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

microport crm pty ltd - 61680 - implantable cardiac device management application software - the smartview connect application is part of the smartview remote monitoring system (rms), which is composed of the software itself installed on a off-the-shelf smartphone-like device and a back-office data management system controlled by microport crm. the purpose of the system is to remotely monitor microport crm implanted bluetooth?-enabled pacemakers in patients? homes. the smartview connect app allows the remote monitoring of patients implanted with a microport crm bluetooth? low energy-enabled pacemaker to treat symptomatic bradycardia. it is thus indicated in patients requiring atrial or ventricular pacing, or synchronous atrioventricular pacing.

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

microport crm pty ltd - 31704 - pacemaker system analyser, magnetic - the magnet, a reusable non-implantable accessory of microport crm implantable pacemakers and defibrillators, is intended to switch the implantable device to the preprogrammed magnet mode when positioned on the skin over the device.

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

microport crm pty ltd - 32547 - telemetry system, physiological signal - the smart monitor is a radio frequency wireless monitor that collects clinical information and device parameters. the data is retrieved by the portable external monitor from an implanted cardiac device and routed through the cellular network, converted to a format that can be reported to the physician. 2 rf bands are used : ism band (2.45 ghz) and mics (402-405 mhz) band for data transfer. the device includes smart monitor, user manual, silicon sleeve, power supply and power adaptor. the smart monitor is designed for use with the microport radio frequency implanted cardiac defibrillator specifically to transmit information stored in the implanted cardiac device to the physician. it is intended to perform the following tasks: - collect data from microport implanted cardiac device using radio- frequency telemetry. 2 rf bands are used : a. ism band (2.45 ghz) for communication initialization (icd wake-up) b. mics (402-405 mhz) band for data transfer - transfer collected data to the back office (data management s

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport programming head for bi-directional telemetry. it can be equipped with the rf wireless technology which enables remote monitoring. connector: atrium is-1 bipolar; r ventricle df4; l ventricle is4. the device is 1.5t and 3t mr conditional. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/v

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport programmer, using a compatible microport programming head for bi-directional telemetry. it can be equipped with the rf wireless technology which enables remote monitoring. connector: atrium sonr; r ventricle df4; l ventricle is4. the device is 1.5t and 3t mr conditional. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/vf) and provide tre

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport dedicated programming head for bi-directional telemetry. it can also be equipped with the rf wireless technology which enables remote monitoring. connector: atrium is-1 bipolar; r ventricle is-1 bipolar, 2 df-1; l ventricle is-1 bipolar. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/vf

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport dedicated programming head for bi-directional telemetry. it can also be equipped with the rf wireless technology which enables remote monitoring. connector: atrium is-1 bipolar; r ventricle df4; l ventricle is-1 bipolar. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/vf) and provide tre

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport dedicated programming head for bi-directional telemetry. it can also be equipped with the rf wireless technology which enables remote monitoring. connector: atrium sonr; r ventricle is-1 bipolar; l ventricle is-1 bipolar. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/vf) and provide tr

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport dedicated programming head for bi-directional telemetry. it can also be equipped with the rf wireless technology which enables remote monitoring. connector: atrium sonr; r ventricle df4; l ventricle is-1 bipolar. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/vf) and provide treatment w

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

microport crm pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - ulys dr is an implantable dual-chamber cardioverter defibrillator. it is equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. it can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport dedicated programming head for bi-directional telemetry. it is also equipped with the rf wireless technology which enables remote monitoring. connector: atrium is-1 bipolar; ventricle is-1 bipolar, 2 df-1. ulys dr is a dual chamber implantable cardioverter defibrillators (icd) used in combination with pacing and defibrillating lead(s). the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial (for dr models only) and right ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices automatically detect ventricular tachyarrhythmias (vt/vf) and provide treatment with defibrillation, cardioversion, and antitachycardia pacing therapi