Timesco Opal (D05.170)
Device Name:
Opal
Device Model:
D05.170
Manufacturer:
Distributer: Timesco Healthcare Ltd., 3 Carnival Park, Basildon, Essex SS14 3WN, UNITED KINGDOM.
OEM: Shanghai Honsun International Trade Co. Ltd., Room C. Floor 22, Zhiyuan Building, 768 Xietu Road, Shanghai 200023, CHINA.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Timesco Opal (D05.170) is a mobile (floor, stand, trolly) manually-operated aneroid sphygmomanometer. Blood pressure measurements are taken from the upper arm. It is intended for professional use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Timesco Opal (D05.170) to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer or a device within a family of equivalent devices. At least one validation needs to be published and equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | This is a manual device. |
Device Family: