
2IFU-26 Rev. J | December 2021
VistaPoint is a software Graphical User Interface
intended for use by healthcare professionals to display
physiological data collected by the Vista Solution
wireless remote monitoring system in home and
healthcare settings. VistaPoint is a secondary, adjunct
patient monitor and is not intended to replace existing
standard-of-care patient monitoring practices.
Contraindications (When not to use)
Do not use the VistaPoint application as a standalone
diagnostic monitor. However, the data may be applicable
for use in diagnosis.
VistaPoint Precautions
• Invalid posture data (shown as “?”) indicates a
non-calibrated state where respiration rate, posture,
and fall data are considered invalid.
• Body movements and contact with the VitalPatch
may produce motion artifacts that aect the
displayed, measured values for ECG and heart rate.
• After applying VitalPatch, it may take 60 seconds for
heart rate to stabilize and respiration rate 180
seconds to stabilize. During the stabilization period
VistaPoint will display “--” for those vital signs.
• After applying VitalPatch, it may take several minutes
for skin temperature to register an accurate value (for
VitalPatch with rmware 1.0.4.x).
Indications for Use
Rev. A Initial release of this document to support
VistaPoint Release 3.1.
Rev. B User interface updates for organization name
and pacemaker status.
Rev. C Added recommendation for a 2-minute pause
between opening VitalPatch pouch and
powering-on VitalPatch. Added instructions
for exiting “download” mode on VistaPhone.
Rev. D Changed usage instructions for Nonin 3230
pulse oximeter to indicate spot-check
behavior (streaming mode no longer
supported for Nonin 3230).
Rev. E Added support VistaPoint Release 3.2.
Changes include controls for modifying and
displaying patient name and device name,
and the addition of Guided Help during
pairing.
Revision History
VitalPatch Warnings and Precautions
Refer to IFU-06, VitalPatch Instructions for Use for a
complete list of Warnings and Precautions related to
using the VitalPatch biosensor.
Pacemaker Precautions
The following precaution applies when using the
VitalPatch described in IFU-06: “The VitalPatch may be
used on patients with pacemakers. However, ECG data,
heart rate, and respiration rate will not be measured and
displayed if a pacemaker is indicated as present.”
Adverse Event Reporting
Adverse events and/or potential patient injury
complications that are reasonably associated with the
use of VitalPatch, VistaPoint, and associated products
should be reported, as follows:
Region Where to Report
USA 1. VitalConnect, Inc.
2. Users and patients can report to FDA at:
https://www.accessdata.fda.gov/scripts/
medwatch/
EU 1. VitalConnect, Inc.
2. The Competent Authority of the Member
State in which the user and/or patient is
established
Rev. F Revised patient name change instructions.
Moved Wi-Fi instructions to Section 1.
Rev. G Added “Related Documents”. Updated
Section 1 with “Parts of the device”,
unpacking details, returning instructions.
Updated pairing instructions to indicate
optional steps (pacemaker, patch position,
body position). Added “Adverse Event
Reporting”. Extensive content rearrangement
for clarity.
Rev. H Removed references to IFU-10-EUA
(VitalPatch with Arrhythmia Detection).
Corrected errors in the blood pressure and
weight instructions.
Rev. J Added instructions for cleaning and sanitizing
the monitoring equipment. Removed 5-day
patch information.