(161 days)
Digital Automatic Blood Pressure Monitor BPM03 Series is for use by medical professional or at home. The BPM03 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm of an individual. The inflatable cuff circumference is limited to 17cm – 44cm via 3 different size of cuff. 3 different cuff sizes are 17-22cm, 22-32cm and 32-44cm.
Digital Automatic Blood Pressure Monitor BPM03 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual in each measurement and then displays the readings on a digital panel.
The BPM03 Series utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for the blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movements into a digital reading.
Here's an analysis of the acceptance criteria and study information for the Digital Automatic Blood Pressure Monitor BPM03 Series, based on the provided text:
Acceptance Criteria and Device Performance Study
The submission states that the Digital Automatic Blood Pressure Monitor BPM03 Series meets the requirements of ANSI/AAMI SP-10-2002. This standard defines the performance, accuracy, and clinical validation requirements for automated sphygmomanometers. While the document doesn't explicitly list specific numerical acceptance criteria (e.g., mean difference and standard deviation for blood pressure readings), compliance with ANSI/AAMI SP-10-2002 implies adherence to its specified limits for accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI SP-10-2002) | Reported Device Performance |
|---|---|
| Blood Pressure Accuracy: | |
| Mean difference (device vs. reference) |
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).