(68 days)
KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is ,a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
It is designed and manufactured according to ANSI/AAMI SP10-manual, electronic or automated sphygmanometers.
The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-5917 is 60 times, the memory capability of KD-5915 is 2 X 60 times, the memory capability of KD-5031 is 3×30 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-5915 and KD-5031 also have the function of averaging the last three measurements, KD-5915 also has the voice function.
This submission pertains to the KD-5917, KD-5915, and KD-5031 Fully Automatic Electronic Blood Pressure Monitors. The primary study used to demonstrate effectiveness is the conformance to the AAMI SP10:2002 standard for sphygmomanometers.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (AAMI SP10:2002) | Reported Device Performance (Summary) |
|---|---|
| Accuracy (Mean Difference) | |
| Mean difference between device and reference for SBP: ≤ ±5 mmHg | Conforms to AAMI SP10:2002 |
| Mean difference between device and reference for DBP: ≤ ±5 mmHg | Conforms to AAMI SP10:2002 |
| Standard Deviation (of Differences) | |
| Standard deviation of differences for SBP: ≤ 8 mmHg | Conforms to AAMI SP10:2002 |
| Standard deviation of differences for DBP: ≤ 8 mmHg | Conforms to AAMI SP10:2002 |
| Pulse Rate Accuracy | Conforms to AAMI SP10:2002 |
| Environmental Parameters | |
| Operational range for humidity: |
§ 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).