{"operation":"document","citation":"11-0295","title":"Precision Medical, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2012-01-11","effective_on":null,"summary":"11-0295 response to Precision Medical, Inc. concerning 173.185, 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0295.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0295.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0295","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2011/110295.pdf","body":"<<>>\n\nU.S. Department 1200 New Jersey Avenue SE\nof Transportation Washington, DC 20590\nPipeline and Hazardous\nMaterials Safety\nAdministration\nJAN 112m2\nMr. Jim Parker\nQuality Manager\nPrecision Medical, Inc.\n300 Held Drive\nNorthampton, P A 18067\nRef. No.: 11-0295\nDear Mr. Parker:\nThis is in response to your November 29, 2011, letter regarding the applicability ofthe\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to a portable oxygen\nconcentrator (POC). According to your letter, the POC (common name Easy Pulse) is a\nportable device that produces an oxygen enriched gas mixture by removing nitrogen from the\nair. The maximum operating pressure ofthe POC is 14.5 psi. The POC is powered by multiple\nsources, including AC or DC power, and a rechargeable lithium-ion battery pack with less than\n6.24 g aggregate equivalent lithium content. The lithium-ion battery pack is a type proven to\nmeet the appropriate tests in the United Nations Manual of Tests and Criteria, and the battery\npack is packaged 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 Easy Pulse POC is currently not subject to\nthe HMR because: (1) the pressure ofthe oxygen in the device does not exceed 200 kPa gauge\n(29.0 psigl43.8 psia) at 20 DC (68 OF); (2) the lithium-ion battery pack used to operate the\ndevice is excepted from the HMR under § 172.1 02( c)( 1), Special provision 188; (3) the POC\ncontains no other materials subject to the HMR; and (4) the battery pack is packaged in a\nmanner to preclude it from creating sparks or generating a dangerous quantity of heat (e.g., by\nthe effective insulation ofexposed terminals).\nAlthough the exception in § 175.1 0(a)(18) ofthe HMR would apply to a passenger carrying an\nEasy Pulse POC as described above, approval by the Federal Aviation Administration (FAA) is\nrequired before it may be used by a passenger onboard an aircraft. The FAA published a final\nrule on July 12, 2005 (70 FR 40155) regarding these devices. For further assistance, you may\ncontact Mr. Dave Catey, Aviation Safety Inspector for the FAA Air Carrier Operations Branch\n\n<<>>\n\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 its\naircraft. We suggest that you contact the airlines to ensure that the Easy Pulse POC may be\ncarried.\nI hope this information is helpful. If you have further questions, please contact this office.\nSincerely,\n---\n~ S~<:..--/\nBenSupko\nActing Chief, Standards Development\nOffice of Hazardous Materials Standards\n\n<<>>\n\nDrakeford, Carolyn (PHMSA)\nFrom: Betts, Charles (PHMSA)\nSent: Tuesday, November 29, 20114:13 PM\nTo; Drakeford, Carolyn (PHMSA)\nSubject: FW: Precsion Medical POC\nAttachments: example_oxus.pdf; request_for_assist_phmsa.pdf; PHMSA letter dated 82311.pdf;\nscandocs@precisionmedical com_2011 0727_093213.pdf; FAA letter072711.doc; 506640\nRevO 062811. pdf\nCarolyn Please\nlog and assign to Kevin for handling.\nThanks,\nCharles\n-----Original Message----From:\nLawson, Eleanor (PHMSA)\nSent: Tuesday, November 29, 2011 1:46 PM\nTo: Betts, Charles (PHMSA)\nSubject: FW: Precsion Medical POC\nThis has been bouncing around for quite awhile. James Parker needs to have the FAA Rule (SFAR\n106) amended to add Precision Medical Inc Portable oxygen concentrator to the list of oxygen\nconcentrator allowed on aircraft. However, before FAA can act on his request, they require\na clarification or review from PHMSA. Apparently, there was a similar request which resulted\nin a review from Standards and this review resulted in a letter of clarification issued by\nStandards. This letter is attached.\nEleanor Lawson\nU.S. Department of Transportation\nPHMSA/OHMS/AP Div./Approvals\n1200 New Jersey Avenue, SE\nEast Building, 2nd Floor, Rm. E23-443\nwashington, DC 20590\nTel: 202-366-3987\nFax: 202-366-3753\nEmail: Eleanor.Lawson@dot.gov\n-----Original Message----From:\nDK.Deaderick@faa.gov [mailto:DK.Deaderick@faa.gov]\nSent: Tuesday, November 29, 2011 12:44 PM\nTo: Lawson, Eleanor (PHMSA)\nSubject: Fw: Precsion Medical POC\nEleanor,\nIt was good talking with you today. Thanks for your offer to assist this petitioner.\nHere's the pdf notes and letters that we discussed. I have provided an example of a PHMSA\nletter from the Oxus rule making project to amend SFAR\n106\n(See attached file: example_oxus.pdf)(See attached file:\n1\n\n<<>>\n\nLet me know if I can assist further. I feel that lowe this manufacturer an apology because\nhe asked for coaching with the rulemaking process and I've been working with him since July.\n----- Forwarded by 0 K Oeaderick/AWA/FAA on 11/29/2011 12:34 PM ----1------------>\n1 From: 1\n1------------>\n>-------------------------------------------------------------------------------------------------------------------------------------------------I\n1 \"James Parker\" \n1\n--------------------------------------------------------I\n1------------>\n1 To: 1\n1------------>\n>--------------------------------------------------------------------------------- ---------------------------------------------------------------I\n10 K Oeaderick/AWA/FAA@FAA\n>-------------------------------------------------------------------------------------------------------------------------------------------------I\n1------------>\n1 Date: 1\n1------------>\n>-------------------------------------------------------------------------------------------------------------------------------------------------I\n111/09/2011 09:48 AM\nI\n>-------------------------------------------------------------------------------------------------------------------------------------------------I\n1------------>\nI Subject: 1\n1------------>\n>--------------------------------------------------------------------------------------------------------------\n----------------------------------1\nIPrecsion Medical poe\nI\n>-------------------------------------------------------------------------------------------------------------------------------------------------I\nHi OK,\nAttached are the documents, I originally sent.\nLet me know if you need anything else.\nThanks for your help.\n2\n\n<<>>\n\nBest Regards,\nJim Parker\nQuality Manager\nPrecision Medical Inc.\n300 Held Drive\nNorthampton, Pa 18067\nEmail:jparker@precisionmedical.com\nPhone: 610-262-6090 ext 228\nFax:610-262-6080\nCell : 610-762-9673\n(See attached file: PHMSA letter dated 82311.pdf)(See attached file:\nscandocs@precisionmedical com_20110727_093213.pdf)(See attached file: FAA\nletter072711.doc)(See attached file: 506640 Rev0 062811.pdf)\n3","truncated":false,"body_characters":6746}