{"operation":"document","citation":"08-0032","title":"Invacare Corporation — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2008-06-16","effective_on":null,"summary":"08-0032 response to Invacare Corporation concerning 172.102, 173.185.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0032.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0032.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0032","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2008/080032.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nJUN 1 6 2008\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nMs. Carroll Martin\nRegulatory Affairs Manager\nInvacare Corporation\nOne lnvacare Way,\nElyria, OH 44035\nRef. No.: 08-0032\nDear Ms. Martin:\nThis is in response to your January 30,2008 letter and subsequent conversation with Ben Supko\nof my staff regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR\nParts 100- 1 80) to a device that your company calls the Invacare Portable Oxygen Concentrator\nXPOl00 and an external battery module.\nOn August 9,2007, PHMSA amended the HMR to tighten the safety standards for transportation\nof lithium batteries, including both primary (non-rechargeable) and secondary (rechargeable)\nlithium batteries (HM-224C & HM-224E; 72 FR 44929). A copy of the rulemaking is enclosed.\nEffective January 1, 2008, the Pipeline and Hazardous Materials Safety Administration revised\nand relocated the 8-gram exception for small lithium batteries formerly found under\n$ 173.185(b)(2) of the HMR. New requirements applicable to the Invacare XPOlOO and external\nbattery module, described in your letter, are provided in Special Provision 188 ( 5 172.102).\nIn your letter, you indicate that the Invacare XPOlOO portable oxygen concentrator and external\nbattery module meet the following criteria:\n(1) the pressure of the oxygen in the device does not exceed 40.6 psia at 20 O C ;\n(2) the cells contain not more than 1.5 grams of lithium equivalent content;\n(3) the lithium ion batteries contain an aggregate equivalent lithium content of not more\nthan 8g;\n(4) the device contains no other materials subject to the HMR; and\n(5) the batteries are fully contained in equipment and packaged in a manner to preclude\nsparks or the generation of a dangerous quantity of heat.\nBased on the information provided, the Invacare XP0 100 portable oxygen concentrator and\nexternal battery module meet Special Provision 188. Provided they continue to meet the\nrequirements established by Special Provision 188, you are not otherwise subject to the HMR.\n\n<<<PAGE 2>>>\n\nYou should also note that Federal Aviation Administration (FAA) approval is required before\nthese electronic devices may be used by passengers on board aircraft. The FAA published a final\nrule in the Federal Register regarding these devices on July 12,2005 (70 FR 40 156). A copy of\nthe rulemaking is enclosed.\nIn addition, even with FAA approval the air carrier ultimately determines what may or may not\nbe camed on its aircraft. We suggest that you check with the air canier to ensure that the\nInvacare XPO 100 portable oxygen concentrator and external battery module may be carried.\nI hope this information is helpful. If you have further questions, please do not hesitate to contact\nthis office.\nSincerely,\n1 '/\nEdward T. Mazzullo\nDirector\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nJanuary 30,2008\nMs. Hattie Mitchell\nChief, Regulatory Review and Reinvention\nU. S. Department of Transportation\nPipeline and Hazardous Materials Safety Administration\nOffice of Hazardous Materials Standards\n1200 New Jersey Avenue, SE East Building, 2nd Floor\nWashington, DC 20590\nRE: Invacare Portable Oxygen Concentrator\nDear Ms. Mitchell:\nInvacare is requesting written confirmation from the Pipeline and Hazardous Materials\nSafety Administration that the Invacare Portable Oxygen Concentrator XPOlOO is not\nsubject to the U.S. hazardous materials regulation under HMR; 49 CFR Parts 100-1 80\nafter review of all appropriate information.\nThe Invacare XPOlOO Portable Oxygen concentrator is a lightweight device that\nseparates nitrogen from room air through the pressure swing adsorption (PSA) process\nand stores the resultant concentrated oxygen gas for delivery to patients who need\nsupplemental oxygen therapy (see Exhibit A). The XPOl00 device delivers the oxygen to\na patient through the pulse dose delivery meihod for maximum effectiveness and\noperational time. This means that the XPOlOO delivers oxygen only when a breath is\ndetected. If no breath is detected (i.e. the cannula detaches from the device or the patient\ntakes the cannula off), no oxygen is delivered. This feature of delivering oxygen only\nwhen a breath is detected prevents oxygen saturation of the surrounding area or materials\nwhen the cannula is not connected to the concentrator or the patient.\nThe maximum internally attainable pressure during the PSA cycle of the Invacare\nXP0100 is 23.5 PSIG (38.2 PSIA) over an operating temperature range of 5°C to 40°C.\nAs this maximum operating pressure is lower than the 40.6 PSIA at 20°C for a Division\n2.2 gas in 49 CFR 173.1 15(b)(l), Invacare feels the XP0100 device is not subject to the\nU.S. HMR regulations for oxygen gas.\nThe XPOl00 device can be powered by an internally captive lithium ion battery pack that\nis not customer removable or replaceable, an external AC to DC power adapter, an\nexternal DC to DC power adapter, or an external accessory lithium ion battery pack. This\nINVACARE CORPORATION\nOne lnvacare Way Elyria, Ohio 44036-2125 USA\n\n<<<PAGE 4>>>\n\nallows for maximum flexibility and operational time with multiple power sources.\nRecharging is only available with the use of the ACIDC or DCIDC power adapters.\nThe internally captive lithium ion battery pack (see Exhibit F) consists of 8 cylindrical\n2.6 amp-hour lithium ion cells (see Exhibits B and C) with a total lithium equivalent\ncontent of 6.24 grams of lithium The internally captive battery pack is not user\naccessible and not replaceable by a patientluser. It is securely captured in the product and\nhas passed all applicable UN Manual of Tests and Criteria requirements for lithium\nbattery packs (see Exhibits D and E). The internally captive mechanism of the Invacare\nXPOlOO also prevents any user from generating sparks or short-circuiting as it is not\nexternally accessible. The battery pack terminals are not exposed to any outside contact\nby virtue of being totally integrated into the product. (see Exhibit A)\nThe external accessory battery module (see Exhibit I) for extended operating time is a\nself-contained power accessory for the Invacare XPOlOO device. The external battery\nmodule contains a separate battery pack that consists of 8 cylindrical 2.6 amp-hour\nlithium ion cells with a total lithium equivalent content o f 6.24 grams of lithium (see\nExhibit G). The lithium battery pack is not user accessible and is not replaceable by a\npatientluser. It is securely captured in the external module and has passed all applicable\nUN Manual of Tests and Criteria requirements for lithium battery packs (Exhibits D and\nE). The captive mounting mechanism of the external battery module also prevents any\nuser fi-om generating sparks or short-circuiting the lithium battery pack. The battery pack\nterminals are not exposed to any outside contact as they are connected to an intervening\npower switching and charging circuit board (see Exhibit K) that interfaces to the Invacare\nXP0100 device. The external battery module connection cable (see Exhibit J) contains a\nconnector that prevents accidental shorting or generation of sparks during handling or\nstorage.\nInvacare feels that based on the requirements of 49 CFR 173.185(~)(2), both the\ninternally captive lithium battery pack and the lithium battery pack in the external battery\nmodule are exempt fi-om the HMR requirements. The individual cells do not contain\nmore than 5 grams of lithium equivalent grams and each battery pack does not contain\nmore than 25 grams of lithium equivalent grams. Each battery pack has been tested and\napproved to the UN Manual of Tests and Criteria for all appropriate lithium celVpack\ntesting. In addition, both the internally captive and external battery packs are packed\nsecurely within the respective product case and are prevented fi-om short-circuiting and\nspark generation.\nINVACARE CORPORATION\nOne Invacare Way Elyria, Ohio 44036-2125 USA\n\n<<<PAGE 5>>>\n\nInvacare believes that all the other materials used in the device are not subject to the U.S.\nhazardous materials regulation under HMR 49 CFR Parts 100-1 80 (Exhibit H).\nWith all of the preceding information, Invacare asks that the PHMSA confirm that the\nInvacare Portable Oxygen Concentrator XPOlOO is not subject to the U.S. hazardous\nmaterials regulation under HMR; 49 CFR Parts 100-1 80.\nIf you need any additional information or wish to speak with me regarding this\nsubmission, please feel free to contact me by phone at 440-329-6356 or by e-mail at\nCarroll. Martin@invacare.com.\nYou may contact us in either ofthe following ways with your decision:\nMail: Carroll Martin, One Invacare Way, Elyria, Ohio 44035\nE-Mail: Carroll. Martin(u;invacare.co~n\nFax: 440-326-3458\nRespectfully submitted, / /\nRegulatory ~ f B k s Manager\nInvacare Corporation\nINVACARE CORPORATION\nOne Invacare Way Elyria, Ohio 44036-2125 USA","truncated":false,"body_characters":8923}