Omron BP765CAN, BP765, BP786N Instruction Manual

Download

Page 1

English

Español

HEM-7321-Z_C_M.book Page i Monday, June 16, 2014 12:09 PM

Page 2

Monitor

AC Adapter

ComFit™ Cuff

El producto incluye:

Monitor

Adaptador de CA

Brazalete ComFit™

Product includes:

HEM-7321-Z_C_M.book Page ii Monday, June 16, 2014 12:09 PM

Page 3

Contents

Thank you for purchasing the OMRON® BP785N Blood Pressure Monitor. Your new blood pressure monitor uses the oscillometric method of blood pressure

measurement. This means the monitor detects your blood movement through your brachial artery and converts the movements into a digital reading. An oscillometric monitor does not need a stethoscope so the monitor is simple to use.

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.

Important Safety Information........................1

1. Know Your Device....................................4

1.1 Display Symbols.....................................5

1.2 Before Taking a Measurement...............6

2. Preparation ...............................................7

2.1 Battery Installation..................................7

3.4 Using the Memory Function................. 18

4. Error Messages and Troubleshooting ..21

4.1 Error Messages ................................... 21

4.2 Troubleshooting................................... 23

5. Maintenance and Storage ......................24

5.1 Maintenance ........................................ 24

HEM-7321-Z_C_M.book Page 1 Monday, June 16, 2014 12:09 PM

Page 4

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.

HEM-7321-Z_C_M.book Page 1 Monday, June 16, 2014 12:09 PM

Page 5

Important Safety Information

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.

HEM-7321-Z_C_M.book Page 2 Monday, June 16, 2014 12:09 PM

Page 6

Important Safety Information

When handling the power cord, take care not to do the following:

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.

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.

HEM-7321-Z_C_M.book Page 3 Monday, June 16, 2014 12:09 PM

Page 7

1. Know Your Device

Monitor

Air jack Blood pressure color indicator Date/Time setting button USER ID selection switch Display Memory button START/STOP button Up/Down buttons Battery compartment

Display

Memory symbol USER ID symbol Average value symbol Systolic blood pressure Diastolic blood pressure Heartbeat symbol

(Flashes during measurement)

Date/Time display TruReadTM symbol

Open the rear cover page to read the following:

The letter identifiers on the rear cover page correspond to those in the body of this page.

ABCDEFGHINO

HEM-7321-Z_C_M.book Page 4 Monday, June 16, 2014 12:09 PM

Page 8

1. Know Your Device

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.

Normal Heartbeat

Irregular Heartbeat

Pulse

Blood pressure

Short

Long

Pulse

HEM-7321-Z_C_M.book Page 5 Monday, June 16, 2014 12:09 PM

Page 9

1. Know Your Device

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

Office Home

Systolic Blood Pressure ≥ 140 mmHg ≥ 135 mmHg

Diastolic Blood Pressure ≥ 90 mmHg ≥ 85 mmHg

HEM-7321-Z_C_M.book Page 6 Monday, June 16, 2014 12:09 PM

Page 10

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

HEM-7321-Z_C_M.book Page 7 Monday, June 16, 2014 12:09 PM

Page 11

2. Preparation

2.2

Using the AC adapter

IMPORTANT SAFETY INSTRUCTIONS

SAVE THESE INSTRUCTIONS

- DANGER -

TO REDUCE THE RISK OF FIRE OR ELECTRIC SHOCK,

CAREFULLY FOLLOW THESE INSTRUCTIONS.

The power unit (AC Adapter) is intended to be correctly oriented in a vertical or floor mount

position.

HEM-7321-Z_C_M.book Page 8 Monday, June 16, 2014 12:09 PM

Page 12

2. Preparation

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.

HEM-7321-Z_C_M.book Page 9 Monday, June 16, 2014 12:09 PM

Page 13

2. Preparation

2.3

Setting the TruRead

Mode

The TruReadTM Mode takes 3 consecutive measurements. The monitor will inflate, take a measurement, and deflate - 3 times, separated by a short interval between

each measurement. The TruRead

Mode is set “oFF” by default

1. Select your USER ID (1 or 2).

2. Press the button.

The TruReadTM symbol ( ) appears on the display.

Press or buttons to select “on” or “oFF”.

HEM-7321-Z_C_M.book Page 10 Monday, June 16, 2014 12:09 PM

Page 14

2. Preparation

2.4

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.

Open the rear cover page to read the following:

The letter identifiers on the rear cover page correspond to those in the body of this page.

Year

Month

Day

HEM-7321-Z_C_M.book Page 11 Monday, June 16, 2014 12:09 PM

Page 15

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.

Open both the front and rear covers to read the following:

The letter identifiers on the cover page correspond to those in the body of this page.

AaM

HEM-7321-Z_C_M.book Page 12 Monday, June 16, 2014 12:09 PM

Page 16

3. Using the Device

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. ---

HEM-7321-Z_C_M.book Page 13 Monday, June 16, 2014 12:09 PM

Page 17

3. Using the Device

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.

Using the Single Mode

1. Select your USER ID (1 or 2).

2. Press the START/STOP button.

The arm cuff starts to inflate automatically.

START

INFLATE

DEFLATE

COMPLETE

HEM-7321-Z_C_M.book Page 14 Monday, June 16, 2014 12:09 PM

Page 18

3. Using the Device

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 TruReadTM Mode

1. Select your USER ID (1 or 2).

HEM-7321-Z_C_M.book Page 15 Monday, June 16, 2014 12:09 PM

Page 19

3. Using the Device

The first measurement is complete, waiting to start the next measurement. The interval will appear on the display.

The second measurement is complete, waiting to start the next measurement. The interval will appear on the display.

HEM-7321-Z_C_M.book Page 16 Monday, June 16, 2014 12:09 PM

Page 20

3. Using the Device

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, and the TruRead

mode is not available 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.

HEM-7321-Z_C_M.book Page 17 Monday, June 16, 2014 12:09 PM

Page 21

3. Using the Device

3.4

Using the Memory Function

The monitor automatically stores the results up to 100 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).

HEM-7321-Z_C_M.book Page 18 Monday, June 16, 2014 12:09 PM

Page 22

3. Using the Device

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.

HEM-7321-Z_C_M.book Page 19 Monday, June 16, 2014 12:09 PM

Page 23

3. Using the Device

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.

HEM-7321-Z_C_M.book Page 20 Monday, June 16, 2014 12:09 PM

Page 24

Error Messages and Troubleshooting

4.1

Error Messages

Display Cause Solution

Irregular heartbeats are detected.

Remove the arm cuff. Wait 2-3 minutes and then take another measurement.

Repeat the steps in section 3.3. If this error continues to appear, contact your physician.

Movement during measurement.

Carefully read and repeat the steps in section

3.3.

The batteries are low.

You should replace the batteries with new ones ahead of time.

Refer to section 2.1.

The batteries are exhausted.

You should replace the batteries with new ones at once.

Refer to section 2.1.

HEM-7321-Z_C_M.book Page 21 Monday, June 16, 2014 12:09 PM

Page 25

4. Error Messages and Troubleshooting

Air plug disconnected.

Insert the air plug securely. Refer to section 3.1.

Arm cuff is applied too loosely.

Apply the arm cuff tighter. Refer to section 3.1.

Air is leaking from the arm cuff.

Replace the arm cuff with a new one. Refer to section 5.3.

Movement during measurement and the arm cuff has not been inflated sufficiently.

Repeat measurement. Remain still and do not talk during measurement.

Refer to section 3.3.

If “E2” appears repeatedly, inflate the arm cuff manually until it is 30 to 40 mmHg above your previous measurement result.

Refer to section 3.3.

The arm cuff was inflated exceeding the maximum allowable pressure, and then deflated automatically when inflating the arm

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.

Display Cause Solution

HEM-7321-Z_C_M.book Page 22 Monday, June 16, 2014 12:09 PM

Page 26

4. Error Messages and Troubleshooting

4.2

Troubleshooting

Problem Cause and Solution

No power. No display appears on the monitor.

Replace all batteries with new ones. Check the battery installation for proper placement of

the battery polarities. Refer to section 2.1.

Measurement values appear too high or too low.

Blood pressure varies constantly. Many factors including stress, time of day, and how you wrap the cuff, may affect your blood pressure. Review the section 1.2 and section 3.3.

HEM-7321-Z_C_M.book Page 23 Monday, June 16, 2014 12:09 PM

Page 27

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.

HEM-7321-Z_C_M.book Page 24 Monday, June 16, 2014 12:09 PM

Page 28

5. Maintenance and Storage

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.

HEM-7321-Z_C_M.book Page 25 Monday, June 16, 2014 12:09 PM

Page 29

5. Maintenance and Storage

5.3

Optional Medical Accessories

Arm Cuff

Arm circumference

9” - 17” (22 - 42 cm)

AC Adapter

CFX-WR17

(Model: HEM-FL31)

HEM-ADPTW5

HEM-7321-Z_C_M.book Page 26 Monday, June 16, 2014 12:09 PM

Page 30

6. Specifications

Model

BP785N HEM-7321-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 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 14 1/8 oz. (400 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))

HEM-7321-Z_C_M.book Page 27 Monday, June 16, 2014 12:09 PM

Page 31

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.

HEM-7321-Z_C_M.book Page 28 Monday, June 16, 2014 12:09 PM

Page 32

8. Limited Warranty

Your BP785N Automatic Blood Pressure Monitor, excluding the arm cuff, 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 MERCHANTABILITY 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.

HEM-7321-Z_C_M.book Page 29 Monday, June 16, 2014 12:09 PM

Page 33

Guidance and Manufacturer’s Declaration

OMRON Automatic Blood Pressure Monitor Information for accompanying documents in the scope of IEC60601-1-2:2007 Model: BP785N including AC-adapter

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 IEC606011-2 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 BP785N 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 BP785N including AC-adapter is to measure a blood pressure and a pulse rate and using the memory function.

The BP785N including AC-adapter may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements.

HEM-7321-Z_C_M.book Page 30 Monday, June 16, 2014 12:09 PM

Page 34

9. Guidance and Manufacturer’s Declaration

Guidance and manufacturer’s declaration - electromagnetic immunity

OMRON BP785N including AC-adapter is intended for use in the electromagnetic environment specified below. The customer or the user of this OMRON BP785N including AC-adapter should assure that it is used in such environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

Mains power quality should be that of a typical commercial and/or hospital environment.

Surge IEC 61000-4-5

±1 kV line(s) to line(s) ±2 kV line(s) to earth

Mains power quality should be that of a typical commercial and/or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply inputlines IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0.5 cycle

Mains power quality should be that of a typical commercial and/or hospital environment. If the user of the OMRON BP785N including ACadapter requires continued operation during power mains interruption, it is recommended that the OMRON BP785N including AC-adapter be powered from an uninterruptible power supply.

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (95 % dip in UT) for 5 sec.

Power frequency (50/60 Hz)

Power frequency magnetic fields should be at

HEM-7321-Z_C_M.book Page 31 Monday, June 16, 2014 12:09 PM

Page 35

9. Guidance and Manufacturer’s Declaration

Guidance and manufacturer’s declaration - electromagnetic immunity

Immunity test IEC 60601 test level

Compliance

level

Electromagnetic environment - guidance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 V rms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 V rms

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the OMRON BP785N including AC-adapter including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter.

Recommend separation distance

d = 1.2 √P

80 MHz to 800 MHz

d = 2.3 √P

800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters as determined by an electromagnetic

site survey,

should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following

HEM-7321-Z_C_M.book Page 32 Monday, June 16, 2014 12:09 PM

Page 36

9. Guidance and Manufacturer’s Declaration

Recommended separation distance between portable and mobile RF communications equipment

and the OMRON BP785N including AC-adapter

OMRON BP785N 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 BP785N including AC-adapter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OMRON BP785N including AC-adapter as recommended below, according to the maximum output power of the communications equipment.

Output Power of Transmitter in Watt

Separation distance according to frequency of transmitter in meter

150 kHz to 80 MHz

d = 1.2 √P

80 MHz to 800 MHz

d = 1.2 √P

800 MHz to 2.5GHz

d = 2.3 √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

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.

HEM-7321-Z_C_M.book Page 33 Monday, June 16, 2014 12:09 PM

Page 37