Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - a dual chamber, rate adaptive icd with home monitoring functions, max. shock energy 40j and df4/is-1 connector. biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. ellipsoid shape facilitates implantation in the pectoral muscle area. the connections for bipolar pacing, sensing and shock delivery are found in the header. mr conditional. acticor 7 dr-t belongs to a family of implantable cardioverter-defibrillators (icds). the primary objective of the therapy is to prevent sudden cardiac death. furthermore, the device is capable of treating bradycardia arrhythmias. the implantation of an icd is a symptomatic therapy with the following objectives: ?termination of spontaneous ventricular fibrillation (vf) through shock delivery ?termination of spontaneous ventricular tachycardia (vt) through antitachycardia pacing (atp); in case of ineffective atp or hemodynamically not tolerated vts, with shock delivery ?comp

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 47805 - implantable cardiac monitor patient programmer - remote assistant iii is an accessory for the implantable cardiac monitor biomonitor iii/biomonitor iiim. pressing the trigger key sends a signal to the monitor. if the monitor successfully receives the signal, it will record and store an ecg. remote assistant iii indicates a successful or unsuccessful recording using the behaviour of the signal transmission led before it automatically turns off. remote assistant iii is powered by 2 batteries that are non-replaceable. the remote assistant iii is an accessory for the biomonitor iii/biomonitor iiim that can be used to manually trigger the recording of an ecg.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 47804 - implantable cardiac monitor - it continuously and automatically records and monitors the heart rhythm. depending on the preset parameters, subcutaneous ecgs, and other data may be recorded. the patient can also trigger the recording of subcutaneous ecgs using the remote assistant iii accessory if subjectively symptomatic episodes occur. the recordings can be transmitted to the biotronik home monitoring service center. this enables physicians to perform complete diagnosis management. mr conditional. biomonitor iii is the product name of an implantable cardiac rhythm monitoring system that records subcutaneous ecgs. recording is activated both automatically and by the patient.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 35853 - lead, defibrillator, implantable - the lead body consists of a coil made embedded in silicone. it has a rv shock coil and the tip is an extendable /retractable screw (distal pole), for fixating in the myocardium. bipolar sensing in the atrium with 2 atrial ring electrodes, sensing and pacing in the ventricle, between the distal pole and ventricular ring electrode. the leads coating improves gliding properties. steroid reduces inflammation and threshold increase after implantation. mr conditional. in combination with a compatible icd, this lead is designed for the following: ? permanent sensing and pacing in the right ventricle ? permanent sensing in the right atrium ? delivery of defibrillation / cardioversion therapies

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 36336 - remote control, foot-switch - a foot-operated switch (pedal) used by the operator to activate the medical device to which it is connected to.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 61438 - cardiac pulse generator reader, home-use - it collects encoded data from a cied and transmits it wirelessly to a service centre via a mobile connection. the data is used for evaluation by a physician/technician for the patient's care. used to automatically and continuously transmit data from a biotronik cardiac implantable electronic device to a service centre. home monitoring is not an emergency system.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 47804 - implantable cardiac monitor - it continuously and automatically records and monitors the heart rhythm. depending on the preset parameters, subcutaneous ecgs, and other data may be recorded. the patient can also trigger the recording of subcutaneous ecgs using the remote assistant iii accessory if subjectively symptomatic episodes occur. the recordings can be transmitted to the biotronik home monitoring service center. this enables physicians to perform complete diagnosis management. mr conditional. biomonitor iiim is the product name of an implantable cardiac rhythm monitoring system that records subcutaneous ecgs. recording is activated both automatically and by the patient.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 61680 - implantable cardiac device management application software - the home monitoring service center is a remote monitoring tool. it provides information to physicians via a protected internet platform. the information is used to make decisions regarding the initiation of diagnostic or therapeutic measures. the data transmitted to the home monitoring service center and the event detection conditions vary depending on the type and family of the implant. the intended purpose of the home monitoring service center (hmsc) is to monitor and support diagnosis of cardiac arrhythmias and in the prediction of worsening heart failure (hf) in patients with implanted biotronik cardiac pacemakers, cardioverter-defibrillators (icds), cardiac resynchronization therapy devices (crts) and cardiac monitors. in addition, the hmsc is used to monitor the status of the active implant and the connected leads.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 47205 - cardiac pulse generator programmer - renamic neo is a portable programmer and monitoring device with an integrated pacing system analyser. can be custom-equipped with a cellular stick/mobile internet adapter. it displays surface ecgs and intracardiac derivations (iegms), stores parameters; records ecg/ iegm. components are: renamic neo programmer incl. neo (software), stylus, ecg patient cable with electrode clips and power cord/brick. external printer can be connected to print current parameter settings/recorded statistical data. the programmer provides communication with biotronik implantable pacemakers, icds, or implantable cardiac monitors (icms) during the implantation procedure or patient follow-up. the programmer is intended to enable the intended use of the implantable products by supplying the user interface to the device functions. therefore, the programmer is used: ? to verify and optimize the therapy delivered by the devices. ? to support diagnosis of the patient status through data delivered by the devices. the psa (pacing system analyzer) of the programmer supports lead implantations during the implantation procedure. therefore, the psa is used: ? to support lead implantations with intraoperative measurements of electrophysiological parameters.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 31704 - pacemaker system analyser, magnetic - the magnet is intended as an accessory for an implantable medical device to generate a magnetic field to activate the magnet response in a biotronik implantable device.