TABLE 3.
Validated devices for office BP measurement in children and adolescents.
| Device (References) | No. of patients/ age range |
No. of pediatric patients/ age range |
Validation protocol | Result | Test device | DBP definition (K4 or K5) | Cuff sizes used | Device commercially available cuff sizes | Funding |
| Successful validation including only children | |||||||||
| BpTru BPM-100 (BpTRU Medical Devices, Canada, USA) (21) | 36/3–18 years | 36/36 (3–18 years) | ANSI/AAMI, BHS | Pass, grade A | Auscultatory mercury sphygmomanometer | K5 | na | Child 13–18 cm, Small adult 18–26 cm, Regular adult 26–34 cm, Large adult 32–43 cm, Extra−large adult 41–52 cm |
nr |
| CasMed 740 (CAS Medical Systems, Branford, Connecticut, USA) (22) |
29/ < 3 years | 29/29 (29 days–1 year: 5, 1–3 years: 3) | ANSI/ AAMI/ISO |
Pass | Invasive arterial measurement | na | Neonate cuffs: #1: 3–6 cm #2: 4–8 cm #5: 8–15 cm, Child cuff: 13–20 cm |
Neonate: #1: 3–6 cm #2: 4–8 cm #3: 6–11 cm #4: 7–14 cm #5: 8–15 cm, Infant 8–14 cm, Child 13–20 cm, Small adult 18–26 cm, Adult 26–35 cm, Adult long 29–38 cm, Large adult 32–42 cm, Large adult long 35–44 cm, Adult thigh 42–50 cm, |
CAS Medical Systems Inc. |
| Datascope Accutorr Plus (Datascope Corporation, Mahwah, New Jersey, USA) (23) |
44/5–15 years | 44/44 (5–15 years) | ESH | Pass | Auscultatory mercury sphygmomanometer | K5 | na | 9–14.8 cm orange, 13.8–21.5 cm green, 20.5–28.5 cm light blue, 27.5–36.5 cm navy blue, 35.5–46 cm burgundy, 45–56.5 cm brown |
Hong Kong Paediatric Nephrology Society, Children’s Kidney Trust Fund |
| Dinamap Procare-120 (Critikon, Tampa, Florida, USA) (23) |
44/5–15 years | 44/44 (5–15 years) | ESH | pass/fail | Auscultatory mercury sphygmomanometer | K5 | na | Infant, Child, Small adult, Adult, Large adult, Adult thigh |
Hong Kong Paediatric Nephrology Society, Children’s Kidney Trust Fund |
| Dinamap Procare-200 (Critikon, Tampa, Florida, USA) (24) |
45/(7–18 years) | 45/45 (7–18 years) | BHS, ESH | pass, pass/fail | Baumanometer Mercury Gravity Sphygmomanometer (W.A. Baum Co., Copiague, NY, USA) |
na | Child 17–22 cm, Small adult 22–30 cm, Large adult 30–38 cm |
Neonate Neo #1 Neo #2 Neo #3 Neo #4 Neo #5, Infant, Child, Small adult, Adult, Large adult, Adult thigh, Adult long cuff (Different assortment packs available) |
Korea Center for Disease and Prevention (KCDC) |
| Successful validation including only children | |||||||||
| Raycome RBP-1200 (Shenzhen Raycome Health Technology, China) (25) |
3–12 years | 87/87 (3–12 years) | ANSI/AAMI/ISO | Pass | Auscultatory mercury sphygmomanometer | K5 | Extra small 15–18 cm, small 18–22 cm, standard 23–32 cm | Extra small (SS) 15–18 cm, Small (S) 18–22 cm |
National Nature Science Foundation of China, Shenzhen Raycom Health Technology Company (Shenzhen, China) |
| Successful validation both adults and children | |||||||||
| CAS 9010 (CAS Medical Systems, Branford, Connecticut, USA) (27) |
4–78 years | 35/88 | AAMI | Pass | Auscultatory mercury sphygmomanometer | na | na | na | nr |
| Colin BP8800MS (Colin Medical Instruments Corp., San Antonio, TX) (28) |
170, 8 months–80 years | 85/170 (8 months–16 years) | ANSI/AAMI | Pass | Mercury manometer (model Marshall Deluxe, Omron Healthcare, Inc., Vermon Hills, IL) | K5 | Infant 8–12.5 cm, Child 12.5–18 cm, Small adult 18–24 cm, Adult 24–32 cm, Large adult 32–40 cm |
Neonate #1 #5, Infant, Child, Small adult, Adult, Large adult |
Nippon Colin (Komaki, Japan) and Colin Medical Instruments (San Antonio, TX) |
| Fukuda Denshi DS-7000/NIBP-701 (Fukuda Denshi Co., Tokyo, Japan) (29) |
119/42.2 ± 21.0 years | 33/119 (15 pediatric (3–12), 18 neonate/infant (< 3)) | ANSI/AAMI, BHS | Pass, pass-grade A | Intraarterial-neonates and infants, auscultatory-children and adults | na | na | Infant cuff, Child cuff, Large/Regular/Small Adult cuff |
Fukuda Denshi |
| Microlife WatchBP Office (Microlife AG, Widnau, Switzerland) (30) |
88/3–70 years | 37/88 (3–12 years) | ANSI/AAMI/ISO | Pass | Auscultatory mercury sphygmomanometer (Baumanometer; WA Baum Co., Inc., New York, New York, USA) |
K5 | Small 14–22 cm, Medium 22–32 cm, Large 32–42 cm |
Medium 22–32 cm, Large 32–42 cm |
Microlife, Widnau Switzerland, University of Athens Special Account for Research Grants |
| Midmark IQvitals Zone (Midmark Corporation, USA) (31) |
85/3–77 years | 35/85 (7–17 years) | ANSI/AAMI/ISO | Pass | Manual auscultation | K5 | na | Child, Small adult, Adult, Adult long, Large adult, Large adult long, Thigh |
Midmark Corporation |
| Nihon Kohden PVM-2701/Impluse-1 (32) |
110/na | 41/110 (<12 years) | ANSI/AAMI/ISO | Pass | Auscultatory mercury sphygmomanometer | K4 | na | Infants 8–13 cm, Children: Small 12–18 cm Standard 15–23 cm, Adults: Standard 21–30 cm Large 23–36 cm, Thigh 33–45 cm |
University of Tennessee Clinical Research Center and the Tennessee Clinical Trials Network, Nihon Kohden |
| Omron HBP-1300 (Omron Healthcare Co., Kyoto, Japan) (33) |
85/4–72 years | 35/85 (<12 years) | ANSI/AAMI/ISO | Pass | Auscultatory mercury sphygmomanometer | K4 | SS 12–18 cm, S 17–22 cm, M 22–32 cm, L 32–42 cm, XL 42–50 cm |
SS 12–18 cm, S 17–22 cm, M 22–32 cm, L 32–42 cm, XL 42–50 cm, |
Guangzhou Boji Medical Biotechnological Co. Ltd. |
| Successful validation including only children | |||||||||
| Omron HBP-1320 (Omron Healthcare Co., Kyoto, Japan) (34) |
88/4–70 years | 38/88 (4–12 years) | ANSI/AAMI/ISO | pass, pass | Auscultatory mercury sphygmomanometer | K5 | SS 12 to 18 cm, S 17 to 22 cm, M 22 to 32 cm, L 32 to 42 cm, XL 42 to 50 cm |
SS 12–18 cm, S 17–22 cm, M 22–32 cm, L 32–42 cm, XL 42–50 cm |
nr |
| Omron M3500 (Omron Healthcare Co., Kyoto, Japan) (35) |
135./≥3 years | 35/135 (3–12 years) | ANSI/AAMI/ISO | Pass | auscultatory mercury sphygmomanometer | K4 and K5 | Super small: 12–18 cm, Small: 17–22 cm, Standard: 22–32 cm, Large: 32–42 cm, Xlarge: > 42 cm |
Standard IEC adult cuff or GS cuff M Optional IEC adult oversized cuff IEC children cuff (9 cm, 7 cm), Adult cuff (S, M, L, XL), GS cuff (SS, S, L, XL) |
OMRON (Japan) |
| Welch Allyn Pro BP 2000 (Welch Allyn, Skaneateles Falls, New York, USA) (36) |
88/ ≥3 years | 35/88 (3–12 years) | ANSI/AAMI/ISO | Pass | Auscultatory mercury sphygmomanometer | K4 | Child 15–21 cm, Small adult 20–26 cm, Adult 25–34 cm, Adult long 32–43 cm, Adult large long 32–43 cm, Thigh 40–55 cm |
Child 15–21 cm, Small adult 20–26 cm, Adult 25–34 cm, Adult long 32–43 cm, Adult large long 32–43 cm, Thigh 40–55 cm |
Welch Allyn |
| Welch Allyn ProBP 3400 (Welch-Allyn Medical Products, New York, USA) (37) |
111, ≥3 years | 14/111 (3–12 years) | ANSI/AAMI, BHS | Pass, pass-grade A | Auscultatory mercury sphygmomanometer | K5 | na | Small child (12 cm) to thigh (55 cm) | nr |
| Welch Allyn SureBP, StepBP (Welch-Allyn Medical Products, New York, USA) (38) |
102/ ≥3 years | 15/102 (3–12 years) | ANSI/AAMI, BHS | Pass, grade A | Auscultatory mercury sphygmomanometer | K5 | na | Extra small 15–24 cm, Standard wide 22–42 cm, Extra large 40–54 cm |
nr |
| Welch-Allyn Spot Vital Signs (Welch-Allyn Medical Products, New York, USA) (39) |
5–77 years, 47 ± 16 | na, >5 years | ANSI/AAMI | Pass | Auscultatory mercury sphygmomanometer (Tycos brand sphygmomanometer; Tycos, Inc., Arden, North Carolina, USA) |
K5 | na | Neonate: #1: 3.3–5.6 cm #2: 4.2–7.1 cm #3: 5.4–9.1 cm #4: 6.9–11.7 cm #5: 8.9–15 cm, Infant 9.8–13.3 cm, Small child 12.4–16.8 cm, Child 15.8–21.3 cm, Small adult 20–27 cm, Adult 25.3–34.4 cm, Large adult 32.1–43.4 cm, Thigh 40.7–55 cm |
Welch Allyn, Inc. |
| YuWell YE900 (Jiangsu Yuyue Medical Equipment and Supply, China) (26) |
85/3–12 years | 35/85 (4–11 years) | AAMI/ESH/ISO | Pass | Auscultatory mercury sphygmomanometer (YuYue, Jiangsu Province, China) | K5 | 18–22 cm (small), 22–32 cm (medium), and 32–42 cm (large) | na | YuYue Medical Equipment & Supply Co., Ltd. |
DBP, diastolic blood pressure; na, not available; nr, not reported.