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The Inmedix® CloudHRV™ System is intended to acquire, display, and record electrocardiographic (ECG) information to measure heart rate variability (HRV) in adult patients (age 22 or above) with normal sinus rhythm and resting heart rate within 40 - 110 bpm. These measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV must be determined by the physician. Assessment is indicated for patients in a healthcare facility including a physician office or a hospital outpatient clinic where the patient is able to remain supine and still. The CloudHRV™ System is not indicated for use in a surgical suite or during transport. Normal sinus rhythm is determined by the physician. The ECG is not intended to be used to diagnose or monitor cardiovascular conditions. The device does not provide assessments of cardiovascular abnormalities/arrhythmias.

The Inmedix® CloudHRV™ System acquires approximately 5 minutes of 3-lead electrocardioaraphic (ECG) data from a patient lying supine and at rest to measure heart rate variability (HRV). The raw cardiac electrical signals are detected using four standard ECG electrodes applied to the wrists and ankles of the patient and a custom 4-lead wire (one reference) ECG cable assembly. The ECG data collected from the patient are transmitted to a cloud-based service hosted by Inmedix. where proprietary mathematical algorithms calculate HRV. The CloudHRV™ System outputs are used as an aid by clinicians who are accustomed to evaluating HRV as a part of their overall medical assessment.

The SENTINEL System is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records the ECG data and transfers the data to the Server. Upon detection by an ECG analysis algorithm at the Server the recorded cardiac activity is flagged for review by a medical professional. The data received from the SENTINEL device can be used by another cleared device for arrhythmia analysis, reporting and signal measurements. The SENTINEL System is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, provide interpretative or diagnostic statements or provide for any life support. The SENTINEL System is for prescription use only.

Cardiomedix ECG SENTINEL System is a self-use, 2-lead ECG continuous acquisition and transmission system. The SENTINEL device connects via Bluetooth to a proprietary mobile phone-based, dedicated ECG acquisition, storage, and transmission application. The phone application facilitates the self-use of the device by providing messages and alerts for specific parameters. ECG SENTINEL System refers to the complete system with all component parts. SENTINEL refers to the monitoring device only. The SENTINEL data is continuously (long-term) transmitted by the phone to a designated server for storage, analysis, decision support, and response by a qualified and dedicated team. The SENTINEL is intended for use on patients with weighing more than 10 kg (22lbs) The SENTINEL monitoring device is a dedicated electronic device that records ECG and consists of electronic circuit board, batteries, a plastic enclosure, and lead wires. The data transmission to the smart phone is via low energy Bluetooth transmission. The smart phone mobile device acts as in in-home communication relay, stores the data, and transfers the data via the WEB, using secure communication, to a call center. The Call Center provides a service platform to monitor, analyze, store, and report ECG data sent from the patient.

The SELEC-3 I.V. Administration Set is used to provide a pathway to deliver fluid into the vascular system. This product is targeted for use by nurses and paramedics in pre-hospital, emergency room and field settings.

The Biomedix SELEC-3 I.V. Administration Set is a single- use, sterile device used for the administration of solutions and fully soluble drugs into the vascular system of a patient.

The BioMedix PADnet 2.0 is a non-invasive device used to assess the lower and upper extremity arterial and venous circulatory systems in order to assist in the identification of vascular disease. To assess the arterial system, PADnet 2.0 uses pulse volume recording, arterial pulse contour analysis, and segmental systolic & diastolic blood pressure measurements. To assess the venous valvular system, PADnet 2.0 measures venous refilling time. For identification of venous obstruction in the deep venous (below knee) system, PADnet 2.0 measures venous outflow rate. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non-intact skin.

The primary goal of the PADnet 2.0 system is to assess the blood vascular system and assist on the diagnosis of arterial and venous vascular disease. The currently released PADnet+ system already provides this type of functionality. With focus on the venous system, PADnet+ permits the assessment of venous reflux in the venous valvular system of the lower extremity. Its native functionality also permits the assessment of venous obstruction in the deep venous system. It accomplishes these ends using photo-plethysmography. Photo-plethysmography refers to a technique whereby localized volume changes due to an optically scattering/absorbant substance (e.g. blood) are measured. PADnet 2.0 adds the air plethysmography modality to the pre-existing venous test suite. Thus, only the methodology used for testing has been augmented. Indications for use are unchanged. With focus on the arterial system, PADnet+ permits the assessment of arterial insufficiency. It accomplishes this end using pneumo-plethysmography (air plethysmography). Pneumo-plethysmography refers to a technique whereby localized volume changes as measured by pressure changes in an inflated blood pressure cuff are recorded. This signal is assessed for waveform morphology and amplitude. Additional information regarding arterial insufficiency may be obtained by measurement of peak arterial systolic blood pressure. . PADnet 2.0 uses oscillometry to assess limb blood pressure.

The NTrainer System reinforces non-nutritive suck (NNS) in newborns and infants born prematurely.

A Soothie™ pacifier is inflated by a low pressure air pump that stimulates the baby's lips, tongue and jaw thus allowing the NTrainer System to reinforce non-nutritive suck (NNS) in newborns and infants. This is accomplished by providing the newborns or infants with a synthetic patterned oral somatosensory input. The NTrainer consists of the motor assembly, air cylinder, control electronics and computer system including a display. The only interface and contact with the baby is the disposable Soothie Pacifier. TM The application software has two modes of operation, NeoSuck, the assessment mode which defines the baby's state of non-nutritive suck development and, NTrainer, the therapy mode which reinforce the development of non-nutritive suck.

The BioMedix PADnet+ is a non invasive device used to gage the lower extremity arterial and venous system, using pulse volume recording, oscillometric segmental systolic blood pressure and photo plethysmograph, to assist in the identification of vascular disease. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non intact skin.

The BioMedix PADnet+ is a non invasive cardiovascular blood flow monitor. It is intended for use by trained medical professionals in a hospital or clinic. It is not to be operated in an explosive atmosphere or in the proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the PADnet Lab+. The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements: - Windows 2000 Operating System or Higher . - 128 MB RAM . - 20 GB Free Hard Disk Space . - 600 MHZ Processor or Higher .

The Q.STEPS Biometer G/C Dual Monitoring System is intended for use with Q.STEPS Glucose and Cholesterol Test Strips with Q.STEPS Biometer G/C System by healthcare professionals and home users. Q.STEPS Biometer G/C System provides a quantitative measurement of Glucose and Cholesterol in whole blood from the fingertips. The Glucose measurements are used in helping the management of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors. Cholesterol measurements are used in the management of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.

The Q. STEPS™ Biometer G/C Dual Monitoring System uses enzymatic electrochemical biosensor technology for a quick and easy measurement of the whole blood glucose and cholesterol levels. When finger stick blood is applied to the test spot of the biosensor (test strip), a reduction oxidation reaction of D-Glucose or Cholesterol occurs, which is catalyzed by Glucose Oxidase and Cholesterol Oxidase respectively, and therefore, the magnitude of the electron transfer at the electrode is proportional to the glucose or cholesterol concentration in the blood. The monitor will quantify the glucose and the cholesterol levels in the blood, and then display on the readout of the monitor.

The BioMedix PADnet Lab is a non invasive device used to record physiological data from the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures for use by the Physician in the identification of vascular pathology. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.

The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use in the early detection of peripheral vascular disease. The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use by trained medical professionals in a hospital or clinic. It is not to be operated in an explosive atmosphere nor in the proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the PADnet Lab. The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements: Windows 2000 Operating System or higher, 128 MB RAM, 20 GB Free Hard Disk Space, 600 MHz Processor or higher.

A properly placed I.V. catheter provides access to a vein or artery. TThe I.V. catheter system is designed for single use and has a needlestick protection feature. The needle guard that automatically locks over the needle as the catheter is threaded into the vessel reduces the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. 16 to 24 gauge catheters may be used with power injectors up to 300 psi.

Protectiv® Jelco® Safety I.V. Catheter

The Q.STEPS™ Biometer G Blood Glucose Monitoring System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for all ages (excluding neonates.) It is intended for use outside the body (for in vitro diagnostic use) by health care professionals in settings such as clinical laboratories and physician offices laboratories (POLs) as an aid to monitor the effectiveness of diabetes control.

The Q.STEPS™ Biometer G Blood Glucose Monitoring System is an in vitro device designed for measuring the concentration of glucose in capillary whole blood from the fingertip. The system uses electrochemical methodology. The system quantifies glucose amperometrically by measuring the current that is produced when glucose oxidase catalyzes the oxidation of glucose to gluconic acid. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and is converted to a readout displayed on the monitor.