Omron M24-7 User Manual

Instruction Manual

M24/7 Ambulatory Blood Pressure Monitor

www.omron-healthcare.com

Introduction

Thank you for purchasing the OMRON M24/7 ambulatory blood pressure monitor.

The OMRON M24/7 is a silent, compact and very reliable ambulatory blood pressure monitor. A large LCD screen insures easy readability and its lightweight design provides for maximum patient comfort. The OMRON M24/7 operates with two 1.5V AA batteries (included in the package) or two 1.2V AA rechargeable batteries. The device can store more than 400 automatic readings along with approximately 200 manual measurements and events in its solid-state memory for an unlimited length of time. Extra measurements can be triggered, and events can be marked manually. The device can be adjusted to the patient’s lifestyle with a push of the DAY/NIGHT button. It provides a voltage display function to show the status of the batteries ensures that fresh batteries or properly charged batteries are used for the monitoring period. The OMRON M24/7 is quiet and equipped with multiple patient safety functions. It can be connected to practically any standard PC with its optical USB interface cable. The user-friendly software provides  exible programming as well as comprehensive analysis, presentation and reporting functions. The OMRON M24/7 has been clinically validated. Quality, safety and reliability of the product are demonstrated by its CE mark.

Content

Introduction ........................................................................................................2

Important Safety Information ...........................................................................4

Recommended use of ambulatory blood pressure monitoring ....................6

1. Overview .....................................................................................................7

1.1. Main Unit......................................................................................................7

1.2. Arm Cuffs .....................................................................................................7

1.3. Display .........................................................................................................8

1.4. Package Contents ......................................................................................8

2. Operating Instructions ..............................................................................9

2.1. Working with the OMRON M24/7 Unit .........................................................9

2.2. Using the Buttons ........................................................................................9

2.3. Overview Display ....................................................................................... 11

2.4. Rules of Monitoring ....................................................................................12

2.5. Monitoring Step by Step ............................................................................12

2.6. Manual Programming ................................................................................14

2.7. Batteries.....................................................................................................15

2.8. Cuffs and their application ......................................................................... 16

3. Care and Maintenance.............................................................................17

3.1. Handling Errors and Problems...................................................................17

3.2. Protection, cleaning and washing ..............................................................18

3.3. Maintenance and Storage Conditions........................................................ 19

3.4. Correct Disposal of this Product ................................................................19

3.5. Accessories ...............................................................................................19

4. Technical Data ..........................................................................................20

4.1. Technical parameters.................................................................................20

4.2. Safety Concerns ........................................................................................21

4.3. EMC Information ........................................................................................22

Patient Diary.....................................................................................................26

4.4. Product Warranty Information ....................................................................27

Important Safety Information

This symbol on the Omron M24/7 monitor is a warning that you should read the accompanying documentation (this manual).

Warning:

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. The ambulatory blood pressure monitor should not be used if any of the following cases apply:

• patients without an indication for ambulatory blood pressure monitoring

• non-cooperative patients

• patients in any way unable to operate a monitor as intended

• patients requiring urgent / emergency cardiac care

• unconscious or otherwise incapable patients

• patients with serious mobility impairments without supervision

• patients with coagulation disturbances

• children without supervision

• children under the age of 8 years

Though the blood pressure measurement algorithm used in the OMRON M24/7 has been tested and found to function properly on patients with atrial  brillation or other common arrhythmias, the oscillometric blood pressure measurement method is generally recommended for use only with special caution in patients with arrhythmias, Parkinson’s disease, or other diseases with tremor.

Always consult a physician for the interpretation of the blood pressure measurements. Note that any blood pressure recording may be affected by the body position, the physiological condition of the patient, and other factors.

Take care to avoid blocking the air  ow in the tube of the cuff and twisting the tube. Make sure the cuff and its tubing do not cause strangulation or a circulation problem. Should the patient experience arm numbness or pain remaining after any blood pressure reading is completed, the cuff should be removed to avoid permanent vascular or neural injury.

Caution:

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property.

(General Usage) No user serviceable parts inside. The OMRON M24/7 monitor

contains high complexity electronic and  ne mechanical components. If you have any problems, please refer your monitor to quali ed service personnel.

OMRON M24/7 described in this manual complies with the requirements of the EU Medical Devices Directive (93/42 EEC). 0120 is the identi er of Noti ed Body (SGS UK)

MDD

IIa

YYYY/nnnnnn

MDD classi cation IIa. EMC class B. EMC group 1.

The  rst four digits of the serial number of a monitor show the year of production. The rest is the serial number.

This symbol shows that according to regulations OMRON M24/7 should be handled as electronic waste during disposal.

Classi cation of Applied Parts - Type CF

Recommended use of ambulatory blood pressure monitoring

The European Society of Hypertension has published recommendations for ambulatory blood pressure measurement (O’Brien, E. et al. on Behalf of the European Society of Hypertension Working Group on Blood Pressure Monitoring, European Society of Hypertension recommendations for conventional, ambulatory and home blood pressure measurement, Journal of Hypertension 2003, 21: 821-848). Ambulatory blood pressure monitoring can bene t patients with in many situations.

Indications

• Suspected white-coat hypertension

• Suspected nocturnal hypertension

• To establish dipper status

• Resistant hypertension

• Elderly patient

• As a guide to antihypertensive drug treatment

• Type 1 diabetes

• Hypertension of pregnancy

• Evaluation of hypotension

• Autonomic failure

On the contrary, ambulatory blood pressure monitoring should be avoided in several situations.

Contraindications

• Non-cooperative patients, unconscious or otherwise incapable patients

• Patients requiring urgent / emergency cardiac care

• Patients with coagulation disturbances

• Patients with serious mobility or other impairments without supervision

• Children without supervision; children younger than 8 years

• Though the blood pressure measurement algorithm used in the

OMRON M24/7 has been found to function properly on patients with atrial  brillation or other common arrhythmias, the oscillometric blood pressure measurement method is generally recommended for use only with special caution in patients with arrhythmias, Parkinson’s disease, or other diseases with tremors.

1. Overview

1.1. Main Unit

Front side Back side

LCD

START button

EVENT button

DAY/NIGHT button

CUFF connection

Interface connection

CUFF connection

1.2. Arm Cuffs

The set contains 2 adult cuffs: normal size (24-32cm) and large size (32-42cm)

A. Arm Cuff B. Air Plug C. Air Tube

1.3. Display



Heart symbol for

pulse indication

Communication

with PC

Time display

Battery voltage

display

Night mode: moon

sign is lit

Crossed battery

symbol warns

symbol warns about low battery

about low battery

For details of different display options see p. 11

1.4. Package Contents

one (1) OMRON M24/7 monitor unit one (1) optical USB cable one (1) carry pouch for monitor, with shoulder and waist straps one (1) normal size neoprene cuff (latex-free, hand washable sleeve) one (1) large size neoprene cuff (latex-free, hand washable sleeve) four (4) 1.5V AA alkaline batteries (LR6) one (1) OMRON BP Tracker Software CD-Rom or DVD including all

manuals one (1) M24/7 Instruction Manual one (1) BP Tracker Software Instruction Manual

Important Note:

Doctor’s Quick Guide and Patient’s Quick Guide ONLY available on the CD-Rom Declaration of Conformity – to obtain a copy please contact your local OMRON Distributor.

incl. template for patient diary

2. Operating Instructions

2.1. Working with the OMRON M24/7 Unit

The OMRON M24/7 device is a compact, lightweight monitoring unit typically worn by the patient for 24 hours. The OMRON M24/7 operates with two AA size batteries. The memory is capable of storing more than 600 measurements. Stepwise pressure de ation ensures quality measurements, even if disturbing environmental factors occur. You may  nd the battery compartment and the rating label on the backside housing. The serial number is placed on the rating label, however it is also stored electronically in the solid state memory of the device. On the front side of the housing, there is the LCD, the buttons of the device and the name of the device. The device can be connected to the USB port of a PC with an optoelectronic interface. The device has its socket positioned on the opposite side from the cuff connector. Patients can start extra blood pressure readings or mark symptomatic events.

2.2. Using the Buttons

On the front side of the housing, below the LCD, you may  nd three buttons: the START button is marked with a triangle, the EVENT button marked by a heart and the DAY/NIGHT button indicated by a crescent moon. If the device is turned on, then every button press is accompanied by a short beeping sound.

START button

EVENT button

DAY/NIGHT button

Cancel a blood pressure measurement

The patient can interrupt a blood pressure measurement by pressing a button at any time while the cuff is in ated. This will result in immediate fast cuff de ation. Such interruption is limited to the measurement in progress only and has no effect on further operation. This function is available with all three buttons. Use this function only if the cuff is hurting the patient’s arm.

Manual blood pressure measurement

If it seems necessary, the patient can start an additional, manual blood pressure measurement by pressing the START button for less than 3 seconds. The result with a manual measurement marker will be stored in the memory of the device. Typical causes for this use: dizziness, palpitations (angina pectoris or headache).

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