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The Team3 fetal monitors are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are intended for use in clinical and hospital-type facilities. Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications: - Single or twin fetal heart rates by means of ultrasound - Uterine activity externally sensed - Fetal movement maternally sensed and externally via ultrasound - Maternal heart rate and oxygen saturation via pulse oximetry - Maternal non-invasive blood pressure - CTG analysis advises whether a number of defined criteria indicative of a normal cardiograph record has been met Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications: - Single or twin fetal heart rates by means of ultrasound and/or FECG - Maternal heart rate via ECG electrodes - Uterine activity externally or internally sensed - Fetal movement maternally sensed and externally via ultrasound - Maternal heart rate and oxygen saturation via pulse oximetry - Maternal non-invasive blood pressure

The Sonicaid Team3, subject device, is a fetal monitoring device designed for perinatal monitoring and includes a software function, the Dawes-Redman CTG Analysis, previously cleared under K992607. The subject device provides non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses during antepartum and intrapartum periods. The subject device includes systems and accessories intended to perform perinatal monitoring as aligned with product code HGM. Features included in the subject device are the Dawes Redman analysis, used to assess clinically indicated antepartum cardiotocographs (CTGs) in pregnancies from 26 weeks gestation onwards, assisting physicians in identifying normal and nonreassuring traces. The Dawes-Redman software is embedded in the subject device, ensuring integration with the existing hardware. The device is not intended for use in latent or established labor due to the influence of additional factors such as labor contractions and pharmacological agents.

The Huntleigh Healthcare Ltd Sonicaid FM820 and FM830 Encore fetal monitors are indicated for use by trained healthcare professionals in non-invasive monitoring of physiological parameters in pregnant adult human females, and fetuses, during the intrapartum and antepartum periods of pregnancy. The devices are intended for use in clinical and hospital-type facilities. They are not intended for use in intensive care units, operating rooms or in transport monitoring applications. Sonicaid FM820E is suitable for use when there is a need to monitor the following physiological parameters: - . Single or twin fetal heart rates by means of ultrasound - ◆ Fetal or maternal heart rate via ECG - Uterine activity externally or internally sensed . - . Fetal movement - maternally sensed. Sonicaid FM830E is suitable for use when there is a need to monitor the following physiological parameters: - . Single or twin fetal heart rates by means of ultrasound - . Fetal or maternal heart rate via ECG - Uterine activity externally or internally sensed . - Fetal movement - maternally sensed. - . Maternal heart rate and oxygen saturation via pulse oximetry - . Maternal non-invasive blood pressure

The FM820E and FM830E are fetal/maternal monitors designed for use in clinical and hospital environments during the ante-partum and intra-partum phases of pregnancy. Both units are designed for use at the bedside and the range includes a wall mounting bracket and a trolley for fixed or transportable use. The units may also be used free-standing on a work surface. The FM820E and FM830E are powered from the local mains electrical supply. The FM820E includes the following facilities: - Monitoring of one or two fetal heart rates via two independent ultrasound transducers. . - Monitoring of maternal uterine activity either via external (Toco) or internal (IUP) transducers. . - Monitoring of maternal or fetal heart rate via ECG. - . Capture of maternally sensed fetal movements via cabled switch. - Display of vital signs parameters via colour LCD screen. . - t Control interface via combination of dedicated and "soft" function buttons in conjunction with on-screen prompts. - . Chart printout via inbuilt thermal printer. - Connection to Central Monitoring System possible via RS232 or Ethernet. . - Audio and visual alerts (user set limits). The following facilities are provided on the FM830E model in addition to the above: - . Monitoring of maternal oxygen saturation and heart rate via pulse oximetry sensor. - Monitoring of maternal Non-Invasive Blood Pressure (NIBP) via inflatable cuff. . The connections for the additional facilities are incorporated in a "side pod", which extends the area of the front panel. Field upgrade of the FM820E to FM830E specification is not allowed.

The Smartsigns MP1 and MP1R handheld pulse oximeter is intended for noninvasive continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. It is intended for use by healthcare professionals for monitoring adult and pediatric patients in hospitals and hospital-type facilities. The specific medical indications for the use of this device is : - This device is a prescription device - . This device is re-useable and is intended for spot or continuous measurement - 트 This device is intended to display oxygen saturation, heart rate and pulse strength or pulsatile signal. - This device is intended to indicate an alarm if the measured saturation or 트 heart rate are outside user-set alarm limits.

The Smartsigns Minipulse MP1 is a hand held, battery powered pulse oximeter used for monitoring pulse rate and saturated oxygen in arterial blood. It is also available as a rechargeable unit (MP1R). The MP1R is supplied with four rechargeable batteries, a Deskstand charger unit and power supply. The MP1R is recharged by docking it on the Deskstand charger unit. The Smartsigns MP1 and MP1R provide audible alarms, a membrane keypad and LED displays to display digital values of heart rate and saturation. Pulse amplitude is displayed by means of a bargraph LED array. The keypad allows the unit to be switched ON and OFF, it also allows the user to set alarm limits for saturation and heart rate.

Dopplex Centrale (DCII) is a software package that collects and manages real-time data from a maximum of 48 individual fetal monitors which are connected to a central server by means communication links. Dopplex Centrale is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive and centralised obstetrical surveillance of those maternal patients who are being monitored by otherwise autonomous CTG devices. Fetal heart rate information can be concurrently viewed on up to 50 conveniently sited computers including a central station, patient bedsides, nurses' lounges and physicians' offices. Dopplex Centrale provides an easy to use means of patient surveillance within a perinatal environment within a hospital. A Dopplex Centrale system is specified, supplied, commissioned and maintained exclusively by the manufacturer, Huntleigh Healthcare, or its appointed agents. It provides storage and archiving of FHR traces together with the associated patient details. The specific medical indications for the use of this device is : - This device is a prescription device - This device is not intended to contact the patient - This device is used continuously in Obstetrical Departments - Basic fetal trace alerting for antepartum and intrapartum applications - The physiological purpose is indirect. The device is intended to gather and store fetal and maternal information provided by the attached fetal monitors which constitute the primary care sources.

The Dopplex Centrale (DCII) monitoring system provides a powerful flexible solution to satisfy current and future central monitoring requirements for perinatal care wards. Various makes of fetal monitor can be linked to Dopplex Centrale which collects data from up to 48 beds in real time. This data is displayed graphically to the user at conveniently sited client workstations. The CTG information is saved using a secure database for subsequent review and patient management. Dopplex Centrale is customisable at manufacturer to cater for disparate needs of particular antenatal clinic or labour ward sites. Dopplex Centrale can be configured to suit the operating protocols of individual customers.