Omron EVOLV BP7000 - Upper ArmBlood Pressure Monitor Manual

INTRODUCTION

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

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.

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.

Data Transmission

Battery Handling and Usage

KNOW YOUR MONITOR

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

Monitor:

Display:

6. Systolic blood pressure
7. Diastolic blood pressure
8. Pulse display

	Connection symbol		Irregular heartbeat symbol
	Connection OFF symbol		Battery symbol (low)
	Connection ON symbol		Battery symbol (depleted)
	Movement error symbol		Deflation symbol
	SYNC symbol		Heartbeat symbol (Flashes during measurement.)

Display symbols

Connection symbol ()
Appears when transferring the data or pairing with your smart device.
Connection OFF symbol ()
Appears when Bluetooth is off.
Connection ON symbol ()
Appears when Bluetooth is on.
Movement error symbol ()
The movement error symbol will display when your body is moving during measurement. If the movement symbol displays, remove the monitor and wait for 2 to 3 minutes. After 2 to 3 minutes, remain still and take another measurement.
SYNC symbol ()

Irregular heartbeat symbol ()

When the monitor detects an irregular rhythm two or more times during the measurement, the irregular heartbeat symbol will appear on the display along with the measurement values. An irregular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure. If the irregular heartbeat symbol displays with your measurement results, we recommend you consult your physician. Follow the directions of your physician.
Battery symbol (low) ()
Appears when the batteries are low.
Battery symbol (depleted) ()
Appears when the batteries are depleted.
Deflation symbol ()
Flashes while arm cuff is deflating.
Heartbeat symbol ()
Flashes while taking a measurement.

2013 ESH/ESC Guidelines for the management of arterial hypertension Definitions of hypertension by office and home blood pressure levels

These are from statistical values for blood pressure.

Before Taking a Measurement

To help ensure an accurate reading, follow these directions:
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.

PREPARATION

Battery Installation

1. Remove the battery cover. Insert your fingernail into the slot of the battery cover, and push downwards to remove the cover.
   
   
2. Insert battery, slide over so it is secured inside the circular battery positioner. Then insert the second battery.
   
   
3. Replace the battery cover.
   
   When the batteries have been securely placed in this monitor, the message below will appear on the screen:
   
   Notes:
   • When the depleted battery symbol "" appears on the display, turn the monitor off and remove all the batteries. Replace with 4 new batteries at the same time. Long life alkaline batteries are recommended.
   • The measurement values continue to be stored in the memory even after the batteries are replaced.
   • The supplied batteries may have a shorter life than new batteries.
   • Disposal of used batteries should be carried out in accordance with the national/local regulations for the disposal of batteries.
   • When the batteries are replaced, the words "Please pair this device." or "Pairing not completed. No data transfer." will appear on the display. Press the [] button to pair with the smart device or transfer the data before taking a measurement.

How to Sit Correctly

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

USING THE MONITOR WITHOUT A SMART DEVICE

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

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.

1. Press the [START/STOP] button.
   The arm cuff will start to inflate.
   
   
   The following symbols indicate incorrect measurement

• If "Please remeasure" and any of these symbols below are displayed, please take another measurement and try again.
  

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.

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.

USING THE MONITOR WITH A SMART DEVICE

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

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.
   The arm cuff will start to inflate.
   
   The following symbols indicate incorrect measurement

• If "Please remeasure" and any of these symbols below are displayed, please take another measurement and try again.
  

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.
   Transferring your readings later
   1. Open the app on your smart device and then follow the instructions.
   2. Press [] button to transfer your readings.
      
      • If your readings are successfully transferred to your smart device, "OK" will flash on the display.
        If "Error" appears, refer to section 5.1 for more detail.
        
        Notes:

• When the SYNC symbol " " appears on the display, transfer the data immediately before the readings are deleted.
• When the Connection OFF symbol " " appears on the display, turn on the Bluetooth feature of your monitor. (Refer to section 4.3) ®
• Once you send your readings to the app, the data cannot be sent again to the app or smart device.

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.

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.

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.
2. Press and hold the [] button for more than 10 seconds. Release the [ ] button when "" appears on the display. When the "" is blinking, you have now turned the Bluetooth ® off in your monitor.
   
   
3. Press the [START/STOP] button to turn the monitor off.
   Note: The monitor will automatically turn off after 2 minutes.
   How to turn "ON" Bluetooth ®
   Perform the following step when the power has been off.
   Press and hold the [] button for more than 2 seconds and then release the [] button when " " appears on the display. The "" will blink to show that the Bluetooth ® in your monitor has been turned on.

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.

ERROR MESSAGES AND TROUBLESHOOTING

Error Messages

Error Display	Cause	Solution
	Irregular heartbeat is detected.	Remove the arm cuff. Wait 2 - 3 minutes and then take another measurement. Repeat the steps in section 2.2. If this error continues to appear, contact your physician.
	Movement during measurement.	Carefully read and repeat the steps in section 4.2.
	The batteries are low.	Recommend replacement of all 4 batteries with new ones.
	The batteries are depleted or battery polarities are not properly aligned.	Immediately replace 4 batteries with new ones.
		Confirm the batteries are properly inserted with polarities correctly aligned.
	Connection failure. Data is not being transmitted.	Refer to "Connection failure. Data is not being transmitted."
	Arm cuff is applied too loosely.	Apply the arm cuff tighter.
	The arm cuff was inflated exceeding the maximum allowable pressure, and then deflated automatically.	Do not touch the arm cuff while taking a measurement.
	Movement during measurement.	Repeat measurement. Remain still and do not talk during measurement.
	Clothing is interfering with the arm cuff.	Remove any clothing interfering with the arm cuff.
*: "XX" will change to display an error number, 6 and higher.	Device error.	Please contact customer service.

Troubleshooting

MAINTENANCE, STORAGE AND CLEANING

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.

Storage

Do not store the monitor in the following situations:

Cleaning

7. DISPOSAL

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

8. SPECIFICATIONS

Model	BP7000 HEM-7600T-Z
Display	OLED display
Cuff pressure range	Pressure: 0 to 299 mmHg
Measurement range	Pressure: 40 to 260 mmHg Pulse: 40 to 180 beats / min.
Accuracy	Pressure: ±3 mmHg Pulse: ±5% of display reading
Inflation	Fuzzy-logic controlled by electric pump
Deflation	Automatic rapid deflation
Measurement method	Oscillometric method
Transmission method	Bluetooth ® Smart
Wireless communication	Frequency range: 2.4 GHz (2400 - 2483.5 MHz) Modulation: GFSK Effective radiated power: <20 dBm
IP classification	IP 22
Power source	4 "AAA" batteries 1.5V
Battery life	Approximately 300 measurements (using new alkaline batteries)
Durable period (Service life) Monitor	5 years
Operating conditions	50°F to 104°F (10°C to 40°C) / 15 to 90% RH (non-condensing) / 800 to 1060 hPa
Storage / Transport conditions	-4°F to 140°F (-20°C to 60°C) / 10 to 90% RH (non-condensing)
Weight	Monitor: Approximately 8 1/2 oz. (240 g) not including batteries
Dimensions	Monitor: Approximately 3 1/2" (w) 4 5/8" (h) 1" (l) (85 mm 120 mm 20 mm) (not including the arm cuff)
Arm circumference	9" to 17" (22 to 42 cm)
Contents	Monitor, 4 "AAA" batteries, instruction manual, quick start guide
Applied part	Type BF
Protection against electric shock	Internally powered ME equipment

Notes:

SYMBOL DESCRIPTIONS / DEFINITIONS

	Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
	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.
Note	Provides additional information to clarify a point in the text.
	Please consult this instruction manual
	Applied part - Type BF Degree of protection against electric shock (leakage current)
	To indicate generally elevated, potentially hazardous, levels of non-ionizing radiation, or to indicate equipment or systems e.g. in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment.
	Catalogue number
	Manufacturer
	Temperature limitation
	Humidity limitation
	Atmospheric pressure limitation
	Artery mark

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:

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).

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.

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.
Guidance and manufacturer's declaration - electromagnetic emissions
OMRON battery-operated BPM is intended for use in the electromagnetic environment specified below. The customer or the user of this OMRON battery-operated BPM should assure that it is used in such environment.
Emissions test			Compliance				Electromagnetic environment - guidance
RF emissions CISPR 11			Group 1				The OMRON battery-operated BPM uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11			Class B				The OMRON battery-operated BPM is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2			Not Applicable.
Voltage fluctuations/ flicker emissions IEC61000-3-3			Not Applicable.
Guidance and manufacturer's declaration - electromagnetic immunity
OMRON battery-operated BPM is intended for use in the electromagnetic environment specified below. The customer or the user of this OMRON battery-operated BPM should assure that it is used in such environment.
Immunity test				IEC 60601 test level					Compliance level		Electromagnetic environment - guidance
Electrostatic discharge (ESD) IEC 61000-4-2				Contact discharge: ±6 kV Air discharge: ±8 kV					Contact discharge: ±8 kV Air discharge: ±15 kV		The relative humidity should be at least 5%.
Electrical fast transient/burst IEC 61000-4-4				±2 kV for power supply lines ±1 kV for input/output lines					Not Applicable.		Not Applicable.
Surge IEC 61000-4-5				±1 kV line(s) to line(s) ±2 kV line(s) to earth					Not Applicable.		Not Applicable.
Voltage dips, short interruptions and voltage variations on power supply inputlines IEC 61000-4-11				<5% UT (>95% dip in UT) for 0.5 cycle					Not Applicable.		Not Applicable.
				40% UT (60% dip in UT) for 5 cycles					Not Applicable.
				70% UT (30% dip in UT) for 25 cycles					Not Applicable.
				<5% UT (>95% dip in UT) for 5 sec.					Not Applicable.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8				3 A/m					30 A/m		Magnetic fields from common appliances are not expected to affect the device.
Note: UT is the A.C. mains voltage prior to application of the test level.
Guidance and manufacturer's declaration - electromagnetic immunity
OMRON battery-operated BPM is intended for use in the electromagnetic environment specified below. The customer or the user of this OMRON battery-operated BPM should assure that it is used in such environment.
Immunity test		IEC 60601 test level			Compliance level			Electromagnetic environment - guidance
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3		3 V rms 150 kHz to 80 MHz 3 V/m			Not Applicable. 10 V/m			Portable and mobile RF communications equipment should be used no closer to any part of the OMRON battery-operated BPM including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter. Recommend separation distance Not Applicable. d = 0.35 80 MHz to 800 MHz d = 0.70 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
Note1: At 80 MHz and 800 MHz, the higher frequency range applies. Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the OMRON battery-operated BPM is used exceeds the applicable RF compliance level above, the OMRON battery-operated BPM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the OMRON battery-operated BPM. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 6 V/m.
Recommended separation distance between portable and mobile RF communications equipment and the OMRON battery-operated BPM
OMRON battery-operated BPM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this OMRON battery-operated BPM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OMRON battery-operated BPM as recommended below, according to the maximum output power of the communications equipment.
Output Power of Transmitter in Watt					Separation distance according to frequency of transmitter in meter
					150 kHz to 80 MHz Not Applicable.				80 MHz to 800 MHz d = 0.35		800 MHz to 2.5 GHz d = 0.70
0.01					Not Applicable.				0.035		0.070
0.1					Not Applicable.				0.11		0.22
1					Not Applicable.				0.35		0.70
10					Not Applicable.				1.1		2.2
100					Not Applicable.				3.5		7.0
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

The Bluetooth^® Smart word mark and logos are registered trademarks owned by 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.

Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.
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© 2015 OMRON HEALTHCARE, INC.