La validation clinique vient appuyer la qualité de nos produits

Il ne suffit pas de dire que nos produits sont précis. Nous devons le prouver. C’est pourquoi nous nous assurons que chaque modèle de nos tensiomètres OMRON répond aux normes de précision et de fiabilité les plus élevées.

Smiling Healthcare Practitioner at Work
Older Woman Being Visited by Healthcare Practictioner
African American Doctor Talking to Patient in Office
Smiling Healthcare Practitioner at Work
Older Woman Being Visited by Healthcare Practictioner
African American Doctor Talking to Patient in Office

Protocoles d’essai reconnus

Il existe plusieurs protocoles d’essai reconnus partout dans le monde par des organisations de normalisation d’importance : l’Association for the Advancement of Medical Instruments (AAMI), l’European Society of Hypertension (ESH), et la British Hypertension Society (BHS). Le tableau ci-dessous détaille les essais menés pour chaque modèle.

Ces tests de validation offrent la paix d’esprit à nos clients et aux médecins, qui peuvent savoir que leurs patients surveillent leur santé avec la même fiabilité que les dispositifs médicaux utilisés en salle d’examen.

Numéro de modèle

Numéro de référence

Numéro de modèle brassard

Numéro de référence brassard

ESH-IP
European Society of Hypertension International Protocol

AAMI
Association for the Advancement of Medical Instrumentation

BSH
British Hypertension Society

ISO 81060:2

Validation

BP4350

HEM-6232T-Z

N/A

N/A

 

 

22

BP5000

HEM-7121J-ZAZ

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

1,6,21,25

BP5100

HEM-7122-Z

CD-WR17, CD-CS9

HEM-RML31-Z, HEM-CS24

 

 

1,6,21,25

BP5150

HEM-7142T2-ZAZ

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

1,6,21,25

BP5250

HEM-7151T-Z

HEM-FL31-B

HEM-FL31-BZ

 

 

7,8,9,21,25

BP5255

HEM-716BT2-ZAZ

HEM-FL31-B

HEM-FL31-BZ

 

 

7,8,9,21,25

BP5350

HEM-7341T-Z

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

1,6,21,25

BP5360

HEM-7377T1-ZAZ

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

 

1,6,21,25

BP5450

HEM-7343T-Z

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

1,6,21,25

BP5465

HEM-7382T1-AZAZ

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

 

1,6,21,25

BP6100

HEM-6180-Z

N/A

N/A

 

 

22

BP629

HEM-6200-Z

N/A

N/A

 

 

22

BP629N

HEM-6130-Z

N/A

N/A

 

 

 

3

BP6350

HEM-6231T-Z

N/A

N/A

 

 

22

BP652

HEM-6052-CA; HEM-6052-Z; HEM-6052-ZCD6

N/A

N/A

 

 

 

2

BP652N

HEM-6300-Z

N/A

N/A

 

 

 

3

BP653

HEM-6320T-Z

N/A

N/A

 

 

 

3

BP654

HEM-6320T-Z

N/A

N/A

 

 

 

3

BP7000

HEM-7600T-Z

N/A

N/A

 

 

19. 26

BP710

HEM-7113-Z; HEM-7113-CAN; HEM-7114-SW

H-RML30, H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN

HEM-RML30, HEM-CR24, HEM-CL9B, HEM-CR17C

 

 

 

4. 5

BP710CAN

HEM-7113-CA

H-RML30, H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN

HEM-RML30, HEM-CR24, HEM-CL9B, HEM-CR17C

 

 

 

4. 5

BP710N

HEM-7121-Z

CD-WR17, CD-CS9

HEM-RML31-Z, HEM-CS24

 

 

1,6,21,25

BP710CANN

HEM-7121-CA

CD-WR17, CD-CS9

HEM-RML31-Z, HEM-CS24

 

 

1,6,21,25

BP7100

HEM-7121-Z2

CD-WR17, CD-CS9

HEM-RML31-Z, HEM-CS24

 

 

1,6,21,25

BP7100CAN

HEM-7121-CA

CD-WR17, CD-CS9

HEM-RML31-Z, HEM-CS24

 

 

1,6,21,25

BP7150

HEM-7142T2-Z

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

1,6,21,25

BP7200

HEM-7150-Z

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

1,6,21,25

BP7250

HEM-7150T-Z

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

1,6,21,25

BP7250CAN

HEM-7150T-CA

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

1,6,21,25

BP7255

HEM-716CT2-Z

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

1,6,21,25

BP7350

HEM-7340T-Z

HEM-FL31-B

HEM-FL31-BZ

 

 

8,9,21,25

BP7350CAN

HEM-7340T-CA

HEM-FL31-B

HEM-FL31-BZ

 

 

8,9,21,25

BP7360

HEM-7376T1-Z

HEM-FL31-B

HEM-FL31-BZ

 

 

8,9,21,25

BP742

HEM-7200-Z; HEM-7200-Z(V); HEM-7200-CA

H-RML30, H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN

HEM-RML30, HEM-CR24, HEM-CL9B, HEM-CR17C

 

 

 

4. 5

BP742CAN

HEM-7200-CA

H-RML30, H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN

HEM-RML30, HEM-CR24, HEM-CL9B, HEM-CR17C

 

 

 

4. 5

BP742N

HEM-7131-Z

CD-WR17, CD-CS9

HEM-RML31-Z, HEM-CS24

 

 

1,6,21,25

BP742CANN

HEM-7131-CA

CD-WR17, CD-CS9

HEM-RML31-Z, HEM-CS24

 

 

1,6,21,25

BP7450

HEM-7342T-Z

HEM-FL31-B

HEM-FL31-BZ

 

 

8,9,21,25

BP7450CAN

HEM-7342T-CA

HEM-FL31-B

HEM-FL31-BZ

 

 

8,9,21,25

BP7455CAN

HEM-7342T1-ACACD6

HEM-FL31-B

HEM-FL31-BZ

 

 

8,9,21,25

BP7465

HEM-7381T1-AZ

HEM-FL31-B

HEM-FL31-BZ

 

 

8,9,21,25

BP755-CD6

HEM-7000-Z4CS

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP755CAN-CD6

HEM-7000-CANCS

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP760

HEM-7220-Z

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP760CAN

HEM-7220-CA

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP760N

HEM-7320-Z

CFX-WR17

HEM-FL31-Z

 

 

8,9,21,25

BP761

HEM-7320T-Z

CFX-WR17

HEM-FL31-Z

 

 

8,9,21,25

BP761CAN

HEM-7320T-CA

CFX-WR17

HEM-FL31-Z

 

 

8,9,21,25

BP761N / BP761NC

HEM-7320T-Z(V)

CFX-WR17

HEM-FL31-Z

 

 

8,9,21,25

BP761CANN

HEM-7320T-CA

CFX-WR17

HEM-FL31-Z

 

 

8,9,21,25

BP762-CD6

HEM-7220-ZCS

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP762CAN-CD6

HEM-7220-CACS

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP765

HEM-7311-ZSA

CD-WR17, CD-CS9

HEM-RML31-Z, HEM-CS24

 

 

1,6,21,25

BP765CAN

HEM-7311-CACS

CD-WR17, CD-CS9

HEM-RML31-Z, HEM-CS24

 

 

1,6,21,25

BP769CAN

HEM-7320T-CACS

CFX-WR17

HEM-FL31-Z

 

 

8,9,21,25

BP785

HEM-7222-Z

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP785CAN

HEM-7222-CA

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP785SC-CD6

HEM-7222-ZCD6

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP785N

HEM-7321-Z

CFX-WR17

HEM-FL31-Z

 

 

8,9,21,25

BP786

HEM-7321T-Z

CFX-WR17

HEM-FL31-Z

 

 

8,9,21,25

BP786CAN

HEM-7321T-CA

CFX-WR17

HEM-FL31-Z

 

 

8,9,21,25

BP786N

HEM-7321T-Z(V)

CFX-WR17

HEM-FL31-Z

 

 

8,9,21,25

BP786CANN

HEM-7321T-CA

CFX-WR17

HEM-FL31-Z

 

 

8,9,21,25

BP7900

HEM-7530T-Z

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

1,6,21,25

BP790ITN

HEM-7080-ITZ2

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP791IT

HEM-7222-ITZ

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP792IT

HEM-7080-Z(V); HEM-7081-ITZ; HEM-7080-ITZ2; HEM-7080-ITCAN

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

BP8000-M

HEM-6410T-ZM

N/A

N/A

 

 

 

20

BP9300T

HEM-7145T2-Z

HEM-RML31-B, HEM-CS24-B

HEM-RML31-BZ, HEM-CS24-BZ

 

 

1,6,21,25

BP9310T

HEM-7149T2-Z

HEM-RML31-B, HEM-CS24-B, HEM-RXL31-B

HEM-RML31-BZ, HEM-CS24-BZ, HEM-RXL31-BZ

 

 

23, 24

HBP-1300

HBP-1300-Z

GCUFF-XL, GCUFF-L, GCUFF-M, GCUFF-S, GCUFF-SS

HXA-GCUFF-XLLB, HXA-GCUFF-LLB, HXA-GCUFF-MLB, HXA-GCUFF-SLB, HXA-GCUFF-SSLB

 

 

 

15

HEM-412C

HEM-412C2-Z

H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN, H-003DS

HEM-CR24, HEM-CL9B, HEM-CR17C, HEM-CS9

 

16, 17

HEM-432CN2

HEM-4011C-Z

H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN, H-003DS

HEM-CR24, HEM-CL9B, HEM-CR17C, HEM-CS9

 

16, 17

HEM-705CPN

HEM-759P-Z; HEM-759P-CAN; HEM-759P-B(C)

H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN, H-003DS

HEM-CR24, HEM-CL9B, HEM-CR17C, HEM-CS9

 

16, 17

HEM-711ACN2

HEM-7011-Z2

H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN, H-003DS

HEM-CR24, HEM-CL9B, HEM-CR17C, HEM-CS9

 

16, 17

HEM-711DLX

HEM-7010-Z

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

HEM-712C

HEM-7051-Z

H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN

HEM-CR24, HEM-CL9B, HEM-CR17C

 

16, 17

HEM-712CLCN2

HEM-7051-ZL

H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN

HEM-CR24, HEM-CL9B, HEM-CR17C

 

16, 17

HEM-712CN2

HEM-7051-Z

H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN

HEM-CR24, HEM-CL9B, HEM-CR17C

 

16, 17

HEM-737

HEM-737

H-CR24, H-003D, H-003DCAN

HEM-CR24, HEM-CL9

 

16, 17

HEM-747IC

HEM-747IC-Z

H-CR24, H-003D, H-003DCAN, H-CR17, H-CR17CAN, H-003DS

HEM-CR24, HEM-CL9B, HEM-CR17C, HEM-CS9

 

16, 17

HEM-773AC

HEM-773-Z

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

HEM-780N3

HEM-7080-Z

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

HEM-790IT

HEM-7080-ITZ

H-CL22, H-CL22CAN

HEM-CL22

 

7,14

HEM-907

HEM-907-Z

HEM-907-CL19, HEM-907-CR19, HEM-907-CS19

HEM-907-CL19, HEM-907-CR19, HEM-907-CS19

 

 

12,13,18

HEM-907XL

HEM-907-Z2

HEM-907-CX19, HEM-907-CL19, HEM-907-CR19, HEM-907-CS19

HEM-907-CX19, HEM-907-CL19, HEM-907-CR19, HEM-907-CS19

 

 

 

27, 28

HEM-9200T

HEM-9200T

CD-WR17, CD-CS9

HEM-RML31-Z, HEM-CS24

 

 

1,6,21,25

HEM-9210T

HEM-9210T

HEM-RML31-B, HEM-CS24-B, HEM-RXL31-B

HEM-RML31-BZ, HEM-CS24-BZ, HEM-RXL31-BZ

 

 

23, 24

Doctor and Patient in Conversation Looking at Tablet
Doctor and Patient in Conversation Looking at Tablet

References

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  2. Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the OMRON M6 (HEM-7001-E) and the OMRON R7 (HEM 637-IT). Blood Press Monit 2006;11:165-171.

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  4. Takahashi H. Validation of the OMRON M6W upper arm blood pressure monitor, in oscillometry mode, for self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2012 Mar 01. 4 p.

  5. Takahashi H. Validation of the OMRON M3W upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2012 Mar 01. 4 p.

  6. Takahashi H, Yokoi T, Yoshika M. Validation of the OMRON M6 AC (HEM-7322-E) upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2014 Jan 22. 4 p.

  7. Topouchian J, Agnoletti D, Blacher J, Youssef A, Chahine MN, Ibanez I, Assemani N, Asmar R. Validation of four devices: OMRON M6 Comfort, OMRON HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol. Vasc Health Risk Manag. 2014 Jan 16;10:33-44.

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  18. El Assaad MA, Topouchian JA, Darne BM, Asmar RG. Validation of the OMRON HEM-907 device for blood pressure measurement. Blood Press Monit 2002;7:237-241.OMRON

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  20. Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of two watch-type wearable blood pressure monitors according to the ANSI/AAMI/ ISO81060-2:2013 guidelines: OMRON HEM-6410T-ZM and HEM-6410T-ZL. J Clin Hypertens. 2019;00:1–6.

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  25. Peprah, Y.A., Lee, J.Y. & Persell, S.D. Validation testing of five home blood pressure monitoring devices for the upper arm according to the ISO 81060-2:2018/AMD 1:2020 protocol. J Hum Hypertens 37, 134–140 (2023).

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  28. Ostchega Y, Nwankwo T, Sorlie PD, Wolz M, Zipf G. Assessing the validity of the Omron HEM-907XL oscillometric blood pressure measurement device in a National Survey environment. J Clin Hypertens (Greenwich). 2010 Jan;12(1):22-8. doi: 10.1111/j.1751-7176.2009.00199.x. PMID: 20047626; PMCID: PMC8673034.

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