Cardiac Rhythm Management External Devices Gebrauchsanweisung SafeSync Module Erweiterungsmodul für Programmiergeräte zur drahtlosen Kommunikation © by BIOTRONIK SE & Co. KG Alle Rechte vorbehalten. Technische Änderungen vorbehalten Revision: D (2011-04-26) 11-D-xx 380184--D_GA_SafeSyncModule_de_Cover_2011-04-xx.indd 1-2 BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin · Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 sales@biotronik.com www.biotronik.com 23.05.
Table of Contents 3 Table of Contents Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 About the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 About this Technical Manual. . . . . . . . . . . . . . . . . . . . . . 8 Safety During Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Intended Medical Use . . . . . . . . . . . . . . . .
4 Table of Contents
Introduction 1 5 Introduction Introduction1380184-DDoc-classECM--SafeSync Module What's in this chapter? This chapter contains the following topics: Topic Page About the Device 6 About this Technical Manual 8
6 Introduction About the Device General description The SafeSync Module can be connected to the ICS 3000 and Renamic programmers and permits: A wandless telemetry connection (SafeSync RF telemetry) between the programmer and devices with the BIOTRONIK SafeSync function and Optional communication with networks via the cellular phone network or WLAN (depending on the software version of the programmer).
Introduction Other functions (depending on the software version of the programmer) The device extends the programming devices of BIOTRONIK to include the following functions: Function Purpose Data transfer Exporting the follow-up data in hospital or private practice networks Update function Downloading the latest, approved software version for the programmer from BIOTRONIK 7
8 Introduction About this Technical Manual Objective This technical manual provides the user with all the safety information required to use the device.
Safety During Use 2 9 Safety During Use Safety During Use2380184-DDoc-classECM--SafeSync Module What's in this chapter? This chapter contains the following topics: Topic Page Intended Medical Use 10 Required Expertise 11 Residual Risk 12 General Safety Instructions 13 Electromagnetic Interference 14 Operating Conditions 16 Maintenance, Care and Disposal 18
10 Safety During Use Intended Medical Use Intended medical use During implantation or follow-up, the SafeSync Module establishes telemetry between a device with BIOTRONIK SafeSync function and the ICS 3000 or Renamic programmer.
Safety During Use 11 Required Expertise Required expertise The programmer is intended for use by physicians and trained medical staff. Along with their basic medical knowledge, a detailed knowledge of cardiac electrotherapy is also required. Only qualified medical specialists with knowledge of cardiac electrotherapy can properly operate the device. German medical device ordinance This ordinance only applies in the Federal Republic of Germany.
12 Safety During Use Residual Risk Risk analysis The risk analysis carried out by the manufacturer's Risk Management Team has determined that the residual risk is as low as reasonably possible. It is a prerequisite that the programmer has been serviced and inspected according to the manufacturer's specifications by qualified medical staff and in compliance with the safety-relevant instructions in this technical manual.
Safety During Use 13 General Safety Instructions Technical manual Only use the programmer in accordance with this technical manual. Risks of improper handling Disregarding the safety instructions can endanger the patient, the staff and the equipment. Note: Failure to observe the safety precautions voids all damage claims and manufacturer liability.
14 Safety During Use Electromagnetic Interference Possible electromagnetic interference The programmer is protected from disturbances resulting from electromagnetic irradiation, electrostatic discharges and other sources. Simultaneously, the emitted interference has been reduced to a minimum. Thus the programmer conforms to the requirements of EN 60601-1-2 (in its valid form at the time of delivery).
Safety During Use 15 Note: If accessories specified by BIOTRONIK are used on other devices, increased interference or lower resistance to interference can be expected. Note: Portable radio communication devices can interfere with the programmer functioning. EMI test Telemetry between the SafeSync Module and the implanted device can be impaired by electromagnetic interference (EMI). This can be observed when it becomes difficult or even impossible to interrogate or program the implanted device.
16 Safety During Use Operating Conditions Storage and transportation If the packaging is damaged, please contact BIOTRONIK immediately. Do not put the device into operation. CAUTION ! Functional impairment due to external damage Mechanical impact, for example dropping the unit even from a height of over 5 cm if unpackaged - can permanently impair the function of the system. Do not use the device if it shows visible damage.
Safety During Use 17 Ensure that there is no condensation on the plugs or in the connector ports. If condensation is present, dry it before use. Do not force plugs into the connector ports and when disconnecting the plugs, do not pull on the cable.
18 Safety During Use Maintenance, Care and Disposal The following regulations are valid for the device. WARNING ! Exposure to fluids may result in fatal injury Before cleaning and disinfecting the device surface: Disconnect all USB cables! CAUTION ! Danger of explosion if exposed to cleaning and disinfecting agents Let cleaning and disinfection agents evaporate before operating the device.
Safety During Use 19 A short test of the device and the approved accessories should be performed prior to each use. This test consists of the following visual inspections and a simple functional test: - Inspect the housing for mechanical damage, dents, loose parts, cracks, etc. - Inspect cables and connection areas to ensure proper insulation, no breaks, etc.
20 Safety During Use Disposal of cables Note: Cables to be disposed of due to contact with blood must be disposed of as medical waste, in accordance with environmental regulations. Non-contaminated cables must be disposed of in accordance with the European Directive 2002/96/EC regarding waste electrical and electronic equipment (WEEE).
Startup 3 21 Startup Startup3380184-DDoc-classECM--SafeSync Module What's in this chapter? This chapter contains the following topics: Topic Page Device Overview 22 Transportation and Setup 23 Connections and Cables 24 Unit Handling 29
22 Startup Device Overview Front view 1 2 Fig. 2: Explanation of items View of the unit from the front Explanation of the individual items: Item Designation / description 1 Status indicator for SafeSync RF telemetry 2 Status indicator for WLAN or mobile connection Back view 3 4 Fig.
Startup 23 Transportation and Setup Transporting the device The unit can be transported in the included carrying case. WARNING ! Danger to the user Danger of tripping over connected cables during device transport. Prior to transporting the unit, remove the attached cables and store them carefully. Setting up the device WARNING ! Danger to the patient The device is not sterile and cannot be sterilized. Do not set up the unit in a sterile area. Place the device on a flat dry surface.
24 Startup Connections and Cables Basic notes for cables and connections WARNING ! Danger to patient by damaged cables Damaged cables are limited in functionality and pose a danger to patients. Do not use damaged cables. WARNING ! Danger to patient from allergic reactions If the cable comes into contact with open wounds, it can cause allergic reactions. Prevent cables from coming into contact with open wounds and the patient's skin.
Startup 25 Connect WARNING ! Risk to the patient caused by interference with or termination of the ECG display. Connecting or disconnecting the SafeSync Module from the programmer can result in interference with or termination of the ECG display. Do not connect the unit to a programmer during follow-up. Do not disconnect the unit from the programmer during follow-up. Do not remove the Operation Module from the ICS 3000 during follow-up.
26 Startup Connection of USB devices WARNING ! Risk to the patient caused by interference with or termination of the ECG display. Connecting or disconnecting USB devices to the SafeSync Module can result in interference with or termination of the ECG display Do not connect any USB devices to the SafeSync Module during follow-up. Do not disconnect any USB devices from the SafeSync Module during follow-up. CAUTION ! Damage to the USB port caused by connecting noncompatible USB devices.
Startup 27 WARNING ! Danger to the user when connecting nonconforming USB accessories. Leakage currents can cause injuries to the skin or cause an arrhythmia. When using in combination with other devices, do not use portable multiple socket outlets, but connect all devices to fixed outlets in the same electrical circuit used for medical purposes.
28 Startup An ECG port is located on the back left of the unit. 7 Fig. 6: Position of the USB port Connect the respective USB device (7) to the USB port.
Startup 29 Unit Handling Indicators during operation The LEDs provide information on the status of the SafeSync Module or the respective function.
30 Startup WARNING ! Risk to the patient caused by termination of the ECG display. Removing the Operation Module on the ICS 3000 causes termination of the ECG display, which may pose a risk to the patient. Do not remove the Operation Module from the ICS 3000 during follow-up. WARNING ! Risk to the patient due to higher power consumption in the device. The SafeSync RF telemetry requires more energy and decreases the device's longevity. Only establish SafeSync RF telemetry if necessary.
Startup 31 Temporary program A temporary program is a program that the pacemaker uses to provide temporary pacing as long as the telemetry connection exists. Safe program A safe program is a device-specific program used for safety pacing with high energy in either VVI or SSI mode.
32 Startup
Appendix 4 33 Appendix Appendix4380184-DDoc-classECM--SafeSync Module What's in this chapter? This chapter contains the following topics: Topic Page Technical Data 34 Scope of Delivery 37 Electromagnetic Compatibility in Compliance with EN 60601-1-2:2007 38 Legend for the Label 42 Symbols on the Device 44
34 Appendix Technical Data Physical characteristics Category Design Dimensions (W x D x H) 203 x 136.5 x 80 mm Weight approx. 450 g Housing material PC/ABS Category Design Classification AIMD according to directive 90/385/EEC Safety class IIb Protection rating IP 30 Operating mode Continuous operation Category Design Longevity 6 years General classification Longevity Ambient conditions Category Design Temperature range for operation +10°C ...
Appendix MICS Category Design Frequency band 9 channels 402 – 405 MHz Bandwidth 300 kHz Modulation FSK Category Design Model G24L or G24 Type GSM/GPRS quadband Motorola GSM frequency 850 MHz, 900 MHz, 1800 MHz, 1900 MHz Max. power of transmission 2 W, 850/900 MHz Max. bandwidth (Downlink) GPRS (G24L/G24): 85.
36 Appendix Category Design Max. bandwidth (Downlink) UMTS: 7.2 Mbps UE CAT [1-8], 11, 12 supported Compressed mode (3GPP TS25.212) GPRS: 80 kbps EGPRS: 236 kbps GPRS Multislot class 12 Category Design Model WiReach BK Transmission frequencies Europe: 2.412 GHz to 2.472 GHz WLAN module USA: 2.412 GHz to 2.462 GHz Japan: 2.412 GHz to 2.484 GHz Typ. transmission power 250 mA @ 16 dbm 235 mA @ 12 dbm Reports WEP, WPA, WPA2, HTTPS Standards IEEE 802.11b, IEEE 802.
Appendix Scope of Delivery Scope of Delivery SafeSync Module (order no.
38 Appendix Electromagnetic Compatibility in Compliance with EN 60601-1-2:2007 As the user, you must ensure that the device is operated in a suitable electromagnetic environment. The following guidelines may not be applicable in all cases. The propagation of electromagnetic values is, for example, affected by the absorption and reflection of structures, objects and people. This data is for your personal information.
Appendix Recommended safety distances (Table 6) 39 Safety distances help prevent interference if you maintain a minimum distance between transmitters such as mobile RF telecommunication devices and the Renamic programmer. The necessary distance depends on the respective power output of the transmitter. Note: At 80 MHz and at 800 MHz, the higher frequency range applies. Transmission frequency 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.
40 Appendix If abnormal performance is observed, change the orientation or the location of the device. In the frequency range of 150 kHz to 80 MHz, ensure that field strengths are lower than 3 V/m. Note: UT is the mains alternating voltage before applying the test levels.
Appendix Testing resistance to interference Test level Compliaccording to ance IEC 60601-1-2 Conducted RF interferences according to IEC 61000-4-6 3 Veff Radiated RF inter- 3 V/m 80 MHz ferences according to 2.5 GHz to IEC 61000-4-3 3V 41 Guidelines for the electromagnetic environment 3 V/m Maintain safety distance of mobile radio equipment to the Renamic programmer; see table 6.
42 Appendix Legend for the Label The label icons symbolize the following: Manufacturing date BIOTRONIK order number Serial number Temperature limit for storage Air pressure limit for storage Humidity limit for storage Non-sterile NON STERILE Consult the instructions for use Contents Do not use if packaging is damaged European approval mark Caution: Federal (U.S.A.) law restricts this product to sale by, or on the order of, a physician.
Appendix 43 Device contains materials that must be correctly disposed of in accordance with environmental protection regulations. European Directive 2002/96/EC regarding waste electrical and electronic equipment (WEEE) applies. Return devices that are no longer used to BIOTRONIK.
44 Appendix Symbols on the Device Symbols on the front side The symbols mean the following: SafeSync RF telemetry WLAN or mobile connection Symbols on the back The symbols mean the following: USB port Consult the instructions for use Symbols on the left side The symbols mean the following: USB port
Directories 5 45 Directories Directories5380184-DDoc-classECM--SafeSync Module What's in this chapter? This chapter contains the following topics: Topic List of Keywords Page 46
46 Directories List of Keywords C Characteristics, 34 Cleaning, 18 Connect, 25 Connection of external devices USB devices, 26 D Damage, 16 Disinfecting, 18 Disposal, 19 Disposal of cables, 20 E Electromagnetic compatibility, 38 Electromagnetic emissions, 38 Electromagnetic interference, 14 Test, 15 Electrostatic potentials, 13 Establishing a WLAN or mobile connection, 31 Establishing SafeSync RF telemetry, 29 Expertise, required, 11 I Indicators during operation, 29 Installation site, 16 Intended use,
Directories S Safety instructions, summary, 13 Scope of delivery, 37 Sterilization, 18 T Technical Data MICS, 35 UMTS module, 35 WLAN module, 36 Technical data, 34 Ambient conditions, 34 General classification, 34 GSM module, 35 Longevity, 34 Physical characteristics, 34 Technical manual, 8 Transport damages, 16 47
48 Directories
