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Microlife Cradle VSA (BP 3GP1-1L)

Device Name:Cradle VSA
Device Model:BP 3GP1-1L
Manufacturer:Sole: Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN PRC.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The Microlife Cradle VSA (BP 3GP1-1L) is included in a current validation and equivalence audit, by Medaval, in preparation for (EU) 2017/745. Validation details will be posted when this has been completed.

Accuracy AssessmentRecommendationBasis
MedavalAuditValidation under audit
ESH (Europe)Professional use for pregnancyA validation, without a reference, which Medaval is unable to identify.

Relevant Publications

Nathan HL, Duhig K, Vousden N, Lawley E, Seed PT, Sandall J, Bellad MB, Brown AC, Chappell LC, Goudar SS, Gidiri MF, Shennan AH; CRADLE-3 Trial Collaboration Group. Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial). Trials. 2018 Mar 27;19(1):206. doi: 10.1186/s13063-018-2581-z. PMID: 29587875. Available from: trialsjournal.biomedcentral.com.

The CRADLE-3 Trial will demonstrate the potential impact of the CRADLE intervention, following protocol evaluation in a feasibility study, with subsequent optimisation, on reducing maternal mortality and morbidity in low-resource settings.

Vousden N, Lawley E, Nathan HL, Seed PT, Brown A, Muchengwa T, Charantimath U, Bellad M, Gidiri MF, Goudar S, Chappell LC, Sandall J, Shennan AH; CRADLE Trial Collaborative Group. Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial. BMC Pregnancy Childbirth. 2018 Apr 27;18(1):115. doi: 10.1186/s12884-018-1737-x. PMID: 29703254. Available from: PMC5924508.

This feasibility study concluded that the components of the intervention were acceptable, methods of implementing were successful and the main CRADLE-3 trial design would be feasible.

Nathan HL, Duhig K, Vousden N, Lawley E, Seed PT, Sandall J, Bellad MB, Brown AC, Chappell LC, Goudar SS, Gidiri MF, Shennan AH; CRADLE-3 Trial Collaboration Group. Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial). Trials. 2018 Mar 27;19(1):206. doi: 10.1186/s13063-018-2581-z. PMID: 29587875. Available from: trialsjournal.biomedcentral.com.

The CRADLE-3 Trial will demonstrate the potential impact of the CRADLE intervention, following protocol evaluation in a feasibility study, with subsequent optimisation, on reducing maternal mortality and morbidity in low-resource settings.

Nathan HL, Duhig K, Vousden N, Lawley E, Seed PT, Sandall J, Bellad MB, Brown AC, Chappell LC, Goudar SS, Gidiri MF, Shennan AH; CRADLE-3 Trial Collaboration Group. Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial). Trials. 2018 Mar 27;19(1):206. doi: 10.1186/s13063-018-2581-z. PMID: 29587875. Available from: trialsjournal.biomedcentral.com.

The CRADLE-3 Trial will demonstrate the potential impact of the CRADLE intervention, following protocol evaluation in a feasibility study, with subsequent optimisation, on reducing maternal mortality and morbidity in low-resource settings.