OMRON HEALTHCARE HEM6410T User Manual

4. Using Your Monitor with a Smart Device

4.3 Taking Activity Measurements

Your monitor automatically measures your activities when you are wearing your monitor. The following items will be measured:

t Steps t Calories burned t Distance

t Aerobic steps

Refer to “Readings Details“ in section 6 (page 45) for more information.

Note

Do not wear your monitor other than on your wrist.

Pair your monitor with your smart device.

Refer to sub-section 4.1 (page 32). The personal information you are asked to provide on the app is to help calculate measurements accurately.

You can also set your daily target steps on the app.

Set your stride length.

The initial stride length displayed on the app is an estimated value calculated by your height setting. You may choose to adjust your stride length by adding the new value in the app. For instructions on calculating your stride manually, refer to the instructions below.

1. Walk 10 steps with your normal stride as illustrated below.

2. Measure the distance from START to END in inches.

3. Calculate your stride length by dividing the total distance by 10.

Example:

Total distance = 320’’ 320 ÷ 10 = 32’’ (2 feet 8 inches)

Conversion Chart

4. Using Your Monitor with a Smart Device

12 inches = 1 foot 24 inches = 2 feet 36 inches = 3 feet 48 inches = 4 feet

Wear your monitor wherever you go.

END

320 inches

When your target steps are achieved, the achievement screen appears.

Press the [FORWARD] button to view the readings stored in the

5000

steps

memory.

Refer to section 6 (page 43) for more information.

SYS

mmHg

DIA

mmHg

PULSE

min

05/17 8:38

118

10217

5.1mile 328kcal

7h26

80% / 8h12

05/17 8:38 AM

THU 17

8:38

START

Blood pressure Activities Sleep

4. Using Your Monitor with a Smart Device

Your monitor may not track your activity data in the following conditions:

Improperly Wearing

t Wearing your monitor somewhere other than your wrist. t Putting your monitor inside a bag or pocket.

Moving Irregularly

t Placing your monitor inside or attached to a bag, and the bag moves irregularly. t Moving your arm continuously when not walking. t Carrying a bag t Extremely slow arm movements. t Doing housework without walking.

Walking at an Inconsistent Pace

t Shuffling or wearing sandals. t Constantly starting and stopping walking, or moving at some other inconsistent pace. t Walking extremely slowly.

Moving Up and Down

t Standing up and sitting down. t Playing sports other than walking.

t Going up or down stairs or a steep slope.

Vibrations from a Moving Vehicle t You are on a bicycle, automobile, train or bus.

4. Using Your Monitor with a Smart Device

4.4 Taking Sleep Measurements

Your monitor measures your sleep by detecting movement of your body while you sleep. The following items will be measured:

t Sleep period time t Awake time

Refer to “Readings Details” in section 6 (page 45) for more information.

Note

t Do not wear your monitor other than on your wrist. t During the sleep mode, your monitor does not count your steps. t If you set the sleep mode manually, you cannot take a blood pressure

measurement, transfer data, or change settings.

Pair your monitor with your smart device.

Before taking a measurement, pair your monitor with your smart device. Refer to sub-section 4.1 (page 32). You can also set your daily target sleep period time on the app.

4. Using Your Monitor with a Smart Device

Go to sleep with your monitor on.

To detect and track your sleep automatically, set your approximate daily bedtime and wake-up time on the app first.

Note

t When you take a measurement, do not place your monitor on the floor, bed,

or shelf.

t To enable the sleep mode manually, refer to the “OMRON connect US/CAN“

app.

Get up.

Your monitor will detect rising and disable the sleep mode automatically.

Your monitor may not track your sleep data in the following instances:

t Wearing your monitor somewhere other than your wrist. t Wearing your monitor too loosely, so that you can insert more than one pointer

finger in between your wrist and the band.

t Sleeping in a Chair or Couch

4. Using Your Monitor with a Smart Device

4.5 Receiving Notification from Your Smart Device

Your monitor receives a notification (phone call, message and email) from your smart device. When your monitor receives a notification, your monitor vibrates. Press any button to close the notification.

Missed call

1-080-209-2939

Phone call

Message From

Brian

Message

Mail from

mail@ohq.omron...

Note

t Refer to “OMRON connect app US/CAN” for compatible email apps or any

other information.

t Your monitor cannot receive a notification from your smart device during

the following:

- During taking a blood pressure measurement.

- When the Bluetooth function of your monitor or smart device is disabled.

t Your monitor only displays English characters.

4. Using Your Monitor with a Smart Device

4.6 Receiving a Reminder

The reminder function will alert you at a specific time of day with vibration and the “Reminder” icon on the display. The time for the reminder can only be set on the app.

Reminder

Note

t To stop the vibration, press any button. t Reminder can be set within 24 hours.

5. Recording an Event

You can record the time of your action or activity as an “Event”, such as time you ate, took a medicine, exercised or had another event.

Note

The recorded time of your events can be viewed on the app only.

Press and hold the [FORWARD] button for more than 3 seconds.

“Record” appears on the display.

THU 17

8:38

Record

6. Viewing the Readings Stored in Memory

Only your latest reading can be viewed on the monitor’s display. Use the “OMRON connect US/CAN” app to view all the readings stored in the memory.

Press the [FORWARD] button.

THU 17

8:38

Press the [FORWARD] button one by one.

The display of your readings changes as below. For activities and sleep, the ring around the reading describes the level of achievement against your target.

SYS

118

mmHg

DIA

mmHg

PULSE

Blood pressure Activities Sleep

min

05/17 8:38

10217

5.1mile 328kcal

7h26

80% / 8h12

05/17 8:38 AM

THU 17

8:38

6. Viewing the Readings Stored in Memory

If this monitor detects any errors during a measurement, the following symbols will appear on the display.

SYS

118

mmHg

DIA

mmHg

PULSE

min

Alternating

pulse/symbols

05/17 8:38

display

Symbol

Meaning

This monitor is not at the

SYS

mmHg

DIA

mmHg

118

05/17 8:38

correct height. Irregular heartbeats are

detected.

Movement during measureing.

6. Viewing the Readings Stored in Memory

Readings Details

Calories burned Indicates the amount of calories burned by

measuring the intensity of your activity.

Distance Indicates you distance traveled by using your step

count.

Note

If you have jogged, climbed up or down stairs, or walked at brisk walking pace, some errors may occur in the value.

Aerobic steps Aerobic steps are the physical exercise that helps us

stay healthy. Aerobic steps are counted separately when walking more than 60 steps per minute and more than 10 minutes successively. If a rest of less than 1 minute is taken after a continuous walk of more than 10 minutes, this will be regarded as part of “a continuous walk”.

Note

Aerobic steps can be viewed on the app only.

Sleep period time Indicates your actual time asleep. Awake time Indicates the time of movement at “restless level 2”

after you fell asleep. For more information on restless levels, refer to “Sleep Mode Details” on the next page.

Note

Awake time can be viewed on the app only.

Sleep Mode Details

6. Viewing the Readings Stored in Memory

Bedtime Fall asleep time

Time until

you fall asleep

Total amount of sleep period time is from the time sleep mode is enabled to the time sleep mode is disabled, except the awake time.

Sleep mode

enabled

Time of movement at restless level 2

Wake up time

Sleep period time

Restless level

2 1 0

Sleep mode

disabled

Awake time

during sleep period time.

7. Settings

ON / OFF

L / R

ON / OFF

L / R

[ ON ]

OFF

7.1 Function settings

To change the function settings on your monitor, press and hold both [START/STOP]

THU 17

button and [FORWARD] button for more than 3 seconds.

7.1.1 Enabling/Disabling Heart Zone Indicator ( )

Press the [START/STOP] button for heart

zone indicator setting.

Press [START/STOP] button to enable, or

press [HOME] button to disable.

Note

The heart zone indicator is enabled by default. The current setting is shown in the bracket.

ON / OFF

L / R

7. Settings

7.1.2 Selecting Your Wrist to Wear ( Left or Right )

Press the [HOME] button for wrist setting.

Press [START/STOP] button if you wear

your monitor on the left wrist, or press

[ L ]

[HOME] button if you wear the monitor on the right wrist.

Note

Left is set by default. Current setting is indicated in the bracket.

7. Settings

7.2 Bluetooth settings

To enter the pairing mode or change Bluetooth setting, follow the instructions below.

7.2.1 Entering Pairing Mode

Press and hold the [HOME] button for more than 3 seconds. Refer to sub-section 4.1 (page

32) to pair your monitor with your smart device.

Note

Bluetooth will be enabled automatically after pairing with your smart device sucessfully.

THU 17

Connect to the

Smartp device app

for Pairing

7. Settings

7.2.1 Disabling/Enabling Bluetooth

Warning

This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in locations where RF is restricted, such as on an aircraft or in hospitals. Turn off the Bluetooth feature in those areas. For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC.

Press and hold the [HOME] button for at least 3 seconds when your monitor is in the pairing mode. When Bluetooth is enabled, this operation will make it disabled. When Bluetooth is disabled, this operation will make it enabled.

Note

t Bluetooth is enabled by default.

Connect to the

Smartp device app

for Pairing

ON →OFF

OFF→ON

7. Settings

7.3 Restoring Your Monitor to the Default Settings

To delete all the information stored in your monitor, follow the instructions below.

Press and hold both the [START/STOP] button and the [HOME] button for at least 7 seconds. When the confirmation screen appears, press [START/STOP] button to restore your monitor.

THU 17

Clear All

Cleared

Cancel

Note

t Reverting to its default setting of your monitor does not delete the information in

the app.

t You will need to re-pair your monitor when using the monitor again. Without

repairing, your readings will not be transferred to your app. Refer to sub-section 4.1 (page 32).

7. Settings

7.4 Turning Off Your Monitor

Press and hold both the [FORWARD] button and the [HOME] button for more than 7 seconds.

Turn off and restart your monitor if either of the following occurs:

t When “Error” with a number other than 1 to 9 appears on the display. t Your monitor cannot be operated even though you pressed a button.

Note

t Turning off your monitor will not delete your reading or any information

in the monitor and the app, however; your step numbers from the past

THU 17

hour may be lost.

t After restarting, open “OMRON connect US/CAN“ app to communicate.

The date and time will be set automatically. When using your monitor without a smart device, you can only take blood pressure measurements. When using your monitor without a smart device, you will not be able to view your prior readings that have been stored in memory.

t If the “Error” with a number other than 1 to 9 appears on the display after

restarting, refer to section 13.

8. Error Messages and Troubleshooting

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

8.1 Error Messages

Display Cause Solution

Irregular heartbeat

Do not move and

take another

measurement

Position device

at heart-level.

Irregular heartbeat detected.

Your body moved during a measurement.

Your monitor is not at the correct height.

Remove your monitor. Wait for 2 - 3 minutes and then take another measurement. Repeat the steps in sub-section 3.1 (page 24). If this error continues to appear, we recommend that you consult with your physician.

Carefully read and repeat the steps in subsection 3.1 (page 24).

Adjust the height of your wrist following the heart zone indicator. Refer to sub-section 3.1 (page 24).

12:35

Please see

the manual.

Error 1

8. Error Messages and Troubleshooting

Display Cause Solution

The battery is depleted.

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

The band is not applied correctly.

Air is leaking from the cuff.

Charge the battery. Refer to sub-section 2.1 (page 19).

Follow the instructions shown in the “OMRON connect US/CAN” app. If it still appears after checking the app, contact customer service. Refer to section 13.

Apply the band correctly, then take another measurement. Refer to sub-section 2.2 (page

21).

Contact customer service. Refer to section 13.

Clothing is interfering with the band.

Remove any clothing interfering with the band. Refer to sub-section 2.2 (page 21).

Please see

the manual.

Error 2

Please see

the manual.

Error 3

Please see

the manual.

Error 4

Please see

the manual.

Error 5

8. Error Messages and Troubleshooting

Display Cause Solution

The band may be applied too

loosely

The cuff was inflated exceeding the maximum allowable pressure.

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

Apply the band correctly, then take another measurement. Refer to sub-section 2.2 (page

21)

Do not touch your monitor while taking a measurement.

Remain still and do not talk during a measurement.

The band was not applied correctly or was moved during a measurement.

Apply the band correctly, then take another measurement. Refer to sub-section 2.2 (page

21). Remain still and sit correctly during a measurement. Refer to sub-section 3.1 (page

24).

Please see

the manual.

Error 7

Please see

the manual.

Error 8

Please see

the manual.

Error 9

Error

8. Error Messages and Troubleshooting

Display Cause Solution

Your wrist is moved up and down during a measurement.

Temperature error is detected.

The monitor has malfunctioned.

The band may be applied too

tightly

Take another measurement making sure not to move your wrist. Refer to sub-section 3.1 (page 24).

Wait for few minutes, then take another measurement in a place with moderate room temperature. If the error appears again, contact customer service. Refer to section 12.

Apply the band correctly, then take another measurement. Refer to sub-section 2.2 (page

21).

Room temperature is too high to charge the battery.

The monitor has malfunctioned.

Charge the battery at a moderate room temperature. If the error still appears, contact customer service. Refer to section 13.

8. Error Messages and Troubleshooting

Display Cause Solution

The monitor has malfunctioned.

Error

123

8.2 Troubleshooting

Problem Cause and Solution

Nothing appears on the display of the monitor.

Readings appear too high or too low.

t Charge the battery. Refer to sub-section 2.1 (page 19). t Your monitor is turned off. Refer to section 2.3 (page 22)

to turn on your monitor.

Blood pressure varies constantly. Many factors including stress, time of day, and/or how you apply the band, may affect your blood pressure. Review sub-section 3.1 (page

24).

Turn off and restart your monitor. Refer to subsection 7.4 (page 52). If the error still appears, contact customer service. Refer to section 13.

Any other communication issue occurs.

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 13.

8. Error Messages and Troubleshooting

Problem Cause and Solution

The monitor cannot be operated.

The monitor or the AC adapter is abnormally hot when charging the battery.

The operating time is short, or the monitor does not operate, even when the battery is fully charged.

Turn off and restart your monitor. Refer to sub-section 7.4 (page 52). If your monitor still does not operate, contact customer service. Refer to section 13.

The monitor or the AC adapter may be damaged. Unplug the AC adapter from the outlet immediately and contact customer service. Refer to section 13.

This may be due to the life of the rechargeable battery. The battery cannot be replaced. Contact customer service (refer to section 13) or dispose of your monitor. Refer to sub-section 9.4.

9. Maintenance

9.1 Maintenance

To protect this monitor from damage, please follow the directions below: t Changes or modifications not approved by the manufacturer will void the

user warranty.

Caution

DO NOT disassemble or attempt to repair this monitor or other components.

9.2 Storage

t Store your monitor in a clean, safe location. t Do not store your monitor:

- If your monitor is wet.

- In locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapors such as bleach.

- In locations exposed to vibrations or shocks.

9. Maintenance

9.3 Cleaning

t Do not use any abrasive or volatile cleaners. t Use a soft dry cloth or a soft cloth moistened with neutral soap to clean

your monitor, and then wipe them with a dry cloth.

t Do not wash or immerse your monitor in water. t Do not use gasoline, thinners or similar solvents to clean your monitor. t Do not use a wet cloth on the plugs of the AC adapter. The charging cable,

or the terminal of the charging clip.

Caution

t Stop using this monitor and consult with your physician if you experience

skin irritation or discomfort.

t Prolonged rubbing and pressure may irritate the skin. Give your wrist a

break by removing your monitor for a while after extended wear.

t Be careful not to let chemical products such as lotions, oils, skin creams

or cosmetics collect on the band. If this happens, wipe them immediately, otherwise it may impact the material and lifetime of product.

9.4 Disposal

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

10. Optional Accessories

■ Charging clip

Model: HEM-CLIP-01

■ AC adapter

Model: HHP-AM02

■ Charging cable

Model: HHX-CB07U

For further information, visit our website at OmronHealthcare.com.

11. Specifications

Model

Display Transflective memory-in-pixel LCD

Memory Blood pressure measurement: Up to 100 times

Transmission method Bluetooth® low energy technology

Wireless communication

Operation mode Continuous operation

IP classification Monitor: IP22

Rating DC 3.8 V 3.0 W

BP8000-M

Activity measurement: Up to 7 days Sleep measurement: Up to 7 times Event: Up to 100 items

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

AC adapter: IPX0

REF

HEM-6411T-ZM

Power source 1 Lithium ion polymer rechargeable battery

(3.8 V; Approximately 164 mAh) AC adapter (INPUT AC100-240 V, 50-60 Hz 0.2-0.13 A)

Battery lifespan Will last for approximately 500 cycles,

8 times/day measurements in normal temperatures of

77.0 °F (25 °C) when new battery fully charged.

11. Specifications

Battery Life Up to 2 days battery life per charge.

(Approximately 16 blood pressure measurements, depending on usage and storage conditions.)

Durable period (Service life)

Operating conditions 41 to 104 °F (5 to 40 °C) / 15 to 90 % RH (non-condensing)

Charging / data transmission conditions

Storage conditions

Transport conditions

Weight Approximately 4.1 oz. (115 g)

Dimensions

Measurable wrist circumference

Monitor: 2 years AC adapter: 2 years

/ 800 to 1060 hPa

50 to 95 °F (10 to 35 °C)

-4 to 104 °F (-20 to 40 °C) / 10 to 90 % RH (non-condensing)

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

Case diameter: Approximately 1.89” (48mm) Case thickness: Approximately 0.55” (14mm) Band width: Approximately 1.18” (30 mm)

6.3” to 7.5” (160 to 190 mm)

Contents Monitor, charging clip (HEM-CLIP-01), charging cable

(HHX-CB07U), AC adapter (HHP-AM02), paper sizing guide, cuff cover, instruction manual, quick start guide

Applied part Type BF (cuf f)

11. Specifications

Protection against electric shock

Maximum temperature of the applied part

Internally powered ME equipment Class II ME equipment (AC adapter)

Lower than +118.4°F (+48°C)

Blood pressure measurement

Cuff pressure range 0 to 299 mmHg Blood pressure measurement range Pulse measurement range Accuracy Pressure: ±3 mmHg

Inflation Automatic by electric pump Deflation Automatic rapid deflation Measurement method Oscillometric method

SYS: 60 to 230 mmHg DIA: 40 to 160 mmHg 40o 180 beats / min.

Pulse: ±5 % of display reading

11. Specifications

Activity / Sleep measurement

Measurement range Steps: 0 to 99,999 steps

Distance: 0.0 to 621.3 mile Time: 12:00 AM to 11:59 PM Calories burned: 0 to 59,999 kcal

Setting range Time: 12:00 AM to 11:59 PM

Weight: 22 to 300 lb (in increments of 1 lb) Height: 3’ 4” to 6’ 6” (in increments of 1 inch) Stride length: 12” to 48” (in increments of 1 inch)

Notes

t These specifications are subject to change without notice. t In the clinical validation study, K5 was used on 85 subjects for

determination of diastolic blood pressure.

t This monitor is comply with the requirements of ISO 81060-2:2013. t This monitor has not been validated for use on pregnant patients. t IP classification is degrees of protection provided by enclosures in

accordance with IEC 60529. This monitor is protected against ingress of dust which would cause issues during a normal operation, and against splashing water which may cause issues during a normal operation.

t This AC adapter is not protected against water.

11. Specifications

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 operate 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

Indicates the correct positioning for the band on the wrist.

Indicates the correct positioning for the monitor on the wrist.

12. FCC Statement

FCC CAUTION

Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any

interference received, including interference that may cause undesired operation.

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:

t Reorient or relocate the receiving antenna. t Increase the separation between the equipment and receiver. t Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. t Consult with 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).

13. Limited Warranty

Your BP8000-M Wrist Blood Pressure Monitor, excluding AC adapter and charging cable, is warranted to be free from defects in materials and workmanship appearing within 1 year 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 or band 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

14. Guidance and Manufacturer’s Declaration

OMRON Battery-operated Blood Pressure Monitor Information for Accompanying Documents in the Scope of IEC60601-1-2:2014

Important information regarding Electro Magnetic Compatibility (EMC)

BP8000-M manufactured by OMRON HEALTHCARE Co., Ltd. conforms to

IEC60601-1-2:2014 Electro Magnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at OmronHealthcare.com/emc. Refer to the EMC information for

BP8000-M

on the website.

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 is a service mark 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 HEM6410T User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual