Use Instructions
Table Of Contents
- GLOSSARY & ACRONYMS
- PART 1. GENERAL SYSTEM INFORMATION
- 2. INDICATIONS AND CONTRAINDICATIONS FOR USE
- 3. WARNINGS AND PRECAUTIONS
- CAUTION
- 6. BASELINE MEASUREMENT PREPARATION AND DEVICE SETUP
- 8. THE ALIGNMENT TOOL
- PART 3. AT-HOME CPM SYSTEM USE
- PART 4. LIGHTS, SOUNDS, AND TROUBLESHOOTING
- 12. CPM DEVICE LIGHTS AND SOUNDS
- 13. BASE STATION INDICATIONS
- 14. BUTTON PRESSES
- 15. GENERAL TROUBLESHOOTING / FAQS
- 15.1 Physician Q&As
- Q: No data from my patient is appearing on the server, but after getting in touch with the patient, they say that they have been taking measurements consistently with no issue and their device is connected to a plugged- in Base Station.
- Q: No size of the CPM Device fits my patient.
- Q: I initiated a patient mode measurement while trying to put the device into Bluetooth pairing mode and now I can’t pair the CPM Device to the Mobile App.
- Q: How do patients get more adhesives when they run out?
- Q: Can the CPM System be used near other electronic or medical equipment such as telephones, televisions, computers, etc.?
- Q: Is data secure when transmitting from the CPM Device to the Mobile App, the Device to the Base Station, or the Base Station to the Cloud platform?
- 15.2 Patient Q&As
- Q: The CPM Device is not lighting up when plugged into the Base Station to charge.
- Q: Nothing happens when I am trying to start a measurement and/or the button is pressed on the CPM Device.
- Q: The device visually does not stick well to my body or is obviously peeling up.
- Q: I lost the clear protective liners for covering the adhesive.
- Q: I pressed the button accidentally/too early and a measurement started before the device was on my body. How do I get the device to stop beeping?
- Q: The CPM Device continues to beep, indicating there are errors, during a measurement.
- Q: Can I shower with the CPM Device or get it wet?
- Q: Can I travel with the CPM System?
- Q: A piece or part broke off the device, base station, or alignment tool.
- Q: What do I do if I think I am having a medical emergency or decompensation event?
- 15.1 Physician Q&As
- PART 5. CLEANING AND MAINTENANCE
- PART 6. SYSTEM SPECIFICATIONS
- PART 7. SYMBOLS GLOSSARY
6
Version C
Clinician Instructions for Use – Device and Mobile Application
C
PART 1. GENERAL SYSTEM INFORMATION
1.
INTRODUCTION
The ADI Cardiopulmonary Management (CPM) System is a non-invasive wearable device that acquires physiological
data and derives parameters associated with the presence and progression of cardiopulmonary conditions. The CPM
System collects, derives, and transmits measurements to a Clinical Care Team daily and with high accuracy, enabling
healthcare providers to more closely monitor patient status and aid in clinical decision making. The CPM System is
not intended to be used as a diagnostic tool. The device is designed for use in outpatient clinics and home settings
and is attached to the body with gentle reusable adhesives for several minutes each day, after which it is placed on a
wireless-enabled Base Station to store and charge the device as well as to transmit data to the secure cloud platform.
The device has the capabilities to measure heart and lung auscultation sounds, thoracic impedance, single lead ECG,
skin temperature and body position. From this, additional parameters are derived and trended.
2.
INDICATIONS AND CONTRAINDICATIONS FOR USE
The ADI At-Home CPM (Cardiopulmonary Management) System is intended for adults undergoing monitoring for
cardiopulmonary conditions under the direction of a licensed medical professional to measure, record, and periodically
transmit physiological data.
The ADI At-Home CPM System monitors, derives, and displays:
•
ECG (Computer generated analysis of potential patient cardiac abnormalities which must be confirmed by a
physician with other relevant clinical information)
•
Heart and Lung Auscultation Sounds
• Skin Temperature
• Thoracic Impedance (including Changes in Thoracic Impedance)
•
Respiration Rate and relative changes in Tidal Volume
•
Heart Rate
•
Diastolic Heart Sounds
• Body Position (including Tilt Angle)
The ADI At-Home CPM System is indicated for patients:
Taking diuretic medication
Living with heart failure
Recovering from a coronary artery disease-related event
Living with Chronic Obstructive Pulmonary Disorder (COPD)
The ADI At-Home CPM System is contraindicated for:
Those patients requiring attended, in-hospital monitoring for life threatening arrhythmias