Omron HBP-1300 User Manual

Professional Blood Pressure Monitor

HBP-1300

Instruction Manual

Table of Contents

Introduction

Intended Use.............................................. 1

Exemptions ................................................ 1

Notes on Safety ......................................... 2

Warnings and Cautions.............................. 3

Using the Unit

Components of the Product ..................... 10

Optional Accessories ............................... 10

Features of the Product ............................11

Features / Functions of Unit..................... 12

Installing the Optional Battery Pack......... 14

Connecting the AC Adapter...................... 15

System Settings

Menu Mode .............................................. 16

Utility Mode .............................................. 17

Non-Invasive Blood Pressure (NIBP)
Measurement

Non-Invasive Pressure Measurement Principles .....

Cuff Selection and Connection ................ 19

Applying the Cuff to Patient ..................... 20

Taking the Measurement in "Manual Mode" ....

Taking the Measurement in "Auscultation Mode" ...

Stopping the Measurement...................... 23

Thank you for purchasing this OMRON Professional
Blood Pressure Monitor.

Please competely read this Instruction Manual before
using the monitor for the first time.

Read this manual to ensure the safe and accurate
use of the monitor.

For Professional Use

KEEP THIS INSTRUCTION MANUAL
NEAR THE BLOOD PRESSURE
MONITOR FOR FUTURE REFERENCE

Displaying Last Reading .......................... 23

Maintenance

Maintenance Inspection and Safety Management ...

Managing Supplies .................................. 24

Device Maintenance ................................ 24

Accessory Care........................................ 24

Check before Use .................................... 25

Troubleshooting ....................................... 26

List of Error Codes ................................... 28

Disposal ................................................... 29

Limited Warranty

Specifications

Factory Default Settings........................... 31

Specifications........................................... 31

Manufacturer's Declaration ...................... 33

18

21
22

24

...................................... 30

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or licensed

healthcare practitioner

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

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.

2

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.

3

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.

4

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

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.

6

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.

7

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

8

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

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)