Phoenix Ambulatory Blood Pressure Monitor

Standards and Guidelines

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Normative Reference

IEEE Std 1708^TM-2014, IEEE Standard for Wearable, Cuffless Blood Pressure Measuring Devices.^{1, 2}

1. The IEEE standards or products listed here are trademarks of The Institute of Electrical and Electronics Engineers, Inc.
2. IEEE publications are available from The Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854, USA (http://standards.ieee.org/).

The standard defines terms pertaining to "Performance Evaluation" but defers other definitions to IEEE Standards Dictionary Online, http://www.ieee.org/portal/innovate/products/standard/standards_dictionary.html, which like other IEEE standards is available via subscription.

Though the standard is intended for home blood pressure measurement (HPBM) and ambulatory blood pressure measurement (ABPM) systems, it does not establish any expectations for continuous measurement. The performance evaluation standard accounts for any calibration specified by the device manufacturer, but leaves the procedure and frequency of calibration to the manufacturer.

Device Accuracy (Performance)

This section describes how to evaluate the accuracy of a device's measurements.

1. Observer training
2. Subject selection
3. Validation procedure
4. Validation criteria
5. Data reporting

The standard prescribes the comparison of a device's measurements to reference measurements taken with a sphygmomanometers.

Wearable sensor

The scope of the standard does not dictate any technology or any form of a device. Consequently, this part of the standard is open-ended. The device is required only to meet the requirements of the standard for the specific kind of sensor under evaluation.

Communication Protocols for Networking

The standard provides normative references to other standards, primarily to the IEEE-11073 series, which addresses personal health device and point-of-care medical device communication.

Electrical Safety

The standard provides normative references to:

• IEC 60601, which governs general electrical safety of medical electrical equipment
• ANSI/NFPA 99, which governs flammable anesthetizing locations

Stability

The standard provides a normative reference to ANSI/AAMI SP10, which governs sphygmomanometers. Within the context of that standard, stability pertains to attributes of the system to maintain its performance and safety attributes over the life of any battery within the system and over the life of the device, as measured by the number of full-scale pressure cycles.

With respect to stability, SP10 seems inadequate to the demands of ambulatory blood pressure monitors, particularly those intended to meet the demands of chronobiological analysis. The standard sets the expected lifetime of a device to 10,000 full-scale pressure cycles. This would encompass less than 7 months of use when measuring every 30 minutes.