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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
Description: The Microlife Cradle VSA (BP 3GP1-1L) is a semi-automatic palm-style blood pressure monitor. Claims for validation are being verified by Medaval. Measurements are taken from the upper arm and it is intended for self-measurement and home use.
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.
Stride BPOffice use for adults and pregnancy (Preferred)Equivalence claim without published evidence

Device Family:Microlife BP 3AS1-2 (BP 3AS1-2R)P, Microlife Cradle VSA (BP 3GP1-1L)P (P Stride Equivalence)
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.

Vousden N, Holmes E, Seed PT, Gidiri MF, Goudar S, Sandall J, Chinkoyo S, Kumsa LY, Brown A, Charantimath U, Bellad M, Nakimuli A, Vwalika B, Chappell LC, Shennan AH; CRADLE Trial Collaborative Group. Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial. BJOG. 2020 Aug;127(9):1082-1089. Epub: 2020 May 7. doi: 10.1111/1471-0528.16309. PMID: 32383337.

The large variation in the rate of pregnancy-related death, irrespective of resource availability, emphasises that inequality and inequity in health care persists.

Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Microlife BP 3AS1-2 (BP 3AS1-2R)

de Greeff A, Nathan H, Stafford N, Liu B, Shennan AH. Development of an accurate oscillometric blood pressure device for low resource settings. Blood Press Monit. 2008 Dec;13(6):342-8. doi: 10.1097/MBP.0b013e32830fd07c. PMID: 19020425.

ESH-IP:2002 - Pass General population

Nathan HL, de Greeff A, Hezelgrave NL, Chappell LC, Shennan AH. An accurate semiautomated oscillometric blood pressure device for use in pregnancy (including pre-eclampsia) in a low-income and middle-income country population: the Microlife 3AS1-2. Blood Press Monit. 2015 Feb;20(1):52-5. doi: 10.1097/MBP.0000000000000086. PMID: 25243711.

BHS:1993 - Pass (B/A) Pregnancy and pre-eclampsia (n=45)

81060-2:2013 - Pass Pregnancy and pre-eclampsia (n=45)

Nathan HL, de Greeff A, Hezelgrave NL, Chappell LC, Shennan AH. Accuracy validation of the Microlife 3AS1-2 blood pressure device in a pregnant population with low blood pressure. Blood Press Monit. 2015 Oct;20(5):299-302. Epub: 2015 May 5. doi: 10.1097/MBP.0000000000000134. PMID: 26020367.

BHS:1993 - Pass (A/A) Low BP pregnancy (n=30)

81060-2:2013 - Pass Low BP pregnancy (n=30)