Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - indicated for monitoring co2 and respiration rate of all hospital patients weighing more than 5kg (11 ibs.).

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - cardiosoft is a pc-based system for electrocardiographic (resting ecgs, exercise tests) and spirometric tests as well as for ambulatory blood-pressure examinations. the program is intended for use under the direct supervision of a health-care practitioner. cardiosoft uses an analysis program which can be used as a tool in interpreting ecg waveforms.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - the s/5 anesthesia monitor with l-ane07 or lane07a software is intended for multiparameter patient monitoring with optional patient care documentation. the s/5 anesthesia monitor with l-ane07 and l-ane07a software is indicated for monitoring of hemodynamic (including arrhythmia and st-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, entropy (state entropy and response entropy) and neurophysiological status of all hospital patients. when the bis module is used with the s/5 anesthesia monitor with l-ane07 and l-ane07a, it is intended for use by personnel trained in its proper use. it is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of eeg signals. the bispectral index (bis), a processed eeg variable, and one component of the bis module, may be used in adults as an aid in monitoring the effects of certain anesthetic agents. the s/5 anesthesia monitor with l-

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - general hospital - the patient side module and accessories are indicated for the monitoring of hemodynamic parameters of all hospital patients. the hemodynamic parameters of the module comprise ecg including st-segment and arrhythmia, impedance respiration (for patients aged 3 and up), nibp (for patients who weigh 5kg and up), temperature, spo2 (including monitoring during conditions of clinical patient motion). impedance respiration measurement is indicated for patients aged 3 and up. the patient side module (model family e-psm(p)) is also indicated for invasive blood pressure.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - brivo xr118 digital x-ray imaging system should be used in combination with conventional x-ray imaging system to generate a digital image.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - general hospital - centricity pacs-iw is a device that receives medical images (including mammograms) from various imaging sources. images and data can be stored, communicated, processed and displayed in the local system or across computer networks at distributed locations. lossy compressed mammoraphics images and digitized film screen images must not be reviewed for primary image interpretations. mammographics images may only be interpreted using a monitor that offers at least 5 mpixel resolution.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - centricity* cardio imaging is a software only picture archiving and communication system (pacs) medical device. it will be sold as a software only device to operate on general purpose computing hardware. centricity* cardio imaging receives medical images and other information from various data sources. information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. centricity* cardio imaging is intended to assist trained professionals in the viewing, analysis, and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. these trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses and technicians. it is not intended for use in the patient vicinity.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the datex-ohmeda network and icentral (including icentral client) transfers information between networked datex-ohmeda devices in the monitor network as well as between monitor network and networked devices in ge unity network™. it also allows information transfer between several icentrals. the icentral maintains the network connections between the datex-ohmeda bedside monitors and other networked devices in monitor network. the icentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. the icentral client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. the datex-ohmeda network will be used for patients in the hospital and it is meant for continuous use.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - the capnostat / capnoflex lf co2 system is intended for continuous, non-invasive measurement of the carbon dioxide concentration and respiration rate of adult, pediatric or neonatal patients to a ge medical systems information technologies' host monitoring system.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the logiq s7 expert/pro is intended for use by a qualified physician for ultrasound evaluation. specific clinical applications and exam types include: fetal/obstetrics, abdominal (includes renal, gyn/pelvic), pediatric, small organ (breast, testes, thyroid), neonatal cephalic, adult cephalic, cardiac (adult and pediatric), peripheral vascular, musculo-skeletal conventional and superficial, urology (including prostate), transrectal, transvaginal, intraoperative (abdominal, thoracic, vascular and neurosurgical).