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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.

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.

The BioMedix, Inc. Flostat Vascular Report Generator is a device for the use to display the outputs from three strip chart recorder based peripheral vascular diagnostic instruments on a PC printer. In essence, this is changing one printer for another. This generic device can bu used to input a signal from any device into a is intended soley for use in conjunction with computer but Blood pressures, displayed peripheral diagnostic instruments. digitally, may be recorded with the original cuffs provided by the original manufacturer. No change in equipment or technique is warranted. The three target devices are the Imex Corp. 3000 Series, 301 The Life Sciences Corp./HealthWatch PVR Series Series, and All these incorporate analog or digital pen diagnostic devices. strip chart recorders to display the output waveforms. The sole use of the VRG is to display the waveforms on the PC printer. une lowest resolution dot matrix printer with 90x90 dots per inch(and certainly much higher resolution laser printers) has a much higher resolution than the relatively meager 100 Hz bandwidth that an analog pen recorder can provide. No alterations in the clinical instructions, indications, methodologies, or outcomes will occur. The VRG is simply connected to an analog output path on the target The VRG is then connected(via a high ESD rated RS-232 device. driver) to the computer. The waveforms are brought into the computer and the opportunity is provided for printing to a printer. The intended use of the VRG-Vascular Diagnostic Unit tandem is the the original intended use of the original vascular same diagnostic unit(ie. peripheral vascular studies). The BMX Vascular Report Generator passes the output information of a peripheral vascular deviceto a computer and then onto a printer. All ourputs of a peripheral vascular device, throuhg the VRG, can displayed, including data that can be shown as a spectrum analysis. The Vascular Report Generator does not change the output of a peripheral vascular devicebut only allows the computer to display the informan: in various forms .

The BioMedix, Inc. Flostat Vascular Report Generator is a device for the use to display the outputs from three strip chart recorder based peripheral vascular diagnostic instruments on a PC printer.

The BioMedix, Inc. Flostat Vascular Lab is a device for the use in the diagnosis of the etiology and extent of vascular pathology primarily in the peripheral vasculature and, in a more restricted sense, in the central vasculature(periorbital region ONLY). These tasks are accomplished via three separate modalities, each of which can be use to test either the arterial or venous system. The three modalities are 1) Pneumoplethysmography (blood pressure cuff air inflation), 2) Photoplethysmography (change in infrared light reflectance on skin as a relection of larger branches) and 31 wave doppler ultrasound velocity waveform Simple continuous measurement. NONE of these testing modalities are intended for FETAL USE and the devices and instruction manuals are so labelled. The air pump Pneumoplethysmograph and infrared Photoplethysmograph are for use in studying the PERIPHERAL VASCULATURE ONLY. The 5 MHz. continuous wave doppler ultrasound velocity meter and the 8 MHz. continuous wave doppler ultrasound velocity meter are for use in studying the PERIPHERAL VASCULATURE ONLY. There is a separate control setting labelled clearly on the FLOSTAT vascular LaB - 'Ophthalmic-8 MHz.' doppler which is intended for an 8 MHz. continuous wave doppler ultrasound velocity meter exactly the same as the 8 MHz. continuous wave doppler velocity meter except that the 'Ophthalmic-8 MHz.' doppler has substantially lower acoustic output which conforms to the safety standards For periorbital studies specified by the Food and Drug Administration (FDA) . Through medical studies performed by the scientists at the it has been determined that ultrasound acoustic levels EDA, rated by various figures of merit (eg. ISPTA; etc.) are safe for different areas of the body : For this reason, DO NOT EVER PERFORM PERIORBITAL STUDIES WITH THE. DOPPLER IN ANY MODE OTHER THAN THE 'Ophthalmic-8 MIZ.' MODE . Labels will also be placed on the doppler transducer that they are NOT FOR FETAL USE and specifying the correct frequency(5 MHz or 8 MHz) - The doppler section is intended to generate velocity waveforms and values for study and audio output for physician analysis of the arterial and venous system. The Ultrasonic Doppler device at 5 MHz. and 8 MHz . applies ultrasound energy through the extremities of the subject to assess blood velocity, blood velocity waveform morphology, spectrum analysis, pressure, and patency of PERIPHERAL VESSELS. The Ultrasonic Ophthalmic- 8 MHz. device applies ultrasound energy to the periorbital region to assess blood velocity, blood velocity waveform morphology, and spectrum analysis in this area. The Pneumoplethysmograph is used to gauge the arterial system the recording studies recording studies and is used to gauge the venous system through maximum venous outflow studies. The Photoplethysmograph is used to gauge the arterial system through pulse waveform analysis and is used to gauge the venous system through venous reflux time tests. Full clinical information is provided in the Operators Instruction Manual(enclosed herein).

The BioMedix, Inc. Flostat Vascular Lab is a device for the use in the diagnosis of the etiology and extent of vascular pathology primarily in the peripheral vasculature and, in a more restricted sense, in the central vasculature(periorbital region ONLY). These tasks are accomplished via three separate modalities, each of which can be use to test either the arterial or venous system. The three modalities are 1) Pneumoplethysmography (blood pressure cuff air inflation), 2) Photoplethysmography (change in infrared light reflectance on skin as a relection of larger branches) and 31 wave doppler ultrasound velocity waveform Simple continuous measurement.

This product would be used by Nurses and Paramedics in prehospital, emergency room and field situations.

The I.V. Extension Line Assembly with Stopcock is attached to the Primary I.V. to facilitate two advantages. One, is to add extra length between the I.V. Supply and the Patient. A second, is to provide additional supply ports for the administration of alternate solutions and special drugs that are adminstered intraveneously. A four-way stopcock offers selection of the fluid types and sources. Biomedix is offering two models, one with a standard Needle-Type Injection Site at the Outlet and a second with a Blunt Cannula (Needleless) Type Injection Site at the outlet.