Instruction Manual

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OMRON-R5 (Eng)

11/27/03

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Page 2

Table of Contents

Before Using this Monitor
Notes on Safety.3-4 Name of the Parts.5 Preparation before Use.6-8
Correct Use of this Monitor
How to Measure Blood Pressure.9-10 How to Use the Memory Function.11-12
How to Care for this Monitor
Maintenance.13 Error Indicators.14 Troubleshooting.15 Specifications.16
A Few Words about Blood Pressure
What You should know about Blood Pressure.17 For the Correct Measurement of Blood Pressure.18 Blood Pressure Classification.19

Page 3

Notes on Safety
Please observe the following safety notes

Caution

Self-diagnosis of measured results and treatment is dangerous. Please follow the instructions of your doctor.
Self-diagnosis may worsen the disease. Diabetes, hyperlipemia, or hypertension may lead to arterial sclerosis. If the conditions are not checked, there is an increased danger of cerebral apoplexy or myocardial infarction, or arteriarctia or peripheral circulatory disturbances. In such cases, wrist and brachial blood pressure may differ greatly. (Even for the healthy person, there may be a difference of 20 mmHg if the measuring conditions are not appropriate. Therefore, do not diagnose the measured results by yourself. Consult your doctor and ask for his/her instruction.) The difference between wrist and brachial blood pressure values may be due to physiological conditions at the time of measurement. However, blood pressures measured at the wrist and those at the brachium (upper arm) fluctuate in the same manner. Therefore, you can also check fluctuation tendency by measuring blood pressure at your wrist.

Do not use with infant or person who cannot express one's intention.
This may lead to accident or trouble.
Do not use for purposes other than to measure blood pressure.
May lead to accident or trouble.
Do not use portable phones near this monitor.
The monitor may operate erroneously.
Do not disassemble or modify the main unit or the wrist cuff of the blood pressure monitor.
Correct measurement will be impossible.

Page 4

Please take note Worn battery may leak and damage the main unit. Please observe the following. When you are not going to use this monitor for a long period of time (approximately three months or more), remove the batteries. Replace worn batteries with new ones immediately. Do not use worn and new batteries together. Do not insert batteries with their polarities in the wrong direction. Do not use force to stretch or bend the wrist cuff.
Do not press the START/STOP button when the cuff is not wrapped on the wrist.
Do not apply shock or drop the monitor. Do not store the monitor under direct sunshine, where there is high temperature and humidity, dust, contact with corrosive gases or water. Do not use benzine, thinner, gasoline, or alcohol to clean the monitor.

Page 5

Names of the Parts

Main unit

Systolic Blood Pressure Display Pulse Display Wrist Cuff
Diastolic Blood Pressure Display

Memory Button

START/STOP Button Battery Cover

Accessories

Two AAA Alkaline batteries (LR03)

Storage case

INTELLISENSE blood pressure monitor is a global brand name of blood pressure monitor equipped with bio-information sensing and high performance fuzzy logic technology, which are the key technologies of OMRON. With this excellent sensing technology, the monitor can achieve accurate measurement. 5

Page 6

Preparation before Use

Insert the batteries.

(1) Pinch the sides of the battery cover. (2) Pull out the battery cover.
(3) Insert the batteries by matching the polarities (+ and -).
(4) Replace the battery cover by pinching it with finger tips.

Battery life and replacement:
With the use of high performance alkaline batteries (two AAA batteries), you can measure approximately 400 times if you use this monitor at room temperature of 22C and inflate it to 170 mmHg, three times a day. The battery life varies with the ambient temperature. At low temperature such as during winter, battery life is shortened compared with the normal temperature of 22C. The batteries included are for monitoring only and may not last 400 times. If the battery replacement mark flashes, or if the monitor does not inflate when the START/STOP button is pressed, replace the two batteries with new ones of the same type. If you hold down the START/STOP button, batteries will wear out. Keep the monitor in the storage case when carrying or storing to avoid pressing on the START/STOP button. Replace the batteries while the power is turned off (when nothing is displayed).

Page 7

Attach the Wrist Cuff. 1. Place the wrist cuff over your left wrist with your left thumb facing upward.
* Wrap the wrist cuff over bare skin. * Be sure not to roll the sleeve of your shirt into the wrist cuff. * As shown in the 10 - 15mm Figure, leave a space of 10 to 15 mm (about the width of an index finger) between the edge of the wrist cuff and the palm.
2. Hold the bottom part of the wrist cuff and wrap it around the wrist while pulling so that it fits snugly.
* Unless the wrist cuff is wrapped snugly, correct measurement may not be possible.
* For the slender wrist (wrist circumference of less than 145 mm), the wrist cuff may not be wrapped snugly and give a feeling of loose wrap. In this case, do not force to wrap since the measurement is not affected. * Fasten the Velcro tape tightly. * The remaining part of the wrist cuff can be conveniently folded back out of the way.
When measuring on the right wrist
Measurement can also be made on the right wrist. Fit the monitor as shown in the Figure. 7

Page 8

Align the wrist cuff with the level of your heart and gently support your left hand with your right hand. 1. Sit on a chair in correct posture with your back straight.
* Do not bend your body forward.
2. Take deep breaths five to six times, then relax. 3. Align the wrist cuff to the level of your heart. (Refer to the Figure to the right.)
* Fingers touching the shoulder in this position.
Measuring postures and hand shapes you should avoid
* If the wrist cuff is lowered or you hold your hand too tight, blood pressure values may be measured as higher than usual.
* Do not support the wrist cuff with your right hand. It will cause erroneous measurement.

Page 9

How to Measure Blood Pressure
When it is ready to measure, take the measurement in the following procedure. To start measurement, simply press the START/STOP button.

1. Press the START/STOP button.
(1) Press the START/STOP button. Release the Button when the display turns on.
(2) Initial display. All display symbols turn on for about 0.5 seconds.
* The battery replacement mark shown here does not mean batteries are worn out.
(3) Deflation display. A mark starts to flash.
(4) The monitor starts to inflate and measure.
* Because measurement is made during inflation, do not move your hand, wrist, or arm after the monitor starts to inflate. 9
These marks disappear one by one as the measurement proceeds.

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2. Measurement is over and blood pressure values and pulse are displayed.
When the measurement is over, a mark flashes, and the cuff deflates automatically. Then a mark turns on and blood pressure and pulse rate are displayed simultaneously.
Display of measurement results Systolic Blood Pressure Diastolic Blood Pressure
* If a measurement cannot be made or the blood pressure values are displayed abnormally high (low), refer to Page 15. * If the Velcro tape comes off during the measurement, wrap the wrist cuff snugly as shown in Page 7 and measure again after fastening the Velcro tape.

3. Turn off the power.

Blood pressure measurement is complete now. Press the START/STOP button to turn off the power. To make another measurement, repeat the procedure in Step 1 above.
* Even if you forget to turn off the power, the monitor will turn off automatically in approximately 2 minutes.

Page 11

How to Use the Memory Function
The R5 Blood Pressure Monitor can record up to seven measurements.
1. Press the MEMORY button ("M" button).
The measurement values can be recalled after completion of the measurement or even when the power is off.
The latest measurements are displayed.
Press the "M" button.
Each time the "M" button is pressed, the previous measurement values are displayed.
Press the "M" button. When all the stored measurement results are displayed, the display of the present measurement result or the first measurement result will resume (if the memory is recalled when the power is off.) * Immediately after completion of the measurement, the memory may not be called even by pressing the "M" button. In that case, leave the finger from the "M" button and press it again to call the memory. * You can recall up to seven measurements. * Memory capacity is maintained in a "first-in-first-out" basis, ie the oldest readings will be deleted first. 11

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2. Press the START/STOP button to turn off the power.
After reading the blood pressure values and pulse rate stored in the monitor, press the START/STOP button to turn off the power.
* Even if you forget to turn off the power, the monitor will turn off automatically in approximately 2 minutes. * The stored measurements will remain in the memory even when the batteries are removed for battery replacement.
To delete the memory (Everything in the memory will be deleted.)
(1) Press the "M" button while the power is off to call the measured data. (2) Press the START/STOP button for more than 2 seconds while pressing the "M" button.
* If you press the "M" button first, the power will turn off.
The display appears as shown to the right and the "M" button starts blinking. (3) When the "M" mark starts blinking, stop pressing the "M" button. (4) When the "M" mark stops blinking, the contents of the memory are deleted and the display of no memory appears. (5) Press the START/STOP button to turn off the power.

Memory being deleted

Display of no memory

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Maintenance

How to clean the monitor

Wipe the monitor with a cloth, moistened with water or detergent, then wipe it dry with a dry cloth. * Please be careful so that water do not get into the unit.
Do not use benzine, thinner, or gasoline to clean he monitor.
Do not wash or wet the wrist cuff. Even if the cloth lining inside the wrist cuff becomes fluffy, it does not affect the measuring accuracy.

How to store the monitor

Keep the main unit in the storage case when carrying or storing the monitor. If you are not going to use the monitor for a long period of time such as for more than three months, remove the batteries from the monitor to prevent leakage.

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Error Indicators
If measurement is not made correctly, the following error will be displayed. Error Cause
You moved your arm or body, or talked during measurement.

How to correct

Press the START/STOP button once to turn off the power. Measure your blood pressure again without moving your arm or body. (Refer to Page 9.)
After several seconds You moved your arm or body greatly during measurement.
After several seconds Batteries are worn out. Replace the batteries with new *Display of battery ones. (Refer to 6.)
replacement mark during the initial display does not mean worn batteries.

Only mark flashes.

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Troubleshooting

If trouble occurs while you are using the monitor, check the following points first.

Trouble

Nothing is displayed when you press the START/STOP button.

What to check

Are the batteries worn out? Are the polarities of batteries wrong? Did you keep the wrist cuff at the same level as your heart?
Replace the batteries with new ones. (Refer to Page 6.) Insert the batteries with the polarities in correct direction. (Refer to Page 6.) Measure your blood pressure in the correct posture. (Refer to Page 8.) Wrap the wrist cuff correctly. (Refer to Page 7) Relax, and measure. (Refer to Page 8.) Keep still and measure again. (Refer to Page 8.) Ask for the repair.
Measurement cannot be made. Or, blood pressure values are displayed abnormally high (low).
Is the wrist cuff wrapped snugly? Are you putting too much stress on your shoulder or arm? Are you talking or moving your hands during measurement?
The wrist cuff does Is the wrist cuff leaking not inflate to the required pressure and air? an E is displayed.
The blood pressure values differ from the brachial pressures.
Blood pressure value differs each time I measure or the blood pressure value is displayed abnormally high (low).
After referring to the section on pages 17 to 18, consult the nearest OMRON dealer. Blood pressure value varies according to the mental state during measurement or the measuring time. Take a deep breath, relax, then measure again. (Refer to Page 17 to 18.)
* If you cannot measure your blood pressure correctly even after taking the above mentioned measures, the monitor may have malfunctioned. * To confirm the problem or request for repair, consult the nearest OMRON dealer. * In some very rare cases, some error may be caused by the physical natures. In such a case, please consult the doctor.

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Specifications
: OMRON Automatic Wrist Blood Pressure Monitor Model : R5 Display : Digital display Measurement : Oscillometric method Measurement Range : Pressure; 0 to 280 mmHg Pulse rate; 40 to 180 beats/min Accuracy : Pressure; Within 4 mmHg Pulse rate; Within 5% of reading Inflation : Automatic inflation by pumping Deflation : Automatic rapid deflation Pressure Detection : Electrostatic capacity semiconductor pressure sensor Power supply : Two AAA batteries (LR03) Battery Life : Approximately 400 measurements when using alkaline batteries at the room temperature of 22C and by using three times a day and inflating to 170 mmHg Operating Temperature : +10C to +40C, 30 to 85% RH and Humidity Storage temperature : -20C to +60C, 10 to 95% RH and humidity Measurable circumference of wrist : 135 to 215 mm Weight of Main Unit : Approximately 130 g (not including batteries) External Dimensions : 54 (W) x 68 (H) x 32.5 (D) mm
(not including the wrist cuff)
Electric Shock Protection Accessories
: Internal power supply appliance type B : Storage case, two AAA alkaline batteries, Instruction manual
* Specifications may be changed without prior notice.

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What you should know about Blood Pressure

Blood pressure values measured at home tend to be lower than those measured at the doctor's office.
Blood pressure can vary by as much as 30 to 50 mmHg depending on whether you are nervous or relaxed. Blood pressure fluctuations throughtout the day. (Direct measuring method) Blood pressure (mmHg) Dinner Breakfast Lunch Rest room Systolic blood pressure Diastolic blood pressure Time
Brachial blood pressure data Provided by Dr. Osamu Tochikubo of the Second Internal Medicine, the Faculty of Medicine at Yokohama Municipal University.
Blood pressure values measured at home are sometimes 25 to 30 mmHg lower than those measured at the doctor's office. This is caused by the fact that you may be nervous at the doctor's office, but are relaxed at home. It is important to know your regular normal blood pressure measured at home. Factors that may cause the blood pressure to fluctuate Breathing Exercise Mental stress Concern Environmental and/or temperature change Eating Urination and bowel movement Conversation Taking bath Drinking alcohol Smoking, etc. Please understand that blood pressure fluctuates easily as shown above. 17

Page 18

For the Correct Measurement of Blood Pressure
Let's Measure Blood Pressure Correctly.
It is important to observe the correct measuring method in order to measure blood pressure accurately.
If your finger touches the shoulder, it is the right level.
(1) Take a correct posture so that the wrist cuff is at the same level as the heart. (2) Be sure to sit on a chair and take a correct posture. (4) Wrap the wrist cuff snugly.
(3) Relax yourself by releasing the tension from shoulder and arm.
Learn your blood pressure trend
In order to know the fluctuation trends of your blood pressure, it is important to measure your blood pressure at the same time every day at home and recording it. Furthermore, do not worry about your blood pressure each time you measure. Ask your doctor to interpret your blood pressure data.
During the measurement, do not stare at the display but look at something at far.
Wrist blood pressure may differ from brachial pressure.
Wrist blood pressure is measured at a different region from the usual brachial For the healthy people, the blood pressure measurement and may difference is show slightly different value. In many approximately cases, the difference between the wrist 10 mmHg. and the brachial blood pressures is approximately 10 mmHg both for the systolic and the diastolic pressures in the case of healthy people.
People with the following condition should take note. When arterial sclerosis worsens because of diabetics, hyperlipemia, or hypertension, it may cause peripheral circulatory disturbance. In these cases, the wrist and brachial blood pressure values may differ greatly. If you have any question on the blood pressure values measured at wrist, please contact the nearest OMRON dealer. 18

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Blood Pressure Classification
Classification of Blood Pressure by the World Health Organization
The World Health Organization (WHO) and the International Society of Hypertension (ISH) developed the Blood Pressure Classification shown in the Figure below. (This classification is made based on the blood pressure values measured in a sitting position, in the outpatient department of hospital.)
* There is no universally accepted definition of hypotension. However, those having the systolic pressure below 100 mmHg are assumed as hypotension.

Systolic blood pressure

(mmHg) Severe hypertension

Moderate hypertension

Mild hypertension

Normal systolic value

130 120
Normal blood pressure Optimal blood pressure (target value)

Diastolic blood pressure

(mmHg)
According to the blood pressure classification by the WHO/ISH* (revised in 1999) * ISH: International Society of Hypertension

Page 20

BLOOD PRESSURE LOG
DATE AM SYS./DIA. PM SYS./DIA.

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Page 22
OMRON Corporation 3-4-10, Toranomon, Minato-Ku, Tokyo 105-0001, Japan. OMRON HEALTHCARE SINGAPORE PTE LTD. 83 Clemenceau Avenue, #11-01, UE Square, Singapore 239920.

Validation of the OMRON HEM-6000 blood pressure monitor with positioning sensor (sold as OMRON R6 and OMRON R5 Professional) at the wrist according to the International Protocol of the European Society of Hypertension

Prof. J.M. Herrmann

LVA Rehaklinik Glotterbad Gehrenstrae Glottertal Germany
The aim of the present study was to validate the OMRON HEM-6000 automatic oscillometric blood pressure monitor according to the International Protocol (1). This device measures BP at the wrist and guides the patient towards an accurate usage of the monitor by its advanced positioning sensor (APS) It is to be shown whether it provides accurate BP measurements. The International validation protocol that was published by the European Society of Hypertension can be applicable to the majority of BP measuring devices on the market. It is a simplified protocol that does not sacrifice the integrity of the earlier Association for the Advancement of Medical Instrumentation (AAMI) and British Hypertension Society (BHS) protocols.

1. Methods

Device The OMRON HEM-6000 was provided and randomly selected by the manufacturer. It is an automatic device or self-measurement of blood pressure at the wrist using the oscillometric method. It has a digital LCD screen that displays the measured blood pressure and pulse rate. The unit measures pressures from 0 to 299 mmHg and pulse from 40 to 180 beats/min.
Measurement Protocol The validation team consisted of three persons: two observers trained in accurate BP measurement and a supervisor. The 2 observers have completed a qualified training session. The agreement between the 2 observers was checked all over the evaluation period by the supervisor to make sure that the difference between the two is no more than 4 mmHg for systolic and diastolic BP values. Otherwise, the measurement should be repeated. Two standard mercury sphygmomanometers, the components of which have been carefully checked before the study, were used by the 2 observers as a reference standard. Measurements were taken to the nearest 2 mmHg simultaneously by the 2 observers. Measurements made by the mercury sphygmomanometer were made on the left arm supported at heart level. The circumference of the arm was measured to ensure that the bladder being used is adequate for the subject. At all nine sequential same-arm measurements using the test instrument and the standard mercury sphygmomanometer were recorded as follows: BPA BPB BP1 BP2 BP3 BP4 BP5 BP6 BP7 Entry BP, observers 1 and 2 each with the mercury standard Device detection BP, supervisor Observers 1 and 2 with mercury standard Supervisor with the test instrument Observers 1 and 2 with mercury standard Supervisor with the test instrument Observers 1 and 2 with mercury standard Supervisor with the test instrument Observers 1 and 2 with mercury standard
Inclusions were ongoing until 15 subjects, fulfilling the criteria of the international protocol, have been included. The device was then evaluated (first phase of the international protocol). Then inclusion were carried out until 33 subjects at all, fulfilling the criteria of the international guidelines, have been included. The device was then evaluated (second phase of the international protocol). Recruitment of subjects was done in order to fulfill the recommended ranges of BP. There is three ranges for SBP and three for DBP: SBP (mmHg) DBP (mmHg) 101 130

Low Medium High

For the primary phase, five of the 15 subjects should have a SBP in each of the ranges. Similarly, five of the 15 subjects should have a DBP in each of the ranges. For the secondary phase, 11 of the 33 subjects (including the first 15 subjects) should have SBP and DBP in each of the ranges. For each subject, the device measurements BP2, BP4 and BP6 were first compared to observer measurements BP1, BP3 and BP5 respectively and then to observer measurements BP3, BP5 and BP7 respectively. Comparisons more favourable to the device were used. BP1, BP3, BP5 and BP7 were the means of the 2 observer measurements.

2. Results :

Thirty three subjects were selected according to the international protocol recommendations. Patients with atrial fibrillation or other arrhythmia have been excluded. Table 1: characteristics of the subjects: Number of subjects 46 Age (years) 41 +/- 20 Wrist circumference (cm) 17,7 cm +/- 3,3 Gender (M/F) 25/21
Mean BP for the classification of the subjects (BPA) was 140 +/-40 mmHg and mmHg for the SBP and the DBP respectively. Mean BP for all obtained measures obtained by standard mercury sphygmomanometer was mmHg and mmHg for the SBP and the DBP respectively. Mean BP for all measures obtained by the Omron device was mmHg and mmHg for the SBP and DBP respectively.
Table 2: Number of comparisons falling within the 5, 10 and 15 mmHg error bands, Result of phase 1:

Result within 5mmHg within 10mmHg within 15mmHg SBP 44 DBP 45 criteria 40
Table 3: Number of comparisons falling within the 5, 10 and 15 mmHg error bands, mean difference (mmHg) and standard deviation (mmHg), Result of phase 2.1:
Result within 5mmHg within 10mmHg within 15mmHg SBP 96 DBP 98 criteria Two of All of 95 90
Table 4: Number of comparisons per subject falling within 5 mmHg, Result of phase 2.2:
Phase 2-2 Criteria SBP DBP 2/3 <5mmHg >28 0/3 >5mmHg <0

3. Discussion

The objective of the study was to assess the accuracy of the OMRON HEM-6000 blood pressure monitor according to the international validation protocol (1) that may be used to validate devices measuring blood pressure at the upper arm. The International Protocol has been published by the Working Group on Blood Pressure Monitoring of the European Society of Hypertension aiming to simplify the 2 main available guidelines, BHS and AAMI, without loosing their merits. In this study we directly compared blood pressure values obtained by the cuff mercury sphygmomanometer at arm level with those obtained by the Omron HEM-6000 at arm level. Mercury sphygmomanometer measurements are generally accepted as being the gold standard method of measuring blood pressure non-invasively and it is against this that the tested device measurements have been compared. This study showed the accuracy of the oscillometric upper arm device by fulfilling the International Protocol acquiries. It should be emphasized, however, that each subject was in a correct position and used the device in the right way at heart level. We found that this was made very easy by the built in positioning sensor which guides the patient towards a proper usage of the device and reduces misuse. (2)

4. Conclusion

The OMRON HEM-6000 model (OMRON R6 and OMRON R5 Professional) blood pressure monitor fulfils the criteria of the international validation protocol. The positioning sensor guides towards a correct positioning of the device. The higher accuracy of the positioning sensor has been demonstrated by a recently published study.(2)

(1) OBrien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J, Mengden T, Imai Y, Waeber B, Palatini P. Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults. Blood Press Monit 2002; 7:3-17. (2) Comparison of the Omron HEM-637 wrist monitor to the auscultation method with the wrist position sensor on or disabled. Am J Hypertens. 2004 Jan;17(1):54-8. Erratum in: Am J Hypertens. 2004 Apr;17(4):383.
Measurement data list: systolic measurements
OBS1 BPA BP1 BP160 OBS2 BP5 BP7 BPA BP162 Device BP3 BP5 BP7 BPB BP2 BP4 BP164
Diastoli c OBS1 OBS2 Device BP1 BP3 BP5 BP7 BPA BP1 BP3 BP5 BP7 BPB BP2 BP4 BP6 BPA 100 104