OMRON HEM-7156-A Automatic Blood Pressure Monitor Instruction Manual

OMRON HEM-7156-A Automatic Blood Pressure Monitor

Introduction

Thank you for purchasing the OMRON Automatic 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 brachia! artery and converts the movements into a digital reading.

Safety Instructions
This instruction manual provides you with important information about the OMRON Automatic 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 your local OMRON representative 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 who can understand this instruction manual with the arm circumference range printed on the arm cuff. This monitor detects the appearance of irregular heartbeats during measurement and indicates this via a symbol with measurement result. 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 local OMRON representative.

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.

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.

AC Adapter 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 and children.

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.

• 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 arteriovenous (A-V) shunt, is present because of temporary interference to blood flow and 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.

• When the monitor malfunctions, it may get hot. DO NOT touch the monitor if it occurs.

• 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 emit electromagnetic fields is within 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 or on an aircraft.

• 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 5.

• 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 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 measurement.

• Remove tight-fitting or 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 on operating and storage/ transport temperature, refer to section 5.

• DO NOT use this monitor after the durable period has ended. Refer to section 5.

• 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 “lf your systolic pressure is more than 21 0 mm Hg” in section 1 o of instruction manual for additional information.

AC Adapter 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 “AN’ 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.

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.

Maintenance

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.

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

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+A 1 :2020. In the clinical validation study, KS 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 AC adapter are protected against solid foreign objects of 12.5 mm diameter and greater such as a finger. The AC adapter is protected against vertically falling water drops which may cause issues during a normal operation.

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

Important Information Regarding Electromagnetic Compatibility (EMC)

• HEM-7156-A manufactured by OMRON HEALTHCARE Co., Ltd. conforms to EN 60601-1-2:2015 Electromagnetic Compatibility
• (EMC) standard. Further documentation in accordance with this EMC standard is available at:
• Asia Pacific: https://www.omronhealthcare-ap.com/emc-information
• Taiwan: https://www.omronhealthcare.com.tw/EMC
• Korea: https://www.omron-healthcare.co.kr/product/HEM-7156
• Refer to the EMC information for HEM-7156-A on the website.

Guidance and Manufacturer’s Declaration

• This blood pressure monitor is designed according to the European Standard EN 1060, Non-invasive sphygmomanometers Part 1: General Requirements and Part 3: Supplementary requirements for electromechanical blood pressure measuring systems.
• 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.

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