Microlife Device Validation Table

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Clinical Devices
Device	AAMI	BHS	ESH	Circumstance	Reference

Microlife BP 3AS1-2			Pass	At rest	1
Microlife WatchBP O3 (3MZ0)			Pass	At rest	2
Microlife WatchBP O3 (3MZ1)			Pass	At rest	3
Microlife WatchBP Office			Pass	At rest	4
Microlife WatchBP Office ABI		A/A	Pass	At rest	5
			Pass	L-XL size cuff	4,6
				Accuracy in assessing ABI	7
				Accuracy in detecting Atrial Fibrillation	8,9
Microlife WatchBP Office AFIB			Pass	WatchBP Office Equivalence	4*
Microlife WatchBP Office AFIB				Accuracy in detecting Atrial Fibrillation	8, 9
Microlife WatchBP Office Target			Pass	BP A100 Equivalence	10*

Self-measurement devices
Device	AAMI	BHS	ESH	Circumstance	Reference

Microlife BP 3AC1-1			Pass	At rest	11
	Pass	A/A		Pregnancy	12
	Pass	B/A		Pre-eclampsia	12
Microlife BP 3AC1-1 PC			Pass	BP 3AC1-1 Equivalence	11*
Microlife BP 3AC1-1 PC			Pass	ESRD population	13
Microlife BP 3AC1-2			Pass	BP 3AC1-1 Equivalence	11*
Microlife BP 3AG1		A/A		BP 3BT0-A Equivalence	14*
Microlife BP 3BTO-1		A/A		BP 3BT0-A Equivalence	14*
Microlife BP 3BTO-A		A/A		Small recruitment violation	14
	Pass	A/B		Normotensive Pregnancy	15
	Pass	B/B		Non-proteinuric HBP	15
	Pass	A/B		Pre-Eclampsia	15
Microlife BP 3BTO-A(2)		A/A		BP 3BT0-A Equivalence	15*
Microlife BP 3BTO-AP		A/A		BP 3BT0-A Equivalence	14*
Microlife BP A100			Pass	BP A100 Plus Equivalence	10*
Microlife BP A100 Plus			Pass	With "M-L Size" Cuff	16
			Pass	At rest	10
			Pass	At rest	17
Microlife Exact BP (BP3MD1-3)			Pass	BP A100 Equivalence M-L cuff	16
Microlife RM 100		A/A		BP 3BT0-A Equivalence	14*
Microlife WatchBP Home (BP3MX1-1)			Pass	At rest	18
	Pass	A/A		Pregnancy	19
	Pass	A/A		Pre-eclampsia	19
Microlife WatchBP Home A (BP3MX1-3)			Pass	Watch BP Home Equivalence	18,19*
Microlife WatchBP Home A (BP3MX1-3)				Accuracy in detecting Atrial Fibrillation	8,9
Microlife WatchBP Home N (BP3MX1-4)			Pass	Watch BP Home Equivalence	18,19*
Microlife WatchBP Home S (BP3MX1-5)			Pass	Watch BP Home Equivalence	18,19*
Microlife WatchBP Home S (BP3MX1-5)				Accuracy in detecting Atrial Fibrillation	8,9
Microlife WatchBP O3 (3MZ0)			Pass	At rest	2
Microlife WatchBP O3 (3MZ1)			Pass	At rest	3

Wrist devices
Device	AAMI	BHS	ESH	Circumstance	Reference

Microlife BP W100	Pass	A/A	Pass	Supine position	20
Microlife BP W200-1			Pass	MAM averaging and supine position	21

* Indicates that the same validation applies to the device because of equivalence

Sources:
BHS - British Hypertension Society
dableducational Trust

Validation Protocols

BHS - British Hypertension Society

BHS A/A
	Microlife Blood Pressure Monitors are successfully validated according to the protocol of the BHS (British Hypertension Society). Microlife's upper automatic arm devices are validated with the highest possible grade of A/A.

BHS A/B




European Society of Hypertension

ESH Protocol
	Microlife Blood Pressure Monitors are successfully validated according to the International Protocol of the ESH (European Society of Hypertension).



Gütesiegel
	It is the aim of the German Hypertension Society to improve measurement accuracy, by testing and awarding Blood Pressure Monitoring devices that fulfill its own test criteria following the strict protocol of the German Hypertension Society.

Publications

1. 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;13:342-8.

2. Stergiou GS, Tzamouranis D, Nasothimiou EG, Karpettas N, Protogerou A. Are there really differences between home and daytime ambulatory blood pressure? Comparison using a novel dual-mode ambulatory and home monitor. J Hum Hypertens 2010;24:207-12.

3. Ragazzo F, Saladini F, Palatini P. Validation of the Microlife WatchBP O3 device for clinic, home, and ambulatory blood pressure measurement, according to the International Protocol. Blood Press Monit 2010;15:59-62.

4. 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;13:299-303.

5. 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;16:258-61.

6. 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;16:99-102.

7. Kollias A, Xilomenos A, Protogerou A, Dimakakos E, Stergiou GS. Automated determination of the ankle-brachial index using an oscillometric blood pressure monitor: validation vs. Doppler measurement and cardiovascular risk factor profile. Hypertens Res 2011;34:825-30.

8. Wiesel J, Fitzig L, Herschman Y, Messineo FC. Detection of atrial fibrillation using a modified microlife blood pressure monitor. Am J Hypertens 2009;22:848-52.

9. Stergiou GS, Karpettas N, Protogerou A, Nasothimiou EG, Kyriakidis M. Diagnostic accuracy of a home blood pressure monitor to detect atrial fibrillation. J Hum Hypertens 2009;23:654-8.

10. 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;11:157-60.

11. Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two devices for self-measurement of brachial blood pressure according to the International Protocol of the European Society of Hypertension: the SEINEX SE-9400 and the Microlife BP 3AC1-1. Blood Press Monit 2005;10:325-31.

12. de Greeff A, Reggiori F, Anthony J, Shennan A. The Microlife 3AC1: An accurate blood pressure measurement device in pregnancy and pre-eclampsia. J Hypertens 2006;24.

13. Thompson AM, Eguchi K, Reznik ME, Shah SS, Pickering TG. Validation of an oscillometric home blood pressure monitor in an end-stage renal disease population and the effect of arterial stiffness on its accuracy. Blood Press Monit 2007;12:227-32.

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

15. 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;112:915-20.

16. 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;14:216-9.

17. 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;3:389-400.

18. 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;12:185-8.

19. Chung Y, de Greeff A, Shennan A. Validation and compliance of a home monitoring device in pregnancy: microlife WatchBP home. Hypertens Pregnancy 2009;28:348-59.

20. Palatini P, Dorigatti F, Bonso E, Ragazzo F. Validation of Microlife BP W100 wrist device assessed according to the European Society of Hypertension and the British Hypertension Society protocols. Blood Press Monit 2009;14:41-4.

21. Palatini P, Dorigatti F, Bonso E, Ragazzo F. Validation of the Microlife BP W200-1 wrist device for blood pressure measurement. Blood Press Monit 2008;13:295-8.


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Microlife Device Validation Table

Clinical Devices

Self-measurement devices

Wrist devices

Validation Protocols

Publications

1.

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;13:342-8.

2.

Stergiou GS, Tzamouranis D, Nasothimiou EG, Karpettas N, Protogerou A. Are there really differences between home and daytime ambulatory blood pressure? Comparison using a novel dual-mode ambulatory and home monitor. J Hum Hypertens 2010;24:207-12.

3.

Ragazzo F, Saladini F, Palatini P. Validation of the Microlife WatchBP O3 device for clinic, home, and ambulatory blood pressure measurement, according to the International Protocol. Blood Press Monit 2010;15:59-62.

4.

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;13:299-303.

5.

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;16:258-61.

6.

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;16:99-102.

7.

Kollias A, Xilomenos A, Protogerou A, Dimakakos E, Stergiou GS. Automated determination of the ankle-brachial index using an oscillometric blood pressure monitor: validation vs. Doppler measurement and cardiovascular risk factor profile. Hypertens Res 2011;34:825-30.

8.

Wiesel J, Fitzig L, Herschman Y, Messineo FC. Detection of atrial fibrillation using a modified microlife blood pressure monitor. Am J Hypertens 2009;22:848-52.

9.

Stergiou GS, Karpettas N, Protogerou A, Nasothimiou EG, Kyriakidis M. Diagnostic accuracy of a home blood pressure monitor to detect atrial fibrillation. J Hum Hypertens 2009;23:654-8.

10.

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;11:157-60.

11.

12.

de Greeff A, Reggiori F, Anthony J, Shennan A. The Microlife 3AC1: An accurate blood pressure measurement device in pregnancy and pre-eclampsia. J Hypertens 2006;24.

13.

Thompson AM, Eguchi K, Reznik ME, Shah SS, Pickering TG. Validation of an oscillometric home blood pressure monitor in an end-stage renal disease population and the effect of arterial stiffness on its accuracy. Blood Press Monit 2007;12:227-32.

14.

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

15.

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;112:915-20.

16.

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;14:216-9.

17.

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;3:389-400.

18.

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;12:185-8.

19.

Chung Y, de Greeff A, Shennan A. Validation and compliance of a home monitoring device in pregnancy: microlife WatchBP home. Hypertens Pregnancy 2009;28:348-59.

20.

Palatini P, Dorigatti F, Bonso E, Ragazzo F. Validation of Microlife BP W100 wrist device assessed according to the European Society of Hypertension and the British Hypertension Society protocols. Blood Press Monit 2009;14:41-4.

21.

Palatini P, Dorigatti F, Bonso E, Ragazzo F. Validation of the Microlife BP W200-1 wrist device for blood pressure measurement. Blood Press Monit 2008;13:295-8.

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