Uploaded by Dự Án Anh Bắc

BP868F Blood Pressure Monitor Operating Manual

advertisement
BP868F Blood Pressure Monitor
OPERATING MANUAL
1
BP868F / UME-03 REV.7
CONTENTS
Thank you very much for your purchasing of AMPall product.,
This device is designed to measure blood pressure. Principle operating is oscillometric system
that warps the cuff on the upper arm and press start button. Then, the air inflows from rolling
pump and it make blood pressure measure and the build in IC reads the gauge and display blood
pressure.
Please read this operating manual carefully before using the device. Keep the operating manual
with the device all the time.
The Warranty Card is included in this operating manual. Please keep the Warranty Card carefully
with the device otherwise you may not get proper customer service.
If it is difficult to understand the operating manual or if there is any problem using the device,
contact our customer center or your retailer for detailed guidance.
IFUs currently offered are only available in English, so if you require IFU in a country that uses
a different language, IFU will be provided in that language.
Thank you.
Features

The angle of the cuff is designed to keep a patient in a comfortable posture when the
patient places their arm into the cuff.

All functions including the ideal tightening pressure of the air cuff and the
pressurization of the fuzzy function are automated for user convenience.

The audio guidance makes the patient measure pulse, and blood pressure easily, and
troubles are notified as the audio guidance as well.

Other than displaying the systolic, diastolic, average blood pressure, and pulse rate,
the device operates with the COIN BOX.

After finishing the measurement, measuring result with current date and time are
printed out automatically. Auto-cutting printer is also available. (Optional – User has to
notice about auto-cutting printer when places an order.)

The blood pressure is displayed on the rear side of the device as well. It makes both of
an operator and a patient can check the data at the same time. (Optional)

With this blood pressure monitor, user can compare its analyzed data with other kinds
of blood pressure measuring device, such as mercury blood pressure monitor or
precision pressure gauge.

BP868 has emergency stop system. In the emergency situation, please press stop
button. Then, the air in cuff emit. It make easily remove the arm form cuff.

It is easy to move the device with its handle on the side of the device.
2
BP868F / UME-03 REV.7
CONTENTS

This blood pressure monitor can recognize troubles and errors by itself and notice it
with audio guidance.
[ e.g. ]
1. “Measuring again. Do not talk or move.”
2. “You pressed the wrong button.”
3. “Please insert the paper.”
4. “Please check the cuff.”
3
BP868F / UME-03 REV.7
CONTENTS
1. Intended of use
2. Cautions for Safety
3. Approval
4. Symbol
5. Description of Each Panel
1) Front
2) Printer
…………………………...
5
…………………………...
5~7
…………………………...
8
…………………………...
9 ~ 10
…………………………...
11
…………………………...
11
…………………………...
12
3) Rear Side
4) Window Display
5) Components
6. Preparation
1) Connecting Power Cord
2)Replacing Fuse
3) Assemble Arm Rest
4) Paper Setting
5) Setting Initial Pressure Level
…………………………...
13
…………………………...
14
…………………………...
15
…………………………...
16
…………………………...
16
…………………………...
16
…………………………...
17
…………………………...
17
…………………………...
18
6) Setting Date and Time
7)Number of Measurement
8)Recall the Store Data
7. Cautions During Measurement
8. How to Measure
9. Knowledge of Blood Pressure
10. Contents of Data
11. Troubleshooting
1) Display
…………………………...
18
…………………………...
19
…………………………...
19
…………………………...
20
…………………………...
21
…………………………...
22
…………………………...
23
…………………………...
24
…………………………...
24
2) Voice
3)Emergency Management
4)Mean Separation from the Power Supply
5) Figure correction
12. Specifications
13. Service Contents
14. Information on EMC
Warranty
…………………………...
24
…………………………...
25
…………………………...
25
…………………………...
26
…………………………...
27
…………………………...
28
…………………………...
29
4
BP868F / UME-03 REV.7
INTENDED OF USE
1. Intended of use
BP868F is a non-invasive blood pressure measurement system intended to measure the
diastolic and systolic blood pressures and pulse rate of an adult(18 years of age and older)
individual by using a non-invasive technique in which an inflatable cuff is wrapped around the
arm.
This product is intended to be used in public places such as hospitals, are available to patients
except neonate or pregnant women.
Following clinical benefits are expected:
Prediction of cardiovascular disease associated with both systolic and diastolic blood
pressure.
Intended medical indication
BP 868F is a non-invasive blood pressure measurement system intended to
measure the diastolic and systolic blood pressures and pulse rate of an adult
individual by using a non-invasive technique in which an inflatable cuff is wrapped
around the arm.
This product is intended to be used in public places such as hospitals, are available
to patients except neonate or pregnant women.
Intended patient population
Considerations : Requirement description
Age: Adult, 18 years old or more
Weight : Not relevant
Health : Not relevant
Nationality : Multiple
Sex : Not relevant
Patient state (arm circumference): 25 – 40 cm
Intended part of the body or type of tissue applied to or interacted with
Intended part: Not limited
Condition: Intact skin
Intended user profile (Operator Profile)
Considerations : Requirement description
Education Minimum : At least graduate of medical college
Maximum : No maximum
Knowledge Minimum : Read and understand 'westernized Arabic' numerals when
written in Arial font
- Can distinguish of human body
- Understands hygiene
Maximum : No maximum
Language understanding Minimum : Local language
Maximum : Understanding of manual that is writing in English
Experience Minimum : Have license of radiologist or have to meet local regulation
Maximum : No maximum
Permissible impairments Minimum : Mild reading vision impairment or vision
corrected to log MAR 0.2
- Average degree of aging-related short term memory impairment
- Impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to 2 kHz
5
BP868F / UME-03 REV.7
INTENDED OF USE
Operating principle
This device is designed to measure blood pressure. Principle operating is
oscillometric system that warps the cuff on the upper arm and press start button.
Then, the air inflows from rolling pump and it make blood pressure measure and
the build in IC reads the gauge and display blood pressure.
2. Cautions for Safety
Please read manual before use.
The safety related warnings indicates in the following are for preventing unexpected danger or
loss in advance by using the product safety and correctly.
This is the symbol for calling attention to matters and operations that can cause danger. Take
cautions and follow instructions in order to avoid danger.
Warning
Attention
1)
If the user does not follow the instructions, the user can lose her or
his life or receive a serious wound.
If the user does not follow the instructions, the user can be
wounded or face property damage.
Warning
① During the installation –
Do not disassemble or remodel the product. (Products disassembled at the user’s

discretion are excluded from after sales service.)

Please contact the manufacturer if the product needs to be repaired.

When grounding the product, make sure not to come in contact with gas pipe, telephone
line, and water pipe.
② About Power –

Do not cut or modify the cord.

Do not use damaged power or plug. It can be the reason of electric shock or fire.

Do not pull plug with wet hands. It can be a risk of electric shock or burn.

Make sure the power and voltage are 230VAC before installation.(If the power and voltage
are over, there are dangerous of fire.

To avoid risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
③ In Use –

Do not spill liquid or put alien substances into the machine.

Do not use the product when it is broken or malfunctioning.

In case the water gets into the product, pull out the power plug immediately and call the
service center.

Do not use this product together with other medical instruments.

When pressure is applied around the cuff, ME device that simultaneously perform
monitoring functions on the same limb may temporarily lose their function.
6
BP868F / UME-03 REV.7
INTENDED OF USE

Do not simultaneously contact the patient with areas where current exceeding the
contact current may flow.

Be sure to replace the power cord with the power off. Otherwise, there is a risk of electric
shock.

Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.

Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper
operation.

Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the device, including cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
Attention
2)
① During the Installation –
 Do not use the product in an unstable place or a place where it can be adversely affected
by dust, vibration and shock.

Do not install or store the produce in a place that stores chemicals or generates gas.

Do not store the product in the place where it can be adversely affected by air pressure,
temperature, humidity, ventilation, and light.

Use the designated parts only.

Do not to position the product so that it is difficult to disconnect the power.
② About Power –

This product can be plugged into ordinary power outlet.

If the product is not going to be used for a long time, unplug the product.

If there are dust and alien substances on the plug pin and the connecting part, wipe
them off cleanly.

Do not bend the power cord excessively.

When pulling out the power cord, do not pull the cable but pull the plug.
7
BP868F / UME-03 REV.7
INTENDED OF USE

After complete inspection, switch off the switch located on the back of the product
③ In Use –

When you turn on the power, it will inspect the system for 3 seconds. Do not shock the
product.

Always check there is no trouble with the product overall while in use.

Please press stop button in emergency situation.

When cleaning the product, use soft cloth. Never use organic solvent (acetone, thinner,
benzene, gasoline, etc.) or wet cloth. (However, in case the exterior of the product is
contaminated seriously, use isopropyl alcohol and dry cloth to clean the product.)

If you want to clean the inside of the cuff, please contact the manufacturer.

If it makes strange sound, smell or smoke while in use unplug the machine immediately
and call the service center.

Measuring repeatedly can overstrain the user. Please wait at least 30 seconds after
each measurement.

In case of using the product after it has not been used for a long time, check the product
for any abnormalities before use.

If a user has interruption in blood circulation or blood related disease, please use the
direction from medical doctor.

Do not use for neonatal patient and pregnant patient.

Do not use mobile phone close to device. It can be a reason of malfunction.

This can be used by persons without disabilities who can perceive whether or not the
product is operating.

Do not use device other than measuring blood pressure.

Do not pressure cuff over 300mm Hg.

It is dangerous to decide and treat by user self without medical doctor’s direction.
Please follow doctor’s treatment.

This product is designed for measuring blood pressure, not for treatment

The patient is an intended operator.

When not in use for a long time, the coin battery inside must be removed
Please note: if you are using this medical device have reason to believe that a serious
incident has occurred, please report this to the dealer, manufacturer and your national
authority
8
BP868F / UME-03 REV.7
APPROVAL
3.
Approval
1) CE Mark
- Approval mark for market in European communities (EC).
2) AMPall Co.Ltd passed performance and safety EMC test from KTL.
3) AMPall Co.Ltd also passed Manufacturing permit test and have permit of manufacturing of
medical device.
4) Applicable Standard
-
IEC 60601-1:2005
-
IEC 60601-1-2:2007
-
IEC 60601-1-6:2010
-
IEC 80601-2-30:2018
9
BP868F / UME-03 REV.7
SYSMBOL FOR USING
4. Symbol for using
No.
Description
Symbol
1
Model Number.
2
UDI Code.
3
Refer to instructions for use
4
BF type protection applied.
5
Medical Device
6
Manufacturing Date and year
7
Manufacture information
8
Manufacturer’s EU representative information
9
Serial Number
10
CE Marking of conformity
11
Keep dry
10
Remark
BP868F / UME-03 REV.7
SYSMBOL FOR USING
12
Fragile
13
This way up
14
Use no hooks
15
16
17
To indicate that transport package shall not be
exposed to sunlight.
Indicates the temperature limits to which the
medical device can be safely exposed.
Indicates the range of humidity to which the
medical device can be safely exposed.
Indicates the range of atmospheric pressure to
18
which the medical device can be safely
exposed.
11
BP868F / UME-03 REV.7
DESCRIPTION OF EACH PANEL
5. Description of Each Panel
1) Front
①
⑥
⑦
②
③
④
⑤
① Display Window
 Window displays all information and measuring data about blood pressure and pulse.
② START Button
 This button begins measurement.
③ STOP Button
 This button stops measurement.
④ Emergency Stop Button
 Press this button to release the cuff and stop the operation when the pressure is too
high that it is hurting the arm or when the system is operating abnormally.
⑤ Paper Outlet
 The blood pressure information shown on the display panel after the measurement is
printed and put out through this outlet.
⑥ Cuff Part (Applied Parts)
 Automatically tightens and releases the cuff while measuring the blood pressure.
The Arm circumference range: 25 ~ 40 cm or less (brachial amidships)
⑦ Print Button
 1) This button prints out the measured data. If the PRINT ON/OFF switch on the back is
on, it will automatically print out the result before you press this button.
2) If you press this button when you are not measuring the blood pressure, it will load
the previously measured values. To print the loaded data, press L/F button under
the print cover.
12
BP868F / UME-03 REV.7
DESCRIPTION OF EACH PANEL
2) Printer
BUTTON
BUTTON
① SET Button
 Use this button to set date and time.
It also changes the maximum pressure value (155 mmHg, 185 mmHg, 215 mmHg, 245
mmHg).
② L/F Button
 This button puts out the paper.
This also changes numbers when setting date and time.
13
BP868F / UME-03 REV.7
DESCRIPTION OF EACH PANEL
3) Rear Side
⑨
①
②
③ ④
⑤
⑥
⑦
⑧
① Inspection Valve
 This is connected to mercury blood pressure monitor and precise pressure gauge to
check the accuracy of the pressure.
② RS232C/COIN CONNECTOR
 Use this to connect the machine to external units such as the machine. (OPTION)
③ Voice Volume
 Use this to adjust the volume or turn on/off the voice guidelines.
④ Printer ON/OFF Switch
 ON: When the blood pressure is measured, the result is automatically printed out.
OFF: Press the print button on the front to print the results after measuring the blood
pressure.
⑤ COIN ON/OFF Switch
 Turn on this switch when using the coin machine. This switch must be turned off if
the coin machine is not installed.
⑥ Equipotentiality port
 It is a connection port to maintain the equipotential when used in the same place as
other medical devices.
 Cable is not provided. Use a cable that meets the specifications below:
- Cable within 2 m length
- It is recommended to use a wire diameter of 0.75 mm (AWG20) or more.
⑦ Power Socket
 Connect the power cord here.
⑧ Power Switch
 Turn on or off the blood pressure monitor.
⑨ Rear Side Display
 Display systolic pressure, diastolic pressure, and pulse rate on the rear side.
14
BP868F / UME-03 REV.7
DESCRIPTION OF EACH PANEL
4) Window Display
 Front Window Display
Diastolic
Systolic
Pulse Detection
Time
Measurement
in Process
Pulse Rate
15
BP868F / UME-03 REV.7
DESCRIPTION OF EACH PANEL
5) Components
① Printer Roll
② Power Cord
This is the thermal paper for printing the result of
blood pressure measurement.
Length: 25M, Breadth: 57.5mm
• Do not store the paper in the humid or hot place.
• Store it in the dark and cool place and make
sure it is not directly exposed to sunlight.
• Make sure the paper is not contaminated by
alien substances.
This power cord supplies power to the blood
pressure monitor.
③ 232C Cable (OPTION)
This cable connects the computer and blood
pressure monitor. Use this cable to transmit data
from blood pressure monitor to computer
and control the blood pressure monitor from
the computer.
④ Arm Supporter
⑥ IFU (Instruction For Use)
⑤ Coin Box(Option)
16
BP868F / UME-03 REV.7
CAUTIONS DURING MEASUREMENT
6. Preparation
1) Connecting Power Cord
① Connect the power cord to the AC power connector of the blood pressure monitor.
② Connect the grounding cable to the grounding terminal.
[Attention] Do not connect the grounding line of the blood
pressure monitor to gas pipe, telephone line, and water pipe.
It is very dangerous.
2) Replacing Fuse
 If it does not display anything after you connect the power
cord to the main unit, plug it to the outlet, and turn on the
power, check the fuse first. Using regular screwdriver,
remove the fuse above the power connector on the back of
the blood pressure monitor, and check the wire inside the
fuse is broken. If the wire is broken, replace it as follows.
Inside the black fuse holder, there is an extra fuse. Remove
the broken fuse and replace it with the new fuse.
Extra Fuse
Fuse in Use
[Fuse Holder]
17
BP868F / UME-03 REV.7
CAUTIONS DURING MEASUREMENT
3) Assemble Arm Rest
 For better and more accurate blood pressure measurement, mount the arm rest supplied with
the machine.
1. A : Prepare the Arm Rest.
2. B ,C : Combine BP868F and Arm Rest as shown in the photo.
3. D : Check BP868F and Arm Rest for good coupling.
18
BP868F / UME-03 REV.7
CAUTIONS DURING MEASUREMENT
4) Paper Setting
 Set the paper in the setup mode as in the picture on the right.
To enter the setup mode, press the STOP button.
1) While the power is on, press the printer cover indicated
area
on the [Fig 1] to open the printer cover.
2) Pull up the lever on the left. [Fig 3]
3) Place the beginning of the roll into B as in Fig 3.
Make sure the data is printed on the outer surface
of the roll.
4) Press L/F button repeatedly until the paper comes
out through C. [Fig 4]
5) In case the paper is tiled or leaned to one side, set
the paper again.
6) When the paper comes out through C, put the shaft
into the roll and put it in place. [Fig 5]
7) Pull down the lever.
8) Put the beginning of the recording paper into the
groove of the cover to pull it toward the outside
9) Place the cover and close.
[Fig 5]
<Attention>
• When you pull out the paper, pull up the lever first.
• If you do not pull down the lever, it will not print.
• Use thermal printing paper only (Length: 25 m, Breadth: 57.5
mm).
• Make sure the paper is clean and not crumpled.
• Do not pull the paper while printing.
• Store the paper in a well ventilated and dark place.
5) Setting Initial Pressure Level
Press L/F button to change initial pressure level to
155mmHg, 185mmHg, 215mmHg, 245mmHg and press SET button to set the pressure.
If you do not need additional settings, press the STOP button.
If you need to make additional settings such as date and time, press the SET button.
6) Setting Date and Time
Turn on the power. Start setting the date and time in the setup mode. Enter the setup mode.
•Open the print cover.
•Set date and time in the order of Year→Month→Date→Hour→Minute.
 Setting Year
① Press the SET button under the print cover and the 3rd digit
of the Year will flicker.
② Press L/F button. Each time you press the button, the number
will change from 0~9.
③ If reach the number you want, press SET button to set the value.
The first two digits of the Year will automatically change to 19 or
20 according to the digits you set.
④ When you press SET button, the 4th digit will begin to flicker.
Press L/F button to select the appropriate value and press SET
19
BP868F / UME-03 REV.7
CAUTIONS DURING MEASUREMENT
button to set.
(Note: The maximum value that can be set for the Year is 2099.)
 Setting Month and Date
① When you set the Year, the ‘Month· Date Setting’screen will
appear automatically. Press L/F button repeatedly to
switch numbers from 1~12, each representing the month.
When you reach the number you want, press SET button to set.
② When you press SET button, the “Date” will start to flicker.
When you press L/F button, it will switch numbers from 0 to 3,
and press SET button to set the number you want. Select
the second digit of the date with L/F button and press SET
button to set.
 Setting Time
① When the month and date are set, the ‘Time Setting’screen will
appear.
Press L/F button to set the number from 1~12 and press SET
button to set. Check AM or PM.
② The “Minute” will flicker automatically. Select the first digit
of the minute using L/F button and press SET button to set.
Select the second digit of the Minute with L/F button and
press SET button to set.
<Attention>
When you press STOP button while setting, the values will not
be stored. When you turn off the power, the date and time values
will remain for 60 days. However the time data can change if it
is not used for a long time (more than 60 days).
7) Number of Measurement
After you set the time, it will display the total
number of use.
The example on the right indicates that it was used
135,789 times to measure blood pressure.
135
789
8) Recall the Stored Data
You can see 5 previous measurements (including systolic and diastolic pressures and pulse
rate) with the device.
The device stores measured data whether it is on or off.
When you proceed to new measurement, the oldest measurement data will be erased and the
new measurement will be stored.
To recall the stored data,
① Press the “PRINT” button while you are not measuring the blood pressure. Recent
measurement will be appeared.
② Every time you press the “PRINT button”, the window will display the stored data in order up
5 measurements.
③ To print the values, press “L/F” button under the print cover.
20
BP868F / UME-03 REV.7
CAUTIONS DURING MEASUREMENT
9) COIN Box
- Connect the cables to the RS232C connector on the BP868F and coin box as shown.
7. Cautions During Measurement

Directions for measuring dairy stable blood pressure
-
Sit in comfortable position during measurement.
-
Do not measure while standing and crossing legs.
-
Close feet against bottom during measurement.
-
Stand sack and arms in stable position
-
Before measuring the blood pressure, adjust the height of the stool so that the level of the heart
comes to the level of the elbow when seated.

Before measuring, calm down and relax for 5 minutes without moving.

Do not talk or move while measuring.

Take off heavy jacket when measuring.

It can be automatic re-pressure cause of lack of pressure. (limit: 1 time)

When you place your arm, push it all the way to place your arm on the arm rest.

Any blood pressure reading can be affected by the measurement site, the position of the
patient(standing, sitting, lying down), exercise, or the patient’s physiologic condition.

Avoid exercise, food, smoking and cold before measuring.

If you want to stop measuring or feel your arm is hurting, press the Emergency Stop button.
21
BP868F / UME-03 REV.7
CAUTIONS DURING MEASUREMENT

Do not roll up the sleeve to the area of the arm that is measured. The blood pressure may be
incorrectly measured.

Do not place another part of the body in the cuff.

Do not measure while the print cover is not in place.

Too frequent measurements can cause injury to the patient due to blood flow interference. Please
measure blood pressure after disappear congestion. – If pressure arm, fingertips of blood vessel
can be stop. For disappearing congestion, remove arm from cuff. Hand up and grasped and
straitening 15 times.

Do not roll up sleeve on measuring part. It might affect on measuring accuracy.

If measure on injured part, it will be worse.

The cuff and its pressurization on any limb where intravascular access or therapy, or and arteriovenous(A-V) shunt, is present because of temporary interference to blood flow and could result
in injury to the patient

Do not measure after breast surgery.

This device does not make damage on the circulation of blood.
The following factors can affect the performance of sphygmomanometers and blood pressure
readings. : common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation,
arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases,
patient motion, trembling, shivering.
8. How to Measure
① Turn on the power.
② Place the right arm into the cuff.
Adjust the stool height so that the level of heart comes to the level of elbow and make sure
your palm is facing the ceiling and put your arm all the way in and put it on the arm rest.
③ Press “START” button.
MENT: “Measuring is started.”
“Don’t speak or move, please.”
The pressure is applied to the cuff automatically and the measurement will begin.
④ “Measurement in Process (MEASURE)” lamp will be lit when the measurement begins
⑤ After the measurement, the air will be exhausted automatically and the cuff will release the
arm. The blood pressure and pulse rate will be displayed.
MENT: “Measuring is finished. Your blood pressure is ___ to ___. ”
⑥ Remove your arm from the cuff.
22
BP868F / UME-03 REV.7
KNOWLEDGE OF BLOOD PRESSURE
⑦ If the PRINT Switch on the back of the machine is ON, the results will be printed out
automatically and if it is OFF, the voice will say, “If you want to print the results, please press
the PRINT button.” Press PRINT button to print out the result if necessary.
⑨ The results will be printed out. When the paper is out, cut the paper.
⑩ MENT : “Thank you, for using”
23
BP868F / UME-03 REV.7
CONTENTS OF DATA
9. Knowledge of Blood Pressure
Blood pressure means the pressure of blood push the blood vessel during heart beat.
Commonly says “120/ 80”. 120 is the measure of pressure exerted by circulating upon the walls
of blood vessels on systolic. 80 is the measure of blood vessel on diastolic.
Diagnosis of high blood pressure
High blood pressure means that measure of blood pressure is higher than normal. WHO,
European Society of Cardiology and JNC 7 give the standard of diagnosis of high blood
pressure. Commonly JNC7 is used. The below table is the standard of diagnosis of high blood
pressure by JNC7.
Level of high blood pressure
Systolic
Diastolic
Normal
Under 120
Under 80
Pre-hypertension
High stage1
High satge2
120 ~ 139
140 ~ 159
Over 160
80 ~ 89
90 ~ 99
Over 100
Reason of high blood pressure
The reasons of high blood pressure are high cholesterol, smoking, diabetes, lack of exercise,
over weight, which are possible to control risk factors and age, gender and family history which
are impossible to control. If you have high blood pressure, need to improve life style to decrease
circumstance factor and take a medicine to decrease blood pressure into normal range.
24
BP868F / UME-03 REV.7
CONTENTS OF DATA
10. Contents of Data
• SYSTOLIC
• DIASTOLIC
• MEAN
• PULSE/min
01:33 PM April 10, 2007
Systolic ····· 128mmHg
Diastolic ····· 062mmHg
Mean ······ 084mmHg
Pulse/min ···· 082/ min
*World Health Organization (WHO) Blood Pressure Categorization
Graph*
25
BP868F / UME-03 REV.7
TROUBLE SHOOTING
11. Trouble shooting
1) Display
Error
Cause
Solutions
EE2
Pulse is too weak to measure
Calm down and relax and measure
again.
Take off thick jacket.
If the pulse is too weak to even hear
it through the stethoscope, it is
difficult to measure the blood
pressure.
EE3
Blood pressure and Pulse are too
irregular to measure (off reference)
Calm down and measure again
EE4
Moved when measuring the pulse
Do not move or talk when measuring
the pulse
2) Voice Guidance
Voice
“Measuring again.
Do not speak or move.”
“Please insert the paper.”
“You pressed the wrong button.”
“Please check the cuff.”
Cause
This happens when the patient moves while measuring
the pulse and it will automatically begin to measure
again.
However, it will stop in case this happens twice.
There is no paper.
(When the red line appears on the side of the paper,
change the paper)
Wrong button is pressed.
The patient pressed the START button without placing
the arm inside the cuff or the air is slightly leaking from
inside.
(Repair is required)
26
BP868F / UME-03 REV.7
TROUBLE SHOOTING
3) Emergency Management
Problems
Nothing
display
is
shown
Solutions
on
the
• Check the power cord.
• Check the fuse.
(Refer to page 2-1 when replacing the fuse.)
Pressure is not applied
• Check the mercury blood pressure monitor tube (CAL
terminal).
• Check whether there are alien substances between cuff and
cuff cover.
Voice is not heard
• Check whether the voice switch volume on the back is ON.
Printer
a. Nothing is printed
• Check the surface and direction of the thermal paper.
• Check whether the lever on the left is pressed down.
Use the designated thermal paper.
• Open the printer cover and check whether the paper is stuck.
• Check whether the printer switch on the back is On.
b. Paper is not out
c.
It
does
not
automatically
Cuff is tight
loosened
and
The
measurements
abnormal
print
is
not
• Press the Emergency Stop switch on the front side.
• Check whether there are alien substances between cuff and
cuff cover.
are
• Check whether the installation location and peripheral
environment are appropriate for measurement. (Temperature
10℃~40℃, humidity 95% or less)
Check whether the measuring posture is appropriate.
When the button is pressed,
the beep sound is heard but it
does not operate
• Check whether the coin is on or off.
Turn off the coin machine if it is not in use.
※ All device repairs must be performed by the manufacturer. For other troubles,
please contact the manufacturer’s Customer Service Center directly or contact your
retailer.
4) Means separation from the power supply
Power cord
- Disconnect the power cord to the AC power.
27
BP868F / UME-03 REV.7
TROUBLE SHOOTING
5)
Figure correction


Caution : Please check the unit with stethoscope before doing this.
Get into TEST MODE :Press SET button(Maximum pressure value is displayed.)-> Press Print
button 3 times -> Press L/F twice -> Press SET button -> Press L/F button twice -> Press SET
button ->Press L/F button once.(Display should show “0000” in the window.)

Get into TEST MODE. Get into “0”by press L/F button. Cuff is wrapped automatically. At this
time there should be such an artificial arm to be measured. Connect Mercury BP monitor with
CAL port and inflate cuff with Air chamber on Mercury BP monitor. Pressure on BP868 and
Mercury BP monitor will go up together. Inflate about 150 to 200mmHg and compare both
monitor. At time, compare both pressure when pressure decreases slowly so both monitor can
be checked easily. Different pressure between BP868 with Mercury BP monitor should be
within ±6mmHg(Error range of Mercury BP monitor is ±4mmHg, Error range of BP868 is
±2mmHg). If difference of pressure is out of range, try Method 0 as below.


When Mercury BP monitor is connected with CAL port on BP868F, there should be no
leakage of pressure on Air chamber and CAL port.
Method 0 : Connect the External pressure equipment(BP Pump to FLUKE) to the CAL terminal of the
blood pressure monitor. After pressurizing more than 300mmHg with the BP pump, press the SET
key when the BP pump indicates 300mmHg. (Execution step by step 300, 5, 0mmHg)
The pressure constant is displayed on the FND window where the time is displayed. The pressure
error can be compensated for by adjusting this value.
Use the LF /PRINT button to set the time constant to the pressure value indicated by the BP Pump
for the part where there is an error. If you press the SET button, the data is saved and the mode
ends. but Pressing the start/end bouton exits the mode without saving data.
Method 1: Get into TEST MODE -> Adjust number 19 by pressing SET button, get into mode by
pressing L/F button -> Basic value is 70, it can be adjusted by pressing L/F button.-> When the
measuring value is high, adjust number less than 70, when the measuring value is low, adjust
28
BP868F / UME-03 REV.7
TROUBLE SHOOTING
number more than 70. -> Save the value by pressing SET button -> Get out of MODE by
pressing START/STOP button. -> Measure blood pressure again.
Method 2: Get into TEST MODE -> Adjust 14 by pressing SET button, get into the mode by pressing
L/F button. -> Basic value is “0”, it can be adjusted by pressing L/F & SET button -> When
Systolic is high, adjust SyS value at ‘-‘as much as it high, when it is low, adjust SyS value at’+’
as much as it low. -> When Diastolic is high, adjust Dia value at ‘-’ as much as it high, when it
is low, adjust Dia value at ‘+’ as much as it low. -> Save the value by pressing START/STOP
button. -> Get out of MODE by pressing START/STOP button -> Measure blood pressure
again.
* This mode shall not be available in NORMAL USE, But restricted to SERVICE
PERSONNEL.
* The BP868F must check the pressure at least once a year.
29
BP868F / UME-03 REV.7
SPECIFICATION
12. Specification
Model Name
BP868F
Measurement
Method
Oscillometric method
Exhaustion Method
Automatic exhaustion by micro controller
Pressure Detection
Semiconductor strain gauge
Display Method
LCD or FND (7-Segment)
Measurement
Scope
Pressure: 30~300mmHg
Pulse: 30~200/min
Minimum
Measurement Unit
1mmHg
Precision
Pressure: ±2mmHg
Pulse: ±3%
Cuff Operating
Method
Belt operation by micro controller
Pressurizing Time
Approximately 10 seconds
Measuring Time
Approximately 30 seconds
Print
Thermal high speed printer (option: auto-cutting)
Power
AC230V (Fuse : F 2.0AL, 250VAC)
Frequency
50 Hz
Classification
Class 1
Type of protection
Type BF
Degree of protection
IPX0
Communication
Connectible to coin machine (option: RS232C cable)
Emergency Stop
Stops by micro processor
Voice Support
Provides voice guidelines
Reads blood pressure value after measurement as well as the error message
Power
Consumption
50VA
Operation Scope
Temperature +10℃~+40℃, humidity 95% or less, pressure 70~106Kpa
Storing Condition
Temperature –5℃~+50℃, humidity 85% or less, pressure 50~106Kpa
Dimension
453 (W)×340(D)×306(H)
Weight
Approximately 8.6kg
Components
1 power cord, thermal paper roll, arm rest, user manual
Options
Customer management program, communication cable, auto-cutting protection cover
Software version
B8M0101K:MAIN, B8I0101K:IO, B8D0101K:SUB
30
BP868F / UME-03 REV.7
Information on EMC
13. Service Contents
In case any trouble is found while it was used under normal condition during the warranty period
or in case any manufacturing defect is found, contact our customer service center for free repair.
Services will be charged in the following cases regardless of the warranty period.
① The warranty period (1 year) is expired
② The trouble was caused by negligence of the user
③ The contents of the product are modified or damaged by the user
④ No warranty certificate
⑤ Trouble due to natural disasters
⑥ The person other than the technician from our service center repaired or remodeled the
product and the trouble is found
The warranty certificate is not reissued. Please keep it importantly.
You must present the warranty when requesting for repair.
►Parts can be replaced or functions can be changed in order to enhance product quality. ◄
31
BP868F / UME-03 REV.7
Information on EMC
14. Information on EMC
14.1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The EUT is intended for use in the electromagnetic environment specified below. The
customer or the user of the EUT should assure that it is used in such an environment.
Emission test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Compliance
Electromagnetic environment - Guidance
The EUT uses RF energy only for its internal function.
Group 1
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment
Class A
The EUT is suitable for use in ail establishments, including
Harmonic
emissions
domestic establishments and those directly connected to
Class A
IEC 61000-3-2
the public low-voltage power supply network that supplies
buildings used for domestic purposes
Voltage fluctuations
/ Flicker emissions
Complies
IEC 61000-3-3
32
BP868F / UME-03 REV.7
Information on EMC
14.2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The EUT is intended for use in the electromagnetic environment specified below. The
customer or the user of the EUT should assure that it is used in such an environment.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic environment Guidance
Floors should be wood, concrete
Electrostatic
discharge (ESD)
IEC 61000-4-2
±(2,4,6)kV Contact
±(2,4,6)kV Contact
±(2,4,8)kV air
±(2,4,8)kV air
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
AC Mains (Line to
AC Mains (Line to
Surge
Line): ± (0.5, 1) kV
Line): ± (0.5, 1) kV
IEC 61000-4-5
(Line to Earth): ±
(Line to Earth): ±
(0.5, 1,2) kV
(0.5, 1,2) kV
immunity
interruptions
IEC 61000-4-11
hospital environment.
should be at levels characteristic
3 A/m
3 A/m
of a typical location in a typical
commercial or hospital
IEC 61000-4-8
Voltage dips, short
that of a typical commercial or
Power frequency magnetic fields
Power frequency
magnetic field
Mains power quality should be
environment.
<5% Uт
<5% Uт
(>95% dip in Uт)
(>95% dip in Uт)
Mains power quality should be
for 0.5cycle
for 0.5cycle
that of a typical commercial or
40% Uт
40% Uт
hospital environment. If the user
(60% dip in Uт )
(60% dip in Uт)
of the EUT image intensifier
for 5 cycle
for 5 cycle
requires continued operation
70% Uт
70% Uт
during power mains
(30% dip in Uт)
(30% dip in Uт)
interruptions, it is recommended
for 25 cycle
for 25 cycle
that the EUT image intensifier be
<5% Uт
<5% Uт
powered from an uninterruptible
(<95% dip in Uт )
(<95% dip in Uт)
power supply or a battery.
for 5 s
for 5 s
NOTE Uт is the A.C. Mains voltage prior to application of the test level.
33
BP868F / UME-03 REV.7
Information on EMC
14.3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The EUT is intended for use in the electromagnetic environment specified below. The
customer or the user of the EUT should assure that it is used in such an environment.
Immunity test
IEC 60601
Compliance
Electromagnetic environment -
Test level
level
Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the EUT, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
3 Vrms
150 kHz to
150 kHz to
80MHz
80MHz
3 V/m
3 V/m
80 MHz to
80MHz to
2.5GHz
2.5GHz
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 meters (m).
Field strengths from fixed RF transmitters,
as deter-mined by an electromagnetic site
survey, a
should be less than the compliance level in
each frequency range. b
Interference may occur in the vicinity of
34
BP868F / UME-03 REV.7
Information on EMC
equipment marked with the following
symbol :
NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the EUT is used exceeds the applicable RF compliance level
above, the EUT should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the EUT.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.
35
BP868F / UME-03 REV.7
Information on EMC
14.4 Recommended separation distances between portable and mobile RF communications
equipment and the EUT
There is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the EUT can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the EUT as recommended below, according
to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter [m]
Rated maximum
80MHz to
800MHz to
800MHz
2.5GHz
V1=3Vrms
E1=3V/m
E1=3V/m
0.01
0.116
0.1166
0.2333
0.1
0.368
0.3687
0.7378
1
1.166
1.1660
2.3333
10
3.687
3.6872
7.3785
100
11.660
11.6600
23.333
output power of
150kHz to 80MHz
transmitter
[W]
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (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 80MHz and 800MHz, 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 reflection from structures, objects and people.
36
BP868F / UME-03 REV.7
Information on EMC
14.5 Immunity and Compliance Level
Immunity test
IEC 60601 Test Level
Conducted RF
3Vrms
IEC 61000-4-6
150kHz to 80MHz
Radiated RF
3Vrms
IEC 61000-4-3
80MHz to 2.5GHz
Actual Immunity
Compliance Level
Level
3Vrms
3Vrms
3V/m
3V/m
14.6 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The EUT is intended for use in the electromagnetic environment specified below. The
customer or the user of the EUT should assure that it is used in such an environment.
Immunity test
IEC 60601
Compliance
Electromagnetic environment -
test level
level
Guidance
The EUT must be used only in a shielded
location with a minimum RF shielding
effectiveness and, for each cable that
Conducted RF
IEC 61000-4-6
enters the shielded location with a
3 Vrms
3 Vrms
150 kHz to
150 kHz to
80MHz
80MHz
minimum RF shielding effectiveness and,
for each cable that enters the shielded
location
Field strengths outside the shielded
location from fixed RF transmitters, as
determined by an
Radiated RF
IEC 61000-4-3
electromagnetic site survey, should be less
3 V/m
3 V/m
80 MHz to
80MHz to
2.5GHz
2.5GHz
than 3V/m.a
Interference may occur in the vicinity of
equipment marked with the following
symbol:
37
BP868F / UME-03 REV.7
Information on EMC
NOTE 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
NOTE 2) It is essential that the actual shielding effectiveness and filter attenuation of the shielded
location be verified to assure that they meet the minimum specification.
a Field strengths from fixed 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 fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength
outside the shielded location in which the EUT is used exceeds 3V/m, the EUT should be observed to
verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as relocating the
EUT or using a shielded location with a higher RF shielding effectiveness and filter attenuation.
38
BP868F / UME-03 REV.7
Information on EMC
Warranty Card
Thank you for your purchasing for AMPall product. The warranty period
of BP868F is valid from the purchasing date. Please notice the purchasing
date on the warranty card and keep this Warranty Card with the device
all the time to get full customer service.
Product Name
Artificial Intelligence Blood Pressure Monitor
Model Name
□ BP868F
Manufacturing
Date
Warranty
Period
1 year
Purchasing
Date
/
/
Name:
(year/ month/ date)
Tel.:
Customer
Add.:
Name:
Tel.:
Retailer
Add.:
Repairing Record
Date
☆
Contents of Repair
Confirmation
Please show this Warranty Card when you request repairing service.
3F. Annex Hankook Junja Hyeopdong B/D, 114, Gasan Digital 2-ro,
Geumcheon-Gu, Seoul, 08506, Korea
TEL : +82-2-858-2839~41 / FAX : +82-505-350-2442
E-mail : ampall@ampall.com / Website: www.ampall.com
39
BP868F / UME-03 REV.7
Information on EMC
■ This is a medical equipment ■
▪ Product Name: Blood Pressure Monitor (BP868F)
▪ Manufacturer: AMPall Co., Ltd
3F Annex Hankook Junja Hyeopdong B/D, 114,
Gasan Digital 2-ro, Geumcheon-Gu, Seoul, 08506, Korea
Tel.+82-2-858-2839~41, Fax.+82-505-350-2442
http://www.ampall.com
▪ EC Representative : AR Experts B.V.
Amerlandseweg 7, 3621 ZC Breukelen, The Netherlands
TEL: +31 (0)88 995 1333
E-mail: info@ar-experts.eu
▪ Protection against Electric Shock and Degree of Protection: First
Class Equipment, Equipment Type BF
▪ Rated: 1-Phase AC230V 50Hz
▪ Power Consumed: 50VA
▪ Fuse: F 2.0AL, 250VAC
▪ Precision and Measurement Range:
Pressure (30~300mmHg, ±2mmHg),
Pulse (30~200/min., ±3%)
▪ Operating Method and Cautions: Refer to the User Manual
▪ Purpose of Use: Measurement of blood pressure and pulse rate
▪ Manufacture Permit: No. 2187
▪ Item Permit: No. 01-431
▪ Weight: 8.6Kg (main unit)
40
BP868F / UME-03 REV.7
Download