{"operation":"document","citation":"15-0002","title":"Invacare Corporation — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2015-02-20","effective_on":null,"summary":"15-0002 response to Invacare Corporation concerning 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0002.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0002.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0002","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2015/150002.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation\n1200 New Jersey Avenue, SE\nPipeline and Hazardous Materials\nWashington, DC 20590\nSafety Administration\nCarol Vierling\nFEB 2 0 2015\nActing Regulatory Affairs Manager\nInvacare Corporation\nOne Invacare Way\nP.O. Box 4028\nElyria, OH 44036\nRef. No. 15-0002\nDear Ms. Vierling:\nThis responds to your December 30, 2014 letter requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to a portable oxygen\n\" concentrator (POC). Specifically, you inquire about obtaining approval from the Pipeline\nand Hazardous Materials Safety Administration (PHMSA) and the Federal Aviation\naircraft.\nAdministration (FAA) to allow a passenger to carry and operate the POC on board an\n• According to your letter, the POC (trade name Invacare XPO2) is a device for use by\npatients requiring high concentrations of oxygen on a supplemental basis. The device in\nquestion is a modified version of an earlier model of the Invacare XPO2 POC that is\ncurrently listed in Special Federal Aviation Regulation 106, \"Rules for Use of Portable\nOxygen Concentrator Systems on Board Aircraft\"(SFAR 106) and approved for use on\nboard aircraft. The modified version of the Invacare XPO2 POC for which you seek\napproval has a maximum operating pressure of less than 21.0 pounds per square inch (psia).\nIt is powered by multiple sources, including AC or DC power, a captive internal lithium ion\nbattery pack, and a rechargeable external accessory lithium ion battery pack. Both the\ncaptive internal lithium ion battery pack and the rechargeable external accessory lithium ion\nbattery pack have a Watt-hour (Wh) rating of 83.5 (2.9 ampere-hour (Ah) x 3.6 volts (V) x 8\ncells). Both the captive internal and the rechargeable external accessory lithium ion battery\npacks meet the appropriate testing requirements of the United Nations Manual of Tests and\nCriteria, and both battery packs are packaged in a manner to prevent short circuits. You ask\nwhether the modified version of the Invacare XPO2 POC is authorized under the HMR to be\ncarried on board an aircraft.\nBased on the information provided in your letter, the modified version of the Invacare XPO2\nPOC is not subject to the HMR as a Division 2.2 non-flammable gas, the captive internal\nand the rechargeable external accessory lithium ion battery packs used to power the device\n\n<<<PAGE 2>>>\n\nconform to § 175.10(a)(18), and the POC contains no other hazardous materials. Therefore,\nin accordance with HMR § 175.10(a)(18), the modified version of the Invacare XPO, POC\nis authorized to be carried on board an aircraft by passengers or crew members.\nPlease note that notwithstanding the passenger exception in § 175.10(a)(18) of the HMR,\nthe provisions of SFAR 106 apply and are under the purview of the FAA. This response\nsatisfies only one requirement in the FAA approval process before a POC may be carried\nand operated on board 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,\nDuaned. The\nDuane A. Pfund\nInternational Standards Coordinator\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nDOTARSPA/ OHMS\nUNIT\nYes, you can\"\n15 JAN -6 PM 3:30\nDecember 30, 2014\nU.S. Department of Transportation\nPipeline and Hazardous Materials Safety Administration\nOffice of Hazardous Materials and Standards\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590-0001\nDear Sir or Madam,\nInvacare Corp. is requesting confirmation from the Pipeline and Hazardous Materials Safety\nAdministration (PHMSA) that the Invacare® XPO_™M Portable Oxygen Concentrator (XPO2\nPOC) is not subject to the U.S. Hazardous Materials Regulation (HMR) under HMR 49 CFR\nParts 100-180 after review of all appropriate information.\nIntroduction\nInvacare Corp. manufactures portable oxygen concentrators (POCs) and has marketed the XPO2\nPOC since receiving 510(k) clearance from the Food and Drug Administration (FDA) on\nDecember 12, 2007. The XPO2 POC is currently allowed to be used onboard aircraft and was\nadded to SFAR No. 106 published in the Federal Register on January 15, 2009. As part of that\napplication, Mr. Mazzullo of the U.S. Department of Transportation sent a letter to Invacare\nCorp. stating that the Invacare® XPO_T Portable Oxygen Concentrator is not subject to the\nHMR. Please refer to Attachment 1 for the Federal Register Notice.\nThe XPO2 POC continues to provide oxygen by separating oxygen from room air utilizing a\nmolecular sieve and pressure swing adsorption methodology. The resultant concentrated oxygen\nis directed toward an oxygen reservoir for delivery to the patient. The XPO2 device delivers the\noxygen to the patient through the pulse delivery method for maximum effectiveness and\noperational time. This means that the subject devices deliver oxygen only when a breath is\ndetected. If no breath is detected (i.e. the cannula detaches from the device or the patient takes\nthe cannula off), no oxygen is delivered. This feature of delivering oxygen only when a breath is\ndetected prevents oxygen saturation of the surrounding area or materials when the cannula is not\nconnected to the concentrator or the patient. The technological characteristics of the modified\nXPO2 POC remains the same as the original XPO2 Portable Oxygen Concentrator listed under\nSFAR No. 106. Please refer to Attachment 2 for the finished device drawing.\nOne Invacare Way P.O. Box 4028\nINVACARE CORPORATION\neeranora\nElyria, Ohio 44036-2125 USA\n\n<<<PAGE 4>>>\n\nYes, you can.\nProposed Modifications\nInvacare Corporation has modified the internal and external batteries of the XPO2 device to\nimprove use duration and to increase the expected lite cycle. In addition, some minor design\nchanges have also been incorporated for quality improvement purposes only.\nPower Source for the Invacare XPО2 POC\nThe subject device can be powered by an internally captive lithium ion battery pack that is not\ncustomer removable or replaceable, an external AC to DC power adapter, an external DC to DC\npower adapter, or an external accessory lithium ion battery pack. This allows for maximum\nflexibility and operational time with multiple power sources. Recharging of either the internal or\nexternal accessory batteries is only available with the use of the Invacare supplied AC/DC or\nDC/DC power adapters.\nThe internally captive lithium ion battery pack (see Attachment 3) consists of 8 cylindrical 2.9\namp-hour lithium ion cells with a total lithium equivalent content of 6.36 grams of lithium, and\nwatt hour rating of 85.3 Whr (see Attachment 4). The internally captive battery pack is not user\naccessible and not replaceable by a patient/user. The internally captive mechanism of the subject\ndevices also prevents any user from generating sparks or short-circuiting as it is not externally\naccessible. The battery pack terminals are not exposed to any outside contact by virtue of being\ntotally integrated into the product.\nThe external accessory battery module for extended operating time is a self-contained power\naccessory for the XPO2 device. The external battery module contains a separate lithium battery\npack that consists of 8 cylindrical 2.9 amp-hour lithium ion cells with a total lithium equivalent\ncontent of 6.36 grams of lithium, and watt hour rating of 85.3 Whr. The lithium battery pack is\nnot user accessible and is not replaceable by a patient/user. The captive mounting mechanism of\nthe external battery module also prevents any user from generating sparks or short-circuiting the\nlithium battery pack. The battery pack terminals are not exposed to any outside contact as they\nare connected to an intervening power switching and charging circuit board that interfaces to the\nInvacare XPO2 device. The external battery module connection cable contains a connector that\nprevents accidental shorting or generation of sparks during handling or storage. Please refer to\nAttachment 5 for the external battery module, external battery pack, circuit board schematic and\nexternal battery module connection cable.\nThe table below compares the XPO2 POC currently marketed with PHMSA approval in 2008\nand the evaluation results of the proposed modification\nINVACARE CORPORATION\nOne Invacare Way P.O. Box 4028\nElyria, Ohio 44036-2125 USA\n\n<<<PAGE 5>>>\n\nPHMSA Special Provision 188 Comparison Table\nInvacare XPO2 Portable Oxygen Concentrator\nItem\nPHMSA Criteria\nPHMSA 2008 Approval\nPressure of the oxygen in the\nValue\nResult\n2014 Submittal.\nValue..\n- Result\nComments\n1\nPSIA at 20C\ndevice does not exceed 40.6\n< 21 PSIA\nPass\n< 21 PSIA\nPass\nNo change\n2\nmore than 1.5 grams of lithium\nLithium cells do not contain\n2.6 AH Cell\nequivalent content\n0.78 LEgram\nPass\n2.9 AH Cell\n0.87 LEgram\nPass\nSlight increase in lithium\ncontent\n3\nLithium batteries contain an\naggregate equivalent lithium\n8 cells/battery\ncontent of not more than 8g\n6.24 L E. grams\nPass\n6.96 L E. grams\n8 cells\nPass\nSlight increase in lithium\ncontent\nNo other\n4\nmaterisl sujbect to the HMR\nThe device contains no other\nhazardous\nPass\nhazardous\nNo other\nmaterials\nPass\nNo change\nThe batteries are fully\nmaterials\ncontained in equipment and\nFully contained\n5\npackaged in a manner to\npreclude sparks or the\nprotective product\ninside of\nFully contained\nPass\ninside of\n[quantity of heat\ngeneration of a dangerous\nenclosure\nprotective product\nPass\nNo change\nenclosure\nL.E. gram = Lithium equivalent grams content\n\n<<<PAGE 6>>>\n\nYes, you can\"\nCompliance with RTCA/DO-160G\nThe Invacare XPO2 POC has successfully undergone testing pursuant to the requirements of\nRTCA/DO-160G, Section 21, Category M to demonstrate that the device will not interfere with\nan aircraft's electrical, navigation or communication equipment. A summary of the test report is\nprovided in Attachment 6.\nConclusion\nIn conclusion, the updated XPO2 device continues to meet the five PHMSA Special Provision\n188 criteria. In addition, data show acceptable RTCA DP-160 test results. Based on this\ninformation, Invacare Corp. asks that the PHMSA confirm that the Invacare XPO2 device is not\nsubject to the U.S. Hazardous Materials Regulation under HMR 49 CFR Parts 100-180.\nInvacare has discussed the minor modifications to the XPO2 with the Federal Aviation\nAdministration (FAA) and submitted the proposed changes with supporting documents to the\nagency. Prior to their approval, the FAA has requested that Invacare Corp. obtain a letter from\nthe PHMSA stating that the XPO2 does not contain hazardous materials.\nWe would appreciate your timely response. A letter from the PHMSA is all that is needed for\nFAA approval. If you have any questions, please contact me by telephone at 706-476-2938 or by\nemail at carol.vierling@yahoo.com.\nSincerely,\nCarol Vierling\nActing RA Manager\nOne Invacare Way P.O. Box 4028\nINVACARE CORPORATION\nAAAAANNA\nner ac man\nElyria, Ohio 44036-2125 USA\n\n<<<PAGE 7>>>\n\n2352\nFederal Register/ Vol. 74, No. 10/Thursday, January 15, 2009/Rules and Regulations\nmore about SBREFA on the Internet at\nregulations_policies/rulemaking/\nour site, http://www.faa.gov/\nrequire the same level of special\nhazardous materials. Thus, they do not\nperformance-based standard for all POC\nWe continue to pursue the\nsbre_act/.\nhandling as compressed oxygen, and are\nsafe for use on board aircraft, provided\ndevices. This process is time-consuming\nAuthority for This Rulemaking\ncertain conditions for their use are met.\nFederal Register and offer the public a\nand we intend to publish a notice in the\nregarding aviation safety is found in\nThe FAA's authority to issue rules\non and use certain POC devices on\nSFAR 106 permits passengers to carry\nwhen it is complete. In the meantime,\nchance to comment on the proposal\nTitle 49 of the United States Code (49\nboard aircraft if the aircraft operator\nthe authority of the FAA Administrator.\nU.S.C.). Subtitle I, Section 106 describes\nensures that the conditions specified in\nmanufacturers continue to create new\nthe SFAR for their use are met. The\nhave requested that their product also\nand better POC devices, and several\nSubtitle VII, Aviation Programs,\ndevices initially determined acceptable\nagency's authority\ndescribes in more detail the scope of the\n2005, were the AirSep Corporation's\nfor use in SFAR 106, published July 12,\nSFAR 106. These new manufacturers\nbe included as an acceptable device in\nfinal rule pursuant to 49 U.S.C. 44701.\nThe FAA is authorized to issue this\nLifeStyle and the Inogen, Inc.'s Inogen\ninclude Delphi Medical Systems and\nOne POCs. SFAR 106 was amended on\ncompanies has formally petitioned the\nInvacare Corporation. Each of these\nauthorized to establish regulations and\nUnder that section, the FAA is\nadd three additional POC devices,\nSeptember 12, 2006 (71 FR 53954) to\nsubmitting documentation of the\nFAA for inclusion in SFAR 106 by\nminimum standards for other practices,\nAirSep Corporation's FreeStyle, SeQual\nmethods, and procedures the\nTechnologies' Eclipse, and Repironics\nManagement System. That\ndevices to the Federal Docket\ncommerce and national security.\nAdministrator finds necessary for air\nfinal rule adds two additional POC\nInc.'s EverGo, to the original SFAR. This\ndocumentation is available at http://\ndevices, Delphi Medical Systems' RS-\nfollowing docket numbers:\nwww.regulations.gov under the\n00400 and Invacare Corporation's\nSpecial Federal Aviation Regulation 106\nOn July 12, 2005, the FAA published\nby a passenger on board an aircraft.\nXPO2, that may be carried on and used\n2008-0261; and\n1. Delphi Medical Systems-FAA-\nPortable Oxygen Concentrator Devices\n(SFAR 106) entitled, \"Use of Certain\nAircraft operators can now offer\n2. Invacare Corporation-FAA-2008-\n106 is the result of a notice of proposed\nOn Board Aircraft\" (70 FR 40156). SFAR\nmedical oxygen service as they did\nno covered device may contain\nAs stated in Section 2 of SFAR 106,\ncan meet certain conditions and allow\nbefore SFAR 106 was enacted, or they\n, hazardous materials as determined by\nrulemaking (NPRM) the FAA published\nthe needs of passengers who must travel\nin July 2004 (69 FR 42324) to address\npassengers to carry on and use one of\nnecessary), and each device must also\nPHMSA (written documentation\nthe POC devices covered in SFAR 106.\nwith medical oxygen. Prior to\nSFAR 106 is an enabling rule, which\nincluded technical specifications for the\nbe regulated by the FDA. Each petitioner\nmeans that no aircraft operator is\nneed of medical oxygen during air\npublication of SFAR 106, passengers in\nrequired to allow passengers to operate\ndevices in their request for approval,\nwhen requesting service. Many aircraft\ntransportation faced many obstacles\nthese POC devices on board its aircraft,\nalong with the required documentation\nboard. If the aircraft operator allows one\nbut it may allow them to be operated on\npetitioners provided the FAA with the\nfrom PHMSA and the FDA. The\noperators did not provide medical\noxygen service aboard flights, and those\nof these devices to be carried on board,\nrequired documentation for the\nthat did often provided service at a price\nthe conditions in the SFAR must be met.\nfollowing POC devices:\nCoordinating service between operators\nthat travelers could not afford.\npublished, the FAA committed to\nWhen SFAR 106 was originally\n1. Delphi Medical Systems', Model\nand suppliers at airports was also\nestablishing a single standard for all\n2. Invacare Corporation's, Model\nchose not to fly because of these\ndifficult, and passengers frequently\nnot apply to specific manufacturers and\nPOC devices so that regulations would\nmodels of devices. Whenever possible,\nNew medical oxygen technologies\nperformance-based standards rather\nthe FAA tries to regulate by creating\ninclude the Delphi Medical Systems'\nThis amendment to SFAR 106 will\napproved by the Food and Drug\nAdministration (FDA) reduce the risks\nmanufacturer. In the case of SFAR 106,\nthan approving specific devices by\nRS-00400 and Invacare Corporation's\nauthorized for use in air commerce. The\nXPO2 devices in the list of POC devices\ntypically associated with compressed\noxygen and provide a safe alternative for both the passenger and the aircraft\nthe quickest and easiest way to serve\nFAA has reviewed each individual\npassengers who need oxygen therapy.\nSeveral manulacturers have developed\ndevices determined to be acceptable by\noperator was to allow the use of the\nprovided by the two manufacturers.\ndevice and accepted the documentation\n(POC) devices that work by separating\nsmall portable oxygen concentrator\ntemporary regulation. As we stated in\nthe FAA in SFAR 106 in a special,\nprovided to the manufacturer by\nThat documentation includes letters\ncontained in ambient air and dispensing\noxygen from nitrogen and other gases\nthat established SFAR 106, \"while we\nthe preamble discussion of the final rule\nPHMSA and the FDA affirming the\nrequisites stated in SFAR 106.\nstatus of each device as it pertains to the\nit in concentrated form to the user with\nan oxygen concentration of about 90%.\nare committed to developing a\nThe POC devices operate using either\nperformance-based standard for all\nsafety standards and the PHMSA\nAfter reviewing the applicable FDA\nrechargeable batteries or, if the aircraft\nfuture POC devices, we do not want to\noperator obtains approval from the FAA,\nhave the effect of stifling new\nprematurely develop standards that\ndetermined by the FAA to be acceptable\nfindings, these two devices were\naircraft electrical power.\nIn addition, the Pipeline and\nWe developed and published SFAR 106\ntechnology of which we are unaware.\"\nfor use in air commerce.\nAdministration (PHMSA) has\nHazardous Materials Safetv\nGood Cause for Adoption of This Final\nnot fly could do so with an affordable\nso that passengers who otherwise could\nRule Without Notice and Comment\ndetermined that the POC devices\ncovered by this amendment are not\nalternative to what existed before SFAR\npublished on July 12, 2005. We stated\nAs stated above, SFAR 106 was\n106 was published.\nin the preamble of that final rule that\n\n<<<PAGE 8>>>\n\nQTY.\n24148300\n1148300\n-( .03)\nPART NO.\nTO DO WORE DEIGNED OR FURIED BY USE ICE\nOHIO\nDO NOT SCALE THIS DRAWING\n1. TORQUE SCREWS (ITEMS 4 & 5) TO 3 IN-LBS.\n2. PRIOR TO APPLYING SEAL (ITEM 7) CLEAN\nSURFACES TO WHICH SEAL WILL ADHERE\nTHOROGHLY WITH ALCOHOL WIPES).\n3. REMOVE PROTECTIVE COVER/FILM PRIOR\n4. INSTALL FERRITE (ITEM 8) ON RED AND BLACK\n= CRITICAL QUALITY ATTRIBUTE\n• = KEY CHARACTERISTIC IDENTIFICATION\nDESCRIPTION\nASM, REAR XPO2\nASM, FRONT XPO2\nASM, BATTERY PACK INTERNAL XP02\nSCREW, 6-19 X .75 TORX PAN HD PLASTITE\nSCREW, 6-19 X .50 TORX PAN HD PLASTITE\nO-RING, 114 ID X .070\nSEAL/NOTICE, XPO2\nFERRITE, SNAPON\nASM, CONCENTRATOR XPO2\nINVACARE CORP. ELYRIA\nSEAL/NOTICE TO BE APPLIED TO\nASSEMBLED UNIT, POSITIONED\nAS SHOWN. SEE NOTE 2.\nTO INSTALLING BATTERY,\nWIRE OF BATTERY (ITEM 3).\nPART DESCR.PIION:\nNOTES:\nDATE: 13/16/07\nPART NO.\n1151575\n1184860\n1183927\n1151831\n1151560\n1148328\n1151839\n1147000\nNOT SHOWN\nITEM NO\nMATERIAL NO.\nMATERIAL DESCRIPTION:\nANT PERPO\nSCALE 1:2\nOPAWN BY: HODOS\nPRE-RELEASE\nDESIGN ENGR/Date:\nMFG/SO ENGR/Bate:\nQUALITY/Date:\nxx/xx/xx/\n3/14/14\n0/7/11\n01/27/11\nOATE\nSEE NOTE 3-\nREVISION\n00. 2/25/14 SW 1184860 WAS 1151580; 1183927 WAS 1148283; REM 1159909; FLIPPED BATTERY UP IN GRAPHICS\nF 3. THE OXYGEN GAS MUST MEET THE REQUIREMENTS OF USP 93 EXCEPT FOR THE OXYGEN\n01. 3/10/14 SW REV SPEC. NOTE 2; ADDED SPEC. NOTE 3: REV NOTES 2 AND 4\n2 OXYGEN VETED SURFACES ARETO BE BIOCOMPATIBLE.\nF 1321003 PENDING OUTCOME OF PRELIM CHANGES\n1121004 | REV; ADDED 1147000 QTY!: ADDED NOTE 4\n02. 7/2/14 SW REV CONTROL PANEL GRAPHICS\nD 1121049 REVISION LEVEL RELEASED IN ERROR\n1421004 ADDED SPECIFICATIONS\nREVISIONS: (1321003)\nSPECIFICATIONS:\n\n<<<PAGE 9>>>\n\n1183%27\n1183927\nSIGNATURE ON FILE\nSEE DISTRIBUTION #038\nD>= CRITICAL QUALTY ATTRIBUTE\n=KEY CHARACTERISTIC IDENIFICATION\nASIM, BATTERY PACK\nINTERNAL XP02\nINVACARE CORP.\nPRE-RELEASE\nDESIGN ENGR/Date:\nMFG/8Q ENAR/Date:\nQUALITY/Date:\n-de GET\nStion beltery (4s2P) w/ shrink sieeve & safety circuit wi fuel gauge based on TI# BO20Z95.\n- Stardovere ver cure disharge protein 75 AMPS miscond ela\n- First tier over cureat rechare pract 2 a AMPS 2 second delay).\n• Shan circuit condition will be sel at 25 Amps for 549 Micro seconds\ncompliant\npermanent text and graphics with tamper resistant adhesive backing.\n0 XXXXX = sequential assembly starting at 00001 beginning each month\n• The phrase \"Lithium lon\" accompanied by electrical specs and\n(1 sec delay, resume 4.1 +/-0:05V)\n1. Cell is approved according to UL1642 and IEC62133\n-Min state of charge: 30%. Place battery in \"Shut Down\" mode\n• Overdischarge detection: 2.7+/-0.05V\nAmbiant Conditions/ Temp range:\n10 fo 60 đeg C\n25 to 70 deo C\n4. Battery pack must meet all IATA requirements\nCabel io be of Polypropylene material and marked with\nDo Not Expose to High Temperatures (140F / 60C)\n• PCM: Vecture # VC4126. - Thermistor: 10K ohm\n• Rated Capacity: 5500mAh min., 5800mAh typical\nCharging Method: Constant current+constant voltage\nLabel itormation to include at a minimum:\n5. Wall-hour rating of 83.5Whr\nLabel Requiremants\n• invacare and Mfos P/N's\n• Name and focation of assembler\n• Serial number formatted MMYY-XXXXX\n• MMYY= manth / year of assembly\n• The phrase \"Lithium Ion Battery\" bolded\n- Max charga voltage: 16.80V (+/-0.2V)\nseries/parallel info\n• Watt hour rating\n• Cell Manufacturer P/N\n• WERE ANNEX IV symbol\n• The phrases\n• Do Not Incinerate\n• Do Not Disassemble\n• Do Not Short Terminals\n• Current Software Revision\n- Cell: Panasonic NCR18650\nMax continuous charge current: 3A\nRec charge cutoff: 160mA or by time 4h\nMax continuous discharge current: 6A\n-Internal Impedance: Approx. 180mOhm\n-Exp. Life cycle: >300 cycles>70% of initial cap.\n• Warning symbol\n-Nominal Voltage: 14,4V\nRec. discharge cutoff: 12V\n-Thermostat operating temperature:\nOpening temp. (off): 77°C =5°C\nClosing temp. (on): 45°C Appox.\nCharge retention / storage (%)\n• 1 year 0-20 to +20 C > 70%%\n3 months @ -20 to +45 C > 70%\nHumidity: 632220% RHC > 70%\nEnvironmental and Satety\n2. Battery assemblv is RoHS\n3. ELC of assembly = 6.96g\nDifferential: Approx 6°C\nCharge\n• Discharge\n• Weight: 410g\nUL1061\nU1.1061\nUL1061\nUL1061\n1183927\n8. 740Ł10\nAWG20 UL1061\nAWG22\nAWG22\nAWG22\nAWG20\n...÷\n2×3\nSPECIFICATION LABEL\nSEE \"TABC CONIENTS*-\nYellow\nGreen\nWhite\nBlack\nRed\nA Label auto conse r er cloned y negat grumber:.\nIE: 0310-00001 = March, 2010 - First pack of that P/N shipped.\nConnector Molex 39-01-2060\n154: 5\n* 1335:10\nSoftware Version: 05\nBatt -\nNC\nT Batt +\n202252222\nÀ22s fo\nPin 4\nPin 5\n[Pin 6\n\n<<<PAGE 10>>>\n\nPanasonic\nideas for le\nNCR-18650\nLITHIUM-ION / NNP + HRL TECHNOLOGY\nPanasonic is one of the leading Lithium-lon battery manufacturers in the world. A perfect combination of high energy density, safely and long\nlife shows what is possible with this battery technology. A continuous co-development with electronical companies all over the world has led to\npeople's safety. On the top of this we have invented our so called NNP technology which gives us the possibility to achieve eminently high battery\noutstandingly good results. Panasonic especially focuses on enhancing safety technologies such as PSS and HRL in order to always guarantee\ncapacities. Excellent battery safety on one hand, and superior battery performance on the other: this is what Panasonic stands for.\n1 Positive pole\n2 PTC (positive\n6 Cathode\ntemperature\n7 Anode\n3 Gasket\ncoefficient device)\n9 Separator\n8 Negative pole (cell can]\n5 insulator\n4 Collector\n10 CID (current interrupt\n•3:\n11 Exhaust gas hole\nENNETECHNOLOGY!\nubiquitous society. As cordless devices become more sophisticated and powerful, they require more robust battery cells. Panasonic has\nLi-lan battery cells have become indispensable as a power source for\ncordless equipment, such as laptops, that supports a\nas its material and processing technology which prevents deformation of the alloy-based negative electrode when subjected to repeated charge\nresponded to these challenges with the new battery cells, employing its unique high capacity nickel based positive electrode technology as well\nand discharge. This new battery technology is called Nickel Oxide based New Platform.*\nCharacteristics of the new Panasonic\nAND SAFETY OF CATHODE MATERIAL\nCOMPARISON BETWEEN CAPACITY\nNNP Technology:\n→ Superior cycle life performance\n→ The new nickel positive electrode exceeds regarding durability in actual use\n→ High energy density contributes to downsizing and weight reduction\nMore Safety\n→ Excellent shelf-life due to low self-discharge performance\nand charge retention\nNNP based\nSHRL TECHNOLOGY\nHigh Capacity\nAs a power source for mobite and digital equipment essential for a ubiquitous networking society, demand for Lithium-lon batteries has\nsophisticated and feature-laden, they require more robust and safer batteries. Increasing energy-density, however, raises the risk of\ngrown fast. As such equipment including notebaok PCs, mobile phones, medical equipment and power-tools become more powerful,\nLithium-lon batteries significantly. This heat resistance layer consist of an insulating metal oxide on the surface of the electrodes which leads\noverheating and igniting due to short-circuiting. Panasonic employs the HRL (Heat Resistance Layer) Technology to improve the safety of\nthe battery not to overheat even if a short-circuit occurs.\nSafety is the base for everything. Higher Energy can be established based on safety technology.\nHRL Technology\nExisting Technology\nHAL\nSeparator\n+ Material\n- Material\nPanasonic\nQuality is ou\n\n<<<PAGE 11>>>\n\nPanasonic\nBartene\nLITHIUM ION\nFeatures & Benefits\nDimensions\n• High energy density and voltage\n• Long stable power with flat discharge voltage\nMax 18.6 mm\n• Ideal for portable communications, portable\ncomputing and robotics\nSpecifications\nPanasonic\nCapacity:\n2.9Ah Typical\n(Charge: CVCC, 4.2V, max.\n(Discharge: CC, 550mA, 2.5V\n1925mA, 50mA cutoff, 25°C)\ncutoff, 25°C)\nMax 65.2 mm\nNominal Voltage: 3.6V\nWeight:\nApproximately 44.5g\nCharge Characteristics\nDischarge Characteristics\n5.0\nCharge Condition:\n3200\n5.0\n4.5\n2900\nCharge Condition: CVCC\nisonarce Condition: CUNSTANT CURRENT 25V cong\" at 15\n40370:192041, 50041\nc# 3: 25 C\n= 2.0\nVOLTACE\n2400\n4.5\n3000 T\nE 1.0\n201t(8500mAI\n1.012 (2760m4)\n0.211;530ms)\nGAROCITY\n2.5\n400\n7.0\n2.0\n0.0\n0.5\n1.0\n1.5\n2.0\nTIME (hour)\n25\n3.0\n3.5\nas°\n2.5\n500\n1000\nDISCHARGE CAPACITY (mAn)\n1500\n2000\n2500\n3000\nDischarge Characteristics\nCycle Life Characteristics (25°C)\n_ITHIUMION/NCR18850/6.11V1 | Copyright © 2011 Panasonic Corporation of Amerca. All Rights Resarved.\n5.0\nDischarne Condition: (r\nCharge Condition: LEV\n1CH CH(760HA\n3200\n4.5\n2000\n60°C\n2400\nVOLTAGE (V)\n4.0\n3.5\ntic\nCAPACITY (mAh)\n=2300 mAk\n79%0\n1200\nRemAining CapACiTY\n3.0\n-10°C\n800\no'c\n400\nCharge Condition: CYCO: 270x07: 2/lex07: 4) 5:\n2.5\n800\n1200\n2000\n2400\n2ano\nCharge/Discharge Rest Time: 29r9224\nDISCHARGE CAPACITY (mAh)\n100\nCYCLE NUMBER\n200\n300\nThe data in this document is for descriptive purposes only and is not intended to make or imply any guarantee or warranty.\nPanasonic\nFor more information on how Panasonic can assist you with your battery power solution needs cal 877-726-2228,\nvisit www.panasonic.com/industrial/batteries-oem or e-mail oembatteries@us.panasonic.com\n\n<<<PAGE 12>>>\n\nNCR-18650\nLITHIUM-ION / NNP + HRL TECHNOLOGY\nMax. 18,6\n5.0 г\nCHARGE CONDITION: CVCC*, 4,2V max. 0.7l (1925mA), 50m4 cul-off at 25deg.C\n4.5\nDISCHARGE CONDITIGN: CC**, 2.5V cut-off at 25deg.C\n4.0\n(+)\nVOLTAGE M\n2.0ft (5500mA) 1.0(2750mA) 0.21 (550mA)\n3.0\nMax. 65.2\n2.5\n500\n1000\n1500\n2000\n2500\n3000\nDISCHARGE CAPACITY [mAh]\n50\nCHARGE CONDITION: CVCC*?, 4.ZV max. 0.7it [1925mA), 50m4 cut-off al 2Sdeg.C\n(-)\n4,5\nDISCHARGE CONDITION: CC*:, 1.0kt (2750mA), 2.5V cut-off at various temperature\n60deg.C\nSPECIFICATIONS\n4.0\n45deg.c\nNominal voltage (VI\nMadel Number\nVOLTAGE M\n25deg.c\n3.6\nNominal capacity*' - Minimum (mAh)\nNominal capacity*! - Typical (mAh)\n2,750\nDimensions - Diameter (mm)\n2,900\n3.0\n-10deg.c\nDimensions - Height (mm)\nmax. 18.6\nOdeg.C\nApprox. Weight (g)\nmax. 65.2\n2.5\n500\n1000\n1500\n2000\n2500\n3000\n45\nDISCHARGE CAPACITY (mAn)\n5.0\n(1925mA), 50mA cut-off at 25deg.c\nCHARGE CONDITION: CVCC*!, 4.2V max. O.7lt\n$ 280D\n3000\n4.5\n2400\n200D\n2500\n1.0\n(VOLTAGE\n1600\n(mAh]\nz0u0\nCURRENT [mA]\nCAPACITY(mAh)\n= 2100 mAh\noR 12 %\nCAPACITY\nCAPACITY\n3.0\n- * CURRENT\n800\n1000\nRemAiNiNg CApACiTY\n400\n500\nCHARGE CONDITION: CVCC**. 4.2V max, 0.7lt [1925mAl, 50mA cut-oft at 25deg.C\nCHARGE / DISCHARGE REST TIME: 20min.\nDISCHARGE CONDITION: CC**. 1.0tt 12750mAl, 2.5V cut-off at 25deg.C\n25%\n0.5\n10\nTIME (hour)\n1.5\n2.0\n2.5\n0\n100\nCYCLE NUMBER\n200\n300\n40D\n500\nWe sauna to lo depor singie tell business or accept orders irom consumers. We design Lihum-lon battery Backs incluting a sul able sately urit\nyour local Panasonic Sales Office. In order to avoid a lack of supply please check the battery availability with your Panasonic sales team before design-in\ndevice based on the technical specification of the customer. Due to the need for careful review when selecting Lithium-Ion battery solutions please contact\nPanasonic\nPanasonic Industrial Europe GmbH | Winsbergring 15 | 22525 Hamburg | Website: http://industrial.panasonic.com/eu\n\n<<<PAGE 13>>>\n\nPATKO.\n1184859\nQIY.\nT PART NO.\n1184859\nD = CRITICAL QUALITY ATTRIBUTE\n* = KEY CHARACTERISTIC IDENTIFICATION\nASM. EXTERNAL\nBATTERY XPO2\nINVACARE CORP. EYRA\nDESCRIPTION\nSHELL, EXTERNAL BATTERY FRONT XPO2\nSHELL, EXTERNAL BATTERY REAR XPO2\nSWITCH, MEMBRANE EXTERNAL BATTERY XPO2\nBRACE, EXTERNAL BATTERY XPO2\nASM, PCB EXTERNAL BATTERY XPO2\nBATTERY PACK, EXTERNAL BATTERY XPO2\nSCREW. 6-19 X.50 TORX PAN HD PLASTITE\nLABEL, WARNING XPO2 SUPPLEMENTAL BATTERY\nFOAM, OPEN CELL 1/4 X 1 X 2 W/ PSA\nLABEL, SERIAL NUMBER (SANFORD RESPIRATORY)\nASM, CABLE EXTERNAL BATIERY XPO2\nMFG REQUIREMENTS, ESD\n(1.36)\nLABEL LOCATION VIEWS\nCAE: 4/16/13\n1148322\n1148323\n1148321\n1148324\n1180060\n1184130\n1151560\n1184854\n1152766\n1153701\n1180059\n1182067\nITEM NO. PART NO.I\nMAMML NG\nSATESAL CESCKPSION\nOZAUN BY: 8. KUSHNER\n11\nAretc.\nSOALE: 1:1\n(6.25)\nPEcanon\"\n04E 199\nV7 Cx 0N2.|DN0. TAGN:\nAND ALGN PER DIMENSIONS ABOVE\nANY CONNECTOR FACING UP\nNOTES:\n\n<<<PAGE 14>>>\n\n1184130\n(6)\n1184130\nWiza slagpe\nM vpr\nMa! : !b:\nConnector Hsg\nIST# XIP-\nI'ciminat\nSXI1-0011-P0.6\nWire\n26 awg Ut.1007\nO.RN. 10-3-14\nELYPIA\nOHIO\nD>= CRITICAL QUALITY ATTRIBUTE\n= KEY CHARACTERISTIC IDENTIFICATION\nBATTERY PACK, EXTERNAL\nBATTERY XPO2\ne tomto omr eupa,\n.te lo.s.?.\nof U3.54h\nINVACARE CORP.\n2092.3\n,Lm82 4 236. F - 10\nAT/ 10-10904060 15\nPRE MELENSE\nDESIGN ENGR/B8t8:\nMEG/SQ ENCR/Bate:\nQUALIYV/DAte:\n659/11/21\ni JST\nХHP-2\n:38893\n\"hew!\n1184130\n43711 -\n,. IONI\n10515\n1815\nA 132+1\nTI!\nHIROSE DF3-5S-2C\nHIROSE DF13-8S-1.251:\n8 41:1\n040 2, M RESI WONI FROM 20510 :11\n142\n4 211\n11 -52•\n1g 'gri\n.. s.11\no XXx = sequenial assembly starling oil 00001 beginning each month\n: 12%\nctesoveds coend dockag@ polecon •66 AMdSf ondd debay\npermanent text and graphics wilh lamper resistan adhesive backing.\nIhe: pistes: \"i allam tori\" es componied by eleciricol specs and\nare dee boves conend edoarkne protes bonr6 AMIS second ebecky)\nic ...\nLabet fo boa Poly oplene maleriol ond marked with\no Do Nol Expose lo High Tomperalures (140F / 60C)\nLatae ploppento dos ay torle ol a minimum:\ntad contenh(4 39x1 00)\nName and localion of assembler\nSeral number formolled MMYY-XXXXX\no MMYY= monih / yeor of assembly\n(l sr sekery mesone s0 ? gov!\n1'x4,375\" SPI• BE ATION LABEL: SEE \"LABEL CONTENTS\"\n0303-3a10\n1:oa0 UF13-63 1.296\n• The phrase \"Lithium lon Baltery\" bolded\nTEVE CHePR MASPA!\nWoll taar costun;\nCe Mesuts bang Dt\n• WELE ANNEX IV symbol\no Do Not incinerale\no Do Noi Disassemble\no Do Not Short Terminals\nCurren i sollwore Revision\n- The phrases\nCell Prolection:\n\n<<<PAGE 15>>>\n\n1185335\n1185335\n>= CRITICAL QUALITY ATTRIBUTE\n= KEY CHARACTERISTIC IDENTIFICATION\nPRIOSCHEMATIC, EXTERNAL\nBATTERY XPO2\nINVACARE CORP, ORA ATIS\nSIGNATURE ON FILE\nSEE DISTRIBUTION #032\nDAE 11/21/13\nAxа72E\nESSP\n20/0-P5\nPRE-RELEASE\nDESIGN ENGR/Date:\nMFG/SO ENGR/Date:\nQUALITY/Bate:\nMATEHA: BESCHPRUK\n2000\nHIND\nAME PRICI\nSCME: 1.375:1\nDRAWN BY S. WEINMAN\nONE\n2-70\n:8: sz\nDE: 52\nhotten i\nalie\nCANNO\n\n<<<PAGE 16>>>\n\n1180059\nV+\nV+\nSECTION A-A\n1180059\nHIROSE DF3-4S-2C\nRED\nBLACK\nBLUE\nWHITE\n0.24\nELYRIA\n2X .041.02\n2X .075‡.020\n› = CRITICAL QUALITY ATTRIBUTE\n= KEY CHARACTERISTIC IDENTIFICATION\nPIN 1\nPIN 2\nPIN 3\nPIN 4\nASM, CABLE EXTERNAL\nBATTERY XPO2\nINVACARE CORP.\n.35+.02\nØ.391.02\n*. Ф.10t.05\n.53+.02\n0p00n2\n2/20|2013\nØ.22+.05\nBERT\n1.85+ 50\nDom Play 12414\nDESIGN ENGA/Date: HUza Ahmad\nA 4.727.50\nPRE-RELEASE\n...10+.02\n01. 03/20/12 H - ADDED SECTION A-A AND MOUNTING PANEL GAP (.102) DIMENSION,\n07. 06/18/13 8K - CHG DC# WAS 1221019: UPDATE TITLE BLOCK AND PRE-RELEASE STAMP\nA 1.97+.25 -\nCHGED VENDOR AND ADDED VENDOR P/N\nA I. MANUFACTURER: PROTEK POWER, P/N 120314-O1R\nOS. 07/07/12 TH - CHANGE SPECIFCATION TO MATCH PROTEK PRINT\n03 04/10/12 TH - ADDED PIN OUT COLOR CODE TABLE\n04, 05/09/12 JMK. CANCEL. 1221025, CHANGE TO 1221019\n00. 03/06/12 TH - CREATED DRAWING\n02. 03/29/12 TH - CORRECTED MFG P/N\n06. 08/07/12 8K - CHG DIM 10:.02 WAS .102\nDF3-4S-2C (PITCH 2mm)\nREVISIONS (1321003):\n08. 2/20/14 SW REV DESC.\nA HIROSE SOCKET\nHIROSE CONTACT\nDF3-22SCF\nWITH\nNOTES:\n\n<<<PAGE 17>>>\n\nCOC14061-040814FA\nF2 Labs\n16740 Peters Road\nMiddlefield, Ohio 44062\nUnited States of America\nwww.f2labs.com\nEMC TEST REPORT\nManufacturer:\nInvacare Corporation\nElyria, Ohio 44036\nOne Invacare Way\nUnited States of America\nProduct:\nPortable Oxygen Concentrator\nModels:\nXPO100B*; XPO100\n*Denotes actual model tested. Refer to Section 2.1 of this Test\nReport for more details.\nTesting Commenced:\nApr. 4, 2014\nTesting Ended:\nApr. 4, 2014\nSummary of Test Results: Page 4\nDeviations (if applicable):\nN/A\nStandards:\nRTCA DO-160G - Environmental Conditions and Test Procedures for Airborne\nEquipment Testing Section 21, Category M\nReport Number F2LQ6037-06E\n012414\nPage 1 of 24\nIssue Date: Apr 23. 2014\n\n<<<PAGE 18>>>\n\nCOC14061-040814FA\nOrder Number: F2LQ6037\nClient: Invacare Corporation\nModels: XPO100B & XPO100\nfor hsupe....\nEvaluation Conducted by:\nJoe Knepper, EMC Proj. Eng.\nReport Reviewed by:\nKen Littell, EMC Tech. Mgr.\n26501 Ridge Road\nF2 Labs\nF2 Labs\nDamascus, MD 20872\n16740 Peters Road\nFax 301.253.5179\nPh 301.253.4500\nPh 440.632.5541\nMiddlefield, OH 44062\nFax 440.632.5542\nonsent of F2 Labs. The results in this report apply only to the equipment tester\nhis test report may be reproduced in full; partial reproduction only may be made with the writte\nmaintenance fia tar\n041014\nReport Number: F2LQ6037-066\nPage 2 of 24\nIssue Date: Apr. 23 2014\n\n<<<PAGE 19>>>\n\nCOC14061-040814FA\nOrder Number: F2LQ6037\nClient: Invacare Corporation\nModels: XPO100B & XPO100\nTABLE OF CONTENTS\n1.0\nADMINISTRATIVE DATA\n1.1\n1.2\nManagement of Test Sample\nAbbreviations and Acronyms\n1.3\nDocument History\nLIST OF EUT, ACCESSORIES AND TEST EQUIPMENT\nEquipment Under Test\nAccessories\nCables\nMODE OF OPERATION\nMETHOD OF MONITORING\nREQUIRED MODIFICATIONS\nRADIATED EMISSIONS TEST\nRadiated Emissions Test Procedure\nRadiated Emissions Test Data Sheet\n6.3\nPhotographs) of Radiated Emissions Test Setup\n7.0\nCONDUCTED EMISSIONS TEST\n7.1\n7.2\nConducted Emissions Test Data Sheet\nConducted Emissions Test Procedure\n7.3\nPhotographs) of Conducted Emissions Test Setup\nReport Number F2LQ6037-06E\nPage 3 of 24\nIssue Date: Apr. 23.2014\n\n<<<PAGE 20>>>\n\n•\nCOC14061-040814FA\nOrder Number: F2LQ6037\nClient: Invacare Corporation\nModeis: XPO100B & XPO100\nGENERAL REPORT SUMMARY\nThis electromagnetic emission test report was generated by F2 Labs. The test report is based\non testing performed by F2 Labs personnel according to the measurement procedures\ndescribed in the test specifications given below and in the Test Procedures section of this\nreport.\nSECTION\nTEST\nRESULTS\nRadiated Emissions:\n6\nInternal Battery Power\nPass\nExternal Power Supply\nPass\n7\nConducted Emissions:\nExternal AC/DC Power Supply\nPass\nNote: Pass/Fail criteria are based upon the following condition: Where the results are\ncompared to published test standard or manufacturer specified limits, the PASS or FAIL\nopinion is considered without applying the laboratory stated measurement uncertainty.\nReports noted as a revision replace all previously issued reports and/or antecedent report\nrevisions issued under this job number.\nReport Number: F2LQ6037-06E\n0410:4\nPage 4 of 24\nIssue Date: Apr. 23. 2014","truncated":false,"body_characters":36289}