5. ERROR MESSAGES AND TROUBLESHOOTING
5.1 Error Messages
5.2 Troubleshooting
6. MAINTENANCE, STORAGE AND CLEANING
6.1 Maintenance
To protect your monitor from damage, please follow the directions below:
• Store the monitor and the components in a clean, safe location.
• Do not wash the monitor and any components or immerse them in water.
• Do not use gasoline, thinners or similar solvents to clean the monitor.
• Changes or modification not approved by the manufacturer will void the
user warranty.
6.2 Storage
Do not store the monitor in the following situations:
• If the monitor 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.
6.3 Cleaning
• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth, or a soft cloth moistened with neutral soap to clean
on the monitor and the arm cuff, and then wipe it with a dry cloth.
7. DISPOSAL
Dispose of the monitor and components according to applicable local
regulations. Unlawful disposal may cause environmental pollution.
8. SPECIFICATIONS
Notes:
• These specifications are subject to change without notice.
• In the clinical validation study, K5 was used on 85 subjects for determination of
diastolic blood pressure.
• This monitor is clinically investigated according to the requirements of
ISO 81060-2:2013.
• 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 device is protected against solid foreign objects of 12 mm
diameter and greater such as a finger, and against oblique falling water drops
which may cause issues during a normal operation.
9. SYMBOL DESCRIPTIONS / DEFINITIONS
10. 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.
This transmitter must not be co-located or operated in conjunction with any other
antenna or transmitter.
This equipment complies with FCC radiation exposure limits set forth for an
uncontrolled environment and meets the FCC radio frequency (RF) Exposure
Guidelines. This equipment has very low levels of RF energy that are deemed to
comply without testing of specific absorption ratio (SAR).
11. LIMITED WARRANTY
Your BP7000 Upper Arm Blood Pressure Monitor, excluding 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 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.
12. GUIDANCE AND MANUFACTURER’S DECLARATION
OMRON Blood Pressure Monitor (BPM)
Information for accompanying documents in the scope of IEC60601-1-2:2007
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 and the Apple logo are trademarks of Apple Inc., registered in the U.S.
and other countries. App Store is a service mark of Apple Inc.
Android and the Google Play logo are trademarks of Google Inc.
Error Display
Cause
Solution
Irregular heartbeat is
detected.
Remove the arm cuff. Wait 2
- 3 minutes and then take
another measurement.
Repeat the steps in section
2.2. If this error continues to
appear, contact your
physician.
Movement during
measurement.
Carefully read and repeat the
steps in section 4.2.
The batteries are
low.
Recommend replacement of
all 4 batteries with new ones.
Refer to section 2.1.
The batteries are
depleted or battery
polarities are not
properly aligned.
Immediately replace 4
batteries with new ones.
Refer to section 2.1.
Confirm the batteries are
properly inserted with
polarities correctly aligned.
Refer to section 2.1.
Connection failure.
Data is not being
transmitted.
Refer to “Connection failure.
Data is not being
transmitted.” in section 5.2.
Arm cuff is applied
too loosely.
Apply the arm cuff tighter.
Refer to section 2.2.
The arm cuff was
inflated exceeding
the maximum
allowable pressure,
and then deflated
automatically.
Do not touch the arm cuff
while taking a measurement.
Refer to section 4.2.
Movement during
measurement.
Repeat measurement.
Remain still and do not talk
during measurement.
Refer to section 4.2.
Clothing is interfering
with the arm cuff.
Remove any clothing
interfering with the arm cuff.
Refer to section 2.2.
* : “XX” will change to
display an error
number, 6 and
higher.
Device error.
Please contact customer
service.
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 apply the arm cuff, may affect your blood
pressure.
Review the section 1.2, 2.3 and 4.2.
Connection failure. /
Data is not being transmitted.
The blood pressure monitor might not be
properly placed within the smart device's
transmission range and is too far from the
smart device. If there are no causes of data
transmission interference found near the
blood pressure monitor, move the blood
pressure monitor within 16 ft. (5 m) of the
smart device and try again.
The
Bluetooth
feature of the smart device
is turned off. Turn on the
Bluetooth
feature
of the smart device and your monitor, and try
sending the data again.
The
Bluetooth
feature of the blood
pressure monitor is turned off.
Refer to “To turn “ON” the
Bluetooth
” in
“4.3 Turning “OFF” the
Bluetooth
”.
The blood pressure monitor did not pair
successfully to the smart device. Try to pair
the devices again.
Refer to “Pair Your Monitor with a Smart
Device” in section 4.1. Confirm your smart
device compatibility with this monitor at
OmronHealthcare.com
The application on the smart device is not
ready. Check the application then try sending
the data again.
Refer to “Pair Your Monitor with a Smart
Device” in section 4.1. If the “Error” symbol
still displays after checking the application,
contact customer service.
*
®
®
®
®
®
Do not disassemble or attempt to repair the monitor or components.
Model
BP7000
HEM-7600T-Z
Display
OLED display
Cuff pressure range
Pressure: 0 to 299 mmHg
Measurement range
Pressure: 40 to 260 mmHg
Pulse: 40 to 180 beats / min.
Accuracy
Pressure: ±3 mmHg
Pulse: ±5% of display reading
Inflation
Fuzzy-logic controlled by electric pump
Deflation
Automatic rapid deflation
Measurement method
Oscillometric method
Transmission method
Bluetooth
Smart
Wireless communication
Frequency range : 2.4 GHz (2400 - 2483.5 MHz)
Modulation : GFSK
Effective radiated power : <20 dBm
IP classification
IP 22
Power source
4 “AAA” batteries 1.5V
Battery life
Approximately 300 measurements
(using new alkaline batteries)
Durable period (Service life)
Monitor : 5 years
Operating conditions
50°F to 104°F (10°C to 40°C) /
15 to 90% RH (non-condensing) / 800 to 1060 hPa
Storage / Transport
conditions
-4°F to 140°F (-20°C to 60°C) /
10 to 90% RH (non-condensing)
Weight
Monitor : Approximately 8 1/2 oz. (240 g)
not including batteries
Dimensions
Monitor : Approximately 3 1/2" (w)
4 5/8" (h)
1" (l)
(85 mm
120 mm
20 mm)
(not including the arm cuff)
Arm circumference
9" to 17" (22 to 42 cm)
Contents
Monitor, 4 “AAA” batteries, instruction manual, quick start
guide
Applied part
Type BF
Protection against electric
shock
Internally powered ME equipment
About a wireless communication interference
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.
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
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.
Note
Provides additional information to clarify a point in the
text.
Please consult this instruction manual
Applied part - Type BF
Degree of protection against electric shock (leakage
current)
To indicate generally elevated, potentially hazardous,
levels of non-ionizing radiation, or to indicate
equipment or systems e.g. in the medical electrical
area that include RF transmitters or that intentionally
apply RF electromagnetic energy for diagnosis or
treatment.
Catalogue number
Manufacturer
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
Artery mark
®
or
FOR CUSTOMER SERVICE
Visit our web site at:
OmronHealthcare.com
Call toll free:
1-800-634-4350
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 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.
Guidance and manufacturer’s declaration - electromagnetic emissions
OMRON battery-operated BPM is intended for use in the electromagnetic environment specified
below. The customer or the user of this OMRON battery-operated BPM should assure that it is
used in such environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The OMRON battery-operated 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.
RF emissions
CISPR 11
Class B
The OMRON battery-operated 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.
Harmonic
emissions
IEC 61000-3-2
Not Applicable.
Voltage
fluctuations/
flicker emissions
IEC61000-3-3
Not Applicable.
Guidance and manufacturer’s declaration - electromagnetic immunity
OMRON battery-operated BPM is intended for use in the electromagnetic environment specified
below. The customer or the user of this OMRON battery-operated BPM 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
Contact discharge:
±6 kV
Air discharge:
±8 kV
Contact discharge:
±8 kV
Air discharge:
±15 kV
The relative humidity should be
at least 5 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
Not Applicable.
Not Applicable.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to earth
Not Applicable.
Not Applicable.
Voltage dips, short
interruptions and
voltage variations
on power supply
inputlines
IEC 61000-4-11
<5 %
U
T
(>95 % dip
in
U
T
)
for 0.5 cycle
Not Applicable.
Not Applicable.
40 %
U
T
(60 % dip in
U
T
)
for 5 cycles
Not Applicable.
70 %
U
T
(30 % dip in
U
T
)
for 25 cycles
Not Applicable.
<5 %
U
T
(>95 % dip
in
U
T
)
for 5 sec.
Not Applicable.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
30 A/m
Magnetic fields from common
appliances are not expected to
affect the device.
Note:
U
T
is the A.C. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration - electromagnetic immunity
OMRON battery-operated BPM is intended for use in the electromagnetic environment specified
below. The customer or the user of this OMRON battery-operated BPM should assure that it is
used in such environment.
Immunity test IEC 60601
test level
Compli-
ance 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
Not
Applicable.
10 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the OMRON
battery-operated BPM including cables, than the
recommended separation distance calculated from the
equation appropriate to the frequency of the transmitter.
Recommend separation distance
Not Applicable.
d
= 0.35
80 MHz to 800 MHz
d
= 0.70
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 compliance 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.
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 battery-operated BPM is used exceeds the
applicable RF compliance level above, the OMRON battery-operated 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 battery-operated BPM.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 6 V/m.
P
P
Recommended separation distance between portable and mobile RF communications
equipment
and the OMRON battery-operated BPM
OMRON battery-operated BPM is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of this OMRON
battery-operated BPM can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
OMRON battery-operated BPM 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
Not Applicable.
80 MHz to 800 MHz
d
= 0.35
800 MHz to 2.5 GHz
d
= 0.70
0.01
Not Applicable.
0.035
0.070
0.1
Not Applicable.
0.11
0.22
1
Not Applicable.
0.35
0.70
10
Not Applicable.
1.1
2.2
100
Not Applicable.
3.5
7.0
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 by:
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.
1-800-634-4350
OmronHealthcare.com
© 2015 OMRON HEALTHCARE, INC.
Made in Japan
P
P
HEM-7600T-Z_C_M01_161201.fm 2 ページ ２０１６年１２月１日 木曜日 午後５時２５分
