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
56
Version C
Clinician Instructions for Use – Device and Mobile Application
C
Radiated Immunity
Test
IEC 61000-4-3
10 V/m,
frequency
80MHz-2700
MHz
385-5800MHz
PM
18Hz, 217Hz
10 V/m
9-28 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the ADI CPM
System including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommend separation distance
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m). Field strengths from fixed RF
transmitters as determined by an electromagnetic site
survey
3
should be less than the compliance level in each
frequency range
4
. Interference may occur in the vicinity of
equipment marked with the following
Conducted
Immunity Test
IEC 61000-4-6
3 V (0.15 MHz -
80 MHz)
6 V (ISM and
amateur radio
Bands between
0.15 MHz and
80 MHz)
6 V (150
kHz- 80MHz)
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people
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. 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. The monitor is suitable for use in domestic establishments and in
establishments directly connected to the low voltage power supply network which supplies buildings used for domestic
purposes. These limits are designed to provide reasonable protection against harmful interference when the
equipment is operated in a residential 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.
3
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the ADI CPM
System is used exceeds the applicable RF compliance level above, the ADI CPM System should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the ADI CPM System.
4
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.