오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

rqsolutions medical devices distribution support - 58713 - automated retinopathy analysis system application software - the medical device is a software product that analyses an input color fundus image for signs of age-related macular degeneration, diabetic retinopathy and glaucoma. the software produces several outputs which includes scores for amd and dr that are indicative of the severity of amd and dr; a score for glaucoma that indicates the likelihood of presence of glaucoma; and heat maps indicating possible abnormal areas. taking the outputs of retcad into account, the intended user can decide if the patient should be referred for additional testing.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 36273 - ultrasonic surgical system generator - intended for use with the ultrasonic surgical system generator to control settings level of system functional outputs.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 36336 - remote control, foot-switch - the footswitch is the foot-controlled part of the ultrasonic surgical system. it includes two pedals and minimum and maximum outputs accordingly.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

masimo australia pty ltd - 36551 - patient monitoring system module, blood pressure, noninvasive - lidco cnap module is an optional non-invasive blood pressure that outputs a continuous arterial blood pressure waveform for connection to patient blood pressure and lidcounity hemodynamic monitor. when outputted to lidcounity monitor, the arterial pressure waveform is treated exactly the same as any / all continuous arterial pressure waveforms by the pulseco algorithm for the subsequent determination of stroke volume (sv), heart rate (hr) and cardiac output (co).the lidco cnap module is an optional accessory device for use only with the lidcounity monitor.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

samson medical technologies pty ltd - 61880 - argon-enhanced electrosurgical handpiece - the electrode handles are designed for cutting and coagulation in electrosurgical procedures. selected handle models work with argon. to be connected with monopolar outputs of emed electrosurgical units with argon module and other compatible units.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

samson medical technologies pty ltd - 61877 - argon-enhanced endoscopic electrosurgical electrode, reusable - reusable argon electrodes are intended for cutting and coagulation with the use of argon in open and laparoscopic surgery. they work connected by means of a suitable holder with monopolar outputs of emed electrosurgical units with argon module and other compatible units.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

device medical pty ltd - 66283 - radio-frequency hyperhidrosis treatment/injection system - doubletite is a medical device combined with high-frequency current, to function as an electrosurgical device for use in dermatology and general surgical procedures, and with a electrical syringe-style drug infusion pump module that repeatedly injects shallowly a drug, ie hyaluronic acid solution, into the target treatment area of patient. it is possible to select and change modes, parameters, outputs, etc. using the panel on the main body and the device must only be operated by qualified medical professionals.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - this pulse generator provides bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias. the pulse generator has independently programmable outputs and accepts one or more of the following leads, depending on the model: ? one is-1 unipolar or bipolar atrial lead ? one is-1 unipolar or bipolar right ventricular lead? device includes zip telemetry. connector type ra: is-1, rv: is-1. case is hermetically sealed titanium. supplied with a torque wrench boston scientific pacemakers are indicated for treatment of the following conditions: ? symptomatic paroxysmal or permanent second- or third-degree av block ? symptomatic bilateral bundle branch block ? symptomatic paroxysmal or transient sinus node dysfunction with or without associated av conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [sa] block) ? bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias ? neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity. dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of av synchrony. dual chamber modes are specifically indicated for treatment of the following: ? conduction disorders that require restoration of av synchrony, including varying degrees of av block ? vvi intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm ? low cardiac output or congestive heart failure secondary to bradycardia

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - this pulse generator provides bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias. the pulse generator has independently programmable outputs and accepts one or more of the following leads, depending on the model: ? one is-1 unipolar or bipolar atrial lead ? one is-1 unipolar or bipolar right ventricular lead? device includes zip telemetry. connector type ra: is-1, rv: is-1. case is hermetically sealed titanium. supplied with a torque wrench boston scientific pacemakers are indicated for treatment of the following conditions: ? symptomatic paroxysmal or permanent second- or third-degree av block ? symptomatic bilateral bundle branch block ? symptomatic paroxysmal or transient sinus node dysfunction with or without associated av conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [sa] block) ? bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias ? neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity. dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of av synchrony. dual chamber modes are specifically indicated for treatment of the following: ? conduction disorders that require restoration of av synchrony, including varying degrees of av block ? vvi intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm ? low cardiac output or congestive heart failure secondary to bradycardia

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 47267 - single-chamber pacemaker, rate-responsive - this pulse generator provides bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias. the pulse generator has independently programmable outputs and accepts one or more of the following leads, depending on the model: ? one is-1 unipolar or bipolar atrial lead ? one is-1 unipolar or bipolar right ventricular lead? device includes zip telemetry. connector type ra/ rv: is-1. case is hermetically sealed titanium. supplied with a torque wrench boston scientific pacemakers are indicated for treatment of the following conditions: ? symptomatic paroxysmal or permanent second- or third-degree av block ? symptomatic bilateral bundle branch block ? symptomatic paroxysmal or transient sinus node dysfunction with or without associated av conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [sa] block) ? bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias ? neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity.