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

nl-tec pty ltd - 40896 - patient positioning device, diagnostic imaging/radiotherapy, moulding, thermoplastic - a position-retaining device, which may be interchangeably described as a pillow, splint, cast, for persons whose bodies or body parts are required to be retained in a particular position or attitude for treatment during radiotherapy

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

philips electronics australia ltd - 43267 - patient positioning sensor - a device designed to detect and respond to movement and transmits a signal proportional to the degree of motion. the sensor is a real-time, three-dimensional position-locating device based on electromagnetic technology. this data is communicated to the computer system so that the physical position of the instrument can be precisely mapped to the images displayed on the monitor.

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

bird healthcare pty ltd - 43267 - patient positioning sensor - somnibel is a body-worn, active device able to detect the position of the patient during sleep and to generate a gentle vibration, depending on the detected position, that induces the patient to change body position. the somnibel pro is a body-worn, active device intended to be used by medical staff for the treatment of positional sleep apnea hypopnea syndrome (sahs) or positional snoring by applying gentle vibration to induce a change in the body position, to reduce the incidence of sleep respiratory events and to record the body position, actigraphy and stimulus power signals for subsequent analysis.

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

gorman promed pty ltd - 43267 - patient positioning sensor - the buzzpod is a battery operated (2x aaa) device worn in a band around the chest in bed. the position of the body is sensed through tilt position switches which are located inside the small abs box in the chest band. when the sleeper lies on their back the device will trigger a vibrating part (identical to the silent mode vibration in a mobile phone). this is sufficient in most cases to prompt the sleeper/wearer to roll off their back. the vibration will then stop. this body position is logged and can be uploaded should the user want to learn about body position. typically though the device is used without the user wanting to download the data. this would be useful to researchers and the more enquiring but only the core function (vibrate when supine) would be utilised in most cases. it senses and impacts on body position and prompts the sleeper to avoid 1 or more positions. there are many derived benefits from avoiding supine from helping reduce supine snoring and sleep apnoea through to pressure sore avoida

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

osseo dental - 65436 - orthodontic resin positioning tray - device description: clearcorrect engager templates are a clear, thin, plastic, thermoformed, removable device that contains cavities that are in the negative shape of the prescribed engager. the engager template is intended to hold and facilitate the positioning of light-cured dental resin onto teeth to form the positive shape of the engager when fully cured. indications for use: used in conjunction with the clearcorrect appliance system, the clearcorrect engager template is indicated for use in the treatment of tooth malocclusion of patients where some teeth are shaped or positioned in a way that can be difficult for an aligner to "grab? onto. by using the engager template, small composite-resin engagers are placed onto the facial surfaces of the teeth so that the aligner has additional surfaces and undercuts to "engage" with.

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

temple healthcare pty ltd - 41451 - patient positioning device, - a disposable inflatable cushion that supports and positions body parts during surgical or medical procedures and examinations. the medical staff can choose the shape and size that best suits their surgical or medical needs and patient. some examples: lifting the thorax for genupectoral/ salaam position, enabling temporary jackknife supine position during open vascular surgery, creating the indirect distraction during an alif procedure. it can also provide prone ventilation support for prone ventilation in the intensive care unit.

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

compliance management solutions - 40891 - patient positioning device, diagnostic imaging/radiotherapy, - the tavi (transcatheter aortic valve implantation) arm support can be used during interventional procedures (fluoroscopy and/or cine-angiography). the product has two key features: 1. to support / immobilize the patient?s arm at their side during the procedure. 2. to reduce operator radiation exposure by absorbing radiation scatter through lead shielding placed in the upright section. for most procedures, two arm supports, one on each side, provide optimal support/constraint and radiation protection. the arm support positioned on the same side as the primary operator provides protection to the operator and those assisting him/her on the same side of the patient. the arm support on the other side provides protection for an assistant working from the other side of the imaging or operating table, and also for those circulating in the room.

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

ge healthcare australia pty ltd - 40902 - patient positioning device, diagnostic imaging/radiotherapy, whole body - the pediatric positioner pad set is intended for use with newborn and infant patients up to 2 years of age or 12kg. it positions patients for pediatric mr neural imaging on brain and spine surface coils designed for adults.

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

bmedical pty ltd - 43267 - patient positioning sensor - intended to provide feedback and data on positions during sleep. the device also gives quantified snoring levels and sleep quality. sensor may be used in conjunction with a pulse oximeter for additional reporting.

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

elekta pty ltd - 45446 - patient positioning system, ultrasound - clarity? is indicated for use in external beam radiation therapy. it provides 3d ultrasound and hybrid imaging of soft tissue anatomy to aid in radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment (image guided radiation therapy). when configured with an autoscan probe kit for transperineal ultrasound (tpus) imaging, clarity? may be used to continuously track and monitor the motion of the prostate and to accurately and precisely guide patient positioning during the delivery of treatment (intrafractional position tracking and monitoring). when configured with a gating option, clarity? may also interface with radiation delivery systems equipped with a compatible external gating control device. with this option, while in tracking and monitoring mode, clarity? can signal the radiation delivery system to automatically impose a beam-hold when the position of the tracked anatomy has exceeded pre-defined monitoring (tracking) limits, and signal again to release the beam-hold when the tracked anatomy returns to a position within those limits (exception gating). exception gating has been shown to be compatible with radiation delivery systems equipped with elekta?s response? gating control system.