Device Equivalence Evaluation Form
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3 Device Equivalence Evaluation Form Comparison of the SEJOY BP-1209 with the SEJOY BP-1307 Devices Item 9 SEJOY BP-1209 SEJOY BP-1307 Pictures Display Image Validation ESH 2010 Category Upper arm blood pressure monitor for home blood pressure monitoring Upper arm blood pressure monitor for home blood pressure monitoring Casing Item 10 Dimensions Approx.134x99x66mm Ports Cuff port Dimensions Approx.166x114x72mm Ports Cuff port 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 t-for-profit organisation. Carraig Court, George s Avenue, Blackrock, Co. Dublin, Ireland Tel Fax info@dableducational.org Web Form DET
4 AC adapter port Blood pressure measurement AC adapter port Blood pressure measurement WHO Classification Display Item 11 Carrying/Mounting Facilities Item 12 Software other than Algorithm Item 13 Memory Capacity Item 14 Printing Facilities Item 15 Facilities Item 16 Supply Item 17 Type LCD Number of stored measurements 120 measurements with date and time Type LCD Other differences ECG measurement, PC software Same Criteria Measurement Accuracy Pressure :±3mmHg Pulse rate: ±5% Number of stored measurements 2x60 measurements with date and time Measurement Accuracy Pressure :±3mmHg Pulse rate: ±5% Method Oscillometric Ranges Cuff pressure 0-300mmHg Pulse beats/min Inflation Automatic inflation by internal pump Method Oscillometric Ranges Cuff pressure 0-300mmHg Pulse beats/min Inflation Automatic inflation by internal pump dabl Educational Trust Limited Page 2 of 5
5 Deflation Automatic speed deflation system Cuffs(Please state sizes and materials used) 22-36cm PVC, Polyester Sensors Semi-conductive pressure 120 measurements with date and time Measurements other than Blood Pressure Buttons/Switches Start/Stop button Memory recall button M button Date and time Setting Setting button Start/Stop for 3 sec Analysis Event Marking Display/Symbols/Indicators Preparation Deflation Automatic speed deflation system Cuffs(Please state sizes and materials used) cm PVC, Polyester Sensors Semi-conductive pressure 2x60 measurements with date and time Measurements other than Blood Pressure WHO Classification Buttons/Switches Start/Stop button Memory recall button M button Date and time setting SET button Analysis Event Marking Display/Symbols/Indicators Preparation dabl Educational Trust Limited Page 3 of 5
6 Measurement Procedure Inflation symbol Deflation symbol Heartbeat symbol during deflation Post Measurement Systolic blood pressure Diastolic blood pressure Pulse rate Memory recall number Low battery detection symbol Not described Algorithms Averages and Differences Diagstic s Measurement Procedure Inflation symbol Deflation symbol Heartbeat symbol during deflation Irregular Heartbeat symbol Post Measurement Systolic blood pressure Diastolic blood pressure Pulse rate WHO indicator Memory recall number Low battery detection symbol Average Not described Algorithms Averages and Differences Diagstic dabl Educational Trust Limited Page 4 of 5
7 Comparable Criteria s Comments This equivalence relates to the blood pressure measurement characteristics of both devices. Recommendation Recommended Date 21 February dabl Educational Trust Limited Page 5 of 5
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