ACCUNIQ BP850 User Manual - 170323 Rev1.1
ACCUNIQ BP850 User Manual - 170323 Rev1.1
ACCUNIQ BP850 User Manual - 170323 Rev1.1
Directive 93/42/EEC.
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TABLE OF CONTENTS
• INTRODUCTION.................................................................................................................. 5
1. INDICATIONS ................................................................................................................. 5
2. WORD DEFINITIONS...................................................................................................... 5
3. CLASSIFICATION AND COMPLIANCE.......................................................................... 6
4. SAFETY PRECAUTIONS................................................................................................ 6
5. SAFETY SYMBOLS AND INFORMATION...................................................................... 9
6. Guidance for Electromagnetic compatibility(EMC)……………………………….. 12
• TERMS OF EACH PART AND FUNCTIONS....................................................................... 16
1. FRONT PART.................................................................................................................. 16
2. REAR PART................................................................................................................… 18
3. ACCESSORIES.............................................................................................................. 20
4. OPTIONS....................................................................................................................... 20
• INSTALLATION................................................................................................................... 21
1. CONNECTING ADAPTER............................................................................................. 21
2. LOADING THE PRINT PAPER.................................................................................... 21
3. CONNECTING PORTS.................................................................................................. 23
4. CONNECTING PRINTER............................................................................................... 23
5. CONNECTING PEDAL SWITCH................................................................................... 24
6. CONNECTING HAND SWITCH..................................................................................... 24
• SYSTEM SETUP................................................................................................................ 25
1. Entering SYSTEM SETUP............................................................................................. 25
2. Menu.............................................................................................................................. 25
3. Entering ‘MENU’ view.................................................................................................... 25
4. How to escape from SYSTEM SETUP.......................................................................... 25
5. How to move into SYSTEM SETUP.............................................................................. 25
6. SETUP......................................................................................................................... 26
• MEASUREMENT................................................................................................................ 30
1. CAUTIONS FOR MEASUREMENT............................................................................... 30
2. MEASUREMENT........................................................................................................... 31
3. RESULT SHEET…………………………….................................................................... 34
4. The measuring method if ID is on.................................................................................. 35
5. The measuring method by using ‘Three measurement MODE’..................................... 37
• MAINTENANCE.................................................................................................................. 39
• ERROR & REPAIR.............................................................................................................. 40
• AFTER SERVICE................................................................................................................ 41
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1. AFTER SERVICE.......................................................................................................... 41
2. PACKING AND TRANSPORT....................................................................................... 41
• SPECIFICATION................................................................................................................. 42
• WARRANTY........................................................................................................................ 43
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INTRODUCTION
1. INDICATIONS
The ACCUNIQ BP850 Non-Invasive Blood Pressure Monitor should not be used with patients
who have the following conditions:
1. Patients with a known arrhythmia.
2. Patients with insufficient peripheral circulation, acute cases of low blood pressure or low
temperature.
3. Patients who use a pacemaker.
4. Patients experiencing a seizure.
5. Children younger than 18 years old.
6. Patients who should not have blood pressure measurements taken from their arms.
7. Patients with an artificial heart.
8. Patients whose artery cannot be found by palpation.
2. WORD DEFINITIONS
To ensure safe operation and long term performance stability, it is essential that you fully
understand the functions, operating and maintenance instructions by reading this manual
before operating your unit.
Particular attention must be paid to all warnings, cautions and notes incorporated herein.
The following conventions are used throughout the manual to denote information of special
emphasis.
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3. CLASSIFICATION AND COMPLIANCE
1) This device is classified as;
- Class 1 type-BF against electric shock
- Ordinary equipment without protection against ingress of water
- Equipment not suitable for use in presence of a flammable anesthetic mixture by standard of
EN 60601-1:2006(Safety of Medical Electrical Equipment)
2) This device is complied with Class A for Noise-Emission, Level B for Noise-immunity, by
standard of IEC 60601-1-2:2007(Electromagnetic Compatibility Requirements).
3) This device is complies with the EN 1060-1: 1995+A2:2009 Non-invasive
Sphygmomanometers general requirements as well as EN 1060-3: 1997+A2:2009
supplementary requirements for electro-mechanical blood pressure measuring systems.
4. SAFETY PRECAUTIONS
This device is designed and manufactured with consideration of safety of the operator and
subject and also to the reliability of the unit.
The following precautions must be observed for additional safety;
This device is designed and manufactured with consideration of safety of the operator and
subject and also to the reliability of the unit.
The following precautions must be observed for additional safety;
1) The unit must be operated only by, or under supervision of a qualified person with our
company or our distributors.
2) This device is specified as Class 1 type BF unit under the standard of EN 60601-
1:2006 (Safety of Medical Electrical Equipment).
Therefore, patients must not touch or handle inner side of the system at any time.
3) Do not modify the unit. If any modification is needed, ask our company or its authorized
dealer for service.
4) The unit has previously been adjusted in the factory for optimum performance.
Do not attempt to adjust switches or any other things except those specified in this
manual for operation.
5) If you have experienced any trouble with the unit, switch it off immediately, and contact
our company or its authorized dealer for assistance.
6) If you plan to connect any device of other manufacturers electrically or mechanically to
the unit, contact our company or its authorized dealer for instructions before doing so.
When you connect computer or other system to the unit (RS-232C), the attached
systems should be those certified by IEC 950 or equivalent standards for data
processing equipment.
Configurations shall comply with the system standard EN 60601-1:2006.
Everybody who connects additional equipment to the signal input part or signal output
part configures a medical system standard EN 60601-1:2006.
If in doubt, consult the A/S department of local distributor.
7) Avoid the following environments for storage;
- Where the ambient temperature falls -20°C or exceeds 60°C.
- Where the atmospheric pressure falls below 70kPa (700mbar) or exceeds 106kPa
(1060mbar).
- Where the humidity is over 95% non-condensing.
- Where the unit is exposed to spray or splashing water.
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- Where the unit is exposed to dust.
- Where the unit is exposed to water vapor.
- Where the unit is exposed to salty atmosphere.
- Where the unit is exposed to explosive gas.
- Where the unit is exposed to excessive shocks or vibrations.
- Where the angle of inclination of mounting surface exceeds 10 degrees.
- Where the unit is exposed to direct sunlight.
8) This equipment has been tested and found to comply with the limits for medical devices
to the IEC 60601-1-2:2007. These limits are designed to provide reasonable protection
against harmful interference in a typical medical installation. This equipment
generates uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to other devices in
the vicinity. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to other
devices, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
- Consult the manufacturer or field service technician for help.
9) Do not to touch signal input, signal output or other connectors, and the patient
simultaneously.
10) a statement that MEDICAL ELECTRICAL EQUIPMENT needs special precautions
regarding EMC and needs to be installed and put into service according to the EMC
information provided in the ACCOMPANYING DOCUMENTS;
11) a statement that portable and mobile RF communications equipment can affect
MEDICAL ELECTRICAL EQUIPMENT.
12) Please consult a physician or a trained health professional for interpretation of
measurement results.
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This manual is made for informational purpose and this manual and product
Caution are not meant to be a substitute for the advice provided by your own
physician or other medical problem. You should not use the information
contained in the product for diagnosis or treatment of health problem or
prescription of medication by yourself.
If you have or suspect that you have a medical problem, consult with your
physician promptly.
Defective unit or accessories must be packed in the replacement cartons to
be shipped off from you to our company.
Shipping and insurance costs for return of defective unit must be prepaid by
the users.
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5. SAFETY SYMBOLS AND INFORMATION
The International Electrotechnical Commission (IEC) has established a set of symbols for
medical electrical equipment which classifies a connection or warning of any potential hazard.
The classifications and symbols are shown below. Save these instructions for your safety.
Caution
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Do not open. This is for factory only.
Alternating current
Direct current
Date of manufacture
Manufacturer
Non-ionizing radiation
CE mark
Serial No.
Keep dry
RoHS2
Foot switch
Start or stop the measurement.
And, when your arm is oppressed due to high pressurizing or
irregular operation is done, press this button then the cuff will be
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exhausted rapidly.
Hand-held switch
Start or stop the measurement.
And, when your arm is oppressed due to high pressurizing or
irregular operation is done, press this button then the cuff will be
exhausted rapidly.
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6. Guidance for Electromagnetic compatibility (EMC)
Details about the electromagnetic compatibility (EMC) of the ACCUNIQ BP850 are given below.
Before using the ACCUNIQ BP850, be sure to read and understand the following information.
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mode
<5 % UT
<5 % UT (>95 % dip in
(>95 % dip in UT) UT) Mains power quality should be that
for 0,5 cycle for 0,5 cycle of a typical commercial or hospital
Voltage drops, 40 % UT 40 % UT environment. If the user of the
dips, and (60 % dip in UT) (60 % dip in UT) ACCUNIQ BP850 requires
fluctuations of for 5 cycles for 5 cycles continued operation during power
input power 70 % UT 70 % UT mains interruptions, it is
supply line IEC (30 % dip in UT) (30 % dip in UT) recommended that the ACCUNIQ
61000-4-11 for 25 cycles for 25 cycles BP850 be powered from an
<5 % UT <5 % UT uninterruptible power supply or a
(>95 % dip in UT) (>95 % dip in battery.
for 5 sec UT)
for 5 sec
Magnetic field of
Power frequency magnetic fields
commercial
should be at levels characteristic of
frequency 3 A/m 3 A/m
a typical location in a typical
(50/60Hz)
commercial or hospital environment.
IEC 61000-4-8
Note
UT is the a.c. mains voltage prior to application of the test level.
d =1.2
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d =1.2 80 MHz to 900 MHz
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4) Recommended separation distances between portable and mobile RF communications
equipment and the ACCUNIQ BP850
The ACCUNIQ BP850 is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the ACCUNIQ BP850 can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the ACCUNIQ BP850 as
recommended below, according to the maximum output power of the communications
equipment.
Rated maximum Separation distance according to frequency of transmitter
output power m
of transmitter 150 kHz to 80 MHz 80 MHz to 900 MHz 900 MHz to 2,5 GHz
W
d =1.2 d =1.2 d =1.2
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 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.
Caution 1. At 80 MHz and 900 MHz, the separation distance for the higher frequency
range applies.
2. These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people.
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TERMS OF EACH PART AND FUNCTIONS
1. FRONT PART
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FRONT PART
⑦ ARM REST
③ CLOCK SECTION
② LCD DISPLAY
⑧ ARM SENSOR
⑥ CUFF
④ PRINTER COVER
⑨ EMERGENCY
STOP BUTTON
⑤ AUTOMATIC CUTTER
① START/STOP BUTTON
⑪ HAND SWITCH
⑩ HAND SWITCH REST ⑫ PEDAL SWITCH
The side part of cart The under part of cart
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2. REAR PART
① POWER
It turns the power on and off.
② POWER INPUT
It connects the adapter.
③ R-CAL
It is only for the inspection. Do not open it.
④ L -CAL
It is only for the inspection. Do not open it.
⑤ EARTH (POTENTIAL EQUALIZATION TERMINAL)
For safety, the device should be placed on the flat surface.
⑥ COMMUNICATION PORTS (RS-232C)
It connects the main to other equipments with cable (RS-232C) to transfer the data.
⑦ USB PORT (A TYPE)
It connects the main body with USB cable (A type).
⑧ USB PORT (B TYPE)
It connects the main body with USB cable (B type).
⑨ PEDAL BUTTON PORT
It connects the PEDAL switch.
⑩ HAND BUTTON PORT
It connects the HAND switch.
⑪ INFORMATION BOARD FIXER
It fixes the Information Board.
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REAR PART
⑪ INFORMATION
BOARD FIXER
⑧ USB PORT
(A TYPE)
⑩ HAND BUTTON
PORT
③ R-CAL ⑤ EARTH
① POWER ⑨ PEDAL BUTTON
④ L-CAL
PORT
⑦ USB PORT
② POWER INPUT (B TYPE)
⑥ COMMUNICATION
PORT
Note
The operator should not touch both USB port and the patient’s body
simultaneously.
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3. ACCESSORIES
Adapter/Power cable User guide
4. OPTIONS
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INSTALLATION
1. CONNECTING ADAPTER
Connect the adaptor to the power input on the back of the device.
Turn on the POWER switch.
Caution
In order to avoid the risk of electrical shock, connect this device only to the
power supply equipped with the protective grounding.
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2. LOADING THE PRINT PAPER
① Pull the Top button up. Then press the Side button. Open the upper printer cover.
② Put the roller into the center hole of the thermal paper.
③ Insert the thermal paper with the roller into the holder as shown in the picture.
④ Take the edge of the paper out.
⑤ Close the cover.
⑥ It automatically cuts the paper.
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3. CONNECTING COMMUNICATION PORT
To transmit the data, connect ACCUNIQ BP850 to a computer or other external devices.
Insert USB cable to the communication port and connect it to the computer as shown in the
picture below.
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5. CONNECTING PEDAL SWITCH
Connect the PEDAL SWITCH as shown in the picture.
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SYSTEM SETUP
2. Menu
1. DATE TYPE
2. DATE/TIME
3. VOLUME
4. PRINT
5. MEASUREMENT MODE
6. Automatic return to initialized screen
7. LOGO
8. PERSONAL DATA INPUT
9. VOICE
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6. Setup
<DATE TYPE>
Set the Date Format.
- Pre-set: YY-MM-DD (Year-Month-Day)
- Select ‘Date type’.
- Press ‘SET’ to save the change.
- Press ‘CLOSE’ and get back to SYSTEM SETUP
menu.
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<THERMAL PRINT>
Choose the print option and set the result sheet form.
- Pre-set: ON
- Select ‘THERMAL PRINT’ and enter the menu.
- ON: Result sheet is printed after the measurement.
OFF: Result sheet is not printed after the measurement.
- Press ‘RESULT SHEET FORM’ and enter the menu.
- Select the print form and press ‘SET’ button.
- Press ‘CLOSE’ to get back to ‘THERMAL PRINT’ menu.
- Press ‘CLOSE’ to get back to SYSTEM SETUP menu.
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< PERSONAL DATA INPUT >
It allows the user to input personal data.
- Select ‘PERSONAL DATA INPUT’ and enter the menu.
- Select either ‘ON’ or ‘OFF’ for ID.
- Select either ‘ON’ or ‘OFF’ for HEIGHT/WEIGHT INPUT.
- Press ‘SET’ to save the change.
- Press ‘CLOSE’ to get back to SYSTEM SETUP menu.
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< PRINT POSITION >
It adjusts the printing position in the direction of U-D (up-
down) and L-R (left-right) to fit to the pre-formatted result
sheet.
- Select ‘PRINT POSITION’ and enter the menu.
- Pre-set: 00 for U-D and 00 for L-R
- Range: 99 for U-D and 99 for L-R
- Choose U-D by pressing ‘▼, ▲’ on touch pad. Choose L-
R by pressing ‘▶, ◀’ on touch pad.
Note
L-R (left-right): - is moving to the left and + is moving to the right.
U-D (up-down): - is moving up and + is moving down.
<RESULT VIEW>
It sets the result screen type.
- Pre-set : GENERAL TYPE
- Select ‘RESULT VIEW’ and enter the menu.
- Select the result type.
* GENERAL TYPE: Basal type.
* DIAGRAM TYPE: The Blood pressure displayed by gage.
- Press ‘SET’ button on touch pad to save it.
- Press ‘CLOSE’ to get back to SYSTEM SETUP menu.
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MEASUREMENT
⑥ When you roll up the sleeves, make sure that the rolled up sleeves are not pressing the
upper arms.
⑦ When the pulse is running too week and hard to be heard from stethoscope, ACCUNIQ
BP850 can not make a measurement.
⑧ During the measurement, straighten your back and relax your arm.
Caution
This device is only for adult.
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2. MEASUREMENT
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⑤ Pressurization starts automatically from the cuff and
LCD indicates the current status.
Note
When the difference between the two arms is more than 20mmHg for systolic
blood pressure or 10mmHg for diastolic blood pressure, the difference is
indicated in red.
Note
At the system setup, there’s PRINT ON/OFF. If the print is off, the result sheet
is not printed out.
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⑩ When you want to measure one more time, press button.
The whole procedure restarts again.
Note
For measuring right arm, put right arm into the cuff on the right side.
For measuring left arm, put left arm into the cuff on the left side.
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⑤ When the measurement is completed, LCD screen
displays the results.
At the same time, voice guidance speaks out,
“Measurement completed, pull your arm out please.
Thank you.”
The cuff deflates and turns to the initial state.
3. Result sheet
▼ Result sheet format (both arms) ▼ Result sheet format (one arm)
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▼Classification of the blood pressure
: National High Blood Pressure Education Program, National Heart, Lung and Blood institute,
NIH (JNC7, 2003)
① Input data
ID: On the initial display, press ‘ID’.
Enter ID using the number buttons.
- ID Input Range is from 000000001 to 999999999.
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② Measurement
After entering the personal data, press ‘START’.
Pressurization starts automatically from the cuff and
LCD indicates the current status.
③ Result
When the measurement is completed, the user’s ID,
weight, height, Body Mass Index (B.M.I) and fatness are
displayed as shown in the picture.
*EAST ASIA
thin normal overweight obese
section 2 2 2 2
<18.5kg/m 18.5~<23.0kg/m 23.0~<25.0kg/m 25.0kg/m and over
* EU and etc.
thin normal overweight obese
section
<18.5kg/m 2 18.5~<25.0kg/m 2 25.0~<30.0kg/m 2 30.0kg/m 2 and over
• Fatness: Based on the standard weight, it calculates how fat the user is in percentage.
[{(current weight-standard weight)/standard weight}X100]+100
2
standard weight=height(m) X22
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5. The measuring method by ‘THREE MEASUREMENT MODE’.
It measures blood pressure 3 times in a row. The average blood pressure from the three
measurements indicates the more accurate data.
It is possible to measure either one arm or both arms.
System setup -> Measurement Mode ->Three measurement mode
You can set the measuring interval. (15sec, 30sec, 45sec, 60sec)
① Measurement
Put both arms or one arm to the cuff and press ‘START’ button.
Pressurization starts automatically from the cuff and LCD indicates the current status.
When the first measurement is completed, device stops until the interval time the user sets.
When the second measurement is completed, device stops until the interval time the user
sets.
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② Result
After the third measurements, the average blood pressure is indicates as follows.
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MAINTENANCE
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ERROR & REPAIR
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AFTER SERVICE
1. AFTER SERVICE
If there is any problem with the unit, please follow the steps below;
※ Contact our company’s Overseas Service Department immediately.
After gathering the model name, Serial Number, date of purchase and description of the
problem, contact our company with information shown below.
※ Try to solve the problem over the phone with the personnel of local service department.
If the problem cannot be solved over the phone, just return to service department directly.
※ Our company or local distributor will make available on-request circuit diagrams, component
part list, descriptions, calibration or other information which will assist your appropriately
qualified technical personnel to repair those parts of unit which are designated by our
company as repairable.
※ Calibration interval for this device is 2 years.
To ensure the device’s proper and sage operation, please contact our company or distributor
periodically for calibration.
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SPECIFICATION
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WARRANTY
WARRANTY
Item Automatic Blood Pressure Monitor Warranty period
Model ACCUNIQ BP850
1year (main unit only)
Serial NO.
Note - When you receive this warranty, make sure that the name of the dealer and
the month, day and year of purchase are all completed.
- This warranty will not be reissued, please keep it in a safe place.
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Periodic Check List
Management No.
Management No.