{"operation":"document","citation":"11-0285","title":"Philips Respironics — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2011-12-22","effective_on":null,"summary":"11-0285 response to Philips Respironics concerning 173.185, 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0285.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0285.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0285","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2011/110285..pdf","body":"<<<PAGE 1>>>\n\nu.s. Department 1200 New Jersey Avenue SE\nof Transportation Washington. DC 20590\nPipeline and Hazardous\nMaterials Safety\nAdministration DEC 2 2 2011\nMr. Joseph E. Olsavsky\nPhilips Respironics\n1740 Golden Mile Highway\nMonroeville, PA 15146\nRef. No.: 11-0285\nDear Mr. Olsavsky:\nThis responds to your November 8, 2011 letter requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to a portable oxygen\nconcentrator (PaC). Specifically, you inquire about obtaining Federal Aviation\nAdministration (FAA) approval to allow a passenger to carry the pac aboard an aircraft.\nAccording to your letter, the pac (trade name SimplyGo) is a device that is for\nprescription use by patients requiring high concentrations of oxygen on a supplemental\nbasis. The maximum operating pressure of the SimplyGo pac is 27 pounds per square\ninch (psi), with a safety relief valve with a lift pressure of 6.5 psi gauge in the gas circuit.\nThe SimplyGo pac is powered by multiple sources, including AC or DC power, and a\nrechargeable lithium-ion battery pack. For the SimplyGo pac powered by the BAK\nbattery pack, the lithium-ion cells have a lithium content of 0.66 grams per cell, or 7.92\ngrams of aggregate equivalent lithium content for the battery pack. For the SimplyGo\npac powered by the Panasonic battery pack, the lithium-ion cells have a lithium content\nof 0.630 grams per cell~ or 7.56 grams of aggregate equivalent lithium content for the\nbattery pack. The lithium-ion battery packs are types proven to meet the appropriate tests\nin the United Nations (UN) Manual of Tests and Criteria, and the battery packs are\npackaged in a manner to prevent short circuits when offered for transport or carried\nonboard passenger aircraft. You ask whether this device is regulated under the HMR.\nBased on the information provided in your letter, the SimplyGo pac is currently not\nsubject to the HMR because: (1) the pressure of the oxygen in the device does not exceed\n200 kPa gauge (29.0 psigl43.8 psia) at 20°C (68 OF); (2) the lithium-ion battery pack used\nto operate the device is excepted from the HMR under § 172.1D2(c)(I), Special provision\n188; (3) the pac contains no other materials subject to the HMR; and (4) the battery pack\nis packaged in a manner to preclude it from creating sparks or generating a dangerous\nquantity of heat (e.g., by the effective insulation of exposed terminalS).\nAlthough the exception in § 175.1O(a)(18) of the HMR would apply to a passenger\ncarrying a SimplyGo pac as described above, approval by the FAA is required before it\nmay be used by a passenger onboard an aircraft. The FAA published a final rule on July\n\n<<<PAGE 2>>>\n\n12,2005 (70 FR 40155) regarding these devices. For further assistance, you may contact\nMr. Dave Catey, Aviation Safety Inspector for the FAA Air Carrier Operations Branch\n(AFS-220) by phone at (202)-267-3732 or email at david.catey@faa.gov. In addition, even\nwith FAA approval, an air carrier ultimately determines what mayor may not be carried on\nits aircraft. We suggest that you contact the airlines directly to ensure that the SimplyGo\nPOC may be carried.\nI hope 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\n2\n\n<<<PAGE 3>>>\n\nPHILIPS\nPhilips Respironics\n1740 Golden Mile Highway\nMonroeville, PA 15146\nNovember 8,2011\nAttn: Charles E. Betts - Chief, Standards Development, OHMS\nUS Department of Transportation\nPipeline and Hazardous Materials Safety Administration (PHMSA)\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nRe: Request for Determination - Respironics SimplyGo Portable Oxygen Concentrator (POC)\nDear Mr. Betts:\nPhilips Respironics is preparing to enter the market with a new Portable Oxygen Concentrator\n(POC) and is requesting an amendment to Special Federal Aviation Regulation 106 - Rules/or\nuse a/portable oxygen concentrator systems on board aircraft (SFAR 106), to include the\nRespironics SimplyGo POC in the list of approved POCs for use on board aircraft. SFAR 106\npermits passengers to carryon and use certain POCs on board aircraft if the aircraft operator\nensures that the conditions specified in the SFAR for their use are met. Section 2 of SFAR 106\nrequires that 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 CPR 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 Portable Oxygen Concentrator is for prescription use by patients\nrequiring high concentrations of oxygen on a supplemental basis. It is small, portable and is\ncapable of continuous use in the home, institutional, and travel/mobile environments. The\n\n<<<PAGE 4>>>\n\ndevice may be used by patients suffering from Chronic Obstructive Pulmonary Disease\n(COPD) and other respiratory disorders.\nThe device was cleared for commercial distribution by the US Food and Drug Administration\non November 4,2011 under premarket notification number 51O(k) K111885. Copies of the\nSimplyGo Portable Oxygen Concentrator 51O(k) clearance letter and User Instruction Manual\nare attached.\nPerformance Specifications and Device Description\nThe SimplyGo Oxygen Concentrator is a portable oxygen concentrator intended to deliver 8796%\npulsed and continuous flow oxygen to the patient. The device has an integrated\nconserving device which triggers a breath by sensing pressure at the onset of inspiration. The\nSimplyGo Oxygen Concentrator has a back up pulsed rate in the event of the patient not\ntriggering the device. In pulse mode, a set volume is delivered with each triggered breath.\nThe volume of the dose varies based on the user selected settings.\nThe SimplyGo Oxygen Concentrator will operate using any of the multiple power sources\nlisted below:\n• Rechargeable batteries\n• AlC Adapter\n• 12v DIC car Adaptor\nUsers\nThe SimplyGo Oxygen Concentrator will be used by patients requiring supplemental oxygen.\nThese patients are typically COPD patients. The patient using this device will be ambulatory\nand will be looking to improve their mobility versus other forms of supplemental oxygen.\nSome patients may have limited vision and hearing.\nEnvironments of Use\nThe SimplyGo Oxygen Concentrator is intended to be used during travel wherever the patient\nmight want to go. Therefore, the device may be used in both good and bad weather\nconditions. These conditions will include the extremes of temperature, rain, humidity, dust\nand snow. The SimplyGo POC is sixed to fit easily under the seat of a commercial aircraft,\npermitting the user to travel by air with their prescribed oxygen therapy.\nSpecifications\nOperating Conditions Operational temperature: 41 0 F to 104° F (5° C to 40° C)\nRelative humidit : 15% to 95%\n21Page\n\n<<<PAGE 5>>>\n\nAltitude: up to 10,000 ft. (3048 m.)\nStorage Conditions -40 F to 1400 F (-20° C to 600 C) - unit only\nRelative humidity: up to 95%, non condensing\nOxygen Concentration* 87%-96% at all settings\nFlow Settings and Pulse\nVolumes\nPulse Modes\n1 = 12 ml; 1 Y2 =18 ml; 2 =24 ml; 2Y2 = 30 mt;\n3 === 36 ml; 3Y2 =42 ml; 4 =48 ml; 4Y2 = 54 ml;\n5 === 60 ml; 5Y2 =66 ml; and 6 =72 ml;\n+/- 10% or 3 ml whichever is greater (Average of 20\nconsecutive breaths)\nup to a max of 2000 mllmin +/- 200 ml\nContinuous Mode\nY2 = 500 mllmin; 1 =1000 mt/min;\n1Y2 =1500 mllmin; 2 =2000 mllmin;\n+/- 10% or 100 mllmin whichever is greater\n(3 minute running average)\nUser Interface Push buttons, back-lit liquid crystal display (LCD)\n! Dimensions 11.5 in x 10 in x 6 in\n(29.2 cm x 25.4 cm x 15.2 cm)\nWeight ]91bS (4.5 kg) with battery installed\nAudio Alalm odecibels (nominal) at 39 in. (1 m)\nOutlet Pressure 3 psi\n*Based on an atmospheric pressure of 14.7 psia (101 kPa) at 70° F (21 0 C)\nS' ImplYl 1 G a Battery\nChemistry Lithium Ion 14.4 VDC (nominal)\nDimensions 0.9 in x 7.4 in x 4.6 in\n(2.7 em x 18.8 cm x 11.7 cm)\nWeight 1.5 Ibs. (0.7 kg)\nBattery Duration 3 hours (Pulse setting of 2 at 20 bpm)\nCharge Time Approximately 2-3 hours per battery from fully discharged\nto fully charged, depending on the power source and usage.\nACPower\nType Philips Respironics 1068987\nInput 100 to 240 V AC, 50/60 Hz, 2.0 A\nOutput 19 VDC, 7.9 A max\nPower Consumption 150 W while charging\n120 W while not charging\n31Page\n\n<<<PAGE 6>>>\n\nDC Power\nIInput: 113-19 VDC 7.9 A max\nStandards Compliance\nThe device is designed to conform to the following standards:\n- TEC 60601-1. Medical Electrical Equipment, Part 1: General Requirement for Safety\n- IEC 60601-1-2, 2nd edition, Medical Electrical Equipment, Part 1-2: General\nRequirement for Safety Collateral Standard: Electromagnetic (EMC)\nCompatibility - Requirements and tests.\n- RTCAJDO-160F section 21, category M; Emission of Radio Frequency Energy\n- ISO 8359, Oxygen Concentrators for Medical use - Safety Requirements.\nClassification\nThe SimplyGo Oxygen Concentrator is classified as:\n• TEC Class II Internally Powered Equipment\n• Type BF Applied Part\n• IPX 1: Drip Proof Equipment\n• Not suitable for use in the presence of a flammable anesthetic mixture with air\nor with oxygen or nitrous oxide.\n• Continuous Operation\nSpecifically, the following characteristics relate to the SimplyGo POC and its battery pack:\nI. The operating pressure of the SimplyGo POC device is 27 psi gauge (maximum), and a\nsafety relief valve with a lift pressure of 6.5 psi gauge is provided in the gas circuit.\n2. The lithium ion battery pack contains less than 8.0 grams of lithium. The battery pack meets\nthe requirements of each test in the UN Manual ofTests 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\ninsulation of exposed terminals). The SimplyGo POC 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 thelma] fuse. All\nsafety systems when activated shut down operation of the battery assembly.\n41Page\n\n<<<PAGE 7>>>\n\nBased on the information provided above, we respectfully submit that the SimplyGo POC is\nnot 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 excepted fro.m 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 portable oxygen concentrator contains no other materials subject to the HMR.\nThank you in advance for your assistance, consideration and review of our request. Ifyou\nrequire additional information, please feel free to contact me at (724)387-7562; by fax at\n(724)387-7490 or by email atjoseph.olsavsky@philips.com.\nSincerely,\n~£.~I/~\nJoseph E. Olsavsky, RAC\nSr. Manager - HRC Regulatory Affairs\nSIPage","truncated":false,"body_characters":12043}