GUIDANCE AND MANUFACTURER’S DECLARATION
(Table 1)
Guidance and manufacturer’s declaration – electromagnetic emissions
Emissions test
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC61000-3-3
(Table 2)
Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test IEC 60601
Test level
Compliance
level
Electromagnetic environment
– guidance
Immunity test IEC 60601
Test level
Compliance
level
Electromagnetic environment
– guidance
(Table 6)
Recommended separation distance between portable and mobile RF
communications equipment and the OMRON BPM
Separation distance according to frequency of
transmitter in meter
Not Applicable.
Not Applicable.
Not Applicable.
Not Applicable.
Not Applicable.
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
0.01
0.1
1
10
100
Output Power of
Transmitter in
Watt
(Table 4)
Guidance and manufacturer’s declaration – electromagnetic immunity
OMRON Wrist Blood Pressure Monitor (BPM)
Information for accompanying documents in the scope of IEC60601-1-2:2007
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 Compatibil-
ity) 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 E
Q
UIPMENT BPM 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 BPM is to measure a blood pressure and a
pulse rate and using the memory function.
The BPM may be interfered with by other equipment, even if that other
equipment complies with CISPR EMISSION requirements.
OMRON BPM is intended for use in the electromagnetic environment
specified below. The customer or the user of this OMRON BPM should assure
that it is used in such environment.
Electromagnetic environment
– guidance
Group 1
Class B
RF emissions CISPR 11
RF emissions CISPR 11
The OMRON BPM 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 BPM
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.
OMRON BPM is intended for use in the electromagnetic environment
specified below. The customer or the user of this OMRON BPM should assure
that it is used in such environment.
OMRON BPM is intended for use in the electromagnetic environment
specified below. The customer or the user of this OMRON BPM should assure
that it is used in such environment.
Compliance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Surge
IEC 61000-4-5
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
Floor should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Not Applicable.
Not Applicable.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
Not Applicable.
Portable and mobile RF
communications
equipment should be used no
closer to any part of
the OMRON BPM
including cables, than the
recommended separation
distance calculated from the
equation appropriate to the
frequency of the transmitter.
±6 kV contact
±8 kV air
±2 kV for
power
supply lines
±1 kV for
input/output
lines
Not
Applicable.
±1 kV
line(s) to
line(s)
±2 kV
line(s) to
earth
Not
Applicable.
<5 %
U
T
(>95 % dip
in
U
T
)
for 0.5 cycle
40 %
U
T
(60 % dip in
U
T
)
for 5 cycles
70 %
U
T
(30 % dip in
U
T
)
for 25 cycles
Not
Applicable.
<5 %
U
T
(>
95 % dip
in
U
T
)
for 5 sec.
±6 kV contact
±8 kV air
3 A/m
3 A/m
Note:
U
T
is the A.C. mains voltage prior to application of the test level.
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 BPM is used exceeds the applicable
RF compliance level above, the OMRON BPM should be observed to
verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the OMRON
BPM.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
3 V rms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 V/m
Not
Applicable.
Recommend
separation distance
Not Applicable.
OMRON BPM is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of this
OMRON BPM can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications
equipment (transmitters) and the OMRON BPM as recommended below,
according to the maximum output power of the communications equipment.
150 kHz to 80 MHz
Not Applicable.
80 MHz to 800 MHz
d
= 1.2 √P
800 MHz to 2.5GHz
d
= 2.3 √P
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.
Not
Applicable.
Not
Applicable.
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,
a
should be less than the compli-
ance level in each frequency
range.
b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
TROUBLESHOOTING TIPS
PROBLEM
No power.
No display appears on the unit.
Readings appear too high or too
low.
CAUSES AND SOLUTIONS
Replace both batteries with new ones at the
same time. Check the battery installation for
proper placement of the battery polarities.
Review the section “Battery Installation”.
Blood pressure varies constantly. Many factors
including stress, time of day, how you wrap the
cuff, where you position your wrist, may affect
your blood pressure.
Review the sections “Before Taking a
Measurement” and “Taking a Measurement”.
LIMITED WARRANTY
Your BP654 Wrist Blood Pressure Monitor, excluding the 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 above warranty extends only to the original retail purchaser.
We will, at our option, replace without charge any monitor 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 Proof of Purchase. 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 which vary from state to state. Some states do not allow limitations on how
long an implied warranty lasts, so the above limitation may not apply to you. Some
states do not allow the exclusion or limitation of incidental or consequential
damages, so the above limitation or exclusion may not apply to you.
FOR CUSTOMER SERVICE
Visit our web site at: www.omronhealthcare.com /
www.omronhealthcare.ca
Call toll free: 1-800-634-4350
SPECIFICATIONS
Model:
Display:
Measurement Range:
Accuracy:
Inflation:
Deflation:
Measurement Method:
IP Classification :
Power Source:
Battery Life:
Operating Temperature
/Humidity:
Storage Temperature
/Humidity/Air Pressure:
Main Unit Weight:
Main Unit Dimensions:
Measurable
Circumference of Wrist:
Memory:
Contents:
Protection against
Electric Shock:
Applied Part:
BP654 HEM-6320T-Z
LCD Digital Display
Pressure: 0 mmHg to 299 mmHg
Pulse: 40 beats/min to 180 beats/min
Pressure: ±3 mmHg or 2% of reading
Pulse: ±5% of reading
Automatic by electric pump
Automatic rapid deflation
Oscillometric method
IP 22
2 “AAA” alkaline batteries 1.5V
Approximately 300 uses with 2 new alkaline batteries
50ºF to 104ºF (10ºC to 40ºC) /15% RH to 90% RH
-4ºF to 140ºF (-20ºC to 60ºC) /10% RH to 95% RH
700 hPa to 1060 hPa
Approximately 3 1/2 oz. (100 g)
not including batteries
Approximately 3 1/2''(w) × 2 3/8''(l) × 1''(d)
(89 mm × 61 mm × 25 mm) (not including the wrist cuff)
Approximately 5 1/4" to 8 1/2" (13.5 cm to 21.5 cm)
Up to 100 readings
Main Unit, Storage Case, 2 “AAA” Alkaline Batteries,
Instruction Manual, and Quick Start Guide
Internally powered ME equipment
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
© 2014 OMRON HEALTHCARE, INC.
Made in Vietnam
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.
This transmitter must not be co-located or operated in conjunction with any other
antenna or transmitter.
This equipment complies with FCC/IC radiation exposure limits set forth for an
uncontrolled environment and meets the FCC radio frequency (RF) Exposure
Guidelines and RSS 102 of the IC radio frequency (RF) Exposure rules. This
equipment has very low levels of RF energy that are deemed to comply without
testing of specific absorption ratio (SAR).
This device complies with Part 15 of FCC Rules and Industry Canada
license-exempt RSS standard(s). Operation is subject to the following two
conditions: (1) this device may not cause interference, and (2) this device must
accept any interference, including interference that may cause undesired operation
of this device.
This Product operates in the unlicensed ISM band at
2.4GHz. In case this Product is used around the other
wireless devices including microwave and wireless LAN,
which operate same frequency band of this Product, there
is a possibility that interference occurs between this
Product and such other devices. If such interference
occurs, please stop the operation of other devices or
relocate this Product before using this Product or do not
use this Product around the other wireless devices.
The
Bluetooth
®
Smart
word mark and logos are registered
trademarks owned by Bluetooth SIG, Inc. and any use of
such marks by OMRON HEALTHCARE Co.,Ltd. is under
license. Other trademarks and trade names are those of
their respective owners.
Apple, the Apple logo, iPad, and iPhone are trademarks of Apple Inc., registered
in the U.S. and other countries.
App Store is a service mark of Apple Inc.
Android and Google Play are both trademarks of Google Inc.
Samsung and Galaxy S are both registered trademarks of Samsung Electronics
Co., Ltd.
FCC/IC STATEMENT AND TRADEMARKS
ERROR MESSAGES
SYMBOL
CAUSE
CORRECTION
Wrist cuff not applied
correctly.
Apply the wrist cuff correctly. Refer to
“Applying the Wrist Cuff ”.
Recommend to replace the batteries
with new ones ahead of time.
Refer to “Battery Installation”.
Do not hold the wrist cuff. Remain still
and do not talk during measurement.
Refer to “Taking a Measurement”.
Remain still until the measurement is
complete. Refer to “Taking a
Measurement”.
Contact Customer Service.
Apply the wrist cuff correctly. Refer to
“Applying the Wrist Cuff ”.
Remain still and do not talk during
measurement. Refer to “Taking a
Measurement”.
Movement during
measurement.
Wrist cuff not applied
correctly or movement
during measurement.
Arm position changed
during measurement.
Device error.
CARE AND MAINTENANCE
To keep your digital blood pressure monitor in the best condition and protect the
unit from damage, follow the directions listed below:
CAUTION
• Do not forcefully bend the cuff. Do not fold tightly.
• Clean the monitor with a soft and dry cloth.
• Do not use any abrasive or volatile cleaners.
• Wipe clean on the surface of the cuff with a soft, moistened cloth with a
dilution of neutral detergent.
• Do not allow any liquids inside the cuff. If a liquid gets in the cuff, dry the
inside well.
CAUTION
Do not wash the device and any components or immerse them in water. Do
not subject the monitor to extreme hot or cold temperatures, humidity or
direct sunlight.
CAUTION
Store the device and the components in a clean, safe location.
CAUTION
Do not subject the monitor to strong shocks, such as dropping the unit on the floor.
CAUTION
Remove the batteries if the unit will not be used for three months or longer.
Always replace all the batteries with new ones at the same time.
CAUTION
Use only OMRON authorized parts and accessories. Parts and accessories
not approved for use with the device may damage the unit.
CAUTION
Changes or modification not approved by the manufacturer will void the user
warranty. Do not disassemble or attempt to repair the unit or components.
CAUTION
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.
Data cannot be sent.
The destination device is too far away from the
monitor. After checking that there are no sources
of interference nearby, move the device to a
distance within 16 ft. (5 m) of the monitor.
The
Bluetooth
function on the destination
device is turned off. Turn on the
Bluetooth
function and try sending the data again.
Pairing (registering) has not been completed.
Perform pairing (registration). Refer to “To Pair
This Device With a Smartphone”.
The application on the destination device is not
ready. Check the application then try sending the
data again. Refer to “To Pair This Device With a
Smartphone”. If the Err symbol still lights after
checking the application, contact customer service.
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.
• IP classification is degrees of protection provided by IEC 60529.
Batteries are low.
Replace the two batteries.
Refer to “Battery Installation”.
Batteries are depleted.
The
Bluetooth
function on the monitor is not
turned on. Press the / button, turn on the
Bluetooth
function and try sending the data again.
Movement during
measurement.
Carefully read and repeat the steps in
section “Taking a Measurement”.
Irregular heartbeats are
detected.
Please remove the wrist cuff, and wait
2-3 minutes. Reapply the wrist cuff and
take another measurement.
Repeat the steps in section “Taking a
Measurement”.
If this error continues to appear, contact
your physician.
