2AB4ZCTL001HeartAssist5 LVAD Controller

HeartAssist 5® VAD System Operator's Manual L00101-01 Rev Z 12/2014 For use with Controller Model: CTL001 ii HeartAssist 5® VAD System Operator's Manual The HeartAssist 5® VAD is a miniaturized ventricular assist technology co-developed with Dr. Michael E. DeBakey, Dr. George P. Noon and the National Aeronautics and Space Administration (NASA). Federal (USA) law limits the sale and use of HeartAssist 5® VAD to investigational use only. HeartAssist 5® and HeartAttendant® are registered trademarks of ReliantHeart Inc. 0086 CE marked since November 2013 Copyright © 2001 – 2014 by ReliantHeart as an unpublished work. All rights reserved. ReliantHeart Confidential – Medical Personnel and Technical Staff iii Customer support Use the contact information below to reach ReliantHeart. International  ReliantHeart (Distributor) Erfstraat 10A 5405 BE Uden, The Netherlands Phone +31 413 245 107 Fax +31 413 270 504  MedPass International Limited (Authorized Representative) Windsor House Bretforton Evesham Worcs WR11 7JJ United Kingdom  Emergency technical and clinical support for medical professionals (24/7 Urgent Support) +44 132-386-2836  Emergency help for patients Contact your health care provider. (See page 1-2.)  Non-emergency technical and clinical support [email protected] United States  ReliantHeart (Manufacturer) 8965 Interchange Drive Houston, TX 77054 Phone: 713-592-0913 Fax: 713-665-0963  Emergency technical and clinical support for medical professionals 877-332-2539  Emergency help for patients Call 911, or contact your health care provider. (See page 1-2.)  Non-emergency technical and clinical support [email protected] iv HeartAssist 5® VAD System Operator's Manual ReliantHeart Confidential – Medical Personnel and Technical Staff Contents v Contents Figures ............................................................................................................................................ xii Tables.............................................................................................................................................. xv Warnings ....................................................................................................................................... xvii Cautions ........................................................................................................................................ xxii Chapter 1 Introduction Purpose of this manual ................................................................................................................. 1-2 Scope of this manual ..................................................................................................................... 1-2 How to use this manual ................................................................................................................. 1-2 Text conventions .............................................................................................................. 1-2 Tips, notes, cautions, and warnings ................................................................................. 1-3 Overview ....................................................................................................................................... 1-4 System components and surgical supplies ................................................................................... 1-4 Included sterile items ....................................................................................................... 1-4 Included non-sterile items that do not require sterilization .............................................. 1-5 Separate non-sterile items that require sterilization ......................................................... 1-5 Hospital-supplied equipment ............................................................................................ 1-6 Proper use ..................................................................................................................................... 1-6 Indications and contraindications for use ...................................................................................... 1-7 Potential complications ................................................................................................................. 1-7 Storage .......................................................................................................................................... 1-8 Training ......................................................................................................................................... 1-8 Conformance to standards ............................................................................................................ 1-8 Maintenance .................................................................................................................................. 1-9 Chapter 2 System Overview Introduction ................................................................................................................................... 2-2 System components ...................................................................................................................... 2-3 Implantable components .................................................................................................. 2-3 Wearable components ..................................................................................................... 2-4 Accessories ................................................................................................................................... 2-6 Patient accessories .......................................................................................................... 2-6 Hospital accessories ........................................................................................................ 2-7 Symbols used in labeling .............................................................................................................. 2-7 …

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(Snernrvnrennr 8965lnteÍchange Ddve * Houston, Texas 77054 pr 713-592-0913 . f: 713-665-0963 vwvw.relianlhearl.com To Whom lt Mav Concern: Subject: AuthorizaÍon for FCC and IC submissions As FCC and IC registered contact for FCC/IC equipment authorization filing submissions for R€liantHeart Inc. 89ó5Interchange Drive Ilouston, Texas 77054 and pursuant to FCC KD8852134D0'1 Authorized Policy Form 73'Í v02r03 I hereby designatê the following individual/ group as agent authorized to submit and to sign related technical and administrative exhibits such as cover letters, applications, attestations, confidentjality requests. Cindy McKelroy VP Rêgulatory and Quality Systems ReliantHeart lnc. A copy of this authorization will be submitted with each application Íor equipment authorizaton. Name of registered contact: Bryan Lynch cTo RelianlHêaÉ lnc.

CETECOMChangeDeclaration Company Name:ReliantHeart Model Name:CTL001 Previous HW Version:M10022 Revision A Previous SW Version:2.40 Current HW Version: M10022 RevisionF Current SW Version: 2.40 List of Changes: Description of ChangeReason for Change Change Revision Initial Release Initial Release of SW A Company Name Change An additional antenna was created for areas which use 900 and 1800 MHz. MicroMed to ReliantHeart New part number was made for the antenna M10217. The original antenna M10079 will be used in US upon approval. B Changed Main Board PN to Reflect the programmed board Number Traceability improvement C Removed the bag label and Reference to Z00026 which Is the RMM board Firmware Tracability improvement D Added FCC ID to drawing Traceability improvement E Added US Antenna to BOM US Antenna not added to BOM until IDE approval. Both Antennas tested F *No other changes were made to the device. Print Name:Cindy McKelroy Signature: Date:January 8, 2015 Page1

ReliantHeart Inc. Controller Model number CTL001 FCC ID: 2AB4ZCTL001 ReliantHeart Inc. Controller Model number CTL001 FCC ID: 2AB4ZCTL001 ReliantHeart Inc. Controller Model number CTL001 FCC ID: 2AB4ZCTL001 ReliantHeart Inc. Controller Model number CTL001 FCC ID: 2AB4ZCTL001 ReliantHeart Inc. Controller Model number CTL001 FCC ID: 2AB4ZCTL001 ReliantHeart Inc. Controller Model number CTL001 FCC ID: 2AB4ZCTL001

Document Name:Controller Label Page 1 of 2 Document Number:L00377Revision:G PROPRIETARY DATA: This document and information herein may not be reproduced, used or disclosed without written permission from ReliantHeart, Inc. 1.0PURPOSE This specification is intended to document the labels applied to the HeartAssist5 ® VAD (Ventricular Assist Device) system Controller Assembly. This procedure results in the label assembly L00377. 2.0APPLICABLE DOCUMENTS The following documents of latest revision form a part of this specification as indicated herein: Doc. NumberDoc. Description M10283-02Label, Poly White Laser, 1.5 x 1.375 M00460Computer Imprintable Label Material CIL-9100 W00079Computer-Generated Labels Procedure 3.0DESIGN AND PERFORMANCE REQUIREMENTS 3.1Materials 3.1.1 Labels shall be produced using label stock part number M10283-02 or M00460 (as a substitute part number). 3.1.2 Labels printed by in-house shall be produced using instructions of W00079. 3.2Copy and Layout 3.2.1 Labels shall be printed with the layout and information indicated in Figure 1. Document Name:Controller Label Page 2 of 2 Document Number:L00377Revision:G PROPRIETARY DATA: This document and information herein may not be reproduced, used or disclosed without written permission from ReliantHeart, Inc. Size: 1.5 x 1.375 inches For reference only Figure 1 Document Name:Conquest Controller Assembly Procedure Page 12 of 18 Document Number:W00259Revision:J PROPRIETARY DATA: This document and information herein may not be reproduced, used or disclosed without written permission from ReliantHeart Inc. SEQPROCEDURE 3. Attach the belt clip to the rear housing using four 4-40 x 1/4” flat head screws. Figure 30- Belt clip fastened to the rear housing with label applied. 4. Remove masking from SIM card gasket and adhere to SIM cover. Fasten SIM cover to right housing using the captive panel screw. Tighten SIM cover to a snug fit. –DO NOT USE LOCTITE THREADLOCKER. Figure 31- SIM card cover with gasket applied Figure 32- Right housing shown without the SIM card cover

8965 Interchange Drive * Houston, Texas 77054 ReliantHeart, Inc. FCC ID: 2AB4ZCTL001 ReliantHeart HeartAssist5® Contoller Model CTL001 Wireless System Components Cinterion Wireless Module TC65i Coaxial RF cable Antenna SIM Card M10277/F – Controller Board M10202/A – RMM BOARD M10079 or M10217 Antenna Assembly

FCC Listed #: A2LA Accredited IC Recognized # 3462B-1 CETECOM Inc. 411 Dixon Landing Road  Milpitas, CA 95035  U.S.A. Phone: + 1 (408) 586 6200  Fax: + 1 (408) 586 6299  E-mail: [email protected]  http://www.cetecom.com CETECOM Inc. is a Delaware Corporation with Corporation number: 2905571 V5.2 2013-02-15 © Copyright by CETECOM SAR Test Report FOR: Manufacturer: ReliantHeart, Inc. Model Number: CTL001 FCC ID: 2AB4ZCTL001 Test Report #: SAR_RELIA_001_14001_FCC_Rev1 Date of Report: January 12, 2015 Test Report #: SAR_RELIA_001_14001_FCC_Rev1 FCC ID: 2AB4ZCTL001 Date of Report: Jan 12, 2015 Page 2 of 21 V5.1 2013-01-09 This report shall not be reproduced except in full without the written approval of: CETECOM Inc.  SAR  411 Dixon Landing Road  Milpitas, CA 95035  U.S.A. TABLE OF CONTENTS 1. Assessment ................................................................................................................................. 4 2. Administrative Data .................................................................................................................. 5 2.1. Identification of the Testing Laboratory Issuing the SAR Test Report ..................... 5 2.2. Identification of the Client .............................................................................................. 5 2.3. Identification of the Manufacturer ................................................................................. 5 3. Equipment under Test (EUT) .................................................................................................. 6 3.1. General Specification of the Equipment under Test .................................................... 6 3.2. Technical Specification of Supported Radios ................................................................ 7 3.3. Identification of the Equipment Under Test (EUT) ...................................................... 7 3.4. Identification of Accessory equipment ........................................................................... 7 3.5. Maximum SAR values ..................................................................................................... 7 4. Subject of Investigation ............................................................................................................. 8 4.1. The IEEE Standard C95.1 and the FCC Exposure Criteria ....................................... 8 4.2. SAR Limit ......................................................................................................................... 8 5. Measurement Procedure ........................................................................................................... 9 5.1. General Requirements ..................................................................................................... 9 5.2. Body-worn and Other Configurations ......................................................................... 10 5.3. Procedure for assessing the peak spatial-average SAR .............................................. 10 5.4. Determination of the largest peak spatial-average SAR ............................................ 13 6. The Measurement System ....................................................................................................... 14 6.1. Robot system specification ............................................................................................ 14 6.2. Isotropic E-Field Probe for Dosimetric Measurements ............................................. 15 6.3. Data Acquisition Electronics ......................................................................................... 15 6.4. Phantoms ........................................................................................................................ 15 6.5. Interpolation and Extrapolation schemes .................................................................... 15 7. Uncertainty Assessment .......................................................................................................... 16 7.1. Measurement Uncertainty Budget According to IEEE 1528:2003 ........................... 16 Test Report #: SAR_RELIA_001_14001_FCC_Rev1 FCC ID: 2AB4ZCTL001 Date of Report: Jan 12, 2015 Page 3 of 21 V5.1 2013-01-09 This report shall not be reproduced except in full without the written approval of: CETECOM Inc.  SAR  411 Dixon Landing Road  Milpitas, CA 95035  U.S.A. 8. Test results summary .............................................................................................................. 17 8.1. Conducted Average Output Power .............................................................................. 17 8.2. Test Positions and Configurations ................................................................................ 18 8.3. SAR Results for Body .................................................................................................... 18 8.5. Dipole verification .......................................................................................................... 19 9. References ................................................................................................................................ 20 10. Report History ......................................................................................................................... 21 Appendices: Appendix A – Plots Appendix B – Antenna location , Test Setup Photos Appendix C – Tissue liquid parameters, Equipment list Test Report #: SAR_RELIA_001_14001_FCC_Rev1 FCC ID: 2AB4ZCTL001 Date of Report: Jan 12, 2015 Page 4 of 21 V5.1 2013-01-09 This report shall not be reproduced except in full without the written approval of: CETECOM Inc.  SAR  411 Dixon Landing Road  Milpitas, CA 95035  U.S.A. 1. Assessment The following device was evaluated against the limits for general population uncontrolled exposure specified in FCC 2.1093 according to measurement procedures specified in FCC regulation as listed in chapter 5 and IEEE 1528:2003 and no …

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FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix A - Plots Page 1 of 4 Plot 1 Date/Time: 2/28/2014 4:16:46 PM Test Laboratory: Cetecom Inc., SAR 3 Lab DUT: Reliant Heart; Type: Medical Device; Serial: IMEI35323402659513003 Communication System: GPRS*FDD (TDMA, GMSK, TN 0*1); Frequency: 837 MHz Medium: MSL900_Batch 100818*1 Medium parameters used: f = 837 MHz; σ = 1.005 mho/m; ε r = 52.626; ρ = 1000 kg/m 3 Phantom section: Flat Section Measurement Standard: DASY5 (IEEE/IEC/ANSI C63.19*2007) Procedure Notes: Test Technician: Kathy; Air Temperature: 21.3C; Medium Temperature: 20.5C; Comments: ; DASY Configuration: • Probe: ES3DV3 * SN3323; ConvF(6.39, 6.39, 6.39); Calibrated: 6/12/2013; • Sensor*Surface: 3mm (Mechanical Surface Detection), z = 2.0, 32.0 • Electronics: DAE4 Sn1265; Calibrated: 1/29/2014 • Phantom: SAM Front; Type: QD000P40CD; Serial: TP*1637 • DASY52 52.8.1(838); Flat-Section/Back 0mm_2TS_836.6MHz/Area Scan (9x13x1): Measurement grid: dx=15mm, dy=15mm Maximum value of SAR (measured) = 0.376 mW/g Flat-Section/Back 0mm_2TS_836.6MHz/Zoom Scan (6x5x7)/Cube 0: Measurement grid: dx=8mm, dy=8mm, dz=5mm Reference Value = 11.411 V/m; Power Drift = *0.11 dB Peak SAR (extrapolated) = 0.506 mW/g SAR(1 g) = 0.335 mW/g; SAR(10 g) = 0.228 mW/g Maximum value of SAR (measured) = 0.381 mW/g 0 dB = 0.376 mW/g = *8.50 dB mW/g FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix A - Plots Page 2 of 4 Plot 2 Date/Time: 2/28/2014 8:12:53 PM Test Laboratory: Cetecom Inc. SAR 1 Lab DUT: Reliant Heart; Type: Medical Device; Serial: IMEI35323402659513003 Communication System: GPRS*FDD (TDMA, GMSK, TN 0*1); Frequency: 1880 MHz Medium: MSL1900_Batch 100824*3 Medium parameters used: f = 1880 MHz; σ = 1.515 mho/m; ε r = 51.246; ρ = 1000 kg/m 3 Phantom section: Flat Section Measurement Standard: DASY5 (IEEE/IEC/ANSI C63.19*2007) Procedure Notes: Test Technician: Mike; Air Temperature: 22.3C; Medium Temperature: 21.2C; Comments: ; DASY Configuration: • Probe: ES3DV3 * SN3260; ConvF(4.85, 4.85, 4.85); Calibrated: 6/19/2013; • Sensor*Surface: 3mm (Mechanical Surface Detection), z = 2.0, 32.0 • Electronics: DAE4 Sn1375; Calibrated: 6/10/2013 • Phantom: ELI 4.0; Type: QDOVA001BB; Serial: 1092 • DASY52 52.8.1(838); Flat-Section/Back 0mm_2TS_1880MHz/Area Scan (9x15x1): Measurement grid: dx=15mm, dy=15mm Maximum value of SAR (measured) = 0.198 mW/g Flat-Section/Back 0mm_2TS_1880MHz/Zoom Scan (6x5x7)/Cube 0: Measurement grid: dx=8mm, dy=8mm, dz=5mm Reference Value = 5.229 V/m; Power Drift = *0.20 dB Peak SAR (extrapolated) = 0.272 mW/g SAR(1 g) = 0.170 mW/g; SAR(10 g) = 0.100 mW/g Maximum value of SAR (measured) = 0.202 mW/g 0 dB = 0.198 mW/g = *14.06 dB mW/g FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix A - Plots Page 3 of 4 Plot 3 Date/Time: 2/28/2014 3:27:05 PM Test Laboratory: Cetecom Inc., SAR 3 Lab DUT: Dipole 835 MHz - D835V2 - SN4d155_June 2013; Type: D835V2; Serial: D835V2 - SN:4d155 Communication System: CW; Frequency: 835 MHz Medium: MSL900_Batch 100818*1 Medium parameters used: f = 835 MHz; σ = 1.001 mho/m; ε r = 52.638; ρ = 1000 kg/m 3 Phantom section: Flat Section Measurement Standard: DASY5 (IEEE/IEC/ANSI C63.19*2007) Procedure Notes: Test Technician: Kathy; Air Temperature: 20.9C; Medium Temperature: 20.5C; Comments: ; DASY Configuration: • Probe: ES3DV3 * SN3323; ConvF(6.39, 6.39, 6.39); Calibrated: 6/12/2013; • Sensor*Surface: 3mm (Mechanical Surface Detection), z = 2.0, 32.0 • Electronics: DAE4 Sn1265; Calibrated: 1/29/2014 • Phantom: SAM Front; Type: QD000P40CD; Serial: TP*1637 • DASY52 52.8.1(838); System Performance Check at Frequencies below 1 GHz/d=15mm, Pin=1W, dist=3.0mm (ES-Probe)/Area Scan (4x4x1): Measurement grid: dx=15mm, dy=15mm Maximum value of SAR (measured) = 9.85 mW/g System Performance Check at Frequencies below 1 GHz/d=15mm, Pin=1W, dist=3.0mm (ES-Probe)/Zoom Scan (7x7x7) (5x5x7)/Cube 0: Measurement grid: dx=8mm, dy=8mm, dz=5mm Reference Value = 106.2 V/m; Power Drift = 0.05 dB Peak SAR (extrapolated) = 13.573 mW/g SAR(1 g) = 9.28 mW/g; SAR(10 g) = 6.13 mW/g Maximum value of SAR (measured) = 10.7 mW/g 0 dB = 9.85 mW/g = 19.87 dB mW/g FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix A - Plots Page 4 of 4 Plot 4 Date/Time: 2/28/2014 7:21:38 PM Test Laboratory: Cetecom Inc. SAR 1 Lab DUT: Dipole 1900 MHz - D1900V2 - SN5d172_June 2013; Type: D1900V2; Serial: D1900V2 - SN:5d172 Communication System: CW; Frequency: 1900 MHz Medium: MSL1900_Batch 100824*3 Medium parameters used: f = 1900 MHz; σ = 1.538 mho/m; ε r = 51.212; ρ = 1000 kg/m 3 Phantom section: Flat Section Measurement Standard: DASY5 (IEEE/IEC/ANSI C63.19*2011) Procedure Notes: Test Technician: Mike; Air Temperature: 22.1C; Medium Temperature: 21.2C; Comments: ; DASY Configuration: • Probe: ES3DV3 * SN3260; ConvF(4.85, 4.85, 4.85); Calibrated: 6/19/2013; • Sensor*Surface: 3mm (Mechanical Surface Detection), z = 2.0, 32.0 • Electronics: DAE4 Sn1375; Calibrated: 6/10/2013 • Phantom: ELI 4.0; Type: QDOVA001BB; Serial: 1092 • DASY52 52.8.1(838); System Performance Check at Frequencies above 1 GHz/d=10mm, Pin=1W, dist=3.0mm (ES-Probe)/Area Scan (4x4x1): Measurement grid: dx=15mm, dy=15mm Maximum value of SAR (measured) = 30.1 mW/g System Performance Check at Frequencies above 1 GHz/d=10mm, Pin=1W, dist=3.0mm (ES-Probe)/Zoom Scan (7x7x7) (5x5x7)/Cube 0: Measurement grid: dx=8mm, dy=8mm, dz=5mm Reference Value = 180.8 V/m; Power Drift = 0.02 dB Peak SAR (extrapolated) = 65.599 mW/g SAR(1 g) = 37 mW/g; SAR(10 g) = 19.4 mW/g Maximum value of SAR (measured) = 46.8 mW/g 0 dB = 30.1 mW/g = 29.58 dB mW/g

FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 1 of 34 Tissue Parameters Recipe for liquids below 1 GHz: W ater 35-58% Sugar 40-60% Salt 0-6% Hydroxyethyl-cellulose <0.3% Preventol-D7 0.1-0.7% Recipe for liquids above 1-3 GHz: W ater 52-75% DGBE 25-48% Salt <1.0% SAR measurements were made within 24 hours of the measurement of liquid parameters. Relative permittivity and conductivity are within ±5% of the target. FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 2 of 34 850 MHz Body Liquid Date Temp (°C) Frequency (MHz) Relative Permativity Conductivity (S/m) 82452.83030.9788 82552.82720.9812 82652.79130.9828 82752.76660.9847 83552.63831.0009 83652.63351.0031 83752.62641.0054 84652.5811.024 84752.57341.0263 84852.57861.0278 84952.5831.0295 2014/02/2820.5 0.9 0.92 0.94 0.96 0.98 1 1.02 1.04 820840 Conductivity (S /m) Frequency (MHz) Conductivity Target Liquid V alue 5% Liquid Tolerance -5% Liquid Tolerance 2014/02/28 51 52 53 54 55 56 57 58 59 820840 Relative Permittivity Frequency (MHz) Permittivity Target Liquid V alue 5% Liquid Tolerance -5% Liquid Tolerance 2014/02/28 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 3 of 34 1900 MHz Body Liquid Date Temp (°C) Frequency (MHz) Relative Permativity Conductivity (S/m) 185051.33011.4725 185151.32331.474 185251.32561.4757 185351.31251.4764 186051.29791.488 186151.29191.4895 186251.27441.49 186351.26541.4915 188051.24561.5153 188151.24361.5163 188251.23951.5173 190051.21181.5382 190951.18091.5462 191051.17941.547 2014/02/2821.2 1.42 1.44 1.46 1.48 1.5 1.52 1.54 1.56 1.58 1.6 18451895 Conductivity (S /m) Frequency (MHz) Conductivity Target Liquid V alue 5% Liquid Tolerance -5% Liquid Tolerance 2014/02/28 50 51 52 53 54 55 56 18451895 Relative Permittivity Frequency (MHz) Permittivity Target Liquid V alue 5% Liquid Tolerance -5% Liquid Tolerance 2014/02/28 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 4 of 34 Test Equipment SAR1 Lab Equipment Model Serial Instrument description Supplier / Manufacturer Model Serial No. Calibration (date) Calibration Due (date) Robot Staubli TX90 F10/5D3NA 1/A/01 N/A N/A SAM Twin Phantom SPEAG SM 000 T01 DA 1592 N/A N/A Elliptical Phantom SPEAG QD OVA 001 BB 1092 N/A N/A Software SPEAG Dasy52.6.2.482 N/A N/A N/A Device Holder SPEAG SD 000H01 N/A N/A N/A SAR 3 Lab Instrument description Supplier / Manufacturer Model Serial No. Calibration (date) Calibration Due (date) Robot Staubli TX90 F11/5G2MA 1/C/01 N/A N/A SAM Twin Phantom SPEAG SM 000 T01 DA 1637 N/A N/A SAM Twin Phantom SPEAG SM 000 T01 DA 1638 N/A N/A Elliptical Phantom SPEAG QD OVA 001 BB 1124 N/A N/A Software SPEAG Dasy52.6.2.482 N/A N/A N/A Device Holder SPEAG SD 000H01 N/A N/A N/A SAR 4 Lab Instrument description Supplier / Manufacturer Model Serial No. Calibration (date) Calibration Due (date) Robot Staubli TX90 F11/5GW9A 1/A/01 N/A N/A SAM Twin Phantom SPEAG SM 000 T01 DA 1639 N/A N/A SAM Twin Phantom SPEAG SM 000 T01 DA 1640 N/A N/A Elliptical Phantom SPEAG QD OVA 001 BB 1125 N/A N/A Software SPEAG Dasy52.6.2.482 N/A N/A N/A Device Holder SPEAG SD 000H01 N/A N/A N/A FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 5 of 34 Shared Equipment Instrument description Supplier / Manufacturer Model Serial No. Calibration (date) Calibration Due (date) 900 MHz Body Tissue Simulant SPEAG MSL 900 100818-1 2/28/2024 N/A 1900 MHz Body Tissue Simulant SPEAG MSL 1900 100824-3 2/28/2024 N/A 835 MHz Dipole SPEAG D835V2 4d113 2012/11/05 2014/11/05 1900 MHz Dipole SPEAG D1900V2 5d135 2012/11/06 2014/11/06 Data Acquisition Electronics SPEAG DAE4 1265 1/29/2014 1/29/2015 Data Acquisition Electronics SPEAG DAE4 1375 6/10/2013 6/10/2014 SAR Probe SPEAG ES3DV3 3323 6/12/2013 6/12/2014 SAR Probe SPEAG ES3DV3 3260 6/19/2013 6/19/2014 Network Analyzer Agilent FieldFox N9923A MY51491621 2013/06/21 2014/06/21 Directional coupler Werlatone C6529 11249 N/A N/A RF Amplifier Vectawave VTL5400 N/A N/A N/A Dielectric Measurement Kit SPEAG DAK-3.5 1023 2012/02/20 2014/02/20 Synthesized CW Generator Agilent 8371213 US37101255 N/A N/A Power Meter Agilent E4419B MY45101996 2013/06/03 2015/06/03 Power Sensor Agilent E9300A MY41498484 2013/06/04 2015/06/04 Power Sensor Agilent E9300A MY41498492 2013/06/04 2015/06/04 Radio Communications Tester Rohde & Schwarz CMU 200 101821 2013/06 2015/06 Radio Communications Tester Rohde & Schwarz CMU 200 109879 2013/06 2015/06 Radio Communications Tester Rohde & Schwarz CMU 200 110759 2013/06 2015/06 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 6 of 34 Equipment Calibration/Performance Documents: Attached: SAR Probe ES3DV3 – SN:3323 Calibration Report 835 MHz Dipole Calibration Report 1900 MHz Dipole Calibration Report FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 7 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 8 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 9 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 10 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 11 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 12 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 13 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 14 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 15 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 16 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 17 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 18 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 19 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 20 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 21 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 22 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 23 of 34 FCC ID: 2AB4ZCTL001 SAR Test Report - Appendix C - Misc Page 24 of 34 FCC ID: 2AB4ZCTL001 SAR…

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FCC listed: A2LA Accredited IC recognized # 3462B-1 CETECOM Inc. 411 Dixon Landing Road  Milpitas, CA 95035  U.S.A. Phone: + 1 (408) 586 6200  Fax: + 1 (408) 586 6299  E-mail: [email protected]  http://www.cetecom.com CETECOM Inc. is a Delaware Corporation with Corporation number: 2905571 V3.0 2010-10-30 © Copyright by CETECOM FCC Partial Scope Test Report FOR: Manufacturer: ReliantHeart, Inc. Model: CTL001 Description: Controller for HeartAssist5 Left Ventricular Assist Device FCC ID: 2AB4ZCTL001 47 CFR Part 2, 22, 24 TEST REPORT #: EMC_RELIA_001_14001_WWAN_Rev1 DATE: January 12, 2015 Test Report #: EMC_RELIA_001_14001_WWAN_Rev1 FCC ID: 2AB4ZCTL001 Date of Report : January 12, 2015 Page 2 of 36 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 Details of the Equipment under Test .............................................................................................. 5 3.2 Identification of the Equipment Under Test (EUT) ....................................................................... 6 3.3 Identification of Accessory e…

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