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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.

WoundExpress aids in the treatment of the following clinical conditions: - Chronic wounds including leg ulcers (venous leg ulcers and mixed aetiology leg ulcers) - The management of lower limb pain

The WoundExpress Therapy Device is an intermittent pneumatic compression system consisting of a pump unit and a thigh garment, interconnected by a detachable three chamber tube set. It is a non-invasive mechanical system designed to enhance blood and lymph flow as a therapy to manage the clinical condition listed above. The pump is a portable, ac mains powered device, that produces a pre-set pneumatic therapy cycle delivered through a 3 port output connector, which is connected to a three chamber garment that is applied to the patient thigh. The pump operates on a 4 minute automatically timed gradient pressure sequence, consisting of a 2 minute venous emptying phase and a 2 minute rest phase. The venous emptying phase consists of six 20 second compression cycles, while no compression takes place during the rest phase. Each 20 second compression cycle is characterised by overlapping synchronous inflations and deflations of the distal (lower), central (middle) and proximal (upper) chambers.

The DIOP8 surgical Doppler is indicated for use by qualified healthcare practitioners in a sterile condition in the operating theatre for the assessment of vascular blood flow by direct application to the vessel wall.

The DIOP8 is a sterile, single use, high sensitivity probe that assists in the performance of safe surgery. It is a lightweight, 8MHz ultrasound, handheld pencil probe' that has a small diameter tip that enables the detection of blood flow in vessels. The DIOP8 ultrasound probe operates in pulsed-wave mode. It has one circular piezo-electric crystal that is mounted behind the front faceplate and the crystal is used for both transmit and receive functions. The DIOP8 is manufactured at a frequency of 8MHz. The output ultrasonic parameters are fixed during the manufacturing process and cannot be adjusted by the user. A connector system at the end of the cable allows the DIOP8 to be removed from the hand held Doppler. An interconnection adapter houses the bi-directional electronics, which are specific for the device application, and is required as an interface between the main unit and DIOP8. The connector is similar to a conventional connector, but has no external conductive contacts, and is totally sealed, thus preventing the ingress of fluid and contaminants. Within the connector is a small coil that transfers electrical energy to and from a similar, but larger coil in the corresponding socket at the end of the PA8/PA8XS adapter. Transmitted and received electrical signals are passed through this connector, but there is no direct electrical connection between the probe and the PA8/PA8XS adapter. The connector provides electrical isolation between the probe and the PA8/PA8XS adapter, which optimises system electrical safety by limiting patient leakage currents to very low levels. During use, the adapter is securely held in the probe holder that is an integral part of the Doppler main unit. When connected this way, the hand held Doppler unit operates as if a normal VP8 probe is connected.

The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors) are indicated for use by trained healthcare professionals in non-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: 1) Single or twin fetal heart rates by means of ultrasound 2) Uterine activity externally sensed 3) Fetal movement maternally sensed and externally via ultrasound 4) Maternal heart rate and oxygen saturation via pulse oximetry 5) Maternal non-invasive blood pressure Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications: 1) Single or twin fetal heart rates by means of ultrasound and/or FECG 2) Maternal heart rate via ECG electrodes 3) Uterine activity externally or internally sensed 4) Fetal movement maternally sensed and externally via ultrasound 5) Maternal heart rate and oxygen saturation via pulse oximetry 6) Maternal non-invasive blood pressure

The Sonicaid Team3 is a mains / battery powered multi-function fetal monitor designed for use in clinical and hospital environments during antepartum and intrapartum phases of pregnancy. The Sonicaid Team3 is designed for use at the bedside; there is a wall mounting bracket available as well as a trolley for fixed or transportable use. The unit may also be used free-standing on a work surface. The units are powered either from local mains electrical supply or an optional internal rechargeable battery. The Sonicaid Team3 fetal monitors include the following: - 8.4" Color LCD Display with LED backlighting. - Touch screen user interface. - Monitoring of up to two fetal heart rates via independent ultrasound transducers. - Monitoring of maternal uterine activity via external tocodynamometer (Toco) or internal intra-uterine pressure (IUP) transducers. - Monitoring of maternal oxygen saturation (SpO2) and heart rate via pulse oximetry sensor. - Monitoring of maternal Non-Invasive Blood Pressure . (NIBP). - Monitoring of fetal heart rate via ECG. - Maternal heart rate (eMHR). - Capture of maternally sensed fetal movements via a cabled switch. - Chart printout via (optional) inbuilt thermal printer - Data output via RS232.

The DMX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the non-invasive assessment of vascular blood flow to assist in diagnosis. The SRX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of fetal heart rate to assist in diagnosis.

The DMX Doppler provides the clinician with the ability to perform vascular investigations. It is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The DMX hand unit is used with a Doppler or Arterial Photoplethysmography (APPG) probe, selected to suit the nature of the investigation to be performed. The device includes a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. Doppler Mode: The probes emit low energy ultrasonic waves into the body which are reflected back into the probe. The reflected ultrasonic waves contain information about the blood flow, which can be heard as audio sounds from the loudspeaker and waveforms presented on the display. There is a range of compatible Doppler probes; the choice of probe is determined by the type of vascular assessment being performed and depth of vessel. APPG Mode: The APPG sensor emits low energy infra-red light into the body, some of which is reflected by blood within the tissue back into the sensor. The variation of this reflected light is related to the blood volume within the tissue. The APPG probe is used with an inflatable cuff and sphygmomanometer gauge to measure toe / finger blood pressures. Dopplex Reporter 5 (DR5) Software Package: The DR5 software is a medical device data system (MDDS) and is an optional accessory to the dopplex® DMX bidirectional Doppler. It can display bidirectional velocity/time waveforms obtained from various vessels. Data can be archived and a printout can be obtained for patients notes. The DR5 is not a standalone medical device – it can only be used with the DMX Doppler to display, archive and print Doppler waveforms and PPG pressures produced by the DMX. The SRX Doppler range is intended to be used by qualified healthcare practitioners for the detection and presentation of the fetal heart rate to assist in the assessment of fetal well-being during pregnancy. Each model is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The SRX hand unit is used with a choice of either a 2MHz (OP2XS) or 3MHz (OP3XS) obstetric Doppler probe. The SR2 and SR3 have fixed probes (2MHz and 3MHz respectively). All models include a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. The probes emit low energy ultrasonic waves into the body some of which are reflected back into the probe. The reflected ultrasonic waves contain information about the fetal heart, which can be heard as audio sounds from the loudspeaker and heart rate values presented on the display.

To enhance fluid flow into and along the vascular and lymphatic vessels. As a treatment for venous and lymphatic disorders. As an effective in the treatment of the following clinical conditions, when combined with an individualized monitoring programme: - Lymphedema. - · Primary and secondary (including post-surgery, radio or chemotherapy). - . Chronic Edema of Venous Origin - Chronic venous insufficiency. . - Acute and chronic wounds including venous leg ulcers and post- surgical wounds. . IPC may also be beneficial in the management of: - . Lipoedema. - Varicose veins . - Postoperative Venous Ligation or Stripping . - . Sports injuries - Post Traumatic Edema . - . Lymphatic Filariasis

The Hydroven 12 system comprises of a range of inflatable sleeves. inserts and a compatible air pump. The sleeves fit around patients' upper and lower limbs. The sleeves contain separate but overlapping air chambers that intermittently compress the limbs in a specific sequence. The resultant pressure on the patient's limb tissues promotes the transport of fluids and proteins. The inflatable inserts can be added to allow large circumference limbs to be treated. The pump provides the compressed air to the sleeves with user selected pressures and sequence of operation.

The Sonicaid™ Freedom Wireless Fetal Monitoring System ('Freedom') is a wireless transducer system for monitoring fetal heart movement and maternal contractions during intrapartum and antepartum periods of pregnancy. It is an optional accessory for use with Huntleigh Healthcare Limited's Sonicaid™ FM820 and FM830 Encore Fetal Monitors ('FM800E Monitors') as an alternative to their wired transducers. When connected to an FM800E Monitor, the system monitors: • Uterine activity by using an external, pressure-sensitive TOCO transducer, and • Fetal Heart Rate (FHR) by pulsed Doppler ultrasound using an external Ultrasound transducer. Freedom is suitable for use with pregnant women in clinical and hospital facilities. The transducers are water tight allowing pregnant women to be monitored while they are mobile, stationary or in a bath or shower environment. This system should only be used by, or under the supervision of, a licensed physician or other health practitioner who is trained in the use of FHR monitors.

The Sonicaid™ Freedom is intended to monitor fetal heart movement and uterine activity by using wireless, non-invasive transducers on pregnant women during antepartum and intrapartum phases of pregnancy. This system is an optional accessory that must be connected to, and used with, a Sonicaid™ FM800E Monitor when a woman wishes to be mobile or in a water environment when being monitored or giving birth. The Freedom has three major components; the Receiver and Ultrasound ('US') and Tocograph ('TOCO') transducers. The wireless transducers are powered by internal batteries that are recharged when docked on the Receiver. The Sonicaid ™Freedom operates in the WMTS frequency bandwidth. There are 100 selectable channels available for use. If there is interference when installing the system, then the channel may be changed to achieve clear transmission.

Dopplex Ability is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). Dopplex Ability is intended for rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults and pulse volume recording (PVR) / volume plethysmography. It is suitable for use in woundcare assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. Dopplex Ability can be used on patients with unilateral lower limb amputation.

Dopplex Ability is intended to measure a patient's Ankle Brachial Index (ABI) and provide PVR. This is done through an automated process. The operator places the four colour coded cuffs on each of the patient's limbs as described in the instruction for use and connect to the device. When connected the operator pushes soft touch button to start measurement, the device then will automatically control the inflation / deflation of the cuffs on each limb and monitor minute variations in individual pressures to determine values to be used for the calculation of the ABI values for both the left and right hand of the patient. Dopplex Ability uses pneumo-plethysmography uses obtain physiological measurements from patient's limbs. Measurements are conducted as a single occurrence on all four limbs, eliminating any requirement to rest the patient between measurements. The test period takes approximately 3 minutes. The ABI indices are calculated using an in house algorithm. ABI values are displayed on the LCD and can also be printed. In addition, records are generated of the Pulse Volume Waveforms (PVR), which may also be displayed on the LCD and can be printed.

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.