Vital Connect VCI MODULE User Manual
Instructions-For-Use (IFU)
& Information Guide
IFU-01
IFU-01, Rev. A Page 1 of 20
Instructions For Use (IFU) & Information Guide
This document provides instructions and information for the VitalConnect Platform, also referred as
Wireless physiological monitoring system. VitalConnect platform is developed as an Application
Programming Interface (API), intended to be used as a programming platform to allow mobile health care
services providers to develop user interface applications enabling the users (i.e. physician, caregiver,
patients) to view and/or access collected vital information. The platform consists of:
1. VitalConnect Sensor
2. VitalConnect Relay Software Library
3. VitalConnect Secure Server Software Library
User Assistance information
For additional information regarding the proper use of the VitaConnect Platform and mobile service
provider user interface, please contact the prescribing physician, caregiver, or health care provider.
Device Description
The VitalConnect Platform consists of the VitalConnect Sensor, Relay Software Library, and Server
Software Library. The VitalConnect Platform is accessible via an application program interface (API) that
allows authorized persons to receive data and notifications generated by the system.
The VitalConnect Sensor is a battery-operated adhesive patch with integrated sensors and wireless
transceiver, worn on the torso to record heart rate, electrocardiography (ECG), heart rate variability,
respiratory rate, skin temperature, fall detection, step count and posture. The sensor continuously gathers
physiologic data and then transmits the data via a Relay Software Library managed bi-directional relay
device to a central server controlled by the Server Software Library, where the data is stored for analysis
by healthcare professionals and researchers.
Authorized healthcare professionals can configure the system parameters via the API to generate
notification of changes in measured data. A notification is triggered when configured physiologic data
parameters are exceeded. Notification can be transmitted to a generic display device (i.e. smartphone,
tablet, PC or monitor).
VitalConnect Platform sub-systems include:
1. VitalConnect Sensor
a) Patch
The Patch is designed as a low cost disposable self-adhesive interface to the body.
b) Sensor Module
Residing within the patch, the sensor module performs processing functions related to capture of
physiologic data and also performs bi-directional communication with the relay device.
IFU-01, Rev. A Page 2 of 20
2. VitalConnect Relay Software Library
The Relay Software Library manages bi-directional communication between the Sensor Module and
the Server Software Library and is installed on a relay device.
3. VitalConnect Server Software Library
The Server Software Library is installed on a central server, manages the upload, processing and
storage of sensor data, as well as real-time configuration of and notifications from the VitalConnect
Platform.
Antenna Description
The VitalConnect Sensor Module utilizes a Fractus Micro Reach Xtend 2.4GHz Chip Antenna (part #FR05S1-N-0-110) in order to communicate via Bluetooth low energy to the relay. This antenna is a linear,
omnidirectional, monopole antenna that operates in the 2.4-2.5GHz range. The antenna is connected to
the Bluetooth transceiver through a 2 inductor matching network that has been optimized to maximize the
power radiated by the antenna and minimize the voltage standing wave ratio (VSWR). The product is for
use with BT 4.0 only.
Indications for Use
The VitalConnect Platform is a wireless monitoring system intended for use by healthcare
professionals and researchers for unattended surveillance of patient physiologic data. This includes
heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, fall
detection, step count and posture. Data is transmitted wirelessly to a central location where it is
stored for analysis. The VitalConnect Platform can be configured by Authorized Persons to notify
healthcare professionals when physiologic data falls outside selected parameters.
The VitalConnect Platform is intended for use on general care patients which are at least 18 years
of age. It is not intended for use on critical care in-patients. It is not intended as a diagnostic or
alarm device.
IFU-01, Rev. A Page 3 of 20
Information Guide:
Warning:
No modification to the VitalConnect Sensor is permitted.
No modification to the relay is permitted.
Do not wear VitalConnect Sensor if you are under the age of 18.
Do not wear VitalConnect Sensor, without the consent of your healthcare provider, if
you have implanted defibrillators.
Do not wear VitalConnect Sensor, without the consent of your healthcare provider, if
you have implanted pace-makers.
Do not wear VitalConnect Sensor if you are Pregnant or breastfeeding
If you are wearing a VitalConnect Sensor and plan on traveling on an airplane, contact
your service provider for instruction.
All components of VitalConnect Sensor should be kept out of the reach of children, pets,
or anyone who may swallow components or otherwise be at risk of being harmed by
components. If any component is swallowed, seek emergency medical attention
immediately.
Do not share your patch or sensor components with others to avoid damage to your
device, potential harm to others, and/ or risk of contamination.
Do not use a patch if the container has been opened or appears to have been used or
damaged.
Do not make any modifications to any components of the VitalConnect System, unless
otherwise instructed by Vital Connect Inc. and its approved affiliates.
If connected to other devices/system through the same user interface (i.e. mobile
phone), while connected to the VitalConnect System via a Bluetooth connection, please
note that performance of either or both Bluetooth connected devices/system could
potentially be affected.
General Warnings and Precautions:
IFU-01, Rev. A Page 4 of 20
Caution:
Do not wear a “previously used” patch beyond its recommended life cycle of three (3)
days.
You may experience slight discomfort and/or itchiness as a result of wearing silicone or
acrylic adhesive materials. If you experience discomfort or irritation, beyond mildly
tolerated symptoms, please remove patch immediately.
It is possible to experience mild soreness and/or redness after the removal of a patch. If
you experience this affect, do not wear the patch in the same area.
Adverse skin reactions may occur due to the nature of this product containing silicone or
acrylic adhesives. Should event of adverse or allergic reactions occur and persist beyond
two to three (2-3) days, contact your healthcare provider for further consultation.
Do not wear patch and module while swimming.
Protect the silicone adhesive patch and sensor module units from excessive moisture
and/or sweating to avoid product malfunction and lack of proper adhesion.
Module and patch will not be damaged while showering or bathing if properly sealed. Do
not submerge in more than 18 inches of water.
Patient / end user physiological signal values shall be set within the allowable configured
minimum and maximum range.
Connectivity and data transmission of device may be interrupted while under water.
Reconnect your device once you are out of the water after allowing for drying time.
Handle the VitalConnect System with care and according to instruction of use.
Incorrect handling, use of excessive force, or dropping of any components of the
VitalConnect System may cause malfunction and/or permanent damage to the patch and
sensor module.
Keep VitalConnect Sensor components away from excessive heat exposure, as this may
cause damage.
To ensure optimal performance of the VitalConnect System, avoid wearing the
VitalConnect Sensor while undergoing any medical imaging procedures such as MRI, CT,
X-ray, PET, etc.
If any component of your VitalConnect System fails to operate after attempting all
suggested troubleshooting methods, contact your product provider immediately.
Do not dispose the patch and battery in a household trash bin. Dispose per local laws,
care facility laws or hospital laws.
If the patch or sensor module becomes un-responsive and unable to link, remove the
module from the patch and replace it in a new patch. If it is still un-responsive and
unable to link, replace the module. User will be notified of the failure via a text message
on the relay (i.e. phone).
When traveling in a car, vital data collected by the sensor module may not be
transmitted to the server, due to the unavailability of Bluetooth (the amount of data
collected by the module is depends on the sensor module memory size).
When traveling on an airplane, vital data collected by the sensor module will not be
transmitted to the server, due to the unavailability of Bluetooth (the amount of data
collected by the module is depends on the sensor module memory size).
IFU-01, Rev. A Page 5 of 20
General Information:
VitalConnect Sensor is tested by UL for electrical safety in accordance with IEC 60601-1-1
VitalConnect Sensor is tested by UL for electromagnetic compatibility in accordance with
IEC 60601-1-2
Vital Connect Sensor complies with the Essential Performance defined in 60601-1,
amendment 1: “performance of a clinical function, other than that related to BASIC
SAFETY, where loss or degradation beyond the limits specified by the MANUFACTURER
results in an unacceptable RISK”, either with applicable testing or via user
documentation.
VitalConnect system is tested by UL for FCC in accordance with ANSI C63.10-2009, FCC
CFR 47 Part 2, FCC CFR 47 Part 15, RSS-GEN Issue 3, and RSS-210 Issue 8.
Electronic components are RoHS compliant.
Patch top layer and adhesive is medical grade.
Software failure, firmware failure or battery failure has no adverse effect on the end-
user. The failure would vital data collection and transmission. In the event this occurs,
the end-user or service provider will be notified as applicable.
VitalConnect Sensor is:
o Type BF applied part
o Not reusable
o IPX4, protected against water spray
o IPX7, protected against water submersion
No installation or maintenance is required.
The patch is intended for a one-time use, for up to 3 days.
The battery is not rechargeable. It’s intended for a one-time use for the life of the patch
which is up to 3 days.
The system does not display any messages
Start-up process is not included in this manual. This IFU is not intended for the end-user.
Shutdown procedure is not included in this manual. This IFU is not intended for the end-
user.
No cable or physical connection required. The only connection is the Sensor Module to
the Patch (as shown in General Description below.
Vital Connect Sensor should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, Vital Connect Sensor should be observed
to verify normal operation in the configuration in which it will be used.
Packaging label is legible within 90 degree viewing angle of the label.
Packaging label is legible within distance of 50 cm (20 inches)
Packaging label is legible within 500 lux – 1000 lux lighting (i.e. foot-candles)
IFU-01, Rev. A Page 6 of 20
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