Omron HBP-1300 Bedienungsanleitung

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

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

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

Specifications

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

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

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

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

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

healthcare practitioner

HBP-1300.book Page -1 Wednesday, March 7, 2012 9:28 AM

HBP-1300.book Page 0 Wednesday, March 7, 2012 9:28 AM

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.

HBP-1300.book Page 1 Wednesday, March 7, 2012 9:28 AM

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.

HBP-1300.book Page 2 Wednesday, March 7, 2012 9:28 AM

Introduction

Warnings and Cautions

Usage warnings and cautions

Setup

Warning

Caution

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.

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.

HBP-1300.book Page 3 Wednesday, March 7, 2012 9:28 AM

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.

HBP-1300.book Page 4 Wednesday, March 7, 2012 9:28 AM

Introduction

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)

-AnSpO

2sensor 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.

HBP-1300.book Page 5 Wednesday, March 7, 2012 9:28 AM

Cleaning

Warning

Caution

Maintenance and inspection

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.

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.

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.

HBP-1300.book Page 6 Wednesday, March 7, 2012 9:28 AM

Introduction

Warnings and cautions for safe measurement

Optional rechargeable battery

Warning

Caution

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.

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.

HBP-1300.book Page 7 Wednesday, March 7, 2012 9:28 AM

Non-Invasive Blood Pressure (NIBP) measurement

Warning

Caution

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 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.

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.

HBP-1300.book Page 8 Wednesday, March 7, 2012 9:28 AM

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