Omron HBP-1100 User Manual

4.5 (2)

Professional Blood Pressure Monitor

HBP-1100

Instruction Manual

Thank you for purchasing this OMRON Professional Blood Pressure Monitor.

Please completely 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.

XXXXXXX-X A

Exemptions

OMRON will not bear any responsibilities on the following matters.

1.When a problem or damage occurs caused by the maintenance and/ or repair conducted by a person other than OMRON or the dealer specified by OMRON

2.The problem or damage of OMRON product caused by the product of other manufacturer not delivered by OMRON

3.The problem and damage caused by the maintenance and/or repair using the repair parts not specified by OMRON

4.The problem and damage caused by the results not observing the Notes on Safety or the operational method mentioned in this Instruction Manual

5.Under the circumstances not within the operating conditions of this unit including the power source or the setting environment mentioned in this Instruction Manual

6.The problem and damage caused by the result(s) of remodeling or improper repair of this product

7.The problem and damage caused by act of god such as fire, earthquake, flood, or lightning

1.The contents of this Instruction Manual may be changed without prior notice.

2.We have thoroughly reviewed the contents of this Instruction Manual. However, if an inadequate description or error is found, please let us know.

3.It is prohibited to copy a part of or the entire Instruction Manual without getting OMRON’s permission. Unless this Instruction Manual is used by an individual (company), it cannot be used without getting OMRON’s permission from the standpoint of the Copyright Law.

Table of Contents

 

Introduction

 

Intended Use ................................................................................

2

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

2

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

3

Using the Unit

 

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

10

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

11

Installing the Batteries ..................................................................

13

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

13

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

14

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

15

Zero indicator function..................................................................

17

Non-Invasive Blood Pressure (NIBP) Measurement

 

Measurement in normal mode......................................................

18

Measurement in auscultation mode..............................................

20

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

21

Non-Invasive Pressure Measurement Principles..........................

22

Maintenance

 

Maintenance Inspection and Safety Management .......................

23

Device Maintenance.....................................................................

23

Accessory Care ............................................................................

23

Managing Supplies.......................................................................

23

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

24

Checking pressure accuracy ........................................................

25

Troubleshooting............................................................................

26

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

29

Disposal........................................................................................

31

Specifications

 

Specifications ...............................................................................

32

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

36

Optional Accessories

 

Optional Medical Accessories ......................................................

40

1

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 12 cm to 50 cm (from 5 inches to 20 inches).

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.

Features of the Product

The blood pressure accuracy of the HBP-1100 is clinically proven. Easy to use, the HBP-1100 is intended for use by medical professionals.

Zero indicator function (page 14): Before each measurement, this device indicates that "zero calibration" was successful.

Auscultation mode

5 cuffs available - (XL: 42 to 50 cm, L: 32 to 42 cm, M: 22 to 32 cm, S: 17 to 22 cm, SS: 12 to 18 cm)

This device and cuff can be cleaned with a soft cloth moistened with alcohol.

Compact, can be stored in a drawer

Motion stop function: When body movement is detected, this device stops deflation for 5 seconds.

Irregular pulse icon: Helps identify changes in heart rate, rhythm, and pulse that may be caused by heart disease or other serious health problems.

2

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

Indicates the matters in which death or severe bodily

damage may arise as a result of incorrect handling.

Caution

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.

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 your local OMRON representative.

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 use with a defibrillator.

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.

3

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.

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 SpO2 sensor and the cuff are attached to the same arm

-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.

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

Dry cell 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 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.

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. Do not insert batteries with their polarities reversed.

Do not connect the positive and negative terminals of the battery with a wire or other metal object.

Do not use the AC adapter and battery at the same time.

Caution

If battery fluid comes in contact with skin or clothing, rinse immediately with water.

Do not use new and old batteries together, or use different types of batteries together.

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 SpO2 sensor, IBP catheter, or other instrument is attached.

-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.

7

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 10 cm (4 inches) 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 an OMRON GS CUFF can be used with this device. The use of any other cuff may result in incorrect measurement.

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 23.

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.

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 your local OMRON representative.

Main unit

Standard Medical Accessories

AC adapter

 

GS CUFF M

 

Instruction

 

 

 

 

Manual

 

 

 

 

 

Caution

Only an OMRON GS CUFF can be used with this device. The use of any other cuff may result in incorrect measurement.

10

Features / Functions of Unit

Front and bottom of unit

1 2

 

4

5

3

6

1

2

3

[Power ON/OFF]

Turns the power ON/OFF.

button

 

[Auscultation] button

Press to enter auscultation mode.

(page 20).

 

 

Press to start blood pressure

[START/STOP]

measurement.

While the cuff is inflating, hold

button

down to continuously inflate (page

 

18).

4

NIBP connector

Connects the cuff tube.

 

5

Power connector

Connects the AC adapter.

 

 

 

 

 

6

Battery cover

Open to install or replace the

 

batteries.

 

 

Other symbols

 

 

 

 

 

 

 

 

Symbol

Description

Symbol

Description

 

Type BF

 

Caution

 

 

 

 

 

 

Class 2

 

 

 

 

Internal powered

 

 

 

 

equipment

 

 

 

11

Omron HBP-1100 User Manual

LCD Display

1

2

8 3

4

5

6 7

1

2

3

4

5

6

7

8

SYS

Displays systolic blood pressure.

DIA

Displays diastolic blood pressure.

Pulse

Displays the pulse rate.

Irregular pulse

Lights in the measurement result display if

the pulse wave interval was irregular or

wave icon

there was body movement during

 

measurement.

Auscultation icon

Lights when "Auscultation Mode" is ON.

Pulse

Flashes in synchronization with the pulse

synchronization

during measurement.

icon

 

Battery

When this icon lights, an E40 error also

replacement icon*

appears. Replace the batteries. (page 13)

Zero indicator

Lights when "zero calibration" is being

performed prior to blood pressure

icon

measurement. When calibration finishes,

 

appears.

* Only when the batteries are installed.

12

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