Omron Evolv User Manual

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Omron Evolv User Manual
Normal Heartbeat
Pulse Blood pressure
Irregular Heartbeat
Short Long Pulse
Blood pressure

Automatic Upper Arm

Blood Pressure Monitor

EVOLV (HEM-7600T-E)

Instruction Manual IM-HEM-7600T-E-EN-01-01/2016

9545878-0B

Introduction

Thank you for purchasing the OMRON EVOLV Automatic Upper Arm Blood Pressure Monitor.

Your new automatic upper arm 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. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. It is mainly designed for general household use.

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.

 

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.

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.

Indicates a potentially hazardous situation which, if not Caution 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.

Note that PATIENT motion, trembling, shivering may affect the measurement reading.

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 or on an airplane.

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 “6. 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.

Read and follow the “Important information regarding Electro Magnetic Compatibility (EMC)” in the “6. Specifications”.

Read and follow the “Correct Disposal of This Product” in “6. Specifications” when disposing of the device and any used accessories or optional parts.

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 Device

Contents:

Monitor, battery set, instruction manual, setup instructions, soft case

Monitor:

 

A.

START/STOP button

 

B.

Connection button

A

C.

Display

D.

Arm cuff

 

E.

Battery compartment

 

D

 

 

C

B

 

E

 

 

 

Display:

 

 

 

F

 

 

 

 

G

F.

Systolic blood pressure

 

G.

Diastolic blood pressure

 

 

H.

Pulse display

 

H

 

 

Connection symbol

 

Battery symbol (low)

Connection OFF symbol

 

Battery symbol (depleted)

Connection ON symbol

 

Deflation symbol

Movement error symbol

 

Heartbeat symbol

 

(Flashes during measurement.)

 

 

 

SYNC symbol

 

Cuff Wrap Guide Symbol

Irregular heartbeat symbol

 

 

1.1 Display symbols

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 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.

Movement Error Symbol ( )

The movement error symbol is displayed if you move your body during the measurement. Please remove the arm cuff, and wait 2 - 3 minutes.

Take another measurement and remain still during measurement.

Cuff Wrap Guide Symbol ( / )

If the cuff was wrapped too loosely, it may cause unreliable results. If the wrapping of cuff is too loose, the cuff wrap guide symbol “” appears.

Otherwise “ ” appears. This is the function which is used as an aid in determining if the cuff is wrapped snugly enough.

SYNC Symbol ( )

When the SYNC symbol appears on the display, make sure that your monitor has been pairing with the smart device or transfer the data.

When the SYNC symbol appears on the display, transfer the data before the measurements are deleted. Maximum internal memory is for

100 measurements. The oldest value will be deleted when this is reached before downloading.

2013 ESH/ESC Guidelines for the management of arterial hypertension

Definitions of hypertension by office and home blood pressure levels

 

Office

Home

Systolic Blood Pressure

≥140 mmHg

≥135 mmHg

Diastolic Blood Pressure

≥90 mmHg

≥85 mmHg

These are from statistical values for blood pressure.

1.2 Before Taking a Measurement

To help ensure an accurate reading, follow these directions:

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

2.Rest for at least 5 minutes before taking the measurement.

3.Stress raises blood pressure. Avoid taking measurements during stressful times.

4.Measurements should be taken in a quiet place.

5.Remove tight-fitting clothing from your arm.

6.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

2.1Battery Installation

1.Remove the battery cover.

Gently slip into the gap of the hook and pull downward.

2. Insert 4 “AAA” batteries as

indicated, into the battery compartment.

3. Replace the battery cover.

When the batteries have been securely placed in this device, the message and SYNC symbol below will appear on the screen:

: Make sure to press the connection button to pair with the smart device or transfer the data before taking a measurement when

the SYNC symbol appears.

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.

2.2Pairing 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.

To begin using the “OMRON connect” app for the first time, please visit omronconnect.com/setup for the initial set-up instructions.

Review the list of compatible smart devices at: omronconnect.com/devices

For details, visit: omronconnect.com

1.Turn on the Bluetooth® feature of the smart device.

2.Download and install the free “OMRON connect” app on your smart device.

* If you already have the “OMRON connect” app, go to: Menu > Devices > Add 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.

If “Err” appears, refer to “Connection failure. / Data is not being transmitted.” in section 4.2 for more detail.

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.

If you use the monitor without pairing, refer to the “Using your Monitor without Pairing” in the “3.3 Taking a Measurement”.

3.Using the Device

3.1Applying the Arm Cuff

Remove tight-fitting clothing from your left upper arm. Do not place the arm cuff over thick clothes.

1. Apply the arm cuff to your left upper arm.

The bottom edge of the arm cuff should be

1 - 2 cm

1 to 2 cm above the elbow. Positioning the

 

display in clear view of the user makes it

 

easier to read the results.

 

2. Securely close with the fabric fastener.

Notes:

• The blood pressure can differ between

the right arm and the left arm, and the measured blood pressure values can

be different. Omron recommends to always use the same arm for measurement. If the values between both arms differ substantially, please check with your physician as to which arm to use for your measurements.

Positioning the monitor with the [START/STOP] button towards the body makes it easier to use the device.

3.2 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.

3.3 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 device will store 100 measurements in the device. 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 the monitor with other electrical devices simultaneously. This may result in incorrect operation of the monitor.

1.Press the [START/STOP] button.

The arm cuff will start to inflate.

START

 

INFLATING

DEFLATING

 

 

 

 

 

 

 

 

 

 

COMPLETED

: The arm cuff was wrapped snugly enough.

: The arm cuff was loose or not wrapped correctly.

Note: The cuff wrap guide result appears on the display during the measurement.

The following symbols indicate incorrect measurement

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

Example:

2.Remove the arm cuff.

3.Transfer your readings.

Please make sure your monitor is within 5 m (16 ft.) of your smart device and your “OMRON connect” app is active.

As soon as the measurement is complete, your reading will be automatically transferred to the app.

Transferring your readings later

1.Open the app on your smart device and then follow the instructions.

2.Press connection button to transfer your readings.

If your readings are successfully transferred to your smart device, “OK” will flash on the display.

If “Err” appears, refer to “Connection failure. / Data is not being transmitted.” in section 4.2 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 3.4)

Once you send your readings to the app, the data cannot be resent 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 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 their prior condition 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 cannot be transferred again to the same smart device, nor to another smart device.

About Multiple Users

This monitor is recommended for personal use.

When this monitor is used by more than one person, the measurement data will be combined.

Using your Monitor without Pairing

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

1.Apply the arm cuff. (Refer to section 3.1)

2.Press [START/STOP] button. (Refer to step 1 to 2 in section 3.3)

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.

Note: When using this blood pressure monitor without a smart device, you will not be able to view your prior readings stored in the memory.

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