Quality seal of the German Hypertension League

'Quality seal of the German Hypertension Society' - Tensoval Blood Pressure Measurement Devices for Self Control passed all requirements
Dr. med. Ulrich Tholl, Chief Physician of Internal Medicine, Klinikum Bremerhaven Reinkenheide, Bremerhaven.

'...The quality seal is of high value on the market...'
(Dr. Siegfried Eckert, senior attending physician at the North-Rhine Westphalian Heart and Diabetes Centre in Bad Oeynhausen, Germany.)

'...Thhe quality seal is a recognized proof of quality that in specialist circles is a prerequisite
for a recommendation - and thereby for me too...'

(Julie Strobach, PTA (pharmaceutical-technical assistant) and director of the FAKTOR X Pharma Academy in Berlin, Germany.)

Validation procedure:
A minimum of 96 subjects who fulfilled the protocol criteria were recruited from different sites. Six same arm measurements according to the manufacturer's instructions were taken from each subject by two observers alternating between mercury sphygmomanometers and the test device.
The Quality Seal of the German Hypertension Society required a minimum of three comparative measurements of each subject to be valid for the evaluation.
(Validation of Tensoval Mobile included 85 patients)

Conclusion:

  • All tested blood pressure measurement devices for self control fulfilled requirements of the Quality Seal of the German Hypertension Society.
  • They can be recommended for self control in an adult population.

 

Quality seal of the British Hypertension Society

Tensoval duo control achieved best results for accuracy according to the British and European Hypertension Societies' standards
Annemarie De Greef, Jasleen Arora, Simon Hervey, Bing Liu and Andrew H. Shennan. Maternal and Fetal Research Unit, Division of Reproduction and Endocrinology, King's College London, North Wing, St. Thomas' Hospital, London, UK.

Aim:
To evaluate the accuracy of Tensoval duo control in adults according to
1. British Hypertension Society (BHS),
2. American Association for the Advancement of Medical Instrumentation (AAMI)
3. European Society of Hypertension (ESH).

Validation procedure:
85 subjects who fulfilled the protocol criteria were recruited from different sites. Nine sequential same arm measurements according to the manufacturer's instructions were taken from each subject by two observers alternating between mercury sphygmomanometers and the test device.

Results:

  • Tensoval duo control achieved an A grade for both, systolic and diastolic pressure values according to the BHS protocol
  • The device also fulfilled the AAMI criteria
  • The device successfully achieved all requirements of the International ESH protocol guidelines and showed excellent intra-patient accuracy with more than 80% of participants having at least 2 out of 3 differences within 5 mmHg of the mercury standard.

Conclusion:

  • Tensoval duo control is the first automated auscultatory device to maintain an A/A grading throughout the low, medium and high pressure categories.
  • The device can therefore be recommended for clinical and home care use in an adult population.

 

Standard Protocol EN 1060 Part IV

Tensoval Blood Pressure Measurement Devices fulfilled requirements of the EN 1060 - Part IV
Dr. med. Ulrich Tholl Klinikum Bremerhaven Reinkenheide, Bremerhaven.
Ikufumi Tajima Medical Corporation Juzankai Tajima Hospital, Nakanojo,
Japan.

Validation procedure:
A minimum of 96 subjects1 who fulfilled the protocol criteria were recruited from different sites. Six same arm measurements according to the manufacturer's instructions were taken from each subject by two observers alternating between mercury sphygmomanometers and the test device.

The EN 1060 - Part IV required:

  • Blood pressure values of one participant that are considered for calculation may not differ more than 12 mmHg for the systolic value and 8 mmHg for the diastolic value, respectively.
  • From six pairs of measured values the first group of three consecutive pairs of measured values are considered

Results:
All tested blood pressure measurement devices for self control passed the protocol according to the EN 1060 - Part IV.
They fulfilled criteria for the mean pressure difference and the corresponding standard deviation.

1Validation of Tensoval Mobile included 85 patients.