Omron Blood Pressure Monitor M24 7 User Manual

Instruction Manual  
M24/7 Ambulatory Blood Pressure Monitor  
EN  
 
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  
3
 
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.  
4
 
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 qualiꢁed 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 identiꢁer of Notiꢁed Body (SGS UK)  
MDD  
IIa  
MDD classiꢁcation 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.  
YYYY/nnnnnn  
This symbol shows that according to regulations OMRON M24/7  
should be handled as electronic waste during disposal.  
Classiꢁcation of Applied Parts - Type CF  
5
 
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 beneꢁt 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.  
6
 
1. Overview  
1.1. Main Unit  
Front side  
Back side  
LCD  
START  
button  
EVENT button  
DAY/NIGHT  
button  
Interface  
connection  
CUFF  
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  
7
 
1.3. Display  
Time display  
Night mode: moon  
sign is lit  
Heart symbol for  
pulse indication  
Crossedbattery
symbol warns  
about low battery
Communication  
with PC  
Battery voltage  
display  
For details of different display options see p. 11  
1.4. Package Contents  
one (1)  
one (1)  
one (1)  
one (1)  
one (1)  
four (4)  
one (1)  
OMRON M24/7 monitor unit  
optical USB cable  
carry pouch for monitor, with shoulder and waist straps  
normal size neoprene cuff (latex-free, hand washable sleeve)  
large size neoprene cuff (latex-free, hand washable sleeve)  
1.5V AA alkaline batteries (LR6)  
OMRON BP Tracker Software CD-Rom or DVD including all  
manuals  
M24/7 Instruction Manual incl. template for patient diary  
BP Tracker Software Instruction Manual  
one (1)  
one (1)  
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.  
8
 
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 deꢀation 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 inꢀated. This will result in immediate fast cuff deꢀation.  
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).  
9
 
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 brieꢀy. 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.  
10  
 
2.3. Overview Display  
TheOMRONM24/7showsimportantstatusinformation, theprocessesandresults  
of individual readings on its LCD. The most important displays are listed here. In  
addition to these, a lot of extraordinary situations and errors have their own code  
displayed on the LCD. These codes are stored together with recorded data and  
listed in the OMRON BP Tracker Software. This helps service personnel in case  
of support issues.  
Normal status: time is  
displayed. Automatically  
set by PC  
Night mode: time is  
displayed, moon sign is lit  
Blood pressure  
measurement initiated.  
[mmHg]  
Blood pressure  
measurement initiated.  
[kPa]  
Pumping for measurement,  
current pressure is  
displayed [mmHg]  
Pumping for measurement,  
current pressure is  
displayed [kPa]  
Heart symbol blinking:  
measurement in progress.  
[mmHg]  
Heart symbol blinking:  
measurement in progress.  
[kPa]  
Deꢀation during  
measurement, current  
pressure displayed[mmHg]  
Deꢀation during  
measurement, current  
pressure displayed [kPa]  
Systolic value of just  
completed measurement  
[mmHg]  
Systolic value of just  
completed measurement  
[19,2 kPa]  
Diastolic value of just  
completed measurement  
[mmHg]  
Diastolic value of just  
completed measurement  
[12,3 kPa]  
Pulse rate value of just  
completed measurement  
[beats per minute]  
Blood pressure  
measurement cancelled by  
pressing a button  
Event marker set due to  
button push  
The crossed battery symbol  
warns about low battery  
Communication with  
personal computer  
Battery voltage display  
(2.37 V)  
Error code display  
LCD check: all segments  
are displayed  
The monitor is switched off  
11  
 
The monitor must be programmed with the OMRON BP Tracker Software  
installed on the computer (for details see Software Manual). Once the pre-  
programmed time is reached, the monitor will start operating automatically and  
perform blood pressure measurements based on the monitoring plan. To obtain  
reliable BP readings, certain rules must be observed.  
2.4. Rules of Monitoring  
1. Inform the patient about the goal and expected results of the monitoring.  
Provide an event/patient diary and rules to observe. The Patient’s Quick  
Guide will help the patient to remember what has been discussed with you.  
The Patient’s Quick Guide can be given to the patient. It also includes a  
patient diary. This can be found at the end of this user manual, electronic  
versions are available on the CD-ROM or DVD.  
2. Patients can ꢁt the unit comfortably with the adjustable straps of the carry  
pouch.  
3. It is advisable to wear a thin shirt under the ABP cuff. This does not inꢀuence  
the accuracy of blood pressure measurement, but it prevents problems  
caused by long-time wear of the cuff (sweat, itching, soreness, etc.).  
4. The cuff should be properly placed and connected.  
5. Patientsshouldavoidexcessmovementduringbloodpressuremeasurements.  
They should hold their arm loose, slightly away from their chest.  
6. Should the blood pressure measurements cause blood shots, torpidity or  
pain in the hand, the cuff should be removed from the arm immediately and  
disconnected from the monitor. Such occurrence should be reported to the  
physician as soon as possible or at the latest after the monitoring session.  
7. Patients should not remove the monitor even at night. By loosening the straps,  
they can avoid problems when turning in their sleep. The monitor does not  
disturb most patients at night.  
8. Patients may start extra blood pressure measurements with the START  
button of the OMRON M24/7 monitor, marked with a triangle. They should  
mark events such as taking medication with the EVENT button, marked with  
a heart. They should also mark the time of going to bed and rising from bed,  
with the DAY/NIGHT button marked with a crescent moon. They may interrupt  
any single blood pressure measurement if necessary by pressing any button.  
9. Should the batteries run down during a monitoring session, they can be simply  
replaced. Monitoring will continue, and data will not be lost.  
10. Patients should never measure anybody else’s blood pressure with an  
OMRON M24/7 during an ambulatory blood pressure monitoring session.  
2.5. Monitoring Step by Step  
Before you begin, you must have the OMRON BP Tracker Software properly  
installed and conꢁgured on your computer, and the monitor correctly connected  
(for details see Software Manual). To program your monitor, you will need the  
optical interface cable which is included in the set properly connected to your  
computer’s USB port and the communication port (USB) correctly selected in  
the OMRON BP Tracker Software.  
12  
 
A successful monitoring session consists of the following steps:  
1. Connecting the OMRON M24/7 monitor to the PC (First connection only  
– not required to repeat with each session)  
1. Connect the optical interface, which was delivered with the device, to the  
USB port of the PC.  
2. The other side of the optical USB interface cable, which is a two-point  
plastic connection, should be connected to the socket of the OMRON  
M24/7, in a way that the red plastic ring is directed to the lower side of the  
device.  
3. Start the OMRON BP Tracker Software and open the Options menu, then  
click on the Communication tab on the left side of the screen.  
4. On the appearing window, click on the USB option. Please connect the  
device to the PC (fresh/charged batteries, device switched on) as noted  
above then click on the Test button. Upon successful communication the  
software will display the serial number and the ꢁrmware version of the  
device.  
2. Preparation of Monitoring Session  
1.  
2.  
Inform your patient about the monitoring rules well in advance.  
Programming the measurement plan into the device:  
Using PC: start the OMRON BP Tracker Software program  
Optionally the device can be programmed without using a PC, for  
details see Manual Programming section.  
3.  
4.  
5.  
Enter new patient data or select patient from the database.  
Create a monitoring plan with respect to the patient’s lifestyle.  
Insert two fresh or fully charged, AA size batteries into the battery  
compartment and check their voltage.  
6.  
7.  
8.  
9.  
Connect the monitor to the computer.  
Send the monitoring plan from the computer to the monitor unit.  
Apply the cuff to the patient with the device placed in the carry pouch.  
Give the Patient’s Quick Guide to the patient along with detailed  
instructions about the rules and the usage of the device.  
3. Evaluation  
1. Remove the unit and cuff from the patient on his/her return.  
2. Ask for the Patient’s Quick Guide /patient diary, and ask the patient  
for any events, symptoms, observations or complaints.  
3. Start the OMRON BP Tracker Software  
4. Connect the device to the PC and then transfer collected data from  
the monitor to your database.  
5. Analyze the blood pressure proꢁle.  
6. Create and print a report.  
13  
 
2.6. Manual Programming  
The OMRON M24/7 can be programmed with using its buttons, without using a  
PC.  
Programming Options  
There are three different measurement plans which may be selected in case  
of manual programming. These plans are stored in the device’s inside memory  
and they cannot be changed. The ꢁrst plan which is also the default one in  
the OMRON BP Tracker Software, measurements every 15 minutes during  
daytime and 30 minutes during night. The second one provides less frequent  
measurements with 20 and 40 minutes respectively. The third version is based on  
30 minute measurement intervals, independent of the time of day.  
Other settings are the same in case of all three plans: cuff size not set, pressure  
limit 300 mmHg, enabled LCD display and disabled day/night shift. Daytime starts  
at 6:00, night time starts at 22:00, special session is disabled. Measurement  
period is exactly 24 hours.  
Measurement Timing  
The ꢁrst measurement has a controlling purpose and it starts in the second  
minute after the programming, then in the next ꢁve minutes there are no  
measurements. The rest of the measurements are taken at speciꢁc 15/20/30/40  
minute intervals and there are measurements at the 6:00 and 22:00 hour shifts.  
The last measurement is exactly 24 hours after the second measurement. Patient  
information can be selected or added later in the OMRON BP Tracker Software.  
Manual Programming Step by Step  
1. Push the measurement (triangle) and the day/night shift (moon) buttons  
simultaneously.  
2. Keep them pushed, in 10 seconds the measurement options will be  
displayed for 3 seconds each along with the measurement frequencies.  
Then the clock will be displayed.  
3. In order to choose the measurement plan, you must release the buttons  
while that plan is displayed. You will hear two beeps and the LCD will display  
four blinking “o” (oooo for four seconds). The process of programming  
takes approximately four seconds, then you will hear ꢁve beeps. For  
ꢁve seconds, the chosen plan will be displayed again for conꢁrmation. If  
programming fails for some reason, the E90 error code will be displayed  
on the LCD.  
In case of manual programming there is no time setting, as the PC would be  
responsible for time synchronizing. If the time setting is imprecise then the time  
of measurements may be false. If you would like to use the manual programming  
function then do not leave the device without batteries for a longer period. If  
you do so then program the device with the PC once and then leave the batteries  
in it, so the time can be set by the PC.  
14  
 
Software  
The OMROM M24/7 programmed manually can be used with the OMRON BP  
Tracker Software version 1.14.6 or newer.  
Manual programming LCD displays:  
Normal status: time is  
displayed  
10 second delay state: time  
is displayed but with no  
double-dot  
1. measurement plan:  
15/30 minute day/night  
intervals  
2. measurement plan:  
20/40 minute day/night  
intervals  
3. measurement plan:  
30/30 minute day/night  
intervals  
Programming in progress:  
blinking signal  
2.7. Batteries  
The OMRON M24/7 ambulatory blood pressure monitor operates with two 1.5V  
AA batteries or two 1.2V AA rechargeable batteries. Use only standard long-  
life (alkaline) batteries, or standard NiCd or NiMH rechargeable batteries of the  
proper size. Do not use lithium batteries. Do not mix different battery types, do not  
mix new and old batteries. Never use batteries of low or unknown quality or pre-  
used batteries, as they may not cover the power needs of the monitor, and they  
may damage the monitor, as they may contain acidic electrolytes which may leak  
and corrode electronic components. Never use batteries damaged in any way.  
Should the batteries run down during a monitoring session, they can be replaced.  
Monitoring will continue and data will not be lost. If you do not use the monitor, it is  
advisable to remove batteries since they may run down due to the constant small  
power consumption of the integrated circuits of the device. Data in the monitor  
are not lost even if batteries run down or are removed. Used batteries may fall  
under the category of hazardous waste and should be disposed of properly.  
Important!Itisstronglyrecommendedtousefreshlychargedaccumulatorsornew  
batteries with every patient so that batteries do not run down during monitoring,  
even in case of very high blood pressure values and/or a long monitoring session.  
After inserting batteries in M24/7monitors, it is advised to check their voltage  
before programming the monitors. Do not start a new monitoring session with  
low batteries. The typical voltage for two fully charged rechargeable batteries  
should be over 2,5 V, and for fresh alkaline batteries, over 3 V. It is possible  
to check battery voltage with the START button. (Please check the Using the  
buttons section for more details.)  
Important! If a monitor is not used for a long period, the in-built backup cell  
ensuring the operation of the internal clock may get discharged. In this case keep  
freshly charged batteries in the monitor for at least one day; this will recharge the  
backup cell. It is possible to use the monitor afterwards. If the backup cell is not  
properly charged, the internal clock may work incorrectly, and the monitor may  
not start measurements in due time.  
A set of new, high capacity batteries will enable the OMRON M24/7 monitor to  
perform 250 blood pressure measurements during a 24-48 hours long monitoring  
session. If you opt to use alkaline batteries, choose high capacity, long-life  
products to enable reliable operation. A small crossed battery sign on the LCD  
shows low battery voltage.  
15  
 
In order to change batteries, take the monitor out of the holder carry pouch and  
remove the battery compartment cover on the back-side. Place two new, long-  
life AA alkaline batteries or two properly charged, high capacity AA rechargeable  
batteries into the compartment as shown in the polarity drawing. Close the  
compartment.  
2.8. Cuffs and their application  
The OMRON M24/7 comes with 2 cuffs, normal and large adult size (see below).  
The bladders are made of neoprene and are latex-free. It is advisable to wear a  
thin shirt or blouse under the cuff. This does not inꢀuence the accuracy of blood  
pressure measurements but it prevents possible problems caused by long-time  
wear (sweating, itching, etc.). Place the cuff on the upper arm so that the  
rubber tube points towards the patient’s shoulder and the bladder is placed  
above the brachial artery, if possible. Contrary to the usual placement with  
the tube pointing downwards, the advantage is that the patient can wear a loose  
jacket over the cuff. Connect the rubber tube of the cuff into the air plug connector,  
which you can ꢁnd on the long edge closer to the buttons of the OMRON M24/7  
monitor. Connect the cuff turning it clockwise with slight pressure.  
16  
 
Note: It is recommended that the cuff be applied as tightly as acceptable for the  
patient. A too loose cuff will cause much longer blood pressure measurement  
times and possibly aborted measurements. With an overly loose cuff, the  
monitor must pump to tighten the cuff on the arm and then it must reach the  
pressure necessary for measurement. This causes considerable inconvenience  
for the patient and results in less data for evaluation. If the patient removes  
the cuff for a period during the monitoring session, it should be re-applied  
with appropriate tightness, with help from another person, if necessary. Should  
blood pressure measurements cause blood shots, torpidity or pain in the hand  
after an individual measurement, the cuff should be removed from the arm and  
disconnected from the monitor. Such occurrence should be reported to the  
physician at once after the monitoring session.  
OMRON M24/7 recognizes and functions with three different cuff sizes. Please  
set the appropriate cuff size to be used during the programming of the device.  
Attention: inappropriate setting of the cuff size may lead to device malfunctioning,  
whichisinconvenientforthepatientandmayleadtoanunsuccessfulmeasurement.  
Name  
Bladder  
dimensions  
Sleeve  
dimensions  
Arm circumference  
range*  
Small cuff (child)  
Normal cuff  
9 x 18 cm  
12 x 25 cm  
15 x 33 cm  
11 x 32 cm  
15 x 56 cm  
17 x 77 cm  
under 24 cm  
24-32 cm  
Large cuff  
32-42 cm  
* When properly applied, the end of the sleeve (the one closer to the tube) should  
fall in the indicated range.  
The cuff is the component which, by deꢁnition of the relevant standard, is  
protected against a deꢁbrillator discharge.  
Caution!  
Substitution of a cuff different from that supplied might result in measurement  
error and/or in certain cases cause damage to the main monitor unit.  
3. Care and Maintenance  
3.1. Handling Errors and Problems  
Below you can ꢁnd a list of potential error code displays, their meaning and a  
description of the error code.  
Unsuccessful measurements  
E 1 aborted measurement  
the measurement timeout is over, the  
measurement had to be aborted (the  
patient was moving)  
the measurement was stopped by pressing  
a button (the display differs from others:  
“OFF” on the LCD)  
E 2 (Off) manually interrupted  
17  
 
E 3 battery rundown  
the AA batteries exhausted during  
measurement  
E 4 batteries changed  
E 8 pressure limit exceeded  
E 9 temporary disturbance  
the AA batteries were replaced during the  
measurement – not shown on LCD  
the pressure in the pneumatic system  
exceeded the preset pressure limit  
external electric signals (e.g., static  
discharge) disturbed the operation of the  
device  
Cuff related errors  
E 31  
cuff missing or loose; there was no cuff  
connected to the device; maybe the cuff is  
too loose on the patient’s arm  
E 32  
E 33  
cuff tubbing clogged; the cuff is clogged or  
the rubber tube is broken  
device or cuff leakage or cuff is loose.  
There is a hole in the cuff or it is very loose  
on the patient’s arm  
E 34  
cuff not on patient’s arm or not connected  
Faulty device  
E 90  
device error: the device could not measure  
due to a hardware error  
device error: the device could not measure  
E 99  
3.2. Protection, cleaning and washing  
OMRON M24/7 ambulatory blood pressure monitors are not specially protected  
against spills or ingression of water or other liquids. Do not immerse the monitor  
in water or any cleaning ꢀuid, and protect it from spills and splashes. Do not  
expose it to heavy rain or steam, and do not wear it in a wet environment  
e.g: shower, bath, or swimming pool. In case of the minor effects of a wet  
environment, wipe off water drops with a dry cloth. Keep the monitor in a normal  
dry room for at least one hour before use if condensation is suspected. In case  
of ingress of water in the monitor, remove batteries from the unit, and refer  
the unit to authorized service. Never place a monitor unit in a disinfecting or  
sterilizing machine! Recommended cleaning method is to wipe the monitor with  
a disinfectant cleaning tissue, e.g., Henkel Ecolab Incides, or a similar product.  
Alternatively, wipe with a slightly damp cloth then dry it with an antistatic tissue.  
Do not expose monitors to extreme heat or radiation, including long exposure to  
direct strong sunlight.  
To wash the cuff please do the following:  
1. Remove the bladder.  
2. Wash by hand the sleeve with lukewarm water and regular washing liquid  
suitable for black material. Rinse well.  
3. If required, wipe the bladder with a disinfectant cleaning tissue.  
4. Allow both bladder and sleeve to air dry.  
5. Replace bladder in the sleeve.  
18  
 
3.3. Maintenance and Storage Conditions  
Temperature: -20 - 50 °C  
Humidity: 10 - 95 %, non condensing  
Regular checks, warranty, service  
Veriꢁcation of pressure measurement accuracy is recommended biannually.  
OMRON M24/7 monitors are covered by a two-year warranty. This warranty  
does not cover any malfunction or defects arising from improper use, the use of  
inadequate accessories, accident, theft, or use of the device outside operating  
environmental speciꢁcations or intended measurement range. Removing the  
closing label from the back side of the device voids this warranty. There are no  
user serviceable parts inside the OMRON M24/7 monitors; they contain high  
complexity electronic and ꢁne mechanical components. If you have any problems,  
please refer the monitor to qualiꢁed service personnel. All consequences of  
improper servicing are the sole responsibility of the user. Contact OMRON or  
your distributor for service information.  
3.4. Correct Disposal of this Product  
OMRON M24/7 should be disposed of according to your local regulations for  
disposal of hazardous waste.  
3.5. Accessories  
Art. Nr.  
Product Description  
M24/7 cuff, small, neoprene, white plug  
M24/7 cuff, normal, neoprene, white plug  
M24/7 cuff, large, neoprene, white plug  
M24/7 cuff, Extra large, neoprene, white plug  
M24/7 sleeve, small  
BP4-A012-NP  
BP4-A010-NP  
BP4-A011-NP  
BP4-A011-LNP  
GPC-A015  
GPC-A013  
M24/7 sleeve, normal  
GPC-A014  
M24/7 sleeve, large  
GPC-A001  
M24/7 carry pouch  
19  
 
4. Technical Data  
4.1. Technical parameters  
Power supply:  
Blood pressure maximum storage:  
over 400 automatic measurements  
Pressure measurement range:  
0-300 mmHg  
2 AA rechargeable NiCd or NiMH  
batteries or 2 AA alkaline batteries  
Display:  
liquid-crystal  
0-40 kPa*  
Data storage:  
Static accuracy:  
internal solid state memory  
3 mmHg or 0,4 kPa or 2% of  
measured value (stability: 2 years)  
Data transmission:  
USB optical cable  
PC interface:  
USB interface  
Blood pressure measurement range  
indication:  
30-260 mmHg  
4-35 kPa*  
Pulse rate measurement range:  
40-200 beat per minute  
Blood pressure measurement accuracy:  
The OMRON M24/7 has been clinically  
validated  
Pressure sensor:  
piezo-resistive  
Operating environment:  
Temperature: 10 - 45 °C  
Humidity: 10 - 95 %, non condensing  
Atmospheric pressure: 70 - 106 kPa  
Storage conditions:  
Temperature: -20 - 50 °C  
Humidity: 10 - 95 %, non condensing  
Size (H x W x D):  
70 x 99 x 30 mm  
Inꢀation:  
automatically controlled pump  
Weight:  
Safety:  
app. 240 g (batteries included)  
maximum inꢀation 300 mmHg  
(40 kPa*);  
Blood pressure measurement method:  
oscillometric  
independent safety release valve  
Deꢀation and rapid air release:  
automatic pressure release valve  
Please note that the OMRON M24/7 might not meet its performance speciꢁcations  
if stored or used outside the speciꢁed environmental conditions.  
*Measuring and LCD displaying in kPa values is an option which can be selected  
in the OMRON BP Tracker Software. The unit of measurement can be changed  
later in the database.  
For information on cuffs and their application, see 2.8.  
This symbol shows that according to regulations OMRON M24/7  
should be handled as electronic waste during disposal.  
Blood pressure measurements determined with the algorithm  
of an OMRON M24/7 monitor on adults are equivalent to those  
obtained by a trained observer using the cuff/stethoscope  
auscultation method Korotkoff phase V, within the limits prescribed  
by the American National Standard for Electronic or Automated  
Sphygmomanometers. The algorithm used in the OMRON M24/7  
also fulꢁls the requirements of the British Hypertension Society  
Validation Protocol for Automated Blood Pressure Measuring  
Devices.  
20  
 
4.2. Safety Concerns  
Electric shock hazard protection  
OMRON M24/7 monitors meet relevant shock hazard protection standards.  
OMRON M24/7 monitors operate with two 1.5V AA batteries or two 1.2V AA  
rechargeable batteries. This excludes all electric shock hazards, even in the  
unlikely case of multiple device errors. Use only standard long-life (alkaline)  
batteries, or standard NiCd or NiMH rechargeable batteries of the proper size.  
Do not use lithium batteries. Do not mix different battery types, do not mix new  
and old batteries, do not use damaged batteries.  
Many personal computers do not meet certain shock hazard protection standards  
or strict safety regulations applicable to medical devices. Therefore, during the  
computer-based use of OMRON monitors, keep at least a 2 meter distance  
between patient and computer. This is the required minimum safety distance.  
OMRON M24/7 monitors communicate using a plastic optical cable, whose 4 m  
standard length allows for the required safety distance. The plastic optical cable  
ensures perfect electric separation and reduces the effects of external electric  
noise. It does not conduct electricity.  
Biocompatibility  
To avoid infection risks, and for general hygienic reasons, the device, cuff and  
tubing should never contact the patient’s skin directly.  
Hazardous materials  
Used batteries qualify as hazardous waste and should be disposed of properly.  
OMRON monitors do not contain any materials qualiꢁed as pharmaceutical  
substance or tissue of animal origin. They emit no material hazardous to humans.  
Risk of incorrect diagnosis  
The basic intended use of OMRON M24/7 monitors is to record blood pressure  
and pulse rate values. Patients should be informed about rules of cooperative  
behaviour; proper handling of the monitor used, and expected results of  
monitoring in advance. OMRON M24/7 monitors only provide data to support  
diagnostic decisions of a qualiꢁed physician; they do not automatically provide a  
diagnosis of any kind. During the evaluation of recorded blood pressure values,  
possible artefacts due to external disturbances, motion artefacts, and electrical  
noise should be observed and handled with caution.  
21  
 
4.3. EMC Information  
Medical electrical equipment should be used with precautions according to EMC,  
and must be installed according to the EMC notices disclosed in this manual as  
mobile RF transceivers could adversely affect it.  
Directive and declaration of manufacturer – Electromagnetic Emission  
The OMRON M24/7 is suitable for use in the speciꢁed electromagnetic environment. The  
purchaser or user of the OMRON M24/7 should assure that it is used in an electromagnetic  
environment as described below  
Emission test  
Compliance  
Electromagnetic Environment  
OMRON M24/7 uses RF energy only for its  
internal function. Therefore, the emission  
is very low and not likely to cause any  
interference in nearby electronic equipment.  
OMRON M24/7 is suitable for use in domestic  
establishments and in establishments directly  
connected to the low voltage power supply  
network which supplies buildings used for  
domestic purposes.  
Radiated and conducted Group 1  
RF emission  
CISPR 11  
Radiated and conducted Class B  
RF emission  
CISPR 11  
Harmonic emission  
Not applicable  
Not applicable  
---  
IEC61000-3-2  
Voltage ꢀuctuations /  
Flickers  
---  
IEC61000-3-3  
22  
 
Directive and declaration of manufacturer – Electromagnetic immunity  
OMRON M24/7 is suitable for use in the speciꢁed electromagnetic environment. The purchaser  
or user of OMRON M24/7 should assure that it is used in an electromagnetic environment as  
described below.  
Immunity test IEC60601-1-2 Compliance Electromagnetic  
test level  
level  
environment  
Electrostatic  
6KV contact  
8KV air  
Floors are wood, concrete or  
ceramic tile, or ꢀoors are covered  
with synthetic material and the  
relative humidity is at least 30  
percent.  
discharge (ESD)  
8KV air  
IEC 61000-4-2  
Electrical fast  
transient/burst  
2KV for power  
supply lines  
Not applicable  
Not applicable  
Not applicable  
Mains power quality is that of a  
typical commercial and/or hospital  
environment.  
IEC 61000-4-4  
1KV for input/  
output lines  
1KV differential  
mode  
Surge  
Mains power quality is that of a  
typical commercial and/or hospital  
environment.  
IEC 61000-4-5  
2KV common  
mode  
Voltage dips, short <5% U (>95%  
Mains power quality is that of  
a typical commercial and/or  
hospital environment. If the user of  
OMRON M24/7 requires CLINICAL  
UTILITY during power mains  
interruptions, it is recommended  
that parts of the OMRON M24/7  
system where applicable be  
powered from an uninterruptible  
power supply.  
interruptions and  
voltage variations  
on power supply  
input lines  
dip) forT0.5 cycle;  
40% UT (60% dip)  
for 5 cycles;  
70% UT (30% dip)  
for 25 cycles;  
IEC 61000-4-11  
<5% U (>95%  
dip) forT5 sec.  
Power frequency  
(50/60Hz) magnetic  
ꢁeld  
3A/m  
3A/m  
Power frequency magnetic ꢁelds  
are at levels characteristic of  
a typical location in a typical  
commercial and/or hospital  
environment.  
IEC 61000-4-8  
Note: UT is the nominal voltage of mains.  
23  
 
Directive and declaration of manufacturer – Electromagnetic immunity  
OMRON M24/7 is suitable for use in the speciꢁed electromagnetic environment. The  
purchaser or user of OMRON M24/7 should assure that it is used in an electromagnetic  
environment as described below.  
Immunity test IEC60601-1-2  
Compliance Electromagnetic  
level  
environment  
Conducted RF  
IEC 6100-4-6  
3Veff  
Not applicable Portable and mobile RF  
communications equipment  
150KHz - 80MHz  
are used no closer to any part  
of OMRON M24/7, including  
cables, than the Recommended  
Separation Distance calculated the  
formula written below.  
Recommended Separation  
distance:  
d=[3.5/V1]ꢂP  
d=[3.5/3V/m]ꢂP;  
(80MHz – 800MHz)  
Radiated RF  
3V/m  
3V/m  
IEC 61000-4-3  
80MHz – 2.5GHz  
d=[7/3V/m]ꢂP;  
(800MHz – 2.5GHz)  
where:  
P is the highest radiated power  
disclosed by the manufacturer of  
transmitter [W];  
d is the recommended separation  
distance [m].  
1. note: in case of frequency 80MHz or 800 MHz, the formula for the higher range is  
applicable.  
2. note: These are guidelines. Actual conditions may vary.  
24  
 
Recommended separation distance  
OMRON M24/7 is intended to be used in electromagnetic environment with controlled RF  
disturbances. The purchaser or user of M24/7may help to reduce electromagnetic disturbances  
by deꢁning the separation distance between the transportable or mobile RF telecommunication  
equipment (transmitters) and OMRON M24/7, depending on the highest output power of the  
telecommunication equipment.  
Separation distance in function of the frequency of the  
transmitter [m]  
The highest  
output  
150KHz –  
80MHz  
80MHz –  
800MHz  
800MHz – 2.5GHz  
d=[7/E1]P  
power of the  
d=[3.5/V1]ꢀP  
d=[3.5/E1]P  
transmitter [W]  
0.01  
0.1  
1
Not applicable  
0.12  
0.38  
1.2  
3.8  
12  
0.23  
0.73  
2.3  
7.3  
23  
Not applicable  
Not applicable  
Not applicable  
Not applicable  
10  
100  
If this table does not contain the highest output power of the transmitter, the d separation  
distance [m] can be calculated by the formula, depending on the frequency of the transmitter,  
where P is the rated highest output power of the transmitter [W].  
1. note: in case of frequency 80MHz or 800 MHz, the formula for the higher range is  
applicable.  
2. note: These are guidelines. Actual conditions may vary.  
25  
 
AMBULATORY BLOOD PRESSURE MONITORING  
PATIENT DIARY  
Name:  
Date of birth:  
Monitoring date:  
8:00-8:30  
20:00-20:30  
20:30-21:00  
21:00-21:30  
21:30-22:00  
22:00-22:30  
22:30-23:00  
23:00-23:30  
23:30-24:00  
0:00-0:30  
0:30-1:00  
1:00-1:30  
1:30-2:00  
2:00-2:30  
2:30-3:00  
3:00-3:30  
3:30-4:00  
4:00-4:30  
4:30-5:00  
5:00-5:30  
5:30-6:00  
6:00-6:30  
6:30-7:00  
7:00-7:30  
7:30-8:00  
8:30-9:00  
9:00-9:30  
9:30-10:00  
10:00-10:30  
10:30-11:00  
11:00-11:30  
11:30-12:00  
12:00-12:30  
12:30-13:00  
13:00-13:30  
13:30-14:00  
14:00-14:30  
14:30-15:00  
15:00-15:30  
15:30-16:00  
16:00-16:30  
16:30-17:00  
17:00-17:30  
17:30-18:00  
18:00-18:30  
18:30-19:00  
19:00-19:30  
19:30-20:00  
Complete the activity diary during the monitoring session using the numbered guide as  
shown below to reduce your work. Careful completion will help the physician evaluate  
the data recorded. Do not forget to record the time you awake and go to sleep.  
1 = Working  
2 = Housework (what kind)  
5 = Driving  
8 = Watching TV  
3 = Walking  
6 = Travelling  
9 = Relaxing  
4 = Exercise (what kind)  
7 = Eating  
10 = Sleeping  
Medication taken during the measurement:push the button marked with heart.  
1.  
2.  
3.  
4.  
5.  
26  
 
4.4. Product Warranty Information  
(a) MONITOR WARRANTY. The main monitor unit will be free from defects in materials  
and workmanship under normal use and service for a period of two (2) years from  
the date of receipt. This warranty covers the monitor unit only. This warranty does not  
cover any accessories that might come with the monitor unit.  
(b) ACCESSORIES WARRANTY. The non-disposable accessories delivered with the  
monitor unit will be free from defects in materials and workmanship under normal use  
and service for a period of one (1) year from the date of receipt. This warranty does  
not cover disposable accessories, packaging materials, accumulators and batteries,  
cuffs, or any of their components.  
(c) CUFF WARRANTY. The cuff(s) will be free from defects in materials and workmanship  
under normal use and service for a period of six (6) months from the date of receipt.  
This warranty covers the cuff(s) delivered with a monitor unit exclusively.  
(d) SOFTWARE WARRANTY. The OMRON BP Tracker Software under normal use  
will perform substantially in accordance with the accompanying written/electronic  
documents for a period of ninety (90) days from the date of receipt.  
This warranty does not cover any malfunction or defects of the monitor unit or any of its  
accessories arising from improper use, the use of inadequate accessories, accident, theft,  
or use of the monitor unit outside its operating speciꢁcations and intended measurement  
range. Removing the closing label from the back side of the monitor unit, or opening the  
unit any other way voids this warranty.  
EXCLUSION OF BIOHAZARD. OMRON will not accept for repair potentially infectious  
products or accessories, especially pouches and cuffs, that might have been in direct  
contact with the patient, and could not be, or (potentially) were not, properly disinfected,  
even within the warranty period. If a problem occurs within the warranty period, such  
accessories will be replaced without any physical inspection, reserving the rights to hold  
an inspection when found necessary.  
NO OTHER WARRANTIES. OMRON disclaims all other warranties, either expressed or  
implied, including, but not limited to, implied warranties of merchantability and ꢁtness for a  
particular purpose, with regard to the monitor unit, any accessory or other accompanying  
hardware, and the OMRON BP Tracker Software.  
NO LIABILITY FOR CONSEQUENTIAL DAMAGES. In no event shall OMRON be liable  
for any special, incidental, indirect, or consequential damages whatsoever (including,  
without limitation, damages for loss of business proꢁts, business interruption, loss of  
business information, loss of data, or any other pecuniary loss) arising out of the use  
of or inability to use the monitor unit, its accessories and/or the OMRON BP Tracker  
Software, even if OMRON has been advised of the possibility of such damages.  
Product Serial number _____________________________________  
Details of fault  
_____________________________________  
_____________________________________  
_____________________________________  
_____________________________________  
_____________________________________  
Name & Address  
OMRON Customer Services becomes the owner of all exchanged units  
27  
 
Remarks  
2010. All rights reserved  
Made in Hungary  
Meditech Ltd.  
H-1184 Budapest,  
Mikszáth Kálmán utca 24, Hungary  
Scorpius 33  
2132 LR Hoofddorp  
IM-ABPM-BP5-EN-04-06/2012  
 

Munchkin Boiler VWH High Efficiency Hot Water Supply Boiler User Manual
Napoleon Grills Outdoor Cart N415 0103 User Manual
Nikon Digital Camera 25438 User Manual
Niles Audio Universal Remote RCA TT User Manual
Nortel Networks IP Phone LDP7016 User Manual
Nostalgia Electrics Blender MMA 600 User Manual
Onkyo Stereo Receiver HT RC360 User Manual
Oreck Vacuum Cleaner XL2100HH User Manual
Panasonic Battery Charger EY0230 User Manual
Patton electronic Network Card 1082 144 I User Manual