Omron HEM-7121 - Automatic Blood Pressure Monitor Manual

• DO NOT adjust medication based on measurement results from this blood pressure monitor. Take medication as prescribed by your doctor. Only a doctor is qualified to diagnose and treat High Blood Pressure.
• Consult your doctor before using this monitor for any of the following conditions: common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases. Note that PATIENT motion, trembling, shivering may affect the measurement reading.
• Do not use this monitor on the injured arm or the arm under medical treatment.
• Do not apply the arm cuff on the arm while being on an intravenous drip or blood transfusion.
• Consult your doctor before using this monitor on the arm with an arteriovenous (A-V) shunt.
• 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.
• Do not use this monitor in the area the HF surgical equipment, MRI, or CT scanner exists, or in the oxygen rich environment. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.
• The air tube or the AC adapter cable may cause accidental strangulation in infants.
• Contains small parts that may cause a choking hazard if swallowed by infants.
• Stop using this monitor and consult your doctor if you experience skin irritation or other troubles.

• Do not use the AC adapter if this monitor or the power cord is damaged. Turn off the power and unplug the power cord immediately.
• Plug the AC adapter into the appropriate voltage outlet. Do not use a multiple-tap.
• Never plug in or unplug the power cord from the electric outlet with wet hands.

• Always consult your doctor. Self-diagnosis of measurement results and self-treatment are dangerous.
• Consult your doctor before using this monitor for any of the following conditions:
  • If you have had a mastectomy.
  • People with severe blood flow problems or blood disorders as cuff inflation can cause bruising.
• Do not take measurements more than necessary. It may cause bruising due to blood flow interference.
• If there are any abnormalities during the measurement, remove the arm cuff.
• Do not use this monitor on infants or persons who cannot express their intentions.
• Do not inflate the arm cuff more than necessary.
• Do not use this monitor for any purpose other than measuring blood pressure.
• Use only the approved arm cuff for this monitor. Use of other arm cuffs may result in incorrect measurement results.
• During measurement, make sure that no mobile phone or any other electrical devices that emit electromagnetic fields is within 30cm of this monitor. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.
• Do not disassemble the monitor or arm cuff. This may cause an inaccurate reading.
• Do not use in a location with moisture, or a location where water may splash on this monitor. This may damage this monitor.
• Do not use this monitor in a moving vehicle (car, airplane).

(Battery Usage)

• Do not insert the batteries with their polarities incorrectly aligned.
• Use only four "AA" alkaline or manganese batteries with this monitor. Do not use other types of batteries. Do not use new and used batteries together.
• Remove the batteries if this monitor will not be used for 3 months or more.
• Use the battery within recommended period mentioned to it.

• Fully insert the power plug.
• When disconnecting the power plug, do not pull the power cord. Be sure to hold the power plug.
• When handling the power cord, observe the following:
  Do not damage.
  Do not break it.
  Do not tamper with it.
  Do not forcibly bend or pull.
  Do not twist.
  Do not bundle during use.
  Do not pinch.
  Do not place under heavy objects.
• Wipe the dust off from the power plug.
• Disconnect the power plug if the product will not be used for a long period of time.
• Disconnect the power plug before starting maintenance.
• Use only the original AC adapter designed for this monitor. Use of unsupported adapters may damage and/or may be hazardous to this monitor.

General Precautions

• Do not forcibly bend the arm cuff or bend the air tube excessively.
• Do not fold or kink the air tube while taking a measurement. This may cause harmful injury by interrupting blood flow.
• To unplug the air plug, pull on the air plug at the connection with the monitor, not the tube itself.
• Do not apply strong shocks and vibrations to or drop the monitor and arm cuff.
• Do not inflate the arm cuff when it is not wrapped around your arm.
• Read and follow the "Important information regarding Electro Magnetic Compatibility (EMC)" in the "6. Technical Data".
• Read and follow the "Correct Disposal of This Product" in the Technical Data Section when disposing of this monitor and any used accessories or optional parts.
• Do not use this monitor outside the specified environment. It may cause an inaccurate reading.
• Dispose of this monitor, components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.
• Please check (for example, by observation of the limb concerned) if this monitor is not causing a prolonged impairment of PATIENT blood circulation.
• If this monitor is stored at the maximum or minimum storage and transport temperature and is moved to an environment with a temperature of 20°C, we recommend waiting for approx. 2 hours before using the monitor.

Arm cuff:

7. Arm Cuff (Arm circumference 22 - 42 cm)
8. Air plug
9. Air tube

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.

• If the low battery symbol () appears on the display, turn the monitor off then replace all batteries at the same time.
• The measurement values continue to be stored in memory even after the batteries are replaced.
• The supplied batteries may have a shorter life.

1. Insert the air plug into the air jack securely.
   
   
2. Put your arm through the cuff loop.
   
   
   The bottom edge of the arm cuff should be 1 to 2 cm above the elbow. The air tube is centred on the middle of your inner arm.
   
   
3. Close the fabric fastener FIRMLY.
   

Notes:

• When you take a measurement on the right arm, the air tube will be at the side of your elbow. Be careful not to rest your arm on the air tube.
• The blood pressure can differ between the right arm and the left arm, and therefore also 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 doctor which arm to use for your measurement.

• Sit on a chair with your legs uncrossed and your feet flat on the floor.
• Sit with your back and arm being supported.
• The arm cuff should be placed on your arm at the same level as your heart.

• Do not subject the monitor and the cuff to extreme temperatures, humidity, moisture or direct sunlight.
• Do not fold the cuff or tubing tightly.
• Do not inflate the arm cuff over 299 mmHg.
• Do not disassemble the monitor or components.
• Do not subject this monitor to strong shocks or vibrations (for example, dropping the monitor on the floor).
• Do not use volatile liquids to clean this monitor.
• Do not wash the arm cuff or immerse it in water.
• Do not use petrol, thinners or similar solvents to clean the arm cuff.
• Do not carry out repairs of any kind yourself. If a defect occurs, consult your local OMRON representative.
  
  
• The monitor should be cleaned with a soft, dry cloth.
• Use a soft, moistened cloth and neutral soap to clean the arm cuff.

• 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 device inspected every two years to ensure correct functioning and accuracy. Please consult your local OMRON representative.

1. Unplug the air plug from the air jack.
2. Gently fold the air tube into the arm cuff.
   
   
   Notes:

• Do not bend the air tube excessively.
• Do not store your monitor in the following situations:
  • If your monitor and other components are wet.
  • Locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapours.
  • Locations exposed to vibrations, shocks or where it will be at an angle.

• Subject to technical modification without prior notice.
• In the clinical validation study, the 5th phase was used on 85 subjects for determination of diastolic blood pressure.
• This monitor is clinically investigated according to the requirements of ISO 81060-2:2013.
• This monitor has not been validated for use on pregnant patients.
• 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 is protected against oblique falling water drops which may cause issues during a normal operation.
  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 is protected against oblique falling water drops which may cause issues during a normal operation.
  
• This device fulfils the provisions of EC directive 93/42/EEC (Medical Device Directive).
• 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.
• 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.