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Datascope iPM 12

Device Name:Datascope iPM 12
Manufacturer:

Brand: SOMA Technology Inc., 166 Highland Park Drive, Bloomfield, CT 06002, UNITED STATES.

OBL: Mindray North America, 800 Macarther Blvd, Mahwah, NJ 07430, UNITED STATES.

OEM: Datascope Corp. (Maquet/Getinge), 1300 MacArthur Blvd, Mahwah, NJ 07430, UNITED STATES.

Measuring functions:Blood pressure, SpO2, Temperature, ECG, Respiration
Primary Client Use:Intended for patient monitoring
Measurement Site:Arm and Intra-Arterial
Measurement Occurrence:Continuous and intermittent measurements
Availability:Available Currently
Assessment:

While the technology used in the Datascope iPM 12, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Hospital useManufacturer declaration of equivalence to a device without published evidence
ESH (Europe)Professional useThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:Datascope iPM 12B, Mindray Beneview T5B, Mindray BeneVision N12B, Mindray iMEC-12B (B BIHS Derivative)