2ACHL-AIR103GContinous Positive Airway Pressure Device

User guide English | User guide 378013r7 Covers.indd 223/06/2014 5:36:53 PM 378013r7 Covers.indd 323/06/2014 5:36:53 PM ENGLISH Welcome The AirSense ™ 10 AutoSet ™ and AirSense 10 AutoSet for Her are ResMed's premium auto-adjusting pressure devices. The AirSense 10 Elite and AirSense 10 CPAP are ResMed's Continuous Positive Airway Pressure (CPAP) devices. WARNING Read this entire guide before using the device. CAUTION In the US, Federal law restricts this device to sale by or on the order of a physician. Indications for use AirSense 10 AutoSet The AirSense 10 AutoSet self-adjusting device is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment. AirSense 10 AutoSet for Her The AirSense 10 AutoSet for Her self-adjusting device is indicated for the treatment of obstructive sleep apnea (OSA) in patients (female patients with mild to moderate OSA when using AutoSet for Her treatment mode) weighing more than 66 lb (30 kg). It is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment. AirSense 10 Elite The AirSense 10 Elite device is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment. AirSense 10 CPAP The AirSense 10 CPAP device is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment. English 1 Contraindications Positive airway pressure therapy may be contraindicated in some patients with the following pre-existing conditions: • severe bullous lung disease • pneumothorax • pathologically low blood pressure • dehydration • cerebrospinal fluid leak, recent cranial surgery, or trauma. Adverse effects You should report unusual chest pain, severe headache, or increased breathlessness to your prescribing physician. An acute upper respiratory tract infection may require temporary discontinuation of treatment. The following side effects may arise during the course of therapy with the device: • drying of the nose, mouth, or throat • nosebleed • bloating • ear or sinus discomfort • eye irritation • skin rashes. At a glance The AirSense 10 includes the following: • Device with HumidAir integrated humidifier • Water tub • Air tubing • Power supply unit • Travel bag • SD card (already inserted). Contact your care provider for a range of accessories available for use with the device including: • Air tubing (heated and non-heated): ClimateLineAir ™ , SlimLine ™ , Standard • Water tub: Standard water tub, cleanable water tub (can be disinfected) • Filter: Hypoallergenic filter, standard filter • Air10 ™ DC/DC converter • SD card reader • Air10 oximeter adapter • Air10 USB adapter. 2 About your device 1 Air outlet 5 Water tub 2 Air filter cover 6 Screen 3 Power inlet 7 Adapter cover 4 Serial number and device number 8 SD card cover About the control panel Start/Stop button Press to start/stop therapy. Press and hold for three seconds to enter power save mode. Dial Turn to navigate the menu and press to select an option. Turn to adjust a selected option and press to save your change. Home button Press to return to the Home screen. Different icons may be displayed on the screen at different times including: Ramp Time Wireless signal strength (green) Ramp Time Auto Wireless transfer not enabled (gray) Humidity No wireless connection Humidifier warming Airplane Mode Humidifier cooling English 3 Setup CAUTION Do not overfill the water tub as water may enter the device and air tubing. 1. Place the device on a stable level surface. 2. Plug the power connector into the rear of the device. Connect one end of the power cord into the power supply unit and the other end into the power outlet. 3. Connect the air tubing firmly to the air outlet located on the rear of the device. 4. Open the water tub and fill it with distilled water up to the maximum water level mark. Do not fill the water tub with hot water. 5. Close the water tub and insert it into the side of the device. 6. Connect the free end of the air tubing firmly onto the assembled mask. See the mask user guide for detailed information. Recommended masks are available on www.resmed.com. 4 Starting therapy 1. Fit your mask. 2. Press Start/Stop or breathe normally if SmartStart is enabled. You will know that therapy is on when the Sleep Report screen is displayed. The current treatment pressure is shown in green. During ramp time the pressure is gradually increasing and you will see a spinning circle. Once the prescribed treatment pressure is reached, the entire circle will be green. The screen will go black automatically after a short period of time. You can press Home or the dial to turn it back on. If power is interrupted during therapy, the device will automatically restart therapy when power is restored. The AirSense 10 device has a light sensor that adjusts the screen brightness based on the light in the room. Stopping therapy 1. Remove your mask. 2. Press Start/Stop or if SmartStart is enabled, therapy will stop automatically after a few seconds. The Sleep Report now gives you a summary of your therapy session. Usage hours–Indicates the number of hours of therapy you received last session. Mask Seal–Indicates how well your mask sealed: Good mask seal. Needs adjusting, see Mask Fit. Humidifier–Indicates if your humidifier is working properly: Humidifier working. Humidifier might be faulty, contact your car…

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20 April 2015 To whom it may concern Subject: Signature Delegation Regarding documents issued by ResMed Ltd to CETECOM for the purposes of obtaining Federal Communications Commission (FCC) and Industry Canada (IC) Registrations for AirSense, and AirCurve Series with 3G, Mr David Mulcahy – VP Product Development, is authorised to sign on my behalf. Sincerely, Greg Dockar | Senior Regulatory Affairs Manager | ResMed Ltd. 1 Elizabeth Macarthur Drive | Bella Vista NSW 2153, Australia  Office: +61 2 8884 2175 |Cell: +61 (0) 418 226 401  E-mail and : [email protected] |  www.resmed.com ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia T +61 (2) 8884 1000 F +61 (2) 8884 2000 E [email protected] ABN 30 003 765 142 ResMed.com

External Front Side View External Back Side View External Left Side of Device External Right Side of Device Therapy Hose AC/DC Power Supply

Display Side of Flow Generator Mother Board Back of Flow Generator Mother Board Cellular Module & Antenna Side of CAM_Board CPU side of CAM Board Front of device with Cover removed

TECHNICAL MANUAL Telit HE910-GA HW rev.0 Data Terminal Module Code: 1vv0300992 Rev. 0 Date: 2012/02/02 ANNEX 2 HE910-GA MODULE PHOTOS Pag.6 of 27 TECHNICAL MANUAL Telit HE910-GA HW rev.0 Data Terminal Module Code: 1vv0300992 Rev. 0 Date: 2012/02/02 Image #1 (Top Side) Image #2 (Bottom Side) Pag.7 of 27 TECHNICAL MANUAL Telit HE910-GA HW rev.0 Data Terminal Module Code: 1vv0300992 Rev. 0 Date: 2012/02/02 Image #3 (Inside Top) Pag.8 of 27

© 2015 RF Exposure Lab, LLC This report shall not be reproduced except in full without the written approval of RF Exposure Lab, LLC. 802 N. Twin Oaks Valley Road, Suite 105 • San Marcos, CA 92069 • U.S.A. TEL (760) 471-2100 • FAX (760) 471-2121 http://www.rfexposurelab.com CERTIFICATE OF COMPLIANCE SAR EVALUATION ResMed Ltd. Dates of Test: March 10-11, 2015 1 Elizabeth Macarthur Drive Test Report Number: SAR.20150304 Bella Vista, NSW 2153 Revision E Australia This wireless mobile and/or portable device has been shown to be compliant for localized specific absorption rate (SAR) for uncontrolled environment/general exposure limits specified in ANSI/IEEE Std. C95.1-1992 and had been tested in accordance with the measurement procedures specified in IEEE 1528-2013 and IEC 62209-2:2010 (See test report). I attest to the accuracy of the data. All measurements were performed by myself or were made under my supervision and are correct to the best of my knowledge and belief. I assume full responsibility for the completeness of these measurements and vouch for the qualifications of all persons taking them. RF Exposure Lab, LLC certifies that no party to this application is subject to a denial of Federal benefits that includes FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Jay M. Moulton Vice President Testing Cert. # 2387.01 FCC ID: 2ACHL-AIR103G IC Certificate: 9103A-AIR103G Model(s): 37018, 37022, 37030, 37035, 37044, 37048, 37055, 37073 Marketing Names: AirSense 10 (37018, 37022, 37030, 37035), AirCurve (37044, 37048, 37055, 37073) Hardware Version: BOM 37030 Rev 1.0 Software Version: SX558-0310 Test Sample: Engineering Unit Same as Production FID Number: 22141203998 Equipment Type: Wireless CPAP Device Classification: Portable Transmitter Next to Body TX Frequency Range: 824 – 848 MHz, 1710 – 1755 MHz, 1850 – 1910 MHz Frequency Tolerance: ± 2.5 ppm Maximum RF Output: 850 MHz (GSM) – 33.5 dBm; 850 MHz (WCDMA) – 24.0 dBm; 1750 MHz (WCDMA) – 24.0 dBm; 1900 MHz (GSM) – 30.5 dBm; 1900 MHz (WCDMA) – 24.0 dBm Conducted Signal Modulation: QPSK, 16QAM, 64QAM, GMSK, 8-PSK Antenna Type: Internal Application Type: Certification FCC Rule Parts: Part 2, 22H, 24E, 27 KDB Test Methodology: KDB 447498, KDB 941225 D01, D02, D03, KDB 865664 D01 Industry Canada: RSS-102 Issue 5, Safety Code 6 Max. Stand Alone SAR Value: 1.57 W/kg Reported Separation Distance: 5 mm – End; 0 mm All Other Sides Report Number: SAR.20150304 © 2015 RF Exposure Lab, LLC Page 2 of 96 This report shall not be reproduced except in full without the written approval of RF Exposure Lab, LLC. Table of Contents 1. Introduction ................................................................................................................................... 3 SAR Definition [5] .............................................................................................................................. 4 2. SAR Measurement Setup .............................................................................................................. 5 Robotic System ................................................................................................................................. 5 System Hardware .............................................................................................................................. 5 System Electronics ............................................................................................................................ 6 Probe Measurement System ............................................................................................................. 6 3. Probe and Dipole Calibration ....................................................................................................... 14 4. Phantom & Simulating Tissue Specifications ............................................................................... 15 Head & Body Simulating Mixture Characterization .......................................................................... 15 5. ANSI/IEEE C95.1 – 1992 RF Exposure Limits [2] ........................................................................ 16 Uncontrolled Environment ............................................................................................................... 16 Controlled Environment ................................................................................................................... 16 6. Measurement Uncertainty............................................................................................................ 17 7. System Verification ...................................................................................................................... 18 Tissue Verification ........................................................................................................................... 18 Test System Verification .................................................................................................................. 18 8. SAR Test Data Summary ............................................................................................................ 19 Procedures Used To Establish Test Signal ..................................................................................... 19 Device Test Condition ..................................................................................................................... 19 9. FCC 3G Measurement Procedures ............................................................................................. 20 9.1 Procedures Used to Establish RF Signal for SAR ................................................................ 20 9.2 SAR Measurement Conditions for WCDMA/HSDPA/HSUPA ............................................... 20 9.3 SAR Measurement Conditions for GSM ............................................................................... 23 SAR Data Summary – 835 MHz Body - WCDMA .............................................…

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FCC: A2LA Accredited IC recognized # 3462E-1 CETECOM Inc. 6370 Nancy Ridge Drive Suite 101  San Diego, CA 92121  U.S.A. Phone: + 1 (858) 362 2400  Fax: + 1 (858) 587 4809  E-mail: [email protected]  http://www.cetecom.com CETECOM Inc. is a Delaware Corporation with Corporation number: 2113686 V4.0 2012-09-24 © Copyright by CETECOM FCC Test Report FOR: ResMed Ltd. Model Number: 37030 Product Description: Continuous Positive Airway Pressure (CPAP) Device FCC ID: 2ACHL-AIR103G IC ID: 9103A-AIR103G 47 CFR Part 2, 22, 24, 27 RSS-GEN Issue 4, RSS-132 Issue 3, RSS-133 Issue 6, RSS-139 Issue 2 TEST REPORT #: EMC_CONNE-038-15001_FCC 22_24_27_WWAN DATE: 2015-05-06 Test Report #: EMC_CONNE-038-15001_FCC 22_24_27_WWAN FCC ID: 2ACHL-AIR 103G Date of Report: 2015-05-06 IC ID : 9103A-AIR 103G Page 2 of 49 Table of Contents 1 Assessment ............................................................................................................................... 3 2 Administrative Data ................................................................................................................. 4 2.1 Identification of the Testing Laboratory Issuing the Test Report .................................................. 4 2.2 Identification of the Client ............................................................................................................. 4 2.3 Identification of the Manufacturer ................................................................................................. 4 3 Equipment under Test (EUT) ................................................................................................... 5 3.1 Specification of the Equipment under Test .................................................................................... 5 3.2 Identification of the Equipment under Test (EUT) ........................................................................ 6 3.3 Identification of Accessory equipment........................................................................................... 6 3.4 Environmental conditions during Test: .......................................................................................... 6 3.5 Dates of Testing: ............................................................................................................................ 6 3.6 Miscellaneous EUT information: ................................................................................................... 6 4 Subject of Investigation ............................................................................................................ 7 5 Summary of Measurement Results .......................................................................................... 8 6 Measurements......................................................................................................................... 11 6.1 RF Power Output .......................................................................................................................... 11 6.1.1 References ............................................................................................................................ 11 6.1.2 Measurement requirements: ................................................................................................. 11 6.1.3 Limits: .................................................................................................................................. 11 6.1.4 Conducted Output Power Measurement .............................................................................. 13 6.1.5 Conducted Power Measurements and calculated ERP/EIRP: ............................................. 14 6.2 Spurious Emissions Radiated ....................................................................................................... 17 6.2.1 References ............................................................................................................................ 17 6.2.2 Measurement requirements: ................................................................................................. 17 6.2.3 Limits: .................................................................................................................................. 17 6.2.4 Radiated out of band measurement procedure: ................................................................... 19 6.2.5 Sample Calculations for Radiated Measurements ............................................................... 20 6.2.6 Measurement Survey: ........................................................................................................... 20 6.2.7 Test Conditions: ................................................................................................................... 20 6.2.8 Test Results: ......................................................................................................................... 20 7 Test Equipment and Ancillaries used for tests ....................................................................... 47 8 Test Setup Diagrams .............................................................................................................. 48 9 Revision History ..................................................................................................................... 49 Test Report #: EMC_CONNE-038-15001_FCC 22_24_27_WWAN FCC ID: 2ACHL-AIR 103G Date of Report: 2015-05-06 IC ID : 9103A-AIR 103G Page 3 of 49 1 Assessment The following device was evaluated against the applicable criteria specified in FCC rules parts 2, 22, 24 and 27 of Title 47 of the Code of Federal Regulations and in Industry Canada Standards RSS-Gen, RSS-132, RSS-133, RSS-139. No deviations were ascertained during the course of the tests performed. Company Description Model # ResMed Ltd. Continuous Positive Airway Pressure (CPAP) Device 37030 Responsible for Testing Laboratory: 2015-05-06 Compliance Milton Ponce de Leon (Test Lab Manager) Date Section Name Signature Responsible for the Report:…

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FCC 47 CFR PART 22H and 24E Product Type ： 2G/3G Module Applicant ： Telit Communications S.p.A. Address ： Via Stazione di Prosecco, 5/B, Sgonico, TS 34010, Italy Trade Name ： Telit Model Number ： HE910 Test Specification ： FCC 47 CFR PART 22H: Oct, 2009 FCC 47 CFR PART 24E: Oct, 2009 CANADA RSS-132 ISSUE 2: Sep., 2005 CANADA RSS-133 ISSUE 5: Feb., 2009 Canada RSS-Gen ISSUE 3: Dec., 2010 ANSI/TIA-603-C-2004 Receive Date ： Nov. 30, 2011 Issue Date ： Feb. 03, 2012 Issue by A Test Lab Techno Corp. No. 140-1, Changan Street, Bade City, Taoyuan County 334, Taiwan R.O.C. Te l：+886-3-2710188 / Fax：+886-3-2710190 T aiwan Accreditation Foundation accreditation number: 1330 Note: This report shall not be reproduced except in full, without the written approval of A Test Lab Techno Corp. This document may be altered or revised by A Test Lab Techno Corp. personnel only, and shall be noted in the revision section of the document. The client should not use it to claim product endorsement by TAF, or any government agencies. The test results in the report only apply to the tested sample. A Test Lab Techno Corp. Report Number: 1112FR12-02 1/115 Revision History Rev. Issue Date Revisions Revised By 00 Dec. 20, 2011 Initial Issue 01 Jan. 30, 2012 Revised software version. Joyce Liao 02 Feb. 03, 2012 Add IC standard and RX of field strength of spurious radiation test data Linda Su A Test Lab Techno Corp. Report Number: 1112FR12-02 2/115 Verification of Compliance Issued Date: 02/03/2012 Product Type : 2G/3G Module Applicant : Telit Communications S.p.A. Address : Via Stazione di Prosecco, 5/B, Sgonico, TS 34010, Italy Trade Name : Telit Model Number : HE910 FCC ID : RI7HE910 IC : 5131A-HE910 EUT Rated Voltage : DC 3.8V Test Voltage : DC 3.4 / 3.8 / 4.2V Applicable Standard : FCC 47 CFR PART 22H: Oct, 2009 FCC 47 CFR PART 24E: Oct, 2009 CANADA RSS-132 ISSUE 2: Sep., 2005 CANADA RSS-133 ISSUE 5: Feb., 2009 Canada RSS-Gen ISSUE 3: Dec., 2010 ANSI/TIA-603-C-2004 Test Result : Complied Performing Lab. : A Test Lab Techno Corp. No. 140-1, Changan Street, Bade City, Taoyuan County 334, Taiwan R.O.C. Te l：+886-3-2710188 / Fax：+886-3-2710190 T aiwan Accreditation Foundation accreditation number: 1330 http://www.atl-lab.com.tw/e-index.htm The above equipment was tested by A Test Lab Techno Corp. The test data, data evaluation, test procedures, and equipment configurations shown in this report were made in accordance with the procedures given in ANSI C63.4: 2009 and the energy emitted by the sample tested as described in this report is in compliance with the requirements of FCC Rules Part 22H, Part 24E. The test results of this report relate only to the tested sample identified in this report. Approved By ： Reviewed By ： (Manager) (Murphy Wang) (Testing Engineer) (Fly Lu) A Test Lab Techno Corp. Report Number: 1112FR12-02 3/115 TABLE OF CONTENTS 1 General Information ....................................................................................................................... 6 1.1. EUT Description ............................................................................................................................ 6 1.2. Mode of Operation ........................................................................................................................ 7 1.3. EUT Exercise Software................................................................................................................. 7 1.4. Configuration of Test System Details ............................................................................................ 8 1.5. Test Site Environment ................................................................................................................... 9 1.6. Summary of Test Result ................................................................................................................ 9 2 RF Output Power Test.................................................................................................................. 10 2.1. Limit............................................................................................................................................. 10 2.2. Test Instruments .......................................................................................................................... 10 2.3. Test Setup ................................................................................................................................... 10 2.4. Test Procedure ............................................................................................................................ 10 2.5. Uncertainty .................................................................................................................................. 11 2.6. Test Result .................................................................................................................................. 11 3 Effective Radiated Power / Equivalent Isotropic Radiated Power Test .................................. 14 3.1. Limit............................................................................................................................................. 14 3.2. Test Instruments .......................................................................................................................... 14 3.3. Setup ........................................................................................................................................... 15 3.4. Test Procedure ............................................................................................................................ 16 3.5. Uncertainty .................................................................................................................................. 16 3.6. Test Result .................................................................................................................................. 17 4 Occupied Bandwidth Test .............................................…

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FCC 47 CFR PART 27 SUBPART L Product Type ： 2G/3G Module Applicant ： Telit Communications S.p.A. Address ： Via Stazione di Prosecco, 5/B, Sgonico, TS 34010, Italy Trade name ： Telit Model No. ： HE910 Test Specification ： FCC 47 CFR PART 27 SUBPART L: Oct. 2010 ANSI/TIA-603-C-2004 RSS-Gen Issue 3, December 2010 RSS-139 Issue 2, February 2009 Issue Date ： Feb. 03, 2012 Issue by A Test Lab Techno Corp. No. 140-1, Changan Street, Bade City, Taoyuan County 334, Taiwan R.O.C. Te l：+86-3-2710188 / Fax：+86-3-2710190 T aiwan Accreditation Foundation accreditation number: 1330 Note: This report shall not be reproduced except in full, without the written approval of A Test Lab Techno Corp. This document may be altered or revised by A Test Lab Techno Corp. personnel only, and shall be noted in the revision section of the document. The client should not use it to claim product endorsement by TAF, or any government agencies. The test results in the report only apply to the tested sample. A Test Lab Techno Corp. Report Number: 1201FR11-02 1/45 A Test Lab Techno Corp. Report Number: 1201FR11-02 2/45 Revision History Rev. Issue Date Revisions Revised By 00 Jan. 11, 2012 Initial Issue 01 Jan. 30, 2012 Delete IC ID Nico Peng 02 Feb. 03, 2012 Add IC standard and RX of radiated emission test data Nico Peng Verification of Compliance Issued Date: 2012/02/03 Product Type : 2G/3G Module Applicant : Telit Communications S.p.A. Address : Via Stazione di Prosecco, 5/B, Sgonico, TS 34010, Italy Trade Name : Telit Model No. : HE910 FCC ID : RI7HE910 IC ID : 5131A-HE910 EUT Rated Voltage : DC 3.8V Test Voltage : DC 3.8V Applicable Standard : FCC 47 CFR PART 27 SUBPART L: Oct. 2010 ANSI/TIA-603-C-2004 RSS-Gen Issue 3, December 2010 RSS-139 Issue 2, February 2009 Test Result : Complied Performing Lab. : A Test Lab Techno Corp. No. 140-1, Changan Street, Bade City, Taoyuan County 334, Taiwan R.O.C. Te l：+886-3-2710188 / Fax：+886-3-2710190 T aiwan Accreditation Foundation accreditation number: 1330 http://www.atl-lab.com.tw/e-index.htm The above equipment was tested by A Test Lab Techno Corp. The test data, data evaluation, test procedures, and equipment configurations shown in this report were made in accordance with the procedures given in ANSI C63.4: 2009 and the energy emitted by the sample tested as described in this report is in compliance with the requirements of FCC Rules Part 27L. The test results of this report relate only to the tested sample identified in this report Approved By ： Reviewed By ： (Manager) (Murphy Wang) (Testing Engineer)(Charlie Chang) A Test Lab Techno Corp. Report Number: 1201FR11-02 3/45 TABLE OF CONTENTS 1 General Information........................................................................................................................... 6 1.1. EUT Description ......................................................................................................................... 6 1.2. Mode of Operation ..................................................................................................................... 6 1.3. EUT Exercise Software.............................................................................................................. 7 1.4. Configuration of Test System Details ......................................................................................... 7 1.5. Test Site Environment ................................................................................................................ 7 1.6. Summary of Test Result............................................................................................................. 8 2 RF Output Power Test ....................................................................................................................... 9 2.1. Limit ........................................................................................................................................... 9 2.2. Test Instruments......................................................................................................................... 9 2.3. Test Setup .................................................................................................................................. 9 2.4. Test Procedure......................................................................................................................... 10 2.5. Uncertainty ...........................................................................................…

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