OMRON HEALTHCARE HEM7150T User Manual

Contraindications

Warning

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

5 series Upper Arm Blood

Caution

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient, or cause damage to the equipment or other property.

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Year

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Bottom edge

0.5 inch (1 to 2 cm)

Bottom edge

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Pressure Monitor

Model BP7250

Instruction Manual

Tabl e of Con tent s

Introduction Important Safety Information

1. Know Your Monitor

2. Preparation

3. Using Your Monitor without a Smart Device

4. Using Your Monitor with a Smart Device

5. Using Memory Function

6. Other Settings

7. Error Messages and Troubleshooting

8. Maintenance

9. Optional Accessories

10. Specifications

11. FCC Statement

12. Limited Warranty

13. Guidance and Manufacturer’s Declaration

Introduction

Thank you for purchasing the OMRON BP7250 Blood Pressure Monitor. This monitor can be used by multiple users. This blood pressure monitor uses the oscillometric method of blood pressure measurement. This means this monitor detects your blood movement through your brachial artery and converts the movements into a digital reading.

Safety Instructions

This instruction manual prov ides you with important information abou t the OMRON BP7250 Blood Pressure Monitor. To ensure the safe and proper use of this monitor, READ and UNDERSTAND all of the safety and operating instructions. If you do not understand these instructions or

have any questions, contact 1-800-634-4350 before attempting to use this monitor. For specific information about your own blood pressure, consult with your physician. Intended Use

This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult pat ient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Environments of Use: Home Patient Population: Adult

Receiving and Inspection

Remove this monitor and other comp onents from the packaging and inspect for damage. If this monitor or any other components is damaged, DO NOT USE and contact 1-800-634-4350.

Symbols Glossary

For symbol information, visit: OmronHealthcare.com/symbols- glossary

•This moni tor is contraindicated for use in ambulator y environments.

•This moni tor is contraindicated for use on aircra ft.

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, CONSULT WITH YOUR PHYSICIAN.

•DO NOT use this monitor on infants, toddlers, children or persons who cannot express themselves.

•DO NOT adjust medication based on readings from this blood pressure monitor. 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 apply the arm cuff on your arm while on an intravenous drip or blood transfusion.

•DO NOT use this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.

•DO NOT use this monitor in oxygen rich environments or near flammable gas.

•Consult with your physician before using this monitor if you have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or renal disease. NOTE that any of these conditions in addition to patient motion, trembling, or shivering may affect the measurement reading.

•NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician.

•To help avoid strangulation, keep the air tube and AC adapter cable away from infants, toddlers or children.

•This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers or children.

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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 monitor and remove batteries and/or unplug the AC adapter when in RF restricted areas. For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC.

AC Adapter (optional accessory) Handling and Usage

•DO NOT use the AC adapter if this monitor or the AC adapter cable is damaged. If this monitor or the cable is damaged, turn off the power and unplug the AC adapter immediately.

•Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a multi-outlet plug.

•NEVER plug in or unplug the AC adapter from the electric outlet with wet hands.

•DO NOT disassemble or attempt to repair the AC adapter.

Battery Handling and Usage

•Keep batteries out of the reach of infants, toddlers or children.

•Stop using this monitor and consult with your physician if you experience skin irritation or discomfort.

•Consult with your physician before using this monitor on an arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because of temporary interference to blood flow which could result in injury.

•Consult with your physician before using this monitor if you have had a mastectomy.

•Consult with your physician before using this monitor if you have severe blood flow problems or blood disorders as cuff inflation can cause bruising.

•DO NOT take measurements more often than necessary because bruising, due to blood flow interference, may occur.

•ONLY inflate the arm cuff when it is applied on your upper arm.

•Remove the arm cuff if it does not start deflating during a measurement.

•DO NOT use this monitor for any purpose other than measuring blood pressure.

•During measurement, make sure that no mobile device or any other electrical device that emits electromagnetic fields is within 12 inches (30 cm) of this monitor. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.

•DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate reading.

•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 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. Refer to section 10.

•During measurement, observe the arm to ensure that the monitor is not causing prolonged impairment to blood circulation.

•DO NOT use this monitor in high-use environments such as medical clinics or physician offices.

•DO NOT use this monitor with other medical electrical (ME) equipment simultaneously. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.

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

•Rest for at least 5 minutes before taking a measure ment.

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

•Remain still and DO NOT talk while taking a measurement.

•ONLY use the arm cuff on persons whose arm circumference is within the specified range of the cuff.

•Ensure that this monitor has acclimated to room temperature before taking a measurement. Taking a measurement after an extreme temperature change could lead to an inaccurate reading. OMRON recommends waiting for approximately 2 hours for the monitor to warm up or cool down when the monitor is used in an environment within the temperature specified as operating conditions after it is stored either at the maximum or at the minimum storage temperature. For additional information of operating and storage/transport temperature, refer to section 10.

•DO NOT use this monitor after the durable period has ended. Refer to section 10.

•DO NOT crease the arm cuff or the air tube excessively.

•DO NOT fold or kink the air tube while taking a measurement. This may cause an injury by interrupting blood flow.

•To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself.

•ONLY use the AC adapter, arm cuff, batteries and accessories specified for this monitor. Use of unsupported AC adapters, arm cuffs and batteries may damage and/or may be hazardous to this monitor.

•ONLY use the approved arm cuff for this monitor. Use of other arm cuffs may result in incorrect readings.

•Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied. NOTE: refer to “If your systolic pressure is more than 210 mmHg” in section 3 of this instruction manual for additional information.

Data Transmission

•DO NOT replace batteries or unplug the AC adapter while your readings are being transferred to your smart device. This may result in incorrect operation of this monitor and failure to transfer your blood pressure data.

AC Adapter (optional accessory) Handling and Usage

•Fully insert the AC adapter into the outlet.

•When unplugging the AC adapter from the outlet, be sure to safely pull from the AC adapter. DO NOT pull from the AC adapter cable.

•When handling the AC adapter cable: DO NOT damage it. DO NOT break it. DO NOT tamper with it. DO NOT forcibly bend or pull it. DO NOT twist it. DO NOT use it if it is gathered in a bundle. DO NOT pinch it. DO NOT place it under heavy objects.

•Wipe any dust off of the AC adapter.

feature in this

•Unplug the AC adapter when not in use.

•Unplug the AC adapter before cleaning this monitor.

Battery Handling and Usage

•DO NOT insert batteries with their polarities incorrectly aligned.

•ONLY use 4 “AA” alkaline or manganese batteries with this monitor. DO NOT use other types of batteries. DO NOT use new and used batteries together. DO NOT use different brands of batteries together.

•Remove batteries if this monitor will not be used for a long period of time.

•If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Consult with your physician immediately.

•If battery fluid should get on your skin, wash your skin immediately with plenty of clean, lukewarm water. If irritation, injury or pain persists, consult with your physician.

•DO NOT use batteries after their expiration date.

•Periodically check batteries to ensure they are in good working condition.

1. Know Your Monitor

1.1 Contents/Product Includes

Monitor, 4 “AA” batteries, Wide-Range D-Ring Cuff, instruction manual, quick start guide

1.2 Monitor and Arm Cuff

Front of the monitor

Display

[Forward/Backward] buttons [Connection] button (Date/Time) [Memory] button

[START/STOP] button

Left side, back and bottom of the monitor

Air jack AC adapter jack (for optional AC adapter) Battery compartment

Arm cuff

(Upper arm circumference: 9" - 17" (22 - 42 cm))

Air plug

Air tube

1.3 Display and Symbols

Memory symbol

Appears when viewing readings stored in the memory.

Average value symbol

Flashes when viewing the aver age of the latest 2 or 3

readings taken within the most recent 10 minute timeframe.

Sync symbol

Flashes/appears when your data needs to be transferred because the stored memory is either almost, or completely full. Once you pair your monitor with your smart device,

transfer your readings immediately before the monitor deletes the oldest reading. Up to 60 readings can be stored in the internal memory of your monitor.

Systolic blood pressure reading

Diastolic blood pressure reading

Deflation symbol

Appears during cuff deflation.

Heartbeat symbol

Flashes while taking a measurement.

Date/time display

Bluetooth ON symbol

Appears when your readings are being transferred.

Bluetooth OFF symbol

Appears when Bluetooth is disabled.

High symbol

Appears if your systolic blood pressure is  130 mmHg or the diastolic blood pressure is  80 mmHg. Refer to subsection 1.4 for more information.

Irregular heartbeat symbol

Appears when irregular rhythm is detected 2 or more times during a measurement. The symbol with the number appears as below:

Irregular heartbeat is detected 2 times: Irregular heartbeat is detected 3 times or more:

An irregular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the aver age rhythm detected

while your monitor is measuring blood pressure.

Irregular Heartbeat

Normal Heartbeat

Irregular heartbeat symbol may be displayed when the monitor detects arm movements. Refer to section 7 for more information.

If it continues to appear, we recommend you to consult with and follow the directions of your physician.

Movement error symbol

Appears with your reading when your body is moving during a measurement. If it appears, remove the arm cuff and wait

for 2 to 3 minutes. Then, reapply the cuff, remain still and take another measurement.

OK symbol

Flashes when your monitor is connected to your smart

device or readings are transferred successfully.

Low battery symbol

Flashes when batteries are lo w.

Depleted battery symbol

Appears when batteries are depleted.

Pulse display / Memory number

Pulse rate appears after the meas urement.

When pressing the button, the memory number will also appear

for approximately 1.5 seconds before the pulse rate shows again on the display.

1.4 Classification of BP (Blood Pressure)

ACC/AHA 2017 Hypertension guidelines define categories of BP in adults as below.

Categories of BP in Adults*

BP Category Systolic BP Diastolic BP

Normal < 120 mmHg and < 80 mmHg

Elevated 120 - 129 mmHg and < 80 mmHg

Hypertension

Stage 1 130 - 139 mmHg or 80 - 89 mmHg

Stage 2  140 mmHg or  90 mmHg

* Individuals with Systolic BP and Diastolic BP in 2 categories should be

designated to the higher BP category. BP indicates blood pressure (based on an average of  2 careful readings obtained on  2 occasions). Source: ACC/AHA 2017 High Blood Pressure Clinical Practice Guideline

•NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician.

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2. Preparation

2.1 Installing Batteries

1. Push down the hook of the

battery cover and pull downward.

2. Insert 4 “AA” batteries as

indicated in the battery compartment.

3. Close the battery cover.

As soon as batteries are correctly installed, the year flashes on the display. Refer to sub-section 2.2 to set the date and time manually, or refer to sub-section 4.1 to pair your monitor to set the date and time automatically.

•When the “ ” symbol flashes on the display, it is recommended you replace batteries.

•To replace batteries, turn your monitor off and remove all batteries. Then replace with 4 new batteries at the same time.

•Replacing batteries will not delete previous readings.

•The supplied batteries may have a shorter life span than new batteries.

•Disposal of used batteries should be carried out in accordance with local regulations.

2.2 Setting the Date and Time

•Set your monitor to the correct date and time before taking a measurement for the first time.

•As soon as batteries are correctly installed, the year flashes on the display of your monitor.

•The date and time will automatically be set when the monitor is paired with “OMRON connect US/CAN” app. Refer to sub-section 4.1.

1. If nothing is displayed, press the button to display the year.

If the year is already displayed, skip this step.

2. Press the or button to adjust the year.

Press and hold the button to quickly advance the years.

Press and hold the button to quickly go backwards through the years.

3. Press the button to

confirm the year, then the month will flash. Repeat the same steps to adjust the month, day, hour, and minute.

4. Press the button to store the sett ing.

Your monitor automatically turns off 3 seconds after the minutes have been set in this sequence.

•If you need to reset the date and time, replace batteries or press the

button, then set the date and time as shown in above steps.

•If the date and time are not set, “ ” flashes during or after measurement.

2.3 Blood Pressure Measurement Tips

To help ensure an accurate reading, follow these directions:

•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. 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.

•Avoid bathin g, drinking alcohol or caffeine, smoking, ex ercising and eating for at least 30 minutes before taking a measurement.

•Rest for at least 5 minutes before taking a measurement.

2.4 Applying the Arm Cuff

•The following steps are for applying the arm cuff to your left arm. When you take a measurement on your right arm, follow the cuff wrap instructions for a right arm use mentioned under “To take a measurement on your right arm” 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. If the readings between both arms differ substantially, check with your physician to determine as to which arm to use for your measurements.

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

1. Plug the arm cuff into your monitor

by inserting the air plug into the air jack securely until it clicks.

2. Place your hand through the cuff loop. Pull

the cuff until it reaches your upper left arm.

•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.

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.

To take a measurement on your right arm

When you take a measurement on your right arm, the air tube should run along the side of your elbow, along the bottom of your arm. Be careful not to rest your arm on the air tube.

2.5 Sitting Correctly

To take a measurement, you need to be relaxed and comfortably seated in a room at a comfortable temperature. Place your arm on the table.

•Sit in a comfortable chair with your back and arm supported.

•Keep your feet flat and your legs uncrossed.

•The arm cuff should be placed on your arm at the same level as your heart, with the arm resting comfortably on a table.

3. Using Your Monitor without a Smart Device

3.1 Taking a Measurement

You can use your monitor without pairing to a smart device. To pair your monitor with a smart device, refer to sub-section 4.1.

•To stop the measurement, press the [START/STOP] button once to deflate the arm cuff.

•DO NOT use this monitor with other medical electrical (ME) equipment simultaneously. This may result in incorrect operation of the monitor and/ or cause an inaccurate reading.

•Remain still and DO NOT talk while taking a measurement.

1. Press the [START/STOP] button.

All symbols appear on the display before starting the measurement.

2. Remain still and do not talk until the entire measurement

process is complete.

The “ ” symbol flashes at every heartbeat. After your monitor has detected your blood pressure and pulse rate, the cuff automatically deflates. Your blood pressure and pulse rate are displayed. If either the systolic or the diastolic reading is high (refer to subsection 1.3), the “ ” symbol appears.

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

•Your monitor automatically turns off after 2 minutes.

•Wait 2 - 3 minutes bet ween measurements. The wait time allo ws the arteries to decompress and return to their pre-measurement state. You may need to increase the wait time depending on your individual physiological characteristics.

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Using the Guest Mode

The guest mode can be used to take a single measurement for another user.

•No readings are stored in the memory.

1. Press and hold the [START/STOP] button for

more than 3 seconds.

The date/time display will disappear.

2. Release the [START/STOP] button when the date/time display

turns off.

The arm cuff automatically starts to inflate.

If your systolic pressure is more than 210 mmHg

If your systolic pressure is more than 210 mmHg, take a measurement manually. After the arm cuff starts to inflate, press and hold the [START/STOP] button until the monitor inflates 30 to 40 mmHg higher than your expected systolic pressure.

•Do not inflate above 299 mmHg.

•Inflating to a higher pressure than necessary may result in bruising where the arm cuff is applied.

4. Using Your 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 your monitor with your smart device.

Review the list of compatible smart devices at OmronHealthcare.com

1. Enable Bluetooth on your smart device.

2. Download and install the free “OMRON connect US/CAN” app

onto your smart device.

If you already have the “OMRON connect US/CAN” app and have created your account, open the a pp and add your new monitor.

3. Open the app and follow the pairing instructions shown on your

smart device.

4. Confirm that your monitor is connected successfully.

When your monitor is connected successfully to your smart device, the “OK” symbol appears.

INFLATINGSTART COMPLETED

5. Press [START/STOP] button to turn your monitor off.

•If the “Er r” symbol appears, follow the instructions in the “OMRON connect US/CAN” app.

•Your monitor automatically turns off after 2 minutes.

•Be aware th at OMRON will not be responsi ble for the loss of data and/or information in the app.

•“OMRON connec t US/CAN” is the only app that we recommend to use with your monitor to transfer data correctly.

4.2 Taking a Measurement

Note

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Warning

Note

Alternating date/time display

Note

Caution

Note

Caution

Note

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.

App Store and App Store logo are service marks of Apple Inc., registered in the U.S and other countries. Google Play and the Google Play logo are trademarks of Google LLC.

OMRON HEALTHCARE Co., Ltd 53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN

Distributed by: OMRON HEALTHCARE, INC. 1925 West Field Court Lake Forest, IL 60045 U.S.A.

Made in Vietnam

Refer to sub-section 3.1 to start a measurement. Open the app on your smart device and follow the instructions.

•Make sure that your monitor is within 16 ft. (5m) of your smart device.

Transferring Data Automatically/Manually

•The readings will be transferred to your smart device within 1 hour after taking a measurement.

•To transfer the readings manually, press the button.

4.3 Disabling/Enabling Bluetooth

•This prod uct 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. When your monitor is off, press and hold the

button for more than 10 seconds.

“oFF” flashes 3 times.

2. Press the [START/STOP] button to turn your monitor off.

•To enable the Bluetooth, press and hold the button for more than 2 seconds. “on” appears on the display.

•Your monitor automatically turns off 2 minutes after the completion.

•When Bluetooth is disabled, the “ ” symbol appears.

5. Using Memory Function

Your monitor automatically stores up to 60 readings.

•This moni tor can be used by multiple users. When you use me mory function with other users, track (or manage) your own readings appropriately.

5.1 Viewing the Readings Stored in Memory

1. Press the button.

The Memory number appears for one second before the pulse rate is displayed. The most recent reading stored in the memory will be numbered as “1”.

•If the reading is high (refer to sub-section 1.3), the “ ” symbol appears.

•If there are no readings stored in the memory, the screen to the right is displayed.

•If the memory is full, new readings will replace the old readings, starting with the oldest reading.

2. Press the or button repeat edly to scroll through the

previous readings stored in the memory.

: To view the older readings

: To view the more recent readings

5.2 Viewing the Average Reading

Your monitor can calculate an average reading based on the latest 2 or 3 readings taken within the most recent 10 minute timeframe.

1. When your monitor is off, press and hold the

button for more than 2 seconds.

The “ ” symbol flashes.

•If there are only 2 readings in the memory for that period, the average will be based on these 2 readings.

•If the average reading is high (refer to sub-section

1.3), the “ ” symbol appears.

6. Other Settings

6.1 Deleting All Readings Stored in Memory

1. Press the button.

After a memory number appears, the latest reading will appear.

2. While holding the button

down, press and hold the [START/STOP] button for more than 3 seconds.

The display to the right flashes.

3. While holding the button

down, press and hold the [START/STOP] button for more than 3 seconds.

4. Press [START/STOP] button to turn your monitor off.

•All readings will be deleted. You cannot partially delete the readings stored in the memory.

•Your monitor automatically turns off after 2 minutes.

6.2 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 [START/ STOP] button for more than 3 seconds.

The display to the right flashes.

2. While holding the

button down, press and hold the [START/ STOP] button for more than 3 seconds.

3. Press [START/STOP] button to turn your monitor off.

•Reverting to the default setting of your monitor does not delete the information in the app.

•Your monitor automatically turns off after 2 minutes.

•You will need to re-pair your monitor when using the monitor again. Without re-pairing, your readings will not be transferred to your app.

7. Error Messages and Troubleshooting

If any of the below problems occur during measurement, check to make sure that no other electrical device is within 12 inches (30 cm). If the problem persists, refer to the table below.

Display/Problem Possible Cause Solution

appears or the arm

cuff does not inflate.

cannot be complete

appears or a

measurement

after the arm cuff

inflates.

appears

Air plug is not completely plugged into the monitor.

The arm cuff is not applied correctly.

Air is leaking from the arm cuff.

You move or talk during a measurement and the arm cuff does not inflate sufficiently.

The systolic pressure is above 210 mmHg and a measurement cannot be taken.

The arm cuff is inflated exceeding the maximum allowable pressure.

You move or talk during a measurement. Vibrations disrupt a measurement.

Insert the air plug securely. Refer to subsection 2.4.

Apply the arm cuff correctly, then take another measurement. Refer to sub-section 2.4.

Replace the arm cuff with a new one. Refer to section 9.

Remain still and do not talk during a measurement. If “E2” appears repeatedly, inflate the arm cuff manually until the systolic pressure is 30 to 40 mmHg above your previous readings. Refer to sub-section 3.1.

Inflate the arm cuff manually until the systolic pressure is 30 to 40 mmHg above your previous readings. Refer to sub-section 3.1.

Do not touch the arm cuff and/or bend the air tube while taking a measurement. If inflating the arm cuff manually, refer to the end of sub-section 3.1.

Remain still and do not talk during a measurement.

Display/Problem Possible Cause Solution

appears

The pulse rate is not

appears

detected correctly.

does not flash during

a measurement

The monitor has malfunctioned.

appears

The monitor cannot connect to a smart device or transmit data correctly.

appears

The monitor is waiting for pairing with the smart device.

flashes

The monitor is ready to transfer your readings to

flashes

the smart device.

There are more than 40 readings in memory to be transferred.

flashes

The date and time is not set.

There are 60 readings in memory to be transferred.

appears

Batteries are low.

flashes

appears or the monitor is turned off unexpectedly during

Nothing appears on the display of the monitor.

Readings appear too high or too low.

Any other communication issue occurs.

Any other problems occur.

Batteries are depleted.

a measurement.

Batteries are depleted.

Battery polarities are not properly aligned.

Blood pressure varies constantly. Many factors including stress, time of day, and/or how you apply the arm cuff, may affect your blood pressur e. Review sub-sections 2.3 - 2.5 and secti on 3.

Follow the instructions shown in the smart device, or visit the “Support” section in the “OMRON connect US/CAN” app for further help. If the problem still persists, contact customer service. Refer to section 12.

Press the [START/STOP] button to turn the monitor off, then press it again to take a measurement. If the problem continues, remove all batteries and wait for 30 seconds. Then re-install batteries. If the problem still persists, contact customer service. Refer to section 12.

Apply the arm cuff correctly, then take another measurement. Refer to sub-section 2.4. Remain still and sit correctly during a measurement. If the “ ” symbol continues to appear, we recommend you to consult with your physician.

Press the [START/ STOP] button again. If “Er” still appears, contact customer service. Refer to section 12.

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 12.

Refer to sub-section 4.1 for pairing your monitor with your smart device.

Open the “OMRON connect US/CAN” app to transfer your readings.

Pair or transfer your readings to the “OMRON connect US/CAN” app so you can keep them in memory in the app, and this error symbol disappears.

Replacing all batteries with 4 new batteries is recommended. Refer to sub-section 2.1.

Immediately replace all batteries with 4 new batteries. Refer to subsection 2.1.

Check the battery installation for proper placement. Refer to subsection 2.1.

8. Maintenance

8.1 Maintenance

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

•Changes or modifications not approved by the manufacturer will void the user warranty.

•DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate reading.

8.2 Storage

Store your monitor and other components in a clean, safe location.

1. Remove the arm cuff from the monitor.

•To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself.

2. Gently fold the air tube into the arm

cuff.

•Do not bend or crease the air tube excessively.

Do not store your monitor and other components:

•If your 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.

8.3 Cleaning

•Do not use a ny abrasive or volatile cleaners.

•Use a soft dry c loth or a soft cloth moistened with mild (neutr al) detergent to clean your monitor and arm cuff and then wipe them with a dry cloth.

•Do not wash or immerse your monitor and arm cuff or other components in water.

•Do not use gasoline, thinners or similar solvents to clean your monitor and arm cuff or other components.

8.4 Disposal

Dispose of your monitor, other components an d optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.

9. Optional Acces sories

Small D-Ring Cuff Wide-Range D-Ring Cuff

Arm circumference 7" - 9" (17 - 22 cm)

Model:

HEM-CS24-B HEM-CS24-BZ

AC Adapter

Model: HEM-ADPTW5

•Do not throw the air plug away. The air plug can be applicable to the optional cuff.

Using the AC Adapter (optional accessory)

•Make sure not to place your monitor in a location where it is difficult to plug and unplug the AC adapter.

•We recommend keeping batteries in your monitor at all times, even if you choose to use the AC adapter. If only the AC adapter is used without keeping batteries in your monitor, you may need to reset the date and time each time you unplug and plug back the AC adapter. The readings will not be deleted.

1. Insert the AC adapter plug into

the AC adapter jack on the rear side of your monitor.

2. Plug the AC adapter into an

electrical outlet.

To unplug the AC adapter, unplug the AC adapter from the electrical outlet and then remove the AC adapter plug from the monitor.

•Only use the AC adapter, the arm cuff, batteries and accessories specified for this monitor. Use of unsupported AC adapters, arm cuffs and batteries may damage and/or may be hazardous to this monitor.

Arm circumference

9" - 17" (22 - 42 cm)

Model:

HEM-RML31-B HEM-RML31-BZ

For further information, visit our website at OmronHealthcare.com

10. Specifications

Model Display LCD digital display Cuff pressure range 0 to 299 mmHg Blood pressure

measurement range Pulse measurement

range

Accuracy

Inflation Automatic by electric pump Deflation Autom atic pressure release valve Measurement method Oscillometric method Transmission method

Wireless communication

Operation mode Continuous operation

IP classification

Rating DC6 V 4.0 W

Power source

Battery life

Durable period (Service life)

Operating conditions

Storage / Transport conditions

Weight

Dimensions

Cuff circumference applicable to the monitor

Memory Stores up to 60 readings

Contents

Protection against electric shock

Applied part Type BF (arm cuff)

•These specifications are subject to change without notice.

•In the cli nical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure.

•This monito r complies with the requirements of ISO 81060- 2:2013.

•This monitor has not been validated for use on pregnant patients.

•IP classif ication is degrees of protection provided b y enclosures in accordance with IEC 60529. This monitor and optional AC adapter are protected against solid foreign objects of 0.5 inches (12.5 mm) diameter and greater such as a finger. The optional AC adapter is protected against vertically falling water drops which may cause issues during a normal operation.

About a wireless communication interference

This product operates in an unlicensed ISM band at 2.4 GHz. In the event this product is used near other wireless devices such as microwave and wireless LAN, which operat e on the same frequency band as this product, there is a possibility that interference may occur. If interference occurs, stop the operation of the other devices or relocate this product away from other wireless devices before attempting to use it.

Pictogram on the Product

BP7250 HEM-7150T-Z

SYS: 60 to 260 mmHg DIA: 40 to 215 mmHg

40 to 180 beats / min.

Pressure: ±3 mmHg Pulse: ±5% of display reading

Bluetooth

low energy technology

Frequency range: 2.4 GHz (2400 - 2483.5 MHz) Modulation: GFSK Effective radiated power: < 20 dBm

Monitor: IP 20 Optional AC adapter: IP21

4 “AA” batteries 1.5 V or optional AC adapter (INPUT AC100 - 240 V 50 - 60 Hz

0.12 - 0.065 A) Approximately 1,000 measur ements (using new

alkaline batteries) Monitor: 5 years

Arm cuff: 5 years Optional AC adapter: 5 years

+50°F to +104°F (+10°C to +40°C) / 15 to 90% RH (non-condensing) / 800 to 1060 hPa

-4°F to +140°F (-20°C to +60°C) / 10 to 90% RH (non-condensing)

Monitor: Approximately 10.2 oz. (290 g) not including batteries Arm cuff: Approximately 6 oz. (170 g)

Monitor: Approximately 4.2" (w) × 3.4" (h) × 6.0" (l) (105 mm × 85 mm × 152 mm) Arm cuff: Approximately 5.7" × 23.4" (air tube:

29.5") (145 mm × 594 mm (air tube: 750mm))

7" to 17" (17 to 42 cm) (included arm cuff: 9" to 17" (22 to 42 cm))

Monitor, Wide-Range D-Ring Cuff, 4 “AA” batteries, instruction manual, quick start guide

Internally powered ME equipment (When using only batteries) Class II ME equipment (Opti onal AC adapter)

Types of marks used to indicate the correct positioning of the artery for the upper arm

Identifies the type of cuff that is compatible with the blood pressure monitor

11. FCC State ment

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.

•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 e quipment 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 connecte d.

•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).

12. Limited Warranty

Your BP7250 Blood Pressure Monitor, exclud ing the arm cuff and batteries is warranted to be free from defects in materials and workmanship appearing within 2 years from t he date of purchase, when used in accordance with the instruct ions provided with the monitor. The arm cuff i s 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. The above warranty extends only to the original retail purchaser. We will, at our option, replace without charge any monitor or arm cuff 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.

Visit our web site at: OmronHealthcare.com

Call toll free: 1-800-634-4350

13. Guidance and Manufacturer’s Declaration

OMRON Information for Accompanying Documents in the Scope of IEC60601-12:2014

Important information regarding Electromagnetic Compatibility (EMC)

BP7250 manufactured by OMRON HEALTHCARE Co., Ltd. conforms to IEC60601-12:2014 Electromagnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at OmronHealthcare.com/emc. Refer to the EMC information for BP7250 on the website.

FOR CUSTOMER SERVICE

Battery-operated / AC Adapter-operated Blood Pressure Monitor