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.
BioMonitor 2 Table of Contents Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Diagnostic Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
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.
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.
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.
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.
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).
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.
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 parame
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) ...
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.
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.
