Device Equivalence Evaluation Form
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3 Device Equivalence Evaluation Form Comparison of the HARTMANN Veroval upper arm blood pressure monitor with the AViTA BPM63S Devices Pictures HARTMANN Veroval upper arm blood pressure monitor AViTA BPM63S Display Validation ESH 2010 Category Arm Type Blood Pressure Monitor Arm Type Blood Pressure Monitor Device 1 Criteria Dimension 150 * 85 * 45 mm (W * H *D) Weight 270g(Excluding batteries) Cuff Size 22-42cm Dimension 113 * 140 * 57 mm (W * H *D) Weight 275g(Excluding batteries) Cuff Size 22-33cm 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
4 Device 2 Criteria Same Criteria Printing Artwork logo, gift box and manual is different from AViTA BPM63S for different functions Measurement Accuracy Blood Pressure Accuracy ± 3 mmhg Pulse Accuracy ± 4% Method Oscillometric Ranges Cuff pressure mmhg Systolic 50 mmhg 280 mmhg Diastolic 30 mmhg 200 mmhg Inflation Automatic inflation by internal pump Deflation Automatic speed deflation system Cuffs (Please state sizes and materials used) cm Bladder dimension: 120x232mm Sensors US S 2*100 times with date and time Measurements other than Blood Pressure Buttons/Switches START/POWER Button ( on / off ) Printing Artwork logo, gift box and manual is different for different functions Measurement Accuracy Blood Pressure Accuracy ± 3 mmhg Pulse Accuracy ± 4% Method Oscillometric Ranges Cuff pressure mmhg Systolic 50 mmhg 280 mmhg Diastolic 30 mmhg 200 mmhg Inflation Automatic inflation by internal pump Deflation Automatic speed deflation system Cuffs(Please state sizes and materials used) cm Bladder dimension: 120x232mm Sensors US S 1*60 times with date and time Measurements other than Blood Pressure Buttons/Switches START/POWER Button ( on / off ) dabl Educational Trust Limited Page 2 of 5
5 Memory Recall Buttons User 1 / User 2 Setting combination of button user 1+user2 Analysis Event Marking Display/Symbols/Indicators Preparation Measurement Procedure Inflation symbol Deflation symbol Heartbeat symbol during deflation Irregular Heartbeat symbol Post Measurement Systolic blood pressure Diastolic blood pressure WHO indicator Memory recall number Low Battery detection symbol Memory Recall Button - MEM Set Button SET Mode (Alarm) Button - Mode Analysis Event Marking Display/Symbols/Indicators Preparation Measurement Procedure Inflation symbol Deflation symbol Heartbeat symbol during deflation Irregular Heartbeat symbol Post Measurement Systolic blood pressure Diastolic blood pressure WHO indicator Memory recall number Low Battery detection symbol Average dabl Educational Trust Limited Page 3 of 5
6 Average Not described Algorithms Averages and Differences Average of all measurement Average morning values of the last seven days measurements between 5:00AM and 9:00AM Average evening values of the last seven days measurements between 6:00PM and 8:00PM Diagnostic s Casing Display LCD Ports Cuff Port USB port DC Jack *AC adapter is optional 4 * AA Batteries Alarm Not described Algorithms Averages and Differences Average of the last 3 measurements Diagnostic s Casing Display LCD Ports Cuff Port DC Jack *AC adapter is optional 4 * AA Batteries dabl Educational Trust Limited Page 4 of 5
7 Comparable Criteria Comments Recommendation RECOMMENDED Date 30 November dabl Educational Trust Limited Page 5 of 5
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