SBG-9000PODSMARTZ POD DATA LOGGER

SIM™ User Manual | Prod Code: 02579_03 | Version: 3a 1 cl Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document number: SAS_GEN1_0039 | Revision: 2 2 Copyright Information Copyright 2010-2019 Simavita Ltd. All rights reserved. The information contained in this User Manual is the sole property of Simavita and may not be duplicated without permission. This User Manual may be revised or replaced by Simavita Ltd at any time and without notice. Please ensure that you have the latest version of this manual; in case help is required; please contact Simavita Technical Support Department. Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document number: SAS_GEN1_0039 | Revision: 2 3 Table of Contents Copyright Information ............................................................................................................................... 2 Table of Contents ............................................................................................................................................... 3 Preface ............................................................................................................................................................... 4 Purpose of this manual .............................................................................................................................. 4 Qualification of Personnel ......................................................................................................................... 4 Warranty .................................................................................................................................................... 4 Document Conventions ............................................................................................................................. 4 Accessibility of this Manual ....................................................................................................................... 4 1.0 Safety Information ....................................................................................................................................... 6 Definitions ................................................................................................................................................. 6 Warnings .................................................................................................................................................... 7 Cautions ................................................................................................................................................... 11 Symbols and markings ............................................................................................................................. 12 Labels 15 Patient Privacy and Security .................................................................................................................... 17 2.0 Overview ...................................................................................................................................................... 1 2.1 What is the Smartz™ system ............................................................................................................... 1 2.2 Indications for Use ............................................................................................................................... 1 2.3 Features ............................................................................................................................................... 2 2.4 Benefits of the Technology .................................................................................................................. 2 2.5 The Smartz™ System Components ...................................................................................................... 3 3.0 User Instructions .......................................................................................................................................... 7 3.1 Smartz™ pod Battery Installation & Replacement ............................................................................... 7 3.2 Clipping Smartz™ pod onto Smartz™ sensor pad ................................................................................ 8 3.3 Smartz™ pod Indicator Light Colours ................................................................................................. 11 3.4 Using the Smartz™ app ...................................................................................................................... 11 3.5 Understanding the Smartz™ System Features & Notifications.......................................................... 27 3.6 Smartz™ dashboard ........................................................................................................................... 31 3.7 Smartz™ pod Cleaning Instructions ................................................................................................... 32 3.8 Disposal .............................................................................................................................................. 33 4.8 Standards and Compliance and IEC Certifications ............................................................................. 34 General & Collateral Standards- Smartz Pod ........................................................................................... 34 4.0 Troubleshooting, Contact and Support ...................................................................................................... 36 4.1 Troubleshooting Guide ...................................................................................................................... 36 4.2 Contact and support .......................................................................................................................... 37 5.0 Appendix A Smartz™ System Specifications ............................................................................................... 39 Smar…

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Document Title POD Label Specification Revision 1 Document # CS_02877_01 Prepared by Ashalatha Issue Date 08-April-2020 Reviewed by Joshua Friedmann Approved by Peter Curran Page 1 (2) Commercial-in -Confidence © Simavita (Aust) Pty Ltd **Uncontrolled copy when printed** 9 Label Specifications – Smartz TM pod label 02877_01 1. Dimensions: 2. Label Location: 3. Label Design and Attributes : 10mm 3mm Document Title POD Label Specification Revision 1 Document # CS_02877_01 Prepared by Ashalatha Issue Date 08-April-2020 Reviewed by Joshua Friedmann Approved by Peter Curran Page 2 (2) Commercial-in -Confidence © Simavita (Aust) Pty Ltd **Uncontrolled copy when printed** Number Description 1. Product Name 2. Product Model Number 3. FCC ID :SBG-9000POD (US) 4. IC : 21921-9000POD (Canada) 5. Symbol for Serial Number Serial Number. S for Simavita, followed by a 6 digit counter starting from 000001—999999. 6. CE mark 7. Label part number 8. QR Code with encoded serial number 9. RF Transmitter in device. Non Ionising Radiation 10. Ingress Protection 11. BF Applied Part Document Revision History Rev. Change Request Detailed Change Description Prepared By Issue Date 1.0 Initial Release Initial release. Ashalatha 08-April-2020 1 2 3 4 5 6 7 8 10 11 9 3 Simavita 28-July-2020 CKC laboratorles, lnc. / Cl(C Certificatlon Seruhes, LLC. Device constnrctlon declaratlon - rerulatorv label To Whom lt May Concern, This letter is to provlde clarification on the construction of the Smartzil pod. The Smartzil pod consists of a hinged lid. The lid is fastened to the main body of the pod by a hinge that is not designed to be removed by a user; it requires specialised tooling to remove the hinge. A laser engraved regulatory label is located on the inner surface of the lid. An essential operation in using the device includes raising the lid to attach the pod to a diaper. This allows the user to view the label during each use; as stated earlier, the user cannot detach the lid with the engraved labelfrom the pod. Therefore, by this letter, we confirm that $e regulatory label is designed to be permanently located on a non-remouable part of th€ detdce. Please let us know if you have any further questions. Sincerely, Peter Curran Chief Technolqyfficer Simvita (Austl Pty ltd Simovito (Aust) Pty Ltd Suite 2.02, 12, 54 Miller St, North Sydney NSW 2060 Australio

060818 Report Number: F2P23302F-11E Page 1 of 30 Issue Date: 2020-07-22 F2 Labs 16740 Peters Road Middlefield, Ohio 44062 United States of America www.f2labs.com CERTIFICATION TEST REPORT Manufacturer: Simavita (Aust.) Pty. Ltd. Suite 2.02, Level 2, 54 Miller Street North Sydney NSW 2060 AUSTRALIA Applicant: Same as Above Product Name: Smartz™ Pod Product Description: The Smartz™ system is intended to provide monitoring services of continence and related wellness data by remote transmission. It is intended for use by, or under the direction of, healthcare professionals, caregivers and for personal use to collect, transmit and report information related to body position, falls monitoring, continence product status and related wellness data for individuals in institutional environments, including hospitals, nursing homes, rehabilitation facilities and within home environments. Operating Voltage/Frequency: Battery-Operated Model: 9000 FCC ID: SBG-9000POD Testing Commenced: 2020-07-09 Testing Ended: 2020-07-20 Summary of Test Results: In Compliance, with Modifications The EUT complies with the EMC requirements when manufactured identically as the unit tested in this report, including any required modifications and/or manufacturer’s statement. Any changes to the design or build of this unit subsequent to this testing may deem it non-compliant. Standards:  FCC Part 15 Subpart C, Section 15.249  FCC Part 15 Subpart C, Section 15.215(c) – Additional provisions to the general radiated emission limitations  FCC Part 15 Subpart A, Section 15.31(e) – Measurement Standards Order Number: F2P23302F Applicant: Simavita (Aust.) Pty. Ltd. Model: 9000 060818 Report Number: F2P23302F-11E Page 2 of 30 Issue Date: 2020-07-22 Evaluation Conducted by: Julius Chiller, EMC/Wireless Engineer Report Reviewed by: Ken Littell, Director of EMC & Wireless Operations F2 Labs F2 Labs F2 Labs 26501 Ridge Road 16740 Peters Road 8583 Zionsville Road Damascus, MD 20872 Middlefield, OH 44062 Indianapolis, IN 46268 Ph 301.253.4500 Ph 440.632.5541 Ph 317.610.0611 This test report may be reproduced in full; partial reproduction only may be made with the written consent of F2 Labs. The results in this report apply only to the equipment tested. Order Number: F2P23302F Applicant: Simavita (Aust.) Pty. Ltd. Model: 9000 060818 Report Number: F2P23302F-11E Page 3 of 30 Issue Date: 2020-07-22 TABLE OF CONTENTS Section Title Page 1 ADMINISTRATIVE INFORMATION 4 2 SUMMARY OF TEST RESULTS/MODIFICATIONS 7 3 TABLE OF MEASURED RESULTS 8 4 ENGINEERING STATEMENT 9 5 EUT INFORMATION AND DATA 10 6 LIST OF MEASUREMENT INSTRUMENTATION 11 7 OCCUPIED BANDWIDTH 12 8 FIELD STRENGTH OF EMISSIONS 19 9 PHOTOGRAPHS - TEST SETUPS 28 Order Number: F2P23302F Applicant: Simavita (Aust.) Pty. Ltd. Model: 9000 060818 Report Number: F2P23302F-11E Page 4 of 30 Issue Date: 2020-07-22 1 ADMINISTRATIVE INFORMATION 1.1 Measurement Location: F2 Labs in Middlefield, Ohio. Site description and attenuation data are on file with the FCC's Sampling and Measurement Branch at the FCC Laboratory in Columbia, MD. 1.2 Measurement Procedure: All measurements were performed according to the 2013 version of ANSI C63.10 and recommended FCC procedure of measurement of DXT operating under Section 15.249. A list of the measurement equipment can be found in Section 6. Order Number: F2P23302F Applicant: Simavita (Aust.) Pty. Ltd. Model: 9000 060818 Report Number: F2P23302F-11E Page 5 of 30 Issue Date: 2020-07-22 1.3 Uncertainty Budget: The uncertainty in EMC measurements arises from several factors which affect the results, some associated with environmental conditions in the measurement room, the test equipment being used, and the measurement techniques adopted. The measurement uncertainty budgets detailed below are calculated from the test and calibration data and are expressed with a 95% confidence factor using a coverage factor of k=2. The Uncertainty for a laboratory is referred to as Ulab. For Radiated and Conducted Emissions, the Expanded Uncertainty is compared to the Ucispr values to determine if a specific margin is required to deem compliance. Ulab Ucispr If Ulab is less than or equal to Ucispr, then:  compliance is deemed to occur if no measured disturbance exceeds the disturbance limit;  non-compliance is deemed to occur if any measured disturbance exceeds the disturbance limit. If Ulab is greater than Ucispr in table 1, then:  compliance is deemed to occur if no measured disturbance, increased by (Ulab – Ucispr), exceeds the disturbance limit;  non-compliance is deemed to occur if any measured disturbance, increased by (Ulab – Ucispr), exceeds the disturbance limit. Note: Only measurements listed in the tables above that relate to tests included in this Test Report are applicable. Measurement Range Combined Uncertainty Expanded Uncertainty Radiated Emissions <1 GHz @ 3m 2.54 5.07dB Radiated Emissions <1 GHz @ 10m 2.55 5.09dB Radiated Emissions 1 GHz to 2.7 GHz 1.81 3.62dB Radiated Emissions 2.7 GHz to 18 GHz 1.55 3.10dB AC Power Line Conducted Emissions, 150kHz to 30 MHz 1.38 2.76dB AC Power Line Conducted Emissions, 9kHz to 150kHz 1.66 3.32dB Measurement Range Expanded Uncertainty Radiated Emissions <1 GHz @ 3m 5.2dB Radiated Emissions <1 GHz @ 10m 5.2dB Radiated Emissions 1 GHz to 2.7 GHz Under Consideration Radiated Emissions 2.7 GHz to 18 GHz Under Consideration AC Power Line Conducted Emissions, 150kHz to 30 MHz 3.6dB AC Power Line Conducted Emissions, 9kHz to 150kHz 4.0dB Order Number: F2P23302F Applicant: Simavita (Aust.) Pty. Ltd. Model: 9000 060818 Report Number: F2P23302F-11E Page 6 of 30 Issue Date: 2020-07-22 1.4 Document History: Document Number Description Issue Date Approved By F2P23302F-11E First Issue 2020-07-22 K. Littell Order Number: F2P23302F Applicant: Simavita (Aust.) Pty. Ltd. Model: 9000 060818 Report Number: F2P23302F-11E Page 7 of 30 Issue Date: 2020-07-22 2 SUMMARY OF TEST RESULTS Test Name Standard(s) Results 99% Occupied Bandwidth CFR 47…

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F2P23302F Page 1 of 3 2020-07-07 PHOTOGRAPHS: EXTERNAL Simavita (Aust.) Pty. Ltd. – Model 9000 Spurious Emissions: Less Than 30 MHz Spurious Emissions: 30 MHz to 1000 MHz Order Number: F2P23302F Client: Simavita (Aust.) Pty. Ltd Model: 9000 F2P23302F Page 2 of 3 2020-07-07 Spurious Emissions: 1 GHz to 18 GHz Spurious Emissions: 18 GHz to 26 GHz Order Number: F2P23302F Client: Simavita (Aust.) Pty. Ltd Model: 9000 F2P23302F Page 3 of 3 2020-07-07 Field Strength of Emissions, Occupied Bandwidth