BIOTRONIK SE and KG BM2 BioMonitor 2-AF, BioMonitor 2-S User Manual QRIBM2 UserMan
BIOTRONIK SE & Co. KG BioMonitor 2-AF, BioMonitor 2-S QRIBM2 UserMan
QRIBM2_UserMan
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| Document ID | 2406345 |
| Application ID | 5V7xi4jyUKx4gJe6uD6Yew== |
| Document Description | QRIBM2_UserMan |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 10.13kB (126592 bits) |
| Date Submitted | 2014-09-30 00:00:00 |
| Date Available | 2015-01-09 00:00:00 |
| Creation Date | 2014-09-08 15:32:52 |
| Producing Software | GPL Ghostscript 9.0 |
| Document Lastmod | 2014-09-12 09:06:00 |
| Document Title | DRAFT_GA-HW_en_406435-0xx_BioMonitor-2DK_2014-09-05.pdf |
| Document Creator | PDFCreator Version 1.2.0 |
| Document Author: | koenig_d1 |
BioMonitor 2 Implantable cardiac monitor with Home Monitoring Implantierbarer Herzmonitor mit Home Monitoring Monitor cardiaco implantable con Home Monitoring Moniteur cardiaque implantable avec Téléc@rdiologie Technical manual Gebrauchsanweisung Manual técnico Manuel technique • • • • en de es fr © BIOTRONIK SE & Co. KG All rights reserved. Specifications subject to modification, revision and improvement. ® BIOTRONIK Home Monitoring and ProMRI are registered trademarks of BIOTRONIK SE & Co. KG 0123 0681 2015 14-D-xx Revision: (2014-09-05) 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 BioMonitor 2 Table of Contents Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Diagnostic Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Follow-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Explantation and Device Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Arrhythmia Detection Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Home Monitoring Parameter Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Electrical Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Battery Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Legend for the Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Table of Contents Implantable cardiac monitor with Home Monitoring Technical manual for the device GA-HW_en_-[[_BioMonitor 2_(ProMRI) Index GA-HW_en- mul_37862 -E_BioMonitor-ProMRITechnicalmanualfor the deviceBioMonitor 1 Product Description Indications • Clinical symptoms or increased risk of cardiac arrhythmias • Temporary symptoms that may indicate cardiac arrhythmia ProductDescription1GA-HW_en- mul_37862 -E_BioMonitor-ProMRITechnicalmanualforthe deviceBioMonitor Intended Medical Use Intended use BioMonitor 2 is the name of an implantable cardiac monitor for the monitoring of heart rhythm. Its primary purpose is to provide early detection and diagnostics of symptoms of arrhythmias, such as atrial fibrillation and the causes of syncope, which can be manifested clinically. Contraindications There are no known contraindications. However, the particular patient's state of health determines whether a subcutaneous device will be tolerated long-term. System Overview Note: BioMonitor 2 does not have a pacing function. Device family BioMonitor 2 is a cardiac monitor.The device family consists of BioMonitor 2-AF and BioMonitor 2-S. Not all device types are available in ecvery country. Form of diagnosis The heart rhythm is continuously monitored; the possible detection types are atrial fibrillation, high ventricular rate, asystole, or bradycardia. Depending on the preset parameters, subcutaneous ECGs and other data are recorded. The patient can also initiate a recording of a subcutaneous ECG. BIOTRONIK Home Monitoring® enables physicians to perform a multi-year diagnosis management at any time. Required expertise In addition to having basic medical knowledge, the user must be thoroughly familiar with the operation of the implantable cardiac monitor and the specified conditions for its use. Only qualified medical specialists having the special knowledge are permitted to implant the BioMonitor 2 and make diagnoses. Guidelines of cardiological societies It is recommended that the indications published by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC (European Society of Cardiology) are observed. This also applies to the guidelines published by the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the American Heart Association (AHA), and other national cardiology associations. Parts The system consists of the following parts: • Device with electrode integrated in the header and insertion tool • Programmer • Current software version for the implanted device • Remote Assistant for the patient Cardiac monitor These devices have a retrospective loop memory, which continuously records the last minutes of a patient's electrocardiograms. They include a patient-activation function, which allows the patient to activate ECG storage (with the help of a patient device) as a result of a symptomatic episode, and an auto-detection function that allows capture of events without relying on patient compliance or perception of symptoms The device's housing is made of biocompatible titanium, welded from the outside and therefore hermetically sealed. It is coated in silicone or parylene. The shape facilitates ingrowth into the pectoral muscle area. The cardiac monitor's sensing principle is based on one vector. The device labeling provides information about the BioMonitor 2. Programmer Implantation and follow-up are performed with a portable BIOTRONIK programmer. During the implantation, the current device program is transferred to the device on initial interrogation via the programmer. In addition, the programmer is used to set parameter combinations, as well as for interrogation and device data storage. Subcutaneous ECG, markers, and functions are displayed simultaneously on the color display. BioMonitor 2 order numbers Not all device types are available in all countries: Note: It is not permitted to use the device's ECG display for diagnostic purposes because it does not meet all requirements of the standard (IEC 60601-2-25) concerning diagnostic ECG devices. Device Coating Order number BioMonitor 2-S Silicone 398494 BioMonitor 2-S Parylene 403227 BioMonitor 2-AF Silicone 398493 BioMonitor 2-AF Parylene 403226 Package contents Telemetry Telemetric communication between the device and the programmer can be carried out by applying a programming head (PGH). The storage package includes the following: • Sterile packaging with device • Serial number label • Patient ID card • Technical manual for the device BIOTRONIK Home Monitoring® The BIOTRONIK cardiac monitor provides a complete diagnosis management system: • With Home Monitoring, diagnostic information as well as technical data of the device are automatically and wirelessly sent to a stationary or mobile transmitter via an antenna in the device header. The data are encrypted and sent from the transmitter to the BIOTRONIK Service Center via the cellular phone network. • The received data are deciphered and evaluated. Each physician can set the criteria for evaluation to be used for each patient and can configure the time of notification via E-mail, SMS or fax. • A clear overview of the results of this analysis is displayed for the attending physicians on the protected Internet platform Home Monitoring Service Center (HMSC). • Data transmission from the device is performed with a daily device message. • Device messages which indicate special events in the heart or in the device are forwarded at the set time. • A test message can be initiated at any time using the programmer to immediately check the Home Monitoring function. The sterile packaging includes the following: • Device 2 Diagnostic Functions General Safety Instructions GeneralSafety Instructions2GA-HW_en- mul_37862 -E_BioMonitor 2-ProMRITechnicalmanualfor the deviceBioMonitor2 General overview • Automatic functions simplify the expeditious implantation, configuration, and assessment of the BioMonitor 2. Operating Conditions Technical manuals The following technical manuals provide information about usage of the device systems: — Technical manual for the device — Technical manual for the HMSC — Technical manuals for the programmer and its accessories — Technical manuals for the user interface — Technical manuals for cables, adapters and accessories • Technical manuals are either included in hard copy form in the product package or in digital form on the internet: https://manuals.biotronik.com/manuals/home • Follow all relevant technical manuals. • Preserve technical manuals for later use. Detection and data storage • Parameters like Sensing high pass filter, Target sensing threshold or Interference interval are based on the sensing settings and may be customized. • The sensing parameters are subsumed in one program (SensingConsult). In addition to a customized program, there are preconfigured programs for PVC detection, T wave suppression and Variable amplitude. • The signals are recorded and stored once a detection type is set. • Multiple detection types can be set simultaneously. • Single episodes up to 40 s in length can be stored. Patient-triggered recordings are stored up to 7.5 min. • The device can record a total of 35.8 min of episodes in subcutaneous ECGs. • When performing follow-ups using the programmer, the subcutaneous ECG is indicated with markers after applying the programming head. Care during shipping and storage • Devices must not be stored or transported close to magnets or sources of electromagnetic interference. • Observe the 'use by date (UBD)' (see the battery data). Home Monitoring functions Important medical information includes but is not limited to the following: • Ongoing atrial and ventricular arrhythmia • Current statistics • High definition subcutaneous ECGs and sending of these recordings with device messages Temperature Extremely low and high temperatures affect the service time of the battery in the device. • The following temperatures are permitted for transport, storage, and use: -10°C to 45°C Sterile delivery The device is delivered after gas sterilization. Sterility is guaranteed only if the blister and quality control seal have not been damaged. Sterile packaging The device is packaged in two separately sealed blisters. The inner blister is also sterile on the outside so that it can be transferred in a sterile state during implantation. Single use only The device is only intended for one-time use. • Do not use the device if the package is damaged. • The device must not be resterilized and reused. Possible Complications Possible Risks General information on medical complications Complications for patients and device systems generally recognized among practitioners also apply to BIOTRONIK devices. • Complications may include, for example, foreign body rejection phenomena, local tissue reactions, migration of the device, or infections. Primary sources of complication information include current scientific and technological knowledge. • It is impossible to guarantee the efficacy of implantable cardiac monitors. Procedures to avoid Possible technical failures Technical failure of a device system cannot be entirely ruled out. Possible causes may include the following: • Device component failures • Battery depletion Risky therapeutic and diagnostic procedures If energy from an external source is introduced to the body for diagnostic or therapeutic purposes, then the device can be subjected to interference and its function can be impaired. Harmful effects may occur, for example, during electrocautery, HF ablation, HF surgery, or lithotripsy. Influences on the device are not always immediately clear. If risky procedures cannot be avoided, the following should be observed at all times: • Electrically insulate the patient. • Do not approximate energy nearby the device. • Monitor the patient during and after every intervention. The following procedures must be avoided as they may cause harm to the patient or damage the device and, as a result, put the system functionality at risk: • Therapeutic ultrasound • Transcutaneous electrical nerve stimulation • Hyperbaric oxygen therapy • Applied higher than normal pressures Electromagnetic interference (EMI) Any device can be sensitive to interference, for example, when external signals are sensed as intrinsic rhythm. • BIOTRONIK devices have been designed so that their susceptibility to EMI is minimal. • Under unfavorable conditions, especially during diagnostic procedures, sources of interference may induce such a high level of energy into the device that the data recording can be influenced or the device may be damaged. External defibrillation The device is protected against the energy that is normally induced by external defibrillation. Nevertheless, any implanted device may be damaged by external defibrillation. The sensing properties may change as a result. • Place adhesive electrodes anterior-posterior or perpendicular to the axis formed from the device to the heart at least 10 cm away from the device and from implanted leads. 3 Radiation therapy The use of radiation therapy must be avoided due to possible damage to the device and the resulting impaired functional safety. If this type of therapy is to be used anyway, prior risk/ benefit analysis is absolutely necessary. The complexity of influencing factors such as different sources of radiation, a variety of devices and therapeutic conditions make it impossible to issue directives that guarantee radiation therapy without an impact on the device. The EN 45502 standard pertaining to active implantable medical devices requires the following information in combination with therapeutic ionizing radiation: • Adhere to instructions for potentially risky therapeutic and diagnostic procedures. • Shield device against radiation. • After applying radiation, double-check the device system to make sure it is functioning properly. Implantation Implanta ion3GA-HW_en- mul_37862 -E_BioMonitor-ProMRITechnicalmanualfor the deviceBioMonitor Implantation Procedure Having parts ready The following parts that correspond to the requirements of the EC Directive 90/385/EEC are required: • BIOTRONIK device and insertion tool • BIOTRONIK programmer and approved cables • External multi-channel ECG device • Keep spare parts for all sterile components. Keeping an external defibrillator ready In order to promptly respond to unforeseeable emergencies or possible technical failures of the device: • Keep an external defibrillator and paddles or patch electrodes ready. Note: Please contact BIOTRONIK with questions on the risk/benefit analysis. Magnetic resonance imaging Magnetic resonance imaging must be avoided due to the associated high frequency fields and magnetic flux density: damage or destruction of the device by strong magnetic interaction and damage to the patient by excessive warming of the body tissue in the area surrounding the device. Under certain conditions and while maintaining mandatory measures, magnetic resonance imaging can be performed to protect the patient and device. • The ProMRI® manual – MR conditional device systems – contains detailed information on safely conducting an MR scan. — Download the digital manual from the internet: https://manuals.biotronik.com/manuals/home — Order the printed manual from BIOTRONIK. • Does approval as "MR conditional" apply in your country or region? Ask for current information at BIOTRONIK. Unpacking the device W WARNING Inadequate function due to defective device If an unpacked device is dropped on a hard surface during handling, electronic parts could be damaged. • Use a replacement device. • Return the damaged device to BIOTRONIK. • Peel the sealing paper off of the outer blister at the marked position in the direction indicated by the arrow. The inner blister must not come into contact with persons who have not sterilized their hands or gloves, nor with non-sterile instruments! • Take hold of the inner blister by the gripping tab and take it out of the outer blister. • Peel the sealing paper off of the sterile inner blister at the marked position in the direction indicated by the arrow. Implantation site • Depending on the patient's anatomy, the BIOTRONIK cardiac monitor can be implanted subpectorally or subcutaneously on the left side. Follow-up Preventing leakage currents Leakage currents between the tools and the device must be prevented during implantation. • Electrically insulate the patient. Follow-up intervals Follow-ups must be performed at regular, agreed intervals. • Following the ingrowth phase, approximately 3 months after implantation, the first follow-up should be carried out by the physician using the programmer (in-office follow-up). • The next in-office follow-up should be carried out once a year and no later than 12 months after the last in-office follow-up. Implanting Form the device pocket with help of the insertion tool. Insert the device. Position the device optimally. Check the signals. Close the device pocket. Follow-up with BIOTRONIK Home Monitoring® Monitoring using the Home Monitoring function does not serve to replace regular inoffice appointments with the physician required for other medical reasons. Follow-up supported by Home Monitoring can be used to functionally replace in-office follow-up under the following conditions: • The patient was informed that the physician must be contacted if symptoms worsen or if new symptoms arise despite use of the Home Monitoring function. • Device messages are transmitted regularly. • The physician decides whether the data transmitted via Home Monitoring with regard to the patient's clinical condition as well as the technical state of the device system are sufficient. If not, an in-office follow-up has to be carried out. Possible early detection due to information gained via Home Monitoring may necessitate an additional in-office follow-up. For example, the data may provide early indication of a foreseeable end of service time (ERI). Furthermore, the data could provide indications of previously unrecognized arrhythmias. Position the device optimally While the device is being positioned, the signals are recorded by the programming head. It must therefore be placed in the surgical field in sterile condition. • Use the programming head with a suitable sterile cover. W CAUTION Poor signal quality Unreliable signals may impair sensing and even lead to misinterpreted sensing. • Try different positions for the implanted device until the best signals are displayed on the programmer. Follow-up with the programmer Applying the programming head The programming head features a diagram of the device. This is used to assist in positioning the head to ensure proper telemetry. • Make sure the PGH is positioned correctly. Use the following procedure for in-office follow-up: 1 Record and evaluate the ECG 2 Interrogate the device. 3 Check the sensing function. 4 Evaluate the status and automatically measured follow-up data. 5 Possibly evaluate statistics and subcutaneous ECGs. 6 If necessary, customize the program functions and parameters. 7 Transmit the program permanently to the device. 8 Print and document follow-up data (print report). 9 Finish the follow-up for this patient. Establishing telemetry contact • When the programming head is applied, time remains for device interrogation. All detection parameters are disabled during this time. Activate diagnostics • Select the current software version with the standard program on the programmer. Patient Information Explantation and Device Replacement Patient ID card A patient ID card is included in delivery. • Provide the patient with the patient ID. • Request that patients contact the physician in case of uncertainties. Explantation • Interrogate the device status. • Remove the device using state-of-the-art technology. • Explants are biologically contaminated and must be disposed of safely due to risk of infection. Prohibitive signs Places with prohibitive signs must be avoided. • Draw the patient's attention to prohibitive signs. Device replacement Basic principles: • The device must not be resterilized and reused. Possible sources of interference Electromagnetic interference should be avoided in daily activities. Sources of interference should not be brought into close proximity with the device. • Draw the patient's attention to special household appliances, safety locks, antitheft devices, strong electromagnetic fields, cell phones, and transmitters among other things. • Request patients to do the following: — Use cell phones on the opposite side of their body from the device. — Keep the cell phone at least 15 cm away from the device both during use and when storing. Cremation Devices should not be cremated. • Explant the device before the cremation of a deceased patient. Disposal BIOTRONIK takes back used products for the purpose of environmentally safe disposal. • Clean the explant with a solution of at least 1% sodium hypochlorite. • Rinse off with water. • Send the cleaned explant to BIOTRONIK. Replacement Indications Possible battery levels • BOS: Beginning of Service: > 70% charge • ERI: Elective Replacement Indication • EOS: End of Service Elective Replacement Indication (ERI) The device can no longer monitor the heart rhythm when in ERI charging status. ERI can be detected by Home Monitoring. EOS replacement indication The end of service has been reached. 4 Parameters Diagnostics: Atrial fibrillation The following can be set: Par met rs4GA-HW_en- mul_37862 -E_BioMonitor-ProMRITechnicalmanualforthe deviceBioMonitor Note: All parameters are subject to change! Arrhythmia Detection Parameters SensingConsult The programs with sensing expert parameters (SensingConsult) are preset as follows: Parameter T-wave Variable suppression amplitude 40% 35% Range of values Standard Factory Atrial fibrillation (AF) ON; OFF OFF ON The programs with AF expert parameters are preset as follows: Programs Standard Parameter PVC detection 25% AF sensitivity Low Medium High RR variability limit 18.75% 12.5% 6.25% Analysis window Onset/end Onset intervals 16/24 8/16 8/16 Lower sensing threshold 50% Sensing high pass filter 10 Hz 18 Hz 10 Hz 10 Hz Resolution intervals Recordings and realtime ECG Full morphology Full morphology Full morphology Full morphology Confirmation time 6 min 6 min 6 min Interference interval 100 ms 100 ms 100 ms 100 ms The AF expert parameters included in the programs can be customized as follows: Parameter Range of values Standard Factory Sensing settings RR variability limit 6.25; 12.5; 18.75% 12.5% — The sensing expert parameters included in the programs can be customized as follows: Parameter Range of values Standard Factory Standard Standard Sensing settings (SensStandard; ingConsult) T-wave suppression; Variable amplitude; PVC detection Analysis window onset/end 8/16; 16/24; 24/32 detection/end 8/16 — Onset intervals 5 ... (2) ... 23 minimum number 5 of consecutive RR cycles with an RR interval outside of the variability limit 1 ... (2) ... 7 maximum number of 3 consecutive RR cycles with an RR interval outside of the variability limit Lower sensing threshold 25; 35; 40; 50% 50% 50% OFF 10; 18; 24 Hz Recordings and real-time Sensing signal; full ECG morphology 10 Hz 10 Hz Full morphology Full morpholog Interference interval 100 ms 100 ms Sensing high pass filter 100; 140; 180 ms Resolution intervals Confirmation time 1 ... (1) ... 6; 10; 20; 30 min 6 min — — — Diagnostics: High ventricular rate Diagnostics: Patient trigger The following can be set: The following can be set: Parameter Range of values Standard Factory Parameter Range of values Standard Factory High ventricular rate ON; OFF ON OFF Patient trigger ON; OFF ON OFF HVR limit 150 ... (10) ... 200 bpm 180 bpm — HVR counter 4; 8; 12; 16; 32; 64 16 — Global parameters The following settings apply to all detection types: Diagnostics: Bradycardia The following can be set: Parameter Brady zone limit Brady duration Brady rate decrease Brady sensitivity Parameter Start resting period Range of values OFF 30 ... (5) ... 80 bpm 5 ... (5) ... 30 s OFF 10 ... (10) ... 50% Low; medium; high Additional bradycardia expert parameters can be set: Parameter Range of values Standard 40 bpm Factory OFF Range of values Standard 00:00 ... (60) ... 23:00 hh:mm 2:00 hh:mm Duration of resting period 00:30 ... (30) ... 12:00 hh:mm 4:00 hh:mm Factory — — Home Monitoring Parameter Settings 10 s — 50% — Low — Parameter Home Monitoring Range of values ON; OFF Standard Factory ON OFF ON; OFF ON Standard Factory HM episode trigger: AF; HVF; Bradycardia; Asystole; Patient trigger Baseline intervals 32; 48; 64 64 — Rate-drop intervals 4; 8; 16 16 — Home Monitoring: HM episode trigger Home Monitoring can be set for all detection types: Note: Depending on the set detection type, the oldest, newest, and the longest episode is stored. In the case of patient-triggered recordings, the oldest and the two newest episodes are stored. Diagnostics: Asystole duration The following can be set: Parameter Range of values Standard Factory Asystole duration OFF 2 ... (1) ... 10 s 3s OFF OFF Global parameters The following settings apply to all detection types: Parameter Range of values Standard Factory Time of transmission STD; 00:00 ... (30) ... 23:30 hh:mm OFF; 1; 2; 30; 60; 90; 120; 180 days STD — 30 days — Periodic subcutaneous ECG 10 5 Technical Data International radio certification Devices with BIOTRONIK Home Monitoring® are equipped with an antenna for wireless communication. • Telemetry information for Canada: This device must neither interfere with meteorological and earth resources technology satellites nor with meteorological stations working in the 400,150 to 406,000 MHZ band, and it must accept any interference received, including interference that may cause undesired operation. This device will be registered with Industry Canada under the following number: IC: 4708A-BM2 The code IC in front of the certification/registration number only indicates that the technical requirements for Industry Canada are met. • Telemetry information for Japan: Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This device is granted pursuant to the Japanese Radio Law (電波法) and the Japanese Telecommunications Business Law(電気通信事業法) This device should not be modified (otherwise the granted designation number will become invalid R: 202-SMC062 • Telemetry information for the USA: Telemetry data for the USA: This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150-406.000 MHz band in the Meteorological Aids ( i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. This device will be registered with Federal Communications Commission under the following number: FCC ID: QRIBM2 TechnicalData5GA-HW_en- mul_37862 -E_BioMonitor-ProMRITechnicalmanualfor the deviceBioMonitor Mechanical Characteristics Measurements for the housing Device W x H x D [mm] Volume [cm3] Mass [g] BioMonitor 2 85 x 15 x 6,5 4.5 10 g [± 2 g] X-ray identification BIO VP Materials in contact with body tissue • Housing: titanium • Leads: titanium, fractally coated • Housing sheath: silicone • Silicone plug (screw cover): Silicone • Header: epoxy resin Electrical Characteristics Components and input values Electrical characteristics determined at 37°C, 500 Ω: Circuit Hybrid electronics with VLSI-CMOS chip Input impedance > 50 kΩ Telemetry Telemetry data for Home Monitoring: Nominal carrier frequency Maximum power of transmission 403.62 MHz < 25 µW -16 dBm Telemetry data • Nominal carrier frequency: 403.62 MHz • Maximum power of transmission: < 25 µW (–16 dBm) 11 Battery Data Legend for the Label Note: All battery data are subject to change! The label icons symbolize the following: Battery characteristics Manufacturing date Use by The following data is provided by the manufacturers: Manufacturer LITRONIK GmbH 01796 Pirna Germany Storage temperature Order number Serial number Product identification number Battery type LiS 2460 System LiMn0x CE mark Type of device Battery voltage at BOS 3.1 V Open-circuit voltage 3.1 V Nominal capacity 1.2 Ah Remaining capacity at ERI 0.15 Ah Contents Power consumption • Battery current: 9 µA • Average additional battery current in transmission mode: 4 µA Follow the instructions for use Sterilized with ethylene oxide Do not resterilize STERILIZE Average service time Average service times are precalculated using the battery manufacturer's technical specifications and the setting of different detection parameters. For BioMonitor 2: 4 years Shortening of the service time after long storage period Depending on the storage period, the service time from the beginning of service BOS to the replacement time ERI decreases as follows: • After 1 year: by n.N. months • After 1.5 years: by n.N. months Do not use if packaging is damaged Single use only. Do not reuse! Non-sterile NON STERILE Transmitter with non-ionizing radiation at designated frequency MR conditional: Patients can be examined using an MRI scan under defined conditions if the device system in their body consists of devices whose packaging is labeled with this symbol. Implantable cardiac monitor Insertion tool 12
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