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
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Version C
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.
FCC Compliance Information
Wearable Sensor and Transmitter devices comply with Part 15 of the Federal Communications Commission (FCC)
Rules – Radio Frequency Devices: Operation is subject to the condition that (1) this device does not cause harmful
interference and (2) this device must accept any interference received, including interference that may cause
undesired operation.
INFORMATION TO THE USER
For Class A and Class B digital devices, information to the user is required to include the following statements
(Section 15.105):
For a Class A digital device or peripheral, the instructions furnished to the user shall include the following or similar
statement, placed in a prominent location in the text of the manual:
NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to
part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference
when the equipment is operated in a commercial environment. This equipment generates, uses,
and can radiate radio
frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct the interference at his own expense.
For a Class B digital device or peripheral, the instructions furnished to the user shall include the following or similar
statement, placed in a prominent location in the text of the manual:
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to
part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interferenc
e in a
residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.