Invacare Corporation — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation 1200 New Jersey Avenue, SE Pipeline and Hazardous Materials Washington, DC 20590 Safety Administration Carol Vierling FEB 2 0 2015 Acting Regulatory Affairs Manager Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, OH 44036 Ref. No. 15-0002 Dear Ms. Vierling: This responds to your December 30, 2014 letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to a portable oxygen " concentrator (POC). Specifically, you inquire about obtaining approval from the Pipeline and Hazardous Materials Safety Administration (PHMSA) and the Federal Aviation aircraft. Administration (FAA) to allow a passenger to carry and operate the POC on board an • According to your letter, the POC (trade name Invacare XPO2) is a device for use by patients requiring high concentrations of oxygen on a supplemental basis. The device in question is a modified version of an earlier model of the Invacare XPO2 POC that is currently listed in Special Federal Aviation Regulation 106, "Rules for Use of Portable Oxygen Concentrator Systems on Board Aircraft"(SFAR 106) and approved for use on board aircraft. The modified version of the Invacare XPO2 POC for which you seek approval has a maximum operating pressure of less than 21.0 pounds per square inch (psia). It is powered by multiple sources, including AC or DC power, a captive internal lithium ion battery pack, and a rechargeable external accessory lithium ion battery pack. Both the captive internal lithium ion battery pack and the rechargeable external accessory lithium ion battery pack have a Watt-hour (Wh) rating of 83.5 (2.9 ampere-hour (Ah) x 3.6 volts (V) x 8 cells). Both the captive internal and the rechargeable external accessory lithium ion battery packs meet the appropriate testing requirements of the United Nations Manual of Tests and Criteria, and both battery packs are packaged in a manner to prevent short circuits. You ask whether the modified version of the Invacare XPO2 POC is authorized under the HMR to be carried on board an aircraft. Based on the information provided in your letter, the modified version of the Invacare XPO2 POC is not subject to the HMR as a Division 2.2 non-flammable gas, the captive internal and the rechargeable external accessory lithium ion battery packs used to power the device#

Page 2conform to § 175.10(a)(18), and the POC contains no other hazardous materials. Therefore, in accordance with HMR § 175.10(a)(18), the modified version of the Invacare XPO, POC is authorized to be carried on board an aircraft by passengers or crew members. Please note that notwithstanding the passenger exception in § 175.10(a)(18) of the HMR, the provisions of SFAR 106 apply and are under the purview of the FAA. This response satisfies only one requirement in the FAA approval process before a POC may be carried and operated on board an aircraft. You may contact Ms. DK Deaderick in FAA's Flight Standards Service at (202) 267-7480 for questions regarding FAA's approval process. I trust this satisfies your inquiry. Please contact us if we can be of further assistance. Sincerely, Duaned. The Duane A. Pfund International Standards Coordinator Standards and Rulemaking Division#

Page 3DOTARSPA/ OHMS UNIT Yes, you can" 15 JAN -6 PM 3:30 December 30, 2014 U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration Office of Hazardous Materials and Standards 1200 New Jersey Avenue, SE Washington, D.C. 20590-0001 Dear Sir or Madam, Invacare Corp. is requesting confirmation from the Pipeline and Hazardous Materials Safety Administration (PHMSA) that the Invacare® XPO_™M Portable Oxygen Concentrator (XPO2 POC) is not subject to the U.S. Hazardous Materials Regulation (HMR) under HMR 49 CFR Parts 100-180 after review of all appropriate information. Introduction Invacare Corp. manufactures portable oxygen concentrators (POCs) and has marketed the XPO2 POC since receiving 510(k) clearance from the Food and Drug Administration (FDA) on December 12, 2007. The XPO2 POC is currently allowed to be used onboard aircraft and was added to SFAR No. 106 published in the Federal Register on January 15, 2009. As part of that application, Mr. Mazzullo of the U.S. Department of Transportation sent a letter to Invacare Corp. stating that the Invacare® XPO_T Portable Oxygen Concentrator is not subject to the HMR. Please refer to Attachment 1 for the Federal Register Notice. The XPO2 POC continues to provide oxygen by separating oxygen from room air utilizing a molecular sieve and pressure swing adsorption methodology. The resultant concentrated oxygen is directed toward an oxygen reservoir for delivery to the patient. The XPO2 device delivers the oxygen to the patient through the pulse delivery method for maximum effectiveness and operational time. This means that the subject devices deliver oxygen only when a breath is detected. If no breath is detected (i.e. the cannula detaches from the device or the patient takes the cannula off), no oxygen is delivered. This feature of delivering oxygen only when a breath is detected prevents oxygen saturation of the surrounding area or materials when the cannula is not connected to the concentrator or the patient. The technological characteristics of the modified XPO2 POC remains the same as the original XPO2 Portable Oxygen Concentrator listed under SFAR No. 106. Please refer to Attachment 2 for the finished device drawing. One Invacare Way P.O. Box 4028 INVACARE CORPORATION eeranora Elyria, Ohio 44036-2125 USA#

Page 4Yes, you can. Proposed Modifications Invacare Corporation has modified the internal and external batteries of the XPO2 device to improve use duration and to increase the expected lite cycle. In addition, some minor design changes have also been incorporated for quality improvement purposes only. Power Source for the Invacare XPО2 POC The subject device can be powered by an internally captive lithium ion battery pack that is not customer removable or replaceable, an external AC to DC power adapter, an external DC to DC power adapter, or an external accessory lithium ion battery pack. This allows for maximum flexibility and operational time with multiple power sources. Recharging of either the internal or external accessory batteries is only available with the use of the Invacare supplied AC/DC or DC/DC power adapters. The internally captive lithium ion battery pack (see Attachment 3) consists of 8 cylindrical 2.9 amp-hour lithium ion cells with a total lithium equivalent content of 6.36 grams of lithium, and watt hour rating of 85.3 Whr (see Attachment 4). The internally captive battery pack is not user accessible and not replaceable by a patient/user. The internally captive mechanism of the subject devices also prevents any user from generating sparks or short-circuiting as it is not externally accessible. The battery pack terminals are not exposed to any outside contact by virtue of being totally integrated into the product. The external accessory battery module for extended operating time is a self-contained power accessory for the XPO2 device. The external battery module contains a separate lithium battery pack that consists of 8 cylindrical 2.9 amp-hour lithium ion cells with a total lithium equivalent content of 6.36 grams of lithium, and watt hour rating of 85.3 Whr. The lithium battery pack is not user accessible and is not replaceable by a patient/user. The captive mounting mechanism of the external battery module also prevents any user from generating sparks or short-circuiting the lithium battery pack. The battery pack terminals are not exposed to any outside contact as they are connected to an intervening power switching and charging circuit board that interfaces to the Invacare XPO2 device. The external battery module connection cable contains a connector that prevents accidental shorting or generation of sparks during handling or storage. Please refer to Attachment 5 for the external battery module, external battery pack, circuit board schematic and external battery module connection cable. The table below compares the XPO2 POC currently marketed with PHMSA approval in 2008 and the evaluation results of the proposed modification INVACARE CORPORATION One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125 USA#

Page 5PHMSA Special Provision 188 Comparison Table Invacare XPO2 Portable Oxygen Concentrator Item PHMSA Criteria PHMSA 2008 Approval Pressure of the oxygen in the Value Result 2014 Submittal. Value.. - Result Comments 1 PSIA at 20C device does not exceed 40.6 < 21 PSIA Pass < 21 PSIA Pass No change 2 more than 1.5 grams of lithium Lithium cells do not contain 2.6 AH Cell equivalent content 0.78 LEgram Pass 2.9 AH Cell 0.87 LEgram Pass Slight increase in lithium content 3 Lithium batteries contain an aggregate equivalent lithium 8 cells/battery content of not more than 8g 6.24 L E. grams Pass 6.96 L E. grams 8 cells Pass Slight increase in lithium content No other 4 materisl sujbect to the HMR The device contains no other hazardous Pass hazardous No other materials Pass No change The batteries are fully materials contained in equipment and Fully contained 5 packaged in a manner to preclude sparks or the protective product inside of Fully contained Pass inside of [quantity of heat generation of a dangerous enclosure protective product Pass No change enclosure L.E. gram = Lithium equivalent grams content#

Page 6Yes, you can" Compliance with RTCA/DO-160G The Invacare XPO2 POC has successfully undergone testing pursuant to the requirements of RTCA/DO-160G, Section 21, Category M to demonstrate that the device will not interfere with an aircraft's electrical, navigation or communication equipment. A summary of the test report is provided in Attachment 6. Conclusion In conclusion, the updated XPO2 device continues to meet the five PHMSA Special Provision 188 criteria. In addition, data show acceptable RTCA DP-160 test results. Based on this information, Invacare Corp. asks that the PHMSA confirm that the Invacare XPO2 device is not subject to the U.S. Hazardous Materials Regulation under HMR 49 CFR Parts 100-180. Invacare has discussed the minor modifications to the XPO2 with the Federal Aviation Administration (FAA) and submitted the proposed changes with supporting documents to the agency. Prior to their approval, the FAA has requested that Invacare Corp. obtain a letter from the PHMSA stating that the XPO2 does not contain hazardous materials. We would appreciate your timely response. A letter from the PHMSA is all that is needed for FAA approval. If you have any questions, please contact me by telephone at 706-476-2938 or by email at carol.vierling@yahoo.com. Sincerely, Carol Vierling Acting RA Manager One Invacare Way P.O. Box 4028 INVACARE CORPORATION AAAAANNA ner ac man Elyria, Ohio 44036-2125 USA#

Page 72352 Federal Register/ Vol. 74, No. 10/Thursday, January 15, 2009/Rules and Regulations more about SBREFA on the Internet at regulations_policies/rulemaking/ our site, http://www.faa.gov/ require the same level of special hazardous materials. Thus, they do not performance-based standard for all POC We continue to pursue the sbre_act/. handling as compressed oxygen, and are safe for use on board aircraft, provided devices. This process is time-consuming Authority for This Rulemaking certain conditions for their use are met. Federal Register and offer the public a and we intend to publish a notice in the regarding aviation safety is found in The FAA's authority to issue rules on and use certain POC devices on SFAR 106 permits passengers to carry when it is complete. In the meantime, chance to comment on the proposal Title 49 of the United States Code (49 board aircraft if the aircraft operator the authority of the FAA Administrator. U.S.C.). Subtitle I, Section 106 describes ensures that the conditions specified in manufacturers continue to create new the SFAR for their use are met. The have requested that their product also and better POC devices, and several Subtitle VII, Aviation Programs, devices initially determined acceptable agency's authority describes in more detail the scope of the 2005, were the AirSep Corporation's for use in SFAR 106, published July 12, SFAR 106. These new manufacturers be included as an acceptable device in final rule pursuant to 49 U.S.C. 44701. The FAA is authorized to issue this LifeStyle and the Inogen, Inc.'s Inogen include Delphi Medical Systems and One POCs. SFAR 106 was amended on companies has formally petitioned the Invacare Corporation. Each of these authorized to establish regulations and Under that section, the FAA is add three additional POC devices, September 12, 2006 (71 FR 53954) to submitting documentation of the FAA for inclusion in SFAR 106 by minimum standards for other practices, AirSep Corporation's FreeStyle, SeQual methods, and procedures the Technologies' Eclipse, and Repironics Management System. That devices to the Federal Docket commerce and national security. Administrator finds necessary for air final rule adds two additional POC Inc.'s EverGo, to the original SFAR. This documentation is available at http:// devices, Delphi Medical Systems' RS- following docket numbers: www.regulations.gov under the 00400 and Invacare Corporation's Special Federal Aviation Regulation 106 On July 12, 2005, the FAA published by a passenger on board an aircraft. XPO2, that may be carried on and used 2008-0261; and 1. Delphi Medical Systems-FAA- Portable Oxygen Concentrator Devices (SFAR 106) entitled, "Use of Certain Aircraft operators can now offer 2. Invacare Corporation-FAA-2008- 106 is the result of a notice of proposed On Board Aircraft" (70 FR 40156). SFAR medical oxygen service as they did no covered device may contain As stated in Section 2 of SFAR 106, can meet certain conditions and allow before SFAR 106 was enacted, or they , hazardous materials as determined by rulemaking (NPRM) the FAA published the needs of passengers who must travel in July 2004 (69 FR 42324) to address passengers to carry on and use one of necessary), and each device must also PHMSA (written documentation the POC devices covered in SFAR 106. with medical oxygen. Prior to SFAR 106 is an enabling rule, which included technical specifications for the be regulated by the FDA. Each petitioner means that no aircraft operator is need of medical oxygen during air publication of SFAR 106, passengers in required to allow passengers to operate devices in their request for approval, when requesting service. Many aircraft transportation faced many obstacles these POC devices on board its aircraft, along with the required documentation board. If the aircraft operator allows one but it may allow them to be operated on petitioners provided the FAA with the from PHMSA and the FDA. The operators did not provide medical oxygen service aboard flights, and those of these devices to be carried on board, required documentation for the that did often provided service at a price the conditions in the SFAR must be met. following POC devices: Coordinating service between operators that travelers could not afford. published, the FAA committed to When SFAR 106 was originally 1. Delphi Medical Systems', Model and suppliers at airports was also establishing a single standard for all 2. Invacare Corporation's, Model chose not to fly because of these difficult, and passengers frequently not apply to specific manufacturers and POC devices so that regulations would models of devices. Whenever possible, New medical oxygen technologies performance-based standards rather the FAA tries to regulate by creating include the Delphi Medical Systems' This amendment to SFAR 106 will approved by the Food and Drug Administration (FDA) reduce the risks manufacturer. In the case of SFAR 106, than approving specific devices by RS-00400 and Invacare Corporation's authorized for use in air commerce. The XPO2 devices in the list of POC devices typically associated with compressed oxygen and provide a safe alternative for both the passenger and the aircraft the quickest and easiest way to serve FAA has reviewed each individual passengers who need oxygen therapy. Several manulacturers have developed devices determined to be acceptable by operator was to allow the use of the provided by the two manufacturers. device and accepted the documentation (POC) devices that work by separating small portable oxygen concentrator temporary regulation. As we stated in the FAA in SFAR 106 in a special, provided to the manufacturer by That documentation includes letters contained in ambient air and dispensing oxygen from nitrogen and other gases that established SFAR 106, "while we the preamble discussion of the final rule PHMSA and the FDA affirming the requisites stated in SFAR 106. status of each device as it pertains to the it in concentrated form to the user with an oxygen concentration of about 90%. are committed to developing a The POC devices operate using either performance-based standard for all safety standards and the PHMSA After reviewing the applicable FDA rechargeable batteries or, if the aircraft future POC devices, we do not want to operator obtains approval from the FAA, have the effect of stifling new prematurely develop standards that determined by the FAA to be acceptable findings, these two devices were aircraft electrical power. In addition, the Pipeline and We developed and published SFAR 106 technology of which we are unaware." for use in air commerce. Administration (PHMSA) has Hazardous Materials Safetv Good Cause for Adoption of This Final not fly could do so with an affordable so that passengers who otherwise could Rule Without Notice and Comment determined that the POC devices covered by this amendment are not alternative to what existed before SFAR published on July 12, 2005. We stated As stated above, SFAR 106 was 106 was published. in the preamble of that final rule that#

Page 8QTY. 24148300 1148300 -( .03) PART NO. TO DO WORE DEIGNED OR FURIED BY USE ICE OHIO DO NOT SCALE THIS DRAWING 1. TORQUE SCREWS (ITEMS 4 & 5) TO 3 IN-LBS. 2. PRIOR TO APPLYING SEAL (ITEM 7) CLEAN SURFACES TO WHICH SEAL WILL ADHERE THOROGHLY WITH ALCOHOL WIPES). 3. REMOVE PROTECTIVE COVER/FILM PRIOR 4. INSTALL FERRITE (ITEM 8) ON RED AND BLACK = CRITICAL QUALITY ATTRIBUTE • = KEY CHARACTERISTIC IDENTIFICATION DESCRIPTION ASM, REAR XPO2 ASM, FRONT XPO2 ASM, BATTERY PACK INTERNAL XP02 SCREW, 6-19 X .75 TORX PAN HD PLASTITE SCREW, 6-19 X .50 TORX PAN HD PLASTITE O-RING, 114 ID X .070 SEAL/NOTICE, XPO2 FERRITE, SNAPON ASM, CONCENTRATOR XPO2 INVACARE CORP. ELYRIA SEAL/NOTICE TO BE APPLIED TO ASSEMBLED UNIT, POSITIONED AS SHOWN. SEE NOTE 2. TO INSTALLING BATTERY, WIRE OF BATTERY (ITEM 3). PART DESCR.PIION: NOTES: DATE: 13/16/07 PART NO. 1151575 1184860 1183927 1151831 1151560 1148328 1151839 1147000 NOT SHOWN ITEM NO MATERIAL NO. MATERIAL DESCRIPTION: ANT PERPO SCALE 1:2 OPAWN BY: HODOS PRE-RELEASE DESIGN ENGR/Date: MFG/SO ENGR/Bate: QUALITY/Date: xx/xx/xx/ 3/14/14 0/7/11 01/27/11 OATE SEE NOTE 3- REVISION 00. 2/25/14 SW 1184860 WAS 1151580; 1183927 WAS 1148283; REM 1159909; FLIPPED BATTERY UP IN GRAPHICS F 3. THE OXYGEN GAS MUST MEET THE REQUIREMENTS OF USP 93 EXCEPT FOR THE OXYGEN 01. 3/10/14 SW REV SPEC. NOTE 2; ADDED SPEC. NOTE 3: REV NOTES 2 AND 4 2 OXYGEN VETED SURFACES ARETO BE BIOCOMPATIBLE. F 1321003 PENDING OUTCOME OF PRELIM CHANGES 1121004 | REV; ADDED 1147000 QTY!: ADDED NOTE 4 02. 7/2/14 SW REV CONTROL PANEL GRAPHICS D 1121049 REVISION LEVEL RELEASED IN ERROR 1421004 ADDED SPECIFICATIONS REVISIONS: (1321003) SPECIFICATIONS:#

Page 91183%27 1183927 SIGNATURE ON FILE SEE DISTRIBUTION #038 D>= CRITICAL QUALTY ATTRIBUTE =KEY CHARACTERISTIC IDENIFICATION ASIM, BATTERY PACK INTERNAL XP02 INVACARE CORP. PRE-RELEASE DESIGN ENGR/Date: MFG/8Q ENAR/Date: QUALITY/Date: -de GET Stion beltery (4s2P) w/ shrink sieeve & safety circuit wi fuel gauge based on TI# BO20Z95. - Stardovere ver cure disharge protein 75 AMPS miscond ela - First tier over cureat rechare pract 2 a AMPS 2 second delay). • Shan circuit condition will be sel at 25 Amps for 549 Micro seconds compliant permanent text and graphics with tamper resistant adhesive backing. 0 XXXXX = sequential assembly starting at 00001 beginning each month • The phrase "Lithium lon" accompanied by electrical specs and (1 sec delay, resume 4.1 +/-0:05V) 1. Cell is approved according to UL1642 and IEC62133 -Min state of charge: 30%. Place battery in "Shut Down" mode • Overdischarge detection: 2.7+/-0.05V Ambiant Conditions/ Temp range: 10 fo 60 đeg C 25 to 70 deo C 4. Battery pack must meet all IATA requirements Cabel io be of Polypropylene material and marked with Do Not Expose to High Temperatures (140F / 60C) • PCM: Vecture # VC4126. - Thermistor: 10K ohm • Rated Capacity: 5500mAh min., 5800mAh typical Charging Method: Constant current+constant voltage Label itormation to include at a minimum: 5. Wall-hour rating of 83.5Whr Label Requiremants • invacare and Mfos P/N's • Name and focation of assembler • Serial number formatted MMYY-XXXXX • MMYY= manth / year of assembly • The phrase "Lithium Ion Battery" bolded - Max charga voltage: 16.80V (+/-0.2V) series/parallel info • Watt hour rating • Cell Manufacturer P/N • WERE ANNEX IV symbol • The phrases • Do Not Incinerate • Do Not Disassemble • Do Not Short Terminals • Current Software Revision - Cell: Panasonic NCR18650 Max continuous charge current: 3A Rec charge cutoff: 160mA or by time 4h Max continuous discharge current: 6A -Internal Impedance: Approx. 180mOhm -Exp. Life cycle: >300 cycles>70% of initial cap. • Warning symbol -Nominal Voltage: 14,4V Rec. discharge cutoff: 12V -Thermostat operating temperature: Opening temp. (off): 77°C =5°C Closing temp. (on): 45°C Appox. Charge retention / storage (%) • 1 year 0-20 to +20 C > 70%% 3 months @ -20 to +45 C > 70% Humidity: 632220% RHC > 70% Environmental and Satety 2. Battery assemblv is RoHS 3. ELC of assembly = 6.96g Differential: Approx 6°C Charge • Discharge • Weight: 410g UL1061 U1.1061 UL1061 UL1061 1183927 8. 740Ł10 AWG20 UL1061 AWG22 AWG22 AWG22 AWG20 ...÷ 2×3 SPECIFICATION LABEL SEE "TABC CONIENTS*- Yellow Green White Black Red A Label auto conse r er cloned y negat grumber:. IE: 0310-00001 = March, 2010 - First pack of that P/N shipped. Connector Molex 39-01-2060 154: 5 * 1335:10 Software Version: 05 Batt - NC T Batt + 202252222 À22s fo Pin 4 Pin 5 [Pin 6#

Page 10Panasonic ideas for le NCR-18650 LITHIUM-ION / NNP + HRL TECHNOLOGY Panasonic is one of the leading Lithium-lon battery manufacturers in the world. A perfect combination of high energy density, safely and long life shows what is possible with this battery technology. A continuous co-development with electronical companies all over the world has led to people'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 outstandingly good results. Panasonic especially focuses on enhancing safety technologies such as PSS and HRL in order to always guarantee capacities. Excellent battery safety on one hand, and superior battery performance on the other: this is what Panasonic stands for. 1 Positive pole 2 PTC (positive 6 Cathode temperature 7 Anode 3 Gasket coefficient device) 9 Separator 8 Negative pole (cell can] 5 insulator 4 Collector 10 CID (current interrupt •3: 11 Exhaust gas hole ENNETECHNOLOGY! ubiquitous society. As cordless devices become more sophisticated and powerful, they require more robust battery cells. Panasonic has Li-lan battery cells have become indispensable as a power source for cordless equipment, such as laptops, that supports a as its material and processing technology which prevents deformation of the alloy-based negative electrode when subjected to repeated charge responded to these challenges with the new battery cells, employing its unique high capacity nickel based positive electrode technology as well and discharge. This new battery technology is called Nickel Oxide based New Platform.* Characteristics of the new Panasonic AND SAFETY OF CATHODE MATERIAL COMPARISON BETWEEN CAPACITY NNP Technology: → Superior cycle life performance → The new nickel positive electrode exceeds regarding durability in actual use → High energy density contributes to downsizing and weight reduction More Safety → Excellent shelf-life due to low self-discharge performance and charge retention NNP based SHRL TECHNOLOGY High Capacity As a power source for mobite and digital equipment essential for a ubiquitous networking society, demand for Lithium-lon batteries has sophisticated and feature-laden, they require more robust and safer batteries. Increasing energy-density, however, raises the risk of grown fast. As such equipment including notebaok PCs, mobile phones, medical equipment and power-tools become more powerful, Lithium-lon batteries significantly. This heat resistance layer consist of an insulating metal oxide on the surface of the electrodes which leads overheating and igniting due to short-circuiting. Panasonic employs the HRL (Heat Resistance Layer) Technology to improve the safety of the battery not to overheat even if a short-circuit occurs. Safety is the base for everything. Higher Energy can be established based on safety technology. HRL Technology Existing Technology HAL Separator + Material - Material Panasonic Quality is ou#

Page 11Panasonic Bartene LITHIUM ION Features & Benefits Dimensions • High energy density and voltage • Long stable power with flat discharge voltage Max 18.6 mm • Ideal for portable communications, portable computing and robotics Specifications Panasonic Capacity: 2.9Ah Typical (Charge: CVCC, 4.2V, max. (Discharge: CC, 550mA, 2.5V 1925mA, 50mA cutoff, 25°C) cutoff, 25°C) Max 65.2 mm Nominal Voltage: 3.6V Weight: Approximately 44.5g Charge Characteristics Discharge Characteristics 5.0 Charge Condition: 3200 5.0 4.5 2900 Charge Condition: CVCC isonarce Condition: CUNSTANT CURRENT 25V cong" at 15 40370:192041, 50041 c# 3: 25 C = 2.0 VOLTACE 2400 4.5 3000 T E 1.0 201t(8500mAI 1.012 (2760m4) 0.211;530ms) GAROCITY 2.5 400 7.0 2.0 0.0 0.5 1.0 1.5 2.0 TIME (hour) 25 3.0 3.5 as° 2.5 500 1000 DISCHARGE CAPACITY (mAn) 1500 2000 2500 3000 Discharge Characteristics Cycle Life Characteristics (25°C) _ITHIUMION/NCR18850/6.11V1 | Copyright © 2011 Panasonic Corporation of Amerca. All Rights Resarved. 5.0 Discharne Condition: (r Charge Condition: LEV 1CH CH(760HA 3200 4.5 2000 60°C 2400 VOLTAGE (V) 4.0 3.5 tic CAPACITY (mAh) =2300 mAk 79%0 1200 RemAining CapACiTY 3.0 -10°C 800 o'c 400 Charge Condition: CYCO: 270x07: 2/lex07: 4) 5: 2.5 800 1200 2000 2400 2ano Charge/Discharge Rest Time: 29r9224 DISCHARGE CAPACITY (mAh) 100 CYCLE NUMBER 200 300 The data in this document is for descriptive purposes only and is not intended to make or imply any guarantee or warranty. Panasonic For more information on how Panasonic can assist you with your battery power solution needs cal 877-726-2228, visit www.panasonic.com/industrial/batteries-oem or e-mail oembatteries@us.panasonic.com#

Page 12NCR-18650 LITHIUM-ION / NNP + HRL TECHNOLOGY Max. 18,6 5.0 г CHARGE CONDITION: CVCC*, 4,2V max. 0.7l (1925mA), 50m4 cul-off at 25deg.C 4.5 DISCHARGE CONDITIGN: CC**, 2.5V cut-off at 25deg.C 4.0 (+) VOLTAGE M 2.0ft (5500mA) 1.0(2750mA) 0.21 (550mA) 3.0 Max. 65.2 2.5 500 1000 1500 2000 2500 3000 DISCHARGE CAPACITY [mAh] 50 CHARGE CONDITION: CVCC*?, 4.ZV max. 0.7it [1925mA), 50m4 cut-off al 2Sdeg.C (-) 4,5 DISCHARGE CONDITION: CC*:, 1.0kt (2750mA), 2.5V cut-off at various temperature 60deg.C SPECIFICATIONS 4.0 45deg.c Nominal voltage (VI Madel Number VOLTAGE M 25deg.c 3.6 Nominal capacity*' - Minimum (mAh) Nominal capacity*! - Typical (mAh) 2,750 Dimensions - Diameter (mm) 2,900 3.0 -10deg.c Dimensions - Height (mm) max. 18.6 Odeg.C Approx. Weight (g) max. 65.2 2.5 500 1000 1500 2000 2500 3000 45 DISCHARGE CAPACITY (mAn) 5.0 (1925mA), 50mA cut-off at 25deg.c CHARGE CONDITION: CVCC*!, 4.2V max. O.7lt $ 280D 3000 4.5 2400 200D 2500 1.0 (VOLTAGE 1600 (mAh] z0u0 CURRENT [mA] CAPACITY(mAh) = 2100 mAh oR 12 % CAPACITY CAPACITY 3.0 - * CURRENT 800 1000 RemAiNiNg CApACiTY 400 500 CHARGE CONDITION: CVCC**. 4.2V max, 0.7lt [1925mAl, 50mA cut-oft at 25deg.C CHARGE / DISCHARGE REST TIME: 20min. DISCHARGE CONDITION: CC**. 1.0tt 12750mAl, 2.5V cut-off at 25deg.C 25% 0.5 10 TIME (hour) 1.5 2.0 2.5 0 100 CYCLE NUMBER 200 300 40D 500 We sauna to lo depor singie tell business or accept orders irom consumers. We design Lihum-lon battery Backs incluting a sul able sately urit your 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 device based on the technical specification of the customer. Due to the need for careful review when selecting Lithium-Ion battery solutions please contact Panasonic Panasonic Industrial Europe GmbH | Winsbergring 15 | 22525 Hamburg | Website: http://industrial.panasonic.com/eu#

Page 13PATKO. 1184859 QIY. T PART NO. 1184859 D = CRITICAL QUALITY ATTRIBUTE * = KEY CHARACTERISTIC IDENTIFICATION ASM. EXTERNAL BATTERY XPO2 INVACARE CORP. EYRA DESCRIPTION SHELL, EXTERNAL BATTERY FRONT XPO2 SHELL, EXTERNAL BATTERY REAR XPO2 SWITCH, MEMBRANE EXTERNAL BATTERY XPO2 BRACE, EXTERNAL BATTERY XPO2 ASM, PCB EXTERNAL BATTERY XPO2 BATTERY PACK, EXTERNAL BATTERY XPO2 SCREW. 6-19 X.50 TORX PAN HD PLASTITE LABEL, WARNING XPO2 SUPPLEMENTAL BATTERY FOAM, OPEN CELL 1/4 X 1 X 2 W/ PSA LABEL, SERIAL NUMBER (SANFORD RESPIRATORY) ASM, CABLE EXTERNAL BATIERY XPO2 MFG REQUIREMENTS, ESD (1.36) LABEL LOCATION VIEWS CAE: 4/16/13 1148322 1148323 1148321 1148324 1180060 1184130 1151560 1184854 1152766 1153701 1180059 1182067 ITEM NO. PART NO.I MAMML NG SATESAL CESCKPSION OZAUN BY: 8. KUSHNER 11 Aretc. SOALE: 1:1 (6.25) PEcanon" 04E 199 V7 Cx 0N2.|DN0. TAGN: AND ALGN PER DIMENSIONS ABOVE ANY CONNECTOR FACING UP NOTES:#

Page 141184130 (6) 1184130 Wiza slagpe M vpr Ma! : !b: Connector Hsg IST# XIP- I'ciminat SXI1-0011-P0.6 Wire 26 awg Ut.1007 O.RN. 10-3-14 ELYPIA OHIO D>= CRITICAL QUALITY ATTRIBUTE = KEY CHARACTERISTIC IDENTIFICATION BATTERY PACK, EXTERNAL BATTERY XPO2 e tomto omr eupa, .te lo.s.?. of U3.54h INVACARE CORP. 2092.3 ,Lm82 4 236. F - 10 AT/ 10-10904060 15 PRE MELENSE DESIGN ENGR/B8t8: MEG/SQ ENCR/Bate: QUALIYV/DAte: 659/11/21 i JST ХHP-2 :38893 "hew! 1184130 43711 - ,. IONI 10515 1815 A 132+1 TI! HIROSE DF3-5S-2C HIROSE DF13-8S-1.251: 8 41:1 040 2, M RESI WONI FROM 20510 :11 142 4 211 11 -52• 1g 'gri .. s.11 o XXx = sequenial assembly starling oil 00001 beginning each month : 12% ctesoveds coend dockag@ polecon •66 AMdSf ondd debay permanent text and graphics wilh lamper resistan adhesive backing. Ihe: pistes: "i allam tori" es componied by eleciricol specs and are dee boves conend edoarkne protes bonr6 AMIS second ebecky) ic ... Labet fo boa Poly oplene maleriol ond marked with o Do Nol Expose lo High Tomperalures (140F / 60C) Latae ploppento dos ay torle ol a minimum: tad contenh(4 39x1 00) Name and localion of assembler Seral number formolled MMYY-XXXXX o MMYY= monih / yeor of assembly (l sr sekery mesone s0 ? gov! 1'x4,375" SPI• BE ATION LABEL: SEE "LABEL CONTENTS" 0303-3a10 1:oa0 UF13-63 1.296 • The phrase "Lithium lon Baltery" bolded TEVE CHePR MASPA! Woll taar costun; Ce Mesuts bang Dt • WELE ANNEX IV symbol o Do Not incinerale o Do Noi Disassemble o Do Not Short Terminals Curren i sollwore Revision - The phrases Cell Prolection:#

Page 151185335 1185335 >= CRITICAL QUALITY ATTRIBUTE = KEY CHARACTERISTIC IDENTIFICATION PRIOSCHEMATIC, EXTERNAL BATTERY XPO2 INVACARE CORP, ORA ATIS SIGNATURE ON FILE SEE DISTRIBUTION #032 DAE 11/21/13 Axа72E ESSP 20/0-P5 PRE-RELEASE DESIGN ENGR/Date: MFG/SO ENGR/Date: QUALITY/Bate: MATEHA: BESCHPRUK 2000 HIND AME PRICI SCME: 1.375:1 DRAWN BY S. WEINMAN ONE 2-70 :8: sz DE: 52 hotten i alie CANNO#

Page 161180059 V+ V+ SECTION A-A 1180059 HIROSE DF3-4S-2C RED BLACK BLUE WHITE 0.24 ELYRIA 2X .041.02 2X .075‡.020 › = CRITICAL QUALITY ATTRIBUTE = KEY CHARACTERISTIC IDENTIFICATION PIN 1 PIN 2 PIN 3 PIN 4 ASM, CABLE EXTERNAL BATTERY XPO2 INVACARE CORP. .35+.02 Ø.391.02 *. Ф.10t.05 .53+.02 0p00n2 2/20|2013 Ø.22+.05 BERT 1.85+ 50 Dom Play 12414 DESIGN ENGA/Date: HUza Ahmad A 4.727.50 PRE-RELEASE ...10+.02 01. 03/20/12 H - ADDED SECTION A-A AND MOUNTING PANEL GAP (.102) DIMENSION, 07. 06/18/13 8K - CHG DC# WAS 1221019: UPDATE TITLE BLOCK AND PRE-RELEASE STAMP A 1.97+.25 - CHGED VENDOR AND ADDED VENDOR P/N A I. MANUFACTURER: PROTEK POWER, P/N 120314-O1R OS. 07/07/12 TH - CHANGE SPECIFCATION TO MATCH PROTEK PRINT 03 04/10/12 TH - ADDED PIN OUT COLOR CODE TABLE 04, 05/09/12 JMK. CANCEL. 1221025, CHANGE TO 1221019 00. 03/06/12 TH - CREATED DRAWING 02. 03/29/12 TH - CORRECTED MFG P/N 06. 08/07/12 8K - CHG DIM 10:.02 WAS .102 DF3-4S-2C (PITCH 2mm) REVISIONS (1321003): 08. 2/20/14 SW REV DESC. A HIROSE SOCKET HIROSE CONTACT DF3-22SCF WITH NOTES:#

Page 17COC14061-040814FA F2 Labs 16740 Peters Road Middlefield, Ohio 44062 United States of America www.f2labs.com EMC TEST REPORT Manufacturer: Invacare Corporation Elyria, Ohio 44036 One Invacare Way United States of America Product: Portable Oxygen Concentrator Models: XPO100B*; XPO100 *Denotes actual model tested. Refer to Section 2.1 of this Test Report for more details. Testing Commenced: Apr. 4, 2014 Testing Ended: Apr. 4, 2014 Summary of Test Results: Page 4 Deviations (if applicable): N/A Standards: RTCA DO-160G - Environmental Conditions and Test Procedures for Airborne Equipment Testing Section 21, Category M Report Number F2LQ6037-06E 012414 Page 1 of 24 Issue Date: Apr 23. 2014#

Page 18COC14061-040814FA Order Number: F2LQ6037 Client: Invacare Corporation Models: XPO100B & XPO100 for hsupe.... Evaluation Conducted by: Joe Knepper, EMC Proj. Eng. Report Reviewed by: Ken Littell, EMC Tech. Mgr. 26501 Ridge Road F2 Labs F2 Labs Damascus, MD 20872 16740 Peters Road Fax 301.253.5179 Ph 301.253.4500 Ph 440.632.5541 Middlefield, OH 44062 Fax 440.632.5542 onsent of F2 Labs. The results in this report apply only to the equipment tester his test report may be reproduced in full; partial reproduction only may be made with the writte maintenance fia tar 041014 Report Number: F2LQ6037-066 Page 2 of 24 Issue Date: Apr. 23 2014#

Page 19COC14061-040814FA Order Number: F2LQ6037 Client: Invacare Corporation Models: XPO100B & XPO100 TABLE OF CONTENTS 1.0 ADMINISTRATIVE DATA 1.1 1.2 Management of Test Sample Abbreviations and Acronyms 1.3 Document History LIST OF EUT, ACCESSORIES AND TEST EQUIPMENT Equipment Under Test Accessories Cables MODE OF OPERATION METHOD OF MONITORING REQUIRED MODIFICATIONS RADIATED EMISSIONS TEST Radiated Emissions Test Procedure Radiated Emissions Test Data Sheet 6.3 Photographs) of Radiated Emissions Test Setup 7.0 CONDUCTED EMISSIONS TEST 7.1 7.2 Conducted Emissions Test Data Sheet Conducted Emissions Test Procedure 7.3 Photographs) of Conducted Emissions Test Setup Report Number F2LQ6037-06E Page 3 of 24 Issue Date: Apr. 23.2014#

Page 20• COC14061-040814FA Order Number: F2LQ6037 Client: Invacare Corporation Modeis: XPO100B & XPO100 GENERAL REPORT SUMMARY This electromagnetic emission test report was generated by F2 Labs. The test report is based on testing performed by F2 Labs personnel according to the measurement procedures described in the test specifications given below and in the Test Procedures section of this report. SECTION TEST RESULTS Radiated Emissions: 6 Internal Battery Power Pass External Power Supply Pass 7 Conducted Emissions: External AC/DC Power Supply Pass Note: Pass/Fail criteria are based upon the following condition: Where the results are compared to published test standard or manufacturer specified limits, the PASS or FAIL opinion is considered without applying the laboratory stated measurement uncertainty. Reports noted as a revision replace all previously issued reports and/or antecedent report revisions issued under this job number. Report Number: F2LQ6037-06E 0410:4 Page 4 of 24 Issue Date: Apr. 23. 2014#