Device Compatibility | Alivecor
Instructions for AliveCor models including: AC-019, KardiaMobile, 6L ECG Device, AC-019 KardiaMobile 6L ECG Device
Instant Analysis indicates normal sinus rhythm, atrial fibrillation, bradycardia, ... DO NOT use alcohol-based or abrasive cleaners and materials as these ...
File Info : application/pdf, 19 Pages, 1.54MB
DocumentDocumentEN
Instructions for Use (IFU) for
KardiaMobile 6L (AC-019)
19LB01.03 November 2020 AliveCor, Inc. 444 Castro Street, Mountain View, CA 94041, USA Obelis s.a Bd. Général Wahis 53 1030 Brussels, Belgium © AliveCor, Inc. 2020
AliveCor is a registered trademark of AliveCor, Inc.
Instructions for Use for KardiaMobile 6L
Table of Contents
Introduction
3
Guide to Parts
3
Warnings
4
Cautions
5
Indications For Use
5
Features & Functionality
5
Setting up your KardiaMobile 6L hardware for the first time
6
Recording a Single-Lead EKG
7
Recording a Six-Lead EKG
7
EKG Analysis
9
Heart Rate
10
Clinical Safety and Performance
10
Environmental Specifications
11
Expected Service Life
11
Maintenance
11
Electromagnetic & Other Interferences
12
FCC Compliance
12
Industry Canada Compliance
12
Ingress Protection Marking
13
Applied Parts
13
Troubleshooting
13
Electrical Safety
15
Equipment Symbols
19
Page 2 of 19
Instructions for Use for KardiaMobile 6L
KardiaMobile 6L
Introduction
1. KardiaMobile 6L is a 3-electrode personal EKG device that records your EKG and wirelessly transmits the data to your smartphone or tablet. a. Contains two electrodes on the top surface, for use with the left and right hands, and one on the bottom surface, for use with the bare skin of the left leg. b. Powered by a replaceable battery located under the bottom electrode. c. Bluetooth wirelessly transmits EKG data to your smartphone or tablet.
2. KardiaMobile 6L is capable of recording two EKG types: a. A Single-Lead EKG: provides a single view of the heart's electrical activity (EKG taken with top two electrodes) b. A Six-Lead EKG: provides six views of the heart's electrical activity (EKG taken using all three electrodes).
3. An instant algorithmic analysis ("Instant Analysis") of your heart rhythm is provided upon completion of your EKG recording. a. Instant Analysis indicates normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, or an unclassified result for both Single-Lead and Six-Lead EKGs.
4. KardiaMobile 6L requires a compatible smartphone or tablet and the Kardia app. a. The list of compatible devices can be viewed at www.alivecor.com/compatibility. b. The Kardia app can be downloaded in the App Store or the Google Play Store.
Guide to Parts
TOP VIEW
Page 3 of 19
Instructions for Use for KardiaMobile 6L
BOTTOM VIEW
Warnings
1. AliveCor does not guarantee that you are not experiencing an arrhythmia or other health conditions with any EKG result, including normal. You should notify your physician for possible changes in your health. DO use this device to record heart rate and heart rhythm only.
2. DO NOT use to diagnose heart- related conditions. 3. DO NOT use to self-diagnose heart related conditions. Consult with your physician before
making any medical decision, including altering your use of any drug or treatment. 4. DO NOT continue use until further instructed by a physician if your skin is irritated or
inflamed around the electrode. 5. AliveCor makes no warranty for any data or information that is collected erroneously by the
device, or misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect, or failure to maintain the products as instructed. Interpretations made by this device are potential findings, not a complete diagnosis of cardiac conditions. All interpretations should be reviewed by a medical professional for clinical decision-making. 6. The device has not been tested for and is not intended for pediatric use. 7. Keep device away from young children. Contents may be harmful if swallowed. Device contains a coin cell battery that is not accessible during normal use but, if exposed, can be a choking hazard and may cause severe tissue injury if ingested. 8. DO NOT replace the battery when device is in use. 9. DO NOT use the electrode on a portion of the body with too much body fat, body hair or very dry skin, as a successful recording may not be possible. 10. DO NOT take a recording while driving or during physical activity. 11. DO NOT store in extremely hot, cold, humid, wet, or bright conditions. 12. DO NOT take a recording if electrodes are dirty. Clean them first. 13. DO NOT use alcohol-based or abrasive cleaners and materials as these products could adversely affect product performance. 14. DO NOT immerse device or expose device to excessive liquid. 15. DO NOT use while charging your phone. 16. DO NOT drop or bump with excessive force. 17. DO NOT expose to strong electromagnetic fields.
Page 4 of 19
Instructions for Use for KardiaMobile 6L
18. DO NOT expose the device to a magnetic resonance (MR) environment. 19. DO NOT use with a cardiac pacemaker, ICDs, or other implanted electronic devices. 20. DO NOT use during cautery and external defibrillation procedures. 21. DO NOT place electrodes in contact with other conductive parts including earth. 22. DO NOT use with un-approved accessories. Use of non-AliveCor approved accessories or
transducers and cables could result in electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation. 23. DO NOT use adjacent to or stacked with other equipment because it could result in improper operation. 24. DO NOT use portable RF communications equipment (including peripherals such as antenna cables and external antennas) closer than 30 cm (12 inches) to any part of the KardiaMobile 6L System. Otherwise, degradation of the performance of the KardiaMobile 6L System could result.
Cautions
1. KardiaMobile 6L does not detect heart attack. 2. DO NOT change your medication without talking to your doctor. 3. Detection of possible Atrial Fibrillation (AF) in your EKG results are not to be used for
diagnosis. If you are experiencing any concerning symptoms, contact your physician. 4. Result of "Bradycardia" or "Tachycardia" are designations of heart rate in the absence of AF,
and are not to be used for diagnosis. Please consult with your physician should you receive consistent identifications of "Bradycardia" or "Tachycardia". 5. "Unreadable" EKG results determines that you didn't have proper EKG recording for analysis. You may try to re-record your EKG.
Indications For Use
The KardiaMobile 6L System is intended to record, store and transfer one- and two-channel electrocardiogram (EKG) rhythms. In single channel mode, the KardiaMobile 6L System can record Lead-I. In two channel mode, the KardiaMobile 6L System can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The KardiaMobile 6L System also displays EKG rhythms and output of EKG analysis from AliveCor's KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. The KardiaMobile 6L System is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and is not intended for pediatric use.
Features & Functionality
KardiaMobile 6L is a 3-electrode personal EKG device that is capable of recording two kinds of EKGs: a Single-Lead EKG and a Six-Lead EKG, which provides more data for you to share with
Page 5 of 19
Instructions for Use for KardiaMobile 6L
your doctor. Both EKG types detect normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and indeterminate results (errors or unclassified rhythms).
KardiaMobile 6L has two electrodes on the top surface and one on the bottom surface. It is powered by a replaceable battery, which is located under the bottom electrode. Bluetooth is used to wirelessly transmit EKG data from the device to your smartphone or tablet.
What is an EKG? Also known as an electrocardiogram, an EKG is a test that detects and records the strength and timing of the electrical activity in your heart. Each heartbeat is triggered by an electrical impulse. Your EKG represents the timing and strength of these impulses as they travel through your heart.
Single-lead EKG A Single-Lead EKG is the simplest way to record your heart rhythm. It measures a single view of the heart. It is taken by laying the device on a flat surface near your smartphone and placing fingers form the left and right hand on the top two electrodes of the device. This is comparable to Lead I on standard EKG machines used in the hospital or doctor's office.
Six-Lead EKG A Six-Lead EKG uses three electrodes to provide information about your heart rhythm from six different viewpoints. It is done by resting the bottom electrode on the bare skin of your left leg (knee or inside of the ankle), and placing fingers from your left and right hand on the top two electrodes. This is comparable to Leads I, II, III, aVF, aVL, and aVR on standard EKG machines used in the hospital or doctor's office.
Setting up your KardiaMobile 6L hardware for the first time
1. Remove your KardiaMobile 6L device from the packaging.
2. Download the Kardia app
from the App Store or Google Play Store.
o Be sure to use a compatible iOS or Android device (check the compatible device list
at www.alivecor.com/compatibility).
3. Make sure Bluetooth is turned on in your smartphone or tablet settings.
4. Launch the Kardia app and tap "Create Account".
5. Follow the on-screen instructions to complete your account setup.
Page 6 of 19
Instructions for Use for KardiaMobile 6L
Recording a Single-Lead EKG
Follow the instructions below to record a Single-Lead EKG. 1. Open the app and tap "Record your EKG". 2. If this is your first time using the KardiaMobile 6L, follow the on-screen instructions to set up and pair your device. 3. Select the Single-Lead EKG option. 4. Lay the device on a flat surface near your smartphone. o Make sure the device is in the correct orientation with the AliveCor "A" facing you.
5. When ready, place two fingers from each hand on the top two electrodes. o There's no need to squeeze or press down firmly.
6. The app will indicate when you have good contact as you begin your recording. 7. Hold still as you watch the timer count down from 30 seconds, until your EKG recording
is complete.
Recording a Six-Lead EKG
Follow the instructions below to record a Six-Lead EKG. 1. Open the app and tap "Record your EKG". 2. If this is your first time using the KardiaMobile 6L, follow the on-screen instructions to set up and pair your device. 3. Select the Six-Lead EKG option. Page 7 of 19
Instructions for Use for KardiaMobile 6L 4. When ready, hold the EKG device with your thumbs touching the top two electrodes. o There's no need to squeeze or press down firmly. o Make sure the device is in the correct orientation with the AliveCor "A" facing you.
5. With your thumbs resting on the top two electrodes, place the EKG device on the bare skin of your left leg (knee or inside of the ankle). o The bottom electrode should contact the skin.
6. The app will indicate when you have good contact as you begin your recording.
7. Hold still as you watch the timer count down from 30 seconds, until your EKG recording is complete.
Page 8 of 19
Instructions for Use for KardiaMobile 6L
EKG Analysis
Upon completion of your EKG recording, KardiaMobile 6L transmits the EKG data to the Kardia mobile app. The EKG is then processed by AliveCor's Instant Analysis algorithms. The app will display your full Single-Lead or Six-Lead EKG and the Instant Analysis result with description.
All possible Instant Analysis results, descriptions, and additional information are displayed in the table below:
Instant Analysis
Description
Additional information
Possible Atrial Fibrillation
Your EKG shows signs of atrial fibrillation.
Kardia does not check for heart attack. If you believe you are having a medical emergency, call emergency services. Do not change your medication without talking to your doctor.
Bradycardia
Your heart rate is less than 50 beats per minute, which is slower than normal for most people.
Kardia does not check for heart attack. If you believe you are having a medical emergency, call emergency services. Do not change your medication without talking to your doctor.
Normal
No rhythm abnormalities detected in your EKG.
Kardia does not check for heart attack. If you believe you are having a medical emergency, call emergency services. Do not change your medication without talking to your doctor.
Tachycardia
Your heart rate is faster than 100 beats per minute. This can be normal with stress or physical activity.
Kardia does not check for heart attack. If you believe you are having a medical emergency, call emergency services. Do not change your medication without talking to your doctor.
No Analysis
Your EKG recording is of insufficient duration. Instant Analysis is not able to provide an analysis on EKG recordings shorter than 30 seconds.
Record a new EKG. Try to relax and hold still, rest your arms, or move to a quiet location that will allow for a full 30 second recording.
Unclassified
Atrial fibrillation was not detected and your EKG does not fall under the algorithmic classifications of Normal, Bradycardia, or Tachycardia. This may be caused by other arrhythmias, unusually fast or slow heart rates, or poor quality recordings.
Kardia does not check for heart attack. If you believe you are having a medical emergency, call emergency services. Do not change your medication without talking to your doctor.
Unreadable
There is too much interference in this recording.
Please re-record the EKG. Try to relax and hold still, rest your arms,
Page 9 of 19
Instructions for Use for KardiaMobile 6L
or move to a quiet location or away from electronics and machinery.
WARNING: After EKG analysis, the app may incorrectly identify ventricular flutter, ventricular bigeminy, and ventricular trigeminy heart conditions as unreadable. Please consult with your physician.
NOTE: All historical EKGs and Instant Analysis results can be viewed, downloaded, and emailed from the "History" section of the Kardia app.
Heart Rate
During your EKG recording, your real-time heart rate will be shown. When reviewing previous EKGs, the average heart rate taken during that recording is displayed.
Heart rate is calculated as the time interval between consecutive heart beats; or more specifically as the inverse of the time interval between consecutive R-waves in your QRS complex. During an EKG recording, the current heart rate is measured from an average of this inverse calculation over the last 5 seconds. For stored EKGs, the average heart rate is the average of this inverse calculation over the entire 30 seconds of the recording.
Clinical Safety and Performance
The performance of the KardiaMobile 6L System for recording a 6-lead EKG was validated in a clinical study. Overall, 44 subjects participated in the study, comprising nearly equal numbers of healthy volunteers and arrhythmia patients. EKG recordings were simultaneously taken by the KardiaMobile 6L and a standard clinical-grade 12-lead EKG device. Qualitative and quantitative analyses of equivalence were performed on the 44 pairs of EKG results.
For qualitative assessment, two board-certified electrophysiologists compared 6-lead EKG rhythm strips acquired from the KardiaMobile 6L device and the corresponding leads from the reference standard 12-lead EKG device for diagnostic equivalence. All paired recordings (100%, n=44 subjects), were deemed equivalent for assessing cardiac arrhythmias by both electrophysiologists. The results of the assessment determined that the subject device records a 6-lead EKG that is qualitatively equivalent to the recordings of corresponding leads from a gold standard 12-lead EKG device.
For quantitative equivalence, median beat cross correlation for Lead I and II and RMS error for all 6 limb leads were computed between the paired EKGs for each subject. This analysis was conducted on the unfiltered EKG output as well as the enhanced filtered (EF) EKG output. KardiaMobile 6L EKGs had a minimum correlation of 0.96 and a maximum RMS error of 47 µV as compared to the corresponding lead of the 12-lead EKG. The results of the quantitative analysis of the EKG recordings further confirmed that the KardiaMobile 6L device EKG has equivalent output to that of the gold standard 12-lead EKG device.
Page 10 of 19
Instructions for Use for KardiaMobile 6L
During this clinical study, no adverse events were observed.
Environmental Specifications
Operational Temperature: Operational Humidity: Storage Temperature: Storage Humidity:
+10°C to +45°C 10% to 95% (non-condensing) 0°C to +40°C 10% to 95% (non-condensing)
Expected Service Life
The expected service life for KardiaMobile 6L is 2 years.
Maintenance
1. No service or repair should be performed on the KardiaMobile 6L hardware other than the maintenance listed in this section.
2. Clean the electrodes by wiping with a soft cloth dampened with water or one of the following approved cleaners: o Soap and water, or o Bleach solution as recommended by the CDC (5 tablespoons bleach per gallon of water OR 4 teaspoons bleach per quart of water) a. To clean, spray the cleaner on a soft cloth and thoroughly wipe the device. b. Ensure the device is sufficiently dried.
WARNING: o DO NOT use alcohol-based or abrasive cleaners and materials as these products could adversely affect product performance. o DO NOT immerse device or expose device to excessive liquid.
3. Exterior Visual Inspection: o Inspect electrodes for warping, surface damage, or corrosion o Check for any other form of damage
4. For battery replacement, AliveCor recommends that you bring your KardiaMobile 6L hardware to a watch repair or hearing-aid repair shop. Battery Type: CR2016 Coin Cell that is IEC 60086-4 compliant Ensure proper orientation of the battery with battery information and (+) terminal facing up
Page 11 of 19
Instructions for Use for KardiaMobile 6L
WARNING: o During replacement, keep device away from young children. Contents may be harmful if swallowed. Device contains a coin cell battery that can be a choking hazard and may cause severe tissue injury if ingested. o DO NOT replace the battery when device is in use.
Electromagnetic & Other Interferences
KardiaMobile 6L has been tested and deemed in conformance with the relevant requirements in IEC 60601-1 -2:2014 Class B for Electromagnetic Compatibility (EMC).
FCC Compliance
FCC ID: 2ASFFAC019
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, and 2. This device must accept any interference received, including interference that may cause
undesired operation.
CAUTION: Changes or modifications not expressly approved by AliveCor could void your authority to use this equipment.
To view FCC information on the Kardia app:
1. On the home screen, tap
to access Kardia app Settings.
2. Tap "About Kardia" to view the FCC ID and other applicable regulatory information.
Industry Canada Compliance
IC ID: 25747-AC019
This device complies with Industry Canada's license-exempt RSSs. Operation is subject to the following two conditions: (1) This device may not cause interference; and
Page 12 of 19
Instructions for Use for KardiaMobile 6L
(2) This device must accept any interference, including interference that may cause undesired operation of the device.
Ingress Protection Marking
KardiaMobile 6L is IP22 rated. KardiaMobile 6L is protected against insertion of fingers and is not affected by vertically dripping water. KardiaMobile 6L has been tested with relevant requirement standard IEC 60601-1-11:2015.
Applied Parts
The 3 electrodes (Left Hand Electrode, Right Hand Electrode, and Left Leg Electrode) are Type CF Applied Parts. Operational temperature of the device is +10°C to +45°C. If ambient temperature exceeds +41°C, Applied Parts can exceed +41°C.
Troubleshooting
If you experience difficulties using your KardiaMobile 6L, refer to the troubleshooting guide below or contact technical support at support@alivecor.com. I'm having trouble getting a clear recording. o Clean the electrodes using a damp soft cloth. Wash your hands with soap and water. Use
a small amount of water to moisten the skin where your fingers make contact with the electrodes. o If recording a Six-Lead EKG, it is important to place device on your left leg (knee or inside of the ankle). The device must be used on bare skin for an accurate recording. o Ensure that your arms, hands and left leg remain still to reduce muscle noise. Do not apply too much pressure to the electrodes. Avoid close proximity to items that may cause electrical interference (electronic equipment, computers, chargers, routers, etc.) If you wear hearing aids, turn them off prior to recording.
Page 13 of 19
Instructions for Use for KardiaMobile 6L
My KardiaMobile 6L is not working. o Make sure Bluetooth is turned on in your smartphone or tablet settings and follow the steps
in "Record a Single-Lead EKG" or "Record a Six-Lead EKG." o If Bluetooth is on, try to un-pair and pair again to your KardiaMobile 6L. If Bluetooth is on and your device is not connecting or pairing it's possible that your battery
needs to be replaced. Follow the "Maintenance" instructions to replace the battery, which is located under the bottom electrode of the device.
I want to take a Six-Lead EKG, but only a Single-Lead EKG appears while recording. o Make sure the Six-Lead EKG option is selected. Ensure that the bottom electrode is touching the skin above your left knee or your left ankle.
The device must be used on bare skin for an accurate recording.
On my EKG, the recording appears upside down. Six-Lead EKG
- Make sure the AliveCor logo is in the correct orientation. - Make sure your thumbs are touching the 2 top electrodes and that the bottom
electrode is touching the skin above your left knee or your left ankle. Single-Lead EKG
- Make sure the AliveCor logo is in the correct orientation. - On the EKG tracing, select the "Invert" option to flip the orientation of the EKG.
Page 14 of 19
Instructions for Use for KardiaMobile 6L
Electrical Safety
Guidance and manufacturer's declaration - electromagnetic emissions
KardiaMobile 6L is intended for use in the electromagnetic environment specified below. The customer or
the user of KardiaMobile 6L should assure that it is used in such an environment.
Emissions test
Compliance Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
KardiaMobile 6L uses RF energy only for its internal function. RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
KardiaMobile 6L is intended for use in domestic surroundings.
Harmonic emissions IEC 61000-3-2
N/A
Voltage fluctuations /
flicker emissions
N/A
KardiaMobile 6L is powered from a lithium coin cell battery and does not require AC mains power.
IEC 61000-3-3
Page 15 of 19
Instructions for Use for KardiaMobile 6L
Guidance and manufacturer's declaration--electromagnetic immunity
KardiaMobile 6L is intended for use in the electromagnetic environment specified below. The customer or
the user of KardiaMobile 6L should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
±2 kV contact
±2 kV contact
Electrostatic Discharge (ESD) IEC 61000-4-2
±4 kV contact ±6 kV contact ±8 kV contact ±2 kV air ±4 kV air ±8 kV air
±4 kV contact ±6 kV contact ±8 kV contact ±2 kV air ±4 kV air ±8 kV air
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
±15 kV air
±15 kV air
Electrical fast
transient/burst
N/A
N/A
IEC 61000-4-4
Surge
IEC 61000-4-5
N/A
N/A
KardiaMobile 6L is powered from
Voltage dips, short
a lithium coin cell battery and
interruptions, and
does not require AC mains power.
voltage variations on power supply
N/A
N/A
input lines
IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Page 16 of 19
Instructions for Use for KardiaMobile 6L
Guidance and manufacturer's declaration--electromagnetic immunity
KardiaMobile 6L is intended for use in the electromagnetic environment specified below. The customer or the user of KardiaMobile 6L should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Complian ce level
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part of KardiaMobile 6L, including cables, than the
recommended separation distance calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
3.5 d = [ ] P < 80MHz
V 1
3.5 d = [ ] P 80 MHz to 800 MHz
E 1
Radiated RF 10 V/m
IEC 61000-4- 80 MHz to
3
2.7 GHz
10 V/m
7 d = [ ] P 800 MHz to 2.7 GHz
E 1
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, a
should be less than the compliance level in each frequency range. b
Interference may occur in the vicinity of
equipment marked with the following symbol:
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
a
Field strength 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 KardiaMobile 6L is used exceeds the applicable RF compliance level
above, KardiaMobile 6L should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating KardiaMobile 6L.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Page 17 of 19
Instructions for Use for KardiaMobile 6L
Recommended separation distances between
portable and mobile RF communications equipment and KardiaMobile 6L
KardiaMobile 6L is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of KardiaMobile 6L can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and KardiaMobile 6L as recommended below, according to
the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output power of transmitter W
m 150 kHz to 80 MHz
3.5 d =[ ] P
V 1
80 MHz to 800 MHz
d = [3.5] P E
1
800 MHz to 2.5 GHz
d =[ 7 ] P E
1
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1--At 80 MHz and 800 MHz, the separation distance for 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.
Page 18 of 19
Instructions for Use for KardiaMobile 6L
Equipment Symbols
These symbols will be used in the packaging and other labeling of the KardiaMobile 6L hardware.
Type CF Applied Part Do not dispose with household waste
Read instructions before use Manufacturer
40
Temperature range Humidity range Model number Serial number
European Authorized Representative
Page 19 of 19