Omron BP710N Instruction Manual page 2

4. Error Messages and Troubleshooting
4.1 Error Messages
Error Display Cause Solution
Remove the arm cuff. Wait 2 - 3
minutes and then take another
Irregular heartbeats are measurement. Repeat the steps
detected. in section 3.3. If this error
continues to appear, contact
your physician.
Carefully read and repeat the
Movement during measurement.
steps in section 3.3.
You should replace the batteries
The batteries are low. with new ones ahead of time.
Refer to section 2.1.
You should replace the batteries
The batteries are exhausted. with new ones at once.
Refer to section 2.1.
Insert the plug securely.
Air plug disconnected.
Refer to section 3.1.
Apply the arm cuff tighter.
Arm cuff is applied too loosely.
Refer to section 3.1.
Replace the arm cuff with a new
Air is leaking from the arm cuff. one.
Refer to section 5.3.
Repeat measurement. Remain
still and do not talk during
measurement.
Refer to section 3.3.
Movement during measurement
and the arm cuff has not been If "E2" appears repeatedly,
inflate the arm cuff manually
inflated sufficiently.
until it is 30 to 40 mmHg above
your previous measurement
result.
Refer to section 3.3.
The arm cuff was inflated Do not touch the arm cuff and/or
exceeding the maximum bend the air tube while taking a
allowable pressure, and then measurement. Do not inflate the
deflated automatically when arm cuff more than necessary.
inflating the arm cuff manually. Refer to section 3.3.
Repeat measurement. Remain
still and do not talk during
Movement during measurement.
measurement.
Refer to section 3.3.
Remove any clothing interfering
Clothing is interfering with the
with the arm cuff.
arm cuff.
Refer to section 3.1.
Device error. Contact Customer Service.
4.2 Troubleshooting
Problem Cause and Solution
Replace all batteries with new ones.
No power.
Check the battery installation for proper
placement of the battery polarities.
No display appears on the monitor.
Refer to section 2.1.
Blood pressure varies constantly. Many
factors including stress, time of day, and
Measurement values appear too high or
how you wrap the cuff, may affect your
too low.
blood pressure. Review the section 1.2
and section 3.3.
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 Arm circumference
7" - 9" (17 - 22 cm) 9" - 17" (22 - 42 cm)
CD-CS9 CD-WR17
(Model: HEM-CS24) (Model: HEM-RML31)
6. Specifications
Model BP710N HEM-7121-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
Battery life Approximately 1000 measurements (using new alkaline batteries)
Operating temperature
50°F to 104°F (10°C to 40°C) / 15 to 90% RH
/ humidity
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 8 7/8 oz. (250 g) not including batteries
Arm cuff : Approximately 6 oz. (170 g)
Dimensions Monitor : Approximately 4" (w) × 3 1/8" (h) × 5 1/8" (l)
(103 mm × 80 mm × 129 mm)
Arm cuff : Approximately 5 3/4" × 23 1/2" (air tube: 29 1/2")
(145 mm × 594 mm (air tube: 750 mm))
Cuff circumference 9" to 17" (220 to 420 mm)
Memory Up to 14
Contents Monitor, arm cuff, instruction manual, quick start guide
Applied part
= Type BF
Protection against
Internally powered ME equipment
electric shock
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 on pregnant patients.
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 BP710N 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.
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.
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
OMRON Automatic Blood Pressure Monitor
Information for accompanying documents in the scope of IEC60601-1-2:2007
Model: BP710N
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 BP710N 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 BP710N is to measure a blood pressure and a pulse rate
and using the memory function.
The BP710N may be interfered with by other equipment, even if that other equipment complies
with CISPR EMISSION requirements.
Guidance and manufacturer's declaration - electromagnetic emissions
OMRON BP710N is intended for use in the electromagnetic environment specified below. The
customer or the user of this OMRON BP710N should assure that it is used in such environment.
Emissions test Compliance Electromagnetic environment - guidance
The OMRON BP710N uses RF energy only for its internal
RF emissions function. Therefore, its RF emissions are very low and are
Group 1
CISPR 11 not likely to cause any interference in nearby electronic
equipment.
RF emissions
Class B
CISPR 11
Harmonic The OMRON BP710N is suitable for use in all
emissions Not Applicable. establishments, including domestic establishments and
IEC 61000-3-2 those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
Voltage
purposes.
fluctuations/
Not Applicable.
flicker emissions
IEC61000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity
OMRON BP710N is intended for use in the electromagnetic environment specified below. The
customer or the user of this OMRON BP710N should assure that it is used in such environment.
IEC 60601 test Electromagnetic environment -
Immunity test Compliance level
level guidance
Floor should be wood, concrete,
Electrostatic discharge or ceramic tile. If floors are
±6 kV contact ±6 kV contact
(ESD) covered with synthetic material,
±8 kV air ±8 kV air
IEC 61000-4-2 the relative humidity should be at
least 30 %.
±2 kV for power
Electrical fast
supply lines
transient/burst Not Applicable. Not Applicable.
±1 kV for
IEC 61000-4-4
input/output lines
±1 kV line(s) to
Surge line(s)
Not Applicable. Not Applicable.
IEC 61000-4-5 ±2 kV line(s) to
earth
<5 % U (>95 % dip
T
in U )
T
for 0.5 cycle
40 % U (60 % dip
T
Voltage dips, short
in U )
T
interruptions and
for 5 cycles
voltage variations on Not Applicable. Not Applicable.
70 % U (30 % dip
power supply inputlines T
in U )
IEC 61000-4-11 T
for 25 cycles
<5 % U (95 % dip
T
in U )
T
for 5 sec.
Power frequency magnetic fields
Power frequency
should be at levels characteristic
(50/60 Hz) magnetic
3 A/m 3 A/m of a typical location in a typical
field
commercial or hospital
IEC 61000-4-8
environment.
Note: U is the A.C. mains voltage prior to application of the test level.
T
Guidance and manufacturer's declaration - electromagnetic immunity
OMRON BP710N is intended for use in the electromagnetic environment specified below. The
customer or the user of this OMRON BP710N should assure that it is used in such environment.
Compli
IEC 60601 test
Immunity test ance Electromagnetic environment - guidance
level
level
Portable and mobile RF communications equipment
should be used no closer to any part of the OMRON
BP710N including cables, than the recommended
separation distance calculated from the equation
appropriate to the frequency of the transmitter.
Recommend separation distance
Conducted RF 3 V rms Not Not Applicable.
IEC 61000-4-6 150 kHz to 80 Applica
MHz ble.
Radiated RF 3 V/m 3 V/m d = 1.2 √P
IEC 61000-4-3 80 MHz to 2.5 80 MHz to 800 MHz
GHz 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
a
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 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 BP710N is used exceeds the applicable RF compliance level above, the OMRON
BP710N should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the OMRON BP710N.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distance between portable and mobile RF communications
equipment
and the OMRON BP710N
OMRON BP710N is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of this OMRON BP710N can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the OMRON BP710N as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
in meter
Output Power of Transmitter in
Watt
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5GHz
Not Applicable. d = 1.2 √P
0.01 0.12
0.1 0.38
1 Not Applicable. 1.2
10 3.8
100 12
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.
Manufactured for: OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN
Distributed by: OMRON HEALTHCARE, INC.
1925 West Field Court, Lake Forest, IL 60045 U.S.A.
www.omronhealthcare.com
© 2013 OMRON HEALTHCARE, INC.
Made in Vietnam
b
d = 2.3 √P
0.23
0.73
2.3
7.3
23