Omron M24 User manual

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Instruction Manual
M24/7 Ambulatory Blood Pressure Monitor
www.omron-healthcare.com
EN
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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.
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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
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Important Safety Information
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.
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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
MDD classication IIa. EMC class B. EMC group 1.
YYYY/nnnnnn 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
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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.
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1. Overview
1.1. Main Unit
Front side Back side
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
CUFF
connection
Interface
connection
START
button
CUFF
connection
DAY/NIGHT
button
LCD
EVENT button
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1.3. Display

Communication
with PC
Heart symbol for
pulse indication
Night mode: moon
sign is lit
Crossed battery
symbol warns
about low battery
Time display
Battery voltage
display
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 incl. template for patient diary
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.
Heart symbol for
pulse indication
Communication
with PC
Night mode: moon
sign is lit
Crossed battery
symbol warns
about low battery
Time display
Battery voltage
display
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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.
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).
START
button
DAY/NIGHT
button
EVENT button
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Switching the device off
Press and hold the START button for more than 10 seconds then release it when
two horizontal segments appear on the LCD, this way the OMRON M24/7 will be
switched off. If you do not release the button in 2 seconds after the two horizontal
segments appeared, the monitor will return to normal operation. This feature helps
to avoid unintended power-off. The device can only be switched on manually.
While the monitor is switched off normal functions are not available, even
prescheduled measurements will not be triggered. Therefore, only in case
of a valid reason should the device be switched off.
Switching the device on
The OMRON M24/7 is switched on to normal operation if the START button is
pressed and held for more than 3 seconds. If the device is switched off, no other
functions are available.
LCD check
Press and hold the START button 3 to 5 seconds to light up all segments of the
LCD to check if they all work correctly.

Battery voltage check
Press and hold the START button for more than 5 seconds to display battery
voltage on the LCD (e.g. 2_37, equal to 2.37 V, see example). After checking
the voltage, please release the button, because after additional 5 seconds, the
device may turn off. The unit will then return to displaying time. The voltage for
fresh alkaline batteries should be over 3 V and for fully charged accumulators
over 2.5 V.

Set a patient event marker
The patient can mark any event without starting a manual blood pressure
measurement by pressing the EVENT button briey. A typical causes for this
use is taking medicine. The patient should be instructed to record the reason for
setting an event marker in a diary (see Patient’s Quick Guide and template for
patient diary at the end of this user manual).
Mark time of going to bed and rising from bed
If the DAY/NIGHT shift function is disabled during programming, the patient can
press the DAY/NIGHT button to mark the time of going to bed (in the evening)
and rising from bed (in the morning).
Manual DAY/NIGHT shift
If this function is enabled during the programming, then the patient can manually
shift the measurement frequency period (day or night) by pressing the DAY/NIGHT
button. The shift is available in the two hour period before the prescheduled shift.
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