Omron EVOLV Upper Arm Blood Pressure Monitor [BP7000] Instruction Manual

Omron EVOLV Upper Arm Blood Pressure Monitor [BP7000] Instruction Manual

INTRODUCTION

Thank you for purchasing the OMRON BP7000 Blood Pressure Monitor. Your new blood pressure monitor uses the oscillometric method of blood pressure measurement. This means the monitor detects your blood movement through your brachial artery and converts the movements into a digital reading. An oscillometric monitor does not need a stethoscope so the monitor is simple to use.

INTENDED USE

This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches to 17 inches (22 cm to 42 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

IMPORTANT SAFETY INFORMATION

Please read the Important Safety Information in this instruction manual before using the unit.
Please follow this instruction manual thoroughly for your safety.
Please keep for future reference. For specific information about your own blood pressure, CONSULT YOUR PHYSICIAN.

Contraindications

• The device is contraindicated for use in ambulatory environments.
• The device is contraindicated for use on aircraft.

Warning
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

• DO NOT adjust medication based on measurement results from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat high blood pressure.
• DO NOT use this monitor on an injured arm or an arm under medical treatment.
• DO NOT wear the arm cuff on your arm while on an intravenous drip or blood transfusion.
• DO NOT apply or inflate the arm cuff around any body parts other than your upper arm.
• DO NOT use this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners or in oxygen rich environments.
• DO NOT use this monitor on infants, toddlers, children or persons who cannot express themselves.
• Consult 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 measurement reading.
• Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.
• Contains small parts that may cause a choking hazard if swallowed by children, toddlers or infants.
• Keep the BATTERY out of the reach of children, toddlers and infants.
• 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. For further information on any potential restrictions refer to documentation on Bluetooth® usage by the FCC.                                                                                                                         Caution: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property.
• Stop using this monitor and consult your physician if you experience skin irritation or discomfort.
• Consult your physician before using this monitor on an arm with an arterio-venous (A-V) shunt.
• Consult your physician before using this monitor if you have had a mastectomy.
• Consult your physician before using the monitor if you have severe blood flow problems or blood disorders as cuff inflation can cause bruising.
• Do not take measurements more often than necessary because bruising, due to blood flow interference, may occur.
• Remove the arm cuff if it does not start deflating during the measurement.
• Do not use this monitor for any purpose other than measuring blood pressure.
• Do not use a mobile phone or other electrical devices that emit electromagnetic fields near this monitor except when transferring your readings to your smart device. This may result in incorrect operation of this monitor.
• Do not disassemble or attempt to repair the monitor or components. This may cause an inaccurate reading.
• Do not use in a location where there is moisture or a risk of water splashing the monitor. This may damage the monitor.
• Do not use this monitor in a moving vehicle such as in a car.
• Do not drop, or subject this monitor to strong shocks or vibrations.
• Do not use this monitor in places with high or low humidity or high or low temperatures. See the “8. SPECIFICATIONS” section of the manual.
• Please check, by observation of the arm being used, that the monitor is not causing any impairment of patient blood circulation.
• Do not use this monitor in high-use environments such as medical clinics or physician offices.
• Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for 30 minutes before taking a measurement.
• Rest for at least 5 minutes before taking the measurement.
• Remove tight-fitting or thick clothing from your arm while taking a measurement.
• Remain still and do not talk while taking a measurement.

Data Transmission

• Do not replace the battery while your reading is being transferred to your smart device. This may result in the incorrect operation of your monitor and failure to transfer your blood pressure data.
• Do not place integrated circuit cards, magnets, metal objects, or other devices that emit electromagnetic fields near this monitor while your reading is being transferred to your smart device. This may result in the incorrect operation of your monitor and failure to transfer your blood pressure data.

Battery Handling and Usage

• Do not insert the batteries with their polarities incorrectly aligned.
• Use only 4 “AAA” alkaline batteries with this monitor. Do not use other types of batteries. Do not use new and used batteries together.
• Remove the batteries if the monitor will not be used for a long period of time.
• If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Consult a 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 a physician.
• Do not use batteries after their expiration date.
• Periodically check your batteries to ensure they are in good working condition.
• Only use batteries specified for this monitor. Use of unsupported batteries may damage and/or may be hazardous to the monitor.

1. KNOW YOUR MONITOR

Contents:
Monitor, 4 “AAA” batteries, instruction manual, quick start guide

Monitor:

A. START/STOP button
B. Connection button
C. Display
D. Arm cuff
E. Battery compartment

Display:

F. Systolic blood pressure
G. Diastolic blood pressure
H. Pulse display

1.1 Display symbols

1.2 Before Taking a Measurement

To help ensure an accurate reading, follow these directions:

Caution Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for 30 minutes before taking a measurement.

Rest for at least 5 minutes before taking the measurement.

• Stress raises blood pressure. Avoid taking measurements during stressful times.
• Measurements should be taken in a quiet place.
• Keep a record of your blood pressure and pulse readings for your physician. A single measurement does not provide an accurate indication of your true blood pressure. You need to take and record several readings over a period of time. Try to measure your blood pressure at the same time each day for consistency.

2. PREPARATION

2.1 Battery Installation

2.2 Applying the Arm Cuff

Remove tight-fitting or thick clothing from your arm while taking a measurement.

2.3 How to Sit Correctly

To take a measurement, you need to be relaxed and comfortably seated, at a comfortable room
temperature.

• Sit in a chair with your legs uncrossed and your feet flat on the floor.
• Sit upright with your back straight.
• Sit with your back and arm being supported.
• The arm cuff should be placed on your arm at the same level as your heart.

3. USING THE MONITOR WITHOUT A SMART DEVICE

You can use this blood pressure monitor without pairing to a smart device.

3.1 Taking a Measurement

Notes:

• To stop the measurement, press the [START/STOP] button once to deflate the arm cuff.
• Remain still and do not talk while taking a measurement.
• When using this blood pressure monitor without a smart device, you will not be able to view your prior readings stored in the memory.
• Do not use the monitor with any other electrical device simultaneously.
  This may result in incorrect operation of the monitor.

2. Remove the arm cuff.
3. Write down your SYS/DIA and Pulse readings, along with the date and time of your measurement on a piece of paper to keep a record of your history.

Caution: DO NOT adjust medication based on measurement results from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat high blood pressure.
Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.

4. USING THE MONITOR WITH A SMART DEVICE

4.1 Pairing Your Monitor with a Smart Device

The date and time on your monitor will automatically be set when you pair it with your smart device.

Review the list of compatible smart devices at: OmronHealthcare.com

1. Make sure the Bluetooth® in your smart device is turned on.
2. Download and install the free “OMRON connect” app on your smart device.

• If you already have the “OMRON connect” app, and have created your account, visit the “Manage Devices” in the “Profile” section of the
  “OMRON connect” app to add this new device.

3. Open the app on your smart device and follow the set-up and pairing instructions.
4. Confirm the monitor is connected successfully.
If the monitor is connected successfully to the smart device, “OK” will appear on the display.

For more information, visit OmronHealthcare.com

Notes:

• If you use any other app instead of “OMRON connect”, the date and time may not be automatically set.
  If you need to set the date and time, pair your monitor or transfer the data by using “OMRON connect” app.

• The date/time will only be set for future measurements taken after the measurement that was transferred. It will not be saved to the measurement that was just transferred.

• Please be aware that OMRON will not be responsible for the loss of data and/or information.

4.2 Taking a Measurement

Notes:

• To stop the measurement, press the [START/STOP] button once to deflate the arm cuff.
• Remain still and do not talk while taking a measurement.
• This monitor will store 100 measurements. Stored measurements cannot be viewed on the monitor’s display. You will need to use the “OMRON connect” app to view all measurements prior to the most recent reading taken.
• Do not use a mobile phone or other electrical devices that emit electromagnetic fields near this monitor except when transferring your readings to your smart device. This may result in incorrect operation of this monitor.

1.Press the [START/STOP] button.

2. Remove the arm cuff.
3. Transfer your readings.
Please make sure your monitor is within 16 ft. (5 m) of your smart device and your “OMRON connect” app is active. As soon as your measurement is complete, tap the “sync” icon in the
Omron connect app on your smart device to transfer your readings.

4. After your readings have been transferred to the “OMRON connect” app, press the [START/STOP] button to turn the monitor off.

Notes:

• The monitor will automatically turn off after 2 minutes.
• Wait 2-3 minutes before taking another measurement. Waiting between measurements allows the arteries to return to the condition they were prior to taking the measurement.
• If you use any other app instead of “OMRON connect”, the data may not be displayed correctly after sending.

Caution: DO NOT adjust medication based on measurement results from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat high blood pressure.
Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.

Data Transfer With Multiple Smart Devices
Once you transfer your data to a smart device, that data can no longer be transferred again to the same smart device, nor to another smart device.

About Multiple Users
To share your blood pressure monitor with other people, please refer to the “Help” section in the “OMRON connect” app.

4.3 Turning “OFF” Bluetooth®

Turn off the Bluetooth® in your monitor in the following areas where use of wireless equipment is prohibited.

• On aircraft • In hospitals • While abroad
Your monitor comes with the Bluetooth® already turned on.

1. Turn your monitor power off if it is on by pressing the [START/STOP] button on the monitor.

4.4 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. It will be off when the screen is not showing numbers or symbols.

3. Press the [START/STOP] button to turn the monitor off.
Notes:

• The monitor will automatically turn off after 2 minutes.
• Reverting to initial settings of this monitor will not delete the information in the app.
• When using this monitor again, first delete the registration of monitor in the app and then pair your monitor.

5. ERROR MESSAGES AND TROUBLESHOOTING

5.1 Error Messages

5.2 Troubleshooting

6. MAINTENANCE, STORAGE AND CLEANING

6.1 Maintenance

To protect your monitor from damage, please follow the directions below:

• Store the monitor and the components in a clean, safe location.
• Do not wash the monitor and any components or immerse them in water.
• Do not use gasoline, thinners or similar solvents to clean the monitor.
• Changes or modification not approved by the manufacturer will void the user warranty.

Do not disassemble or attempt to repair the monitor or components.

6.2 Storage

Do not store the monitor in the following situations:

• If the monitor is wet.
• Locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapors such as bleach.
• Locations exposed to vibrations, shocks or where it will be at an angle.

6.3 Cleaning

• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth, or a soft cloth moistened with neutral soap to clean on the monitor and the arm cuff, and then wipe it with a dry cloth.

7. DISPOSAL

Dispose of the monitor and components according to applicable local regulations. Unlawful disposal may cause environmental pollution.

8. SPECIFICATIONS

Notes:

• 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 clinically investigated according to 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 device is protected against solid foreign objects of 12 mm diameter and greater such as a finger, and against oblique falling water drops which may cause issues during a normal operation.

About a wireless communication interference

This Product operates in the unlicensed ISM band at 2.4GHz. In case this Product is used around the other wireless devices including microwave and wireless LAN, which operate same frequency band of this Product, there is a possibility that interference occurs between this Product and such other devices. If such interference occurs, please stop the operation of other
devices or relocate this Product before using this Product or do not use this Product around the other wireless devices.

9. SYMBOL DESCRIPTIONS / DEFINITIONS

10. 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.

Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.

However, there is no guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines. This equipment has very low levels of RF energy that are deemed to comply without testing of specific absorption ratio (SAR).

11. LIMITED WARRANTY

Your BP7000 Upper Arm Blood Pressure Monitor, excluding batteries, is 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 above warranty extends only to the original retail purchaser.

We will, at our option, replace without charge any monitor covered by the above warranty. Replacement is our only responsibility and your only remedy under the above warranty.

To obtain warranty service contact Customer Service by calling 1-800-634-4350 for the address of the inspection center and the return shipping and handling fee. Enclose the original printed receipt. Include a letter, with your name, address, phone number, and description of the specific problem. Pack the product carefully to prevent damage in transit. 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. IMPLIED WARRANTIES AND OTHER TERMS THAT MAY BE IMPOSED BY LAW, IF ANY, ARE LIMITED IN DURATION TO THE PERIOD OF THE ABOVE EXPRESS WARRANTY.

OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT COSTS, EXPENSES OR DAMAGES.

This warranty provides you with specific legal rights, and you may have other rights that vary by jurisdiction. Because of special local requirements, some of the above limitations and exclusions may not apply to you.

FOR CUSTOMER SERVICE
Visit our web site at: OmronHealthcare.com
Call toll free: 1-800-634-4350

12. GUIDANCE AND MANUFACTURER’S DECLARATION

OMRON Blood Pressure Monitor (BPM)
Information for accompanying documents in the scope of IEC60601-1-2:2007

Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular) telephones,
medical devices in use may be susceptible to electromagnetic interference from other devices.
Electromagnetic interference may result in incorrect operation of the medical device and create a
potentially unsafe situation. Medical devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to
prevent unsafe product situations, the IEC60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum
levels of electromagnetic emissions for medical devices.

Medical devices manufactured by OMRON Healthcare conform to this IEC60601-1-2:2007
standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:

• The use of accessories and cables other than those specified by OMRON, with the exception of cables sold by OMRON as replacement parts for internal components, may result in increased emission or decreased immunity of the device.

• The medical devices should not be used adjacent to or stacked with other equipment.
  In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used.

• Refer to further guidance below regarding the EMC environment in which the device should be used.

• The MEDICAL ELECTRICAL EQUIPMENT BPM needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this documentations.

• The Essential Performance of the BPM is to measure a blood pressure and a pulse rate and using the memory function.

The BPM may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements.

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