Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 44836 - video capsule endoscopy system - the capsule endoscopy system is applicable to gastrointestinal tract diseases examination, which mainly consists of three parts: capsule endoscope, image recorder, and image workstation. after being swallowed by a patient, the capsule will move forward along the gastrointestinal tract, take snap shootings, and transmit the photos wirelessly in real time to the recorder carried by the patient. then physicians can download the photo data to the image workstation, analyze them and give the diagnosis report.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 58357 - gastrointestinal telemetric monitoring system - the ph capsule monitoring system is for examining gastroesophageal reflux disease (gerd). it may continuously monitor ph variation within the esophagus for 96 hours. examination data is stored in the data recorder and transmitted to the workstation by means of radio frequency. after the examination, doctors may learn the patient?s ph variation within the esophagus based on the recorded data and the analysis report generated from the workstation in order to make a diagnosis. the system is comprised of the ph capsule, conveyor, data recorder, data analysis workstation and relevant accessories.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 60656 - rectal ultrasound navigational image processor - isr?obot? mona lisa is intended for use by a trained urologist or physician to perform the computer-assisted transperineal prostate biopsy under transrectal ultrasound guidance. the device serves as a biopsy needle guide only. it shall be used in conjunction with a third party ultrasound machine and endorectal probe that supports b-mode, and a third party prostate biopsy gun and needle. isr?obot? mona lisa is a platform-hosted motorized device integrating a probe-driving system for 3-d image collection and a precise biopsy guidance mechanism (biopsy needle platform) to control the orientation of needle insertion and depth of puncture to assist the surgeon to perform targeted transperineal prostate biopsy in conjunction with the guidance of transrectal ultrasound.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 44054 - surgical procedure kit, orthopaedic, reusable - a collection of various surgical instruments, dressings and the necessary materials to perform an orthopaedic surgical procedure. this device can be presented as a kit, tray or set. it is reusable after the appropriate cleaning/sterilizing of the instruments/reusable products and the consumable/medicinal products have been replenished.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 58038 - joint/spinal manipulator - the activator v-e is a hand-held battery-powered instrument intended to be used by a healthcare professional for the chiropractic adjustment or manipulation of the joints of the spine and/or extremities. this electromechanical instrument is pistol-like in shape and uses a plunger-like mechanism to deliver thrust to the patient's body with a rubber-tipped stylus; it has four force settings. this is a reusable device.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 60212 - magnetic nanoparticle tracer - the device is a magnetic tracer intended and calibrated for use with the sentimag? device only as part of an overall system to mark and locate lymph nodes in cancer patients prior to their surgical removal. intended to be injected into interstitial tissue only in close proximity to a tumour to facilitate its migration to sentinel lymph nodes for their subsequent localization by the sentimag magnetometer.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 12516 - metal detector, magnetic - the sentimag probe is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (supplied separately) which is injected into the interstitial tissue to locate sentinel lymph nodes (after the iron oxide particles have migrated to the nodes) for their subsequent surgical removal. the device detects and locates the iron oxide particles via the delivery of a small, time-varying magnetic field indicating the proximity of the particles to an attached probe by producing an audible and numerical signal.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 16173 - automatic-inflation electronic sphygmomanometer, non-portable - the withings wireless blood pressure monitor is a fully automatic blood pressure monitor, operating on the cuff oscillometric method. it measures your blood pressure and pulse rate simply and easily.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 36252 - patient data recorder, long-term, physical activity - the system is an ultra light-weight, waterproof, wrist-worn tri-axial actigraph designed for long-term or short-term monitoring of physical activity. the system provides an empirical assessment of movement in every minute of the day (or user defined epoch). the system interprets the data to quantify the intensity and duration of daily physical activity and to assess night-time activity for estimating sleep quality. the system allows for the set-up, download and analysis of data captured with the actigraph device. the system also incorporates a light sensor to record luminous intensity (lux) of white light and an event marker button. utilizing the latest low-power mems technology, the system provides a convenient, flexible platform for actigraphy studies of all sizes.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 36252 - patient data recorder, long-term, physical activity - the system consists of a wrist-worn electronic patient diary and associated pc program which can record the user?s answers to questions during daily living in a very flexible and easy to use way. the system also incorporates a tri-axial accelerometer to allow objective actigraphy data to be collected while the device is worn. actigraphy data may be saved and loaded into the program for analysis of sleep, circadian rhythm, and activity levels. the system can be used to monitor a wearer?s condition and symptoms before treatment, or detect a change in the wearer?s symptoms during or after intervention. it can also be used to remind the wearer to take treatment at regular or irregular intervals or to record events when marked by the wearer. the system is very flexible to different recording requirements for various areas of research.