Search Results

CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a Hospital or in a Physician's Office. CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. Cardio View 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion. - Patient Population: Male/Female, Adults . - Environment of Use: Hospital and Clinic . - Prescription Device by a Physician ●

CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a Hospital or in a Physician's Office. CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. Cardio View 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion.

The BPCard is a Non-Invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, adult subjects. The BPCard also measures heart rate. - Patient Population: Male/Female, Adults . - Environment of Use: Hospital, Clinic and Home Use . - Prescription Device by a Physician .

Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the ausculatory method. The BPCard also measures heart rate. - . Patient Population: Male/Female Adults - . Environment of Use: Hospital, Clinic and Home Use - . Prescription Device by a Physician

The BPCard is a non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in 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 BPCard.

The BPCard™ is a non-invasive Blood Pressure Monitor. The patient population is for both male and female, pediatric and adult. The BP Card has been tested to the following standards: AAMI SP10-1992-Electronic or Automated Sphygmomanometers I FDA-1997-NIBP Monitor Guidance EN1060-1-Non-Invasive Sphygmomanometers General Requirements EN1060-3-Non-Invasive Sphygmomanometers Supplementary Requirements EN980-Symbols EN46001-Quality EN1441-Risk Analysis EN60601-1-2-EMC EN60601-1-Electrical Safety 93/42/EEC-MDD 89/336/EEC-EMC Directive 92/37/EEC-Product Safety 93/465/EEC-Conformity Assessment and CE Marking UL 2601-1-Safety US ISO 10993-1-Biological Evaluation ISO 9001:1994-Quality ISO 9001:2000-Quality ISO 13485:1996/1998-Medical Devices 21CFR Part801-Labeling 21CFR Part820-QSR FDA Blue Book Memorandum G95-1-Biocompatibility The BPCard is a non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in 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 BPCard. The BPCard is a Prescription Device, not life supporting or live sustaining, not an implant, supplied non-sterile with a cuff, valve and microphone that requires a Personal Computer with the following requirements: Windows 2000 Operating System 32 MB RAM 1 GB Free Hard Disc Space 133 MHz Processor

Diagnostic ECG for 12 Channel Resting ECG Patient Population: Male/Female, Pediatric to Adult Environment of Use: Hospital, Clinic and Home Use Prescription Device by a Physician

The EKGCard™ System is a diagnostic electrocardiograph (ECG or EKG) for 12 channel resting ECG's. The patient population is for both male and female, pediatric and adult. The System requires a Type II PC Card Slot and Windows CE Pocket PC 2002 and is a Prescription Device.

Diagnostic Spirometry. Patient Population: Male/Female, Podistric to Adult. Device Functionality: Diagnostic Spirometry. Spirometric Parameters: FVC, MVV, SVC, and FEF. Environment of Use: Hospital, Clinical and Home Use. Prescription device by a physician.

The SpiroCard is a spirometery diagnostic device that measures the breathing functions of The volume and rate of exhalation and inhalation is measured and calculated by the patients. spirometer. Information provided by the spirometer assists the physician in diagnosing and treating respiratory diseases. The SpiroCard uses the same pneumotachometer mouthpiece and connecting tube as the predicate device so that no new materials are introduced to the patient. The SpiroCard measures and calculates the results the same as the predicate device using the pressure produced by the pneumotachometer, the same correction factors and formulas for final results. The pressure sensor is the same type but in a smaller package and of higher resolution and accuracy. The main difference is that the SpiroCard is in a PC Card package and that the reporting and user interface will be completely handled by a host computing device whereas the PFM-7000 was a desktop standalone device with a keypad, processor and displays built in.