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sorin SMARTVIEW KA961 User Manual

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User's manual
KA961 – Wireless model

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Summary of Contents for sorin SMARTVIEW KA961

  • Page 1 User's manual KA961 – Wireless model...
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  • Page 3: Table Of Contents

    TABLE OF CONTENTS Introduction ................. 6     Indication ..................6     Warnings and precautions ............7     3.1. Warnings ................7     3.2. Safety precautions ............7     3.3. Precautions for safe operation ........8  ...
  • Page 4   Guidance and manufacturer’s declaration ......21   14.1.   Electromagnetic emissions ..........21   14.2.   Electromagnetic immunity ..........22   14.3.   Recommended separation distances between portable and mobile RF communications equipment and the SMARTVIEW monitor ...... 25  ...
  • Page 5 SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH IEC 60601-1, CAN/CSA 60601-1, ANSI/AAMI ES 60601-1. Name and address of the manufacturer. Sorin Reference of the SMARTVIEW monitor Serial number Temperature limits for storage and transportation Humidity limits for storage and transportation USB Type B Power supply connector at SMARTVIEW Monitor level ENGLISH –...
  • Page 6 Ref. P601006 Use only power block ref. P601006 with your monitor The monitor shall be powered only with direct current. The power block packaged with your monitor fulfils this requirement. This electronic product is subject to disposal and recycling regulations that vary by country and region.
  • Page 7 This manual addresses many of the questions you or your family may have about your SMARTVIEW monitor and its use. If you have technical or usage questions that are not covered in this manual or you want more in-depth information, please contact the Sorin toll-free technical assistance. ENGLISH –...

  • Page 8: Introduction

    The SMARTVIEW monitor you received is part of the SMARTVIEW Remote Monitoring System. This system has been specially designed to transmit information stored in your Sorin implanted cardiac device to your doctor on a regular basis. Your Sorin cardiac device is equipped with a transmitter which sends clinical information and device parameters to your doctor through the SMARTVIEW monitor using Radio Frequency wireless technology.

  • Page 9: Warnings And Precautions

    Sorin. Unauthorized modification may void the equipment authorization from the FCC and will void the Sorin warranty. Use only Sorin supplied accessories. Keep Children Away –...

  • Page 10: Precautions For Safe Operation

    Power supply – The SMARTVIEW monitor should be connected exclusively to a Sorin power adaptor. Power supply protection –...

  • Page 11: Familiarise Yourself With Your Smartview Monitor

    4. FAMILIARISE YOURSELF WITH YOUR SMARTVIEW MONITOR 4.1. PACKAGE CONTENTS Inside the box you will find: 1 SMARTVIEW 1 Power adaptor User’s manual monitor Do not use any other parts than the ones supplied with the SMARTVIEW monitor, as this may result in increased emissions or decreased immunity of the equipment.

  • Page 12: Description

    4.2. DESCRIPTION A/ Patient initiated transfer button B/ Progress bar C/ Status light D/ Power supply inlet (cable with the orange mark) – ENGLISH...

  • Page 13: Meaning Of The Lights And Buttons

    4.3. MEANING OF THE LIGHTS AND BUTTONS Light or button State Colour Meaning Status light No colour The SMARTVIEW monitor is not plugged in properly. Please check the connections. If the status light remains off, please contact our toll-free technical assistance.

  • Page 14: Using Your Smartview Monitor

    5. USING YOUR SMARTVIEW MONITOR The Sorin SMARTVIEW monitor works automatically. Therefore, you will have no interaction with it except at installation and only on your doctor’s request. 5.1. SETTING-UP YOUR SMARTVIEW MONITOR In order to perform the installation of your SMARTVIEW monitor in a quick, easy and safe way, we recommend you to call our technical assistance (see toll-free phone numbers at the end of this manual).

  • Page 15: Complete The Installation With Communication Setup

    COMMUNICATION SETUP At this stage, your SMARTVIEW monitor will need to “talk” with your Sorin implanted device. You will not feel anything as it is fully independent of your clinical treatment. Press the Patient Initiated Transfer button gently until you feel a click.

  • Page 16: Patient Initiated Transfer Operation

    5.4. PATIENT INITIATED TRANSFER OPERATION Your doctor may ask you to press the Patient Initiated Transfer button. Follow his instructions closely, but do not use this button unless your doctor requests it. 6. TRAVELLING If you are planning to travel, you should inform your doctor of your dates of absence.

  • Page 17: Maintenance And Recycling

    10. FAQ Why do I need to be monitored? You have been advised to install Sorin’s monitor in your home so that your doctor can closely follow your heart disease and identify potential needs for adjustments to your treatment. Should you have any questions or need further information, please contact your doctor.

  • Page 18: Technical Specifications

    11. TECHNICAL SPECIFICATIONS If you suspect any kind of default, please call our toll-free technical assistance. Our technicians will help you and run investigations if needed. Part number KA961 Dimensions Height: 59 mm Width: 156 mm Depth: 122 mm Weight 250 g Power supply AC input : 100-240 V~ 50-60 Hz 250 mA...

  • Page 19: Data Protection

    Please contact your doctor or our toll-free technical assistance. 13. DECLARATION OF CONFORMITY Sorin declares that this device conforms to the following Product Specifications: Safety - IEC 60601-1:2005 (Ed. 3) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
  • Page 20 EN 301 489-27 v1.1.1 - Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI- EN 301 489-17 v2.1.1 - Specific conditions for Broadband Data Transmission Systems. EN 301 489-7 v1.3.1 - Specific conditions for mobile and portable radio and ancillary equipment of digital cellular radio telecommunications systems (GSM and DCS).
  • Page 21  Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.  Consult the dealer or an experienced radio/TV technician for help. CAUTION: This equipment may not be modified, altered, or changed in any way without signed written permission from Sorin. Unauthorized ENGLISH –...
  • Page 22 FCC and will void the Sorin warranty. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

  • Page 23: Guidance And Manufacturer's Declaration

    14. GUIDANCE AND MANUFACTURER’S DECLARATION 14.1. ELECTROMAGNETIC EMISSIONS The SMARTVIEW monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the SMARTVIEW monitor should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...

  • Page 24: Electromagnetic Immunity

    14.2. ELECTROMAGNETIC IMMUNITY The SMARTVIEW monitor is intended for use in the electromagnetic environment specified below. The user of the SMARTVIEW monitor should assure that it is used in such an environment. Immunity test IEC 60601 test Compliance Electromagnetic level level environment - guidance...
  • Page 25 Immunity test IEC 60601 test Compliance Electromagnetic level level environment - guidance Voltage dips, short <5 % UT <5 % UT Mains power quality interruptions and (>95 % dip in UT) (>95 % dip in should be that of a voltage variations on for 0,5 cycle typical home...
  • Page 26 Recommended separation distance: 3 Vrms Conducted RF  150 kHz IEC 61000-4-6 80 MHz  80 to 3 V/m Radiated RF 800 MHz 3 V/m 80 MHz IEC 61000-4-3  2.5 GHz 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

  • Page 27: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Smartview Monitor

    14.3. RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE SMARTVIEW MONITOR The SMARTVIEW monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the SMARTVIEW monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SMARTVIEW monitor as recommended below, according to the maximum output power of the...

  • Page 28: Technical Assistance

    15. TECHNICAL ASSISTANCE For any assistance or question you may have about your SMARTVIEW monitor, please call our toll-free Sorin technical assistance. Our technical assistance desk is open from Monday to Friday from 8:00 AM to 6:00 PM local time, except public holidays.
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  • Page 30 Manufactured in )UDQFH for: Distributed by: Sorin CRM S.r.l. Sorin CRM USA, Inc. Via Crescentino s.n. 14401 West 65th Way 13040 Saluggia (VC) - Italy Arvada, CO 80004 USA Tel: +39 0161 487095 Tel: 877.663.7674 Facsimile: +39 0161 487524 Facsimile: 763.383.4713 or 877.443.3134 www.sorin.com...

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