9. Guidance and Manufacturer’s Declaration...........................................30
2
Introduction
Contraindications
Thank you for purchasing the OMRON BP7100 Blood Pressure Monitor. This new
blood pressure monitor uses the oscillometric method of blood pressure
measurement. This means this monitor detects your blood movement through your
brachial artery and converts the movements into a digital reading.
Safety Instructions
This instruction manual provides you with important information about the OMRON
BP7100 Blood Pressure Monitor. To ensure the safe and proper use of this monitor,
READ and UNDERSTAND all of these instructions. If you do not understand
these instructions or have any questions, contact 1-800-634-4350 before
attempting to use this monitor. For specific information about your own blood
pressure, consult with your physician.
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 appearance of
irregular heartbeats during measurement and gives a warning signal with readings.
Environments of Use: Home
Patient Population: Adult
Receiving and Inspection
Remove this monitor from the packaging and inspect for damage. If this monitor is
damaged, DO NOT USE and contact 1-800-634-4350.
Symbols Glossary
For symbol information, visit:
OmronHealthcare.com/symbols-glossary
• This monitor is contraindicated for use in ambulatory environments.
• This monitor is contraindicated for use on aircraft.
3
Important Safety Information
Please read the Important Safety Information in this instruction manual before
using this monitor.
Please follow this instruction manual thoroughly for your safety.
Please keep for future reference. For specific information about your own blood
pressure, CONSULT WITH YOUR PHYSICIAN.
Warning
• DO NOT use this monitor on infants, toddlers, children or persons who
cannot express themselves.
• DO NOT adjust medication based on readings from this blood pressure
monitor. Take medication as prescribed by your physician. ONLY a physician
is qualified to diagnose and treat high blood pressure.
• DO NOT use this monitor on an injured arm or an arm under medical
treatment.
• DO NOT apply the arm cuff on your arm while on an intravenous drip or
blood transfusion.
• DO NOT use this monitor in areas containing high frequency (HF) surgical
equipment, magnetic resonance imaging (MRI) equipment, computerized
tomography (CT) scanners or in oxygen rich environments. This may result
in incorrect operation of the monitor and/or cause an inaccurate reading.
• Consult with your physician before using this monitor if you have common
arrhythmias such as atrial or ventricular premature beats or atrial fibrillation;
arterial sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or
renal disease. NOTE that any of these conditions in addition to patient
motion, trembling, or shivering may affect the measurement reading.
• NEVER diagnose or treat yourself based on your readings. ALWAYS consult
with your physician.
• To help avoid strangulation, keep the air tube away from infants, toddlers or
children.
• This product contains small parts that may cause a choking hazard if
swallowed by infants, toddlers or children.
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
4
Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers or children.
Indicates a potentially hazardous situation which, if not
Caution
• Stop using this monitor and consult with your physician if you experience
skin irritation or discomfort.
• Consult with your physician before using this monitor on an arm where
intravascular access or therapy, or an arteriovenous (A-V) shunt, is present
because of temporary interference to blood flow which could result in injury.
• Consult with your physician before using this monitor if you have had a
mastectomy.
• Consult with your physician before using this monitor if you have severe
blood flow problems or blood disorders as cuff inflation can cause bruising.
• DO NOT take measurements more often than necessary because bruising,
due to blood flow interference, may occur.
• ONLY inflate the arm cuff when it is applied on your upper arm.
• Remove the arm cuff if it does not start deflating during a measurement.
• DO NOT use this monitor for any purpose other than measuring blood
pressure.
• Do not use a mobile phone or other devices that emit electromagnetic fields,
near the monitor. This may result in incorrect operation of the monitor.
• DO NOT disassemble or attempt to repair this monitor or other components.
This may cause an inaccurate reading.
• DO NOT use in a location where there is moisture or a risk of water
splashing this monitor. This may damage this monitor.
• DO NOT use this monitor in a moving vehicle such as in a car.
• DO NOT drop or subject this monitor to strong shocks or vibrations.
• DO NOT use this monitor in places with high or low humidity or high or low
temperatures. Refer to section 5.
• Ensure this monitor is not impairing blood circulation by observing the arm
while measurement is occurring.
avoided, may result in minor or moderate injury to the user
or patient, or cause damage to the equipment or other
property.
5
• DO NOT use this monitor in high-use environments such as medical clinics
or physician offices.
• DO NOT use this monitor with other medical electrical (ME) equipment
simultaneously. This may result in incorrect operation of the monitor and/or
cause an inaccurate reading.
• Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating
for at least 30 minutes before taking a measurement.
• Rest for at least 5 minutes before taking a measurement.
• Remove tight-fitting, thick clothing from your arm while taking a
measurement.
• Remain still and DO NOT talk while taking a measurement.
• ONLY use the arm cuff on persons whose arm circumference is within the
specified range of the cuff.
• Ensure that this monitor has acclimated to room temperature before taking a
measurement. Taking a measurement after an extreme temperature change
could lead to an inaccurate reading. OMRON recommends waiting for
approximately 2 hours for the monitor to warm up or cool down when the
monitor is used in an environment within the temperature specified as
operating conditions after it is stored either at the maximum or at the
minimum storage temperature. For additional information of operating and
storage/transport temperature, refer to section 5.
• DO NOT crease the arm cuff or the air tube excessively.
• DO NOT fold or kink the air tube while taking a measurement. This may
cause an injury by interrupting air flow.
• To unplug the air plug, pull on the plastic air plug at the base of the tube, not
the tube itself.
• ONLY use the arm cuff, batteries and accessories specified for this monitor.
Use of unsupported arm cuffs and batteries may damage and/or may be
hazardous to this monitor.
• ONLY use the approved arm cuff for this monitor. Use of other arm cuffs may
result in incorrect readings.
• Inflating to a higher pressure than necessary may result in bruising of the
arm where the cuff is applied. NOTE: please refer to “If your systolic
pressure is more than 210 mmHg” in section 3 of this instruction manual for
additional information.
• Read and follow the “Important information regarding Electromagnetic
Compatibility (EMC)” in section 9 of this manual.
6
Battery Handling and Usage
• DO NOT insert batteries with their polarities incorrectly aligned.
• ONLY use 4 “AA” alkaline or manganese batteries with this monitor. DO NOT
use other types of batteries. DO NOT use new and used batteries together.
• Remove batteries if this monitor will not be used for a long period of time.
• If battery fluid should get in your eyes, immediately rinse with plenty of
clean water. Consult with your physician immediately.
• If battery fluid should get on your skin, wash your skin immediately with
plenty of clean, lukewarm water. If irritation, injury or pain persists, consult
with your physician.
• DO NOT use batteries after their expiration date.
• Periodically check batteries to ensure they are in good working condition.
7
1. Know Your Monitor
F
H
G
F. Arm cuf f
(Arm circumference 9" - 17" (22 - 42 cm))
G. Air plug
H. Air tube
Contents:
Monitor, arm cuff, instruction manual, quick start guide
Monitor:
C
A. Display
B. START/STOP button
C. Memory button
Arm cuff:
A
B
D. Battery compartment
E. Air jack
8
D
E
Display:
I
N
O
J
K
L
P
M
I. Memory symbol
J. Systolic blood pressure
K. Diastolic blood pressure
L. Low battery symbol
M. Heartbeat symbol
(Flashes during measurement.)
Q
N. Irregular heartbeat symbol
O. Movement error symbol
P. Pulse display / Memory number
Q. Deflation symbol
9
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
Blood pressure
Blood pressure
Normal Heartbeat
Pulse
Irregular Heartbeat
Pulse
Short
Long
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.
10
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.
Classification of BP (Blood Pressure)
ACC/AHA 2017 Hypertension guidelines define categories of BP in adults as
below.
Categories of BP in Adults*
BP CategorySystolic BPDiastolic BP
and
and
or
or
< 80 mmHg
< 80 mmHg
80-89 mmHg
≥ 90 mmHg
Normal< 120 mmHg
Elevated120-129 mmHg
Hypertension
Stage 1
Stage 2
* Individuals with Systolic BP and Diastolic BP in 2 categories should be
designated to the higher BP category.
BP indicates blood pressure (based on an average of ≥ 2 careful readings
obtained on ≥ 2 occasions).
130-139 mmHg
≥ 140 mmHg
Source: ACC/AHA 2017 High Blood Pressure Clinical Practice Guideline
Warning
NEVER diagnose or treat yourself based on your
readings. ALWAYS consult with your physician.
11
1.2 Blood Pressure Measurement Tips
To help ensure an accurate reading, follow these directions:
• It is important to take measurements at the same times each day.
Taking measurements in the morning and in the evening is recommended.
• Remember to have 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.
• Avoid bathing, drinking alcohol or caffeine, smoking,
Caution
exercising and eating for at least 30 minutes before
taking a measurement.
• Rest for at least 5 minutes before taking a measurement.
12
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.
• Disposal of used batteries should be carried out in accordance with local
regulations.
13
3. Using the Monitor
0.5 inch
(1 - 2 cm)
Bottom edge
3.1 Applying the Arm Cuff
Caution
1. Insert the air plug into the air jack
securely.
2. Wrap the arm cuff firmly in
place around your left upper
arm.
The bottom edge of the arm cuff
should be 0.5 inch (1 to 2 cm) above
the elbow. Air tube is on the inside of
your arm and aligned with your middle
finger.
Remove tight-fitting, thick clothing from your arm
while taking a measurement.
14
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.
15
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 in a chair with your legs uncrossed and
feet flat on the floor.
• Sit with your back and arm supported.
• The arm cuff should be placed on your arm at
the same level as your heart, with the arm
resting comfortably on a table.
16
3.3 Taking a Measurement
STARTINFLATINGCOMPLETED
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.
Caution
Inflating to a higher pressure than necessary may
result in bruising where the arm cuff is applied.
Notes:
• To stop the measurement, press the START/STOP button once to deflate
the arm cuff.
• Remain still and quiet while taking a measurement.
1. Press the START/STOP button.
The arm cuff will start to inflate automatically.
17
2. Remove the arm cuff.
3.
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.
18
3.4 Using the Memory Function
The monitor automatically stores the results up to 14 sets.
Note: If the memory is full, the monitor will delete the oldest value.
To View the Measurement Values Stored in Memory
1. Press the button.
The Memory number appears for a second
before the pulse rate is displayed.
The newest set is numbered “1”.
2. Press the button repeatedly to view the values stored in
memory.
To Delete All the Values Stored in Memory
1. Press the button, while the memory symbol appears.
2. While holding the button
down, press the START/STOP
button for more than 3 seconds.
Note: You cannot partially delete the values stored in memory.
19
4. Error Messages and Troubleshooting
4.1 Error Messages
Error DisplayCauseSolution
Remove the arm cuff. Wait 2 - 3
Irregular heartbeats are
detected.
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.
The batteries are low.
The batteries are exhausted.
Air plug disconnected.
Arm cuff is applied too loosely.
Air is leaking from the arm cuff.
20
Carefully read and repeat the
steps in section 3.3.
You should replace the batteries
with new ones ahead of time.
Refer to section 2.1.
You should replace the batteries
with new ones at once.
Refer to section 2.1.
Insert the plug securely.
Refer to section 3.1.
Apply the arm cuff tighter.
Refer to section 3.1.
Replace the arm cuff with a new
one.
Refer to section 5.5.
Error DisplayCauseSolution
Repeat measurement. Remain
still and do not talk during
measurement.
Movement during measurement
and the arm cuff has not been
inflated sufficiently.
The arm cuff was inflated
exceeding the maximum
allowable pressure, and then
deflated automatically when
inflating the arm cuff manually.
Movement during measurement.
Clothing is interfering with the
arm cuff.
Device error.Contact Customer Service.
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.
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 section 3.3.
Repeat measurement. Remain
still and do not talk during
measurement.
Refer to section 3.3.
Remove any clothing interfering
with the arm cuff.
Refer to section 3.1.
21
4.2 Troubleshooting
ProblemCause and Solution
No power.
No display appears on the monitor.
Measurement values appear too high or
too low.
Replace all batteries with new ones.
Check the battery installation for proper
placement of the battery polarities.
Refer to section 2.1.
Blood pressure varies constantly. Many
factors including stress, time of day, and
how you wrap the cuff, may affect your
blood pressure. Review section 1.2 and
section 3.3.
22
5. Maintenance
5.1 Maintenance
To protect your monitor from damage, please follow the directions
below:
• Changes or modifications not approved by the manufacturer
will void the user warranty.
• DO NOT disassemble or attempt to repair this monitor or
other components. This may cause an inaccurate reading.
5.2 Storage
Store your monitor and other components in a clean, safe location.
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 your monitor and other components:
• If your monitor and other components are wet.
• In locations exposed to extreme temperatures, humidity, direct sunlight, dust
or corrosive vapors such as bleach.
• In locations exposed to vibrations or shocks.
23
5.3 Cleaning
• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth or a soft cloth moistened with neutral soap to clean your
monitor and arm cuff, and then wipe them with a dry cloth.
• Do not wash or immerse your monitor and arm cuff or other components in water.
• Do not use gasoline, thinners or similar solvents to clean your monitor and arm
cuff or other components.
5.4 Disposal
• Dispose of your monitor, other components and optional accessories according to
applicable local regulations.
• Unlawful disposal may cause environmental pollution.
5.5 Optional Medical Accessories
Arm circumference
7" - 9" (17 - 22 cm)
CD-CS9
(Model: HEM-CS24)
Arm cuff
24
Arm circumference
9" - 17" (22 - 42 cm)
CD-WR17
(Model: HEM-RML31)
6. Specifications
Model
DisplayLCD digital display
Cuff pressure rangePressure: 0 to 299 mmHg
Measurement rangePressure: 20 to 280 mmHg
AccuracyPressure: ±3 mmHg
InflationFuzzy-logic controlled by electric pump
DeflationAutomatic pressure release valve
Measurement method Oscillometric method
IP classificationIP 20
RatingDC6 V 4 W
Power source
Battery lifeApproximately 1000 measurements (using new alkaline batteries)
Durable period
(Service life)
Operating conditions +50 °F to +104 °F (+10 °C to + 40 °C) / 15 to 90% RH
Storage / Transport
conditions
WeightMonitor : Approximately 8.8 oz. (250 g) not including batteries
MemoryUp to 14 Readings
Contents
Applied partType BF (arm cuff)
Protection against
electric shock
BP7100 HEM-7121-Z2
Pulse: 40 to 180 beats / min.
Pulse: ± 5% of display reading
4 “AA” batteries 1.5 V
Monitor: 5 years
Cuff: 5 years
(non-condensing) / 800 to 1060 hPa
-4 °F to +140 °F (-20 °C to +60 °C) / 10 to 90% RH (non-condensing)
Arm cuff : Approximately 6 oz. (170 g)
Arm cuff : Approximately 5.7" × 23.4" (air tube: 29.5")
7" to 17" (170 to 420 mm) (included arm cuff 9” to 17” (220 to 420
mm))
Monitor, arm cuff, instruction manual, quick start guide
Internally powered ME equipment
(103 mm × 80 mm × 129 mm)
(145 mm × 594 mm (air tube: 750 mm))
25
Notes:
• These specifications are subject to change without notice.
• This monitor is clinically investigated according to the requirements of ISO
81060-2:2013. In the clinical validation study, K5 was used on 85 subjects
for determination of diastolic blood pressure.
• This monitor has not been validated for use on pregnant patients.
• IP classification is degrees of protection provided by enclosures in
accordance with IEC 60529. This monitor is protected against solid foreign
objects of 12.5 mm diameter and greater such as a finger.
Pictogram on the Product
Type of marks used to indicate the correct positioning of the artery for
the upper arm
Identifies the type of cuff that is compatible with the blood Pressure
Monitor
26
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.
27
8. Limited Warranty
Your BP7100 Automatic Blood Pressure Monitor, excluding the arm cuff, is
warranted to be free from defects in materials and workmanship appearing within
2 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, and only to
products purchased from an Omron authorized seller who is subject to and follows
Omron’s quality control standards, unless otherwise prohibited by law.
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.
OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL,
INCIDENTAL, CONSEQUENTIAL OR INDIRECT COSTS, EXPENSES OR
DAMAGES.
28
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
29
9. Guidance and Manufacturer’s Declaration
OMRON Automatic Blood Pressure Monitor
Information for accompanying documents in the scope of IEC60601-1-2:2007
Model: BP7100
Important information regarding Electromagnetic Compatibility (EMC)
With the increased number of electronic devices such as PCs 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 (Electromagnetic 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 BP7100 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 BP7100 is to measure a blood pressure and a pulse rate
and using the memory function.
The BP7100 may be interfered with by other equipment, even if that other equipment complies
with CISPR EMISSION requirements.
30
Guidance and manufacturer’s declaration - electromagnetic emissions
OMRON BP7100 is intended for use in the electromagnetic environment specified below. The
customer or the user of this OMRON BP7100 should assure that it is used in such environment.
Voltage
fluctuations/
flicker emissions
IEC61000-3-3
OMRON BP7100 is intended for use in the electromagnetic environment specified below. The
customer or the user of this OMRON BP7100 should assure that it is used in such environment.
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Group 1
Class B
Not Applicable.
Not Applicable.
Guidance and manufacturer’s declaration - electromagnetic immunity
IEC 60601 test
level
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for
input/output lines
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
The OMRON BP7100 uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
The OMRON BP7100 is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
Compliance level
±6 kV contact
±8 kV air
Not Applicable.Not Applicable.
Not Applicable.Not Applicable.
Electromagnetic environment -
Floor should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
guidance
31
<5 % U
T (>95 % dip
in U
T)
for 0.5 cycle
40 % U
Voltage dips, short
interruptions and
voltage variations on
power supply inputlines
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
Note: U
T is the A.C. mains voltage prior to application of the test level.
T (60 % dip
in U
T)
for 5 cycles
70 % U
T (30 % dip
in U
T)
for 25 cycles
<5 % U
T (95 % dip
in U
T)
for 5 sec.
Not Applicable.Not Applicable.
3 A/m3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
32
OMRON BP7100 is intended for use in the electromagnetic environment specified below. The
P
P
customer or the user of this OMRON BP7100 should assure that it is used in such environment.
Immunity test
IEC 60601 test
level
Compli
ance
level
Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the OMRON
BP7100 including cables, than the recommended
separation distance calculated from the equation
appropriate to the frequency of the transmitter.
Recommend separation distance
Guidance and manufacturer’s declaration - electromagnetic immunity
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
Not
Applica
ble.
3 V/m
Not Applicable.
d = 1.2
80 MHz to 800 MHz
d = 2.3
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,
the compliance level in each frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones
and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters,
an electromagnetic site survey should be considered. If the measured field strength in the location in
which the OMRON BP7100 is used exceeds the applicable RF compliance level above, the OMRON
BP7100 should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the OMRON BP7100.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
a
should be less than
b
33
Recommended separation distance between portable and mobile RF communications
P
P
OMRON BP7100 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of this OMRON BP7100 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the OMRON BP7100 as recommended below,
according to the maximum output power of the communications equipment.
Output Power of Transmitter in
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
Watt
0.01
0.10.380.73
11.22.3
103.87.3
1001223
absorption and reflection from structures, objects, and people.
equipment and the OMRON BP7100
Separation distance according to frequency of transmitter