SELVAS Healthcare ACCUNIQ BP210 User manual

The device bears the CE label in accordance with the provisions of Medical Device Directive 93/42/EEC.
THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE EC MARKET UNDER MDD 93/42/EEC
SELVAS Healthcare, Inc.
155, Sinseong-ro, Yuseong-gu, Daejeon, 34109 Republic of Korea
TEL: [phone], FAX: [phone]
Obelis s.a.
Bd. Général Wahis, 53, B-1030, Brussels, Belgium
Any serious incident that has occurred in relation to the device should be reported to the manufacturer
and the competent authority of the Member State in which the user and/or patient is established.

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•INTRODUCTION.............................................................................................
4
1. IINTENDED USE...........................................................................................
4
2. WORD DEFINITIONS....................................................................................
4
3. CLASSIFICATION AND COMPLIANCE........................................................
5
4. SAFETY PRECAUTIONS..............................................................................
5
5. SAFETY SYMBOLS AND INFORMATION.....................................................
8
6. Guidance for Electromagnetic compatibility (EMC) .......................................
10
• TERMS OF EACH PART AND FUNCTIONS..............................................
11
1. FRONT PART.................................................................................................
11
2. PRINTER........................................................................................................
13
3. REAR PART....................................................................................................
14
4. ACCESSORIES..............................................................................................
16
5. OPTIONS.......................................................................................................
16
• INSTALLATION................................................................................................
17
1. CONNECTING ADAPTER.............................................................................
17
2. LOADING THE PRINT PAPER......................................................................
17
3. CONNECTING PORTS (RS-232C)................................................................
18
4. SETTING TIME AND DATE...........................................................................
19
• MEASUREMENT.............................................................................................
21
1. CAUTIONS FOR MEASUREMENT...............................................................
21
2. MEASUREMENT............................................................................................
22
3. DATA ON MEASUREMENT BY PRINTER.....................................................
25
4. HOW TO SET PRINTER PAPER...................................................................
26
•OPTION.............................................................................................................
29
• MAINTENANCE...............................................................................................
37
• ERROR&REPAIR.............................................................................................
39
• AFTER SERVICE.............................................................................................
40
1. AFTER SERVICE..........................................................................................
40
2. PACKING AND TRANSPORT........................................................................
40
• SPECIFICATION..............................................................................................
41
• WARRANTY.....................................................................................................
42
TABLE OF CONTENTS

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We highly appreciate that you chose our company’s product.
You are kindly requested to be familiar with these directions before using this product and always keep it
together with the product. In case you are not sure about any directions or problems arising while using
the product, please contact our service center.
We will provide you with detailed instructions.
1. INTEDED USE
ACCUNIQ BP210 Automatic Blood Pressure Monitor is designed to measure systolic and diastolic blood
pressure and pulse rate of Persons who are 18 years and older using the oscillometric method on a
cuffed arm.
ACCUNIQ BP210 (Left type) measure the Left arm.
ACCUNIQ BP210 (Right type) measure the Right arm.
•Target user: Persons who are 18 years and older
•This medical device is not for home use
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.
Warning
Important information to indicate any possible hazard which can cause severe
personal injury of death from substantial property damage when ignored.
Caution
Important information to indicate any possible hazard which will or can cause minor
personal injury or property damage when ignored.
Note
Important information to notify to the user about installation, operation, or
maintenance information which is important but not hazardous. Warnings against
hazard are not to be included under the NOTE signal word.
INTRODUCTION

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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 IEC
60601-1:2005/A1:2012(Basic safety and essential performance of Medical Electrical Equipment)
2) This device is complied with Class A for Noise-Emission, Level B for Noise-immunity, by standard of
IEC 60601-1-2:2014(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;
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 IEC 60601-
1:2005/A1:2012(Safety of Medical Electrical Equipment).
Do not touch or handle inner side of the system at any time.
The INTERNAL ELECTRICAL POWER SOURCE is to be used if the integrity of the PROTECTIVE
EARTH CONDUCTOR or the protective earthing system in the installation is in doubt.
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 60950 or equivalent standards for data processing equipment.
Configurations shall comply with the system standard IEC 60601-1:2005/A1:2012.
Everybody who connects additional equipment to the signal input part or signal output part configures
a medical system standard IEC 60601-1:2005/A1:2012.
If in doubt, consult the A/S department of local distributor.

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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.
- 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
60601-1-2:2014. 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.
13) No phthalates are used for this product and its container.
14) The cuff is not made with natural rubber latex

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Caution
1. Measurements may be impaired if this device is used near televisions, microwave
ovens, X-ray equipment or other devices with strong electrical fields. To prevent
such interference, use the meter at a sufficient distance from such devices or turn
them off.
2. Incorrect operation or failure of user to maintain the unit spares the manufacturer
or his agent of the responsibility for system’s non-compliance with specifications or
responsibility for any damage or injury.
Caution
This manual is made for informational purpose and this manual and product 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.
Degree of protection against electric shock: TYPE BF
Please observe operating instructions
General warning sign
General prohibition sign
General mandatory action sign
Caution
Waste Electrical and Electronic Equipment (WEEE)
The device could be sent back to the manufacturer for recycling or
proper disposal after their useful lives. Alternatively the device shall be
disposed in accordance with national laws after their useful lives.
"OFF" (only for a part of equipment)
"ON" (only for a part of equipment)

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This symbol is used inside system.
Identifies the point where the safety ground of the system is fastened to
the chassis.
Do not open. This is for factory only.
Alternating current
Direct current
Date of manufacture
Manufacturer
Non-ionizing radiation
CE mark
Serial No.
Authorized representative in the European community.
Keep dry
This way up
Fragile

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Use no hooks
RoHS2
6. Guidance for Electromagnetic compatibility (EMC)
Details about the electromagnetic compatibility (EMC) of the ACCUNIQ BP210 are given below. Before
using the ACCUNIQ BP210, be sure to read and understand the following information.
1) Guidance and manufacturer’s declaration – electromagnetic emissions
The ACCUNIQ BP210 is intended for use in the electromagnetic environment specified IEC
60601-1-2:2014 (Fourth Edition).
2) Guidance and manufacturer’s declaration – electromagnetic immunity
The ACCUNIQ BP210 is intended for use in the electromagnetic environment specified IEC
60601-1-2:2014 (Fourth Edition).
3) Guidance and manufacturer’s declaration – electromagnetic immunity 2
The ACCUNIQ BP210 is intended for use in the electromagnetic environment specified IEC
60601-1-2:2014 (Fourth Edition).
4) Recommended separation distances between portable and mobile RF communications
equipment and the ACCUNIQ BP210
The ACCUNIQ BP210 is intended for use in the electromagnetic environment specified IEC
60601-1-2:2014 (Fourth Edition).

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1. FRONT PART
①START BUTTON
Press START button after being ready to measure, the cuff will be wrapped automatically and begins to
pressurize.
②STOP BUTTON
Press STOP button if you want to stop it during measurement. Pressurizing will stop and the air will
exhaust from the cuff.
③SYSTOLIC DISPLAY
It indicates systolic blood pressure values.
④DIASTOLIC DISPLAY
It indicates diastolic blood pressure values.
⑤PULSE DISPLAY
It indicates pulse rate.
⑥TIMER
It indicates time.
⑦EMERGENCY STOP BUTTON
When your arm is oppressed due to high pressurizing or irregular operation is done, press this button
then the cuff will be exhausted rapidly.
⑧PRINTER COVER
It protects the printer.
⑨AUTOMATIC CUTTER (printing paper let-out slot)
Printing paper is automatically cut off when it comes out through the slot.
⑩CUFF
It wraps and releases the arm automatically for measurement.
⑪ARM REST
When the arm is placed on the cuff, the arm supporter sustains the arm and makes the right position.
⑫HUMAN SENSOR(option)
When a user approaches, power is automatically turned on and vice versa.
⑬RFID CARD-READER(option)
When RFID card is applied, it reads information in it and stores the measured results.
⑭MAGNETIC CARD-READER(option)
When magnetic card is swiped, it reads information in it and stores the measured results.
TERMS OF EACH PART AND FUNCTIONS

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Note
The cuff and the buttons (START and STOP button) of this device are located at
reverse side by R and L type.
FRONT PART
Note
Printer, card reader and human sensor are optional.
ID card can be issued either by the machine manager or by the manufacturer of the
model.
The card stores six previous measured results and can contain seven measured
results with the current one altogether.
When the model manager writes the card, please refer to the manual and
specifications for operation and programs attached to the card writing device at
purchase.
⑩CUFF
⑨PAPER OUTPUT
⑧PRINTER COVER
⑦EMERGENCY
STOP BUTTON
⑭MAGNETIC CARD-READER
⑪ARM REST
②STOP BUTTON
①START BUTTON
⑫HUMAN SENSOR
③SYSTOLIC DISPLAY
⑥TIMER
④DIASTOLIC DISPLAY
⑤PULSE DISPLAY
⑬RFID CARD-READER

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2. PRINTER
①PRINT button
- Use it when you print out the data.
- If you set [ON] at the rear (PRINT ON/OFF switch), the data is printed automatically even when you do
not press PRINT button.
- Normally, when you press this button, one previous data will be printed. (If you turn it off, all memorized
data would be deleted.)
- When you set the date and time, the number goes up with this button pressed.
②FEED button
- Use this button for setting the paper.
- When you set the date and time, the number goes down with this button pressed.
③SET button
- Set the date and time.
- The functions are as follows when pressing this before or after measurement.
(It does not work during measurement)
- Sequence is HOUR →MIN. →MON. →DAY →YEAR
- If you do not press PRINT or FEED button within 5seconds, setting of the date and time finished.
- See the page ‘15’ for detailed method.

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3. REAR PART
①POWER
It is used to turn the power on and off.
②POWER INPUT
It is used to connect with the adapter.
③CAL
This is only for inspection. Never open it.
④EARTH (POTENTIAL EQUALIZATION TERMINAL)
Please make sure for safety.
⑤COMMUNICATION PORTS (RS-232C)
Connect between the main body and a computer or other equipment with cable (RS-232C) to transfer
the data collected or measured. Or connect between the main body and the coin slot with RS-232C
cable to transfer the data.
⑥BACK MONITOR PORT(option)
Connect the main body to the reverse monitor cable.
⑦USB PORT
Connect the main body and USB cable.
⑧SENSOR ON/OFF
Human sensor is switched on and off.
⑨SOUND ON/OFF
Music and voice output functions are activated with the switch [ON], and vice versa.
⑩CARD ON/OFF
Card is usable when the switch [ON], and vice versa.
⑪PRINT ON/OFF
Measured results are printed out when switched [ON], and vice versa.
⑫VOLUME (ANNOUNCE ON/OFF)
It controls volume output when switch is on while all volume is [OFF].
⑬REVERSE MONITOR(optional)
You can see the ID No, B.M.I., and Fatness as well as Blood Pressure on the reverse monitor.
⑭INFORMATION BOARD FIXER
Fix the information board here.

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Note
1. While sound switch is activated on (so sound is functioning), place the VOLUME
ON/OFF switch to [OFF] for deactivation of voice message and music play.
2. Printer, card reader, human sensor and reverse monitor is optional.
3. The operator should not touch both USB port and the patient’s body
simultaneously.
Note
The operator shall not contact the parts (SIP/SOP) and the patient simultaneously and
“SIP/SOP shall be available to operator only”
REAR PART
⑩CARD ON/OFF
⑧SENSOR ON/OFF
⑤COMMUNICATION
PORTS
④EARTH
⑫VOLUME
⑨SOUND ON/OFF
②POWER INPUT
⑪PRINT ON/OFF
③CAL
⑬REVERSE
MONITOR
①POWER
⑦USB PORT
⑥BACK MONITOR
PORT
⑭INFORMATION
BOARD FIXER

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4. ACCESSORIES
5. OPTIONS
Cart / Chair
RFID Card/Magnetic Card
Thermal paper / Printer
Human sensor
Reverse monitor
Adapter/Power cable
Guide
Reverse monitor support/cable
User guide

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1. CONNECTION ADAPTER
Just connect the power cable to the adapter on the rear and turn the POWER ON/OFF switch on the
lower part of the rear (See the picture).
Caution
In order to avoid the risk of electrical shock, connect this device only to the power
supply equipped with the protective grounding.
Caution
When connecting adaptor, place the arrow mark of adaptor connection
part up and correctly stick it in the socket on the rear of the main body.
Wrong connection could be a fire hazard.
2. LOADING THE PRINT PAPER
①Check and see if power is turned on.
②Turn the nut (with a driver on the groove in the middle) on the lower printer cover clockwise to 90
degrees and open the cover.
③Load the print paper as shown in the picture.
④Insert the paper edge deep under the black roll, then it comes out above the CUTTER.
⑤Balance the paper in the right place.
⑥Cut the paper by pressing the FEED button.
⑦Close the cover and turn the nut counterclockwise back.
INSTALLATION

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Note
Being thermal type, printing is photocopied on one side of the paper (slippery side),
without using printing ink.
Please check remainder of the paper always and then replace it.
Please use exclusive paper (58mm).
Keep paper rolls in a dark and ventilated place.
Avoid any dust on the paper.
Do not pull the paper during printing. It could cause jam.
When printing paper is not loaded in correct place, it may cause the malfunction of the
printer or paper will be shoved out.
After the exchange of paper to the printer cover does not close properly, the alarm
sounds, LED on the 'Err' is displayed. Please check the status of the printer cover.
3. CONNECTING PORT (RS-232C)
To transmit the data, connect a computer or other external options to the unit.
Connect the RS-232C cable both to port of the unit and to the computer jack or other external options.
(See the picture)

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4. SETTING TIME AND DATE
•Turn on the unit.
•Open the printer cover.
•Sequence is HOUR →MINUTE →MONTH →DAY →YEAR
YEAR
①After setting the day, press SET button again.
②First 2 figures will blink.
③Set the current year with PRINT and FEED button.
HOUR
①Press SET button, then indicator will blink. At that time,
press PRINT button. Its counts that have been measured
since keeping button ON will be printed.
②Press SET button once again. First 2 figures will blink.
③To set the current hour, press PRINT button to make the
number goes up or press FEED button to make the number
goes down.
MINUTE
①After setting the hour, press the SET button again.
②In this time, last 2 figures will blink.
③As the same way as above, set the current minute with
PRINT and FEED button.
MONTH
①After setting the minute, press SET button again.
②First 2 figures will blink.
③Set the current month with PRINT and FEED button.
DAY
①After setting the month, press SET button again.
②Last 2 figures will blink.
③Set the current day with PRINT and FEED button.

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Note
If you want to measure blood pressure during setting the date and time, press STOP
button. Then you can measure again immediately.
Note
You should set all data at once (hour, minute, month, day and year).
In case of stopping setting, the values return to previous ones which you have done
before.
The calendar and time functions work without plugging power cord in.
Calendar program is inputted for 100 years, and it would be adjusted automatically
even at a leap year.