Table of Contents
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TABLE OF CONTENTS
1. Introduction.................................................................................5
2. Indication.....................................................................................5
3. Warnings and precautions.........................................................5
3.1. Warnings ...........................................................................5
3.2. Safety Precautions ...........................................................6
3.3. Precautions for safe operation .......................................6
4. familiarise yourself with your SMARTVIEW monitor ..............7
4.1. Package contents.............................................................7
4.2. Description........................................................................8
4.3. Meaning of the lights and buttons..................................9
5. Using your SMARTVIEW monitor .............................................10
5.1. Setting-up your SMARTVIEW monitor ...........................10
5.3. Operational usage............................................................13
5.4. On-demand operation......................................................13
6. Travelling.....................................................................................13
7. Moving home...............................................................................14
8. SMARTVIEW monitor basic care...............................................14
9. Maintenance and Recycling ......................................................14
10. FAQ ..............................................................................................15
11. Technical specifications ............................................................16
12. Data protection ...........................................................................17
13. Declaration of conformity ..........................................................17
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ENGLISH -
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Summary of Contents for sorin SMARTVIEW KA960
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Page 1: Table Of Contents
TABLE OF CONTENTS 1. Introduction.................5 2. Indication..................5 3. Warnings and precautions............5 3.1. Warnings ................5 3.2. Safety Precautions ............6 3.3. Precautions for safe operation ........6 4. familiarise yourself with your SMARTVIEW monitor ....7 4.1. Package contents.............7 4.2. Description................8 4.3. Meaning of the lights and buttons........9 5. - Page 2 14. Guidance and manufacturer’s declaration.......19 14.1. Electromagnetic emissions..........19 14.2. Electromagnetic immunity ..........20 14.3. Recommended separation distances between portable and mobile RF communications equipment and the SMARTVIEW monitor......23 15. Technical assistance..............24 – ENGLISH...
- Page 3 LIST OF SYMBOLS This symbol is used to encourage you to consult the documentation and manual enclosed in the packaging. This symbol confers the approval of the US Federal Communications Commission. This symbol indicates that the device meets UL requirements. Remote Cardiac Monitor (Medical Equipment) WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH IEC 60601-1, CAN/CSA 60601-1, ANSI/AAMI ES 60601-1.
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Page 4: About This Manual
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 CRM toll- free technical assistance. – ENGLISH... -
Page 5: Introduction
Monitoring System. This system has been specially designed to transmit information stored in your Sorin CRM implanted cardiac device to your doctor on a regular basis. Your Sorin CRM 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 6: Safety Precautions
SORIN. Unauthorized modification may void the equipment authorization from the FCC and will void the SORIN warranty. Use only Sorin CRM supplied accessories. Keep Children Away –... -
Page 7: Familiarise Yourself With Your Smartview Monitor
Interferences – The SMARTVIEW monitor can be influenced by other household appliances (such as alarm clock, mobile phone). If possible, you should avoid placing electrical appliances next to the SMARTVIEW monitor. Check button - Do not press the Check button on the bottom of the transmitter unless requested to do so by our toll-free technical... -
Page 8: Description
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. 4.2. DESCRIPTION A/ On-Demand button B/ Progress bar C/ Status light D/ Telephone ports 1 and 2 E/ Power supply inlet (cable with the orange mark) –... -
Page 9: 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 properly plugged in or not connected to the telephone network. Please check the connections. If the status light remains off, please contact our toll-free technical assistance. -
Page 10: Using Your Smartview Monitor
5. USING YOUR SMARTVIEW MONITOR The Sorin CRM 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 quickly, easily and safely way, we recommend you to call our technical assistance (see toll-free phone numbers at the end of this manual). - Page 11 Sorin CRM black telephone cable to connect the SMARTVIEW monitor to the telephone wall socket as shown in the picture below: - if your phone is already plugged into the telephone wall socket, unplug your own telephone cable from the telephone wall socket and plug it into one of the telephone ports at the back of the SMARTVIEW monitor.
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Page 12: Complete The Installation With Communication Setup
COMMUNICATION SETUP At this stage, your SMARTVIEW monitor will need to “talk” with your Sorin CRM implanted device. You will not feel anything as it is fully independent of your clinical treatment. Press the On-Demand button gently until you feel a click. You will see the On-Demand button constant green for between 30 seconds and 1 minute. -
Page 13: Operational Usage
5.3. OPERATIONAL USAGE In order to reduce any inconvenience, your SMARTVIEW monitor is set up to read your Sorin CRM implanted device at night while you sleep. If the status light is OFF, check all connections. If the problem persists, call our toll-free technical assistance.. -
Page 14: Moving Home
It requires no maintenance. As with all electronic devices recycling your SMARTVIEW monitor is mandatory, therefore please return it to Sorin CRM if you do not use or need it anymore. Please contact our toll-free technical assistance for more information on the collecting procedure. -
Page 15: Faq
10. FAQ Why do I need to be monitored? You have been advised to install Sorin CRM's SMARTVIEW 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 16: 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 KA960 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 17: Data Protection
(R&TTE) and with the Directive 90/385/EEC on Active Implantable Medical Devices and, − carries the CE marking accordingly. Sorin CRM 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 18 FCC Interference Statement 47 CFR Section 15.21 - No Unauthorized Modifications CAUTION: This equipment may not be modified, altered, or changed in any way without signed written permission from SORIN. Unauthorized modification may void the equipment authorization from the FCC and will void the SORIN warranty.
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Page 19: Guidance And Manufacturer'sdeclaration
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 20: 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 21 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 22 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).
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Page 23: 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 communications equipment. -
Page 24: 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 weekends.
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