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The technology used in the Andon KD-556, to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| ESH (Europe) | Self-measurement | Published evidence | ||
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Andon KD-5031
Wu N, Zhang X, Wang W, Zhang H. Validation of the Andon KD5031 for clinical use and self-measurement according to the European Society of Hypertension International Protocol. Blood Press Monit. 2016 Oct;21(5):310-2. Epub: 2016 Jul 7. doi: 10.1097/MBP.0000000000000204. PMID: 27392206.
ESH-IP:2010 - Pass General population
Andon KD-5915
Huang QF, Wang J, Sheng CS, Zhang NN, Li Y, Wang JG. Validation of the ANDON KD-5915 blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2010 Aug;15(4):232-4. PMID: 20658765.
ESH-IP:2002 - Pass General population
Andon KD-5917
Guo WG, Li BL, He Y, Xue YS, Wang HY, Zheng QS, Xiang DC. Validation of the Andon KD-5917 automatic upper arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Aug;19(4):242-5. doi: 10.1097/MBP.0000000000000048. PMID: 24847724.
ESH-IP:2010 - Pass General population
Andon KD-595
Wu N, Zhang X, Wang W, Zhang H. Validation of the Andon KD-595 for clinical use and self-measurement according to the European Society of Hypertension International Protocol. Blood Press Monit. 2016 Apr;21(2):124-7. Epub: 2015 Nov. doi: 10.1097/MBP.0000000000000164. PMID: 26544523.
ESH-IP:2010 - Pass General population
Andon KD-5965
Huang J, Li Z, Li G, Liu Z. Validation of the Andon KD-5965 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Oct;20(5):283-5. Epub: 2015 May 5. doi: 10.1097/MBP.0000000000000129. PMID: 25968093.
ESH-IP:2010 - Pass General population
Beurer BM 44
Lüders S, Krüger R, Zemmrich C, Forstner K, Sturm CD, Bramlage P. Validation of the Beurer BM 44 upper arm blood pressure monitor for home measurement, according to the European Society of Hypertension International Protocol 2002. Blood Press Monit. 2012 Dec;17(6):248-52. doi: 10.1097/MBP.0b013e32835b9e8e. PMID: 23147534.
ESH-IP:2002 General population (Note: ESH-02 not recognised since 01 July 2011)
iHealth Track (KN-550BT)
Van Den Heuvel JFM, Lely AT, Franx A, Bekker MN. Validation of the iHealth Track and Omron HEM-9210T automated blood pressure devices for use in pregnancy. Pregnancy Hypertens. 2019 Jan;15:37-41. Epub: 2018 Nov 2. doi: 10.1016/j.preghy.2018.10.008. PMID: 30825925.
ESH-IP:2010 - Pass Pregnancy (n=33) including pre-eclampsia (n=10)
KD-556 Automatic blood pressure monitor with big display and 2 x 60 memories WHO blood pressure indicator 2 x 60 memories, date and time Average of last three measurements Irregular heartbeat detection Managing your health is all about understanding the signals of your body. To really manage your blood pressure, it should be measured on a daily basis. Andon products empower people to make life-changing choices. Model number Measurement method Display Measurement range KD-556 oscillometric 60 x 48 mm LCD Pressure: 0 - 295 mmHg Pulse: 40 - 199 beats/min Accuracy Pressure: within 3 mmHg Pulse: within 5% Memories 2 x 60 Dimensions 135 x 97 x 49 mm Weight 223 g Power supply 4 x AA alkaline batteries Operating temperature +10 to +40°C, 85% R.H. Storage temperature -20 to +50°C, 85% R.H. Specifications are subject to technical improvement, changes or modifications without notice Multi -User W.H.O indicator High Normal High Normal Andon Health Co., Ltd. No 3 Jin Ping Rd - Ya An Street - Nankai District - Tianjin - China Email : contact@andonhealth.com