2AONF-27C01ReDS Pro System

RA-24629 Rev. D February 2020 ReDS™ ProSystem Healthcare Provider User Manual ReDS™ Pro System V2.7 ReDS™ System Healthcare Provider User Manual 2 About This Manual This user manual describes how to use the ReDS™ Pro Systemto monitor the fluid status of patients. This manual describes the ReDS Pro System V2.7. It applies to healthcare providers (HCPs) who are using the device to monitor patients. This manual contains the following chapters: xChapter 1, Introducing the ReDS Pro System, page 14, introduces the ReDS Pro System and describes its components. xChapter 2, Setting Up, page 22, describes general setup procedures to be performed before using the ReDS Pro System or that can be changed when needed. xChapter 3, Taking a Measurement,page 31, describes how to adjust the sensor unit to fit a specific patient and how to measure a patient using the ReDS Pro System. xChapter 4, The SensiCloud™ Portal, page 62, describes how to use of the SensiCloud Portal to monitor the thoracic fluid status of multiple patients. xChapter 5, Troubleshooting, page 84, describes how to troubleshoot various system problems. This information is provided in order to allow you to solve simple problems. If a problem cannot be solved, please contact support. xAppendix A, Labeling, page 87, shows the labels that are attached to the ReDS Pro System components and describes the symbols that appear on them. xAppendix B, Handling,page 89, describes how to store, clean and maintain the ReDS Pro System. xAppendix C, Technical Information, page 98, provides ReDS Pro System technical specifications and other technical information. About This Manual 3 Table of Contents About This Manual ................................................................................. 2 Table of Contents ................................................................................... 3 Table of Figures ...................................................................................... 6 Legal Notice ........................................................................................... 8 Support and Contact Information .......................................................... 8 Conventions Used in This Manual .......................................................... 9 Important Safeguards .......................................................................... 10 1Introducing the ReDS Pro System ................................................... 14 Overview............................................................................................................ 14 Indications for Use ............................................................................................. 14 Patient Population ............................................................................................. 15 Contraindications ............................................................................................... 15 System Components .......................................................................................... 15 Bedside Console ......................................................................................... 15 Sensor Unit ................................................................................................ 18 Auxiliary Equipment ................................................................................... 19 SensiCloud ™ Portal ..................................................................................... 20 2Setting Up ....................................................................................... 22 General Setup .................................................................................................... 22 Step 1: Adjusting the Bedside Console ........................................................ 22 Step 2, Setting Up Communication ............................................................. 23 Step 3: Powering Up ................................................................................... 23 Settings .............................................................................................................. 26 3Taking a Measurement ................................................................... 31 ReDS™ System Healthcare Provider User Manual 4 Taking a Measurement – Workflow .................................................................... 32 Step 1: Preparing the Patient.............................................................................. 33 Step 2: Selecting the Patient ............................................................................... 33 Step 3: Applying the Sensor Unit on the Patient ................................................. 37 Step 4: Taking a Measurement ........................................................................... 54 Unsuccessful Measurement ....................................................................... 59 Step 5: Reviewing Measurement Results ............................................................ 60 Step 6: Cleaning and Disinfection ....................................................................... 61 Shutting Down the ReDS Pro System .................................................................. 61 4Generating Reports from The ReDS™ Pro System ........................... 62 Usage Report ..................................................................................................... 62 5The SensiCloud™ Portal ................................................................... 65 SensiCloud Overview .......................................................................................... 65 SensiCloud Main Screens .................................................................................... 66 Patient List ................................................................................................. 67 Patient Graph View .................................................................................... 68 My Account .........................................…

Text truncated - open the document above for the full version.

RF_160, Issue 04 Declaration of Authorization We Name: Sensible Medical Innovations Ltd. Address: P.O.Box 8702, Meir Ariel 6, intergama Building 1 City: Netanya, 4053942 Country: Israel . Declare that: Name Representative of agent: ............. (1) Agent Company name: Hermon Laboratories Ltd. . Address: Harakevet Industrial Zone .. City: Binyamina 30500 .. Country Israel . is authorized to apply for Certification of the following product(s): Product description:  ReDS Pro System . Type designation:  V2.7 Conf. C. Trademark: ReDS Pro system . Validity/ expiry date Marc 17, 2021 on our behalf. Date: Marc 17, 2020.. Name: Mr. Nadav Mizrahi.. (2) Function: VP R&D ............................... Signature: מרץ 1820208:11AM Nadav Mizrahi Notes: (1): Required for FCC application (2): For FCC it must be the Grantee Code “owner” or the authorized agent.

FCC, Request for non-disclosure Date: 16-Jul-10 RF_501, Issue 6 Page 1 of 1 Company Name: Sensible Medical Innovations Ltd. Address: P.O.Box 8702, Meir Ariel 6, intergama Building 1 City: Netanya, 4250364 Country: Israel To: Telefication B.V., Dept. FCC TCB Edisonstraat 12A 6902 PK ZEVENAAR The Netherlands Subject: Request for confidentiality FCC ID: 2AONF-27C01 Reference number: ###### Dear FCC TCB, 1. Long-Term Confidentiality Pursuant to 47 CFR Section 0.459(a) & (b), we hereby requests non-disclosure and confidential treatment of the following materials submitted in support of FCC certification application: Bill(s) of Material Block Diagrams Operational Description Schematic Diagrams Tune-up Procedure Above materials contain secrets, proprietary and technical information, which would customarily be guarded from competitors under 47 CFR, section 0.457(d)(2). Disclosure or publication or any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. 2. Short-Term Confidentiality (STC) Pursuant to Public Notice DA 04-1705 of the Commission’s policy, in order to comply with the marketing regulations in 47 CFR §2.803 and the importation rules in 47 CFR §2.1204, applicant hereby requests Short-Term Confidential treatment of the following materials (note 1): Internal Photos User’s Manual Test Set-up Photos External Photos Justification: This device is a new concept of product and contains a trade secret of the company,novel technology and the know how of the company Planned Release Date STC: 180 days from the grant date (notes 2, 3, 4, 5) Date: February 19, 2020 Name and signature of applicant: Mr. Nadav Mizrahi-VP R&D מרץ 3202010:16PM Nadav Mizrahi Notes: 1) A document or type of document can only have ONE type of confidentiality! 2) Short-Term confidentiality is in principle for 45 days from date of grant; it can be extended max 3 times (total time 180 days max.)! 3) FCC must be informed when marketing begins earlier. FCC, Request for non-disclosure Date: 16-Jul-10 RF_501, Issue 6 Page 1 of 1 4) Release takes place automatically thus extension must be requested in time. Telefication does not remind you of this! 5) Request for extension or for release must be received by Telefication at least 7 days before date of actual marketing or before expiration of the STC period

Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 1 of 5 EXTERNAL PHOTOGRAPHS This document contains 4 photographs Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 2 of 5 Photograph No.1 ReDS™ Pro System V2.7 Conf. C general view Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 3 of 5 Photograph No.2 Sensor of ReDS™ Pro System V2.7 Conf. C general view Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 4 of 5 Photograph No.2 Sensor of ReDS™ Pro System V2.7 Conf. C general view Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 5 of 5 Photograph No.5 Bedside console of ReDS™ Pro System V2.7 Conf. C rear side view

Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 1 of 1 LABEL The labels are affixed on the rear side panel of the unit as shown below. The label material is PVC with a permanent adhesive. Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 1 of 1 ReDS™ Pro System V2.7 Conf. C rear side panel, label with FCC ID: 2AONF-27C01 location

Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 1 of 8 INTERNAL PHOTOGRAPHS This document contains 9 photographs Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 2 of 8 Photograph No.1 ReDS™ Pro System V2.7 Conf. C internal view Transmitter Receiver Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 3 of 8 Photograph No.2 RF Engine CS Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 4 of 8 Photograph No.3 RF Engine PS Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 5 of 8 Photograph No.4 RX ISO CS Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 6 of 8 Photograph No.5 RX ISO PS Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 7 of 8 Photograph No.6 TX ISO CS Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 8 of 8 Photograph No.7 TX ISO PS

Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 1 of 4 Analysis report for SAR test exclusion according to KDB 447498 1. General information The “ReDS™ Pro System V2.7 Conf. C” is a non-invasive bedside monitor connected to a wearable vest and used for the measurement of lung fluid. The “ReDS™ Pro System V2.7 Conf. C” transmitter of wearable vest is a portable device operating in the 957 MHz -1718 MHz range using stepped CW modulation. It is equipped with a body-coupled shielded EM transducer (antenna) located at 1.5 mm from the human body. 2. SAR test exclusion justification The applicability SAR limits and RF exposure analysis was performed under the following conditions representing the worst-case scenario in terms of Peak power (no average factors or duty cycle were applied), conducted power was evaluated for the exclusion and the allowance was made for the applicable tune-up tolerances: 1) Peak conducted power measurements were taken accordingly. 2) Tune-up tolerance limits for conducted power were also evaluated accordingly. 3) A minimum separation distance is taken as 1.5mm (although according to KDB 447498 section 4.3.1 (a) a 5 mm minimal separation distance should be applied) The following formulas are used: (1) Transmitter power [dBm] = 10log(Transmitter power [mW]) The SAR exclusion threshold was calculated as follows: 푃(푚푊)× √ 푓(퐺퐻푧) 퐷(푚푚) ≤3.0 푓표푟 1−푔 푆퐴푅 P – is the maximum allowed power including manufacturing tune up tolerance in mW; D - is the minimum separation distance required for exclusion from SAR testing in mm; f – is the transmitter carrier frequency in GHz. Converting the equation into the power threshold exclusion for the given separation distance of 1.5 mm will get: 푃 푆퐴푅 푒푥푐푙푢푠푖표푛 (푚푊)≤ 3.0×퐷(푚푚) √ 푓(퐺퐻푧) 푓표푟 1−푔 푆퐴푅 The SAR exclusion threshold for the investigated frequencies at 1.5 mm test separation distance is provided in the table below: Carrier frequency, MHz Power, mW Power, dBm 957 4.6 6.6 958 4.6 6.6 1242 4.0 6.1 1636 3.5 5.5 1718 3.4 5.2 Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 2 of 4 3. Measurement results 3.1 Conducted output power measurements The conducted power measurements test setup is provided in the Photograph 3.1.1 below. Photograph 3.1.1 Power measurements test setup According to the tune-up procedure the conducted power levels in production have to be within the ranges shown in Table 3.1.2. Table 3.1.2 Power levels in production (including tolerances) Carrier frequency, MHz Min level of peak conducted power, dBm Nominal level of peak conducted power, dBm Max level of peak conducted power, dBm 957.0625 -43.5 -42.5 -41.5 958.0625 -43.5 -42.5 -41.5 1242.0625 -26.8 -25.8 -24.8 1636.0625 -26.3 -25.3 -24.3 1718.0625 -27.6 -26.6 -25.6 Conducted power measurements (refer to plots below) were performed to verify the values of the single sample are within the applicable ranges of the power including the relevant tolerances, however the SAR exclusion evaluation was performed based on the maximum values that could be reached after ATP in the mass production. Table 3.1.3 Conducted output power levels test results Carrier frequency, MHz Measured power Tune-up max power 1-g SAR exclusion threshold, mW 1-g SAR evaluation 1-g SAR test exclusion threshold Verdict dBm mW dBm mW 957.10 -42.521 0.0000559 -41.5 0.0000707 4.6 0.001458 3.0 Pass 958.08 -42.565 0.0000554 -41.5 0.0000707 4.6 0.001458 Pass 1242.10 -25.778 0.0026430 -24.8 0.0033113 4.0 0.077800 Pass 1636.07 -25.255 0.0029819 -24.3 0.0037153 3.5 0.100185 Pass 1718.05 -26.461 0.0022589 -25.6 0.0027542 3.4 0.076039 Pass Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 3 of 4 Plot 3.1.1 Power measurements at 957 MHz Plot 3.1.2 Power measurements at 958 MHz Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 4 of 4 Plot 3.1.3 Power measurements at 1242 MHz Plot 3.1.4 Power measurements at 1636 MHz Plot 3.1.5 Power measurements at 1718 MHz Conclusion: According to KDB 447498 D01 v06 the device is excluded from SAR evaluation.

Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 1 of 3 OBW measurement results Plot 1 Occupied bandwidth test result at 957 MHz operating frequency Plot 2 Occupied bandwidth test result at 958 MHz operating frequency Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 2 of 3 Plot 3 Occupied bandwidth test result at 1242 MHz operating frequency Plot 4 Occupied bandwidth test result at 1636 MHz operating frequency Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 3 of 3 Plot 5 Occupied bandwidth test result at 1718 MHz operating frequency

Hermon Laboratories Ltd. P.O. Box 23, Binyamina 3055001, Israel Tel. +972 4628 8001 Fax. +972 4628 8277 E-mail: [email protected] Page 1 of 62 Report ID: SENRAD_FCC.34190_Rev2 Date of Issue: 17-Mar-20 ELECTRICAL TESTING 0839.01 TEST REPORT ACCORDING TO: FCC 47CFR part 15 subpart C §15.209 FOR: Sensible Medical Innovations Ltd. ReDS Pro System Version: 2.7 Conf. C Part number: GAS0047 FCC ID:2AONF-27C01 This report is in conformity with ISO/ IEC 17025. The "A2LA Accredited" symbol endorsement applies only to the tests and calibrations that are listed in the scope of Hermon Laboratories accreditation. The test results relate only to the items tested. This test report shall not be reproduced in any form except in full with the written approval of Hermon Laboratories Ltd. Report ID: SENRAD_FCC.34190_Rev2 Date of Issue: 17-Mar-20 Page 2 of 62 Table of contents 1 Applicant information ..................................................................................................................................................... 3 2 Equipment under test attributes .................................................................................................................................... 3 3 Manufacturer information .............................................................................................................................................. 3 4 Test details .................................................................................................................................................................... 3 5 Tests summary .............................................................................................................................................................. 4 6 EUT description ............................................................................................................................................................. 5 6.1 General information ....................................................................................................................................................... 5 6.2 EUT parts ...................................................................................................................................................................... 5 6.3 Operating frequencies ................................................................................................................................................... 5 6.4 Test configuration .......................................................................................................................................................... 5 6.5 Transmitter characteristics ............................................................................................................................................ 6 7 Transmitter tests according to 47CFR part 15 subpart C .............................................................................................. 7 7.1 Field strength of emissions ............................................................................................................................................ 7 7.2 Conducted emissions .................................................................................................................................................. 39 8 Unintentional emissions according to 47CFR part 15 subpart B ................................................................................. 42 8.1 Radiated emissions ..................................................................................................................................................... 42 8.2 Conducted emissions .................................................................................................................................................. 51 8.3 Antenna requirements ................................................................................................................................................. 54 9 APPENDIX A Test equipment and ancillaries used for tests ....................................................................................... 55 10 APPENDIX B Test equipment correction factors ......................................................................................................... 56 11 APPENDIX C Test facility description ......................................................................................................................... 59 12 APPENDIX D Measurement uncertainties .................................................................................................................. 60 13 APPENDIX E Specification references........................................................................................................................ 61 14 APPENDIX F Abbreviations and acronyms ................................................................................................................. 62 Report ID: SENRAD_FCC.34190_Rev2 Date of Issue: 17-Mar-20 Page 3 of 62 1 Applicant information Client name: Sensible Medical Innovations Ltd. Address: P.O.Box 8702, Meir Ariel 6, intergama Building 1, Netanya, 4053942, Israel Telephone: 058-6999563 Fax: 09-8654472 E-mail: [email protected] Contact name: Mr. Keren Halperin 2 Equipment under test attributes Product name: ReDS Pro System Product type: Medical Part number: GAS0047 Serial number: 2009CVXWUK Hardware version: V2.7 Conf. C Software release: 1.10 Receipt date 13 Aug 2019 3 Manufacturer information Manufacturer name: Sensible Medical Innovations Ltd. Address: P.O.Box 8702, Meir Ariel 6, intergama Building 1, Netanya, 4053942, Israel Telephone: 058-6999563 Fax: 09-8654472 E-Mail: [email protected] Contact name: Mr. Keren Halperin 4 Test details Project ID: 34190 Location: Hermon Laboratories Ltd. P.O. Box 23, Binyamina 3055001, Israel Test started: 02-Dec-19 Test completed: 05-Dec-19 Test specification(s): FCC 47CFR part 15, subpart C, §15.209 Report ID: SENRAD_FCC…

Text truncated - open the document above for the full version.

Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 1 of 6 SETUP PHOTOGRAPHS This document contains 5 photographs Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 2 of 6 Photograph No.1 Setup for spurious emission field strength measurements in the anechoic chamber below 30 MHz Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 3 of 6 Photograph No.2 Setup for carrier and spurious emission field strength measurements in the anechoic chamber in 30 – 1000 MHz range Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 4 of 6 Photograph No.3 Setup for spurious emission field strength measurements in the anechoic chamber above 1000 MHz Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 5 of 6 Photograph No.4 Setup for spurious emission field strength measurements at the OATS above 1000 MHz Sensible Medical Innovations Ltd. FCC ID:2AONF-27C01 Page 6 of 6 Photograph No.5 Setup for conducted emission measurements on AC power lines