.

IBP Performance Report: I

ALGORITHM V2.0.0

Production Launch Date: October 1st, 2015

Updated: April 17th, 2016 4:37 PM PT

For reference, we conduct internal studies guided by the ANSI/AAMI/ISO 81060-2:2013 internationally-accepted protocol for blood pressure cuff performance assessment to develop the performance characteristics of the technology powering Instant Blood Pressure. The performance characteristics of Instant Blood Pressure and other important safety and intended use information are included below.

DETAILS & RESULTS

These performance characteristics are developed through an in-house study using the ANSI/AAMI/ISO 81060-2:2013 protocol modified to compare Instant Blood Pressure to reference upper-arm, oscillometric blood pressure cuff devices. The results of this study find that Instant Blood Pressure does not yet meet the performance standards set forth by the ANSI/AAMI/ISO 81060-2:2013 protocol and, for this reason, it provides an estimate of blood pressure only. Furthermore, traditional automated upper-arm blood pressure monitors are currently more accurate and provide blood pressure readings over a greater range than Instant Blood Pressure.

Systolic BP Supported Range†:

  • Low Range: 102 (mmHg)

  • High Range: 158 (mmHg)

  • Total Range: 56 (mmHg)

Systolic BP Accuracy*:

  • Mean Difference: ± 1.6 (mmHg)

  • Standard Deviation (Sm): 11.1 (mmHg)

  • Standard Deviation (Sn): 11.3 (mmHg)

  • Pearson: r=0.580 (P<0.0001)

Systolic Data:

  • Number of  Subject: 68

  • Determination Pairs: 174

Diastolic BP Supported Range†:

  • Low Range: 65 (mmHg)

  • High Range: 99 (mmHg)

  • Total Range: 34 (mmHg)

Diastolic BP Accuracy*:

  • Mean Difference: ± 2.1 (mmHg)

  • Standard Deviation (Sm): 6.9 (mmHg)

  • Standard Deviation (Sn): 7.0 (mmHg)

  • Pearson: r=0.652 (P<0.0001)

Diastolic Data:

  • Number of  Subject: 68

  • Determination Pairs: 174

Pulse Rate Range†:

  • Low Range: 39 (bpm)

  • High Range: 240 (bpm)

  • Total Range: 201 (bpm)

Pulse Rate Accuracy*:

  • Mean Difference: ± 1.0 (bpm)

  • Standard Deviation (Sm): 2.9 (bpm)

  • Standard Deviation (Sn): 3.7 (bpm)

  • Pearson: r=0.955 (P<0.0001)

Pulse Rate Data:

  • Number of  Subject 99

  • Determination Pairs: 275

† Instant Blood Pressure will not produce an estimate outside of its supported range. Do not attempt to use Instant Blood Pressure to produce a reading outside of its range. If you know your blood pressure or pulse rate to fall outside this range or if you intend to estimate blood pressure or pulse rate outside of this range, Instant Blood Pressure is not suitable for your use.

* Mean = mean difference compared to reference, SD = standard deviation of difference. RMSD = root mean squared deviation. Pearson = Pearson correlation coefficient with reference. This accuracy characteristic is representative of the supported range only. Accuracy performance may be poor outside of the supported range.


caution: Important Safety & USE Information

Use Instant Blood Pressure to estimate blood pressure and pulse rate immediately before, during, or after a recreational activity.

For example, Instant Blood Pressure may be used to estimate cool-­down and recovery from cardiovascular exercise or estimate the impact of a meditation session or breathing exercise on pulse rate and blood pressure. Instant Blood Pressure is intended to be used by adults 18 years of age or older and it has not been tested for use on children or pregnant women.

Do not rely on Instant Blood Pressure for medical advice or diagnosis. 

Instant Blood Pressure is intended for recreational use only. It is not a replacement or substitute for a cuff or other blood pressure monitor. Instant Blood Pressure’s performance and accuracy characteristics do not meet international standards for a blood pressure monitor intended for clinical use.

Instant Blood Pressure is not a replacement or substitute for a cuff or other blood pressure monitor. 

Blood pressure cuffs and other blood pressure monitors are medical devices intended for clinical use. Instant Blood Pressure is intended for recreational use only. Blood pressure cuffs and other blood pressure monitors are currently more accurate than Instant Blood Pressure and provide a wider range of measurement. Instant Blood Pressure provides an estimate of blood pressure only.

Consult your doctor if you have any health concern. Do not self-­adjust medications.

Take medications as prescribed by your doctor. Only a doctor is qualified to diagnose and treat disease such as hypertension (i.e. high blood pressure). Self-­diagnosis and self-­treatment may lead to deterioration of your health.

Do not use Instant Blood Pressure if you wear a pacemaker or any internal electronic medical device. 

Use of a cell phone in close proximity to a pacemaker or other internal electronic medical device can interfere with its normal operation.