Manufacturer
EU-representative
OMRON HEALTHCARE CO., LTD.
24, Yamanouchi Yamanoshita-cho, Ukyo-ku, Kyoto,
615-0084 Japan
OMRON HEALTHCARE EUROPE B.V.
Kruisweg 577, 2132 NA Hoofddorp, The Netherlands www.omron-healthcare.com
Production facility
Site de production
Produktionsstätte
Subsidiary
Succursale
Niederlassung
Oficina de producción
Productiefaciliteit
OMRON DALIAN Co, Ltd.
Economic & Technical Development Zone
Производственное подразделение
Dalian 116600, China
Empresa filial
Dochteronderneming
Дочерняя компания
OMRON HEALTHCARE UK LTD.
Opal Drive
Fox Milne, Milton Keynes MK15 0DG, United Kingdom
OMRON Medizintechnik Handelsgesellschaft mbH
John-Deere-Str. 81a, 68163 Mannheim, Germany www.omron-medizintechnik.de
OMRON SANTÉ FRANCE SAS
14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, France
Made in China
Fabriqué en Chine
Hergestellt in China
Prodotto in Cina
Fabricado en China
Geproduceerd in China
Сделано в Китае
ﺹُﻥﻉ ﻑﻱ ﺍﻝﺹﻱﻥ
Wrist Blood Pressure Monitor
Model R3
Instruction Manual
HEM-6200-E_A_M09_090605.pdf
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IM-HEM-6200-E-01-10/09
5325660-5B
Wrist B lood Press
Model R3 ure Monitor
Instruction M anual
English
Français
Deutsch
Italiano
Espanõl
Nederlands
IM-HEM-6200
-E-01-1 0/09
5325660-5A
c e f d b a
Contents
Thank you for purchasing the OMRON R3 Wrist Blood Pressure Monitor.
The OMRON R3 is a compact and easy to use blood pressure monitor, operating on the oscillometric principle. It measures your blood pressure and pulse rate simply and quickly. For comfortable controlled inflation without the need of pressure pre-setting or re-inflation the devices uses its advanced “IntelliSense” technology.
Important Safety Information............................. 1
1.
Overview....................................................... 3
2.
Preparation................................................... 4
2.1
Installing/Replacing the Batteries ............ 4
2.2
Setting the Date and Time....................... 5
3.
Using the Unit .............................................. 6
3.1
Applying the Wrist Cuff............................ 6
3.2
How to Sit Correctly................................. 7
3.3
Taking a Reading .................................... 8
3.4
Using the Memory Function .................. 10
4.
Troubleshooting and Maintenance ..........12
4.1
The Icons and Error Messages .............12
4.2
Troubleshooting.....................................14
4.3
Maintenance..........................................16
5.
Technical Data............................................18
6.
Some Useful Information about Blood Pressure ... 21
Please read this instruction manual thoroughly before using the unit.
Please keep for future reference.
For specific information about your own blood pressure, CONSULT YOUR DOCTOR.
A
B
C
D
E
F
G
H I
J
K
L
M
N
O
S R Q P
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Important Safety Information
Consult your doctor prior to using in pregnancy or if diagnosed with arrhythmia or arteriosclerosis.
Please read this section carefully before using the unit.
Warning:
• Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
(General Usage)
• Always consult your doctor. Self-diagnosis of measurement results and self-treatment are dangerous.
• People with severe blood flow problems, or blood disorders, should consult a doctor before using the unit, as cuff inflation can cause internal bleeding.
(Battery Usage)
• If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Consult a doctor immediately.
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)
• Do not leave the unit unattended with infants or persons who cannot express their consent.
• Do not use the unit for any purpose other than measuring blood pressure.
• Do not disassemble the unit or wrist cuff.
• Do not inflate the wrist cuff over 299 mmHg.
EN
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Important Safety Information
• Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
• Do not operate unit in a moving vehicle (car, airplane).
(Battery Usage)
• If battery fluid should get on your skin or clothing, immediately rinse with plenty of clean water.
• Use only two “AAA” alkaline (LR03) batteries with this unit. Do not use other types of batteries.
• Do not insert the batteries with their polarities incorrectly aligned.
• Replace old batteries with new ones immediately. Replace both batteries at the same time.
• Remove the batteries if the unit will not be used for three months or more.
• Do not use new and used batteries together.
General Precautions
• Do not apply strong shocks and vibrations to or drop the unit.
• Do not take measurements after bathing, drinking alcohol, smoking, exercising or eating.
• Do not inflate the wrist cuff when it is not wrapped around your wrist.
• Do not wash the wrist cuff or immerse it in water.
• Read and follow the “Important information regarding Electro Magnetic Compatibility (EMC)” in the
Technical Data Section.
• Read and follow the “Correct Disposal of This Product” in the Technical Data Section when disposing of the device and any used accessories or optional parts.
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1. Overview
Open the rear cover page to read following:
The alphabet in the rear cover page correspond to those in the body page.
Main unit
E
F
G
A
B
C
D
Display
Battery compartment cover
Wrist cuff
MEM (Memory) button
O/I START ( ) button
SET ( ) button
Date/Time setting ( ) button
Display
L
M
N
O
H
I
J
K
P
Q
R
S
Systolic blood pressure
Diastolic blood pressure
Memory symbol
Average value symbol
Irregular heartbeat symbol
Pulse display
Movement error symbol
Battery low symbol
Date/Time display
Heartbeat symbol
(Flashes during measurement.)
Deflation symbol
Blood pressure level indicator
EN
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2. Preparation
2.1 Installing/Replacing the Batteries
1.
Remove the battery cover.
1) Push the hook on the bottom of the battery cover.
2) Pull the cover off the main unit.
2
1
2.
Insert two 1.5V “AAA” alkaline (LR03) batteries as indicated in the battery compartment and then replace the battery cover.
Notes:
• If the battery low symbol ( ) appears on the display, turn the unit off then replace both batteries at the same time.
• The measurement values continue to be stored in memory even after the batteries are replaced.
Disposal of used batteries should be carried out in accordance with the national regulations for the disposal of batteries.
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2. Preparation
2.2 Setting the Date and Time
1.
Set the monitor to the correct date and time before taking a measurement for the first time.
Press the button.
1)
Push the button to change.
• Hold down to advance the digit rapidly.
2)
Push the button to confirm.
Next setting appears.
Year
Month
Day
Hour
Minute
2.
Press the O/I START button to store the setting.
Notes:
• To reset the date and time, hold down the button while the power is off.
• If the batteries have been removed for 30 seconds or more, the date and time setting will need to be reset.
• If the date and time are not set, “-:--” appears during or after measurement.
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EN
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3. Using the Unit
Open both the front and rear covers to read following:
The alphabet and number in the cover page correspond to those in the body page.
3.1 Applying the Wrist Cuff
Do not apply over clothing.
1.
Place the wrist cuff over your wrist.
2.
Wrap the wrist cuff around your wrist.
Make sure that the wrist cuff does not cover the protruding part of the wrist bone (ulna) on the outside of the wrist. --- a
Your thumb should face upward.
Notes:
• You can take a measurement on either your left or b right wrist.
• Wrap the wrist cuff securely around the wrist for taking accurate measurements.
• The blood pressure can differ between the right arm and the left arm, and therefore also the measured blood pressure values can be different. Omron recommends to always use the same arm for measurement. If the values between the two arms differ substantially, please check with your physician which arm to use for your measurement.
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3. Using the Unit
3.2 How to Sit Correctly
To take a measurement, you need to be relaxed and comfortably seated, under comfortable room temperature. No eating, smoking or exercising 30 minutes before taking a measurement.
• Sit on a chair with your feet flat on the floor.
• Sit upright with your back straight. --- c
• The cuff should be at the same level as your heart. --- d
• Relax your wrist and hand. Do not bend your wrist back, clench your fist, or bend your wrist forward. --- e
• Do not use your other hand to support the wrist cuff. This can result in inaccurate measurement results. --- f
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3. Using the Unit
3.3 Taking a Reading
Notes:
• To cancel a measurement, press the O/I START button at any time during measurement.
• Remain still while taking a measurement.
1.
Press the O/I START button.
The wrist cuff will start to inflate automatically.
START INFLATE DEFLATE COMPLETE
8
Alternating date/time display
2.
Undo the wrist cuff and remove the unit.
3.
Press the O/I START button to turn off the monitor.
The monitor automatically stores the measurement in its memory.
It will automatically turn off after two minutes.
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3. Using the Unit
Important:
• Recent research suggests that the following values can be used as a guide to high blood pressure for measurements taken at home.
Systolic Blood Pressure Above 135 mmHg
Diastolic Blood Pressure Above 85 mmHg
This criteria is for home blood pressure measurement.
For professional office blood pressure measurement criteria, please refer to Chapter 6.
• Your blood pressure monitor includes an irregular heartbeat feature. Irregular heartbeats can influence the results of the measurement. The irregular heartbeat algorithm automatically determines if the measurement is usable or needs to be repeated.
If the measurement results are affected by irregular heartbeats but the result is valid, the result is shown together with the irregular heartbeat symbol ( ). If the irregular heartbeats cause the measurement to be invalid, no result is shown. If the irregular heartbeat symbol ( ) is shown after you have taken a measurement, repeat the measurement. If the irregular heartbeat symbol ( ) is shown frequently, please make your doctor aware of it.
EN
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3. Using the Unit
3.4 Using the Memory Function
The monitor automatically stores the result up to 60 sets. It can also calculate an average reading based on the measurements from the last three readings taken within 10 minutes. If there are only two readings in memory for that period, the average will be based on two readings. If there is one reading in memory for that period, the average will be based on one reading.
Notes:
• If the memory is full, the monitor will delete the oldest readings.
• When viewing the reading taken without setting the date and time, “-:--” is displayed instead of the date and time.
Average Value Previous Reading
Alternating date/time display
View the Average
Value
• If the previous reading was taken without setting the date and time, the average value is not calculated.
View Previous
Reading
• The Memory number appears for a second before the pulse rate is displayed. The newest set is numbered “1”.
View Readings
Stored in Memory
• Hold down to view readings rapidly.
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3. Using the Unit
To delete all the values stored in memory
When the memory symbol ( ) appears, first press the MEM button. Then while holding it down, press the O/I START button simultaneously for about 2-3 seconds.
First Second
Note:
You cannot partially delete the stored readings.
EN
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4. Troubleshooting and Maintenance
4.1 The Icons and Error Messages
Error Display Cause
Irregular or weak pulses are detected.
Remedy
Remove the wrist cuff. Wait 2-3 minutes and then take another measurement.
Repeat the steps in section 3.3. If this error continues to appear, contact your doctor.
Blink The batteries are low.
Lit
Movement during measurement.
The batteries are exhausted.
Carefully read and repeat the steps in section 3.3.
You should replace them with new ones ahead of time.
Refer to section 2.1.
You should replace them with new ones at once.
Refer to section 2.1.
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4. Troubleshooting and Maintenance
Error Display Cause Remedy
Cuff is over inflated.
Carefully read and repeat the steps listed under section 3.3.
EN
Movement during measurement.
An Er mark with a code/number indicates the device has a hardware failure.
Consult your OMRON retail outlet or distributor.
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4. Troubleshooting and Maintenance
4.2 Troubleshooting
Problem Cause
The wrist cuff is not at heart level.
The cuff is wrapped snugly around the wrist.
The reading is extremely low
(or high).
Your arms and shoulders are tense.
Wrist cuff pressure does not rise.
Wrist cuff deflates too soon.
Movement or talking during measurement.
Air is leaking from the wrist cuff.
The wrist cuff is loose.
Remedy
Measure while in the correct posture. Refer to section 3.2.
Wrap the cuff correctly. Refer to section 3.1.
Relax and try taking the measurement again. Refer to section 3.3.
Remain still and do not talk during measurement. Refer to section 3.3.
Consult your OMRON retail outlet or distributor.
Apply the cuff correctly so that it is securely wrapped around the wrist. Refer to section 3.1.
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4. Troubleshooting and Maintenance
Problem Cause Remedy
The blood pressure is different each time. The reading is extremely low (or high).
The unit loses power during measurement.
Nothing happens when you press the buttons.
Other problems.
The batteries are drained.
Blood pressure readings constantly vary with time of day and how relaxed you are. Take several deep breaths and try to remain relaxed before taking a measurement.
Replace the batteries with new ones.
The batteries are drained.
The batteries have been inserted incorrectly.
Replace the batteries with new ones.
Insert the batteries with the correct (+/-) polarity.
• Press the O/I START button and repeat measurement.
• If the problem continues, try replacing the batteries with new ones.
If this still does not solve the problem, contact your OMRON retail outlet or distributor.
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4. Troubleshooting and Maintenance
4.3 Maintenance
To protect your unit from damage, please avoid the following:
• Subjecting your unit to extreme temperatures, humidity, or direct sunlight.
• Washing the cuff or exposing the cuff or unit to water.
• Disassembling the unit.
• Subjecting the unit to strong shocks or vibrations. Dropping the Unit.
• Cleaning the unit with volatile liquids. THE UNIT SHOULD BE CLEANED WITH A
SOFT, DRY CLOTH.
16
Use a soft, moistened cloth and soap to clean the cuff.
Keep the unit in its storage case when not in use.
Fold the cuff into the storage case.
Do not store the unit in the following situations:
• If the unit is wet.
• Locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapours.
• Locations exposed to vibrations, shocks or where it will be at risk of falling.
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4. Troubleshooting and Maintenance
Calibration and Service
• The accuracy of this blood pressure monitor has been carefully tested and is designed for a long service life.
• It is generally recommended to have the unit inspected every two years to ensure correct functioning and accuracy. Please consult your authorised OMRON dealer or the OMRON Customer Service at the address given on the packaging or attached literature.
EN
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5. Technical Data
Product Description
Model
Display
Measurement Method
Measurement Range
Accuracy
Inflation
Deflation
Pressure Detection
Memory
Power Source
Battery Life
Wrist Blood Pressure Monitor
OMRON R3 (HEM-6200-E)
LCD Digital Display
Oscillometric method
Pressure: 0 mmHg to 299 mmHg Pulse: 40 to 180 beats/min.
Pressure: ±3 mmHg
Pulse: ± 5% of reading
Automatic inflation by pump
Automatic rapid deflation
Capacitive pressure sensor
60 Measurements
2 “AAA” alkaline (LR03) batteries 1.5V
Approx. 300 measurements with new alkaline batteries at a room temperature of 23°C
Applied Part
Protection Against Electric
Shock
Operating temperature/
Humidity
Storage temperature/
Humidity/ Air pressure
= Type B
Internally powered ME equipment
+10°C to +40°C / Maximum: 30 to 85% RH
-20°C to +60°C / Maximum: 10 to 95% RH / 700-1060 hPa
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5. Technical Data
Console Weight
Outer Dimensions
Measurable circumference of wrist
Cuff Material
Package Content
Approximately 117g without batteries
Approximately 71 (w) mm × 41 (h) mm × 70 (d) mm without the wrist cuff
Approximately 13.5 to 21.5 cm
Nylon and polyester
Main unit, storage case, two “AAA” alkaline (LR03) batteries, instruction manual, guarantee card, blood pressure pass
Note:
Subject to technical modification without prior notice.
• This device fulfils the provisions of EC directive 93/42/EEC (Medical Device Directive).
• This blood pressure monitor is designed according to the European Standard EN1060, Noninvasive sphygmomanometers Part 1: General Requirements and Part 3: Supplementary requirements for electromechanical blood pressure measuring systems.
• This OMRON product is produced under the strict quality system of OMRON Healthcare Co.
Ltd., Japan. The Core component for OMRON blood pressure monitors, which is the Pressure
Sensor, is produced in Japan.
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5. Technical Data
20
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation.
Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the EN60601-1-2:2007 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices.
This medical device manufactured by OMRON Healthcare conforms to this EN60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• Do not use mobile (cellular) telephones and other devices, which generate strong electrical or electromagnetic fields, near the medical device. This may result in incorrect operation of the unit and create a potentially unsafe situation. Recommendation is to keep a minimum distance of 7 m. Verify correct operation of the device in case the distance is shorter.
Further documentation in accordance with EN60601-1-2:2007 is available at OMRON Healthcare Europe at the address mentioned in this instruction manual.
Documentation is also available at www.omron-healthcare.com.
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)
This marking shown on the product or its literature, indicates that it should not be disposed of, with other household wastes at the end of its working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate this from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources.
Household users should contact either the retailer where they purchased this product, or their local government office, for details of where and how they can take this item for environmentally safe recycling.
Business users should contact their supplier and check the terms and conditions of the purchase contract.
This product should not be mixed with other commercial wastes for disposal.
This product does not contain any hazardous substances.
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6. Some Useful Information about Blood Pressure
What is Blood Pressure?
Blood pressure is a measure of the force of blood flowing against the walls of the arteries.
Arterial blood pressure is constantly changing during the course of the heart’s cycle.
The highest pressure in the cycle is called the Systolic Blood Pressure; the lowest is the Diastolic
Blood Pressure.
Both pressure readings, the Systolic and Diastolic, are necessary to enable a doctor to evaluate the status of a patient’s blood pressure.
EN
What is Irregular Heartbeat?
An irregular heartbeat is a heartbeat rhythm that varies by more than 25% from the average heartbeat rhythm detected while the unit is measuring the systolic and diastolic blood pressure.
Pulse
Blood pressure
Normal Heartbeat
If the irregular heartbeat symbol ( ) is shown frequently, please make your doctor aware of it.
Irregular Heartbeat
Short Long
Pulse
What is Arrhythmia?
Blood pressure
Arrhythmia is a condition where the heartbeat rhythm is abnormal due to flaws in the bio-electrical system that drives the heartbeat. Typical symptoms are skipped heartbeats, premature contraction, an abnormally rapid (tachycardia) or slow
(bradycardia) pulse.
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6. Some Useful Information about Blood Pressure
Why is it a Good Thing to measure Blood Pressure at Home?
Many factors such as physical activity, anxiety, or the time of day, can influence your blood pressure. A single measurement may not be sufficient for an accurate diagnosis. Thus it is best to try and measure your blood
200
150
100
Upper curve: systolic blood pressure
Lower curve: diastolic blood pressure pressure at the same time each day, to get an accurate indication of any changes in blood pressure. Blood
50
6 12
Time of day
18
Example: fluctuation within a day (male, 35 years old)
24 pressure is typically low in the morning and increases from afternoon to evening. It is lower in the summer and higher in the winter.
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6. Some Useful Information about Blood Pressure
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 this figure.
This classification is based on the blood pressure values measured on people in a sitting position in outpatient departments of hospitals.
Note:
There is no universally accepted definition of hypotension. However, those having the systolic pressure below 100 mmHg are assumed as hypotensive.
Systolic blood pressure
(mmHg)
Severe hypertension
180
Moderate hypertension
160
Mild hypertension
140
Normal systolic value
130
120
Normal blood pressure
Optimal blood pressure
(target value)
80 85 90 100 110
Diastolic blood pressure
(mmHg)
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