Omron 7 Blood Pressure Monitor BP760N Manual

OMRON 7 series Blood Pressure Monitor Model BP760N

Product includes:

Important Safety Information

Warning: 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.
• The monitor is not intended to be a diagnostic device.
• 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.
• 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.
• Contains 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.

Caution: 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.
  * Do not take measurements more than necessary. It may cause bruising due to blood flow interference.
  * People with severe blood flow problems or blood disorders as 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).
• Read “If your systolic pressure is more than 210 mmHg” (page11) 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.

General Precautions

• Do not forcibly crease the arm cuff or the air tube excessively.
• Do not press the air tube while taking a measurement.
• 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.
• Dispose of the device, components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.

1. Know Your Device

Monitor

1. Air jack
2. Blood pressure color indicator
3. Date/Time setting button
4. USER ID selection switch
5. Display
6. Memory button
7. START/STOP button
8. Up/Down buttons
9. Battery compartment
10. AC adapter jack (for optional AC adapter)

Arm cuff

1. Arm cuff (Arm circumference 9” – 17” (22 – 42 cm))
2. Air plug
3. Air tube

Display

1. Memory symbol
2. USER ID symbol
3. Average value symbol
4. Systolic blood pressure
5. Diastolic blood pressure
6. Heartbeat symbol (Flashes during measurement)
7. Date/Time display
8. Movement error symbol
9. Irregular heartbeat symbol
10. Blood pressure level indicator
11. Low battery symbol
12. Deflation symbol
13. Pulse display / Memory number

1.1 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.

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.

Blood Pressure Color Indicator

If your Systolic Blood Pressure is 135 mmHg or above and/or the Diastolic Blood Pressure is 85 mmHg or above, the blood pressure color indicator will light in “orange” when the measurement result is displayed. If the results are within the standard range, the blood pressure color indicator will light in “green”.

2013 ESH/ESC Guidelines for the management of arterial hypertension

Definitions of hypertension by office and home blood pressure levels
These are from statistical values for blood pressure.

1.2 Before Taking a Measurement

To help ensure an accurate reading, follow these directions:

1. Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for 30 minutes before taking a measurement. Rest for at least 15 minutes before taking the measurement.
2. Stress raises blood pressure. Avoid taking measurements during stressful times.
3. Measurements should be taken in a quiet place.
4. Remove tight-fitting clothing from your arm.
5. Sit on a chair with your feet flat on the floor. Rest your arm on a table so that the arm cuff is at the same level as your heart.
6. Remain still and do not talk during the measurement.
7. Keep a record of your blood pressure and pulse readings for your physician. A single measurement does not provide an accurate indication of your true blood pressure. You need to take and record several readings over a period of time. Try to measure your blood pressure at the same time each day for consistency

2. Preparation

2.1 Battery Installation

1. Remove the battery cover.
2. Insert 4 “AA” batteries as indicated in the battery compartment.
3. Replace the battery cover

Notes:

• When the low battery symbol ( ) appears on the display, turn the monitor off, then replace all 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.
• Dispose of the device, components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.

2.2 Setting the Date and Time

Set the monitor to the correct date and time before taking a measurement for the first time.

1. Press the Date/Time setting (  ) button.
   The year flashes on the Date/Time display.
2. Push or button 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.
   
3. 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.

3. Using the Device

3.1 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.

1. Insert the air plug into the air jack securely.
2. Apply the arm cuff to your left upper arm. The bottom edge of the arm cuff should be 1/2 inch (1 to 2 cm) above the elbow. Air tube is on the inside of your arm and aligned with your middle finger.
3. 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.

3.2 How to Sit Correctly

To take a measurement, you need to be relaxed and comfortably seated, under comfortable room temperature. Avoid bathing, drinking alcohol or caffeine, smoking, exercising or eating 30 minutes before taking a measurement.

• Sit on a chair with 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. —

3.3 Taking a Measurement

Notes:

• To stop the measurement, press the START/STOP button once to deflate the arm cuff.
• Remain still and quiet 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.

1. Select your USER ID (1 or 2).
   
2. Press the START/STOP button.
   The arm cuff starts to inflate automatically.
   
3. Remove the arm cuff.
4. 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.

1. . Press and hold the START/STOP button for more than 3 seconds.
   The USER ID symbol and the Date/Time display will disappear.
   
2. Release the START/STOP button when the Date/Time display turns off. The arm cuff will start to inflate automatically.

• 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.
• This device is not intended to be a diagnostic device.
• Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.
  Inflating to a higher pressure than necessary may result in bruising
• where the arm cuff is applied.

3.4 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

1. Select your USER ID (1 or 2).
2. Press the button.
   The Memory number appears for a second before the pulse rate is displayed. The newest set is numbered “1”.
   
3. . Press the  or  button to view the values stored in the memory.
   : To view the older values
   : To view the more recent values
   Note: The value with the TruRead symbol is the average for the consecutive 3 measurements. To display the individual measurement values, press the button while the average is displayed.

To View the Average Value

1. Select your USER ID (1 or 2).
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 measurement values stored in the memory, the screen to the right is displayed.

To Delete All the Values Stored in Memory

The values stored in the memory are deleted by USER ID.

1. Select your USER ID (1 or 2).
2. Press the Memory button, while the memory symbol ( ) appears.
3. 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.

4. Error Messages and Troubleshooting

4.1 Error Messages

4.2 Troubleshooting

5. Maintenance and Storage

5.1 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 gasoline, 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 Customer Service.

5.2 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.

5.3 Optional Medical Accessories

Arm Cuff
Arm circumference 9” – 17” (22 – 42 cm)
CFX-WR17
(Model: HEM-FL31)

AC Adapter

HEM-ADPTW5

Using the Optional 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.

6. Specifications

Model: BP760N HEM-7320-Z
Display LCD digital display
Measurement range Pressure: 0 to 299 mmHg
Pulse: 40 to 180 beats / min.
Accuracy Pressure: ±3 mmHg or 2% of reading
Pulse: ± 5% of display reading
Inflation Fuzzy-logic controlled by electric pump
Deflation Automatic pressure release valve
Measurement method Oscillometric method
IP classification IP 20
Power source 4 “AA” batteries 1.5V or optional AC adapter (INPUT AC100-240V 50/60Hz 0.12A) Battery life Approximately 1000 measurements (using new alkaline batteries)
Operating temperature / humidity 50°F to 104°F (10°C to 40°C) / 15 to 90% RH
Storage temperature / humidity / air pressure -4°F to 140°F (-20°C to 60°C) / 10 to 95% RH / 700 to 1060 hPa
Weight Monitor : Approximately 13 5/8 oz. (385 g) not including batteries
Arm cuff : Approximately 5 3/4 oz. (163 g)
Dimensions Monitor : Approximately 4 7/8” (w) × 3 1/2” (h) × 6 3/8” (l) (124 mm × 90 mm × 161 mm) Arm cuff : Approximately 5 3/4” × 21” (air tube: 29 1/2”) (145 mm × 532 mm (air tube: 750 mm))
Cuff circumference 9” to 17” (220 to 420 mm)
Memory Up to 60 per user
Contents Monitor, arm cuff, battery set, instruction manual, quick start guide Applied part
Protection against electric shock Internally powered ME equipment (When using only the batteries)
= Type BF
= Class II ME equipment (Optional AC adapter)

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 has not been validated for use in pregnancy.

7. FCC Statement

FCC CAUTION:
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

8. Limited Warranty

Your BP760N Automatic Blood Pressure Monitor, excluding the arm cuff and batteries, is warranted to be free from defects in materials and workmanship appearing within 5 years from the date of purchase, when used in accordance with the instructions provided with the monitor. The arm cuff is warranted to  be free from defects in materials and workmanship appearing within 1 year from the date of purchase when the monitor is used in accordance with the instructions provided with the monitor. The above warranty extends only to the original retail purchaser. We will, at our option, replace without charge any monitor or arm cuff covered by the above warranty. Replacement is our only responsibility and your only remedy under the above warranty. To obtain warranty service contact Customer Service by calling 1-800-634 4350 for the address of the inspection center and the return shipping and handling fee. Enclose the original printed receipt. Include a letter, with your name, address, phone number, and description of the specific problem. Pack the product carefully to prevent damage in transit. Because of possible loss in transit, we recommend insuring the product with return receipt requested.
THE FOREGOING IS THE SOLE WARRANTY PROVIDED BY OMRON IN CONNECTION WITH THIS PRODUCT, AND OMRON HEREBY DISCLAIMS ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANT ABILITY AND FITNESS FOR A PARTICULAR PURPOSE. IMPLIED WARRANTIES AND OTHER TERMS THAT MAY BE IMPOSED BY LAW, IF ANY, ARE LIMITED IN DURATION TO THE PERIOD OF THE ABOVE EXPRESS WARRANTY. OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT COSTS, EXPENSES OR DAMAGES.
This warranty provides you with specific legal rights, and you may have other rights that vary by jurisdiction. Because of special local requirements, some of the above limitations and exclusions may not apply to you.

FOR CUSTOMER SERVICE
Visit our web site at: www.omronhealthcare.com
Call toll free: 1-800-634-4350

9. Guidance and Manufacturer’s Declaration

Important information regarding Electro Magnetic Compatibility (EMC)

With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices. In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the IEC60601- 1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices.
Medical devices manufactured by OMRON Healthcare conform to this IEC60601-1-2:2007 standard for both immunity and emissions. Nevertheless, special precautions need to be observed:

• The use of accessories and cables other than those specified by OMRON, with the exception of cables sold by OMRON as replacement parts for internal components, may result in increased emission or decreased immunity of the device.
• The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used.
• Refer to further guidance below regarding the EMC environment in which the device should be used.
• The MEDICAL ELECTRICAL EQUIPMENT BP760N including AC adapter needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this documentations.
• The Essential Performance of the BP760N including AC-adapter is to measure a blood pressure and a pulse rate and using the memory function

The BP760N including AC-adapter may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements.

Guidance and manufacturer’s declaration – electromagnetic immunity

OMRON BP760N including AC-adapter is intended for use in the electromagnetic environment specified below. The customer or the user of this OMRON BP760N including AC-adapter should assure that it is used in such environment.

Recommended separation distance between portable and mobile RF communications equipment and the OMRON BP760N including AC-adapter.

OMRON BP760N including AC-adapter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this OMRON BP760N including AC-adapter can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OMRON BP760N including AC-adapter as recommended below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.