Singapore - English - 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 - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. it provides uninterrupted monitoring of physiological patient data. it is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous po2 and pco2, co2 and respiratory mechanics. it is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, o2, impedance cardiography, electroencephalography and bispectral index. the solar 8000i patient monitoring system also provides physiological data over the unity network.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - the ge datex-ohmeda aisys is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. the device is intended for volume or pressure control ventilation. the aisys is not suitable for use in a mri environment.

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

ge healthcare australia pty ltd - 47487 - medical device electrical cable, general purpose - novii interface cables enable interconnection of ge corometrics 259cx or corometrics 174 maternal/fetal monitor to the novii wireless patch system for wireless monitoring fetal/maternal electrocardiogram (fecg/mecg) and uterine activity (ua).

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - the intended use of the ivent101 ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. the intended patient population includes infants from 5 kg through adult patients. the ivent10 ventilator is suitable for use in institution, home and portable settings. the ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. indications the ivent101 is capable of providing the following types of ventilatory support: • assist/control and simv with either volume, pressure, or pressure regulated volume control (prvc) • cpap with pressure support • adaptive bi-level for either niv or invasive ventilation.

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

ge healthcare australia pty ltd - 47487 - medical device electrical cable, general purpose - a device is a cable to provide a connection between two or more devices for the purpose of transmitting energy.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - ca1000 is intended for viewing and diagnostic interpretation of images acquired from ct, mr, cr, dr, us, xa and other dicom-compliant medical imaging systems when installed on suitable commercial-standard pc hardware. ca1000 is intended for use as a primary diagnostic and analysis workstation in radiology/cardiology or other departments. it is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger pacs configuration. aw suite is a third-party application that interfaces with ca1000. at the heart of aw suite is the volume viewer. this allows you to process, review and analyze 3d reconstructed images originally acquired from ct, mr, x-ray angio, nm and pet scanning devices. the combination of acquired images, reconstructed images, annotations and measurements provides you with clinically relevant information for diagnosis, surgery and treatment planning.

Singapore - English - 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 - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - the compact airway module, e-caiovx family (e-caio, e-caiov, e-caiovx, e-co, e-cov and e-covx) is indicated for monitoring hospital patients respiration (co2, 02, n20, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (oxygen consumption vo2, carbon dioxide production vco2, respiratory quotient rq, and energy expenditure, ee). gas exchange status monitoring is not indicated in the presence of n20+02 mixtures.

Singapore - English - 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.).