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Hokanson Digit and Penile cuffs are intended to measure blood pressure in small peripheral body parts. In general, the width of a blood pressure cuff should be approximately 40% of the diameter of the limb or digit being measured. The length of the cuff, in the case of these devices, is long enough to completely encircle the object being measured. The usage is the same as the predicate device which has been manufactured by our company since 1973.

Hokanson Blood Pressure Digit and Penile cuffs

This product will be used to detect fetal heartbeats to help determine fetal viability.

OB1 Obstetrical Doppler is a handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats. There are only four user controls; Up and Down audio volume, Freeze Display, and Power On/Off. A three inch loudspeaker provides good Doppler audio. A digital LCD readout shows the fetal heart rate when it is stable for three or four seconds.

The intended use of the Al6 is the measurement of arterial blood flow by means of venous occlusion plethysmography. The Al6 replaces the predicate instruments which are used primarily in research studies. Applications include studies that relate to protocols that influence limb blood flow through exercise, reactive hyperemia, or the influence of drugs. The intended use of the Al6 is the measurement of blood flow by means of venous occlusion plethysmography. This is the same usage as one of the uses of our EC6 Plethysmograph and it has not changed.

The Al6 Blood Flow Measuring system measures blood flow in one or two limbs or digits simultaneously using the principles of venous occlusion plethysmography. This involves inflating a blood pressure cuff on the proximal part of the limb to a pressure that exceeds the venous pressure in the limb, but which is less than the arterial pressure. The cuff inflation is done quickly so as to obtain a distinct starting point for the measurement. When the cuff is inflated the limb begins to swell due to the blood flowing into the limb since the normal venous outflow is stopped by the cuff. The resulting change in the volume of the limb is measured by the plethysmographs and the rate of change is equal to the blood flow at the moment of venous occlusion. The Al6 is controlled by a computer program that causes the cuff inflators to inflate, records the plethysmographic volume measurements and calculates the rate of change of volume. By combining the instruments and controlling them with one computer it is possible to make measurements in quick succession and more easily analyze the results.

The EC6 is two plethysmographs in one. A mercury strain gauge plethysmograph accurately measures volume changes in limbs or digits. It is used, in conjunction with blood pressure cuffs, to measure blood pressure, pulse volume waveforms and amplitudes, and blood flow into or out of limbs and digits. The instrument also contains an infrared photo plethysmograph which, although not calibrated, is a sensitive pulse detector which is used to evaluate pulse wave shapes and measure blood pressure in the extremities in conjunction with blood pressure cuffs.

The EC6 is two plethysmographs in one. A mercury strain gauge plethysmograph accurately measures volume changes in limbs or digits. It is used, in conjunction with blood pressure cuffs, to measure blood pressure, pulse volume waveforms and amplitudes, and blood flow into or out of limbs and digits. The instrument also contains an infrared photo plethysmograph which, although not calibrated, is a sensitive pulse detector which is used to evaluate pulse wave shapes and measure blood pressure in the extremities in conjunction with blood pressure cuffs.

The ANS2000 is an ECG Monitor and Respiration Pacer that measures heart rate and provides a respiration timer for the purpose of measuring heart rate variations in response to respiration. The measuring board is used in studies of patients in which it is important to know the interval between heartbeats and also to have analysis with the patient's breathing.

The ANS2000 is an ECG Monitor and Respiration Pacer.

NIVP3 is a computer program which is used with Hokanson vascular diagnostic instruments and an IBM compatible personal computer to produce comprehensive reports. These reports are stored in a computer database and may be sorted, retrieved, and printed. The program allows the user to select and record plethysmographic and Doppler waveforms and blood pressure measurements .. Patient demographics and history are also stored by the program. The user may enter comments to enhance the report.

Safety and effectiveness of NIVP3 are equal or better than for NIVP. The same non-invasive diagnostic instruments are used to provide data inputs to the computer. These are the MD35 Procord (K896034), the TL400 Totalab (K872517), the EC5R Plethysmograph (K932812), and the TD312 Calculating Cuff Inflator K842067). In each case optical isolation is employed to prevent electrical leakage from a computer power supply from reaching the diagnostic instrument, and from there being able to reach a patient. There is no direct electrical connection from the computer to the diagnostic instrument. Data is collected by the computer and incoming waveforms are displayed on the computer screen. The user selects the data to be retained and may edit decision points by moving cursors on the screen. The data is stored in a database using the ACCESS® database engine. A run-time version of ACCESS® is furnished with the program. No diagnostic decisions are made by the program. The program is not intended to replace the need for a skilled vascular technologist, but is intended to increase the technologist's efficiency by eliminating the need for cutting out chart recordings and writing extensive reports. The advantages of using NIVP3 are that reports are neat and uniform and that patient records are easily stored and retrieved. In some cases tests, like arterial inflow, are semi automated since the program can perform some functions such as inflate a cuff or balance and calibrate the plethysmograph at the correct time to facilitate data collection. Extensive use is made of the Windows® help system to aid the user in operation of the program and give instructions on how to perform certain diagnostic tests.