Philips Respironics — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department 1200 New Jersey Avenue, SE Washington, D.C. 20590 Materials Safet ipeline and Hazardou Administration JAN 0 5 2015 Colleen L. Witt Manager, Regulatory Affairs Philips Respironics 1740 Golden Mile Highway Monroeville, PA 15146 Ref. No. 14-0197 Dear Ms. Witt: This responds to your October 13, 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 Administration (FAA) to allow a passenger to carry and operate the POC aboard an aircraft. According to your letter, the POC (trade name Respironics SimplyGo Mini POC) is a device that is for use by patients requiring high concentrations of oxygen on a supplemental basis. The maximum operating pressure of the Respironics SimplyGo Mini POC is 20.0 pounds per square inch (psig). The Respironics SimplyGo Mini POC is powered by multiple sources, including AC or DC power, and a rechargeable lithium ion battery pack. For the Respironics SimplyGo Mini POC powered by the rechargeable lithium ion battery pack, the standard battery pack has a Watt-hour (Wh) rating of 97.9 (3.4 ampere-hour (Ah) × 3.6 volts (V) x 8 cells). The lithium ion battery pack meets the appropriate testing requirements of the United Nations Manual of Tests and Criteria, and the battery pack is packaged in a manner to prevent short circuits when offered for transport or carried onboard an aircraft. You ask whether the POC is regulated under the HMR. Based on the information provided in your letter, the Respironics SimplyGo Mini POC is not subject to the HMR as a Division 2.2 non-flammable gas. The standard lithium ion battery pack used to operate the device conforms to § 172.102(c)(1)(i) Special Provision 188, for the transportation of small lithium ion cells and batteries and the POC contains no other hazardous materials. Therefore, the Respironics SimplyGo Mini POC is not subject to any other requirements in the HMR.#

Page 2Please note that notwithstanding the passenger exception in § 175.10(a)(18) of the HMR, Special Federal Aviation Regulation 106, "Rules for Use of Portable Oxygen Concentrator Systems on Board Aircraft" (SFAR 106) apply and are under the purview of the FAA. This response satisties only one requirement in the FAA approval process before a POC may be operated onboard 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, T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 3Stevens §175.10 Portable Oxygen PHILIPS concentrator (Pol) 14-0197 Philips Respironics 1740 Golden Mile Highway Monroeville, PA 15146 October 13, 2014 Attn: Charles Betts, Director, Standards and Rulemaking Division US Department of Transportation/PHMSA (PHH-10) 1200 New Jersey Avenue, SE East Building, 2ªd Floor Washington, DC 20590 Re: Request for Determination - Respironics Portable Oxygen Concentrator (POC) Dear Mr. Betts: Philips Respironics is preparing to enter the market with a miniature version of the currently sold SimplyGo Portable Oxygen Concentrator (POC) and is requesting an amendment to Special Federal Aviation Regulation 106 - Rules for use of portable oxygen concentrator systems on board aircraft (SFAR 106). This amendment would include the Respironics SimplyGo Mini POC in the list of approved POCs for use on board aircraft. SFAR 106 permits passengers to carry on and use certain POCs on board aircraft if the aircraft operator ensures that the conditions specified in the SFAR for their use are met. Section 2 of SFAR 106 requires that PHMSA determine that the POC does not contain hazardous materials and that the requestor includes this determination in the SFAR amendment application. This letter is a request for such a determination and response by PHMSA regarding the applicability of the Hazardous Material Regulations (HMR; 49 CFR Parts 171-180). Background Philips Respironics is the principal provider of innovative solutions for the global sleep and respiratory markets. Our success spans more than three decades and can be traced to a history deeply rooted in ingenuity and a passion to deliver solutions to those in need. This tradition of innovation, combined with an ability to anticipate market needs, is fundamental to the Company. It has made Philips Respironics a name acknowledged worldwide as a pace-setter in the sleep and respiratory markets. The Respironics SimplyGo Mini Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and capable of continuous use in the home, institutional, and travel /mobile environments.#

Page 4Per the US FDA Memorandum #K97-1 "Deciding When to Submit a 510(k) for a change to an Existing Device" ', it was determined that a 510(k) was not required to market the SimplyGo Mini device within the United States. This decision was based on the comparison of the SimplyGo Mini device to its predicate device, SimplyGo Portable Oxygen Concentrator. Therefore, the SimplyGo Mini Portable Oxygen Concentrator is cleared under the SimplyGo Portable Oxygen Concentrator premarket notification number 510(k) K111885. A copy of the SimplyGo Portable Oxygen Concentrator 510(k) clearance letter is attached, along with a copy of the SimplyGo Mini User Instruction Manual. Performance Specifications and Device Description The SimplyGo Mini is a portable oxygen concentrator intended to deliver at least 87% pulsed oxygen to the patient. The device has an integrated conserving device which triggers a pulse of oxygen by sensing pressure at the onset of inspiration. The SimplyGo Mini delivers fixed pulse volumes up to a maximum minute volume per setting on the device. The volume of the dose varies based on the user selected settings. The SimplyGo Mini POC will operate using any of the multiple power sources listed below: Rechargeable batteries (single battery and double battery) • A/C Adapter • 12v D/C car Adaptor Users The SimplyGo Mini POC will be used by patients requiring supplemental oxygen. These patients are typically COPD patients. The patient using this device will be ambulatory and will be looking to improve their mobility versus other forms of supplemental oxygen. Some patients may have limited vision and hearing. Environments of Use The SimplyGo Mini POC is intended to be used during travel wherever the patient might want to go. Therefore, the device may be used in both good and bad weather conditions. The SimplyGo Mini Portable Oxygen Concentrator is designed to fit easily under the seat of a commercial aircraft, permitting the user to travel by air with their prescribed oxygen therapy. 2| Page#

Page 5Specifications Operating Conditions Operational temperature: 41º F to 95° F (5° C to 35° C) Relative humidity: 15% to 93% Altitude: up to 10,000 ft. (3048 m.) Storage Conditions -4° F to 140° F (-20° C to 60° C) - unit only Relative humidity: up to 93%, non condensing Oxygen Concentration* At least 87% at all settings Pulse Modes (pulse volumes at 20 breaths per minute) 1 = 11 ml 2 = 22 ml 3 = 33 ml Flow Settings and Pulse 4 = 44 ml Volumes 5 = 50 ml +/- 15% or 5 ml whichever is greater for 20 consecutive breaths Up to a max of 1000 ml/min +/- 100 ml User Interface TFT LCD w/Projective Capacitive Touch Screen 9.4 in x 8.3 in x 3.6 in (single battery) (23.9 cm x 21.1 cm x 9.1 cm) Dimensions 10.2 in x 8.3 in x 3.6 in (double battery) (25.9 cm x 21.1 cm x 9.1 cm) Weight 5 Ibs (2.3 kg) with single battery installed 6Ibs (2.7 kg) with double battery installed Audio Alarm 56 decibels or greater when measured at 1 meter Outlet Pressure 20 psig *Based on an atmospheric pressure of 14.7 psia (101 kPa) at 70° F (21° C) 3 | Page#

Page 6SimplyGo Mini Battery Chemistry Lithium Ion 14.4 VDC (nominal) Battery Options Single battery Double battery (equals two single batteries) 7.9 in x 3.6 in x 1.0 in (single battery) (20.1 cm x 9.1 cm x 2.5 cm Dimensions 7.9 in x 3.6 in x 1.9 in (double battery) (20.1 cm x 9.1 cm x 4.8 cm) Weight 1.1 Ibs (single battery) (0.50 kg) 2.1 Ibs (double battery) (0.95 kg) Watt-hour Rating per single battery 3.4 Ah x 3.6 V x 8 cells = 97.9 Wh Battery Duration 4 hours (Pulse setting of 2 at 20 bpm with single battery) 8 hours (Pulse setting of 2 at 20 bpm with double battery) Maximum recharge time is 4 hours for the single battery and 8 Charge Time hours for the double battery from fully discharged to fully charged, depending on the power source and usage. AC Power Type Philips Respironics Part Number 1116818 Input 100 to 240 VAC, 50/60 Hz Output 19 VDC, 6.3 A Power Consumption 120 W while charging DC Power Type Philips Respironics Part Number 1116819 Input 12-16 VDC Output 19 +/- 5% VDC, 6.3A 4| Page#

Page 7Standards Compliance The SimplyGo Mini POC is designed to conform to the following standards: • IEC 60601-1 3'd edition, Medical Electrical Equipment, Part 1: General Requirement for Safety • IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirement for Safety - Collateral Standard: Electromagnetic (EMC) Compatibility - Requirements and tests. • RTCA/DO-160F section 21, category M; Emission of Radio Frequency Energy • ISO 8359, Oxygen Concentrators for Medical use - Safety Requirements. • ISO 80601-2-67, Medical electrical equipment, Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment. • ISO 80601-2-69, Medical electrical equipment, Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment. Classification The SimplyGo Mini POC is classified as: • IEC Class II Internally Powered Equipment Type BF Applied Part IP22: Drip Proof Equipment Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Continuous Operation Specifically, the following characteristics relate to the SimplyGo Mini POC and its battery pack: 1. The maximum operating pressure of the SimplyGo Mini POC is 20 psig. This maximum operating pressure limit is a shutdown condition controlled by a pressure sensor within the device. 2. Each single lithium ion battery pack satisfies the requirements of § 173.185(c)(1)(i) which states that the Watt-hour rating may not exceed 20 Wh for a lithium ion cell or 100 Wh for a lithium ion battery and be marked with the Watt-hour rating on the outside case. The battery pack meets the requirements of each test in the UN Manual of Tests and Criteria. 3. The lithium ion battery pack satisfies the requirements of § 173.21(c) which states that an electrical device is forbidden for transportation unless it is packaged in a manner to preclude it from creating sparks or generating a dangerous quantity of heat (for example, by the effective 5 Page#

Page 8insulation of exposed terminals). The SimplyGo Mini battery pack has no exposed terminals which could be the source of a short circuit. The safety profile of the battery pack includes safety circuit to protect against over current, over voltage and over temperature conditions. In addition, there are also single fault tolerances for both over-current and over-temperature safety protection provided by a current limiting fuse and over-temperature thermal fuse. All safety systems when activated shut down operation of the battery assembly. Based on the information provided above, we respectfully submit that the SimplyGo Mini POC is not currently subject to the HMR because it meets the following criteria: (1) The pressure of the oxygen in the device does not exceed 40.6 psia at 20°C; (2) The lithium ion battery used to operate the device is exempted from the HMR; (3) The battery pack is packaged in a manner to preclude it from creating sparks or generating a dangerous quantity of heat (for example, by the effective insulation of exposed terminals); and (4) The SimplyGo Mini POC contains no other materials subject to the HMR. Thank you in advance for your assistance, consideration and review of our request. If you require additional information, please feel free to contact me at (724)387-4870; by fax at (724)387-7490 or by email at colleen.witt@philips.com. Sincerely, Count. Witt Colleen L. Witt Manager, Regulatory Affairs 6| Page#

Page 9Respironics inc. Murrysville, PA 15668 USA 1001 Murry Ridge Lane PHILIPS 11110202000 (REF) 1118724 SimplyGo Mini O Persiss PHILIPS RESPIRONICS#

Page 10English Table of Contents Introduction Intended Use Device and Accessories Description Contraindications... Warnings and Cautions.... SimplyGo Mini System......... Symbol Key... ...3 Getting Started... How to Contact Philips Respironics.. .7 ...7 System Overview.. Battery Duration Times.. Inserting and Removing the Batteries.... Operating the SimplyGo Mini Device Charging the Battery with the AC Power Supply... Power Options... Setting up the Cannula and Tubing Device Warm-Up Powering Off the Device Powering on the Device.... Navigating the Display Screens Device Backlight. Viewing and Changing Settings... Home Screen.... Troubleshooting Alarm Indicators and Screen Symbols... Caring for your Battery... Caring for your SimplyGo Mini System... Battery Storage Cleaning the Device and Rechargeable Battery... Device Storage Cleaning the Accessories... SimplyGo Mini Portable Oxygen Concentrator Mobility Device Disposal... Traveling With Your System.. SimplyGo Mini Carrying Case.. 32 By Motor Vehicle. 34 On Arrival.. By Bus or Train.... 35 34 35 Standards Compliance.... 36 EMC Information Classification. 39 38 Limited Warranty .42 40 © 2014 Koninklijke Philips N.V. All rights reserved.#

Page 12SimplyGo Mini User Manual Introduction Intended Use The Philips Respironics SimplyGo Mini Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a the home, institutional, and travel /mobile environments. supplemental basis. It is small, portable, and is capable of continuous use in Contraindications • This device is not intended to be life-sustaining or life-supporting. This device is not intended for newborn and infant use. Device and Accessories Description accessories are described in detail in this manual. Read and understand it The SimplyGo Mini Portable Oxygen Concentrator, its features, and its completely before operating the device. This manual applies to the following accessories: AC Power Supply • AC Power Cord • DC Power Supply Rechargeable Lithium lon Standard and Extended Batteries • Carrying Case • Accessory Bag This manual does not apply to the following accessory items sold separately: • Standard Single Lumen Nasal Cannula Battery Charger SimplyGo Mini Backpack • Me dese#

Page 13SimplyGo Mini User Manual SimplyGo Mini System The device comes with the following items. If any are missing, contact your equipment provider. SimplyGo Mini Device in Carrying Case with Shoulder Strap This User Manual • Standard or Extended Rechargeable Batteries AC Power Supply and Cord • DC Power Supply Accessory Bag 2#

Page 14SimplyGo Mini User Manual Warnings and Cautions Caution: U.S. federal law restricts this device to sale by or on the order of a physician. Warnings A warning represents the possibility of harm to the operator or patient. • The operator should read and understand this entire manual before using the device. The device is not intended for life support. Where the prescribing health care professional has determined that an interruption in the supply of oxygen, for any reason, may have serious consequences to the user, an alternate source of oxygen should be available for immediate use. Geriatric or any other patient unable to communicate discomfort, or hear or see the alarms while using this device, may require additional monitoring. If you feel discomfort or are experiencing a medical emergency while undergoing oxygen therapy, seek medical assistance immediately to avoid harm. periodically reassessed for the effectiveness of the therapy. The oxygen delivery settings of the oxygen concentrator should be • Set the device at the prescribed level and do not increase or decrease your flow rate from the prescribed level until you first consult with your physician or healthcare professional. • Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame. Do not use the device in the presence of a flammable anesthetic nitrous oxide. mixture in combination with oxygen or air, or in the presence of • Do not use oil or grease on the concentrator or its components as these substances, when combined with oxygen, can greatly increase the potential for a fire hazard and personal injury. • Only use this device as prescribed. The use of oxygen therapy can be hazardous in some circumstances, so consult your health care practitioner before using the SimplyGo Mini device. To ensure that you receive the correct therapeutic amount of oxygen delivery according to your medical condition, the Philips Respironics 3#

Page 15SimplyGo Mini User Manual Warnings (continued) SimplyGo Mini device must be used: - Only after one or more settings have been individually determined or prescribed for you at your specific activity levels With the specific combination of parts and accessories that are in line with the specification of the oxygen concentrator manufacturer and that were used while your settings were determined • The settings of the Philips Respironics SimplyGo Mini device might not correspond with continuous flow oxygen. • The settings of other models or brands of oxygen therapy equipment do not correspond with the settings of the Philips Respironics SimplyGo Mini device. Use only water-based lotions or salves that are oxygen compatible during setup or use during oxygen therapy. To avoid the risk of fire and burns, never use petroleum or oil-based lotions or salves. If you notice any of the following, discontinue use and contact your home care provider: - unexplained changes in the performance of this device - unusual or harsh sounds - dropped or mishandled device or the power supply water spilled into the enclosure - broken enclosure Oxygen makes it easier for a fire to start and spread. Do not leave the nasal cannula on bed coverings or chair cushions if the oxygen materials flammable. Turn the oxygen concentrator off when not in concentrator is turned on, but not in use; the oxygen will make the use. To ensure proper function and to avoid the risk of fire and burns: - Use only with Philips Respironics SimplyGo Mini AC power supply. - Use only with Philips Respironics SimplyGo Mini batteries. - Use only approved SimplyGo Mini accessories. Incompatible parts or accessories can result in degraded performance. Repairs and adjustments must be performed by Philips Respironics authorized service personnel only. Unauthorized service could cause 4#

Page 16SimplyGo Mini User Manual injury, invalidate the warranty, or result in costly damage. • Periodically inspect electrical cords, cables, and the power supply for damage or signs of wear. Discontinue use and replace if damaged. • To avoid electric shock, unplug the device and remove the batteries before cleaning the bag. DO NOT immerse the device in any fluids. • Your home care provider is responsible for performing appropriate preventive maintenance at the intervals recommended by Philips Respironics. For proper operation, your device requires unobstructed ventilation. Always make sure any openings in the case are not obstructed by items which may impede ventilation. Do not place the device in a small closed space (such as a closet). The device should not be used adjacent to or stacked with other equipment. For more information, contact your home care provider. Do not use an extension cord. • Device operation above or outside of the voltage, breath rate, temperature, humidity and/or altitude values specified may decrease oxygen concentration levels. Never drop or insert any object into any opening. Be aware that the electrical cord and/or tubing could present a tripping or strangulation hazard. Use only power cords supplied by Philips Respironics for this device. overheating or damage to the device and may result in increased Use of power cords not supplied by Philips Respironics may cause emissions or decreased immunity of the equipment or system. Do not operate without the battery installed and working. If primary without warning the user. If the device must be operated without the power is lost with no battery in place, the device will stop operating battery, the user should be aware that there is no backup power and no warning if primary power is lost. remove the battery from the device. If the SimplyGo Mini device will not be used for a long period of time, Medical Electrical Equipment needs special precautions regarding EMC information provided in this manual. EMC and needs to be installed and put into service according to the Place the device in a location so as to avoid pollutants and fumes. Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment. See the EMC section of this manual for 5#

Page 17SimplyGo Mini User Manual distances to observe between RF Generators and the SimplyGo Mini device to avoid interference. The use of cables and accessories other than those approved for use by Philips Respironics may negatively affect EMC performance. Cautions A caution represents the possibility of damage to the equipment. Do not immerse the device or allow any liquid to enter the enclosure. • When the device is used in an automobile, disconnect it from the DC auto adapter outlet when the automobile is turned off. Do not operate the device in a non-running vehicle for an extended period vehicle from starting. Do not allow the device to be connected to the of time, as this may deplete the vehicle's battery and prevent the auto adapter outlet while starting the automobile normally or while you are starting the automobile with battery recharging cables. Wait until the automobile starts before connecting the device to the DC power outlet. Secure the device securely when used in any moving vehicle. (The same cautions apply if using the DC adapter outlet on a boat or recreational vehicle.) Turn off the device before removing the battery. The device should not be operated without the batteries installed. If the device is routine will not be implemented when the power is disconnected operated without the batteries installed, the standard shut-down prior to turning off the unit. This can result in damage to the device. Only use the supplied handle and shoulder strap to carry your device. With every use, verify that the case, shoulder strap and handle are in good condition. Note: Additional warnings, cautions, and notes are located throughout the manual. 6#

Page 18SimplyGo Mini User Manual Symbol Key accompanying Consult instructions REF Model number for use No smoking [SN Serial number No oil or grease Type BF Applied Part Keep away from open flames 424 Rechargeable Battery Do not disassemble IP22 Drip proof equipment == DC power AC Power Caution: U.S. federal RONY device to sale by or law restricts this Class II (Double on the order of a Insulated) physician. Note: Also see the section on alarm indicators and screen symbols. How to Contact Philips Respironics To have your device serviced, contact your home care provider. If you need at 1-724-387-4000 or 1-800-345-6443 (US or Canada). You can also use the to contact Philips Respironics directly, call the Customer Service department following address: Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 USA 7#

Page 19SimplyGo Mini User Manual Getting Started Attach the shoulder strap(s) to the carrying case. Before using the SimplyGo Mini device for the first time, the SimplyGo Mini time of 3.5 hours minimum for the standard and 7 hours minimum for the standard or extended batteries require an initial uninterrupted charging extended battery. This can be accomplished by installing the battery and using the AC Power Cord, as described in the following pages. Or optionally, you can use the Smart Battery Charger to charge the SimplyGo Mini batteries. Note: Philips Respironics does not recommend using DC power for this initial charging. Caution: Use only Philips Respironics batteries in your SimplyGo Mini device. Using other batteries could damage the device and will void the for an extended period of time. warranty. Remove the battery if the SimplyGo Mini will not be used System Overview Begin by becoming familiar with your SimplyGo Mini device. (2) Item Description Function 1 Control Panel TFT LCD with projected capacitive touch screen 8#

Page 20SimplyGo Mini User Manual 2 Patient Cannula Connector Oxygen output and connection point for patient cannula 3 Rechargeable Battery Standard or extended rechargeable lithium- ion battery 4 Power Input Connection point for Philips Respironics- Connector provided external power supplies: AC line voltage, vehicle DC Control Panel Item Description Function 1 Power Button Turns the device On and Off 2 Display Screen Shows information about the operating status of the device and device settings. 3 Home Button Accesses the Home screen. screen from any 2#

Page 21SimplyGo Mini User Manual Battery Duration Times standard and extended rechargeable batteries when the batteries are fully The following table displays the approximate battery duration times for the charged. SETTING STANDARD BATTERY EXTENDED BATTERY 4.5 hours 9.0 hours 2 3.5 hours 7.0 hours 3 2.5 hours 5.0 hours 4 2.0 hours 4.0 hours 5 1.5 hours 3.0 hours Inserting and Removing the Batteries You can use a standard battery or extended battery with your SimplyGo Mini device. They are inserted using the same method. To insert the batteries, complete the following steps: 1. Place your device in a well-ventilated location and make sure it is turned off. Note: The SimplyGo Mini device is shipped from the factory with the battery removed. 2. Hold the SimplyGo Mini device in one hand, and use your other hand to insert the battery compartment into the bottom of the SimplyGo Mini as shown in the following illustration. Caution: Only remove the battery when the SimplyGo Mini is turned off. Never remove the battery while the device is operating. 10#

Page 22SimplyGo Mini User Manual 3. To remove the standard or extended battery, push the eject button on the center of the battery compartment down as shown in the following illustration. The battery will release from the device. If the device has been operating, the surfaces may be warm to the touch. This is normal. 4. When the standard or extended battery is not installed, you can check the battery gauge on the battery to determine the amount of charge available. If you are using the standard battery, press the black button on the battery, press the two black buttons and watch how many LEDs light battery and watch how many LEDs light up. If using the extended up. If the batteries are low, you can recharge them. See the Charging the Battery with AC Power Supply section. No. of LEDS Standard Battery Extended Battery Battery Charge No. of LEDS 4 LEDs Light: 8 LEDs Light: 75% to 100% full 3 LEDs Light: 6 LEDs Light: 50% to 75% full 2 LEDs Light: 4 LEDs Light: 25% to 50% full 1 LED Lights: 2 LEDs Light: |10% to 25% full 1 LED Blinks 3 Times: : LEDs Blink Battery is less tha 3 Times: 10% full and needs to be recharged 11#

Page 23SimplyGo Mini User Manual Charging the Battery with the AC Power Supply Important: The first time you charge the battery, be sure to charge it fully. Do not use the DC power cord to do so; instead use AC power. Note: The battery will begin charging whenever you connect the device to an AC outlet, regardless of whether or not it is in use. follow these steps. To charge the battery using the AC Power Cord provided with your system, 1. Connect the AC Power Supply's output cable to the SimplyGo Mini power input connector. 2. Connect the AC Power Cord's connector into the AC power supply. 3. Connect the AC Power Cord's plug into an AC outlet installed to meet national or regional electrical code. Note: The AC Power Supply is equipped with a green light, which illuminates as soon as you connect the device to an energized AC power source. 4. When charging is complete (this takes four hours or less for the standard battery), disconnect the AC Power Supply and store it with the AC Power Cord for future use. Note: Replacement and spare batteries are available separately. For information, contact your home care provider. Note: An optional SimplyGo Mini Smart Battery Charger (sold separately) is available for your system. For more information, contact your home 12 care provider.#

Page 24SimplyGo Mini User Manual Operating the SimplyGo Mini Device Power Options Warning: Do not use the device without the battery installed and operating. To run the device on battery power, make sure the battery is properly inserted and sufficiently charged. (The battery should be fully charged the first time you use it.) To run the device using AC power, first make sure you have a battery installed. Then, follow these steps: 1. Connect the output cable of the AC Power Supply to the SimplyGo Mini power input connector. 2. Connect the AC Power Cord's connector into the AC power supply. 3. Connect the AC Power Cord's plug into an AC outlet installed to meet national or regional electrical code. Note: • To run the device using DC power from an automobile or other and connect one end of the DC Power Cord to the device's power inlet motorized vehicle, make sure the battery is installed. Start the vehicle and the other end into the vehicle's DC electrical outlet. Because the amount of current available in the vehicle electrical system is limited, the current available to charge the SimplyGo Mini battery will the time required to charge the battery will be much longer, and at the be determined by the operating mode of the device. At high settings, highest settings, it may not charge at all. Device Warm-Up When you turn on your SimplyGo Mini device, it will sense if you are breathing from it. If you are not yet breathing through the cannula, SimplyGo Mini will begin to pulse automatically about once every five seconds. As soon as you begin breathing through the cannula, the device will begin delivering pulses based on your breathing. It may take up to 20 minutes for the SimplyGo Mini reathing from the SimplyGo Mini at any time. Durina the initial stabilizatior utput to stabilize within its O, purity specifications. However, you may begir period, the displayed O, setting number will blink. It will stop blinking when the output is stabilized and within the target specification. 13#

Page 25SimplyGo Mini User Manual Setting up the Cannula and Tubing To set up the SimplyGo Mini device, follow these steps. 1. Connect a nasal cannula to the patient cannula connector on the device, as shown. Ensure that the cannula is routed to prevent it from being pinched or kinked to avoid a disruption of oxygen flow. Note: A standard single lumen nasal cannula and tubing (not supplied) should be used to deliver oxygen from the SimplyGo Mini device. The device works with cannula tubing up to 30 ft. (9 m). 2. Power on the device as described in the next section. 3. Position the nasal cannula on your face, as shown below, and breathe normally through your nose. Powering on the Device 1. You can press the Power button once or simply touch the black screen on the device to quickly view your settings. following information displayed: The screen shown here will appear with the • O, setting Battery capacity • Number of hours the device has been used 2 • Software version Version: 1.31 14#

Page 26SimplyGo Mini User Manual The screen will automatically shut off again after 5 seconds. If you want to fully power on the device, press unwanted starts or inadvertent changes in oxygen flow. The Philips the Power button a second time. This second press helps prevent Respironics splash screen appears briefly followed by the Home screen, both shown below. * 9:30 pm PHILIPS ... RESPIRONICS Every time it starts up, the device starts producing oxygen to meet specified purity levels for the setting. It is safe to begin breathing the specified setting. It may take up to 20 minutes to reach the from the SimplyGo Mini device immediately. Breathing from the device will cause it to reach oxygen purity levels faster. Note: When it is turned on, the device will automatically start at the oxygen flow rate setting used when the device was last turned off. As a precaution, each time you start the device, verify the flow setting. Powering Off the Device To turn the device off, press the Power button and the confirmation screen shown here appears. 2. Press the Power button a second time to turn the device off. Note: If you do not press the Power button a second time, the screen will return to the Home screen. 15#

Page 27SimplyGo Mini User Manual Device Backlight automatically whenever: The device features a backlight that turns on You touch the screen An alarm occurs The device is plugged into an external power supply • A battery is inserted into the device The backlight automatically shuts off after one minute of inactivity, as a power-saving feature. Navigating the Display Screens As you access each of the display screens, there are some common actions you can take to move from screen to screen, adjust settings, return to a previous screen, etc. Press the Home button (1n.)) from any of the display screens if you want to quickly return to the Home screen. • If a screen has + and - buttons at the bottom, press those to . scroll through setting selections and choose the desired setting. The Device Tools menus may also have < and > buttons at the you want to modify (for example, the hour and minute settings bottom. Press these to scroll back and forth through the items within the Time menu), and select the data you need to change. Note: If you've reached the limit for a setting, then the < or > buttons will appear gray on the screen and will be disabled. • The Device Tools menus may also have an i in the top left corner of the screen. Press that arrow to return to the previous screen. 16#

Page 28SimplyGo Mini User Manual Viewing and Changing Settings This section describes how to view and change settings on the SimplyGo Mini device. Home Screen 9:30 pm three main items: The Home screen shown here contains • Tool icon • O, Setting • Battery Charge Level Additionally, the Status bar at the top of the screen displays the following: SYMBOL DESCRIPTION The device has detected an active alarm. An active alarm has been silenced but not resolved. A battery is installed in the device, and AC power is also connected. Battery level is normal. Battery level is low. Battery level is depleted. 17#

Page 29SimplyGo Mini User Manual Changing the O, Setting To change the O, setting, complete the following steps: 1. Touch the O, number shown on the Home screen to access the 0, Settings screen, shown below. 9.30 pm 2 2. Press the + or - buttons to scroll up and down and increase or to 5 in increments of 1. decrease the O, setting as needed. You can adjust the setting from 1 Note: When you've reached the setting limit, the + or - symbols will be greyed out to indicate that they are disabled and can no longer be selected. The device detects when the user begins to take a breath and then delivers a pulsed volume of oxygen during the inhalation period. no breath is detected for a period of time, the system automatically The volume of the oxygen pulse is dependent on the setting value. If number at a fixed rate of 12 breaths per minute. If no breath is delivers the pulsed volume of oxygen determined by the setting detected for 2 minutes, the device signals an alarm and shuts down after 15 minutes if the device is running on battery power. 18#

Page 30SimplyGo Mini User Manual Checking the Battery Status To check the battery status, complete the following steps: 1. Touch the battery symbol on the Home screen to access the Battery Information screen, shown below. 9:30pm 50% how much battery power is left, and the battery level symbol appears The battery percentage number appears on the screen to indicate below the number. The table below describes each of the battery symbols: SYMBOL DESCRIPTION Battery level at 25% Battery level at 50% Battery level at 75% Battery level at 100% Note: The green battery bar blocks will scroll while Battery charging or battery charge complete the battery is charging and this symbol appears. Once fully charged, the battery blocks stop scrolling and one long beep sounds. Low battery - indicates battery level is below xx% 19#

Page 31SimplyGo Mini User Manual SYMBOL DESCRIPTION Battery depleted AC power connected; no battery installed Accessing the Device Tools Menu There are two device tool menus: Brightness menu Alarm Log menu To access the Device Tools menu, complete the following steps: Change the Brightness Setting 1. Touch the Toolicon ({O3) on the Home screen to access the Device Tools Menu. The Brightness menu screen appears first, shown below. Note: You can use the < and > buttons to scroll to the Date and Time Settings menu or Alarm Log menu if desired. 9:30 pm • . 2. Press on the Brightness icon to access the Brightness setting screen, shown below.#

Page 32SimplyGo Mini User Manual 9:30 pm 3. Press the + and - buttons to scroll through the three brightness settings and choose the desired brightness. Note: If you want to exit the Device Tools menu and return to the previous screen, press the arrow in the top left corner of the screen. Access the Alarm Log Menu 1. Press the 4f to return to the Tools menu, and press the < and > buttons to navigate to the Alarm Log menu, shown below. * 9•30 pm < Press on the Alarm Log tile to access the screens shown below. If no alarms have ever occurred, the screen shown on the left will appear. Otherwise, a screen similar to the one on the right appears. 21#

Page 33SimplyGo Mini User Manual 930pm 9:30 pm N/A :29 am. 03/18/2014 3. You can view the type of alarm that occurred and the start time and date of the alarm on the Alarm Log screen. 4. Press the < and > buttons to navigate through the list of alarms in the log history. The log will list at a minimum the 16 most recent alarms. Notes: • The alarm log is maintained between device Power Off and Power On cycles (the time of Power Off is not logged). • The most recent alarm events in the log from the current Power On session may be lost if the device experiences a total loss of power and improperly shuts down. The alarm log maintains the most recent 16 alarms and will discard the oldest data once its memory is full and a new alarm occurs. 22#

Page 34SimplyGo Mini User Manual Alarm Indicators and Screen Symbols Indicators Visual, Audio Description What To Do No Breath Alarm breath is not detected for This alarm occurs when a Check the a period of 2 minutes or connection from NEED TO ADD more. It can be silenced the cannula to the SCREEN TBD by pressing the Alarm device. Make sure symbol. This alarm resets the nasal cannula is 1 beep itself as soon as a breath properly positioned that repeats every is detected. If the device nd that you ar n your face 15 seconds is on battery power and no breath is detected breathing through after approximately 15 sure the cannula your nose. Make down to conserve power. minutes, the device shuts tubing is not kinked (This alarm is inactive for or obstructed. ten minutes after startup.) Low Oxygen Concentration Alarm This alarm occurs when a lower concentration of the device is delivering oxygen than specified. NEED TO ADD Note: This alarm occurs SCREEN TBD when the internal o, Change to another sensor reads < 82% O This alarm will turn off and contact source of oxygen 1 beep that repeats every recover from the fault and if the system is able to your equipment 15 seconds provider. achieve >84% 0,: If in normal operation, the internal oxygen sensor monitors O, purity during the warmup period and after that. then at 1 hour intervals 23#

Page 35SimplyGo Mini User Manual Indicators Visual, Audio Description What To Do High Breath Rate Alarm NEED TO ADD This alarm indicates that SCREEN TBD the user's breath rate is The indicator exceeding the maximum the breath rate resets itself when 1 beep pulse rate of the device. The device is still working is reduced. If this that repeats every properly and is still indicator regularly 15 seconds providing the maximum home care provider. occurs, contact your amount of oxygen for the user's setting. Technical Fault Alarm NEED TO ADD This alarm occurs when SCREEN TBD the device has a general malfunction and the Change to another 1 beep device is no longer operating properly. source of oxygen and contact your that repeats every The device may or may home care provider. 15 seconds on the severity of the not shut down depending alarm. Low Battery Alarm NEED TO ADD This alarm occurs when SCREEN TBD approximately 10 minutes of battery life remains. Replace the battery 1 beep dependent on your device Remaining battery life is or connect to a that repeats every power source. 15 seconds level. The empty battery settings and your activity symbol flashes on-screen. NEED TO ADD SCREEN TBD No Flow Alarm Check the cannula the device detects there is This alarm occurs when for kinks or other 1 beep obstructions that no oxygen flowing in the are stopping that repeats every patient cannula. hrouah it oxygen flow 15 seconds 24#

Page 36SimplyGo Mini User Manual Visual, Audio Indicators Description What To Do NEED TO ADD Depleted Battery Alarm SCREEN TBD This alarm occurs when approximately two Replace or recharge 1 beep minutes of battery life battery. that repeats every remains. The battery 15 seconds symbol flashes on-screen. Alarm Symbol This symbol appears Refer to the when an event occurs associated alarm that generates an audible indicator also being alarm. displayed. Alarm Silenced Symbol This symbol appears Refer to the when you have pressed associated alarm the alarm silence button indicator also being on the control panel to displayed. silence an audible alarm. If the device is carrying case, makı operating in th sure it has been placed correctly Attention the outlet vents in the case so that when corrective action is This symbol appears are not blocked. See the Carrying required. Case section of this manual. Allow the device to warm up. If the contact your home care provider. 25#

Page 37SimplyGo Mini User Manual Indicators Visual, Audio Description What To Do Battery Charging While Almost Empty Symbol This battery symbol TBD appears (with the charging bars scrolling) No action needed. when the battery is almost depleted and Battery Charging While Partly Full Symbol TBD When a battery symbol (with the charging bars similar to this appears No action needed. scrolling), the battery is partly full and recharging. Battery Charge Complete Symbol TBD This battery symbol No action needed. is hulays wage the battery Symbol Power Connection This symbol appears when the device is No action needed. connected to an AC, DC, or airline power source. (Power The Power Connection Connection Symbol Disappears) when thedeviers disconnected from the No action needed. 26#

Page 38SimplyGo Mini User Manual Visual, Audio Indicators Description What To Do Press the Power button to turn the 1st press of the Power button On/Off Symbol device on or off. = 1 long beep. This symbol appears Note: To prevent when the device is inadvertent starts powered on, or is ready to and stops, the be turned on or off device requires two presses of the Power button to turn it on and off. Pulse Symbol Dotted animation under TBD the setting value indicates that the device detected No action needed. a breath and delivered a pulse of oxygen. If this is your flow Flow Control Setting setting, no action is The large number on needed. the screen shows the If this is not your 2.0 flow setting, press the + button. to increase this to 5 in increments of .5. number or press the - button to decrease the number. 27#

Page 39SimplyGo Mini User Manual Troubleshooting The table below lists common problems and actions you can take. If you are unable to resolve a problem, please contact your home care provider. Problem Possible Cause What You Should Do Device Won't Turn On Battery is depleted. Use the AC or DC power cords to inserted) to recharge the battery. If operate the device (with the battery this does not resolve the problem, contact your home care provider. Battery is not installed correctly. Remove the battery and re-install it correctly. Power button not pressed twice. Press the power button twice. Device Will Not SimplyGo Mini is rigger A Pulse not turned on. Press the power button twice. Of Oxyger Cannula tubing is kinked or twisted Make sure the tubing is connected properly to the oxygen outlet port and that it is free of any obstruction. Device malfunction. Contact your home care provider. Oxygen Device is warming Not At Full Continue using your device, and Concentration up. wait 20 minutes for the device to concentration. If the condition deliver oxygen at the prescribed persists, contact your home care provider. Alarm Occurs The device needs See the Alarm Indicators and Screen your attention. Symbols section for information about specific alarms and what you should do. 28#

Page 40SimplyGo Mini User Manual Caring for your Battery Handle your battery with care. • Do not allow the battery's terminals to touch together as this will cause it to fail. • Do not immerse the battery in water. • Do not disassemble or deform the battery. • Do not expose to, or dispose of, the battery in fire. • Avoid exposing the battery to excessive physical shock or vibration (dropping, etc.). • Keep all batteries out of the reach of children. • Do not use any battery that has been damaged in any way. • Always charge the battery in accordance with the manufacturer's instructions, using specified chargers only. • Do not use modified battery chargers. • An optional, external charger can be purchased to charge the batteries. Contact your home care provider for more information. Battery Storage to 80% relative humidity. However, they are best stored below Lithium ion batteries can be stored from -4° F (-20° C) to 140° F (+60° C) at up 70° F (21° C) in a cool, dry, well-ventilated facility free from corrosive gas or vapor. Storage at temperatures above 113° F (45° C), such as in a hot car, may degrade battery performance and reduce battery life. Storage at low temperatures may affect initial battery performance. The optimal temperature range for charging the batteries is 0° F to 113° F (0° C to 45° C) at up to 80% relative humidity. The device will not charge the battery if the battery cells exceed 113° F (45° C). Battery charging will be inhibited until the battery temperature returns to at or below 111° F (44° C). 29#

Page 41SimplyGo Mini User Manual Caring for your SimplyGo Mini System Cleaning the Device and Rechargeable Battery Warning: To avoid electrical shock, do not remove the SimplyGo Mini covers. The covers should only be removed by authorized service personnel. Do not apply liquid directly to the covers. Do not use alcohol, solvents, polishes, or any oily substances on the device, as they are flammable. Caution: Do not allow liquids into any of the controls, the interior of the case, or the oxygen tubing connector. If this occurs, contact your home care provider for assistance. Cleaning The exterior covers of the device and rechargeable battery should be cleaned between patient use and as needed by performing the following steps: 1. Turn the device off and disconnect from the power source before cleaning. 2. Remove the device from the carrying case. 3. If the battery is removed, wipe the battery bay and battery with a dry cloth. 4. Clean the device exterior using a damp cloth with a mild household cleaner and wipe it dry. Disinfection The exterior covers of the device and rechargeable battery should be disinfected between patient use as follows: 1. Clean the device as indicated above. 2. Per the manufacturer's instructions, use a Discide Ultra Towelette to disinfect the exterior of the device and wipe dry. (Manufacturer - Palmero, www.palmerohealth.com or equivalent) 30#

Page 42SimplyGo Mini User Manual Cleaning the Accessories Follow the instructions below when cleaning the accessories. Carrying Case If necessary, the carrying case can be washed in a washing machine using a mild laundry detergent. Air dry. dish detergent: To wash the carrying case by hand, use only warm water and a mild liquid Remove the SimplyGo Mini device from the carrying case. 2. Dampen a cloth in the detergent and water solution and wipe the outside surfaces of the case clean. AC and DC Power Supplies/Power Cord The AC and DC power supplies and power cord should be cleaned as needed. 1. Disconnect cords from device before cleaning. 2. Clean the cords using a cloth with a mild household cleaner and wipe dry. Cannula and Tubing Clean and replace the cannula and tubing as instructed by the manufacturer and your home care provider. Device Storage Store your device in a place where it will remain clean and dry. Caution: Do not store your device or accessories in extreme temperatures, below -4° F (-20° C) or above 140° F (60° C). Device Disposal home care provider. Dispose of the device in accordance with local regulations or contact your 31#

Page 43SimplyGo Mini User Manual SimplyGo Mini Portable Oxygen Concentrator Mobility Your SimplyGo Mini system has been designed to provide you with a source of oxygen that can be carried with you. To enable you to do so, your SimplyGo Mini device has a carrying case bag with it. SimplyGo Mini Carrying Case The SimplyGo Mini carrying case allows you to take your supply of oxygen with you as you go about your normal, daily activities. It provides protection for your SimplyGo Mini as well as a carrying strap to transport the device. To place the SimplyGo Mini into its carrying bag: 1. If you are using the device with the extended battery, unzip the bottom of the carrying case to allow for the device to easily slide into the bag. If you are only using the standard battery or AC power, you only need to unzip the side of the bag as shown below. 2 32#

Page 44SimplyGo Mini User Manual 2. Insert the device into the top of the bag as shown below, and pull the bag that SimplyGo Mini is firmly installed in the bag and close the Velcro tabs. up around the device. Zip the zipper up on the side of the bag to ensure Check to ensure that the power input and cannula connectors align with their openings in the case. 3 4 3. If the extended battery is installed on the SimplyGo Mini, ensure that the bottom zipper is unzipped around the carry bag to allow the required space at the bottom of the carry bag for the extended battery. 33#

Page 45SimplyGo Mini User Manual Traveling With Your System traveling within your community and beyond. Before you leave, make sure With your SimplyGo Mini system and proper advance planning, you can enjoy you pack the following: • Fully charged battery (and extra batteries for a long trip) AC power supply and connector cord DC power supply • Carrying bag Also, be sure to take the telephone numbers of your home care provider and physician in case of an emergency. Note: If traveling internationally, make sure you have the proper AC power cord for the country you are traveling to. By Motor Vehicle vehicle's cigarette lighter or DC power input. Whenever the SimplyGo Mini Use the SimplyGo Mini DC power supply to plug in your system using the system is running from a DC power source, the battery installed in your device will begin recharging. You can also use the SimplyGo Mini device while it is running from a DC power source. Caution: Make sure the vehicle has been started before plugging in your DC DC power cord while the vehicle engine is turned off, you could power supply. If you operate the SimplyGo Mini system using the inadvertently drain the vehicle's battery. vehicle, make sure the battery is installed. Start the vehicle and connect one To run the device using DC power from an automobile or other motorized end of the DC Power Cord to the device's power inlet and the other end into the vehicle's DC electrical outlet. Because the amount of current available in the vehicle electrical system is limited, the current available to charge the SimplyGo Mini battery will time required to charge the battery will be much longer and at the highest be determined by the operating mode of the device. At high settings the settings, it may not charge at all. 34#

Page 46SimplyGo Mini User Manual By Bus or Train Most bus and train lines allow passengers to use portable oxygen your travel arrangements, contact your carrier well before your departure for concentrators, but you may need to notify them in advance. When you make permission to bring your system and use it on board Note: Bus and rail carriers outside the United States may have additional requirements for oxygen concentrators. Contact them several weeks before you leave to identify any requirements or specifications that may require your attention. On Arrival When you arrive at your destination, check the status of your system's battery. when you need them. The charge level on your batteries can be checked by This is an excellent time to recharge all batteries, so they're ready to go following the instructions in the Inserting and Removing the Battery section of this manual. If a battery requires charging, this can be done as described in the Charging the Battery with the AC Power Supply section of this manual. If you have any questions or concerns about traveling with your SimplyGo Mini system, contact your home care provider. 35#

Page 47SimplyGo Mini User Manual Specifications Operational temperature: Conditions Operating 41° F to 95° F (5° C to 35° C) Relative humidity: 15% to 93% Altitude: up to 10,000 ft. (3048 m.) Storage and Transport -4° F to 140° F (-20° C to 60° C) - unit only Conditions Relative humidity: up to 93%, non condensing Concentration* Oxygen At least 87% at all settings (Maximum of 96%) Nominal pulse volume at 20 BPM 1 = 11 ml 2 = 22 ml 3 = 33 ml 4 = 44 ml 5 = 50 ml Puise Volumes Flow Settings and Maximum minute volume output 1 = 220 ml/min 2 = 440 ml/min 3 = 660 ml/min 4 = 880 ml/min 5 = 1000 ml/min +/- 25% or 6 ml, whichever is greater (average of 20 range. consecutive pulses) over the rated environmental Breathing Frequency | Up to 40 BPM User Interface TFT LCD with Projective Capacitive Touch Screen 9.4 in x 8.3 in x 3.6 in (standard battery) (23.9 cm x 21.1 cm x 9.1 cm) Dimensions 10.2 in x 8.3 in x 3.6 in (extended battery) (25.9 cm x 21.1 cm x 9.1 cm) 36#

Page 48SimplyGo Mini User Manual Weight 5.0 Ibs (2.3 kg) with standard battery installed 6lbs (2.7 kg) with extended battery installed 42 dBA typical at setting 2 and 20 BPM Sound Level Maximum Sound Power level of XXX at setting 5 Audio Alarm 56 decibels or greater when measured at 1 meter Outlet Pressure | 20 psig *Based on an atmospheric pressure of 14.7 psia (101 kPa) at 70° F (21° C) SimplyGo Mini Battery Chemistry Lithium Ion 14.4 VDC (nominal) Battery Options Standard Battery Extended Battery (equals 2 standard batteries) 7.9 in x 3.6 in x 1.0 (standard battery) (20.1 cm x 9.1 cm x 2.5 cm) Dimensions 7.9 in x 3.6 in x 1.9 in (extended battery) (20.1 cm × 9.1 cm x 4.8 cm) Weight 1.1 Ibs (0.50 kg) (standard battery) 2.1 Ibs (0.95 kg) (extended battery) Watt-hour Rating Per Standard Battery 3.4 Ah x 3.6V x8 cells = 97.9Wh 4 hours (Pulse setting of 2 at 20 BPM with Standard Battery Duration battery) 8 hours (Pulse setting of 2 at 20 BPM with Extended battery) Maximum recharge time is 4 hours for the standard Charge Time battery and 8 hours for the extended battery from fully discharged to fully charged, depending on the power source and usage. 37#

Page 49SimplyGo Mini User Manual AC Power Type Philips Respironics REF 1116818 Input 100 to 240 VAC, 50/60 Hz Output 19 VDC, 6.3 A max Power Consumption 120W while charging DC Power Type Philips Respironics REF 1116819 Input 12-16 VDC Output 19 +/- 5% VDC, 6.3 A Standards Compliance The device is designed to conform to the following standards - IEC 60601-1, Medical Electrical Equipment, Part 1: General Requirement for Safety IEC 60601-1-2, 2nd edition, Medical Electrical Equipment, Part 1-2: Gen- eral Requirement for Safety - Collateral Standard: Electromagnetic (EMC) Compatibility - Requirements and tests. IEC 60601-1 3rd edition, Medical Electrical Equipment, Part 1: General Requirements for Safety ISO 8359, Oxygen Concentrators for Medical use - Safety Requirements. - ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing (Biocompatibility) ISO 18779, Medical Devices for Conserving Oxygen and Oxygen Mixtures: Particular Requirements ISO 80601-2-67, Medical electrical equipment, Part 2-67: Particular requirements for basic safety and essential performance of oxygen-con- serving equipment - ISO 80601-2-69, Medical electrical equipment, Part 2-69: Particular re- quirements for basic safety and essential performance of oxygen concen- trator equipment 38#

Page 50SimplyGo Mini User Manual Classification The SimplyGo Mini is classified as: IEC Class Il Internally Powered Equipment Type BF Applied Part IP22: Drip Proof Equipment Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Continuous Operation 39#

Page 51SimplyGo Mini User Manual EMC Information Guidance and Manufacturer's Declaration - Electromagnetic Emissions Simply do listended for el the entomagnetic enviorment specied below. The use of Simplyco Mini should Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions CISPR 11 Group 1 ction. Therefore, its RF emissions are v Device uses RF energy only for its inte low and are not likely to cause any interference in nearby electronic equipment. LASER Tons Class B The Device is suitable for use in all • Class A establishments, including domestic establishments and those directly connected to the public low-voltage power supply network oltage Fluctuations/Flicker Emissio that supplies buildings used for domestic : 61000-3 Complies Guidance and Manufacturer's Declaration - Electromagnetic Immunity simply otis einsed an elich metromagnet environment specied below. The use of simply so Mini should Immunity Test JEC 60601 Test Level [Compliance Level Electromagnetic Environment - Guidance Electrostatic charge (ES t6 KV Contact +8 KV Air ₺8 KV Air $6 kV Contact : 61000-4 Electrical Fast LEC 61000-4-4 Transient/Burst *2 kV for Power Supply *1 kV for Input/Output Lines + for peer Supl # k for input/Output name ost even ethat of typical Lines Lines SEC 61000-45 kV Line to Grou kV Line to Li home or hospital environment. Mains power quality should be that of a typical Voltage Dips, Short Interruptions and <5% U, (>95% Dip in U,) <5 % U, (>95% Dip in U,) Voltage Variations on Lines Power Supply Input IEC 61000-4-11 70% U, (30% Dip in U,) for 25 Cycles for 5 Seconds ower Frequenc 50/60 Hz) Magneti 3 A/m 3 A/m Power frequency magnetic fields should be at IEC 61000-4-8 Field levels characteristic of a typical location in a typical home or hospital environment. Note: U, is the A.C. mains voltage prior to application of the test level. 40#

Page 52SimplyGo Mini User Manual Guidance and Manufacturer's Declaration - Electromagnetic Immunity Shat is it an ed for use in the electromagnetic environment specied below. The user of simply o Mini should assure Immunity Test Test Level IEC 60601 Compliance /Level Electromagnetic Environment - Guidance to any part of the Device, including cables, than the recommended separation Portable and mobile RF communications equipment should be used no closer transmitter. distance calculated from the equation applicable to the frequency of the Recommended separation distance IEC 61000-4-6 Conducted RF 13 Vrms 150 kHzto 3V 80 MHz d= 1.2 JP 150 kHz to 80 MHz IEC 61000-4-3 Radiated RF 13 V/m 80 MHz to 10 V/m' d = 0.35 JP 80 MHz to 800 MHz 2.5 GHz d = 0.7 JP 800 M to 25 Giz Field strengths from fixed RF transmitters, as determined by an separation distance in meters (m). frequency range. " electromagnetic site survey, * should be less than the compliance level in each with the following symbol: Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: objects, and people. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, a eld strength from fixed transmitters such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM al transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Device is used exceeds 1 radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed e applicable RF compliance level above, the Device should be observed to verify normal operation. If abnormal performance is observed, additio Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. asures may be necessary, such as re-orienting or relocating the Devi requirement is 3 V/m. SimplyGo Mini incorporates a robust design and conforms with Radiated RF Immunity Test up to 10 V/m between 80 MHz and 2.5 Giz while the test SimplyGo Mini is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The user Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the Device mobile RF communication equipment (transmitters) and SimplyGo Mini as recommended below, according to the maximum of SimplyGo Mini can help prevent electromagnetic interference by maintaining a minimum distance between portable and output power of the communications equipment. Separation Distance According to Frequency of Transmitter (meters) (Watts) 0 kHz to 80 M O MHz to 800 MH 1 = 0.35 J7 0 MHz to 2.5 Gr 0.01 0.12 0.04 0.07 0.1 0.37 0.11 1 0.22 1.17 0.35 0.70 100 10 3.69 1.11 11.67 3.50 2.21 7.00 e estimated in that main please pore rodend be the rector ented separator lisance i peter mi ca he transmitter in watts (W) according to the transmitter manufactur Note 1: LAr 80 M and 800 MH, the higher frequency range applies. Note 2: reflection from structures, objects, and people. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and 41#

Page 53SimplyGo Mini User Manual Limited Warranty Respironics, Inc. ("Respironics") warrants the SimplyGo Mini Portable Oxygen Concentrator System (the "Product") as set forth in the following paragraphs. Limited Warranty workmanship under normal and proper use and when correctly maintained in accordance with applicable Respironics warrants that the Product, except as otherwise stated herein, is free from defects in materials and instructions, for a period equal to the warranty period purchased with the device, or if not otherwise specified, for a period of two (2) years from the date of shipment. Products Not Under Warranty warranty. However, Respironics warrants that the battery in the Product will be free from defects in material Accessories and replacement parts, including, but not limited to, filters and fuses, are not covered under this and workmanship, under normal and proper use and when correctly maintained in accordance with applicable instructions, for a period of 90 days from the date of shipment by Respironics to the original purchaser. This shipped. warranty does not apply to batteries that are dropped, misused, altered or otherwise damaged after they are Limitations If any Product purchased from Respironics fails to conform to the warranties set forth herein during the obligation by repairing or replacing the Product, in Respironics' sole discretion. This may be accomplished by Warranty Period, as determined by Respironics in its sole discretion, Respironics may discharge its warranty installing new or remanufactured assemblies or components, or by other repairs deemed appropriate in the remedy of the original purchaser. Respironics reserves the right, in its sole discretion, to refund the purchase sole discretion of Respironics. The choice of repair or replacement by Respironics shall be the sole and exclusive these warranties exceed the price paid to Respironics by the original purchaser for the Product. price in lieu of repair or replacement of the Product. In no event shall Respironics' maximum liability under Conditions caused by accident, misuse, abuse, negligence, failure to install in accordance with Respironics' installation This warranty does not cover damage or injury whether to the Product or to personal property or persons instructions, failure to operate under conditions of normal use and in accordance with the terms of the alteration or any defects not related to materials or workmanship of the Product. This warranty does not cover operating manual and instructions, failure to maintain in accordance with the applicable service manuals, or damage which may occur in shipment. This warranty does not apply to any Product or individual part of a service center. This warranty does not apply to any Product which is not purchased new. Product that may have been repaired or altered by anyone other than Respironics or an authorized Respironics Exclusions of Warranties OR IMPLIED, STATUTORY OR OTHERWISE, REGARDING THE PRODUCT, ITS QUALITY OR PERFORMANCE. EXCEPT AS SET FORTH IN THIS LIMITED WARRANTY, RESPIRONICS MAKES NO WARRANTIES, EXPRESSED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL RESPIRONICS BE LIABLE FOR THE RESPIRONICS SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE IMPLIED PUNITIVE, EXEMPLARY OR INCIDENTAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, COMMERCIAL LOSS OR COST OF PROCUREMENT OF SUBSTITUTE PRODUCTS OR FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, RESPIRONICS WAS AWARE OR SHOULD HAVE BEEN AWARE OF THE POSSIBILITY OF THESE DAMAGES. EXCEPT LOST REVENUES), FOR ANY CAUSE OF ACTION, WHETHER IN CONTRACT OR TORT, AND WHETHER OR NOT OR LIABILITY FOR ANY OTHER LOSS, DAMAGE OR INJURY RESULTING DIRECTLY OR INDIRECTLY FROM THE FOR THE OBLIGATIONS UNDER THIS LIMITED WARRANTY, RESPIRONICS SHALL NOT HAVE ANY OBLIGATION PRODUCT. PURCHASER'S SOLE AND EXCLUSIVE REMEDY FOR BREACH OF THE WARRANTIES SET FORTH IN THIS DOCUMENT SHALL BE AS PROVIDED IN THE PARAGRAPH DESCRIBING LIMITATIONS Purchaser is cautioned that no person or entity is authorized to make any warranties on behalf of Respironic: and any such alleged warranties are hereby disclaimed by Respironics Respironics Inc. Murrysville, PA 15668 USA 1001 Murry Ridge Lane 42#

Page 54DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 10903 New Hampshire Avenue Food and Drug Administration Document Control Room - W066-0609 Silver Spring, MD 20993-0002 Mr. Joseph E. Olsavsky NOV - 4 2011 Sr. Manager, Regulatory Affairs Respironics Incorporated 1740 Golden Mile Highway Monroeville, Pennsylvania 15146 Re: K111885 Trade/Device Name: Respironics SimplyGo Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: October 6, 2011 Received: October 7, 2011 Dear Mr. Olsavsky: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluale information related to contract liability warranties: We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.#

Page 55Page 2 - Mr. Olsavsky Please be advised that FDA's issuance of a substantial equivalence determination does not mean that PDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm| 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Th for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure#

Page 56Respironics SimplyGo Oxygen Concentrator Premarket Notification - Special 510(k) Section 6.0 Indications for Use Indications for Use 510(k) Number (ifknown): K111885 Device Name: Respironics SimplyGo Oxygen Concentrator The Respironics SimplyGo Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments. Prescription Use _ _X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) I shalther (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K111885 -Tab 6 Page 1 of 1 000019#