Omron HEM-9000AI Bedienungsanleitung

INSTRUCTION MANUAL

HEM-9000AI

Non-Invasive

Blood Pressure Monitor

with Augmentation Index (AI)

• Thank you for purchasing the Omron HEM-9000AI unit.

• Read all of the instructions in the instruction manual before you operate the unit.

• Retain the instruction manual for future reference when operating the unit.

Table of Contents

Indications ................................................................................................................................4

Disclaimer ................................................................................................................................5

Warnings .................................................................................................................................. 6

Warnings and Precautions ...................................................................................................... 7

Care and Maintenance ............................................................................................................11

Package Contents.................................................................................................................. 12

Accessories ............................................................................................................................13

Introduction to the HEM-9000AI..............................................................................................14

General Preparation

Component Names/Descriptions ........................................................................................ 15

Connecting the Main Unit and AI Pulse Wave Measurement Unit ......................................16

Inserting the Memory Card ................................................................................................ 16

Turning on the power, and checking the time/date ..............................................................17

Setting the Date and Time .................................................................................................. 18

Setting the Blood Pressure/AI Measurement Method and Registering ID Information ...... 20

Loading Printer Paper ........................................................................................................ 21

Measurement Preparation

How to Apply the Blood Pressure Cuff .............................................................................. 22

How to Apply the AI Pulse Wave Sensor Unit .................................................................... 24

Post-Measurement

How to Remove the AI Pulse Wave Sensor Unit................................................................ 27

Selecting the Measurement Method ...................................................................................... 28

Al + Blood Pressure Measurement

Measuring AI + Blood Pressure Together .......................................................................... 29

Blood Pressure Measurement

Blood Pressure Measurement ............................................................................................ 34

Auscultation ........................................................................................................................ 36

Al Measurement

AI Measurement.................................................................................................................. 38

Changing Magnification and Scroll Speed.......................................................................... 41

Table of Contents

Printing Measurement Results............................................................................................ 42

Print Sequential Pulse Waves While Measuring ................................................................ 43

Memory Retrieval

Show All Data List .............................................................................................................. 44

ID Search ............................................................................................................................ 45

Data Detail .......................................................................................................................... 47

Trend Graph........................................................................................................................ 48

Adding and Modifying Blood Pressure Measurement Values................................................ 50

Registering ID Information

ID Registration .................................................................................................................... 51

Retrieval .............................................................................................................................. 55

Modifications ...................................................................................................................... 56

Configuration Options

How to Change the Setup .................................................................................................. 57

How to Change the Settings .............................................................................................. 58

How to Change the Measurement Settings........................................................................ 59

How to Change Settings for Memory Contents .................................................................. 62

How to Change Display/Sound Settings ............................................................................ 63

How to Change the Clock Settings .................................................................................... 66

Memory Card ...................................................................................................................... 67

Returning to the Default Settings........................................................................................ 69

Keyboard ............................................................................................................................ 70

Calibration Measurement

Checking the Accuracy of the Blood Pressure Display ...................................................... 71

How to Execute a Test Measurement ................................................................................ 72

Validation Study ......................................................................................................................73

Introduction to Troubleshooting ..............................................................................................75

Error List ................................................................................................................................76

Specifications ........................................................................................................................ 80

Limited Warranty .................................................................................................................... 81

Professional Services ........................................................................................................82

Notes Page..............................................................................................................................83

Indications

Indications for use

The HEM-9000AI is intended to measure systolic and diastolic blood pressure and pulse rate

in adults with an arm circumference of 17-50 cm (7-20 inches), and to calculate radial augmentation

index (AI). The HEM-9000AI is intended for use in physicians’ offices, hospitals, clinics and other

medical facilities where non-invasive blood pressure and radial AI measurements/calculations are

performed on patients and invasive measurement is contraindicated.

The Augmentation Index (AI) function of the HEM-9000AI has not been evaluated on patients

who have intra-ventricular conduction delays (VCD).

Contraindications for use

As with any non-invasive measurement device, there are clinical conditions which can

influence the accuracy of the results. Also, the subject’s position, physiological condition and other

environmental factors can affect the measurement/calculation.

The Omron HEM-9000AI Non-Invasive Blood Pressure Monitor with Augmentation Index

should not be used with patients who have the following conditions:

1. Patients with a known arrhythmia

2. Patients with insufficient peripheral circulation, acute cases of low blood pressure or low temperature.

3. Patients who use a pacemaker.

4. Patients experiencing a seizure.

5. Babies or children younger than 18 years old.

6. Patients who should not have blood pressure measurements taken from their arms.

7. Patients with an artificial heart.

8. Patients whose artery cannot be found by palpation.

Disclaimer

1. The contents of this book may be modified without any notice.

2. Care has been exercised in writing this instruction manual. Contact Omron Healthcare

should you notice any defects or mistakes.

3. It is prohibited to copy a part or all of this instruction manual without written permission.

Read and familiarize yourself with all Instruction Manual materials, including the

instructions for use, warnings, precautions, limitations and capabilities before using

the Omron HEM-9000AI Device.

Omron is not responsible for failure of or damage to the HEM-9000AI, its accessories,

supplies, collateral equipment or to any other equipment or furnishings resulting from:

1. Maintenance or repair by any person other than Omron or an authorized agent of Omron.

2. Use of products or supplies manufactured or distributed by a party other than Omron unless

purchased from Omron.

3. Maintenance, operation or repair utilizing parts, supplies or equipment other than those

specified by Omron.

4. Failure to follow the safety instructions and operating instructions in this manual.

5. Failure to comply with the instructions regarding power supply and environmental conditions

as described in this manual.

6. Modification or inappropriate repair.

7. Acts of God including but not limited to fire, earthquake, flood, lightning strikes.

Warnings

GIVE PARTICULAR ATTENTION TO ALL SAFETY PRECAUTIONS

Warning signs and graphic symbols are intended for the safe and correct use of the product, and to

prevent harm or damage to you and others.

Symbols and definitions are as follows:

WARNING

Indicates a possibility that people will be injured or objects will be damaged resulting from

incorrect use.

Caution: Federal Law restricts this device to use by or on the order of a physician, or other

licensed practitioner.

Indicates a possibility that people will suffer death or serious injury resulting

from incorrect use.

Clinical

• Do not use unless you are a healthcare worker.

• Do not use for monitoring vital signs in an intensive care unit.

• The device has a safety mechanism built in to prevent pressure from rising

above 300mmHg. If this safety mechanism fails or pressurization fails to stop

while measuring, disconnect the AI pulse wave sensor cuff, or unplug an air

tube from the blood pressure monitor itself.

• Peripheral nerve damage might result.

• Do not apply a cuff or use the AI pulse wave measurement unit on an arm

being transfused or injected with an intravenous injection.

• Intravenous injection or transfusion can not be performed properly.

• Do not use this device on patients who cannot clearly describe their pain.

• It may cause injury to the user if cuff pressurization release stops or pulse wave sensor

pressure release is delayed.

• Do not use this device during an MRI scan.

• It might cause an accident.

• If a power outage occurs while the device is measuring, promptly detach the

cuff and pulse wave sensor unit.

• Injury may result when pressing the wrist for a long period.

• Do not slide the AI pulse wave sensor during AI measurement.

• Injury to the wrist might result.

Device Set Up

• Do not touch the power cord with a wet hand.

• Electric shock might result.

• Do not use cords except those provided.

• Electric shock might result.

• Do not plug into outlet without grounding pin receptacle. Use 2 pole - 3

conductor - grounded receptacle only.

• If plugged into incorrect outlet, electric shock might result.

Device Use

• Plug the main unit into an outlet (do not plug into a multi-plug outlet adapter).

• Fire or electrical shock might result.

• Plug the power cord in firmly. Clean off dust on the power cord.

• Electric shock, a short-circuit or fire might result.

• Do not use when the power cord is damaged or not firmly plugged in.

• Electric shock, a short-circuit or fire might result.

• Do not pull the power cord when unplugging the power cord from an outlet.

• It might cause fire or electric shock due to breaking or short circuiting the power cord.

• Do not use in the presence of a flammable gas or where flammable gas may

be generated or released. (e.g., combustible anesthetics, hyperbaric

chambers, oxygen tents, in presence of combustible/flammable liquids.)

• Explosion or fire might result.

• When you use this device with other medical devices, read the instruction

manuals of those devices carefully, as well, and understand all warnings and

notes before using.

Warnings and Precautions

WARNING

Warnings and Precautions

• If the following cases or situations occur, stop using this device immediately,

turn it off, unplug the power cord from the outlet, and contact Omron

Healthcare Professional Services.

• If there is smoke or an unusual odor.

• If this device is dropped or subject to a strong impact.

• If liquid or foreign substances enter the device.

• Failure state.

• Electric shock, a short circuit or fire might result.

• In addition, follow the instructions below in any of the above situations:

• Display an “Out of Order, Do Not Use” sign on the front of the main unit.

• Stop using the device.

• Electric shock might result.

• Do not disassemble or modify this device.

• Electric shock, fire, failure or malfunction might result.

• Do not use with any cuffs except those provided by Omron specifically for this

device and model.

• It might cause incorrect measurement results.

• Do not use any power cords except power cords provided by Omron

specifically for this device.

• Fire or electric shock might result.

• The power cord included with this device may only be used in the United States or Canada

(AC120V). If this device will be used in any country other than the United States or Canada

(AC120V), take the following precaution: Confirm the voltage and safety standard used in

the country in which the device will be operated. Contact Professional Services for

information on where to acquire the correct power cord.

• Do not replace the fuses on your own.

• Fire or electric shock might result.

• The fuses are specifically designed for this device. Contact Professional Services for

replacement of the fuses.

• Fuse model: 2183.15 (Littlefuse, Inc.)

• Do not connect the HEM-9000AI to commercial computers or devices that do

not meet medical safety standards:

• This could cause electric shock.

• This device meets medical safety standards and the leakage current is limited to be within

standard specifications.

Device Maintenance

• After using the unit or cleaning, do not plug the power cord into an outlet until

the unit and power cord are sufficiently dry.

• Fire or electric shock might result.

• Do not place or store in a place that can be reached by water or chemicals.

• Electric shock might result.

WARNING

Omron Healthcare Professional Services 1-877-216-1336

Warnings and Precautions

Clinical

• When results are erratic, use other measurement procedures prior to

invasive techniques.

• Make sure that the patient does not touch this device while the test is being

conducted.

• Only measure when the patient is quiet, not talking or moving.

• In the following cases, check blood pressure and pulse by auscultation:

(a) When an irregular pulse wave is found

• Advise the patient not to shake or move the body while measuring. This may cause the

similar condition to irregular pulse wave.

(b) When an error occurs or you have doubt about the measurement value.

• An incorrect measurement may be registered due to external vibration or patient

movement while measuring.

• A measurement error or inability to measure may occur in cases of abnormal

peripheral circulation or very low blood pressure.

• A measurement error or inability to measure may occur in cases of a patient with a

short blood pressure fluctuation, such as an irregular heartbeat.

Device Set up

• Do not connect the air tube, cuff or AI pulse wave measurement unit to

another device’s tube.

• Erroneous results may occur.

• Do not insert or remove the AI pulse wave sensor if a connector or an air

tube is unplugged.

• Damage to the AI pulse wave sensor or pressure air bag might result.

Device Use

• Do not install parts or instruments not specified for this device.

• Do not push the buttons or LCD display with any sharp or hard material.

• Failure or damage might result.

• Do not touch the AI pulse wave sensor with any sharp or hard material.

• Damage might result.

• Do not insert and remove the memory card while saving or retrieving data.

• Memory card data damage might result.

• Make sure the time is set correctly on the main unit.

• Measurement might be recorded with the wrong time.

• Turn off the power to the unit and unplug the power cord from the electrical

outlet before moving the unit.

• Do not insert or remove the AI pulse wave sensor while measuring AI.

• Damage to the AI pulse wave sensor or pressure air bag might result.

• Do not inflate without wrapping the cuff around the arm.

• Do not use a damaged cuff.

• Do not unplug the electrical connector that connects the pulse wave

measurement unit and the pulse wave sensor unit while measuring.

• The device cannot measure correctly.

• During measurement, do not unplug the connector that connects the AI

measurement to the main unit.

• Measurement will not be possible.

• Do not use a cellular phone or a radio transceiver in the room where this

device is located.

• Malfunction might result.

Omron Healthcare Professional Services 1-877-216-1336

Warnings and Precautions

• Do not use other medical devices near this device.

• Malfunction might result.

• Other medical devices might be affected.

• This device might be affected by an electric appliance or microwave apparatus.

Do not use any electronics or microwaves in the vicinity of this device.

• Do not use in extreme meteorological environments, such as unmanaged high

temperature, high humidity, low temperature, and low humidity.

• Malfunction might result.

• Do not use this unit in a vehicle, such as an ambulance.

• Do not use any printer paper other than the printer paper provided by Omron

specifically for this device and model.

• Damage to the printer might result.

• Printed text, waveforms and measurement results may smear or fade.

• Do not pull on paper before printing is complete.

• Damage to the printer might result.

• Use only an Omron designated memory card.

• Using memory cards not designated for use with this device might result in measurement

results or ID information not saving correctly, or might prevent them from being retrieved later.

• Do not drop this device.

Device Maintenance

• Unplug the main unit connector from outlet when not in use for a long period.

• Electric shock or an electric discharge fire due to deterioration of the insulating material

might result.

• Unplug the main connector when installing/removing parts or performing

maintenance.

• Electric shock or injury might result.

• Turn off and unplug the main unit connector to prevent an electric shock when

performing maintenance.

• Do not damage, modify, bend forcefully, pull, twist, or bundle the power cord.

In addition, do not put heavy material on it.

• Failure or damage might result.

Shipping

• This is a high-precision device. Before shipping this device contact Omron

Healthcare Professional Services for shipping instructions.

Omron Healthcare Professional Services 1-877-216-1336

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