ZOLL Medical Israel UCOR100 uCOR System Monitor, uCOR V1.0.0 User Manual IFU USA FCCx

Kyma Medical Technologies Ltd. uCOR System Monitor, uCOR V1.0.0 IFU USA FCCx

Contents

Users Manual

µCor 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: info@Kyma-med.com 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 ...................................................................... 20 5.7 CLEANING THE CARTRIDGE .................................................................................................................. 20 6. Troubleshooting ............................................................................. 21 7. Cleaning and Maintenance ............................................................. 22 7.1. NOTES ON CLEANING AND MAINTENANCE ............................................................................................ 22 7.2. GENERAL CLEANING PROCEDURES ....................................................................................................... 22 8. Repair policy ................................................................................... 23 9. Storage ........................................................................................... 24 10. System Labels and Symbols .......................................................... 25 10.1. SYSTEM LABELS .............................................................................................................................. 25 10.2. EXPLANATION OF SYMBOLS .............................................................................................................. 27 11. Specifications ................................................................................ 28 11.1. SYSTEM ACCURACY ......................................................................................................................... 28 11.2. ENVIRONMENTAL INFORMATION ....................................................................................................... 28 11.3. ELECTRICAL ................................................................................................................................... 28 11.4. CARTRIDGE DIMENSIONS ................................................................................................................. 28
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 5 12. Warranty ...................................................................................... 29 Appendix A: LED Indicator Lights on the Cartridge .............................. 30 Appendix B: Cartridge Battery Maintenance and Care ........................ 31 Appendix C: Hospital Protocol ............................................................ 31 DESCRIPTION: ........................................................................................................................................ 31 TERMS .................................................................................................................................................. 32 PATIENT RECRUITMENT ............................................................................................................................ 32 PATIENT FOLLOW-UP ............................................................................................................................... 33 PATIENT RELEASE .................................................................................................................................... 34
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 6 1. INTRODUCTION 1.1. ABOUT THIS USER GUIDE This User Guide provides the information necessary to operate the Kyma µCor System. PLEASE READ THIS USER GUIDE BEFORE OPERATING THE SYSTEM. If any part of this User Guide is not clear, contact Customer Support for assistance. 1.2. GLOSSARY AND ABBREVIATIONS BT: Blue Tooth CHF: Congestive Heart Failure ESS: Electronic Synchronization Signal GUI: Graphic User Interface RF: Radio Frequency FS: Fluid Status UCID: Identification number of the Medical Cartridge CLOUD: BT TO TCP/IP COMMUNICATION 1.3. THE KYMA µCOR SYSTEM µCor is a non-invasive, impedance-based device that assesses a patient's Fluid Status (FS) by measuring the electromagnetic properties of the thorax. The µCor system consists of the following main parts: 1. Disposable Medical Patch – An adhesive patch with a plastic anchoring frame and two ESS electrodes. The Cartridge clicks into the plastic frame. 2. Reusable Cartridge – A plastic box which includes the RF bio-impedance sensor, communication unit, and two additional sensors: Electronic synchronization signal (ESS) leads and accelerometer. The Cartridge has also a green/amber LED light indicator. 3. Charger – A charging cradle for recharging the Cartridge battery. 4. Server – Data base application software, used to collect the data, analyze it and present the data to the user. This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 7 2. CONDITIONS FOR USE 2.1. INTENDED USE AND INDICATIONS FOR USE The µCor System is indicated for patients: • With fluid management problems • Taking diuretic medication • Living with heart failure • Living with end-stage renal disease • Recovering from an event related to coronary artery disease • Suffering from recurrent dehydration • With severe infection (such as sepsis) • With hypertension. 2.2.CONTRAINDICATIONS The system is not for use by patients: • with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive • with implanted Neurostimulators • with skin breakdown in areas on the chest where electrode device placement is required. • Pregnant women.
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 8 3. SAFETY 3.1. TYPES OF WARNINGS, CAUTIONS AND NOTES Three types of special message appear in this User Guide: Warning: A warning indicates precautions to avoid the possibility of personal injury or death. Caution: A caution indicates a condition that may lead to damage to equipment, or a lower quality of treatment. Note: A note provides other important information. 3.2. GENERAL SAFETY INSTRUCTIONS Warnings: DO NOT USE BEFORE READING THIS USER GUIDE. Remove Cartridge and Medical Patch before external defibrillation or any emergency medical procedure. Changes or modifications not expressly approved by Kyma Medical Technologies Ltd. can affect the safety and effectiveness of the system and will void the system's warranty. The system contains no user-serviceable components. Electrical shock and flammability hazard – Cleaning the device should be limited to the simple procedure discussed on page 22. For any additional cleaning or servicing, always consult Kyma Medical Technologies Ltd. Electrical shock hazard – Do not remove the cover from any components of the system. An operator may only perform maintenance procedures specifically described in this User Guide. Refer servicing to qualified service personnel trained in the repair of this equipment. Electrical shock hazard – Connect this equipment only to a hospital-grade AC electrical socket. Electrical shock hazard –Keep any kind of liquid or food away from the charger
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 9 Cautions: Disposal of this device should be performed in accordance with local regulations. If the device is not working correctly, discontinue use and contact Customer Support for assistance. Do not use this device in the presence of MRI or when entering extreme heat conditions. (over 50°C) Do not disassemble any part of the system components. This system is not user-serviceable. 3.3. ELECTRICAL SAFETY The device complies with IEC/EN 60601-1 for general requirements of medical electrical equipment safety: • Type BF applied part • Mode of operation: spot measurement • Degree of mobility: portable • Compatibility with implanted defibrillators • Compatibility with pacemaker. 3.4. EMC COMPLIANCE The unit has IEC 60601-1-2 Class B compliance.
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 10 3.5. FCC COMPLIANCE STATEMENT The FCC Wants You to Know This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: a) Reorient or relocate the receiving antenna. b) Increase the separation between the equipment and receiver. c) Connect the equipment to an outlet on a circuit different from that to which the receiver is connected. d) Consult the dealer or an experienced radio/TV technician. FCC Warning Modifications not expressly approved by the manufacturer could void the user authority to operate the equipment under FCC Rules. THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO OR TV INTERFERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS EQUIPMENT. SUCH MODIFICATIONS COULD VOID THE USER’S AUTHORITY TO OPERATE THE EQUIPMENT.
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 11 4. OVERVIEW OF SYSTEM COMPONENTS 4.1. DEVICE DESCRIPTION The Kyma µCor system is an RF-based non-invasive device that assesses and displays a patient's Fluid Status (FS) trends. The system is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications. The system can monitor heart rate, respiratory rate and motion level on top of FS. 4.2. DIAGRAM OF SYSTEM MAIN COMPONENTS AND COMMUNICATION The main components of the Kyma µCor System and their connections are illustrated in the diagram below: Communication between device main components The description of system components is provided in the following sections. 4.3. CARTRIDGE The Cartridge is a thin, waterproof, reusable plastic housing. It contains two ESS leads and a LED light. Note that while wearing the Cartridge the patient can do everyday activities such as walking or taking a shower. The Cartridge clicks into a disposable Medical Patch (page 13). There is a wireless link between the Cartridge and the server. The Cartridge transmits the data to the Cloud, where the data is sent to the server. A Bi-Color LED (amber/green) is located close to the center of the Cartridge for status indications. See Appendix A for a description of the LED indicator light on the Cartridge and its meaning. Note: The Cartridge contains a button for technician use only. TCP/IP BT communication Cartridge
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 12 4.3.1. CARTRIDGE FRONT PANEL The Cartridge front panel contains most of the components that are relevant for the user. The components are shown below. 4.3.2. CARTRIDGE BACK PANEL The Cartridge back panel contains the following: Caution: Avoid spilling food or liquids on the Cartridge. Cartridge Front Panel Components Number Description 1 ESS leads (Left and Right) 2 LED light (Amber/Green) 3 Technician button 4 Upper snap in clip 5 Lower snap in joints Caution: if you experience a problem with the Cartridge, do not use the device. Call customer support. Caution: When not in use, the Cartridge must be stored in the Charger. Cartridge Back Panel Components Number Description 1 ESS leads (Left and Right) 2 Upper snap in clip 3 4 Lower snap in joint Cartridge Serial Number and FCC ID Cartridge front view Cartridge back panel
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 13 Note: The Cartridge Serial Number (S/N) and FCC ID can be found on the back of the Cartridge: 4.4. CHARGER A dedicated Charger is supplied along with the Cartridge. The Charger is a charging cradle for recharging the Cartridge battery. The charger does not contain any LED lights, as battery status is shown on the Cartridge. The charger is supplied with an AC adapter. Caution: The Charger has its own AC adapter. Be sure to use only the adapter that is supplied with the charger. 4.5. MEDICAL PATCH The adhesive Medical Patch is disposable and intended for one-time use. Although the Medical Patch is normally worn by the patient continuously, from patient admission to discharge, it may require replacement under certain circumstances (see page 17). S/N DG3212-000-001 The cartridge ID FCC ID 2ABHFUCOR100
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 14 ESS Electrode ESS Electrode Patch Frame Snap-in mechanism Medical Patch The Medical Patch consists of a plastic Frame for the Cartridge and two ESS electrodes embedded on each side of the Frame. Attachment of the Cartridge to the Medical Patch is performed using a snap-in mechanism, while attachment of the ESS leads is done by clicking in the ESS electrodes. The Cartridge is connected to the Frame part of the Medical Patch when patient is admitted, and disconnected after the patient is released from hospitalization. Cartridge and Patch, showing Patch Frame Cartridge attached to the Medical Patch
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 15 Caution: If you suspect that the Medical Patch may be damaged, discontinue use and replace with a new Medical Patch. See page 17 for detailed Medical Patch replacement instructions. Caution: If you are experiencing a problem with the Cartridge or components, contact Kyma Medical Technologies customer support. Caution: Monitor the patch location for any irritation or inflammation. 4.6. COMPONENTS: SERVER The server manages the data received from the Cartridge, using specialized database software. The server: • Notes changes in the Cartridge status • Downloads data from the Cartridge on a scheduled basis, and • Processes the measured data.
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 16 Cartridge and Medical Patch 5. USING THE UCOR DEVICE Before using the Kyma µCor system, first read the system Contraindications on page 7. If the patient presents any of the Contraindications, do not use the system. After you have verified that the Contraindications allow use of the system, prepare the patient by describing the system and procedure. 5.1. DETERMINING THE CORRECT LOCATION FOR THE MEDICAL PATCH The Medical Patch should be located at or near the following desired anatomical location: • Left (patient side) mid-axillar line at the fifth intercostal space. Caution: The Medical Patch should be aligned with the mid-axillary line. 5.2. APPLYING THE MEDICAL PATCH Once the correct anatomical location for the Medical Patch is found, proceed as follows to attach the Medical Patch to the patient: [1] Turn the Medical Patch so that the word "Kyma" that is printed on the bottom is pointing in the direction of the patient's legs: Proper attachment of the Patch to the left side of the patient's chest Location of the Medical Patch
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 17 [2] Remove the Medical Patch's paper backing. [3] Attach the Medical Patch. The woven part of the Medical Patch should be flat and even. Please note that the Medical Patch is normally worn by the patient from admission until discharge. Note: When attaching the medical patch please ensure minimal air bubbles 5.3. REPLACING THE MEDICAL PATCH After the initial attachment, the Medical Patch should remain in place on the left side of the patient's body, unless it requires replacement. It is advised to use water to assist in removing the patch. The patch should be removed gently. It is recommended to hold the skin with one hand while using the other hand to detach the patch from the patient's body. Caution: Replace the old Medical Patch if one of the following conditions occurs: • Medical Patch is causing discomfort to the patient. • Medical Patch appears to be soiled. • Medical Patch is not securely attached to the patient. • Medical Patch is not smooth and even, or shows other signs of wear. • The patch Frame part of the Medical Patch is worn, broken or otherwise unsuitable to providing a secure connection for the Cartridge. It is recommended to replace the Medical Patch at least every 5 days. Caution: In order to ensure accuracy in the measurements, the Cartridge (and therefore the Medical Patch) must be in the same location for all measurements. If the old Medical Patch requires replacement make sure to relocate the new Medical Patch at the same location as the old Medical Patch. Warning: Be careful that removal of the Medical Patch does not harm the skin, especially for elderly patients.
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 18 5.4. CONNECTING THE CARTRIDGE TO THE MEDICAL PATCH The Cartridge is attached to the Medical Patch during patient hospitalization for the TFC measurements. The Cartridge is attached to the patch Frame area of the Medical Patch, as shown below: Proceed as follows to connect the Cartridge to the Medical Patch: 1. Place the lower snap in joints of the Cartridge on the lower part of the patch Frame, pressing first on the bottom of the Cartridge. Make sure the lower snap-in joints are between the Frame and the woven part. 2. While pressing the upper snap in clip, press the rest of the Cartridge onto the Medical Patch. 3. The Cartridge should be firmly attached, and should stay connected to the Medical Patch without any effort on the part of the patient. 4. Attach the two ESS leads to the two ESS electrodes and make sure they are well attached. It is preferable to charge the Cartridge when it is not assigned to a patient, unless it is assigned and the battery power is low. Note: When applying the cartridge to a new patient, make sure the previous patient was released from the GUI application and that a flashing green LED light is on the Cartridge. 5.5. CHARGING THE CARTRIDGE It is recommended that the Cartridge will be charged every two days for one hour in order to maintain adequate battery status. Cartridge and Medical Patch, showing the patch Frame area of the Medical Patch Cartridge attached to the Medical Patch Cartridge located at final position
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 19 In order to charge the Cartridge, remove the device and its connections from the patient. The Cartridge should be removed from the Medical Patch as follows: 1. Disconnect the two µCor ESS leads from the Medical Patch. 2. Tilt and remove the Cartridge from the Medical Patch while pressing the upper snap in clip. 3. Place the Cartridge in the charger and wait for a steady amber LED light. 4. The steady amber light should change to a steady green light within around one hour, indicating the device is fully charged. 5. Reconnect the Cartridge to the Medical Patch as described at page 23. Steady amber light Steady green light
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 20 5.6. REMOVING THE DEVICE CONNECTIONS FROM THE PATIENT The Cartridge should be removed from the Medical Patch as follows: 1. Disconnect the two µCor ESS leads from the Medical Patch. 2. Tilt and remove the Cartridge from the Medical Patch while pressing the upper snap in clip. 3. Remove the Medical Patch from the patient. 4. Place the Cartridge in the charger and wait for a steady amber LED light. (If no light appears after 1-2 seconds check troubleshooting table for required actions) 5. If patient is still active, the amber light will change to green after 1-2 hours, indicating the device is fully charged. 6. If the patient has been discharged, the steady amber light should change to a flashing green light within around two hours, indicating the device is charged and ready for a new patient. Note: A steady (non-flashing) green light means the µCor is still referenced to the previous patient at the server. The Cartridge is ready for a new patient only when there is a flashing green LED light- DO NOT APPLY DEVICE TO A NEW PATIENT UNTIL THIS INDICATION OCCURS. The Cartridge should be cleaned and disinfected before using it for a new patient. Please see cleaning and disinfecting instructions on page 22. 5.7 CLEANING THE CARTRIDGE After disconnecting the Cartridge from the patient: • Clean and disinfect the Cartridge, as shown on page 22. • Place the Cartridge in the charger and make sure the LED light is on. When the green LED light is flashing, the system is ready for a new patient. (previous patient is released and the battery is fully charged) Caution: If the green LED light is not flashing, the last active patient was not yet released from the server. Steady amber light Flashing green light
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 21 6. TROUBLESHOOTING The following table lists the recommend actions that assist in µCor System troubleshooting. Condition Possible Cause Recommended Action Improper patch attachment to skin Improper patch attachment Replace the Patch and re-attach according to instructions(see page 22) Disposable patch re-use Attach only new Medical Patch. Re – using patches may result in patient cross – contamination and inaccurate measurements Low battery Cartridge is not charged place the Cartridge in the charger Charger is not connected to AC power Make sure charger is connected to AC power and amber LED light is on No LED light while in charger Charger is not connected to AC power Make sure charger is connected to AC power System fault Contact customer support
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 22 7. CLEANING AND MAINTENANCE 7.1. NOTES ON CLEANING AND MAINTENANCE The µCor System does not require maintenance or cleaning on a routine basis, except as suggested in this User Guide. Any other service should only be provided by an authorized Kyma Medical Technologies Ltd. representative. Failure to do so voids the warranty and may cause user injury. Please see Appendix B on page 41 for Cartridge battery maintenance and care. 7.2. GENERAL CLEANING PROCEDURES Note: . The Medical Patch is normally worn by the patient from admission until discharge. However, see page 17 for conditions that require replacement of the Medical Patch. Caution: The Medical Patch is for one-time use on one patient only. A Medical Patch that has been used once must be discarded. It cannot be reused. Re – using patches may result in patient cross – contamination and inaccurate measurements If you replace the Medical Patch on a patient, please be sure to follow the directions on page 17. Please observe the following cautions when cleaning the Cartridge: 7.2.1. CLEANING THE CARTRIDGE The plastic and metal outer surface of the Cartridge may be cleaned with a soft, lint-free cloth dampened in a mild soap and water solution or ethyl alcohol (70-85%). If disinfecting is required, wipe the surface with isopropyl alcohol (IPA), then wipe with a water-moistened soft cloth. Caution: Use cleaning solution sparingly. Excessive solution can cause damage to internal components. Caution: Contact with solvents can cause severe deterioration of plastic parts and malfunctioning of the instrument and accessories.
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 23 8. REPAIR POLICY When under warranty, repair and service must be performed by Kyma Medical Technologies Ltd. When the Kyma warranty is not applicable, repairs may be made by Kyma or authorized representatives. Warning: Do not remove the covers of the device components. Only perform procedures specifically described in this User Guide.
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 24 9. STORAGE Environmental Conditions for Storage and Transportation Temperature -20°C to +60°C Relative Humidity 5% to 93%, non-condensing
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 25 10. SYSTEM LABELS AND SYMBOLS 10.1. SYSTEM LABELS System Label Serial Label FCC Label Cradle Label
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 26 Patch Label
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 27 10.2. EXPLANATION OF SYMBOLS The following symbols may appear on the device or shipping materials. Follow instructions for use The serial number for this product Dispose of this product according to local environmental regulations Type BF applied part Date of Manufacture Do not re-use Manufacturer Expiry date Direct current
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 28 11. SPECIFICATIONS 11.1. SYSTEM ACCURACY The overall system accuracy presents an error of less than 25cc fluid at a confidence level of 90%. 11.2. ENVIRONMENTAL INFORMATION Operating room temperature +10 to +35° C (+50 to +95° F) Relative humidity 10% to 90% non-condensing 11.3. ELECTRICAL 11.3.1. POWER Cartridge: Max Power Consumption: 0.85W Nominal Power Consumption: 0.65W Max Rating: 4.2V, 0.2A Nominal Rating: 3.7V, 0.18A Battery Type: Li-Pol, 3.7V, 350mAh Charger: Consumption during charging: 1W Input (plug): 5VDC, 0.4A Adaptor: Input: 100 to 240 VAC at 50/60Hz; 0.18A Output: 5VDC; 0.6A 11.4. CARTRIDGE DIMENSIONS • Height: 60.5 mm • Width: 99 mm • Depth: 15.9 mm • Weight: maximum of 62 gram
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 29 12. WARRANTY Service Support Repairs of the µCor System under warranty must be made by authorized repair centers. If the device needs repair, contact Kyma Medical Technologies Ltd. service department or your local distributor. If you need to ship the device, pack the device and its accessories carefully to prevent shipping damage. Duration Kyma Medical Technologies Ltd. will repair or replace, at its sole discretion, the product or any defective part, provided it is returned to Kyma service within 30 days.
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 30 APPENDIX A: LED INDICATOR LIGHTS ON THE CARTRIDGE The table below describes the Cartridge LED lights indications. The LED is a two-color (green/amber), single element light. GENERAL LED LIGHT NOTES: • When the Cartridge is out of the charger there is no light • When the Cartridge is placed in the charger the light will be on (see table below for options) • Green light means battery is fully charged • Amber light means battery is being charged. LED Constant/Flashing LED Color Green Amber Constant LED light Active patient (the Cartridge placed in charger during patient admission and is fully charged) Cartridge is being charged Flashing LED light Previous patient is released and Cartridge is ready for a new patient (the Cartridge placed in charger is fully charged) Error, if repeats more than once contact Kyma Note: Only when the flashing green LED light is on, the battery is full and the Cartridge is ready for a new patient. Cartridge, showing amber LED Light
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 31 APPENDIX B: CARTRIDGE BATTERY MAINTENANCE AND CARE The Li-Pol battery used in the Cartridge will provide optimum life when the unit is fully charged every two days and after each patient release. With the battery fully charged, the device can operate for about four days assuming measurement every two hours. Operation times may vary according to the measurement schedule and battery retention. A depleted battery requires up to 120 minutes of continuous charge time to fully charge. Time between charging operations depends on measurement scheduling, for example: - If scheduling 4 measurements per day of 1 minute each, device should be charged once a week. - If scheduling a 1 minute measurement every 2 hours, device should be charged every 2-3 days. Battery life varies depending on frequency of use and maintenance. For improved battery life, keep the Cartridge in the charger when not in use. If the battery has been fully charged and requires recharging after a few measurements, consider contacting customer service. FOR OPTIMAL BATTERY PERFORMANCE: • Always fully charge battery prior to assigning a new patient. • Put the Cartridge in the charger when not in use. • Connect the charger only to an AC power source that is supplied with the charger and wait for the amber LED light to change to green. • Operate the Cartridge, charge batteries, and store at room temperature (25 °C / 77 °F). • If the µCor system is not in use for more than a week, fully charge the battery prior to using the Cartridge. • Repeated undercharging of the battery will damage the battery and reduce battery life. • A fully charged Cartridge battery stored outside the charger will need to be recharged every six months. If the Cartridge battery is not charged every three months it will be damaged. A depleted battery will not perform as expected after a full recharge and will eventually require replacement. APPENDIX C: STUDY PROTOCOL DESCRIPTION: uCor device is used supervised by Kyma field technician. Technician is responsible for all maintenance operations: charging, adhesive patch replacement, device removal & attachment. For each patient one uCor device is attached. Cellular Gateway (GW) is placed near patient bed. Server monitoring is performed by experiment supervisor at Kyma, on a daily basis. Experiment duration: from admission until discharge and no longer than two month.
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 32 TERMS F.T – Field Technician E.S. – Experiment Supervisor PATIENT RECRUITMENT Step Title E.S Action F.T Action 1 Device Attachment Verify that LED is blinking green when device is in charger ("ready for new patient"). Attach the device to the patch. Attach the Patch to the patient's chest; Inform E.S by e-mail that a new patient had been recruited (report: time of patch attachment, device Index). 2 Recruitment Form Fill-in Form A. Send to E.S 3 Website patient recruitment. Assign a patient ID at website. Fill in the patient details (uCor device Idxs, patient Idx, GW idx) at xls table (Use-at-hospital Device status.xls). Observe the first 2-3 measurements and verify ESS and RF signals are ok.
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 33 PATIENT FOLLOW-UP Step Title E.S Action F.T Action 1 E.S follow-up (Performed twice a day) Review error page and measurement results per patient twice a day and instruct the technician accordingly by mail. Fill in the relevant checks at experiment log. - 2 F.T pre follow-up Check your mail for instructions from E.S right before the visit. If any special instructions appear, act accordingly. If no special instructions, proceed according to next steps 3 Charging Remove device from patient and place in the charger. Check patch condition- Replace if not satisfactory (starting to peel off) or 5 days from last replacement. 4 Back to work After LED has turned green, place device back on patient (~1-2 hours charging time).
User Guide Kyma µCor © 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0 Page 34 PATIENT RELEASE Step Title E.S Action F.T Action 1 Device Removal Take off patch and Cartridge, collect the GW. 2 Server Release Verify all measurement had been downloaded from uCor to server PRIOR to releasing the patient. Perform release procedure at server. Place cartridge in charger and inform E.S of patient release by e-mail. Place device, charger & GW at storing room, connected to chargers.

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