Omron Complete BP7900 Instruction Manual

Omron Complete BP7900 Instruction Manual

Blood pressure monitor + ekg
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Complete
TM
Blood Pressure Monitor + EKG
Model BP7900
Instruction Manual
4602711-0B

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Table of Contents
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Summary of Contents for Omron Complete BP7900

  • Page 1 Complete Blood Pressure Monitor + EKG Model BP7900 Instruction Manual 4602711-0B...
  • Page 2: Table Of Contents

    Table of Contents Introduction ................2 10. Maintenance ..............47 Safety Instructions ..............2 10.1 Maintenance..............47 10.2 Storage................47 Intended Use ................3 10.3 Cleaning ................. 48 Receiving and Inspection ............3 10.4 Disposal ................. 48 Symbols Glossary..............3 11.
  • Page 3: Introduction

    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.
  • Page 4: Intended Use

    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.
  • Page 5: Important Safety Information

    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.
  • Page 6 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 ®...
  • Page 7 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.
  • Page 8 • 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.
  • Page 9 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. •...
  • Page 10: Know Your Monitor

    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 Smartphone stand Top electrodes Side electrode (both sides) [Connection] button BP reading display* BP [START/STOP] button* Battery compartment Air jack Arm cuff...
  • Page 11: Bp Reading Display And Symbols On The Monitor

    1. Know Your Monitor 1.3 BP Reading Display and Symbols on the Monitor Heartbeat symbol Flashes while taking a blood pressure measurement. 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.
  • Page 12 1. Know Your Monitor Bluetooth ON symbol Appears when your readings are being transferred. 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.
  • Page 13: Classification Of Bp (Blood Pressure)

    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 Systolic BP Diastolic BP Normal <120 mmHg <80 mmHg Elevated 120 - 129 mmHg <80 mmHg Hypertension Stage 1 130 - 139 mmHg...
  • Page 14: Reading Your Ekg Result

    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.
  • Page 15 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.
  • Page 16 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.
  • Page 17 • 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.
  • Page 18: Distinction Between Pulse Rate And Heart Rate

    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 Start Deflate...
  • Page 19: Preparation

    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.
  • Page 20 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. •...
  • Page 21: Pairing Your Monitor With A Smartphone

    1. Enable Bluetooth on your smartphone. 2. Download and install the free “OMRON connect US/CAN” app onto your smartphone. If you already have this app and have created your account, open the app and add your new monitor. You may use your account to access to view blood pressure readings and/or EKG recordings on the app.
  • Page 22 • Please be aware that OMRON will not be responsible for the loss of data and/or information in the app. • “OMRON connect US/CAN” is the only app that we recommend to use with your monitor to transfer your blood pressure readings...
  • Page 23 When paired, the user’s EKG recordings are available to be viewed by their physicians. Note • Users without a referral code may send their EKG recordings to their physician by emailing the PDF from the “OMRON connect US/CAN” app on the smartphone.
  • Page 24: Blood Pressure Measurement/Ekg Recording Tips

    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.
  • Page 25: Taking A Blood Pressure Measurement And Recording An Ekg

    “Note” located at the end of this sub-section. • The blood pressure can differ between the right arm and the left arm, and the measured blood pressure readings can be different. OMRON recommends to always use the same arm for measurement.
  • Page 26 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 0.5 inch air tube is on the inside of your arm and aligned with your middle finger.
  • Page 27: Sitting Correctly

    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. •...
  • Page 28: Taking A Blood Pressure Measurement And Recording An Ekg

    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.
  • Page 29 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.
  • Page 30 3. Taking a Blood Pressure Measurement and Recording an EKG 5. Touch 4 electrodes as shown in the image. Top electrodes Put your thumbs on the top electrodes, and 2 or more fingers on each Side electrode of the side electrodes to record your EKG. (both sides) Once fingers are placed on the electrodes, an EKG recording will automatically start.
  • Page 31 3. Taking a Blood Pressure Measurement and Recording an EKG Blood pressure measurement BP reading display 1) The “ ” symbol flashes at every heartbeat. for blood pressure measurement ▼START 2) After your monitor has detected your blood pressure and pulse rate, the cuff automatically deflates.
  • Page 32 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.
  • Page 33 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.
  • Page 34: Taking Only A Blood Pressure Measurement

    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. •...
  • Page 35 Note • If your monitor has not been paired with your smartphone, skip following steps 3) and 4). 3) As soon as your measurement is complete, open the “OMRON connect US/CAN” app on your smartphone to transfer your readings. Note •...
  • Page 36: Recording Only An Ekg

    EKG may not be recorded successfully. 1. Sit correctly. Refer to sub-section 3.2. 2. Open the “OMRON connect US/CAN” app on your smartphone. 3. Tap “Record your (first) EKG” on your smartphone, and follow the instructions.
  • Page 37 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. Top electrodes Put your thumbs on the top electrodes, and 2 or more fingers on each Side electrode of the side electrodes to record your EKG.
  • Page 38 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.
  • Page 39: Transfer Your Blood Pressure Readings Manually

    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.
  • Page 40: Taking A Blood Pressure Measurement Manually

    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.
  • Page 41: Other Settings On The Monitor

    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.
  • Page 42: Restoring Your Monitor To The Default Settings

    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.
  • Page 43: Error Messages And Troubleshooting

    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.
  • Page 44 9. Error Messages and Troubleshooting BP reading display / Possible Cause Solution Problem The arm cuff was inflated exceeding the Do not touch the arm cuff and/or bend the air tube while taking a maximum allowable pressure. measurement. If inflating the arm cuff manually, refer to section 7. appears You move or talk during a measurement.
  • Page 45 Refer to sub-section 2.2 for pairing your monitor with your smartphone. smartphone. flashes The monitor is ready to transfer blood Open the “OMRON connect US/CAN” app to transfer your blood pressure readings to the smartphone. pressure readings. flashes Internal stored blood pressure memory is almost full.
  • Page 46 9. Error Messages and Troubleshooting BP reading display / Possible Cause Solution Problem appears Batteries are depleted. Immediately replace all 4 batteries with new ones. the monitor is turned Refer to sub-section 2.1. off unexpectedly during a measurement. Nothing appears on Batteries are depleted.
  • Page 47 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. Try the following tips for acquiring the best quality EKG recording: I have a lot of artifact, •...
  • Page 48: Maintenance

    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.
  • Page 49: Cleaning

    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.
  • Page 50: Optional Accessories

    11. Optional Accessories Arm cuff Arm circumference Arm circumference 7" - 9" (17 - 22 cm) 9" - 17" (22 - 42 cm) Small D-Ring Cuff Wide-Range D-Ring Cuff Model: HEM-CS24-B HEM-CS24-BZ Model: HEM-RML31-B HEM-RML31-BZ • Same as the arm cuff provided with the product.
  • Page 51: Specifications

    12. Specifications Model BP7900 HEM-7530T-Z BP reading display LCD digital display Transmission method Bluetooth ® low energy technology Wireless communication Frequency range: 2.4 GHz (2400 - 2483.5 MHz) Modulation: GFSK Effective radiated power: <20 dBm Operation mode Continuous operation IP classification IP 21 Rating DC6 V 4 W...
  • Page 52 12. Specifications Blood pressure measurement Cuff pressure range 0 to 299 mmHg Blood pressure measurement range SYS: 60 to 260 mmHg DIA: 40 to 215 mmHg Pulse measurement range 40 to 180 beats / min. Accuracy Pressure: ±3 mmHg Pulse: ±...
  • Page 53 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. •...
  • Page 54: Fcc Statement

    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.
  • Page 55: Limited Warranty

    Because of possible loss in transit, we recommend insuring the product with return receipt requested. THE FOREGOING IS THE SOLE WARRANTY PROVIDED BY OMRON IN CONNECTION WITH THIS PRODUCT, AND OMRON HEREBY DISCLAIMS ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
  • Page 56: Guidance And Manufacturer's Declaration

    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. Refer to the EMC information for...
  • Page 57 The Bluetooth word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by OMRON HEALTHCARE Co., Ltd. is under license. Other trademarks and trade names are those of their respective owners.

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