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LifeWatch FGL-00005 User Manual

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LifeWatch Technologies Ltd. Vital Signs Patch (VSP) Gateway
The LifeWatch Technologies Ltd. Vital Signs Patch (VSP) device is
used with the VSP Gateway as part of the VSP System.
Before using the VSP Gateway, please read the sections of this guide
that describe its method of use and operation.
The VSP Gateway model number FGL-00005, FCC ID: SMTLWVGW
The references to gateway within this user guide refer to the VSP
Gateway.
If you have any questions about the use of Vital Signs Patch, please
contact:
Customer Service at:
1

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  • Page 1 LifeWatch Technologies Ltd. Vital Signs Patch (VSP) Gateway The LifeWatch Technologies Ltd. Vital Signs Patch (VSP) device is used with the VSP Gateway as part of the VSP System. Before using the VSP Gateway, please read the sections of this guide that describe its method of use and operation.
  • Page 2 Copyright 2014 LifeWatch Technologies Ltd.® All rights reserved. LifeWatch Technologies Ltd., LifeWatch Technologies Ltd. logo, LifeWatch Inc., LifeWatch Inc. logo, Vital Signs Patch System and VSP are trademarks or registered trademarks of LifeWatch Technologies Ltd.®. All other brand names and product names used in this document are trade names, service marks, trademarks, or registered trademarks of their respective owners.
  • Page 3 Declaration of Conformity LifeWatch Technologies’ Quality System (QS) is certified to ISO-9001:2008, ISO 13485:2003 CE 93/42 MDD and Canadian QS Requirements WARNING No modification of this equipment is allowed. Refer servicing to qualified personnel only. Equipment not suitable for use in the presence of flammable...
  • Page 4 Symbols on VSP System Label Description Warning Precaution Notes; indicates important general information for using the system successfully. Refer to instruction manual/ booklet NOTE: On ME EQUIPMENT "Follow instructions for use.” Manufacturer and date of manufacture XXXX WEEE Directive for disposal of Electrical and Electronic Equipment...

  • Page 5: Table Of Contents

    Table of Contents Glossary ................... 7 VSP System Introduction ............8 ........... 8 ENERAL ESCRIPTION ..........9 HYSICAL ESCRIPTION VSP G .......... 10 ATEWAY LACEMENT VSP Gateway Basic Operation .......... 11 ........11 ENERAL AFETY Getting Started ..............12 ....12 NSTALLING THE CARD MICRO...
  • Page 6 ............. 18 ONDITIONS OF VSP G ......... 18 ARING FOR YOUR ATEWAY ..............19 LEANING .............. 19 NVIRONMENT Troubleshooting ..............20 Specifications ............... 21 Appendix A Warnings and Precautions ........23 NOTICE POLICY AND MEDICAL WASTE DISCLAIMER ..

  • Page 7: Glossary

    VSP Gateway User Guide 1 GLOSSARY Main Processing Unit, vital sign data communication device that collects the body vital VSP TRANSMITTER signs and sends these signs to the gateway device. Electrocardiogram; a representation of the heart's electrical activity recorded from electrodes on the body surface Device for receiving vital signs from the VSP VSP Gateway...

  • Page 8: Vsp System Introduction

    VSP Gateway User Guide 2 VSP SYSTEM INTRODUCTION 2.1 General Description The VSP system is a medical device that records heart rate, ECG (3 Lead), surface temperature, blood oxygen saturation and respiration; the VSP transmits the vital sign recordings to a Monitoring station for viewing by medical personnel.

  • Page 9: Physical Description

    VSP Gateway User Guide 2.2 Physical Description Front View Front camera Power on/off Speaker Menu Key Earphone plug Home Key Volume +/– Back Key USB connector Microphone Rear Cover Removed Rear View Loudspeaker Rear Camera Reset Button Micro SD Card Slot SIM card Slot...

  • Page 10: Vsp Gateway Placement

    VSP Gateway User Guide 2.3 VSP Gateway Placement For optimal system performance, the recommended distances between the VSP Gateway and VSP Patch should be as follows: – Within 20 inches (50 cm) for normal operation – Within 10 feet (3 meters) during VSP Gateway charging –...

  • Page 11: Vsp Gateway Basic Operation

    VSP Gateway User Guide 1 VSP GATEWAY BASIC OPERATION 1.1 For Your General Safety The VSP Gateway device is a cell phone used within a medical system. Keep the device away from pacemakers, ICDs Do not make or receive handheld calls while driving; and other electronic medical devices (at least 6 do not text while driving.

  • Page 12: Getting Started

    VSP Gateway User Guide 3 GETTING STARTED 3.1 Installing the SIM card/micro SD card 1. Switch off your device before installing SIM. 2. Open the SIM card holder by sliding it in the direction of the OPEN arrow. 3. Hold the SIM card by the cut corner and slip it into the card holder. 4.

  • Page 13: Charging The Battery

    VSP Gateway User Guide 3.2 Charging the Battery 1. Connect the supplied USB plug to the USB/adapter jack. Ensure that you insert the plug with the correct orientation. Do not force the plug into the jack. USB input is 5 VDC: maximum 5.25VDC to minimum 4.75VDC at 1A max.

  • Page 14: Switching Your Device On/Off

    3.3 Setting up Your Device for the First Time will be done by LifeWatch Technical staff 3.3.1 Waking Up Your Device 1. Press Power to activate your screen display.

  • Page 15: Using The Gateway Application

    VSP Gateway User Guide 4 USING THE GATEWAY APPLICATION 4.1 Starting the Application To start the Gateway application  Activate the device running the application. The application is automatically launched and the Main Screen is displayed. The maximum unblocked distance between the VSP Transmitter and the Gateway is 10 meters (30 ft.);...
  • Page 16 VSP Gateway User Guide Figure 2 – Medical signal display To choose display of ECG or respiration 1. Select the vital sign signal viewer from the display. 2. The raw signal data is displayed. Figure 3 – ECG Respiration...

  • Page 17: Displaying Alerts

    VSP Gateway User Guide 4.4.1 Displaying HW/SW Version on the About Screen To display hardware/software information on the screen  On the left bottom, press the Menu button. Then, click Info. The Info screen is displayed with the hardware, software and Gateway application versions.

  • Page 18: Cleaning And Maintenance

    VSP Gateway User Guide 5 CLEANING AND MAINTENANCE 5.1 Conditions of Use The VSP Gateway conforms to international regulations insofar as it is used under normal conditions and in accordance with the instructions below. 5.2 Caring for your VSP Gateway ...

  • Page 19: Cleaning

    VSP Gateway User Guide 5.3 Cleaning A trained and certified technician is responsible for maintaining and cleaning the reusable parts of the VSP System. The VSP Gateway should be cleaned prior to transferring to another patient. 5.4 Environment  Keep the VSP Gateway away from extreme heat. Do not leave it on the dashboard of a car or near a heater.

  • Page 20: Troubleshooting

    Contact LifeWatch functional. customer service. If you are experiencing a critical error not included in this table, restart any running applications and then disconnect and reconnect the VSP Transmitter. If the critical error is not resolved, contact LifeWatch Customer Service.

  • Page 21: Specifications

    VSP Gateway User Guide 3 SPECIFICATIONS Basic Parameters LCD Parameter 4.3 inch 480*800 Pixels (WVGA) Touch Lens Yes (Capacitive Touch screen) Processor Dual-core, Cortex A9, 1GHz Memory 4GB Flash + 1GB RAM Android OS Android 4.1.2, Jelly Bean Storage Card Micro-SD, up to 32GB Battery Capacity 1480 mAh LI-IO, BAK512880P...
  • Page 22 VSP Gateway User Guide Front Camera Pixel 0.3MP Camera technology CMOS Picture Size Max 640*480 Physical Dimensions 132*71*13 mm (H*W*D) Weight 157 gram Environmental +10ºC to +40ºC Note: Body temperature measurement Operating temperature should be performed within an ambient temperature range of 22-26°C Humidity 10% to 95%, non-condensing Atmospheric...

  • Page 23: Appendix A Warnings And Precautions

    VSP Gateway User Guide APPENDIX A WARNINGS AND PRECAUTIONS Declaration of RoHS Compliance The VSP was designed by LifeWatch Technologies Ltd. to comply with Directive 2011/65 /EC of the European Parliament - RoHS (Restriction of Hazardous Substances) - with respect to the limited use or non-use use of the following substances in the device: ...
  • Page 24 VSP Gateway User Guide Warnings Due to the risk of ignition or fire, the VSP system is not intended for use in a hyperbaric chamber, within an oxygen tent or in the presence of flammable anesthetics / medical gases. To prevent an allergic reaction, do not use the VSP system or accessories if you have a known allergy to nickel, silver or other metals.
  • Page 25 VSP Gateway User Guide Precautions The VSP System generates, uses, and can radiate radio frequency energy and, if not used in accordance with the instruction manual, may cause harmful interference to radio communications. The VSP System employs cellular technology. The location of the VSP System and the associated environment, including cellular phone coverage in the particular area, may cause transmission interruption or delay.
  • Page 26 VSP Gateway User Guide Note: Modifications not expressly approved by the manufacturer could void the user authority to operate the equipment. 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.
  • Page 27 VSP Gateway User Guide Warning - Specific Absorption Rate (SAR) information SAR tests are conducted using standard operating positions accepted by the FCC with the phone transmitting at its highest certified power level in all tested frequency bands, although the SAR is determined at the highest certified power level, the actual SAR level of the phone while operating can be well below the maximum value, in general, the closer you are to a wireless base...
  • Page 28 RADIO OR TV INTERFERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS EQUIPMENT. SUCH MODIFICATIONS COULD VOID THE USER'S AUTHORITY TO OPERATE THE EQUIPMENT. Gateway (Model number FGL-00005, FCC ID: SMTLWVGW) Warnings Using Your Gateway near Other Electronic Devices Most modern electronic equipment is shielded from radio frequency (RF) signals.
  • Page 29 VSP Gateway User Guide Persons who have such devices: • Should ALWAYS keep the phone more than six (6) inches (15 cm) from their implantable medical device when the phone is turned • Should not carry the phone in a breast pocket; •...
  • Page 30 VSP Gateway User Guide Other Medical Devices If you use any other personal medical device, consult the manufacturer of your device to determine if it is adequately shielded from external RF energy. Your physician may be able to assist you in obtaining this information.

  • Page 31: Notice Policy And Medical Waste Disclaimer

    YOU SHOULD DISCONTINUE USE OF THE DEVICE, SOFTWARE, AND/OR OTHER SERVICES. MEDICAL WASTE DISCLAIMER In no event shall LifeWatch be liable for personal injury, or any incidental, special, indirect or consequential damages whatsoever that result from the disposal of any medical waste.

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