Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 44862 - cable/lead, external temporary pacemaker, reusable - the cables provide a connection between an external temporary pacemaker and implanted cardiac pacing leads / heart wires for the purpose of transmitting electrical impulses to the heart. the pacing leads / heart wires may also relay information about the hearts activity back to the temporary pacemaker via the cables. the proximal end consists of a connector that plug into the temporary pacemaker or an adaptor and the distal end, which connects to the pacing leads/heart wires.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 44863 - cable/lead, external temporary pacemaker, single-use - the cables provide a connection between an external temporary pacemaker and implanted cardiac pacing leads / heart wires for the purpose of transmitting electrical impulses to the heart. the pacing leads / heart wires may also relay information about the hearts activity back to the temporary pacemaker via the cables. the cables are for single use

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 17184 - catheter, angioplasty, balloon dilatation - the passeo-18 peripheral dilatation catheter is indicated to dilatestenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.