BIOTRONIK SE and KG SAFESYNC SafeSync Module User Manual 380184 D GA SafeSyncModule en 2011 06 15

BIOTRONIK SE & Co. KG SafeSync Module 380184 D GA SafeSyncModule en 2011 06 15

15_SafeSync UserMan

Revision: D (2011-04-26)11-D-xx© by BIOTRONIK SE & Co. KGAlle Rechte vorbehalten.Technische Änderungen vorbehaltenBIOTRONIK SE & o KWoermannkehre 112359 Berln  ermanyTel +49 (0) 30 68905-0Fax +49 (0) 30 6852804salesbotronkcomwwwbotronkcomSafeSync ModuleErweterungsmodul fr Programmergerte zur drahtlosen KommunkatonCardiac Rhythm ManagementExternal DevicesGebrauchsanweisung380184--D_GA_SafeSyncModule_de_Cover_2011-04-xx.indd 1-2 23.05.2011 12:28:48
Table of Contents 3 Table of ContentsTable of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5About the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6About this Technical Manual. . . . . . . . . . . . . . . . . . . . . . 8Safety During Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . 10Required Expertise . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Residual Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12General Safety Instructions. . . . . . . . . . . . . . . . . . . . . . 13Electromagnetic Interference. . . . . . . . . . . . . . . . . . . . 14Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Maintenance, Care and Disposal . . . . . . . . . . . . . . . . . 18Startup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Transportation and Setup . . . . . . . . . . . . . . . . . . . . . . . 23Connections and Cables . . . . . . . . . . . . . . . . . . . . . . . . 24Unit Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Scope of Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Electromagnetic Compatibility in Compliance with EN 60601-1-2:2007 . . . . . . . . . . . . . . . . . . . . . . . . 38Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Symbols on the Device. . . . . . . . . . . . . . . . . . . . . . . . . . 44Directories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45List of Keywords. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
4Table of Contents
Introduction 51IntroductionIntroductio n1380184-DDoc-classE CM--SafeSync Modul eWhat's in this chapter?This chapter contains the following topics: Topic PageAbout the Device 6About this Technical Manual 8
6IntroductionAbout the DeviceGeneral descrip-tionThe 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).Devices with the BIOTRONIK SafeSync function are equipped with a special transmitter and receiver (1). This sends all the relevant information to the SafeSync Module (2), which then forwards the infor-mation to the programmer (3). The device also receives all information that the programmer forwards to the SafeSync Module for transmission.Fig. 1: SafeSync function principleIt is used during the implantation procedure and follow-up of implantable pacemakers and ICDs (implantable cardioverter-defibrillators) with the BIOTRONIK SafeSync function.Primary function The device extends the programming devices of BIOTRONIK to include the following functions: Function PurposeBIOTRONIK SafeSync functionWandless telemetry connection (SafeSync RF telemetry) for interrogating, testing and programming pacemakers and ICDs with the BIOTRONIK SafeSync function
Introduction 7Other functions (depending on the software version of the programmer)The device extends the programming devices of BIOTRONIK to include the following functions: Function PurposeData transfer Exporting the follow-up data in hospital or private practice networksUpdate function Downloading the latest, approved software version for the programmer from BIOTRONIK
8IntroductionAbout this Technical ManualObjective This technical manual provides the user with all the safety information required to use the device.The following topics are covered in this manual: Device startupTarget group This technical manual is intended for physicians and trained medical personnel who are familiar with the following: The use of implantable pulse generators and ICDs The risks and possible complications associated with using these systemsAdditional requirements include: Medical knowledge:- Basic medical knowledge of the therapy applied- Training in the handling and programming of implantable pulse generators and ICDsTechnical knowledge:- Ability to work with a PC - Ability to use software-controlled medical devicesOther technical manualsTo ensure the safe and correct use of the device, you must follow these additional instructions: The technical manual for the programmerTechnical software manual for programming the intended implantable pulse generator / ICDTechnical manual for the intended implantable pulse generator / ICD
Safety During Use 92 Safety During Use Safety Duri ng Use2380184-DDoc-cl assECM--SafeSync Mo duleWhat's in this chapter?This chapter contains the following topics: Topic PageIntended Medical Use 10Required Expertise 11Residual Risk 12General Safety Instructions 13Electromagnetic Interference 14Operating Conditions 16Maintenance, Care and Disposal 18
10 Safety During UseIntended Medical UseIntended medical useDuring implantation or follow-up, the SafeSync Module establishes telemetry between a device with BIOTRONIK SafeSync function and the ICS 3000 or Renamic programmer.Thus the programmer is able to perform the following without a programming head: Conduct sensing, pacing threshold and impedance testsInterrogate data of the implanted device such as program parameters, recorded statistical data and episodes, as well as real-time IEGMsDisplay, printout, save and export data of the implanted device for analysis and reporting purposesTransferring parameters to the device
Safety During Use 11Required ExpertiseRequired expertise The programmer is intended for use by physicians and trained medical staff. Along with their basic medical knowledge, a detailed knowledge of cardiac electro-therapy is also required. Only qualified medical specialists with knowledge of cardiac electrotherapy can properly operate the device.German medical device ordinanceThis ordinance only applies in the Federal Republic of Germany. However, we recommend that customers in other countries comply with this ordinance as well.According to section 2, § 5, operation and use:'The user may operate a (...) listed medical product only after the manufacturer or the authorized agent who acts on behalf of the manufacturer has performed the following requirements:1. Checked the functionality of this medical product at the location where the device will be used. 2. Trained the staff appointed by the user to correctly handle, use and operate the medical product. This training must include handling, using and operating the product in conjunction with other medical products, implements and accessories in accordance with the technical manual, as well as any applicable safety-related information and maintenance instructions. (...)(3) Proof of a functional test have been performed as stated in Paragraph 1 Item 1, and the training record of the staff appointed by the user, discussed in Para-graph 1 Item 2, are to be documented.'
12 Safety During UseResidual RiskRisk 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 manufac-turer's specifications by qualified medical staff and in compliance with the safety-relevant instructions in this technical manual.
Safety During Use 13General Safety InstructionsTechnical manual Only use the programmer in accordance with this technical manual.Risks of improper handlingDisregarding the safety instructions can endanger the patient, the staff and the equipment.The following dangers may arise in the event of improper use: Failure of important device functionsDanger to persons due to electrical effectsChanges not permittedOnly the manufacturer or a party expressly authorized by BIOTRONIK may perform corrective maintenance, enhancements or modifications to the device.Replacement parts and accessoriesTo ensure safety compliance, use only original replacement parts and accessories authorized by BIOTRONIK. Using any other parts voids the manufac-turer's liability for any consequences, guarantee and warranty.Defects Do not use defective or damaged devices.Liquids Never use a damp or wet device.Protect the device from the accidental ingression of fluids (e.g. infusion fluids).Electrostatic potentials Ensure that electrostatic potentials between medical staff and patients are balanced. Before handling the device, the electrostatic potential between the doctor or medical staff and the patient must be balanced by touching the patient at a point as far away from the leads as possible.Note: Failure to observe the safety precautions voids all damage claims and manufacturer liability.
14 Safety During UseElectromagnetic InterferencePossible electro-magnetic interfer-enceThe programmer is protected from disturbances resulting from electromagnetic irradiation, electro-static 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).However, strong electromagnetic interferences that occur in the close vicinity of electrical motors, power cables, PCs, monitors, or other – possibly defective – electrical devices may compromise the function of the programmer in certain cases.This kind of device malfunction should be considered if the following is observed:The device switches on by itself.The unit passes on incorrect intrinsic events, which are displayed on the ECG, IEGM or marker channel (artifacts) of the programmer and monitoring device.The device displays other inexplicable functions.Correct operation of the device can be restored with the following: Switch off the malfunctioning electronic device.Remove the source of interference from the device.Switch the programmer on and off or cut off the electrical connection between the device and the source of interference if this is possible without causing any danger.If the interference continues, contact BIOTRONIK immediately.Note: If accessories other than those specified by BIOTRONIK are used, increased interference or lower resistance to interference can be expected.
Safety During Use 15EMI 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. Using the EMI test (refer to device software help), the source of the elec-tromagnetic interference can be located and then turned off.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.
16 Safety During UseOperating ConditionsStorage and transportationIf the packaging is damaged, please contact BIOTRONIK immediately. Do not put the device into operation.Installation site Only operate the device in rooms that fulfill the following conditions: No danger of explosionSuitable for medical purposesPlace the unit on a flat, dry surface so that the patient cannot touch it. The unit should be placed so that it cannot slide – even with the cables connected.Power supply The unit is powered via the programmer's USB cable.Cable and plug connectionsReplace any cable that shows even slight damage.Lay all cables within the measuring apparatus in such a way that they pose no danger of tripping over them and that any tensile forces that may occur can be safely buffered.As a general rule, cables should only be connected or disconnected when the unit is switched off, unless expressly permitted in the corresponding section of this technical manual.Ensure that the contacts of all connections and plugs are clean. Soiled contacts can lead to signal distortions, and thus to false diagnoses.Do not touch any connections such as USB ports or interfaces for modules and the patient at the same time.!!CAUTIONFunctional impairment due to external damageMechanical 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.Contact BIOTRONIK for testing and, if necessary, repair of the equipment.
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 UseMaintenance, Care and DisposalThe following regulations are valid for the device. Cleaning and disinfectingUse soft, lint-free cloths.Clean the housing with a damp cloth and mild soap solution or 70% isopropanol.Disinfect with alcohol or aldehyde-based agents such as Aerodesin 2000, Fugaten spray, Lysoformin 2000 or Aldasan 2000.Visually inspect the connections: make sure that the contacts for all connections and cables are clean and free of any type of dirt.To disinfect the patient cable and patient adapter, use a mixture of 70% isopropanol and 30% water or Lysoformin 3000: Allow it to take effect for 15 minutes at 2% concentration.Do not use the unit for about 1 hour after cleaning and disinfecting.Sterilization The device cannot be sterilized.!!WARNINGExposure to fluids may result in fatal injuryBefore cleaning and disinfecting the device surface: Disconnect all USB cables!!!CAUTIONDanger of explosion if exposed to cleaning and disinfecting agentsLet cleaning and disinfection agents evaporate before operating the device.!!CAUTIONMay be damaged by cleaning agentsStrong and abrasive cleaning agents and other organic solvents, such as ether or benzine, corrode the surface of the device and must not be used.
Safety During Use 19Test before each useA short test of the device and the approved acces-sories 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.- Inspect the labeling for legibility- Simple electrical function test: by connecting the unit, an internal function test will be conducted automatically- If no error message appears, then no errors were found and the device can be usedInspection The inspection consists of the regular safety inspec-tion according to medical device standards. This ensures the safety of the device. The inspection must be performed- After use in conjunction with high-frequency surgical instruments or defibrillators,- If malfunctions are suspected,-Once a year.This inspection can be performed by BIOTRONIK.The inspection should conform with the manufac-turer specifications. These are available upon request. The specifications list all necessary test steps and the necessary equipment.Disposal This device contains materials that must be correctly disposed of in accordance with environ-mental protection regulations. The European Directive 2002/96/EC regarding waste electrical and electronic equipment (WEEE) applies.The symbol on the label – a crossed out garbage can – indicates that the device must be disposed of in accordance with the WEEE directive. The black bar indicates that the device was sold after the national implementation of the WEEE directive was enforced in your country.Return devices that are no longer used to BIOTRONIK.
20 Safety During UseDisposal of cablesNon-contaminated cables must be disposed of in accordance with the European Directive 2002/96/EC regarding waste electrical and electronic equipment (WEEE).Note: Cables to be disposed of due to contact with blood must be disposed of as medical waste, in accordance with environmental regulations.
Startup 213 StartupStartup33 80184-DDoc-classEC M--SafeSync M oduleWhat's in this chapter?This chapter contains the following topics: Topic PageDevice Overview 22Transportation and Setup 23Connections and Cables 24Unit Handling 29
22 StartupDevice OverviewFront viewFig. 2: View of the unit from the frontExplanation of itemsExplanation of the individual items: Back viewFig. 3: View of the unit from the backExplanation of itemsExplanation of the individual items: 12Item Designation / description1 Status indicator for SafeSync RF telem-etry2 Status indicator for WLAN or mobile connection34Item Designation / description3 Port for a USB printer or flash memory stick (functional only when using the ICS 3000)4 Mini USB port to connect to the programmer.
Startup 23Transportation and SetupTransporting the deviceThe unit can be transported in the included carrying case.Setting up the devicePlace the device on a flat dry surface. Make sure that the unit cannot slip even with the cables connected and cannot be touched by the patient. The physician must not touch any connections such as USB ports or interfaces for modules and the patient at the same time.Make sure that the distance between the SafeSync Module (2) and the patient (3) does not exceed 3 m and that the patient cannot touch the SafeSync Module (2).Make sure that the distance between the SafeSync Module (2) and the programmer (1) is at least 50 cm and does not exceed 3 m.Fig. 4: Distance of the SafeSync Module from the programmer and from the patient!!WARNINGDanger 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.!!WARNINGDanger to the patientThe device is not sterile and cannot be sterilized.Do not set up the unit in a sterile area.
24 StartupConnections and CablesBasic notes for cables and connections!!WARNINGDanger to patient by damaged cablesDamaged cables are limited in functionality and pose a danger to patients.Do not use damaged cables.!!WARNINGDanger to patient from allergic reactionsIf 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.!!WARNINGDanger from loss of functionDamp cables have limited functionality and pose a danger to patients.Do not use damp cables.Note: Cables to be disposed of due to contact with blood must be disposed of as medical waste in accor-dance with environmental regulations.Do not force the plugs into the ports. When disconnecting plugs, do not pull on the cable.
Startup 25ConnectThe mini USB port for connecting to the programmer is located on the left side of the device. Fig. 5: Mini USB connector on the SafeSync ModuleConnect the mini USB connector (5) of the USB cable to the SafeSync Module and the USB connector (6) to the programmer.If the programmer is switched on, the unit performs a self-test and the LEDs all light up yellow. After successful completion of the self-test, the LEDs all light up green.If the self-test is not successful, the LEDs flash yellow.!!WARNINGRisk 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.Note: The SafeSync Module can be connected when the programmer is switched on.Note: You cannot connect more than 1 SafeSync Module to a single programmer.You cannot connect a SafeSync Module to another SafeSync Module.56
26 StartupConnection of USB devicesOnly the following compatible devices can be connected to the unit's USB port:USB flash memory sticks with USB 2.0 and older USB standardsPrinters with USB 2.0 and older USB standard (battery-powered or mains-operated)!!WARNINGRisk 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.!!CAUTIONDamage to the USB port caused by connecting non-compatible USB devices.Connecting non-compatible USB devices can damage the USB port.Only connect the USB devices listed below.Note: Units that derive their power from the USB port may not require more than 100 mA.The USB port can be disconnected and recon-nected while the device is still active.
Startup 27!!WARNINGDanger to the user when connecting non-conforming 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.!!CAUTIONRisk of exceeding the leakage currents when connecting external devices with their own power supply or an electrically conductive connection to other devices.Only connect devices that comply with IEC standard 60601-1:2005 or IEC 60950.Line-powered devices must comply with the standard IEC 60601-1:2005 or must be connected to the USB port via an isolating separator (IEC 60601-1:2005 paragraph 16.5) with a dielectric strength of at least 1.5 kV (e.g. an isolating USB hub model UISOHUB4 by B&B electronics).Place devices that do not adhere to the IEC 60601-1:2005 standard at least 1.5 m away from the patient.Before initial commissioning, check and document all device combinations according to IEC 60601-1:2005 paragraph 16.6 for observance of leakage currents.Perform this inspection at least once per year according to the legal requirements.
28 StartupAn ECG port is located on the back left of the unit. Fig. 6: Position of the USB portConnect the respective USB device (7) to the USB port.7
Startup 29Unit HandlingIndicators during operationThe LEDs provide information on the status of the SafeSync Module or the respective function.Establishing SafeSync RF telemetryThe telemetry connection is controlled using the programmer software. The software is installed on the drive of the programmer by BIOTRONIK employees.You can use the programmer's user interface to activate or disable the SafeSync function independent of the WLAN and cellular function. Both features can be activated, but you can not use both simultaneously. Using the user interface, you can either establish SafeSync RF telemetry with a device or set up commu-nication with a network (depending on the software version of the programmer).Establishment of the SafeSync RF telemetry depends on the respective device and the suitable location of the SafeSync Module. To establish SafeSync RF telemetry, proceed as described in the device's technical manual.Position the SafeSync Module using the user inter-face and the programmer's online help.LED behavior StatusBoth LEDs are constantly yellowSelf-test is being performed or the firmware of the SafeSync Module is being updatedThe respective LED flashes yellowSelf-test not passed; function is not availableThe respective LED is constantly greenThe function is technically ready for use (but may be turned off in the programmer software)The respective LED flashes greenThe function is active and data is being exchanged with a device or network
30 StartupInterrogating and programming the deviceThe BIOTRONIK devices can communicate bidirec-tionally with the programmer. Once the telemetry connection has been established via the SafeSync Module, the program data and all data stored in the device can be transferred to the programmer.Depending on the implanted device, a large number of adjustable parameter sets are available. These parameter sets are combined and saved in the program that is currently active. The programmer detects obvious program errors and requires these to be corrected before the program is transferred to the device.The following programs can be transmitted: Permanent programA permanent program is a program that is programmed in the pacemaker and which performs pacing permanently without a telemetry connection.!!WARNINGRisk 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.!!WARNINGRisk to the patient due to higher power consump-tion in the device.The SafeSync RF telemetry requires more energy and decreases the device's longevity.Only establish SafeSync RF telemetry if neces-sary.Check the device's battery capacity at regular intervals (refer to the online help for the programmer).
Startup 31Temporary programA temporary program is a program that the pace-maker uses to provide temporary pacing as long as the telemetry connection exists.Safe programA safe program is a device-specific program used for safety pacing with high energy in either VVI or SSI mode.Establishing a WLAN or mobile connection (depending on the programmer's software version)You can use the programmer's user interface to activate or disable the WLAN or cellular function inde-pendent of the SafeSync function. Both features can be activated, but you can not use both simultaneously. Using the user interface, you can either establish SafeSync RF telemetry with a device or set up commu-nication with a network (depending on the software version of the programmer).Establishing the WLAN or mobile connection depends on the respective network.To set up the WLAN or mobile connection, proceed as described in the programmer's online help.Note: Use of a temporary program can be stopped at any time and the permanent program of the implanted device can be automatically reactivated with the following:Disconnect the telemetry connection using the programmer's user interface.Or:Switch the programmer off.
32 Startup
Appendix 334 AppendixAppendix4380184-DDoc-classECM-- SafeSync ModuleWhat's in this chapter?This chapter contains the following topics: Topic PageTechnical Data 34Scope of Delivery 37Electromagnetic Compatibility in Compliance with EN 60601-1-2:200738Legend for the Label 42Symbols on the Device 44
34 AppendixTechnical DataPhysical characteristicsGeneral classificationLongevityAmbient conditionsCategory DesignDimensions (W x D x H) 203 x 136.5 x 80 mmWeight approx. 450 gHousing material PC/ABSCategory DesignClassification AIMD according to direc-tive 90/385/EECSafety class IIbProtection rating IP 30Operating mode Continuous operationCategory DesignLongevity 6 yearsCategory DesignTemperature range for operation+10°C ... +40°CTemperature range for storage0°C ... +50°CRelative humidity 30% ... 75%, no condensationAtmospheric pressure 700 ... 1060 hPaOperation at altitudes Up to 3000 m
Appendix 35MICSGSM moduleUMTS moduleCategory DesignFrequency band 9 channels 402 – 405 MHzBandwidth 300 kHzModulation FSKCategory DesignModel G24L or G24Type GSM/GPRS quadband MotorolaGSM frequency 850 MHz, 900 MHz, 1800 MHz, 1900 MHzMax. power of transmis-sion2 W, 850/900 MHz1 W, 1800/1900 MHzMax. bandwidth (Downlink)GPRS (G24L/G24): 85.6 kbpsEGPRS (G24): 270 kbpsGPRS Multislot class 10Category DesignModel H24Type Motorola, 4 band GSM + 3 band UMTSUMTS frequencies 850 MHz, 1900 MHz, 2100 MHzGSM frequencies 850 MHz, 900 MHz, 1800 MHz, 1900 MHzMax. UMTS transmission power0.25 WMax. GSM power of transmission2 W, 850/900 MHz1 W, 1800/1900 MHz
36 AppendixWLAN moduleMax. bandwidth (Downlink)UMTS:7.2 MbpsUE CAT [1-8], 11, 12 supportedCompressed mode (3GPP TS25.212)GPRS: 80 kbpsEGPRS: 236 kbpsGPRS Multislot class 12Category DesignCategory DesignModel WiReach BKTransmission frequenciesEurope: 2.412 GHz to 2.472 GHzUSA: 2.412 GHz to 2.462 GHzJapan: 2.412 GHz to 2.484 GHzTyp. transmission power 250 mA @ 16 dbm235 mA @ 12 dbmReports WEP, WPA, WPA2, HTTPSStandards IEEE 802.11b, IEEE 802.11gChannels Europe: 13 channelsUSA: 11 channelsJapan: 14 channels
Appendix 37Scope of DeliveryScope of Delivery SafeSync Module (order no.: 37xxxx) Item designation AmountSafeSync Module (single device) WLAN module* Customer-specificGSM module* Customer-specificUMTS module* Customer-specificUSB cable 1Case 1Protective cover 1Multilingual technical manual (de, en, es, fr, it) Country-specificMultilingual technical manual (pl, tr) Country-specificTechnical manual ZH (printed) Country-specificQuick reference guide DE (printed) Country-specificQuick reference guide EN (printed) Country-specificQuick reference guide ES (printed) Country-specificQuick reference guide FR (printed) Country-specificQuick reference guide IT (printed) Country-specificQuick reference guide PL (printed) Country-specificQuick reference guide TR (printed) Country-specificQuick reference guide ZH (printed) Country-specific*Not available in all countries
38 AppendixElectromagnetic Compatibility in Compliance with EN 60601-1-2:2007As the user, you must ensure that the device is operated in a suitable electromagnetic environ-ment. 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. There should be at least 20 cm distance between the device and the SafeSync Module to avoid interfer-ence with the device caused by the electromagnetic fields emitted by the SafeSync Module.Electromagnetic Emissions (Table 1)Units with the warning sign “Transmitter with non-ionizing radiation at designated frequency” must not be operated in the envi-ronment of the device due to potential inter-ference.Measuring the emitted interfer-enceCompliance Guidelines for the electromagnetic environmentRF interference according to CISPR 11Group 1 The device uses RF energy exclusively for its own function. Therefore, the RF interference emitted is very low and not likely to cause any interference in nearby electronic equipment.RF interference according to CISPR 11Class B The device is suitable for use in all establishments. This includes resi-dences and facilities directly connected to the public power supply network that supplies buildings used for domestic purposes.
Appendix 39Recommended safety distances (Table 6)Safety distances help prevent interference if you maintain a minimum distance between transmit-ters such as mobile RF telecommunication devices and the Renamic programmer. The necessary distance depends on the respective power output of the transmitter.For transmitters whose maximum output power is not indicated in the table, the recommended safety distance [d] can be calculated in meters using an equation that is suitable for the respective trans-mission frequency range. P is the maximum output power of the transmitter in watts [W] according to the specification of the transmitter's manufac-turer.Resistance to elec-tromagnetic inter-ference (tables 2 and 4)When the measured field strength exceeds the specified compliance level at the operating location of the Renamic device, observe the device in order to determine whether it is functioning properly.Note: At 80 MHz and at 800 MHz, the higher frequency range applies.Transmission frequency150 kHz to 80 MHz80 MHz to 800 MHz800 MHz to 2.5 GHzMaximum output power of the trans-mitter [W]Safety distance [m] 0.01 0.12 0.12 0.240.1 0.37 0.37 0.741 1.17 1.17 2.3410 3.70 3.70 7.40100 11.7 11.7 23.4Transmission frequency150 kHz to 80 MHz80 MHz to 800 MHz800 MHz to 2.5 GHzEquation d = 1.17 P d = 1.17 P d = 2.34 P
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.Test of resistance to interferenceTest level according to IEC 60601-1-2Compli-anceGuidelines for the elec-tromagnetic environ-mentElectrostatic discharge (ESD) according to IEC 61000-4-26kV contact discharge8 kV air dischargeSame as test levelOperate the devices on floors made of wood, concrete, or ceramic tile. If the floor is covered with synthetic material, the relative humidity must be at least 30%.Note: At 80 MHz and at 800 MHz, the higher frequency range applies.
Appendix 41Testing resistance to interferenceTest level according to IEC 60601-1-2Compli-anceGuidelines for the elec-tromagnetic environ-mentConducted RF interferences according to IEC 61000-4-63Veff 3V Maintain safety distance of mobile radio equipment to the Renamic programmer; see table 6.The field strength of stationary transmit-ting devices must be measured on site and must be lower than the compliance level at all frequencies: consider conducting a study of the site.The field strength must be lower than 3 V/m over the frequency range of 150 kHz to 80 MHz.Radiated RF inter-ferences according to IEC 61000-4-33 V/m 80 MHz to 2.5 GHz3V/m
42 AppendixLegend for the LabelThe label icons symbolize the following: Manufacturing dateBIOTRONIK order numberSerial numberTemperature limit for storageAir pressure limit for storageHumidity limit for storageNon-sterileConsult the instructions for useContentsDo not use if packaging is damagedEuropean approval markCaution: Federal (U.S.A.) law restricts this product to sale by, or on the order of, a physician.NONSTERILE
Appendix 43Device 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.SafeSync Module
44 AppendixSymbols on the DeviceSymbols on the front sideThe symbols mean the following: Symbols on the backThe symbols mean the following: Symbols on the left sideThe symbols mean the following: SafeSync RF telemetryWLAN or mobile connectionUSB portConsult the instructions for useUSB port
Directories 455 DirectoriesDirectories53801 84-DDoc-classECM--SafeSyn c ModuleWhat's in this chapter?This chapter contains the following topics: Topic PageList of Keywords 46
46 DirectoriesList of KeywordsC Characteristics, 34Cleaning, 18Connect, 25Connection of external devicesUSB devices, 26DDamage, 16Disinfecting, 18Disposal, 19Disposal of cables, 20EElectromagnetic compatibility, 38Electromagnetic emissions, 38Electromagnetic interference, 14Test, 15Electrostatic potentials, 13Establishing a WLAN or mobile connection, 31Establishing SafeSync RF telemetry, 29Expertise, required, 11IIndicators during operation, 29Installation site, 16Intended use, medical, 10Interrogating and programming the device, 30MMaintenance, 18Maintenance, inspection, 19Maintenance, test before each use, 19RRecommended safety distances, 39Resistance to electromagnetic interference, 39Risks, 12
Directories 47SSafety instructions, summary, 13Scope of delivery, 37Sterilization, 18TTechnical DataMICS, 35UMTS module, 35WLAN module, 36Technical data, 34Ambient conditions, 34General classification, 34GSM module, 35Longevity, 34Physical characteristics, 34Technical manual, 8Transport damages, 16
48 Directories

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