Omron HEM-9210T - Automatic Upper Arm Blood Pressure Monitor Manual

Introduction

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 presence of irregular heartbeats during measurement and gives a warning signal with the measurement result.
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.

Important Safety Information

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

General Usage

• 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.
• Consult your physician before using the device 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 the device on an injured arm or an arm under medical treatment.
• Stop using the device and consult your physician if you experience skin irritation or other troubles.
• Do not apply the arm cuff on the arm while being on an intravenous drip or blood transfusion.
• Consult your physician before using the device on the arm with an arterio-venous (A-V) shunt.
• Do not use the device with other medical electrical (ME) equipment simultaneously.
• Do not use the device in the area of high frequency (HF) surgical equipment, magnetic resonance imaging (MRI), or computerized tomography (CT) scanner exists, or in the oxygen rich environment.
• 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.

Data Transmission

• Do not use this product on an aircraft or in hospitals. Please remove the battery and AC adapter from the device. This product emits radio frequencies (RF) in the 2.4 GHz band, use of this product in locations where RF is restricted is not recommended.
  The use of RF in this product is licensed for use by the FCC, for further information on any potential restrictions refer to documentation on Bluetooth^® usage by the FCC.

AC Adapter (optional accessory)

• Do not use the AC adapter if the device 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 in a multi-outlet plug.
• Never plug in or unplug the power cord from the electric outlet with wet hands.
• Do not disassemble or attempt to repair the AC adapter.

Battery Usage

Keep the battery out of reach of children.

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property.

General Usage

• Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.
• Consult your physician before using the device 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 often than necessary. It may cause bruising due to blood flow interference.
• Remove the arm cuff if it does not start deflating during the measurement.
• Do not use this device on infants or persons who cannot express their intentions.
• Do not use the device for any purpose other than measuring blood pressure.
• Use only the approved arm cuff for this device. Use of other arm cuffs may result in incorrect measurement results.
• Do not use a mobile phone or other devices that emit electromagnetic fields near the device except when in use for wireless communications. This may result in incorrect operation of the device.
• Do not disassemble or attempt to repair the device or components. This may cause an inaccurate reading.
• Do not use in a location with moisture, or a location where water may splash on the device. This may damage the device.
• Do not use the device in a moving vehicle. For example, the car or airplane.
• Read "What to do if your systolic pressure is more than 210 mmHg" of this instruction manual, if your systolic pressure is known to be more than 210 mmHg. Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied.

Data Transmission

• Do not replace the battery or unplug the AC adapter when in use for wireless communications. This may result in incorrect operation of the device or damage to the data.
• Do not place integrated circuit cards, magnets, metal objects, or other devices that emit electromagnetic fields near the device when in use for wireless communications. This may result in incorrect operation of the device or damage to the data.

AC Adapter (optional accessory)

• Fully insert the power plug into the outlet.
• When disconnecting the power plug from the outlet, be sure to safely pull from the power plug. Do not pull from the power cord.
• When handling the power cord, take care not to do the following:

• Wipe any dust off of the power plug.
• Unplug the monitor when not in use.
• Disconnect the power plug before cleaning.

Battery Usage

• Do not insert the batteries with their polarities incorrectly aligned.
• Use only 4 "AA" alkaline or manganese batteries with this device. Do not use other types of batteries. Do not use new and used batteries together.
• Remove the batteries if the device will not be used for three months or more.
• If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Consult a physician immediately.
• Use the battery within recommended period mentioned to it.

General Precautions

• Do not forcibly crease the arm cuff or the air tube excessively.
• Do not fold or kink the air tube while taking a measurement. This may causeharmful injury by interrupting blood flow.
• To unplug the air plug, pull on the air plug at the connection with the monitor, notthe tube itself.
• Do not drop the monitor or subject the device to strong shocks or vibrations.
• Do not inflate the arm cuff when it is not wrapped around your arm.
• Do not use the device outside the specified environment. It may cause aninaccurate reading.
• Use only an AC adapter, arm cuff, batteries and etc, specified for this device. Useof unsupported adapters, arm cuff and batteries may damage and/or may be hazardous to the device.
• Dispose of the device, components and optional accessories according toapplicable local regulations. Unlawful disposal may cause environmental pollution.
• Please check (for example, by observation of the limb concerned) if the device isnot causing a prolonged impairment of PATIENT blood circulation.

Know Your Device

Contents

• Monitor,
• arm cuff,
• battery set,
• instruction manual,
• quick start guide

Monitor

1. Display
2. START/STOP button
3. Battery compartment
4. Air jack
5. AC adapter jack (for optional AC adapter)

Arm cuff

Arm circumference 22 - 42 cm (9" - 17")

6. Arm cuff
7. Air plug
8. Air tube

Display

9. SYNC symbol
10. Connection symbol
11. OK symbol
12. Systolic blood pressure
13. Diastolic blood pressure
14. Battery symbol (low/depleted)
15. Heartbeat symbol (Flashes during measurement.)
16. Movement error symbol
17. Irregular heartbeat symbol
18. Deflation symbol
19. Pulse display

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.

Normal Heartbeat

Irregular Heartbeat

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, remain still during measurement.

SYNC Symbol

The SYNC symbol is displayed if the device is not connected to Telehealth service receiver or if measured data is not transmitted successfully. Please refer to "Connection failure. / Data is not being transmitted.".

Wireless Function

Before use, thoroughly read the instruction manual included with the Telehealth service receiver (in some cases, receiver may be your smartphone) being used with this blood pressure monitor for instruction about your monitor to Telehealth service receiver, and receiver transmission range. It will be necessary for the blood pressure monitor to be within the receiver's transmission range to successfully transfer data. This Omron blood pressure monitor is designed to connect to specific Bluetooth® Smart receivers, and is not guaranteed to connect to all Bluetooth® Smart compatible devices and Telehealth service receivers. "OMRON HEALTHCARE Co., Ltd. cannot accept liability for any damages incurred due to impaired operation or data loss, etc. that occur through the use of this product."

Before Taking a Measurement

To help ensure an accurate reading, follow these directions:

1. Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eatingfor 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 stressfultimes.
4. Measurements should be taken in a quiet place.
5. Remove tight-fitting clothing from your arm.

Preparation

Battery Installation

Below connection process (step 4 and 5) can only be completed when inserting batteries.

1. Remove the battery cover.
2. Insert 4 "AA" batteries as indicated, into the battery compartment.
3. Replace the battery cover.

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 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.

4. The device will start the connection process.
   As soon as inserting the batteries, it will automatically start to connect to the Telehealth service receiver, as below.
   

If the display shown above does not appear, refer to "Connection failure.
/ Data is not being transmitted."
To retry connecting the Telehealth service receiver, remove batteries and press [START/STOP] button for 2-3 times. Then start with step 2 again.

Note: If your Telehealth service receiver asks for a PIN code, enter the digits of the PIN code located on the rating label at the bottom of the device.

5. Confirm the device is successfully connected.
   If the device is connected successfully to the Telehealth service receiver, OK symbol " " will appear on the display, as shown below.
   

If "Err" appears, refer to "Connection failure. / Data is not being transmitted." for more detail.

Notes:

• We recommend keeping batteries in the device at all times, even if youchoose to use the AC adapter.
• If only the AC adapter is used without keeping the batteries in the device, the device connection process (steps 4 and 5) is necessary each time you unplug and plug back the AC adapter.

Using the Device

Applying the Arm Cuff

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

1. Connect the air plug to the unit.
   
2. Wrap the arm cuff firmly in place around your left upper arm.
   

The bottom edge of the arm cuff should be 1/2 inch (1 to 2 cm) above the elbow. The air tube is on the inside of your arm and aligned with your middle finger.

Note: Please refer to the operating instruction of the HEM-RXL31 for applying the extra large cuff.

3. Securely close with the fabric fastener.
   

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 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.

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 uncrossedand your feet flat on the floor.
• Sit upright with your back straight.
• Sit with your back and arm beingsupported.
• The arm cuff should be placed on yourarm at the same level as your heart.

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.
• The reading is stored in the memory and cannot be viewed on the display.

1. Press the [START/STOP] button. The arm cuff will automatically start to inflate.

What to do if your systolic pressure is more than 210 mmHg
After the arm cuff starts to inflate, press and hold the [START/STOP] button until the monitor inflates 30 to 40 mmHg higher than your expected systolic pressure.

Notes:

• The monitor will not inflate above 299 mmHg.
  Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied.

2. Transfer your readings.
   As soon as the measurement is completed, your readings will be automatically transferred, as shown below.
   
   If the connection symbol " " does not appear, refer to "Connection failure. / Data is not being transmitted." for more detail.
   
3. After data transfer is completed, press the [START/STOP] button to turn the monitor off.
   It will automatically turn off after 2 minutes.
   Note: Wait 2-3 minutes before taking another measurement. Waiting between measurements allows the arteries to return to their prior condition to taking a measurement.
   
4. Remove the arm cuff.

• 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.
• Read "What to do if your systolic pressure is more than 210 mmHg" of this instruction manual, if your systolic pressure is known to be more than 210 mmHg. Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied.

Error Messages and Troubleshooting

Error Messages

Error Display	Cause	Solution
	Irregular heartbeat is detected.	Remove the arm cuff. Wait 2 - 3 minutes and then take another measurement. Repeat the steps in "Taking a Measurement". If this error continues to appear, contact your physician.
	Movement during measurement.	Carefully read and repeat the steps in "Taking a Measurement".
	Connection failure. / Data is not being transmitted.	Refer to "Connection failure. / Data is not being transmitted." in Troubleshooting.
	The batteries are low.	Recommend to replace 4 batteries with new ones at this time. Refer to Preparation.
	The batteries are depleted.	Immediately replace the 4 batteries with new ones. Refer to Preparation.
	Air plug is disconnected.	Insert the plug securely. Refer to "Applying the Arm Cuff".
	Arm cuff is applied too loosely.	Apply the arm cuff tighter. Refer to "Applying the Arm Cuff".
	Air is leaking from the arm cuff.	Replace the arm cuff with a new one. Refer to Optional Accessories.
	Movement during measurement and the arm cuff has not been inflated sufficiently.	Repeat measurement. Remain still and do not talk during measurement. Refer to "Taking a Measurement".
		If "E2" appears repeatedly, inflate the arm cuff manually until it is 30 to 40 mmHg above your previous measurement result. Refer to "Taking a Measurement".
	The arm cuff was inflated exceeding the maximum allowable pressure, and then deflated automatically.	Do not touch the arm cuff and/or bend the air tube while taking a measurement. Do not inflate the arm cuff more than necessary. Refer to "Taking a Measurement".
	Movement during measurement.	Repeat measurement. Remain still and do not talk during measurement.
	Movement during measurement.	Refer to "Taking a Measurement".
	Clothing is interfering with the arm cuff.	Remove any clothing interfering with the arm cuff. Refer to "Applying the Arm Cuff".
	Communication failed.	Refer to "Connection failure. / Data is not being transmitted." in Troubleshooting.
	Device error.	Contact your Telehealth service provider.

Troubleshooting

Maintenance and Storage

Maintenance

To protect your device from damage, please follow the directions below:

• Store the device and the components in a clean, safe location.
  
• Do not use any abrasive or volatile cleaners.
  
• Do not wash the device and any components or immerse them in water.
  
• Do not use gasoline, thinners or similar solvents to clean the device.
  
• Use a soft dry cloth, or a soft cloth moistened with neutral soap to clean on the monitor and the arm cuff.
  
• Changes or modification not approved by the manufacturer will void the user warranty. Do not disassemble or attempt to repair the device or components.
  

Storage

1. Unplug the air plug from the air jack.
2. Gently fold the air tube into the arm cuff.
   Note: Do not bend or crease the air tube excessively. Do not store the device in the following situations:
   • If the device is wet.
   • Locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapors such as bleach.
   • Locations exposed to vibrations, shocks or where it will be at an angle.

Optional Accessories

Arm cuff
Arm circumference 42 - 50 cm (17" - 20")	Arm circumference 22 - 42 cm (9" - 17")	Arm circumference 17 - 22 cm (7" - 9")
Extra Large Cuff	Wide Range Cuff Same as the arm cuff provided with the product.	Small Cuff

Note: Please refer to the operating instruction of the HEM-RXL31 for applying the extra large cuff.

Optional Accessories List

Note: Please check with your Telehealth service provider or local OMRON representatives for the appropriate optional parts models

Visit: OmronHealthcare.com

Using the Optional AC Adapter

AC Adapter

Note: Make sure to use an easily accessible power socket in which to connect and disconnect the AC adapter.

1. Insert the AC adapter plug into the AC adapter jack on the rear side of the monitor.
   
2. Plug the AC adapter into an electrical outlet.

To disconnect the AC adapter, unplug the AC adapter from the electrical outlet first, and then remove the AC adapter plug from the monitor.

Specifications

Notes:

• These specifications are subject to change without notice.
• In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure.
• This device is clinically investigated according to the requirements of ISO81060-2:2013.
• This device has not been validated for use on pregnant patients.
• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This device is protected against solid foreign objects of 12 mm diameter and greater such as a finger.

• 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.

Documents / Resources

References

• Omron Healthcare

Download manual

Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.

Download Omron HEM-9210T - Automatic Upper Arm Blood Pressure Monitor Manual