Accuniq BP250 User manual

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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, Shinseong-ro, Yuseong-gu, Daejeon, 34109 Republic of Korea
TEL: [phone], FAX: [phone]
VITAKO Sp. z o.o.
ul. Stanisława Żaryna 7c 02-593 Warszawa, POLAND
TEL: [phone]

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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..............................................
15
1. FRONT PART.................................................................................................
15
2. PRINTER........................................................................................................
17
3. REAR PART....................................................................................................
18
4. ACCESSORIES..............................................................................................
20
5. OPTIONS.......................................................................................................
20
• INSTALLATION................................................................................................
21
1. CONNECTING ADAPTER.............................................................................
21
2. LOADING THE PRINT PAPER......................................................................
21
3. CONNECTING PORTS..................................................................................
22
4. SETTING TIME AND DATE...........................................................................
23
• 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.............................................................................................
29
1. CAUTIONS FOR MEASUREMENT...............................................................
29
2. MEASUREMENT............................................................................................
30
3. DATA ON MEASUREMENT BY PRINTER.....................................................
33
•OPTION.............................................................................................................
35
• MAINTENANCE...............................................................................................
45
• ERROR&REPAIR.............................................................................................
47
• AFTER SERVICE.............................................................................................
48
1. AFTER SERVICE..........................................................................................
48
2. PACKING AND TRANSPORT........................................................................
48
• SPECIFICATION..............................................................................................
49
• WARRANTY.....................................................................................................
50
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 BP250 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 BP250 (Left type) measure the Left arm.
ACCUNIQ BP250 (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 EN
60601-1: 2006(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 60601-1-2:2007(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;
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(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.
Everybody who connects additional equipment to the signal input part or signal output part configures
a medical system standard IEC 60601-1:2005.
If in doubt, consult the A/S department of local distributor.
7) Avoid the following environments for storage;

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- 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
60601-1-2:2007. 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.
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
RoHS2

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6. Guidance for Electromagnetic compatibility (EMC)
Details about the electromagnetic compatibility (EMC) of the ACCUNIQ BP250 are given below. Before
using the ACCUNIQ BP250, be sure to read and understand the following information.
1) Guidance and manufacturer’s declaration – electromagnetic emissions
The ACCUNIQ BP250 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ACCUNIQ BP250 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
Group 1
The ACCUNIQ BP250 uses RF energy only for its
internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class B
The ACCUNIQ BP250 is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Compliance
2) Guidance and manufacturer’s declaration –electromagnetic immunity
The ACCUNIQ BP250 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ACCUNIQ BP250 should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment-
guidance
Electrostatic
discharge(ESD)
IEC 61000-4-2
±6kV: Contact
±8kV: Air
±6kV: Contact
±8kV: Air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30 %.
Electrical fast
transition/burst
IEC 61000-4-4
±2kV: Power
supply lines
±1kV:
Input/output lines
±2kV: Power
supply lines
±1kV:
Input/output
Mains power quality should be that of
a typical commercial or hospital
environment.