{"operation":"document","citation":"14-0197","title":"Philips Respironics — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2015-01-05","effective_on":null,"summary":"14-0197 response to Philips Respironics concerning 172.102, 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0197.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0197.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0197","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2015/140197.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nMaterials Safet\nipeline and Hazardou\nAdministration\nJAN 0 5 2015\nColleen L. Witt\nManager, Regulatory Affairs\nPhilips Respironics\n1740 Golden Mile Highway\nMonroeville, PA 15146\nRef. No. 14-0197\nDear Ms. Witt:\nThis responds to your October 13, 2014 letter requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to a portable oxygen\nconcentrator (POC). Specifically, you inquire about obtaining approval from the Pipeline\nand Hazardous Materials Safety Administration (PHMSA) and the Federal Aviation\nAdministration (FAA) to allow a passenger to carry and operate the POC aboard an aircraft.\nAccording to your letter, the POC (trade name Respironics SimplyGo Mini POC) is a device\nthat is for use by patients requiring high concentrations of oxygen on a supplemental basis.\nThe maximum operating pressure of the Respironics SimplyGo Mini POC is 20.0 pounds per\nsquare inch (psig). The Respironics SimplyGo Mini POC is powered by multiple sources,\nincluding AC or DC power, and a rechargeable lithium ion battery pack. For the Respironics\nSimplyGo Mini POC powered by the rechargeable lithium ion battery pack, the standard\nbattery pack has a Watt-hour (Wh) rating of 97.9 (3.4 ampere-hour (Ah) × 3.6 volts (V) x 8\ncells). The lithium ion battery pack meets the appropriate testing requirements of the United\nNations Manual of Tests and Criteria, and the battery pack is packaged in a manner to\nprevent short circuits when offered for transport or carried onboard an aircraft. You ask\nwhether the POC is regulated under the HMR.\nBased on the information provided in your letter, the Respironics SimplyGo Mini POC is not\nsubject to the HMR as a Division 2.2 non-flammable gas. The standard lithium ion battery\npack used to operate the device conforms to § 172.102(c)(1)(i) Special Provision 188, for the\ntransportation of small lithium ion cells and batteries and the POC contains no other\nhazardous materials. Therefore, the Respironics SimplyGo Mini POC is not subject to any\nother requirements in the HMR.\n\n<<<PAGE 2>>>\n\nPlease note that notwithstanding the passenger exception in § 175.10(a)(18) of the HMR,\nSpecial Federal Aviation Regulation 106, \"Rules for Use of Portable Oxygen Concentrator\nSystems on Board Aircraft\" (SFAR 106) apply and are under the purview of the FAA. This\nresponse satisties only one requirement in the FAA approval process before a POC may be\noperated onboard an aircraft. You may contact Ms. DK Deaderick in FAA's Flight\nStandards Service at (202) 267-7480 for questions regarding FAA's approval process.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nStevens\n§175.10\nPortable Oxygen PHILIPS\nconcentrator (Pol)\n14-0197\nPhilips Respironics\n1740 Golden Mile Highway\nMonroeville, PA 15146\nOctober 13, 2014\nAttn: Charles Betts, Director, Standards and Rulemaking Division\nUS Department of Transportation/PHMSA (PHH-10)\n1200 New Jersey Avenue, SE East Building, 2ªd Floor\nWashington, DC 20590\nRe: Request for Determination - Respironics Portable Oxygen Concentrator (POC)\nDear Mr. Betts:\nPhilips Respironics is preparing to enter the market with a miniature version of the currently\nsold SimplyGo Portable Oxygen Concentrator (POC) and is requesting an amendment to\nSpecial Federal Aviation Regulation 106 - Rules for use of portable oxygen concentrator\nsystems on board aircraft (SFAR 106). This amendment would include the Respironics\nSimplyGo Mini POC in the list of approved POCs for use on board aircraft. SFAR 106 permits\npassengers to carry on and use certain POCs on board aircraft if the aircraft operator ensures\nthat the conditions specified in the SFAR for their use are met. Section 2 of SFAR 106 requires\nthat PHMSA determine that the POC does not contain hazardous materials and that the\nrequestor includes this determination in the SFAR amendment application. This letter is a\nrequest for such a determination and response by PHMSA regarding the applicability of the\nHazardous Material Regulations (HMR; 49 CFR Parts 171-180).\nBackground\nPhilips Respironics is the principal provider of innovative solutions for the global sleep and\nrespiratory markets. Our success spans more than three decades and can be traced to a history\ndeeply rooted in ingenuity and a passion to deliver solutions to those in need. This tradition of\ninnovation, combined with an ability to anticipate market needs, is fundamental to the\nCompany. It has made Philips Respironics a name acknowledged worldwide as a pace-setter\nin the sleep and respiratory markets.\nThe Respironics SimplyGo Mini Portable Oxygen Concentrator is for prescription use by\npatients requiring high concentrations of oxygen on a supplemental basis. It is small, portable\nand capable of continuous use in the home, institutional, and travel /mobile environments.\n\n<<<PAGE 4>>>\n\nPer the US FDA Memorandum #K97-1 \"Deciding When to Submit a 510(k) for a change to\nan Existing Device\"\n', it was determined that a 510(k) was not required to market the SimplyGo\nMini device within the United States. This decision was based on the comparison of the\nSimplyGo Mini device to its predicate device, SimplyGo Portable Oxygen Concentrator.\nTherefore, the SimplyGo Mini Portable Oxygen Concentrator is cleared under the SimplyGo\nPortable Oxygen Concentrator premarket notification number 510(k) K111885. A copy of the\nSimplyGo Portable Oxygen Concentrator 510(k) clearance letter is attached, along with a copy\nof the SimplyGo Mini User Instruction Manual.\nPerformance Specifications and Device Description\nThe SimplyGo Mini is a portable oxygen concentrator intended to deliver at least 87% pulsed\noxygen to the patient. The device has an integrated conserving device which triggers a pulse\nof oxygen by sensing pressure at the onset of inspiration. The SimplyGo Mini delivers fixed\npulse volumes up to a maximum minute volume per setting on the device. The volume of the\ndose varies based on the user selected settings.\nThe SimplyGo Mini POC will operate using any of the multiple power sources listed below:\nRechargeable batteries (single battery and double battery)\n• A/C Adapter\n• 12v D/C car Adaptor\nUsers\nThe SimplyGo Mini POC will be used by patients requiring supplemental oxygen. These\npatients are typically COPD patients. The patient using this device will be ambulatory and\nwill be looking to improve their mobility versus other forms of supplemental oxygen. Some\npatients may have limited vision and hearing.\nEnvironments of Use\nThe SimplyGo Mini POC is intended to be used during travel wherever the patient might want\nto go. Therefore, the device may be used in both good and bad weather conditions. The\nSimplyGo Mini Portable Oxygen Concentrator is designed to fit easily under the seat of a\ncommercial aircraft, permitting the user to travel by air with their prescribed oxygen therapy.\n2| Page\n\n<<<PAGE 5>>>\n\nSpecifications\nOperating Conditions\nOperational temperature: 41º F to 95° F (5° C to 35° C)\nRelative humidity: 15% to 93%\nAltitude: up to 10,000 ft. (3048 m.)\nStorage Conditions\n-4° F to 140° F (-20° C to 60° C) - unit only\nRelative humidity: up to 93%, non condensing\nOxygen Concentration*\nAt least 87% at all settings\nPulse Modes (pulse volumes at 20 breaths per minute)\n1 = 11 ml\n2 = 22 ml\n3 = 33 ml\nFlow Settings and Pulse\n4 = 44 ml\nVolumes\n5 = 50 ml\n+/- 15% or 5 ml whichever is greater for 20 consecutive\nbreaths\nUp to a max of 1000 ml/min +/- 100 ml\nUser Interface\nTFT LCD w/Projective Capacitive Touch Screen\n9.4 in x 8.3 in x 3.6 in (single battery)\n(23.9 cm x 21.1 cm x 9.1 cm)\nDimensions\n10.2 in x 8.3 in x 3.6 in (double battery)\n(25.9 cm x 21.1 cm x 9.1 cm)\nWeight\n5 Ibs (2.3 kg) with single battery installed\n6Ibs (2.7 kg) with double battery installed\nAudio Alarm\n56 decibels or greater when measured at 1 meter\nOutlet Pressure\n20 psig\n*Based on an atmospheric pressure of 14.7 psia (101 kPa) at 70° F (21° C)\n3 | Page\n\n<<<PAGE 6>>>\n\nSimplyGo Mini Battery\nChemistry\nLithium Ion 14.4 VDC (nominal)\nBattery Options\nSingle battery\nDouble battery (equals two single batteries)\n7.9 in x 3.6 in x 1.0 in (single battery)\n(20.1 cm x 9.1 cm x 2.5 cm\nDimensions\n7.9 in x 3.6 in x 1.9 in (double battery)\n(20.1 cm x 9.1 cm x 4.8 cm)\nWeight\n1.1 Ibs (single battery) (0.50 kg)\n2.1 Ibs (double battery) (0.95 kg)\nWatt-hour Rating per\nsingle battery\n3.4 Ah x 3.6 V x 8 cells = 97.9 Wh\nBattery Duration\n4 hours (Pulse setting of 2 at 20 bpm with single battery)\n8 hours (Pulse setting of 2 at 20 bpm with double battery)\nMaximum recharge time is 4 hours for the single battery and 8\nCharge Time\nhours for the double battery from fully discharged to fully charged,\ndepending on the power source and usage.\nAC Power\nType\nPhilips Respironics Part Number 1116818\nInput\n100 to 240 VAC, 50/60 Hz\nOutput\n19 VDC, 6.3 A\nPower Consumption\n120 W while charging\nDC Power\nType\nPhilips Respironics Part Number 1116819\nInput\n12-16 VDC\nOutput\n19 +/- 5% VDC, 6.3A\n4| Page\n\n<<<PAGE 7>>>\n\nStandards Compliance\nThe SimplyGo Mini POC is designed to conform to the following standards:\n• IEC 60601-1 3'd edition, Medical Electrical Equipment, Part 1: General\nRequirement for Safety\n• IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General\nRequirement for Safety - Collateral Standard: Electromagnetic (EMC)\nCompatibility - Requirements and tests.\n• RTCA/DO-160F section 21, category M; Emission of Radio Frequency Energy\n• ISO 8359, Oxygen Concentrators for Medical use - Safety Requirements.\n• ISO 80601-2-67, Medical electrical equipment, Part 2-67: Particular requirements\nfor basic safety and essential performance of oxygen-conserving equipment.\n• ISO 80601-2-69, Medical electrical equipment, Part 2-69: Particular requirements\nfor basic safety and essential performance of oxygen concentrator equipment.\nClassification\nThe SimplyGo Mini POC is classified as:\n•\nIEC Class II Internally Powered Equipment\nType BF Applied Part\nIP22: Drip Proof Equipment\nNot suitable for use in the presence of a flammable anesthetic mixture with air\nor with oxygen or nitrous oxide.\nContinuous Operation\nSpecifically, the following characteristics relate to the SimplyGo Mini POC and its battery\npack:\n1. The maximum operating pressure of the SimplyGo Mini POC is 20 psig. This maximum\noperating pressure limit is a shutdown condition controlled by a pressure sensor within the\ndevice.\n2. Each single lithium ion battery pack satisfies the requirements of § 173.185(c)(1)(i) which\nstates that the Watt-hour rating may not exceed 20 Wh for a lithium ion cell or 100 Wh for a\nlithium ion battery and be marked with the Watt-hour rating on the outside case. The battery\npack meets the requirements of each test in the UN Manual of Tests and Criteria.\n3. The lithium ion battery pack satisfies the requirements of § 173.21(c) which states that an\nelectrical device is forbidden for transportation unless it is packaged in a manner to preclude it\nfrom creating sparks or generating a dangerous quantity of heat (for example, by the effective\n5 Page\n\n<<<PAGE 8>>>\n\ninsulation of exposed terminals). The SimplyGo Mini battery pack has no exposed terminals\nwhich could be the source of a short circuit. The safety profile of the battery pack includes\nsafety circuit to protect against over current, over voltage and over temperature conditions. In\naddition, there are also single fault tolerances for both over-current and over-temperature\nsafety protection provided by a current limiting fuse and over-temperature thermal fuse. All\nsafety systems when activated shut down operation of the battery assembly.\nBased on the information provided above, we respectfully submit that the SimplyGo Mini\nPOC is not currently subject to the HMR because it meets the following criteria:\n(1) The pressure of the oxygen in the device does not exceed 40.6 psia at 20°C;\n(2) The lithium ion battery used to operate the device is exempted from the HMR;\n(3) The battery pack is packaged in a manner to preclude it from creating sparks or generating\na dangerous quantity of heat (for example, by the effective insulation of exposed terminals);\nand\n(4) The SimplyGo Mini POC contains no other materials subject to the HMR.\nThank you in advance for your assistance, consideration and review of our request. If you\nrequire additional information, please feel free to contact me at (724)387-4870; by fax at\n(724)387-7490 or by email at colleen.witt@philips.com.\nSincerely,\nCount. Witt\nColleen L. Witt\nManager, Regulatory Affairs\n6| Page\n\n<<<PAGE 9>>>\n\nRespironics inc.\nMurrysville, PA 15668 USA\n1001 Murry Ridge Lane\nPHILIPS\n11110202000\n(REF) 1118724\nSimplyGo Mini O\nPersiss\nPHILIPS\nRESPIRONICS\n\n<<<PAGE 10>>>\n\nEnglish\nTable of Contents\nIntroduction\nIntended Use\nDevice and Accessories Description\nContraindications...\nWarnings and Cautions....\nSimplyGo Mini System.........\nSymbol Key...\n...3\nGetting Started...\nHow to Contact Philips Respironics..\n.7\n...7\nSystem Overview..\nBattery Duration Times..\nInserting and Removing the Batteries....\nOperating the SimplyGo Mini Device\nCharging the Battery with the AC Power Supply...\nPower Options...\nSetting up the Cannula and Tubing\nDevice Warm-Up\nPowering Off the Device\nPowering on the Device....\nNavigating the Display Screens\nDevice Backlight.\nViewing and Changing Settings...\nHome Screen....\nTroubleshooting\nAlarm Indicators and Screen Symbols...\nCaring for your Battery...\nCaring for your SimplyGo Mini System...\nBattery Storage\nCleaning the Device and Rechargeable Battery...\nDevice Storage\nCleaning the Accessories...\nSimplyGo Mini Portable Oxygen Concentrator Mobility\nDevice Disposal...\nTraveling With Your System..\nSimplyGo Mini Carrying Case..\n32\nBy Motor Vehicle.\n34\nOn Arrival..\nBy Bus or Train....\n35\n34\n35\nStandards Compliance....\n36\nEMC Information\nClassification.\n39\n38\nLimited Warranty\n.42\n40\n© 2014 Koninklijke Philips N.V. All rights reserved.\n\n<<<PAGE 11>>>\n\n\n\n<<<PAGE 12>>>\n\nSimplyGo Mini User Manual\nIntroduction\nIntended Use\nThe Philips Respironics SimplyGo Mini Portable Oxygen Concentrator is for\nprescription use by patients requiring high concentrations of oxygen on a\nthe home, institutional, and travel /mobile environments.\nsupplemental basis. It is small, portable, and is capable of continuous use in\nContraindications\n• This device is not intended to be life-sustaining or life-supporting.\nThis device is not intended for newborn and infant use.\nDevice and Accessories Description\naccessories are described in detail in this manual. Read and understand it\nThe SimplyGo Mini Portable Oxygen Concentrator, its features, and its\ncompletely before operating the device.\nThis manual applies to the following accessories:\nAC Power Supply\n• AC Power Cord\n• DC Power Supply\nRechargeable Lithium lon Standard and Extended Batteries\n• Carrying Case\n• Accessory Bag\nThis manual does not apply to the following accessory items sold separately:\n• Standard Single Lumen Nasal Cannula\nBattery Charger\nSimplyGo Mini Backpack\n• Me dese\n\n<<<PAGE 13>>>\n\nSimplyGo Mini User Manual\nSimplyGo Mini System\nThe device comes with the following items. If any are missing, contact your\nequipment provider.\nSimplyGo Mini Device in Carrying Case\nwith Shoulder Strap\nThis User Manual\n•\nStandard or Extended\nRechargeable Batteries\nAC Power Supply and Cord\n•\nDC Power Supply\nAccessory Bag\n2\n\n<<<PAGE 14>>>\n\nSimplyGo Mini User Manual\nWarnings and Cautions\nCaution: U.S. federal law restricts this device to sale by or on the order of a\nphysician.\nWarnings\nA warning represents the possibility of harm to the operator or patient.\n•\nThe operator should read and understand this entire manual before\nusing the device.\nThe device is not intended for life support. Where the prescribing\nhealth care professional has determined that an interruption in the\nsupply of oxygen, for any reason, may have serious consequences\nto the user, an alternate source of oxygen should be available for\nimmediate use.\nGeriatric or any other patient unable to communicate discomfort, or\nhear or see the alarms while using this device, may require additional\nmonitoring.\nIf you feel discomfort or are experiencing a medical emergency while\nundergoing oxygen therapy, seek medical assistance immediately to\navoid harm.\nperiodically reassessed for the effectiveness of the therapy.\nThe oxygen delivery settings of the oxygen concentrator should be\n• Set the device at the prescribed level and do not increase or decrease\nyour flow rate from the prescribed level until you first consult with\nyour physician or healthcare professional.\n•\nOxygen supports combustion. Oxygen should not be used while\nsmoking or in the presence of an open flame.\nDo not use the device in the presence of a flammable anesthetic\nnitrous oxide.\nmixture in combination with oxygen or air, or in the presence of\n• Do not use oil or grease on the concentrator or its components as\nthese substances, when combined with oxygen, can greatly increase\nthe potential for a fire hazard and personal injury.\n• Only use this device as prescribed. The use of oxygen therapy can\nbe hazardous in some circumstances, so consult your health care\npractitioner before using the SimplyGo Mini device.\nTo ensure that you receive the correct therapeutic amount of oxygen\ndelivery according to your medical condition, the Philips Respironics\n3\n\n<<<PAGE 15>>>\n\nSimplyGo Mini User Manual\nWarnings (continued)\nSimplyGo Mini device must be used:\n- Only after one or more settings have been individually\ndetermined or prescribed for you at your specific activity levels\nWith the specific combination of parts and accessories that\nare in line with the specification of the oxygen concentrator\nmanufacturer and that were used while your settings were\ndetermined\n• The settings of the Philips Respironics SimplyGo Mini device might\nnot correspond with continuous flow oxygen.\n• The settings of other models or brands of oxygen therapy equipment\ndo not correspond with the settings of the Philips Respironics\nSimplyGo Mini device.\nUse only water-based lotions or salves that are oxygen compatible\nduring setup or use during oxygen therapy. To avoid the risk of fire\nand burns, never use petroleum or oil-based lotions or salves.\nIf you notice any of the following, discontinue use and contact your\nhome care provider:\n- unexplained changes in the performance of this device\n- unusual or harsh sounds\n- dropped or mishandled device or the power supply\nwater spilled into the enclosure\n- broken enclosure\nOxygen makes it easier for a fire to start and spread. Do not leave\nthe nasal cannula on bed coverings or chair cushions if the oxygen\nmaterials flammable. Turn the oxygen concentrator off when not in\nconcentrator is turned on, but not in use; the oxygen will make the\nuse.\nTo ensure proper function and to avoid the risk of fire and burns:\n- Use only with Philips Respironics SimplyGo Mini AC power\nsupply.\n- Use only with Philips Respironics SimplyGo Mini batteries.\n- Use only approved SimplyGo Mini accessories.\nIncompatible parts or accessories can result in degraded\nperformance.\nRepairs and adjustments must be performed by Philips Respironics\nauthorized service personnel only. Unauthorized service could cause\n4\n\n<<<PAGE 16>>>\n\nSimplyGo Mini User Manual\ninjury, invalidate the warranty, or result in costly damage.\n• Periodically inspect electrical cords, cables, and the power supply for\ndamage or signs of wear. Discontinue use and replace if damaged.\n• To avoid electric shock, unplug the device and remove the batteries\nbefore cleaning the bag. DO NOT immerse the device in any fluids.\n• Your home care provider is responsible for performing appropriate\npreventive maintenance at the intervals recommended by Philips\nRespironics.\nFor proper operation, your device requires unobstructed ventilation.\nAlways make sure any openings in the case are not obstructed by\nitems which may impede ventilation. Do not place the device in a\nsmall closed space (such as a closet). The device should not be used\nadjacent to or stacked with other equipment. For more information,\ncontact your home care provider.\nDo not use an extension cord.\n•\nDevice operation above or outside of the voltage, breath rate,\ntemperature, humidity and/or altitude values specified may decrease\noxygen concentration levels.\nNever drop or insert any object into any opening.\nBe aware that the electrical cord and/or tubing could present a\ntripping or strangulation hazard.\nUse only power cords supplied by Philips Respironics for this device.\noverheating or damage to the device and may result in increased\nUse of power cords not supplied by Philips Respironics may cause\nemissions or decreased immunity of the equipment or system.\nDo not operate without the battery installed and working. If primary\nwithout warning the user. If the device must be operated without the\npower is lost with no battery in place, the device will stop operating\nbattery, the user should be aware that there is no backup power and\nno warning if primary power is lost.\nremove the battery from the device.\nIf the SimplyGo Mini device will not be used for a long period of time,\nMedical Electrical Equipment needs special precautions regarding\nEMC information provided in this manual.\nEMC and needs to be installed and put into service according to the\nPlace the device in a location so as to avoid pollutants and fumes.\nPortable and Mobile RF Communications Equipment can affect\nMedical Electrical Equipment. See the EMC section of this manual for\n5\n\n<<<PAGE 17>>>\n\nSimplyGo Mini User Manual\ndistances to observe between RF Generators and the SimplyGo Mini\ndevice to avoid interference.\nThe use of cables and accessories other than those approved for use\nby Philips Respironics may negatively affect EMC performance.\nCautions\nA caution represents the possibility of damage to the equipment.\nDo not immerse the device or allow any liquid to enter the enclosure.\n•\nWhen the device is used in an automobile, disconnect it from the\nDC auto adapter outlet when the automobile is turned off. Do not\noperate the device in a non-running vehicle for an extended period\nvehicle from starting. Do not allow the device to be connected to the\nof time, as this may deplete the vehicle's battery and prevent the\nauto adapter outlet while starting the automobile normally or while\nyou are starting the automobile with battery recharging cables. Wait\nuntil the automobile starts before connecting the device to the DC\npower outlet. Secure the device securely when used in any moving\nvehicle. (The same cautions apply if using the DC adapter outlet on a\nboat or recreational vehicle.)\nTurn off the device before removing the battery. The device should\nnot be operated without the batteries installed. If the device is\nroutine will not be implemented when the power is disconnected\noperated without the batteries installed, the standard shut-down\nprior to turning off the unit. This can result in damage to the device.\nOnly use the supplied handle and shoulder strap to carry your device.\nWith every use, verify that the case, shoulder strap and handle are in\ngood condition.\nNote: Additional warnings, cautions, and notes are located throughout the\nmanual.\n6\n\n<<<PAGE 18>>>\n\nSimplyGo Mini User Manual\nSymbol Key\naccompanying\nConsult\ninstructions\nREF\nModel number\nfor use\nNo smoking\n[SN\nSerial number\nNo oil or grease\nType BF Applied Part\nKeep away from open\nflames\n424\nRechargeable Battery\nDo not disassemble\nIP22\nDrip proof equipment\n==\nDC power\nAC Power\nCaution: U.S. federal\nRONY\ndevice to sale by or\nlaw restricts this\nClass II (Double\non the order of a\nInsulated)\nphysician.\nNote: Also see the section on alarm indicators and screen symbols.\nHow to Contact Philips Respironics\nTo have your device serviced, contact your home care provider. If you need\nat 1-724-387-4000 or 1-800-345-6443 (US or Canada). You can also use the\nto contact Philips Respironics directly, call the Customer Service department\nfollowing address:\nRespironics Inc.\n1001 Murry Ridge Lane\nMurrysville, PA 15668 USA\n7\n\n<<<PAGE 19>>>\n\nSimplyGo Mini User Manual\nGetting Started\nAttach the shoulder strap(s) to the carrying case.\nBefore using the SimplyGo Mini device for the first time, the SimplyGo Mini\ntime of 3.5 hours minimum for the standard and 7 hours minimum for the\nstandard or extended batteries require an initial uninterrupted charging\nextended battery. This can be accomplished by installing the battery and\nusing the AC Power Cord, as described in the following pages. Or optionally,\nyou can use the Smart Battery Charger to charge the SimplyGo Mini batteries.\nNote: Philips Respironics does not recommend using DC power for this initial\ncharging.\nCaution: Use only Philips Respironics batteries in your SimplyGo Mini device.\nUsing other batteries could damage the device and will void the\nfor an extended period of time.\nwarranty. Remove the battery if the SimplyGo Mini will not be used\nSystem Overview\nBegin by becoming familiar with your SimplyGo Mini device.\n(2)\nItem\nDescription\nFunction\n1\nControl Panel\nTFT LCD with projected capacitive touch\nscreen\n8\n\n<<<PAGE 20>>>\n\nSimplyGo Mini User Manual\n2\nPatient Cannula\nConnector\nOxygen output and connection point for\npatient cannula\n3\nRechargeable\nBattery\nStandard or extended rechargeable lithium-\nion battery\n4\nPower Input\nConnection point for Philips Respironics-\nConnector\nprovided external power supplies: AC line\nvoltage, vehicle DC\nControl Panel\nItem\nDescription\nFunction\n1\nPower Button\nTurns the device On\nand Off\n2\nDisplay Screen\nShows information\nabout the operating\nstatus of the device\nand device settings.\n3\nHome Button\nAccesses the Home\nscreen.\nscreen from any\n2\n\n<<<PAGE 21>>>\n\nSimplyGo Mini User Manual\nBattery Duration Times\nstandard and extended rechargeable batteries when the batteries are fully\nThe following table displays the approximate battery duration times for the\ncharged.\nSETTING\nSTANDARD BATTERY\nEXTENDED BATTERY\n4.5 hours\n9.0 hours\n2\n3.5 hours\n7.0 hours\n3\n2.5 hours\n5.0 hours\n4\n2.0 hours\n4.0 hours\n5\n1.5 hours\n3.0 hours\nInserting and Removing the Batteries\nYou can use a standard battery or extended battery with your SimplyGo Mini\ndevice. They are inserted using the same method. To insert the batteries,\ncomplete the following steps:\n1. Place your device in a well-ventilated location and make sure it is\nturned off.\nNote:\nThe SimplyGo Mini device is shipped from the factory with the\nbattery removed.\n2. Hold the SimplyGo Mini device in one hand, and use your other hand\nto insert the battery compartment into the bottom of the SimplyGo\nMini as shown in the following illustration.\nCaution: Only remove the battery when the SimplyGo Mini is turned off.\nNever remove the battery while the device is operating.\n10\n\n<<<PAGE 22>>>\n\nSimplyGo Mini User Manual\n3. To remove the standard or extended battery, push the eject button\non the center of the battery compartment down as shown in the\nfollowing illustration. The battery will release from the device. If the\ndevice has been operating, the surfaces may be warm to the touch.\nThis is normal.\n4.\nWhen the standard or extended battery is not installed, you can\ncheck the battery gauge on the battery to determine the amount of\ncharge available.\nIf you are using the standard battery, press the black button on the\nbattery, press the two black buttons and watch how many LEDs light\nbattery and watch how many LEDs light up. If using the extended\nup. If the batteries are low, you can recharge them. See the Charging\nthe Battery with AC Power Supply section.\nNo. of LEDS\nStandard Battery\nExtended Battery Battery Charge\nNo. of LEDS\n4 LEDs Light:\n8 LEDs Light: 75% to 100% full\n3 LEDs Light:\n6 LEDs Light: 50% to 75% full\n2 LEDs Light:\n4 LEDs Light: 25% to 50% full\n1 LED Lights:\n2 LEDs Light: |10% to 25% full\n1 LED Blinks\n3 Times:\n: LEDs Blink Battery is less tha\n3 Times: 10% full and\nneeds to be\nrecharged\n11\n\n<<<PAGE 23>>>\n\nSimplyGo Mini User Manual\nCharging the Battery with the AC Power Supply\nImportant: The first time you charge the battery, be sure to charge it fully. Do\nnot use the DC power cord to do so; instead use AC power.\nNote: The battery will begin charging whenever you connect the device to an\nAC outlet, regardless of whether or not it is in use.\nfollow these steps.\nTo charge the battery using the AC Power Cord provided with your system,\n1. Connect the AC Power Supply's output cable to the SimplyGo Mini\npower input connector.\n2. Connect the AC Power Cord's connector into the AC power supply.\n3. Connect the AC Power Cord's plug into an AC outlet installed to meet\nnational or regional electrical code.\nNote: The AC Power Supply is equipped with a green light, which illuminates\nas soon as you connect the device to an energized AC power source.\n4. When charging is complete (this takes four hours or less for the\nstandard battery), disconnect the AC Power Supply and store it with\nthe AC Power Cord for future use.\nNote: Replacement and spare batteries are available separately. For\ninformation, contact your home care provider.\nNote: An optional SimplyGo Mini Smart Battery Charger (sold separately) is\navailable for your system. For more information, contact your home\n12\ncare provider.\n\n<<<PAGE 24>>>\n\nSimplyGo Mini User Manual\nOperating the SimplyGo Mini Device\nPower Options\nWarning: Do not use the device without the battery installed and operating.\nTo run the device on battery power, make sure the battery is properly\ninserted and sufficiently charged. (The battery should be fully\ncharged the first time you use it.)\nTo run the device using AC power, first make sure you have a\nbattery installed. Then, follow these steps:\n1. Connect the output cable of the AC Power Supply to the\nSimplyGo Mini power input connector.\n2. Connect the AC Power Cord's connector into the AC power\nsupply.\n3. Connect the AC Power Cord's plug into an AC outlet installed to\nmeet national or regional electrical code.\nNote: • To run the device using DC power from an automobile or other\nand connect one end of the DC Power Cord to the device's power inlet\nmotorized vehicle, make sure the battery is installed. Start the vehicle\nand the other end into the vehicle's DC electrical outlet.\nBecause the amount of current available in the vehicle electrical system\nis limited, the current available to charge the SimplyGo Mini battery will\nthe time required to charge the battery will be much longer, and at the\nbe determined by the operating mode of the device. At high settings,\nhighest settings, it may not charge at all.\nDevice Warm-Up\nWhen you turn on your SimplyGo Mini device, it will sense if you are breathing\nfrom it. If you are not yet breathing through the cannula, SimplyGo Mini will\nbegin to pulse automatically about once every five seconds. As soon as you\nbegin breathing through the cannula, the device will begin delivering pulses\nbased on your breathing. It may take up to 20 minutes for the SimplyGo Mini\nreathing from the SimplyGo Mini at any time. Durina the initial stabilizatior\nutput to stabilize within its O, purity specifications. However, you may begir\nperiod, the displayed O, setting number will blink. It will stop blinking when\nthe output is stabilized and within the target specification.\n13\n\n<<<PAGE 25>>>\n\nSimplyGo Mini User Manual\nSetting up the Cannula and Tubing\nTo set up the SimplyGo Mini device, follow these steps.\n1. Connect a nasal cannula to the patient cannula connector on the\ndevice, as shown. Ensure that the cannula is routed to prevent it from\nbeing pinched or kinked to avoid a disruption of oxygen flow.\nNote: A standard single lumen nasal cannula and tubing (not supplied)\nshould be used to deliver oxygen from the SimplyGo Mini device. The\ndevice works with cannula tubing up to 30 ft. (9 m).\n2. Power on the device as described in the next section.\n3. Position the nasal cannula on your face, as shown below, and breathe\nnormally through your nose.\nPowering on the Device\n1. You can press the Power button once or simply touch the black\nscreen on the device to quickly view your settings.\nfollowing information displayed:\nThe screen shown here will appear with the\n• O, setting\nBattery capacity\n•\nNumber of hours the device has been used\n2\n• Software version\nVersion: 1.31\n14\n\n<<<PAGE 26>>>\n\nSimplyGo Mini User Manual\nThe screen will automatically shut off again after 5 seconds.\nIf you want to fully power on the device, press\nunwanted starts or inadvertent changes in oxygen flow. The Philips\nthe Power button a second time. This second press helps prevent\nRespironics splash screen appears briefly followed by the Home\nscreen, both shown below.\n*\n9:30 pm\nPHILIPS\n...\nRESPIRONICS\nEvery time it starts up, the device starts producing oxygen to meet\nspecified purity levels for the setting. It is safe to begin breathing\nthe specified setting. It may take up to 20 minutes to reach the\nfrom the SimplyGo Mini device immediately. Breathing from the\ndevice will cause it to reach oxygen purity levels faster.\nNote: When it is turned on, the device will automatically start at the oxygen\nflow rate setting used when the device was last turned off. As a\nprecaution, each time you start the device, verify the flow setting.\nPowering Off the Device\nTo turn the device off, press the Power button and the confirmation\nscreen shown here appears.\n2.\nPress the Power button a second time to turn the device off.\nNote: If you do not press the Power button a second time, the screen will\nreturn to the Home screen.\n15\n\n<<<PAGE 27>>>\n\nSimplyGo Mini User Manual\nDevice Backlight\nautomatically whenever:\nThe device features a backlight that turns on\nYou touch the screen\nAn alarm occurs\nThe device is plugged into an external power\nsupply\n• A battery is inserted into the device\nThe backlight automatically shuts off after one minute of inactivity, as a\npower-saving feature.\nNavigating the Display Screens\nAs you access each of the display screens, there are some common actions\nyou can take to move from screen to screen, adjust settings, return to a\nprevious screen, etc.\nPress the Home button (1n.)) from any of the display screens if\nyou want to quickly return to the Home screen.\n• If a screen has + and - buttons at the bottom, press those to\n. scroll through setting selections and choose the desired setting.\nThe Device Tools menus may also have < and > buttons at the\nyou want to modify (for example, the hour and minute settings\nbottom. Press these to scroll back and forth through the items\nwithin the Time menu), and select the data you need to change.\nNote: If you've reached the limit for a setting, then the < or > buttons will\nappear gray on the screen and will be disabled.\n•\nThe Device Tools menus may also have an i in the top left\ncorner of the screen. Press that arrow to return to the previous\nscreen.\n16\n\n<<<PAGE 28>>>\n\nSimplyGo Mini User Manual\nViewing and Changing Settings\nThis section describes how to view and change settings on the SimplyGo Mini\ndevice.\nHome Screen\n9:30 pm\nthree main items:\nThe Home screen shown here contains\n• Tool icon\n• O, Setting\n•\nBattery Charge Level\nAdditionally, the Status bar at the top of the screen displays the following:\nSYMBOL\nDESCRIPTION\nThe device has detected an active alarm.\nAn active alarm has been silenced but not resolved.\nA battery is installed in the device, and AC power is also\nconnected.\nBattery level is normal.\nBattery level is low.\nBattery level is depleted.\n17\n\n<<<PAGE 29>>>\n\nSimplyGo Mini User Manual\nChanging the O, Setting\nTo change the O, setting, complete the following steps:\n1. Touch the O, number shown on the Home screen to access the 0,\nSettings screen, shown below.\n9.30 pm\n2\n2. Press the + or - buttons to scroll up and down and increase or\nto 5 in increments of 1.\ndecrease the O, setting as needed. You can adjust the setting from 1\nNote: When you've reached the setting limit, the + or - symbols will be greyed\nout to indicate that they are disabled and can no longer be selected.\nThe device detects when the user begins to take a breath and then\ndelivers a pulsed volume of oxygen during the inhalation period.\nno breath is detected for a period of time, the system automatically\nThe volume of the oxygen pulse is dependent on the setting value. If\nnumber at a fixed rate of 12 breaths per minute. If no breath is\ndelivers the pulsed volume of oxygen determined by the setting\ndetected for 2 minutes, the device signals an alarm and shuts down\nafter 15 minutes if the device is running on battery power.\n18\n\n<<<PAGE 30>>>\n\nSimplyGo Mini User Manual\nChecking the Battery Status\nTo check the battery status, complete the following steps:\n1. Touch the battery symbol on the Home screen to access the Battery\nInformation screen, shown below.\n9:30pm\n50%\nhow much battery power is left, and the battery level symbol appears\nThe battery percentage number appears on the screen to indicate\nbelow the number.\nThe table below describes each of the battery symbols:\nSYMBOL\nDESCRIPTION\nBattery level at 25%\nBattery level at 50%\nBattery level at 75%\nBattery level at 100%\nNote: The green battery bar blocks will scroll while\nBattery charging or battery charge complete\nthe battery is charging and this symbol appears.\nOnce fully charged, the battery blocks stop scrolling\nand one long beep sounds.\nLow battery - indicates battery level is below xx%\n19\n\n<<<PAGE 31>>>\n\nSimplyGo Mini User Manual\nSYMBOL\nDESCRIPTION\nBattery depleted\nAC power connected; no battery installed\nAccessing the Device Tools Menu\nThere are two device tool menus:\nBrightness menu\nAlarm Log menu\nTo access the Device Tools menu, complete the following steps:\nChange the Brightness Setting\n1. Touch the Toolicon ({O3) on the Home screen to access the Device\nTools Menu. The Brightness menu screen appears first, shown below.\nNote: You can use the < and > buttons to scroll to the Date and Time Settings\nmenu or Alarm Log menu if desired.\n9:30 pm\n• .\n2. Press on the Brightness icon to access the Brightness setting screen,\nshown below.\n\n<<<PAGE 32>>>\n\nSimplyGo Mini User Manual\n9:30 pm\n3. Press the + and - buttons to scroll through the three brightness\nsettings and choose the desired brightness.\nNote: If you want to exit the Device Tools menu and return to the previous\nscreen, press the arrow in the top left corner of the screen.\nAccess the Alarm Log Menu\n1.\nPress the 4f to return to the Tools menu, and press the < and >\nbuttons to navigate to the Alarm Log menu, shown below.\n*\n9•30 pm\n<\nPress on the Alarm Log tile to access the screens shown below. If no\nalarms have ever occurred, the screen shown on the left will appear.\nOtherwise, a screen similar to the one on the right appears.\n21\n\n<<<PAGE 33>>>\n\nSimplyGo Mini User Manual\n930pm\n9:30 pm\nN/A\n:29 am. 03/18/2014\n3. You can view the type of alarm that occurred and the start time and\ndate of the alarm on the Alarm Log screen.\n4. Press the < and > buttons to navigate through the list of alarms in the\nlog history. The log will list at a minimum the 16 most recent alarms.\nNotes:\n• The alarm log is maintained between device Power Off and Power On\ncycles (the time of Power Off is not logged).\n• The most recent alarm events in the log from the current Power On\nsession may be lost if the device experiences a total loss of power and\nimproperly shuts down.\nThe alarm log maintains the most recent 16 alarms and will discard the\noldest data once its memory is full and a new alarm occurs.\n22\n\n<<<PAGE 34>>>\n\nSimplyGo Mini User Manual\nAlarm Indicators and Screen Symbols\nIndicators\nVisual, Audio\nDescription\nWhat To Do\nNo Breath Alarm\nbreath is not detected for\nThis alarm occurs when a\nCheck the\na period of 2 minutes or\nconnection from\nNEED TO ADD\nmore. It can be silenced\nthe cannula to the\nSCREEN TBD\nby pressing the Alarm\ndevice. Make sure\nsymbol. This alarm resets\nthe nasal cannula is\n1 beep\nitself as soon as a breath\nproperly positioned\nthat repeats every\nis detected. If the device\nnd that you ar\nn your face\n15 seconds\nis on battery power and\n","truncated":true,"body_characters":72781}