitoring or attention may be required for patients using this device who are unable to hear or see alarms or communicate discomfort If the patient shows any signs of discomfort a physician should be consulted immediately Accessories not specified for use with the oxygen concentrator may impair performance Always use accessories according to manufacturer s instructions Nasal cannula should be rated 5 liters per minute to ensure proper patient usage and oxygen delivery Replace the nasal cannula on a regular basis Check with your equipment provider or health care professional to determine how of
17. ten the cannula should be replaced It is recommended the oxygen concentrator accessory tubing and cannula include a means to reduce the propagation of fire Do not operate the concentrator without the intake filter and particle filter in place Particles drawn into the oxygen concentrator may damage the equipment Refer to the environmental range specifications for proper storage and use conditions Temperatures in excess of the indicated range may cause device malfunction Do not obstruct air intake or exhaust when operating the oxygen concentrator Blockage of air circulation or proximity to a heat source may lead to internal heat buildup and shutdown or damage Always maintain a minimum of six inches of clearance Do not place anything in the power supply port other than the supplied wall cord Avoid the use of electrical extension cords with the concentrator If an extension cord must be used use an extension cord that has an Underwriters Laboratory UL Mark and a minimum wire thickness of 18 gauge Do not connect any other device to the same extension cord Do not sit or stand on the concentrator doing so can be hazardous In order to ensure a safe installation and operation of the Inogen At Home Oxygen Concentrator Model GS 100 read and understand this entire manual before using the device The Inogen At Home Oxygen Concentrator has a 5 year expected life except 1year expected life for user serviceable sieve bed columns 3 Indi
18. will be illuminated and column will be reset Release the plus button 15 Press the power button W to turn on the concentrator and use normally NOTE Column change instructions are only to be used when maintenance is required Columns should only be removed during this maintenance procedure Storage When not in use store indoors away from excessive moisture and temperatures Storage conditions outside of range specified may result in damage and device malfunction Disposal of Equipment and Accessories Follow your local governing ordinances for disposal and recycling of the concentrator and accessories 9 Specifications Inogen At Home Model GS 100 90 6 3 at all settings Environmental Ranges Temperature 41 to 104 F 5 to 40 C for Use Humidity 15 to 95 non condensing Altitude o to 10 000 ft o to 3048 m Environmental Ranges for Temperature 13 to 158 F 25 to 70 C Shipping amp Storage Humidity o to 93 non condensing Altitude n a Maximum Outlet Pressure 19 6 40 6 psia 135 280 KPa Absolute 20 C Flow Control Settings 5 Settings 1 to 5 liters per minute Standards Compliance This device is designed to conform to the following standards EN ISO 8359 2012 Oxygen Concentrators for Medical Use Safety Requirements ISO 8359 1996 Second edition Amendment 1 ASTM F 1464 2005 Oxygen Concentrators for Domiciliary Use IEC 60601 1 Edition 3 1 2012 Medical Electrical Equipme
19. y decreased level Contact your equipment provider to arrange service The concentrator is operating to specification but requires service at the earliest convenience Contact your equipment provider to arrange service One of the concentrator s sensors has malfunctioned If the condition persists contact your equipment provider to arrange service The concentrator is producing oxygen at a slightly decreased rate If condition persists contact your equipment provider to arrange service The following medium priority alarm messages are accompanied by a triple beep repeated every 25 seconds and a flashing yellow light Oxygen Error The concentrator is producing oxygen at a low concentration Switch to a backup oxygen source and contact your equipment provider to arrange service Proper oxygen delivery has not been detected Check for kinked tubing If condition persists switch to a backup oxygen source and contact your equipment provider to arrange service Flow Error High Priority Alarms The following high priority alarm messages are accompanied by a five beep pattern repeated every 10 seconds and a flashing yellow light warning indicating immediate response by the operator is required Fire Hazard Smoke has been detected inside the device and device is shutting down Allow the concentrator to air out in a smoke free environment and restart If condition persists switch to a backup source of oxygen and contac
20. y contaminate the oxygen concentrator and degrade its performance Do not use the oxygen concentrator if either the plug or the power cord is damaged to prevent accidental electrical shock Do not submerge the oxygen concentrator in liquids expose to liquids or otherwise allow liquids to enter into the case this may lead to electrical shock and or damage If the oxygen concentrator is exposed to liquids turn it off and unplug from electrical outlet before attempting to clean and dry the liquid spill When using a compatible humidifier do not refill humidifier while attached to the oxygen concentrator Remove the humidifier from the oxygen concentrator prior to refilling to prevent accidental spills on the concentrator and prevent electrical shock hazard Do not use cleaning agents other than those specified in this manual Always unplug the oxygen concentrator before performing any cleaning Do not use alcohol isopropyl alcohol ethylene chloride or petroleum based cleaners This may impair the proper function and or increase the risk of fire and burns Do not disassemble the oxygen concentrator or attempt any maintenance other than tasks described in this user manual disassembly creates a hazard of electrical shock and will void the warranty Servicing of the concentrator is to be performed by qualified and trained personnel only Do not use any columns other than those specified in this user manual The use of non specified columns may crea
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