| Accession |
PRJCA012243 |
| Title |
Ultrasonic Pocket Doppler (SpO2 and PR detection function) clinical investigation |
| Relevance |
Medical |
| Data types |
Demographic data
|
| Organisms |
Homo sapiens
|
| Description |
The purpose of this investigation is to evaluate the safety and efficacy of SD2 series Ultrasonic Pocket Doppler, which is producted by EDAN INSTRUMENTS, Inc. and validate whether the its SpO2 and PR detection function meet the requirements of protocol and standards ISO 80601-2-61:2017 and YY 0784-2010, etc. This investigation is an invasive controlled desaturation study on healthy aldult volenteers, according to the standards ISO 80601-2-61:2017 and YY 0784-2010, etc. In this investigation, SpO2 will be measured by investigational medical device and compared with SaO2 is detected from arterial blood by blood gas analyser, which is uesd as comparator. PR is compared with ECG heart rate. |
| Sample scope |
gender, height, weight, etc. |
| Release date |
2022-10-01 |
| Grants |
| Agency |
program |
Grant ID |
Grant title |
| EDAN INSTRUMENTS, Inc.
|
|
N/A
|
Ultrasonic Pocket Doppler (SpO2 and PR detection function) clinical investigation
|
|
|
| Submitter |
Yalan
Li (13500013993@139.com)
|
| Organization |
Guangzhou Overseas Chinese Hospital |
| Submission date |
2022-09-29 |
