HEM-7530T-Z_B_M07_181114.
Table of Contents Introduction ............................................................................ 2 Safety Instructions .................................................................... Intended Use ............................................................................ Receiving and Inspection ......................................................... Symbols Glossary..................................................................... 2 3 3 3 Important Safety Information ...............
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.
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.
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. Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
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.
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.
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.
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.
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 a Smartphone stand b Top electrodes c Side electrode (both sides) d [Connection] button e BP reading display* f BP [START/STOP] button* g Battery compartment h Air jack i Arm cuff (Arm circumference 9" - 17" (22 - 42 cm)) j Air plug k Air tube *BP indicates blood pressure.
1. Know Your Monitor 1.3 BP Reading Display and Symbols on the Monitor A C A B C D E G H I J Movement error symbol Appears 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 Appears during cuff deflation.
1. Know Your Monitor Bluetooth ON symbol Appears when your readings are being transferred. H I J Bluetooth OFF symbol Appears when Bluetooth is disabled. Sync symbol Flashes/appears when your data needs to be transferred because the internal stored blood pressure memory is either almost, 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.
1. Know Your Monitor 1.4 Classification of BP (Blood Pressure) ACC/AHA 2017 Hypertension guidelines defines categories of BP in adults as below. Categories of BP in Adults* BP Category Normal Systolic BP Diastolic BP <120 mmHg and <80 mmHg 120 - 129 mmHg and <80 mmHg Stage 1 130 - 139 mmHg or 80 - 89 mmHg Stage 2 or ≥90 mmHg Elevated Hypertension ≥140 mmHg * Individuals with Systolic BP and Diastolic BP in 2 categories should be designated to the higher BP category.
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.
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.
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.
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.
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.
2. Preparation 2.1 Installing Batteries 1. Push down the hole of the battery cover with a thin object such as a pen, and pull the hook upward. Note • When using a thin object, be careful not to get yourself injured. 2. Insert 4 “AA” alkaline batteries as indicated in the battery compartment.
2. Preparation 3. Close the battery cover securely. Note • When the “ ” symbol appears on the BP reading display, it is recommended you replace batteries. • To replace batteries, turn your monitor off and remove all batteries. Then replace with 4 new alkaline batteries at the same time. • Before taking blood pressure measurements, your monitor needs to be set with the correct date and time.
2. Preparation 2.2 Pairing Your Monitor with a Smartphone The date and time on your monitor will automatically be set when you pair your monitor with your smartphone. Note • You must download the app and pair it to your smartphone before you can use the EKG function. Review the list of compatible smartphones at OmronHealthcare.com. Any devices and operating systems not listed on our website are not supported. 1. Enable Bluetooth on your smartphone. 2.
2. Preparation 4. Confirm that your monitor is connected successfully. When your monitor is connected successfully to your smartphone, the “OK” symbol flashes. 5. Press the BP [START/STOP] button to turn your monitor off. Note • Your monitor will automatically turn off after 10 seconds. • If you do not pair this monitor to set the date and time, any blood pressure readings you take with this monitor will not be transferred.
2. Preparation Free medical interpretation of your first EKG recording A U.S. board-certified cardiologist will automatically review your first EKG recording for free and will provide a medical interpretation within 24 hours. Due to FDA regulations, the heart rhythm for your first recording will not be visible on your smartphone screen and you will not be able to record any additional EKGs while the cardiologist is preparing your report.
2. Preparation 2.3 Blood Pressure Measurement/EKG Recording Tips Blood pressure measurement tips to help ensure an accurate reading: • Stress raises blood pressure. Avoid taking measurements during stressful times. • Measurements should be taken in a quiet place. • It is important to take measurements at the same times each day. Taking measurements in the morning and in the evening is recommended. • Remember to have a record of your blood pressure and pulse readings for your physician.
3. Taking a Blood Pressure Measurement and Recording an EKG There are 3 ways to use this monitor. 1. Taking a blood pressure measurement and recording an EKG simultaneously: refer to the steps in this section. 2. Taking only a blood pressure measurement: refer to section 4. 3. Recording only an EKG: refer to section 5. 3.1 Applying the Arm Cuff Note • The following steps are for applying the arm cuff to your left arm.
3. Taking a Blood Pressure Measurement and Recording an EKG 2. Place your hand through the cuff loop. Pull the cuff until it reaches your upper left arm. Note • The bottom edge of the arm cuff should be 0.5 inch (1 to 2 cm) above the inside elbow. The air tube is on the inside of your arm and aligned with your middle finger. 0.5 inch (1 to 2 cm) Bottom edge 3. Make sure that the air tube is positioned on the inside of your arm and wrap the cuff securely so it can not move around your arm.
3. Taking a Blood Pressure Measurement and Recording an EKG 3.2 Sitting Correctly To take a blood pressure measurement and record an EKG, you need to be relaxed and comfortably seated in a quiet room with a comfortable temperature. • Sit in a comfortable chair with your back and arms supported. • Keep your feet flat and your legs uncrossed. • Both arms should be resting comfortably on a table. • Place your monitor close enough to touch with your bent elbows.
3. Taking a Blood Pressure Measurement and Recording an EKG 3.3 Taking a Blood Pressure Measurement and Recording an EKG Free medical interpretation of your first EKG recording A U.S. board-certified cardiologist will automatically review your first EKG recording for free and will provide a medical interpretation within 24 hours.
3. Taking a Blood Pressure Measurement and Recording an EKG 1. Open the “OMRON connect US/CAN” app on your smartphone. 2. Tap “Record your (first) EKG” on your smartphone, and follow the instructions. Note • The instructions for recording your first EKG will not appear with the next recording, and it will not appear if you have created an account with referral code. 3. Place your smartphone on the smartphone stand of your monitor. Note • Make sure to sit correctly. Refer to sub-section 3.2. 4.
3. Taking a Blood Pressure Measurement and Recording an EKG 5. Touch 4 electrodes as shown in the image. Put your thumbs on the top electrodes, and 2 or more fingers on each of the side electrodes to record your EKG. Once fingers are placed on the electrodes, an EKG recording will automatically start. Top electrodes Side electrode (both sides) Note • To reduce muscle noise, rest your arms on a flat surface for better support while you are recording an EKG.
3. Taking a Blood Pressure Measurement and Recording an EKG Blood pressure measurement 1) The “ ” symbol flashes at every heartbeat. 2) After your monitor has detected your blood pressure and pulse rate, the cuff automatically deflates. Your blood pressure and pulse rate are displayed on the monitor. 3) As soon as a blood pressure measurement is complete, the blood pressure reading will be transferred to your smartphone.
3. Taking a Blood Pressure Measurement and Recording an EKG EKG recording When recording an EKG for the first time, EKG wave and analysis are not visible but a 30-second countdown is shown. A message of waiting for a report from the cardiologist within 24 hours appears on the “OMRON connect US/CAN” app. After receiving a report, following EKG wave and analysis will be visible. If you have created an account with referral code, following EKG wave and analysis will be visible from the first EKG recording.
3. Taking a Blood Pressure Measurement and Recording an EKG 7. Release both of your hands from the electrodes and remove the arm cuff. Note • After taking a blood pressure measurement and recording an EKG, you can promptly add tags such as symptoms, activities, diet, etc. on the app. You may also add personalized notes, and send your EKG recording by email. 8. Press the BP [START/STOP] button to turn your monitor off. Note • Your monitor will automatically turn off after 2 minutes.
4. Taking Only a Blood Pressure Measurement Note • You can take a blood pressure measurement without pairing to a smartphone. To pair your monitor with your smartphone, refer to sub-section 2.2. • When taking a blood pressure measurement and recording an EKG simultaneously, refer to section 3. • When recording only an EKG, refer to section 5. Caution • DO NOT use this monitor with other medical electrical (ME) equipment simultaneously.
4. Taking Only a Blood Pressure Measurement 4. Remain still and do not talk until the entire measurement process is complete. 1) The “ ” symbol flashes at every heartbeat. 2) After your monitor has detected your blood pressure and pulse rate, the cuff automatically deflates. Your blood pressure and pulse rate are displayed on the monitor. Note • If your monitor has not been paired with your smartphone, skip following steps 3) and 4).
5. Recording Only an EKG Note • When taking a blood pressure measurement and recording an EKG simultaneously, refer to section 3. • When taking only a blood pressure measurement, refer to section 4. Caution • Remain still while recording an EKG. • When your fingertips are dry, your EKG recording may not be successful. If dry, moisten your fingers with a wet towel, a water-based lotion, or something similar. • DO NOT record an EKG with dirty hands.
5. Recording Only an EKG 4. Place your smartphone on the smartphone stand of your monitor. 5. Touch 4 electrodes as shown in the image. Put your thumbs on the top electrodes, and 2 or more fingers on each of the side electrodes to record your EKG. Once fingers are placed on the electrodes, an EKG recording will automatically start. Note • To reduce muscle noise, rest your arms on a flat surface for better support while you are recording an EKG.
5. Recording Only an EKG 6. Remain still until the entire recording process is complete. When recording an EKG for the first time, EKG wave and analysis are not visible but a 30-second countdown is shown. A message of waiting for a report from the cardiologist within 24 hours appears on the “OMRON connect US/CAN” app. After receiving a report, EKG wave and analysis will be visible. If you have created an account with referral code, EKG wave and analysis will be visible from the first EKG recording.
6. Transfer Your Blood Pressure Readings Manually As soon as a blood pressure measurement is complete, open the “OMRON connect US/CAN” app on your smartphone to transfer your readings. If you need to transfer the readings later, try transferring them manually. 1. Make sure your monitor is within 16 ft. (5 m) of your smartphone. 2. Open the “OMRON connect US/CAN” app on your smartphone. Note • Make sure that your monitor is turned off. If it is on, press the BP [START/STOP] button to clear the LCD screen.
7. Taking a Blood Pressure Measurement Manually If your systolic blood pressure is more than 210 mmHg, take a blood pressure measurement manually. Prepare for taking a blood pressure measurement by referring to sub-sections 3.1 and 3.2. And press the BP [START/STOP] button. After the arm cuff starts to inflate, press and hold the BP [START/STOP] button until the monitor inflates 30 to 40 mmHg higher than your expected systolic blood pressure.
8. Other Settings on the Monitor 8.1 Disabling/Enabling Bluetooth Warning • 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. Bluetooth is enabled as default. 1.
8. Other Settings on the Monitor 8.2 Restoring Your Monitor to the Default Settings To delete all the information stored in your monitor, follow the instructions below. Make sure that your monitor is turned off. 1. While holding the button down, press and hold the BP [START/STOP] button for more than 10 seconds. 2. Release the button and BP [START/STOP] button when “CLr” appears on the BP reading display. Your monitor reverts back to the default settings. 3.
9. Error Messages and Troubleshooting If any of the below problems occur during a blood pressure measurement and an EKG recording, check to make sure that the monitor is 12 inches (30 cm) from other electrical devices, except for the smartphone that is being used with the monitor. For example, electrical outlets, PCs, PC monitors or other wireless devices such as Wi-Fi routers which emit radio frequencies. If the problem persists, refer to the table below.
9. Error Messages and Troubleshooting BP reading display / Problem Possible Cause Solution The arm cuff was inflated exceeding the maximum allowable pressure. Do not touch the arm cuff and/or bend the air tube while taking a measurement. If inflating the arm cuff manually, refer to section 7. You move or talk during a measurement. Vibrations disrupt a measurement. Remain still and do not talk during a measurement. The pulse rate is not detected correctly.
9. Error Messages and Troubleshooting BP reading display / Problem appears Possible Cause Solution The monitor cannot connect to a smartphone or transmit blood pressure readings correctly. Follow the instructions shown in the “OMRON connect US/CAN” app. If the “Err” symbol still appears after checking the app, contact customer service. Refer to section 14. The monitor is waiting to pair with the smartphone. Refer to sub-section 2.2 for pairing your monitor with your smartphone.
9. Error Messages and Troubleshooting BP reading display / Problem appears or the monitor is turned off unexpectedly during a measurement. Possible Cause Batteries are depleted. Solution Immediately replace all 4 batteries with new ones. Refer to sub-section 2.1. Nothing appears on the BP reading display of the monitor. Batteries are depleted. Blood pressure readings appear too high or too low. Blood pressure varies constantly.
9. Error Messages and Troubleshooting EKG recordings Problem Solution Ensure that the “OMRON connect US/CAN” app has access to the microphone of the smartphone. Open the settings of your smartphone, and enable the microphone of the app. I have a lot of artifact, noise, interference, or see “No EKG” in my EKG recording. The HUD symbol is covered up when I rotate my smartphone I see large spikes at the start of my EKG recording Any other communication issue occurs.
10. Maintenance 10.1 Maintenance To protect your monitor from damage, follow the directions below: • Changes or modifications not approved by the manufacturer will void the user warranty. Caution • DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate blood pressure readings and/ or EKG recordings. 10.2 Storage Keep your monitor and other components in the storage case when not in use. • Store your monitor and other components in a clean, safe location. 1.
10. Maintenance 3. Place your monitor with both hands and other components into the storage case. Do not store your monitor and other components: • If the monitor and other components are wet. • In locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapors such as bleach. • In locations exposed to vibrations or shocks. 10.3 Cleaning • Do not use any abrasive or volatile cleaners.
11. Optional Accessories Arm cuff Arm circumference 7" - 9" (17 - 22 cm) Small D-Ring Cuff Model: HEM-CS24-B HEM-CS24-BZ Arm circumference 9" - 17" (22 - 42 cm) Wide-Range D-Ring Cuff Model: HEM-RML31-B HEM-RML31-BZ • Same as the arm cuff provided with the product.
12. Specifications Model BP reading display Transmission method Wireless communication Operation mode IP classification Rating Power source Battery life Durable period (Service life) Operating conditions Storage / Transport conditions Weight Dimensions Cuff circumference applicable to the monitor 50 BP7900 HEM-7530T-Z LCD digital display Bluetooth® low energy technology Frequency range: 2.4 GHz (2400 - 2483.
12. Specifications Blood pressure measurement Cuff pressure range Blood pressure measurement range Pulse measurement range Accuracy Inflation Deflation Measurement method 0 to 299 mmHg SYS: 60 to 260 mmHg DIA: 40 to 215 mmHg 40 to 180 beats / min.
12. Specifications Note • • • • • These specifications are subject to change without notice. In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure. This monitor is comply with the requirements of ISO 81060-2:2013. This monitor has not been validated for use on pregnant patients. IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This monitor is protected against solid foreign objects of 12.
13. FCC Statement FCC CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 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.
14. Limited Warranty Your BP7900 Blood Pressure Monitor + EKG, excluding the arm cuff and batteries are warranted to be free from defects in materials and workmanship appearing within 5 years from the date of purchase, when used in accordance with the instructions provided with the monitor. The arm cuff is warranted to be free from defects in materials and workmanship appearing within 1 year from the date of purchase when the monitor is used in accordance with the instructions provided with the monitor.
15. Guidance and Manufacturer’s Declaration OMRON Battery-operated Blood Pressure Monitor + EKG Information for Accompanying Documents in the Scope of IEC60601-1-2:2014 Important information regarding Electromagnetic Compatibility (EMC) BP7900 manufactured by OMRON HEALTHCARE Co., Ltd. conforms to IEC60601-1-2:2014 Electromagnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at OmronHealthcare.com/emc.
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