2ABHFUCOR100uCOR System Monitor, uCOR V1.0.0

μC or Non-Invasive Fluid Status Monitor User Guide Kyma Medical Technologies Ltd. User Guide Kyma μCor © 2012 Kyma Medical Technologies Ltd. μCor V.1.0.0 Page 2 Important This User Guide is subject to periodic review, update and revision. Do not use a defective product. Do not repair this product or any of its parts other than in accordance with written instructions provided by Kyma. The user of this product has sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, unauthorized service, damage, or alteration by anyone other than Kyma. The safety, reliability, and performance of this device can only be assured under the following conditions: 1. The device has been used according to the accompanying operating instructions. 2. All fittings, extensions, readjustments, changes, or repairs have been carried out by Kyma's authorized representatives. © Copyright 2012 Kyma Medical Technologies Ltd. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photo reproductive, recording or otherwise without the express prior written permission of Kyma Medical Technologies Ltd. Kyma Medical Technologies Ltd. reserves the right to change or improve its products and accompanying technical literature without specific notice of changes or improvements. This product is patent protected. User Guide RA-72-002-008 Revision 3 ∙ May 2013 Kyma Medical Technologies Atir-Yeda Industry park 17th Atir-Yeda St. Kfar-Sava 44643, ISRAEL 2nd floor, East Entrance Tel: +972.72.2119301 Fax: +972.72.2119304 E-mail: [email protected] http://www.kyma-med.com User Guide Kyma μCor © 2012 Kyma Medical Technologies Ltd. μCor V.1.0.0 Page 3 The symbol CE 0344 indicates compliance of this device with the Medical Device Directives 93/42/ EEC, 2007/47/CE. MedNet GmbH Borkstrasse 10, 48163 Münster, Germany; Tel.: 49-2506-8644-0 Fax: 49-2506-8644-22 Disclaimer Information provided by Kyma Medical Technologies Ltd. is believed to be accurate and reliable. However, Kyma Medical Technologies Ltd. assumes no responsibility for the use of such information, nor for any infringements of patents or other rights of third parties, that may result from its use. PLEASE READ THIS USER GUIDE BEFORE OPERATING THE SYSTEM User Guide Kyma μCor TABLE OF CONTENTS Contents 1. Introduction ..................................................................................... 6 1.1. ABOUT THIS USER GUIDE..................................................................................................................... 6 1.2. GLOSSARY AND ABBREVIATIONS ............................................................................................................ 6 1.3. THE KYMA μCOR SYSTEM ..................................................................................................................... 6 2. Conditions for Use ............................................................................ 7 2.1. INTENDED USE ................................................................................................................................... 7 2.2. INDICATIONS ...................................................................................................................................... 7 2.3. CONTRAINDICATIONS .......................................................................................................................... 7 3. Safety ............................................................................................... 8 3.1. TYPES OF WARNINGS, CAUTIONS AND NOTES .......................................................................................... 8 3.2. GENERAL SAFETY INSTRUCTIONS ........................................................................................................... 8 3.3. ELECTRICAL SAFETY ............................................................................................................................. 9 3.4. EMC COMPLIANCE ............................................................................................................................. 9 4. Overview of System components .................................................... 11 4.1. DEVICE DESCRIPTION ........................................................................................................................ 11 4.2. DIAGRAM OF SYSTEM MAIN COMPONENTS AND COMMUNICATION ............................................................ 11 4.3. CARTRIDGE ..................................................................................................................................... 11 4.4. CHARGER ........................................................................................................................................ 13 4.5. MEDICAL PATCH .............................................................................................................................. 13 4.6. COMPONENTS: SERVER ..................................................................................................................... 15 5. Using the uCor Device ..................................................................... 16 5.1. DETERMINING THE CORRECT LOCATION FOR THE MEDICAL PATCH .............................................................. 16 5.2. APPLYING THE MEDICAL PATCH .......................................................................................................... 16 5.3. REPLACING THE MEDICAL PATCH ......................................................................................................... 17 5.4. CONNECTING THE CARTRIDGE TO THE MEDICAL PATCH ............................................................................ 18 5.5. CHARGING THE CARTRIDGE ................................................................................................................ 18 5.6. REMOVING THE DEVICE CONNECTIONS FROM THE PATIENT .....................…

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Bluetooth Antenna

Test Report E133980.03 Kyma Medical Technological Ltd. Page 1 of 67 FCC ACC M Ver 1.1 05Mayl 2000 DATE: 16 June 2014 I.T.L. (PRODUCT TESTING) LTD. FCC Radio Test Report for Kyma Medical Technological Ltd. Equipment under test: μCOR System Monitor μCOR V1.0.0 Written by: _____________________________ R. Pinchuck, Documentation Approved by: ____________________________ A. Sharabi, Test Engineer Approved by: _____________________________ I. Raz, EMC Laboratory Manager This report must not be reproduced, except in full, without the written permission of I.T.L. (Product Testing) Ltd. This report relates only to items tested. Test Report E133980.03 Kyma Medical Technological Ltd. Page 2 of 67 FCC ACC M Ver 1.1 05Mayl 2000 Measurement/Technical Report for Kyma Medical Technological Ltd. μCOR System Monitor μCOR V1.0.0 FCC ID: 2ABHFUCOR100 This report concerns: Original Grant: X Class I Change: Class II Change: Equipment type: Low Power Transceiver, Rx Verified Limits used: 47CFR15 Section 15.209 Measurement procedure used is ANSI C63.4: 2003. Application for Certification Applicant for this device: prepared by: (different from "prepared by") R. Pinchuck Moshik Mosesko ITL (Product Testing) Ltd. Kyma Medical Technologies Ltd. 1 Bat Sheva Street Atir-Yeda Industry Park, Lod 7116002 17 Atir-Yeda St Israel Kfar-Sava, 4464313 e-mail [email protected] Israel Tel: +972- 72-211-9301 - Fax: +972- 72-211-9304- e-mail: [email protected] Test Report E133980.03 Kyma Medical Technological Ltd. Page 3 of 67 FCC ACC M Ver 1.1 05Mayl 2000 TABLE OF CONTENTS 1. GENERAL INFORMATION ------------------------------------------------------------------------------- 4 1.1 Administrative Information ................................................................................. 4 1.2 List of Accreditations ......................................................................................... 5 1.3 Product Description: .......................................................................................... 6 1.4 Test Methodology .............................................................................................. 6 1.5 Test Facility ....................................................................................................... 6 1.6 Measurement Uncertainty ................................................................................. 6 2. SYSTEM TEST CONFIGURATION --------------------------------------------------------------------- 7 2.1 Justification ........................................................................................................ 7 2.2 EUT Exercise Software ..................................................................................... 7 2.3 Special Accessories .......................................................................................... 7 2.4 Equipment Modifications ................................................................................... 7 2.5 Configuration of Tested System ........................................................................ 8 3. TEST SETUP PHOTO -------------------------------------------------------------------------------------- 9 4. FIELD STRENGTH OF FUNDAMENTAL ------------------------------------------------------------11 4.1 Test Specification ............................................................................................ 11 4.2 Test Procedure ................................................................................................ 11 4.3 Test Results..................................................................................................... 11 4.4 Test Instrumentation Used, Field Strength of Fundamental ........................... 30 5. RADIATED EMISSION, 9 KHZ – 30 MHZ -----------------------------------------------------------31 5.1 Test Specification ............................................................................................ 31 5.2 Test Procedure ................................................................................................ 31 5.3 Test Results..................................................................................................... 31 5.4 Test Instrumentation Used, Radiated Measurements ..................................... 32 5.5 Field Strength Calculation ............................................................................... 32 6. SPURIOUS RADIATED EMISSION, 30 – 25000 MHZ -------------------------------------------33 6.1 Test Specification ............................................................................................ 33 6.2 Test Procedure ................................................................................................ 33 6.3 Test Results..................................................................................................... 34 6.4 Test Equipment Used, Spurious Radiated Emission, 30 MHz – 25 GHz ....... 42 6.5 Field Strength Calculation 30 MHz – 1000 MHz ............................................. 43 7. AVERAGE FACTOR CALCULATION ----------------------------------------------------------------44 7.1 Test Instrumentation Used .............................................................................. 45 8. PLOTS OF THE HOPPING FREQUENCIES PER BAND ---------------------------------------46 8.1 Test Instrumentation Used .............................................................................. 52 9. DWELL TIME ON EACH CHANNEL ------------------------------------------------------------------53 9.1 Test Specification ............................................................................................ 53 9.2 Test Procedure ................................................................................................ 53 9.3 Test Instrumentation Used .............................................................................. 54 10. ANTENNA GAIN/INFORMATION ----------------------------------------------------------------------55 11. R.F EXPOSURE/SAFETY -----------…

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FCC 15.247 Test Set Up . Conducted Emission on AC Mains Test Conducted Emission from Antenna Port Test Radiated Emission Test as Stand-alone Radiated Emission Test as Stand-alone Radiated Emission Test as Stand-alone Radiated Emission Test as Stand-alone . Radiated Emission Test in Charging Mode . Radiated Emission Test in Charging Mode Radiated Emission Test in Charging Mode . Radiated Emission Test in Charging Mode FCC 15.209 Test Set Up Radiated Emission Test Setup Radiated Emission Test Setup Radiated Emission Test Setup . Radiated Emission Test Setup