CompleteTM
Blood Pressure Monitor + EKG
Model BP7900
Instruction Manual
4602711-0B
Table of Contents
Introduction ............................................................................ |
2 |
10. Maintenance ..................................................................... |
47 |
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Safety Instructions.................................................................... |
2 |
10.1 Maintenance................................................................... |
47 |
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Intended Use ............................................................................ |
3 |
10.2 Storage........................................................................... |
47 |
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Receiving and Inspection ......................................................... |
3 |
10.3 Cleaning ......................................................................... |
48 |
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Symbols Glossary |
3 |
10.4 Disposal ......................................................................... |
48 |
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11. Optional Accessories |
49 |
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Important Safety Information ................................................ |
4 |
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1. |
Know Your Monitor ........................................................... |
9 |
12. Specifications .................................................................. |
50 |
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1.1 |
Contents........................................................................... |
9 |
13. FCC Statement ................................................................. |
53 |
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1.2 |
Monitor and Arm Cuff ....................................................... |
9 |
14. Limited Warranty ............................................................. |
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1.3 |
BP Reading Display and Symbols on the Monitor ......... |
10 |
15. Guidance and Manufacturer’s Declaration.................... |
55 |
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1.4 |
Classification of BP (Blood Pressure) ............................ |
12 |
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1.5 |
Reading Your EKG Result ............................................. |
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1.6 |
Distinction between Pulse Rate and Heart Rate ............ |
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2. |
Preparation ...................................................................... |
18 |
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2.1 |
Installing Batteries.......................................................... |
18 |
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2.2 |
Pairing Your Monitor with a Smartphone ....................... |
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2.3 |
Blood Pressure Measurement/EKG Recording Tips...... |
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3. |
Taking a Blood Pressure Measurement |
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and Recording an EKG ................................................... |
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3.1 |
Applying the Arm Cuff .................................................... |
24 |
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3.2 |
Sitting Correctly.............................................................. |
26 |
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3.3 |
Taking a Blood Pressure Measurement |
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and Recording an EKG .................................................. |
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4. |
Taking Only a Blood Pressure Measurement ............... |
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5. |
Recording Only an EKG.................................................. |
35 |
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6. |
Transfer Your Blood Pressure Readings Manually...... |
38 |
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7. |
Taking a Blood Pressure Measurement Manually........ |
39 |
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8. |
Other Settings on the Monitor........................................ |
40 |
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8.1 |
Disabling/Enabling Bluetooth ......................................... |
40 |
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8.2 |
Restoring Your Monitor to the Default Settings.............. |
41 |
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9. |
Error Messages and Troubleshooting........................... |
42 |
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1
Introduction
Thank you for purchasing the OMRON BP7900 Blood Pressure Monitor + EKG.
This monitor has 2 main features; a blood pressure measurement and an electrocardiogram (EKG or ECG) recording. There are 3 ways to use this monitor: measuring blood pressure only; EKG only; blood pressure and EKG simultaneously. Visit the “Support” section in the “OMRON connect US/CAN” app for additional information about using the app.
Blood pressure measurement
This monitor uses the oscillometric method of blood pressure measurement. This means this monitor detects your blood movement through your brachial artery and converts the movements into a digital reading.
Electrocardiogram (EKG or ECG) recording
This model also has a clinical-quality EKG recorder which allows users to record and display EKGs on their smartphones with the “OMRON connect US/CAN” app.
The “OMRON connect US/CAN” app also provides instant analysis of the recorded EKG to evaluate whether the heart rhythm is normal or if possible atrial fibrillation, bradycardia and tachycardia are detected.
EKG software and services powered by AliveCor
Safety Instructions
This instruction manual provides you with important information about the OMRON BP7900 Blood Pressure Monitor + EKG. To ensure the safe and proper use of this monitor, READ and UNDERSTAND all of the safety and operating instructions. If you do not understand these instructions or have any questions, contact 1-800-634-4350 before attempting to use this monitor. For specific information about your own blood pressure and heart related conditions, consult with your physician.
2
Introduction
Intended Use
The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously.
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population.
The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and detects the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm (when prescribed or used under the care of a physician). The device 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 it is not intended for pediatric use.
Receiving and Inspection
Remove this monitor and other components from the packaging and inspect for damage. If this monitor or any other components are damaged, DO NOT USE and contact 1-800-634-4350.
Symbols Glossary
For symbol information, visit: OmronHealthcare.com/symbols-glossary
Contraindications
•This monitor is contraindicated for use in ambulatory environments.
•This monitor is contraindicated for use on aircraft.
3
Important Safety Information
Read the Important Safety Information in this instruction manual before using this monitor.
Follow this instruction manual thoroughly for your safety.
Keep for future reference. For specific information about your own blood pressure and heart related conditions, CONSULT WITH YOUR PHYSICIAN.
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Warning |
Indicates a potentially hazardous situation which, if not avoided, could result in death or |
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serious injury. |
•DO NOT use this monitor on infants, toddlers, children or persons who cannot express themselves.
•DO NOT adjust medication based on readings from this blood pressure monitor and/or EKG recordings. Take medication as prescribed by your physician. ONLY a physician is qualified to diagnose and treat high blood pressure and other heart related conditions.
•DO NOT use this monitor on an injured arm/fingers or an arm/fingers under medical treatment.
•DO NOT apply the arm cuff on your arm while on an intravenous drip or blood transfusion.
•DO NOT use this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners. This may result in incorrect operation of the monitor and/or cause an inaccurate blood pressure readings and/or EKG recordings.
•DO NOT use this monitor in oxygen rich environments or near flammable gas.
•Consult with your physician before using this monitor if you have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or renal disease.
NOTE that any of these conditions in addition to patient motion, trembling, or shivering may affect the blood pressure readings and/or EKG recordings.
•NEVER diagnose or treat yourself based on your blood pressure readings and/or EKG recordings. ALWAYS consult with your physician.
•To help avoid strangulation, keep the air tube away from infants, toddlers or children.
•Keep components out of the reach of infants, toddlers or children.
This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers or children.
•DO NOT record an EKG with a cardiac pacemaker, Implantable Cardioverter Defibrillators, or other implanted electronic devices.
4
Important Safety Information
Data Transmission
•This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in locations where RF is restricted, such as on an aircraft or in hospitals.
Turn off the Bluetooth® feature in this monitor and remove batteries when in RF restricted areas. For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC.
Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers or children.
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Caution |
Indicates a potentially hazardous situation which, if not avoided, may result in minor or |
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moderate injury to the user or patient, or cause damage to the equipment or other property. |
•Stop using this monitor and consult with your physician if you experience skin irritation or discomfort.
•Consult with your physician before using this monitor on an arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because of temporary interference to blood flow which could result in injury.
•Consult with your physician before using this monitor if you have had a mastectomy.
•Consult with your physician before using this monitor if you have severe blood flow problems or blood disorders as cuff inflation can cause bruising.
•DO NOT take blood pressure measurements more often than necessary because bruising, due to blood flow interference, may occur.
•ONLY inflate the arm cuff when it is applied on your upper arm.
•Remove the arm cuff if it does not start deflating during a blood pressure measurement.
•DO NOT use this monitor for any purpose other than measuring blood pressure, heart rate and heart rhythm.
•During a blood pressure measurement and/or an EKG recording, make sure that no mobile device or any other electrical device that emits electromagnetic fields, other than the smartphone to be used with the monitor, is within 12 inches (30 cm) of this monitor. This may result in incorrect operation of the monitor and/or cause inaccurate blood pressure readings and/or EKG recordings.
•DO NOT disassemble or attempt to repair this monitor or other components. This may cause inaccurate blood pressure readings and/or EKG recordings.
5
Important Safety Information
•DO NOT use in a location where there is moisture or a risk of water splashing this monitor. This may damage this monitor.
•DO NOT use this monitor in a moving vehicle such as a car or during physical activity.
•DO NOT drop or subject this monitor to strong shocks or vibrations.
•DO NOT use or store this monitor in places with high or low humidity, high or low temperatures or in bright and sunny environments. Refer to section 12.
•Ensure this monitor is not impairing blood circulation by observing the arm while blood pressure measurement is occurring.
•DO NOT use this monitor in high-use environments such as medical clinics or physician offices.
•DO NOT use this monitor with other medical electrical (ME) equipment simultaneously. This may result in incorrect operation of the monitor and/or cause an inaccurate blood pressure readings and/or EKG recordings.
•Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for at least 30 minutes before taking a blood pressure measurement.
•Rest for at least 5 minutes before taking a blood pressure measurement.
•Remove tight-fitting and thick clothing from your arm while taking a blood pressure measurement.
•Remain still and DO NOT talk while taking a blood pressure measurement.
•Remain still while recording an EKG.
•ONLY use the arm cuff on persons whose arm circumference is within the specified range of the cuff.
•Ensure that this monitor has acclimated to room temperature before taking a blood pressure measurement and/or recording an EKG. Taking a blood pressure measurement and/or recording an EKG after an extreme temperature change could lead to an inaccurate blood pressure readings and/or EKG recordings. OMRON recommends waiting for approximately 2 hours for the monitor to warm up or cool down when the monitor is used in an environment within the temperature specified as operating conditions after it is stored either at the maximum or at the minimum storage temperature. For additional information of operating and storage/transport temperature, refer to section 12.
•DO NOT use this monitor after the durable period has ended. Refer to section 12.
•DO NOT crease the arm cuff or the air tube excessively.
•DO NOT fold or kink the air tube while taking a blood pressure measurement. This may cause an injury by interrupting blood flow.
•To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself.
•ONLY use the approved arm cuff for this monitor. Use of other arm cuffs may result in incorrect blood pressure readings.
6
Important Safety Information
•Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied. NOTE: please refer to section 7 for taking a blood pressure measurement manually.
•ONLY use the arm cuff, batteries and accessories specified for this monitor. Use of unsupported arm cuffs and batteries may damage and/or may be hazardous to this monitor.
•The use of accessories and cables other than those specified or provided by OMRON could result in increased electromagnetic emission or decreased electromagnetic immunity of the monitor and result in improper operation.
•During a blood pressure measurement and/or an EKG recording, the use of the monitor adjacent to or stacked with another device, other than the smartphone to be used with the monitor, should be avoided because it could result in improper operation. In case such use is necessary, the monitor and the other device should be observed to verify that they are operating normally.
•OMRON makes no warranty for any data or information that is collected erroneously by the monitor, or misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect, or failure to maintain the product as instructed.
•Interpretations made by this monitor are potential findings, not a complete diagnosis of cardiac conditions. All interpretations should be reviewed by a medical professional for clinical decision-making.
•DO NOT use this monitor in the presence of flammable anesthetics or drugs.
•DO NOT expose this monitor to strong electromagnetic fields.
•DO NOT use this monitor while charging your smartphone.
•DO NOT record an EKG during cautery and external defibrillation procedures.
•DO NOT record an EKG in close vicinity to other equipment emitting acoustic sound.
•DO NOT record an EKG if the electrodes are dirty. Clean them first.
•After EKG analysis, the app may incorrectly identify ventricular flutter, ventricular bigeminy, and ventricular rigeminy heart conditions as unreadable. Consult with your physician.
•OMRON does not guarantee that you are not experiencing an arrhythmia or other health conditions when labeling an EKG as normal. You should notify your physician for possible changes in your health.
•If the “OMRON connect US/CAN” app detects possible atrial fibrillation in an EKG, consult with your physician before making any medical decision, including altering your use of any drug or treatment.
•The atrial fibrillation detector evaluates for possible atrial fibrillation ONLY. It will NOT detect other potentially life threatening arrhythmias, and it is possible that other cardiac arrhythmias may be present.
7
Important Safety Information
•The atrial fibrillation detector ONLY evaluates for possible atrial fibrillation after you have recorded an EKG. It does NOT continuously monitor your heart and therefore cannot alert you if atrial fibrillation happens at any other time.
•Result of “Bradycardia” or “Tachycardia” are designations of heart rate, not a clinical diagnosis of an actual arrhythmia. Consult with your physician.
•When your fingertips are dry, your EKG recording may not be successful. If dry, moisten your fingers with a wet towel, a waterbased lotion, or something similar.
•DO NOT record an EKG with dirty hands.
•Make sure to place your smartphone on the smartphone stand of the monitor when recording an EKG. If it is not placed appropriately on the smartphone stand, there may be communication issues between the smartphone and the monitor, and your EKG may not be recorded successfully.
•The EKG electrodes should not touch any other conductive parts.
•If you wear hearing aids, turn them off.
Data Transmission
•DO NOT replace batteries while your blood pressure readings are being transferred to your smartphone. This may result in incorrect operation of this monitor and failure to transfer your blood pressure readings.
Battery Handling and Usage
• DO NOT insert batteries with their polarities incorrectly aligned.
• ONLY use 4 “AA” alkaline batteries with this monitor. DO NOT use other types of batteries. DO NOT use new and used batteries together. DO NOT use different brands of batteries together.
• Remove batteries if this monitor will not be used for 3 months or more.
• If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Consult with your physician immediately.
• If battery fluid should get on your skin, wash your skin immediately with plenty of clean, lukewarm water. If irritation, injury or pain persists, consult with your physician.
• DO NOT use batteries after their expiration date.
• Periodically check batteries to ensure they are in good working condition.
• Make sure the battery compartment is securely closed with the battery cover when recording an EKG. If the battery cover is
not in place, recording an EKG may not be successful. If you have lost the battery cover, contact customer service.
8
1. Know Your Monitor
1.1 Contents
Monitor, Wide-Range D-Ring Cuff, storage case, 4 “AA” alkaline batteries, instruction manual, quick start guide.
1.2 Monitor and Arm Cuff
aSmartphone stand
bTop electrodes
cSide electrode (both sides)
d[Connection] button
eBP reading display*
f BP [START/STOP] button*
gBattery compartment
hAir jack
iArm cuff
(Arm circumference 9" - 17" (22 - 42 cm))
jAir plug
k Air tube
*BP indicates blood pressure.
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1.Know Your Monitor
1.3BP Reading Display and Symbols on the Monitor
A B
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G H I J |
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Heartbeat symbol |
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A |
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Flashes while taking a blood pressure measurement. |
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Movement error symbol
BAppears along with a blood pressure reading when your body is moving during a blood pressure measurement. If it appears, remove the arm cuff, and wait for 2 to 3 minutes. Then, remain still and take another measurement.
Deflation symbol
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Appears during cuff deflation. |
DSystolic blood pressure reading
EDiastolic blood pressure reading Pulse display
FPulse rate appears after the blood pressure measurement.
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OK symbol |
G |
Flashes when your monitor is connected to your smartphone or readings are transferred successfully. |
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1. Know Your Monitor
Bluetooth ON symbol
Appears when your readings are being transferred.
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Bluetooth OFF symbol |
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Appears when Bluetooth is disabled. |
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Sync symbol
Flashes/appears when your data needs to be transferred because the internal stored blood pressure memory is either
Ialmost, or completely full. Once you pair your monitor with your smartphone, transfer your blood pressure readings immediately before the monitor deletes the oldest blood pressure readings. Up to 90 blood pressure readings can be stored in the internal memory of your monitor.
Low battery symbol
Appears when batteries are low.
J |
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Depleted battery symbol |
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Appears when batteries are depleted. |
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11
1.Know Your Monitor
1.4Classification of BP (Blood Pressure)
ACC/AHA 2017 Hypertension guidelines defines categories of BP in adults as below.
Categories of BP in Adults*
BP Category |
Systolic BP |
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Diastolic BP |
Normal |
<120 mmHg |
and |
<80 mmHg |
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Elevated |
120 - 129 mmHg |
and |
<80 mmHg |
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Hypertension |
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Stage 1 |
130 - 139 mmHg |
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80 - 89 mmHg |
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Stage 2 |
≥140 mmHg |
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≥90 mmHg |
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* Individuals with Systolic BP and Diastolic BP in 2 categories should be designated to the higher BP category. BP indicates blood pressure (based on an average of ≥2 careful readings obtained on ≥2 occasions).
Source: ACC/AHA 2017 High Blood Pressure Clinical Practice Guideline
Warning
• NEVER diagnose or treat yourself based on your blood pressure readings and/or EKG recordings. ALWAYS consult with your physician.
12
1. Know Your Monitor
1.5 Reading Your EKG Result
When the EKG recording is finished, the results are displayed on the downloaded “OMRON connect US/CAN” app as: Possible Atrial Fibrillation (or AFib), Bradycardia, Tachycardia, Normal, Unreadable or Unclassified.
The detectors of EKG have been developed and tested on Lead I recordings only.
Note
• You must download and follow up instructions for setting up the app.
Atrial Fibrillation detector
The Atrial Fibrillation detector detects possible atrial fibrillation in an EKG tracing. After you record an EKG, if possible atrial fibrillation is detected you will be notified as Possible Atrial Fibrillation (or AFib) within the app. This finding is not a diagnosis, it is only a potential finding for the recorded EKG. You should contact your physician to review any EKG recording in which possible atrial fibrillation was detected. If you are experiencing any symptoms or concerns contact a medical professional.
Atrial fibrillation means the most common type of non-sinus tachyarrhythmia. In atrial fibrillation, disorganized electrical impulses that originate in the atria and pulmonary veins initiate the electrical activity in the conduction system of the heart. This causes what are commonly termed as “irregularly irregular” heart beats.
When a heart is in atrial fibrillation, its two upper chambers, the right and left atria, essentially quiver instead of beating efficiently.
This does not allow for complete emptying of the atria and thus blood may become stagnant and create blood clots. This can lead to major health problems, including strokes, transient ischemic attacks (TIAs), and pulmonary emboli (PEs); depending which chamber of the heart has the blood clot in it.
Approximately 15 percent of strokes occur in people with atrial fibrillation. As age increases in a population, so too does the incidence of atrial fibrillation, which peaks at about 3-5 % in people over the age of 65.
The most common presenting symptoms of atrial fibrillation are palpitations, dizziness, fast heart rate, irregularly irregular rhythm, an abnormal heart sound (S1), chest pain, chronic shortness of breath, abnormal jugular venous pressure,
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1. Know Your Monitor
fatigue, and impaired exercise tolerance. Other symptoms related to TIAs and strokes may be the initial symptoms of atrial fibrillation.
Some of the most common causes of atrial fibrillation are long-standing hypertension, congestive heart disease, cardiac valvular lesions, myocardial infarctions, history of coronary artery bypass grafts, hyperthyroidism, alcohol abuse, smoking, diabetes mellitus, and electrolyte imbalances.
Bradycardia detector
Bradycardia detector detects bradycardia, in an EKG tracing.
After you record an EKG, if bradycardia is detected you will be notified as Bradycardia within the app.
Bradycardia means a type of arrhythmia due to slower heart rate (40-50 beats per minute). The app analyzes EKGs to detect normal sinus rhythm without major abnormalities between 40-50 beats per minute.
Tachycardia detector
Tachycardia detector detects tachycardia, in an EKG tracing.
After you record an EKG, if tachycardia is detected you will be notified as Tachycardia within the app.
Tachycardia means a type of arrhythmia due to faster heart rate (100-140 beats per minute). The app detects normal sinus rhythm without major abnormalities at these heart rates.
Normal detector
Normal detector notifies you as Normal within the app, when a EKG recording is normal.
Normal means that the heart rate is between 50 and 100 beats per minute, there are no or very few abnormal beats, and the shape, timing and duration of each beat is considered normal sinus rhythm. It is important to remember that there is a wide range of normal variability among different individuals. Changes in the shape or timing of an EKG might be normal for a single individual, but since the apps are used by a large and diverse population, the Normal detector has been
14 designed to be conservative with what it detects as normal.
1. Know Your Monitor
If you have been diagnosed with a condition that affects the shape of your EKG (e.g., intraventricular conduction delay, left or right bundle branch block, Wolff-Parkinson-White Syndrome, etc.), experience a large number of premature ventricular or atrial contractions (PVC and PAC), are experiencing an arrhythmia, or took a poor-quality recording it is unlikely that you will be notified that your EKG is normal.
It is also important to note that the Normal detector looks at the entire signal before determining if it can be declared to be normal. If you experience a small number of PACs or PVCs in a recording of otherwise normal beats in normal rhythm, the Normal detector will likely declare that EKG recording to be normal.
The Normal detector will not declare an EKG outside the heart rate of 50-100 beats per minute as normal, even if the EKG has normal sinus rhythm. As a result, if you typically get normal results but take an EKG immediately after any physical activity that raises your heart rate above 100 beats per minute, you may not get a normal result.
Unreadable detector
The Unreadable detector determines whether a recording can be accurately interpreted or not. After recording an EKG, if interference is detected you will be notified within the app that your recording has “No analysis” and given some suggestions for acquiring good quality EKG recording. You subsequently have the option to save the recording, or try again. If the recording can be analyzed, the Atrial Fibrillation, Bradycardia, Tachycardia and Normal detectors will run on the EKG and inform you as described previous pages.
Unclassified
The app may display the Unclassified message for an EKG recording that was not detected as Normal, nor as Possible Atrial Fibrillation, nor as Bradycardia, nor as Tachycardia, and not as Unreadable.
Unclassified means the result is not Normal, nor Possible Atrial Fibrillation, nor Bradycardia, nor Tachycardia and not Unreadable.
Unclassified result may be normal rhythms, such as when your heart rate is higher than 100 beats per minute after physical activity, or abnormal rhythms; if you consistently get unclassified results, you may want to share your these EKG recordings with your physician. You can send the recordings by email.
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1. Know Your Monitor
Note
•Other than Possible Atrial Fibrillation, Bradycardia, Tachycardia, Normal, Unclassified and Unreadable, EKG error messages may appear on the app due to some reasons such as a shortage of recording time, too noisy to interpret or etc. If it appears, follow the suggestions on the app.
Caution
•After EKG analysis, the app may incorrectly identify ventricular flutter, ventricular bigeminy, and ventricular rigeminy heart conditions as unreadable. Consult with your physician.
•OMRON does not guarantee that you are not experiencing an arrhythmia or other health conditions when labeling an EKG as normal. You should notify your physician for possible changes in your health.
•If the “OMRON connect US/CAN” app detects possible atrial fibrillation in an EKG, consult with your physician before making any medical decision, including altering your use of any drug or treatment.
•The atrial fibrillation detector evaluates for possible atrial fibrillation ONLY. It will NOT detect other potentially life threatening arrhythmias, and it is possible that other cardiac arrhythmias may be present.
•The atrial fibrillation detector ONLY evaluates for possible atrial fibrillation after you have recorded an EKG. It does NOT continuously monitor your heart and therefore cannot alert you if atrial fibrillation happens at any other time.
•Result of “Bradycardia” or “Tachycardia” are designations of heart rate, not a clinical diagnosis of an actual arrhythmia. Consult with your physician.
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1. Know Your Monitor
1.6 Distinction between Pulse Rate and Heart Rate
The pulse rate on blood pressure measurement and the heart rate on EKG recording are calculated differently as follows. There may be a difference between both values.
Pulse rate on
blood pressure measurements
Heart rate on
EKG recordings
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Start |
Deflate |
Completed |
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Duration of calculation |
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Start |
Completed |
Duration of calculation
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