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IFU-08, Rev D | Date: November 2019
Page 4 of 39
healthcare settings. VistaPoint is a secondary, adjunct patient monitor and is not intended to replace
existing standard-of-care patient monitoring practices.
Contraindications
•
The biosensor is not intended as a stand-alone diagnostic monitor, but the data may be
applicable for use in diagnosis.
Warnings
•
See the
VitalPatch Instructions for Use
(IFU-02 or IFU-06, depending on version) for additional
Vista Solution warnings and precautions.
Precautions
•
Invalid posture data (shown as “?”) indicates a non-calibrated state. In such a state, respiration
rate, posture, and fall data are considered invalid.
•
Body movements and contact with the connected biosensor may produce motion artifacts that
affect the displayed, measured values for both Live ECG and Heart Rate.
•
Heart rate and respiratory rate take 60 seconds and 180 seconds, respectively, after initial
biosensor application to stabilize. During that timeframe “--" will be displayed.
•
Skin temperature (for VitalPatch with firmware 1.4.0.x) may take several minutes after the
biosensor has been applied to the patient to register accurate skin temperature values.
About VitalConnect, Inc.
VitalConnect is a leader in wearable biosensor technology for wireless patient monitoring in both hospital
and remote patient populations. VitalConnect leverages extensive expertise in biomedical engineering,
data analytics, chip design, and mobile and cloud software to create technology that supports decision-
making paradigms that achieve better health and economic outcomes. VitalConnect products are
designed for use in a broad range of inpatient and outpatient settings, such as hospital monitoring, post
discharge care, cardiac monitoring and pharmaceutical solutions. For more information, please visit
Document History
Revision
Description
Rev. A
Initial release of this document.
Rev. B
Modify body temperature and adhesive overlay instructions for patch-off
conditions. Add instructions for performing a maintenance boot of the
VistaTablet.
Rev. C
Modify instructions for body temperature calibration to include a
recommended schedule for calibration.
Rev. D
Change length of time for first visibility of heart rate (from 45 to 60
seconds) and respiration rate (from 120 to 180 seconds).