Rossmax AD761F User Manual

Model: AD761 f
EN
Instruction Manual
www.rossmaxhealth.com
1. Introduction
Blood pressure measurements determined with AD761f are equivalent to those obtained by a trained observer using cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Elec­tronic or Automated Sphygmomanometers. This unit is to be used by adult consumers in a home environment. Do not use this device on infants or neo­nates. AD761f is protected against manufacturing defects by an established International Warranty Program. For warranty information, you can contact the manufacturer, Rossmax International Ltd.
Attention: Consult the accompanying documents. Please read this manual
2. Name/Function of Each Part
carefully before use. For specic information on your own blood
pressure, contact your physician. Please be sure to keep this manual.
Date/Time Set Key
AC Adapter Jack
Data Link Socket
4“AA”(R06) size,
1.5V batteries.
LCD Display
Resting Detector
Arm Cuff
LED
User-Switching Key
START/STOP Key
Memory Key
Air Tube and Connector
Battery Cover (Located on back of unit)
3. Real Fuzzy Measuring Technology
This unit uses the oscillometric method to detect your blood pressure. Be­fore the cuff starts inating, the device will establish a baseline cuff pres­sure equivalent to the air pressure. This unit will determine the appropriate
ination level based on pressure oscillations, followed by cuff deation. During the deation, the device will detect the amplitude and slope of
the pressure oscillations and thereby determine for you the systolic blood pressure, diastolic blood pressure, and pulse.
4. Preliminary Remarks
This Blood Pressure Monitor complies with the European regulations and bears the CE mark “CE 0366”. The quality of the device has been veri-
ed and conforms to the provisions of the EC council directive 93/42/EEC dated 14 June 1993 concerning medical devices:
EN 1060-1: 1995/A1: 2002 Non-invasive sphygmomanometers
- Part 1 - General requirements
EN 1060-3: 1997/A2: 2009 Non-invasive sphygmomanometers
- Part 3 - Supplementary requirements for electro-mechanical blood pres­sure measuring systems
EN 1060-4: 2004 Non-invasive sphygmomanometers
- Part 4: Test Procedures to determine the overall system accuracy of auto-
mated non-invasive sphygmomanometers.
This blood pressure monitor was designed for long service time. To ensure continued accuracy, it’s recommended that all digital blood pressure mon­itors require re-calibration. This monitor (under normal usage with approx. 3 measurements a day) does not require re-calibration for 2 years. Once the unit should be re-calibrated the device will display The unit should also be re-calibrated if the monitor sustains damage due to blunt force (such as dropping) or exposure to uids and / or extreme hot or cold temperature / humid­ity changes. When appears, simply return to your nearest dealer for re-calibration service.
.
5. Blood Pressure Standard
The National High Blood Pressure Education Program Coordinating Committee has developed a blood pressure standard, classifying blood
pressure ranges into 4 stages. (Ref. The Seventh Report of the Joint Na­tional Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure-Complete Report JNC-7, 2004).
This blood pressure classification are based on historical data, and may not be directly applicable to any particular patient. It is important that you consult with your physi­cian regularly. Your physician will tell you your normal blood pressure range as well as the point at which you will be considered at risk. For reliable monitoring and refer­ence of blood pressure, keeping long- term records is recommended. Please download the blood pressure log at our website www. rossmaxhealth.com.
6. Blood Pressure Fluctuation
Blood pressure uctu­ates all the time!
You should not be overly worried if you encoun­tered two or three meas­urements at high levels. Blood pressure changes over the month and even throughout the day. It is
also inuenced by season
and temperature.
7. Resting Detector Using HSD Technology
Rossmax HSD (Hemodynamic Stability) technology communicates to a user if a measurement is taken in the appropriate state of rest ensuring more correct blood pressure readings. The most common error in blood pressure measurement is taking the measurement when the users not being at rest physically or mentally or hemodynamically unstable thus measurements can be affected and incorrect.
Physical and mental factors can have a signicant impact on actual blood
pressure. Simply walking up stairs has a measurable affect on blood pres­sure. By monitoring changes of the heart rate frequency throughout a blood pressure measurement, Rossmax HSD can determine if a diagnosis is taken in the appropriate physiological state of rest. Rossmax HSD prompts the user to disregard results taken when not at rest and retake another
measurement. Blood pressure measurement can be affected not only by one’s physiologic conditions but also physical load, mental stress and certain disorders of
the body:
Physical Causes
Actual Exercise Post Exercise
Pulse Period & Pulse Pattern Changes during measurement
Blood Pressure Unstable during measurement
Hemodynamic Stability
indicates that the circulatory system is sufciently at rest when taking the
measurement thus measurement results are reliable and good for refer­ence.
Lack of Hemodynamic Stability
indicates that the circulatory system is not sufciently at rest (hemody­namic instability) when taking the measurement thus the measurement results should be ignored. Wait a minimum of 5 minutes before re-taking measurements. More time may be needed depending on one’s physilogic conditions. If icon repeatedly appears, see page 11 for important notes regarding your blood pressure measurements. If continues to appear even after long period of relaxation, this indicates the circulatory system is still not
sufciently at rest and cannot be relieved within a short period of rest.
Possible causes are, but not limited to, inner unrest of the nervous system, chronic mental conditions or the developing cardiac arrhythmia that can cause hemodynamic instability for a long time and may persist continu­ously even after long period of rest. Rossmax HSD is simple to use and requires no additional user skill and device adjustments. Rossmax HSD uses only one measurement to determine if the users were at rest (HSD NEGATIVE) or not at rest (HSD POSITIVE) while taking the measure­ment.
Important Notes: Regarding Your Blood Pressure Measurement
8.
1. Take your reading in a comfortable environment as measurements can be affected by hot or cold temperatures. Take your blood pressure at normal body temperature.
Mental Causes
Excitement Anxiety White Coat Effect Distraction
Talking during measurement
HSD Instability Indication
HSD Negative
(at resting state)
HSD Positive
(not at resting
state)
Medical Causes
Cardiac Arrhythmia Impaired Vasal Control Medication Hyperventilation
2. Do not move or talk during measurement as this can elevate readings.
3. Do not move or cross legs during measurements. Keep feel at on oor
4. It’s suggested that you take your measurements at the same time each day and use the same arm for consistency.
5. Users should wait a minimum of 5 minutes before taking additional measurements. More time may be needed depending on your physiol­ogy.
6. This product is not suitable for people with arryhthmias
7. This device may have difculty determining the proper blood pressure
for users with diabetes, poor circulation of blood, kidney problems, or for users who have suffered a stroke.
9. Display Explanations
1. Date/Time Indicator
2. Hypertension Risk Indicator
3. Memory Zones
4. Resting Detector
5. Memory Average
6. Memory Sequence Number
7. Weak Battery Mark
8. Irregular Heartbeat Detector (IHB)
9. Systolic Pressure
10. Diastolic Pressure
11. Pulse Rate
12. Pulse Mark
1
2
9
3
4
10 5 6
7
8
11
12
10. Hypertension Risk Indicator
The National High Blood Pressure Educa­tion Program Coordinating Committee has developed a blood pressure standard, classifying blood pressure ranges into 4 stages. This unit is equipped with innova­tive blood pressure risk indicator, which visually indicates the assumed risk level (prehypertension / stage 1 hypertension / stage 2 hypertension) of the result after each measurement.
11. Irregular Heartbeat Detector (IHB)
This unit is equipped with an Irregular Heartbeat Detector (IHB) which allows those who have an ir­regular heartbeat to obtain accurate measurements alerting the user of the presence of an irregular heart beat during the measurement. Note: It is strongly recommended that you consult
your physician if the IHB icon ( often.
) appears
12. Using the AC Adapter (Optional)
1. Connect the AC adapter with the AC adapter jack in the back of the unit.
2. Plug the AC adapter into the socket. (AC adapters with re­quired voltage and current indicated near the AC adapter jack.)
Caution: 1. Please unload the batteries when operating with
2. No batteries are needed when
operating with the AC mode.
3. AC adapters are optional. Please contact
4. Use only the authorized AC Adaptor with this blood pressure
the AC mode for a longer period of time . Leav­ing the batteries in the compartment for a long time may cause leakage, which may lead to damage of the unit.
the distributor for the compatible AC adapters.
monitor.
AC Adapter
(Ø3.8/Ø1.3)
13. Installing Batteries
1. Press down and lift the battery cover in the direction of the arrow to open
the battery compartment.
2. Install or replace 4 “AA” sized batteries in the battery compartment accord-
ing to the indications inside the compartment.
3. Replace the battery cover by clicking in the bottom hooks rst, then push in
the top end of the battery cover.
4. Replace the batteries in pairs. Remove batteries when unit is not in use for
extended periods of time.
You need to replace the batteries when
1. low battery icon appears on display.
2. the START/STOP key is pressed and nothing appears on display.
Caution
1. Batteries are hazardous waste. Do not dispose them together with the
household garbage.
2. There are no user serviceable parts inside. Batteries or damage from old
batteries are not covered by warranty.
3. Use exclusively brand batteries. Always replace with new batteries together.
Use batteries of the same brand and same type.
14. Applying the Cuff
1. Unwrap the arm cuff, leaving the end of the cuff through the D-ring of
the cuff.
2. Put your left arm through the cuff loop. The color strip indication should be
positioned closer to you with the tube pointing in the direction of your arm (Fig. 1). Turn your left palm upward and place the edge of the arm cuff at approximately 1.5 to 2.5 cm above the inner side of the elbow joint (Fig. 2). Tighten the cuff by pulling the end of the cuff.
Fig.1
Fig.5
Fig.2
3. Center the tube over the middle of the arm. Press the hook and loop material together securely. Al­low room for 2 fingers to fit between the cuff and your arm. Position the artery mark (Ø) over the main artery (on the inside of your arm) (Fig. 3,4). Note: Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery.
4. Plug in the cuff connecting tube into the unit (Fig. 5).
5. Lay your arm on a table (palm upward) so the cuff is at the same height as your heart. Make sure the tube is not kinked (Fig. 6).
6. This cuff is suitable for your use if the arrow falls within the solid color line as shown on the right (Fig. 7). If the arrow falls outside the solid color line, you will need a cuff with other circumferences. Contact your local dealer for additional size cuffs.
Fig.3
Fig.4
Fig.6
Fig.7
15. Measurement Procedures
Here are a few helpful tips to help you obtain more accurate readings:
• Blood pressure changes with every heartbeat and is in constant fluctua-
tion throughout the day.
• Blood pressure recording can be affected by the position of the user, his
or her physiological condition and other factors. For greatest accuracy, wait one hour after exercising, bathing, eating, drinking beverages with alcohol or caffeine, or smoking to measure blood pressure.
• Before measurement, it’s suggested that you sit quietly for at least 5
minutes as measurement taken during a relaxed state will have greater accuracy. You should not be physically tired or exhausted while taking a measurement.
• Do not take measurements if you are under stress or tension.
• During measurement, do not talk or move your arm or hand muscles.
• Take your blood pressure at normal body temperature. If you are feeling
cold or hot, wait a while before taking a measurement.
• If the monitor is stored at very low temperature (near freezing), have it
placed at a warm location for at least one hour before using it.
• Wait 5 minutes before taking the next measurement.
1. Press the User-Switching key to select memory zone 1 or memory zone 2.
After a memory zone is selected, press the START/STOP key to reset
the monitor so it can start measurement in the chosen memory zone.
2. Press the START/STOP key. All digits will light up, checking the display functions. The checking procedure will be completed in 2 seconds.
3. After all symbols appear, the display will show a blinking “0”. The monitor is ready to measure and will automatically inflate the cuff slowly to start measurement.
4. When the measurement is completed, the cuff will deflate entirely. Sys­tolic pressure, diastolic pressure and pulse will be shown simultaneously on the LCD screen. The memory sequence number will blink and the Resting Detector symbol will appear on the display. The measurement is then automatically stored in the memory.
) appears on the display, this means the measurement was taken
If (
in a resting state (HSD Negative). Such measurement result can serve as a reference for the users and will be put into the Average of the last 3 measurement calculation.
) appears on the display, the Resting Detector orange light will flash
If (
about 6 times simultaneously. This means the measurement was taken not in a resting state (HSD Positive) therefore such measurement result shall be disregarded and will not be put into the Average of the last 3 measurement calculation.
If the user suffers from bradycardia or very slow heart rate, the device
may not be able to detect the HSD properly during measurement. When this happens, the Resting Detector icon will not appear on the
LCD screen. This monitor will re-inflate automatically to approximately 220 mmHg if the system detects that your body needs more pressure to measure your blood pressure. Note: 1. This monitor automatically switches off approximately 1 minute
after last key operation.
2. To interrupt the measurement, simply press the START/STOP or
Memory key; the cuff will deflate immediately.
3. During the measurement, do not talk or move your arm or
hand muscles.
16. Recalling Values from Memory
1. The monitor has two memory zones (1 and 2). Each zone can store up to
60 measurements.
2. To read memory values from a selected memory zone, use the User-Switch-
ing key to select a memory zone (1 or 2) from which you want to recall
values. Press the Memory key. The first reading displayed is the average of
the last 3 measurements stored in memory.
3. Continue to press the Memory key to view the last previously stored meas-
urement. Every measurement comes with an assigned memory sequence
number. Note: The memory bank can store up to 60 readings per memory zone. When
the number of readings exceeds 60, the oldest data will be replaced with the new record.
17. Clearing Values from Memory
1. Press the User-Switching key to select memory zone 1 or memory zone 2.
2. Continue to press and hold the Memory key for approximately 5 seconds,
then the data in the pre-designated memory zone can be erased automati­cally.
18. Time Adjustment
1. To adjust the date / time in the monitor, press the show a blinking number showing the month.
2. Change the month by pressing the number by one in a cycling manner. Press the entry and the screen will show a blinking number representing the date.
3. Change the date, the hour and the minute as described in Step 2 above, using the “0” will reappear as the Blood Pressure Monitor is ready for measurement again.
4.
key to change and the key to confirm the entries.
key. Each press will increase the
key. The display will
key again to confirm the
19. Data Transfer to PC (Optional)
Rossmax provides a free, integrated and user-friendly blood pressure management software which can be downloaded and installed on your computer. You may purchase a special designed USB cable in order to connect Rossmax’s blood pressure monitor and your PC. Please visit the website at http://www.rossmaxhealth.com for proceeding the download­ing and installation process.
20. Troubleshooting
If any abnormality should arise during use, please check the following points.
EE / Measurement Error:
air socket and measure again. Wrap the cuff correctly and keep arm steady during measurement. If the error keeps occurring, return the device to your local distributor or service center.
E1 / Air Circuit Abnormality:
to the air socket on the side of the unit and measure again. Another possible cause can be due to the short circuit of the microphone embedded in the cuff. If the errors still occur, return the device to your local distributor or service center for help.
E2 / Pressure Exceeding 300 mmHg:
again. If the error keeps occurring, return the device to your local distributor or service center.
E3 / Data Error:
the error keeps occurring, return the device to your local distributor or service center.
Er / Exceeding Measurement Range:
occurring, return the device to your local distributor or service center.
No display when the START/STOP key is pressed:
in the correct positions.
Note:
If the unit still does not work, return it to your dealer. Under no circum­stance should you disassemble and repair the unit by yourself.
Make sure the L-plug is securely connected to the
Make sure the L-Plug is securely connected
Switch the unit off and measure
Remove the batteries, wait for 60 seconds, and reload. If
Measure again. If the error keeps
Re-insert the batteries
21. Cautionary Notes
1. The unit contains high-precision assemblies. Therefore, avoid extreme temperatures, humidity, and direct sunlight. Avoid dropping or strongly shocking the main unit, and protect it from dust.
2. Clean the blood pressure monitor body and the cuff carefully with a slightly damp, soft cloth. Do not press. Do not wash the cuff or use chemical cleaner on it. Never use thinner, alcohol or petrol (gasoline) as cleaner.
3. Leaky batteries can damage the unit. Remove the batteries when the unit is not used for a long time.
4. The unit should not be operated by children so to avoid hazardous situations.
5. If the unit is stored near freezing, allow it to acclimate at room temperature before use.
6. This unit is not field serviceable. You should not use any tool to open the device nor should
you attempt to adjust anything inside the device. If you have any problems, please contact the store or the doctor from whom you purchased this unit or please contact Rossmax International Ltd.
7. As a common issue for all blood pressure monitors using the oscillometric measurement
function, the device may have difficulty in determining the proper blood pressure for users diagnosed with common arrhythmia (atrial or ventricular premature beats or atrial fibrillation), diabetes, poor circulation of blood, kidney problems, or for users suffered from stroke, or for unconscious users.
8. To stop operation at any time, press the START/STOP key, and the air in the cuff will be
rapidly exhausted.
9. Once the inflation reaches 300 mmHg, the unit will start deflating rapidly for safety reasons.
10. Please note that this is a home healthcare product only and it is not intended to serve as
a substitute for the advice of a physician or medical professional.
11. Do not use this device for diagnosis or treatment of any health problem or disease.
Measurement results are for reference only. Consult a healthcare professional for interpretation of pressure measurements. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or healthcare professional.
12. Electromagnetic interference: The device contains sensitive electronic components. Avoid
strong electrical or electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones, microwave ovens). These may lead to temporary impairment of measurement accuracy.
13. Dispose of device, batteries, components and accessories according to local regulations.
14. This monitor may not meet its performance specification if stored or used outside
temperature and humidity ranges specified in Specifications.
15. If a constant arrhythmic pattern is present (e.g. atrial fibrillation), this will mean that HSD might become positive.
22. Specications
Measurement Method Oscillometric Measurement Range Pressure: 30-260 mmHg; Pulse: 40~199 beats/ minute Pressure Sensor Semi conductor
Accuracy Pressure: ± 3mmHg; Pulse: ± 5% of reading
Inflation Pump Driven Deflation Automatic Air Release Valve Memory capacity 60 memories fro each zone x 2 zones Auto-shut-off 1 minute after last key operation
Operation Environment 10°C~40°C (50°F~104°F); 40%~85% RH Storage Environment -10°C~60°C (14°F~140°F); 10%~90% RH
DC Power Source DC 6V four R06 (AA) Batteries AC Power Source Dimensions 120 (L) X 121 (W) X 178 (H) mm Weight 417g (G.W.) (w/o Batteries)
Arm circumference Adult: 24~36 cm (9.4”~14.2”)
Limited Users Adult users
: Type BF :Device and cuff are designed to provide special
*Specifications are subject to change without notice.
DC12V, >600mA(Plug size: outer(-) is Ø3.8, inner(+) is Ø1.3)
protection against electrical shocks.
23. EMC guidance and manufacturer’s declaration
The AD761f is intended for use in the electromagnetic environment specied below. The customer or the user of the AD761f should assure that it is used in such an environment.
RF emissions CISPR 11 Group 1 The AD761f uses RF energy only for its internal function. Therefore, its
RF emissions CISPR 11 Class B The AD761f is suitable for use in all establishments, including Harmonic emissions
IEC 61000-3-2
Voltage uctuations/icker
emissions IEC 61000-3-3
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance Electrostatic dis­charge (ESD) IEC 61000-4-2 Electrical fast
transient/burst IEC
61000-4-4
Surge IEC 61000­4-5
Voltage Dips, short
interruptions and voltage variations
on power supply
input lines IEC 61000-4-11
Power frequency (50/60 Hz) mag­netic eld IEC
61000-4-8
The AD761f is intended for use in the electromagnetic environment specied below. The customer or the user of the AD761f should assure that is used in such and environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
Guidance and manufacturer’s declaration-electromagnetic emissions
Emission test Compliance Electromagnetic environment-guidance
RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
domestic establishments and those directly connected to the public
Class A
low-voltage power supply network that supplies buildings used for domestic purposes.
Compliance
Guidance and manufacturer’s declaration-electromagnetic immunity
The AD761f is intended for use in the electromagnetic environment specied below.
The customer or the user of the AD761f should assure that it is used in such an environment.
± 6 kV contact ± 8 kV air
± 2kV for power supply
lines
± 1kV for input / output
lines
± 1kV line(s) to line(s)
± 2kV line(s) to earth <5% UT(>95% dip in UT) for 0,5 cycle 40% UT(60% dip in UT) for 5 cycles 70% UT(30% dip in UT) for 25 cycles <5% UT(>95% dip in UT) for 5 s 3 A/m 3 A/m Power frequency magnetic elds should be at
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration-electromagnetic immunity
3 Vrms
150 KHz to 80 MHz
3 V/m 80MHz to 2,5 GHz
± 6 kV contact ± 8 kV air
± 2kV for power sup-
ply lines
Not applicable
± 1kV differential
mode
Not applicable <5% UT(>95% dip in UT) for 0,5 cycle 40% UT(60% dip in UT) for 5 cycles 70% UT(30% dip in UT) for 25 cycles <5% UT(>95% dip in UT) for 5 s
3 Vrms
3 V/m
Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30% Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the AD761f requires continued operation during power mains interruptions, it is recom­mended that the AD761f be powered from an uninterruptible power supply or a battery.
levels characteristics of a typical location in a
typical commercial or hospital environment.
Portable and mobile RF communications equipment should be used no closer to any part of the AD761f includ­ing cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1,2 √P d = 1,2 √P 80MHz to 800 MHz d = 2,3 √P 800MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m). Field strengths from xed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
b
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reection from structures, objects and people.
a: Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the AD761f is used exceeds the applicable RF com­pliance level above, the AD761f should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the AD761f.
b: Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Recommended separation distance between portable and mobile RF communications equipment and the AD761f The AD761f is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AD761f can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AD761f as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter / W
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reection from structures, objects and people.
Separation distance according to frequency of transmitter / m
150 kHz to 80 MHz / d=1,2√P 80 MHz to 800 MHz / d=1,2√P 800 MHz to 2,5 GHz / d=2,3√P
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IN0AD761f000000XX
Issue date: 2011/05/03
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