User's manual KA961 – Wireless model
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TABLE OF CONTENTS 1. Introduction ................................................................................. 6 2. Indication ..................................................................................... 6 3. Warnings and precautions ........................................................ 7 3.1. Warnings ........................................................................... 7 3.2. Safety precautions ........................................................... 7 3.3.
14. 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 15. Technical assistance....................................................................
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. Name and address of the manufacturer.
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. Many countries prohibit the disposal of waste electronic equipment in standard waste receptacles. For more details, please refer to the European Directive 2002/96/CEE.
SYMBOLS USED IN THIS MANUAL This icon is used to call your attention to a particularly important point. This icon alerts you to a hazard that may result in equipment damage or personal injury. Carefully read the instructions provided with this icon. ABOUT THIS MANUAL Your doctor should be your first source of information regarding your health. This manual addresses many of the questions you or your family may have about your SMARTVIEW monitor and its use.
1. 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.
3. WARNINGS AND PRECAUTIONS 3.1. WARNINGS If at any time you feel that you need a fast response, CALL YOUR LOCAL EMERGENCY SERVICE IMMEDIATELY. The SMARTVIEW Remote Monitoring System is not intended as an emergency response system. 3.2. SAFETY PRECAUTIONS Alteration – Your SMARTVIEW monitor and supplied accessories shall not be modified, altered, or changed in any way without signed written permission from Sorin.
3.3. PRECAUTIONS FOR SAFE OPERATION Location – Preferably the SMARTVIEW monitor should be placed in a stable position on the nightstand of the patient, as close as possible to the side of the bed the patient usually sleeps. Power supply – The SMARTVIEW monitor should be connected exclusively to a Sorin power adaptor. Power supply protection – Power adaptors should be routed so they are not likely to be walked on or pinched by items placed on or against them.
4. FAMILIARISE YOURSELF WITH YOUR SMARTVIEW MONITOR 4.1. PACKAGE CONTENTS Inside the box you will find: 1 SMARTVIEW monitor 1 Power adaptor User’s manual 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.
4.3. MEANING OF THE LIGHTS AND BUTTONS Light or button State Colour Meaning Status light OFF 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. ON Constant amber You have just connected the SMARTVIEW monitor to the wall socket. The SMARTVIEW monitor is setting up. Please wait. This process takes less than 5 minutes. Constant green The SMARTVIEW monitor is operational.
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). Our technicians will assist you. It is free and takes little time.
To operate properly, your SMARTVIEW monitor should always be connected to the mains power outlet. 5.2. COMPLETE THE INSTALLATION WITH 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.
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. Some of the scheduled events may need to be temporarily changed.
9. MAINTENANCE AND RECYCLING Your SMARTVIEW monitor remains property of Sorin. It requires no maintenance. If you don't have anymore use of the SMARTVIEW Monitor, please call Sorin helpdesk toll-free number and we will organize its collection. Sorin will be in charge of recycling it in compliance with European Directive 2002/96/CEE. 10.
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.
The SMARTVIEW monitor may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements. 12. DATA PROTECTION Any clinical data is fully secured with restricted access. You have the right to access this information at any time and ask for any change by request only. Please contact your doctor or our toll-free technical assistance. 13.
EN 301 489-27 v1.1.1 - Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMIP) 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).
47 CFR Part 15 - Code of Federal Regulations - Telecommunication Radiofrequency devices: Part 15.247 - Operation within the bands 902928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz. 47 CFR Part 22 - Code of Federal Regulations - Telecommunication Public mobile services. 47 CFR Part 24 - Code of Federal Regulations - Telecommunication Personal communications services. Part 95 - Personal Radio Services - Part 95.628 MedRadio transmitters. The FCC Product ID is YSGKA961, contains FCC ID UDV0606020080701.
modification may void the equipment authorization from the 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. This device may not interfere with stations operating in the 400.150 406.
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 RF emissions CISPR 11 Group 1 The SMARTVIEW monitor uses RF energy only for its internal function.
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 level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) ± 6 kV contact ± 6 kV contact ± 8 kV air ± 8 kV air Floors should be wood, concrete or ceramic tile.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Voltage dips, short interruptions and voltage variations on power supply input lines <5 % UT (>95 % dip in UT) for 0,5 cycle <5 % UT (>95 % dip in UT) for 0,5 cycle Mains power quality should be that of a typical home environment.
Recommended separation distance: Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz 80 MHz to 3V d 1.2 P 80 to 3 V/m 80 MHz 2.5 GHz d 1.2 P to 3 V/m 800 MHz d 2.3 P 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).
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.
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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Manufactured in for: Sorin CRM S.r.l. Distributed by: Sorin CRM USA, Inc. Via Crescentino s.n. 13040 Saluggia (VC) - Italy Tel: +39 0161 487095 Facsimile: +39 0161 487524 www.sorin.com 14401 West 65th Way Arvada, CO 80004 USA Tel: 877.663.7674 Facsimile: 763.383.4713 or 877.443.
