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Microlife BP A3 Basic (BP 3GX1-4N)
Device Name:
BP A3 Basic
Device Model:
BP 3GX1-4N
Manufacturer:
Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN ROC.
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
Availability according to Countries or Regions:
Australia, China and Colombia
Description:
The Microlife BP A3 Basic (BP 3GX1-4N) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Microlife BP A3 Basic (BP 3GX1-4N), to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP BIHS (UK and IRL) Self-measurement Manufacturer declaration of equivalence to the Microlife BP 3BT0-A
Consumer BodyYear(s)LevelComment
BP Choice (Australia) Previous B
Device Family:
Aponorm Basis Plus Bluetooth 3GP, Aponorm Professionell Touch 3GP, Braun ExactFit 1 (BUA5000)B, Microlife BP 3BT0-AB,D, Microlife BP 3BT0-A (2)D, Microlife BP A1 Easy (BP 3GR1-1P)D,P, Microlife BP A100 (Type A)B,D,P, Microlife BP A100 Plus (BP 3MC1-1N)B,D, Microlife BP A150 Afib (BP 3MS1-4F)P, Microlife BP A2 Basic (BP 3GQ1-3P)B,D,P, Microlife BP A200 Afib (BP 3MS1-4KT)P, Microlife BP A6 PC (aka A6 Plus, A6 Basic)D,P, Microlife BP A150-30 AfibP, Microlife WatchBP Home (BP 3MX1-1)D,P,F, Microlife WatchBP Home A (BP 3MX1-3)D,P, Microlife WatchBP Home N (BP 3MX1-4)D, Microlife WatchBP Home S (BP 3MX1-5)P, Microlife WatchBP Office (Twin200)D,P,F, Microlife WatchBP Office ABI (Twin200 ABI)B,P, Microlife WatchBP Office AFib (Twin200 AFS)D,P,F, Microlife WatchBP Office Central (Twin200 CBP)P, Microlife WatchBP Office Target (BP 3MD1-4)D, Microlife BP A6 BT (BP 3GU1-7B)P, Microlife BP A7 TouchP, Microlife BP A2 Classic (BP 3AQ1-1P) (aka A2 Standard)P, Microlife BP 3AG1 (BP 3AQ1-2P)B,D, Microlife BP 3BT0-1D,F, Microlife BP 3BT0-APD, Microlife As easy as 123 (BP 3BX0-A)B, Microlife WatchBP Home A BT (BP 3MX1-3C)P, Microlife BP A3 Basic (BP 3GX1-4N)B, Microlife BP A3 PC (BP 3GX1-5X)P, Microlife WatchBP Office 2G (BP 3SK1-3B)P, Microlife BP 3AC1-APF, Microlife BP 3AC1-PCF, Riester ri-champion NB, Riester RBP-100B, Hillrom ProBP 2400B,F
Legend: B BIHS Derivative, D DET Equivalence, P Stride Equivalence, F FDA 510(k)
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 3BT0-A

Cuckson AC, Reinders A, Shabeeh H, Shennan AH; British Hypertension Society. Validation of the Microlife BP 3BTO-A oscillometric blood pressure monitoring device according to a modified British Hypertension Society protocol. Blood Press Monit. 2002 Dec;7(6):319-24. PMID: 12488652.

BHS:1993 - Pass (A/A) General population

Reinders A, Cuckson AC, Lee JT, Shennan AH. An accurate automated blood pressure device for use in pregnancy and pre-eclampsia: the Microlife 3BTO-A. BJOG. 2005 Jul;112(7):915-20. PMID: 15957992.

BHS:1993 - Pass (A/B) Normotensive pregnancy (n=35), Non-proteinuric hypertensive pregnancy (n=35), Pre-eclampsia (n=35)

Nouwen E, Snijder M, van Montfrans G, Wolf H. Validation of the Omron M7 and Microlife 3BTO-A blood pressure measuring devices in preeclampsia. Hypertens Pregnancy. 2012;31(1):131-9. Epub: 2011 Feb 18. doi: 10.3109/10641955.2010.544799. PMID: 21332327.

ESH-IP:2002 - Fail Pre-eclampsia

Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.

DHL:1999 - Pass General population (Note: 2001)

Microlife BP A100 (Type A)

Bonso E, Dorigatti F, Palatini P. Accuracy of the BP A100 blood pressure measuring device coupled with a single cuff with standard-size bladder over a wide range of arm circumferences. Blood Press Monit. 2009 Oct;14(5):216-9. doi: 10.1097/MBP.0b013e328330d3f8. PMID: 19734782.

ESH-IP:2002 - Pass General population

Bonso E, Saladini F, Zanier A, Benetti E, Dorigatti F, Palatini P. Accuracy of a single rigid conical cuff with standard-size bladder coupled to an automatic oscillometric device over a wide range of arm circumferences. Hypertens Res. 2010 Nov;33(11):1186-91. Epub: 2010 Aug 5. doi: 10.1038/hr.2010.146. PMID: 20686489.

ESH-IP:2002 - Pass General population

Microlife BP A100 Plus (BP 3MC1-1N)

Stergiou GS, Giovas PP, Neofytou MS, Adamopoulos DN. Validation of the Microlife BPA100 Plus device for self-home blood pressure measurement according to the International Protocol. Blood Press Monit. 2006 Jun;11(3):157-60. PMID: 16702824.

ESH-IP:2002 - Pass General population

Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2007;3(4):389-400. PMID: 17969368. Available from: PMC2291343.

ESH-IP:2002 - Pass General population

Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.

DHL:1999 - Pass General population (Note: 2007)

Microlife BP A3 PC (BP 3GX1-5X)

Beime B, Krüger R, Hammel G, Bramlage P, Deutsch C. Validation of the Microlife BP A3 PC upper arm blood pressure monitor in patients with diabetes mellitus according to the ANSI/AAMI/ISO 81060-2: 2013 protocol. Blood Press Monit. 2018 Feb;23(1):52-7. Epub: 2017 Nov 14. doi: 10.1097/MBP.0000000000000302. PMID: 29140801.

81060-2:2013 - Pass Type 1 Diabetes Mellitus (n=4), Type 2 Diabetes Mellitus (n=81)

Microlife WatchBP Home (BP 3MX1-1)

Stergiou GS, Giovas PP, Gkinos CP, Patouras JD. Validation of the Microlife WatchBP Home device for self home blood pressure measurement according to the International Protocol. Blood Press Monit. 2007 Jun;12(3):185-8. PMID: 17496469.

ESH-IP:2002 - Pass General population

Chung Y, de Greeff A, Shennan A. Validation and compliance of a home monitoring device in pregnancy: Microlife WatchBP home. Hypertens Pregnancy. 2009;28(3):348-59. doi: 10.1080/10641950802601286. PMID: 19263287.

BHS:1993 Pregnancy (n=45), Pre-eclampsia (n=15) (Note: BHS results not in abstract)

Clark K, Snowball O, Nzelu D, Kay P, Kametas NA. Validation of the Microlife WatchBP Home blood pressure device in pregnancy for medium and large arm circumferences. Blood Press Monit. 2018 Jun;23(3):171-4. doi: 10.1097/MBP.0000000000000315. PMID: 29596069.

BHS:1993 - Pass (A/A) Pregnancy, arm circumference 22 cm to 31 cm (n=51)

BHS:1993 - Pass (B/A) Pregnancy, arm circumference 32 cm to 52 cm (n=46)

Microlife WatchBP Office (Twin200)

Stergiou GS, Tzamouranis D, Protogerou A, Nasothimiou E, Kapralos C. Validation of the Microlife Watch BP Office professional device for office blood pressure measurement according to the International protocol. Blood Press Monit. 2008 Oct;13(5):299-303. doi: 10.1097/MBP.0b013e3283057af6. PMID: 18799957.

ESH-IP:2002 - Pass General population

Kollias A, Ntineri A, Kyriakoulis KG, Stambolliu E, Lagou S, Boubouchairopoulou N, Stergiou GS. Validation of the professional device for blood pressure measurement Microlife WatchBP Office in adults and children according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization standard. Blood Press Monit. 2018 Apr;23(2):112-4. Epub: 2017 Dec 12. doi: 10.1097/MBP.0000000000000307. PMID: 29239866 .

81060-2:2013 - Pass General population

Stergiou GS, Kyriakoulis KG, Bountzona I, Menti A, Destounis A, Kalogeropoulos P, Kollias A. Automated blood pressure measurement in atrial fibrillation: validation process modification and evaluation of a novel professional device which detects atrial fibrillation and adapts its blood pressure measurement algorithm. J Hypertens. 2021 Apr 1;39(4):614-620. doi: 10.1097/HJH.0000000000002684. PMID: 33060450.

81060-2:2019 - Pass Atrial fibrillation (n=35)

Microlife WatchBP Office ABI (Twin200 ABI)

Masiero S, Saladini F, Benetti E, Palatini P. Accuracy of the Microlife large-extra large-sized cuff (32-52 cm) coupled to an automatic oscillometric device. Blood Press Monit. 2011 Apr;16(2):99-102. doi: 10.1097/MBP.0b013e328344c73c. PMID: 21346560.

ESH-IP:2002 - Pass General population

Saladini F, Benetti E, Masiero S, Palatini P. Accuracy of Microlife WatchBP Office ABI monitor assessed according to the 2002 European Society of Hypertension protocol and the British Hypertension Society protocol. Blood Press Monit. 2011 Oct;16(5):258-61. doi: 10.1097/MBP.0b013e32834af72e. PMID: 21885961.

ESH-IP:2002 - Pass General population

BHS:1993 - Pass (A/A) General population

Palatini P, Fania C, Gasparotti F. Accuracy of the WatchBP office ABI device for office blood pressure measurement over a wide range of arm sizes. Blood Press Monit. 2018 Apr;23(2):117-9. doi: 10.1097/MBP.0000000000000312. PMID: 29406326.

81060-2:2013 - Pass General population (Note: Arm circumferences 15 cm to 46 cm; 4 cuff sizes)

Microlife WatchBP Office Central (Twin200 CBP)

Cheng HM, Sung SH, Shih YT, Chuang SY, Yu WC, Chen CH. Measurement accuracy of a stand-alone oscillometric central blood pressure monitor: a validation report for Microlife WatchBP Office Central. Am J Hypertens. 2013 Jan;26(1):42-50. doi: 10.1093/ajh/hps021. PMID: 23382326.

SP10:2002 - Fail Cuff BP (n=255/85) (Note: IA validation)

SP10:2002 - Pass Central BP (n=255/85) (Note: IA validation)

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