(261 days)
The Fully Automatic Blood Pressure Monitors are intended to measure the systolic and diastolic blood pressure and pulse rate of adults and adolescents age 12 through 21 years of age.
The wrist-type Fully Automatic Digital Blood Pressure Monitors with an inflatable cuff wrapping around the patient's wrist. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.
Here's an analysis of the acceptance criteria and study details for the JOYTECH Healthcare Co., Ltd. Wrist-type Fully Automatic Digital Blood Pressure Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ISO 81060-2:2013) | Reported Device Performance (Systolic Blood Pressure) | Reported Device Performance (Diastolic Blood Pressure) |
|---|---|---|
| Criterion A: Mean difference ≤ ±5 mmHg, with standard deviation of differences ≤ 8 mmHg (between test device and reference method) | Method 1: Average = 0.84 mmHg ( |
§ 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).