2AOL9-RS500C4G1RS500C4G1

User Manual Portable Oxygen Concentrator Models: RS-00500 & RS-00500C GCE HEALTHCARE EN 2/44 English User manual: Zen-O™ Portable Oxygen Concentrator (Models: RS-00500 & RS-00500C) CONTENT 1. Foreword ............................................................................4 1.1. General Information ................................................................4 1.2. Classification ......................................................................4 1.3. Typographical Conventions .........................................................5 2. Intended Use ........................................................................5 3. Safety Instructions ...................................................................6 3.1. Warnings Overview ................................................................6 3.2. Cautions Overview ................................................................8 3.3. Important Information ..............................................................10 4. Instructions and Training ..............................................................10 5. Product Description ..................................................................11 5.1. Schematic Description ..............................................................11 6. General Instructions Before Use .......................................................12 6.1. Accessories List ...................................................................12 6.2. Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 6.3. Nasal Cannula ....................................................................14 6.4. Pull Cart .........................................................................15 6.5. Connecting a Humidifier ...........................................................15 7. Operating Zen-O™ ....................................................................16 7.1. Connecting Nasal Cannula ..........................................................16 7.2. Turning On .......................................................................17 7.3. Choosing a Preferred Language .....................................................17 7.4. Adjusting Setting ..................................................................17 7.5. ECO Mode ........................................................................18 7.6. Battery Button ....................................................................18 3/44 2/44 EN English User manual: Zen-O™ Portable Oxygen Concentrator (Models: RS-00500 & RS-00500C) 7.7. Responding to Alarms ..............................................................19 7.8. Turning Off .......................................................................19 8. Traveling with the Zen-O™ POC by Air ..................................................20 8.1. Passenger Pre-flight Preparation .....................................................20 8.2. Boarding and In-flight Information ...................................................22 8.3. Transportation Security Administration (TSA) Requirements .............................24 8.4. Placing your device in Airplane Mode ................................................24 9. Alarm Indicators .....................................................................25 9.1. Alarms ...........................................................................26 10. Troubleshooting .....................................................................29 11. Maintenance and Cleaning ............................................................30 11.1. Routine Maintenance ..............................................................30 11.2. Cleaning and Disinfection ..........................................................30 11.3. Service Life ......................................................................30 12. Device Repair and Disposal ..........................................................31 12.1. Repair ...........................................................................31 12.2. Disposal .........................................................................31 13. Warranty ...........................................................................31 14. Trademarks and Disclaimer ...........................................................33 14.1. Trademark .......................................................................33 14.2. Disclaimer .......................................................................33 15. Technical Description ................................................................34 15.1. Electromagnetic Compatibility (EMC) Information ......................................37 15.2. FCC warning statement for Model RS-00500C: .......................................40 15.3. EU RED Article 10(10) Restrictions on Use for Model RS-00500C: .......................41 15.4. RF Exposure Information: ..........................................................42 16. Glossary - Explanation of Packaging and Labelling Symbols ...............................42 EN 4/44 1. FOREWORD Please refer to this manual for detailed instructions on warnings, cautions, specifica- tions, and additional information. Important: Users should read this entire manual before operating the Zen-O™ Portable Oxygen Concentrator. Failure to do so could result in personal injury and/or death. If you have questions about the information in this user manual or about the safe operation of this system, contact your distributor. 1.1. GENERAL INFORMATION This user manual provides information for users of the Zen-O™ Portable Oxygen Con- centrator. For the sake of brevity, the terms “concentrator,” "POC", “unit,” or “device” are sometimes used in this document to refer to the Zen-O™ Portable Oxygen Concentrator. "Patient" and "User" are used interchangeably. 1.2. CLASSIFICATION This device is listed with an internationally recognised testing lab…

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Design History DHF-05020 Revision 1 1 of 8 | P a g e Zen-O Clarity External Photos Revision Release Date ECO No Created by Notes 1 25/08/2020 E1157 W Turner First Release Unit without carry bag Note see bill of materials for the latest rating label drawing information. Design History DHF-05020 Revision 1 2 of 8 | P a g e Design History DHF-05020 Revision 1 3 of 8 | P a g e Design History DHF-05020 Revision 1 4 of 8 | P a g e Unit in carry bag Design History DHF-05020 Revision 1 5 of 8 | P a g e Design History DHF-05020 Revision 1 6 of 8 | P a g e Design History DHF-05020 Revision 1 7 of 8 | P a g e External AC PSU Note shown with UK plug, provided with EU, UK and US plugs out of the box. Design History DHF-05020 Revision 1 8 of 8 | P a g e External PSU for Automotive use

No Smoking No Oil or Grease Do Not Disassemble DL-05026 Rev 2 See Instructions Before Use Continuous Operation: 41°F(5°C) to 104°F(40°C) 19-24V 90% +6/-3% Oxygen 2460 No Open Flames Access cover to be removed by authorized persons only Do not get wet IP20 60°C -20°C The manufacturer of this POC has determined this device conforms to all applicable FAA acceptance criteria for POC carriage and use on board aircraft. Manufactured For: Contains FCC IDs: 2AOL9-RS500C4G1, QOQ13 Designed in the UK Assembled in Mexico Gas Control Equipment Ltd 100 Empress Park, Penny Lane St Helens, WA11 9DB, United Kingdom

Design History DHF-05021 Revision 1 1 of 10 | P a g e Zen-O Clarity Internal Photos Revision Release Date ECO No Created by Notes 1 25/08/2020 E1157 W Turner First Release Unit Front Cover Removed Design History DHF-05021 Revision 1 2 of 10 | P a g e Rear Cover Removed 1 = GPS Antenna 2 = BLE module and trace antenna 3 = GPS Module and UF-L connection points 4 = Cellular Main (tx&rx) antenna 5 = Cellular Diversity (rx only) antenna 6 = Cellular module and UF-L connection points 6 1 2 4 5 3 GCE FCC ID: 2AOL9-RS500C4G1 Design History DHF-05021 Revision 1 3 of 10 | P a g e Main (Tx & Rx) Cellular Antenna Diversity (Rx Only) Antenna Design History DHF-05021 Revision 1 4 of 10 | P a g e Battery PCBA location in rear cover Design History DHF-05021 Revision 1 5 of 10 | P a g e Main PCBA fitted to midframe, note red and blue hoses are pneumatic. GCE FCC ID: 2AOL9-RS500C4G1 Design History DHF-05021 Revision 1 6 of 10 | P a g e GPS Antenna location behind cannula Design History DHF-05021 Revision 1 7 of 10 | P a g e BLE module close up showing module and copper trace antenna Design History DHF-05021 Revision 1 8 of 10 | P a g e Main PCBA Design History DHF-05021 Revision 1 9 of 10 | P a g e Design History DHF-05021 Revision 1 10 of 10 | P a g e Battery Charger PCBA

Copyright©Verkotan Document ID: FCC SAR report_Zeno_ID3640_30072020 1 (62) SAR Compliance Test Report Date of Report 3/08/2020 Client’s Contact person: Will Turner Number of pages: 62 Responsible Test engineer: Kirsi Kyllönen Testing laboratory: Verkotan Oy Elektroniikkatie 17 90590 Oulu Finland Client: GCE Group 100 Empress Park Penny Lane Haydock ST HELENS WA11 9DB Tested device Zen-O Related reports: - Testing has been carried out in accordance with: 47CFR §2.1093 Radiofrequency Radiation Exposure Evaluation: Portable Devices FCC published RF exposure KDB procedures IEEE 1528 - 2013 IEEE Recommended Practice for Determining the Peak Spatial-Average Specific Absorption Rate (SAR) in the Human Head from Wireless Communications Devices: Measurement Technique Documentation: The test report must always be reproduced in full; reproduction of an excerpt only is subject to written approval of the testing laboratory Test Results: The EUT complies with the requirements in respect of all parameters subject to the test. The test results relate only to devices specified in this document Date and signatures: 03.08.2020 For the contents: Laboratory Manager Copyright©Verkotan Document ID: FCC SAR report_Zeno_ID3640_30072020 2 (62) TABLE OF CONTENTS 1. SUMMARY OF SAR TEST REPORT .............................................................................................................. 3 1.1 TEST DETAILS ..................................................................................................................................... 3 1.2 MAXIMUM RESULTS .......................................................................................................................... 3 1.2.1 Maximum Drift .............................................................................................................................. 4 1.2.2 Measurement Uncertainty ............................................................................................................. 4 2. DESCRIPTION OF THE DEVICE UNDER TEST (DUT) ............................................................................... 5 2.1 SUPPORTED FREQUENCY BANDS AND OPERATIONAL MODES ........................................................ 5 2.2 SAR TEST EXCLUSIONS ...................................................................................................................... 6 2.2.1 Separations .................................................................................................................................... 6 2.2.2 BLE SAR test exclusion ................................................................................................................... 8 3. OUTPUT POWER ..................................................................................................................................... 11 3.1 MAXIMUM OUTPUT POWER ............................................................................................................ 11 3.2 TESTED CONDUCTED POWER .......................................................................................................... 12 4. TEST EQUIPMENT ................................................................................................................................... 20 4.1 TEST EQUIPMENT LIST ..................................................................................................................... 20 4.1.1 Isotropic E-field Probe Type EX3DV4 ........................................................................................... 21 4.2 PHANTOMS ...................................................................................................................................... 21 4.3 TISSUE SIMULANTS .......................................................................................................................... 21 4.4 SYSTEM VALIDATION STATUS ......................................................................................................... 22 4.5 SYSTEM CHECK ................................................................................................................................ 22 4.5.1 Tissue Simulant Verification ......................................................................................................... 22 5. TEST PROCEDURE ................................................................................................................................... 24 5.1 TEST POSITIONS ............................................................................................................................... 24 5.2 TEST EXEMPTIONS ........................................................................................................................... 25 5.3 SCAN PROCEDURES ......................................................................................................................... 25 5.4 SAR AVERAGING METHODS ............................................................................................................ 25 6. MEASUREMENT UNCERTAINTY ............................................................................................................ 26 7. TEST RESULTS ......................................................................................................................................... 27 7.1 SAR RESULTS FOR BODY-WORN: .................................................................................................... 27 7.2 CALCULATED BLUETOOTH SAR RESULTS ........................................................................................ 29 7.3 CALCULATED SAR RESULTS, LTE 5, LTE12 AND LTE17 ..................................................................... 29 7.4 SIMULTANEOUS TRANSMISSION ANALYSIS ................................................................................... 30 APPENDIX A: PHOTOS OF THE DUT ............................................................................................................. 31 APPENDIX B: SYSTEM CHECK SCAN .....................…

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Report on the Radio Testing For Gas Control Equipment Limited on Zeno Clarity 4G Report no. TRA-047787-47-05C 10 March 2021 REPORT ON THE TESTING OF A Gas Control Equipment Limited Zeno Clarity 4G WITH RESPECT TO SPECIFICATIONS 47CFR PARTS 22H, 24E, 27 TEST DATE: 2020-06-23 to 2020-12-02 Written by: Steven Garwell Radio Test Engineer Approved by: John Charters Department Manager- Radio Date: 10 March 2021 Disclaimers: [1] THIS DOCUMENT MAY BE REPRODUCED ONLY IN ITS ENTIRETY AND WITHOUT CHANGE [2] THE RESULTS CONTAINED IN THIS DOCUMENT RELATE ONLY TO THE ITEM(S) TESTED Report Number: TRA-047787-47-05C Issue: C Report Number: TRA-047787-47-05C Page 3 of 37 1 Revision Record Issue Number Issue Date Revision History A 2020-08-04 Original B 2021-03-08 Added results for GSM850, GSM1900, WCDMA bands 2, 4 and 5 and updated conducted power results – general updates. C 2021-03-10 Updated GSM power measurements in section 12 and RSE in section 11 Report Number: TRA-047787-47-05C Page 4 of 37 2 Summary TEST REPORT NUMBER: TRA-047787-47-05C WORKS ORDER NUMBER: TRA-047787-01 PURPOSE OF TEST: Class II Permissive Change TEST SPECIFICATION(S): 47CFR Parts 22H, 24E, 27 EQUIPMENT UNDER TEST (EUT): Zeno Clarity 4G containing FCCID: 2AOL9-RS500C4G1 EUT SERIAL NUMBER: ZC101001 MANUFACTURER/AGENT: Gas Control Limited ADDRESS: Farrington Way Eastwood Nottingham Nottinghamshire NG16 3AG United Kingdom CLIENT CONTACT: Will Turner  01942 292962  [email protected] ORDER NUMBER: UK-1929 TEST DATE: 2020-06-23 to 2020-12-02 TESTED BY: Steven Garwell Element Report Number: TRA-047787-47-05C Page 5 of 37 2.1 Test Summary Test Method and Description Requirement Clause Applicable to this equipment Result / Note 47CFR Spurious emissions 24.238, 24.232, 22.917, 22.913, 27.53, 2.1051 PASS Output power 22.913, 24.232, 27.50 Information Only Notes: The results contained in this report relate only to the items tested, in the condition at time of test, and were obtained in the period between the date of initial receipt of samples and the date of issue of the report. The apparatus was set up and exercised using the configurations, modes of operation and arrangements defined in this report only. Any modifications made are identified in Section 8 of this report. Particular operating modes, apparatus monitoring methods and performance criteria required by the standards tested to have been performed except where identified in Section 5.2 of this test report (Deviations from Test Standards). Report Number: TRA-047787-47-05C Page 6 of 37 3 Contents 1 Revision Record ......................................................................................................................................... 3 2 Summary .................................................................................................................................................... 4 2.1 Test Summary .................................................................................................................................... 5 3 Contents ..................................................................................................................................................... 6 4 Introduction ................................................................................................................................................. 7 5 Glossary of Terms ...................................................................................................................................... 8 6 Equipment Under Test ................................................................................................................................ 9 6.1 EUT Identification ............................................................................................................................... 9 6.2 System Equipment .............................................................................................................................. 9 6.3 EUT Mode of Operation ...................................................................................................................... 9 6.3.1 Transmission .............................................................................................................................. 9 6.4 EUT Description ................................................................................................................................. 9 7 EUT Radio Parameters............................................................................................................................. 10 7.1 General ............................................................................................................................................. 10 7.2 Antennas .......................................................................................................................................... 10 8 Modifications ............................................................................................................................................. 11 9 EUT Test Setup ........................................................................................................................................ 12 9.1 Block Diagram .................................................................................................................................. 12 9.2 General Set-up Photograph .............................................................................................................. 13 9.1 Measurement software ..................................................................................................................... 13 10 General Technical Parameters ............................................................................................................. 14 10.1 Normal Conditions ............................................................................................................................ 14 11 Radiated emissions ..............................................…

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RF915 4.0 Report on Intermodulation Testing For Gas Control Equipment Limited On Zeno Clarity 4G Report no. TRA-047787-47-06C 8 March 2021 RF915 4.0 REPORT ON THE INTERMODULATION TESTING OF A Gas Control Equipment Limited Zeno Clarity 4G WITH RESPECT TO SPECIFICATIONS 47CFR PARTS 15, 22H, 24E, 27 INTERMODULATION EMISSIONS INVESTIGATION TEST DATE: 2020-06-23 to 2020-12-02 Written by: Steven Garwell Radio Test Engineer Approved by: John Charters Department Manager- Radio Date: 8 March 2021 Disclaimers: [1] THIS DOCUMENT MAY BE REPRODUCED ONLY IN ITS ENTIRETY AND WITHOUT CHANGE [2] THE RESULTS CONTAINED IN THIS DOCUMENT RELATE ONLY TO THE ITEM(S) TESTED Report Number: TRA-047787-47-06C Issue: C Report Number: TRA-047787-47-06C RF915 4.0 Page 3 of 65 1 Revision Record Issue Number Issue Date Revision History A 8 August 2020 Original B 11 January 2021 Added results for GSM850,GSM1900 and WCDMA bands 2, 4 and 5 – general updates. C 08 March 2021 Updated GSM results in section 11 Report Number: TRA-047787-47-06C RF915 4.0 Page 4 of 65 2 Summary TEST REPORT NUMBER: TRA-047787-47-06C WORKS ORDER NUMBER: TRA-047787-01 PURPOSE OF TEST: USA: Testing of radio frequency equipment per the relevant authorization procedure of chapter 47 of CFR (code of federal regulations) Part 2, subpart J. TEST SPECIFICATION(S): Intermodulation emissions investigation using 47CFR Parts 15, 22H, 24E, 27 EQUIPMENT UNDER TEST (EUT): Zeno Clarity 4G EUT SERIAL NUMBER: ZC101001 MANUFACTURER/AGENT: Gas Control Equipment Limited ADDRESS: 100 Empress ParkwayFarrington Way Eastwood Nottingham Nottinghamshire NG16 3AG United Kingdom CLIENT CONTACT: Will Turner  01942 292962  [email protected] ORDER NUMBER: UK-1929 TEST DATE: 2020-06-23 to 2020-12-02 TESTED BY: Steven Garwell Element Report Number: TRA-047787-47-06C RF915 4.0 Page 5 of 65 2.1 Test Summary Test Method and Description Requirement Clause Applicable to this equipment Result / Note 47CFR Intermodulation spurious emissions Parts 15, 22H, 24E, 27 PASS Notes: The results contained in this report relate only to the items tested, in the condition at time of test, and were obtained in the period between the date of initial receipt of samples and the date of issue of the report. The apparatus was set up and exercised using the configurations, modes of operation and arrangements defined in this report only. Any modifications made are identified in Section 8 of this report. Particular operating modes, apparatus monitoring methods and performance criteria required by the standards tested to have been performed except where identified in Section 5.2 of this test report (Deviations from Test Standards). Report Number: TRA-047787-47-06C RF915 4.0 Page 6 of 65 3 Contents 1 Revision Record ......................................................................................................................................... 3 2 Summary .................................................................................................................................................... 4 2.1 Test Summary .................................................................................................................................... 5 3 Contents ..................................................................................................................................................... 6 4 Introduction ................................................................................................................................................. 7 5 Glossary of Terms ...................................................................................................................................... 8 6 Equipment Under Test ................................................................................................................................ 9 6.1 EUT Identification ............................................................................................................................... 9 6.2 System Equipment .............................................................................................................................. 9 6.3 EUT Mode of Operation ...................................................................................................................... 9 6.3.1 Transmission .............................................................................................................................. 9 6.4 EUT Description ................................................................................................................................. 9 7 EUT Radio Parameters............................................................................................................................. 10 7.1 General ............................................................................................................................................. 10 8 Modifications ............................................................................................................................................. 10 9 EUT Test Setup ........................................................................................................................................ 10 9.1 Block Diagram .................................................................................................................................. 10 9.2 General Set-up Photograph .............................................................................................................. 11 9.3 Measurement software ..................................................................................................................... 11 10 General Technical Parameters ............................................................................................................. 12 10.1 Normal Conditions ............................................................................................................................ 12 11 Radiated emissions, intermodulation prod…

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Copyright©Verkotan Document ID: FCC SAR report_Zeno_ID3640_30072020 31 (62) APPENDIX A: PHOTOS OF THE DUT Dimension of the DUT are: 313 x 212 x 168 mm The location of the antenna Top Left Right Front Bottom Back Copyright©Verkotan Document ID: FCC SAR report_Zeno_ID3640_30072020 32 (62) Left side of the device against the phantom, 4mm separation Right side of the device against the phantom, 4mm separation 4 mm 4 mm 4 mm Copyright©Verkotan Document ID: FCC SAR report_Zeno_ID3640_30072020 33 (62) Back side of the device against the phantom, 4mm separation Front side of the device against the phantom, 6mm separation 4 mm 6 mm 6 mm Copyright©Verkotan Document ID: FCC SAR report_Zeno_ID3640_30072020 34 (62) Top of the device against the phantom, 6mm separation 6 mm