SmartTouch USER MANUAL
TABLE OF CONTENTS 1. WARNINGS AND PRECAUTIONS............................................................................ 5 2. WARRANTY CONDITIONS ....................................................................................... 7 3. THE PROGRAMMER SYSTEM................................................................................. 8 3.1. General information.................................................................................................... 8 3.2. System overview ..........
11.1. Cleaning ................................................................................................................... 24 11.2. Disinfection and sterilisation..................................................................................... 24 11.3. System end-of-life .................................................................................................... 24 11.4. Spare parts...........................................................................................................
1. WARNINGS AND PRECAUTIONS 1. WARNINGS AND PRECAUTIONS ― The programmer is not a life-saving device. In case of emergency, use an external defibrillator. ― The programmer is Magnetic Resonance (MR) unsafe. Don’t bring the programmer into MRI site Zone 3 or 4 as defined by the Guidance Document for Safe MR Practices published by the American College of Radiology 1.
1. WARNINGS AND PRECAUTIONS ― The medical centre shall control access to the programmer and prevent its use by unauthorized personnel. For warnings and precautions on the ‘Radio Frequency (RF) Link’ accessory, please refer to the associated user manual.
2. WARRANTY CONDITIONS 2. WARRANTY CONDITIONS For detailed information about the compatibility of programming devices and implantable patient devices, please refer to the Device-Compatibility-Matrix that is available under the reference number UA193 at www.microportmanuals.com. The manufacturer agrees to replace any defective material. If a technical problem occurs, please contact your company representative or the company’s service department. WARNING: Never modify the configuration of the programmer.
3. THE PROGRAMMER SYSTEM 3. THE PROGRAMMER SYSTEM 3.1. GENERAL INFORMATION The SmartTouch programmer is a microprocessor-based medical tablet used to program pacemakers and defibrillators. Additionally, it provides measurement, ECG display and report printing functions. This manual does not explain how to use the programming software; please refer to the corresponding user manual or programming guide at www.microportmanuals.com 3.2.
4. THE PROGRAMMER TABLET 4. THE PROGRAMMER TABLET 4.1.
4.
4. THE PROGRAMMER TABLET Left view 1) I/O ports cover 3) USB 3.0 (blue marking) 2) Micro HDMI 4) USB 2.0 5) Audio jack (not in use) Power adapter and cable NOTE: The power adapter connects the programmer tablet or the docking station with the external power supply. 4.2. CHARGING THE TABLET Only use the power adapter provided by the manufacturer for charging the programmer tablet. Fully charge the battery of the programmer tablet before using it in battery mode for the first time.
4. THE PROGRAMMER TABLET Leave the tablet to charge for a minimum of 2 hours. If the battery performance decreases due to aging, programmer maintenance will be required. Please contact your company representative. 4.3. SETTING UP THE SYSTEM Before using the programmer follow the steps below: Step 1: Installing the tablet battery 1. Align and insert the battery at the rear of the programmer tablet. 2. Secure the battery by moving the mechanical lock to the “locked” position.
4. THE PROGRAMMER TABLET To interrogate radiofrequency-enabled implanted devices connect the Radio Frequency (RF) Link to the USB 2.0 port on the left side of the programmer tablet. 4.4. STARTING THE PROGRAMMER 1. Be sure to follow the steps described in chapter 4.2. and 4.3. before using the programmer. 2. Start the programmer with a short press on the power on/off button in the top right corner of the tablet. 3. The welcome window will be displayed on the screen.
5. THE PROGRAMMER SOFTWARE 5. THE PROGRAMMER SOFTWARE 5.1. GENERAL INFORMATION The programmer software consists of the ‘Manager’ software and of application software ‘Modules’ which are specific for each implantable cardiac device. After starting the programmer, the home screen of the ‘Manager’ software will be displayed: This screen allows you to perform the following actions: ― View, enter, import and export data to/from the programmer’s ‘Manager’ software.
5. THE PROGRAMMER SOFTWARE 8. Remove the USB key and press “OK” in order to confirm that the installation was successful. 9. The programmer tablet will shut down automatically and will be ready for use when restarted. 5.3. STORING THE PATIENT DATA Patient data is stored on the programmer tablet hard drive. We recommend regular back-up of the patient data stored on the programmer tablet hard drive.
6. THE DOCKING STATION 6. THE DOCKING STATION The docking station is used to place the programmer tablet in a fixed, vertical position during implantation, follow-ups, charging or storage, when programmer tablet mobility is not required. 6.1. COMPONENTS Front View 1) Lock mechanism 4) Earphone jack (not in use) 2) USB 2.
6. THE DOCKING STATION 6.2. GENERAL INFORMATION When placing the programmer tablet in the docking station, ensure that the docking station is positioned on an even, stable surface. The lock mechanism of the docking station will automatically lock in the tablet when placed in the correct position. The docking station can be used to charge the tablet. To do so, connect the docking station with an electrical outlet using the power adapter as described in chapter 4.2.
7. THE INDUCTIVE PROGRAMMING HEAD 7. THE INDUCTIVE PROGRAMMING HEAD The programming head provides inductive communication between the programmer tablet and the implanted cardiac device. The programmer tablet must only be used with a ‘CPR3H’ inductive programming head. 7.1.
7. THE INDUCTIVE PROGRAMMING HEAD ― activate the telemetry, ― identify the implanted device model, ― conduct telemetry in order to communicate with the implanted device when telemetry is performed in inductive mode. The inductive programming head can be used in auto-interrogation mode. After pressing the interrogate button on the programmer screen, the physician has up to 5 minutes to place the inductive programming head over the implanted device for the telemetry to start automatically.
8. THE RADIO FREQUENCY (RF) LINK 8. THE RADIO FREQUENCY (RF) LINK Wireless Radio Frequency (RF) communication between the programmer tablet and compatible Radio Frequency implantable devices is provided by the Radio Frequency (RF) Link (Orchestra Plus Link). 8.1. COMPONENTS 1. Functioning status LED ― Orange: Device is running software initialization and self-tests ― Green: Device is ready for use 2.
8. THE RADIO FREQUENCY (RF) LINK section (8.3). During the use of the RF Link, reciprocal interferences with other electrical instruments may happen, causing a deterioration of performance (slow-down of the communication, interruption of the communication) or the inability to perform the requested action. 8.3.
9. THE ECG 9. THE ECG 9.1. GENERAL INFORMATION In order to display an ECG in the programmer’s application software ‘Module’, the programmer can be connected with a compatible wireless ECG device via Bluetooth. The tablet-based programmer has been tested for compatibility with selected wireless ECG devices. For detailed information about the wireless ECG devices that are compatible with the programmer, please contact your company representative. 9.2.
10. THE PRINTER 10. THE PRINTER 10.1. GENERAL INFORMATION In order to print report files or in-session data, the programmer tablet can be paired with supported ‘plug and play’ printers via Bluetooth or USB. The programmer has been tested for compatibility with selected printers. For detailed information about the printers that are supported by the programmer software, please contact your company representative. 10.2. PAIRING A PRINTER WITH THE PROGRAMMER 1.
11. MAINTENANCE 11. MAINTENANCE 11.1. CLEANING The programmer and its accessories should never be immersed in any liquid or cleaned with sterilization products. Avoid spilling liquid on any part of the programmer system. In order to clean the following items: ― SmartTouch Tablet ― SmartTouch docking station ― CPR3H and Dongle 1. Visually inspect them for contaminants and remove loose material with a dry or watermoistened cloth. 2.
11. MAINTENANCE Description Reference ECG cable RC016 / V208-RC042US Power adapter TAC0188 Power cable TAC0190 External thermal printer (WOOSIM) V175 Thermal paper (for WOOSIM) TAC0191 SmartTouch tablet battery TAC0192 To order, please contact your company representative.
12. GUIDANCE AND MANUFACTURER'S DECLARATION 12. GUIDANCE AND MANUFACTURER'S DECLARATION NOTE: For the guidance and manufacturer’s declaration of the Radio Frequency (RF) Link accessory, please refer to the associated user manual. 12.1.
12. GUIDANCE AND MANUFACTURER'S DECLARATION Cables and accessories 12.4. Maximum length Test type In compliance with Immunity to conducted disturbances, induced by radio-frequency fields IEC61000-4-6 Radiated immunity Magnetic fields IEC61000-4-8 Voltage dips, short interruptions and voltage variation immunity IEC 61000-4-11 ELECTROMAGNETIC EMISSIONS The programmer is intended for use in the electromagnetic environment specified below.
12. GUIDANCE AND MANUFACTURER'S DECLARATION Immunity test IEC 60601 test level Compliance level ± 2 kV between line(s) to earth ± 2 kV between line(s) to earth Magnetic field at industrial rated frequency (IEC61000-4-8) 30 A/m 30 A/m Professional health care establishment. Voltage dips 0% UT 0% UT (IEC 61000-4-11) For 0.5 cycle For 0.5 cycle A 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° A 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° Professional health care establishment.
12. GUIDANCE AND MANUFACTURER'S DECLARATION Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Radiated RF IEC 3 V/m 3 V/m 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz Professional health care establishment.
13. TECHNICAL DATA 13. TECHNICAL DATA NOTE: For the technical specifications and declaration of conformity of the Radio Frequency (RF) Link accessory, please refer to the associated user manual. 13.1. CONFORMITY OF THE PROGRAMMER Conformity with Directives 90/385/EEC, 2014/53/EU Patient safety IEC 60601-1, Class I, BF Type EMC IEC 60601-1-2 EN 301 489-1 EN 301 489-17 EN 301 489-27 EN 301 489-31 ERM EN 300 328 EN 302-195 FCC CFR 47 RSS-GEN 13.2.
13. TECHNICAL DATA 13.2.2. Programmer Tablet 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; 2. This device must accept any interference received, including interference that may cause undesired operation. 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.
13. TECHNICAL DATA 13.5. 13.6. 13.7. 13.8. 13.9. DIMENSIONS PROGRAMMER TABLET Height 196 mm Width 292 mm Depth 20 mm Weight 1.1 kg DIMENSIONS DOCKING STATION Height 185 mm Width 260.8 mm Depth 103.8 mm Weight 1 kg DIMENSIONS INDUCTIVE PROGRAMMING HEAD Height 160 mm Width 80 mm Depth 38 mm Weight 0.
14. EXPLANATION OF SYMBOLS 14. EXPLANATION OF SYMBOLS General symbols Explanation of symbols Manufacturer Product reference number. General symbols Explanation of symbols Medical equipment with respect to electric shock, fire, and mechanical hazards, only in: ― AAMI/ES 60601-1(2006) / A2 (2010) and ― CSA 22.2 NO 60601-1 CAN/CSA:2008. Product serial number. Connector for a USB device. Connector for an external screen. Connector for an Ethernet LAN connection.
14. EXPLANATION OF SYMBOLS General symbols Explanation of symbols This icon is used to call your attention to a particularly important point. 34 General symbols Explanation of symbols This icon alerts you to a hazard that may result in equipment damage or personal injury. Carefully read the instructions provided with this icon.
15. GLOSSARY 15.
MANUFACTURED IN FRANCE FOR: MicroPort CRM S.r.l. Via Crescentino S.N. 13040 Saluggia (VC) Italy Tel: +39 0161 487095 US Phone: 877.663.7674 www.crm.microport.
