Device |
Mode |
AAMI |
BHS |
ESH 2002 |
ESH 2010 |
ISO 81060-2:2013 |
ISO 81060-2:2018 |
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 |