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 3 of 17
Contraindications
•
The Cardi/o
®
Sensor is not intended as a stand-alone diagnostic monitor for vital signs, but the data
may be applicable for use in diagnosis.
Warnings
•
Depending on wireless connectivity, a temporary interruption of data transmission is possible, which
may impact continuous or real-time monitoring. Limited data will be stored on the device for transfer
once connectivity is reestablished.
•
The Cardi/o
®
Sensor is designed to monitor one individual at a time. Having more than one
individual in the field of view of the sensor may produce skewed data that may not represent the
parameters of the intended subject.
•
Disturbances to cardiac-respiratory signals include distortions due to foreign interference and noise
artifacts may occur when using the Cardi/o
®
Sensor. Do not rely entirely upon heart rate signals of
the Cardi/o
®
Sensor. Keep patients under close surveillance.
•
Automated interpretation of heart rate variability by the Cardi/o
®
Sensor is a valuable tool when
used properly. However, no automated interpretation is completely reliable, and a qualified
physician shall review the interpretations before treatment, or non-treatment, of any patient.
•
Heart rate, respiratory rate, stress level (HRV), and motion data will not be transmitted or stored if the
Sensor is not powered.
•
The patient must be in the field of view of the Cardi/o
®
Sensor to collect physiological data.
•
Clinical validation has not been performed on patients who are pregnant or breastfeeding.
Precautions
•
For data to be sent to a healthcare professional for review:
o
The Cardi/o
®
Sensor must be properly used by the patient.
o
The patient must remain in range of their Sensor device.
o
The Cardi/o
®
Sensor must have adequate power for data transmission. Notification of
interruption in data collection of the Cardi/o
®
Sensor will be indicated on the Cardi/o
®
App when
the Sensor device is offline and may also be sent via SMS Text if this feature is enabled.
o
The Sensor device must remain connected to the Internet and functional for data transmission.
Wireless connectivity must be active for transmission of data from the Sensor device to the
Cardi/o
®
.
•
The healthcare professional can be notified when there are interruptions in data connectivity if this
feature is enabled.
•
Physiological data collected by the Cardi/o
®
Sensor for patients experiencing stress may indicate
slightly higher or lower respiratory rate values, compared to visual observation.
•
The Cardi/o
®
Sensor is for Individual Use Only. Do not monitor more than one patient at a time.
•
Wireless electronic devices may cause signal interference during data transmission. Avoid close
proximity with interfering devices.
•
Do not use the Cardi/o
®
Sensor if the package has been opened, or appears used, damaged, or
expired.