Omron HBP-1120 Bedienungsanleitung

Professional Blood Pressure Monitor

HBP-1120

• Instruction Manual

• Mode d’emploi

• Gebrauchsanweisung

• Manuale di istruzioni

• Manual de instrucciones

• Gebruiksaanwijzing

•

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Thank you for purchasing this OMRON Professional Blood Pressure Monitor.

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

IM-HBP-1120-E-05-07/2022

2829457-8D

Issue Date/Date de publication/Ausgabedatum/

Data di pubblicazione/Fecha de publicación/

: 2022-08-30

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Table of Contents

Introduction

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

Exemptions............................................................................................2

Notes on Safety.....................................................................................3

Using the Unit

Components of the Product ..................................................................9

Options ..................................................................................................9

Features 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

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Measurement in “Normal Mode”.........................................................18

Measurement in “Auscultation Mode”.................................................19

Stopping the Measurement.................................................................20

Turning the Power OFF.......................................................................20

Non-Invasive Pressure Measurement Principles ...............................21

Maintenance

Maintenance Inspection and Safety Management.............................22

Cleaning of the Device........................................................................22

Cuff Care .............................................................................................22

Check before Use ...............................................................................23

Checking Pressure Accuracy..............................................................24

Troubleshooting...................................................................................25

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

Disposal...............................................................................................30

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Manufacturer’s Declaration.................................................................36

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.

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The instrument is designed for use in physicians’ offices, hospitals,

clinics and other medical facilities.

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5 years (only when appropriate inspection is performed)

Measurement Parameter

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Precautions for Use

Warnings and cautions described in the instruction manual should be

observed at all times.

Exemptions

OMRON will not bear any responsibilities on the following matters.

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

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.

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.

Storage/Setup

Warning

•

Install the unit in a location close to a power outlet where the AC adapter

can be easily disconnected. If the power cannot be quickly disconnected

when an abnormal condition occurs, an accident or fire may result.

• 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 OMRON retail dealer or distributor.

• 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.

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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.

•

During measurement, make sure that no mobile phone or any other electrical

devices that emit electromagnetic fields is within 30 cm of this monitor. This may

result in incorrect operation of the monitor and/or cause an inaccurate reading.

Caution

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- 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 in a location with noise-emitting equipment such as a room

with MRI, CT, X-ray or HF surgical equipment or an operating room.

Noise from the equipment may interfere with the operation of the unit.

Before use / during use

Warning

• The unit complies with the EMC (Electromagnetic Compatibility)

standard (EN60601-1-2). 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.

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- 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. This

may damage and/or may be hazardous to the device.

• 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 physicians’ office, hospitals, clinics and

other medical facilities.

• 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.

Caution

• Before using the unit, verify that none of the following apply to the

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- 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)

- The patient has a mastectomy or lymph node clearance

- 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.

•

Do not wrap the cuff on an arm with an SpO

sensor or other monitoring

equipment attached. The pulse may disappear when the cuff pressurizes,

causing a temporary loss of monitoring function.

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. This may damage on the surface of the device.

• Clean the unit regularly.

Maintenance and inspection

Warning

• To use the unit 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.

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.

• Use only the specified type of battery.

Caution

• If battery fluid comes into contact with the skin or clothes, immediately

rinse with water.

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

batteries together.

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Warning

•

If a cuff is used on some patients with an infection, treat the cuff as medical

waste, or disinfect before reuse. Otherwise, an infection may result.

• 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.

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- An upper arm on which intravenous drip or a blood transfusion is

being performed.

- An upper arm on which SpO2sensor, IBP catheter, or other instrument

is attached.

- An upper arm with a shunt for hemodialysis.

- An injured upper arm.

• 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 measurement, 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

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- 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 CUFF2 can be used with this device. The use of

any other cuff may result in incorrect measurement.

Note:

Setup

• Read and understand the manual for each optional accessory.

This manual does not contain cautionary information for optional

accessories.

• Exercise caution with the cables and arrange so that the patient does

not become entangled or bound.

Before use / during use

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- No smoke, abnormal odor, or abnormal noise 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 (page 12).

- 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 22.

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• 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.

•

Clinical evaluation of the unit was carried out in a resting position (feet on

floor without crossing legs, back supported by backrest, arm supported

such that cuff is attached at same height as heart) in accordance with

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position may result in differences in measurement results.

• As the patient’s posture or physiological condition influences blood

pressure, it easily fluctuates. Recommend the followings to take a more

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- Make the patient relaxed.

- Do not talk to the patient.

- Let the patient rest for at least 5 minutes before the measurement.

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