Lohman Technologies AfibAlert User manual

© Copyright 2016 by Lohman Technologies, LLC –All Rights Reserved
AfibAlert®
Instruction Manual

© Copyright 2016 by Lohman Technologies, LLC –All Rights Reserved
Please read this entire booklet before using the AfibAlert®.
It contains important information on its use.
CAUTION!
This device is contra-indicated for use in combination with pacemakers. Do not use the AfibAlert®if you
have a pacemaker. It will not harm you or the pacemaker, but the pacemaker pulses will negate the
accuracy of the internal AfibAlert®algorithm.
Note: Operation of this device near sources of electromagnetic interference (such as radio
transmitters) may adversely affect the quality of the ECG signal. This device complies with AAMI EC-38
applicable specifications regarding electromagnetic compatibility.
The AfibAlert®is designed to help you and your physician manage your Atrial Fibrillation. It is not a
substitute for medical care. Only your physician can make a conclusive diagnosis of Atrial Fibrillation.
If you are experiencing any symptoms (see page 13), please consult with your physician, or if you feel
you are in immediate danger, call 911 or other emergency personnel immediately.
THIS DEVICE MONITORS FOR ATRIAL FIBRILLATION ONLY. IT WILL NOT
DETECT OTHER POTENTIALLY LIFE THREATENING ARRHYTHMIAS, AND IT IS POSSIBLE THAT OTHER
CARDIAC ARRHYTHMIAS MAY BE PRESENT EVEN IF THE GREEN LIGHT ILLUMINATES. AGAIN, ITS
ONLY PURPOSE IS TO DETECT THE PRESENCE OF ATRIAL FIBRILLATION.
Although the AfibAlert®is highly accurate in the detection of Atrial Fibrillation, certain cardiac
rhythms and electrode contact failure can reduce the accuracy. If you feel you are in Atrial
Fibrillation or are unsure of your symptom, please consult with your physician. It is always best to
take a reading and transmit the data if you are symptomatic. If properly transmitted, your data will
be available if your physician would like to review it at a later date.
The AfibAlert®only monitors for Atrial Fibrillation during the 45-second testing period. It does not
continuously monitor your heart and therefore cannot alert you if Atrial Fibrillation happens at any
other time.
IF YOU FEEL YOU ARE IN IMMEDIATE DANGER, CALL 911 OR OTHER EMERGENCY PERSONNEL
IMMEDIATELY!
Save all packaging materials in the event you must return the AfibAlert®for software updates and/or
exchanges.
IMPORTANT: Stored test data must be sent to your physician for interpretation. This can be done by
either:
a) uploading the data through your computer to an Internet web site (see page 30)
b) transmitting the data over the telephone.
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
ORDER OF A LICENSED HEALTHCARE PROFESSIONAL.

© Copyright 2016 by Lohman Technologies, LLC –All Rights Reserved
TABLE OF CONTENTS
1. INTRODUCTION...................................................................................................................................4
AfibAlert®Physical Features ...................................................................................................................................... 4
AfibAlert®Description and Purpose........................................................................................................................... 5
Indications for Use .................................................................................................................................................... 6
Contra-Indications for Use ........................................................................................................................................ 6
What is Atrial Fibrillation?......................................................................................................................................... 6
Atrial Fibrillation Symptoms...................................................................................................................................... 7
How the AfibAlert®Works ......................................................................................................................................... 7
Operation Summary.................................................................................................................................................. 8
Additional System Features ...................................................................................................................................... 8
2. DATA INTERPRETATION.......................................................................................................................8
3. INSTRUCTIONS FOR USE......................................................................................................................9
What the Lights Mean............................................................................................................................................... 9
Taking a Reading ..................................................................................................................................................... 10
Thumb Electrodes ................................................................................................................................................... 10
Installing the Patient Cable ..................................................................................................................................... 11
Wrist Electrodes...................................................................................................................................................... 11
4. DATA TRANSMISSION........................................................................................................................13
Uploading to the AfibAlert®Web Site Using a USB Connection .............................................................................. 13
Transmitting Using a Standard (Analog) Telephone............................................................................................... 15
5. SOFTWARE UPDATES ........................................................................................................................16
Internet Software Updates ..................................................................................................................................... 16
Mail-In Updates....................................................................................................................................................... 16
Resetting the ECG Data ........................................................................................................................................... 17
6. MAINTENANCE AND SERVICE............................................................................................................18
Handling Precautions .............................................................................................................................................. 18
Batteries.................................................................................................................................................................. 18
Care and Handling of Your Batteries....................................................................................................................... 19
Cleaning the AfibAlert®........................................................................................................................................... 20
Troubleshooting...................................................................................................................................................... 20
Limited Written Warranty....................................................................................................................................... 20
Supplies................................................................................................................................................................... 21
7. SYMBOLS ...........................................................................................................................................21
8. SPECIFICATIONS ................................................................................................................................22
9. CONTACTING SUPPORT.....................................................................................................................24

© Copyright 2016 by Lohman Technologies, LLC –All Rights Reserved
Page 4of 24
1. INTRODUCTION
AfibAlert®Physical Features
1.1 Front View of AfibAlert®
1.2 Rear View of AfibAlert®
1. Left Thumb Electrode –Used for acquiring ECG data from thumbs.
2. YELLOW Light (Circular Arrow Icon) –Lights when the test needs to be repeated due to a poor
connection between your thumb(s) and an electrode(s) or you removed your thumbs before the test
was complete.
3. GREEN Light (Circle with Checkmark Icon) –When lit at end of test, it means that data has been
successfully stored for later transmission. If you are experiencing symptoms (see page 7), you should
transmit your data (see page 13). If there is any question about the seriousness of the symptoms,
call 911. Also lights at end of successful data transmission or web upload.
4. Side Mounted Blue Light –Lights while test is in progress or while transmission of data is in progress.
This is the same as #5.
5. BLUE Light (Clock Icon) –Lights while test is in progress or while transmission of data is in progress.

© Copyright 2016 by Lohman Technologies, LLC –All Rights Reserved
Page 5of 24
6. Right Thumb Electrode –Used for acquiring ECG data from thumbs.
7. Power Button –Activates either data acquisition, data transmission, or to upload data to web site.
8. Heart Rate LCD –Displays your average heart rate in beats per minute (BPM) while your ECG is being
recorded.
9. Patient Cable Connector Port –Electrode cable is plugged into this connector for use with wrist band
electrodes or sticky leads.
10. RED Light (Telephone Icon) –When lit at end of test, call your receiving service and transmit your
data immediately, or upload the data to the web site and contact your physician (see page 13). If
appropriate, the nurse or technologist will contact your physician. Your physician may contact you
and provide further instructions.
11. USB Port –Small end of USB cable is plugged into this connector to connect the AfibAlert® to a
Windows computer.
12. Battery Door –Slides off for inserting or replacing batteries.
13. Speaker –When transmitting data over a phone, place the mouthpiece of the phone over this
speaker.
14. Flash Erase Button –Used for deleting all stored ECG data from device memory.
AfibAlert®Description and Purpose
The AfibAlert®is a cardiac event recorder capable of storing 34, 45-second events, in solid state non-
volatile memory. The AfibAlert®allows patients who have been diagnosed with, or are susceptible to
developing Atrial Fibrillation to take periodic readings with a computerized heart rhythm monitor. The
system was developed for the patient who has been previously diagnosed with Atrial Fibrillation, has a
history of heart bypass, ablation or other cardiac abnormalities, or is taking heart (antiarrhythmic)
medications.
The AfibAlert®can record a single channel of ECG data in two ways: (1) via the two raised thumb
electrodes, or (2) by utilizing the patient cable with wristband or sticky electrodes. In each case, the
patient initiates the recording and the test takes approximately 45 seconds. Immediately following data
acquisition, an internal computer algorithm is used to analyze the patient’s rhythm and the appropriate
LED (light emitting diode) lights signaling what action is needed (see page 9 for description of lights).
If the RED Light illuminates, or concerning symptoms are present, the patient should immediately make
a telephone call to a service provider as specified by their physician and transmit or upload the ECG data
to the receiving personnel or the website. If uploading data to the web site, upload the data and
immediately notify your physician new data has been uploaded.

© Copyright 2016 by Lohman Technologies, LLC –All Rights Reserved
Page 6of 24
Indications for Use
The AfibAlert®is indicated for self-testing by patients who have been diagnosed with, or are susceptible
to developing Atrial Fibrillation and who would like to monitor and record their heart rhythm on an
intermittent basis.
Contra-Indications for Use
This device is contra-indicated (not recommended) for use in combination with pacemakers.
What is Atrial Fibrillation?
We’ve all heard or felt our heart beat, often when lying with our head on a pillow. Most often it is a
steady rhythm, but sometimes there is a noticeable change which may be caused either by a simple
ectopic beat (sometimes called a skipped beat), by Atrial Fibrillation, or a number of other cardiac
arrhythmias.
The heart is a four-chambered mechanical pump that keeps blood circulating throughout the body.
Normally, it beats regularly at 60 to 80 times per minute but does increase with exercise, excitement,
or in response to outside factors.
1.3 A normal heart rhythm
1.4 A heart rhythm experiencing Atrial Fibrillation
A normal heart beat starts as a tiny impulse that originates in the sino-atrial node (S - A node) and as
this pulse spreads throughout the heart, it causes first the upper chambers (atria) to contract and then
the lower (ventricles), forcing blood to flow to the lungs and throughout the body.
This process becomes unreliable when Atrial Fibrillation causes the atria to beat erratically (fibrillate). If
the blood does not flow effectively, it can stagnate and cause clots in the atria. When this occurs, the
patient is at risk of having either a heart attack or stroke. A stroke occurs when one of the formed clots
breaks loose from the atria, lodges in an artery and blocks the blood flow to the brain.
Atrial Fibrillation is a chaotic and rapid beating of the atria (upper chambers of the heart). But no
matter how rapid the atria contract, the lower chambers (the ventricles) tend to respond at will,
although just as chaotically. It is this erratic heart beat that is detected by the computer algorithm
located in the AfibAlert®. If the resulting heart rate exceeds 120 BPM for long periods of time, damage
to the heart muscles can occur.

© Copyright 2016 by Lohman Technologies, LLC –All Rights Reserved
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Important note: Atrial Fibrillation may or may not be accompanied by symptoms. When symptoms
occur, the data should be transmitted to your receiving service, or uploaded to the web site,
regardless of whether the LED is Red or Green.
Atrial Fibrillation Symptoms
While some patients with Atrial Fibrillation are asymptomatic (do not feel symptoms), others can
experience symptoms such as:
•palpitations (heart thumping or skipping)
•shortness of breath
•dizziness, wooziness
•syncope (fainting)
•angina (chest pain)
•fatigue
•cough
•anxiety (severe apprehension or sweating)
•hypotension (low blood pressure)
•pulmonary edema
•congestive heart failure
These are a just a few of the many possible symptoms and is not intended to be a complete list. These
symptoms can also be associated with arrhythmias other than Atrial Fibrillation.
Note: when using the AfibAlert®, do not rely solely on the computer algorithm. While computer
algorithms can be 90%–95% accurate, there is no guarantee that it will detect all episodes, especially
when poor electrode contact causes artifact and algorithm confusion. Therefore, regardless of whether
or not the Red Light illuminates, if you are symptomatic, it is best to transmit or upload your ECG data
for professional review!
How the AfibAlert®Works
The AfibAlert®allows daily or even hourly checks of your heart rhythm. Your physician needs to be
contacted when the Red Light illuminates and/or when you are experiencing concerning symptoms (see
page 7).
The AfibAlert®has 17 memory sectors capable of storing 2 recordings in each sector for a maximum
total of 34 recordings/events. A failed recording (i.e, yellow light) will be stored just like a
successfully completed recording (green or red light). The AfibAlert®memory functions in a
cascading fashion that cycles saved tests through its memory system. When it gets to the maximum
number of events stored before you upload, it will overwrite the first memory slot removing your
first two recordings (i.e. the oldest two recordings on the device).
As each new test is performed, the internal computer algorithm analyzes and stores the data in one
of the memory sectors. As subsequent tests are performed, the oldest data is discarded and the
most recent recordings are saved in memory.
The AfibAlert®can connect with your computer through the USB port to upload the data to a web
site your physician can access (see page 13).

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When used with a cardiology monitoring service, the 5 most recent recordings can be transmitted to
a receiving center for analysis by trained technologists or cardiac nurses. (To view important
information about data interpretation see page 8).
Operation Summary
The AfibAlert®records 45 seconds of your heart rhythm and a computer algorithm analyzes the data.
You have the option of uploading it to the AfibAlert®web site (www.AfibAlert.com) or transmitting the
saved ECG data to a qualified receiving center for your physician’s review (see page 13).
Additional System Features
Patient Cable and Wrist Electrodes are for patients who prefer, have physical limitations, or are unable
to obtain a reading using the thumb electrodes. A patient cable allows the use of wrist electrodes. The
wrist electrodes eliminate the need to press and hold your thumbs to the recorder. (Please see page
11)
Universal Serial Bus (USB) Cable Connection allows the AfibAlert® to be connected to a Windows PC to
upload recordings to the secure AfibAlert® website and download software updates to the device. If
your physician or receiving service would like to use the Internet to review your ECG strips, you can
use the USB cable to connect your device and upload your data to the AfibAlert®web site
(www.AfibAlert.com). Once uploaded, your physician or designated service will be able to (or your
own) review them. For either a physician or receiving center to have direct data access, you must
authorize them to view your uploaded ECG data. To request a physician or receiving center be
provided access to your account, submit a support request with their information from the AfibAlert
application under the Support tab. The AfibAlert®will have periodic software updates to maximize its
effectiveness. This is done by connecting a USB cable (included with purchase) between the AfibAlert®
and your computer. Lohman Technologies will contact you when updates are available. (Please see
page 38 for details.)
The AfibAlert®is capable of storing up to 34 recordings. However, due to analog phone line limitations,
only 5 tests can be sent trans-telephonically. Only the most recent tests (not previously uploaded) will
be sent with each transmission whether you use the USB or trans-telephonic upload method. It is not
recommended to use a cell or smartphone in conjunction with the trans-telephonic upload option.
2. DATA INTERPRETATION
IMPORTANT: Stored test data can be sent to your physician for interpretation. This can be done by
either a) uploading the data through your computer to an Internet web site or b) transmitting the data
over the telephone.
Unlimited uploading of recordings to the AfibAlert®website is included with your purchase for either 1
or 3 years and can be renewed as needed while you are using the device. Additional fees for physician
interpretation may apply. Please consult with your physician regarding interpretation fees. It is the

© Copyright 2016 by Lohman Technologies, LLC –All Rights Reserved
Page 9of 24
patient’s responsibility to verify insurance coverage. Service provider and physician interpretation fees
may not be reimbursable.
Transmitting the data over the phone: Verify with your physician to whom your data should be
transmitted. If your physician’s office is unable to receive your data, you must contract directly with an
independent service provider. Your physician may provide you with the name and phone number of a
service provider. The service provider may charge a fee for this service. Costs may vary among services.
It is the patient’s responsibility to contract directly with the service. A physician interpretation fee may
also apply. It is the patient’s responsibility to verify insurance coverage. Service provider and physician
interpretation fees may not be reimbursable.
ALERT: The AfibAlert®web site is NOT a monitored web site. You must contact your physician
immediately after uploading data to inform them that data has been uploaded for their review.
3. INSTRUCTIONS FOR USE
What the Lights Mean
It is recommended that the AfibAlert®be used indoors. The display may not be visible outdoors or under bright
light conditions. The light and recorder will automatically shut off after 30 seconds.
A RED Light means that Atrial Fibrillation might be present in that particular recording. You should
transmit your data immediately (See page 13). Your physician may contact you and provide further
instructions.
A GREEN Light will illuminate at the end of a test. It means that data has been successfully stored for
later transmission and the algorithm did not detect the likelihood of Atrial Fibrillation being present.
However, if you are experiencing symptoms (see page 7), contact your physician or receiving service
and upload or transmit your data. If there is any question about the seriousness of the symptoms,
call 911. The GREEN Light will also illuminate at the end of a successful data transmission or data
upload to the AfibAlert® web site. (See page 13).
Special note: If the GREEN Light comes on but symptoms are or were present, it is recommended
that you transmit your data for review.
A YELLOW Light means that poor electrode contact was present and the test should be repeated. Be
certain that you are holding the electrodes firmly (though not too firm that it causes tremor)
Consistently poor contact may require a more diligent preparation such as moistening your thumbs
or cleaning your skin with an ECG prep pad or alcohol before application. If you cannot get accurate
readings with the thumb, you may need to use the wrist electrodes. (See page 11).
A BLUE Light will appear while taking the reading. This icon indicates the recorder is acquiring and
analyzing your data. Remember to stay as relaxed as possible during this process. Your heart rate will
appear in the display during the analysis process. Continue with the test until a RED, GREEN or
YELLOW indicator light appears. The BLUE Light will also appear while data is being transmitted (see
page 13).

© Copyright 2016 by Lohman Technologies, LLC –All Rights Reserved
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Taking a Reading
Insert new batteries as described on page 18, if you have not already done so.
There are two methods of taking a reading.
1. Placing your thumbs on the thumb pad electrodes
2. Using the electrode cable and wristband electrodes
The BLUE Light will appear on the front and the top side while taking a reading. This indicates the
recorder is acquiring and analyzing your data. Remember to stay as relaxed and still as possible during
this process.
Note: Three dashes will appear in the LCD display until your heart rate is calculated and displayed. It
takes typically 10 to 15 seconds to before your heart rate will display. Continue to hold your thumbs on
the electrodes. Your heart rate will appear in the display during the analysis process and may fluctuate
during the test. Continue keeping your thumbs on the thumb pad electrodes or the wristbands on until a
RED, GREEN, or YELLOW indicator light appears.
IT IS BEST TO TAKE THE READING IN THE EARLY MORNING, JUST AFTER RISING FROM BED. You must be
at rest while taking the test. Do not take the test during or immediately following exercise. If
subsequent readings are taken during the day, it is best to relax for 5-10 minutes before taking the
test. Watch TV, read a book or just sit and relax. This provides the best opportunity for a high quality
reading.
Using the Thumb Pad Electrodes
Relax for 10 minutes before taking the reading. Sit down or get in a comfortable position so you can
remain motionless while the test is taking place.
1. Turn On the recorder. Press the Black Power button on the right side of the recorder for one second.
The recorder will emit a high-low beep and all five lights will flash once. (If “Lo Bat” appears on
display, or it does not turn on, please replace the batteries as described on page 18.)
3.1 Press the Black Start button to turn on the recorder.
2. Immediately place your thumbs firmly on the electrodes (raised metal tabs). The BLUE Light will
illuminate while the recorder is taking the reading. Three (3) dashes will flash on the LCD display
until your heart rate reading is calculated and displayed. Continue to hold your thumbs on the
electrodes. Your heart rate will appear in the display during the analysis process. KEEP YOUR
THUMBS ON THE ELECTRODES until a RED, GREEN, or YELLOW indicator light appears. This will take
approximately 45 seconds.