Omron M3 Comfort, HEM-7134-E - Automatic Blood Pressure Monitor Manual
Introduction
Thank you for purchasing the OMRON M3 Comfort Automatic Upper Arm Blood Pressure Monitor.
The OMRON M3 Comfort is a compact, fully automatic upper arm blood pressure monitor, operating on the oscillometric principle. It measures your blood pressure and pulse rate simply and quickly. For comfortable controlled inflation without the need of pressure pre-setting or re-inflation the device uses its advanced "IntelliSense" technology.
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. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with the measurement result. It is mainly designed for general household use.
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.
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 the injured arm or the 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 the HF surgical equipment, MRI, or CT scanner exists, or in the oxygen rich environment.
- The air tube or the AC adapter cable may cause accidental strangulation in infants.
- Contained small parts that may cause a choking hazard if swallowed by infants.
(AC Adapter (optional) Usage)
- 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.
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.
- People with severe blood flow problems, or blood disorders, should consult a physician before using the device, as the arm cuff inflation can cause bruising.
- 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. This may result in incorrect operation of the device.
- 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 the device. This may damage the device.
- Do not use the device in a moving vehicle (car, airplane).
- Do not take measurements more than necessary. It may cause bruising due to blood flow interference.
- Consult your physician before using the device if you had a mastectomy.
- Read "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 where the cuff is applied.
(AC Adapter (optional) Usage)
- Fully insert the power plug into the outlet.
- When disconnecting the power plug from the outlet, do not pull the power cord.
Be sure to pull from the power plug safely. - When handling the power cord, take care not to do 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.
- Unplug monitor when not in use.
- Disconnect the power plug before cleaning.
- Use only an OMRON AC adapter designed for this device. Use of unsupported adapters may damage and/or may be hazardous to the device.
(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.
- 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 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 drop the monitor or subject 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 an inaccurate reading.
- Read and follow the "Important information regarding Electro Magnetic Compatibility (EMC)" in the "Specifications".
- Read and follow the "Correct Disposal of This Product" in "Specifications" when disposing of the device and any used accessories or optional parts.
- Please check (for example, by observation of the limb concerned) if the device is not causing a prolonged impairment of PATIENT blood circulation.
Know Your Device
Contents
Monitor, arm cuff, instruction manual, storage case, battery set, blood pressure pass
Monitor
- Display
- Memory button
- START/STOP button
- Date/Time setting button
- USER ID selection switch
- Cuff wrap guide lamp
- Up/Down buttons
- Blood pressure level indicator (colour)
- Battery compartment
- AC adapter jack (for optional AC adapter)
- Air jack
Arm cuff
- Arm cuff (Arm circumference 22 - 42 cm)
- Air plug
- Air tube
Display
- USER ID symbol
- Systolic blood pressure
- Diastolic blood pressure
- Battery symbol (low/depleted)
- Cuff wrap guide symbol
- Heartbeat symbol (Flashes during measurement.)
- Memory symbol
- Average value symbol
- Date/Time display
- Movement error symbol
- Irregular heartbeat symbol
- Blood pressure level indicator (bar)
- Deflation symbol
- Pulse display/Memory number
Display symbols
Irregular Heartbeat Symbol
When the monitor detects an irregular Normal Heartbeat 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.
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.
Average Value Symbol
The average value symbol is displayed when you press and hold the memory button for more than 3 seconds. The most recent average value appears on the display screen.
Cuff Wrap Guide Lamp
If the cuff was wrapped too loosely, it may cause unreliable values. If the wrapping of cuff is too loose, the cuff wrap guide lamp does not light.
Otherwise lights in green. This is the function which is used as an aid in determining if the cuff is wrapped snugly enough.
Blood Pressure Level Indicator (Colour)
If your systolic or diastolic pressure is above the standard range (135 mmHg for the systolic blood pressure and/or 85 mmHg for the diastolic blood pressure), the blood pressure level indicator (colour) will light in orange when the measurement result is displayed. If they are within the standard range, no light will appear.
The JNC7* Guideline recommends the following guideline.
| General Guidelines for Blood Pressure |
Prehypertension at Office | Hypertension at Home |
Systolic Blood Pressure | 120 - 139 mmHg | 135 mmHg |
Diastolic Blood Pressure | 80 - 89 mmHg | 85 mmHg |
These are form statistical values for blood pressure.
* JNC7: The Seventh Report, 2003 Dec, of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.
Before Taking a Measurement
To help ensure an accurate reading, follow these directions:
- Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for 30 minutes before taking a measurement.
- Rest for at least 5 minutes before taking the measurement.
- Stress raises blood pressure. Avoid taking measurements during stressful times.
- Measurements should be taken in a quiet place.
- Remove tight-fitting clothing from your arm.
Preparation
Battery Installation
- Remove the battery cover.
- Insert 4 "AA" batteries as indicated in the battery compartment.
- 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.
Disposal of used batteries should be carried out in accordance with the national/local regulations for the disposal of batteries.
Setting the Date and Time
Set the monitor to the correct date and time before taking a measurement for the first time.
- Press the button.
- Push or to change the year
Push button to confirm the year and then the month flashes. Repeat the same steps to change the month, day, hour, and minute.
: Forward
: Back
- Press the START/STOP button to turn the monitor off.
Notes:
- If the batteries have been replaced, the date and time setting will need to be reset.
- If the date and time are not set, "-:--" appears during or after measurement.
Using the Device
Applying the Arm Cuff
Remove tight-fitting clothing or tight rolled up sleeve from your left upper arm.
Do not place the arm cuff over thick clothes.
- Insert the air plug into the air jack securely.
- Apply the arm cuff to your left upper arm.
The bottom edge of the arm cuff should be 1 to 2 cm above the elbow. Cuff should be positioned on the upper arm with the air tube pointing towards your hand.
- Secure closed 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 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 uncrossed and your feet flat on the floor.
- Sit upright with your back straight.
- Sit with your back and arm being supported.
- The arm cuff should be placed on your arm at the same level as your heart.
Taking a Measurement
Notes:
- To stop a measurement, press the START/STOP button once to release the air in the arm cuff.
- Remain still and do not talk while taking a measurement.
The monitor is designed to take measurements and store the measurement values in the memory for 2 people using USER ID 1 and USER ID 2.
- Select your USER ID (1 or 2).
- Press the START/STOP button.
The arm cuff will start to inflate automatically.
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.
- Do not apply more pressure than necessary.
- Remove the arm cuff.
- Press the START/STOP button to turn the monitor off.
The monitor automatically stores the measurement result in its memory. 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 the condition prior to taking a measurement.
Using the Guest Mode
The monitor stores measurement values for 2 users in the memory.
The guest mode can be used to take a single measurement for another user. No measurement values are stored in the memory when the guest mode is selected.
- Press and hold the START/STOP button for more than 3 seconds.
The USER ID symbol and the Date/Time display will disappear. - Release the START/STOP button when the Date/Time display turns off.
The arm cuff will start to inflate automatically.
Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.
Using the Memory Function
The monitor automatically stores the results up to 60 sets for each user (1 and 2). It can also calculate an average value based on the last 3 measurement values taken within 10 minutes.
Notes:
- If there are only 2 measurement values in the memory for that period, the average will be based on these 2 values.
- If there is 1 measurement value in the memory for that period, this is displayed as the average.
- If the memory is full, the monitor will delete the oldest value.
- When viewing the measurement value taken without setting the date and time, "-:--" is displayed instead of the date and time.
To View the Measurement Values Stored in Memory
- Select your USER ID (1 or 2).
- Press the button.
The Memory number appears for a second before the pulse rate is displayed. The newest set is numbered "1".
Note: The cuff wrap guide result appears on the display with the measurement values. The cuff wrap guide lamp will not light.
: The arm cuff was wrapped snugly enough.
: The arm cuff was loose or not wrapped correctly. - Press the or button to view the values stored in memory.
: To view the older values
: To view the more recent values
To View the Average Value
- Select your USER ID (1 or 2).
- Press and hold the button for more than 3 seconds.
Notes:
- If the previous measurement was taken without setting the date and time, the average value is not calculated.
- If there are no measurements results stored in the memory, the screen to the right is displayed.
To Delete All the Values Stored in Memory
- Select your USER ID (1 or 2).
- Press the Memory button, while the memory symbol () appears.
- While holding the button down, press the START/STOP button for more than 3 seconds.
Note: You cannot partially delete the values stored in the memory.
All values for the user you select will be deleted.
Error Messages and Troubleshooting
Error Messages
Error Display | Cause | Solution |
| Irregular heartbeats are detected. | Remove the arm cuff. Wait 2 - 3 minutes and then take another measurement. Repeat the steps in "Taking a Measurement" section. If this error continues to appear, contact your physician. |
| Movement during measurement. | Carefully read and repeat the steps in "Taking a Measurement" section. |
| Arm cuff is applied too loosely. | Apply the arm cuff tighter. Refer to "Applying the Arm Cuff" section. |
| The batteries are low. | Recommend to replace the batteries with new ones ahead of time. Refer to "Battery Installation". |
| The batteries are depleted. | Replace 4 batteries with new ones at once. Refer to "Battery Installation". |
| Air plug disconnected. | Insert the plug securely. Refer to "Applying the Arm Cuff" section. |
Arm cuff is applied too loosely. | Apply the arm cuff tighter. "Applying the Arm Cuff" section. |
Air is leaking from the arm cuff. | Replace the cuff with a new one. Refer to "Optional Medical 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" section. |
If "E2" appears repeatedly, inflate the cuff manually until it is 30 to 40 mmHg above your previous measurement result. Refer to "Taking a Measurement" section. |
| 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" section. |
| Movement during measurement. | Repeat measurement. Remain still and do not talk during measurement. |
| Movement during measurement. | Refer to "Taking a Measurement" section. |
Clothing is interfering with the arm cuff. | Remove any clothing interfering with the arm cuff. Refer to "Applying the Arm Cuff" section. |
| Device error. | Contact your OMRON retail outlet or distributor. |
Troubleshooting
Problem | Cause | Solution |
The measurement result is extremely high (or low). | Arm cuff is applied too loosely. | Apply the arm cuff tighter. Refer to "Applying the Arm Cuff" section. |
Movement or talking during measurement. | Remain still and do not talk during measurement. Refer to "Taking a Measurement" section. |
Clothing is interfering with the arm cuff. | Remove any clothing interfering with the arm cuff. Refer to "Applying the Arm Cuff" section. |
Arm cuff pressure does not rise. | The air connector is not securely connected into the air jack. | Make sure that the air tube is connected securely. Refer to "Applying the Arm Cuff" section. |
Air is leaking from the arm cuff. | Replace the arm cuff with a new one. Refer to "Optional Medical Accessories" section. |
Arm cuff deflates too soon. | The arm cuff is loose. | Apply the cuff correctly so that it is firmly wrapped around the arm. Refer to "Applying the Arm Cuff" section. |
Cannot measure or the results are too low or too high. | The arm cuff has not been inflated sufficiently. | Inflate the cuff so that it is 30 to 40 mmHg above your previous measurement result. Refer to "Taking a Measurement" section. |
Nothing happens when you press the buttons. | The batteries are depleted. | Replace 4 batteries with new ones. Refer to "Battery Installation" section.. |
The batteries have been inserted incorrectly. | Insert the batteries with the correct (+/-) polarity. Refer to "Battery Installation" section.. |
Other problems. | - Press the START/STOP button and repeat measurement.
- Replace the batteries with new ones.
If the problem continues, contact your OMRON retail outlet or distributor. |
Maintenance and Storage
Maintenance
To protect your device from damage, please observe the following:
- 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 petrol, thinners or similar solvents to clean the device.
- Use a soft and dry cloth, or a soft and moistened cloth and 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. Consult your authorised OMRON retail outlet or distributor.
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 device inspected every 2 years to ensure correct functioning and accuracy. Please consult your authorised OMRON retail outlet or distributor.
Storage
Keep the device in its storage case when not in use.
- Unplug the air plug from the air jack.
- Gently fold the air tube into the arm cuff.
Note: Do not bend or crease the air tube excessively.
- Place the monitor and the arm cuff in the storage case.
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 vapours such as bleach.
- Locations exposed to vibrations, shocks or where it will be at an angle.
Optional Medical Accessories
(within the scope of EC Medical Device Directive 93/42/EEC)
Arm cuff
Arm circumference
22 - 42 cm
AC adapter
HHP-CF01
(2-Pin plug EU)
HHP-BFF01
(3-Pin plug UK)
Using the Optional AC Adapter
Note: Make sure to use an easily accessible power socket in which to
- Insert the AC adapter plug into the AC adapter jack on the rear side of the monitor.
- 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
Product category | Electronic Sphygmomanometers |
Product description | Automatic Upper Arm Blood Pressure Monitor |
Model (code) | M3 Comfort (HEM-7134-E) |
Display | LCD Digital Display |
Measurement method | Oscillometric method |
Measurement range | Pressure: 0 to 299 mmHg Pulse: 40 to 180 beats/min. |
Accuracy | Pressure: ± 3 mmHg Pulse: ± 5% of display reading |
Inflation | Fuzzy-logic controlled by electric pump |
Deflation | Automatic pressure release valve |
Memory | 60 measurements with date and time for each user (1 and 2) |
Rating | DC6V 4W |
Power source | 4 "AA" batteries 1.5V or optional AC adapter (INPUT AC100-240V 50/60Hz 0.12-0.065A) |
Durable period (Service life) | Monitor: 5 years Cuff: 1 year Optional AC adapter: 5 years |
Battery life | Approx. 1000 measurements (using new alkaline batteries) |
Applied part | Type BF |
Protection against electric shock | Internally powered ME equipment (When using only the batteries) Class II ME equipment (Optional AC adapter) |
IP classification | Monitor: IP20 ptional AC adapter: IP21 |
Operating conditions | +10 to +40°C (50 to 104°F) 15 to 90% RH (non-condensing) 700 to 1060 hPa |
Storage/Transport conditions | -20 to +60°C (-4 to 140°F) 10 to 95% RH (non-condensing) 700 to 1060 hPa |
Weight | Monitor: Approx. 300 g without batteries Arm cuff: Approx. 163 g |
Outer dimensions | Monitor: Approx. 107 (w) mm x 79 (h) mm x 141 (l) mm Arm cuff: Approx. 145 mm x 532 mm |
Cuff circumference | 22 to 42 cm |
Cuff / Tube material | Nylon, polyester, polyvinyl chloride |
Package contents | Monitor, arm cuff, instruction manual, storage case, battery set, blood pressure pass |
Notes:
- These specifications are subject to change without notice.
- In the clinical validation study, the 5th phase was used on 85 subjects for determination of diastolic blood pressure.
- This device is clinically investigated according to the requirements of ISO 81060-2:2013.
- 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.
- The device and optional AC adapter are protected against solid foreign objects of 12 mm diameter and greater such as a finger. The optional AC adapter is protected against vertically falling water drops which may cause issues during a normal operation.
Documents / ResourcesDownload manual
Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.
Download Omron M3 Comfort, HEM-7134-E - Automatic Blood Pressure Monitor Manual
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