Singapore - engelsk - HSA (Health Sciences Authority)

draeger singapore pte ltd - general hospital - the inifinity acute care system (iacs): the iacs is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained healthcare professionals. the iacs obtains the physiologic, multi-parameter data from the connection to the m540 monitor and optional medical devices and displays. the transfer of this data is accomplished by the infinity network. the infinity m540 (m540) is intended for the monitoring of multi-parameter, physiologic patient information obtained from connected hardware in environments where patient care is provided by trained healthcare professionals. the m540 is intended to monitor one patient at a time. the m540 and any connected hardware are not intended for use in the following hospital environments: – hyperbaric chambers – environments containing mri equipment

Singapore - engelsk - HSA (Health Sciences Authority)

draeger singapore pte ltd - cardiovascular - the monitors are capable of monitoring: heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, st segment analysis, 12-lead st segment analysis, tcpo2/tcpco2, eeg signals, fio2 and end tidal co2. scio gas module sampled breathing gases from adults and pediatrics. the gas module continuously measures the content of co2, n2o, o2 and one of the anesthetic agents, halothane, isoflurane, enflurane, sevoflurane and desflurane in any mixture and communicates real time and derived gas information to the infinity monitors. the devices are intended for use in the adult, pediatric and neonatal populations, with the exception of the parameter cardiac output, st segment analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpo2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

Singapore - engelsk - HSA (Health Sciences Authority)

draeger singapore pte ltd - cardiovascular - the devices are capable of monitoring heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation, pulse rate, central apnea, end-tidal carbon dioxide and st segment analysis. this device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. the devices will connect to r50 recorders either directly or via the infinity network. when a gammaxl is connected to a scio module sampled breathing gases from adults and pediatrics can be displayed. the gas module continuously measures the content of co2, n2o, o2 and one of the anesthetic agents, halothane, isoflurane, enflurane, sevoflurane and desflurane in any mixture and communicates real time and derived gas information to the gammaxl. the devices are intended for use in the adult, pediatric and neonatal populations, with the exception of arrhythmia and st segment analysis which are not intended for the neonatal population.

Singapore - engelsk - HSA (Health Sciences Authority)

draeger singapore pte ltd - cardiovascular - the monitors are capable of monitoring: heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, cardiac output , arterial oxygen saturation, pulse rate, apnea, st segment analysis, 12-lead st segment analysis, fio2 and end tidal co2. scio gas module sampled breathing gases from adults and pediatrics. the gas module continuously measures the content of co2, n2o, o2 and one of the anesthetic agents, halothane, isoflurane, enflurane, sevoflurane and desflurane in any mixture and communicates real time and derived gas information to the infinity monitors. the devices are intended for use in the adult, pediatric and neonatal populations, with the exception of the parameter cardiac output, st segment analysis, and arrhythmia which are intended for use in the adult and pediatric populations only.

Singapore - engelsk - HSA (Health Sciences Authority)

draeger singapore pte ltd - cardiovascular - the devices are capable of monitoring heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation, pulse rate, central apnea, and st segment analysis. this device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. the devices will connect to r50 recorders either directly or via the infinity network. the devices are intended for use in the adult, pediatric and neonatal populations, with the exception of arrhythmia and st segment analysis which are not intended for the neonatal population.

Singapore - engelsk - HSA (Health Sciences Authority)

draeger singapore pte ltd - general hospital - the infinity ics indicated for use by healthcare professionals for the purposes of centralized monitoring within the hospital or clinical environment of adult, pediatric and neonatal patient monitor data on the infinity patient monitoring network. the infinity centralstation is intended to measure and produce visual and audible alarms for one or more physiological parameters. the infinity® m300 is indicated to be used by healthcare professionals for the purpose of monitoring ecg and pulse oximetry parameters of ambulatory and non-ambulatory adult and pediatric patients in healthcare type facilities.

Singapore - engelsk - HSA (Health Sciences Authority)

draeger singapore pte ltd - obstetrics & gynaecology - jaundice meter is non-invasive transcutaeous bilirubinometer. it measures yellowness of subcutaneous tissue in newborn infants. the unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants. the jaundice meter is indicated for use in neonatal patients born ≥24 weeks gestation who have not undergone exchange transfusion. the device is indicated only for use before, during, and after phototherapy treatment. the device is intended for use in hospitals or doctors offices under a physician's supervision, or at their direction. it helps clinicians to monitor newborn infants. the device is not intended as a standalone screening device for diagnosis of hyperbilirubinemia. it is used as a screening device with other clinical signs and laboratory measurements.

Singapore - engelsk - HSA (Health Sciences Authority)

draeger singapore pte ltd - obstetrics & gynaecology - the jaundice mater is a non-invasive transcutaneous bilirubinometer. it measures yellowness of subcutaneous tissue in newborn infants. the unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants. the device is intended for use in hospitals or doctors' offices under a physician's supervision or at their direction to assist clinicians in monitoring of newborn infants. the device is not intended as a standalone screening devices for diagnosis of hyerbilirubinemia. it is to be used as a screening device in conjunction with other clinical signs and laboratory measurements. newborn infants whose jaundice meter test results are indicative of hyperbilirubinemia should be evaluated by their physician(s) for appropriate patient management. specific neonatal patient bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations. the jaundice meter is not intended for home use.

Singapore - engelsk - HSA (Health Sciences Authority)

draeger singapore pte ltd - general hospital - the vista 120 monitors parameters such as ecg (3-lead or 5-lead selectable), respiration (resp), functional arterial oxygen saturation (spo2), invasive or non-invasive blood pressure (ibp, nibp), temperature (dual-temp), end-tidal co2, cardiac output (c.o.), and ag. vista 120 is intended to be used only under regular supervision of clinical personnel. it is applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient transport inside a healthcare facility.

Singapore - engelsk - HSA (Health Sciences Authority)

draeger singapore pte ltd - general hospital - a disposable water trap for separating of water from the sample line of extracting monitors. for protection of the monitor against water, bacteria and viruses. indicated for use with dräger water trap holder without luer lock connection and with the dräger water trap holder with luer lock connection and adapter.