Device Equivalence Evaluation Form
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5 Comparison of the Microlife BP A150 AFIB with the Microlife BP A100 Plus and Microlife BP A100 Device Equivalence Evaluation Form Devices Microlife BP A150 AFIB 9 Microlife BP A100 Plus 9 Microlife BP A100 9 Image Validation ESH 2002 ESH 2002 LCD Display Device Criteria Memory Capacity for stored values: set - shown with symbol «M» set - shown with symbol «M» and date and time 14-1 set - shown with symbol «M» and date and time dabl Educational Trust Limited No reproduction of this document is permitted without the written authorisation of dabl Educational Trust Limited dabl Educational Trust Limited is a not-for-profit organisation. Carraig Court, George s Avenue, Blackrock, Co. Dublin, Ireland Tel Fax info@dableducational.org Web Form DET
6 dabl Educational Trust Device Equivalence Evaluation Form Other Facilities: 18 Display/Symbols/Indicators - Error 6 (AFIB/MAM Mode) Display/Symbols/Indicators - Error 6 (MAM Mode) 18 Display/Symbols/Indicators 18 - Cuff check Indicator (symbol instead of Error, improved function) - Armmovement Indicator (symbol instead of Error, improved function) - Error 3 (leakage) - Error 2 (artifact) - Error 3 (leakage) - Error 2 (artifact) - MAM Function (triplicate measurement): Yes - Pulse Arrhythmia Indicator (PAD): No - Pulse Beep during measurement: No - MAM Function (triplicate measurement): Yes - Pulse Arrhythmia Indicator (PAD): Yes (indicates pulse irregularities during measurement which may affect the reading) - Pulse Beep during measurement: Yes - MAM Function (triplicate measurement): No - Pulse Arrhythmia Indicator (PAD): Yes (indicates pulse irregularities during measurement which may affect the reading) - Pulse Beep during measurement: Yes AFIB: Yes 1), 2) - Software other than algorithm (Detection of atrial fibrillation) AFIB: No AFIB: No - Date and Time display: Yes - Date and Time display: Yes (with 2 alarm times i.e. for medication) - Date and Time display: No Cuff compartment: No Cuff compartment: Yes (part of the casing) Cuff compartment: Yes (part of the casing) Traffic Light Indication: Yes (following ESH) Traffic Light Indication: Yes (following WHO 2003) Traffic Light Indication: No Cuffs: Microlife M-Cuff (22-32cm) 3) Microlife L-Cuff (32-42cm) 3) Microlife M-L-Cuff (22-42cm) 4) optional: Microlife M-L-Rigid-conical Cuff (22-42cm) 5) Cuffs: Microlife M-Cuff (22-32cm) 3) Microlife L-Cuff (32-42cm) 3) Cuffs: Microlife M-Cuff (22-32cm) 3) Microlife L-Cuff (32-42cm) 3) Microlife M-L-Cuff (22-42cm) 4) optional: Microlife M-L-Rigid-conical Cuff (22-42cm) 5) 2016 dabl Educational Trust Limited Page 2 of 3
7 dabl Educational Trust Device Equivalence Evaluation Form Reference documents 1) Reference dev. BP A150 AFIB Stergiou GS, Karpettas N, Protogerou A, Nasothimiou EG, Kyriakidis M. Diagnostic accuracy of a home blood pressure monitor to detect atrial fibrillation. Journal of Human Hypertension 2009; 23, ) Reference dev. BP A150 AFIB Kearly K, Selwood M, Van den Bruel A, Thompson M, Mant D, FD Hobbs R, Fitzmaurice D, Heneghan C. Triage tests for identifying atrial fibrillation in primary care: a diagnostic accuracy study comparing single-lead ECG and modified BP monitors. BMJ Open 2014; 4, 1-7 3) Reference dev. BP A100 Plus validated with Microlife S-Cuff (17-22cm), M-Cuff (22-32cm) and L-Cuff (32-42cm) Stergiou GS, Giovas PP, Neofytou MS, Adamopoulos DN. Validation of the Microlife BP A 100 Plus device for self-home blood pressure measurement according to the International Protocol Blood Press Monit 2006;11: ) Reference dev. BP A100 validated with Microlife M-L-Cuff (22-42cm) Bonso E, Dorigatti F, Palatini P. Accuracy of the BP A100 blood pressure measuring device coupled with a single cuff with standard-size bladder over a wide range of arm circumferences. Blood Press Monit 2009;14: ) Reference dev. BP A100 validated with Microlife M-L-Cuff Rigid Conical Cuff (22-42cm) Elisa Bonso, Francesca Saladini, Ada Zanier, Elisabetta Benetti, Francesca Dorigatti and Paolo Palatini. Accuracy of a single rigid conical cuff with standard-size bladder coupled to an automatic oscillometric device over a wide range of arm circumferences. Hypertension Research (2010) 33, Web link sion/automatic/bp-a150-afib/ on/automatic/bp-a100-plus tic/bp-a100/ Recommend. Equivalence is recommended Date 9 May dabl Educational Trust Limited Page 3 of 3
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