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Sphygmomanometers for Clinical Use

 

Automated Devices for Clinical Use

Device Mode AAMI BHS ESH 2002 ESH 2010 ISO 81060-2:2013 Circumstance Recommendation
A&D TM-2564G Osc Pass A/A       Serious protocol violations Questionable
A&D TM-2655 Osc Pass A/A       Methods poorly explained Questionable
A&D TM-2656 Osc Pass A/A       A&D TM-2656 Equivalence Recommended
A&D TM-2657 Osc Pass A/A       At rest Recommended
A&D UM-201 Osc       Pass   At rest
Cuff sizes of 16-24, 22-32, and 31-45 cm.
Recommended
A&D UM-211 Osc       Pass   At rest
Cuff sizes of 16-24, 22-32, and 31-45 cm.
Recommended
Andon KD-595 Osc       Pass   At Rest Recommended
Andon KD-5031 Osc       Pass   At Rest Recommended
Andon KD-5917 Osc       Pass   At Rest Recommended
Beurer BM45 Osc       Pass   Andon KD-5917 Equivalence Recommended
Beurer BM85 Osc       Pass   iHealth BP3 Equivalence Recommended
BpTRU
BPM-100
BPM-300
Osc Pass A/A       At rest. Pressure ranges Recommended
Pass         Children Questionable
Pass A/A       Mixed adult/paediatric population
Protocol Violations
Should have used 1990 instead of 1993 BHS criteria but still A/A
Questionable
BpTRU
(unspecified)
            Pass Ad Hoc Protocol;
Abstract
Questionable
CA-MI Srl CHIESI 0100000328 (DIESIS PLUS) Osc       Pass   Nissei DSK-1011 Equivalence Recommended
CA-MI Srl CHIESI 0100000329 (DIESIS) Osc       Pass   Nissei DSK-1011 Equivalence Recommended
Citizen CHU305 Osc       Pass   Andon KD-5917 Equivalence Recommended
Citizen CHUD514 Osc       Pass   Andon KD-595 Equivalence Recommended
Citizen CHUD517 Osc       Pass   Andon KD-5917 Equivalence Recommended
Colin 8800C Osc Pass         AAMI only Questionable
CVProfilor DO-2020 Dynamic linear deflation, Osc & Acoustic           New methodology, Passed Ad-hoc protocol Questionable
Datascope Accutorr Plus Osc Pass A/A       At rest Recommended
Pass         Trimline cuff replacement, at rest, protocol variation Questionable
    Pass     Children. Adaptation of protocol along BHS guidelines. Recommended
DiaTecne
PulsePen
Tonometry           Abstract;
Pass ad hoc protocol;
Developer assessment
Questionable
Dinamap ProCare Osc     Pass     At rest Recommended
Osc Pass A/A       At rest Recommended
Dinamap ProCare-120 Osc     Fail     Children. Adaptation of protocol along BHS guidelines. Not Recommended
Dixtal DX-2020 Osc       Fail   At rest Not Recommended
Erkameter 125 PRO Osc       Pass   At rest Recommended
Foracare Fora P30 Plus Osc       Pass   At rest Recommended
G-Care Electronics
SP-800
Osc     Pass     Abstract Only Questionable
HARTMANN Tensoval Duo Control Aus-Osc Pass A/A Pass     At rest Recommended
HARTMANN Tensoval Duo Control II Aus-Osc Pass A/A   Pass*   *ESH-IP 2010 in Aus mode only Recommended
HARTMANN Veroval Duo Control Aus-Osc Pass A/A   Pass*   *ESH-IP 2010 in Aus mode only
HARTMANN Tensoval Duo Control II Equivalence
Recommended
Health and Life
(Health & Life)
HL-868ED
Osc   A/A       At rest Recommended
      Pass   At rest Recommended
HoMedics BPA-300 Aus & Osc Pass         Sample size well over 85. Low mean BP Questionable
iHealth BP3 (KD-931) Osc       Pass   At rest Recommended
    Pass     KD-5915 Equivalence Recommended
InBody BP170 Osc         Pass At rest
ISO 81060-2:2018
Recommended
InBody BP170B Osc         Pass InBody BP170 Equivalence Recommended
InBody BPBIO250 Osc         Pass At rest
ISO 81060-2:2018
Recommended
InBody BPBIO320 Osc       Pass   At rest Recommended
InBody BPBIO320N Osc       Pass   InBody BPBIO320 Equivalence Recommended
InBody BPBIO320S Osc       Pass   InBody BPBIO320 Equivalence Recommended
InBody BPBIO330 Osc       Pass   InBody BPBIO320 Equivalence Recommended
InBody BPBIO330N Osc       Pass   InBody BPBIO320 Equivalence Recommended
InBody BPBIO750 Osc       Pass   InBody BPBIO320 Equivalence Recommended
InBody HBP170 Osc         Pass InBody BP170 Equivalence Recommended
InBody HBP570 Osc         Pass InBody BPBIO250 Equivalence Recommended
Lohmeier B-606 Osc     Pass     Abstract Questionable
Microlife BP 3AS1-2 Osc     Pass     At rest Recommended
  A/A       Pregnancy Recommended
  B/A       Pre-Eclampsia Recommended
Microlife WatchBP Home (BP3MX1-1) Osc     Pass     At rest Recommended
  A/A       Pregnancy Recommended
  B/A       Pre-Eclampsia Recommended
Microlife WatchBP Home A (BP3MX1-3) Osc     Pass     Microlife WatchBP Home Equivalence Recommended
Microlife WatchBP Home N (BP3MX1-4) Osc     Pass     Microlife WatchBP Home Equivalence Recommended
Microlife WatchBP Home S (BP3MX1-5) Osc     Pass     Microlife WatchBP Home Equivalence Recommended
Microlife WatchBP O3 (3MZ0) Osc     Pass     At rest Recommended
Microlife WatchBP O3 (3MZ1) Osc     Pass     At rest Recommended
Microlife WatchBP Office Osc     Pass     At rest Recommended
Microlife WatchBP Office ABI Osc Pass A/A Pass     At rest Recommended
    Pass     L-XL size cuff Recommended
Microlife WatchBP Office AFIB Osc     Pass     WatchBP Office Equivalence Recommended
Microlife WatchBP Office Target Osc     Pass     BP A100 Equivalence Recommended
Nissei DM-3000 Osc     Pass     Automatic Mode Recommended
Nissei DS-A10 Osc       Pass   Nissei DSK-1011 Equivalence Recommended
Nissei DS-B10 Osc       Pass   Nissei DSK-1011 Equivalence Recommended
Nissei DS-G10 Osc       Pass   Nissei DSK-1011 Equivalence Recommended
Nissei DS-N10 Osc       Pass   Nissei DSK-1031 Equivalence Recommended
Nissei DS-S10 Osc       Pass   Nissei DSK-1031 Equivalence Recommended
Nissei DSK-1011 Osc       Pass   At rest Recommended
Nissei DSK-1031 Osc       Pass   At rest Recommended
Nissei DSK-1051 Osc       Pass   DSK-1031 Equivalence Recommended
Omron 705IT (HEM-759-E) Osc     Pass       Recommended
Pass A/A       Minor recruitment modification Recommended
    Pass     Children and adolescents. Reasonable adaptation of protocol. Recommended
Omron 725 CIC (HEM-725CIC) Osc           Ad Hoc Protocol. None
Omron 907 (HEM-907) Osc & Aus     Pass     Data analysed according to IP proposal only, Osc mode only Questionable
Pass         At rest, Osc mode only, AAMI only, Recruitment violation Questionable
    Pass     Elderly Population. Mode not stated. Recommended
    Fail     In ESRD before and after haemodialysis, Osc mode only Not Recommended
Omron HBP-1100 Osc       Pass   Omron HBP-1300 Equivalence Recommended
Omron HBP-1120 Osc Pass     Pass   Omron HBP-1320 Equivalence Recommended
Omron HBP-1300 Osc       Pass   At rest Recommended
Omron HBP-1320 Osc         Pass At rest Recommended
      Pass   At rest Recommended
Omron HBP-9030 Osc         Pass Omron HBP-9031C Equivalence Recommended
Omron HBP-9031C Osc         Pass General population; At rest Recommended
Omron HBP-T105 Osc     Pass     High speed mode with smart inflation Recommended
Omron HEM-7130 (Japanese model) Osc       Pass   At rest Recommended
Omron HEM-7250-IT Osc       Pass   Omron HEM-7251G Equivalence Recommended
Omron HEM-7251G Osc       Pass   At rest Recommended
Omron HEM-7252G-HP Osc       Pass   At rest Recommended
Omron HEM-7320F Osc       Pass   At rest Recommended
Omron HEM-7500F Osc       Pass   At rest Recommended
Omron EVOLV
(HEM-7600T-E)
Osc       Pass*   Pregnancy
* Modified ESH-IP 2010
Recommended
Omron i-Q142
(HEM-1040-E)
Osc       Pass   At rest Recommended
Omron M2
(HEM-7121-E)
Osc       Pass   Omron HEM-7130 (Japanese model) Equivalence Recommended
Omron M2 Basic
(HEM-7120-E)
Osc       Pass   Omron HEM-7130 (Japanese model) Equivalence Recommended
Omron M3
(HEM-7131-E)
Osc       Pass   Omron M6 AC (HEM-7322-E) Equivalence Recommended
Omron M3
(HEM-7154-E)
Osc       Pass   Omron M6 AC (HEM-7322-E) Equivalence Recommended
Omron M3 Comfort
(HEM-7134-E)
Osc       Pass   Omron M6 Comfort(HEM-7321-E) Equivalence Recommended
      Pass*   Pregnancy
* Modified ESH-IP 2010
Recommended
Omron M3 Comfort
(HEM-7155-E)
      Pass   Omron M6 Comfort(HEM-7321-E) Equivalence Recommended
Omron M3 IT
(HEM-7131U-E)
Osc       Pass   Omron M6 AC (HEM-7322-E) Equivalence Recommended
Omron M3W
(HEM-7202-E)
Osc       Pass   At rest Recommended
Omron M4-I (HEM-752-E) Osc     Pass     705IT (HEM-759-E) Equivalence Recommended
Omron M4 Intelli IT
(HEM-7155T-EBK)
      Pass   Omron M6 Comfort(HEM-7321-E) Equivalence Recommended
Omron M6 AC
(HEM-7322-E)
Osc       Pass   At rest Recommended
Omron M6 Comfort
(HEM-7321-E)
Osc       Pass   At rest Recommended
Omron M6 Comfort
(HEM-7360-E)
      Pass   Omron M6 Comfort(HEM-7321-E) Equivalence Recommended
Omron M6 Comfort IT
(HEM-7322U-E)
Osc       Pass   Omron M6 Comfort (HEM-7321-E) Equivalence Recommended
Omron M7 Intelli IT
(HEM-7322T-E)
Osc       Pass   Omron M6 Comfort(HEM-7321-E) Equivalence Recommended
Omron M7 Intelli IT
(HEM-7361T-EBK)
      Pass   Omron M6 Comfort(HEM-7321-E) Equivalence Recommended
Omron MIT Elite
(HEM-7300-WE)
Osc   A/A       Pregnancy Recommended
  A/A       Pre-Eclampsia Recommended
Omron (Colin) Pressmate BP-10 Osc     Pass     At rest Recommended
Omron X3 Comfort
(HEM-7155-EO)
      Pass   Omron M6 Comfort(HEM-7321-E) Equivalence Recommended
Omron X4 Smart
(HEM-7155T-ESL)
      Pass   Omron M6 Comfort(HEM-7321-E) Equivalence Recommended
Omron X6 Comfort
(HEM-7360-EO)
      Pass   Omron M6 Comfort(HEM-7321-E) Equivalence Recommended
Omron X7 Smart
(HEM-7361T-ESL)
      Pass   Omron M6 Comfort(HEM-7321-E) Equivalence Recommended
Pic Solution (Artsana) CARDIOSimple Osc       Pass   Andon KD-5917 Equivalence Recommended
Plusmed pM-NT 01 Osc     Pass     Microlife BP3AS1-2 Equivalence Recommended
Primo RACD Osc (Pass)         RAL catheter in ICU. Limited sample. Device "shows promise" (Authors). Questionable
SAFETY PRONTEX INTEGRA (NISSEI DS-B33-03) Osc       Pass   Nissei DSK-1011 Equivalence Recommended
SAFETY PRONTEX SYNTESI (NISSEI DS-B23-03) Osc       Pass   Nissei DSK-1011 Equivalence Recommended
Somnomedics Somnotouch-NIBP Wrist,PTT       Pass   At rest Recommended
Spengler Tensionic Mod EPS 112 Osc Pass B/A       At rest; Abstract Questionable
SunTech Medical SunTech 247 Osc Pass A/A Pass     At rest Recommended
Terumo ES-H55 Osc
Double-cuff
Pass         Manufacturer Assessment Questionable
Thermor Bios BD215 Osc       Pass   At rest Recommended
UEBE Visomat Comfort E (Ref 24016) Osc       Pass   Double Comfort (Osc Mode) Equivalence Recommended
UEBE Visomat Comfort Eco (Ref 24026) Osc       Pass   Double Comfort (Osc Mode) Equivalence Recommended
UEBE Visomat Double Comfort Osc       Pass   At rest Recommended
Aus       Pass   At rest Recommended
Welch Allyn Spot Vital Signs Osc Pass         Only Method 1 completed. Ages 5-77 Questionable
YuWell YE690A Osc       Pass   At rest Recommended
 

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