Use Instructions
Table Of Contents
- Device Description
- Indications for Use
- Components Included with the Cardi/o Remote Patient Monitor System
- CARDI/O® USE INSTRUCTIONS
- Cardi/o® Overview
- Cardi/o® Remote Patient Monitor (RMP) may be use for synchronous telehealth consultations where real-time intermittent spot-checking of vital signs may be desired; and for asynchronous telehealth consultations where historical data can be viewed and d...
- Step 1. Connect the Cardi/o® Sensor to the Internet via WiFi
- Scan the barcode containing a unique ID that is located on the sensor device with a smart phone, then input the local WiFi passcode to complete the Sensor connection.
- Determine whether the Cardi/o® RMP will be for intermittent use or long-term use and position the Sensor device according to Figure A or Figure B below.
- Step 2.A Positioning Cardi/o® for Intermittent Use – tabletop option
- Step 2.B Positioning Cardi/o® for Long Term Use – wall-mount option
- Step 3. Accessing Patient Data
- Step 4. Managing Patient Alerts
- Step 5. Downloading and Reporting Data
- Cardi/o® Sensor Return or Disposal
- Troubleshooting
- Contact Information
- Product Specifications
- General Symbols
IFU-EUA Rev. 01
Date: 01Sep2020
Page 2 of 17
Device Description
The Cardi/o
®
Sensor device is a component of the Cardi/o
®
remote patient monitoring (RPM) platform.
The Cardi/o Sensor device is a wireless, no-touch/no-wearable vital signs sensor, set on a desktop or
mounted to a wall to record heart rate, respiratory rate, and stress related to heart rate variability, and
motion. The Cardi/o
®
Sensor continuously gathers physiological data from the person being monitored
and then transmits encrypted data via WiFi to the Cardi/o
®
Cloud platform. The encrypted wireless data
provided by the Cardi/o
®
Sensor may be accessed and viewed via Cardi/o
®
App for mobile phones or
Cardi/o
®
Central Dashboard web app for desktop computers. The data from the Cardi/o Sensor may be
downloaded from the Cardi/o
®
Cloud for storage or integrated into a Third-Party Relay Application via the
APIs of the Cardi/o
®
Software Library. The data provided by the Cardi/o Sensor is intended to aid
caregivers in making diagnoses by providing additional information.
During normal operation, data is collected via touchless radar sensing capability of the Cardi/o
®
Sensor
and transmitted immediately to the Cardi/o
®
Cloud via WiFi. A continuous connection is needed between
the Cardi/o
®
Sensor and the Internet to facilitate continuous physiological data transmission. The
continuous wireless transmission of data occurs with an update rate of 2 seconds between data collection
and transmission.
Patients may opt in to request assistance from healthcare providers through predefined alarm thresholds
that, when exceeded, send alerts via a wall-mounted transceiver that is connected to the cloud.
Indications for Use
The Cardi/o
®
RPM is a wireless “no-wearable” remote monitoring system intended for use by healthcare
professionals for continuous collection of physiological data in healthcare settings as well as in
environments where healthcare is administered, such as home healthcare services, assisted living and
skilled nursing facilities. This physiological data can include heart rate, respiratory rate, heart rate
variability, and motion. The RPM may be used for synchronous or asynchronous for telemedicine
consultations.
The Cardi/o
®
Sensor is intended for use on general care patients who are 18 years of age or older who
may be susceptible to decubitus ulcers of the skins, such as the elderly, for use as a general patient
monitor, to provide physiological information. The collection and transmission of data is performed on the
device.
The data from the device is intended for use by healthcare professionals as an aid to remote diagnosis
and treatment while preventing the spread of communicable diseases such as COVID-19.
The device can be used on patients unable or averse to wearable patient monitors, such as patients
living with dementia or autism. The device is not intended for use on critical care patients.
The data provided by the Cardi/o
®
Sensor may also be intended for trained technicians at a remote site
to review the data and determine if they concur with the analysis made by the algorithm in the Cardi/o
®
Sensor.
The data collected by the Cardi/o
®
Sensor is an adjunct to clinical assessment; clinician review of the
data should precede any diagnosis or therapeutic intervention.