INSTRUCTIONS FOR USE CARDI/O® [kar-dee-o] (remote patient monitor) for touchless, no-wearable use IFU-10-EUA Rev.
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.
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.
• Incorrect handling, excessive force, or dropping the Cardi/o® Sensor may cause malfunction or permanent damage. • If the Cardi/o Sensor fails to operate, contact your healthcare provider immediately. • Dispose of the Cardi/o® Sensor per local laws, care facility laws or hospital laws for routine/nonhazardous electronic waste.
Product Storage • Storage temperature range: (-15) – 85o C • Storage relative humidity range: 10 – 95% RH System Interoperability The Cardi/o® Remote Patient Monitor is compatible with Sensor devices and software developed with the Cardi/o® Application Programming Interface (API). Please contact Advanced Telesensors Inc. to obtain implementation information, including the Cardi/o® Application Programming Interface (API) Instructions.
CARDI/O® USE INSTRUCTIONS Note: It is recommended that healthcare providers advise users on correct placement of the Cardi/o® Sensor. To collect data the Cardi/o® Sensor must be connected to the Internet. 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 downloaded. Follow Steps 1 through 2.
Step 2.B Positioning Cardi/o® for Long Term Use – wall-mount option See Figure B below for a view of the Cardi/o® Sensor wall placement in relation to patient. The sensor is placed between 6 to 8 feet vertical from the floor facing the bed where the patient spends most of their time at rest. The Sensor device is designed to record physiological data of the patient sitting, laying prone or standing within the Sensor’s 10-foot range and 30º field of view.
Step 3. Accessing Patient Data See Figure D below for five (5) steps to access patient data collected by the Cardi/o® remote monitor system. Figure D represents the top-level navigation screens. After login, navigate between the Patients list, Stats and Settings. Note: Step 1: “Download Phone App is performed once Step 2: “Login to app” may accept biometric fingerprint login if the feature is enabled on the phone.
See Figure E below for five (5) primary steps to navigate patient data collected by the Cardi/o® Sensor. Figure E: Investigate patient data by clicking the respective bars. Access historical data trends for analysis by clicking the down arrow located on the bar of each parameter. Note: Step 1: Displays a patient dashboard Step 2: Click the heart rate bar to view a graph indicating data trending over time. Step 3: Click the respiratory rate bar to view a graph indicating data trending over time.
Personalize Alarm Thresholds via the Cardi/o®Central Dashboard Administrator Portal Adjust the high and low thresholds of the alarm parameters in the Cardi/o®Central Dashboard administrator portal to personalize alert settings for individual patients. Table 1 below indicates the default values for the high and low thresholds for each parameter.
Cardi/o® Sensor Return or Disposal Follow instructions given by your healthcare provider to return the Cardi/o® sensor. If directed to dispose of the Sensor, please observe local laws for disposal of electronic products. Note: The Cardi/o® Sensor is a re-usable device. Use standard sterilization practices before re-issuing the device to another user. The device will need to be reconfigured for WiFi connectivity to the Internet if reissued to a user at a different location.
Product Specifications Measurements Heart Rate Dynamic Range Not available for patients with pacemakers. 20 – 180 Beats Per Minute (BPM) Accuracy tested +/- 2 BPM of 3-lead ECG Respiration Rate Dynamic Range Not available for patients with pacemakers. 0 – 60 breaths per minute (bpm) Accuracy tested +/- 2 BPM of 3-lead ECG Stress ~ Heart Rate Variability (stationary and ambulatory) Dynamic sensing range Not available for patients with pacemakers.
Electromagnetic Emission Declaration The Cardi/o® Sensor is intended for use in the electromagnetic environment specified below. The end user of the device should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment RF emissions CISPR 11 Group 1 The Cardi/o® Sensor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Guidance and Declaration – Electromagnetic Immunity (For ME equipment ME system that are not life-supporting) The Cardi/o® Sensor is intended for use in the electromagnetic environment specified below. The end user of the device should assure that it is used in such an environment. Immunity test Compliance level Electromagnetic environment- guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 8 kV contact ± 15 kV air Floors should be wood, concrete, or ceramic tile.
Recommended separation distance between portable and mobile RF communications equipment and Cardi/o® Sensor. (For ME equipment ME system that are not life-supporting) The Cardi/o® Sensor is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
General Symbols Symbol Title Symbol Title Protected against splashing water Read usage instructions Properly dispose of EEE (Electrical and Electronic Equipment) Non-ionizing radiation Prescription only FCC Marking Manufacturer Manufacture Date YYY-MM-DD Caution, consult documents Not to be used in case package is damaged Catalogue number Batch code Serial number Humidity limits (Storage) 70° Temperature limits (Storage) Contents (Numeral represents quantity of units inside) Underwriter
Document History Revision Description Rev. 01 Initial release of this document. This “Instructions for Use” has been approved by the U.S. Food and Drug Administration. IFU-EUA Rev.
