ADI CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM Clinician Instructions for Use – Device and Mobile Application DOC #: CFU0001 READ ENTIRE INSTRUCTIONS FOR USE BEFORE OPERATING THE ADI CPM SYSTEM Revision C – March 2021 For assistance operating the CPM System, please contact Analog Devices: One Technology Way PO Box 9106 Norwood, MA 02062 USA (781) 329-4700 (800) 262-5643 DISCLAIMER: Information, operation, specifications, and product appearance may change without notice.
Clinician Instructions for Use – Device and Mobile Application Contents Glossary & Acronyms ................................................................................................................................................................ 4 Part 1. General System Information ................................................................................................................................. 6 1. Introduction ........................................................................
Clinician Instructions for Use – Device and Mobile Application Data Quality: what to look for ................................................................................................................................ 28 7.2 Removing the CPM Device from the body ....................................................................................................... 30 7.3 Charging the CPM Device ..........................................................................................................
Clinician Instructions for Use – Device and Mobile Application GLOSSARY & ACRONYMS ∆Z ADI Alignment Tool Base Station BLE BP HF Clinical Care Team (CCT) CPM CPM System ECG Electronics Housing EMC EU FCC FDA HCP HF HR ICD IEC IP ISO LED MR MRI Packaging PCB PHI PII Position 1/Position 2 RR rTV TI TV Wearable Device Delta Impedance / Change in Impedance from Position 1 to Position 2 Analog Devices, Inc.
Clinician Instructions for Use – Device and Mobile Application WARNING AND PRECAUTION SYMBOLS WARNING This graphic will appear if there is a WARNING. Warnings indicate hazardous situations that could result in serious injury if not avoided. CAUTION This graphic will appear if there is a PRECAUTION. Precautions indicate situations that may result in minor injury to the user or damage to the device if not avoided. IMPORTANT This graphic will appear if there is a MANDATORY ACTION.
Clinician Instructions for Use – Device and Mobile Application 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.
Clinician Instructions for Use – Device and Mobile Application 3. 3.1 WARNINGS AND PRECAUTIONS General WARNING The CPM System is NOT intended to be used as a diagnostic tool. Rather, CPM System outputs are intended to provide insight into how patients are trending. The Clinical Care Team should confirm any CPM System information with other relevant clinical information and analyses. This device is NOT intended to be used as an apnea monitor.
Clinician Instructions for Use – Device and Mobile Application CAUTION The device is NOT meant to be worn between readings. It should be removed immediately following each measurement and returned to the base station. • The CPM System is for prescription use only. Federal law restricts this device to sale by or on the order of licensed practitioners. • Each device is configured for a specific patient.
Clinician Instructions for Use – Device and Mobile Application 3.2 Implant Information WARNING Do NOT place the electrodes of the CPM Device directly on top of implanted devices such as pacemakers, defibrillators, or loop monitors. Do NOT wear the device while externally communicating with implanted devices or external defibrillators. Use with caution if the patient or you have an implant such as a pacemaker or an ICD.
Clinician Instructions for Use – Device and Mobile Application 4. DETAILED DESCRIPTION OF THE SYSTEM The ADI CPM System consists of the following components: ■ ■ ■ 4.1 The measurement hardware that is used by the patient to collect data daily, including ▪ the CPM Device wearable; ▪ the cloud-connected CPM Base Station used to charge and store the device; ▪ Disposable Adhesives which attach the device to the body; ▪ and an Alignment Tool used to repeatably locate the device on the body.
Clinician Instructions for Use – Device and Mobile Application Adhesive Disposables The adhesive disposables attach to the CPM Device with gentle hook and loop material like that found on an infant diaper. The skin-side adhesive is a low-tack medical silicone. Hydrogel material is embedded in the adhesive stack, and these hydrogel areas overlay the metal electrodes on the device to create a robust electrode-skin contact.
Clinician Instructions for Use – Device and Mobile Application Base Station A Base Station is supplied with the CPM System. The Base Station provides a place to store the device and extra adhesive disposables, charges the device, updates the device’s firmware, and uploads collected data to a secure cloud platform.
Clinician Instructions for Use – Device and Mobile Application Cloud Software The Clinical Care Team can view patient reports, compliance, notifications, trends, and derived measurement data via the CPM Cloud Software, accessed via URL link or through your organization’s EMR (depending on system implementation). The Software does not modify the data or control functions of the CPM measurement hardware.
Clinician Instructions for Use – Device and Mobile Application Figure 8. Raw and derived measurements from the CPM Analytics Engine. Thoracic Impedance (TI) Thoracic Impedance, measured in ohms (Ω), has been demonstrated1 to be a surrogate measurement for the fluid content in the thoracic cavity and lungs, with lower values indicating a greater hydration or fluid level and higher values meaning a patient is dryer.
Clinician Instructions for Use – Device and Mobile Application WARNING This device is NOT intended to be used as an apnea monitor. Do not rely on the respiration monitoring function of the device for detection of the cessation of breathing. Respiration Rate/Tidal Volume (RR/TV) This is a metric that computes the ratio of respiration rate and relative tidal volume. An upward trend can indicate an increase in respiration rate and/or a decrease in tidal volume, suggesting a rapid shallow breathing pattern.
Clinician Instructions for Use – Device and Mobile Application NOT DETECTED – Pre-Ventricular Contraction (PVC) WARNING This is NOT a final diagnosis of Atrial Fibrillation or any other cardiac abnormality. A clinician should always confirm the CPM System’s analysis with other relevant clinical information, including a clinical 12-lead ECG if deemed necessary.
Clinician Instructions for Use – Device and Mobile Application CAUTION Thresholds should only be set and/or changed by licensed medical professionals to suit the clinical needs of their patients. Threshold changes apply only to individual patients. 4.5 Device Use and Duration The ADI CPM System is intended for long term (up to one year) once-or-twice daily monitoring.
Clinician Instructions for Use – Device and Mobile Application Figure 9 a-b. Sensor locations of the CPM Device on a) men and b) women. Guidance for Correct Clinician Placement Acoustic sensor (place first): Locate the 5th (for men) or 6th (for women) intercostal space or the area directly below where the breast tissue attaches to the chest wall. You can auscultate this position with a stethoscope for clear heart sounds if desired.
Clinician Instructions for Use – Device and Mobile Application Figure 10. Correct CPM Device placement on men. Figure 11. Correct CPM Device placement on women.
Clinician Instructions for Use – Device and Mobile Application Incorrect CPM Device Placements C Version C 20
Clinician Instructions for Use – Device and Mobile Application IMPORTANT Ensure: • The lateral island does not sit on top of breast tissue. • There is a full adhesive seal around the acoustic sensor. If the sensor peels up, you may have to re-place the device in a slightly different position to accommodate body curvature. • There is no gapping under the sensors of the device. Any gapping is likely to lead to poor electrode contact.
Clinician Instructions for Use – Device and Mobile Application PART 2. IN-CLINIC INSTRUCTIONS FOR USE 5. GETTING STARTED The ADI CPM System packaging contains: 1. CPM Device (packaged in the Base Station) 5. Charging cable and wall adaptor 2. CPM Base Station 6. Locking snaps for CPM device (2) 3. CPM Device alignment tool strap 7. Base Station adjustment plates (5) 4. CPM Device alignment tool housing attachment mechanism 8. Box of 15 adhesive disposables 9. Patient User Manual Figure 12.
Clinician Instructions for Use – Device and Mobile Application 6.2 Preparing the skin IMPORTANT This step ensures good adhesion to the skin and improves data quality. Figure 13. Areas to be trimmed under the CPM Device. • Trim chest hair where the CPM Device adhesive patches contact the body (about a 6” long x 2” wide area at the sternum, under the left nipple, and a 4” long x 2” wide area on the left side of the chest). Trimming may not be needed in all cases.
Clinician Instructions for Use – Device and Mobile Application Figure 15 a-b. CPM Device incorrect sizing that is a) too large and b) too small. 3) Insert the two snaps into the top and bottom of the device as shown. 4) Match the adjusted device size with the appropriate Base Station adjustment plate. One adjustment plate is included for each possible device length. 5) Drop the adjustment plate into the Base Station’s right side well. The sized wearable should now sit snugly inside the Base Station.
Clinician Instructions for Use – Device and Mobile Application 6.4 Pairing the CPM Device to the Mobile App 1) Make sure you are connected to a network and Bluetooth is enabled on the phone with the CPM Mobile Application downloaded. Log into the app. 2) Patients ready for a baseline reading should already be enrolled and searchable in the mobile application. Search for the patient using the filters available on the landing page of the app.
Clinician Instructions for Use – Device and Mobile Application 6) A popup window will list devices in range. Select “Assign Device to Patient” and select the appropriate device from the list using the Device ID printed on the back of the CPM Device. 7) The message “Device assigned and connected!” should display on the screen. IMPORTANT Ensure that the battery charge is greater than 20% before proceeding. 7.
Clinician Instructions for Use – Device and Mobile Application 7.1 Taking a Baseline Reading using the CPM Mobile App 1) Apply the device to the patient as described on page 17: Device Placement and Location. Press down around all sensors to ensure good contact with the skin. 2) Select “Take Reading” and then “Start Reading” in the app. 3) The “pre-screen data check” will now begin. Ensure that the patient is in your desired First Position.
Clinician Instructions for Use – Device and Mobile Application Data Quality: what to look for ECG: No clipping, clean Minimal drift in the baseline of the ECG (fairly flat) Clear QRS complex and T- wave waveform showing characteristics of lead 1 ECG tracing Auscultation Sounds: Heart sounds clearly heard using noise-cancelling headphones with a consistent volume Periodic waveform aligning with heartbeat in ECG No sporadic spikes or flat periods in the waveform Thoracic Impedance:
Clinician Instructions for Use – Device and Mobile Application 6) When Position 1 is complete, review the data and proceed using the “Looks Good Continue” button. 7) Move the patient into your desired Second Position. IMPORTANT The default for Position Two is at least 50 degrees less than Position One. You can override this default by selecting “Skip and Continue” when the tilt error pop-up box appears. 8) Select the “Continue Reading” button and repeat the steps above for the second position.
Clinician Instructions for Use – Device and Mobile Application CAUTION Thresholds changed in the mobile app will only apply to this specific patient and should ONLY be selected by a licensed medical professional. 10) Review and Confirm your Patient’s details and medical information. These will appear on the Web Application if/when completed. When finished, select “Confirm and Save”. 11) The baseline reading is now complete.
Clinician Instructions for Use – Device and Mobile Application 3) Close the lid of the Base Station when the CPM Device is not in use to prevent dust build-up. Before shifting the Base Station, ensure that the magnetic clasp on the front of the Base Station is securely fastened. IMPORTANT Always connect the CPM Device in the Base Station to charge when not in use. Figure 19 a-c. a) Plugging in the Base Station b) The CPM Device charging with LEDs illuminated c) Base Station clasp.. 8.
Clinician Instructions for Use – Device and Mobile Application 3) Once the housing attachment mechanism is in place, push the quick release slider down to lock the component securely in place on the CPM Device. 4) Gently press the protruding bulb of the flexible strap into the patient’s clavicular notch, fitting it comfortably into the bottom of the notch. CAUTION Bruising can occur when the alignment tool is applied with excessive pressure at the base of the clavicular notch.
Clinician Instructions for Use – Device and Mobile Application Figure 20 a-b. Fit of the alignment tool with the CPM Device on a) men and b) women. 8.2 Using the tool 1) Snap the alignment tool onto the CPM Device electronics housing, aligning the two nubs on the alignment tool with the divots on the sides of the electronics housing. Slide the blue quick-release slider down to secure the alignment tool onto the device.
Clinician Instructions for Use – Device and Mobile Application PART 3. AT-HOME CPM SYSTEM USE This section of the Clinician Instructions for use is intended to help you train your patient on how to use their CPM System at home. 9. HOME SETUP IMPORTANT The CPM Device and Base Station should be located near your patient’s place of sleep, on a sturdy table, with the Base Station plugged in and the lid closed when not in use.
Clinician Instructions for Use – Device and Mobile Application Figure 23. Adhesive storage compartment in the Base Station. 10. PATIENT MODE MEASUREMENTS IMPORTANT For best results, take measurements at the same time each day (recommended at morning wake-up). 10.1 Measurement preparation 1) Ensure that the room is quiet (e.g. no talking, no loud machines in the background such as air conditioners, fans, radios, TVs, etc.). 2) The patient should remove their shirt and/or bra to expose the chest.
Clinician Instructions for Use – Device and Mobile Application 1) Once the device is securely adhered to the body, move into the first position (Position One) specified by the clinical care team during the baseline measurement. Press the large blue button on the CPM Device until a small beep is heard, about 2 seconds. 2) The device will start by checking to see if the patient is in the right position and for electrode contact quality for a maximum of 1 minute.
Clinician Instructions for Use – Device and Mobile Application 11. REPLACING THE ADHESIVES ON THE DEVICE IMPORTANT Replace the adhesive patches on the device… Every week, OR After more than 5 uses, OR When the device no longer adheres well enough to the skin to complete a measurement, OR When significant dirt, lint, hair, or dust is visible on the skin-side adhesive.
Clinician Instructions for Use – Device and Mobile Application 1) Gently pull the non-adhesive tabs on the used adhesive on the two islands to separate them from the from the device. 2) Also remove the small disc-shaped adhesive from the acoustic sensor using the blue tab. Discard the three pieces of used adhesive disposables in the trash. Remove and throw away the old clear liners (2) from the Base Station as well, if they are still seated inside.
Clinician Instructions for Use – Device and Mobile Application PART 4. LIGHTS, SOUNDS, AND TROUBLESHOOTING Figure 24. Locations of the light bar on the CPM Device and Base Station LEDs. 12. CPM DEVICE LIGHTS AND SOUNDS The CPM Device is equipped with a LED light bar on the electronics housing below the blue button. The device also has a speaker which will play tones as indicated below during certain device events. 12.
Clinician Instructions for Use – Device and Mobile Application 12.2 Battery and Charging When the CPM Device is plugged into the Base Station to charge, the LED bar will “breathe” green. To get a sense of the charge of the device when it is NOT plugged into the Base Station, tap the blue button on the device and it will blink green, yellow, or red depending on device charge as shown below. The light will blink twice and then stay on for 5 seconds to indicate the charge.
Clinician Instructions for Use – Device and Mobile Application 12.3 Notifications and alerts during a measurement Description Sounds Actions Description Sounds Active reading is taking place CPM Device is currently recording data. A tone will play every 5 seconds. Move to the next position Error resolved / measurement position beginning / measurement complete Single note every 5 seconds Remain still and quiet for the duration of the measurement and do not touch the sensors.
Clinician Instructions for Use – Device and Mobile Application 12.4 Errors Description Actions 13. Critical Device Error Malfunction or needs reset Connect the device to the Base Station and contact the clinical care team or logistics partner for support or replacement device BASE STATION INDICATIONS The CPM Base Station has three embedded multicolored LEDs. They are labeled on the Base Station as follows below, with the LEDs at the left of the label.
Clinician Instructions for Use – Device and Mobile Application Power When the Base Station is plugged into an electrical wall outlet, the power LED will illuminate green indicating that the Base Station is powered. If it is not powered, all LEDs will be off. Cellular Signal This light may take up to a minute to illuminate after the Base Station is powered as signal is being acquired.
Clinician Instructions for Use – Device and Mobile Application Press the button for 1-3 seconds (a small beep will sound) and then release. Ensure the device is on the body before initiating a measurement. RESET DEVICE If the device stops functioning as expected, you can reset the device. Use a paperclip in the pinhole on the back of housing of the CPM Device. The device should shut off and then reboot after a few seconds. 15. GENERAL TROUBLESHOOTING / FAQS 15.
Clinician Instructions for Use – Device and Mobile Application Q: No size of the CPM Device fits my patient. A: Your patient may be outside the range of body types that the CPM Device was designed for. This device was designed to accommodate about 95% of the population, but very large or very small people, or those with large breasts, may not be able to wear the device.
Clinician Instructions for Use – Device and Mobile Application device is charging. If it is red, it is NOT yet ready to take a measurement, and you should continue to charge the device until the LED bar is yellow or green. Q: The device visually does not stick well to my body or is obviously peeling up. A: For men: The CPM Device is not intended to be used on patients with a large amount of chest hair – men that do have chest hair may need to trim in the area of the device.
Clinician Instructions for Use – Device and Mobile Application A: The CPM System is designed to be surface-cleanable using an alcohol wipe or damp cloth. This device is NOT meant to be used in the shower or any other very wet environment. Q: Can I travel with the CPM System? A: Traveling with the CPM System is encouraged, especially if you are travelling for a longer period of time. There is a leather strap on the CPM Base Station to allow patients to easily carry the Device inside the Base Station.
Clinician Instructions for Use – Device and Mobile Application PART 5. CLEANING AND MAINTENANCE OF THE SYSTEM 16. CLEANING Cleaning is recommended after every several uses of the CPM Device. Gentle cleansers can be used to clean the Base Station, Device, and Alignment Tool as follows: In the clinic Wipe any exposed surfaces of the CPM Device, Base Station, or Alignment Tool with isopropyl alcohol or alcohol prep pads to clean the device and/or remove any dirt, stains, lint, etc.
Clinician Instructions for Use – Device and Mobile Application 17. ADHESIVE DISPOSAL The CPM System Adhesive disposables can be disposed of after they are used in normal residential conditions (e.g. home garbage cans). Do NOT dispose of the CPM Device or Base Station at home. CPM Adhesives must be used by their use-by date listed on the packaging. 18. MAINTENANCE AND RETURN OF THE SYSTEM No maintenance on the part of the user is required for this device.
Clinician Instructions for Use – Device and Mobile Application PART 6. SYSTEM SPECIFICATIONS 19. TECHNICAL SPECIFICATIONS MEASUREMENT PARAMETERS Impedance Range: 50 – 250 Ohms Accuracy: 0.
Clinician Instructions for Use – Device and Mobile Application ELECTRICAL (POWER) REQUIREMENTS Wearable Max Power Consumption: 150 mW Nominal Power Consumption: 0.4 mW Battery Type: Li-Ion Polymer Battery, HCP - 451223 Nominal Rating: 3.7 V, 85 mAh Max Rating: 3.96 V, 90 mAh Base Station Max Power Consumption: 5W Nominal Power Consumption: 1W Base Station Charger Part Number: CUI-SWM12-5 Series Max Power Consumption: 12 W Nominal Power Consumption: 0.1 W Adaptor Type: Barrel Plug (2.
Clinician Instructions for Use – Device and Mobile Application DIMENSIONS Wearable Width: 10.75 in Height: 8.5 in Depth: 1.25 in (at electronics housing) Weight: 100g Base Station Width: 14.5 in Height: 11.25 in Depth: 2 in Weight: 3.
Clinician Instructions for Use – Device and Mobile Application Adhesive Storage Conditions Temperature: 10 – 27 °C Relative Humidity: 40 - 60 % Pressure: 500 -1060 hPa Shipping and Transport Conditions Temperature: -30 – 60 °C Relative Humidity: 5 - 93 % Pressure: 700 -1060 hPa Other Specifications Wearable Shelf Life: 6 months Base Station Shelf Life: 6 months Adhesive Shelf Life: 6 months CPM System Operating Life: 1 year Wearable Battery Life Expectancy: > 80% after 500 charge-discha
Clinician Instructions for Use – Device and Mobile Application IEC 62133-2 BS EN 60601-1-6 BS EN ISO 10993-10 EN ISO 10993-5 ANSI AAMI EC57 AAMI TIR69 ISO 27000-1 ISO 14117 AAMI/ANSI/IEC 62304 Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems Medical Electrical Equipment.
Clinician Instructions for Use – Device and Mobile Application The ADI CPM system is intended for use in the electromagnetic environment specified below. The customer or user of the ADI CPM system should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions Class B The ADI CPM system uses RF energy only for its internal CISPR11 function.
Clinician Instructions for Use – Device and Mobile Application Radiated Immunity Test IEC 61000-4-3 Conducted Immunity Test IEC 61000-4-6 10 V/m, frequency 80MHz-2700 MHz 10 V/m 385-5800MHz PM 18Hz, 217Hz 3 V (0.15 MHz 80 MHz) 9-28 V/m 6 V (ISM and amateur radio Bands between 0.
Clinician Instructions for Use – Device and Mobile Application PART 7.
Clinician Instructions for Use – Device and Mobile Application General Mandatory Action Sign Refer to Instruction Manual FCC ID (7 to 25 characters in length) Batch Code Wireless Transmission Symbol Upper and Lower Temperature Limits Keep away from rain Keep away from sunlight Use-by Date Protect from heat and radioactive elements Do not use if package is damaged Non-sterile Humidity limitations Atmospheric pressure limitations Fragile, handle with care Do not dispose of in trash C Version C 58
Clinician Instructions for Use – Device and Mobile Application PART 8. FCC Compliance Statement (USA) I. BASE STATION FCC ID: 2AZELADCP1P0BS Compliance Statements: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference. 2. This device must accept any interference received, including, an interference that may cause undesired operation.
Clinician Instructions for Use – Device and Mobile Application Warnings & Cautions • Patients with implants such as pacemakers or defibrillators should use caution to maintain a distance of at least 8 inches or 20 centimeters away from the CPM Base Station at all times when it is plugged in. Failure to do so could result in an unintended shock or malfunction of your implant.
Clinician Instructions for Use – Device and Mobile Application II. WEARABLE DEVICE FCC ID: 2AZELADCP1P0WB Compliance Statements: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference. 2. This device must accept any interference received, including, an interference that may cause undesired operation.
Clinician Instructions for Use – Device and Mobile Application Note: RF exposure evaluation for CPM wearable is performed for considering separation distance of 5mm from transmitter antenna. The RF exposure evaluation meets the SAR exclusion limits specified in clause 4.3.
