Omron HEM-9000AI Bedienungsanleitung

HEM-9000AI

Non-Invasive

Blood Pressure Monitor

with Augmentation Index (AI)

• Instruction Manual

• Mode d’emploi

• Gebrauchsanweisung

• Manuale de instructone

• Manual de instrucciones

• Gebruiksaanwijzing

•

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IM-HEM9000-AI-E-01-07/06

Thank you for purchasing the OMRON HEM-9000AI unit.

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

and keep it near the unit all the times for future reference.

Contents

1. Indications .................................................................................... 4

2. Exemptions .................................................................................. 5

3. Notes on Safety ........................................................................... 6

4. Cleaning and Maintenance ........................................................11

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

5.1. Main Unit ............................................................................. 12

5.2. Accessories (Included and Sold Separately) ...................... 12

6. Accessories ............................................................................... 13

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

8. General Preparation .................................................................. 15

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

8.2. Connecting the Main Unit and AI Pulse Wave

Measurement Unit Inserting the Memory Card ................... 17

8.3. Setting the Date and Time .................................................. 19

8.4. Setting the Blood Pressure/AI Measurement Method

and Registering ID Information ........................................... 22

8.5. Loading Printer Paper ......................................................... 23

9. Measurement Preparation ......................................................... 24

9.1. How to Apply the Blood Pressure Cuff ................................ 24

9.2. How to Apply the AI Pulse Wave Sensor Unit .................... 26

10. Post - Measurement .................................................................. 29

10.1.How to Remove the AI Pulse Wave Sensor Unit ................ 29

11. Selecting the Measurement Method ........................................ 30

11.1. Selecting the Measurement Method ................................... 30

12. AI + Blood Pressure Measurement .......................................... 31

12.1.Measuring AI + Blood Pressure Together ........................... 31

13. Blood Pressure Measurement .................................................. 36

13.1.Blood Pressure Measurement ............................................ 36

13.2.Auscultation ........................................................................ 38

14. AI Measurement ......................................................................... 40

14.1.AI Measurement .................................................................. 40

14.2.Changing Magnification and Scroll Speed .......................... 43

15. Print ............................................................................................ 44

15.1.Printing Measurement Results ............................................ 44

16 Memory Retrieval ....................................................................... 46

16.1.Show All Data List ............................................................... 46

16.2.ID Search ............................................................................ 48

16.3.Delete Data ......................................................................... 49

16.4.Data Detail .......................................................................... 50

16.5.Print Continuous Pulse Waves ........................................... 51

16.6.Trend Graph ........................................................................ 53

16.7.Adding and Modifying Blood Pressure

Measurement Values .......................................................... 55

17. Registering ID Information ....................................................... 57

17.1.ID Registration .................................................................... 57

17.2.Retrieval / Edit ID ................................................................ 61

17.3.Replace ID .......................................................................... 63

18. Configuration Options .............................................................. 64

18.1.How to Change the Settings .............................................. 64

18.2.How to Change the Setup ................................................... 66

18.3.How to Change the Measurement Settings ........................ 67

18.4.How to Change Settings for Printing ................................... 70

18.5.How to Change Display/Sound Settings ............................. 74

18.6.How to Change the Clock Settings ..................................... 76

18.7.How to Change Settings for Storing .................................... 77

18.8.Returning to the Default Settings ........................................ 78

18.9.Registering Hospital Name ................................................. 79

18.10.Memory Card ..................................................................... 80

18.11.Keyboard ............................................................................ 82

19. Calibration Measurement .......................................................... 83

19.1.How to Execute a Test Measurement ................................. 83

20. Introduction to Troubleshooting .............................................. 85

21. Error List .................................................................................... 86

22. Specifications ............................................................................ 92

1.Indications

1. 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 17-42 cm, 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. 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.

2.Exemptions

2. Exemptions

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 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 lightening.

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

2.We have thoroughly reviewed the contents of this lnstruction 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 lnstruction Manual without obtaining OMRON’s

permission. Unless this lnstruction Manual is used by an individual (company), it cannot be

used without getting OMRON’s permission from the standpoint of the Copyright Law.

3.Notes on Safety

3. Notes on Safety

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 suffer death or serious injury resulting from

incorrect use.

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

incorrect use.

3.Notes on Safety

Warning:

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 300 mmHg. If

this safety mechanism fails or pressurization fails to stop while measuring, disconnect the AI

pulse wave sensor unit or cuff, or unplug the 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 cannot 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 or pin receptacle.

•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 dust off 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. Ensure that all the warnings and notes are also understood on those devices

before using.

•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.

•If there is smoke or an unusual order.

•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.

3.Notes on Safety

•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.

•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.

•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.

•Apply the pulse wave sensor on bare skin.

•Pulse waves might not be detected, and unnecessary pressure might be applied on the

pulse wave sensor.

•The user might be injured.

Device Maintenance

•After using the unit or cleaning, do not plug the power cord into a mains 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.

3.Notes on Safety

Caution:

Clinical

•When results seems unreliable, 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 a

condition similar 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.

•Erroneous results may occur.

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

•It may cause damage to the AI pulse wave sensor or pressure air bag might result.

•Do not place this device upside down.

•Electric parts and mechanical parts might break down.

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.

•It may cause 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 use a cellular phone or a radio transceiver in the room where this device is located.

•Malfunction might result.

•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.

3.Notes on Safety

•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.

•Do not put anything on this device.

•The printer cover might crack.

•Do not install or store this unit near water or liquid medication.

•Electric parts might break down.

•A patient might receive an electric shock.

•Do not slide the pulse wave sensor when the power supply is off.

•The pulse wave sensor might be damaged.

•Attach the Pulse Wave Sensor Unit properly. (Refer to Section 9.2.)

•The device might display an inaccurate measurement result.

•Apply the Blood Pressure Cuff properly. (Refer to Section 9.1.)

•The device might display an inaccurate measurement result.

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.

•Turn off and unplug the main connector when installing/removing parts or performing

maintenance.

•Electric shock or injury might result.

•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.

•Do not disinfect this device by autoclave or gas sterilization.

•Damage might result.

•The user might get a rash.

•Do not wash with water or immerse in water.

•Damage might result.

•The device may display an inaccurate measurement result.

•Do not slide the AI pulse wave sensor when the power supply is off.

•It may cause damage to the AI pulse wave sensor.

•Be sure to inspect the unit on regular basis. Check accuracy on a 1 year interval.

Shipping

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

instructions.

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