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2AB4ZCTL002Controller for HeartAssist 5 Left Ventricular Assist Device

ReliantHeart Inc.
Controller for HeartAssist 5 Left Ventricular Assist Device - FCC ID 2AB4ZCTL002 - ReliantHeart Inc.
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Application Details

Equipment Class
PCB - PCS Licensed Transmitter
Date of Grant
Nov 10, 2015
Application Purpose
Original Equipment
Date of Application
Nov 10, 2015
Equipment Note
Controller for HeartAssist 5 Left Ventricular Assist Device
Frequency Range
1852.40000000 - 1907.60000000
Company
ReliantHeart Inc.
Country
United States

Documents & Files

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Users Manual

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Attestation Statements

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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Internal Photos

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RF Exposure Info

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Test Report

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Test Setup Photos

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

HeartAssist 5® VAD System Patient User's Manual L00088-01 Rev R 12/2014 For use with Controller Model: CTL002 ii HeartAssist 5® VAD System Patient User'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). F ederal (USA) law limits the sale and use of HeartAssist 5® VAD to investigational use only. Hea rtAssist 5® and HeartAttendant® are registered trademarks of ReliantHeart Inc. 0086 CE marked since November 2013 Copyright © 2001 – 2 014 by ReliantHeart as an unpublished work. All rights reserved. ReliantHeart Confidential – Patient and Heath Care Provider Use iii Customer support Use the contact information below to reach ReliantHeart. International ReliantHeart (Distributor) Erfs traat 10A 5405 BE Uden, The Netherlands Phone +31 413 245 107 Fax +31 413 270 504 MedPass International Limited (Authorized Representative ) W indsor House Bretforton Evesham Worcs, WR117JJ 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 sup [email protected] United States ReliantHeart (Manufacturer) 8965 Interch ange 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 sup [email protected] iv HeartAssist 5® VAD System Patient User's Manual ReliantHeart Inc. Confidential – Patient and Heath Care Provider Use Contents v Contents Figures ............................................................................................................................................. x Tables.............................................................................................................................................. xii Warnings ........................................................................................................................................ xiii Cautions .......................................................................................................................................... xv Chapter 1 Emergency Information Introduction ................................................................................................................................... 1-2 Support team phone numbers quick reference ............................................................................. 1-2 Conditions for calling emergency assistance ................................................................................ 1-2 Call 911 ............................................................................................................................ 1-2 Call your doctor ................................................................................................................ 1-3 Chapter 2 About This Manual Introduction ................................................................................................................................... 2-2 Purpose of this manual ................................................................................................................. 2-2 Scope of this manual ..................................................................................................................... 2-2 Intended audience ......................................................................................................................... 2-2 How to use this manual ................................................................................................................. 2-2 Text conventions .............................................................................................................. 2-3 Tips, notes, cautions, and warnings ................................................................................. 2-3 Description of chapters ................................................................................................................. 2-4 Chapter 3 Description of the HeartAssist 5® VAD System Introduction ................................................................................................................................... 3-2 Indications and contraindications for use ...................................................................................... 3-2 Potential complications ................................................................................................................. 3-3 Maintenance .................................................................................................................................. 3-3 System components ...................................................................................................................... 3-3 Implantable components .................................................................................................. 3-4 Wearable components ..................................................................................................... 3-5 Accessories ................................................................................................................................... 3-7 Patient accessories .......................................................................................................... 3-7 Hospital accessories ........................................................................................................ 3-8 Symbols used in labeling .............................................................................................................. 3-8 Documentation ............................................................................................................................ 3-11 Chapter 4 Gettin…

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Cover Letter(s)

8965 Interchange Drive * Houston, Texas 77054 p: 713-592-0913 * f: 713-665-0963 www.reliantheart.com Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 August 24, 2015 Dear FCC Examiner, Pursuant to Paragraphs §0.457 and 0.459 of the Commission’s Rules (47 C.F.R.) and Section §552(b)(4) of the Freedom of Information Act, ReliantHeart, Inc. requests confidentiality for the following products: FCC ID Number ProductTitle/Model 2AB4ZCTL002HeartAssist 5® Controller / Conquest model CTL002 For the product stated above, we request that the following information be held confidential: 1)Block Diagram 2)Schematics 3)Parts List 4)Tune-up procedure 5)Operational Description The above exhibits containReliantHeart, Inc. (FRN0023477615)trade secrets and proprietary information that could be of benefit to our competitors regarding the design of our device. This material is not customarily available to the general public and we request that it be withheld from public inspection. If you have any questions, please feel free to contact me at the address shown below. Sincerely, Bryan E. Lynch CTO ReliantHeart, Inc.

External Photos

ReliantHeart Inc. Controller Model number CTL002 FCC ID: 2AB4ZCTL002 HeartAssist5 VAD ReliantHeart Inc. Controller Model number CTL002 FCC ID: 2AB4ZCTL002 ReliantHeart Inc. Controller Model number CTL002 FCC ID: 2AB4ZCTL002 ReliantHeart Inc. Controller Model number CTL002 FCC ID: 2AB4ZCTL002 ReliantHeart Inc. Controller Model number CTL002 FCC ID: 2AB4ZCTL002 ReliantHeart Inc. Controller Model number CTL002 FCC ID: 2AB4ZCTL002

ID Label/Location Info

Document Name:Controller Label Page 1 of 2 Document Number:L00377Revision:H 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:H 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 Label Placement For reference only Figure 2

Internal Photos

8965 Interchange Drive * Houston, Texas 77054 p: 713-592-0913 * f: 713-665-0963 ReliantHeart, Inc. FCC ID: 2AB4ZCTL002 ReliantHeart HeartAssist5® Contoller Model CTL002 Wireless System Components Telit Wireless ModuleHE910-D Coaxial RF cable SIM Card Antenna Antenna (M10418) Position within Right Housing (M10076) Board Stack within Controller (M10022) Remote Monitoring Module Board Main Board FlowMeterBoard Remote Monitoring Module Board (M10419) (Top) Remote Monitoring Module Board (M10419) (Bottom) Main Board (M10277) without RF Absorber material (Top) Main Board (M10277) with RF Absorber material (M10378) (Top) Main Board (M10277) without RF Absorber material (Bottom) Main Board (M10277) with RF Absorber material (M10379) (Bottom) Flow Meter Board (M10205) without RF Absorber Material (Top) Flow Meter Board (M10205) with RF Absorber Material (M10365) (Top) Flow Meter Board (M10205) without RF Absorber Material (Bottom) Flow Meter Board (M10205) with RF Absorber Material (M10376 & M10377) (Bottom) Antenna (M10418)&Antenna (M10418) within Right Housing (M10076) Antenna (M10418) within Right Housing (M10076) grounded to Main Board (M10277)

Internal Photos

TECHNICAL MANUAL Telit HE910-D HW rev.0 Data Terminal Module Code: 1vv0300993 Rev. 0 Date: 2012/02/02 ANNEX 2 HE910-D MODULE PHOTOS Pag.6 of 27 TECHNICAL MANUAL Telit HE910-D HW rev.0 Data Terminal Module Code: 1vv0300993 Rev. 0 Date: 2012/02/02 Image #1 (Top Side) Image #2 (Bottom Side) Pag.7 of 27 TECHNICAL MANUAL Telit HE910-D HW rev.0 Data Terminal Module Code: 1vv0300993 Rev. 0 Date: 2012/02/02 Image #3 (Inside Top) Pag.8 of 27

RF Exposure Info

A2LA Accredited FCC Recognized 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: CTL002 FCC ID: 2AB4ZCTL002 Test Report #: SAR_RELIA_004_15001_FCC-Rev1 Date of Report: Nov 3, 2015 Test Report #: SAR_RELIA_004_15001_FCC-Rev1 FCC ID: 2AB4ZCTL002 Date of Report: Nov 3, 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 ....................................................................................................................... 8 4. Subject of Investigation .............................................................................................................................. 9 4.1. The IEEE Standard C95.1 and the FCC Exposure Criteria ......................................................... 9 4.2. SAR Limit ........................................................................................................................................... 9 5. Measurement Procedure........................................................................................................................... 10 5.1. General Requirements ..................................................................................................................... 10 5.2. Body-worn and Other Configurations ........................................................................................... 10 5.3. Procedure for assessing the peak spatial-average SAR ................................................................ 11 5.4. Determination of the largest peak spatial-average SAR .............................................................. 12 6. The Measurement System ........................................................................................................................ 13 6.1. Robot system specification .............................................................................................................. 13 6.2. Isotropic E-Field Probe for Dosimetric Measurements ............................................................... 14 6.3. Data Acquisition Electronics .......................................................................................................... 14 6.4. Phantoms .......................................................................................................................................... 14 6.5. Interpolation and Extrapolation schemes...................................................................................... 14 7. Test Results Summary .............................................................................................................................. 15 7.1. Conducted Average Output Power ................................................................................................ 15 7.2. Test Positions and Configurations.................................................................................................. 18 7.3. SAR Results for Body ...................................................................................................................... 18 7.4. Dipole verification ............................................................................................................................ 19 Test Report #: SAR_RELIA_004_15001_FCC-Rev1 FCC ID: 2AB4ZCTL002 Date of Report: Nov 3, 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. References .................................................................................................................................................. 20 9. 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_004_15001_FCC-Rev1 FCC ID: 2AB4ZCTL002 Date of Report: Nov 3, 2015 Page 4 of 21 V5.1 2013-01-09 This report shall not be reproduced except in full without the written approval of:…

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RF Exposure Info

FCC ID: 2AB4ZCTL002 SAR Test Report - Appendix A - Plots Page 1 of 9 Plot 1 Date/Time: 6/23/2015 3:48:08 PM Test Laboratory: Cetecom Inc. SAR 1 Lab DUT: Reliant Heart; Type: Heart Assist; Serial: 00070 Communication System: GPRS-FDD (TDMA, GMSK, TN 0-1); Frequency: 1880 MHz Medium: MSL1900_Batch 110530-3 Medium parameters used: f = 1880 MHz; σ = 1.489 mho/m; ε r = 52.372; 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: 20.8C; Medium Temperature: 22.2C; Comments: ; DASY Configuration:  Probe: ES3DV3 - SN3260; ConvF(4.69, 4.69, 4.69); Calibrated: 3/19/2014;  Sensor-Surface: 3mm (Mechanical Surface Detection), Sensor-Surface: 4mm (Mechanical Surface Detection), z = 2.0, 32.0  Electronics: DAE4 Sn1265; Calibrated: 1/29/2014  Phantom: ELI 4.0; Type: QDOVA001BA; Serial: xxxx  DASY52 52.8.1(838); Flat-Section/Back 0mm_2TS/Area Scan (11x17x1): Measurement grid: dx=12mm, dy=12mm Maximum value of SAR (measured) = 0.337 mW/g Flat-Section/Back 0mm_2TS/Zoom Scan (7x7x7)/Cube 0: Measurement grid: dx=5mm, dy=5mm, dz=5mm Reference Value = 9.026 V/m; Power Drift = 0.07 dB Peak SAR (extrapolated) = 0.459 mW/g SAR(1 g) = 0.288 mW/g; SAR(10 g) = 0.170 mW/g Maximum value of SAR (measured) = 0.314 mW/g 0 dB = 0.337 mW/g = -9.45 dB mW/g FCC ID: 2AB4ZCTL002 SAR Test Report - Appendix A - Plots Page 2 of 9 Plot 2 Date/Time: 6/23/2015 4:51:27 PM Test Laboratory: Cetecom Inc. SAR 1 Lab DUT: Reliant Heart; Type: Heart Assist; Serial: 00070 Communication System: UMTS-FDD (WCDMA); Frequency: 1880 MHz Medium: MSL1900_Batch 110530-3 Medium parameters used: f = 1880 MHz; σ = 1.489 mho/m; ε r = 52.372; 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: 20.8C; Medium Temperature: 22.2C; Comments: ; DASY Configuration:  Probe: ES3DV3 - SN3260; ConvF(4.69, 4.69, 4.69); Calibrated: 3/19/2014;  Sensor-Surface: 3mm (Mechanical Surface Detection (Locations From Previous Scan Used)), Sensor-Surface: 4mm (Mechanical Surface Detection), z = 2.0, 32.0  Electronics: DAE4 Sn1265; Calibrated: 1/29/2014  Phantom: ELI 4.0; Type: QDOVA001BA; Serial: xxxx  DASY52 52.8.1(838); Flat-Section 2/Back 0mm_1880MHz/Area Scan (11x17x1): Measurement grid: dx=12mm, dy=12mm Maximum value of SAR (measured) = 0.377 mW/g Flat-Section 2/Back 0mm_1880MHz/Zoom Scan (5x5x7)/Cube 0: Measurement grid: dx=8mm, dy=8mm, dz=5mm Reference Value = 8.545 V/m; Power Drift = 0.02 dB Peak SAR (extrapolated) = 0.529 mW/g SAR(1 g) = 0.325 mW/g; SAR(10 g) = 0.190 mW/g Maximum value of SAR (measured) = 0.352 mW/g 0 dB = 0.377 mW/g = -8.47 dB mW/g FCC ID: 2AB4ZCTL002 SAR Test Report - Appendix A - Plots Page 3 of 9 Plot 3 Date/Time: 6/24/2015 10:38:48 AM Test Laboratory: Cetecom Inc. SAR 1 Lab DUT: Reliant Heart; Type: Heart Assist; Serial: 00070 Communication System: UMTS-FDD (WCDMA); Frequency: 1732.6 MHz Medium: MSL1900_Batch 110530-3 Medium parameters used: f = 1733 MHz; σ = 1.46 mho/m; ε r = 53.087; 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: 19.8C; Medium Temperature: 20.2C; Comments: ; DASY Configuration:  Probe: ES3DV3 - SN3260; ConvF(4.9, 4.9, 4.9); Calibrated: 3/19/2014;  Sensor-Surface: 3mm (Mechanical Surface Detection (Locations From Previous Scan Used)), Sensor-Surface: 4mm (Mechanical Surface Detection), z = 2.0, 32.0  Electronics: DAE4 Sn1265; Calibrated: 1/29/2014  Phantom: ELI 4.0; Type: QDOVA001BA; Serial: xxxx  DASY52 52.8.1(838); Flat-Section 3/Back 0mm/Area Scan (11x17x1): Measurement grid: dx=12mm, dy=12mm Maximum value of SAR (measured) = 0.346 mW/g Flat-Section 3/Back 0mm/Zoom Scan (5x5x7)/Cube 0: Measurement grid: dx=8mm, dy=8mm, dz=5mm Reference Value = 10.729 V/m; Power Drift = -0.07 dB Peak SAR (extrapolated) = 0.480 mW/g SAR(1 g) = 0.312 mW/g; SAR(10 g) = 0.194 mW/g Maximum value of SAR (measured) = 0.342 mW/g 0 dB = 0.346 mW/g = -9.23 dB mW/g FCC ID: 2AB4ZCTL002 SAR Test Report - Appendix A - Plots Page 4 of 9 Plot 4 Date/Time: 11/2/2015 8:04:19 PM Test Laboratory: Cetecom Inc. SAR 1 Lab DUT: Reliant Heart; Type: Heart Assist; Serial: 00070 Communication System: GPRS-FDD (TDMA, GMSK, TN 0-1); Frequency: 836.6 MHz Medium: MSL900_Batch 100818-1 Medium parameters used (interpolated): f = 836.6 MHz; σ = 0.988 mho/m; ε r = 53.124; ρ = 1000 kg/m 3 Phantom section: Flat Section Measurement Standard: DASY5 (IEEE/IEC/ANSI C63.19-2011) Procedure Notes: Test Technician: John; Air Temperature: 21C; Medium Temperature: 20.5C; Comments: ; DASY Configuration:  Probe: ES3DV3 - SN3260; ConvF(6.14, 6.14, 6.14); Calibrated: 3/19/2014;  Sensor-Surface: 3mm (Mechanical Surface Detection), Sensor-Surface: 4mm (Mechanical Surface Detection), z = 2.0, 32.0  Electronics: DAE4 Sn1233; Calibrated: 3/17/2014  Phantom: SAM; Type: QD 000 P40 CC; Serial: 1592  DASY52 52.8.1(838); 11-02-2015/Back 0mm_2TS/Area Scan (9x16x1): Measurement grid: dx=12mm, dy=12mm Info: Interpolated medium parameters used for SAR evaluation. Maximum value of SAR (measured) = 0.652 mW/g 11-02-2015/Back 0mm_2TS/Zoom Scan (6x5x7)/Cube 0: Measurement grid: dx=8mm, dy=8mm, dz=5mm Reference Value = 16.272 V/m; Power Drift = -0.08 dB Peak SAR (extrapolated) = 0.853 mW/g SAR(1 g) = 0.585 mW/g; SAR(10 g) = 0.394 mW/g Info: Interpolated medium parameters used for SAR evaluation. Maximum value of SAR (measured) = 0.621 mW/g 0 dB = 0.652 mW/g = -3.72 dB mW/g FCC ID: 2AB4ZCTL002 SAR Test Report - Appendix A - Plots Page 5 of 9 Plot 5 Date/Time: 6/23/2015 11:40:55 AM Test Laboratory: Cetecom Inc. SAR 1 Lab DUT: Reliant Heart; Type: Heart Assist; Serial: 00070 Communication System: UMTS-FDD (WCDMA); Frequency: 836.6 MHz Medium: MSL900_Batch 110518-7 Medium parameters used: f = 837 MHz; σ = 0.97 mho/m; ε r = 54.308; ρ = 1000 kg/m 3 Phantom section: Flat Section M…

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RF Exposure Info

FCC ID: 2AB4ZCTL002 SAR Test Report - Appendix B - Photos Page 1 of 4 Antenna Locations FCC ID: 2AB4ZCTL002 SAR Test Report - Appendix B - Photos Page 2 of 4 Setup Photos Photo 1: Touch Position under Elliptical Phantom FCC ID: 2AB4ZCTL002 SAR Test Report - Appendix B - Photos Page 3 of 4 Photo 2: Touch Position under SAM Phantom FCC ID: 2AB4ZCTL002 SAR Test Report - Appendix B - Photos Page 4 of 4 Photo 3: 15cm Liquid Depth in Flat Section of SAM Phantom Photo 4: 15cm Liquid Depth in Elliptical Phantom

RF Exposure Info

FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 1 of 49 Tissue Parameters Recipe for liquids below 1 GHz: Water 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: Water 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: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 2 of 49 850 MHz Body Liquid Date Temp (°C) Frequency (MHz) Relative Permativity Conductivity (S/m) 82454.45790.9537 82554.45780.9547 82654.44410.9558 82754.4270.9566 83554.31820.967 83654.31820.9687 83754.30770.9702 84654.23320.9823 84754.2290.9837 84854.2090.9849 84954.21190.9866 2015/06/2319.6 0.9 0.92 0.94 0.96 0.98 1 1.02 1.04 820840 Conductivity (S/m) Frequency (MHz) Conductivity Target Liquid Value 5% Liquid Tolerance -5% Liquid Tolerance 2015/06/23 51 52 53 54 55 56 57 58 59 820840 Relative Permittivity Frequency (MHz) Permittivity Target Liquid Value 5% Liquid Tolerance -5% Liquid Tolerance 2015/06/23 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 3 of 49 1750 MHz Body Liquid Date Temp (°C) Frequency (MHz) Relative Permativity Conductivity (S/m) 171053.20761.4362 171153.20761.4381 171253.1981.4382 172053.16111.4476 172153.14881.4477 172253.14321.4494 174953.00991.4772 175052.99831.4789 175152.99231.4783 176952.92381.5005 177052.92211.5009 2015/06/2421.7 1.38 1.43 1.48 1.53 1.58 17101760 Conductivity (S/m) Frequency (MHz) Conductivity Target Liquid Value 5% Liquid Tolerance -5% Liquid Tolerance 2015/06/24 50 51 52 53 54 55 56 17101760 Relative Permittivity Frequency (MHz) Permittivity Target Liquid Value 5% Liquid Tolerance -5% Liquid Tolerance 2015/06/24 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 4 of 49 1900 MHz Body Liquid Date Temp (°C) Frequency (MHz) Relative Permativity Conductivity (S/m) 185352.46451.4545 186052.43171.4649 186152.43791.4665 186252.42941.4673 186352.4281.4687 188052.37231.4892 188152.37281.4901 188252.36781.4913 190052.31211.5106 190952.27491.5187 191052.27361.5205 2015/06/2322.3 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 Value 5% Liquid Tolerance -5% Liquid Tolerance 2015/06/23 50 51 52 53 54 55 56 18451895 Relative Permittivity Frequency (MHz) Permittivity Target Liquid Value 5% Liquid Tolerance -5% Liquid Tolerance 2015/06/23 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 5 of 49 850 MHz Body Liquid Date Temp (°C) Frequency (MHz) Relative Permativity Conductivity (S/m) 82453.26360.9741 82953.20950.9798 83453.15380.9852 83953.09670.9904 84453.04090.9956 84952.98841.0007 2015/11/0220.7 0.9 0.95 1 1.05 820840 Conductivity (S/m) Frequency (MHz) Conductivity Target Liquid Value 5% Liquid Tolerance -5% Liquid Tolerance 2015/11/02 51 53 55 57 59 820840 Relative Permittivity Frequency (MHz) Permittivity Target Liquid Value 5% Liquid Tolerance -5% Liquid Tolerance 2015/11/02 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 6 of 49 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 Data Acquisition Electronics SPEAG DAE4 1265 2014/01/29 2016/01/29 SAR Probe SPEAG ES3DV3 3260 2014/03/19 2016/03/19 Shared Equipment Instrument description Supplier / Manufacturer Model Serial No. Calibration (date) Calibration Due (date) 900 MHz Body Tissue Simulant SPEAG MSL 900 100818-1 2015/06/23 N/A 900 MHz Body Tissue Simulant SPEAG MSL 900 100818-1 2015/11/2 N/A 1750 MHz Body Tissue Simulant SPEAG MSL 1750 100824-2 2015/06/24 N/A 1900 MHz Body Tissue Simulant SPEAG MSL 1900 110530-3 2015/06/23 N/A 835 MHz Dipole SPEAG D835V2 4d113 2014/04/07 2016/04/07 1750 MHz Dipole SPEAG D1750V2 1045 2014/04/10 2016/04/10 1900 MHz Dipole SPEAG D1900V2 5d135 2014/04/09 2016/04/09 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 1118 2014/04/08 2016/04/08 Synthesized CW Generator Agilent 8371213 US37101255 N/A N/A Power Meter Agilent E4419B MY45101996 2013/06/03 2016/06/03 Power Sensor Agilent E9300A MY41498484 2013/06/04 2016/06/04 Power Sensor Agilent E9300A MY41498492 2013/06/04 2016/06/04 Radio Communications Tester Rohde & Schwarz CMU 200 110759 2013/06 2015/06 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 7 of 49 Equipment Calibration/Performance Documents: Attached: SAR Probe ES3DV3 Calibration Report – SN:3260 835 MHz Dipole Calibration Report – SN:4d113 1750 MHz Dipole Calibration Report – SN:1045 1900 MHz Dipole Calibration Report-SN:5d135 DAE 4 Calibration Report – SN:1265 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 8 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 9 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 10 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 11 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 12 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 13 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 14 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 15 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 16 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 17 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 18 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 19 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Appendix C - Misc Page 20 of 49 FCC ID: 2AB4ZCTL002 # SAR Test Report - Append…

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Test Report

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…

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Contact Information

Applicant

Bryan E Lynch(CTO)
[email protected]+1 713-412-3418Fax: +1 713-665-0963

Test Firm

CETECOM Inc.Sabrina Sarne
[email protected]408-586-6249Fax: 408 586 6299

Technical Specifications

#Rule PartsFrequency RangePower OutputEmissionTolerance
724E1.85 GHz - 1.91 GHz230.00 mW4M10F9W2.5 ppm
Confidentiality
Long Term
Grant Notes
Output power listed is ERP for part 22 and EIRP for part 24 and part 27. This device contains functions that are not operational in U.S. Territories. This filing is only applicable for US operations. This device has been tested to be compliant with FCC RF exposure guidelines for body worn operation with zero distance. End users must be informed of the body worn requirements for satisfying RF Exposure compliance. The highest reported SAR for body-worn transmission use condition is 0.68 W/kg.

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Equipment Class

PCT - PCS Licensed Transmitter worn on body