medaval rating of blood pressure monitors recommended by ......artsana (pic solution) cs-410...

4
BPMs recommended by the BIHS (UK and IRL) - 5th March 2021 Page 1 of 4 Medaval rating of Blood Pressure Monitors recommended by the British and Irish Hypertension Society Monitors are listed according to clinical validation. Medaval certication is awarded only to devices with the most accurate measurement technology. For accreditation, proof of validation and adherence to international standards is scrutinised by Medaval with independent peer-review. Devices without evidence of validation include those where the cited paper refers to a dierent device and those without evidence of possible MDR equivalence to a validated device. Medaval will update devices where scientic proof of validation or MDR equivalence is provided. Warning: Wrist monitor accuracy requires strict adherence to manufacturer instructions. If the monitor is not positioned correctly, the results can be very inaccurate. BIHS Recommendations: Not recommended Not recommended for pregnancy Not recommended for pregnancy in those with large arms Listed Previously Adults Children e Elderly Pregnancy Obese Adults Other Symbols: Discontinued Obsolete Research Device Certied 5-Star Blood Pressure Monitors A&D UA-651 Microlife BP W2 Slim Omron RS3 (HEM-6130-E) iHealth Feel BP5 Novacor Diasys 3 Plus Visomat Double Comfort Certied 4-Star Blood Pressure Monitors A&D UB-543 Honsun Scian LD-735 Omron RS6 (HEM-6221-E) Andon KD-5851 iHealth BP3 (KD-931) Omron RS8 (HEM-6310F-E) Andon KD-5917 iHealth Sense BP7 (KD-972) PangaO PG-800B11 Andon KD-5965 Omron HEM-7252G-HP PangaO PG-800B5-1 Avita BPM63S Omron HEM-7320F PangaO PG-800B68 BIOS BD215 (Precision 8.0) Omron HEM-7500F Rossmax CF175f (V1) 3-Star Blood Pressure Monitors Grandway G.LAB MD2200 Microlife WatchBP Oce (Twin200) Omron M3 Comfort (HEM-7134-E) Grandway G.LAB MD2231 Microlife WatchBP Oce ABI (Twin200 ABI) PangaO PG-800A36 Grandway G.LAB MD2680 Nissei DM-3000 PangaO PG-800B26 Grandway MD2301 Omron Evolv (HEM-7600T-E) H&L HL868ED Omron HEM-9210T 2-Star Blood Pressure Monitors A&D UA-1020 Hartmann Tensoval Duo Control II Omron M6 Comfort (HEM-7221-E) A&D UB-542 Hingmed WBP-02A Hospital PangaO PG-800A11 A&D UM-201 InBody BP170 PAR Tonoport VI A&D UM-211 InBody BPBIO250 Petr Telegin BpLab Andon KD-595 InBody BPBIO320 Qardio QardioArm A100 Avita BPM-64 InBody BPBIO750 Sejoy BP-1307 Avita BPM15 Medipro MC-100F Spacelabs OnTrak (90227) Avita BPM17 Medisana MTP Plus (51043) Suntech CT40 Beneware 24h-ABPM (ABP-021) Meditech ABPM-06 Transtek TMB-1491 Bpump BF-1112 Omron HBP-1300 (HBP-1300-E) Withings BP-800 ERKA. Erkameter 125 PRO Omron M3 (HEM-7200-E) Yuwell YE690A © 2021 Medaval Ltd. 48 Serpentine Ave, Dublin 4, IRELAND. +353 1 664 3768 [email protected] www.medaval.ie

Upload: others

Post on 05-Mar-2021

8 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Medaval rating of Blood Pressure Monitors recommended by ......Artsana (Pic Solution) CS-410 Microlife BP 3AC1-1 Visomat Comfort Eco (v2) Artsana (Pic Solution) CSI-610 Omron Elite

BPMs recommended by the BIHS (UK and IRL) - 5th March 2021 Page 1 of 4

Medaval rating of Blood Pressure Monitorsrecommended by the British and Irish Hypertension

SocietyMonitors are listed according to clinical validation.

Medaval certification is awarded only to devices with the most accurate measurement technology. For accreditation, proof of validationand adherence to international standards is scrutinised by Medaval with independent peer-review.Devices without evidence of validation include those where the cited paper refers to a different device and those without evidence ofpossible MDR equivalence to a validated device. Medaval will update devices where scientific proof of validation or MDR equivalence isprovided.Warning: Wrist monitor accuracy requires strict adherence to manufacturer instructions. If the monitor is not positioned correctly, theresults can be very inaccurate.BIHS Recommendations: Not recommended Not recommended for pregnancy Not recommended for pregnancy in thosewith large arms Listed Previously Adults Children The Elderly Pregnancy Obese AdultsOther Symbols: Discontinued Obsolete Research Device

Certified 5-Star Blood Pressure Monitors A&D UA-651 Microlife BP W2 Slim Omron RS3 (HEM-6130-E)iHealth Feel BP5 Novacor Diasys 3 Plus Visomat Double Comfort

Certified 4-Star Blood Pressure Monitors A&D UB-543 Honsun Scian LD-735 Omron RS6 (HEM-6221-E)Andon KD-5851 iHealth BP3 (KD-931) Omron RS8 (HEM-6310F-E)Andon KD-5917 iHealth Sense BP7 (KD-972) PangaO PG-800B11Andon KD-5965 Omron HEM-7252G-HP PangaO PG-800B5-1Avita BPM63S Omron HEM-7320F PangaO PG-800B68BIOS BD215 (Precision 8.0) Omron HEM-7500F Rossmax CF175f (V1)

3-Star Blood Pressure Monitors Grandway G.LAB MD2200 Microlife WatchBP Office (Twin200) Omron M3 Comfort (HEM-7134-E)

Grandway G.LAB MD2231 Microlife WatchBP Office ABI (Twin200ABI) PangaO PG-800A36

Grandway G.LAB MD2680 Nissei DM-3000 PangaO PG-800B26Grandway MD2301 Omron Evolv (HEM-7600T-E) H&L HL868ED Omron HEM-9210T

2-Star Blood Pressure Monitors A&D UA-1020 Hartmann Tensoval Duo Control II Omron M6 Comfort (HEM-7221-E)A&D UB-542 Hingmed WBP-02A Hospital PangaO PG-800A11A&D UM-201 InBody BP170 PAR Tonoport VIA&D UM-211 InBody BPBIO250 Petr Telegin BpLabAndon KD-595 InBody BPBIO320 Qardio QardioArm A100Avita BPM-64 InBody BPBIO750 Sejoy BP-1307Avita BPM15 Medipro MC-100F Spacelabs OnTrak (90227)Avita BPM17 Medisana MTP Plus (51043) Suntech CT40Beneware 24h-ABPM (ABP-021) Meditech ABPM-06 Transtek TMB-1491Bpump BF-1112 Omron HBP-1300 (HBP-1300-E) Withings BP-800ERKA. Erkameter 125 PRO Omron M3 (HEM-7200-E) Yuwell YE690A

© 2021 Medaval Ltd. 48 Serpentine Ave, Dublin 4, IRELAND. +353 1 664 3768 [email protected] www.medaval.ie

Page 2: Medaval rating of Blood Pressure Monitors recommended by ......Artsana (Pic Solution) CS-410 Microlife BP 3AC1-1 Visomat Comfort Eco (v2) Artsana (Pic Solution) CSI-610 Omron Elite

BPMs recommended by the BIHS (UK and IRL) - 5th March 2021 Page 2 of 4

Medaval rating of Blood Pressure Monitorsrecommended by the British and Irish Hypertension

SocietyMonitors are listed according to clinical validation.

1-Star Blood Pressure Monitors A&D TM-2430 Microlife BP A100 Plus Omron MIT (HEM-751-E)A&D TM-2656 Microlife WatchBP Home (BP 3MX1-1) Omron MX3 Plus (HEM-742-E)Accoson Greenlight 300 (AC0702A) Microlife WatchBP O3 (BP 3MZ1-1) Omron R2 (HEM-6113-E)BpTru BPM-100 Omron 637IT (HEM-637IT-E) Omron R5-I (HEM-630-E)Datascope Accutorr Plus Omron 705IT (HEM-759-E) Panasonic EW-3106H&L HL888HA Omron HEM-907 (HEM-907-E7) Spacelabs 90207Hartmann Tensoval Duo Control Omron i-Q132 SpotArm (HEM-1010-E) Spacelabs 90217HoMedics BPA-540 Omron M2 (HEM-7117-E) Suntech Oscar 2

IEM Mobil-O-Graph NG Omron M3 Intellisense (HEM-7051-E) Welch Allyn Connex ProBP 3400 withSureBP

Microlife BP 3AS1-2 Omron M6 (HEM-7001-E) Microlife BP A100 Omron M7 (HEM-780-E)

Other Validated Blood Pressure Monitors

A&D TM-2655 Citizen CH-432BOmron MIT Elite Plus (HEM-7301-ITKE7)

A&D UA-704 Citizen CH-656C Omron R3-I Plus (HEM-6022-E)A&D UA-705 Dinamap ProCare 100 Oregon BPU 330A&D UA-767 EnviteC PhysioQuant ABPM (45-00-0500) Oregon BPW810A&D UA-767 Plus H&L HL168JD Panasonic EW-3109A&D UA-774 H&L HL868BA Rossmax ME701A&D UA-779 HealthSTATS BPro Schiller BR-102 PlusA&D UA-787 Heine Gamma G5 Seinex SE-9400A&D UA-851 Heine Gamma G7 SensaCare SAA-102A&D UA-852 Heine Gamma XXL LF (Desk) SensaCare SAW-102A&D UA-853 Honsun Scian LD-578 Sorin AgilisA&D UA-854 Kingyield BP-101H Spengler Pro MA&D UA-855 Lloyds BP11 Suntech 247Andon KD-391 Meditech ABPM-04 Transtek TMB-986Andon KD-5915 Microlife BP 3AC1-1 Transtek TMB-988Artsana (Pic Solution) CS-410 Omron Elite 7300W (HEM-7300-EZ) Visocor HM40Artsana (Pic Solution) CSI-610 Omron HEM-711DLX Visomat Comfort Eco (v2)Braun SensorControl BP-3550 Omron M1 Plus (HEM-4011C-E) Visomat HandyBraun VitalScan Plus (BP-1650) Omron M2 Compact (HEM-7102-E) Welch Allyn Maxi Stabil 3

Blood Pressure Monitors Validated in a Specific Population iHealth Track (KN-550BT) Microlife BP 3AC1-1 PC Omron MIT Elite (HEM-7300-WE7)Kinetik BPM1C Omron HEM-7320-LA

Blood Pressure Monitors with an Internal or Non-Published Validation EuroMedix Stabil-O-Graph Riester Big Ben Square Desk Riester Big Ben Square WallMindray Beneview T5 Riester Big Ben Square Floor Mortara Ambulo 2400 Riester Big Ben Square Rail

© 2021 Medaval Ltd. 48 Serpentine Ave, Dublin 4, IRELAND. +353 1 664 3768 [email protected] www.medaval.ie

Page 3: Medaval rating of Blood Pressure Monitors recommended by ......Artsana (Pic Solution) CS-410 Microlife BP 3AC1-1 Visomat Comfort Eco (v2) Artsana (Pic Solution) CSI-610 Omron Elite

BPMs recommended by the BIHS (UK and IRL) - 5th March 2021 Page 3 of 4

Medaval rating of Blood Pressure Monitorsrecommended by the British and Irish Hypertension

SocietyMonitors are listed according to clinical validation.

Blood Pressure Monitors with a possible MDR Equivalence to a Validated Device A&D UA-1010 GE Carescape V100 Lloyds LBPK1A&D UA-1030T GE Tonoport V Maestro HL158JAA&D UA-611 H&L Airssential AI-H971 Maestro HL158SAA&D UA-767BT H&L HL168KB Maestro HL858JAA&D UA-767PC H&L HL168ZA Maestro HL858SAA&D UA-782 H&L HL858BA Medicare Lifesense A2 (MD638)Alvita CG-155F H&L HL858DK Meditech ABPM-05Alvita MA-801F H&L HL858GA Medset Scanlight-IIIAndon BM-091 H&L HL858HA Microlife As easy as 123 (BP 3BX0-A)Andon KD-5001 H&L HL868ZA Microlife BP 3AG1Andon KD-557 H&L HL868ZB Microlife BP 3BT0-A (2)Andon KD-558 H&L HL888HC Microlife BP A2 Basic (BP 3GQ1-3P)Andon KD-5901 Health Assure HL158JA Microlife BP A200 (BP 3MS1-4K)Andon KD-5902 Health Assure HL858JA Microlife BP A3 Basic

Andon KD-5905 HealthWorks SCLV-2007 Cardio-VascularLab Mindray BeneVision N12

Andon KD-5909 Heine Gamma XXL LF (Rail) Mindray iMEC-12Andon KD-5918 Heine Gamma XXL LF (Stand) Omron 705CP-II (HEM-759-E2)Andon KD-5961 Heine Gamma XXL LF (Wall) Omron 708-BT (HEM-7081-ITE)Andon KD-5962 HoMedics BPA-2000-EU Omron HEM Solar (HEM-4500-Sole)Andon KD-5971 HoMedics BPA-3000-EU Omron HEM-7117Aspen C5 HoMedics BPW-1000-EU Omron i-C10 (HEM-7070-E)Aspen CF155F HoMedics Mibody 360EU Omron M1 (HEM-4030-E)Boots 46-61-486 (HEM-757-UK) Honsun LD30 Omron M1 Compact (HEM-4022-E)Boots 56-90-404 (HEM-7041-BS) Honsun Scian LD-520 Omron M10-IT (HEM-7080IT-E)Boots 56-90-420 (HEM-7115-BS) Honsun Scian LD-522 Omron M2 (HEM-7121-E)Boots 56-90-447 (HEM-7101) Honsun Scian LD-526 Omron M2 Basic (HEM-7116-E)Boots 65-90-412 Honsun Scian LD-528 Omron M2 Basic (HEM-7120-E)BpTru BPM-200 Honsun Scian LD-530 Omron M24/7 (ABPM-BP5)BpTru BPM-300 Honsun Scian LD-532 Omron M4-I (HEM-752-E)Braun ExactFit 1 (BUA-5000) Honsun Scian LD-533 Omron MIT Elite (HEM-7300-WE)Braun ExactFit 3 (BP-6000) Honsun Scian LD-568 Omron MX2 Basic (HEM-742-E2)Braun ExactFit 3 (BP-6100) Honsun Scian LD-582 Omron Pro Logic PL100 (HEM-7101-PR)Braun ExactFit 5 (BP-6200) Honsun Scian LD-586N Omron R2 (HEM-6113-FR)BTL Cardiopoint BTL-08 ABPM (V1) Honsun Scian LD-587 Omron R6 (HEM-6000-E7)Cardioline Walk200b Honsun Scian LD-588 Omron R6 (HEM-6052-2)Citizen CH-617 iHealth Neo BP5S Omron R7 (HEM-637-E2)Citizen CH-618 iHealth View (BP7S) Omron RS2 (HEM-6121-E)Cresta BPM-610 Keeler Big Ben Round Oregon Ssmart Talking (BPU321OS)Cresta BPM-701 Keeler Big Ben Square Oregon Tunstall BPU-329Datascope Accutorr V Keeler Classic Par Physio-PortDatascope iPM 12 Keeler Palm Proton PHC-888EADesa Pharma Tecnico Easy Keeler Windsor Proton PHC-888UPDinamap Carescape V100 Kessler KS 551 Proton PHCP-868BFDinamap ProCare 200 Kinetik BPM1K Riester Big Ben Round DeskDinamap Procare 420 Kinetik BPM1KTL Riester Big Ben Round FloorDuronic BPM-300 Kinetik WBP1 Riester Big Ben Round RailErgoline Ergoscan Lloyds LBP1 Riester Big Ben Round Wall

© 2021 Medaval Ltd. 48 Serpentine Ave, Dublin 4, IRELAND. +353 1 664 3768 [email protected] www.medaval.ie

Page 4: Medaval rating of Blood Pressure Monitors recommended by ......Artsana (Pic Solution) CS-410 Microlife BP 3AC1-1 Visomat Comfort Eco (v2) Artsana (Pic Solution) CSI-610 Omron Elite

BPMs recommended by the BIHS (UK and IRL) - 5th March 2021 Page 4 of 4

Medaval rating of Blood Pressure Monitorsrecommended by the British and Irish Hypertension

SocietyMonitors are listed according to clinical validation.

Blood Pressure Monitors with a possible MDR Equivalence to a Validated Device Riester E-Mega (1-tube) Rossmax Accumed MH901 Rossmax X5 (V1)Riester E-Mega (2-tube) Rossmax AD701 Rossmax X9Riester Exacta Rossmax AE701 Rossmax Z1Riester Minimus II Rossmax AJ701 Rossmax Z5Riester Minimus III Rossmax AK150f Salter BPA-8200-EURiester Precisa N Rossmax AU941f (V1) Salter BPA-9200-GBRiester Precisa N shock-proof Rossmax AV151f Seagull S-868BARiester R1 Shock-Proof Rossmax AW151 Seagull S-888HARiester RBP-100 Rossmax CF155f Spengler TB-101Riester ri-cardio Rossmax CH155f (V1) Suresign LD3Riester ri-champion N Rossmax CH155f (V2) Unimedic TensiodayRiester ri-medic Desk Rossmax MA350 Uscom BP+Riester ri-medic Floor Rossmax MG150f Visomat ComfortRiester ri-medic Wall Rossmax MH150 Walgreens WGNBPA-730Riester ri-san Rossmax MJ150f Walgreens WGNBPA-740Rossmax AB701 Rossmax MJ701 Walgreens WGNBPA-750Rossmax AC1000f (V1) Rossmax MR250 Walgreens WGNBPW-710Rossmax AC701 Rossmax MW701f (V2) Walgreens WGNBPW-720Rossmax Accumed AF701 Rossmax MW821f Welch Allyn ABPM 6100Rossmax Accumed AW150 Rossmax X1 (V1) Welch Allyn ABPM 7100Rossmax Accumed Carrdio C5 Rossmax X3 (V1) Welch Allyn ProBP 2400

Blood Pressure Monitors being Audited Beurer BM 44

Blood Pressure Monitors with a Validation Fail Welch Allyn Vital Signs 300 Series

Visit www.medaval.ie for more information☤ The world's top registry ☤ Device Manuals ☤ Blood Glucose Meters☤ Check if your device is validated ☤ Manufacturer Statistics ☤ Pulse Oximeters☤ Devices not proven to be validated ☤ Validation procedures ☤ Connected Health Devices

© 2021 Medaval Ltd. 48 Serpentine Ave, Dublin 4, IRELAND. +353 1 664 3768 [email protected] www.medaval.ie