OMRON HEM-7143T1-EBK Automatic Upper Arm Blood Pressure Monitor Instruction Manual

OMRON HEM-7143T1-EBK Automatic Upper Arm Blood Pressure Monitor Instruction Manual

Product Overview

• A. Display
• B. [Connection] (Memory) button
• C. [START/STOP] button
• D. Battery compartment
• E. AC adapter jack
• F. Air jack
• G. Arm cuff
• H. Air plug
• I. Air tube

Introduction

Thank you for purchasing the M2 Intelli IT Automatic Upper Arm Blood Pressure Monitor. This blood pressure monitor uses the oscillometric method of blood pressure measurement. This means this monitor detects your blood movement through your bronchial artery and converts the movements into a digital reading.

Safety Instructions

This instruction manual provides you with important information about the M2 Intelli IT Automatic Upper Arm Blood Pressure Monitor. To ensure the safe and proper use of this monitor, READ and UNDERSTAND all of these instructions. If you do not understand these instructions or have any questions, contact your OMRON retail outlet or distributor 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 patient population. This monitor detects the appearance of irregular heartbeats during measurement and indicates this via a symbol with readings. It is mainly designed for general household use.

Receiving and Inspection
Remove this monitor from the packaging and inspect for damage. If this monitor is damaged, DO NOT USE and consult with your OMRON retail outlet or distributor.

Important Safety Informantion

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.

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

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

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 orin hospitals. Turn off the Bluetooth® feature in this monitor,remove batteries and/or unplug the AC adapter when in RF restricted areas.

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 pinch 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 place it under heavy objects.

• Wipe any dust off of the AC adapter.

• 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.

General Precautions

• When you take a measurement on the right arm, the air tube should be at the side of your elbow. Be careful not to rest your arm on the air tube.
  

• Blood pressure may differ between the right and left arm, and may result in a different measurement value. Always use the same arm for measurements. If the values between both arms differ substantially, check with your physician on which arm to use for your measurements.

• When using an optional AC adapter, make sure not to place your monitor in a location where it is difficult to plug and unplug the AC adapter.

• To stop a measurement, press the [START/STOP] button while taking a measurement. Battery Handling and Usage

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

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

Battery Handling and Usage

• Disposal of used batteries should be carried out in accordance witi local regulations.
• The supplied batteries may have a shorter life span than new batteries.

Error Messages and Troubleshooting

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

turn the monitor off. After inserting the air plug securely and applying the arm cuff correctly, press the [START/STOP] button.
Air plug is not completely plugged into the monitor.| Insert the air plug securely.
The arm cuff is not applied correctly.|

Apply the arm cuff correctly, then take another measurement. Refer to section 6 of instruction manual.

Air is leaking from the arm cuff.| Replace the arm cuff to the new one. Refer to section 12 of instruction manual .
appears or a measurement cannot be complete after the arm cuff inflates.| You move or talk during a measurement and the arm cuff does not inflate sufficiently.| 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 section 8 of instruction manual.
Due to the systolic pressure is above 210 mmHg, a measurement cannot be taken.
appears| The arm cuff is inflated exceeding the maximum allowable pressure.| Do not touch the arm cuff and/or bend the air tube while taking a measurement. If inflating the arm cuff manually, refer to section 8 of instruction manual .
appears| You move or talk during a measurement. Vibrations disrupt a measurement.| Remain still and do not talk during a measurement.
| | Solution

| The pulse rate is not detected correctly.| Apply the arm cuff correctly, then take another measurement. Refer to section 6 of instruction manual   . Remain still and sit correctly during a measurement If the “ ” symbol continues to appear, we recommend you to consult with your physician.
appears| |
appears| |
does not flash during a measurement| |
appears| The monitor has malfunctioned.| Press the [START/STOP] button again. If “Er” still appears, contact your OMRON retail outlet or distributor.
appears| The monitor cannot connect to a smart device or transmit data correctly.| Follow the instructions shown in the “OMRON connect” app. If the “Err” symbol still appears after checking the app, contact your OMRON retail outlet or distributor.
flashes| The monitor is waiting for pairing with the smart device.| Refer to section 5 of instruction manual  for pairing your monitor with your smart device, or press the [START/STOP] button to cancel pairing and turn your monitor off.
flashes| More than 24 readings are not transferred.| Pair or transfer your readings to the “OMRON connect” app so you can keep them in memory in the app, and this error symbol disappears.
| Your monitor is not paired or not connected with your smart device.|
appears| There are 30 readings in memory to be transferred|
Flashes and appears or the monitor is turned off unexpectedly during a measurement.| Batteries are low.

| Replacing all 4 batteries with new ones is recommended. Refer to section 3 of instruction manual.

| Batteries are depleted.| Immediately replace all 4 batteries with new ones. Refer to section 3 of instruction manual   .
Nothing appears on the display of the monitor.| Batteries are depleted. Battery polarities are not properly aligned.| Check the battery installation for proper placement. Refer to section 3 of instruction manual.
Readings appear too high or too low.| Blood pressure varies constantly. Many factors including stress, time of day, and/or how you apply the arm cuff, may affect your blood pressure. Review section 2 of instruction manual   .
Any other communication issue occurs.| Follow the instructions shown in the smart device, or visit the “Help” section in the “OMRON connect” app for further help. If the problem still persists, contact your OMRON retail outlet or distributor.
Any other problems occur.| 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 your OMRON retail outlet or distributor.

Maintenance

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

• 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. This may cause an inaccurate reading.

Storage

Keep your monitor in the storage case when not in use.

1. Remove the arm cuff from the monitor.
   Caution

   • 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.
   Note

   • Do not bend or crease the air tube excessively.

3. Place your monitor and other components in the storage case.

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.

Cleaning

• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth or a soft cloth moistened with mild (neutral) 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.

Calibration and Service

• The accuracy of this blood pressure monitor has been carefully tested and is designed for a long service life.
• It is generally recommended to have the unit inspected every two years to ensure correct functioning and accuracy. Please consult your authorised OMRON dealer or the OMRON Customer Service at the address given on the packaging or attached literature.

Specifications

DIA: 40 to 215 mmHg
Pulse measurement range| 40 to 180 beats / min.
Accuracy| Pressure: ±3 mmHg
Pulse: ±5% of display reading
Inflation| Automatic by electric pump
Deflation| Automatic pressure release valve
Measurement method| Oscillometric method
Transmission method| Bluetootif Low Energy
Wireless communication| Frequency range: 2.4 GHz
(2400 2483.5 MHz)
Modulation: GFSK
Effective radiated power: < 20 dBm
Operation mode| Continuous operation
IP classification| Monitor: IP20
Optional AC adapter: IP21 for HHP-CM01, IP22 for HHP-BFH01
---|---
Rating| DC6 V 4W
Power source| 4-AKbatteries 1.5 V or optional AC adapter (INPUT AC 100 – 240 V 50 – 60 Hz 0.12- 0.065 A)
Battery life| Approximately 900 measurements (Using new alkaline batteries and included arm cuff. Depending on the type of battery and arm cuff.)
Durable period (Servke life)| Monitor: 5 years
Arm cuff: 5 years
Optional AC adapters years
Operating conditions| +10 to r-40°C / 15 to 9096 RH (non.condensing) / 800 to 1060 hPa
Storage /Transport conditions| -20 to .604C / 10 to 90% RH (non.condensing)
Weight| Monitor: approximately 250 g (not including batteries) Arm cuff: approximately 110 g
Dimensions (approximately value)| Monitor: 103 mm (W) x 82 mm (H) x 140 mm (L) Arm cuff: 146 mm x 466 mm (air tube: 610 mm)
Cuff circumference applicable to the monitor| 17 to 42 cm (included arm cuff: 22 to 32 cm)
Memory| Stores up to 30 readings
Contents| Monitor, arm cuff (HEM-CR24), 4 °AA” batteriek storage case, Instruction Manual
Protection against electric shock| Internally powered ME equipment (when using only batteries) Class II ME equipment (optional AC adapter)
Applied part| Type BF (arm cuff)

Note

• These specifications are subject to change without notice.
• This monitor is clinically investigated according to the requirements of EN ISO 81060-2:2014 and complies with EN ISO 81060-2:2014 and EN ISO 81060-2:2019+A1:2020 (excluding pregnant and pre-eclampsia patients). In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure.
• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This monitor and optional AC adapter are protected against solid foreign objects of 12.5 mm diameter and greater such as a finger. The optional AC adapter HHP-CM01 is protected against vertically falling water drops which may cause issues during a normal operation. The optional AC adapter HHP-BFH01 is protected against oblique falling water drops which may cause issues during a normal operation.
• Operation mode classification complies with IEC 60601-1.

About a wireless communication interference
The Bluetooth option in the product is used to connect to dedicated apps on mobile devices to synchronize date/time data from mobile device to the product, and to synchronize measurement data from the product to mobile device. Further handling of the data on the mobile device is up to the user’s discretion. This product operates in an unlicensed ISM band at 2.4 GHz where any third party can intercept the radio waves, willfully or accidentally, for any unknown purpose. 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.

Limited Warranty

Thank you for buying an OMRON product.This product is constructed of high quality materials and great care has been taken in its manufacturing. It is designed to give you every satisfaction, provided that it is properly operated and maintained as described in the instruction manual.
This product is warranted by OMRON for a period of 3 years after the date of purchase. The proper construction, workmanship and materials of this product is warranted by OMRON. During this period of warranty OMRON will, without charge for labour or parts, repair or replace the defect product or any defective parts.

The warranty does not cover any of the following:

1. Transport costs and risks of transport.
2. Costs for repairs and / or defects resulting from repairs done by unauthorised persons
3. Periodic check-ups and maintenance.
4. Failure or wear of optional parts or other attachments other than the main device itself, unless explicitly warranted above.
5. Costs arising due to non-acceptance of a claim (those will be charged for).
6. Damages of any kind including personal caused accidentally or from misuse.
7. Calibration service is not included within the warranty.
8. Optional parts have a one (1) year warranty from date of purchase. Optional parts include, but are not limited to the following items: cuff and cuff tube.

Should warranty service be required please apply to the dealer whom the product was purchased from or an authorised OMRON distributor. For the address refer to the product packaging / literature or to your specialised retailer. If you have difficulties in finding OMRON customer services, contact us for information: www.omron-healthcare.com

Repair or replacement under the warranty does not give rise to any extension or renewal of the warranty period. The warranty will be granted only if the complete product is returned together with the original invoice / cash ticket issued to the consumer by the retailer.

Guidance and Manufacturer’s Declaration

• This blood pressure monitor is designed according to the European Standard EN1060, Non-invasive sphygmomanometers Part 1: General Requirements and Part 3: Supplementary requirements for electromechanical blood pressure measuring systems.
• Hereby, OMRON HEALTHCARE Co., Ltd., declares that the radio equipment type HEM-7143T1-EBK is in compliance with Directive 2014/53/EU.
• The full text of the EU declaration of conformity is available at the following internet address: www.omron-healthcare.com
• This OMRON product is produced under the strict quality system of OMRON HEALTHCARE Co., Ltd., Japan. The Core component for OMRON blood pressure monitors, which is the Pressure Sensor, is produced in Japan.
• Please report to the manufacturer and the competent authority of the Member State in which you are established about any serious incident that has occurred in relation to this device.

Important information regarding Electromagnetic Compatibility (EMC)

HEM-7143T1-EBK manufactured by OMRON HEALTHCARE Co., Ltd. conforms to EN60601-1-2:2015 Electromagnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at: www .omron-healthcare.com. Refer to the EMC information for HEM-7143T1-EBK on the website.

Correct Disposal of This Product (Waste Electrical & Electronic Equipment)

This marking shown on the product or its literature, indicates that it should not be disposed of, with other household wastes at the end of its working life.
To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate this product from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources.

Household users should contact either the retailer where they purchased this product, or their local government office, for details of where and how they can return this item for environmentally safe recycling.
Business users should contact their supplier and check the terms and conditions of the purchase contract.This product should not be mixed with other commercial waste for disposal.

The Bluetooth 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 and regions. App Store is a service mark of Apple Inc. Google Play and Google Play logo are trademarks of Google LLC.

References

• OMRON Healthcare Europe | Medical Devices and Healthcare Solutions
• Distribution Network
• OMRON Healthcare Europe | Medical Devices and Healthcare Solutions

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