Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or licensed
healthcare practitioner
Page 2
Page 3
Introduction
Intended Use
Medical Purpose
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult and
pediatric patient population with arm circumference ranging from 5 inches to 20 inches (from 12 cm to 50 cm).
Intended User
This device should be used by a medical professional.
Patient Population
This device is intended for use on adults and children of age 3-years and older.
Environment
The instrument is designed for use in physicians' offices, hospitals, clinics and other medical facilities.
Measurement Parameter
■ Non-Invasive Blood Pressure
■ Pulse rate
Precautions for Use
Warnings and cautions described in the instruction manual should be observed at all times.
Exemptions
Liability and Warranty
OMRON HEALTHCARE does not accept liability and the warranty becomes void under the following
circumstances:
1. Failures, damage, or injuries due to maintenance or repair work performed by persons or
a repair facility not authorized by OMRON HEALTHCARE.
2. Failures, damage, or injuries when use and / or operation of this device is adversely
affected by a device not manufactured by OMRON HEALTHCARE.
3. Failures, damage, or injuries caused by failure to odserve the safety instructions and
operational procedures provided in this manual.
4. Use and / or operation of this unit in conditions that do not conform to the product usage
conditions indicated in this manual.
5. Failures, damage, or injuries due to natural catastrophes, such as fire, earthquake,
flooding or other natural disasters.
HBP-1300 Instruction Manual
1. The contents of this manual are subject to change without notice.
2. Considerable care has been taken in the preparation of this manual. If you suspect there
may be an error in the instruction manual, please contact OMRON HEALTHCARE by
calling 1-877-216-1336.
3. Unauthorized reproduction or copying any or this entire instruction manual without the
permission of OMRON HEALTHCARE is prohibited by copyright.
4. Product brand names shown in this maual are trademarks or registered trademarks of
OMRON HEALTHCARE.
Introduction
1
Page 4
Notes on Safety
The warning signs and symbol examples indicated below are intended to ensure safe use of the
product and prevent damage and injury to you and others. The signs and symbols are explained below.
Safety Symbols used in this Instruction Manual
Warning
Caution
Indicates the matters in which death or severe bodily damage may arise as a result
of incorrect handling.
Indicates the matters in which bodily harm or material damage may arise as a result
of incorrect handling.
General Information
Note:
Indicates general information to keep in mind when using the unit and other useful information.
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Warnings and Cautions
Usage warnings and cautions
Setup
Warning
Do not use the cuff or AC adapter to lift the unit, it can also cause the unit to malfunction.
If the unit has broken down, contact OMRON HEALTHCARE Customer Service.
Do not use in combination with a hyperbaric oxygen therapy device, or in an environment where
combustible gas may be generated.
Do not use in combination with magnetic resonance imaging (MRI) equipment. If MRI is to be
performed, remove cuff connected to the unit from the patient.
Do not install the unit in the following locations:
- Locations subject to vibration such as ambulances and emergency helicopters.
- A location where there is gas or flame.
- A location where there is water or steam.
- A location where chemicals are stored.
Do not use at extremely high temperature, high humidity, or high altitude. Use only within the required
ambient conditions.
Do not subject the unit to intense shock.
Do not place heavy objects on the AC adapter cable, or allow the unit to sit on the cord.
Clinical testing has not been conducted on newborn infants and pregnant women. Do not use on
newborn infants and pregnant women.
Do not plug in or unplug the AC adapter with wet hands.
Introduction
Caution
Do not install the unit in the following locations:
- Locations with dust, salt, or sulfur.
- Locations directly exposed to sunlight for extended periods of time (in particular, do not leave in
direct sunlight or near a source of ultraviolet light for extended periods, as ultraviolet light will cause
deterioration of the LCD).
- Locations subject to vibration or shock.
- Near heaters.
Do not use the unit near large equipment that uses a switching relay for power ON/OFF.
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Before use / during use
Warning
The unit complies with the EMC standard (IEC60601-1-2). As such, it can be used simultaneously
with multiple medical instruments. However, if instruments that generate noise such as an electric
scalpel or a microwave therapy device are near the unit, check the operation of the unit during and
after use of these instruments.
If an error occurs or a measurement result is questionable, check the vital signs of the patient by
auscultation or palpation. Avoid relying solely on the measurement results of the unit when judging
the patient's condition.
Only trained healthcare providers should use this device. Do not allow patients to operate this
device.
Properly connect the connectors and AC adapter cable.
Do not place objects or liquids on top of this unit.
Check the following before using the unit:
- Make sure the AC adapter cable is not damaged (wires are not exposed or broken), and the
connections are firm.
For the AC adapter connected to the unit, supplies, and optional devices, use only the standard
accessories or OMRON-specified products.
Do not use in a location with moisture, or a location where water may splash on the unit.
This unit is intended for use in a physician's office.
Do not use the unit if it emits smoke, an abnormal odor, or abnormal noise.
Do not bring cellular telephones or transceivers into the room where the unit is installed or being
used.
Do not connect multiple monitors to the same patient.
Do not connect the unit to a power outlet that is controlled by a wall switch.
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Caution
Before using the unit, verify that none of the following apply to the patient:
- Poor peripheral circulation, noticeably low blood pressure, or low body temperature (there will be
low blood flow to the measurement position)
- The patient uses an artificial heart and lung (there will be no pulse)
-An SpO
- The patient has an aneurysm
- The patient has frequent arrhythmia
- Body motions such as convulsions, arterial pulsations, or trembling (cardiac massage in progress,
minute continuous vibrations, rheumatism, etc.)
Before use, visually inspect the unit to make sure there are no deformations due to falling, and that
there is no dirt or moisture on the unit.
When the unit has not been used for an extended period of time, always verify that it operates
normally and safely before use.
Do not use in a location where the unit may easily fall. In the event that the unit falls, verify that it
operates normally and safely.
sensor and the cuff are attached to the same arm
2
Introduction
5
Page 8
Cleaning
Warning
When cleaning the unit, turn off the power and disconnect the AC adapter from the unit.
After cleaning the unit, make sure it is completely dry before connecting to a power outlet.
Do not spray, pour, or spill liquids into or onto the unit, accessories, connectors, buttons, or openings
in the housing.
Caution
Do not use thinner, benzene, or other solvents to clean the unit.
Do not sterilize by autoclave or gas sterilization (EOG, formaldehyde gas, high-concentration ozone, etc.).
If using an antiseptic solution for cleaning, follow the instructions of the manufacturer.
Clean the unit regularly.
Maintenance and inspection
Warning
To use the unity safely and correctly, always inspect the unit when starting work.
Unauthorized modification is prohibited by law. Do not attempt to disassemble or modify the unit.
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Warnings and cautions for safe measurement
Optional rechargeable battery
Warning
If battery fluid comes in contact with the eye, immediately flush with copious amounts of water. Do not
rub. Seek medical attention immediately.
Do not use the optional battery pack in any other device besides this unit. Do not throw into flame,
disassemble, or heat.
Always disconnect the AC adapter from the unit before removing or installing a battery.
If the unit will not be used for a month or longer, remove the battery from the unit and store. Charge
the battery once every 6 months. (Storage conditions for the battery are a temperature of -20 to 30°C
(-4 to 86°F) and a humidity of 65 ±20%.)
Before use, always charge the battery.
Do not attempt to disassemble or modify the battery.
Do not apply pressure to and deform the battery. Do not throw, pound, drop, bend, or hit the battery.
The battery has positive/negative polarity. If the battery does not connect well to the unit, do not
forcibly connect it.
Do not connect the positive and negative terminals of the battery with a wire or other metal object. Do
not carry or store a battery with metal necklaces, hairpins, or other metal objects.
Use only the specified type of battery.
Caution
Introduction
Do not touch the positive and negative terminals of the optional battery pack with a wire or other
metal object. If battery fluid comes into contact with the skin or clothes, immediately rinse with water.
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Non-Invasive Blood Pressure (NIBP) measurement
Warning
If a cuff is used on a patient with an infection, treat the cuff as medical waste, or sterilize before
reuse.
If frequently performing NIBP measurement using a cuff over an extended period of time, periodically
check the patient's circulation. In addition, wrap the cuff as indicated in the cautionary points in this
manual.
Do not connect the NIBP cuff or cuff joint to a luer lock adapter.
Do not bend cuff tube during inflation and deflation, particularly after a change of body position.
Do not wrap the cuff on the following parts:
- An upper arm on which intravenous drip or a blood transfusion is being performed.
- An upper arm on which an SpO
- An upper arm with a shunt for hemodialysis
If measuring blood pressure with the cuff wrapped on the arm on the side of the body where a
mastectomy was performed, check the patient's condition.
Caution
NIBP measurement should be performed on the upper arm.
During NIBP, stop excessive body movement by the patient and minimize trembling.
If a doctor has indicated that the patient has hemorrhagic diathesis or hypercoagulability, check the
condition of the arm after measurement.
Use the appropriate cuff size to ensure correct measurements. If too large a cuff is used, the
measured blood pressure value tends to be lower than the actual blood pressure. If too small a cuff is
used, the measured blood pressure value tends to be higher.
Before and during measurement, verify that none of the following apply to the patient:
- An inappropriate cuff size is used.
- The part where the cuff is wrapped is at a different height than the heart.
(A difference of 4 inches (10 cm) in height may cause a variation in the blood pressure value of up
to 7 or 8 mmHg.)
- Body movement or conversing during measurement.
- Cuff wrapped over thick clothing.
- Pressure on the arm due to a rolled up sleeve.
In the case of a cuff for adults, the cuff should be wrapped to a tightness that allows two fingers to be
inserted in between the cuff and the arm.
The accuracy of a flashing measurement value that is out of the measurement range cannot be
guaranteed. Always check the patient's condition before deciding what steps to take.
Do not use the cuff if it is damaged or has holes.
Only OMRON GS CUFF can be used with this device.
sensor, IBP catheter, or other instrument is attached.
2
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Page 11
Note:
Setup
• Read and understand the manual for each optional accessory. This manual does not contain
cautionary information for optional accessory.
• Exercise caution with the cables and arrange so that the patient does not become entangled or
bound.
Before use / during use
• Check the following after turning on the power:
- No smoke, abnormal odor, or abnormal sound is emitted.
- Press each button and verify that it operates.
- For functions that cause icons to light or flash, verify that the icons light or flash.
- Measurement can be performed normally, and measurement error is within the tolerance value.
• If the screen is not displayed normally, do not use the unit.
• When recycling or disposing of parts (including batteries) of the unit, follow local government rules
and regulations.
Cleaning
• For cleaning, see page 24.
Optional rechargeable battery
• To prevent accidents, keep batteries out of reach of infants and small children.
• If you sense that something is wrong with a battery, immediately move it to a safe location and contact
the administrator responsible for the unit or OMRON HEALTHCARE Customer Service.
• If the battery voltage is low, operation by battery may not be possible.
Non-Invasive Blood Pressure (NIBP) measurement
• If the patient has acute inflammation, a pyogenic ailment, or an external wound at the location where
the cuff is to be wrapped, follow the instructions of the doctor.
• Non-Invasive Blood Pressure measurement (NIBP) is performed by compressing the upper arm.
Some people may experience intense pain, or transient spotting caused by subcutaneous
hemorrhaging (bruising) may appear. The spotting will disappear with time; however, it may be
appropriate to inform patients for whom this may be a concern that spotting sometimes occurs, and if
necessary, refrain from measurement.
• To measure correctly, it is recommended that the patient relax and not talk during measurement.
• To measure correctly, it is recommended that the patient rest quietly for 5 minutes before
measurement.
Introduction
9
Page 12
Using the Unit
Components of the Product
Before using the unit, make sure that no accessories are missing and that the unit and accessories are
not damaged. If an accessory is missing or there is damage, please contact OMRON HEALTHCARE
Customer Service.
Main unit
Standard accessories
AC adapter
Optional Accessories
Wall mount kit
WMKIT-1300
(HXA-WMKIT-1300)
10
GS CUFF L and M
Battery pack
BAT-2000
(HXA-BAT-2000)
Instruction Manual
AC adapter
AC-1300Z
(60120H1040SW-Z)
Page 13
GS CUFF XL
GCUFF-XL
(HXA-GCUFF-XLLB)
GS CUFF L
GCUFF-L
(HXA-GCUFF-LLB)
GS CUFF M
GCUFF-M
(HXA-GCUFF-MLB)
GS CUFF S
GCUFF-S
(HXA-GCUFF-SLB)
GS CUFF SS
GCUFF-SS
(HXA-GCUFF-SSLB)
CUFF HOSE (3.5 m)
HOSE15ZZ
(A015ZZ)
CUFF HOSE (1.5m)
HOSE16ZZ
(A016ZZ)
Caution
Only OMRON GS CUFF can be used with this device.
Features of the Product
The OMRON HBP-1300 is an affordable professional blood pressure unit that is clinically proven
accurate and provides fast, reliable results and is easy to use.
Key features, benefits, look
• 5 cuffs available - (SS: 5 to 7 inches, S: 7 to 9 inches, M: 9 to 13 inches, L: 13 to 17 inches,
XL: 17 to 20 inches) (5 to 20 inches arm circumference range)
• Designed to be used on a table or mounted on the wall
• Motion stop function (When body movement is detected, the device stops deflation for 5 seconds.)
• Irregular pulse Indicator - Helps identify changes in heart rate, rhythm, or pulse which may be caused
by heart disease or other serious health issues.
Press when the power is off to turn on the power and start
1
2[MODE] button
3
4Alarm lampLights up or flashes when an alarm occurs (page 28).
5NIBP connectorConnects the cuff tube.
6DC jackConnects the AC adapter.
7Battery coverOpen to install or replace the battery.
[START/STOP] button
(Power ON/OFF)
[] [] button
blood pressure measurement. During inflation or
measurement, press to stop.
Power OFF
Hold down at least 3 seconds to turn off the power.
Press to enter "Menu Mode" and configure various settings.
If held down at least 3 seconds when a measurement result
is displayed, the measured data is cleared without being
stored in memory.
Displays the system settings (page 16) and the last reading
(page 23). When using "Auscultation Mode", inflates and
deflates the cuff.
7
Meaning of the Symbols
SymbolDescriptionSymbolDescription
This shows the type BF device.Refer to manual.
MEDICAL EQUIPMENT
WITH RESPECT TO ELECTRICAL
SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE
WITH UL60601-1 and CAN/CSA C22.2
No.601.1
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LCD Display
1
2
4
5
3
6
7
8
9
10
1SYSDisplays systolic blood pressure.
2DIADisplays diastolic blood pressure.
3PulseDisplays the pulse rate.
4
5
6Memory icon
7Charge icon*
8
9Auscultation iconLights when "Auscultation Mode" is ON (page 16).
10Inflation setting iconThe set initial Inflation pressure value lights (page 16).
* Only when the optional battery is installed.
Pulse
synchronization icon
Irregular pulse wave
icon
Battery charge level
icon*
Flashes in synchronization with the pulse during
measurement.
Lights in the measurement result display and memory
display if the pulse wave interval was irregular or there
was body movement during measurement (page 23).
Lights while the previous data are being displayed
(page 23).
Flashes during charging. Solid colored light displays
when charging is finished.
Displays how much charge the battery has (page 14).
Using the Unit
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Page 16
Installing the Optional Battery Pack
Warning
• If battery fluid comes in contact with the eye, immediately flush with copious amounts of water.
Do not rub. Seek medical attention immediately.
• Do not use the optional battery pack in any other device besides this unit. Do not throw into
flame, disassemble, or heat.
Caution
Do not short the positive and negative terminals of the optional battery pack with a wire or other metal
object. If battery fluid comes into contact with the skin or clothes, immediately rinse with water.
1. Make sure the AC adapter has been disconnected.
2. Remove the two screws from the top of the rear
unit cover, and remove the battery cover.
3. Connect the battery pack to the connector on the
monitor, and insert the battery pack into the
compartment so that the triangle mark on the
battery pack is aligned with the triangle mark on
the monitor.
4. Replace the battery cover and secure with screws.
Take care not to pinch the wires when replacing the cover.
5. Connect the AC adapter to the unit and charge the battery pack.
When using the battery pack for the first time, be sure to fully charge (about 4 hours) before using.
Battery life
• About 300 measurements are possible with one charge.
• A general guideline for replacement of the battery pack is about one year, however, the usage time
per charge may grow shorter depending on usage conditions. If you find that the usage time after
each charge has grown shorter and the icon frequently appears, replace the battery pack.
Charging time
• Charging automatically starts after the AC adapter is connected.
When a new battery pack or a battery pack that has not been used for a long time is used, some time
may elapse before charging starts.
• The icon flashes during charging.
• Charging is completed in about 4 hours.
Low battery
When the icon starts flashing, promptly charge the battery pack.
When the icon changes to , the battery is too low for blood pressure measurement. Charge the
battery.
Auto Power Off
• When the unit is powered by the optional battery pack, the power automatically turns off after the set
time elapses if you forget to turn off the power.
• When the unit is used with the AC adapter connected, the "Auto Power Off" setting does not operate.
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Battery charging
StateLCD contents and operationsIcon
ChargingThe icon is flashed.
Fully charged
(Charging completed)
Problem with the
battery
The icon is lit.
Error message is displayed.-
Battery level
Battery levelLCD contents and operationsIcon
Fully charged
Battery level is 20%.
Battery level is 5%.
The icon is lit.
The unit can be used.
The icon is flashed (E40 error not displayed).
The unit can be used.
The icon is flashed (E40 error displayed).
The unit cannot be used.
If the unit is being continuously used, the power will be
automatically turned off in 30 seconds.
Connecting the AC Adapter
AC power
Verify that the power outlet supplies the specified voltage and frequency (100 - 240 V AC, 50/60 Hz).
Using the Unit
Connect the AC adapter to the DC jack on the unit and the power outlet.
Note:
When the optional battery pack is installed
If there is no problem with the following.
- AC adapter
-DC jack
- Power outlet
- Battery
And the icon does not flash, contact OMRON HEALTHCARE Customer Service.
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System Settings
The system settings are divided into two modes, "Menu Mode" and "Utility Mode".
Menu Mode
"Menu Mode" allows you to configure the "Initial Inflation Pressure Value" and "Auscultation Mode" settings.
Auscultation Mode
1. Press the [MODE] button.
The "Initial Inflation Pressure Value" setting screen appears.
2. Press the [] or [] button to change the setting.
• Press the [] button to change the setting in the order "280", "250", "220", "AUTO", "280"...
• Press the [] button to change the setting in the order "220", "250", "280", "AUTO", "220"...
When the "Initial Inflation Pressure Value" is set, inflation takes place at a fixed speed to the set
value and thus is quicker.
"AUTO" estimates the systolic blood pressure during inflation and automatically inflates the cuff to a
suitable value.
When using "220", "250", or "280" mmHg, select the value that is 30 to 40 mmHg higher than the
estimated systolic blood pressure.
3. When you have completed the "Initial Inflation Pressure Value" setting,
press the [MODE] button.
The "Auscultation Mode" settings screen appears.
4. Press the [] or [] button to set to "ON" or "OFF".
When set to "ON", SYS and DIA can be recorded using auscultation measurement.
For information on auscultation measurement, see page 22.
5. When you have completed the "Auscultation Mode" setting, press the
[MODE] button.
"0" appears.
To start blood pressure measurement, press the [START/STOP] button.
Initial Inflation
Pressure Value
"ON" or "OFF"
appears.
Note:
• The body movement detection function is disabled while "Auscultation Mode" is in use.
• If the power is turned off, the settings revert to the factory settings.
"Initial Inflation Pressure Value" changes to "AUTO", and "Auscultation Mode" changes to "OFF".
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Utility Mode
"Utility Mode" allows you to configure the "Auto Power Off" and "Pressure Accuracy Confirmation" setting.
1. Confirm that the device is switched off.
2. Hold down the [MODE] button until the
"Auto Power Off" setting screen appears.
The "Initial Inflation Pressure Value" setting screen appears,
and changes to the "Auto Power Off" setting screen appears.
"5" or "10" appears.
3. Press the [] or [] button to change the auto power off setting.
The "5 min." or "10 min." setting is entered.
When the unit is powered by the battery pack and is not used for the set time ("5 min." or "10 min."),
the power automatically turns off to save battery power.
If an alarm has occurred, the power does not turn off automatically.
4. When you have completed the "Auto Power Off" setting, press the [MODE] button.
The "Pressure Accuracy Confirmation" screen appears. "0" appears.
5. Check the Pressure Accuracy.
Change the pressure externally.
Compare with the displayed value and verify that there is no problem.
"0" appears.
6. When you have completed "Pressure Accuracy Confirmation", press the
[START/STOP] button.
The power turns off.
Example:
1. Connect the blood pressure monitor, the standard pressure gauge, and
the cuff and rubber ball.
For details on the standard pressure gauge, contact OMRON HEALTHCARE Customer Service.
2. Check the blood pressure value of the blood pressure monitor and the
blood pressure value of the standard pressure gauge.
Note:
• The standard is within ± 3 mmHg or 2 % of manometer reading.
• To rapidly deflate the cuff, press the [ ] button.
To repeat "Pressure Accuracy Confirmation", turn off the power and repeat the procedure from step 1
of "Utility Mode".
System Settings
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Non-Invasive Blood Pressure (NIBP) Measurement
Non-Invasive Pressure Measurement Principles
Oscillometric method
The beat in the pulsation generated by the contraction of the heart is captured as the pressure inside
the cuff to measure the blood pressure. If the cuff wrapped around the upper arm is pressurized
sufficiently, the blood flow stops, but the beat of the pulsation is present and the pressure inside the cuff
receives this and oscillates. Next, as the pressure inside the cuff gradually decreases, the oscillation of
the pressure within the cuff gradually increases and reaches a peak. As the pressure within the cuff
decreases further, the oscillation decreases from its peak.
The pressure within the cuff and the relationship with the increase and decrease of the oscillation within
the cuff in this series of processes are stored into memory, calculations are carried out, and the blood
pressure value is determined.
The pressure within the cuff when the oscillation increases drastically is the systolic pressure and the
pressure within the cuff when the oscillation decreases drastically is the diastolic pressure. Also, the
pressure within the cuff when the oscillation peaks is taken as the average pulsation pressure.
The oscillometric method does not determine the blood pressure value instantly like a microphone type
automatic blood pressure gauge with the auscultation method, but rather determines it from the series
of change curves as explained above. Therefore, it is not easily affected by external noise, an electric
scalpel or other electro surgical instruments.
KOROTKOV SOUNDS
18
RADIAL PULSE
Page 21
Cuff Selection and Connection
Selecting the cuff
Warning
Treat a cuff used on a patient with an infection as medical waste, or sufficiently sterilize the cuff
before reuse.
Caution
• Do not use the cuff if it is damaged or has holes.
• Use the appropriate cuff size to ensure correct measurements. If too large a cuff is used, the
measured blood pressure value tends to be lower than the actual blood pressure. If too small a cuff is
used, the measured blood pressure value tends to be higher.
Note:
It is important to use the correct sized cuff for a patient in order to get an accurate reading.
Measure the circumference of the patient's arm and select the cuff size
that is appropriate for the circumference.
Select the cuff that is suitable for the patient from the cuffs below.
Cuff name
GS CUFF XL (GCUFF-XL)*17-2042 - 50
GS CUFF L (GCUFF-L)13-1732 - 42
GS CUFF M (GCUFF-M)9-1322 - 32
GS CUFF S (GCUFF-S)*7-917 - 22
GS CUFF SS (GCUFF-SS)*5-712 - 18
* Available as an optional accessory.
Arm circumference
(inch)(cm)
Connecting the cuff
Connect the cuff tube to the NIBP connector on the unit and turn
clockwise to lock.
Caution
Only OMRON GS CUFF can be used with this device.
Note:
• If the cuff tube is too short, the optional 3.5 m or 1.5 m CUFF HOSE can be connected to lengthen the
cuff tube. Do not make the hose longer than 3.5 m, as this will affect measurement accuracy.
• Make sure the connections are tight.
19
Non-Invasive Blood Pressure (NIBP) Measurement
Page 22
Applying the Cuff to the Patient
1. Wrap on a bare arm or over thin clothing.
Wrap the cuff on a bare arm or over thin clothing. Thick clothing or a rolled up sleeve will cause
inaccurate blood pressure measurements.
The device can be used on either the right or left arm.
2. Align the artery mark "INDEXARTERY" with the brachial artery.
Run the cuff tube out the peripheral side with no bends (the brachial artery is on the inner side of the
patient's upper arm).
Make sure that "
1/2 -1 inches from the inner side of the elbow joint.
INDEXARTERY" is outside the "RANGE", error in the blood pressure value will increase. In this
If "
case, use a different cuff size.
As a guideline for the tightness of the cuff, It should be possible to insert about two fingers under the
cuff.
1.
INDEXARTERY" is within the "RANGE" and the lower edge of the cuff is
3.2.
1/2"-1"
3. During measurement, keep the brachial artery on which the cuff is
wrapped at the same height as the right atrium of the heart.
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Caution
Make sure the cuff is wrapped in the correct arm position and is at the same height as the heart.
A difference of 4 inches (10 cm) in height may cause a variation in the blood pressure value of up to
7 - 8 mmHg.
Note:
• If measurement is difficult due to arrhythmia, use a different blood pressure measurement method.
• If the patient has acute inflammation, a pyogenic ailment, or an external wound at the location where
the cuff is to be wrapped, follow the instructions of the doctor.
• Non-Invasive Blood Pressure (NIBP) measurement is performed by compressing the upper arm.
Some people may experience intense pain, or transient spotting caused by subcutaneous hemorrhaging
may appear. The spotting will disappear over time, however, if it is possible that this will disturb the patient,
try the following technique:
- Wrap a thin towel or cloth (one layer) under the cuff.
If the towel or cloth is too thick, there will be insufficient cuff compression and the blood pressure value
will measure high.
• If the patient moves or the cuff is touched, this may be falsely detected as a pulse and over-inflation
will occur.
• Do not inflate the cuff when it is not wrapped on the upper arm. This may damage the cuff.
Taking the Measurement in "Manual Mode"
1. Press the [START/STOP] button.
Blood pressure measurement is performed once.
2. The measurement results are displayed.
If a measurement value is outside the corresponding range below, the value will flash.
SYS: 59 mmHg or less, or 251 mmHg or higher.
DIA: 39 mmHg or less, or 201 mmHg or higher.
PULSE: 39 bpm or less, or 201 bpm or higher.
■ Normal measurement■ Measurement error /
failure
Caution
The accuracy of a flashing measurement value that is outside the measurement range is not
guaranteed. Always check the patient's condition before deciding what steps to take.
Note:
If inflation is insufficient, inflation may restart while measurement is in progress.
Non-Invasive Blood Pressure (NIBP) Measurement
21
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Irregular pulse wave detection function
If the pulse wave interval becomes irregular during measurement, the irregular pulse wave detection
icon will light to notify you.
Body movement detection function
If body movement is detected during measurement, deflation stops for 5 seconds. The irregular pulse
wave icon appears in the measurement result display.
■ Deflation stopped
After 5 seconds, measurement resumes, and an attempt is made to complete measurement in one
cycle.
Taking the Measurement in "Auscultation Mode"
Use a stethoscope to perform measurement.
When set to "ON", SYS and DIA can be recorded using auscultation measurement.
To determine SYS and DIA during measurement, press the [MODE] button.
SYS is registered the first time and DIA is registered the second time you press the [MODE] button
during deflation.
After DIA is determined, the cuff rapidly deflates and SYS and DIA are displayed as the measurement
results.
The pulse rate does not appear in the measurement result display.
During deflation, the [] button can be held down to re-inflate, or the [] button can be held down to
deflate faster.
Stored data that was measured in "Auscultation Mode" is displayed when the auscultation icon is lit.
■ During re-inflation
Note:
The body movement detection function is disabled while "Auscultation Mode" is in use.
For Auscultation Mode settings, see page 16.
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Stopping the Measurement
To stop measurement while measurement is in progress, press [START/STOP] button.
Displaying Last Reading
The previous measurement value (systolic blood pressure, diastolic blood pressure, and pulse rate)
and whether or not an irregular pulse wave was detected can be displayed. In the case of auscultation
measurement, the auscultation icon appears.
Press the [] or [] button to display the previous data. This function is also available when the
device is switched off.
If an irregular pulse wave or
body movement was detected,
the irregular pulse wave icon
appears.
When the data was measured
in "Auscultation Mode", the
auscultation icon appears.
If held down at least 3 seconds when a measurement result is
displayed, the measured data is cleared without being stored.
Lights while the previous
data are being displayed.
Note:
When the monitor is left idle for one minute, the backlight will disappear.
Non-Invasive Blood Pressure (NIBP) Measurement
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Maintenance
Maintenance Inspection and Safety Management
The HBP-1300 must be maintained to ensure functionality and to secure the safety of patients and
operators.
Daily checks and maintenance should be performed by the operator. (page 25)
In addition, qualified personnel are necessary to maintain the performance and the safety, and to
conduct periodic inspections. We recommend that the verification test be performed at least once a
year. (page 17)
Managing Supplies
Keep the following supplies on hand.
• GS CUFF - All sizes
Device Maintenance
Cleaning and disinfecting should be performed in accordance with your facility's infection control
practice and OSHA regulations.
Surface cleaning
Wipe with a cloth that has been moistened with isopropyl alcohol diluted to 50 v/v%, or ethyl alcohol
(disinfection alcohol) diluted to 76.9 - 81.4 v/v% and wrung out.
Do not wipe the DC jack or allow it to become wet.
Removing dust
Use a moistened cotton bud to remove dust that has accumulated on the vent ports.
Service
The device requires no routine service other than cleaning, and visually checking the cuffs, tubing, etc.
Caution
• Do not sterilize by autoclave or gas sterilization (EOG, formaldehyde gas, high-concentration ozone,
etc.).
• If using an antiseptic solution for cleaning, follow the instructions of the manufacturer.
Accessory Care
Non-Invasive Blood Pressure Measurement (NIBP)
Cuff
Wipe clean on the surface of the cuff with a cloth moistened with a 70 v/v% dilution of isopropyl alcohol,
or a 76.9 to 81.4 v/v% dilution of disinfection ethanol (ethyl alcohol).
Do not allow any liquids inside the cuff. If a liquid gets in the cuff, dry the inside well.
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Page 27
Check before Use
Before conducting safety checks, be sure to implement the items in the "Device Maintenance" and
"Accessory Care" sections. (page 24)
Before turning on the power
Before turning on the power, check for the following
External appearance
■ The device or accessories are not deformed due to falling or other impact.
■ The device is not dirty.
■ The device is not wet.
AC adapter
■ The AC adapter is firmly connected to the connector on the device.
■ There are no heavy objects lying on the AC adapter cable.
■ The AC adapter cable is not damaged (core-wire exposure, breaks, etc.).
When turning on the power
When turning on the power, check the following
Display/lamp
■ When the [START/STOP] button is pressed to turn on the power, the screen below appears and the
alarm lamp lights.
The alarm lamp is lit up.
After turning on the power
After turning on the power, check for the following
External appearance
■ There is no smoke or odor coming from the device.
■ The device is not making any unusual noises.
Buttons
■ Press each button and check that it works.
Non-invasive blood pressure (NIBP)
■ Make sure that a suitable OMRON GS CUFF is attached (one that fits the circumference of the
patient's arm).
■ The cuff tube is firmly connected.
■ The person checking the cuff should wrap the cuff around arm, perform cuff measurement and check
to see that blood pressure is in the vicinity of normal measurements.
■ While measurement is in progress, bend the relevant arm and move body to halt discharge and
during this halt check that cuff pressure does not drop.
25
Maintenance
Page 28
Troubleshooting
The power does not turn on
CauseSolution
If the unit is being powered by the battery, the battery
is not installed or the charge is depleted.
Internal part failure
• Check if the AC adapter is disconnected or the connection is loose.
• Check if the AC adapter or battery has failed.
The unit display does not operate
Cause / solution
Stop using the unit and contact OMRON HEALTHCARE Customer Service.
The unit becomes hot
CauseSolution
An object is on top of the unit or right next to the unit. Keep the area around the unit free of objects.
If the unit becomes too hot to be touched, there may be a problem in the unit. Turn off the unit power,
disconnect the AC adapter, remove the battery, and contact OMRON HEALTHCARE Customer Service at
1-877-216-1336.
The unit is connected to a power outlet, but it runs on the the battery pack
Cause / solution
If AC power cannot be supplied, the unit will operate by battery only.
• Check if the AC adapter is properly connected to the unit.
• Check if AC adapter is connected to a power outlet.
• Check that the electrical outlet is working by connecting a different device to the same power outlet.
Insert battery or replace with a new battery (page 14).
Disconnect the AC adapter, remove the battery, and
contact OMRON HEALTHCARE Customer Service.
The cuff does not inflate when the [START/STOP] button is pressed
CauseSolution
Loose cuff tube connection.Check the connection.
There is an air leak in the cuff.Replace the cuff.
If pressure is displayed, the cuff tube is bent.Make sure no part of the cuff tube is bent.
Measurement was not possible
Cause / solution
Check the patient by palpation or other method.
After checking the patient, check the error code and see "List of Error Codes" (page 28) for Non Invasive
Blood Pressure (NIBP) measurement.
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Abnormal measurement value
Cause / solution
The causes below are possible. Check the patient by palpation and then repeat measurement.
• Body movement (chills or other trembling)
• Arrhythmia.
• Noise in the cuff
- A nearby person touched the patient.
- Cardiac massage was being performed.
The measurement value is questionable
CauseSolution
Deflates quicklyCheck for a loose cuff connection.
Stethoscope
Blood pressure may vary widely due to physiological effects.
The causes below are possible.
• Emotional excitement or agitation
- Pain due to cuff wrapping
- White coat hypertension
• Cuff size or wrapping method not correct
• Cuff wrapping position on upper arm not at the same height as the heart
• Patient's blood pressure not stable due to pulsus alternans, respiratory changes, or other reason
Incorrect cuff size used.
Cuff wrapped over thick clothing.
Patient not seated properly.
Patient ate, drank, or exerted themselves recently.
Simultaneously perform measurement with a stethoscope.
Place the stethoscope and listen while viewing the pressure display of the
manometer.
Measure circumference or patient's arm and ensure
correct sized cuff is used.
Ensure cuff is applied to a bare arm, or very thin
clothing.
Ensure patient is seated, feet flat on the floor, cuff at
heart level.
Ensure before measurement taken, patient has not
had food, caffeinated or alcohol beverages, or
exerted/exercised in the last 30 minutes.
27
Maintenance
Page 30
List of Error Codes
The alarm lamp flashes when a medium-priority alarm occurs, and lights steadily when a low-priority
alarm occurs.
To clear an alarm, press any button.
■ If a low-priority alarm and a medium-priority alarm occur at the same time, the medium-priority alarm
is displayed.
If the alarms are the same priority level, the error code of the alarm that occurred first is displayed.
However, to prevent battery consumption when powered by battery, a low battery error (E40 error) is
always given priority.
■ Example: E2
SYSTEM
Error
PriorityDescriptionPoints to check
code
Sensor failure:
Sensor range not stable
Outside of sensor range
Pressure gain lower limit value / upper
limit value
The cuff tube is not connectedFirmly connect the cuff tube.
Air is leaking from the cuff.
Did not inflate properly because the arm
or body moved during measurement.
Moved body or arm during
measurement, or talked.
The cuff is not applied correctly.Correctly apply the cuff.
The sleeve is rolled up and is
compressing the arm.
Measurement time has exceeded
specified time.
Specified time: 165 seconds
Replace with an OMRON GS CUFF that
does not leak.
Have the patient not move the arm or body,
and repeat measurement.
Have the patient not talk or move, and
repeat measurement.
Remove the garment and re-wrap the cuff.
The measurement time exceeds the
expected time, so the measurement was
ended in order to avoid patient discomfort.
There is a possibility that measurement is
being repeated over and over due to air
leaking from the cuff.
Page 31
Other problems
Error
PriorityCauseSolution
code
Inflated the cuff to 300 mmHg or more
during inflation in "Auscultation Mode".
E3Low
Over-inflation occurs
E40Medium The battery is depleted.
E41Medium Battery failed to charge.
E42Medium Battery voltage error
When inflating in "Auscultation Mode",
release the button when the pressure
reaches the desired value.
If this occurs during measurement, repeat
measurement.
If this occurs when not performing
measurement, contact OMRON
HEALTHCARE Customer Service.
Recharge the battery, or replace with a new
battery. (page 14)
Try charging again. If continues to fail,
replace with a new battery. (page 14)
Replace the battery with a new battery. If the
error continues, contact OMRON
HEALTHCARE Customer Service.
Disposal
Description
As there is a risk of environmental pollution, follow your applicable Federal, state and local legal
regulations regarding disposal or recycling of this equipment and batteries.
The main constituents of each part are listed in the table below. As there is a risk of infection, do not
recycle patient attachments such as cuffs, but dispose of them as instructed by your facility's
procedures and applicable regulations.
ItemPartsMaterial
Package
Main unit and
accessories
Battery pack
BoxCardboard
CushionCardboard
BagPE
EnclosureABS, PC , SR
Internal partsGeneral electronic components
Outer tubePVC
Cell batteriesNickel-hydrogen battery
Internal partsGeneral electronic components
Maintenance
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Page 32
Limited Warranty
Your OMRON HBP-1300 Professional Blood Pressure Monitor, excluding the arm cuffs 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 unit. The arm cuffs are
warranted to be free from defects in materials and workmanship appearing within one year from the
date of purchase when used in accordance with the instructions provided with the unit. The above
warranties extend only to the original retail purchaser.
We will, at our option, repair or replace without charge any unit or arm cuffs covered by the above
warranties. Repair or replacement is our only responsibility and your only remedy under the above
warranties.
To obtain warranty service contact Customer Service by calling 1-877-216-1336 for the address of
the repair location 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 that vary by
jurisdiction. Because of special local requirements, some of the above limitations and exclusions
may not apply to you.
FOR CUSTOMER SERVICE
Call toll free: 1-877-216-1336
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Page 33
Specifications
Factory Default Settings
Factory default settings and backup are as shown below.
Backup
: Setting is retained even if the power is interrupted.
: Reverts to factory default setting if the power is turned off.
DimensionMain unit: 4.84 x 7.91 x 3.90 (inch) 123 x 201 x 99 (mm) (W x H x D)
Weight
Display7 segment LCD
UL ClassfieldWITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL
Safety StandardsIEC 60601-1:1988+A1:1993+A2:1995
Protection ClassClass II
Degree of Protection
AC adapter: 1.81 x 2.60 x 1.46 (inch) 46 x 66 x 37 (mm) (W x H x D)
Battery: 2.13 x 1.71 x 0.61 (inch) 54 x 43.5 x 15.4 (mm) (W x H x D)
Main unit: Approx. 18.34 oz (0.52 kg) (not including accessories and options)
AC adapter: Approx. 7.05 oz (0.2 kg)
Battery: Approx. 3.53 oz (0.1 kg) (optional accessory)
HAZARDS ONLY.
UL60601-1:First Edition
Medical electrical equipment-Part1:General requirements for safety
Internal powered equipment
Type B F
MDD ClassificationClass II a
Specifications
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Page 34
Power supply
AC adapterInput voltage range: AC 100 V to 240 V
Rated Current: 1.6 A
Frequency: 50/60 Hz
Output voltage range: DC 6 V ±5%
Optional rechargeable batteryType: 3.6 V, 1900 mAh
Number of operation cycles when fully charged: 300
Measurement conditions
The HBP-1300 is intended for use in the electromagnetic environment specified below.
The customer or the user of the HBP-1300 should assure that it is used in such an environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
(50/ 60 Hz) magnetic
field
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.
Group 1The HBP-1300 uses RF energy only for internal functions.
Therefore, this RF emission is extremely weak and there is
little chance of it creating any kind of interference
whatsoever with nearby electronic equipment.
Class BThe HBP-1300 is suitable for use in all establishments,
including domestic establishments and those directly
Class A
connected to the public low voltage power supply network
that supplies buildings used for domestic purposes.
Complies
IEC60601-1-2
test level
±6 kV contact
±8 kV air
Compliance level
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
Electromagnetic
environment - guidance
synthetic material, the relative
humidity should be at least 30 %.
±2 kV for
power supply lines
±1 kV for
input/output lines
±1 kV
differential mode
±2 kV
common mode
<5 % U
T
for 0.5 cycle
40 % U
T
for 5 cycles
70 % U
T
for 25 cycles
<5 % U
T
for 5 sec.
±2 kV for
power supply lines
±1 kV for
input/output lines
±1 kV
differential mode
±2 kV
common mode
<5 % U
T
for 0.5 cycle
40 % U
T
for 5 cycles
70 % U
T
for 25 cycles
<5 % U
T
for 5 sec.
Mains power quality should be that of
a typical commercial or hospital
environment.
Mains power quality should be that of
a typical commercial or hospital
environment.
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the HBP1300 requires continued operation
during power mains interruptions, it is
recommended that the HBP-1300 be
powered from an uninterruptible
power supply or a battery.
3 A/m3 A/mPower frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
Specifications
33
Page 36
Immunity test
IEC60601-1-2
test level
IEC60601-1-2
test level
Electromagnetic
environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the HBP-1300, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommend separation distance
P
P
P
a
, should be less than the compliance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
80% AM (2Hz)
3 Vrms
80 MHz to 2.5
GHz
80% AM (2Hz)
3 Vrms
3 V/m
d = 1.2
d = 1.280 MHz to 800 MHz
d = 2.3800 MHz to 2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to he
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
level in each frequency rangeb.
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 radios, amateur 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 HBP-1300 is used exceeds the applicable RF
compliance level above, the HBP-1300 should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the HBP-1300.
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.
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Page 37
Note:
POTENTIAL FOR RADIO / TELEVISION INTERFERENCE (for U.S.A. only)
This product 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. The product 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 the product
does cause harmful interference to radio or television reception, which can be determined by turning
the product on and off, 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 product and the receiver.
• Connect the product 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.
POTENTIAL FOR RADIO / TELEVISION INTERFERENCE (for Canada only)
This digital apparatus does not exceed the Class B limits for radio noise emissions from digital
apparatus as set out in the interference-causing equipment standard entitled
003 of the Canadian Department of Communications.
Cet appareil numérique respecte les limites de bruits radioeléctriques applicables aux appareils
numériques de Clase B prescrites dans la norme sur le materiel brouilleur: "Appareils Numériques",
ICES-003 édictée par le minister des communications.
Changes or modifications not expressly approved by the party responsible for compliance could void
the user’s authority to operate the equipment.
"Digital Apparatus", ICES-
35
Specifications
Page 38
Recommended Separation Distances:
Recommended separation distance between portable and mobile RF communications equipment
and the HBP-1300
The HBP-1300 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the HBP-1300 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the HBP-1300 as recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter
Rated maximum output
power of transmitter
(W)
0.010.120.120.23
0.10.380.380.73
11.21.22.3
103.83.87.3
100121223
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be determined 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.
Note1:At 80MHz and 800MHz, the separation distance for 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.