Omron HBP-1100 Bedienungsanleitung

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.

Professional Blood Pressure Monitor

HBP-1100

Instruction Manual

5339134-0 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

speci¿ed 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 speci¿ed 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 monitor 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 ¿re,

earthquake, Àood, 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 Monitor...................................................................... 2

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

Using the Monitor

Components of the Monitor.............................................................. 10

Features / Functions of Monitor........................................................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

Monitor 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

Speci¿cations

Speci¿cations................................................................................... 32

Manufacturer's Declaration..............................................................36

Optional Accessories

Optional Medical Accessories ......................................................... 40

Introduction

Intended Use

Medical Purpose

This instrument 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 instrument should be used by a medical professional.

Patient Population

This instrument is intended for use on adults and children of age 3-years

and older.

Environment

The instrument is designed for use in physicians' of¿ces, hospitals, clinics

and other medical facilities.

Measurement Parameter

ŶNon-Invasive Blood Pressure

ŶPulse rate

Precautions for Use

Warnings and cautions described in the instruction manual should be

observed at all times.

Features of the Monitor

The blood pressure accuracy of the HBP-1100 is clinically proven. Easy

to use, the HBP-1100 is intended for use by medical professionals.

ŶZero indicator function (page 17): Before each measurement, this

monitor indicates that "zero calibration" was successful.

ŶAuscultation mode

Ŷ5 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)

ŶThis monitor and cuff can be cleaned with a soft cloth moistened with

alcohol.

ŶCompact, can be stored in a drawer

ŶMotion stop function: When body movement is detected, this monitor

stops deÀation for 5 seconds.

ŶIrregular pulse icon: Helps identify changes in heart rate, rhythm, and

pulse that may be caused by heart disease or other serious health

problems.

Notes on Safety

The warning signs and symbol examples indicated below are intended to

ensure safe use of the monitor 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 monitor

and other useful information.

Setup

Warning

• Do not use the cuff or AC adapter to lift the monitor, it can also cause

the monitor to malfunction.

• If the monitor has broken down, contact your local OMRON representative.

• Do not use in combination with a hyperbaric oxygen therapy instrument,

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

monitor from the patient.

• Do not use with a de¿brillator.

• Do not install the monitor in the following locations:

- Locations subject to vibration such as ambulances and emergency

helicopters.

- A location where there is gas or Àame.

- 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 monitor to intense shock.

• Do not place heavy objects on the AC adapter cable, or allow the

monitor 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.

Caution

• Do not install the monitor 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 monitor near large equipment that uses a switching relay

for power ON/OFF.

Before use / during use

Warning

• The monitor 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 instrument are near the monitor, check the

operation of the monitor 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 monitor when judging the

patient's condition.

• Only trained healthcare providers should use this monitor. Do not allow

patients to operate this monitor.

• Properly connect the connectors and AC adapter cable.

• Do not place objects or liquids on top of this monitor.

• Check the following before using the monitor:

- Make sure the AC adapter cable is not damaged (wires are not

exposed or broken), and the connections are ¿rm.

•

For the AC adapter connected to the monitor, supplies, and optional

instruments, use only the standard accessories or OMRON-speci¿ed

products.

• Do not use in a location with moisture, or a location where water may

splash on the monitor.

This monitor is intended for use in a physician's of¿ce.

• Do not use the monitor if it emits smoke, an abnormal odor, or abnormal

noise.

• Do not bring cellular telephones or transceivers into the room where the

monitor is installed or being used.

• Do not connect multiple monitors to the same patient.

• Do not connect the monitor to a power outlet that is controlled by a wall

switch.

Caution

• Before using the monitor, 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 Àow to the measurement position)

- The patient uses an arti¿cial heart and lung (there will be no pulse)

- An SpO2sensor 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 monitor to make sure there are no

deformations due to falling, and that there is no dirt or moisture on the

monitor.

• When the monitor 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 monitor may easily fall. In the event

that the monitor falls, verify that it operates normally and safely.

Cleaning

Warning

• When cleaning the monitor, turn off the power and disconnect the AC

adapter from the monitor.

• After cleaning the monitor, make sure it is completely dry before

connecting to a power outlet.

• Do not spray, pour, or spill liquids into or onto the monitor, accessories,

connectors, buttons, or openings in the housing.

Caution

• Do not use thinner, benzene, or other solvents to clean the monitor.

• 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 monitor regularly.

Maintenance and inspection

Warning

• To use the monitor safely and correctly, always inspect the monitor

when starting work.

• Unauthorized modi¿cation is prohibited by law. Do not attempt to

disassemble or modify the monitor.

Dry cell battery

Warning

• If battery Àuid comes in contact with the eye, immediately Àush

with copious amounts of water. Do not rub. Seek medical attention

immediately.

• Do not throw into Àame, disassemble, or heat.

• Always disconnect the AC adapter from the monitor before removing or

installing a battery.

• If the monitor will not be used for a month or longer, remove the battery

from the monitor 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 Àuid 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 inÀation and deÀation, 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 SpO2sensor, 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.

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:

- 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 ¿ngers to be inserted in between the cuff and the arm.

• The accuracy of a Àashing 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 monitor. The use of

any other cuff may result in incorrect measurement.

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