Omron EVOLV BP7000 User Manual Download

Page: 10 / 10

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

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.

Surge
IEC 61000-4-5

±1 kV line(s) to
line(s)
±2 kV line(s) to earth

Not Applicable.

Voltage dips, short
interruptions and
voltage variations
on power supply
inputlines
IEC 61000-4-11

<5 %

(>95 % dip

)

for 0.5 cycle

Not Applicable.

40 %

(60 % dip in

)

for 5 cycles

Not Applicable.

70 %

(30 % dip in

)

for 25 cycles

Not Applicable.

<5 %

(>95 % dip

)

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:

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.

= 0.35

80 MHz to 800 MHz

= 0.70

800 MHz to 2.5 GHz

where

is the maximum output power rating of the

transmitter in watts (W) according to the transmitter

manufacturer and

is the recommended separation

distance in meters (m).

Field strengths from fixed RF transmitters as
determined 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.

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.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 6 V/m.

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

= 0.35

800 MHz to 2.5 GHz

= 0.70

0.01

Not Applicable.

0.035

0.070

0.1

Not Applicable.

0.11

0.22

Not Applicable.

0.35

0.70

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

in meters (m) can be estimated using the equation applicable to the frequency of the

transmitter, where

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

Made in Japan

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