Advertisement
Available languages
Available languages
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.
ERROR MESSAGES
SYMBOL
CAUSE
CORRECTION
Please remove the wrist cuff, and wait
2-3 minutes. Reapply the wrist cuff and
take another measurement.
Irregular heartbeats are
Repeat the steps in section "Taking a
detected.
Measurement".
If this error continues to appear, contact
your physician.
Movement during
Carefully read and repeat the steps in
measurement.
section "Taking a Measurement".
Wrist cuff not applied
Apply the wrist cuff correctly. Refer to
correctly.
"Applying the Wrist Cuff ".
Do not hold the wrist cuff. Remain still
Movement during
and do not talk during measurement.
measurement.
Refer to "Taking a Measurement".
Apply the wrist cuff correctly. Refer to
Wrist cuff not applied
"Applying the Wrist Cuff ".
correctly or movement
Remain still and do not talk during
during measurement.
measurement. Refer to "Taking a
Measurement".
Remain still until the measurement is
Arm position changed
complete. Refer to "Taking a
during measurement.
Measurement".
Device error.
Contact Customer Service.
Recommend to replace the batteries
with new ones ahead of time.
Batteries are low.
Refer to "Battery Installation".
Replace the two batteries.
Batteries are depleted.
Refer to "Battery Installation".
TROUBLESHOOTING TIPS
PROBLEM
CAUSES AND SOLUTIONS
Replace both batteries with new ones at the
No power.
same time. Check the battery installation for
No display appears on the unit.
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
Readings appear too high or too
cuff, where you position your wrist, may affect
low.
your blood pressure.
Review the sections "Before Taking a
Measurement" and "Taking a Measurement".
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.
The Bluetooth function on the monitor is not
turned on. Press the
/
button, turn on the
Data cannot be sent.
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.
FCC/IC STATEMENT AND TRADEMARKS
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.
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
BP654
HEM-6320T-Z
Model:
Display:
LCD Digital Display
Pressure: 0 mmHg to 299 mmHg
Measurement Range:
Pulse: 40 beats/min to 180 beats/min
Pressure: ±3 mmHg or 2% of reading
Accuracy:
Pulse: ±5% of reading
Automatic by electric pump
Inflation:
Automatic rapid deflation
Deflation:
Oscillometric method
Measurement Method:
IP 22
IP Classification :
2 "AAA" alkaline batteries 1.5V
Power Source:
Approximately 300 uses with 2 new alkaline batteries
Battery Life:
50ºF to 104ºF (10ºC to 40ºC) /15% RH to 90% RH
Operating Temperature
/Humidity:
-4ºF to 140ºF (-20ºC to 60ºC) /10% RH to 95% RH
Storage Temperature
700 hPa to 1060 hPa
/Humidity/Air Pressure:
Approximately 3 1/2 oz. (100 g)
Main Unit Weight:
not including batteries
Approximately 3 1/2''(w) × 2 3/8''(l) × 1''(d)
Main Unit Dimensions:
(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)
Measurable
Circumference of Wrist:
Up to 100 readings
Memory:
Main Unit, Storage Case, 2 "AAA" Alkaline Batteries,
Contents:
Instruction Manual, and Quick Start Guide
Internally powered ME equipment
Protection against
Electric Shock:
Applied Part:
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.
GUIDANCE AND MANUFACTURER'S DECLARATION
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 EQUIPMENT 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.
(Table 1)
Guidance and manufacturer's declaration – electromagnetic emissions
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
Emissions test
Compliance
– guidance
The OMRON BPM uses
RF energy only for its internal
function. Therefore, its RF emissions
RF emissions CISPR 11
Group 1
are very low and are not likely to cause
any interference in nearby electronic
equipment.
RF emissions CISPR 11
Class B
The OMRON BPM
is suitable for use in all establishments,
Not
Harmonic emissions
including domestic establishments and
IEC 61000-3-2
Applicable.
those directly connected to the public
low-voltage power supply network that
Voltage fluctuations/
Not
supplies buildings used for domestic
flicker emissions
Applicable.
purposes.
IEC61000-3-3
(Table 2)
Guidance and manufacturer's declaration – electromagnetic immunity
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.
IEC 60601
Compliance
Electromagnetic environment
Immunity test
Test level
level
– guidance
Floor should be wood, concrete,
or ceramic tile. If floors are
Electrostatic
±6 kV contact
±6 kV contact
covered with synthetic material,
discharge (ESD)
±8 kV air
±8 kV air
the relative humidity should be at
IEC 61000-4-2
least 30 %.
±2 kV for
power
Electrical fast
supply lines
Not
Not Applicable.
transient/burst
Applicable.
IEC 61000-4-4
±1 kV for
input/output
lines
±1 kV
line(s) to
line(s)
Surge
Not
Not Applicable.
IEC 61000-4-5
Applicable.
±2 kV
line(s) to
earth
<5 % U
T
(>95 % dip
in U
)
T
for 0.5 cycle
40 % U
Voltage dips,
T
(60 % dip in
short
U
)
interruptions
T
for 5 cycles
and voltage
Not
Not Applicable.
variations on
70 % U
Applicable.
T
power supply
(30 % dip in
inputlines
U
)
T
IEC 61000-4-11
for 25 cycles
<5 % U
T
(>95 % dip
in U
)
T
for 5 sec.
Power
Power frequency magnetic fields
frequency
should be at levels characteristic
3 A/m
3 A/m
(50/60 Hz)
of a typical location in a typical
magnetic 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
(Table 4)
Guidance and manufacturer's declaration – electromagnetic immunity
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.
IEC 60601
Compliance
Electromagnetic environment
Immunity test
Test level
level
– guidance
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.
Recommend
separation distance
Conducted RF
3 V rms
Not
Not Applicable.
IEC 61000-4-6
150 kHz to
Applicable.
80 MHz
d = 1.2 √P
Radiated RF
3 V/m
3 V/m
IEC 61000-4-3
80 MHz to
80 MHz to 800 MHz
2.5 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 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:
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/
a
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.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less
b
than 3 V/m.
(Table 6)
Recommended separation distance between portable and mobile RF
communications equipment and the OMRON BPM
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.
Separation distance according to frequency of
Output Power of
transmitter in meter
Transmitter in
Watt
80 MHz to 800 MHz
800 MHz to 2.5GHz
150 kHz to 80 MHz
d = 1.2 √P
d = 2.3 √P
Not Applicable.
0.01
Not Applicable.
0.12
0.23
0.1
Not Applicable.
0.38
0.73
1
Not Applicable.
1.2
2.3
10
Not Applicable.
3.8
7.3
100
Not Applicable.
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.
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
Advertisement
